国家: 以色列
语言: 英文
来源: Ministry of Health
PEMETREXED
ELI LILLY ISRAEL LTD, ISRAEL
L01BA04
POWDER FOR SOLUTION FOR INFUSION
PEMETREXED 100 MG/VIAL
I.V
Required
LILLY FRANCE S.A.S., FRANCE
PEMETREXED
PEMETREXED
Alimta in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. Alimta in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
2018-08-31
I ALIMVL F 05 Page 1 of 6 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only ALIMTA 100 MG POWDER FOR SOLUTION FOR INFUSION COMPOSITION: Each vial contains: 100 milligrams pemetrexed (as pemetrexed disodium) After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further dilution by a healthcare provider is required prior to administration. FOR INFORMATION ON INACTIVE INGREDIENTS AND ALLERGENS - see section 2 “Important information about some of the ingredients of this medicine” and section 6 “Additional information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please contact 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 it seems to you that their illness is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? ALIMTA is a medicine used in the treatment of cancer. ALIMTA in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma, whose disease is unresectable or who are otherwise not candidates for curatible surgery. ALIMTA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ALIMTA is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. THERAPEUTIC GROUP: folic acid analogues. 2. BEFORE 阅读完整的文件
X ALIMVL F 16 Page 1 of 20 1. NAME OF THE MEDICINAL PRODUCT ALIMTA 100 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ALIMTA 100 mg powder for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium). _Excipient with known effect _ Each vial contains approximately 11 mg sodium. After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to either light yellow or green-yellow lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma ALIMTA in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. Non-small cell lung cancer : ALIMTA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). ALIMTA is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1). ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ALIMTA must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. _ALIMTA in combination with cisplatin _ X ALIMVL F 16 Page 2 of 20 The recommended dose of ALIMTA is 500 mg/m 2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day c 阅读完整的文件