Menopur

Menopur – the drug of a menopauzny human gonadotrophin relating to group of menotropin.

Form of release and structure

Dosage form – the lyophilisate for preparation of solution for injections representing a briquette of almost white or white color (in bottles of 2 ml, 5 bottles complete with 5 ampoules of solvent (on 1 ml) in a planimetric strip packaging, 1 or 2 packagings in a pack cardboard).

Active ingredients:

• Luteinizing hormone – 75 IU (international units);
• Follicle-stimulating hormone – 75 ME.

Additional components: sodium hydroxide, Acidum hydrochloricum, polysorbate 20, lactoses monohydrate.

Solvent (colourless transparent solution): isotonic solution of sodium of chloride.

Indications to use

For women:

• Infertility owing to gipotalamo-pituitary disturbances (the drug use purpose – stimulation of growth of one dominating follicle);
• Carrying out auxiliary reproductive technologies (the purpose of purpose of drug – stimulation of growth of multiple follicles and approach of conception).

For men: stimulation of a spermatogenesis at the oligoastenospermiya or an azoospermism which developed owing to primary or secondary hypogonadotropic hypogonadism (in a combination with drugs of a chorionic gonadotrophin of the person (HGch), for example, Horagon).

Contraindications

Absolute for patients of both floors:

• Giperprolaktinemiya;
• Tumors of gipotalamo-pituitary area;
• Diseases of a thyroid gland and adrenal glands;
• Hypersensitivity to Menopur's components or other menotropina (the drugs containing follicle-stimulating and/or luteinizing hormone).

In addition for women:

• Pregnancy;
• Hysteromyoma or anomalies of development of generative organs incompatible with pregnancy;
• Vaginal bleedings of not clear etiology;
• Primary insufficiency of ovaries;
• The formation of a cyst or persistent increase in ovaries which are not connected with a syndrome of polycystic ovaries;
• Breast cancer, ovaries, uterus;
• Lactation period.

In addition for men: prostate cancer or existence of other androgenzavisimy tumors.

Route of administration and dosage

Menopur enter subcutaneously (п / to) or intramusculary (in oil). Lyophilisate is dissolved the solvent enclosed in packaging just before an injection.

If the doctor did not order other scheme of treatment, usually apply the dosing modes described below.

To women:

• The infertility caused by gipotalamo-pituitary disturbances: the dose and duration of treatment are defined individually depending on data of ultrasonography, level of estrogen in blood and clinical observation. The initial daily dose usually makes 75-150 ME. In case of lack of reaction of ovaries the dose is gradually increased until increase in level of estrogen in blood or growth of follicles is noted. Further the picked-up dose is applied till the moment when concentration of estrogen reaches preovulyatorny level. At bystry increase in level of estrogen at the beginning of stimulation the dose is reduced;
• Induction of an ovulation: in 1-2 days after the termination of a course of therapy by Menopur once enter a human chorionic gonadotrophin in a dose of 5000-10 000 ME.

To men for stimulation of a spermatogenesis 3 times a week enter 1000-3000 ME HGch until normalization of level of testosterone into blood. Further 3 times a week enter Menopur in a dose 75-150 ME within several months.

Side effects

• Digestive tract: sometimes – pains of kolikoobrazny character, nausea, vomiting;
• Allergic reactions: arthralgia; in rare instances – hypersensitivity reactions (including fervescence, an enanthesis); in some cases at prolonged treatment – antibody formation and, as a result, decrease in efficiency of drug;
• Endocrine system: men have a gynecomastia; women have a sharp increase in excretion of estrogen with urine, a mastalgiya, formation of cysts of ovaries, moderately expressed (uncomplicated) increase in ovaries;
• Local reactions: an itch, hypostasis, reddening in a drug injection site;
• Others: a lowering of arterial pressure, reduction of amount of the urine separated by kidneys, increase in body weight, polycarpous pregnancy;
• Syndrome of hyper stimulation of ovaries: early symptoms – the increase in body weight, nausea, vomiting expressed to pain in the bottom of a stomach, increase in quantity of erythrocytes in plasma, disturbance of electrolytic balance, a hypovolemia, ascites, a hydrothorax, a hemoperitoneum (availability of blood in an abdominal cavity), a thromboembolic syndrome.

Special instructions

Before Menopur's appointment it is recommended to carry out haemo concentration correction, and also the corresponding treatment in the presence of associated diseases, such as tumors of gipotalamo-pituitary area, a giperprolaktinemiya, a hypothyroidism, insufficiency of bark of adrenal glands.

Drug is usually inefficient at men with primary testicular insufficiency what the high level of follicle-stimulating hormone testifies to.

Before Menopur's use concerning infertility for women it is necessary to estimate a condition of ovaries: to conduct ultrasonic examination and to determine oestradiol level in a blood plasma. The same measures need to be undertaken systematically and during all course of treatment, daily or every other day.

It is necessary to consider that drugs of a menopauzny human gonadotrophin can cause in women hyper stimulation of ovaries which is shown by clinical signs after administration of drugs HGch for the purpose of an ovulation and is expressed as formation of big cysts of ovaries. The thromboembolic syndrome, ascites, arterial hypotension and a hydrothorax with an oliguria can accompany this process.

At emergence of the first signs (an abdominal pain and/or the educations in the bottom of a stomach palpated or defined at ultrasonography) which can demonstrate hyper stimulation of ovaries, Menopur it is necessary to cancel immediately.

In case of development of hyper stimulation of ovaries it is not necessary to administer the drug HGch for the purpose of an ovulation.

Medicinal interaction

If necessary Menopur can be applied in a combination with Horagon (drug HGch) to induction of an ovulation at women (after stimulation of growth of follicles) and stimulations of a spermatogenesis at men.

Terms and storage conditions

To store at a temperature up to 25 °C in the place protected from light influence. To protect from children.

Period of validity – 2 years.