Country: Նոր Զելանդիա
language: անգլերեն
source: Medsafe (Medicines Safety Authority)
Pancreatin 60.12mg (3,600 Ph. Eur. u/Amylase, 5,000 Ph. Eur. u/Lipase and 200 Ph. Eur. u/Protease)
Viatris Limited
Pancreatin 60.12 mg (3,600 Ph. Eur. u/Amylase, 5,000 Ph. Eur. u/Lipase and 200 Ph. Eur. u/Protease)
60.12 mg
Modified release granules
Active: Pancreatin 60.12mg (3,600 Ph. Eur. u/Amylase, 5,000 Ph. Eur. u/Lipase and 200 Ph. Eur. u/Protease) Excipient: Cetyl alcohol Dimeticone Hypromellose phthalate Macrogol 4000 Triethyl citrate
Bottle, glass, with LDPE stopper and dosing scoop, 20 g
General sale
General sale
Abbott Laboratories GmbH
For treatment of conditions associated with pancreatic exocrine insufficiency, such as: cystic fibrosis, chronic pancreatitis, post-pancreatectomy, post-gastrointestinal bypass surgery, e.g. Billroth II, gastroenterostomy; ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm).
Package - Contents - Shelf Life: Bottle, glass, with LDPE stopper and dosing scoop - 20 g - 36 months from date of manufacture stored at or below 25°C protect from moisture 3 months opened stored at or below 25°C protect from moisture
2011-03-15
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION CREON ® MICRO _PANCREATIN MODIFIED RELEASE GRANULES _ _ _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Creon Micro. This leaflet answers some common questions about Creon Micro. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Creon Micro against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CREON MICRO IS USED FOR Creon Micro is a pancreatic enzyme used to treat conditions associated with pancreatic exocrine insufficiency, such as: Cystic fibrosis Chronic pancreatitis Various upper gastrointestinal surgery People with pancreatic exocrine insufficiency often suffer with symptoms of: abdominal pain diarrhoea steatorrhoea (foul fatty stools which float in the toilet) bloating weight loss These symptoms appear because the body is unable to digest food normally. When this happens, your body's ability to absorb important nutrients from food is impaired and leads to malnutrition. If left untreated these symptoms can affect your quality of life and a poor nutritional status could have long term health implications. Creon Micro contains digestive enzymes (amylase, lipase and protease) extracted from pancreas of pigs. It works by restoring normal digestive action in your body to relieve abdominal symptoms and improve nutritional status. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN ADVISED FOR YOU. There is no evidence that Creon Micro granules are addictive. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU TAKE CREON read_full_document
Page 1 of 6 NEW ZEALAND DATA SHEET CREON ® MICRO 1. PRODUCT NAME Creon Micro, 60.12 mg, modified release granules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg of minimicrospheres (equivalent to one measuring spoonful) contains 60.12 mg of pancreatin, containing the following pancreatic enzymes: Lipase 5000 Ph.Eur. units, Amylase 3600 Ph.Eur. units and Protease 200 Ph.Eur. units. Pancreatin extract derived from porcine pancreas gland. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Creon Micro is a round, light brown minimicrospheres (gastro-resistant pellets). 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ For treatment of conditions associated with pancreatic exocrine insufficiency, such as: cystic fibrosis chronic pancreatitis post-pancreatectomy post-gastrointestinal bypass surgery (e.g. Billroth II, gastroenterostomy) ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm) _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ The posology aims at individual needs and depends on the severity of the disease and the composition of food. It is recommended to take the enzymes during or immediately after the meals. DOSE Creon Micro is a specific dosage form with a small minimicrosphere size in particular for use in infants and children unable to swallow capsules. Creon Micro allows improved individual dosing when low lipase doses are needed for adequate treatment of young children. _DOSING IN PAEDIATRIC AND ADULT PATIENTS WITH CYSTIC FIBROSIS _ Based upon a recommendation of the Cystic Fibrosis (CF) Consensus Conference, the US CF Foundation case-control study, and the UK case-control study, the following general dosage recommendation for pancreatic enzyme replacement therapy can be proposed: In infants dosing should be initiated at a dose of 2000 to 5000 lipase units for each feeding (usually 120 ml) and adjusted up to a dose no greater than 2500 lipase units per kilogram per feeding with a maximum daily dose of 10,000 lipase units read_full_document