البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
CRIZOTINIB
PFIZER PHARMACEUTICALS ISRAEL LTD
L01XE16
CAPSULES
CRIZOTINIB 200 MG
PER OS
Required
PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY
CRIZOTINIB
CRIZOTINIB
XALKORI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. Xalkori is indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive.
2017-01-31
Xalkori PIL CC 270722 ENG 2022-0076331, 2022-0077209 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only XALKORI ® 200MG, CAPSULES XALKORI ® 250MG, CAPSULES Each capsule contains CRIZOTINIB 200 MG OR 250 MG Inactive ingredients and allergens: 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 medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) positive for a mutation in a gene called anaplastic lymphoma kinase (ALK). The medicine is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) positive for a mutation in a gene called ROS1. THERAPEUTIC GROUP: A medicine from the protein kinase inhibitors group, antineoplastic. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to crizotinib or to any of the other ingredients in this medicine (see section 6). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH XALKORI, TELL YOUR DOCTOR IF: • You have a moderate or severe liver disease. • You have ever had any lung problems. Some lung problems may worsen during treatment with Xalkori, as Xalkori may cause inflammation of the lungs during the treatment. Symptoms may be similar to those of lung cancer. Contact your doctor immediately if you have any new or worsening symptoms including difficulty breathing, shortness of breath, or cough with or without mucus, or fever. • You have اقرأ الوثيقة كاملة
Xalkori LPD CC 270722 2022-0077209, 2022-0076331 Xalkori ® 200 mg Xalkori ® 250 mg 1. NAME OF THE MEDICINAL PRODUCT XALKORI 200 mg, capsules XALKORI 250 mg, capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION XALKORI 200 mg capsules Each hard capsule contains 200 mg of crizotinib. XALKORI 250 mg capsules Each hard capsule contains 250 mg of crizotinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM capsule. XALKORI 200 mg capsules White opaque and pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 200” on the body. XALKORI 250 mg capsules Pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 250” on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALK-POSITIVE METASTATIC NSCLC XALKORI is indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. ROS1-POSITIVE METASTATIC NSCLC XALKORI is indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with XALKORI should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. PATIENT SELECTION Select patients for the treatment of metastatic NSCLC with XALKORI based on the presence of ALK or ROS1 positivity in tumor specimens RECOMMENDED DOSING Xalkori LPD CC 270722 2022-0077209, 2022-0076331 The recommended dose of XALKORI is 250 mg orally, twice daily until disease progression or no longer tolerated by the patient. The recommended dose of XALKORI in patients with severe renal impairment [creatinine clearance (CLcr) <30 mL/min] not requiring dialysis is 250 mg orally, once daily XALKORI may be taken with or without food. Swallow capsules whole. If a dose of XALKORI is missed, make up that dose unless the next dose is due within 6 hours. If vomiting occurs after taking a dose of XALKORI, take the next dose at the regular time. DOSE MODIFICATION Redu اقرأ الوثيقة كاملة