GAMASTAN (immune globulin- human injection, solution GAMASTAN (immune globulin- human injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

Human Immunoglobulin G (UNII: 66Y330CJHS) (Human Immunoglobulin G - UNII:66Y330CJHS)

Disponible des:

GRIFOLS USA, LLC

Designació comuna internacional (DCI):

Human Immunoglobulin G

Composición:

Human Immunoglobulin G 0.165 g in 1 mL

Vía de administración:

INTRAMUSCULAR

indicaciones terapéuticas:

GAMASTAN is a human immune globulin indicated for: GAMASTAN is indicated for prophylaxis following exposure to hepatitis A.(1,2) The prophylactic value of GAMASTAN is greatest when given before or soon after exposure to hepatitis A. GAMASTAN is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously. GAMASTAN is indicated to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.(3) A susceptible person is one who has not been vaccinated and has not had measles previously. - GAMASTAN 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.(3) - GAMASTAN is also indicated for pregnant women without evidence of immunity. - Do not give GAMASTAN and measles vaccine at the same time. If a child is older than 12 months and has received GAMASTAN, give measles vaccine about five months later when the measles a

Resumen del producto:

GAMASTAN is supplied in 2 mL and 10 mL single dose vials. GAMASTAN contains no preservative and is not made with natural rubber latex.

Estat d'Autorització:

Biologic Licensing Application

Fitxa tècnica

GAMASTAN- IMMUNE GLOBULIN (HUMAN) INJECTION, SOLUTION
GAMASTAN- IMMUNE GLOBULIN (HUMAN) INJECTION, SOLUTION
GRIFOLS USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GAMASTAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GAMASTAN.
GAMASTAN[IMMUNE GLOBULIN (HUMAN)], SOLUTION FOR INTRAMUSCULAR
INJECTION
INITIAL U.S. APPROVAL: 1944
WARNING: THROMBOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
GAMASTAN. RISK
FACTORS MAY INCLUDE: ADVANCED AGE, PROLONGED IMMOBILIZATION,
HYPERCOAGULABLE
CONDITIONS, HISTORY OF VENOUS OR ARTERIAL THROMBOSIS, USE OF
ESTROGENS, INDWELLING
CENTRAL VASCULAR CATHETERS, HYPERVISCOSITY, AND CARDIOVASCULAR RISK
FACTORS.
THROMBOSIS MAY OCCUR IN THE ABSENCE OF KNOWN RISK FACTORS._ [SEE
WARNINGS AND_
_PRECAUTIONS (5.2), PATIENT COUNSELING INFORMATION (17)]_
FOR PATIENTS AT RISK OF THROMBOSIS, DO NOT EXCEED THE RECOMMENDED DOSE
OF
GAMASTAN. ENSURE ADEQUATE HYDRATION IN PATIENTS BEFORE ADMINISTRATION.
MONITOR
FOR SIGNS AND SYMPTOMS OF THROMBOSIS AND ASSESS BLOOD VISCOSITY IN
PATIENTS AT RISK
FOR HYPERVISCOSITY. _[WARNINGS AND PRECAUTIONS (5.2)]_
INDICATIONS AND USAGE
GAMASTAN is a human immune globulin indicated:
For prophylaxis following exposure to hepatitis A. (1.1)
To prevent or modify measles in a susceptible person exposed fewer
than 6 days previously. (1.2)
To modify varicella. (1.3)
To modify rubella in exposed women who will not consider a therapeutic
abortion. (1.4)
Not indicated for routine prophylaxis or treatment of viral hepatitis
type B, rubella, poliomyelitis, mumps
or varicella. (1.5)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR USE ONLY. DO NOT ADMINISTER INTRAVENOUSLY.
INDICATION
DOSAGE
INSTRUCTION
Hepatitis A (2.1)
0.1 mL/kg
Administer within two weeks of prior exposure
to hepatitis A.
Administer before departure to persons traveling to
areas with endemic hepatitis A:
0.1 mL/kg
if the length of stay will be up to 1