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Protropin

"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"...

Protropin

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

PATIENT INFORMATION

Patients being treated with growth hormone and/or their parents should be informed of the potential benefits and risks associated with treatment. If home use is determined to be desirable by the physician, instructions on appropriate use should be given, including a review of the contents of the Patient Information Insert. This information is intended to aid in the safe and effective administration of the medication. It is not a disclosure of all possible adverse or intended effects.

STABILITY AND STORAGE

Before Reconstitution--Protropin® (somatrem for injection), and Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), must be stored at 2-8°C/36-46°F (under refrigeration). Avoid freezing the vials of Protropin (somatrem) and Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). Expiration dates are stated on the labels.

After Reconstitution--Vial contents are stable for 14 days when reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) at 2-8°C/36-46°F (under refrigeration). Store the unused portion of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) at 2-8°C/36-46°F (under refrigeration). Avoid freezing the vials of Protropin (somatrem) and Bacteriostatic Water for Injection, USP (benzyl alcohol preserved).

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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