Composition
Each lyophilized ampoule contains:
Follicle-stimulating hormone (FSH) ...........
75 IU activity
Luteinizing hormone (LH) ...........................
75 IU activity
Each solvent ampoule contains:
Sterile saline ...............................................1 ml

Therapeutic Indications
Women:
EPIGONAL, followed by hCG-(Epifasi), is given for induction of ovulation and pregnancy in anovulatory infertility in whom the cause is functional and is not due to primary ovarian failure.

Men:
EPIGONAL, and concomitant hCG-(Epifasi), are given for stimulation of spermatogenesis in men with primary or secondary hypogonadotrophic hypogonadism.

Dosage and Administration
Individualize dosage.

Anovulation (Women):
Initially, EPIGONAL 1 ampoule/day given I.M., for 7-12 days, followed by 5000-10000 IU of hCG-(Epifasi) given I.M., 1 day after the last dose of EPIGONAL.

Treat the patient until indices of estrogenic activity (estimated by measuring serum or urinary estrogen levels and sonographic visualization of the ovaries) are equivalent to or greater than those of the normal individual.
This generally occurs by the eighth or twelfth day.

If the patient does not respond to 12 days of EPIGONAL administration, generally no response can be expected and therapy should be discontinued.

If there is evidence of ovulation, but no pregnancy, repeat the above regimen for 2 more courses before increasing the dose to 2 ampoules/day for 7-12 days followed by 5000-10000 IU of hCG-(Epifasi) 1 day after the last dose of EPIGONAL.

If evidence of ovulation is present, but pregnancy does not ensue, repeat the same dose for 2 more courses, but larger doses are not recommended.

The couple should have intercourse daily beginning on the day prior to hCG-(Epifasi) administration until ovulation occurs; ensure insemination.

During treatment with EPIGONAL and hCG-(Epifasi) and for 2 weeks post-treatment, patient should be examined at least every other day for signs of excessive ovarian stimulation.
If the ovaries become abnormally enlarged or if abdominal pain occurs, treatment should be stopped.

Hyperstimulation usually occurs after treatment has been discontinued and reaches its maximum 7-10 days post-ovulation.

Infertility (Men): Treatment with 5000 IU of hCG-(Epifasi) three times a week for 4-6 months; then 1 ampoule of EPIGONAL I.M., three times weekly (given with 2000 IU of hCG-(Epifasi) twice weekly) for at least 4 months.

If spermatogenesis does not increase, dosage is increased to 2 ampoules of EPIGONAL three times weekly (dosage of hCG-(Epifasi) remains unchanged).

Preparation of solution:
The solvent is added to the lyophilized powder; the reconstituted solution of EPIGONAL should be immediately administered by intramuscular injection only.
Any unused portion should be discarded.