Country: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
FULVESTRANT
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
L02BA03
FULVESTRANT
Oplossing voor injectie
BENZYLALCOHOL (E 1519) 100 mg/ml ; BENZYLBENZOAAT ; CASTOROLIE ; ETHANOL 96 % 100 mg/ml
Intramusculair gebruik
Fulvestrant
2019-08-14
FULVESTRANT 250 MG SOLUTION FOR INJECTION Edition: 2023-10-12 MODULE 1 ADMINISTRATIVE INFORMATION MODULE1.3 PRODUCT INFORMATION, THE NETHERLANDS MODULE 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET Page 1/9 PACKAGE LEAFLET: INFORMATION FOR THE USER FULVESTRANT STADA 250 MG OPLOSSING VOOR INJECTIE Fulvestrant 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 Fulvestrant STADA 250 mg oplossing voor injectie is and what it is used for 2. What you need to know before you use Fulvestrant STADA 250 mg oplossing voor injectie 3. How to use Fulvestrant STADA 250 mg oplossing voor injectie 4. Possible side effects 5. How to store Fulvestrant STADA 250 mg oplossing voor injectie 6. Contents of the pack and other information 1. WHAT FULVESTRANT STADA 250 MG OPLOSSING VOOR INJECTIE IS AND WHAT IT IS USED FOR Fulvestrant STADA 250 mg oplossing voor injectie contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer. Fulvestrant STADA 250 mg oplossing voor injectie is used either: • alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or • in combination with palbociclib to treat women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, that is locally Baca dokumen lengkap
FULVESTRANT 250 MG SOLUTION FOR INJECTION Edition: 2023-07-19 MODULE 1 ADMINISTRATIVE INFORMATION MODULE1.3 PRODUCT INFORMATION, THE NETHERLANDS MODULE 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET Page 1/33 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fulvestrant Stada 250 mg oplossing voor injectie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution. Each ml solution for injection contains 50 mg fulvestrant. Excipients with known effect: Each ml of solution contains 100 mg ethanol (96%), 100 mg benzyl alcohol and 150 mg benzyl benzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. Clear, colourless to yellow, practically free from visible particle, oily and viscous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fulvestrant STADA 250 mg oplossing voor injectie is indicated: • as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: − not previously treated with endocrine therapy, or − with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. • in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1). In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. FULVESTRANT 250 MG SOLUTION FOR INJECTION Edition: 2023-07-19 MODULE 1 ADMINISTRATIVE INFORMATION MODULE1.3 PRODUCT INFORMATION, THE NETHERLANDS MODULE 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET Page 2/33 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult females (including Elderly) _ The recommended dose is 500 mg at intervals of one month, with an additional 50 Baca dokumen lengkap