Ország: Málta
Nyelv: angol
Forrás: Malta Medicines Authority
GOSERELIN ACETATE
Boston Biopharma Limited Malta Life Sciences Park, Building 2, Level 0, San Gwann SGN 3000, Malta
L02AE03
GOSERELIN ACETATE
IMPLANT
GOSERELIN ACETATE 3.6 milligram(s)
POM
ENDOCRINE THERAPY
Authorised
2019-04-03
Page 1 of 8 _Version 4.1, 02/2020 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PACKAGE LEAFLET Page 2 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER GOSERELIN BOSTON BIOPHARMA 3.6 MG IMPLANT, IN A PRE-FILLED SYRINGE Goserelin Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Goserelin Boston Biopharma is and what it is used for 2. What you need to know before you use Goserelin Boston Biopharma 3. How to use Goserelin Boston Biopharma 4. Possible side effects 5. How to store Goserelin Boston Biopharma 6. Contents of the pack and other information Most of the information in this leaflet applies to both men and women. - Where information only applies to men, it is shown by the heading Information for men. - Where information only applies to women, it is shown by the heading Information for women. 1. WHAT GOSERELIN BOSTON BIOPHARMA IS AND WHAT IT IS USED FOR Goserelin Boston Biopharma contains a medicine called goserelin. This belongs to a group of medicines called ‘LHRH analogues’. USE OF GOSERELIN BOSTON BIOPHARMA BY MEN In men, Goserelin Boston Biopharma is used to treat prostate cancer. It works by reducing the amount of ‘testosterone’ (a hormone) that is produced by your body. USE OF GOSERELIN BOSTON BIOPHARMA BY WOMEN In women, Goserelin Boston Biopharma is used to: - Treat breast cancer. - Treat a condition called ‘endometriosis’. This is where cells normally only found in the lining of the womb (uterus) are f Olvassa el a teljes dokumentumot
Page 1 of 11 _Version 4.1, 02/2020_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 11 1. NAME OF THE MEDICINAL PRODUCT Goserelin Boston Biopharma 3.6 mg implant, in a pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One implant contains 3.6 mg goserelin (as goserelin acetate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Implant, in a pre-filled syringe White to off-white cylindrical rods (approximate dimensions: diameter 1.2 mm, length 13 mm, mass 18 mg), embedded in biodegradable polymer matrix. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (i) Treatment of prostate cancer in the following settings (see also section 5.1): - In the treatment of metastatic prostate cancer where goserelin has demonstrated comparable survival benefits to surgical castrations (see section 5.1). - In the treatment of locally advanced prostate cancer, as an alternative to surgical castration where goserelin has demonstrated comparable survival benefits to an anti-androgen (see section 5.1). - As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer where goserelin has demonstrated improved disease-free survival and overall survival (see section 5.1). - As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer where goserelin has demonstrated improved disease-free survival (see section 5.1). - As adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression where goserelin has demonstrated improved disease- free survival (see section 5.1). (ii) Advanced breast cancer in pre and perimenopausal women suitable for hormonal manipulation. (iii) Goserelin Boston Biopharma 3.6 mg is indicated as an alternative to chemotherapy in the standard of care for pre/perimenopausal women with oestrogen receptor (ER) positive early Olvassa el a teljes dokumentumot