Ovitrelle 250 micrograms Solution for Injection in Prefilled Syringe

HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. Prepubertal cryptorchidism not due to anatomical obstruction. In general, hCG is thought to induce testicular descent in situations when descent would have occurred at puberty. hCG thus may help predict whether or not orchiopexy will be needed in the future. …

• 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. 4000 USP units 3 times weekly for 3 weeks. 5000 USP units every second day for 4 injections. 15 injections for 500 to 1000 USP units over a period of 6 weeks. 500 USP units 3 times weekly for 4 to 6 weeks
• If this course of treatment is not successful, another series is begun 1 month later, giving 1000 USP units per injection
• Selected cases of hypogonadotropic hypogonadism in males. 500 to 1000 USP units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks. 4000 USP units 3 times weekly for 6 to 9 months, following which the dosage may be reduced to 2000 USP units 3 times weekly for an additional 3 months
• 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. …

• Induction of androgen secretion by hCG may induce precocious puberty
• In pediatric patients treated for cryptorchidism
• Discontinue therapy if signs of precocious puberty occur

Clinical studies of PREGNYL (chorionic gonadotropin) for injection did not include subjects aged 65 and over.

• Prior hypersensitivity reactions to human gonadotropins, including hCG, or any of the excipients (see ADVERSE REACTIONS )
• High serum FSH, indicating primary gonadal failure in women
• Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders)
• Tumors of the hypothalamus or pituitary gland and ovary, breast, or uterus in females and breast or prostate in males
• Malformations of the reproductive organs incompatible with pregnancy. …

Use hCG in conjunction with gonadotropin therapy only if the physician is experienced with infertility problems and is familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for gonadotropins. Gonadotropin therapy, including hCG, requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities (see PRECAUTIONS/Laboratory Tests ). Safe and effective induction of ovulation with use of PREGNYL requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis. …

For males and females: Immune system disorders Hypersensitivity reactions, both localized and systemic in nature, including anaphylaxis have been reported. In rare cases, generalized rash or fever may occur (see CONTRAINDICATIONS and WARNINGS ). If a hypersensitivity reaction is suspected, discontinue PREGNYL and assess for other potential causes for the event. Psychiatric disorders Irritability Restlessness Depression Nervous system disorders Headache General disorders and administration site conditions PREGNYL may cause reactions at the site of injection, such as bruising, pain, redness, swelling and itching. …

Pregnancy PREGNYL is not indicated in pregnancy. PREGNYL may be used for luteal phase support, but is discontinued upon confirmation of pregnancy. There are no data on the use of hCG in pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Storage: Store unopened vial at controlled room temperature 15°C to 25°C (59°F to 77°F). If reconstituted solution in vial is not used immediately, then store refrigerated [2°C to 8°C (36°F to 46°F)] until use and discard after 60 days. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.