Gammagard S/d
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Questions & Answers
Side Effects & Adverse Reactions
Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death.18 Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.*
See PRECAUTIONS and DOSAGE AND ADMINISTRATION sections for important information intended to reduce the risk of acute renal failure.
*GAMMAGARD S/D does not contain sucrose.
GAMMAGARD S/D, Immune Globulin Intravenous (Human) is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses (see DESCRIPTION). Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation at 1-800-423-2862 (in the U.S.). The physician should discuss the risks and benefits of this product with the patient.
GAMMAGARD S/D, Immune Globulin Intravenous (Human), should only be administered intravenously. Other routes of administration have not been evaluated.
Immediate anaphylactic and hypersensitivity reactions are a remote possibility. Epinephrine and antihistamines should be available for treatment of any acute anaphylactoid reactions.
GAMMAGARD S/D, IgA < 1 μg/mL, contains trace amounts of IgA (less than 1 μg/mL in a 5% solution). GAMMAGARD S/D is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern. It should be given with caution to patients with antibodies to IgA or IgA deficiencies, that are a component of an underlying primary immunodeficiency disease for which IGIV therapy is indicated.7,19 GAMMAGARD S/D, IgA < 1 μg/mL, has an IgA concentration less than 1 μg/mL. GAMMAGARD S/D has an IgA concentration less than or equal to 2.2 μg/mL. IGIV preparations depleted of IgA (0.4 to 2.9 μg/mL) were shown to be better tolerated by a limited number of patients 19,46,47 who reacted to IGIV preparations with higher IgA concentrations. However, the concentration of IgA that will not provoke a reaction is not known, and therefore all IGIV preparations carry the risk of inducing an anaphylactic reaction to IgA. In such instances, a risk of anaphylaxis may exist despite the fact that GAMMAGARD S/D, IgA < 1 μg/mL, contains trace amounts of IgA.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
GAMMAGARD S/D is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern (see WARNINGS).
GAMMAGARD S/D is indicated for the treatment of primary immunodeficient states, such as: congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.6,7 This indication was supported by a clinical trial of 17 patients with primary immunodeficiency who received a total of 341 infusions. GAMMAGARD S/D is especially useful when high levels or rapid elevation of circulating IgG are desired or when intramuscular injections are contraindicated (e.g., small muscle mass).
GAMMAGARD S/D is indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL). In a study of 81 patients, 41 of whom were treated with GAMMAGARD, Immune Globulin Intravenous (Human), bacterial infections were significantly reduced in the treatment group.8,9 In this study, the placebo group had approximately twice as many bacterial infections as the IGIV group. The median time to first bacterial infection for the IGIV group was greater than 365 days. By contrast, the time to first bacterial infection in the placebo group was 192 days. The number of viral and fungal infections, which were for the most part minor, was not statistically different between the two groups.
When a rapid rise in platelet count is needed to prevent and/or to control bleeding in a patient with Idiopathic Thrombocytopenic Purpura, the administration of GAMMAGARD S/D should be considered.
The efficacy of GAMMAGARD has been demonstrated in a clinical study involving 16 patients. Of these 16 patients, 13 had chronic ITP (11 adults, 2 children), and 3 patients had acute ITP (one adult, 2 children). All 16 patients (100%) demonstrated a clinically significant rise in platelet count to a level greater than 40,000/mm3 following the administration of GAMMAGARD. Ten of the 16 patients (62.5%) exhibited a significant rise to greater than 80,000 platelets/mm3. Of these 10 patients, 7 had chronic ITP (5 adults, 2 children), and 3 patients had acute ITP (one adult, 2 children).
The rise in platelet count to greater than 40,000/mm3 occurred after a single 1 g/kg infusion of GAMMAGARD in 8 patients with chronic ITP (6 adults, 2 children), and in 2 patients with acute ITP (one adult, one child). A similar response was observed after two 1 g/kg infusions in 3 adult patients with chronic ITP, and one child with acute ITP. The remaining 2 adult patients with chronic ITP received more than two 1 g/kg infusions before achieving a platelet count greater than 40,000/mm3. The rise in platelet count was generally rapid, occurring within 5 days. However, this rise was transient and not considered curative. Platelet count rises lasted 2 to 3 weeks, with a range of 12 days to 6 months. It should be noted that childhood ITP may resolve spontaneously without treatment.
GAMMAGARD S/D is indicated for the prevention of coronary artery aneurysms associated with Kawasaki syndrome. The percentage incidence of coronary artery aneurysm in patients with Kawasaki syndrome receiving GAMMAGARD either at a single dose of 1 g/kg (n=22) or at a dose of 400 mg/kg for four consecutive days (n=22), beginning within seven days of onset of fever, was 3/44 (6.8%). This was significantly different (p=0.008) from a comparable group of patients that received aspirin only in previous trials and of whom 42/185 (22.7%) experienced coronary artery aneurysms.10,11,12 All patients in the GAMMAGARD trial received concomitant aspirin therapy and none experienced hypersensitivity-type reactions (urticaria, bronchospasm or generalized anaphylaxis).13
Several studies have documented the efficacy of intravenous gammaglobulin in reducing the incidence of coronary artery abnormalities resulting from Kawasaki syndrome.10-12, 14-17
History
There is currently no drug history available for this drug.
Other Information
GAMMAGARD S/D, Immune Globulin Intravenous (Human) [IGIV], IgA less than 1 µg/mL in a 5% Solution (IgA < 1 µg/mL), is GAMMAGARD S/D, selected to have an IgA concentration of less than 1 µg/mL of IgA in a 5% solution. GAMMAGARD S/D, Immune Globulin Intravenous (Human) [IGIV] is a solvent/detergent treated, sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. The product is manufactured by the Cohn-Oncley cold ethanol fractionation process followed by ultrafiltration and ion exchange chromatography. Source material for fractionation may be obtained from another U.S. licensed manufacturer. The manufacturing process includes treatment with an organic solvent/detergent mixture,1,2 composed of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80.3 The GAMMAGARD S/D manufacturing process provides a significant viral reduction in in vitro studies.3 These studies, summarized in Table 1, demonstrate virus clearance during GAMMAGARD S/D manufacturing using human immunodeficiency virus; Type 1 (HIV-1); as a relevant virus and model for HIV-2; bovine viral diarrhea virus (BVD), a model virus for enveloped RNA viruses such as hepatitis C virus (HCV); pseudorabies virus (PRV), a generic model virus for enveloped DNA viruses such as hepatitis B virus (HBV); hepatitis A virus (HAV); and mice minute virus (MMV), a model for small non-enveloped DNA viruses such as human parvovirus B19 (B19V). These reductions are achieved through a partitioning and inactivation during cold ethanol fractionation and the solvent/detergent treatment.3
|
||||||
| Process Step Evaluated | Virus Clearance (log10) | |||||
| Enveloped Viruses | Non-Enveloped Viruses | |||||
| BVD | HIV-1 | PRV | HAV | MMV | ||
| Step 1 | Processing of Cryo-Poor Plasma to Fraction I+II+III Precipitate | 0.6* | 5.6 | 1.0* | 0.5* | NT† |
| Step 2-3 | Processing of Resuspended Suspension A Precipitate to Suspension B Cuno 70 Filtrate | 2.6 | >5.7 | >5.2 | >5.2 | >5.3 |
| Step 4 | Solvent/Detergent Treatment | >4.9 | >3.7 | >4.1 | NA‡ | NA |
| Cumulative Reduction of Virus (log10) | >7.5 | >15.0 | >9.3 | >5.2 | >5.3 | |
When reconstituted with the total volume of diluent (Sterile Water for Injection, USP) supplied, this preparation contains approximately 50 mg of protein per mL (5%), of which at least 90% is gamma globulin. The product, reconstituted to 5%, contains a physiological concentration of sodium chloride (approximately 8.5 mg/mL) and has a pH of 6.8 ± 0.4. Stabilizing agents and additional components are present in the following maximum amounts for a 5% solution: 3 mg/mL Albumin (Human), 22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol (PEG), 1 µg/mL tri-n-butyl phosphate, 1 µg/mL octoxynol 9, and 100 µg/mL polysorbate 80. The manufacturing process for GAMMAGARD S/D, isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. GAMMAGARD S/D contains all of the IgG antibody activities which are present in the donor population. On the average, the distribution of IgG subclasses present in this product is similar to that in normal plasma.3 GAMMAGARD S/D, IgA < 1 µg/mL, contains trace amounts of IgA (less than 1 µg/mL in a 5% solution) . IgM is also present in trace amounts. If it is necessary to prepare a 10% (100 mg/mL) solution for infusion, half the volume of diluent should be added, as described in DOSAGE AND ADMINISTRATION. In this case, the stabilizing agents and other components, including IgA, will be present at double the concentrations given for the 5% solution.
