Rx Item-Hypertet Tetanus Immune Globulin 250 Unit Syringe 1Ml By ASD Healthcare

HYPERTET S/D - human clostridium tetani toxoid immune globulin injection
TALECRIS BIOTHERAPEUTICS, INC.


Syringe UsageLabelVial Label
DESCRIPTION

Tetanus Immune Globulin (Human) - HyperTET TM S/D treated with solvent/detergent is a sterile solution of tetanus hyperimmune immune globulin for intramuscular administration; it is preservative-free, in a latex-free delivery system. HyperTET S/D is prepared by cold ethanol fractionation from the plasma of donors immunized with tetanus toxoid. 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. HyperTET 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. HyperTET 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 Antitoxin and the U.S. Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per container.



The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperTET 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.(18-21)

Studies of the HyperTET 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 occurrence of tetanus in the United States has decreased dramatically from 560 reported cases in 1947, when national reporting began, to a record low of 48 reported cases in 1987.(1) The decline has resulted from widespread use of tetanus toxoid and improved wound management, including use of tetanus prophylaxis in emergency rooms.(2)
INDICATIONS AND USAGE

HyperTET S/D is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus.(7,8,15)

A thorough attempt must be made to determine whether a patient has completed primary vaccination. Patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.(2)

RX ITEM-Hypertet Tetanus Immune Globulin
NDC 13533-0634-02 UPC/GTIN No.3-13533-63402-5 Mfg.Part No.27254

Hypertet Tetanus Immune Globulin 250 Uni
BRAND: HYPERTET NDC: 13533-0634-02,13533063402 UPC: 3-13533-63402-5,313533634025 ASD Specialty Healthcare-Special Order

TETANUS IMMUNE GLOBULIN/P
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

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

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