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Proquad

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Proquad

INDICATIONS

ProQuad (measles mumps rubella varicella vaccine live) is indicated for simultaneous vaccination against measles, mumps, rubella, and varicella in children 12 months through 12 years of age.

ProQuad (measles mumps rubella varicella vaccine live) may be used in children 12 months through 12 years of age if a second dose of measles, mumps and rubella vaccine is to be administered.

DOSAGE AND ADMINISTRATION

Dosage

When reconstituted, each vial of ProQuad (measles mumps rubella varicella vaccine live) contains a single 0.5-mL dose. Individuals 12 months through 12 years of age should receive a single 0.5-mL dose of ProQuad (measles mumps rubella varicella vaccine live) administered subcutaneously. At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R II, and a dose of ProQuad (measles mumps rubella varicella vaccine live) . If for any reason a second dose of varicella-containing vaccine is required, at least 3 months should elapse between administration of the 2 doses.

Preparation

CAUTION: Preservatives, antiseptics, detergents, and other anti-viral substances may inactivate the vaccine. Use only sterile syringes that are free of preservatives, antiseptics, detergents and other anti- viral substances for reconstitution and injection of ProQuad (measles mumps rubella varicella vaccine live) .

Withdraw the entire volume of the supplied diluent into a syringe. Use only the diluent supplied with the vaccine since it is free of preservatives or other anti-viral substances.

Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely.

Visually inspect the vaccine before and after reconstitution for particulate matter and discoloration prior to administration. Before reconstitution, the lyophilized vaccine is a white to pale yellow compact crystalline plug. ProQuad (measles mumps rubella varicella vaccine live) , when reconstituted, is a clear pale yellow to light pink liquid.

Withdraw the entire amount of the reconstituted vaccine from the vial into the same syringe and inject the entire volume.

TO MINIMIZE LOSS OF POTENCY, THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION. DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.

Method of Administration

FOR SUBCUTANEOUS ADMINISTRATION

DO NOT INJECT INTRAVASCULARLY

Use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.

The vaccine is to be injected subcutaneously in the outer aspect of the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

Properly dispose of all needles and syringes. Do not recap needles.

Use With Other Vaccines

If another vaccine is administered concomitantly, a different injection site should be used.

See PRECAUTIONS: DRUG INTERACTIONS, Use With Other Vaccines.

HOW SUPPLIED

No. 4999-ProQuad (measles mumps rubella varicella vaccine live) is supplied as follows: (1) a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4999-00 (package A); and (2) a separate package of 10 vials of sterile water diluent (package B).

Storage

During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of 5°F (-15°C) or colder.

Before reconstitution, store the lyophilized vaccine continuously in a freezer (e.g., chest, frost- free) for up to 18 months, at an average temperature of 5°F (-15°C) or colder. Any freezer that reliably maintains an average temperature of 5°F or colder and has a separate sealed freezer door is acceptable for storing ProQuad (measles mumps rubella varicella vaccine live) .

ProQuad (measles mumps rubella varicella vaccine live) may be stored at refrigerator temperature (36 to 46°F, 2 to 8°C) for up to 72 hours prior to reconstitution. Vaccine stored at 36 to 46°F which is not used within 72 hours of removal from 5°F storage should be discarded.

For information regarding stability under conditions other than those recommended, call 1-800- MERCK-90.

Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses.

DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.

DO NOT FREEZE RECONSTITUTED VACCINE.

Diluent should be stored separately at room temperature (68 to 77°F, 20 to 25°C), or in a refrigerator (36 to 46°F, 2 to 8°C).

Dist. by: MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Issued October 2007. FDA Rev date: 10/23/2007

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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