Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
pemetrexed disodium
KRKA d.d.
L01BA04
pemetrexed
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Malignant pleural mesotheliomaPemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Krka 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 Krka 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 Krka 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: 6
Authorised
2018-05-22
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER PEMETREXED KRKA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED KRKA 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION pemetrexed READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pemetrexed Krka is and what it is used for 2. What you need to know before you use Pemetrexed Krka 3. How to use Pemetrexed Krka 4. Possible side effects 5. How to store Pemetrexed Krka 6. Contents of the pack and other information 1. WHAT PEMETREXED KRKA IS AND WHAT IT IS USED FOR Pemetrexed Krka is a medicine used in the treatment of cancer. Pemetrexed Krka 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 Krka is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Pemetrexed Krka 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 Krka 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 KRKA DO NOT USE PEMETREXED KRKA - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6). - if you are breast-feeding; you must discontinue breast-feeding during treatment with Pemetrexed Krka. - if you have recently received or Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Pemetrexed Krka 500 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate). After reconstitution (see section 6.6), each vial contains 25 mg/ml pemetrexed. _Excipient with known effect_ Each vial contains approximately 11 mg (0.48 mmol) sodium. Pemetrexed Krka 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate). After reconstitution (see section 6.6), each vial contains 25 mg/ml pemetrexed. _Excipient with known effect_ Each vial contains approximately 54 mg (2.35 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). White to either light yellow or green yellow lyophilized cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Krka 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 Krka 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 Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastat Aqra d-dokument sħiħ