Merional lyophilisate for solution + r-75m Pharmstandart + 75m lg N1
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Active ingredients
Menotropins
Release form
Lyophilisate
Composition
1 bottle contains: Active substance: follicle-stimulating hormone 75 IU, luteinizing hormone 75 IU. Adjuvants: lactose monohydrate 10 mg. Solvent: sodium chloride (pyrogen-free d / i) 9 mg, water d / and (up to 1 ml).
Pharmacological effect
The drug of human menopausal gonadotropin (hMG) high purity. Belongs to the group of menotropinov. The ratio of the biological activity of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) is 1: 1. The drug is obtained from the urine of postmenopausal women. Specific receptors for gonadotropins are present only in the tissues of the genital organs. In the ovaries, LH binds to receptors on the surface of the tech-cells and the corpus luteum, as well as with the granulosa cells of large follicles. FSH binds to receptors on the surface of granular cells of small follicles in the ovaries and Sertoli cells in the testes. The receptors for LH and FSH are associated with adenylate cyclase through a guanine-nucleotide-binding regulatory protein (Gs-protein). An increase in intracellular cAMP causes an increase in the amount of the mitochondrial enzymatic complex, which, by oxidation, breaks down the side chains of cholesterol; This reaction is the limiting stage in the process of converting cholesterol to pregnenalon. Although the mechanism of stimulating gametogenesis by gonadotropins is unknown, it is also carried out with the participation of cyclic AMP.
Pharmacokinetics
Absorption After a single SC and IM administration at a dose of 225 ME, the time to reach the Cmax of the drug in plasma is 17.9 and 27.5 hours, respectively. After repeated use (150 ME daily for 7 days) the time to reach the Cmax of the drug in plasma is 8.0 hours for subcutaneous doses and 9.0 hours for intramuscular administration. With a single subcutaneous dose and intramuscular administration, Cmax averages 8.5 and 7.8 mIU / ml, respectively. With repeated s / c and v / m injection, Cmax averages 15.0 mIU / ml and 12.5 mIU / ml, respectively. AUC with a single s / c and v / m administration averages 726.2 mIU h / ml and 656.1 mIU × h / ml, respectively. With repeated s / c and v / m administration, AUC averages 622.7 mIU h / ml and 546.2 mIU h / ml, respectively. The bioavailability of the drug during s / c administration is higher than with i / m administration. T1 / 2 FSH injection with repeated administration is approximately 11-13 hours
Indications
In women, anovulation with the ineffectiveness of clomiphene therapy; - Controlled ovarian stimulation to induce the growth of multiple follicles when conducting assisted reproductive technologies, such as in vitro fertilization, intrafallopian gamete transfer, intraphalopia zygote transfer. in combination with human chorionic gonadotropin (hCG).
Contraindications
- Tumors of the hypothalamic-pituitary region; - Hyperprolactinemia; - Diseases of the adrenal glands and thyroid gland; - Organic lesions of the CNS, for example, pituitary tumors; - Children age; - Increased sensitivity to the drug. For women - Primary ovarian failure; - Persistent ovarian enlargement, cyst ovaries (not due to the presence of polycystic ovary syndrome); - Polycystic ovary syndrome; - Abnormal development of the genital organs (incompatible with the normal course of pregnancy); - Uterine myoma; - Metrorrhagia ( unclear etiology); - Estrogen-dependent tumors (ovarian cancer, uterine cancer, breast cancer); - Primary ovarian failure; - Pregnancy; - Lactation period. For men - Prostate cancer; - Testicular tumor; - Androgen-dependent tumors. drug in the presence of risk factors for thromboembolism, such as individual or family predisposition, severe obesity (body mass index> 30 kg / m2) or with thrombophilia, as 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 treatment with gonadotropins should exceed the risk of their use.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and lactation.
