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Sermorelin Acetate

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Sermorelin Acetate

INDICATIONS

Sermorelin is approved for diagnostic evaluation of pituitary function and also for increasing growth in children. Off label usage may include acute or age-related growth hormone insufficiency

DOSAGE AND ADMINISTRATION

A dosage of 0.2 - 0.3 mcg once daily at bedtime by subcutaneous injection is recommended. It is also recommended that subcutaneous injection sites be periodically rotated.

To prevent possible contamination, wipe the rubber vial stopper with an antiseptic solution before puncturing it with the needle. It is recommended that Sermorelin 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.

To reconstitute Sermorelin, inject the diluent into the vial of Sermorelin aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. Do not administer Sermorelin if particles are visible in the reconstituted solution or if the reconstituted solution is cloudy.

HOW SUPPLIED

Vials of Sermorelin (sermorelin acetate for injection) should be stored refrigerated (2°-8°C/36°-46°F). Expiration dates are stated on the labels.

Sermorelin acetate (sermorelin) is a sterile, nonpyrogenic, lyophilized powder supplied in packages containing:

1 vial 0.5 mg Sermorelin and 1 vial 2 mL Sodium Chloride Injection, USP NDC xxxxxxxxxxxx
1 vial 3.0 mg Sermorelin and 1 vial 2 mL Sodium Chloride Injection, USP NDC xxxxxxxxxxxx

Manufacturer information: n/a. FDA rev date: 10/2/2001

Last reviewed on RxList: 7/16/2008
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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