Epifasi 5000 I.U.1 ampoule + ampoule with solution for I/M injection

Epifasi 5000 I.U.1 ampoule + ampoule with solution for I/M injection

Composition:

Each lyophilized ampoule contains:

Human Chorionic Gonadotropin 5000 I.U.

Each ampoule of solvent contains l ml of sterile saline.

Properties:

Epifasi® (human chorionic gonadotropin; HCG) is a hormone produced by the placenta and obtained from the urine of pregnant women. Its action is identical to the luteinizing hormone (LH) secreted from the pituitary gland. It also has a small degree of follicle stimulating hormone (FSH) activity. Epifasi (HCG) has different uses in men and women. In men, it stimulates sex glands, specially the cells in the testicles, to stimulate their growth and development and production of androgens (e.g. testosterone). It also causes the development of secondary sex characteristics and may cause the testicles to descent. In women, Epifasi® stimulates the corpus luteum of the ovary to produce progesterone.

Indications:

• Men:

-Prepubertal cryptorchidism not caused by anatomical obstruction: to stimulate testicular descent in prepubescent males whose testicles have not dropped or descended.

-Male infertility associated with hypogonadotropic hypogonadism: for selected cases of hypogonadism caused by pituitary deficiency.

-Delayed puberty associated with hypogonadism; to assist in thể development of secondary sex Characteristics in cases of hormone deficiency.

• Women:

-Anovulatory infertility due to absent due to absent or low concentrations of gonadotropins; to promote ovulation; where the cause of anovulation is not due to primary Ovarian failure, and the women have been appropriately pretreated with human menotropins.

-In combination with menotropins as an adjunct to in-vitro fertilization conception procedures and other assisted techniques..

Dosage and administration:

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

• Prepubertal cryptorchidism: There is considerable variation in the dose regimen, but usually ranges from 500 – 5000 units every second day for 4 injections.

• Hypogonadotropic hypogonadism in males: 4000 units 3 times weekly fo 6-9 months; reduce dosage to 2000 unitS 3 times weekly for an additional 3 months. Cases of delayed puberty associated with hypogonadism in males an initial dose of CG (500-1500 units) is given twice weekly. Dose should be titrated against plasma-testosterone concentration.

• Induction of ovulation and pregnancy: 5000- 10000 units one day following the last dose of menotropins.

Side effects:

Possible side effects include headache, irritability, tiredness, restlessness, edema, precocious puberty, gynecomastia, pain at injection site, aggressive behavior, ovarian hyperstimulation syndrome, enlargement of ovarian cysts and possible rupture, arterial thromboembolism and multiple births.

Contraindications:

-Hypersensitivity to the drug;

-Precocious puberty;

-Prostatic carcinoma or other androgen- dependent neoplasms;

-Pregnancy.

Warnings and precautions:

• Drug Interactions:

No significant drug / drug interactions have been reported so far during Epifasi® therapy.

• Combination therapy with menotropins for infertility should be used only by physicians experienced with infertility problems.
• Induction of androgens secretion by Epifasi® may cause fluid retention; therefore the drug should be used with caution in patients with:

-Epilepsy

-Migraine

-Asthma

-Heart disease

-Renal disorders

• Patients suspected to be susceptible to hypersensitivity reactions should be given skin tests before treatment.

Storage:

Store at a temperature 15°C – 30°C. After reconstitution, refrigerate the product at a temperature 2°C –  8°C, and use within 30 days.

Package :

Carton box holds 1 lyophilized ampoule, 1 ampoule of solvent and an insert leaflet.