국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Goserelin acetate 11.34mg equivalent to 10.8 mg goserelin;
AstraZeneca Limited
Goserelin acetate 11.34 mg (equivalent to 10.8 mg goserelin)
10.8 mg
Injection (depot)
Active: Goserelin acetate 11.34mg equivalent to 10.8 mg goserelin Excipient: Polyglactin
Syringe, depot implant, 1 implant
Prescription
Prescription
AstraZeneca UK Ltd
ZOLADEX 10.8 mg is indicated for the management of: 1. Prostate cancer suitable for hormonal manipulation.
Package - Contents - Shelf Life: Syringe, depot implant - 1 implants - 36 months from date of manufacture stored at or below 25°C
1995-02-13
Zoladex® 10.8 mg CMI 080520 Copyright 1(6) ZOLADEX ® 10.8 MG GOSERELIN ACETATE, 10.8 MG, INJECTABLE IMPLANT CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ZOLADEX 10.8. It does not contain all the information that is known about ZOLADEX 10.8. 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 10.8 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 10.8 IS USED FOR ZOLADEX 10.8 is a special preparation of goserelin acetate which is designed to work in the body for 12 to 13 weeks after each injection. Most people will need one injection for each 12 to 13 weeks of treatment. ZOLADEX 10.8 is otherwise similar to Zoladex 3.6 mg which you may have received in the past. Zoladex 3.6 mg lasts for only 28 days. ZOLADEX 10.8 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 10.8 lowers sex hormones, all these actions will be reduced. Due to the action of ZOLADEX 10.8 on hormones, ZOLADEX 10.8 can treat very different illnesses in both men and women. _ _ _MEN: _ _PROSTATE CANCER _ ZOLADEX 10.8 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: _ _ENDOMETRIOSIS _ For endometriosis, ZOLADEX 10.8 may be used instead of 전체 문서 읽기
Z OLADEX 10.8 mg Data Sheet 080520 Copyright 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Z OLADEX ® 10.8 mg Depot Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Goserelin (present as goserelin acetate) 10.8 mg injection. 3. PHARMACEUTICAL FORM Injection (depot) A sterile, white to cream coloured cylindrical depot in which goserelin acetate (equivalent to 10.8 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 10.8 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. Endometriosis: Z OLADEX alleviates symptoms including pain, and reduces the size and number of endometrial lesions. 4. 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. 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. Use extra care when administering Z OLADEX to patients with a low BMI and/or who are receiving full anticoagulation medication (see section 4.4). Z OLADEX 10.8 mg Data Sheet 080520 Copyright 2 For correct administration of Z OLADEX , see instructions on the administration card (also see Method of administration below). ADULT MEN One depot of Z OLADEX 10.8 mg injected subcutaneously into the anterior abdominal wall every 3 months. Adjuvant and/or neoadjuvant Z OLADEX therapy in combination with radio 전체 문서 읽기