Country: European Union
Language: English
Source: EMA (European Medicines Agency)
pemetrexed
medac Gesellschaft für klinische Spezialpräparate mbH
L01BA04
pemetrexed
Folic acid analogues, Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed medac 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 medac 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 medac 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: 8
Authorised
2015-11-26
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER PEMETREXED MEDAC 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED MEDAC 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED MEDAC 1,000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION pemetrexed READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have 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 medac is and what it is used for 2. What you need to know before you use Pemetrexed medac 3. How to use Pemetrexed medac 4. Possible side effects 5. How to store Pemetrexed medac 6. Contents of the pack and other information 1. WHAT PEMETREXED MEDAC IS AND WHAT IS IT USED FOR Pemetrexed medac is a medicine used in the treatment of cancer. Pemetrexed medac 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 medac is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Pemetrexed 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 medac 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 MEDAC DO NOT USE PEMETREXED MEDAC − if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6). − if you are breast-feeding; you must discontinue Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 100 mg powder for concentrate for solution for infusion Pemetrexed medac 500 mg powder for concentrate for solution for infusion Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed medac 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate). _Excipient with known effect _ Each 100 mg vial contains approximately 11 mg sodium. Pemetrexed medac 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate). _Excipient with known effect _ Each 500 mg vial contains approximately 54 mg sodium. Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate). _Excipient with known effect _ Each 1,000 mg vial contains approximately 108 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 light yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed medac 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 medac 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 immed Read the complete document