Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Goserelin acetate 3.8mg equivalent to 3.6 mg goserelin;
AstraZeneca Limited
Goserelin acetate 3.8 mg (equivalent to 3.6 mg goserelin)
3.6 mg
Injection (depot)
Active: Goserelin acetate 3.8mg equivalent to 3.6 mg goserelin Excipient: Polyglactin
Syringe, depot implant, 1 implant
Prescription
Prescription
AstraZeneca UK Ltd
ZOLADEX 3.6 mg is indicated for the management of: 1. Prostate cancer suitable for hormonal manipulation.
Package - Contents - Shelf Life: Syringe, depot implant physician sample pack - 1 implants - 36 months from date of manufacture stored at or below 25°C - Syringe, depot implant - 1 implants - 36 months from date of manufacture stored at or below 25°C
1987-04-30
Zoladex® 3.6 mg CMI 080520 Copyright 1(7) ZOLADEX ® 3.6 MG GOSERELIN ACETATE, 3.6 MG, INJECTABLE IMPLANT CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ZOLADEX 3.6. It does not contain all the information that is known about ZOLADEX 3.6. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking ZOLADEX 3.6 against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZOLADEX 3.6 IS USED FOR ZOLADEX 3.6 is a special preparation of goserelin acetate which is designed to work in the body for 28 days after each injection. ZOLADEX 3.6 is a member of the anti-hormonal group of medicines. This means that it affects the levels of various hormones (natural chemicals produced by the body). In men it will reduce levels of the male hormone, testosterone. In women it will reduce the levels of the female hormone, oestrogen. In women, female hormones make the breasts grow, prepare the womb and other sex organs for pregnancy, and increase the sex drive. In men, male hormones make the testicles grow, assist an erection, and increase the sex drive. When ZOLADEX 3.6 lowers sex hormones, all these actions will be reduced. Due to the action of ZOLADEX 3.6 on hormones, ZOLADEX 3.6 can treat very different illnesses in both men and women. _ _ _MEN: _ _PROSTATE CANCER _ ZOLADEX 3.6 can treat prostate cancer in some men. It is not a cure for prostate cancer, and does not work in every patient with prostate cancer. _WOMEN_: _BREAST CANCER _ ZOLADEX 3.6 is used to treat hormone sensitive breast cancer in women before menopause. It is not a cure for breast cancer. It can often keep the cancer controlled for a period of time. _ENDOMETRIOSIS _ For endometriosis, ZOLADEX 3.6 may be used instead of surgery. ZOLADEX 3.6 is Đọc toàn bộ tài liệu
Z OLADEX ® 3.6 mg Data Sheet 080520 Copyright 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Z OLADEX ® 3.6 mg Depot Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Goserelin (present as goserelin acetate) 3.6 mg injection. 3. PHARMACEUTICAL FORM Injection (depot) A sterile, white to cream coloured cylindrical implant in which goserelin acetate (equivalent to 3.6 mg of peptide base) is dispersed in a biodegradable matrix. It is supplied in a single dose syringe applicator. The SafeSystem TM incorporates a protective needle sleeve that automatically locks in place following administration of the implant to aid in the prevention of needle stick injury. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Z OLADEX 3.6 mg is indicated for the management of: 1. Prostate cancer suitable for hormonal manipulation. 2. Adjuvant and neoadjuvant therapy in combination with radiotherapy for the management of locally advanced prostate cancer in men suitable for hormonal manipulation. 3. Pre- and peri-menopausal women with hormone receptor positive breast cancer suitable for hormonal manipulation. 4. Endometriosis:- Z OLADEX alleviates symptoms including pain, and reduces the size and number of endometrial lesions. 5. Uterine fibroids:- Z OLADEX shrinks the lesions, reduces symptoms including pain, and causes cessation of menses in the majority of patients thereby improving haematological status when previous heavy menstrual loss has caused anaemia. 6. Endometrial thinning:- Use as an endometrial thinning agent prior to endometrial ablation. As a prethinning agent Z OLADEX 3.6 mg should be administered as two implants, four weeks apart, with surgery planned for between zero and two weeks after the second implant injection. 7. Assisted reproduction:- Pituitary down regulation in preparation for superovulation. 4.2 DOSE AND METHOD OF ADMINISTRATION Caution should be taken while inserting Z OLADEX into the anterior abdominal wall due to the proximity of underlying inferior epigastric artery and its branches. Z OLADEX ® 3.6 mg D Đọc toàn bộ tài liệu