"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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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
The recommended dose is up to 0.1 mg/kg administered subcutaneously three (3) times per week ( up to 0.3 mg/kg/week).
Tev-Tropin 5 mg should be reconstituted with 1-5 mL of bacteriostatic 0.9% sodium chloride for injection, USP (benzyl alcohol preserved). Reconstituted Tev-Tropin 5 mg vials should not be used if the patient has a known sensitivity to benzyl alcohol. 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.
Tev-Tropin 10 mg should be reconstituted with 1 mL syringe of bacteriostatic water for injection containing 0.33% metacresol as a preservative. Reconstituted Tev-Tropin 10 mg vials should not be used if the patient is allergic to metacresol.
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.
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 5 mg and 10 mg can be administered using a standard sterile disposable syringe or a Tjet Needle-Free injection device. For proper use, please refer to the User's Manual provided with the administration device.
Stability And Storage
Vials of Tev-TropinPP(5 and 10 mg) are stable when refrigerated at 36° to 46°F (2° to 8°C). Avoid freezing the accompanying diluent. Expiration dates are stated on the labels.
Tev-Tropin 5 mg is 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-TropinPP10 mg is stable for up to 28 days when reconstituted with 1 mL syringe of bacteriostatic water for injection containing 0.33% metacresol as a preservative, 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 and 10 mg of lyophilized, sterile somatropin per vial.
Tev-Tropin 5 mg carton (NDC 57844-713-19) 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.
Tev-Tropin 10 mg carton (NDC 57844-716-19) contains one vial of Tev-Tropin (10 mg per vial), one syringe of diluent [1 mL of bacteriostatic water for injection with 0.33% metacresol as preservative] and a 25G reconstitution needle, and is supplied in single cartons.
Tev-Tropin 10 mg carton (NDC 57844-715-19) contains one vial of Tev-Tropin (10mg per vial), one syringe of diluent [1 mL of bacteriostatic water for injection with 0.33% metacresol as preservative], 1 vial adapter, and is supplied in single cartons.
Distributed By: Teva Select Brands, Horsham, PA 19044 Division of Teva Pharmaceuticals USA, Inc. Revised: Feb 2015
Last reviewed on RxList: 3/20/2015
This monograph has been modified to include the generic and brand name in many instances.
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