Country: Նոր Զելանդիա
language: անգլերեն
source: Medsafe (Medicines Safety Authority)
Fulvestrant 50 mg/mL;
AstraZeneca Limited
Fulvestrant 50 mg/mL
250 mg/5mL
Solution for injection
Active: Fulvestrant 50 mg/mL Excipient: Benzyl alcohol Benzyl benzoate Castor oil Ethanol
Syringe, glass, Prefilled x 5mL, 5 mL
Prescription
Prescription
AstraZeneca UK Ltd
FASLODEX is indicated for the treatment of locally advanced or metastatic breast cancer in postmenopausal women of any age: - not previously treated with endocrine therapy, or - previously treated with endocrine therapy (antioestrogen or aromatase inhibitor) therapy, irrespective of whether their postmenopausal status occurred naturally or was artificially induced.
Package - Contents - Shelf Life: Syringe, glass, , cardboard carton containing two pre-filled 5 mL syringes - 1 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2004-09-15
Faslodex CMI 160720 1(4) FASLODEX FULVESTRANT, 250 MG/ 5 ML, SOLUTION FOR INJECTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about FASLODEX. It does not contain all the information that is known about FASLODEX. 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 FASLODEX 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 FASLODEX IS USED FOR FASLODEX is used to treat oestrogen receptor positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic) in women who have been through menopause. FASLODEX stops some of the actions of oestrogen within the body. Oestrogen is a female sex hormone that may help cancer cells grow in women with breast cancer. FASLODEX should only be given to women. FASLODEX is not recommended for use in men or children. FASLODEX does not kill cancer cells, however it stops or slows their growth. Your doctor will have explained why you are being treated with FASLODEX and will determine what dose to give you. Follow all directions given to you by your doctor. They may differ from the information contained in this leaflet. Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information. This medicine in only available with a doctor’s prescription. FASLODEX is not addictive. BEFORE YOU ARE GIVEN FASLODEX _WHEN YOU MUST NOT BE GIVEN THIS MEDICINE _ You should not be given this medicine if you have an allergy to: fulvestrant or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body ra read_full_document
F ASLODEX Data Sheet 160720 Copyright 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME F ASLODEX ® ; 250 mg/5 mL; solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 250 mg fulvestrant in 5 mL solution. EXCIPIENTS WITH KNOWN EFFECT (PER 5 ML) Ethanol (96%, 500 mg) Benzyl alcohol (500 mg) Benzyl benzoate (750 mg) For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to yellow, viscous liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS F ASLODEX is indicated for the treatment of locally advanced or metastatic breast cancer in postmenopausal women of any age: not previously treated with endocrine therapy, or previously treated with endocrine therapy (antioestrogen or aromatase inhibitor) therapy, irrespective of whether their postmenopausal status occurred naturally or was artificially induced. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULT FEMALES (INCLUDING THE ELDERLY) The recommended dose is 500 mg to be administered intramuscularly as two 5 mL injections, one in each buttock (gluteal area), at intervals of 1 month with an additional 500 mg dose given 2 weeks after the initial dose. It is recommended that the injection be administered slowly (1-2 minutes/injection). F ASLODEX Data Sheet 160720 Copyright 2 Figure 1 CHILDREN Not recommended for use in children or adolescents as safety and effectiveness have not been established in this age group. PATIENTS WITH RENAL INSUFFICIENCY No dose adjustments are recommended for patients with a creatinine clearance greater than 30 mL/min. Safety and efficacy have not been further evaluated in patients with creatinine clearance less than 30 mL/min (see section 4.4). PATIENTS WITH HEPATIC INSUFFICIENCY No dose adjustments are recommended for patients with Child-Pugh category A and B hepatic impairment. The use of F ASLODEX has not been evaluated in patients with Child-Pugh C hepatic impairment (see sections 4.4 and 5.2). ELDERLY No dose adjustment is required for read_full_document