Menopur
Producer: Ferring GmbH (Ferring Gmbh) Germany
Code of automatic telephone exchange: G03GA02
Release form: Liquid dosage forms. Lyophilisate for preparation of solution for injections.
General characteristics. Structure:
Active agent: follicle-stimulating hormone 75 ME luteinizing hormone 75 ME
Excipients: lactoses monohydrate, polysorbate 20, sodium hydroxide, Acidum hydrochloricum.
Solvent: isotonic solution of sodium of chloride.
Pharmacological properties:
Менопур® is drug of a human menopauzny gonadotrophin (chMG), high extent of cleaning. Treats group of menotoropin, contains FSG and LG in the ratio 1:1. Drug is received from urine of women in a postmenopause.
Drug causes increase in level of estrogen in blood in women and stimulates growth and maturing of follicles of an ovary, proliferation of an endometria.
At men Menopur's use leads to increase in concentration of testosterone in blood and stimulates a spermatogenesis, influencing Sertoli's cells of seed tubules.
Pharmacokinetics. Cmax of FSG in a blood plasma is reached in 6-24 h after administration of the drug Menopur® in oil. After that concentration of FSG in blood gradually decreases. T1/2 of menotropin is 4-12 h.
Indications to use:
For women
— the infertility caused by gipotalamo-pituitary disturbances (for the purpose of stimulation of growth of one dominating follicle);
— when carrying out auxiliary reproductive techniques for conception approach (stimulation of growth of multiple follicles).
For men
— stimulation of a spermatogenesis at an azoospermism or an oligoastenospermiya, caused by primary or secondary hypogonadotropic hypogonadism (in combination with therapy by drugs of a human chorionic gonadotrophin, for example, drug Horagon).
Route of administration and doses:
The drug is administered in oil or п / to. Solution for injections is prepared just before introduction, using the enclosed solvent.
If other is not offered, the following scheme of therapy is recommended:
To women
At the infertility caused by gipotalamo-pituitary disturbances for the purpose of stimulation of growth of one dominating follicle
The mode of a drug dosing is set individually. The optimum dose of drug and duration of treatment are selected on the basis of ultrasonography of ovaries, by determination of level of estrogen in blood, and also clinical observation. About maturing of a follicle judge by increase in level of estrogen in blood.
The initial dose of the drug Menopur® makes 75-150 ME (1-2 bottles/days). In the absence of reaction of ovaries the dose is gradually increased before increase in level of estrogen in blood or growth of follicles. The dose is left without change until when concentration of estrogen reaches preovulyatorny level. At bystry rise in level of estrogen at the beginning of stimulation the dose of drug should be lowered.
For the purpose of induction of an ovulation in 1-2 days after the last injection of Menopur once enter 5 000-10 000 ME chHG.
To men
For the purpose of stimulation of a spermatogenesis enter 1 000-3 000 ME chHG 3 times a week before normalization of level of testosterone into blood. Then within several months 3 times a week administer the drug Menopur® on 75-150 ME (1-2 bottles).
Features of use:
Before purpose of the drug Menopur® performing the corresponding treatment in the presence of the accompanying hypothyroidism is recommended, to insufficiency of bark of adrenal glands, a giperprolaktinemiya, tumors of gipotalamo-pituitary area, haemo concentration correction.
Before an initiation of treatment of infertility it is necessary to estimate a condition of ovaries (ultrasonography and level of oestradiol in a blood plasma). During a course of treatment these researches have to be conducted daily or every other day.
It is necessary to consider that against the background of use of drugs chMG development of hyper stimulation of ovaries which becomes clinically expressed after introduction for the purpose of an ovulation of drugs chHG and is shown in formation of cysts of ovaries of the big size is possible. At the same time there can be an ascites, a hydrothorax which are followed by an oliguria, arterial hypotension and a thromboembolic syndrome.
At emergence of the first signs of hyper stimulation of ovaries (the abdominal pain, the educations palpated or defined at ultrasonography in the bottom of a stomach) treatment should be stopped immediately!
In case of development of hyper stimulation of ovaries it is not necessary to administer the drug chHG for the purpose of an ovulation.
At treatment by drugs chMG polycarpous pregnancy often develops.
At men with the FSG high level in blood (that testifies to primary testicular insufficiency) Menopur® is usually inefficient.
Side effects:
From endocrine system: a mastalgiya, sharp increase in excretion of estrogen with urine, moderately expressed (uncomplicated) increase in ovaries, formation of cysts of ovaries; men have a gynecomastia.
Syndrome of hyper stimulation of ovaries: precursory symptoms - the expressed pains in a stomach bottom, nausea, vomiting, increase in body weight; a hypovolemia, increase in quantity of erythrocytes in plasma (connected with reduction of volume of plasma), disturbance of electrolytic balance, ascites, a hemoperitoneum (availability of blood in an abdominal cavity), a hydrothorax, a thromboembolic syndrome.
From the alimentary system: sometimes - nausea, vomiting, kolikoobrazny pains.
Local reactions: reddening, hypostasis, an itch in the place of an injection.
Allergic reactions: arthralgia; seldom – hypersensitivity reactions (including skin rash, fervescence); very seldom at prolonged use of drug - antibody formation (that leads to decrease in efficiency of the carried-out therapy).
Others: oliguria, decrease in the ABP, increase in body weight, polycarpous pregnancy.
Interaction with other medicines:
Менопур® Horagon (a human chorionic gonadotrophin) at women - for the purpose of induction of an ovulation, after stimulation of growth of follicles can be used in combination with drug; at men - for the purpose of stimulation of a spermatogenesis.
Contraindications:
— diseases of a thyroid gland and adrenal glands;
— tumors of gipotalamo-pituitary area;
— giperprolaktinemiya;
— the persistent increase in ovaries or developing of cysts which are not connected with a syndrome of polycystic ovaries;
— anomalies of development of generative organs or hysteromyoma incompatible with pregnancy;
— vaginal bleedings of not clear etiology;
— cancer of a uterus, ovaries or mammary glands;
— primary insufficiency of ovaries;
— a prostate cancer or other androgenozavisimy tumors at men;
— pregnancy;
— lactation period;
— hypersensitivity to menotropina (the drugs containing LG and/or FSG) and other components of drug.
Use of the drug MENOPUR® at pregnancy and feeding by a breast
Менопур® it is contraindicated to use at pregnancy and in the period of a lactation.
At pregnancy of manifestation of a syndrome of hyper stimulation of ovaries become aggravated, their duration is increased, such fortune can lead to threat for the patient's life.
Overdose:
Now about cases of overdose of the drug Menopur® it was not reported.
Storage conditions:
Drug should be stored in the unavailable to children, protected from light place at a temperature not above 25 °C.
Issue conditions:
According to the recipe
Packaging:
Lyophilisate for пригот. solution for инъекц. 75 ME+75 ME: фл. 5 or 10 pieces in set. with solvent.