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

1 bottle contains:

active substance: menotropins - follicle-stimulating hormone (FSH) 75 ME and 150 ME, luteinizing hormone (LH) 75 ME and 150 ME;

Excipients: mannitol 20 mg, sodium hydrogen phosphate dihydrate 0.134 mg, sodium dihydrogen phosphate dihydrate 0.08 mg.

The solventSodium chloride, water for injection.

Description:

Lyophilizate: white lyophilized mass.

Solvent: clear, colorless liquid.

Pharmacotherapeutic group:follicle stimulating agent
ATX: & nbsp
  • Gonadotropin-menopausal
  • Pharmacodynamics:

    The drug is a human menopausal gonadotropin (hMG), produced from the urine of women in the postmenopausal period. The drug contains FSH and LH in a ratio of 1: 1.

    Has follicle-stimulating and gonadotropic action. Increases the concentration of sex hormones in the plasma.

    Among women causes an increase in the concentration of estrogens in the blood and stimulates the growth of the ovaries, the maturation of follicles in them and ovulation, causes proliferation of the endometrium.

    In men stimulates spermatogenesis (by activating the synthesis of proteins binding androgens in the seminiferous tubules and Sertoli cells), activates the production of testosterone.The effectiveness is mainly due to the action of FSH.

    Pharmacokinetics:

    The maximum concentration of FSH in the blood plasma is reached 6-24 hours after intramuscular injection, after which the concentration of FSH in the blood gradually decreases. The half-life period is 4-12 hours. After absorption into the blood hMG is distributed mainly in the tissues of the ovary and kidneys and is excreted mainly by the kidneys. Excretion can be reduced in patients with renal insufficiency.

    Indications:

    - Female infertility associated with a violation of the maturation of follicles, against a background of hypo- and normalnadotropic ovarian failure;

    - stimulation of superovulation (growth of multiple follicles for assisted reproductive techniques that facilitate the onset of conception) in combination with human chorionic gonadotropin (hCG);

    - Male infertility associated with a violation of spermatogenesis against hypo- and normogonadotropic hypogonadism in combination with hCG.

    Contraindications:

    Hypersensitivity, tumors of the hypothalamic-pituitary region, hyperprolactinaemia, adrenal and thyroid gland diseases.

    For women - persistent increase in ovaries, ovarian cyst (not due to the presence of polycystic ovary syndrome), polycystic ovary syndrome, abnormalities of genital organs (incompatible with normal pregnancy), uterine myoma, metrorrhagia (unknown etiology), estrogen-dependent tumors (ovarian cancer, uterine cancer, breast cancer), primary ovarian failure, pregnancy, lactation.

    For men - prostate cancer, testicular tumor, androgen-dependent tumors.

    Childhood.
    Carefully:

    Presence of risk factors for thromboembolism, such as individual silt and familial predisposition; severe obesity (body mass index> 30 kg / m2) or thrombophilia, t. in this case there is an increased risk of venous or arterial thromboembolism during or after treatment with gonadotropins.

    In this case, the benefits of gonadotropin treatment should exceed the risk of their use.

    Pregnancy and lactation:

    The use of the drug is contraindicated in pregnancy and during lactation.

    Dosing and Administration:The drug HuMoG is administered intramuscularly after dissolution in the attached solvent.

    Application in Women: to stimulate the growth of one dominant follicle in women, two different injection schemes are used.

    The first scheme: a daily dose of 75 ME in the first 7 days of the cycle in menstruating women. Injections continue until an adequate response can be judged, which can be judged by the daily analysis of the concentration of estrogens in the blood and the determination of the size of the follicles by ultrasound (ultrasound). Maturation of follicles occurs usually during the treatment cycle lasting 7-12 days. In the absence of ovarian response to administration, the daily dose of the drug can be gradually increased to 150 ME.

    Second scheme: an introduction every other day for 1 week. The initial dose is 225-375 IU / day. If adequate stimulation is not achieved, the dose may be gradually increased.

    After the treatment of any of the schemes and in the presence of adequate but not excessive reaction of the ovaries controlled by ultrasonic folliculometry and determination of the concentration of estradiol in the plasma 24-48 hours after the last administration of the preparation HuMoG with the aim of inducing ovulation, 5-10 thousand ME hCG, increasing the content of LH and stimulating the release of a mature egg.

    In the presence of at least 3 follicles with a diameter of 16-20 mm (according to ultrasound) and an adequate ovarian response (estradiol concentration in the blood plasma of 300-400 pg / ml (1000-1300 pmol / l) per follicle with a diameter of more than 18 mm) hHG Do not inject and take measures to protect against possible pregnancy to prevent multiple pregnancies. Since each follicle with a diameter of more than 14 mm is preovulatory, the presence of several follicles with a diameter of more than 14 mm carries the risk of multiple pregnancies.

    In the presence of ovulation and the absence of pregnancy, treatment can be repeated according to one of the above schemes for 2 cycles. On the day of hCG administration and the next 2-3 days, the patient is recommended to have coitus. When stimulating superovulation (when performing assisted reproductive techniques - ART), the duration of administration of the drug may be longer.

    Application in men: when hypogonadotropic hypogonadism in men for the stimulation of spermatogenesis the drug is prescribed if the previous therapy with hCG caused only an androgenic reaction without signs of increased spermatogenesis.In this case, the treatment is continued by administering 2,000 IU hCG 2 times a week, along with injections of HuMoG 75 ME 3 times per week. Treatment for this regimen should be continued for at least 4 months, with ineffectiveness, treatment is continued, introducing hCG 2,000 IU twice a week and 150 IU of HuMoG 3 times a week.

