Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Pemetrexed
Genthon B.V.
L01BA; L01BA04
Pemetrexed
25 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Folic acid analogues; pemetrexed
Not marketed
2017-12-22
M1.3.1_03.PXD.inj.001.07.IE.3923.01 PACKAGE LEAFLET: INFORMATION FOR THE USER PEMETREXED GENTHON 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 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 Genthon is and what it is used for 2. What you need to know before you use Pemetrexed Genthon 3. How to use Pemetrexed Genthon 4. Possible side effects 5. How to store Pemetrexed Genthon 6. Contents of the pack and other information 1 WHAT PEMETREXED IS AND WHAT IT IS USED FOR Pemetrexed Genthon is a medicine used in the treatment of cancer. Pemetrexed Genthon 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 Genthon is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Pemetrexed Genthon 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 Genthon 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 GENTHON DO NOT USE PEMETREXED GENTHON 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. if you have recently received or are about to receive a VACCINE A Baca dokumen lengkapnya
Health Products Regulatory Authority 27 May 2019 CRN008TT5 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pemetrexed Genthon 25 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains 25 mg pemetrexed (as pemetrexed diarginine) One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diarginine). One vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diarginine). One vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diarginine). For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless to slightly yellow to brown, brown yellow or green yellow solution. The pH of the concentrate is between 8.3 and 9.0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed Genthon in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Genthon 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 Genthon 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 Genthon 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 Genthon must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. Pemetrexed Gent Baca dokumen lengkapnya