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Tev-Tropin

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Tev-Tropin

Tev-Tropin

INDICATIONS

TEV-TROPIN® is indicated for the treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone.

DOSAGE AND ADMINISTRATION

A dosage of up to 0.1 mg/kg (0.3 lU/kg) of body weight administered 3 times per week by subcutaneous injection is recommended. TEV-TROPIN® should be reconstituted with l-5mL of bacteriostatic 0.9% sodium chloride for injection, USP (benzyl alcohol preserved).* The stream of normal saline should be aimed against the side of the vial to prevent foaming. Swirl the vial with a GENTLE rotary motion until the contents are completely dissolved and the solution is clear. DO NOT SHAKE. Since TEV-TROPIN is a protein, shaking or vigorous mixing will cause the solution to be cloudy. If the resulting solution is cloudy or contains particulate matter, the contents MUST NOT be injected.

* Benzyl alcohol as a preservative in bacteriostatic normal saline, USP, has been associated with toxicity in newborns. When administering TEV-TROPIN® to newborns, reconstitute with sterile normal saline for injection, USP.

Occasionally, after refrigeration, some cloudiness may occur. This is not unusual for proteins like TEV-TROPIN®. Allow the product to warm to room temperature. If cloudiness persists or particulate matter is noted, the contents MUST NOT be used.

Before and after injection, the septum of the vial should be wiped with rubbing alcohol or an alcoholic antiseptic solution to prevent contamination of the contents by repeated needle insertions.

TEV-TROPIN® can be administered using (1) a standard sterile disposable syringe or (2) using a Tjet Needle-Free injection device. For proper use, please refer to the User's Manual provided with the administration device.

Stability and Storage

Before Reconstitution - Vials of TEV-TROPIN® are stable when refrigerated at 36° to 46°F (2° to 8°C). Expiration dates are stated on the labels.

After Reconstitution - Vials of TEV-TROPIN® are stable for up to 14 days when reconstituted with bacteriostatic 0.9% sodium chloride (normal saline), USP, and stored in a refrigerator at 36° to 46°F (2° to 8°C). Do not freeze the reconstituted solution.

HOW SUPPLIED

TEV-TROPIN® (somatropin, rDNA origin, for injection) is supplied as 5 mg (15 IU) of lyophilized, sterile somatropin per vial.

Each 5 mg carton contains one vial of TEV-TROPIN® (5 mg per vial) and one vial of diluent [5-mL of bacteriostatic 0.9% sodium chloride for injection, USP (benzyl alcohol preserved)], and is supplied in single cartons or cartons of six.

Manufactured In Israel By: Bio-Technology General (Israel) Ltd. Be'er Tuvia, Israel, Distributed By: Gate Pharmaceuticals., Div. of Teva Pharmaceuticals USA Sellersville, PA 18960. Revised: 07/2011

Last reviewed on RxList: 8/29/2011
This monograph has been modified to include the generic and brand name in many instances.

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