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Mumps Skin Test Antigen

"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...

Mumps Skin Test Antigen

WARNINGS

This product contains dry natural latex rubber as follows: The stopper to the vial contains dry natural latex rubber.

Neurologic complications, such as encephalopathies or peripheral-nervous systems disorders, or anaphylactic reactions have followed the administration of almost all biologics, although these have not been reported after the injection of MSTA.

PRECAUTIONS

General

Care is to be taken by the health-care provider for the safe and effective use of this product and to possible sensitivity to dry natural latex rubber.

EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE TO COMBAT UNEXPECTED ANAPHYLACTIC OR OTHER ALLERGIC REACTIONS.

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis or other infectious agents from person to person. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.

Special care should be taken to ensure the product is not injected into a blood vessel.

The antigen must be given intradermally. If it is injected subcutaneously, no reaction or an unreliable reaction may occur.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

MSTA has not been evaluated for its carcinogenic, mutagenic potentials or impairment of fertility.

Pregnancy

Reproductive Studies - Pregnancy Category C

Animal reproduction studies have not been conducted with Mumps Skin Test Antigen. It is not known whether Mumps Skin Test Antigen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mumps Skin Test Antigen should be given to a pregnant woman only if clearly needed. There are no carefully done studies available on the effect ofthe drug on later growth, development and functional maturation of the child.

Usage In Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mumps Skin Test Antigen is administered to a nursing woman.

Pediatric Use

SAFETY AND EFFECTIVENESS OF MSTA IN CHILDREN HAVE NOT BEEN ESTABLISHED.

Usage In Young Adults

SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN YOUNG ADULTS WHO HAVE BEEN IMMUNIZED WITH MUMPS VACCINE.

Last reviewed on RxList: 12/19/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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