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Instructions

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Instruction for use: Buserelin-long FS

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ATX Code L02AE01 Buserelin

Pharmacological group

Antitumor agent, gonadotropin-releasing hormone analog (GnRH) [Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists]

Antineoplastic agent, gonadotropin-releasing hormone analog (GnRH) [Antitumor hormonal agents and hormone antagonists]

Nosological classification (ICD-10)

C50 Malignant neoplasm of breast

Cancer of the nipple and areola of the breast, Breast carcinoma, The hormone-dependent form of recurrent breast cancer in women in menopause, Hormone-dependent breast cancer, Disseminated breast carcinoma, Disseminated Breast Cancer, Malignant breast cancer, Malignant neoplasm of breast, Contralateral breast cancer, Locally advanced or metastatic breast cancer,Locally-distributed breast cancer, Locally-recurring breast cancer, Metastatic breast carcinoma, Metastasis of breast tumors, Metastatic breast carcinoma, Inoperable breast carcinoma, Incompatible breast cancer, Breast cancer in women with metastases, Breast cancer in men with metastases, Breast Cancer, Breast cancer in men, Mammary cancer, Breast cancer with distant metastases, Breast cancer in postmenopausal women, Breast cancer hormone-dependent, Breast cancer with local metastases, Breast cancer with metastases, Breast cancer with regional metastases,Breast cancer with metastases, Common hormone-dependent forms of breast cancer, Common Breast Cancer, Recurrent Breast Cancer, Recurrence of breast tumors, Breast cancer, Estrogen-dependent breast cancer, Estrogen-Dependent Breast Cancer, Disseminated breast cancer with overexpression of HER2, Tumors of the mammary glands

C61 Malignant neoplasm of prostate

Adenocarcinoma of the prostate, Hormone-dependent prostate cancer, Hormone-Resistant Prostate Cancer, Malignant tumor of prostate, Malignant neoplasm of prostate, Carcinoma of the prostate, Locally-distributed non-metastatic prostate cancer, Locally advanced prostate cancer, Locally spread prostate cancer, Metastatic prostatic carcinoma, Metastatic prostate cancer, Metastatic hormone-resistant prostate cancer, Non-metastatic prostate cancer, Incompatible prostate cancer, Prostate Cancer, Prostate cancer, Common prostate cancer, Testosterone-Depot Prostate Cancer

D25 Leiomyoma of the uterus

Fibroids of the uterus

D26 Other benign neoplasms of the uterus

Fibromyoma of the uterus, Myoma, Uterine fibroids, Fibromyoma, Myoma of the uterus, Fibrrios, Meigs syndrome, Tumors of the uterus

E28.0 Excess of estrogens

Hyperestrogenism, Absolute hyperestrogenism, Hyperestrogenism

E34.8 Other specified endocrine disorders

Progeria, Syndrome of an empty Turkish saddle

N80 Endometriosis

Endometrioid endometriosis

N85.0 Endometrial glandular hyperplasia

Hyperplastic processes of the endometrium, Cystic glandular hyperplasia of the endometrium

N85.1 Adenomatous endometrial hyperplasia

N97 Female infertility

Female infertility in anovulation, Hyperprolactinemic infertility, Hyperprolactinaemia with infertility, Endocrine infertility, Infertility due to hypothalamic-pituitary dysfunction, Infertility infertility, Infertility, Infertility on the background of hyperprolactinaemia, Functional infertility, Marriage is infertile, Infertility of ovarian genesis, Stimulation of the growth of a single follicle

Composition

Liofilizate for the preparation of a suspension for intramuscular administration of prolonged action 1 fl.

Buserelina acetate 3.93 mg

In terms of Buserelin - 3.75 mg

Auxiliary substances: dl-lactic and glycolic acid copolymer - 200 mg; D-mannitol 85 mg; Carmellose sodium - 30 mg; Polysorbate-80 - 2 mg

Solvent: mannitol, 0.8% solution (in 1 ml: d-mannitol - 8.0 mg, water for injection - up to 1.0 ml)

Description of dosage form

Active substance: lyophilized powder (brittle lyophilizate) or compressed into a tablet porous mass of white or white with a slight yellowish tint of color.

Solvent: clear, colorless liquid.

