Data from FDA - Curated by Toby Galbraith - Last updated 18 April 2017
FDA (Food and Drug Administration, USA)
CONTRAINDICATIONS Individuals known to have had an anaphylactic or
Nabi-HB contains not more than
The physician must weigh the potential
The number of patients with reactions related to the administration of Nabi-HB included local reactions such as erythema 6 (12 percent) and
The majority (92 percent) of
However, these reactions, although
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
Any vial of Nabi - HB, Hepatitis B Immune Globulin (Human) that has been entered should be
Do not reuse or
This product contains
Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to one
An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as
Consult the hepatitis B vaccine package insert for dosage information regarding the vaccine.
Hepatitis B Immune
Globulin (Human) X1 immediately 2.
Initiate HB Vaccine series 1.
Initiate HB Vaccine series 2.
Test source for HBsAG.
Test source for HBsAG only if
Known Source -
Less than 10 mIU/mL anti-HBs by radioimmunoassay,
Two doses of Hepatitis B Immune Globulin (Human) is
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
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
While test results are pending, the newborn infant should receive hepatitis B vaccine within 12 hours of birth (see manufacturers '
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
If HBsAg is not detectable and anti-HBs is present, the child has been protected12.
Human) Birth (Within 12 hours) If mother is found to be HBsAG -
Second Vaccination 1 month 1-2 months Third Vaccination 6 months 6 months See manufacturers '
0.5 mL administered IM at a site different from that used for the vaccine.
Sexual Exposure to HBsAg-positive Persons All
Administering the vaccine with Hepatitis B Immune Globulin (Human) may
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
Such exposures should be treated like sexual exposures.
If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine19.
|Agency product number||XII270YC6M|
|Date Last Revised||25-08-2010|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||STORAGE Refrigerate between 2 to 8 C (36 to 46 F). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.|
|Marketing authorisation holder||Biotest Pharmaceuticals Corporation|