Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Pancreatin 150mg (amylase 8,000 Ph Eur U, lipase 10,000 Ph Eur U, total protease 600 Ph Eur U.); Pancreatin 150mg equivalent to amylase 8,000 Ph Eur U, lipase 10,000 Ph Eur U, total protease 600 Ph Eur U.
Viatris Limited
Pancreatin 150 mg (amylase 8,000 Ph Eur U, lipase 10,000 Ph Eur U, total protease 600 Ph Eur U.)
150 mg
Modified release capsule
Active: Pancreatin 150mg (amylase 8,000 Ph Eur U, lipase 10,000 Ph Eur U, total protease 600 Ph Eur U.) Excipient: Acetone Dibutyl phthalate Dimeticone Gelatin Hypromellose phthalate Iron oxide black Iron oxide red Iron oxide yellow Liquid paraffin Macrogol 4000 Propyl alcohol Titanium dioxide Active: Pancreatin 150mg equivalent to amylase 8,000 Ph Eur U, lipase 10,000 Ph Eur U, total protease 600 Ph Eur U. Excipient: Cetyl alcohol Dimeticone Ferrosoferric oxide Gelatin Hypromellose phthalate Iron oxide red Iron oxide yellow Macrogol 4000 Sodium laurilsulfate Titanium dioxide Triethyl citrate
Bottle, plastic, HDPE bottle with tamper evident PP twist-off closure, 100 capsules
General sale
General sale
Abbott Laboratories GmbH
Creon is indicated for the treatment of pancreatic exocrine insufficiency (PEI) in paediatric and adult patients. Pancreatic exocrine insufficiency is often associated with, but not limited to: · 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, plastic, HDPE bottle with tamper evident PP twist-off closure - 100 capsules - 24 months from date of manufacture stored at or below 25°C 6 months opened stored at or below 25°C protect from moisture - Bottle, plastic, HDPE - 100 capsules - 24 months from date of manufacture stored at or below 25°C 6 months opened stored at or below 25°C protect from moisture
1998-08-03
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION _CREON_ _®_ _ 10,000, CREON_ _®_ _ 25,000,_ _PANCREATIN CAPSULES _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Creon. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. Please read this leaflet before you start taking Creon. If you are helping someone else to take Creon, please read this leaflet before you give the first dose. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Creon 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 IS USED FOR Creon is a pancreatic enzyme supplement 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 capsules contain digestive enzymes (amylase, lipase, protease) extracted from the pancreas of pigs. The supplementation of pancreatic enzymes using Creon helps restore the normal digestive action in your body to relieve abdominal symptoms and improve nutritional status. Creon 25,000 is available only with a doctor’s prescription. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is Przeczytaj cały dokument
Page 1 of 8 NEW ZEALAND DATA SHEET CREON ® 10,000, CREON ® 20,000 CREON ® 25,000, CREON ® 35,000 1. PRODUCT NAME Creon 10,000 capsules Creon 20,000 capsules Creon 25,000 capsules Creon 35,000 capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Creon 10,000 capsule contains brownish coloured, enteric-coated pellets containing 150 mg pancreatin (pancreas powder) equivalent to not less than 8,000 Ph.Eur. units amylase, 10,000 Ph.Eur. units lipase and 600 Ph.Eur. units protease. Each Creon 20,000 capsule contains brownish coloured, enteric-coated pellets containing 300 mg pancreatin (pancreas powder) equivalent to not less than 16,000 Ph.Eur. units amylase, 20,000 Ph.Eur. units lipase and 1,200 Ph.Eur. units protease. Each Creon 25,000 capsule contains brownish coloured, enteric-coated pellets containing 300 mg pancreatin (pancreas powder) equivalent to not less than 18,000 Ph.Eur. units amylase, 25,000 Ph.Eur. units lipase and 1,000 Ph.Eur. units protease. Each Creon 35,000 capsule contains brownish coloured, enteric-coated pellets containing 420 mg pancreatin (pancreas powder) equivalent to not less than 25,200 Ph.Eur. units amylase, 35,000 Ph.Eur. units lipase and 1,400 Ph.Eur. units protease. The pancreatin is produced from porcine pancreatic tissue. Excipients with known effect: gelatin and pancreatin. Allergen Declaration: sulfites and phenylalanine. 3. PHARMACEUTICAL FORM Creon 10,000 is a size 2 hard gelatin capsule with a brown opaque cap and a colourless transparent body, filled with minimicrospheres (gastro-resistant pellets). Creon 20,000 is a size 0 elongated hard gelatin capsule with a brown opaque cap and a colourless transparent body, filled with minimicrospheres (gastro-resistant pellets). Creon 25,000 is a size 0 elongated hard gelatin capsule with a Swedish orange opaque cap and a colourless transparent body, filled with minimicrospheres (gastro-resistant pellets). Creon 35,000 is a size 00 elongated hard gelatin capsule with a burnt-orange cap and a colourless transparent body, filled wi Przeczytaj cały dokument