Dosage and administration
Treatment with Merional should be carried out only under the supervision of a physician who has the appropriate specialization and experience in the treatment of infertility. It is used in v / m or s / c. The solution is prepared immediately before injection using the attached solvent. The contents of 5 bottles can be dissolved in 1 ml of the solvent. Doses are given in FSH. For anovulation, the women are given a daily dose of 75-150 IU / day for the first 7 days of the cycle in menstruating women.Injections continue until an adequate response is achieved, which can be judged by daily analysis of estrogen concentrations and follicle size determination using USI. Follicle maturation usually occurs during the treatment cycle of 7-12 days. In the absence of ovarian response to the introduction of a daily dose of the drug can be gradually increased. The maximum daily dose usually does not exceed 225 ME. After treatment, and if there is an adequate but not excessive ovarian response, determined according to clinical and biochemical studies, within 24-48 hours after the last administration of the drug, 5000-10 is administered once to induce ovulation. 000 IU hCG, which increases the content of LH and stimulates the release of a mature egg. The day of hCG injection and the next day are optimal for conception. In the presence of ovulation and in the absence of pregnancy, treatment can be repeated for 2 cycles. In the absence of an adequate response to therapy within 4 weeks from its beginning, the drug should be canceled and a new course with a higher initial dose should be started. When stimulating superovulation (when conducting assisted reproductive technologies), the drug is used daily at a dose of 150-225 IU / day, starting with 2 or 3 days of the cycle. Injections continue until an adequate response is achieved, which can be judged by daily analysis of the concentration of estrogen and determination of the size of the follicles using ultrasound. The dose is selected in accordance with the response of the patient. The maximum daily dose usually does not exceed 450 ME. Adequate maturation of follicles usually occurs on the 10th day of treatment (in the range from 5 to 25 days). After 24-48 hours after the last injection of Merional, it is necessary to inject 5000-10 000 ME hCG to stimulate the maturation of the follicles. In patients who use a GnRH agonist to suppress the gonadotropic activity of the pituitary, Merional begins approximately two weeks after the start of treatment with a GnRH agonist and continues to use both drugs until adequate development of the follicles is achieved. For example, after two weeks of use of a GnRH agonist, Merional is administered at a dose of 150-225 IU for 7 days. Then the dose is adjusted in accordance with the patient's ovarian response.Dose adjustment should be carried out no more than once every 2 days and no more than 150 ME.Experience in using assisted reproductive technologies shows that the degree of treatment success remains stable during the first four attempts and then gradually decreases. Anovulation caused by severe failure LH and FSH, treatment can be started at any time, as these patients have amenorrhea and a very low endogenous concentration of estrogen. The drug is administered daily at a dose of 75-150 IU / day until an adequate response is reached, Fishing of occurrence of which can be on a daily analyzes concentration of estrogens and follicle size determination via UZI.Esli dose required to increase, dose selection should be preferably 7-14 days, and preferably about 150 to increase ME. The duration of stimulation in one cycle can reach 5 weeks. After treatment, and if there is an adequate, but not excessive, ovarian response, determined according to clinical and biochemical studies, 24-48 hours after the last injection of the drug, in order to induce ovulation, 5000 10 000 ME hHG. The day of hCG injection and the next day are optimal for conception. In this case, luteal support may be needed, since a lack of substances with luteotropic activity (LH / hCG) after ovulation can lead to premature degradation of the corpus luteum. 2 thousand ME chHG 2-3 times a week to normalize the concentration of testosterone in the blood. Then, Merional is administered at 75-150 ME 2-3 times a week for at least 3 months before any improvements in spermatogenesis appear. Available clinical experience shows that treatment can be continued for 18 months to achieve spermatogenesis.
Side effects
On the part of the digestive system: often - abdominal pain, gastrointestinal syndrome, including nausea, vomiting, diarrhea, abdominal cramps and bloating. From the nervous system: very often - headache. From the reproductive system: very often - ovarian cysts; often - mild and moderate ovarian hyperstimulation syndrome; infrequently - severe ovarian hyperstimulation syndrome; rarely - ovarian torsion, complication of ovarian hyperstimulation syndrome. Allergic reactions: very rarely - light erythema, rash or swelling of the face. On the whole body: very rarely - thromboembolic disease,usually associated with severe ovarian hyperstimulation syndrome. Local reactions: very often severe and mild reactions at the injection site (pain, redness, bruising, swelling and / or irritation). In addition, the following adverse reactions may occur: mastalgia, a significant increase in estrogen clearance with urine, abdominal pain, increase in ovaries in size, hypovolemia, blood clots, water and electrolyte disorders, ascites, hydrothorax, fever, arthralgia, oliguria, decrease in blood pressure, weight gain, hemoperitoneum, m ogoplodnaya beremennost.U men using Merionala combination with the drug hCG, reported side effects such as swelling of the mammary glands, acne and weight gain. These effects are mostly caused by hCG. Occasionally, when taking similar drugs, abdominal blood coagulation was observed (blood clots in the vessels), which can also occur when taking Merional.
