Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Fulvestrant 50 mg/mL; ;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
250 mg/5mL
Solution for injection
Active: Fulvestrant 50 mg/mL Excipient: Benzyl alcohol Benzyl benzoate Castor oil Ethanol
Prescription
FULVESTRANT EVER PHARMA is indicated for the treatment of locally advanced or metastatic breast cancer in postmenopausal women of any age: · 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, Type I, 5 ml fill, fluoropolymer coated bromobutyl rubber plunger, in carton - 2 dose units - 24 months from date of manufacture stored at or below 25°C
2022-03-01
FULVESTRANT EVER PHARMA CMI V1.1 JAN 2023 Page 1 of 4 FULVESTRANT EVER PHARMA FULVESTRANT, 250 MG/ 5 ML, SOLUTION FOR INJECTION CONSUMER MEDICINE INFORMATION This leaflet answers some of the common questions people ask about FULVESTRANT EVER PHARMA. It does not contain all the information that is known about FULVESTRANT EVER PHARMA. 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 FULVESTRANT EVER PHARMA 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. FULVESTRANT EVER PHARMA 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. FULVESTRANT EVER PHARMA 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. FULVESTRANT EVER PHARMA should only be given to women. FULVESTRANT EVER PHARMA is not recommended for use in men or children. FULVESTRANT EVER PHARMA does not kill cancer cells, however it stops or slows their growth. Your doctor will have explained why you are being treated with FULVESTRANT EVER PHARMA 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. FULVESTRANT EVER PHARMA is not addictive. _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 • Կարդացեք ամբողջական փաստաթուղթը
1 FULVESTRANT EVER PHARMA DS V1.2 Aug 2023 Page 1 of 13 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Fulvestrant EVER Pharma; 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, slightly yellow to yellow solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fulvestrant EVER Pharma 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). Children Not recommended for use in children or adolescents as safety and effectiveness have not been established in this age group. 2 FULVESTRANT EVER PHARMA DS V1.2 Aug 2023 Page 2 of 13 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 Fulvestrant EVER Pharma has not been evaluated in patients with Child-Pugh C hepatic impairment (see section Կարդացեք ամբողջական փաստաթուղթը