GAMMAGARD S/D, Immune Globulin Intravenous (Human) contains no preservative.
Sources
Gammagard S/d Manufacturers
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Baxter Healthcare Corporation
![Gammagard S/d (Human Immunoglobulin G) Kit [Baxter Healthcare Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gammagard S/d | Baxter Healthcare Corporation
Primary Immunodeficiency DiseasesFor patients with primary immunodeficiencies, monthly doses of approximately 300-600 mg/kg infused at 3 to 4 week intervals are commonly used.42,43 As there are significant differences in the half-life of IgG among patients with primary immunodeficiency, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response. The minimum serum concentration of IgG necessary for protection varies among patients and has not been established by controlled clinical trials.
B-cell Chronic Lymphocytic Leukemia (CLL)For patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell Chronic Lymphocytic Leukemia, a dose of 400 mg/kg every 3 to 4 weeks is recommended.
Kawasaki SyndromeFor patients with Kawasaki syndrome, either a single 1 g/kg dose or a dose of 400 mg/kg for four consecutive days beginning within seven days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day in four divided doses) is recommended.44
Idiopathic Thrombocytopenic Purpura (ITP)For patients with acute or chronic Idiopathic Thrombocytopenic Purpura, a dose of 1 g/kg is recommended. The need for additional doses can be determined by clinical response and platelet count. Up to three separate doses may be given on alternate days if required.
No prospective data are presently available to identify a maximum safe dose, concentration, and rate of infusion in patients determined to be at increased risk of acute renal failure. In the absence of prospective data, the recommended doses should not be exceeded and the concentration and infusion rate selected should be the minimum level practicable. Reduction in dose, concentration, and/or rate of administration in patients at risk of acute renal failure has been proposed in the literature in order to reduce the risk of acute renal failure.45
Reconstitution: Use Aseptic TechniqueWhen reconstitution is performed aseptically outside of a sterile laminar air flow hood, administration should begin as soon as possible, but not more than 2 hours after reconstitution.
When reconstitution is performed aseptically inside of a sterile laminar air flow hood, the reconstituted product may be either maintained in the original glass container or pooled into VIAFLEX bags and stored under constant refrigeration (2-8°C), for up to 24 hours. (The date and time of reconstitution/pooling should be recorded). If these conditions are not met, sterility of the reconstituted product cannot be maintained. Partially used vials should be discarded.
A. 5% Solution
Note: If refrigerated, allow GAMMAGARD S/D to reach room temperature before administration.
1. Remove bottle caps and clean stoppers with germicidal solution.
2. Remove spike cap from one end of the transfer device. Do not touch spike.
3a. Place the diluent bottle on a flat surface. Use exposed end of transfer device to spike diluent bottle through center of the stopper.
CAUTION: Failure to insert spike into center of the stopper may result in dislodging of the stopper.
3b. Ensure that the collar collapses fully into the device by pushing down on the transfer device firmly.
While holding onto transfer device, remove remaining spike cover. Do not touch spike.
4a. Hold diluent bottle with attached transfer device at an angle to the concentrate bottle to prevent spilling the diluent.
Note: Do not hold diluent bottle upside down, for this can lead to diluent spillage.
5a. Spike concentrate bottle through center of the stopper while quickly inverting the diluent vial to minimize spilling out diluent.
CAUTION: Failure to insert the spike into the center of the stopper may result in dislodging of the stopper and loss of vacuum.
5b. Ensure that the collar collapses fully into the device by pushing down on the diluent bottle firmly.
6. After transfer of diluent is complete, remove transfer device and empty diluent bottle. Immediately swirl the concentrate bottle gently to thoroughly mix contents.
CAUTION: Do not shake. Avoid foaming.
Discard transfer device after single use per local guidelines.
B. 10% Solution
1. Follow step 1 as previously described in A.
2. To prepare a 10% solution, it is necessary to remove half of the volume of diluent. Table 2 indicates the volume of diluent that should be removed from the vial before attaching the transfer device to produce a 10% concentration. Using aseptic technique, withdraw the unnecessary volume of diluent using a sterile hypodermic syringe and needle. Discard the filled syringe into a suitable puncture proof container (Sharps Container).
3. Using the residual diluent in the diluent vial, follow steps 2-6 as previously described in A.
Table 2 Required Diluent Volume to be Removed 5g 10g Concentration bottle bottle 5% Do not remove any diluent for reconstitution of 5% Solution 10% 48 mL 96 mL Rate of AdministrationIt is recommended that initially a 5% solution be infused at a rate of 0.5 mL/kg/Hr. If infusion at this rate and concentration causes the patient no distress, the administration rate may be gradually increased to a maximum rate of 4 mL/kg/Hr for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/Hr can be infused with the 10% concentration starting at 0.5 mL/kg/Hr. If no adverse effects occur, the rate can be increased gradually up to a maximum of 8 mL/kg/Hr.
In general, it is recommended that patients beginning therapy with IGIV or switching from one IGIV product to another be started at the lower rates of infusion and should be advanced to the maximal rate only after they have tolerated several infusions at intermediate rates of infusion. It is important to individualize rates for each patient. As noted in the WARNINGS section, patients who have underlying renal disease or who are judged to be at risk of developing thrombotic events should not be infused rapidly with any IGIV product.
Although there are no prospective studies demonstrating that any concentration or rate of infusion is completely safe, it is believed that risk may be decreased at lower rates of infusion.45 Therefore, as a guideline, it is recommended that these patients who are judged to be at risk of renal dysfunction or thrombotic complications be gradually titrated up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hr of a 10% or < 4mL/kg/hr of a 5% solution).
It is recommended that antecubital veins be used especially for 10% solutions, if possible. This may reduce the likelihood of the patient experiencing discomfort at the infusion site (see ADVERSE REACTIONS).
A rate of administration which is too rapid may cause flushing and changes in pulse rate and blood pressure. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.
Drug Interactions
Admixtures of GAMMAGARD S/D, Immune Globulin Intravenous (Human), with other drugs and intravenous solutions have not been evaluated. It is recommended that GAMMAGARD S/D be administered separately from other drugs or medications which the patient may be receiving. The product should not be mixed with Immune Globulin Intravenous (Human) from other manufacturers.
Antibodies in immune globulin preparations may interfere with patient responses to live vaccines, such as those for measles, mumps, and rubella. The immunizing physician should be informed of recent therapy with Immune Globulin Intravenous (Human) so that appropriate precautions can be taken.
AdministrationGAMMAGARD S/D should be administered as soon after reconstitution as possible, or as described in DOSAGE AND ADMINISTRATION.
The reconstituted material should be at room temperature during administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Reconstituted material should be a clear to slightly opalescent and colorless to pale yellow solution. Do not use if particulate matter and/or discoloration is observed.
Follow directions for use which accompany the administration set provided. If another administration set is used, ensure that the set contains a similar filter.
-
Baxter Healthcare Corporation
Gammagard S/d | Baxter Healthcare Corporation
Primary Immunodeficiency DiseasesFor patients with primary immunodeficiencies, monthly doses of approximately 300-600 mg/kg infused at 3 to 4 week intervals are commonly used.42,43 As there are significant differences in the half-life of IgG among patients with primary immunodeficiency, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response. The minimum serum concentration of IgG necessary for protection varies among patients and has not been established by controlled clinical trials.
B-cell Chronic Lymphocytic Leukemia (CLL)For patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell Chronic Lymphocytic Leukemia, a dose of 400 mg/kg every 3 to 4 weeks is recommended.
