Kogenate Fs

Kogenate Fs Manufacturers

• Bayer Healthcare Llc
  

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  Kogenate Fs | Bayer Healthcare Llc

  

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  For intravenous use after reconstitution only.

  2.1 Dose • Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition. 1 Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes. • Each vial of Kogenate FS has the recombinant factor VIII (rFVIII) potency in international units (IU, unit) stated on the label. One IU (unit), as defined by the World Health Organization standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. • The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % normal) can be estimated using the following formulas:   Dosage (units) = body weight (kg) x desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)   or   IU/dL (or % normal) = Total Dose (IU)/body weight (kg) x 2 [IU/dL]/[IU/kg] • Titrate dose to the patient’s clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to Kogenate FS. 2,3,4 Although the dose can be estimated by the calculations above, it is highly recommended that appropriate laboratory tests, including serial factor VIII activity assays, are performed [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. Control and Prevention of Bleeding Episodes

  A guide for dosing Kogenate FS for the control and prevention of bleeding episodes is provided in Table 1. The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma levels (in % of normal or in IU/dL) outlined in Table 1.

  Table 1 Dosing for Control and Prevention of Bleeding Episodes

  Type of Bleeding Episodes

  Factor VIII Level Required
  (IU/dL or % of normal)

  Dose

  (IU/kg)

  Frequency of Doses

  (hours)

  Duration of Therapy

  (days)

  Minor

  Early hemarthrosis, minor muscle or oral bleeds.

  20 – 40

  10 – 20

  Repeat dose if there is evidence of further bleeding.

  Until bleeding is resolved

  Moderate

  Bleeding into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma.

  30 – 60

  15 – 30

  12 – 24

  Until bleeding is resolved

  Major

  Gastrointestinal bleeding. Intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces, or iliopsoas sheath.

  Fractures.

  Head trauma.

  80 – 100

  Initial: 40 – 50

  Repeat: 20 – 25

  8 – 12

  Until bleeding is resolved

  Peri-operative Management

  A guide for dosing Kogenate FS during surgery (perioperative management) is provided in Table 2. The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma level (in % of normal or in IU/dL) outlined in Table 2.

  Table 2 Dosing for Peri-operative Management

  Type of Surgery

  Factor VIII Level Required
  (IU/dL or % of normal)

  Dose

  (IU/kg)

  Frequency of Doses

  (hours)

  Duration of Therapy

  (days)

  Minor

  Including tooth extraction

  30 – 60

  15 – 30

  12 – 24

  Until bleeding is resolved.

  Major

  Examples include tonsillectomy, inguinal herniotomy, synovectomy, total knee replacement, craniotomy, osteosynthesis, trauma.

  100

  50

  Pre-operatively to achieve 100% activity.

  6 – 12 to keep FVIII activity in desired range

  Until healing is complete.

  Routine Prophylaxis in Adults

  The recommended dose for routine prophylaxis is 25 units per kg of body weight three times per week.

  Routine Prophylaxis in Children

  The recommended dose for routine prophylaxis is 25 units per kg of body weight every other day.5

  2.2 Preparation and Reconstitution

  Kogenate FS is administered by intravenous injection after reconstitution. Patients should follow the specific reconstitution and administration procedures provided by their physicians.

  Reconstitute and administer Kogenate FS with the components provided with each package. If any component of the package is opened or damaged, do not use this component.

  Product reconstitution, administration, and handling of the administration set and needles must be done with caution because percutaneous puncture with a needle contaminated with blood can transmit infectious viruses, including HIV (AIDS) and hepatitis. Place needles in a sharps container after single use. Discard all equipment, including any reconstituted Kogenate FS product, in an appropriate container. Obtain immediate medical attention if injury occurs.

  For any questions about the handling, reconstitution and administration of Kogenate FS, contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937).

  For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling.

  The procedures below are provided as general guidelines for the reconstitution of Kogenate FS.

  • Work on a clean surface and wash hands thoroughly using soap and warm water before performing the procedures. • Reconstitute the product with the components provided with each package. If any component of the package is opened or damaged, do not use this component. • Filter the reconstituted product to remove potential particulate matter in the solution. Filtering can be achieved by following the reconstitution steps as described below.