Reduced suspension: when adding a solvent and stirring, a homogeneous suspension of white or white with a weak yellowish hue is formed; When standing, the suspension precipitates, but it is easily resuspended by shaking; The suspension must pass into the syringe freely through needle No. 0840.

pharmachologic effect

Pharmacological action - antiandrogenic, antigonadotropic, antiestrogenic.

Pharmacodynamics

Synthetic analogue of endogenous GnRH. Buserelin competitively binds to the receptors of the anterior pituitary cells, causing a short-term increase in the level of sex hormones in the blood plasma, further leading to a complete reversible blockade of the gonadotropic function of the pituitary, thus inhibiting the release of LH and FSH. As a result, there is a suppression of the synthesis of sex hormones in the gonads, which is manifested by a decrease in the concentration of estradiol in the blood plasma to post-menopausal values in women and a decrease in the testosterone content to the post -astration level in men. After the first injection of Buserelin by the 21st day in men, the concentration of testosterone decreases to the postastrational level (characteristic of the state of the orchidectomy), i.e. Called pharmacological castration. And in women, the concentration of estradiol is reduced to a level corresponding to ovariectomy or post-menopause.

The concentration of testosterone and estradiol remains reduced throughout the treatment period, which is conducted every 28 days, which leads to inhibition of growth and the reverse development of hormone-dependent tumors. After discontinuation of treatment, the physiological secretion of hormones is restored.

Pharmacokinetics

Bioavailability is high. Cmax in the plasma is achieved approximately 2-3 hours after the / m administration and remains at a level sufficient to inhibit the synthesis of gonadotropins by the pituitary gland for at least 4 weeks.

indications

Hormone-dependent prostate cancer;

mammary cancer;

Endometriosis (pre- and postoperative periods);

Uterine myoma;

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 period.

pregnancy and lactation

Contraindicated in pregnancy.

Side effects

Allergic reactions: urticaria, skin hyperemia, rarely - angioedema.

From the side of the central nervous system: a frequent change of mood, sleep disturbance, depression, headache.

From the musculoskeletal system: with prolonged use - demineralization of bones with the risk of osteoporosis.

Women - headache, depression, sweating and changes in libido, dryness of the vaginal mucosa, pain in the lower abdomen, rarely - menstrual like bleeding (during the first weeks of treatment).

In men, in the treatment of prostate cancer - during the first 2-3 weeks after the first injection, buserelin can cause an exacerbation and progression of the underlying disease (associated with the stimulation of the synthesis of gonadotropins and testosterone, respectively), gynecomastia, possible flushing of the blood, increased sweating And a decrease in potency (seldom requires the withdrawal of therapy), a transient increase in androgen concentration in the blood, a delay in urination, renal edema - swelling of the face, eyelids, legs; Muscle weakness in the lower limbs. At the beginning of treatment of patients with prostate cancer, temporary pain in the bones may develop temporarily; In this case, symptomatic therapy should be performed. Individual cases of development of obstruction of the ureters and compression of the spinal cord are recorded.

Other: in single cases (cause-and-effect relationship is not clearly established) - pulmonary embolism, dyspeptic disorders.

Interaction

The simultaneous use of Bucerelin-long FS with preparations containing sex hormones (for example, in the induction of ovulation) may contribute to the emergence of the ovarian hyperstimulation syndrome.

With simultaneous application of Buserelin-long FS may reduce the effectiveness of hypoglycemic agents.

Dosing and Administration

In / m.

In breast cancer and hormone-dependent prostate cancer, Buserelin-long FS is administered at a dose of 3.75 mg (1 injection) every 4 weeks. Long under the supervision of a doctor.

In the treatment of endometriosis, hyperplastic endometrial processes, the drug is administered at a dose of 3.75 mg IM once every 4 weeks. Treatment should begin in the first five days of the menstrual cycle. Duration of treatment - 4-6 months.

In the treatment of uterine fibroids Buserelin-long FS is administered at a dose of 3.75 mg IM once every 4 weeks. Treatment should begin in the first five days of the menstrual cycle. The duration of treatment before the operation is 3 months, in the remaining cases - 6 months.

In the treatment of infertility by IVF, Buserelin-long FS is administered at a dose of 3.75 mg (1 injection) IM once at the onset of folliculin (on the 2nd day of the menstrual cycle) or in the middle of the luteal phase (21-24 days) of the menstrual period Cycle, preceding stimulation. After blockade of the pituitary function, confirmed by a decrease in the serum level of estrogens, not less than 50% of the baseline (usually determined 12-15 days after Buserelin-long FS injection), in the absence of ovarian cysts (according to ultrasound data), the thickness of the endometrium is not More than 5 mm, stimulation of superovulation with gonadotropic hormones begins under ultrasound monitoring and control of the level of estradiol in serum.