Kawasaki SyndromeFor patients with Kawasaki syndrome, either a single 1 g/kg dose or a dose of 400 mg/kg for four consecutive days beginning within seven days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day in four divided doses) is recommended.44
Idiopathic Thrombocytopenic Purpura (ITP)For patients with acute or chronic Idiopathic Thrombocytopenic Purpura, a dose of 1 g/kg is recommended. The need for additional doses can be determined by clinical response and platelet count. Up to three separate doses may be given on alternate days if required.
No prospective data are presently available to identify a maximum safe dose, concentration, and rate of infusion in patients determined to be at increased risk of acute renal failure. In the absence of prospective data, the recommended doses should not be exceeded and the concentration and infusion rate selected should be the minimum level practicable. Reduction in dose, concentration, and/or rate of administration in patients at risk of acute renal failure has been proposed in the literature in order to reduce the risk of acute renal failure.45
Reconstitution: Use Aseptic TechniqueWhen reconstitution is performed aseptically outside of a sterile laminar air flow hood, administration should begin as soon as possible, but not more than 2 hours after reconstitution.
When reconstitution is performed aseptically inside of a sterile laminar air flow hood, the reconstituted product may be either maintained in the original glass container or pooled into VIAFLEX bags and stored under constant refrigeration (2-8°C), for up to 24 hours. (The date and time of reconstitution/pooling should be recorded). If these conditions are not met, sterility of the reconstituted product cannot be maintained. Partially used vials should be discarded.
A. 5% Solution
Note: If refrigerated, allow GAMMAGARD S/D to reach room temperature before administration.
1. Remove bottle caps and clean stoppers with germicidal solution.
2. Remove spike cap from one end of the transfer device. Do not touch spike.
3a. Place the diluent bottle on a flat surface. Use exposed end of transfer device to spike diluent bottle through center of the stopper.
CAUTION: Failure to insert spike into center of the stopper may result in dislodging of the stopper.
3b. Ensure that the collar collapses fully into the device by pushing down on the transfer device firmly.
While holding onto transfer device, remove remaining spike cover. Do not touch spike.
4a. Hold diluent bottle with attached transfer device at an angle to the concentrate bottle to prevent spilling the diluent.
Note: Do not hold diluent bottle upside down, for this can lead to diluent spillage.
5a. Spike concentrate bottle through center of the stopper while quickly inverting the diluent vial to minimize spilling out diluent.
CAUTION: Failure to insert the spike into the center of the stopper may result in dislodging of the stopper and loss of vacuum.
5b. Ensure that the collar collapses fully into the device by pushing down on the diluent bottle firmly.
6. After transfer of diluent is complete, remove transfer device and empty diluent bottle. Immediately swirl the concentrate bottle gently to thoroughly mix contents.
CAUTION: Do not shake. Avoid foaming.
Discard transfer device after single use per local guidelines.
B. 10% Solution
1. Follow step 1 as previously described in A.
2. To prepare a 10% solution, it is necessary to remove half of the volume of diluent. Table 2 indicates the volume of diluent that should be removed from the vial before attaching the transfer device to produce a 10% concentration. Using aseptic technique, withdraw the unnecessary volume of diluent using a sterile hypodermic syringe and needle. Discard the filled syringe into a suitable puncture proof container (Sharps Container).
3. Using the residual diluent in the diluent vial, follow steps 2-6 as previously described in A.
Table 2 Required Diluent Volume to be Removed 5g 10g Concentration bottle bottle 5% Do not remove any diluent for reconstitution of 5% Solution 10% 48 mL 96 mL Rate of AdministrationIt is recommended that initially a 5% solution be infused at a rate of 0.5 mL/kg/Hr. If infusion at this rate and concentration causes the patient no distress, the administration rate may be gradually increased to a maximum rate of 4 mL/kg/Hr for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/Hr can be infused with the 10% concentration starting at 0.5 mL/kg/Hr. If no adverse effects occur, the rate can be increased gradually up to a maximum of 8 mL/kg/Hr.
In general, it is recommended that patients beginning therapy with IGIV or switching from one IGIV product to another be started at the lower rates of infusion and should be advanced to the maximal rate only after they have tolerated several infusions at intermediate rates of infusion. It is important to individualize rates for each patient. As noted in the WARNINGS section, patients who have underlying renal disease or who are judged to be at risk of developing thrombotic events should not be infused rapidly with any IGIV product.
Although there are no prospective studies demonstrating that any concentration or rate of infusion is completely safe, it is believed that risk may be decreased at lower rates of infusion.45 Therefore, as a guideline, it is recommended that these patients who are judged to be at risk of renal dysfunction or thrombotic complications be gradually titrated up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hr of a 10% or < 4mL/kg/hr of a 5% solution).
It is recommended that antecubital veins be used especially for 10% solutions, if possible. This may reduce the likelihood of the patient experiencing discomfort at the infusion site (see ADVERSE REACTIONS).
A rate of administration which is too rapid may cause flushing and changes in pulse rate and blood pressure. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.
Drug Interactions
Admixtures of GAMMAGARD S/D, Immune Globulin Intravenous (Human), with other drugs and intravenous solutions have not been evaluated. It is recommended that GAMMAGARD S/D be administered separately from other drugs or medications which the patient may be receiving. The product should not be mixed with Immune Globulin Intravenous (Human) from other manufacturers.
Antibodies in immune globulin preparations may interfere with patient responses to live vaccines, such as those for measles, mumps, and rubella. The immunizing physician should be informed of recent therapy with Immune Globulin Intravenous (Human) so that appropriate precautions can be taken.
AdministrationGAMMAGARD S/D should be administered as soon after reconstitution as possible, or as described in DOSAGE AND ADMINISTRATION.
The reconstituted material should be at room temperature during administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Reconstituted material should be a clear to slightly opalescent and colorless to pale yellow solution. Do not use if particulate matter and/or discoloration is observed.
Follow directions for use which accompany the administration set provided. If another administration set is used, ensure that the set contains a similar filter.
-
Baxter Healthcare Corporation
Gammagard S/d | Baxter Healthcare Corporation
Primary Immunodeficiency DiseasesFor patients with primary immunodeficiencies, monthly doses of approximately 300-600 mg/kg infused at 3 to 4 week intervals are commonly used.42,43 As there are significant differences in the half-life of IgG among patients with primary immunodeficiency, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response. The minimum serum concentration of IgG necessary for protection varies among patients and has not been established by controlled clinical trials.
B-cell Chronic Lymphocytic Leukemia (CLL)For patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell Chronic Lymphocytic Leukemia, a dose of 400 mg/kg every 3 to 4 weeks is recommended.
Kawasaki SyndromeFor patients with Kawasaki syndrome, either a single 1 g/kg dose or a dose of 400 mg/kg for four consecutive days beginning within seven days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day in four divided doses) is recommended.44
Idiopathic Thrombocytopenic Purpura (ITP)For patients with acute or chronic Idiopathic Thrombocytopenic Purpura, a dose of 1 g/kg is recommended. The need for additional doses can be determined by clinical response and platelet count. Up to three separate doses may be given on alternate days if required.
No prospective data are presently available to identify a maximum safe dose, concentration, and rate of infusion in patients determined to be at increased risk of acute renal failure. In the absence of prospective data, the recommended doses should not be exceeded and the concentration and infusion rate selected should be the minimum level practicable. Reduction in dose, concentration, and/or rate of administration in patients at risk of acute renal failure has been proposed in the literature in order to reduce the risk of acute renal failure.45
Reconstitution: Use Aseptic TechniqueWhen reconstitution is performed aseptically outside of a sterile laminar air flow hood, administration should begin as soon as possible, but not more than 2 hours after reconstitution.
When reconstitution is performed aseptically inside of a sterile laminar air flow hood, the reconstituted product may be either maintained in the original glass container or pooled into VIAFLEX bags and stored under constant refrigeration (2°-8°C), for up to 24 hours. (The date and time of reconstitution/pooling should be recorded). If these conditions are not met, sterility of the reconstituted product cannot be maintained. Partially used vials should be discarded.
