MENOPUR

Active material: HCG menopauznыy
When ATH: G03GA02
CCF: Human menopausal gonadotropin preparation (FSH:LG = 1:1)
ICD-10 codes (testimony): E23.0, N46, N97, Z31.1
When CSF: 15.06.05.04
Manufacturer: FERRING GmbH (Germany)

Pharmaceutical form, composition and packaging

Valium for solution for injection in the form of briquettes white or almost white, without smell; the solvent is a colorless, transparent solution.

Excipients: lactose monohydrate, polysorbate 20, Sodium hydroxide, hydrochloric acid.

Solvent: isotonic sodium chloride solution.

Vials 2 ml (5) together with the solvent (amp. 1 ml 5 PC.) – packings Valium planimetric (1) – cardboard boxes.
Vials 2 ml (5) together with the solvent (amp. 1 ml 5 PC.) – packings Valium planimetric (2) – cardboard boxes.

Pharmacological action

Menopur^® is the drug of human menopausal gonadotropin (chMG), high purity. It refers to a group menotoropinov, It contains FSH and LH in a ratio 1:1. The preparation obtained from the urine of postmenopausal women.

In women, the drug causes an increase in estrogen levels in the blood and stimulates the growth and maturation of the ovarian follicles, endometrial proliferation.

Men use Menopur^® It leads to increased concentrations of testosterone in the blood and stimulates spermatogenesis, acting on Sertoli cells of the seminiferous tubules.

Pharmacokinetics

C_max FSH plasma levels achieved after 6-24 h after i / m administration Menopur^®. Thereafter, the concentration of FSH in the blood is gradually reduced. T_1/2 menotropynov – 4-12 no.

Testimony

For women

- Infertility, due to hypothalamic-pituitary disorders (in order to stimulate the growth of the dominant follicle);

- During assisted reproductive techniques for the offensive conception (stimulation of the growth of multiple follicles).

For men

- Stimulation of spermatogenesis in the azoospermia or oligoastenospermii, caused by a primary or secondary hypogonadotropic hypogonadism (in combination with drug therapy of human chorionic gonadotropin, eg, drug Horagon).

Dosage regimen

The drug is introduced into / m or s / c. The solution for injection is prepared immediately prior to administration, Using the supplied solvent.

Unless otherwise, We recommend the following regimen:

Women

At infertility, conditioned by the hypothalamic-pituitary disorders, in order to stimulate the growth of the dominant follicle

The dosage regimen of the drug is determined individually. The optimal dose and duration of treatment are selected on the basis of ultrasound of the ovaries, determining the level of estrogen in the blood, as well as clinical observations. About follicular maturation is judged to increase estrogen levels in the blood.

The initial dose Menopur^® is 75-150 ME (1-2 vial / day). In the absence of ovarian response dose gradually increased to increase the level of estrogen in the blood or follicular. Dose left unchanged until, when the concentration reaches the preovulatory estrogen levels. With the rapid rise in estrogen levels at the beginning of the stimulation dose should be reduced.

FROM to induce ovulation through 1-2 days after the last injection Menopur^® once introduced 5 000-10 000 IU hCG.

Men

FROM to stimulate spermatogenesis administered by 1 000-3 000 IU hCG 3 twice weekly until testosterone levels normalize blood. Thereafter, for several months 3 times a week, injected drug Menopur^® by 75-150 ME (1-2 bottle).

Side effect

On the part of the endocrine system: mastalgïya, a dramatic increase in estrogen excretion in the urine, moderate severity (Uncomplicated) ovarian enlargement, the formation of ovarian cysts; males – gynecomastia.

Ovarian hyperstimulation syndrome: early signs – severe pain in the lower abdomen, nausea, vomiting, weight gain; gipovolemiя, increasing the number of red blood cells in plasma (associated with a decrease in plasma volume), electrolyte imbalance, ascites, gemoperitoneum (the presence of blood in the peritoneal cavity), gidrotoraks, thromboembolism.

From the digestive system: sometimes – nausea, vomiting, colicky pain.

Local reactions: redness, edema, itching at the injection site.

Allergic reactions: arthralgia; rarely - hypersensitivity reactions (incl. skin rash, fever); very rarely with prolonged use of the drug – antibody formation (that reduces the efficiency of the therapy).

Other: oligurija, decrease in blood pressure, weight gain, polycyesis.

Contraindications

- Diseases of the thyroid and adrenal glands;

- Tumors of the hypothalamic-pituitary region;

- Hyperprolactinemia;

- Persistent increase in the occurrence of ovarian cysts or, not related to polycystic ovary syndrome;

- Anomalies of the genital or uterine fibroids, incompatible with pregnancy;

- Vaginal bleeding of unknown etiology;

- Uterine cancer, ovarian or breast;

- Primary ovarian failure;

- Prostate cancer or other tumors in men androgenozavisimye;

- Pregnancy;

- Lactation;

- Hypersensitivity to menotropinam (preparations, comprising LH and / or FSH) and other ingredients.

Pregnancy and lactation

Menopur^® contraindicated during pregnancy and lactation.

When pregnancy symptoms of ovarian hyperstimulation syndrome aggravated, increases their duration, this condition can lead to a threat to the patient's life.

Cautions

Before the appointment of the drug Menopur^® It recommends appropriate treatment in the presence of concomitant hypothyroidism, adrenal insufficiency, hyperprolactinemia, tumors of the hypothalamic-pituitary region, hemoconcentration correction.

Before the treatment of infertility should be to assess the condition of the ovaries (Ultrasound and estradiol levels in blood plasma). During the course of treatment, these studies should be carried out every day or every other day.

It should be taken into account, that against the use of drugs hMG may develop ovarian hyperstimulation, which becomes clinically evident after the introduction of the purpose of ovulation drugs hCG is manifested in the formation of ovarian cysts large size. This may occur ascites, gidrotoraks, accompanied by oliguria, hypotension and thromboembolic syndrome.

At the first signs of ovarian hyperstimulation (abdominal pain, palpable or determined by ultrasound education in the abdomen) Treatment should be stopped immediately!

In the case of ovarian hyperstimulation should not be introduced with a view to the preparation of hCG ovulation.

In the treatment of hMG preparations often develops multiple pregnancy.

In men with high levels of FSH in the blood (indicating that primary testicular failure) Menopur^® usually ineffective.

Overdose

Currently, cases of drug overdose Menopur^® not reported.

Drug Interactions

Menopur^® It can be used in combination with a drug Horagon (human chorionic gonadotropin) female – to induce ovulation, after stimulation of follicular growth; males – to stimulate spermatogenesis.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dark place at a temperature no higher than 25 ° C. Shelf life – 2 year.