Chorionic gonadotropin lyophilisate for preparation of solution for intramuscular injection 1000ED, No. 5

Hypofunction of the gonads in men and women, caused by impaired activity of the hypothalamus and pituitary gland.
In women: anovulatory infertility, insufficiency of the corpus luteum (in the presence of ovarian estrogenic function), induction of superovulation during assisted reproductive techniques, recurrent miscarriage, threatening spontaneous miscarriage.
In men: hypogenitalism, eunuchoidism; hypoplasia of testicles, cryptorchidism; adiposogenital syndrome, pituitary dwarfism, sexual infantilism; oligoasthenospermia, azoospermia.
For the purpose of differential diagnosis of cryptorchidism and anarchism in boys and for the purpose of assessing testicular function in hypogonadotropic hypogonadism.

The drug is administered intramuscularly.
For women, for the induction of ovulation - 5000-10000 units at once, for stimulating the function of the corpus luteum - 1500-5000 units for 3-6-9 days after ovulation.
For the induction of superovulation in the course of assisted reproductive measures - up to 10,000 U once after the induction of the growth of multiple follicles, which is achieved as a result of stimulation according to the established scheme. The oocyte is taken 34-36 hours after injection.
With habitual miscarriage, the introduction begins immediately after the pregnancy is diagnosed (but no later than 8 weeks) and continues until the 14th week of pregnancy, inclusive: 10,000 units on day 1, then 5,000 units 2 times a week.
With the threat of spontaneous miscarriage (if symptoms appeared in the first 8 weeks of pregnancy) - 10,000 IU initially, then 5000 IU 2 times a week until 14 weeks of pregnancy, inclusive.
With delayed sexual development in boys - 3000-5000 ME 1 time per week for at least 3 months. For men - 500-2000 IU once a day 2-3 times a week for 1.5-3 months.
With hypogonadotropic hypogonadism: 1500-6000 IU (in combination with menotropins) once a week.
For the purpose of differential diagnosis of cryptorchidism and anarchism in boys and in order to assess the function of the testicles in hypogonadotropic hypogonadism, once - 5000 units.
With cryptorchidism: at the age of 6 years - 500-1000 IU 2 times a week for 6 weeks; over 6 years old - 1500 IU 2 times a week for 6 weeks.
With idiopathic normogonadotropic oligospermia - 5000 IU weekly for 3 months together with menotropins. With oligo- and asthenospermia caused by relative androgenic insufficiency - 2500 IU every 5 days or 10000 IU once every 2 weeks for 3 months.

active substance - chorionic gonadotropin 1000 IU,

excipients - mannitol (mannitol).

Solvent: sodium chloride solution / and 0.9% - 1 ml.

Hypersensitivity to the components of the drug, pituitary tumor, hormone-active tumors of the gonads (including androgen-dependent), absence of gonads (congenital or after surgery), early onset of menopause, thrombophlebitis, lactation, ovarian cancer, hypothyroidism, adrenal insufficiency , hyperprolactinemia, obstruction of the fallopian tubes.

With care : adolescence, coronary heart disease, arterial hypertension, chronic renal failure, bronchial asthma, migraine.

Trade name : Chorionic gonadotropin

International non-proprietary name : chorionic gonadotropin.

Dosage form : lyophilisate for preparation of a solution for intramuscular administration.

Ingredients :

active substance - chorionic gonadotropin 1000 IU,

excipients - mannitol (mannitol).

Solvent: sodium chloride solution / and 0.9% - 1 ml.

Description: Freeze-dried white or off-white powder.

Pharmacotherapeutic group : Luteinizing agent.

Pharmacological properties :

The drug has a gonadotropic effect, mainly luteinizing. Stimulates the synthesis of sex hormones in the ovaries and testicles. Stimulates ovulation in women and spermatogenesis in men. Enhances the development of genitals and secondary sexual characteristics.

Indications for use :

Hypofunction of the gonads in men and women, caused by impaired activity of the hypothalamus and pituitary gland.
In women: anovulatory infertility, insufficiency of the corpus luteum (in the presence of ovarian estrogenic function), induction of superovulation during assisted reproductive techniques, recurrent miscarriage, threatening spontaneous miscarriage.
In men: hypogenitalism, eunuchoidism; hypoplasia of testicles, cryptorchidism; adiposogenital syndrome, pituitary dwarfism, sexual infantilism; oligoasthenospermia, azoospermia.
For the purpose of differential diagnosis of cryptorchidism and anarchism in boys and for the purpose of assessing testicular function in hypogonadotropic hypogonadism.

