Gamastan S/d

Gamastan S/d

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Questions & Answers

Side Effects & Adverse Reactions

Administer GamaSTAN S/D cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.(9)

GamaSTAN S/D is made from human plasma. Because GamaSTAN S/D is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for GamaSTAN S/D. ALL infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807].

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Hepatitis A

The prophylactic value of GamaSTAN S/D is greatest when given before or soon after exposure to hepatitis A. GamaSTAN S/D is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.

Measles (Rubeola)

To prevent or modify measles give GamaSTAN S/D in a susceptible person exposed fewer than 6 days previously.(7) A susceptible person is one who has not been vaccinated and has not had measles previously. GamaSTAN S/D may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest.(7) GamaSTAN S/D and measles vaccine should not be given at the same time.(7) If a child is older than 12 months and has received GamaSTAN S/D, he should be given measles vaccine about 3 months later when the measles antibody titer will have disappeared.

If a susceptible child exposed to measles is immunocompromised, GamaSTAN S/D should be given immediately.(8)

Do not administer measles vaccine or any other live viral vaccine to children who are immunocompromised.

Varicella

Passive immunization against varicella in immunosuppressed patients is best accomplished by use of Varicella-Zoster Immune Globulin (Human) [VZIG]. If VZIG is unavailable, GamaSTAN S/D, promptly given, may also modify varicella.(5)

Rubella

The routine use of GamaSTAN S/D for prophylaxis of rubella in early pregnancy is of dubious value and cannot be justified.(6) Some studies suggest that the use of GamaSTAN S/D in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, GamaSTAN S/D may benefit those women who will not consider a therapeutic abortion.(4)

History

There is currently no drug history available for this drug.

Other Information

Immune Globulin (Human) — GamaSTAN® S/D treated with solvent/detergent is a colorless to pale yellow or pink sterile solution of immune globulin for intramuscular administration; it is preservative-free and latex-free. GamaSTAN S/D 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. GamaSTAN 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. GamaSTAN S/D is then incubated in the final container for 21–28 days at 20–27°C.

The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for GamaSTAN 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. 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.  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.(11-14)

Studies of the GamaSTAN 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.

Gamastan S/d Manufacturers


  • Grifols Usa, Llc
    Gamastan S/d (Immune Globulin (Human)) Injection [Grifols Usa, Llc]

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