  Vacuum Transfer and Reconstitution

  1. Prepare the product under aseptic conditions. 2. Warm the unopened diluent and the concentrate to a temperature not to exceed 37°C or 99°F. 3. After removing the plastic flip-top caps (Fig. A), aseptically cleanse the rubber stoppers of both vials with alcohol, being careful not to handle the rubber stopper. 4. Remove the protective cover from one end of the plastic transfer needle cartridge and penetrate the stopper of the diluent vial (Fig. B). 5. Remove the remaining portion of the protective cover, invert the diluent vial and penetrate the rubber seal on the concentrate vial (Fig. C) with the needle at an angle. 6. The vacuum will draw the diluent into the concentrate vial. Hold the diluent vial at an angle to the concentrate vial in order to direct the jet of diluent against the wall of the concentrate vial (Fig. C). Avoid excessive foaming. If the diluent does not get drawn into the vial, there is insufficient vacuum and the product should not be used. 7. After removing the diluent vial and transfer needle (Fig. D), swirl until completely dissolved without creating excessive foaming (Fig. E). 8. Re-swab top of reconstituted Kogenate FS vial with alcohol. Allow the stopper to air dry. 9. After the concentrate powder is completely dissolved, withdraw the solution into the syringe through the filter needle that is supplied in the package (Fig. F). Replace the filter needle with the administration set provided and inject intravenously. 10. If the same patient is to receive more than one vial, the contents of two vials may be drawn into the same syringe through a separate unused filter needle before attaching the vein needle. 2.3 Administration

  For intravenous use after reconstitution only.

  • Inspect Kogenate FS visually for particulate matter and discoloration prior to administration, wherever solution and container permit. Do not use Kogenate FS if you notice any particulates or turbidity in the solution. • Store the reconstituted Kogenate FS at room temperature prior to administration, but administer it within 3 hours. • Administer Kogenate FS with the administration set provided with the product as it incorporates an in-line filter. In situations where the administration set provided cannot be used (e.g. when infusing into a peripheral or central line), use a separate filter compatible with Kogenate FS.   NOTE: Do not use the administration set provided with the product to draw blood because it contains an in-line filter. When blood must be withdrawn prior to an infusion, use an administration set without a filter, then infuse Kogenate FS through an injection filter. For any questions about compatible separate filters, contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937). • Administer Kogenate FS over a period of 1 to 15 minutes. Adapt the rate of administration to the response of each individual patient. Determine the pulse rate before and during administration of Kogenate FS. If there is a significant increase in pulse rate, reduce the rate of administration or temporarily halt the infusion allowing the symptoms to disappear promptly.

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  Kogenate Fs | Hospira, Inc.

  

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  Clindamycin Injection, USP can be administered by IM (should be used undiluted) or IV injection (should be diluted, see Dilution for IV Use and IV Infusion Rates below). However, the intent of the ADD-VANTAGE vial is for the preparation of solutions for IV infusion only.

  If diarrhea occurs during therapy, this antibiotic should be discontinued. (See WARNING box.)

  Adults

  Parenteral (IM or IV) Administration:

  Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):

  600 to 1200 mg/day in 2, 3 or 4 equal doses

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:

  1200 to 2700 mg/day in 2, 3 or 4 equal doses

  For more serious infections, these doses may have to be increased. In life threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution and Infusion Rates section below.

  Single intramuscular injections of greater than 600 mg are not recommended.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum
  clindamycin levels

  Rapid infusion rate

  Maintenance
  infusion rate

  Above 4 mcg/mL

  10 mg/min for 30 min

  0.75 mg/min

  Above 5 mcg/mL

  15 mg/min for 30 min

  1.00 mg/min

  Above 6 mcg/mL

  20 mg/min for 30 min

  1.25 mg/min

  Neonates (less than 1 month)

  15 to 20 mg/kg/day in three to four equal doses. The lower dosage may be adequate for small prematures.

  Pediatric patients (1 month of age to 16 years)

  Parenteral (IM or IV) Administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to clindamycin palmitate hydrochloride for oral solution or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution for IV Use and Infusion Rates

  The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg

  50 mL

  10 min

  600 mg

  50 mL

  20 min

  900 mg

  50 to 100 mL

  30 min

  1200 mg

  100 mL

  40 min

  Administration of more than 1200 mg in a 1-hour infusion is not recommended.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Dilution and Compatibility

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin phosphate in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin 

  Room temperature: 6, 9, and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  INSTRUCTIONS FOR USE 

  To Open Diluent Container 

  Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

  To Assemble Vial and Flexible Diluent Container 

  (Use Aseptic Technique) 

  1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Do not access vial with syringe.