Contraindications:

Hypersensitivity to the components of the drug, pituitary tumor, hormone-active tumors of the gonads (including androgen-dependent), absence of gonads (congenital or after surgery), early onset of menopause, thrombophlebitis, lactation, ovarian cancer, hypothyroidism, adrenal insufficiency , hyperprolactinemia, obstruction of the fallopian tubes.

With care : adolescence, coronary heart disease, arterial hypertension, chronic renal failure, bronchial asthma, migraine.

Method of administration and dosage .

The drug is administered intramuscularly.
For women, for the induction of ovulation - 5000-10000 units at once, for stimulating the function of the corpus luteum - 1500-5000 units for 3-6-9 days after ovulation.
For the induction of superovulation in the course of assisted reproductive measures - up to 10,000 U once after the induction of the growth of multiple follicles, which is achieved as a result of stimulation according to the established scheme. The oocyte is taken 34-36 hours after injection.
With habitual miscarriage, the introduction begins immediately after the pregnancy is diagnosed (but no later than 8 weeks) and continues until the 14th week of pregnancy, inclusive: 10,000 units on day 1, then 5,000 units 2 times a week.
With the threat of spontaneous miscarriage (if symptoms appeared in the first 8 weeks of pregnancy) - 10,000 IU initially, then 5000 IU 2 times a week until 14 weeks of pregnancy, inclusive.
With delayed sexual development in boys - 3000-5000 ME 1 time per week for at least 3 months. For men - 500-2000 IU once a day 2-3 times a week for 1.5-3 months.
With hypogonadotropic hypogonadism: 1500-6000 IU (in combination with menotropins) once a week.
For the purpose of differential diagnosis of cryptorchidism and anarchism in boys and in order to assess the function of the testicles in hypogonadotropic hypogonadism, once - 5000 units.
With cryptorchidism: at the age of 6 years - 500-1000 IU 2 times a week for 6 weeks; over 6 years old - 1500 IU 2 times a week for 6 weeks.
With idiopathic normogonadotropic oligospermia - 5000 IU weekly for 3 months together with menotropins. With oligo- and asthenospermia caused by relative androgenic insufficiency - 2500 IU every 5 days or 10000 IU once every 2 weeks for 3 months.

Side effect . Local reactions (pain at the injection site, hyperemia); allergic reactions; headache; increased fatigue; irritability; anxiety; depression; suppression of the gonadotropic function of the pituitary gland.
In women with combined treatment of infertility (in combination with menotropins and clomiphene) - ovarian hyperstimulation syndrome. In men - fluid retention, edema, increased sensitivity of the nipples of the mammary glands, gynecomastia, an increase in testicles in the inguinal canal (with cryptorchidism).
As a result of prolonged use of the drug in men, a decrease in the number of spermatozoa in the ejaculate was found.

Overdose . In case of an overdose of the drug in women, ovarian hyperstimulation syndrome may occur with an increase in their size due to ovarian cysts with the danger of rupture, the appearance of ascites and hydrothorax. Symptoms such as a feeling of tension and abdominal pain, vomiting, diarrhea, difficulty breathing, and weight gain may indicate its appearance. Treatment is symptomatic.

Interaction with other medicinal products . Chorionic gonadotropin is used in combination with menopausal gonadotropin in the treatment of infertility.

Special instructions .
In men, the drug is ineffective with a high content of follicle-stimulating hormone (FSH). With prolonged treatment or use in high doses in male adolescents with impaired physical and sexual development, premature puberty is possible. Unreasonably long-term use of the drug for cryptorchidism, especially if surgery is indicated, can lead to degeneration of the gonads. Inhibition of FSH production due to stimulation of the production of androgens and estrogens contributes to the atrophy of the seminiferous tubules.
Long-term administration can lead to the formation of antibodies to the drug.
Increases the likelihood of multiple pregnancies. Erroneous results are possible when using a pregnancy test during drug treatment and within 7 days after its cancellation.

Release form . Lyophilisate for the preparation of a solution for intramuscular administration of 5000 IU in 5 ml vials.
5 vials with the drug in a blister and 5 ampoules of 1 ml of sodium chloride solution for injection 0.9% in a blister, together with instructions for use of the drug and solvent, are placed in a cardboard box.

Storage conditions . List B. In a place protected from light and out of reach of children, at a temperature not exceeding 20 ? C.

Expiration date . 3 years.
Do not use after the expiration date printed on the package.

Conditions of dispensing from pharmacies . On prescription.