Nchi: Uswidi
Lugha: Kiswidi
Chanzo: Läkemedelsverket (Medical Products Agency)
pemetrexeddinatrium-2,5-hydrat
Laboratorio Reig Jofre S.A.
L01BA04
pemetrexeddinatrium-2,5-hydrat
500 mg
Pulver till koncentrat till infusionsvätska, lösning
mannitol Hjälpämne; pemetrexeddinatrium-2,5-hydrat 616,2 mg Aktiv substans
Receptbelagt
Förpacknings: Injektionsflaska, 1 st (500 mg)
Avregistrerad
2015-12-04
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PEMETREXED REIG JOFRE 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED REIG JOFRE 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 Reig Jofre is and what it is used for 2. What you need to know before you use Pemetrexed Reig Jofre 3. How to use Pemetrexed Reig Jofre 4. Possible side effects 5. How to store Pemetrexed Reig Jofre 6. Contents of the pack and other information 1. WHAT PEMETREXED REIG JOFRE IS AND WHAT IT IS USED FOR Pemetrexed Reig Jofre is a medicine used in the treatment of cancer. Pemetrexed Reig Jofre 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 Reig Jofre is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Pemetrexed Reig Jofre 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 Reig Jofre 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 REIG JOFRE DO NOT USE PEMETREXED REIG JOFRE - 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 b Soma hati kamili
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pemetrexed Reig Jofre 500 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of pemetrexed (as pemetrexed disodium 2.5 H 2 O). Excipient with known effect: Each vial contains 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 faint yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed Reig Jofre in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Reig Jofre 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 Reig Jofre 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 Reig Jofre 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 Posology Pemetrexed Reig Jofre must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. _Pemetrexed Reig Jofre in combination with cisplatin_ The recommended dose of Pemetrexed Reig Jofre is 500 mg/m 2 of body surface area (BSA) 2 administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle. The recommended dos Soma hati kamili