Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
pemetrexed diacid monohydrate
Actavis Group PTC ehf
L01BA04
pemetrexed
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Malignant pleural mesotheliomaPemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed 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 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 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
2016-01-18
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER ARMISARTE 25 MG/ML 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Armisarte is and what it is used for 2. What you need to know before you use Armisarte 3. How to use Armisarte 4. Possible side effects 5. How to store Armisarte 6. Contents of the pack and other information 1. WHAT ARMISARTE IS AND WHAT IT IS USED FOR Armisarte 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 cells to divide. Armisarte 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. Armisarte is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Armisarte 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. Armisarte 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 ARMISARTE DO NOT USE ARMISARTE - 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 Armisarte. - if yo Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Armisarte 25 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 25 mg pemetrexed (as pemetrexed diacid). Each vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid). Each vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diacid). Each vial of 34 ml concentrate contains 850 mg pemetrexed (as pemetrexed diacid). Each vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). The concentrate is clear, colourless to slightly yellowish or yellow-greenish solution. The pH is between 7.0 and 8.0. 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 ADMINISTRATION Posology Pemetrexed must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. 3 _Pemetrexed in combination with cisplatin Izlasiet visu dokumentu