The gonadotrophin is chorionic

General characteristics. Structure:

Active ingredient: 5000 ME gonadotrophins chorionic.

Excipients: Mannitolum (mannitol).

Pharmacological properties:

Pharmacodynamics. The gonadotrophin chorionic human (HGCh) - gonadotropic hormone which is produced by a placenta during pregnancy then in not changed look is removed by kidneys. For receiving drug it is extracted from urine and cleared. It is necessary for the normal growth and maturing of gametes at women and men, and also for production of sex hormones.

Has gonadotropic effect, follicle-stimulating and luteinizing. Luteinizing activity prevails over follicle-stimulating. Stimulates development of generative organs and secondary sexual characteristics. Drug causes an ovulation in women and stimulates synthesis of estrogen (oestradiol) and progesterone. At men - stimulates a spermatogenesis, products of testosterone and dihydrotestosterone.

Pharmacokinetics. After intramuscular introduction it is well soaked up. The elimination half-life makes 8 h. The maximum concentration of HGCh in a blood plasma is reached in 4-12 hours. The elimination half-life of a gonadotrophin chorionic makes 29-30 h, in case of daily intramuscular injections drug cumulation can be observed. The gonadotrophin chorionic is removed by kidneys. About 10-20% of the entered dose are found in urine in not changed look, the main part is removed in the form of β-chain fragments.

Indications to use:

At women:

- induction of an ovulation at the infertility caused by anovulation or disturbance of maturing of follicles;

- preparation of follicles for a puncture in programs of controlled hyper stimulation of ovaries (for techniques of an auxiliary reproduction);

- maintenance of a phase of a yellow body.

At men:

- hypogonadotropic hypogonadism;

- carrying out the functional test of Leydiga for assessment of function of testicles at a hypogonadotropic hypogonadism before the long-term stimulating treatment.

Route of administration and doses:

After addition of solvent to lyophilisate the recovered solution of a gonadotrophin chorionic is entered intramusculary, slowly.

The prepared solution is not subject to storage as further preservation of sterility of solution is not guaranteed. The specified dosages are approximate, treatment has to be adjusted by the doctor individually depending on necessary reaction to administration of drug.

At women:

- at induction of an ovulation at the infertility caused by anovulation or disturbance of maturing of follicles one injection of a gonadotrophin chorionic in a dose from 5000 to 10000 ME for completion of treatment is usually carried out by drugs of follicle-stimulating hormone;

- by preparation of follicles for a puncture in programs of controlled hyper stimulation of ovaries the gonadotrophin chorionic is once entered in a dosage 5000 ME - 10000 ME;

- for maintenance of a phase of a yellow body everyone can be made from two to three repeated injections of drug in a dose from 1500 to 5000 ME within 9 days after an ovulation or transfer of an embryo (for example, for the 3, 6 and 9 day after induction of an ovulation).

At men:

- at a hypogonadotropic hypogonadism - 1500 ME - 6000 ME once a week. In case of infertility the combination of a gonadotrophin chorionic with the additional drug containing follitropin (follicle-stimulating hormone) 2-3 times a week is possible. The course of treatment has to proceed not less than 3 months when it is possible to expect any improvement of a spermatogenesis. During this treatment it is necessary to suspend replaceable, therapy by testosterone. When improvement of a spermatogenesis is reached, for its maintenance it is enough in certain cases the isolated use of a gonadotrophin chorionic;

- when carrying out the functional test of Leydiga within 3 days the gonadotrophin chorionic in a dose 5000 ME intramusculary at the same time is entered. Next day after the last injection blood sampling is carried out and testosterone level is investigated. If its increase from reference values for 30-50% or more is observed, then test is estimated as positive.

It is preferable to combine this test with carrying out on the same day (the next day after the last injection) one more spermogram.

Features of use:

Pregnancy and lactation. Drug Gonadotrophin use chorionic during pregnancy and breastfeeding is contraindicated.

