국가: 이스라엘
언어: 영어
출처: Ministry of Health
PALBOCICLIB
PFIZER PHARMACEUTICALS ISRAEL LTD
L01XE33
FILM COATED TABLETS
PALBOCICLIB 100 MG
PER OS
Required
PFIZER INC, USA
PALBOCICLIB
IIBRANCE 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.
2023-06-22
Ibrance tablets, PIL, Israel, CC TC 021123 2023-0088988 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only IBRANCE ® TABLETS 75 MG IBRANCE ® TABLETS 100 MG IBRANCE ® TABLETS 125 MG FILM-COATED TABLETS Each tablet contains: palbociclib 75 mg, 100 mg or 125 mg List of inactive ingredients and allergens in the preparation: see 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 initial (endocrine-based) combination therapy in postmenopausal women or in 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). SPECIAL WARNINGS REGARDING USE OF THE 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 are pregnant or plan to become pregnant. For more information, see section 2 under 'Pregnancy, breastfeeding and fertility'. ● you are breastfeeding or plan to breastfeed. For more information, see section 2 under 'Pregnancy, breastfeeding and fertility'. Tell your doctor if you are taking Ibrance and 전체 문서 읽기
Ibrance tablets 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 ® tablets 75 mg Ibrance ® tablets 100 mg Ibrance ® tablets 125 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 75 mg, 100 mg or 125 mg Palbociclib For the full list of excipients, see section 11. PHARMACEUTICAL FORM Film coated tablets 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 tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE tablet may be taken with or without 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. 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 tablets should be swallowed Ibrance tablets 75 mg, 100 mg, 125 mg, LPD, Israel, CC 041223 2022-0077820, 2023-0084987, 2022-0082924 2 whole (do not chew, crush, or split them prior to swallowing). Tablets should not be ingested if they are broken, cra 전체 문서 읽기