Land: Israel
Språk: engelsk
Kilde: Ministry of Health
FULVESTRANT
ASTRAZENECA (ISRAEL) LTD
L02BA03
SOLUTION FOR INJECTION
FULVESTRANT 250 MG / 5 ML
I.M
Required
ASTRA ZENECA UK LIMITED
FULVESTRANT
FULVESTRANT
MonotherapyFaslodex is indicated for the treatment of oestrogen 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 endocrine therapy;or* with disease progression on endocrine therapy.Combination Therapy Faslodex is indicated for the treatment of:- HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in men and postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.- HR- positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
2020-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only FASLODEX ® SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE For intramuscular injection Composition: Each pre-filled syringe (5 ml) contains: Fulvestrant 250 mg For the list of inactive ingredients in the preparation, see section 2 "Important information regarding some of the medicine ingredients" and section 6 - “Further Information”. Read the leaflet carefully in its entirety before using the medicine. Keep the leaflet; you may need it again. This leaflet contains concise information about the medicine. If you have further questions, please refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? • Faslodex is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with hormonal therapy, or with disease relapse/progression on or after adjuvant endocrine therapy. • Faslodex, in combination with the preparation Palbociclib or Abemaciclib, is intended for women with advanced or metastatic estrogen receptor-positive and HER2-negative breast cancer, whose disease has progressed after receiving prior hormonal treatment for this ailment. • Faslodex, in combination with Ribociclib, is intended for men and postmenopausal women with advanced or metastatic estrogen receptor-positive and HER2-negative breast cancer, whose disease has progressed after receiving prior endocrine treatment for this ailment or as initial endocrine treatment. When used in combination with Palbociclib (Ibrance), Abemaciclib (Verzenio) or Ribociclib (Kisqali) please read the Palbociclib (Ibrance), Abemaciclib (Verzenio) or Ribociclib (Kisqali) patient package insert as well. Therapeutic group: Estrogen antagonist. Faslo Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Faslodex ® 250 mg/5 ml solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution. Excipients with known effect (per 5 ml) Ethanol (96%. 500mg) 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 solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Monotherapy Faslodex is indicated 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 endocrine therapy; or - disease progression on endocrine therapy Combination Therapy FASLODEX is indicated for the treatment of: • HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in men and postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. • HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. 4.2 Posology and method of administration Monotherapy Adult females (including the elderly): The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose. Combination Therapy with Palbociclib When FASLODEX is used in combination with palbociclib, abemaciclib, or ribociclib, the recommended dose of FASLODEX is 500 mg to be administered intramuscularly into the buttocks (gluteal area) slowly (1-2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29 and once monthly thereafter. When FASLODEX is used in combination with Palbociclib, the recommended dos Les hele dokumentet