Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.

Manufacturer Details

There are currently no manufacturer details available.

Octapharma Pharmazeutika Produktionsgesellschaft M.b.h. Drugs

Albumin

Albumin

2.1 Dosage

General Recommendations

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.

The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 5% per kg of body weight.

Hypovolemia

In adults, an intravenous infusion of 25 g of ALBUMIN (HUMAN) 5% should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

Hemodilution may follow administration of ALBUMIN (HUMAN) 5%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

Hypoalbuminemia

In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 5% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.

In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 5% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 5% may be given for every 1,000 mL of ascitic fluid removed.

2.2 Administration

Intravenous use only.

Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.

Do not dilute with sterile water for injection.

Do not use solutions of ALBUMIN (HUMAN) 5% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 5% is not required.

The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.

If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.
Albumin

Albumin

2.2 Dosage

General Recommendations

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.

The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.

The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 20% per kg of body weight.

Hypovolemia

In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

Hemodilution may follow administration of ALBUMIN (HUMAN) 20%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

Hypoalbuminemia

In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 20% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.

In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 20% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 20% may be given for every 1,000 mL of ascitic fluid removed.

Ovarian Hyperstimulation Syndrome

In adults, as a guideline, doses of 50 – 100 g of ALBUMIN (HUMAN) 20% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [ 7 ]

Adult Respiratory Distress Syndrome (ARDS)

In adults, a dose of 25 g of ALBUMIN (HUMAN) 20% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [ 5 ]

Induction of Diuresis in Patients with Acute Nephrosis

In adults, a dose of 25 g of ALBUMIN (HUMAN) 20% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.

Hemolytic Disease of the Newborn

In newborns, ALBUMIN (HUMAN) 20% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [ 6 ]

2.1 Administration

Intravenous use only.

Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.

Do not dilute with sterile water for injection.

Do not use solutions of ALBUMIN (HUMAN) 20% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 20% is not required.

The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.

If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.
Albumin

Albumin

2.1 Dosage

General Recommendations

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.

The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.

The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 25% per kg of body weight.

Hypovolemia

In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

Hemodilution may follow administration of ALBUMIN (HUMAN) 25%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

Hypoalbuminemia

In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 25% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.

In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 25% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 25% may be given for every 1,000 mL of ascitic fluid removed.

Ovarian Hyperstimulation Syndrome

In adults, as a guideline, doses of 50 – 100 g of ALBUMIN (HUMAN) 25% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [ 7 ]

Adult Respiratory Distress Syndrome (ARDS)

In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [ 5 ]

Induction of Diuresis in Patients with Acute Nephrosis

In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.

Hemolytic Disease of the Newborn

ALBUMIN (HUMAN) 25% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [ 6 ]

2.2 Administration

Intravenous use only.

Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.

Do not dilute with sterile water for injection.

Do not use solutions of ALBUMIN (HUMAN) 25% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 25% is not required.

The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.

If large volumes (greater than or equal to 1500 ml) are administered, the product should be warmed to room temperature before use.
Octagam Immune Globulin...

Octagam Immune Globulin

For intravenously use only

Preparation and handling
Octagam 5% liquid should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid and/or discoloration is observed. Octagam 5% liquid must not be mixed with other medicinal products or administered simultaneously with other intravenous preparation in the same infusion set. Do not mix with immune globulin intravenous (IGIV) products from other manufacturers. Do not freeze. Solutions that have been frozen should not be used. Octagam 5% liquid bottle is for single use only. Octagam 5% liquid contains no preservative. Any bottle that has been entered should be used promptly. Partially used bottles should be discarded. Content of Octagam 5% liquid bottles may be pooled under aseptic conditions into sterile infusion bags and infused within 8 hours after pooling. Do not use after expiration date. Octagam 5% liquid should not be diluted.
Treatment of Primary Humoral Immunodeficiency

As there are significant differences in the half-life of IgG among patients with primary humoral immunodeficiencies, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.

The dose of Octagam 5% liquid for replacement therapy in primary humoral immunodeficiency diseases is 300 to 600 mg/kg body weight (6-12ml/kg) administered every 3 to 4 weeks. The dosage may be adjusted over time to achieve the desired trough levels and clinical responses.

