Gonadotropin chorionic - instructions for use, dose, side effects, contraindications

Active substanceGonadotropin chorionicGonadotropin chorionic

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Gonadotropin chorionic

lyophilizate w / m

MOSCOW ENDOCRINE FACTORY, FSUE Russia

Gonadotropin chorionic

lyophilizate w / m

MOSCOW ENDOCRINE FACTORY, FSUE Russia

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lyophilizate w / m PC

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lyophilizate w / m

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Khoral

lyophilizate w / m

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Dosage form: & nbsplyophilizate for the preparation of a solution for intramuscular injection

Composition:

Per 1 bottle:

active substance: gonatotropin chorionic 5000 ME;

Excipients: mannitol (mannitol) 20.0 mg.

Description:Lyophilized white or almost white powder.

Pharmacotherapeutic group:Luteinizing agent

ATX: & nbsp

G.03.G.A.01 Gonadotropin chorionic

Pharmacodynamics:

Gonadotropin chorionic human (hCG) is a gonadotropic hormone that is produced by the placenta during pregnancy, then in unchanged form is excreted by the kidneys. To obtain the drug it is extracted from the urine and purified. It is necessary for normal growth and maturation of gametes in women and men, as well as for the production of sex hormones.

Has gonadotropic action, follicle-stimulating and luteinizing. Luteinizing activity predominates over follicle-stimulating activity.Stimulates the development of genital organs and secondary sexual characteristics.

Among women the drug causes ovulation and stimulates the synthesis of estrogens (estradiol) and progesterone.

In men - stimulates spermatogenesis, production of testosterone and dihydrotestosterone.

Pharmacokinetics:

After intramuscular injection is well absorbed. The half-life is 8 hours. The maximum concentration of hCG in the blood plasma is reached in 4-12 hours. The half-life of gonadotropin chorionic is 29-30 hours, in the case of daily intramuscular injections, cumulation of the drug may occur. Gonadotropin chorionic is excreted by the kidneys. About 10-20% of the administered dose is found in the urine unchanged, the main part is excreted as fragments of the β-chain.

Indications:

Among women:

- induction of ovulation with infertility due to anovulation or disturbance of maturation of follicles;

- preparation of follicles for puncture in controlled ovarian hyperstimulation programs (for assisted reproduction techniques);

- maintaining the phase of the yellow body.

In men:

hypogonadotropic hypogonadism;

- Conducting the Leydig functional test to assess testicular function in hypogonadotropic hypogonadism before initiating long-term stimulatory treatment.

Contraindications:

- Hypersensitivity to hCG or to any component of the drug;

- hormone-dependent malignant tumors of genital organs and breast cancer at present or suspected of them (ovarian cancer, breast cancer, uterine cancer in women and prostate cancer, breast carcinoma in men);

- organic lesions of the central nervous system (CNS) (tumors of the pituitary gland, hypothalamus);

- deep vein thrombophlebitis;

- hypothyroidism;

- adrenal insufficiency;

hyperprolactinemia.

In men (in addition):

- Infertility, not associated with hypogonadotropic hypogonadism.

In women (in addition):

- wrong formation of genital organs, incompatible with pregnancy;

- a fibrous tumor of the uterus, which is incompatible with pregnancy;

- Ovarian hyperstimulation syndrome (HNS) in the anamnesis;

- Polycystic ovary syndrome (PCOS);

- primary failure of the ovaries;

- bleeding or spotting from the vagina of an unclear etiology;

- Pregnancy and the period of breastfeeding.

Carefully:

Have women, with risk factors for thrombosis (thrombosis or thromboembolism in history, or with relatives of the first degree of kinship, severe obesity (body mass index> 30 kg / m²) or a congenital or hereditary predisposition to thrombosis (including resistance to activated protein C, anthrombin III deficiency, protein C deficiency, protein deficiency S, hyperhomocysteinemia, antibodies to phospholipids)).

Have men with latent or overt heart failure, impaired renal function, arterial hypertension, epilepsy or migraine (or in the presence of these conditions in the anamnesis); in patients with bronchial asthma.

If you have one of the listed diseases, before taking the drug must be consulted with your doctor.

