Khoral - instructions for use, doses, side effects, contraindications

Excipients: Mannitol (mannitol) 5 mg, sodium hydrophosphate dodecahydrate (sodium phosphate disubstituted 12-water) in terms of anhydrous 0.25 mg, sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dibasic) in terms of anhydrous 0.25 mg.

Description:

The porous mass is white or almost white.

Pharmacotherapeutic group:luteinizing agent

ATX: & nbsp

G.03.G.A.01 Gonadotropin chorionic

Pharmacodynamics:

Choral contains human gonadotropin chorionic (hCG). This hormone has biological activity similar to that of human luteinizing hormone (hLH). LH is indispensable for normal growth and maturation of female and male gametes and for the formation of sex hormones.

Among women:

Gonadotropin chorionic is used as a substitute for ejection in the middle of the endogenous LH cycle in order to induce the final phase of follicular maturation, leading to ovulation. Gonadotropin is also used as a substitute for endogenous LH during the luteal phase.

In boys and men:

Gonadotropin chorionic is used to stimulate Leydig cells to accelerate the formation of testosterone.

Pharmacokinetics:

The maximum concentration of hCG in the blood plasma after a single intramuscular or subcutaneous injection is achieved after 6-16 hours in men and approximately 20 hours in women. Despite the fact that there is a high individual variability, sex differences in the rate of absorption of the drug are associated, most likely, with a greater thickness of subcutaneous fat in women. Approximately 80% of hCG is subjected to metabolic transformations in the kidneys. It was found that a single intramuscular or subcutaneous injection of hGH is bioequivalent with respect to the duration of absorption and the apparent half-life value of approximately 33 hours.Given the recommended dosage regimens and half-life, no cumulation of the drug is expected.

Indications:

Among women:

- induction of ovulation infertility due to anovulation or impaired follicular maturation;

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

- maintaining the phase of the yellow body.

In boys and men:

- hypogonadotropic hypogonadism;

- delay in puberty due to deficiency in gonadotropic pituitary gland function;

- cryptorchidism, not due to anatomical obstruction.

Contraindications:

- Hypersensitivity to human gonadotropins or any component of the drug;

- established or suspected tumors dependent on sex hormones (ovarian carcinoma, breast carcinoma and uterine carcinoma in women, prostate carcinoma, breast carcinoma in men), pituitary tumors;

- gonadal dysgenesis;

- obstruction of the fallopian tubes (except for techniques of assisted reproduction);

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

- hypothyroidism;

- adrenal insufficiency;

hyperprolactinemia;

- lactation period;

- early onset of menopause;

- Thrombophlebitis.

Carefully:

Ischemic heart disease, heart failure, arterial hypertension, chronic renal failure, bronchial asthma, migraine, and:

- among women, having risk factors for thrombosis (personal or family history, severe obesity with a body mass index> 30 kg / m², thrombophilia), the risk of venous or arterial thromboembolic events may be increased during or after treatment with gonadotropins. These women need to evaluate the benefits of in vitro fertilization (IVF) and possible risks. It should be noted that pregnancy itself is also accompanied by an increased risk of thrombosis;

- in boys and men treatment with gonadotropin chorionic leads to increased production of androgens. In pre-pubertal boys, hCG should be used with caution in order to avoid premature closure of the epiphyses or premature puberty. You should regularly monitor the development of the skeleton.

Pregnancy and lactation:

Gonadotropin chorionic can be used to maintain the function of the ovarian's yellow body.

The use of chorionic gonadotropin is contraindicated during pregnancy and lactation.

Dosing and Administration:

Intramuscularly.

Among women

For the induction of ovulation in infertility due to anovulation or impaired follicular maturation

Typically, one injection of hCG is given in a dose of 5,000 to 10,000 ME to complete treatment with FSH.

When preparing follicles for puncture in controlled ovarian hyperstimulation programs

Typically, one injection of hCG is given in a dose of 5,000 to 10,000 ME to complete treatment with FSH.

To maintain the phase of the yellow body

Can be done from two to three repeated injections of the drug at a dose of 1000 to 3000 ME each for 9 days after ovulation or embryo transfer (for example, on days 3, 6 and 9 after ovulation).

In boys and men

With gonadotropic hypogonadism

1000-2000 ME 2-3 times a week. In case of infertility, a combination of gonadotropin chorionic with an additional drug containing follylotropin (FSH) 2-3 times a week is possible. The course of treatment should last at least 3 months, after which you can expect improvement in spermatogenesis.During this treatment, it is necessary to suspend testosterone replacement therapy. When the improvement of spermatogenesis has been achieved, to maintain it is sufficient, in some cases, isolated application of hCG.

When delayed puberty, due to the lack of gonadotropic function of the pituitary gland

1500 ME 2-3 times a week. The course of treatment - at least 6 months.

In cryptorchidism, not due to anatomical obstruction

- at the age of 2 years: 250 ME 2 times a week for 6 weeks;

- at the age of 6 years: 500-1000 ME 2 times a week for 6 weeks;

- over 6 years of age: 1500 ME 2 times a week for 6 weeks.

The course of treatment, if necessary, can be repeated.

Preparation of the solution:

Chorale solution for intramuscular injections is prepared by dissolving the lyophilizate in a 0.9% solution of sodium chloride for injection.

Side effects:

From the immune system: allergic reactions, rarely - generalized rash, fever.

Local reactions: hematoma, pain, redness, swelling, itching, allergic reaction in the form of rash (at the injection site).

Other: headache, fatigue, irritability, anxiety, depression, suppression of gonadotrophic pituitary gland function.