A. 5% Solution Note: Reconstitute immediately before use. If refrigerated, warm the Sterile Water for Injection, USP (diluent) and GAMMAGARD S/D, Immune Globulin Intravenous (Human) (dried concentrate), to room temperature. Remove caps from concentrate and diluent bottles to expose central portion of rubber stoppers. Cleanse stoppers with germicidal solution. Remove protective covering from one end of double-ended needle and insert exposed needle through diluent stopper at its center. Remove protective covering from other end of double-ended needle. Invert diluent bottle over upright concentrate bottle, then rapidly insert free end of the needle through the concentrate bottle stopper at its center. The vacuum in the concentrate bottle will draw in the diluent. When diluent transfer is complete, remove empty diluent bottle from needle and then needle from concentrate bottle. Discard needle after single use. Thoroughly wet the dried material by tilting or inverting and gently rotating the bottle. Do not shake. Avoid foaming. Repeat gentle rotation as long as undissolved product is observed. B. 10% SolutionFollow steps 1-4 as previously described in A.
5. To prepare a 10% solution, reconstitute with the appropriate volume of diluent by using a sterile hypodermic syringe and needle. Table 2 indicates the volume of diluent required for a 5% or 10% concentration. Using aseptic technique, draw required volume into a sterile hypodermic syringe and needle. The diluent is then injected into the concentrate bottle.
Table 2 Required Diluent Volume Concentration 0.5g Bottle 5% 10 mL 10% 5 mL6. Discard any unused diluent after single use.
7. Thoroughly wet the dried material by tilting or inverting and gently rotating the bottle. Do not shake. Avoid foaming.
8. Repeat gentle rotation as long as undissolved product is observed.
Rate of AdministrationIt is recommended that initially a 5% solution be infused at a rate of 0.5 mL/kg/Hr. If infusion at this rate and concentration causes the patient no distress, the administration rate may be gradually increased to a maximum rate of 4 mL/kg/Hr for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/Hr can be infused with the 10% concentration starting at 0.5 mL/kg/Hr. If no adverse effects occur, the rate can be increased gradually up to a maximum of 8 mL/kg/Hr.
In general, it is recommended that patients beginning therapy with IGIV or switching from one IGIV product to another be started at the lower rates of infusion and should be advanced to the maximal rate only after they have tolerated several infusions at intermediate rates of infusion. It is important to individualize rates for each patient. As noted in the WARNINGS section, patients who have underlying renal disease or who are judged to be at risk of developing thrombotic events should not be infused rapidly with any IGIV product.
Although there are no prospective studies demonstrating that any concentration or rate of infusion is completely safe, it is believed that risk may be decreased at lower rates of infusion45. Therefore, as a guideline, it is recommended that these patients who are judged to be at risk of renal dysfunction or thrombotic complications be gradually titrated up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2 mL/kg/hr of a 10% or < 4 mL/kg/hr of a 5% solution).
It is recommended that antecubital veins be used especially for 10% solutions, if possible. This may reduce the likelihood of the patient experiencing discomfort at the infusion site (see ADVERSE REACTIONS).
A rate of administration which is too rapid may cause flushing and changes in pulse rate and blood pressure. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.
Drug Interactions
Admixtures of GAMMAGARD S/D, Immune Globulin Intravenous (Human), with other drugs and intravenous solutions have not been evaluated. It is recommended that GAMMAGARD S/D be administered separately from other drugs or medications which the patient may be receiving. The product should not be mixed with Immune Globulin Intravenous (Human) from other manufacturers.
Antibodies in immune globulin preparations may interfere with patient responses to live vaccines, such as those for measles, mumps, and rubella. The immunizing physician should be informed of recent therapy with Immune Globulin Intravenous (Human) so that appropriate precautions can be taken.
Administration.
GAMMAGARD S/D should be administered as soon after reconstitution as possible, or as described in DOSAGE AND ADMINISTRATION .
The reconstituted material should be at room temperature during administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Reconstituted material should be a clear to slightly opalescent and colorless to pale yellow solution. Do not use if particulate matter and/or discoloration is observed.
Intravenous Syringe Injection Attach filter needle to a disposable syringe and draw back plunger to admit air into syringe. Insert needle into reconstituted GAMMAGARD S/D. Inject air into bottle and then withdraw the reconstituted material into the syringe. Remove and discard the filter needle from the syringe; attach a suitable needle and inject intravenously as instructed under Rate of Administration . -
Baxter Healthcare Corporation
Gammagard S/d | Baxter Healthcare Corporation
For Intravenous Use Only
2.1 Preparation and HandlingInstruction for Reconstitution:
Allow GAMMAGARD S/D and diluent to reach room temperature before reconstitution and administration if refrigerated.
Reconstitution:
1. Remove caps from concentrate and diluent bottles to expose central portion of rubber stoppers, and cleanse stoppers with germicidal solution.
To make a 5% solution: Use the full volume of the diluent bottle
To make a 10% solution: Remove half of the volume of the diluent bottle
Table 1 indicates the volume of diluent that should be removed from the vial before attaching the transfer device to produce a 10% concentration. Using aseptic technique, withdraw the unnecessary volume of diluent using a sterile hypodermic syringe and needle. Discard the filled syringe into a suitable puncture proof container (Sharps Container).
Table 1. Required Diluent Volume to be Removed Concentration 2.5 g bottle 5 g bottle 10 g bottle 5% Do not remove any diluent for reconstitution of 5% Solution 10% 25 ml 48 mL 96 mL2. Remove spike cap from one end of the transfer device. Do not touch spike.
3a. Place the diluent bottle on a flat surface and hold the bottle to prevent slipping. Use exposed end of transfer device to spike diluent bottle perpendicularly through center of the stopper.
CAUTION: Failure to insert spike into center of the stopper may result in dislodging of the stopper.
3b. Ensure that the collar collapses fully into the device by pushing down on the transfer device firmly.
While holding onto transfer device, remove remaining spike cover from the other end of the transfer device. Do not touch spike.
4. Hold diluent bottle with attached transfer device at an angle to the concentrate bottle to prevent spilling the diluent.
Note: Do not hold diluent bottle upside down, for this can lead to diluent spillage.
5a. Spike concentrate bottle through center of the stopper while quickly inverting the diluent bottle to minimize spilling out diluent.
CAUTION: Failure to insert the spike into the center of the stopper may result in dislodging of the stopper and loss of vacuum.
5b. Ensure that the collar collapses fully into the device by pushing down on the diluent bottle firmly.
6. After transfer of diluent is complete, remove transfer device and empty diluent bottle. Immediately swirl the concentrate bottle gently to thoroughly mix contents. Repeat gentle rotation as long as undissolved product is observed.
CAUTION: Do not shake. Avoid foaming.
Discard transfer device after single use per local guidelines.
Reconstituted GAMMAGARD S/D is a clear to slightly opalescent and colorless to pale yellow solution. Visually inspect parenteral drug product for particulate matter and discoloration prior to administration. Do not use if particulate matter and/or discoloration is observed.
Follow directions for use which accompany the administration set provided. If another administration set is used, ensure that the set contains a similar filter.
Begin administration as soon as possible within 2 hours if reconstitution is performed aseptically outside of a sterile laminar air flow hood.
Administer within 24 hours if reconstitution is performed aseptically inside of a sterile laminar flow hood and stored in the original glass container or pooled into ViaFlex bags under constant refrigeration (2 °C to 8 °C). Record the date and time of reconstitution/pooling. Discard partially used vials.
2.2 DosePrimary Immunodeficiency (PI)
The recommended dose of GAMMAGARD S/D for patients with PI is 300-600 mg/kg infused at 3 to 4 week intervals.1,2,6 Adjust dose according to the clinical response; the frequency and dose of immunoglobulin may vary from patient to patient. No randomized controlled clinical trials are available to determine an optimum target trough serum IgG level.
B-cell Chronic Lymphocytic Leukemia (CLL)
The recommended dose of GAMMAGARD S/D for patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell CLL is 400 mg/kg body weight infused at every 3 to 4 week intervals.4
Idiopathic Thrombocytopenic Purpura (ITP)
The recommended dose of GAMMAGARD S/D for patients with chronic ITP is 1 g/kg. The need for additional doses can be determined by clinical response and platelet count. Up to three separate doses may be given on alternate days if required.
