Currently, no cases of overdose of the drug have been reported.
hypersensitivity to the components of the drug,
pregnancy,
lactation.
With caution arterial hypertension, diabetes mellitus, depression.
Concomitant use of the drug Buserelin FSintez with drugs containing sex hormones (for example, in the mode of ovulation induction) may contribute to the occurrence of ovarian hyperstimulation syndrome.
In type 1 and 2 diabetes mellitus, Buserelin FSintez may reduce the effectiveness of hypoglycemic agents.
Transparent colorless liquid without foreign inclusions.
Allergic reactions: urticaria, hyperemia of the skin, itching, very rarely-anaphylactic shock, angioedema.
From the central nervous system: dizziness, headache, frequent mood changes, sleep disorders, nervousness, fatigue, decreased memory and ability to concentrate, depression.
From the CCC side: palpitations, increased blood pressure (in patients with arterial hypertension).
From the gastrointestinal tract: nausea, vomiting, diarrhea, constipation, loss of appetite, 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-nosebleeds, pulmonary embolism, swelling in the ankles and feet, back pain, joints.
On the part of laboratory parameters: decreased glucose tolerance, hyperglycemia, changes in the lipid spectrum, increased serum transaminase activity, hyperbilirubinemia, thrombocytopenia or leukopenia.
Local reactions: irritation of the nasal mucosa, dryness and pain in the nose.
By prescription.
Before starting treatment with Buserelin FSintez, it is recommended to exclude pregnancy and stop taking hormonal contraceptives, but during the first two months of using the drug, it is necessary to use other (non-hormonal) methods of contraception.
During treatment with 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 for endometriosis reduces the size of pathological foci, their blood supply, inflammatory manifestations and, consequently, reduces the operation time, and postoperative therapy improves the results, reducing the frequency of postoperative relapses and reducing the formation of adhesions.
A second course of treatment should be started only after a careful assessment of the ratio of the expected benefit and potential risk.
Ovulation induction should be performed under strict medical supervision.
In the initial stage of treatment with the drug, the development of an ovarian cyst is possible.
Patients who use contact lenses may show signs of eye irritation.
Given the intranasal method of use, it is possible to irritate the nasal mucosa, sometimes-nasal bleeding. The drug can be used for rhinitis, but before using it, you should clean the nasal passages.
Influence on the ability to drive a car and other mechanisms. Caution should be exercised when prescribing the drug to patients when driving vehicles and engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions.
Hormone-dependent pathology of the reproductive system caused by absolute or relative hyperestrogenism:
endometriosis (pre-and postoperative periods),
uterine fibroids,
endometrial hyperplastic processes,
infertility treatment (during the in vitro fertilization (IVF) program.
Buserelin is a synthetic analog of endogenous GnRH. It competitively binds to the receptors of the cells of the anterior pituitary gland 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 after 12-14 days) leads to a complete blockade of the gonadotropic function of the pituitary gland and reduces the release of LH and FSH. As a result, there is a suppression of the synthesis of sex hormones in the ovaries and a decrease in the concentration of estradiol (E2) in the blood plasma to post-menopausal values.
With intranasal use, buserelin is completely absorbed through the nasal mucosa. T1/2 it is about 3 hours.
In small amounts, the drug is excreted in breast milk.
In a dry place, protected from light, at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life of the drug Buserelin FSintez2 года.Do not use after the expiration date indicated on the package.
| Nasal spray, metered | 1 dose |
| buserelin acetate | 157.5 mcg |
| in terms of buserelin — 150 mcg | |
| excipients: benzalkonium chloride — 7.5 mcg, water for injection-up to 75 mcl |
Nasal spray dosed 150 mcg / dose. In dark glass bottles of 17.5 ml (the nominal number of doses — at least 187). 1 fl. complete with a plastic stopper-pump is placed in a cardboard pack.
Contraindicated.
Intranasally, after cleansing the nasal passages. A single dose of the drug when the pump is fully pressed is 150 mcg.
Remove the plastic screw cap from the glass bottle with the drug (there should be a click of the first opening control — fig. 1) and screw on the metering plastic pump plug (Fig. 2).
Figure 1.
Figure 2.
Holding the wide rim of the pump plug with your fingers, remove the protective cap. Direct the bottle with the solution vertically upwards and press the rim sharply 3-5 times to test release 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 is injected into the nasal passages after their purification (Fig. 3).
Figure 3.
In the treatment of endometriosis, uterine fibroids, endometrial hyperplastic processes the recommended daily dose of Buserelin FSintez is 900 mcg/day.
The daily dose of the drug is administered in equal portions of one injection (150 mcg) in 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 1st or 2nd day of the menstrual cycle, the administration of the drug is continuous throughout the entire course of treatment. The course of treatment is 4-6 months.
In the treatment of infertility by IVF the recommended daily dose of Buserelin FSintez is 600 mcg. The drug is administered by one injection (150 mcg) in one nostril 4 times a day at regular intervals, from the middle of the luteal phase of the menstrual cycle (from the 21-24 th day of the cycle) to the day of administration of the ovulatory dose of HCG. Against this background, when the blockade of estradiol synthesis is achieved from the 2nd-5th day of menstrual-like bleeding, stimulation with gonadotropin preparations is carried out according to standard schemes.
With severe blockage of the reproductive system and a weak ovarian response to ovulation stimulation with gonadotropin preparations, the daily dose of Buserelin FSintez should be reduced to 2 injections per day or increase the dose of gonadotropins.
A second course of treatment is carried out only as prescribed by a doctor and after a medical examination under the dynamic control of the hormonal profile and ultrasound monitoring.
L02AE01 Buserelin