If a patient is at risk of measles exposure (ie., outbreak in US or travel to endemic areas outside of the US) and receives a dose of less than 400 mg/kg every 3 to 4 weeks, the dose should be increased to at least 400 mg/kg. If a patient has been exposed to measles, this dose should be administered as soon as possible after exposure.

Missed Doses

If a patient on regular treatment missed a dose, the missed dose should be administered as soon as possible, and then treatment should continue as before.

Administration

Octagam 5% liquid should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid and/or discoloration is observed.

Octagam 5% liquid should be at room temperature during administration. Only administer intravenously.

Any bottle that has been opened should be used promptly. Partially used bottles should be discarded.

Octagam 5% liquid is not supplied with an infusion set. If an in-line filter is used the pore size should be 0.2 – 200 microns.

Do not use a needle of larger than 16 gauge to prevent the possibility of coring. Insert needle only once, within the stopper area delineated (by the raised ring for penetration). The stopper should be penetrated perpendicular to the plane of the stopper within the ring.

Rate of Administration

It is recommended that Octagam 5% liquid be initially infused at infusion rates stated below, at least until the physician has had adequate experience with a given patient.

Infusion rates: 0.5mg/kg/min (30mg/kg/hr for the first 30 minutes; if tolerated, advance to 1mg/kg/min (60mg/kg/hr) for the second 30 minutes; and if further tolerated, advance to 2mg/kg/min (120mg/kg/hr) for the third 30 minutes. Thereafter the infusion can be maintained at a rate up to, but not exceeding, 3.33mg/kg/min (200mg/kg/hr)

For patients judged to be at risk for developing renal dysfunction, administer Octagam 5% liquid at the minimum infusion rate practicable, not to exceed 0.07 ml/kg (3.3 mg/kg)/minute (200 mg/kg/hour).

Table 1
Rate of Administration mg/kg/min (mg/kg/hour) ml/kg/min
first 30 min

0.5 (30)

0.01

next 30 min

1.0 (60)

0.02

next 30 min

2.0 (120)

0.04

Maximum

< 3.33 (<200)

<0.07

Certain severe adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.

Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue Octagam 5% liquid if renal function deteriorates.

For patients at risk of renal dysfunction or thromboembolic events, administer Octagam 5% liquid at the minimum infusion rate practicable.

Incompatibilities

Octagam 5% liquid must not be mixed with other medicinal products or administered simultaneously with other intravenous preparations in the same infusion set.

Shelf-life

Octagam 5% liquid may be stored for 24 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture.

Special Precautions for Storage

Do not freeze. Frozen product should not be used.

Do not use after expiration date.
Wilate – Von Will...

Wilate – Von Willebrand Factorcoagulation Factor Viii Complex

For Intravenous Use after Reconstitution Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders. Each vial of Wilate contains the labeled amount in International Units (IU) of von Willebrand factor (VWF) activity as measured with the Ristocetin cofactor assay (VWF:RCo), and coagulation factor VIII (FVIII) activity measured with the chromogenic substrate assay. The number of units of VWF:RCo and FVIII activities administered is expressed in IU, which are related to the current WHO standards for VWF and FVIII products. VWF:RCo and FVIII activities in plasma are expressed either as a percentage (relative to normal human plasma) or in IU (relative to the International Standards for VWF:RCo and FVIII activities in plasma).
2.1 Dosage in von Willebrand Disease

The ratio between VWF:RCo and FVIII activities in Wilate is approximately 1:1.

The dosage should be adjusted according to the extent and location of the bleeding. In VWD type 3 patients, especially in those with gastro-intestinal (GI) bleedings, higher doses may be required.

2.2 Dosing Schedule

Physician supervision of the treatment regimen is required. A guide for dosing in the treatment of major and minor hemorrhages is provided in Table 1 .