Kawasaki Syndrome
The recommended dose of GAMMAGARD S/D for patients with Kawasaki Syndrome is either a single 1 g/kg dose or a dose of 400 mg/kg for four consecutive days beginning within seven days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day in four divided doses) is recommended.5,7,8
2.3 AdministrationAdminister GAMMAGARD S/D as soon after reconstitution as possible and administer the reconstituted material at room temperature.
The recommended initial 5% solution infusion rate is 0.5 mL/kg/hour. The infusion rate may be gradually increased to a maximum rate of 4 mL/kg/hour as tolerated for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/hour can be infused with the 10% concentration starting at 0.5 mL/kg/hour. The rate can be increased gradually up to a maximum of 8 mL/kg/hour if no adverse effects occur.9
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in reoccurrence of the symptoms.
It is recommended that, if possible, the antecubital veins are used, especially for 10% solutions, to reduce the likelihood of discomfort at the infusion site (see ADVERSE REACTIONS [6]).
Adverse reactions may occur more frequently in patients who receive human IGIV for the first time, upon switching brands, or if there has been a long hiatus since the previous infusion. In such cases, start at a lower rate and gradually increase as tolerated.
There are no prospective studies demonstrating that any concentration or rate of infusion is completely safe. However, the risk may be decreased at lower rates of infusion.10 For patients who are judged to be at risk of renal dysfunction or thrombotic complications, administer GAMMAGARD S/D at the minimum allowable rate of infusion and gradually titrated up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hour of a 10% or < 4mL/kg/hour of a 5% solution) (see WARNINGS AND PRECAUTIONS [5.3]).
2.3 AdministrationAdminister GAMMAGARD S/D as soon after reconstitution as possible and administer the reconstituted material at room temperature.
The recommended initial 5% solution infusion rate is 0.5 mL/kg/hour. The infusion rate may be gradually increased to a maximum rate of 4 mL/kg/hour as tolerated for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/hour can be infused with the 10% concentration starting at 0.5 mL/kg/hour. The rate can be increased gradually up to a maximum of 8 mL/kg/hour if no adverse effects occur.9
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in reoccurrence of the symptoms.
It is recommended that, if possible, the antecubital veins are used, especially for 10% solutions, to reduce the likelihood of discomfort at the infusion site (see ADVERSE REACTIONS [6]).
Adverse reactions may occur more frequently in patients who receive human IGIV for the first time, upon switching brands, or if there has been a long hiatus since the previous infusion. In such cases, start at a lower rate and gradually increase as tolerated.
There are no prospective studies demonstrating that any concentration or rate of infusion is completely safe. However, the risk may be decreased at lower rates of infusion.10 For patients who are judged to be at risk of renal dysfunction or thrombotic complications, administer GAMMAGARD S/D at the minimum allowable rate of infusion and gradually titrated up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hour of a 10% or < 4mL/kg/hour of a 5% solution) (see WARNINGS AND PRECAUTIONS [5.3]).
-
Baxter Healthcare Corporation
Gammagard S/d | Baxter Healthcare Corporation
For Intravenous Use Only
2.1 Preparation and HandlingInstruction for Reconstitution:
Allow GAMMAGARD S/D and diluent to reach room temperature before reconstitution and administration if refrigerated.
Reconstitution:
1. Remove caps from concentrate and diluent bottles to expose central portion of rubber stoppers, and cleanse stoppers with germicidal solution.
To make a 5% solution: Use the full volume of the diluent bottle
To make a 10% solution: Remove half of the volume of the diluent bottle
Table 1 indicates the volume of diluent that should be removed from the vial before attaching the transfer device to produce a 10% concentration. Using aseptic technique, withdraw the unnecessary volume of diluent using a sterile hypodermic syringe and needle. Discard the filled syringe into a suitable puncture proof container (Sharps Container).
Table 1. Required Diluent Volume to be Removed Concentration 2.5 g bottle 5 g bottle 10 g bottle 5% Do not remove any diluent for reconstitution of 5% Solution 10% 25 ml 48 mL 96 mL2. Remove spike cap from one end of the transfer device. Do not touch spike.
3a. Place the diluent bottle on a flat surface and hold the bottle to prevent slipping. Use exposed end of transfer device to spike diluent bottle perpendicularly through center of the stopper.
CAUTION: Failure to insert spike into center of the stopper may result in dislodging of the stopper.
3b. Ensure that the collar collapses fully into the device by pushing down on the transfer device firmly.
While holding onto transfer device, remove remaining spike cover from the other end of the transfer device. Do not touch spike.
4. Hold diluent bottle with attached transfer device at an angle to the concentrate bottle to prevent spilling the diluent.
Note: Do not hold diluent bottle upside down, for this can lead to diluent spillage.
5a. Spike concentrate bottle through center of the stopper while quickly inverting the diluent bottle to minimize spilling out diluent.
CAUTION: Failure to insert the spike into the center of the stopper may result in dislodging of the stopper and loss of vacuum.
5b. Ensure that the collar collapses fully into the device by pushing down on the diluent bottle firmly.
6. After transfer of diluent is complete, remove transfer device and empty diluent bottle. Immediately swirl the concentrate bottle gently to thoroughly mix contents. Repeat gentle rotation as long as undissolved product is observed.
CAUTION: Do not shake. Avoid foaming.
Discard transfer device after single use per local guidelines.
Reconstituted GAMMAGARD S/D is a clear to slightly opalescent and colorless to pale yellow solution. Visually inspect parenteral drug product for particulate matter and discoloration prior to administration. Do not use if particulate matter and/or discoloration is observed.
Follow directions for use which accompany the administration set provided. If another administration set is used, ensure that the set contains a similar filter.
Begin administration as soon as possible within 2 hours if reconstitution is performed aseptically outside of a sterile laminar air flow hood.
Administer within 24 hours if reconstitution is performed aseptically inside of a sterile laminar flow hood and stored in the original glass container or pooled into ViaFlex bags under constant refrigeration (2 °C to 8 °C). Record the date and time of reconstitution/pooling. Discard partially used vials.
2.2 DosePrimary Immunodeficiency (PI)
The recommended dose of GAMMAGARD S/D for patients with PI is 300-600 mg/kg infused at 3 to 4 week intervals.1,2,6 Adjust dose according to the clinical response; the frequency and dose of immunoglobulin may vary from patient to patient. No randomized controlled clinical trials are available to determine an optimum target trough serum IgG level.
B-cell Chronic Lymphocytic Leukemia (CLL)
The recommended dose of GAMMAGARD S/D for patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell CLL is 400 mg/kg body weight infused at every 3 to 4 week intervals.4
Idiopathic Thrombocytopenic Purpura (ITP)
The recommended dose of GAMMAGARD S/D for patients with chronic ITP is 1 g/kg. The need for additional doses can be determined by clinical response and platelet count. Up to three separate doses may be given on alternate days if required.
Kawasaki Syndrome
The recommended dose of GAMMAGARD S/D for patients with Kawasaki Syndrome is either a single 1 g/kg dose or a dose of 400 mg/kg for four consecutive days beginning within seven days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day in four divided doses) is recommended.5,7,8
2.3 AdministrationAdminister GAMMAGARD S/D as soon after reconstitution as possible and administer the reconstituted material at room temperature.
The recommended initial 5% solution infusion rate is 0.5 mL/kg/hour. The infusion rate may be gradually increased to a maximum rate of 4 mL/kg/hour as tolerated for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/hour can be infused with the 10% concentration starting at 0.5 mL/kg/hour. The rate can be increased gradually up to a maximum of 8 mL/kg/hour if no adverse effects occur.9
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in reoccurrence of the symptoms.
It is recommended that, if possible, the antecubital veins are used, especially for 10% solutions, to reduce the likelihood of discomfort at the infusion site (see ADVERSE REACTIONS [6]).
Adverse reactions may occur more frequently in patients who receive human IGIV for the first time, upon switching brands, or if there has been a long hiatus since the previous infusion. In such cases, start at a lower rate and gradually increase as tolerated.
There are no prospective studies demonstrating that any concentration or rate of infusion is completely safe. However, the risk may be decreased at lower rates of infusion.10 For patients who are judged to be at risk of renal dysfunction or thrombotic complications, administer GAMMAGARD S/D at the minimum allowable rate of infusion and gradually titrated up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hour of a 10% or < 4mL/kg/hour of a 5% solution) (see WARNINGS AND PRECAUTIONS [5.3]).
