Zoladex capsule for half-dose vv.prol-d 3.6mg syringe applicator (Hozerelyn)

Latin name

Zoladex

Release form

Depot extended-release capsules for SC administration

Packing

1 syringe applicator complete with safe injection system

ФармакологичРскоРдРйствимbr>
ЗоладРкс - противоопухолРвоР, аналог гонадотропин-рилизинг гормона.

Фармакодинамика

СинтРтичРский аналог природного ГнРГ. При постоянном примРнРнии прРпарат ЗоладРкс®ингибируРт в дРлРниРгипофизом ЛГ, что вРдРт к снижРнию концРнтрации тРстостРрона в с вороткРкрови у мужчин и концРнтрации эстрадиола в с вороткРкрови у жРнщин. Данн й эффРкт обратим послРотмРн тРрапии. На пРрвоначальной стадии прРпарат ЗоладРкс®, подобно другим агонистам ГнРГ, можРт в з вать врРмРнноРувРличРниРконцРнтрации тРстостРрона в с вороткРкрови у мужчин и концРнтрации эстрадиола в с вороткРкрови у жРнщин.На ранних стадиях тРрапии прРпаратом ЗоладРкс® у нРкотор х жРнщин могут отмРчаться вагинальн РкровотРчРния различной продолжитРльности и интРнсивности.

У мужчин примРрно к 21-му дню послРввРдРния пРрвой капсул концРнтрация тРстостРрона снижаРтся до кастрационн х уровнРй и продолжаРт оставаться снижРнной при постоянном лРчРнии, проводимом кажд Р3 мРс в случаРпрРпарата ЗоладРкс® 10,8 мг. ТакоРснижРниРконцРнтрации тРстостРрона на фонРпримРнРния прРпарата ЗоладРкс® 10,8 мг у большинства больн х приводит к рРгрРссии опухоли прРдстатРльной жРлРз и к симптоматичРскому улучшРнию.

ПослРввРдРния прРпарата ЗоладРкс® 10,8 мг концРнтрация эстрадиола в с вороткРу жРнщин снижаРтся в тРчРниР4 нРд послРввРдРния пРрвой капсул и остаРтся снижРнной до уровня сравнимого с тРм, что наблюдаРтся у жРнщин в мРнопаузР.При начальном примРнРнии других аналогов ГнРГ и пРрРходРна прРпарат ЗоладРкс® 10,8 мг подавлРниРуровня эстрадиола сохраняРтся. ПодавлРниРуровня эстрадиола приводит к лРчРбному эффРкту при эндомРтриозРи фибромах матки.

На фонРприРма агонистов ГнРГ у жРнщин можРт имРть мРсто наступлРниРмРнопауз . РРдко у нРкотор х жРнщин нРпроисходит восстановлРния мРнструаций послРокончания тРрапии.

ФармакокинРтика

ВвРдРниРкапсул кажд Р12 нРд обРспРчиваРт поддРржаниРэффРктивн х концРнтраций. Кумуляции в тканях при этом нРпроисходит. ПрРпарат ЗоладРкс® плохо связ ваРтся с бРлком, T1/2Рго из с воротки крови — 2–4 ч у больн х с нормальной функциРй почРк. T1/2 увРличиваРтся у больн х с нарушРниями почРчной функции. При ввРдРнии прРпарата ЗоладРкс® 10,8 мг кажд Р12нРд данноРизмРнРниРнРбудРт имРть значитРльн х послРдствий,поэтому измРнять дозу для данн х пациРнтов нРтрРбуРтся. У больн х с пРчРночной нРдостаточностью значитРльн х измРнРний в фармакокинРтикРнРнаблюдаРтся.

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.

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: low molecular weight lactic and glycolic acid copolymer (95: 5) and high molecular weight lactic and glycolic acid copolymer (95: 5) - up to a total weight of 36 mg (weight ratio) between low molecular weight and high molecular weight copolymer - 3: 1).

Dosage and Administration

Zoladex Depot 3.6 mg is administered subcutaneously into the anterior abdominal wall every 28 days.

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), 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 testing: often - a decrease in bone mineral density, an 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 doctor's prescription

AstraZeneca, Russia



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