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
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.
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.
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)
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.
Sources
Gamastan S/d Manufacturers
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Grifols Usa, Llc
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Gamastan S/d | Grifols Usa, Llc
FOR INTRAMUSCULAR ADMINISTRATION ONLY. DO NOT ADMINISTER SUBCUTANEOUSLY OR INTRAVENOUSLY. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Administer GamaSTAN S/D intramuscularly (see PRECAUTIONS), preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. Do not use the gluteal region as an injection site because of the risk of injury to the sciatic nerve.(10) Doses over 10 mL should be divided and injected into several muscle sites to reduce local pain and discomfort. An individual decision as to which muscle is injected must be made for each patient based on the volume of material to be administered. Draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel. A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use. Hepatitis AGamaSTAN S/D in a dose of 0.01 mL/lb (0.02 mL/kg) is recommended for household and institutional hepatitis A case contacts.
The following doses of GamaSTAN S/D are recommended for persons who plan to travel in areas where hepatitis A is common.(3)
Length of Stay Dose Volume Less than 3 months 0.02 mL/kg 3 months or longer 0.06 mL/kg (repeat every 4–6 months) Measles (Rubeola)Give GamaSTAN S/D in a dose of 0.11 mL/lb (0.25 mL/kg) to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.(7)
To a susceptible child who is exposed to measles and who is immunocompromised, administer a dose of 0.5 mL/kg (maximum dose, 15 mL) of GamaSTAN S/D immediately.(8)
VaricellaIf Varicella-Zoster Immune Globulin (Human) is unavailable, GamaSTAN S/D at a dose of 0.6 to 1.2 mL/kg, promptly given, may also modify varicella.(5) For patients at risk of thrombosis, administer GamaSTAN S/D at the lower range of the recommended dose.
RubellaSome 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 at a dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion.(4)
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