2.3 AdministrationAdminister GAMMAGARD S/D as soon after reconstitution as possible and administer the reconstituted material at room temperature.
The recommended initial 5% solution infusion rate is 0.5 mL/kg/hour. The infusion rate may be gradually increased to a maximum rate of 4 mL/kg/hour as tolerated for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/hour can be infused with the 10% concentration starting at 0.5 mL/kg/hour. The rate can be increased gradually up to a maximum of 8 mL/kg/hour if no adverse effects occur.9
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in reoccurrence of the symptoms.
It is recommended that, if possible, the antecubital veins are used, especially for 10% solutions, to reduce the likelihood of discomfort at the infusion site (see ADVERSE REACTIONS [6]).
Adverse reactions may occur more frequently in patients who receive human IGIV for the first time, upon switching brands, or if there has been a long hiatus since the previous infusion. In such cases, start at a lower rate and gradually increase as tolerated.
There are no prospective studies demonstrating that any concentration or rate of infusion is completely safe. However, the risk may be decreased at lower rates of infusion.10 For patients who are judged to be at risk of renal dysfunction or thrombotic complications, administer GAMMAGARD S/D at the minimum allowable rate of infusion and gradually titrated up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hour of a 10% or < 4mL/kg/hour of a 5% solution) (see WARNINGS AND PRECAUTIONS [5.3]).
-
Baxter Healthcare Corporation
Gammagard S/d | Baxter Healthcare Corporation
For Intravenous Use Only
2.1 Preparation and HandlingInstruction for Reconstitution:
Allow GAMMAGARD S/D and diluent to reach room temperature before reconstitution and administration if refrigerated.
Reconstitution:
1. Remove caps from concentrate and diluent bottles to expose central portion of rubber stoppers, and cleanse stoppers with germicidal solution.
To make a 5% solution: Use the full volume of the diluent bottle
To make a 10% solution: Remove half of the volume of the diluent bottle
Table 1 indicates the volume of diluent that should be removed from the vial before attaching the transfer device to produce a 10% concentration. Using aseptic technique, withdraw the unnecessary volume of diluent using a sterile hypodermic syringe and needle. Discard the filled syringe into a suitable puncture proof container (Sharps Container).
Table 1. Required Diluent Volume to be Removed Concentration 2.5 g bottle 5 g bottle 10 g bottle 5% Do not remove any diluent for reconstitution of 5% Solution 10% 25 ml 48 mL 96 mL2. Remove spike cap from one end of the transfer device. Do not touch spike.
3a. Place the diluent bottle on a flat surface and hold the bottle to prevent slipping. Use exposed end of transfer device to spike diluent bottle perpendicularly through center of the stopper.
CAUTION: Failure to insert spike into center of the stopper may result in dislodging of the stopper.
3b. Ensure that the collar collapses fully into the device by pushing down on the transfer device firmly.
While holding onto transfer device, remove remaining spike cover from the other end of the transfer device. Do not touch spike.
4. Hold diluent bottle with attached transfer device at an angle to the concentrate bottle to prevent spilling the diluent.
Note: Do not hold diluent bottle upside down, for this can lead to diluent spillage.
5a. Spike concentrate bottle through center of the stopper while quickly inverting the diluent bottle to minimize spilling out diluent.
CAUTION: Failure to insert the spike into the center of the stopper may result in dislodging of the stopper and loss of vacuum.
5b. Ensure that the collar collapses fully into the device by pushing down on the diluent bottle firmly.
6. After transfer of diluent is complete, remove transfer device and empty diluent bottle. Immediately swirl the concentrate bottle gently to thoroughly mix contents. Repeat gentle rotation as long as undissolved product is observed.
CAUTION: Do not shake. Avoid foaming.
Discard transfer device after single use per local guidelines.
Reconstituted GAMMAGARD S/D is a clear to slightly opalescent and colorless to pale yellow solution. Visually inspect parenteral drug product for particulate matter and discoloration prior to administration. Do not use if particulate matter and/or discoloration is observed.
Follow directions for use which accompany the administration set provided. If another administration set is used, ensure that the set contains a similar filter.
Begin administration as soon as possible within 2 hours if reconstitution is performed aseptically outside of a sterile laminar air flow hood.
Administer within 24 hours if reconstitution is performed aseptically inside of a sterile laminar flow hood and stored in the original glass container or pooled into ViaFlex bags under constant refrigeration (2 °C to 8 °C). Record the date and time of reconstitution/pooling. Discard partially used vials.
2.2 DosePrimary Immunodeficiency (PI)
The recommended dose of GAMMAGARD S/D for patients with PI is 300-600 mg/kg infused at 3 to 4 week intervals.1,2,6 Adjust dose according to the clinical response; the frequency and dose of immunoglobulin may vary from patient to patient. No randomized controlled clinical trials are available to determine an optimum target trough serum IgG level.
B-cell Chronic Lymphocytic Leukemia (CLL)
The recommended dose of GAMMAGARD S/D for patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell CLL is 400 mg/kg body weight infused at every 3 to 4 week intervals.4
Idiopathic Thrombocytopenic Purpura (ITP)
The recommended dose of GAMMAGARD S/D for patients with chronic ITP is 1 g/kg. The need for additional doses can be determined by clinical response and platelet count. Up to three separate doses may be given on alternate days if required.
Kawasaki Syndrome
The recommended dose of GAMMAGARD S/D for patients with Kawasaki Syndrome is either a single 1 g/kg dose or a dose of 400 mg/kg for four consecutive days beginning within seven days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day in four divided doses) is recommended.5,7,8
2.3 AdministrationAdminister GAMMAGARD S/D as soon after reconstitution as possible and administer the reconstituted material at room temperature.
The recommended initial 5% solution infusion rate is 0.5 mL/kg/hour. The infusion rate may be gradually increased to a maximum rate of 4 mL/kg/hour as tolerated for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/hour can be infused with the 10% concentration starting at 0.5 mL/kg/hour. The rate can be increased gradually up to a maximum of 8 mL/kg/hour if no adverse effects occur.9
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in reoccurrence of the symptoms.
It is recommended that, if possible, the antecubital veins are used, especially for 10% solutions, to reduce the likelihood of discomfort at the infusion site (see ADVERSE REACTIONS [6]).
Adverse reactions may occur more frequently in patients who receive human IGIV for the first time, upon switching brands, or if there has been a long hiatus since the previous infusion. In such cases, start at a lower rate and gradually increase as tolerated.
There are no prospective studies demonstrating that any concentration or rate of infusion is completely safe. However, the risk may be decreased at lower rates of infusion.10 For patients who are judged to be at risk of renal dysfunction or thrombotic complications, administer GAMMAGARD S/D at the minimum allowable rate of infusion and gradually titrated up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hour of a 10% or < 4mL/kg/hour of a 5% solution) (see WARNINGS AND PRECAUTIONS [5.3]).
2.3 AdministrationAdminister GAMMAGARD S/D as soon after reconstitution as possible and administer the reconstituted material at room temperature.
The recommended initial 5% solution infusion rate is 0.5 mL/kg/hour. The infusion rate may be gradually increased to a maximum rate of 4 mL/kg/hour as tolerated for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/hour can be infused with the 10% concentration starting at 0.5 mL/kg/hour. The rate can be increased gradually up to a maximum of 8 mL/kg/hour if no adverse effects occur.9
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in reoccurrence of the symptoms.
It is recommended that, if possible, the antecubital veins are used, especially for 10% solutions, to reduce the likelihood of discomfort at the infusion site (see ADVERSE REACTIONS [6]).
Adverse reactions may occur more frequently in patients who receive human IGIV for the first time, upon switching brands, or if there has been a long hiatus since the previous infusion. In such cases, start at a lower rate and gradually increase as tolerated.
There are no prospective studies demonstrating that any concentration or rate of infusion is completely safe. However, the risk may be decreased at lower rates of infusion.10 For patients who are judged to be at risk of renal dysfunction or thrombotic complications, administer GAMMAGARD S/D at the minimum allowable rate of infusion and gradually titrated up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hour of a 10% or < 4mL/kg/hour of a 5% solution) (see WARNINGS AND PRECAUTIONS [5.3]).