Among women

From the side of the cardiovascular system: rarely thromboembolism associated with FSH / hCG therapy, usually associated with a severe ovarian hyperstimulation syndrome (GHSV).

From the respiratory system: hydrothorax as a complication of severe FSH.

From the digestive system: abdominal pain, nausea and diarrhea associated with moderate FSH; ascites as a complication of severe FSH.

From the reproductive system and breast: undesirable ovarian hyperstimulation, moderate SGUS (small or medium increase in ovaries and ovarian cysts) or severe SWSD (large, prone to rupture, ovarian cysts, weight gain); tenderness of mammary glands.

In boys and men

Metabolic disorders: in some cases, with the introduction of high doses of hCh, sodium and water retention (as a result of excessive formation of androgens), edema.

From the reproductive system and breast: increased testicles in the inguinal canal (with cryptorchidism), increased sensitivity of the nipples of the mammary glands, sporadically - gynecomastia.

Overdose:

It was shown that the acute toxicity of hCG drugs released from urine is very low.Nevertheless, it is likely that too high a dose of hCG can lead to a severe ovarian hyperstimulation syndrome.

Special instructions:

Among women

- When pregnancy occurs after induction of ovulation with gonadotropic drugs, there is an increased risk of multiple pregnancies.

- Since infertility women undergoing assisted reproductive technologies (ART), and in particular in vitro fertilization (IVF), often have abnormalities from the fallopian tubes, the incidence of ectopic pregnancy may increase. To exclude an ectopic pregnancy, an early ultrasound examination is necessary.

- The frequency of pregnancy loss in women undergoing ART is higher than in the usual population.

- It is necessary to exclude the presence of uncontrolled non-native endocrinopathies (for example, a violation of the thyroid gland, adrenal gland or pituitary gland).

- The frequency of malformation of the genitals after ART is slightly higher than after spontaneous conception. It is believed that this is due to differences in the characteristics of parents (maternal age, sperm characteristics), as well as the high frequency of multiple pregnancies after ART.There is no evidence that an increased risk of malformation of the genitals during ART is associated with the use of gonadotropins.

- Undesirable hyperstimulation of the ovaries. In patients receiving treatment for infertility due to anovulation or a disturbance in the maturation of follicles, the previous administration of an FSH-containing preparation may lead to unwanted ovarian hyperstimulation. Therefore, before starting FSH treatment and at regular intervals during FSH treatment, it is necessary to perform an ultrasound study to evaluate the development of follicles and to determine the levels of estradiol. Estradiol levels can rise very quickly, for example, for more than two or three consecutive days, more than a daily doubling can be observed, and can reach extremely high values. The diagnosis of unwanted ovarian hyperstimulation can be confirmed by ultrasound. In the event of undesirable ovarian hyperstimulation (i.e., not as part of a treatment directed towards in vitro fertilization (IVF) and embryo transfer (PE), intrabubram gamete transfer (GIFT),ICSI (intracytoplasmic sperm injection)), the administration of the FSH-containing drug should be stopped immediately. In this case, it is necessary to avoid pregnancy and not to introduce PPH, since the administration of LH-active gonadotropin at this stage can cause additionally a multitude of ovulations, Ovarian Hyperstimulation Syndrome (SSI). This warning is especially important for patients with polycystic ovaries.

Clinical symptoms of severe musculoskeletal syndrome are disorders of the gastrointestinal tract (pain, nausea, diarrhea), tenderness of the mammary glands, enlargement of the ovaries and cysts of the ovaries (from small to moderate). There were reports of abnormalities in the results of tests of liver barrier function, indicative of hepatic dysfunction, which may be accompanied by morphological changes in liver biopsy. In rare cases, a severe SSG occurs, which can pose a threat to life. It is characterized by large cysts (prone to rupture), ascites, weight gain, often hydrothorax and, in some cases, thromboembolic events.

- Chorale should not be used to reduce body weight, hGH does not affect metabolism and fat distribution or appetite.

- Prolonged use may lead to the formation of antibodies to the drug.

- There may be erroneous results during the test to determine pregnancy during treatment with the drug and within 7 days after its withdrawal.

- In men It is ineffective with a high content of FSH.

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

hGH does not affect the concentration of attention and the speed of psychomotor reactions.

Form release / dosage:

Lyophilizate for solution for intramuscular injection, 1500 ME or 5000 ME.

Packaging:

By 1500 ME or 5000 ME lyophilizate in bottles of colorless glass.

Each bottle with instructions for use in a pack of cardboard.

For 3 vials with instructions for use in a pack with partitions or special cardboard sockets.

For 1 or 3 bottles complete with 1 or 3 ampoules, respectively, with a solution of 0.9% sodium chloride isotonic 0.9% for injections of 1 ml or 2 ml together with instructions for use in a pack with septums or special cardboard sockets.In the case of a solvent bundle, a knife for ampoules or an ampoule ampoule is put into each pack. When using ampoules with incisions or a rupture ring, the ampoule opener or ampoule scaper is not inserted.

For 20, 30 vials without ampoules with a solvent with an equal number of instructions for use, in a box of cardboard (for hospitals).

Storage conditions:

In the dark place at a temperature of 2 to 15 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002247/09

Date of registration:23.03.2009

The owner of the registration certificate:LENS-PHARM, LLC LENS-PHARM, LLC Russia

Manufacturer: & nbsp

LENS-PHARM, LLC Russia

Information update date: & nbsp23.12.2015

Illustrated instructions

Instructions

Khoral (Choral)