Alterpur (Alterpur)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceUrophrolthyropinUrophrolthyropin
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  • Alterpur
    solution w / m PC 
    IBSA Institute Biokimik S.A.     Switzerland
  • Bravelle
    solution w / m PC 
    Ferring Artsynmittel GmbH     Germany
    • Dosage form: & nbsp

    lyophilizate for the preparation of a solution for intramuscular and subcutaneous administration

    Composition:

    1 bottle with lyophilizate contains:

    Active substance urophallitropine 75.150 ME

    Auxiliary components - actoses monohydrate 10.00 mg 1 ampoule with a solvent contains: sodium chloride (pyrogen-free for injection) 9 mg, water for injection up to 1 ml.

    Description:

    Sealed mass from white to light yellow color.

    Solvent is a clear, colorless, odorless liquid.
    Pharmacotherapeutic group:Follicle stimulating agent
    ATX: & nbsp

    G.03.G.A.04   Urophrolthyropin

    G.03.G.A   Gonadotropins

    G.03.G   Gonadotropins and other stimulants of ovulation

    Pharmacodynamics:

    Highly inverse follicular stimulating hormone (FSH), obtained from urine in postmenopausal women, with minor irnumio luteinizing hormone (LH). The content of LH in the final product is minimized due to the purification procedure by chromatographic method with antibodies to human chorionic gonadotropin. Stimulates the growth and maturation of follicles, causing an increase in the concentration of estrogens and proliferation of the endometrium.Almost no luteinizing effect. FSH interacts with specific receptors on the surface of small granular cells of the ovaries and Sertoli cells in the testes: these receptors are bound to adenylate cyclase by the guanine nucleotide regulatory protein (Gs squirrel).

    Pharmacokinetics:

    Suction

    After a single subcutaneous and intramuscular injection at a dose of 225 ME the time to reach the maximum concentration of the drug in plasma (Tmax) is 20.5 and 17.4 hours, respectively. However, after a single application (150 ME daily for 7 days) Tmax is approximately 10 hours for both routes of administration.

    With multiple subcutaneous and intramuscular injections, the bioavailability of FSH is 81.8% and 77.7%, respectively.

    With a single subcutaneous and intramuscular injection, the maximum plasma concentration (Stach) is 6.0 ± 1.7 mIU / ml and 8.8 ± 4.5 mIU / ml, respectively. In the case of a single subcutaneous and intramuscular injection, the Stach is 14.8 ± 2.9 mIU / ml and 11.5 ± 2.9 mIU / ml, respectively.

    Area under the concentration-time curve (AUC) with a single subcutaneous and intramuscular injection is 379 ± 111 mIUh / ml and 331 ± 179 mIUh / ml, respectively. With miogokraljum subcutaneous and intramuscular introduction AUC is 234.7 ± 77.0 mIUh / ml and 192.1 ± 52.3 mIUh / ml, respectively.

    Excretion

    The average period of seminal exposure of FSH for anodiocrapic subcutaneous and intramuscular injection is 31.8 and 37 hours, respectively. However, after multiple application, the half-life period is 20.6 and 15.2 hours for subcutaneous and intramuscular injection, respectively.
    Indications:

    Anovulation in the syndrome of polycystic ovaries in women only when clomiphene is ineffective.

    Controlled ovarian hyperstimulation with the aim of inducing the growth of multiple follicles during assisted reproductive technologies such as fertilization in vitro, intra-fallopian gamete transfer, intra-phalopic transfer of zygotes, only when clomiphene is ineffective.
    Contraindications:

    Hypersensitivity, high concentration of FSH in primary ovarian insufficiency, decompensated pathology of the thyroid gland and adrenal glands, organic lesions of the CNS, for example, pituitary tumors, infertility not associated with impaired ovarian function, persistent increase in ovaries, ovarian cyst (not caused by polycystic ovary syndrome)abnormalities of genitalia, uterine fibroids (incompatible with pregnancy), metrorrhagia and other bleeding of unknown etiology, cancer of the buttercup, uterus and / or breast, primary failure of the ovaries, pregnancy, lactation period, children's age.

    Carefully:

    The presence of risk factors for thromboembolism, such as individual or family predisposition, severe obesity (body mass index> 30 kg / m2) Or thrombophilia, since 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 drug is contraindicated in pregnancy and lactation.
    Dosing and Administration:

    It is used intramuscularly (in / m) or subcutaneously (sc).

