País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Pemetrexed sodium
Waverley Pharma Europe Limited
L01BA; L01BA04
Pemetrexed sodium
500 milligram(s)
Powder for concentrate for solution for infusion
Folic acid analogues; pemetrexed
2020-02-21
PACKAGE LEAFLET: INFORMATION FOR THE USER [PRODUCT NAME] <100 MG>[PRODUCT NAME] <500 MG> Leia o documento completoREAD 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 is and what it is used for 2. What you need to know before you use 3. How to use 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR is a medicine used in the treatment of cancer. This medicine 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. This medicine is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. This medicine 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. This medicine 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 DO NOT USE - 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 breast-feeding during treatment with This medicine. - if you have recently received or are about to receive a v
Health Products Regulatory Authority 19 August 2020 CRN009Q55 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pemetrexed Waverley 500 mg powder for concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of pemetrexed (as pemetrexed disodium). _Excipients with known effect: _ Each vial contains approximately 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 either light yellow or green-yellow lyophilised powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma: Pemetrexed Waverley in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer: Pemetrexed Waverley in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology (see section 5.1). Pemetrexed Waverley 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 Waverley 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 Waverley must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. Pemetrexed Waverley _in combination with cisplatin_ The recommended dose of Pemetrexed Waverley is 500 mg/m 2 of body surface area (BSA) administered Leia o documento completo