Buserelin FSintez (Buserelin FSintez)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBuserelinBuserelin
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    NATIVA, LLC     Russia
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    • Dosage form: & nbspnasal dosing spray
    Composition:
    One dose of the spray contains:
    Buserelina acetate 157.5 μg
    in terms of Buserelin 150 mcg
    Excipients:
    Benzalkonium chloride 7.5 μg
    Water for injection up to 75 μl
    Description:
    Transparent colorless liquid without foreign inclusions.
    Pharmacotherapeutic group:An antineoplastic agent, gonadotropin-releasing hormone analog (GnRH)
    ATX: & nbsp

    L.02.A.E.01   Buserelin

    Pharmacodynamics:
    Buserelin is a synthetic analogue of endogenous gonadotropin-releasing hormone (GnRH). Competitively binds to the receptors of the anterior pituitary cells and causes a short-term increase in the level of sex hormones in the blood plasma. Further use of therapeutic doses of the drug (on average 12-14 days) leads to complete blockade of the gonadotropic function of the pituitary gland and reduces the release of luteinizing (LH) and follicle-stimulating hormone (FSH). As a result, the synthesis of sex hormones in the ovary is suppressed and the concentration of estradiol (E2) in the blood plasma is reduced to post-menopausal values.
    Pharmacokinetics:
    With intranasal application buserelin completely absorbed through the nasal mucosa. The half-life is about 3 hours.
    In small amounts, the drug is excreted in breast milk.
    Indications:
    The hormone-dependent pathology of the reproductive system, caused by absolute or relative hyperestrogenism:
    - endometriosis (pre- and postoperative periods);
    - myoma of the uterus;
    - hyperplastic processes of the endometrium;
    - treatment of infertility (when carrying out the program of in vitro fertilization (IVF)).
    Contraindications:
    - hypersensitivity to the components of the drug;
    - Pregnancy;
    - lactation.
    Carefully:Use with caution in arterial hypertension, diabetes, depression.
    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:A single dose of the drug with a full pressure pump is 150 mcg.
    From the glass bottle with the drug, remove the plastic screw cap (there must be a click of the first opening control) and screw the dispensing plastic stopper. While holding the wide rim of the pump stopper with your fingers, remove the protective cap.Direct the vial with the solution vertically up and 3-5 times sharply to press the rim for trial discharge of the solution into the air (this is necessary to fill the spray head with the drug mixture). The drug is ready for use. Buserelin FSintez enter into the nasal passages after their cleansing.



    In the treatment of endometriosis, uterine fibroids, endometrial hyperplastic processes:
    The recommended daily dose of the drug "Buserelin FSintez" 900 mcg per day. The daily dose of the drug is administered in equal portions, one injection (150 μg) into each nostril 3 times a day at regular intervals (8 hours) in the morning, afternoon and evening. Treatment with buserelin should be started on the first or second day of the menstrual cycle, the introduction of the drug is continuous throughout the course of treatment. The course of treatment is 4-6 months.
    In the treatment of infertility by extracorporeal fertilization (IVF):
    The recommended daily dose of the drug "Buserelin FSintez" 600 mcg. The drug is administered intranasally on a single injection (150 mcg) in one nostril 4 times a day at regular intervals. The drug is administered from the middle of the luteal phase of the menstrual cycle (from 21-24 days of the cycle) to the day of administration of the ovulatory dose of the chorionic gonadotropin.Against this background, upon reaching the blockade of the synthesis of estradiol (E2) from 2 to 5 days of menstrual bleeding according to standard schemes, stimulation with gonadotropins is carried out.
    With severe blockade of the reproductive system and a "weak" response of the ovaries to stimulation of ovulation with preparations of gonadotropins, the daily dose of the drug "Buserelin FSintez" should be reduced to 2 injections per day or increase the dose of gonadotropins.
    The repeated course of treatment is carried out only on the prescription of the doctor and after the medical. examinations under the dynamic control of the hormonal profile and ultrasound monitoring.
    Side effects:Allergic reactions: urticaria, skin flushing, itchy skin, very rarely - anaphylactic shock, angioedema.
    From the side of the central nervous system: dizziness, headache, frequent mood swings, sleep disturbances, nervousness, fatigue, memory loss and concentration, depression.
    From the cardiovascular system: a feeling of palpitations, an increase in blood pressure (in patients with arterial hypertension).
    From the digestive tract: nausea, vomiting, diarrhea, constipation, anorexia, thirst.Other: pain in the lower abdomen, vaginal dryness, decreased libido; rarely menstrual like bleeding (usually during the first weeks of treatment); in isolated cases - nasal bleeding; pulmonary embolism; edema in the ankles and feet; pain in the back, joints.
    From the laboratory indicators: a decrease in glucose tolerance, hyperglycemia; changes in the lipid spectrum; an increase in the activity of serum transaminases, hyperbilirubinemia; thrombocytopenia or leukopenia.
    Local Reactions - irritation of the nasal mucosa, dryness and pain in the nose.
    Overdose:
    At present, no cases of drug overdose have been reported.
    Interaction:
    The simultaneous use of the drug "Buserelin FSintez" with preparations containing sex hormones (for example, in the induction of ovulation), can contribute to the emergence of the syndrome of ovarian hyperstimulation. With type 1 and type 2 diabetes Buserelin FSintez can reduce the effectiveness of hypoglycemic agents.
    Special instructions:Before starting treatment with Buserelin FS, it is recommended to exclude pregnancy and stop taking hormonal contraceptives,However, during the first two months of using the drug, it is necessary to use other (non-hormonal) methods of contraception.
    During the treatment of the drug, patients with any form of depression should be under the supervision of a doctor.
    The use of the drug "Buserelin FSintez" before surgical treatment with endometriosis reduces the size of pathological foci, their blood supply, inflammatory manifestations and, consequently, shortens the operation time, and postoperative therapy improves the results, reducing the frequency of postoperative relapses and reducing the formation of adhesions. Repeated treatment should be started only after a thorough assessment of the relationship between expected benefit and potential risk.
    Induction of ovulation should be carried out under strict medical supervision.
    In the initial stage of treatment with the drug, the development of ovarian cysts is possible.
    Patients who use contact lenses may develop signs of eye irritation.
    Given the intranasal route of administration, irritation of the nasal mucosa is possible, and sometimes nosebleeds. The drug can be used in rhinitis, but before using it, the nasal passages should be cleared.
    Effect on the ability to drive transp. cf. and fur:
    Care should be taken when prescribing the drug to patients when driving vehicles and engaging in potentially dangerous activities requiring increased attention and speed of mental and motor reactions.
    Form release / dosage:
    Spray nasal dosed with 150 mcg / dose.
    Packaging:
    At 17.5 ml (a nominal amount of not less than 187 doses) of the drug in bottles of dark glass, sealed with plastic caps screwed with the control ring of the first opening. For 1 bottle complete with a dosing plastic stopper and instructions for use are placed in a cardboard box.
    Storage conditions:
    In dry, the dark place at a temperature of no higher than 25 ° C, in places inaccessible to children.
    Shelf life:
    2 years.
    Do not use after the time specified on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003577/10
    Date of registration:29.04.2010 / 12.05.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:NATIVA, LLC NATIVA, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp12.03.2017
    Illustrated instructions
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