Universal reference book for medicines
Product name: BUSERELIN-DEPO (BUSERELIN-DEPO)

Active substance: buserelin

Type: Gonadotropin-releasing hormone analogue - depot form

Manufacturer: PHARM-SYNTHESIS (Russia) manufacturer of lyophilizate DIAMED (Russia) solvent manufacturer PHARM-SYNTHESIS (Russia)
Composition, form of production and packaging
Lyophilizate for the preparation of a suspension for the / m administration of prolonged action of
white or with a slight yellowish hue of color, in the form of a powder;
the applied solvent is a colorless transparent liquid; the reconstituted suspension is homogeneous, white or white with a slight yellowish tinge.
1 f.

Buserelina acetate 3.93 mg,

which corresponds to the content of Buserelin 3.75 mg

Excipients: copolymer DL-lactic and glycolic acids - 200 mg, mannitol - 85 mg, carmellose sodium - 30 mg, polysorbate 80 - 2 mg.

Solvent: rn mannitol 0.8% d / and - 2 ml.

Vials of dark glass (1) complete with a solvent (amp.), A syringe, needles (2 pcs.) And alcohol swabs (2 pcs.) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Antitumor drug, a synthetic analogue of 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. On average, after 12-14 days, the use of the drug in therapeutic doses leads to a complete 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 content of testosterone to the post -astration level in men.
The concentration of testosterone in continuous treatment decreases by 2-3 weeks to the content typical for the state of orchiectomy, i.е.
the drug causes pharmacological castration.
PHARMACOKINETICS

Bioavailability is high.
C max in plasma is achieved approximately 2-3 hours after the / m administration and is maintained 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);

- myoma of the uterus;

- hyperplastic processes of the endometrium;

- Infertility treatment (when carrying out the program of in vitro fertilization).

DOSING MODE

With hormone-dependent prostate cancer - 3.75 mg IM every 4 weeks.

In the treatment of endometriosis, endometrial hyperplastic processes are 3.75 mg IM once every 4 weeks.
Treatment should begin in the first five days of the menstrual cycle. Duration of treatment is 4-6 months.
When treating uterine fibroids - 3.75 mg IM once every 4 weeks.
Treatment should begin in the first five days of the menstrual cycle. Duration of treatment - before the operation 3 months, in the remaining cases - 6 months.
In the treatment of infertility by in vitro fertilization, 3.75 mg IM once at the beginning of the follicular (on the 2nd day of the menstrual cycle) or in the middle of the luteal phase (21-24 days) of the menstrual cycle preceding stimulation.
After blockade of the pituitary function, confirmed by a decrease in the serum level of estrogen in the serum, not less than 50% of the baseline (usually determined 12-15 days after Buserelin-Depot injection), in the absence of cysts in the ovaries (according to ultrasound), thickness of the endometrium no more than 5 mm, stimulation of superovulation with gonadotropic hormones under ultrasound monitoring and control of estradiol levels in serum begins.
Rules for the preparation of suspension and drug administration

The drug is administered only in / m.
The suspension for the IM injection is prepared with the help of the applied solvent immediately before administration. The drug should be prepared and administered only by specially trained medical personnel.
The bottle with Buselinom-depot should be kept strictly vertically.
Tapping lightly on a vial, it is necessary to achieve that all лиофилизат was on the bottom of a vial.
Open the syringe, attach a needle with a pink pavilion (1.2 × 50 mm) to it to pick up the solvent.

Open the ampoule and dial into the syringe all the contents of the ampoule with the solvent, install the syringe to a dose of 2 ml.

Remove the plastic cap from the vial containing the lyophilizate.
Disinfect the rubber stopper of the bottle with an alcohol swab. 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.
The bottle must remain stationary until the solvent is completely saturated with the lyophilizate and the suspension is formed (for about 3-5 minutes).
After that, without turning the bottle, you should 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.
After the remaining dry lyophilizate is not left, the contents of the vial should be gently stirred in a circular motion for 30-60 seconds until a uniform suspension is formed.
Do not overturn and shake the bottle, this can lead to the loss of flakes and the unfitness of the suspension.
It is necessary to quickly insert the needle through the rubber stopper into the vial.
Then cut the needle cut down and, tilting the bottle at an angle of 45 °, slowly fill the syringe completely. Do not flip the bottle 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.
Immediately replace the needle with a pink pavilion on a needle with a green pavilion (0.8-40 mm), gently turn the syringe and remove air from the syringe.

Suspension Buserelina-depot should be administered immediately after preparation.

Using an alcohol sponge, you need to disinfect the injection site.
Insert the needle deep into the gluteus muscle, then gently pull the plunger of the syringe backward to make sure that there is no damage to the vessel. Administer the suspension intramuscularly slowly with constant pressure on the syringe plunger. When the needle is clogged, it is replaced with another needle of the same diameter.
SIDE EFFECT

Allergic reactions: urticaria, skin hyperemia;
rarely - angioedema.
From the side of the central nervous system: frequent mood changes, sleep disturbances, depression, headache.

From the musculoskeletal system: demineralization of bones, which is a risk of osteoporosis.

Women - headache, depression, sweating and changes in libido, dryness of the mucous membrane of the vagina, pain in the lower abdomen;
rarely menstrual like bleeding (usually during the first weeks of treatment).
In men with prostate cancer treatment, during the first 2-3 weeks after the first injection, the main disease may worsen and progress (which is associated with stimulating the synthesis of gonadotropins and testosterone, respectively), gynecomastia, possible "hot flashes", increased sweating and decreased potency rarely requires a change in therapy), a transient increase in androgen concentration in the blood, a delay in urination, "renal" swelling (swelling of the face, eyelids, legs), muscle weakness in the lower limbs.
At the beginning of treatment for patients with prostate cancer, temporary pain in the bones may develop temporarily; In this case, symptomatic therapy should be performed. There have been isolated cases of development of obstruction of the ureters and compression of the spinal cord.
Other: in isolated cases (the cause-and-effect relationship is not clearly established) - pulmonary embolism, dyspeptic phenomena.

CONTRAINDICATIONS

- Pregnancy;

- lactation period;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

Application during pregnancy and during lactation is contraindicated.

SPECIAL INSTRUCTIONS

Women.
Patients with any form of depression during treatment with the drug Buserelin Depot 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 beginning of treatment with the drug, 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.

The men.
In order to effectively prevent possible side effects in the first phase of the drug, antiandrogens should be used 2 weeks before the first injection of Buserelin Depot and within 2 weeks after the first injection.
Impact on the ability to drive vehicles and manage mechanisms

Care should be taken when prescribing the drug to patients who engage in potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

OVERDOSE

At present, no cases of an overdose with Bucerelin Depo have been reported.

DRUG INTERACTION

Simultaneous use of Buserelin Depot 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 may reduce the effectiveness of hypoglycemic agents.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, protected from light at a temperature of 8 ° to 25 ° C.
Shelf life - 3 years, solvent - 5 years.
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