Pregnancy and lactation:

Application of the drug Gonadotropin chorionic during pregnancy and breastfeeding is contraindicated.

Dosing and Administration:

After the addition of the solvent to the lyophilizate, the reconstituted gonadotropin-chorionic solution is administered intramuscularly, slowly.

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

Among women:

- when induction of ovulation infertility due to anovulation or disturbance of maturation of follicles, usually one injection of gonadotropin chorionic in a dose of 5000 to 10,000 ME to complete treatment with follicle-stimulating hormone;

- when preparing follicles for puncture in controlled ovarian hyperstimulation programs gonadotropin chorionic once administered at a dosage of 5000 ME - 10000 ME;

- to maintain the phase of the yellow body can be done from two to three repeated injections of the drug at a dose of 1500 to 5000 ME each for 9 days after ovulation or embryo transfer (for example, on days 3, 6 and 9 after induction of ovulation).

In men:

- with hypogonadotropic hypogonadism - 1500 ME - 6000 ME 1 time a week. In case of infertility, a combination of gonadotropin chorionic with an additional drug containing follicotropin (follicle-stimulating hormone) 2-3 times a week is possible.The course of treatment should last at least 3 months, when you can expect any improvement in spermatogenesis. During this treatment, it is necessary to suspend the substitution therapy with testosterone. When the improvement of spermatogenesis is achieved, in order to maintain it, in some cases isolated application of gonadotropin chorionic is sufficient;

- when carrying out the functional test Leydig within 3 days is introduced gonadotropin chorionic in a dose of 5000 ME intramuscularly at the same time. The day after the last injection, blood is taken and the testosterone level is examined. If there is an increase from the initial values by 30-50% or more, the sample is evaluated as positive.

It is preferable to combine this test with the same day (the day after the last injection) of another spermogram.

Side effects:

Immune system disorders: In rare cases, generalized rash or fever.

General disorders and disorders at the site of administration: when applying gonadotropin chorionic can occur reactions at the injection site, for example, bruising, pain, redness, swelling and itching.In some cases, allergic reactions have been reported, most of which have been manifested as pain and / or rash at the injection site; increased fatigue.

Among women:

Disorders from the metabolism and nutrition: weight gain as a sign of severe SWC; edema.

Disorders of the psyche: irritability, anxiety, depression.

Impaired nervous system: headache.

Vascular disorders: In rare cases, thromboembolic complications associated with combination therapy of anovulatory infertility (in combination with follicle-stimulating hormone), complicated by severe form of SWN.

Disturbances from the respiratory system, organs of the chest and mediastinum: hydrothorax in severe form of HH.

Disorders from the gastrointestinal tract: abdominal pain and dyspeptic symptoms such as nausea and diarrhea associated with moderateOGY; ascites in severe form of acute hypoglycemia.

Violations of the genitals and mammary gland: tenderness of the mammary glands; SHG of moderate severity (the size of the ovaries is more than 5 cm in diameter) and of a severe form (large ovarian cysts, more than 12 cm in diameter, prone to rupture).

Clinical manifestations of acute hypoglycemia of moderate severity and severe form (diarrhea, a feeling of heaviness in the abdomen, abdominal pain, hemoperitoneum, tachycardia, lowering of arterial pressure, hemostasis disorders, increased activity of hepatic transaminases, oliguria, acute renal failure, dyspnea, respiratory failure).

In men:

Disturbances from the skin and subcutaneous tissues: acne.

Violations of the genitals and the breast: treatment with gonadotropin chorionic sporadically can cause gynecomastia; hyperplasia of the prostate, an increase in the penis, increased sensitivity of the nipples of the mammary glands in men.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Gonadotropin chorionic is characterized by extremely low toxicity.

Have women on the background of an overdose, a severe OHSS may occur.

Treatment is carried out in a hospital.

