Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
pemetrexed disodium, pemetrexed disodium hemipentahydrate
Pfizer Europe MA EEIG
L01BA04
pemetrexed
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Malignant pleural mesotheliomaPemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Pfizer 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 Pfizer 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 Pfizer 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: 14
Authorised
2015-11-19
59 B. PACKAGE LEAFLET 60 Package leaflet: Information for the user Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 1,000 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 or nurse. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Pemetrexed Pfizer is and what it is used for 2. What you need to know before you use Pemetrexed Pfizer 3. How to use Pemetrexed Pfizer 4. Possible side effects 5. How to store Pemetrexed Pfizer 6. Contents of the pack and other information 1. What Pemetrexed Pfizer is and what it is used for Pemetrexed Pfizer is a medicine used in the treatment of cancer. Pemetrexed Pfizer 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 Pfizer is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Pemetrexed Pfizer 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 Pfizer 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 Pfizer Do not use Pemetrexed Pfizer - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of this medicine (listed in section Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Pfizer 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 vial contains approximately 11 mg sodium. Pemetrexed Pfizer 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 vial contains approximately 54 mg sodium. Pemetrexed Pfizer 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 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 either light yellow or green-yellow lyophilised powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Malignant pleural mesothelioma Pemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. 3 Non-small cell lung cancer Pemetrexed Pfizer 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 Pfizer 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 pr Lestu allt skjalið