Overdose
Symptoms: ovarian hyperstimulation syndrome (ovarian enlargement, lower abdominal pain, nausea, vomiting, diarrhea, weight gain, oliguria, ascites, hydrothorax, hemoperitoneum, hemoconcentration, shortness of breath), multiple pregnancy, thromboembolic complications. stage is aimed at reducing the concentration of hormones in the blood and preventing the development of thromboembolic complications (pneumonia, acute renal failure), it consists in the / in the introduction of small amounts of albumin (with constant monitoring concentration of electrolytes in the blood and hematocrit). The second stage begins after stabilization of the patient's condition and should lead to a decrease in the fluid content in the body cavities, for which small amounts of hypertonic sodium chloride and albumin are injected into / in. The third stage is intended to prevent the development of pulmonary edema associated with a massive flow of fluid from the body cavities into the vascular bed, and includes the use of diuretics (with constant monitoring of hematocrit and plasma electrolyte concentration).
Interaction with other drugs
PharmacodynamicCompatible use of Merional with other drugs used to stimulate ovulation (for example, hCG, clomiphene) may enhance the response of the follicles. When used together with GnRH agonists, an increase in the dose of menotropin may be required. The PharmaceuticalMerial should not be mixed with other drugs in one syringe.
special instructions
Before treatment, it is necessary to conduct a thorough gynecological and endocrinological examination, including the anatomy of the pelvis. In patients with obstruction of the fallopian tubes, Merional can be used only in the case of assisted reproductive technologies. It is necessary to exclude primary ovarian failure. It is necessary to conduct a thorough examination to exclude early pregnancy. Patients in late reproductive age have an increased susceptibility to endometrial carcinoma, as well as a greater incidence of anovulatory disorders. Patients with abnormal uterine bleeding or other signs of endometrial pathologies must undergo a thorough diagnostic examination. It is also necessary to assess the fertility of the partner. Before prescribing the drug, it is necessary to carry out appropriate treatment for disorders of the thyroid gland or adrenal cortex, hyperprolactinemia of various etiologies, and tumors of the hypothalamic-pituitary region. The outcome of treatment may be the onset of multiple pregnancy. In case of signs of ovarian hyperstimulation (pain in the abdomen and palpated by a doctor or determined by ultrasound, increased education in the lower abdomen), treatment is stopped (most often develops in women with polycystic ovary syndrome). During therapy, daily hormonal control and ultrasound of developing follicles are necessary (ovarian reaction can be evaluated by cervical index). If the concentration of estrogen in the urine reaches 540 nmol (150 μg) / 24 h or the concentration of 17β-estradiol in plasma reaches 3000 pmol / l (800 pg / ml) or If an excessive increase in these values occurs, then there is an increased risk of ovarian hyperstimulation, and the treatment by Merional should be immediately stopped and hCG should be discontinued. In the event of ovarian hyperstimulation syndrome, injecting an ovulatory dose of hCG is contraindicated! In the event of pregnancy, the symptoms of excessive hyperstimulation may increase and be observed during for a long time, being a threat to the patient's life. Thromboembolic complications are likely to develop. Intravascular thrombosis and embolism developing in arteries and veins,can lead to a decrease in blood flow to vital organs and limbs. Venous thrombophlebitis, pulmonary embolism, pulmonary infarction, stroke, and arterial thrombosis resulting in loss of limb can be a complication of this. In men with high concentration of FSH, menotropins are ineffective in the treatment period .