    The solution for injections is prepared immediately before administration (up to 5 vials of urofolthropine can be dissolved in 1 ml of solvent).

    During the first 7 days of the cycle menstruating women are given 75-150 IU per day daily. Maturation of follicles is usually achieved during the treatment cycle - 7-12 days.Adequacy of the response to treatment is assessed by daily analysis of estrogen concentration, direct visualization of the follicular value by ultrasound (ultrasound) and clinical data.

    If adequate stimulation is not achieved, the dose may be gradually increased. After the treatment and in the presence of an adequate but not excessive ovarian response according to clinical and biochemical studies, 24-48 hours after the last injection, the patient is administered a single human chorionic gonadotropin (hCG) dose of 5000-1000 ME in / m with the aim of inducing ovulation. The next day is optimal for conception. In the presence of ovulation and the absence of pregnancy, the course can be repeated for another 2 cycles. In the absence of an adequate response to therapy within 4 weeks from the beginning of the drug should be canceled.

    For the stimulation of superovulation in the conduct of assisted reproductive technologies, treatment begins with 2-3 days of the menstrual cycle - ISO- 225 IU / day. In the process of stimulation, the dose can be changed depending on the response of the ovaries, while the daily dose should not exceed 450 ME. Treatment continues until adequate maturation of the follicles. After 24-48 hours after the last injection, hCG 5000-10000 ME in / m with the induction of ovulation. With the stimulation of ovulation with the use of GnRH agonists, the introduction of urofolitropin begins 2 weeks after the start of agonist application at 225 IU / day for 7 days (the drug is continued until adequate size of the follicle is reached), from 8 days the dose can be adjusted (depending on the ovarian response) .

    A warning: treatment with this drug should be carried out only under the supervision of a doctor who has the appropriate specialization and experience in treating infertility.

    Side effects:

    Adverse adverse reactions were classified as follows: very frequent - (> 1/10); frequent - (from> 1/100 to <1/10); infrequent - (from> 1/1000 to <1/100); rare - (from> 1/10000 to <1/1000); very rare - (<1/10000).

    The following undesirable side reactions were noted for the drug: Disorders from the endocrine system: infrequently hyperthyroidism.

    Violations mentality: infrequently - depression.

    Violations from the nervous system: often - a headache, infrequently - lethargy, dizziness.

    Disturbances from the respiratory system: infrequently - shortness of breath, nosebleed.

    Disorders from the gastrointestinal tract: often - constipation, bloating, infrequently - nausea, abdominal pain, indigestion.

    Disturbances from the skin and subcutaneous tissues: infrequently, erythema, itching. Disorders from the kidneys and urinary tract: infrequently - cystitis.

    Hapyuiemm from the genitals and the breast: often - a syndrome of ovarian hyperstimulation, infrequently - an increase in the mammary glands, tenderness of the mammary glands, hot flashes.

    General disorders and disorders at the site of administration: often - pain, infrequently - fatigue.

    Laboratory and instrumental data: infrequently - an increase in the duration of bleeding.

    Local reactions at the injection site (pain, redness, bruising) are rare.

    In rare cases, there arterial thromboembolism associated with the treatment of human menotropin / chorionic gonadotropin.

    The frequency of abortions in gonadotropic therapy is comparable to that of women with other fertility disorders. A small risk of ectopic pregnancy and multiple pregnancies is documented.

    In addition, the following adverse reactions may occur: lung atelectasis, respiratory distress syndrome,non-cardiogenic pulmonary edema, vomiting, diarrhea, ovarian enlargement, ovarian cysts, abdominal pain, increased vascular wall permeability, hemoperitoneum, blood thickening, epistaxis, chromosomal abnormalities (trisomy in 13 and 18 pairs of chromosomes), anaphylactic shock, hypovolemia, electrolyte disorders, ascites, hydrothorax, alopecia, arthralgia, myalgia, "tides" of blood to the skin of the face. If any of the n adverse events listed in the instructions are aggravated, or if you notice any other adverse reactions not indicated in the instructions, tell your doctor.

    Overdose:

    Symptoms: ovarian hyperstimulation syndrome (ovarian enlargement, abdominal pain, nausea, vomiting, diarrhea, weight gain, olguria, ascites, hydrothorax, hemoperitoneum, hemoconcentration, dyspnea), fetal pregnancy, thromboembolic complications.

