País: Singapur
Idioma: inglés
Fuente: HSA (Health Sciences Authority)
Hepatitis B Immune Globulin (Human)
GRIFOLS ASIA PACIFIC PTE. LTD.
J06BB04
15-18%
INJECTION
Hepatitis B Immune Globulin (Human) 15-18%
INTRAMUSCULAR
Prescription Only
Grifols Therapeutics LLC
ACTIVE
2008-07-15
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 log 10 ). 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: 7 DAY % OF SUBJECTS ____ ________________ 3 38.9% 7 41.7% 14 11.1% 21 8.3% Mean values for half-life were between 17.5 and 25 days, with the shortest being 5.9 days and the longest 35 days. 7 Cases of type B hepatitis are rarely seen following exposure to HBV in persons with preexisting anti-HBs. No confirmed instance of transmission of hepatitis B has been associated with this product. In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), HyperRAB® S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results suggest that p Leer el documento completo
colors: PMS 287 K/P Corporation Job No. 92097 / 113099 Client: Grifols Therapeutics LLC Cat. No. 3062848 Fonts: Stone Serif, Trade Gothic Edits: reb Date: 3/23/2022, 2/2/2023 ID: 1,11,15 Size: 7" x 16" (Spec 9028538) Proof 2 DESCRIPTION HyperHEP B ® is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution of human hepatitis B immune globulin for intramuscular administration. HyperHEP B contains no preservative. HyperHEP B is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperHEP B consists of a 15 to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The product 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. When medicinal biological products are administered, the risk of infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogen. In the manufacturing process of HyperHEP B, there are several steps with the capacity for viral inactivation or removal.(1) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: - Caprylate precipitation/depth filtration - Caprylate incubation - Depth filtration - Column chromato Leer el documento completo