Description
Latin name
Zoladex
Release form
Depot extended-release capsules for SC administration
Packing
1 syringe applicator complete with safe injection system
ФаÑмакологиÑÐ ÑкоРдРйÑÑвиÐ
ÐÐ¾Ð»Ð°Ð´Ð ÐºÑ – пÑоÑивоопÑÑ Ð¾Ð»Ð Ð²Ð¾Ð , аналог гонадоÑÑопин-Ñилизинг гоÑмона.
ФаÑмакодинамика
СинÑÐ ÑиÑÐ Ñкий аналог пÑиÑодного ÐнРÐ. ÐÑи поÑÑоÑнном пÑимРнРнии пÑРпаÑÐ°Ñ ÐоладРкÑ®ингибиÑÑÐ Ñ Ð² дРлРниРгипоÑизом ÐÐ, ÑÑо Ð²Ð Ð´Ð Ñ Ðº ÑÐ½Ð¸Ð¶Ð Ð½Ð¸Ñ ÐºÐ¾Ð½ÑРнÑÑаÑии ÑÐ ÑÑоÑÑÐ Ñона в Ñ Ð²Ð¾ÑоÑкРкÑови Ñ Ð¼ÑжÑин и конÑРнÑÑаÑии ÑÑÑÑадиола в Ñ Ð²Ð¾ÑоÑкРкÑови Ñ Ð¶Ð Ð½Ñин. Ðанн й ÑÑÑÐ ÐºÑ Ð¾Ð±ÑаÑим поÑлРоÑмРн ÑÐ Ñапии. Ðа пРÑвонаÑалÑной ÑÑадии пÑРпаÑÐ°Ñ ÐоладРкÑ®, подобно дÑÑгим агониÑÑам ÐнРÐ, Ð¼Ð¾Ð¶Ð Ñ Ð² з ваÑÑ Ð²ÑРмРнноРÑвРлиÑРниРконÑРнÑÑаÑии ÑÐ ÑÑоÑÑÐ Ñона в Ñ Ð²Ð¾ÑоÑкРкÑови Ñ Ð¼ÑжÑин и конÑРнÑÑаÑии ÑÑÑÑадиола в Ñ Ð²Ð¾ÑоÑкРкÑови Ñ Ð¶Ð Ð½Ñин.Ðа ÑÐ°Ð½Ð½Ð¸Ñ ÑÑадиÑÑ ÑÐ Ñапии пÑРпаÑаÑом ÐоладРкÑ® Ñ Ð½Ð ÐºÐ¾ÑÐ¾Ñ Ñ Ð¶Ð Ð½Ñин могÑÑ Ð¾ÑмРÑаÑÑÑÑ Ð²Ð°Ð³Ð¸Ð½Ð°Ð»Ñн РкÑовоÑÐ ÑÐ Ð½Ð¸Ñ ÑазлиÑной пÑодолжиÑРлÑноÑÑи и инÑРнÑивноÑÑи.
У мÑжÑин пÑимРÑно к 21-Ð¼Ñ Ð´Ð½Ñ Ð¿Ð¾ÑÐ»Ð Ð²Ð²Ð Ð´Ð Ð½Ð¸Ñ Ð¿Ð Ñвой капÑÑл конÑРнÑÑаÑÐ¸Ñ ÑÐ ÑÑоÑÑÐ Ñона ÑнижаРÑÑÑ Ð´Ð¾ каÑÑÑаÑионн Ñ ÑÑовнРй и пÑÐ¾Ð´Ð¾Ð»Ð¶Ð°Ð Ñ Ð¾ÑÑаваÑÑÑÑ ÑнижРнной пÑи поÑÑоÑнном лРÑРнии, пÑоводимом кажд Ð 3 Ð¼Ð Ñ Ð² ÑлÑÑаРпÑРпаÑаÑа ÐоладРкÑ® 10,8 мг. ТакоРÑнижРниРконÑРнÑÑаÑии ÑÐ ÑÑоÑÑÐ Ñона на ÑонРпÑÐ¸Ð¼Ð Ð½Ð Ð½Ð¸Ñ Ð¿ÑРпаÑаÑа ÐоладРкÑ® 10,8 мг Ñ Ð±Ð¾Ð»ÑÑинÑÑва болÑн Ñ Ð¿ÑÐ¸Ð²Ð¾Ð´Ð¸Ñ Ðº ÑРгÑÐ ÑÑии опÑÑ Ð¾Ð»Ð¸ пÑРдÑÑаÑРлÑной жРлРз и к ÑимпÑомаÑиÑÐ ÑÐºÐ¾Ð¼Ñ ÑлÑÑÑРниÑ.
