Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
PANCREAS POWDER
BGP Products Ltd
A09AA02
PANCREAS POWDER
60.12 Milligram
Granules Gastro-Resistant
Oral use
20 g of gastro-resistant granules
Product subject to prescription which may be renewed (B)
Abbott Laboratories GmbH
Multienzymes (amylase, lipase, protease)
Enzyme preparations
For the treatment of pancreatic exocrine insufficiency
Authorised
2015-03-27
PACKAGE LEAFLET: INFORMATION FOR THE USER CREON FOR CHILDREN 5000 GASTRO-RESISTANT GRANULES Pancreatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Creon for Children is and what it is used for 2. Before you take Creon for Children 3. How to take Creon for Children 4. Possible side effects 5. How to store Creon for Children 6. Further information 1. WHAT CREON FOR CHILDREN IS AND WHAT IT IS USED FOR WHAT CREON FOR CHILDREN IS Creon for Children contains an enzyme mixture called “pancreatin”. Pancreatin helps you digest food. The enzymes are taken from pig pancreas glands. The small pellets of Creon for Children slowly release the pancreatin in your gut (gastro- resistant pellets, called Minimicrospheres™). Creon for Children is for children and infants who cannot swallow capsules. It is used when low doses of pancreatin are needed. WHAT CREON FOR CHILDREN IS USED FOR Creon for Children is intended for use in children and infants with “pancreatic exocrine insufficiency”. This is when their pancreas gland does not make enough enzymes to digest food. HOW CREON FOR CHILDREN WORKS The enzymes in Creon for Children work by digesting food as it passes through the gut. You should take Creon for Children during or immediately after a meal or a snack. This will allow the enzymes to mix thoroughly with the food. 2. BEFORE YOU TAKE CREON FOR CHILDREN DO NOT TAKE CREON FOR CHILDREN IF: you are allergic (hypersensitive) to pig pancreatin or to any of the other ingredients of Creon for Children (listed in section 6). If you are not sure, t Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Creon for Children 5000 Gastro-resistant Granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg of gastro-resistant granules (equivalent to one measuring spoonful) contains 60.12mg Pancreatin, containing the following pancreatic enzymes: Lipase 5,000 Ph. Eur. units Amylase 3,600 Ph. Eur. units Protease 200 Ph. Eur. units Produced from porcine pancreatic tissue. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro resistant granules Round, 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 Initially 100 mg (5000 lipase units) of gastro-resistant granules (one measure) should be taken with each feed or meal or immediately after. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The maximum daily dosage should not exceed 10,000 units lipase/kg/day. The required quantity of gastro-resistant granules should be dispensed using the measuring spoon contained in the pack which holds 100 mg. In young infants, Creon for Children 5000 granules should be mixed with a small amount of infant formula, expressed breast milk or fruit puree and given immediately from a spoon, directly before the feed. The granules should not be added to the baby’s bottle. In weaned infants, granules should be taken with acidic liquids or acidic soft foods but without chewing, directly before the meal. Suitable foodstuffs for use with the granules include apple sauce or yoghurt or fruit juice with a pH less than 5.5(e.g. apple, orange or pineapple juice. Alternatively, the granules can be mixed with a small amount of milk on a spoon and administered to the infant immediately. The granules should not be added to the baby’s bottle. It is important to ensure adequate hydration of patients at all times whilst dosing with Creon. The daily dose of pancreatic enzy Belgenin tamamını okuyun