Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
PANCREATIN
E. Merck Ltd
PANCREATIN
155 Milligram
Capsule
Product subject to prescription which may be renewed (B)
Withdrawn
2010-11-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nutrizym 10, 000 Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Pancreas Powder 154mg with not less than the following activities: Lipase 10,000 FIP Units, Protease 500 FIP Units and Amylase FIP 9,000 Units. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule. Hard gelatin capsule, with a yellow body and red cap, containing uniform white enteric coated pancreas powder minitablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of pancreatic exocrine insufficiency such as in fibrocystic disease of the pancreas and chronic pancreatitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Since the individual response to pancreatin supplements is variable, the number of capsules taken may need to be titrated to the individual according to symptoms at the discretion of the physician. Capsules should be swallowed whole with water. Where the swallowing is difficult, the capsule may be opened, the minitablets removed and swallowed with fluid or mixed with soft food which does not require chewing. In the latter case the food should be swallowed unchewed and it should be used straight away. The suggested starting dose is as follows: Adults (including elderly) and children: 1 - 2 capsules with meals Further dose increases, if required, should be added slowly with careful monitoring of response and symptomatology. If food is taken without Nutrizym 10000 inadvertently, the next meal should be taken with the capsules at the recommended dose. Colonic damage has been reported in children with cystic fibrosis taking in excess of 10,000 units of lipase per kg day. The daily dose of pancreatic enzymes for most patients should remain below 2500 un Прочитать полный документ