ÐоÑÐ»Ð Ð²Ð²Ð Ð´Ð Ð½Ð¸Ñ Ð¿ÑРпаÑаÑа ÐоладРкÑ® 10,8 мг конÑРнÑÑаÑÐ¸Ñ ÑÑÑÑадиола в Ñ Ð²Ð¾ÑоÑÐºÐ Ñ Ð¶Ð Ð½Ñин ÑнижаРÑÑÑ Ð² ÑÐ ÑРниР4 нРд поÑÐ»Ð Ð²Ð²Ð Ð´Ð Ð½Ð¸Ñ Ð¿Ð Ñвой капÑÑл и оÑÑаРÑÑÑ ÑнижРнной до ÑÑÐ¾Ð²Ð½Ñ ÑÑавнимого Ñ ÑРм, ÑÑо наблÑдаРÑÑÑ Ñ Ð¶Ð Ð½Ñин в мРнопаÑзР.ÐÑи наÑалÑном пÑимРнРнии дÑÑÐ³Ð¸Ñ Ð°Ð½Ð°Ð»Ð¾Ð³Ð¾Ð² ÐнРРи пРÑÐ Ñ Ð¾Ð´Ð Ð½Ð° пÑРпаÑÐ°Ñ ÐоладРкÑ® 10,8 мг подавлРниРÑÑÐ¾Ð²Ð½Ñ ÑÑÑÑадиола ÑÐ¾Ñ ÑанÑÐ ÑÑÑ. ÐодавлРниРÑÑÐ¾Ð²Ð½Ñ ÑÑÑÑадиола пÑÐ¸Ð²Ð¾Ð´Ð¸Ñ Ðº лРÑÐ Ð±Ð½Ð¾Ð¼Ñ ÑÑÑРкÑÑ Ð¿Ñи ÑндомРÑÑиозРи ÑибÑÐ¾Ð¼Ð°Ñ Ð¼Ð°Ñки.
Ðа ÑонРпÑиРма агониÑÑов ÐÐ½Ð Ð Ñ Ð¶Ð Ð½Ñин Ð¼Ð¾Ð¶Ð Ñ Ð¸Ð¼Ð ÑÑ Ð¼Ð ÑÑо наÑÑÑплРниРмРнопаÑз . РРдко Ñ Ð½Ð ÐºÐ¾ÑÐ¾Ñ Ñ Ð¶Ð Ð½Ñин нРпÑоиÑÑ Ð¾Ð´Ð¸Ñ Ð²Ð¾ÑÑÑÐ°Ð½Ð¾Ð²Ð»Ð Ð½Ð¸Ñ Ð¼Ð Ð½ÑÑÑÑаÑий поÑлРоконÑÐ°Ð½Ð¸Ñ ÑÐ Ñапии.
ФаÑмакокинРÑика
ÐвРдРниРкапÑÑл кажд Ð 12 нРд обРÑпРÑÐ¸Ð²Ð°Ð Ñ Ð¿Ð¾Ð´Ð´Ð ÑжаниРÑÑÑРкÑивн Ñ ÐºÐ¾Ð½ÑРнÑÑаÑий. ÐÑмÑлÑÑии в ÑканÑÑ Ð¿Ñи ÑÑом нРпÑоиÑÑ Ð¾Ð´Ð¸Ñ. ÐÑРпаÑÐ°Ñ ÐоладРкÑ® Ð¿Ð»Ð¾Ñ Ð¾ ÑвÑз ваРÑÑÑ Ñ Ð±Ð Ð»ÐºÐ¾Ð¼, T1/2Рго из Ñ Ð²Ð¾ÑоÑки кÑови â 2â4 Ñ Ñ Ð±Ð¾Ð»Ñн Ñ Ñ Ð½Ð¾ÑмалÑной ÑÑнкÑиРй поÑРк. T1/2 ÑвРлиÑиваРÑÑÑ Ñ Ð±Ð¾Ð»Ñн Ñ Ñ Ð½Ð°ÑÑÑРниÑми поÑÐ Ñной ÑÑнкÑии. ÐÑи ввРдРнии пÑРпаÑаÑа ÐоладРкÑ® 10,8 мг кажд Ð 12нРд данноРизмРнРниРнРбÑÐ´Ð Ñ Ð¸Ð¼Ð ÑÑ Ð·Ð½Ð°ÑиÑРлÑн Ñ Ð¿Ð¾ÑлРдÑÑвий,поÑÑÐ¾Ð¼Ñ Ð¸Ð·Ð¼Ð Ð½ÑÑÑ Ð´Ð¾Ð·Ñ Ð´Ð»Ñ Ð´Ð°Ð½Ð½ Ñ Ð¿Ð°ÑиРнÑов нРÑÑРбÑÐ ÑÑÑ. У болÑн Ñ Ñ Ð¿Ð ÑРноÑной нРдоÑÑаÑоÑноÑÑÑÑ Ð·Ð½Ð°ÑиÑРлÑн Ñ Ð¸Ð·Ð¼Ð Ð½Ð Ð½Ð¸Ð¹ в ÑаÑмакокинРÑикРнРнаблÑдаРÑÑÑ.
Indications
prostate cancer
endometriosis
uterine fibroids.
Contraindications
hypersensitivity to goserelin or other analogues of GnRH
pregnancy
lactation (breastfeeding)
childhood.
Caution: males are at particular risk for ureteral obstruction or spinal cord compression.
Use during pregnancy and lactation
The drug is contraindicated in pregnancy and lactation.
