Biotest Pharmaceuticals Corporation
Manufacturer Details
There are currently no manufacturer details available.
Biotest Pharmaceuticals Corporation Drugs
-
![Nabi-hb (Human Hepatitis B Virus Immune Globulin) Injection [Biotest Pharmaceuticals Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8847ff27-8bad-45fd-a9db-594e4f811803&name=nabihb5ml.jpg)
Nabi-hb
DOSAGE AND ADMINISTRATION This product is for intramuscular use only. The use of this product by the intravenous route is not indicated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. It is important to use a separate vial, sterile syringe, and needle for each individual patient, in order to prevent transmission of infectious agents from one person to another. Any vial of Nabi- HB, Hepatitis B Immune Globulin (Human) that has been entered should be used promptly. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately. Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine11. Acute Exposure to Blood Containing HBsAg Table 2 summarizes prophylaxis for percutaneous (needlestick, bite, sharps), ocular, or mucous membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure, as its value after seven days following exposure is unclear12. An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult the hepatitis B vaccine package insert for dosage information regarding the vaccine. For persons who refuse hepatitis B vaccine or are known non-responders to vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given one month after the first dose12. Table 2 Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure 12 Exposed Person Source Unvaccinated Vaccinated HBsAg-positive 1. Hepatitis B Immune Globulin (Human) X1 immediately 2. Initiate HB Vaccine series 1. Test exposed person for anti-HBs 2. If inadequate antibody, Hepatitis B immune Globulin (Human) X 1 immediately plus either HB Vaccine booster dose or second dose of Hepatitis B Immune Globulin (Human) one month later Known Source - High Risk for HBsAG-Positive 1. Initiate HB Vaccine series 2. Test source for HBsAG. If positive, Hepatitis B Immune Globulin (Human)1 X 1. Test source for HBsAG only if exposed is vaccine nonresponder; if source is HBsAG-Positive, Give Hepatitis B Immune Globulin (Human) 1 X immediately plus either HB vaccine booster dose or second dose of Hepatitis B immune Globulin (Human) one month later. Known Source - Low Risk for HBsAG - Positive Initiate HB Vaccine series Nothing Required Unknown Source Initiate HB vaccine series Nothing Required Hepatitis B Immune Globulin (Human) dose of 0.06 mL/kg IM. See manufacturers' recommendation for appropriate dose. Less than 10 mIU/mL anti-HBs by radioimmunoassay, negative by enzyme immunoassay. Two doses of Hepatitis B Immune Globulin (Human) is preferred if no response after at least four doses of vaccine. Prophylaxis of Infants Born to Mothers who are Positive for HBsAg with or without HBeAg Table 3 contains the recommended schedule of hepatitis B prophylaxis for infants born to mothers that are either known to be positive for HBsAg or have not been screened. Infants born to mothers known to be HBsAg-positive should receive 0.5 mL Hepatitis B Immune Globulin (Human) after physiologic stabilization of the infant and preferably within 12 hours of birth. The hepatitis B vaccine series should be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently with the Hepatitis B Immune Globulin (Human), but at a different site. Subsequent doses of the vaccine should be administered in accordance with the recommendations of the manufacturer. Women admitted for delivery, who were not screened for HBsAg during the prenatal period, should be tested. While test results are pending, the newborn infant should receive hepatitis B vaccine within 12 hours of birth (see manufacturers' recommendations for dose). If the mother is later found to be HBsAg-positive, the infant should receive 0.5 mL Hepatitis B Immune Globulin (Human) as soon as possible and within seven days of birth; however, the efficacy of Hepatitis B Immune Globulin (Human) administered after 48 hours of age is not known10,19. Testing for HBsAg and anti-HBs is recommended at 12-15 months of age. If HBsAg is not detectable and anti-HBs is present, the child has been protected12. Table 3 Recommended Schedule of Hepatitis B Immunoprophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus Infection 19 Age of Infant Administer Infant born to mother known to be HBsAG-Positive Infant born to mother not screened for HBsAG First Vaccination Birth (Within 12 hours) Birth (Within 12 hours) Hepatitis B Immune Globulin (Human) Birth (Within 12 hours) If mother is found to be HBsAG - positive, administer dose to infant as soon as possible, not later than 1 week after birth. Second Vaccination 1 month 1-2 months Third Vaccination 6 months 6 months See manufacturers' recommendations for appropriate dose. 0.5 mL administered IM at a site different from that used for the vaccine. See ACIP recommendation. Sexual Exposure to HBsAg-positive Persons All susceptible persons whose sexual partners have acute hepatitis B infection should receive a single dose of Hepatitis B Immune Globulin (Human) (0.06 mL/kg) and should begin the hepatitis B vaccine series, if not contraindicated, within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Administering the vaccine with Hepatitis B Immune Globulin (Human) may improve the efficacy of post exposure treatment. The vaccine has the added advantage of conferring long-lasting protection19. Household Exposure to Persons with Acute HBV Infection Prophylaxis of an infant less than 12 months of age with 0.5 mL Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless they had an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine19.
