Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PEMETREXED DINATRIUM 2,5-WATER 604,1 mg/flacon SAMENSTELLING overeenkomend met ; PEMETREXED 500 mg/flacon
Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)
L01BA04
PEMETREXED DINATRIUM 2,5-WATER 604,1 mg/flacon SAMENSTELLING overeenkomend met ; PEMETREXED 500 mg/flacon
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);
2015-12-14
PEMETREXED_100 mg_500 mg_1000 mg_powder for concentrate for solution for infusion_EN_NL-H-3329-001-003_EPAR 11/2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pemetrexed Zentiva 100 mg poeder voor concentraat voor oplossing voor infusie Pemetrexed Zentiva 500 mg poeder voor concentraat voor oplossing voor infusie Pemetrexed Zentiva 1000 mg poeder voor concentraat voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100, 500 or 1,000 mg pemetrexed (as pemetrexed disodium hemipentahydrate). After reconstitution (see section 6.6), each vial contains 25 mg/ml pemetrexed. Excipients 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 1,000 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 Pemetrexed Zentiva in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. PEMETREXED_100 mg_500 mg_1000 mg_powder for concentrate for solution for infusion_EN_NL-H-3329-001-003_EPAR 11/2020 Non-small cell lung cancer Pemetrexed Zentiva 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 Zentiva 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 Zentiva is indicated as monotherapy for the second line treatment of patients with locally adva Läs hela dokumentet
PEMETREXED_100 mg_500 mg_1000 mg_powder for concentrate for solution for infusion_NL_NL-H-3329-001-003_06/2022 EPAR+QRD SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Pemetrexed Zentiva 100 mg poeder voor concentraat voor oplossing voor infusie Pemetrexed Zentiva 500 mg poeder voor concentraat voor oplossing voor infusie Pemetrexed Zentiva 1000 mg poeder voor concentraat voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100, 500 or 1,000 mg pemetrexed (as pemetrexed disodium hemipentahydrate). After reconstitution (see section 6.6), each vial contains 25 mg/ml pemetrexed. Excipients 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 1,000 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 Pemetrexed Zentiva in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Zentiva 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 Zentiva 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_100 mg_500 mg_1000 mg_powder for concentrate for solution for infusion_NL_NL-H-3329-001-003_06/2022 EPAR+QRD Pemetrexed Zentiva is indicated as monotherapy for the second line treatment of patients with locally Läs hela dokumentet