    Treatment consists of 3 stages: the first one is aimed at reducing the concentration of the hormone in the blood and the prevention of the development of thromboembolic complications (pneumonia, acute renal failure), it consists in the / in the administration of small amounts of albumin (with a constant control of the 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 cavities of the body, for which in / in injected small amounts of hypertonic sodium chloride and albumin solution. The third stage is to prevent the development of pulmonary edema associated with the massive flow of fluid from the body cavities into the vascular bed, and involves the use of diuretics (with constant monitoring of hematocrit and electrolyte concentration in plasma).

    Interaction:

    Alterpur should not be confused with other medicines.

    Special instructions:

    Probably the emergence of multiple pregnancies. Perhaps the emergence of ectopic pregnancy, especially in diseases of the fallopian tubes in the anamnesis. The frequency of early and spontaneous abortions in pregnancy after treatment with urofollitropine is higher than in healthy patients, but comparable to that of infertility of another etiology.

    Before the beginning of treatment, hypothyroidism, insufficiency of the adrenal cortex, hyperprolactinemia, pituitary and hypothalamic tumors, and analysis of the sperm of the sexual partner are treated.

    When enlarging the ovaries, gynecological examination is carried out carefully, in order to avoid rupture of the ovarian cysts, it is recommended to avoid sexual intercourse. Ovarian hyperstimulation syndrome (OCS) often occurs on the 7-10th day after ovulation, stimulated by the introduction of human hCG. It is characterized by a sharp increase in the permeability of the vessels, which can lead to a rapid accumulation of fluid in the abdominal cavity, chest and pericardium. Early signs of development of CHD are severe pelvic pain, nausea, vomiting, weight gain. With CHOS, the following symptoms can occur: abdominal pain, bloating, gastrointestinal symptoms, including nausea, vomiting and diarrhea, a significant increase in ovaries, weight gain, dyspnoea and oliguria. The following clinical signs can also be observed: hypovolemia, blood thickening, electrolyte balance disturbance, ascites, hemoperitoneum, pleural effusion, hydrothorax, acute respiratory distress syndrome, thromboembolic complications. The likelihood of development of OHSS during the "superovulation" (created during assisted reproductive technologies) can be reduced,if the contents of all follicles are aspirated before the onset of ovulation. When the appearance of signs of HSH, the drug should be discontinued.

    Probably development of thromboembolic complications. Intravascular thromboses and embolisms located in venous and arterial vessels can lead to a decrease in blood flow to vital organs and limbs. Complications of this may be venous thrombophlebitis, pulmonary embolism, lung infarction, stroke and blockage of the arteries, leading to loss of limb.


    Effect on the ability to drive transp. cf. and fur:During the period of drug use, it is necessary to refrain from potentially dangerous activities requiring an increased concentration of attention and speed of psychomotor reactions, as the drug may cause dizziness and other side effects that may affect these abilities.
    Form release / dosage:

    Lyophilizate for solution for intramuscular and subcutaneous administration 75 ME, 150 ME complete with a solvent: sodium chloride injection for 0.9%.

    Packaging:Lyophilizate: 75 ME, 150 ME in a vial of transparent siliconeized glass type I for parenteral preparations (Hearth.F.) with bromobutyl-rubberstopper and lid (type flip of).

    Solvent: 1 ml each in an ampoule of clear glass type I.

    One vial containing the lyophilizate is placed in a pack of cardboard together with one ampoule of solvent and instruction for use. Either 10 individual cardboard packs, each containing a vial of lyophilizate, an ampoule with a solvent and instructions for use are placed in a common cardboard pack.
    Storage conditions:

    Store at a temperature of no higher than 25 ° C in a dark place.

    The reconstituted solution should be used immediately.

    Keep out of the reach of children.

    Shelf life:

    Lyophilizate - 2 years.

    Solvent - 5 years.

    The shelf life of the kit is determined by the component with the shortest shelf life.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000134
    Date of registration:11.01.2011
    The owner of the registration certificate:IBSA Institute Biokimik S.A.IBSA Institute Biokimik S.A. Switzerland
    Manufacturer: & nbsp
    Representation: & nbspPharma Riace Co., Ltd. Pharma Riace Co., Ltd. United Kingdom
    Information update date: & nbsp25.11.15
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