Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
RALOXIFENE HYDROCHLORIDE
ELI LILLY ISRAEL LTD, ISRAEL
G03XC01
FILM COATED TABLETS
RALOXIFENE HYDROCHLORIDE 60 MG
PER OS
Required
LILLY S.A., SPAIN
RALOXIFENE
RALOXIFENE
Evista is indicated for the treatment of osteoporosis in post menopausal women. Evista is indicated for the prevention of osteoporosis in post menopausal women . Evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. Evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.
2023-12-31
I EVISTB A 04 Page 1 of 6 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed by a doctor's prescription only EVISTA FILM COATED TABLETS ACTIVE INGREDIENT AND QUANTITY: Each film coated tablet contains: Raloxifene HCl 60 mg. For the list of inactive ingredients and allergens, please see section “important information about some of the ingredients of this medicine” in chapter 2 and chapter 6 "Additional information". PLEASE READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This package insert contains concise information on the medicine. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them even if their condition seems similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? EVISTA is used for the treatment and prevention of osteoporosis in postmenopausal women. EVISTA is used for the prevention of osteoporosis in postmenopausal women when estrogen therapy is considered unsuitable. Prevention of breast cancer - EVISTA reduces the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. THERAPEUTIC GROUP: EVISTA belongs to the non-hormonal drug group known as Selective Estrogen Receptor Modulators (SERMs). When a woman reaches menopause, the level of the sex hormone estrogen decreases. EVISTA simulates some of the supporting effects of estrogen at the postmenopausal stage. Osteoporosis is a disease which causes a decrease in bone mass and increases the bones’ tendency to fracture - this disease is especially common in postmenopausal women, although it is possible that initially no symptoms will appear. Osteoporosis increases the risk of bone fractures, especially those of the spinal column, hips and wrists, and may cause back pain, loss of height and a curved back. 2. BEFORE USING THIS MEDICINE DO Přečtěte si celý dokument
EVISTA RALOXIFENE HYDROCHLORIDE 60MG FILM COATED TABLET FULL PRESCRIBING INFORMATION WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE • Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA _[see Warnings and _ _Precautions (5.1)]_ . . Women with active or past history of venous thromboembolism should not take EVISTA _[see _ _Contraindications (4.1)]_ .. • Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke _[see Warnings and _ _Precautions (5.2) and Clinical Studies (14.5)]._ 1 INDICATIONS AND USAGE 1.1 TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN EVISTA is indicated for the treatment of osteoporosis in postmenopausal women _[see Clinical Studies (14.1, 14.2)]_ . Evista is indicated for the prevention of osteoporosis in post menopausal women for whom estrogen therapy is considered unsuitable 1.2 REDUCTION IN THE RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis _[see _ _Clinical Studies (14.3)]_ . 1.3 REDUCTION IN THE RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL WOMEN AT HIGH RISK OF INVASIVE BREAST CANCER EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer _[see Clinical Studies (14.4)]_ . The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years _[see Clinical Studies (14.4)]_ . Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known. High risk of breast cancer is defined as at least one breast biopsy s Přečtěte si celý dokument