Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
pemetrexed disodium hemipentahydrate
Sandoz GmbH
L01BA04
pemetrexed
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Sandoz 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 Sandoz 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 Sandoz 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
Authorised
2015-09-18
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE USER PEMETREXED SANDOZ 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED SANDOZ 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED SANDOZ 1000 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, 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 Sandoz is and what it is used for 2. What you need to know before you use Pemetrexed Sandoz 3. How to use Pemetrexed Sandoz 4. Possible side effects 5. How to store Pemetrexed Sandoz 6. Contents of the pack and other information 1. WHAT PEMETREXED SANDOZ IS AND WHAT IT IS USED FOR Pemetrexed Sandoz is a medicine used in the treatment of cancer. Pemetrexed Sandoz 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 Sandoz is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Pemetrexed Sandoz 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 Sandoz 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 SANDOZ _ _ DO NOT USE PEMETREXED SANDOZ: - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of this medicine (listed in section 6). - Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion One vial of powder contains 100 mg of pemetrexed (as disodium). _Excipient with known effect _ One vial of powder contains approximately 11 mg of sodium. Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion One vial of powder contains 500 mg of pemetrexed (as disodium). _Excipient with known effect _ One vial of powder contains approximately 54 mg of sodium. Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion One vial of powder contains 1000 mg of pemetrexed (as disodium). _Excipient with known effect _ One vial of powder contains approximately 108 mg of 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 off-white or pale yellow lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Sandoz 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 Sandoz 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 followin Aqra d-dokument sħiħ