2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

Do not administer intravenously.

2.1 Dose

Indication	Dosage	Instruction
* 0.05 milliliter per pound † 0.11 milliliter per pound
Prophylaxis for exposure to hepatitis A	0.1 mL/kg*	Administer within two weeks of prior exposure for household and institutional hepatitis A case contacts.
		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 month(9,10)
	0.2 mL/kg	if the length of stay will be up to 2 months(9,10)
	0.2 mL/kg	if the length of stay will be 2 months or longer; repeat every 2 months.(9,10)
Prevent or modify measles in a susceptible person exposed fewer than six days previously	0.25 mL/kg†	Administer to a susceptible person within 6 days of exposure.
	0.5 mL/kg	Immediately administer (maximum dose, 15 mL) to an immunocompromised child.
Modify varicella	0.6 mL/ kg to 1.2 mL/kg	Administer promptly only if Varicella-Zoster Immune Globulin (Human) is unavailable.
Modify rubella only in an exposed woman who will not consider a therapeutic abortion	0.55 mL/kg	Only administer to an exposed pregnant woman who will not consider a therapeutic abortion.

If the product shows any sign of tampering, do not use it and notify Grifols Therapeutics LLC immediately [1-800-520-2807].
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. GAMASTAN is a clear or slightly opalescent, and colorless to pale yellow sterile solution.

Administer GAMASTAN intramuscularly, 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.(4) [see Warnings and Precautions (5.3)]
Draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel. [see Warnings and Precautions (5.3)]
Divide and inject doses greater than 10 mL 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.
If Hepatitis A Vaccine is recommended along with GAMASTAN, administer simultaneously but at separate anatomical sites.