                                                                                               

    b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.) 2. Screw the vial into the vial port until it will go no farther. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go.

            NOTE: Once vial is seated, do not attempt to remove it. (SEE FIGURE 4.)

  3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.

                                                                                            

  To Prepare Admixture

  1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 3. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4. Mix container contents thoroughly and use within the specified time.

                                                                                     

  Preparation for Administration

  (Use Aseptic Technique)

  1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.

            NOTE: See full directions on administration set carton.

  6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp.

  WARNING: Do not use flexible container in series connections.

  Dilution for IV Use and Infusion Rates

  The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg

  50 mL

  10 min

  600 mg

  50 mL

  20 min

  900 mg

  50 to 100 mL

  30 min

  1200 mg

  100 mL

  40 min

  Administration of more than 1200 mg in a 1-hour infusion is not recommended.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Dilution and Compatibility

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin phosphate in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin 

  Room temperature: 6, 9, and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  INSTRUCTIONS FOR USE 

  To Open Diluent Container 

  Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

  To Assemble Vial and Flexible Diluent Container 

  (Use Aseptic Technique) 

  1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Do not access vial with syringe.

                                                                                               

    b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.) 2. Screw the vial into the vial port until it will go no farther. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go.

            NOTE: Once vial is seated, do not attempt to remove it. (SEE FIGURE 4.)

  3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.

                                                                                            

  To Prepare Admixture

  1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 3. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4. Mix container contents thoroughly and use within the specified time.

                                                                                     

  Preparation for Administration

  (Use Aseptic Technique)

  1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.

            NOTE: See full directions on administration set carton.

  6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp.

  WARNING: Do not use flexible container in series connections.

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• Bayer Healthcare Llc
  

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  Kogenate Fs | Bayer Healthcare Llc

  

  ---

  For intravenous use after reconstitution only.

  2.1 Dose • Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition. 1 Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes. • Each vial of Kogenate FS has the recombinant factor VIII (rFVIII) potency in international units (IU, unit) stated on the label. One IU (unit), as defined by the World Health Organization standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. • The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % normal) can be estimated using the following formulas:

  Dosage (units) = body weight (kg) x desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)

  or

  IU/dL (or % normal) = Total Dose (IU)/body weight (kg) x 2 [IU/dL]/[IU/kg]

  • Titrate dose to the patient’s clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to Kogenate FS. 2,3,4 Although the dose can be estimated by the calculations above, it is highly recommended that appropriate laboratory tests, including serial factor VIII activity assays, are performed [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. Control and Prevention of Bleeding Episodes

  A guide for dosing Kogenate FS for the control and prevention of bleeding episodes is provided in Table 1. The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma levels (in % of normal or in IU/dL) outlined in Table 1.

  Table 1 Dosing for Control and Prevention of Bleeding Episodes

  Type of Bleeding Episodes

  Factor VIII Level Required
  (IU/dL or % of normal)

  Dose

  (IU/kg)

  Frequency of Doses

  (hours)

  Duration of Therapy

  (days)

  Minor

  Early hemarthrosis, minor muscle or oral bleeds.

  20 – 40

  10 – 20

  Repeat dose if there is evidence of further bleeding.

  Until bleeding is resolved

  Moderate

  Bleeding into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma.

  30 – 60

  15 – 30

  12 – 24

  Until bleeding is resolved

  Major

  Gastrointestinal bleeding. Intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces, or iliopsoas sheath.

  Fractures.

  Head trauma.

  80 – 100

  Initial: 40 – 50

  Repeat: 20 – 25

  8 – 12

  Until bleeding is resolved

  Peri-operative Management

  A guide for dosing Kogenate FS during surgery (perioperative management) is provided in Table 2. The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma level (in % of normal or in IU/dL) outlined in Table 2.

  Table 2 Dosing for Peri-operative Management

  Type of Surgery

  Factor VIII Level Required
  (IU/dL or % of normal)

  Dose

  (IU/kg)

  Frequency of Doses

  (hours)

  Duration of Therapy

  (days)

  Minor

  Including tooth extraction

  30 – 60

  15 – 30

  12 – 24

  Until bleeding is resolved.

