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Rx Item-Hyperrho S/D Full Dose Syringe Each By Grifolis ASD Healthcare

NDC 13533-0631-02 UPC/GTIN No.3-13533-63102-4 Mfg.Part No.27252BRAND: HYPERRHO  NDC: 13533-0631-02,13533063102 UPC: 3-13533-63102-4,313533631024 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-Hyperrho S/D Full Dose Syringe Each By Grifolis ASD Healthcare

$95.39$90.58

item No.:RX430114Each NDC No.13533063102 UPC No.:313533631024 NDC No. 13533-0631-10 UPC/GTIN No. 3-13533-63102-4 MPN 27252 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. Rx430114each Hyperrho S/D FULL DOSE Syringe Each PACK by GRIFOLIS ASD Healthcare. Item No. 3430114 NDC No. 13533063110 UPC No. 3

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HYPERRHO S/D FULL DOSE- human rho(d) immune globulin solution
GRIFOLS USA, LLC

HyperRHO SD Full Dose cartonHyperRHO SD Full Dose Syringedigrams-a-b-cPregnant WomanPatient Id and Injection Card10 Pack Carton
DESCRIPTION

Rho (D) Immune Globulin (Human) - Hyper RHO� S/D Full Dose treated with solvent/detergent is a colorless to pale yellow or pink sterile solution of immune globulin containing antibodies to Rho (D) for intramuscular administration; it is preservative-free, in a latex-free delivery system. HyperRHO S/D Full Dose is prepared by cold ethanol fractionation from human plasma. 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. HyperRHO S/D Full Dose is formulated as a 15�18% protein solution at a pH of 6.4�7.2 in 0.21�0.32 M glycine. HyperRHO S/D Full Dose is then incubated in the final container for 21�28 days at 20�27�C.



The potency is equal to or greater than 1500 IU. Each single dose syringe contains sufficient anti-Rho (D) to effectively suppress the immunizing potential of 15 mL of Rho (D) positive red blood cells. [2-4]

The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperRHO S/D Full Dose 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 HyperRHO 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

HyperRHO S/D Full Dose is used to prevent isoimmunization in the Rho (D) negative individual exposed to Rho (D) positive blood as a result of a fetomaternal hemorrhage occurring during a delivery of an Rho (D) positive infant, abortion (either spontaneous or induced), or following amniocentesis or abdominal trauma. Similarly, immunization resulting in the production of anti-Rho (D) following transfusion of Rh positive red cells to an Rho (D) negative recipient may be prevented by administering Rho (D) Immune Globulin (Human). [5,6]

NDC 13533-0631-02 UPC/GTIN No.3-13533-63102-4 Mfg.Part No.27252
RX ITEM-Hyperrho S/D Full Dose Syringe E
NDC 13533-0631-02 UPC/GTIN No.3-13533-63102-4 Mfg.Part No.27252

BRAND: HYPERRHO  NDC: 13533-0631-02,13533063102 UPC: 3-13533-63102-4,313533631024 ASD Specialty Healthcare-Special Order
Hyperrho S/D Full Dose Syringe Each By G
BRAND: HYPERRHO NDC: 13533-0631-02,13533063102 UPC: 3-13533-63102-4,313533631024 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
RHO(D) IMMUNE GLOBULIN IN
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

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

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