Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pemetrexed (pemetrexed disodium heptahydrate)
Lilly France S.A.S.
L01BA04
pemetrexed (pemetrexed disodium heptahydrate)
500mg
powder for concentrate for solution for infusion
glass vial
Prescription
Registered
2021-07-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ALIMTA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ALIMTA 500 MG POWDER FOR 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 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 ALIMTA is and what it is used for 2. What you need to know before you use ALIMTA 3. How to use ALIMTA 4. Possible side effects 5. How to store ALIMTA 6. Contents of the pack and other information 1. WHAT ALIMTA IS AND WHAT IT IS USED FOR ALIMTA contains pemetrexed as an active substance. Pharmacotherapeutic group: Folic acid analogues, ATC code: L01BA04. ALIMTA is a medicine used in the treatment of cancer. ALIMTA 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. ALIMTA is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Alimta 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. ALIMTA 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 ALIMTA 2.1 DO NOT USE ALIMTA - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of of this medicine (listed in section 6). - if you are breast-feeding; you must discontinue breast-feeding during treatment with ALIMTA. - if you have recently received or are a Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ALIMTA 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium). _Excipients with known effect _ Each vial contains approximately 11 mg sodium. ALIMTA 500 mg powder for concentrate for solution for infusion 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 ALIMTA in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer ALIMTA 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). ALIMTA 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). ALIMTA 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). 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ALIMTA must only be administered under the supervision of a physician qualified Les hele dokumentet