  Major

  Examples include tonsillectomy, inguinal herniotomy, synovectomy, total knee replacement, craniotomy, osteosynthesis, trauma.

  100

  50

  Pre-operatively to achieve 100% activity.

  6 – 12 to keep FVIII activity in desired range

  Until healing is complete.

  Routine Prophylaxis in Adults

  The recommended dose for routine prophylaxis is 25 units per kg of body weight three times per week.

  Routine Prophylaxis in Children

  The recommended dose for routine prophylaxis is 25 units per kg of body weight every other day.5

  2.2 Preparation and Reconstitution

  Kogenate FS is administered by intravenous injection after reconstitution. Patients should follow the specific reconstitution and administration procedures provided by their physicians.

  Reconstitute and administer Kogenate FS with the components provided with each package. If any component of the package is opened or damaged, do not use this component.

  Product reconstitution, administration, and handling of the administration set and needles must be done with caution because percutaneous puncture with a needle contaminated with blood can transmit infectious viruses, including HIV (AIDS) and hepatitis. Place needles in a sharps container after single use. Discard all equipment, including any reconstituted Kogenate FS product, in an appropriate container. Obtain immediate medical attention if injury occurs.

  For any questions about the handling, reconstitution and administration of Kogenate FS, contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937).

  For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling.

  The procedures below are provided as general guidelines for the reconstitution of Kogenate FS provided with a sterile vial adapter with 15-micrometer filter and a prefilled diluent syringe, which together serve as an alternative needleless reconstitution system.

  • Work on a clean surface and wash hands thoroughly using soap and warm water before performing the procedures. • Reconstitute Kogenate FS with the components provided with each package. If any component of the package is opened or damaged, do not use this component. • Filter the reconstituted product prior to administration to remove potential particulate matter in the solution. Filtering can be achieved by using the vial adapter.

  Vacuum Transfer and Reconstitution

  1. Prepare the product under aseptic conditions. 2. Warm both unopened vial and syringe in your hands to a comfortable temperature (do not exceed 37°C or 99°F). 3. Remove protective cap from the vial (A). Aseptically cleanse the rubber stopper with alcohol, being careful not to handle the rubber stopper. 4. Place product vial on a firm, non-skid surface. Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down (B). The adapter will snap over the vial cap. Do not remove the adapter housing at this step. 5. Holding the syringe by the barrel, snap the syringe cap off the tip (C). Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use. 6. Now remove and discard the adapter housing (D). 7. Attach the prefilled syringe to the threaded vial adapter by turning clockwise (E). 8. Grasp the plunger rod by the top plate and remove from carton. Avoid touching the sides and threads of the plunger rod. Immediately attach the plunger rod by turning it firmly clockwise into the threaded syringe rubber stopper (F). 9. Inject the diluent by slowly pushing down on the plunger rod (G). 10. Swirl vial gently until all material is dissolved (H). Do not shake vial. Be sure that the powder is completely dissolved. Do not use solutions containing visible particles or that are cloudy. 11. Withdraw solution into the syringe by holding the vial on end above the vial adapter and syringe (I) then draw the plunger rod out slowly and smoothly. Ensure that the entire content of the vial is drawn into the syringe. 12. With the plunger rod in place, remove the syringe from the vial adapter (the latter should remain attached to the vial). Attach the syringe to the administration set provided and inject intravenously (J). 13. If the same patient is to receive more than one bottle, reconstitute each bottle with the diluent syringe provided then combine solutions in a larger syringe (not provided) and administer as usual. 2.3 Administration

  For intravenous use after reconstitution only.

  • Inspect Kogenate FS visually for particulate matter and discoloration prior to administration, wherever solution and container permit. Do not use Kogenate FS if you notice any particulates or turbidity in the solution. • Store the reconstituted Kogenate FS at room temperature prior to administration, but administer it within 3 hours. • Administer Kogenate FS using the administration set provided over a period of 1 to 15 minutes. Adapt the rate of administration to the response of each individual patient. Determine the pulse rate before and during administration of Kogenate FS. If there is a significant increase in pulse rate, reduce the rate of administration or temporarily halt the infusion allowing the symptoms to disappear promptly.

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