The careful control of replacement therapy is especially important in life-threatening hemorrhages. When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII activity.[ 1 ]

Table 1 Guide to Wilate Dosing for Treatment of Minor and Major Hemorrhages
Type of Hemorrhages Loading Dosage (IU VWF:RCo /kg BW) Maintenance Dosage (IU VWF:RCo /kg BW) Therapeutic Goal
Minor Hemorrhages

20-40 IU/kg

20-30 IU/kg every 12-24 hours*

VWF:RCo and FVIII activity through levels of >30%

Major Hemorrhages

40-60 IU/kg

20-40 IU/kg every 12-24 hours*

VWF:RCo and FVIII activity through levels of >50%

*This may need to be continued for up to 3 days for minor hemorrhages and 5-7 days for major hemorrhages

Repeat doses are administered for as long as needed based upon repeat monitoring of appropriate clinical and laboratory measures.

Although dose can be estimated by the guidelines above, it is highly recommended that whenever possible, appropriate laboratory tests should be performed on the patient’s plasma at suitable intervals to assure that adequate VWF:RCo and FVIII activity levels have been reached and are maintained.

In the unlikely event that a patient who is actively bleeding should miss a dose, it may be appropriate to adopt a dosage depending on the level of coagulation factors measured, extent of the bleeding, and patient's clinical condition.

2.3 Administration

Wilate is administered via intravenous infusion. Wilate is provided with a Mix2Vial TM transfer device for reconstitution of the freeze-dried powder in diluent, a 10-mL syringe, an infusion set and two alcohol swabs.

Instructions for Reconstitution:

1) Warm the Powder and Diluent in the closed vials up to room temperature. This temperature should be maintained during reconstitution. If a water bath is used for warming, care must be taken to avoid water coming into contact with the rubber stoppers (latex-free) or the caps of the vials. The temperature of the water bath should not exceed +37°C (98°F).

2) Remove the caps from the concentrate (Wilate) vial and the diluent vial and clean the rubber stoppers with an alcohol swab.

3) Peel away the lid of the outer package of the Mix2Vial™ transfer set. To maintain sterility, leave the Mix2Vial™ device in the clear outer packaging. Place the diluent vial on a level surface and hold the vial firmly. Take the Mix2Vial™ in its outer package and invert it over the diluent vial. Push the blue plastic cannula of the Mix2Vial™ firmly through the rubber stopper of the diluent vial (Fig. 1). While holding onto the diluent vial, carefully remove the outer package from the Mix2Vial™, being careful to leave the Mix2Vial™ attached firmly to the diluent vial (Fig. 2).

4) With the concentrate (Wilate) vial held firmly on a level surface, quickly invert the diluent vial with the Mix2Vial™ attached and push the transparent plastic cannula end of the Mix2Vial™ firmly through the stopper of the concentrate (Wilate) vial (Fig. 3). The diluent will be drawn into the concentrate (Wilate) vial by the vacuum.

5) With both vials still attached, gently swirl the product vial to ensure the product is fully dissolved to a clear solution. Once the contents of the Wilate vial are completely dissolved, firmly hold both the transparent and blue parts of the Mix2Vial™. Unscrew the Mix2Vial™ into two separate pieces (Fig. 4) and discard the empty diluent vial and the blue part of the Mix2Vial™.
The powder should be reconstituted only directly before injection. As Wilate contains no preservatives, the solution should be used immediately after reconstitution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The filtered solution is clear or slightly opalescent, colourless or slightly yellow. If the concentrate fails to dissolve completely or an aggregate is formed, the preparation must not be used.
Instructions for Injection:
With the Wilate vial still upright, attach a plastic disposable syringe to the Mix2Vial™ (transparent plastic part). Invert the system and draw the reconstituted Wilate into the syringe. Once Wilate has been transferred into the syringe, firmly hold the barrel of the syringe (keeping the syringe plunger facing down) and detach the Mix2Vial™ from the syringe. Discard the Mix2Vial™ (transparent plastic part) and empty Wilate vial. Clean the intended injection site with an alcohol swab. Attach a suitable infusion needle to the syringe. Inject the solution intravenously at a slow speed of 2-4 mL/minute. As a precautionary measure, the patient’s pulse rate should be measured before and during the injection. If a marked increase in the pulse rate occurs, the injection speed must be reduced or the administration must be interrupted. Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities

Wilate must not be mixed with other medicinal products or administered simultaneously with other intravenous preparation in the same infusion set.

Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.

Manufacturer Details

Share This Page

Octapharma Pharmazeutika Produktionsgesellschaft M.b.h. Drugs