Principles of treatment of severe hypoglycemia:

- monitoring the function of the cardiovascular system (CVS), respiratory system,liver, kidney, electrolyte and water balance (diuresis, weight dynamics, abdominal circumference changes); control of hematocrit; crystalloid solutions intravenously drip (to restore and maintain the volume of circulating blood (BCC));

- colloidal solutions intravenously drip - 1,5-3 l / day (with preservation of hemoconcentration) and oliguria resistant;

- hemodialysis (with the development of renal failure);

- corticosteroid,anti-prostaglandin, antihistamines (to reduce the permeability of capillaries);

- with thromboembolism - low molecular weight heparins (Fraxiparin, Clexane);

- plasmapheresis - 1-4 sessions with an interval of 1-2 days (improvement of the rheological properties of blood, normalization of the acid-base state (CBS) and gas composition of the blood, reduction in the size of the ovaries);

- Paracentesis and transvaginal puncture of the abdominal cavity with ascites.

In men possibly the development of gynecomastia; atrophy of the seminiferous tubules (due to inhibition of the production of follicle-stimulating hormone (FSH) as a result of stimulation of the production of androgens and estrogens); decrease in the number of spermatozoa in the ejaculate (when the drug is misused).Long-term use of the drug may lead to increased side effects.

Interaction:

In the treatment of infertility, gonadotropin, a human used in combination with preparations of human menopausal gonadotropin (MHC), can enhance the symptoms of ovarian hyperstimulation resulting from the use of MHC. It is necessary to avoid joint use of the drug Gonadotropin chorionic with high doses of glucocorticosteroids.

No other interactions with drugs were noted.

Special instructions:

The use of gonadotropin increases the risk of venous or arterial thromboembolism, so it is necessary to evaluate the benefits of in vitro fertilization therapy for patients at risk. It should also be noted that pregnancy itself is also accompanied by an increased risk of thrombosis.

Increases the likelihood of multiple pregnancies. Multiple pregnancy is accompanied by an increased risk for the mother (complicated course of pregnancy and childbirth, premature birth) and for newborns (low body weight, prematurity, etc.).

During treatment with the drug and within 10 days after discontinuation of treatment, the drug Gonadotropin chorionic can exert influence on the values of immunological tests for the concentration of hCG in blood plasma and urine, which can lead to a false positive result of the pregnancy test.

Before starting the use of the drug in women, ultrasound (ultrasound) of the pelvic organs should be performed to determine the size and number of follicles; in the process of treatment - daily monitoring ultrasound, determination of the concentration of estradiol in blood plasma, careful monitoring of the patient's condition. If the OHSS develops, treatment should be stopped.

Among women with infertility, which suggested treatment with assisted reproductive technologies (especially in vitro fertilization), often there is a pathology of the fallopian tubes, which can lead to an increased risk of ectopic pregnancy, so in the early stages of pregnancy, an ultrasound should be performed to clarify the location of the fetal egg.

Treatment of male patients with gonadotropin chorionic leads to increased production of androgens,therefore, patients at risk should be under strict medical supervision, since exacerbation of the disease or relapse may sometimes result from increased production of androgens.

In men The drug is ineffective with a high content of follicle-stimulating hormone.

Prolonged administration can lead to the formation of antibodies to the drug.

Effect on the ability to drive transp. cf. and fur:

During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Lyophilizate for solution for intramuscular injection, 5000 IU.

Packaging:

By 5000 ME preparation in bottles of a glass tube.

5 bottles of the drug in a contoured cell pack of a polyvinylchloride film complete with 5 ampoules of 1 ml of solvent (sodium chloride, injection for 9 mg / ml) in a contiguous cell pack of polyvinyl chloride film together with instructions for use of the preparation and solvent, scarifier or with a knife amputated in a pack of cardboard.

When packing ampoules with incisions, rings and break points, scarifiers or ampoule knives do not.

Storage conditions:

In the dark place at a temperature of not more than 20 ^°FROM.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-002615

Date of registration:04.05.2012

Expiration Date:Unlimited

The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia

Manufacturer: & nbsp

MOSCOW ENDOCRINE FACTORY, FSUE Russia

Representation: & nbspMOSCOW ENDOCRINE FACTORY FGUP MOSCOW ENDOCRINE FACTORY FGUP Russia

Information update date: & nbsp04.05.2017

Illustrated instructions

Instructions

Gonadotropin chorionic (Gonadotrophin chorionic)