Use of a gonadotrophin increases risk of development of a venous or arterial thromboembolism therefore the patients getting into risk group need to estimate advantages of therapy of extracorporal fertilization. Also it should be noted that pregnancy in itself is also followed by the increased risk of thrombosis.

The probability of emergence of polycarpous pregnancy increases. Polycarpous pregnancy is followed by the increased risk for mother (the complicated course of pregnancy and childbirth, premature births) and for newborns (low body weight, prematurity, etc.).

During treatment by drug and within 10 days after the treatment termination the drug Gonadotrophin chorionic can render, influence on values of immunoassays on concentration of HGCh in a blood plasma and urine that can result in false positive test result on pregnancy.

Before use of drug for women it is necessary to conduct ultrasonic examination (ultrasonography) of bodies of a small pelvis for specification of the sizes and quantity of follicles; in the course of treatment - daily control ultrasonography, definition of concentration of oestradiol in a blood plasma, careful observation of a condition of the patient. In case of development of SGYa treatment has to be stopped.

Pathology of uterine tubes often occurs at women with infertility which treatment by methods of auxiliary reproductive technologies is offered (especially, extracorporal fertilization) that can lead to increase in risk of ectopic pregnancy in this connection at early stages of pregnancy it is necessary to conduct ultrasonography for specification of localization of fetal egg.

Treatment of male patients by means of a gonadotrophin chorionic leads to increase in products of androgens therefore the patients getting into risk group have to be under strict medical control as the exacerbation of a disease or a recurrence can sometimes be result of the raised products of androgens.

At men drug is inefficient at the high content of follicle-stimulating hormone.

Long introduction can lead to antibody formation to drug.

Influence on ability to manage vehicles and mechanisms. During treatment it is necessary to abstain from driving of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Disturbances from immune system: in rare instances there can be generalized rash or fever.

The general frustration and disturbances in an injection site: at use of a gonadotrophin chorionic there can be reactions in the place of an injection, for example, bruise, pain, reddening, a swelling and an itch. It was in certain cases reported about allergic reactions from most of which part was shown in the form of pain and/or rash in the place of an injection; increased fatigue.

At women:

Disturbances from a metabolism and food: increase in body weight as sign of heavy SGYa; hypostases.

Disturbances of mentality: irritability, uneasiness, depression.

Disturbances from a nervous system: headache.

Disturbances from vessels: in rare instances the tromboembolic episodes connected with the combination therapy of anovulatory infertility (in combination with follicle-stimulating hormone) which was complicated by a severe form of SGYa.

Disturbances from respiratory system, bodies of a thorax and a mediastinum: a hydrothorax at a severe form of SGYa.

Disturbances from digestive tract: an abdominal pain and dispeptic symptoms, such as the nausea and diarrhea connected with moderate SGYa; ascites at a severe form of SGYa.

Disturbances from generative organs and a mammary gland: morbidity of mammary glands; SGYa of moderate severity (the sizes of ovaries more than 5 cm in the diameter) and a severe form (big cysts of ovaries, more than 12 cm in the diameter, inclined to a gap).

Clinical manifestations of SGYa of moderate severity and severe form (diarrhea, feeling of weight in the bottom of a stomach, arching abdominal pains, a hemoperitoneum; tachycardia, lowering of arterial pressure; disturbances of a hemostasis, increase in activity of hepatic transaminases; oliguria, acute renal failure, asthma, respiratory insufficiency).

At men:

Disturbances from skin and hypodermic fabrics: eels.

Disturbances from generative organs and chest gland: treatment by a gonadotrophin chorionic sporadic can cause a gynecomastia; a prostate hyperplasia, increase in a penis, hypersensitivity of nipples of chest glands at men.

If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

At treatment of infertility the gonadotrophin human, applied in combination with drugs of a human menopauzny gonadotrophin (MGCh), can strengthen symptoms of the hyper stimulation of ovaries which was caused use of MGCh. It is necessary to avoid combined use of the drug Gonadotrophin chorionic with high doses of glucocorticosteroids.

