ประเทศ: สหภาพยุโรป
ภาษา: อังกฤษ
แหล่งที่มา: EMA (European Medicines Agency)
pemetrexed
Fresenius Kabi Deutschland GmbH
L01BA04
pemetrexed
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Malignant pleural mesotheliomaPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Fresenius Kabi 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.Pemetrexed Fresenius Kabi 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. Pemetrexed Fresenius Kabi 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.
Revision: 13
Authorised
2016-07-22
75 B. PACKAGE LEAFLET 76 PACKAGE LEAFLET: INFORMATION FOR THE USER PEMETREXED FRESENIUS KABI 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED FRESENIUS KABI 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION pemetrexed READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pemetrexed Fresenius Kabi is and what it is used for 2. What you need to know before you use Pemetrexed Fresenius Kabi 3. How to use Pemetrexed Fresenius Kabi 4. Possible side effects 5. How to store Pemetrexed Fresenius Kabi 6. Contents of the pack and other information 1. WHAT PEMETREXED FRESENIUS KABI IS AND WHAT IT IS USED FOR Pemetrexed Fresenius Kabi is a medicine used in the treatment of cancer. Pemetrexed Fresenius Kabi is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy. Pemetrexed Fresenius Kabi is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Pemetrexed Fresenius Kabi can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy. Pemetrexed Fresenius Kabi is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PEMETREXED FRESENIUS KABI DO NOT USE PEMETREXED FRESENIUS KABI - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in sectio อ่านเอกสารฉบับเต็ม
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 100 mg of pemetrexed (as pemetrexed diacid). 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 off-white lyophilised powder or solid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Fresenius Kabi 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). Pemetrexed Fresenius Kabi 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). Pemetrexed Fresenius Kabi 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 Pemetrexed Fresenius Kabi must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. Posology _Pemetrexed Fresenius Kabi in combination with cisplatin_ The recommended dose of Pemetrexed Fresenius Kabi 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 cycle. 3 The recommended dose of อ่านเอกสารฉบับเต็ม