Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
PANCREAS POWDER
Abbott Healthcare Products Ltd
400 Milligram
Capsule
2006-09-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Creon 40000 Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 400 mg pancreatin equivalent to: Lipase 40000 Ph.Eur. units Amylase 25000 Ph. Eur. units Protease 1600 Ph. Eur. units For excipients see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard Brown/clear size 00 hard gelatin capsule containing light brown, gastro-resistant granules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of pancreatic exocrine insufficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly) and children: Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack. Creon 40000 should only be used in patients in whom the minimum effective dose has already been determined using lower strength pancreatic enzyme products. Initially one or two capsules with meals. The capsules should be swallowed whole. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. It is important to ensure adequate hydration of patients at all times whilst dosing Creon 40000. Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see section 4.8). 4.3 CONTRAINDICATIONS Patients with known hypersensitivity to porcine proteins or to any of the excipients. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/07/2011_ _CRN 2103010_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The product is of porcine origin_._ Oral medications should not be administered during the early stages of acute pancreatitis. 4.5 INTERACTION WITH OTHER MEDICINAL Lue koko asiakirja