-
![Nabi-hb (Human Hepatitis B Virus Immune Globulin) Injection [Biotest Pharmaceuticals Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=17fda474-4e87-4ca4-b5f5-0df5978f83b7&name=FrontPackageDisplay.jpg)
Nabi-hb
DOSAGE AND ADMINISTRATION This product is for intramuscular use only. The use of this product by the intravenous route is not indicated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. It is important to use a separate vial, sterile syringe, and needle for each individual patient, in order to prevent transmission of infectious agents from one person to another. Any vial of Nabi- HB, Hepatitis B Immune Globulin (Human) that has been entered should be used promptly. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately. Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine11. Acute Exposure to Blood Containing HBsAg Table 2 summarizes prophylaxis for percutaneous (needlestick, bite, sharps), ocular, or mucous membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure, as its value after seven days following exposure is unclear12. An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult the hepatitis B vaccine package insert for dosage information regarding the vaccine. For persons who refuse hepatitis B vaccine or are known non-responders to vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given one month after the first dose12. Table 2 Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure 12 Exposed Person Source Unvaccinated Vaccinated HBsAg-positive 1. Hepatitis B Immune Globulin (Human) X1 immediately 2. Initiate HB Vaccine series 1. Test exposed person for anti-HBs 2. If inadequate antibody, Hepatitis B immune Globulin (Human) X 1 immediately plus either HB Vaccine booster dose or second dose of Hepatitis B Immune Globulin (Human) one month later Known Source - High Risk for HBsAG-Positive 1. Initiate HB Vaccine series 2. Test source for HBsAG. If positive, Hepatitis B Immune Globulin (Human)1 X 1. Test source for HBsAG only if exposed is vaccine nonresponder; if source is HBsAG-Positive, Give Hepatitis B Immune Globulin (Human) 1 X immediately plus either HB vaccine booster dose or second dose of Hepatitis B immune Globulin (Human) one month later. Known Source - Low Risk for HBsAG - Positive Initiate HB Vaccine series Nothing Required Unknown Source Initiate HB vaccine series Nothing Required Hepatitis B Immune Globulin (Human) dose of 0.06 mL/kg IM. See manufacturers' recommendation for appropriate dose. Less than 10 mIU/mL anti-HBs by radioimmunoassay, negative by enzyme immunoassay. Two doses of Hepatitis B Immune Globulin (Human) is preferred if no response after at least four doses of vaccine. Prophylaxis of Infants Born to Mothers who are Positive for HBsAg with or without HBeAg Table 3 contains the recommended schedule of hepatitis B prophylaxis for infants born to mothers that are either known to be positive for HBsAg or have not been screened. Infants born to mothers known to be HBsAg-positive should receive 0.5 mL Hepatitis B Immune Globulin (Human) after physiologic stabilization of the infant and preferably within 12 hours of birth. The hepatitis B vaccine series should be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently with the Hepatitis B Immune Globulin (Human), but at a different site. Subsequent doses of the vaccine should be administered in accordance with the recommendations of the manufacturer. Women admitted for delivery, who were not screened for HBsAg during the prenatal period, should be tested. While test results are pending, the newborn infant should receive hepatitis B vaccine within 12 hours of birth (see manufacturers' recommendations for dose). If the mother is later found to be HBsAg-positive, the infant should receive 0.5 mL Hepatitis B Immune Globulin (Human) as soon as possible and within seven days of birth; however, the efficacy of Hepatitis B Immune Globulin (Human) administered after 48 hours of age is not known10,19. Testing for HBsAg and anti-HBs is recommended at 12-15 months of age. If HBsAg is not detectable and anti-HBs is present, the child has been protected12. Table 3 Recommended Schedule