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Details with Side Effects
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.
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.
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.
Additional Tev-Tropin Information
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