País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
pemetrexed
Eli Lilly Netherlands
L01BA04
pemetrexed
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Malignant pleural mesotheliomaPemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Lilly 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 Lilly 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 Lilly 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: 7
Withdrawn
2015-09-14
31 B. PACKAGE LEAFLET Medicinal product no longer authorised 32 PACKAGE LEAFLET: INFORMATION FOR THE USER PEMETREXED LILLY 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED LILLY 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 further questions, please 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 Lilly is and what it is used for 2. What you need to know before you use Pemetrexed Lilly 3. How to use Pemetrexed Lilly 4. Possible side effects 5. How to store Pemetrexed Lilly 6. Contents of the pack and other information 1. WHAT PEMETREXED LILLY IS AND WHAT IT IS USED FOR Pemetrexed Lilly is a medicine used in the treatment of cancer. Pemetrexed Lilly 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 Lilly is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Pemetrexed Lilly 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 Lilly 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 LILLY DO NOT USE PEMETREXED LILLY - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of this medicine (listed in section 6). - if you are breast-feeding; you must discontinue breast-feed Leia o documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Lilly 100 mg powder for concentrate 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. Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium). _Excipient with known effect _ Each vial contains approximately 54 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 Pemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Lilly 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 Lilly 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 Lilly 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). Medicinal produ Leia o documento completo