Other interactions with medicines are noted.

Contraindications:

- govyshennaya sensitivity to HGCh or to any component of drug;

- hormonedependent malignant tumors of generative organs and a mammary gland now or suspicion on them (ovary cancer, a breast cancer, uterus cancer at women and a prostate cancer, a carcinoma of chest gland at men);

- organic lesions of the central nervous system (CNS) (tumor of a hypophysis, hypothalamus);

- thrombophlebitis of deep veins;

- hypothyroidism;

- adrenal insufficiency;

- giperprolaktinemiya.

At men (in addition):

- the infertility which is not connected with a hypogonadotropic hypogonadism.

At women (in addition):

- wrong formation of generative organs incompatible with pregnancy;

- fibrous tumor of a uterus incompatible with pregnancy;

- the syndrome of hyper stimulation of ovaries (SHSO) in the anamnesis;

- syndrome of polycystic ovaries (SPKYa);

- primary insufficiency of ovaries;

- bleeding or bloody allocations from a vagina of not clear etiology;

- pregnancy and period of breastfeeding.

With care. At the women having risk factors of thrombosis (fibrinferments or a thromboembolism in the anamnesis, or at relatives of the 1st degree of relationship, heavy obesity (a body weight index> of 30 kg/sq.m) either inborn or genetic predisposition to fibrinferments (including resistance to the activated protein With, deficit of antithrombin III, deficit of a protein With, deficit of a protein of S, a gipergomotsisteinemiya, antibodies to phospholipids)).

At men with latent or explicit heart failure, a renal failure, arterial hypertension, epilepsy or migraine (or in the presence of these states in the anamnesis); at patients with bronchial asthma.

If at you one of the listed diseases, before administration of drug surely consult with the doctor /

Overdose:

The gonadotrophin chorionic is characterized extremely by a hypotoxicity.

Women against the background of overdose can have SGYa of heavy degree.

Treatment is carried out in the conditions of a hospital.

Principles of treatment of SGYa of heavy degree:

- control of function of cardiovascular system (CCC), respiratory system, liver, kidneys, electrolytic and water balance (diuresis, dynamics of weight, change of a circle of a stomach); control of level of a hematocrit; crystalloid solutions intravenously kapelno (for recovery and maintenance of the volume of the circulating blood (VCB));

- colloidal solutions intravenously kapelno - 1,5-3 l/days (at haemo concentration preservation) and a resistant oliguria;

- a hemodialysis (at development of a renal failure);

- corticosteroid, antiprostaglandinovy, antihistaminic drugs (for decrease in permeability of capillaries);

- at a thromboembolism - low-molecular heparins (фраксипарин, клексан);

- a plasma exchange - 1-4 sessions with an interval of 1-2 days (improvement of rheological properties of blood, normalization of the acid-base state (ABS) and gas composition of blood, reduction of the sizes of ovaries);

- a paracentesis and a transvaginal puncture of an abdominal cavity at ascites.

At men development of a gynecomastia is possible; an atrophy of seed tubules (owing to braking of products of follicle-stimulating hormone (FSG) as a result of stimulation of products of androgens and estrogen); reduction of quantity of spermatozoa in an ejaculate (at abuse of drug). Prolonged use of drug can lead to strengthening of side effects.

Storage conditions:

In the place protected from light, at a temperature not above 20 °C. To store in the places unavailable to children. A period of validity - 3 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of solution for intramuscular introduction, 5000 ME. Packaging: on 5000 ME drugs in bottles from a tube glass. 5 bottles with drug in a blister strip packaging from a film polyvinyl chloride complete with 5 ampoules on 1 ml of solvent (sodium chloride, solution for injections of 9 mg/ml) in a blister strip packaging from a film polyvinyl chloride together with application instructions of drug and solvent, the scarificator or a knife ampoule in a pack from a cardboard. When packaging ampoules with notches, rings and points of a break scarificators or knives ampoule do not put.