Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PEMETREXED DINATRIUM 2,5-WATER SAMENSTELLING overeenkomend met ; PEMETREXED
Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)
L01BA04
PEMETREXED DISODIUM 2,5-WATER COMPOSITION corresponding to ; PEMETREXED
Poeder voor concentraat voor oplossing voor infusie
MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; ZOUTZUUR (E 507),
Intraveneus gebruik
Pemetrexed
Hulpstoffen: MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941); ZOUTZUUR (E 507);
2016-02-10
Common Technical Document Pemetrexed lyophilized powder for concentrate for solution for infusion Page 1 of 9 1.3.1 Package leaflet - Core PACKAGE LEAFLET: INFORMATION FOR THE USER TRIXID 100 MG, POEDER VOOR CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE TRIXID 500 MG, POEDER VOOR CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE TRIXID 1000 MG, POEDER VOOR CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Trixid is and what it is used for 2. What you need to know before you use Trixid 3. How to use Trixid 4. Possible side effects 5. How to store Trixid 6. Contents of the pack and other information 1 WHAT TRIXID IS AND WHAT IT IS USED FOR Trixid is a medicine used in the treatment of cancer. Trixid 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. Trixid is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. Trixid 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. Trixid 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 TRIXID DO NOT USE TRIXID Common Technical Document Pemetrexed lyophilized powder for concentrate for solution for infusion Page 2 of 9 • if you are allergic to pemetrexed or any of the other ingred Leggi il documento completo
Common Technical Document Pemetrexed lyophilized powder for concentrate for solution for infusion Page 1 of 20 1.3.1. Summary of product characteristics - Core 1. NAME OF THE MEDICINAL PRODUCT Trixid 100 mg, poeder voor concentraat voor oplossing voor infusie Trixid 500 mg, poeder voor concentraat voor oplossing voor infusie Trixid 1000 mg, poeder voor concentraat voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100, 500 or 1000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate). After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed. Excipient with known effect Each 100 mg vial contains approximately 11 mg sodium (<1 mmol). Each 500 mg vial contains approximately 54 mg sodium (2.35 mmol). Each 1000 mg vial contains approximately 108 mg sodium (4.70 mmol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to light yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Trixid in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Trixid 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). Trixid 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). Trixid 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). Common Technical Document Pemetrexed lyophilized powder for concentrate Leggi il documento completo