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Tev-Tropin

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Tev-Tropin

TEV-TROPIN®
[somatropin (rDNA origin) for injection] 5 mg (15 IU)

Tev-Tropin

DRUG DESCRIPTION

TEV-TROPIN® (somatropin, rDNA origin, for injection), a polypeptide of recombinant DNA origin, has 191 amino acid residues and a molecular weight of about 22,124 daltons. It has an amino acid sequence identical to that of human growth hormone of pituitary origin. TEV-TROPIN® is a strain of Escherichia coli modified by insertion of the human growth hormone gene.

TEV-TROPIN® is a sterile, white, lyophilized powder, intended for subcutaneous administration, after reconstitution with bacteriostatic 0.9% sodium chloride injection, USP, (normal saline) (benzyl alcohol preserved). The quantitative composition of the lyophilized drug per vial is:

5 mg (15IU) vial:

Somatropin      5 mg (15 IU)
Mannitol          30 mg

The diluent contains bacteriostatic 0.9% sodium chloride injection, USP, (normal saline), 0.9% benzyl alcohol as a preservative, and water for injection. A 5 mL vial of the diluent will be supplied with each dispensed vial of TEV-TROPIN®.

TEV-TROPIN® is a highly-purified preparation. Reconstituted solutions have a pH in the range of 7.0 to 9.0.

What are the possible side effects of somatropin?

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your...

Read All Potential Side Effects and See Pictures of Tev-Tropin »

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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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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