Land: Indonesien
Språk: indonesiska
Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LANSOPRAZOLE
TAKEDA INDONESIA - Indonesia
LANSOPRAZOLE
15 MG
TABLET
DUS, 2 BLISTER @ 14 TABLET
KOKANDO Co Ltd - Japan
2019-04-16
PROSOGAN ® FD TABLET LANSOPRAZOLE 15 and 30 mg 1 NAME OF THE MEDICINAL PRODUCT PROSOGAN ® FD Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 Prosogan FD Tablet 15 mg Each tablet contains 15 mg Lansoprazole. 2.2 Prosogan FD tablet 30 mg Each tablet contains 30 mg Lansoprazole. 3 PHARMACEUTICAL FORM 3.1 Prosogan FD tablet 15 mg are white to yellowish-white uncoated tablet speckled with red- orange to dark brown, with “15” debossed on one side of the tablet. 3.2 Prosogan FD tablet 30 mg are white to yellowish-white uncoated tablet speckled with red- orange to dark brown, with “30” debossed on one side of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Duodenal ulcer. - Benign gastric ulcer. - Reflux esophagitis. - Treatment of NSAID-associated gastric ulcer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage : - Duodenal ulcer : Prosogan FD tablet 30 mg once daily for 4 weeks. - Benign gastric ulcer : Prosogan FD tablet 30 mg once daily for 8 weeks. - Reflux esophagitis : Prosogan FD tablet 30 mg once daily for 4 weeks. - Treatment of NSAID-associated gastric ulcer : Prosogan FD tablet 30 mg once daily for 8 weeks. Administration : For oral administration Page 1 of 7 DISETUJUI OLEH BPOM : 22/03/2021 ID REG : EREG10023512000109 Prosogan FD tablet should be placed on the tongue and gently sucked. The tablet rapidly disperses in the mouth, releasing the gastro-resistant microgranules which are swallowed with the patient’s saliva. Alternatively, the tablet can be swallowed whole with a drink of water. The tablets should not be crushed or chewed. To achieve the optimal acid inhibitory effect, and hence most rapid healing and symptom relief, once daily should be administered in the morning before food. Alternatively, for other patients who have difficulty swallowing tablets, Prosogan FD tablet can be delivered in different way : Nasogastric tube administration For administration via a nasogastric tube, Prosogan FD tablet can be administered as follow : - Place a 15 mg tablet in a syringe a Läs hela dokumentet