Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
RIBOCICLIB AS SUCCINATE
NOVARTIS ISRAEL LTD
L01XE42
FILM COATED TABLETS
RIBOCICLIB AS SUCCINATE 200 MG
PER OS
Required
NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD, SINGAPORE
RIBOCICLIB
Kisqali is indicated in combination with:* a non-steroid aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, as initial endocrine-based therapy.or* fulvestrant for the treatment of men and postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.
2023-06-30
DOR-Kis-PIL-0223-09 KIS APL JAN23 V6 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 The medicine is dispensed with a doctor’s prescription only KISQALI ® 200 MG FILM-COATED TABLETS ACTIVE INGREDIENT: Each tablet contains: ribociclib 200 mg (as ribociclib succinate 254.40 mg) Inactive and allergenic ingredients: see section 2 under “Important information about some of the ingredients of the medicine” and section 6 “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of 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? Kisqali is intended for the treatment in combination with: • A non-steroidal aromatase inhibitor in pre/perimenopausal or postmenopausal women, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, as initial endocrine-based therapy. • Fulvestrant in men and postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy. THERAPEUTIC GROUP: Cyclin-dependent kinase enzyme inhibitors. Kisqali contains the active ingredient ribociclib, which belongs to a group of medicines called cyclin-dependent kinase (CDK) inhibitors. Kisqali works by blocking proteins called cyclin-dependent kinases 4 and 6, which are important for the growth and division of cells. Blocking these proteins can slow down the growth of cancer cells and delay the progression of the cancer. If you have questions about how Kisqali works or why it was prescribed, ask your doctor. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (alle Læs hele dokumentet
1 KIS SPI 23OCT23 V7 EU SmPC AUG 23 1. NAME OF THE MEDICINAL PRODUCT Kisqali 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains ribociclib succinate, equivalent to 200 mg ribociclib. Excipients with known effect Each film-coated tablet contains 0.344 mg soya lecithin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light greyish violet, unscored, round, curved with bevelled edges (approximate diameter: 11.1 mm), debossed with “RIC” on one side and “NVR” on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Kisqali is indicated in combination with: • a non-steroid aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, as initial endocrine-based therapy; or • fulvestrant for the treatment of men and postmenopausal women with HR-positive, HER2- negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy. 4.2 Posology and method of administration Treatment with Kisqali should be initiated by a physician experienced in the use of anticancer therapies. Posology The recommended dose is 600 mg (three 200 mg film-coated tablets) of ribociclib once daily for 21 consecutive days followed by 7 days off treatment, resulting in a complete cycle of 28 days. The treatment should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs. Kisqali should be used together with 2.5 mg letrozole or another non-steroidal aromatase inhibitor or with 500 mg fulvestrant. When Kisqali is used in combination with a non-steroidal aromatase inhibitor, the non steroidal aromatase inhibitor should be taken orally once daily continuously throughout the 28-day cycle. Please KIS API OCT23 V7 EU SmPC Aug 23 2 refer to the Pre Læs hele dokumentet