Kraj: Szwecja
Język: szwedzki
Źródło: Läkemedelsverket (Medical Products Agency)
pemetrexeddinatrium (vattenfri)
Sigillata Limited
L01BA04
pemetrexeddinatrium (anhydrous)
1000 mg
Pulver till koncentrat till infusionsvätska, lösning
mannitol Hjälpämne; pemetrexeddinatrium (vattenfri) 1103 mg Aktiv substans
Receptbelagt
Förpacknings: Injektionsflaska, 1 st (1000 mg)
Avregistrerad
2016-08-18
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER RUNARORN 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION RUNARORN 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION RUNARORN 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, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Runarorn is and what it is used for 2. What you need to know before you use Runarorn 3. How to use Runarorn 4. Possible side effects 5. How to store Runarorn 6. Contents of the pack and other information 1. WHAT RUNARORN IS AND WHAT IT IS USED FOR Runarorn is a medicine used in the treatment of cancer. It contains the active substance pemetrexed. Pemetrexed belongs to a group of medicines known as folic acid analogues and disrupts processes that are essential for cell replication. Runarorn 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. Runarorn is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Runarorn 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. Runarorn 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 RUNARORN DO NOT USE RUNARORN - if you are allergic to pemetrexed or any of the other ingredients of this medicine (li Przeczytaj cały dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Runarorn 100 mg powder for concentrate for solution for infusion Runarorn 500 mg powder for concentrate for solution for infusion Runarorn 1000 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate). Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate). Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate). After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed. Excipient with known effect: Each 100 mg vial contains approximately 11.29 mg sodium. Each 500 mg vial contains approximately 53.77 mg sodium. Each 1000 mg vial contains approximately 107.54 mg sodium. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to yellow or greenish-yellow lyophilisate powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed 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 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 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 AD Przeczytaj cały dokument