Land: Indonesien
Språk: indonesiska
Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LANSOPRAZOLE
TAKEDA INDONESIA - Indonesia
LANSOPRAZOLE
30 MG
SERBUK INJEKSI
DUS, 1 VIAL @ 30 MG
TAKEDA INDONESIA - Indonesia
2016-10-31
PROSOGAN ® INJECTION LANSOPRAZOLE 30 MG 1 NAME OF THE MEDICINAL PRODUCT PROSOGAN ® INJECTION 30 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 EACH VIAL CONTAINS 30 MG OF LANSOPRAZOLE. 3 PHARMACEUTICAL FORM White to yellowish-white mass or powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Patients with the following diseases who are unable to take the oral formulations : Gastric ulcer, duodenal ulcer, acute stress ulcer, and acute gastric mucosal lesion (accompanied by bleeding). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Usually, for adults, PROSOGAN ® Injection 30 mg is mixed with isotonic sodium chloride solution or 5% glucose injection and administered by intravenous drip twice a day; alternatively, PROSOGAN ® Injection 30 mg is dissolved in 20 mL of isotonic sodium chloride solution or 5% glucose injection and administered slowly by intravenous injection twice a day. 1. As PROSOGAN ® Injection 30 mg was shown to have high hemostatic effect based on the data up to 3 days after starting treatment, once the patient is able to take medications orally, therapy should be switched to an oral formulation and this drug should not be administered aimlessly for a long period. 2. There is no clinical experience of treatment over 7 days in Japanese clinical trials. SPECIAL PATIENT POPULATIONS PROSOGAN ® Injection 30 mg should be administered with care in the following patients : 1. Patients with a history of drug hypersensitivity. 2. Patients with hepatic disorders. (A delay in the metabolism and excretion of PROSOGAN ® Injection 30 mg may occur). Intravenous dose reduction in patients with severe hepatic disease should be considered. These patients should be kept under regular supervision. 3. Elderly patients : since physiological function is generally decreased in elderly patients, PROSOGAN ® Injection 30 mg should be carefully administered. A daily dose of 30 mg should not be exceeded. Renal impairment patients do not require dosage adjustment. 4. Pediatric use : The safety of PROSOGAN ® Injection Läs hela dokumentet