Medofasi
(Chorionic Gonadotropin)




COMPOSITION

One ampoule of agent contains:
Active ingredient: human chorionic gonadotropin 5000 IU
Inactive ingredient: lactose, dipotassium hydrogen phosphate, potassium hydrogen phosphate
Solvent: 0.9 % sodium chloride (1 ml)

THERAPEUTIC INDICATIONS

For women:
- Agenesia due to anuvolatory cycles or follicular maturation disturbances;
- Preparation of follicles for paracentesis during the course of controlled ovarian hyperstimulation (for assisted reproduction methods);
- luteal phase support.
For boys and men:
- Hypogonadotropism;
- Prepubertal cryptorchidism not due with anatomic obstruction;
- Delayed puberty due to hypophysary dysfunction.

CONTRAINDICATIONS

- Hypersensitivity to drug compounds.
- Defined or suspected reproductive hormone dependent tumors of different localizations;
- Cryptorchidism caused by congenital factors (inguinal hernia, consequences of operative interventions in inguinal region, malposition of testicles) in boys and men.

ADVERSE EFFECTS

Immune system disorders: rarely - generalized rash or fever.
Injection place disturbances: echymoma, pain, erubescence, bulge, itching, rash

In women:

- Vascular system disturbances
- Gastrointestinal tract disturbances
- Reproductive system and mammary glands disturbances
- Other: hydrothorax as severe ovarian hyper stimulation syndrome complication

In boys and men:

- Dysmetabolism and nutritional disorder, and in some cases of high doses administration, water and sodium retention is possible.
Reproductive system and mammary glands disturbances
Special warnings and precautions for use.
In women:
During treatment of anovulation-related or follicular immaturity-related female infertility, pre-administration of follicle-stimulating hormone can result in unwanted ovarian hyper stimulation.
Clinical symptoms of mild ovarian hyper stimulation syndrome include gastro-intestinal problems painful breasts, and mild to moderate enlargement of ovaries and ovarian cysts.
The severe form of ovarian hyper stimulation syndrome may be life-threatening and is characterized by large ovarian cysts (prone to rupture), acute abdominal pain, ascites, weight gain, very often hydrothorax and occasionally thrombo-embolic phenomena.
In men:
Treatment with hCG leads to increased androgen production. Therefore the patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production.

Effects on ability to drive and use machines.
Medofasi has no influence on the ability to drive and use machines requiring high speed of psychomotor reactions.

DOSAGE AND ADMINISTRATION

For women:

Agenesia due to anuvolatory cycle or follicular maturation disturbances: 5000-10000 IU of human chorionic gonadotropin is administered for ovulation initiation, with subsequent therapy with follicle-stimulating hormone medications.
Preparation of follicles for puncture is during the course of controlled ovarian hyperstimulation (for assisted reproduction methods): 5000-10000 IU of human chorionic gonadotropin is administered for therapy termination with follicle-stimulating hormone medications.
Maintenance of corpus luteum stage: during subsequent 9 days 3 repeated injections of human chorionic gonadotropin are administered in a dose of up to 5000 IU as a prophylaxis of corpus luteum disturbances.
Medofasi is not to be administered in case of non-compliance with the following conditions:
- 17ß-estradiol level is not less than 3500 pmol/l (920 picogram/ml) at least 3 follicle of 17 mm in diameter are observed;
- Follicular puncture is performed 32-36 hours after human chorionic gonadotropin administration.

For boys and men:

Hypogonadotropism: 5000 IU is administered 3 times per week during 6-9 months, later the dose is decreased down to 2500 IU 3 times per week during 3 months.
Prepubertal cryptorchidism (not due to anatomic obstruction): 5000 IU once per 2 days. Course of treatment: 4 injections.
Delayed puberty caused by hypophysary dysfunction: 1500 IU 2-3 times per week. Course of treatment is at least 6 months.

PREGNANCY AND LACTATION

Application of Medofasi is not recommended during pregnancy and lactation.

MANUFACTURED FORM

1 ampoule with lyophilized powder and 1 ampoule with a 0.9 % sodium chloride (1 ml) in a blister.

Genitourinary System and Sex Hormones

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