Rx Item-Hyperhep 220 Ml (5) Vial 5Ml By ASD Healthcare

HYPERHEP B S/D � human hepatitis b virus immune globulin injection
Grifols Therapeutics Inc.


Syringe Usage1 mL Label1 mL Vial
DESCRIPTION

Hepatitis B Immune Globulin (Human) � Hyper HEP B� S/D treated with solvent/detergent is a colorless to pale yellow or pink sterile solution of hepatitis B hyperimmune immune globulin for intramuscular administration; it is preservative-free and latex-free. HyperHEP B S/D is prepared by cold ethanol fractionation from the plasma of donors with high titers of antibody to the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30�C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperHEP B S/D is formulated as a 15�18% protein solution at a pH of 6.4�7.2 in 0.21�0.32 M glycine. HyperHEP B S/D is then incubated in the final container for 21�28 days at 20�27�C. Each vial or syringe contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220 international units (IU) per mL.



The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperHEP B S/D has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III.

Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [22�25]

Studies of the HyperHEP B S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log10 ). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

CLINICAL PHARMACOLOGY

Hepatitis B Immune Globulin (Human) provides passive immunization for individuals exposed to the hepatitis B virus (HBV) as evidenced by a reduction in the attack rate of hepatitis B following its use. [1-6] The administration of the usual recommended dose of this immune globulin generally results in a detectable level of circulating anti-HBs which persists for approximately 2 months or longer. The highest antibody (IgG) serum levels were seen in the following distribution of subjects studied.

RX ITEM-Hyperhep 220 Ml (5) Vial 5Ml By
NDC 13533-0636-05 UPC/GTIN No.3-13533-63605-1 Mfg.Part No.27249

Hyperhep 220 Ml (5) Vial 5Ml By ASD Heal
BRAND: HYPERHEP NDC: 13533-0636-05,13533063605 UPC: 3-13533-63605-1,313533636051 ASD Specialty Healthcare-Special Order

HEPATITIS B IMMUNE GLOBUL
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