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tev tropin somatropin (rDNA origin)

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Description

tev tropin somatropin (rDNA origin)

tev tropin somatropin (rDNA origin) (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).

DOSAGE AND ADMINISTRATION
A dosage of up to 0.1 mg/kg (0.3 IU/kg) of body weight administered 3 times per week by subcutaneous injection is
recommended. The dosage schedule for TEV-TROPIN™ should be reconstituted with 1 to 5 mL 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™
growth hormone. 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. It is recommended that TEV-TROPIN be
administered using sterile disposable syringes and needles. The syringes should be of small enough volume that the
prescribed dose can be drawn from the vial with reasonable accuracy.
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 TEVTROPIN™ 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.

Brand

tev tropin

Additional information

Quantity

1 kit of Tev-Tropin 5mg, 2 kit of Tev-Tropin 5mg, 3 kit of Tev-Tropin 5mg, 5 kit of Tev-Tropin 5mg

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