Generic Name: CHORIOGONADOTROPIN ALFA 10000[USP'U] in 10mL;
Dosage Form: injection
Drug Class: Gonadotropins
Generic Name: CHORIOGONADOTROPIN ALFA 10000[USP'U] in 10mL;
Dosage Form: injection
Drug Class: Gonadotropins
For intramuscular use only. Each multiple-dose vial is to be used for one patient. The dosage regimen employed in any particular case will depend upon the indication for the use, the age and weight of the patient, and the physician’s preference. The following regimens have been advocated by various authorities:
Prepubertal cryptorchidism not due to anatomical obstruction. Generally, institute therapy in children between the ages of 4 and 9.
Selected cases of hypogonadotropic hypogonadism in males.
Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately treated with gonadotropins. (See also prescribing information for gonadotropins for dosage and administration for that drug product.)
5000 to 10,000 USP units 1 day following the last dose of gonadotropins. (A dosage of 10,000 USP units is recommended in the labeling for gonadotropins.)
Withdraw sterile air from vial with lyophilized powder and inject into vial with solvent. Remove 1 to 10 mL of solvent and add to vial with lyophilized powder; agitate gently until powder is completely dissolved in solution. Do not shake.
PREGNYL is a white, dry powder / cake. The solvent is a clear and colorless aqueous solution.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. If there is a discoloration or particulates, do not use.
IMPORTANT: IF NEEDED, THE RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED. DO NOT FREEZE. USE THE RECONSTITUTED SOLUTION WITHIN 60 DAYS OF RECONSTITUTION. IF THE RECONSTITUTED SOLUTION IS NO LONGER NEEDED, DISCARD UNUSED PORTION.