-
Baxter Healthcare Corporation
Gammagard S/d | Baxter Healthcare Corporation
For Intravenous Use Only
2.1 Preparation and HandlingInstruction for Reconstitution:
Allow GAMMAGARD S/D and diluent to reach room temperature before reconstitution and administration if refrigerated.
Reconstitution:
1. Remove caps from concentrate and diluent bottles to expose central portion of rubber stoppers and cleanse stoppers with germicidal solution.
To make a 5% solution: Use the full volume of the diluent bottle To make a 10% solution: Remove half of the volume of the diluent bottleTable 1 indicates the volume of diluent that should be removed from the vial before attaching the transfer device to produce a 10% concentration. Using aseptic technique, withdraw the unnecessary volume of diluent using a sterile hypodermic syringe and needle. Discard the filled syringe into a suitable puncture proof container (Sharps Container).
Table 1 Required Diluent Volume to be Removed 5g 10g Concentration bottle bottle 5% Do not remove any diluent for reconstitution of 5% Solution 10% 48 mL 96 mL2. Remove spike cap from one end of the transfer device. Do not touch spike.
3a. Place the diluent bottle on a flat surface and hold the bottle to prevent slipping. Use exposed end of transfer device to spike diluent bottle perpendicularly through center of the stopper
CAUTION: Failure to insert spike into center of the stopper may result in dislodging of the stopper.
3b. Ensure that the collar collapses fully into the device by pushing down on the transfer device firmly.
While holding onto transfer device, remove remaining spike cover from the other end of the transfer device. Do not touch spike.
4. Hold diluent bottle with attached transfer device at an angle to the concentrate bottle to prevent spilling the diluent.
Note: Do not hold diluent bottle upside down, for this can lead to diluent spillage.
5a. Spike concentrate bottle through center of the stopper while quickly inverting the diluent bottle to minimize spilling out diluent. CAUTION: Failure to insert the spike into the center of the stopper may result in dislodging of the stopper and loss of vacuum.
5b. Ensure that the collar collapses fully into the device by pushing down on the diluent bottle firmly.
6. After transfer of diluent is complete, remove transfer device and empty diluent bottle. Immediately swirl the concentrate bottle gently to thoroughly mix contents. Repeat gentle rotation as long as undissolved product is observed. CAUTION: Do not shake. Avoid foaming. Discard transfer device after single use per local guidelines.
Visually inspect parenteral drug product for particulate matter and discoloration prior to administration. Reconstituted GAMMAGARD S/D is a clear to slightly opalescent and colorless to pale yellow solution. Do not use if particulate matter and/or discoloration is observed. Follow directions for use which accompany the administration set provided. If another administration set is used, ensure that the set contains a similar filter. Begin administration as soon as possible within 2 hours if reconstitution is performed aseptically outside of a sterile laminar air flow hood. Administer within 24 hours if reconstitution is performed aseptically inside of a sterile laminar flow hood and stored in the original glass container or pooled into ViaFlex bags under constant refrigeration (2°C to 8°C). Record the date and time of reconstitution/pooling. Discard partially used vials. 2.2 DosePrimary Immunodeficiency (PI)
The recommended dose of GAMMAGARD S/D for patients with PI is 300-600 mg/kg infused at 3 to 4 week intervals.1,2,6 Adjust dose according to the clinical response; the frequency and dose of immunoglobulin may vary from patient to patient. No randomized controlled clinical trials are available to determine an optimum target trough serum IgG level.
B-cell Chronic Lymphocytic Leukemia (CLL)
The recommended dose of GAMMAGARD S/D for patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell CLL is 400 mg/kg body weight infused at every 3 to 4 week intervals.4
Idiopathic Thrombocytopenic Purpura (ITP)
The recommended dose of GAMMAGARD S/D for patients with chronic ITP is 1 g/kg. The need for additional doses can be determined by clinical response and platelet count. Up to three separate doses may be given on alternate days if required.
Kawasaki Syndrome
The recommended dose of GAMMAGARD S/D for patients with Kawasaki syndrome is either a single 1 g/kg dose or a dose of 400 mg/kg for four consecutive days beginning within seven days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day in four divided doses).5,7,8
2.3 AdministrationAdminister GAMMAGARD S/D as soon after reconstitution as possible and administer the reconstituted material at room temperature.
The recommended initial 5% solution infusion rate is 0.5 mL/kg/hour. The infusion rate may be gradually increased to a maximum rate of 4 mL/kg/hour as tolerated for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/hour can be infused with the 10% concentration starting at 0.5 mL/kg/hour. The rate can be increased gradually up to a maximum of 8 mL/kg/hour if no adverse effects occur.9
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in reoccurrence of the symptoms.
It is recommended that, if possible, the antecubital veins are used, especially for 10% solutions, to reduce the likelihood of discomfort at the infusion site [see Adverse Reactions (6)].
Adverse reactions may occur more frequently in patients who receive human IGIV for the first time, upon switching brands, or if there has been a long hiatus since the previous infusion. In such cases, start at a lower rate and gradually increase as tolerated.
There are no prospective studies demonstrating that any concentration or rate of infusion is completely safe. However, the risk may be decreased at lower rates of infusion.10 For patients who are judged to be at risk of renal dysfunction or thrombotic complications, administer GAMMAGARD S/D at the minimum allowable rate of infusion and gradually titrate up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hour of a 10% or < 4mL/kg/hour of a 5% solution) [see Warnings and Precautions (5.3)].
2.1 Preparation and HandlingInstruction for Reconstitution:
Allow GAMMAGARD S/D and diluent to reach room temperature before reconstitution and administration if refrigerated.
Reconstitution:
1. Remove caps from concentrate and diluent bottles to expose central portion of rubber stoppers and cleanse stoppers with germicidal solution.
To make a 5% solution: Use the full volume of the diluent bottle To make a 10% solution: Remove half of the volume of the diluent bottleTable 1 indicates the volume of diluent that should be removed from the vial before attaching the transfer device to produce a 10% concentration. Using aseptic technique, withdraw the unnecessary volume of diluent using a sterile hypodermic syringe and needle. Discard the filled syringe into a suitable puncture proof container (Sharps Container).
Table 1 Required Diluent Volume to be Removed 5g 10g Concentration bottle bottle 5% Do not remove any diluent for reconstitution of 5% Solution 10% 48 mL 96 mL2. Remove spike cap from one end of the transfer device. Do not touch spike.
3a. Place the diluent bottle on a flat surface and hold the bottle to prevent slipping. Use exposed end of transfer device to spike diluent bottle perpendicularly through center of the stopper
CAUTION: Failure to insert spike into center of the stopper may result in dislodging of the stopper.
3b. Ensure that the collar collapses fully into the device by pushing down on the transfer device firmly.
While holding onto transfer device, remove remaining spike cover from the other end of the transfer device. Do not touch spike.
4. Hold diluent bottle with attached transfer device at an angle to the concentrate bottle to prevent spilling the diluent.
Note: Do not hold diluent bottle upside down, for this can lead to diluent spillage.
5a. Spike concentrate bottle through center of the stopper while quickly inverting the diluent bottle to minimize spilling out diluent. CAUTION: Failure to insert the spike into the center of the stopper may result in dislodging of the stopper and loss of vacuum.
5b. Ensure that the collar collapses fully into the device by pushing down on the diluent bottle firmly.
6. After transfer of diluent is complete, remove transfer device and empty diluent bottle. Immediately swirl the concentrate bottle gently to thoroughly mix contents. Repeat gentle rotation as long as undissolved product is observed. CAUTION: Do not shake. Avoid foaming. Discard transfer device after single use per local guidelines.
Visually inspect parenteral drug product for particulate matter and discoloration prior to administration. Reconstituted GAMMAGARD S/D is a clear to slightly opalescent and colorless to pale yellow solution. Do not use if particulate matter and/or discoloration is observed. Follow directions for use which accompany the administration set provided. If another administration set is used, ensure that the set contains a similar filter. Begin administration as soon as possible within 2 hours if reconstitution is performed aseptically outside of a sterile laminar air flow hood. Administer within 24 hours if reconstitution is performed aseptically inside of a sterile laminar flow hood and stored in the original glass container or pooled into ViaFlex bags under constant refrigeration (2°C to 8°C). Record the date and time of reconstitution/pooling. Discard partially used vials. 2.2 DosePrimary Immunodeficiency (PI)
The recommended dose of GAMMAGARD S/D for patients with PI is 300-600 mg/kg infused at 3 to 4 week intervals.1,2,6 Adjust dose according to the clinical response; the frequency and dose of immunoglobulin may vary from patient to patient. No randomized controlled clinical trials are available to determine an optimum target trough serum IgG level.
