البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PALBOCICLIB
PFIZER PHARMACEUTICALS ISRAEL LTD
L01XE33
CAPSULES
PALBOCICLIB 100 MG
PER OS
Required
PFIZER INC, USA
PALBOCICLIB
IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:- An aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or- fulvestrant in patients with disease progression following endocrine therapy
2021-07-31
Ibrance capsules, PIL, Israel, CC 010223 2021-0068110, 2022-0082722 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only IBRANCE ® CAPSULES 75 MG IBRANCE ® CAPSULES 100 MG IBRANCE ® CAPSULES 125 MG CAPSULES Each capsule contains: palbociclib 75 mg, 100 mg or 125 mg List of inactive ingredients and allergens in the preparation: see section 2 under “Important information about some of this medicine’s ingredients” and section 6 “Further information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. This medicine is intended for women and men over the age of 18. 1. WHAT IS THIS MEDICINE INTENDED FOR? Ibrance is intended for the treatment of estrogen receptor-positive and HER2-negative advanced or metastatic breast cancer, in combination with: ● An aromatase inhibitor as the first (endocrine-based) combination therapy in postmenopausal women or men. OR ● Fulvestrant in patients with disease progression following previous endocrine therapy. THERAPEUTIC GROUP: antineoplastic, kinase inhibitor. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: ● you are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine listed in section 6 “Further information” in this leaflet. SPECIAL WARNINGS ABOUT USING THIS MEDICINE: BEFORE TREATMENT WITH IBRANCE, TELL YOUR DOCTOR IF: ● you have fever, chills, or any other symptom of infection. ● you have impaired liver or kidney function. ● you have any other medical condition. ● you are pregnant or plan to become pregnant. For more information, see section 2 under "Pregnancy, breastfeeding and fertility". اقرأ الوثيقة كاملة
Ibrance capsules 75 mg, 100 mg, 125 mg, LPD, Israel, CC 041223 2022-0077820, 2023-0084987, 2022-0082924 1 FULL PRESCRIBING INFORMATION NAME OF THE MEDICINAL PRODUCT Ibrance ® capsules 75 mg Ibrance ® capsules 100 mg Ibrance ® capsules 125 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 75 mg, 100 mg or 125 mg Palbociclib Each 75 mg capsule contains 55.78 of lactose monohydrate. Each 100 mg capsule contains 74.37 of lactose monohydrate. Each 125 mg capsule contains 92.96 of lactose monohydrate. For the full list of excipients, see section 11. PHARMACEUTICAL FORM Capsules 1 INDICATIONS AND USAGE IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: • an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or • fulvestrant in patients with disease progression following endocrine therapy. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dose and Schedule The recommended dose of IBRANCE is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE should be taken with food _[see Clinical Pharmacology (12.3)]_. Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Please refer to the Full Prescribing Information for the aromatase inhibitor being used. When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant. Patients should be encouraged to take their dose of IBRANCE at approximately the same time each day. Ibrance capsules 75 mg, 100 mg, 125 mg, LPD, Israel, CC 041223 2022-0077820, 2023-0084987, 2022-0082924 2 If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE cap اقرأ الوثيقة كاملة