    The state of spermatogenesis should be assessed on a monthly basis, and if there are no positive results within the next 3 months, treatment should be discontinued.

    With idiopathic normogonadotrophic oligospermia is introduced weekly 5 thousand ME hCG subcutaneously or intramuscularly, with parallel administration of 75-150 ME the drug HuMoG 3 times a week for 3 months.

    Side effects:

    From the digestive system: nausea, vomiting, flatulence, gastralgia.

    From the endocrine system: mastalgia, ovarian hyperstimulation syndrome (OCS), ovarian enlargement in size, development of large ovarian cysts, significant increase in the excretion of estrogen in the urine, and in men - gynecomastia.

    From the side of metabolism: water-electrolyte disturbances.

    Allergic reactions: skin rash, urticaria (the formation of antibodies with prolonged use), fever, arthralgia; generalized allergic reactions - erythema, urticaria.

    Local reactions: swelling, pain, or itching in the area of ​​injection.

    Other: oliguria, hypovolemia, blood thickening, lowering blood pressure, ascites, hydrothorax, hemoperitoneum, weight gain, thromboembolic disease, multiple pregnancy, abdominal pain.

    Overdose:

    Ovarian hyperstimulation:

    - hyperstimulation of 1 degree - mild - does not require treatment, accompanied by a slight increase in the size of the ovaries (up to 5-7 cm), an increased level of sex steroids and abdominal pain. The patient should be informed about her condition and carefully monitored.

    - hyperstimulation 2 degree requires hospitalization and symptomatic treatment, including intravenous infusions of solutions to maintain the general circulation of blood (in case of an increase in the concentration of hemoglobin). Cysts ovaries with dimensions up to 8-10 cm accompanied by abdominal symptoms, nausea and vomiting.

    - for hyperstimulation of 3 degrees characterized by ovarian cysts in size 10 cm and more, ascites, hydrothorax, an increase in abdominal pain, dyspnea, salt retention, an increase in hemoglobin concentration in the blood, and an increase in its viscosity, accompanied by increased adhesion of platelets to the risk of thromboembolism. Requires mandatory hospitalization.

    Interaction:

    Do not mix with other medicines in the same syringe.

    When combined with clomiphene, the ovarian response to the administration of HuMoG is increased.

    Special instructions:

    Before the treatment of infertility among women should assess the functional status of the ovaries (ultrasound and the concentration of estradiol in the blood plasma). In the process of treatment, these studies should be performed daily or a day before the appearance of a reaction that can be assessed by the cervical index. Careful observation of the patient's condition is necessary throughout the course of treatment.

    At the first signs of development of HHV (abdominal pains and palpable by a doctor or ultrasound-determined enlarged formations in the lower abdomen) treatment should be stopped immediately!

    In case of occurrence of HHV, it is contraindicated to introduce an ovulatory dose of hCG!

    In the case of pregnancy, the symptoms of excessive hyperstimulation can be amplified and observed for a long time, threatening the life of the patient.

    Induction of ovulation with hMG increases the risk of developing a multiple pregnancy, the appropriate dose adjustment prevents the development of multiple follicles.With multiple pregnancy, there is a higher risk of complications during pregnancy and childbirth. Before starting treatment, the patient should be warned about the possibility of developing a multiple pregnancy. The first administration of HuMoG should be performed under the direct supervision of a physician.

    In women with infertility, to which ART is applied, often there are abnormalities of the fallopian tubes, which increases the risk of ectopic pregnancy. Therefore, it is important to obtain an early ultrasound confirmation of the location of the fetal egg in the uterine cavity.

    The risk of early termination of pregnancy in women who undergo in vitro fertilization (IVF) procedure is higher than with natural conception. There is also a slight increase in the incidence of congenital malformations. Perhaps this is due to the characteristics of the parents (for example, their age or sperm characteristics), as well as a higher frequency of multiple pregnancy with ART.

    Before the appointment of the drug, it is necessary to conduct appropriate treatment for violations of the thyroid gland or adrenal cortex, hyperprolactinaemia of various etiologies,tumors of the hypothalamic-pituitary region.

    During the treatment period in men with a high concentration in the blood of FSH menotropins ineffective.
    Effect on the ability to drive transp. cf. and fur:There are no reports on the effect of the drug on the ability to drive vehicles and mechanisms.
    Form release / dosage:

    Lyophilizate for solution for intramuscular injection, 75 IU LH + 75 IU FSH, 150 IU LH + 150 IU FSH.

    Packaging:

    Lyophilizate - in bottles of a transparent, colorless neutral glass with a volume of 2 ml, closed with a rubber stopper, an aluminum cap and a plastic lid.

    Solvent - 1 ml per ampoule of dark neutral glass with a volume of 1 ml.

    One vial with lyophilizate and one ampoule of solvent is packed in a plastic contour mesh package, which is placed in a cardboard box together with an instruction for use.

    Storage conditions:

    Lyophilizate - at a temperature of 2 to 8 ° C, in a place protected from light and inaccessible to children. Do not freeze.

    Solvent - at a temperature not exceeding 25 ° С.
    Shelf life:Lyophilizate- 3 years.
    The solventь - 5 years.
    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-001964
    Date of registration:07.11.2011 / 05.08.2013
    The owner of the registration certificate:Bharat Searms & Waxings LimitedBharat Searms & Waxings Limited India
    Manufacturer: & nbsp
    Representation: & nbspMEDINTORG, ZAOMEDINTORG, ZAO
    Information update date: & nbsp15.03.2016
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