Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
GOSERELIN AS ACETATE
ASTRAZENECA (ISRAEL) LTD
L02AE03
IMPLANT
GOSERELIN AS ACETATE 3.6 MG/UNIT
S.C
Required
ASTRA ZENECA UK LIMITED
GOSERELIN
GOSERELIN
Treatment of prostate cancer suitable for hormonal manipulation. Breast cancer in pre-menopausal women suitable for hormone manipulation.Endometriosis. Assisted reproduction: pituitary down regulation in preparion for superovulation. Endometrial thinning: Zoladex is indicated for the prethinning of the utetine endometrium prior ro endometrial ablation or resection. Uterine Fibroids: For reduction of fibroid size prior to surgery.
2023-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only Zoladex ® Implant for subcutaneous injection in a pre-filled syringe Composition: Each syringe contains: goserelin (as acetate) 3.6 mg For inactive ingredients, please see section 6 – "Further Information". Read this leaflet carefully in its entirety before using this medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. Most of the information in this leaflet applies to women and men. When the information applies to men only, it will be labeled with the heading "Information for men". When the information applies to women only, it will be labeled with the heading "Information for women". 1. WHAT IS ZOLADEX AND WHAT IT IS INTENDED FOR? Information for men: For treatment of prostate cancer. Zoladex works by lowering the levels of testosterone, a hormone produced by the body. Information for women: In women, Zoladex works by lowering the levels of estrogen, a hormone produced by the body. • For treatment of breast cancer in premenopausal women. • For treatment of endometriosis – a disease of the womb lining (a condition where pain is caused by excess tissue which grows within or outside of the womb). • Helps fertility by preparing for superovulation. • Uterine fibroids (benign growths that appear in the womb), to decrease the size of fibroids before surgery. • Prethinning of the womb lining before surgery. Therapeutic activity: Zoladex contains a medicine called goserelin. This belongs to a group of medicines called: LHRH analogues. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • You are sensitive to the active ingredient goserelin or to any of the other ingredients of the preparation Olvassa el a teljes dokumentumot
1. NAME OF THE MEDICINAL PRODUCT ZOLADEX R 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Goserelin acetate (equivalent to 3.6 mg goserelin) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Implant, in pre-filled syringe. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of prostate cancer suitable for hormonal manipulation. Breast cancer in pre- menopausal women suitable for hormone manipulation. Endometriosis. Assisted reproduction: pituitary down regulation in preparation for superovulation. Endometrial thinning: Zoladex is indicated for the prethinning of the utetine endometrium prior to endometrial ablation or resection. Uterine Fibroids: For reduction of fibroid size prior to surgery. 4.2 Posology and method of administration Adults One 3.6 mg depot of ZOLADEX injected subcutaneously into the anterior abdominal wall, every 28 days. No dosage adjustment is necessary for patients with renal or hepatic impairment or in the elderly. Endometriosis should be treated for a period of six months only, since at present there are no clinical data for longer treatment periods. Repeat courses should not be given due to concern about loss of bone mineral density. In patients receiving ZOLADEX for the treatment of endometriosis, the addition of hormone replacement therapy (a daily oestrogenic agent and a progestogenic agent) has been shown to reduce bone mineral density loss and vasomotor symptoms. For use in endometrial thinning, four or eight weeks treatment. The second depot may be required for the patient with a large uterus or to allow flexible surgical timing. Page 2 of 15 2 For women who are anaemic as a result of uterine fibroids: ZOLADEX 3.6 mg depot with supplementary iron may be administered for up to three months before surgery. Assisted reproduction: ZOLADEX 3.6 mg is administered to downregulate the pituitary gland, as defined by serum oestradiol levels similar to those observed in the early follicular phase (approximately 150 pmol/l). This will usually take between 7 and 21 Olvassa el a teljes dokumentumot