of Hepatitis B Immunoprophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus Infection 19 Age of Infant Administer Infant born to mother known to be HBsAG-Positive Infant born to mother not screened for HBsAG First Vaccination Birth (Within 12 hours) Birth (Within 12 hours) Hepatitis B Immune Globulin (Human) Birth (Within 12 hours) If mother is found to be HBsAG - positive, administer dose to infant as soon as possible, not later than 1 week after birth. Second Vaccination 1 month 1-2 months Third Vaccination 6 months 6 months See manufacturers' recommendations for appropriate dose. 0.5 mL administered IM at a site different from that used for the vaccine. See ACIP recommendation. Sexual Exposure to HBsAg-positive Persons All susceptible persons whose sexual partners have acute hepatitis B infection should receive a single dose of Hepatitis B Immune Globulin (Human) (0.06 mL/kg) and should begin the hepatitis B vaccine series, if not contraindicated, within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Administering the vaccine with Hepatitis B Immune Globulin (Human) may improve the efficacy of post exposure treatment. The vaccine has the added advantage of conferring long-lasting protection19. Household Exposure to Persons with Acute HBV Infection Prophylaxis of an infant less than 12 months of age with 0.5 mL Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless they had an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine19.
-
![Bivigam (Human Immunoglobulin G) Injection, Solution [Biotest Pharmaceuticals Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a80da7b0-fd11-4dcd-b58c-1a475147476d&name=Bivigam59730-6502.jpg)
Bivigam
For Intravenous Use Only
2.1 Preparation and Handling
BIVIGAM is a clear or slightly opalescent, colorless to pale yellow solution. Inspect BIVIGAM visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or turbid, or contains particulate matter. Allow refrigerated product to come to room temperature before use. Do not freeze or heat. Do not use any solution that has been frozen or heated. DO NOT SHAKE. Do not mix BIVIGAM with other IGIV products or other intravenous medications. If large doses of BIVIGAM are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags and infused. Do not dilute BIVIGAM. BIVIGAM contains no preservatives. BIVIGAM vial is for single use only. Any vial of BIVIGAM that has been entered should be used promptly and any unused portion should be discarded immediately. Do not reuse or save for future use. Maintain BIVIGAM at room temperature during administration. Do not use after expiration date.2.2 Recommended Dose
As there are significant differences in the half-life of IgG among patients with primary humoral 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 recommended dose of BIVIGAM for replacement therapy in primary humoral immunodeficiency (PI) is 300 to 800 mg/kg body weight administered every 3 to 4 weeks. The dosage may be adjusted over time to achieve the desired trough levels and clinical response.
BIVIGAM dose adjustments may be required in patients who fail to maintain trough total IgG concentrations of at least 500 mg/dL with a target of 600 mg/dL. Starting with the second infusion, the dose will be adjusted proportionally, targeting a trough of more than equal to 600 mg/dL, based on the previous trough and the associated dose.
2.3 Administration
It has been reported that the frequency of adverse drug reactions to IGIV increases with the infusion rate. Initial infusion rates should be slow. If there are no adverse drug reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate. For patients experiencing adverse drug reactions, it is advisable to reduce the infusion rate in subsequent infusions.
Table 1: Recommended Infusion Rates for BIVIGAM
Monitor patient vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients judged to be at risk for renal dysfunction or thrombotic events, administer BIVIGAM at the minimum infusion rate practicable, and consider discontinuation of administration if renal function deteriorates (see Boxed Warning, Warnings and Precautions [5.1, 5.3]
Sign Up for a Free Account