Rules for preparation of suspension and drug administration

1. The drug is administered only intramuscularly.

2. The suspension for the IM injection is prepared immediately before administration with the aid of the supplied solvent.

3. The drug should be prepared and administered only by specially trained medical personnel.

4. The bottle with Buserelin-long FS should be kept strictly vertically. Easily tapping on the vial, to ensure that all the lyophilizate was at the bottom of the vial

5. Open the syringe, attach to it a 1.2 × 50 mm needle for solvent extraction.

6. Open the ampoule with the solvent and collect all the contents of the ampoule into the syringe, place the syringe on a dose of 2 ml

7. Remove the plastic cap from the vial containing the lyophilizate. Disinfect the rubber stopper of the vial with an alcohol swab

8. Insert the needle into the vial with lyophilizate through the center of the rubber stopper and carefully insert the solvent into the inner wall of the vial without touching the needle with the contents of the vial. Remove the syringe from the vial

9. The vial should remain stationary until the solvent is fully saturated with the lyophilizate and a suspension is formed (about 3-5 minutes). After that, without turning the vial, check the presence of dry lyophilizate at the walls and bottom of the vial. If a dry residue of the lyophilizate is found, leave the vial until it is completely soaked

10. After the residues of the dry lyophilizate have disappeared, gently stir the contents of the vial in a circular motion for 30-60 seconds until a uniform suspension is formed. Do not overturn or shake the vial

11. Insert the needle quickly through the rubber stopper into the vial. Then cut the needle cut down and, tilting the vial at an angle of 45 , slowly fill the syringe with the suspension completely

12. Do not turn over the vial when typing. A small amount of the drug can remain on the walls and bottom of the vial. The consumption of the residue on the walls and the bottom of the vial is taken into account

13. Remove the needle immediately after dialing. Replace with a 0.8 × 40 mm needle, gently turn the syringe and remove air from the syringe

14. Suspension Buserelin-long FS should be administered immediately after preparation.

15. Using an alcohol tampon, disinfect the injection site. Insert the needle deep into the gluteus muscle, then slightly pull the syringe plunger backward to make sure that there is no damage to the vessel. Introduce the suspension slowly, with constant pressure on the plunger of the syringe. When clogging the needle, replace it with another needle of the same diameter.

16. With repeated injections, the left and right sides should alternate.

Overdose

At present, no cases of overdose have been reported.

special instructions

Among women. Patients with any form of depression during drug treatment should be under close medical supervision.

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.

Before the start of treatment, 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.

After cessation of treatment, the function of the ovaries is restored. The first menstruation resumes after 3 months.

In men. In order to effectively prevent possible side effects in the first phase of the drug, it is necessary to use antiandrogens 2 weeks before the first injection of Buserelin-long FS and for 2 weeks after the first injection.

Effect on the ability to drive and other mechanisms. Caution should be exercised when prescribing the drug to patients engaged in potentially hazardous activities requiring increased attention and speed of mental and motor reactions.

Form of issue

Lyophilizate for the preparation of a suspension for intramuscular administration of prolonged action, containing 3.75 mg buserelin. In bottles of dark glass with a capacity of 10 ml. 2 ml of solvent (mannitol, 0.8% solution) in a neutral glass ampoule.

In the contour mesh package are placed: 1 fl. With the drug; 1 amp. With a solvent; 1 disposable syringe with a capacity of 5 ml; 1 sterile injection needle, 0.8 mm × 40 mm; 1 sterile solvent needle, 1.2 mm × 50 mm; 1 knife for opening ampoules or 1 scarifier; 2 alcohol wipes.

When you pack the solvent into imported ampoules that have rings for opening or a break point, the ampoule scapegrator or the opener for opening the ampoule is not put. 1 circuit pack of the kit is placed in a cardboard pack.

Terms of leave from pharmacies

On prescription.

storage Conditions

In dry, the dark place at a temperature of no higher than 25 C.

Keep out of the reach of children.

Shelf life

2 years. Solvent - 3 years.

Do not use after the expiry date printed on the package.

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