Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
pemetrexed disodium hemipentahydrate
Accord Healthcare S.L.U.
L01BA04
pemetrexed
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Malignant pleural mesotheliomaPemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Accord 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 Accord 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 Accord 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: 10
Authorised
2016-01-18
58 B. PACKAGE LEAFLET 59 PACKAGE LEAFLET: INFORMATION FOR THE USER PEMETREXED ACCORD 25 MG/ML 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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 Accord is and what it is used for 2. What you need to know before you use Pemetrexed Accord 3. How to use Pemetrexed Accord 4. Possible side effects 5. How to store Pemetrexed Accord 6. Contents of the pack and other information 1. WHAT PEMETREXED ACCORD IS AND WHAT IT IS USED FOR Pemetrexed Accord is a medicine used in the treatment of cancer. Pemetrexed Accord 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 Accord is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Pemetrexed Accord 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 Accord 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 ACCORD DO NOT USE PEMETREXED ACCORD - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6). - if you are breast-feed Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pemetrexed Accord 25 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains pemetrexed disodium hemipentahydrate equivalent to 25 mg pemetrexed. One vial of 4 ml of concentrate contains pemetrexed disodium hemipentahydrate equivalent to 100 mg Pemetrexed. One vial of 20 ml of concentrate contains pemetrexed disodium hemipentahydrate equivalent to 500 mg pemetrexed. One vial of 34 ml of concentrate contains pemetrexed disodium hemipentahydrate equivalent to 850 mg pemetrexed. One vial of 40 ml of concentrate contains pemetrexed disodium hemipentahydrate equivalent to 1000 mg pemetrexed. Excipient with known effect Each ml of solution contains 8.4 mg (0.4mmol) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). A clear, colourless to pale yellow solution. pH is between 7.0 - 8.5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Accord 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 Accord 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 Accord 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). Прочетете целия документ