Clinical Information: hepatitis B immune globulin INTRAMUSC VIAL >1560/5ML
Gen. Code and Des.
62278 hepatitis B immune globulin INTRAMUSC VIAL >1560/5ML
GCN and Des.
98066 hepatitis B immune globulin INTRAMUSC VIAL >1560/5ML
Strength
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80040000 ANTITOXINS AND IMMUNE GLOBULINS
Active Ingredients
3048 hepatitis B immune globulin
Inactive Ingredients
2551 polysorbates 9005645
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DESCRIPTION
Hepatitis B Immune Globulin (Human), Nabi-HB, is a sterile solution of immunoglobulin (5 ± 1% protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma ...
CLINICAL PHARMACOLOGY
Hepatitis B Immune Globulin (Human) products provide passive immunization for individuals exposed to the hepatitis B virus as evidenced by a reduction in the attack rate of hepatitis B following ...
INDICATIONS AND USAGE
Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure ...
CONTRAINDICATIONS
Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB, Hepatitis B Immune Globulin (Human), or any other human immune globulin ...
WARNINGS
In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB, Hepatitis B Immune Globulin (Human), should be given only if ...
PRECAUTIONS
General - Nabi-HB, Hepatitis B Immune Globulin (Human), must be administered only intramuscularly for post-exposure prophylaxis. The preferred sites for intramuscular injections are the ...
ADVERSE REACTIONS SECTION
Fifty male and female volunteers received Nabi-HB, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials - 20. The number of patients with reactions related to ...
OVERDOSAGE
Although no data are available, clinical experience reported with other human immune globulins suggests that the only manifestations of overdose with Nabi-HB, Hepatitis B Immune Globulin (Human) ...
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 ...
HOW SUPPLIED
Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as: NDC Number Contents - 69800-4202-1 a carton containing a 1 mL dose in a single-use vial (>312 IU) and package ...
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.
REFERENCES
Cohn E.J., Strong W.L., Mulford D.J., Ashworth J.N., Melin M., Taylor H.L. Preparation and Properties of Serum and Plasma Proteins IV. A system for the separation into fractions of the protein ...
PRINCIPAL DISPLAY PANEL - NDC: 69800-4202-2 - Vial Label
Nabi-HB Vial 1 mL
PRINCIPAL DISPLAY PANEL - NDC: 69800-4202-1 - Carton
Nabi-HB Carton 1 mL
PRINCIPAL DISPLAY PANEL - NDC: 69800-4203-2 - Vial Label
Nabi-HB Vial 5 mL
PRINCIPAL DISPLAY PANEL - NDC: 69800-4202-1 - Carton
Nabi-HB Carton 5 mL
INGREDIENTS AND APPEARANCE
Product Information