B-cell Chronic Lymphocytic Leukemia (CLL)
The recommended dose of GAMMAGARD S/D for patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell CLL is 400 mg/kg body weight infused at every 3 to 4 week intervals.4
Idiopathic Thrombocytopenic Purpura (ITP)
The recommended dose of GAMMAGARD S/D for patients with chronic ITP is 1 g/kg. The need for additional doses can be determined by clinical response and platelet count. Up to three separate doses may be given on alternate days if required.
Kawasaki Syndrome
The recommended dose of GAMMAGARD S/D for patients with Kawasaki syndrome is either a single 1 g/kg dose or a dose of 400 mg/kg for four consecutive days beginning within seven days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day in four divided doses).5,7,8
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Baxter Healthcare Corporation
Gammagard S/d | Baxter Healthcare Corporation
For Intravenous Use Only
2.1 Preparation and HandlingInstruction for Reconstitution:
Allow GAMMAGARD S/D and diluent to reach room temperature before reconstitution and administration if refrigerated.
Reconstitution:
1. Remove caps from concentrate and diluent bottles to expose central portion of rubber stoppers, and cleanse stoppers with germicidal solution.
To make a 5% solution: Use the full volume of the diluent bottle To make a 10% solution: Remove half of the volume of the diluent bottleTable 1 indicates the volume of diluent that should be removed from the vial before attaching the transfer device to produce a 10% concentration. Using aseptic technique, withdraw the unnecessary volume of diluent using a sterile hypodermic syringe and needle. Discard the filled syringe into a suitable puncture proof container (Sharps Container).
Table 1 Required Diluent Volume to be Removed Concentration 2.5 g bottle 5 g bottle 10 g bottle 5% Do not remove any diluent for reconstitution of 5% Solution 10% 25 ml 48 mL 96 mL2. Remove spike cap from one end of the transfer device. Do not touch spike.
3a. Place the diluent bottle on a flat surface and hold the bottle to prevent slipping. Use exposed end of transfer device to spike diluent bottle perpendicularly through center of the stopper.
CAUTION: Failure to insert spike into center of the stopper may result in dislodging of the stopper.
3b. Ensure that the collar collapses fully into the device by pushing down on the transfer device firmly.
While holding onto transfer device, remove remaining spike cover from the other end of the transfer device. Do not touch spike.
4. Hold diluent bottle with attached transfer device at an angle to the concentrate bottle to prevent spilling the diluent. Note: Do not hold diluent bottle upside down, for this can lead to diluent spillage.
5a. Spike concentrate bottle through center of the stopper while quickly inverting the diluent bottle to minimize spilling out diluent.
CAUTION: Failure to insert the spike into the center of the stopper may result in dislodging of the stopper and loss of vacuum.
5b. Ensure that the collar collapses fully into the device by pushing down on the diluent bottle firmly.
6. After transfer of diluent is complete, remove transfer device and empty diluent bottle. Immediately swirl the concentrate bottle gently to thoroughly mix contents. Repeat gentle rotation as long as undissolved product is observed. CAUTION: Do not shake. Avoid foaming.
Discard transfer device after single use per local guidelines.
Visually inspect parenteral drug product for particulate matter and discoloration prior to administration. Reconstituted GAMMAGARD S/D is a clear to slightly opalescent and colorless to pale yellow solution. Do not use if particulate matter and/or discoloration is observed. Follow directions for use which accompany the administration set provided. If another administration set is used, ensure that the set contains a similar filter. Begin administration as soon as possible within 2 hours if reconstitution is performed aseptically outside of a sterile laminar air flow hood. Administer within 24 hours if reconstitution is performed aseptically inside of a sterile laminar flow hood and stored in the original glass container or pooled into ViaFlex bags under constant refrigeration (2°C to 8°C). Record the date and time of reconstitution/pooling. Discard partially used vials. 2.2 DosePrimary Immunodeficiency (PI)
The recommended dose of GAMMAGARD S/D for patients with PI is 300-600 mg/kg infused at 3 to 4 week intervals.1,2,6 Adjust dose according to the clinical response; the frequency and dose of immunoglobulin may vary from patient to patient. No randomized controlled clinical trials are available to determine an optimum target trough serum IgG level.
B-cell Chronic Lymphocytic Leukemia (CLL)
The recommended dose of GAMMAGARD S/D for patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell CLL is 400 mg/kg body weight infused at every 3 to 4 week intervals.4
Idiopathic Thrombocytopenic Purpura (ITP)
The recommended dose of GAMMAGARD S/D for patients with chronic ITP is 1 g/kg. The need for additional doses can be determined by clinical response and platelet count. Up to three separate doses may be given on alternate days if required.
Kawasaki Syndrome
The recommended dose of GAMMAGARD S/D for patients with Kawasaki syndrome is either a single 1 g/kg dose or a dose of 400 mg/kg for four consecutive days beginning within seven days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day in four divided doses).5,7,8
2.3 AdministrationAdminister GAMMAGARD S/D as soon after reconstitution as possible and administer the reconstituted material at room temperature.
The recommended initial 5% solution infusion rate is 0.5 mL/kg/hour. The infusion rate may be gradually increased to a maximum rate of 4 mL/kg/hour as tolerated for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/hour can be infused with the 10% concentration starting at 0.5 mL/kg/hour. The rate can be increased gradually up to a maximum of 8 mL/kg/hour if no adverse effects occur.9
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in reoccurrence of the symptoms.
It is recommended that, if possible, the antecubital veins are used, especially for 10% solutions, to reduce the likelihood of discomfort at the infusion site [see Adverse Reactions (6)].
Adverse reactions may occur more frequently in patients who receive human IGIV for the first time, upon switching brands, or if there has been a long hiatus since the previous infusion. In such cases, start at a lower rate and gradually increase as tolerated.
There are no prospective studies demonstrating that any concentration or rate of infusion is completely safe. However, the risk may be decreased at lower rates of infusion.10 For patients who are judged to be at risk of renal dysfunction or thrombotic complications, administer GAMMAGARD S/D at the minimum allowable rate of infusion and gradually titrate up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hour of a 10% or < 4mL/kg/hour of a 5% solution) [see Warnings and Precautions (5.3)].
2.3 AdministrationAdminister GAMMAGARD S/D as soon after reconstitution as possible and administer the reconstituted material at room temperature.
The recommended initial 5% solution infusion rate is 0.5 mL/kg/hour. The infusion rate may be gradually increased to a maximum rate of 4 mL/kg/hour as tolerated for patients with no history of adverse reactions to IGIV and no significant risk factors for renal dysfunction or thrombotic complications. Patients who tolerate the 5% concentration at 4 mL/kg/hour can be infused with the 10% concentration starting at 0.5 mL/kg/hour. The rate can be increased gradually up to a maximum of 8 mL/kg/hour if no adverse effects occur.9
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in reoccurrence of the symptoms.
It is recommended that, if possible, the antecubital veins are used, especially for 10% solutions, to reduce the likelihood of discomfort at the infusion site [see Adverse Reactions (6)].
Adverse reactions may occur more frequently in patients who receive human IGIV for the first time, upon switching brands, or if there has been a long hiatus since the previous infusion. In such cases, start at a lower rate and gradually increase as tolerated.
There are no prospective studies demonstrating that any concentration or rate of infusion is completely safe. However, the risk may be decreased at lower rates of infusion.10 For patients who are judged to be at risk of renal dysfunction or thrombotic complications, administer GAMMAGARD S/D at the minimum allowable rate of infusion and gradually titrate up to a more conservative maximal rate of less than 3.3 mg/kg/min (< 2mL/kg/hour of a 10% or < 4mL/kg/hour of a 5% solution) [see Warnings and Precautions (5.3)].
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