Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Pancreatic extract, Quantity: 150 mg (Equivalent: Amylase, Qty 8000 PH Eur unit; Equivalent: lipase, Qty 10000 PH Eur unit; Equivalent: protease, Qty 600 PH Eur unit)
Viatris Pty Ltd
Pancreatic extract
Capsule, enteric
Excipient Ingredients: iron oxide yellow; sodium lauryl sulfate; macrogol 4000; iron oxide black; triethyl citrate; titanium dioxide; cetyl alcohol; dimeticone 1000; Gelatin; iron oxide red; hypromellose phthalate
Oral
100
Not scheduled. Not considered by committee
Creon is indicated as pancreatic enzyme replacement in paediatric and adult patients with pancreatic exocrine insufficiency (PEI). Pancreatic exocrine insufficiency is often associated with, but not limited to: cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrointestinal bypass surgery (eg. Bilroth II gastroenterostomy), ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm)
Visual Identification: Dark Brown/colourless-transparent capsule containing brownish minimicrospheres; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2009-03-26
CREON ® 10,000, CREON ® 25,000, CREON ® 35,000, CREON ® 40,000 C R E O N 1 0 , 0 0 0 , 2 5 , 0 0 0 , 4 0 , 0 0 0 C A P S U L E S CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING CREON? CREON contains the active ingredient Pancreatic extract. CREON is used in a condition called pancreatic exocrine insufficiency where the body does not make enough enzymes to digest food. For more information, see Section 1. Why am I using CREON? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CREON? Do not use if you have ever had an allergic reaction to CREON or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use CREON? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CREON and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CREON? • Your doctor will tell you how many capsules to take to suit your particular needs. Do not increase the number of capsules yourself without informing your doctor. • Swallow the capsules whole with a full glass of water or, if you prefer, open the capsules and mix the granules with soft food. More instructions can be found in Section 4. How do I use CREON? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CREON? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using CREON. • Drink plenty of water every day when you are taking CREON. • Call your doctor straight away if you are still having problems with fatty stools or abdominal pain while you are taking CREON. THINGS YOU SHOULD NOT DO • Do not stop taking CREON unless told to do so by your doctor. • Do not us Læs hele dokumentet
AUSTRALIAN PRODUCT INFORMATION CREON ® 10,000, CREON ® 20,000, CREON ® 25,000, CREON ® 35,000, CREON ® 40,000 _pancreatic extract capsules _ _ _ 1 NAME OF THE MEDICINE Pancreatic extract 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CREON 10,000, 20,000, 25,000, 35,000 and 40,000 are porcine pancreatic enzyme preparations containing pancreatic extract encapsulated in minimicrospheres with a pH-sensitive coating. Each CREON 10,000 capsule contains pancreatic extract 150 mg equivalent to not less than 10,000 Ph.Eur. units lipase, 8,000 Ph.Eur. units amylase and 600 Ph.Eur. units protease. Each CREON 20,000 capsule contains pancreatic extract 300 mg equivalent to not less than 20,000 Ph.Eur. units lipase, 16,000 Ph.Eur. units amylase and 1,200 Ph.Eur. units protease. Each CREON 25,000 capsule contains pancreatic extract 300 mg equivalent to not less than 25,000 Ph.Eur. units lipase, 18,000 Ph.Eur. units amylase and 1,000 Ph.Eur. units protease. Each CREON 35,000 capsule contains pancreatic extract 420 mg equivalent to not less than 35,000 Ph.Eur. units lipase, 25,200 Ph.Eur. units amylase and 1,400 Ph.Eur. units protease. Each CREON 40,000 capsule contains pancreatic extract 400 mg equivalent to not less than 40,000 Ph.Eur. units lipase, 25,000 Ph.Eur. units amylase and 1,600 Ph.Eur. units protease. CREON 10,000 CREON 20,000 CREON 25,000 CREON 35,000 CREON 40,000 Lipase activity (Ph.Eur. units) 10,000 20,000 25,000 35,000 40,000 Amylase activity (Ph.Eur. units) 8,000 16,000 18,000 25,200 25,000 Protease activity (Ph.Eur. units) 600 1,200 1,000 1,400 1,600 Excipients with known effect: CREON contains traces of sulfites. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM CREON 10,000: Opaque dark brown/colourless-transparent capsule containing brownish minimicrospheres. CREON 20,000: Opaque brown/colourless-transparent capsule containing brownish minimicrospheres. CREON® - PRODUCT INFORMATION 2 CREON 25,000: Swedish orange/colourless-transparent capsule containing brownish mi Læs hele dokumentet