Tev-Tropin

In the U.S.

• Accretropin
• Genotropin
• Genotropin Miniquick
• Humatrope
• Norditropin
• Norditropin Flexpro
• Nutropin
• Nutropin AQ NuSpin 10
• Nutropin AQ NuSpin 5
• Nutropin AQ Pen
• Omnitrope
• Tev-Tropin

In Canada

• Nutropin Aq
• Saizen

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somatropin

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 the accompanying diluent.

Tev-Tropin® 5 mg vial contains recombinant somatropin 5 mg and mannitol 30 mg. The 5 mg vial is supplied in a combination package with an accompanying 5 mL vial of diluting solution. The diluent contains bacteriostatic 0.9% sodium chloride injection, USP, (normal saline), 0.9% benzyl alcohol as a preservative, and water for injection.

Tev-Tropin® 10 mg vial contains recombinant somatropin 10 mg, mannitol 10 mg, disodium phosphate dodecahydrate 3.57 mg, and sodium dihydrogen phosphate dehydrate 0.79 mg. The 10 mg vial is supplied in a combination package with an accompanying 1 mL syringe of diluting solution. The diluent contains bacteriostatic water for injection with 0.33% metacresol as a preservative.

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

A dosage of up to 0.1 mg/kg of body weight administered 3 times per week by subcutaneous injection is recommended.

Tev-Tropin® 5 mg should be reconstituted with 1 to 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.

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® 5 mg can be administered using a standard sterile disposable syringe or a Tjet Needle-Free injection device. However, Tev-Tropin® 10 mg can only be administered using a standard sterile disposable syringe.  For proper use, please refer to the User's Manual provided with the administration device.

NDC 57844-713-46

Tev-Tropin™

[Somatropin (rDNA origin) for Injection]

5 mg (15 IU)

Reconstitute with Bacteriostatic 0.9% Sodium Chloride Injection, USP (Benzyl Alcohol Preserved)

GATE Rx only

PROTECT FROM LIGHT.

For Subcutaneous Use Only.

Each vial contains: 5 mg (15 IU) of somatropin lyophilized with 30 mg of mannitol.

Swirl gently to dissolve. DO NOT SHAKE.

Refrigerate at 2° to 8°C (36° to 46°F). Reconsituted vials

should be refrigerated and used within 14 days. Do Not Freeze.

Manufactured In Israel:

Distributed By:

GATE PHARMACEUTICALS

div. TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A. 9/2004                  0082-1016v2

Lot No.:

Exp. Date: