Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PEMETREXED DISODIUM 2.5 HYDRATE
Eucogen Pharma Sdn. Bhd.
PEMETREXED DISODIUM 2.5 HYDRATE
1 Vials
Korea United Pharm. Inc.
PEMIREX POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Pemetrexed 500 mg ROUTE OF ADMINISTRATION : For Intravenous use COMPOSITION Each vial contains Pemetrexed Disodium 2.5 hydrate ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥ 604.10 mg (as Pemetrexed 500 mg) Excipients with known effect : Each vial contains approximately 54 mg sodium. DESCRIPTION White to either light yellow or green-yellow, freeze-dried powder in a colorless vial. After reconstitution, the solution is clear and ranges in color from colorless to yellow or green-yellow without adversely affecting product quality. The pH of the reconstituted solution is between 6.6 and 7.8. INDICATIONS 1) Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. 2) Pemetrexed 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. 3) Pemetrexed 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. 4) Pemetrexed 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 DOSAGE AND ADMINISTRATION Pemetrexed must only be administered under the supervision of a physician qualified in the use of anti- cancer chemotherapy. 1. Combination use with cisplatin The recommended dose of Pemetrexed is 500 mg/m 2 BSA administered as the completion of the pemetrexed infusion on the first day of each 21-day cycle. The recommended dose of cisplatin is 75 mg/m 2 infused over 2 hours beginning approximately 30 minutes after the completion of pemetrexed infusion on the first day of each 21-day cycle. Patients Przeczytaj cały dokument