Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN (UNII: XII270YC6M) (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN - UNII:XII270YC6M)
ADMA Biologics, Inc
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU] in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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 to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings: Acute Exposure to Blood Containing HBsAg Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum. Perinatal Exposure of Infants Born to HBsAg-positive Mothers Infants born to mothers positive for HBsAg with or without HBeAg12. Sexual Exposure to HBsAg-positive Persons Sexual partners of HBsAg-positive persons. Household Exposure to Persons with Acute HBV Infection Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other household contacts with an identifiable blood exposure to the i
HOW SUPPLIED Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as: NDC Number Contents 59730-4202-1 a carton containing a 1 mL dose in a single-use vial (>312 IU) and package insert 59730-4203-1 a carton containing a 5 mL dose in a single-use vial (>1560 IU) and package insert
Biologic Licensing Application
NABI-HB- HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN INJECTION ADMA BIOLOGICS, INC ---------- HEPATITIS B IMMUNE GLOBULIN (HUMAN) NABI-HB SOLVENT DETERGENT TREATED AND FILTERED DESCRIPTION Hepatitis B Immune Globulin (Human), Nabi-HB, is a sterile solution of immunoglobulin (5 1 percent protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs. The plasma is processed using a modified Cohn 6 Oncley 9 cold-alcohol fractionation process1, 2 with two added viral reduction steps described below. Nabi-HB is formulated in 0.042-0.108 M sodium chloride, 0.10-0.20 M glycine, and 0.005-0.050 percent polysorbate 80, at pH 5.8-6.5. The product is supplied as a nonturbid sterile liquid in single dose vials and appears as clear to opalescent. It contains no preservative and is intended for single use by the intramuscular route only. Each plasma donation used for the manufacture of Nabi-HB is tested for the presence of hepatitis B virus (HBV) surface antigen (HBsAg), human immunodeficiency viruses (HIV) 1/2, and hepatitis C virus (HCV) antibodies. In addition, pooled samples of Source Plasma used in the manufacture of this product are tested by FDA licensed Nucleic Acid Testing (NAT) for HIV and HCV and found to be negative. Investigational NAT for hepatitis A virus (HAV) and HBV is also performed on pooled samples of all Source Plasma used, and found to be negative; however, the significance of a negative result has not been established. Investigational NAT for parvovirus B19 (B19) is also performed on pooled samples of all Source Plasma and the limit for B19 DNA in a manufacturing pool is set not to exceed 104 IU/mL. The manufacturing steps for Nabi-HB are designed to reduce the risk of transmission of viral disease. The solvent/detergent treatment step, using tri-n-butyl phosphate and Triton X-100, is effective in inactivating known enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency Les hele dokumentet