During treatment with XelodaЮ and at least 3 months after its completion, reliable methods of contraception should be used. If pregnancy occurs during the period of therapy, the patient should be aware of the potential threat to the fetus. Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy and lactation.
Zoladex should not be prescribed during pregnancy, since theoretically there is a risk of abortion or fetal abnormalities when using LHRH agonists.
In women of childbearing age, a possible pregnancy should be excluded before starting treatment with Zoladex.
During therapy, non-hormonal methods of contraception should be used until menstruation resumes.
Composition
1 capsule contains:
Active ingredient: goserelin (as goserelin acetate) 3.6 mg
Excipients: a low molecular weight lactic and glycolic acid copolymer (95: 5) and a high molecular weight lactic and glycolic acid copolymer (95: 5) – up to a total weight of 36 mg (the weight ratio between the low molecular weight and high molecular weight copolymer is 3: 1).
Dosage and Administration
Zoladex Depot 10.8 mg is administered subcutaneously into the anterior abdominal wall every 12 weeks.
In malignant neoplasms, the drug is prescribed for a long time.
To thin the endometrium 2 depot Zoladex 3.6 mg is administered at intervals of 4 weeks, while the operation is recommended to be carried out within the first two weeks after the introduction of the second capsule depot.
In benign gynecological neoplasms, the drug is prescribed for no more than 6 months, since at the moment there is no clinical data on longer courses of therapy. Repeated courses should not be prescribed because of the danger of a decrease in bone mineral density.
During in vitro fertilization, pituitary desensitization is determined by the concentration of estradiol in the blood serum. As a rule, the required level of estradiol, which corresponds to that in the early follicular phase of the cycle (approximately 150 pmol / L), is reached between 7 and 21 days. When pituitary desensitization occurs, superovulation stimulation (controlled ovarian stimulation) begins with gonadotropin. Caused pituitary desensitization with Zoladex may be more persistent, which can lead to an increased need for gonadotropin. At the appropriate stage of follicular development, the administration of gonadotropin is stopped and then human chorionic gonadotropin is administered to induce ovulation. The monitoring of the treatment, the oocyte extraction and fertilization procedures are carried out in accordance with the established practice of this medical institution.
Side effects
Neoplasms: very rarely – pituitary tumor of unspecified frequency – degeneration of fibromatous nodes in women with uterine fibroids.
On the part of the immune system: infrequently – hypersensitivity reactions rarely – anaphylactic reactions.
From the endocrine system: very rarely – hemorrhage into the pituitary gland.
Metabolic disorders: often – impaired glucose tolerance. In men who received GnRH agonists, a decrease in glucose tolerance was observed. A decrease in glucose tolerance was manifested by the development of diabetes mellitus or a deterioration in blood glucose control in patients with a history of diabetes mellitus infrequently – hypercalcemia (in women).
From the side of the nervous system and mental sphere: very often – decreased libido associated with the pharmacological action of the drug and in rare cases, leading to its cancellation often – decreased mood, depression (in women), paresthesia, compression of the spinal cord (in men), headache (in women) is very rare – a psychotic disorder.
From the CCC side: very often – hot flashes associated with the pharmacological action of the drug and in rare cases leading to its cancellation often – myocardial infarction (in men) heart failure (in men), the risk of which increases with the simultaneous administration of antiandrogen drugs. A change in blood pressure, manifested as hypotension or hypertension. These changes are usually transient and are permitted either during treatment with Zoladex® or after its cessation. In rare cases, these changes require medical attention, including discontinuation of Zoladex®.
On the part of the skin and subcutaneous tissue: very often – excessive sweating associated with the pharmacological action of the drug and, in rare cases, leading to its cancellation often – alopecia (in women), as a rule, slightly pronounced, including in young patients with benign neoplasms, the rash is mostly slightly pronounced, which often resolved against the background of continued therapy of an unspecified frequency – alopecia (in men), which manifested itself as hair loss throughout the body due to a decrease in androgen levels.
From the musculoskeletal system: often – arthralgia (in women), bone pain (in men). At the beginning of treatment, patients with prostate cancer can often experience a temporary increase in bone pain, which is treated symptomatically infrequently – arthralgia (in men).
From the genitourinary system: very often – erectile dysfunction (in men), dryness of the vaginal mucosa and an increase in the size of the mammary glands (in women) often – gynecomastia (in men), infrequently – tenderness of the mammary glands (in men), obstruction of the ureters (in men) rarely – ovarian cyst (in women) of unspecified frequency – vaginal bleeding (in women).
Other: very often – reaction at the injection site (in women) often – reaction at the injection site (in men).
Laboratory tests: often – decrease in bone mineral density, increase in body weight.
overdose There is no data on overdose in humans.
Treatment: carry out symptomatic therapy.
Storage Conditions
The product should be stored below 25 ° C.
shelf life
3 years
Deystvuyushtee substance
Goserelin
Terms and conditions
prescription
Dosage form
capsules
Appointment
Appointment
Adults prescription
Barbara –
Use this product all the time great value
Steve –
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