1 syringe with the drug contains: The active substance dosage of 0.1 mg / ml: 105 micrograms Sustanon 250 gains acetate ekvivaletno Sustanon 250 gains (base) 95.6 mg dose of 0.5 mg / ml: 525 micrograms Sustanon 250 gains acetate ekvivaletno Sustanon 250 gains (base) 478.1 g Excipients sodium chloride, water for injection, acetic acid glacial
The contents of the syringe is clear, colorless, odorless solution.
The antitumor agent – Gonadotropin-releasing hormone analog
Pharmacological properties Pharmacodynamics. The active ingredient of the drug Dekapeptil – Sustanon 250 gains – a synthetic analogue gonadortropin-releasing hormone. Substitutions result the second amino acid residue in the molecule of natural substances were: more pronounced affinity for GnRH and longer than that of the natural molecule half-life. Immediately after administration, Sustanon 250 gains causes an increase in the level of FSH (follicle stimulating hormone) and LH (luteinising hormone) in blood, leading to a transient increase in the concentration of sex hormones. Continuous stimulation of the pituitary (in the case of a constant concentration in the blood Sustanon 250 gains) leads to blockade gonadotropic function, resulting in a decrease in sex hormone levels in the blood or to postcastration menopausal levels. These effects are reversible.
Animal studies have not revealed teratogenic or mutagenic effects.
Pharmacokinetic tests were performed on a patient with a confirmed diagnosis of endometriosis or uterine fibroids, patients with carcinoma of the prostate and healthy male volunteers.
In the first hours after intramuscular injection Dekapeptil recorded the highest level of Sustanon 250 gains concentration in the blood.
Then the Sustanon 250 gains concentration decreases significantly within 24 hours . Metabolism and excretion half-life in plasma Sustanon 250 gains – 18.7 min, and for natural gonadotropin-releasing hormone, the figure of 7.7 minutes. Sustanon 250 gains clearance (503 mL / min) three times slower than that of the natural hormone releasing (1766 ml / min) and consists of two components -. Fast and slow clearance than 4% Sustanon 250 gains unaltered excreted in urine.
Indications In women: endometriosis, uterine fibroids, treatment of infertility using assisted reproductive technologies (IVF in vitro fertilization and embryo transfer to the uterus). Men: simtomaticheskoe treatment of advanced hormone-dependent prostate carcinoma.
: Hypersensitivity to the drug. Men: hormone-independent prostate cancer, previous surgical castration. In females: pregnancy, lactation, clinical signs or risk of osteoporosis. Dekapeptil should be administered with extreme caution to patients with polycystic ovaries when the program of assisted reproductive technologies (IVF), especially in cases where the number of follicles, as determined by ultrasound, is greater than 10.
should be prescribed the drug Dekapeptil when the program of assisted reproductive technologies (IVF) patients with polycystic ovaries particularly in cases where the number of follicles, as determined by ultrasound, more than 10, as well as patients with clinical manifestations of osteoporosis or at high risk for its development.
Pregnancy and lactation
The drug is contraindicated in pregnancy, breast-feeding should be discontinued during treatment.
Dosing and dose
preparation is injected subcutaneously. Uterus myoma, endometriosis, prostatic carcinoma: typically administered 0.5 mg subcutaneously daily for 7 days, then starting at day 8 – 0.1 mg daily one time a day as a maintenance therapy. The injection site should be changed. For the duration of treatment is recommended Dekapeptil depot preparation containing 3.75 mg Sustanon 250 gains, and has a prolonged action – one injection every 28 days. Assisted reproductive technologies: the dose depends on the protocol used, usually 0.1 mg per day of the first day of the cycle or early follicular phase before the introduction of human chorionic gonadotropin (hCG) (short report) or the first day of the cycle or early follicular phase for 3 days (ultra-short protocol)
Side effects Side effects are due to a decrease in the level of sex hormones (testosterone and estrogen) in the blood, which can lead to the appearance of men and women symptoms such as: mood lability, depression, weakening of libido, frequent headaches, sleep disorders, weight gain, ” tides “, increased sweating; With the genitourinary system: urinary obstruction, pain during intercourse; women: dryness of the vaginal mucosa, uterine bleeding; men: decrease in potency, gynecomastia, decrease testicular size. From the nervous system: paresthesia, visual disturbances. From the digestive system: nausea, decreased appetite, increased activity of “liver” transaminases, hypercholesterolemia. From the musculoskeletal system: pain in back, bone pain caused by metastases, spinal cord compression, muscle weakness, myalgia, arthralgia, bone demineralization (chronic administration). Other: thrombophlebitis, swollen lymph nodes, swelling of the feet. The men – a decrease in the growth of the beard and hair loss on the chest, legs and arms. Local reactions: pain at the injection site. Also, there may be hypersensitivity reactions (itching, redness, fever, anaphylaxis).
All these side effects, tend to have moderate severity and disappear after treatment.
Cases of overdose of the drug Dekapeptil not observed, in the event – treat symptomatically.
Interaction with other medicinal products
are not described.
Treatment should be carried out under the control of the levels of sex steroid hormones in serum. Men A transient increase in testosterone levels in the plasma of some patients may result in temporary deterioration (urinary tract in the form of obstruction of bone pain caused by metastases, spinal cord compression, muscle weakness, swollen lymph nodes, swelling of the feet). In the case of one of the symptoms of the patient should seek medical advice. In the initial stage of treatment may provide the feasibility of anti-androgen agents as a means of suppressing the symptoms caused by an increase in testosterone levels. Women Women must first be ruled out pregnancy. During therapy unacceptable use of hormonal contraceptives, in cases of endometriosis or fibroids, treatment should be continued until the full restoration of the menstrual cycle. During treatment Dekapeptilom forbidden to take estrogen-containing medicines. During the course of treatment is required for the ultrasonic inspection of the size of fibroids and endometriosis sites. The rapid reduction in size of the uterus can lead to bleeding. Women should be advised that during the course of treatment Dekapeptilom menstruation will be absent, on the case of regular menses the patient must necessarily inform the doctor.
The effect on the ability to drive and use machinery
Solution for subcutaneous injection 0.1 mg / ml, 0.5 mg / ml.
1 ml in a disposable glass syringe with a needle with a protective cap.
At 7 in plastic syringes cellular packaging cardboard unit in instructions for use.