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RX ITEM-Hyperrab 150 Unit/1 Vial 10Ml By Grifolis ASD Healthcare

NDC 13533-0618-10 UPC/GTIN No.3-13533-61810-2 Mfg.Part No.27251BRAND: HYPERRAB  NDC: 13533-0618-10,13533061810 UPC: 3-13533-61810-2,313533618102 ASD Specialty Healthcare-Special OrderOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Hyperrab 150 Unit/1 Vial 10Ml By Grifolis ASD Healthcare

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item No.:RX332243 NDC No.13533061810 UPC No.:313533618102 NDC No.13533-0618-10 UPC/GTIN No.3-13533-61810-2 MPN 27251 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx332243 Hyperrab 150 Unit/1 Vial 10ml by ASD Healthcare Item No.3332243 NDC No.13533061810 UPC No.313533618102 Other Name Hyperrab The

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HYPERRAB S/D - human rabies virus immune globulin injection
Grifols Therapeutics Inc.


HyperRAB CartonHyperRAB Vial
DESCRIPTION

Rabies Immune Globulin (Human) - Hyper RAB� S/D treated with solvent/detergent is a colorless to pale yellow or pink sterile solution of antirabies immune globulin for intramuscular administration; it is preservative-free and latex-free. HyperRAB S/D is prepared by cold ethanol fractionation from the plasma of donors hyperimmunized with rabies vaccine. 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. HyperRAB 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. HyperRAB S/D is then incubated in the final container for 21�28 days at 20�27�C. The product is standardized against the U.S. Standard Rabies Immune Globulin to contain an average potency value of 150 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody.



The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperRAB 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. [27-30]

Studies of the HyperRAB 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

The usefulness of prophylactic rabies antibody in preventing rabies in humans when administered immediately after exposure was dramatically demonstrated in a group of persons bitten by a rabid wolf in Iran. [1,2] Similarly, beneficial results were later reported from the U.S.S.R. [3] Studies coordinated by WHO (World Health Organization) helped determine the optimal conditions under which antirabies serum of equine origin and rabies vaccine can be used in man. [4-7] These studies showed that serum can interfere to a variable extent with the active immunity induced by the vaccine, but could be minimized by booster doses of vaccine after the end of the usual dosage series.

NDC 13533-0618-10 UPC/GTIN No.3-13533-61810-2 Mfg.Part No.27251
RX ITEM-Hyperrab 150 Unit/1 Vial 10Ml By
NDC 13533-0618-10 UPC/GTIN No.3-13533-61810-2 Mfg.Part No.27251

BRAND: HYPERRAB  NDC: 13533-0618-10,13533061810 UPC: 3-13533-61810-2,313533618102 ASD Specialty Healthcare-Special Order
Hyperrab 150 Unit/1 Vial 10Ml By Grifoli
BRAND: HYPERRAB NDC: 13533-0618-10,13533061810 UPC: 3-13533-61810-2,313533618102 ASD Specialty Healthcare-Special Order

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
RABIES IMMUNE GLOBULIN/PF
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.