Pregnyl (Chorionic Gonadotropin for Injection): Side …

Feb, 7th 2019 1:42 am, Article Recommended by Dr. J. Smith

DOSAGE AND ADMINISTRATION

For intramuscular use only. The dosage regimen employedin any particular case will depend upon the indication for the use, the age andweight of the patient, and the physician’s preference. The following regimenshave been advocated by various authorities:

Induction of ovulation and pregnancy in theanovulatory, infertile woman in whom the cause of anovulation is secondary andnot due to primary ovarian failure and who has been appropriately pretreatedwith human menotropins. (See prescribing information for menotropins fordosage and administration for that drug product.)

5000 to 10,000 USP units 1 day following the last dose ofmenotropins. (A dosage of 10,000 USP units is recommended in the labeling formenotropins.)

Two-vial package: Withdraw sterile air from lyophilizedvial and inject into diluent vial. Remove 110 mL from diluent and add tolyophilized vial; agitate gently until powder is completely dissolved in solution.

Parenteral drug products should be inspected visually forparticulate matter and discoloration prior to administration, whenever solutionand container permit.

IMPORTANT: USE COMPLETELY AFTER RECONSTITUTION.RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED.

Two-vial package containing:

1-10 mL lyophilized multiple dose vial containing: 10,000USP units chorionic gonadotropin per vial, NDC 0052-0315-10.

1-10 mL vial of solvent containing: water for injectionwith sodium chloride 0.56% and benzyl alcohol 0.9%, NDC 0052-0325-10.

If required pH adjusted with sodium hydroxide and/orphosphoric acid.

Store at controlled room temperature 15-30C (59-86F).Reconstituted solution is stable for 60 days when refrigerated.

PREGNYL manufactured by: Baxter Oncology GmbH, Halle 33790,Germany. PREGNYL Solvent manufactured by: Baxter Pharmaceutical Solutions LLC, Bloomington,IN 47403, USA. Merck Sharp & Dohme B.V., a subsidiary of Merck & Co.,Inc. Manufactured for: Merck Sharp& Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station,NJ 08889, USA. Revised: Jan 2015

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Pregnyl (Chorionic Gonadotropin for Injection): Side …