CREON 10,000 pancreatic extract 150 mg capsules bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

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)

Dostupné z:

Viatris Pty Ltd

INN (Medzinárodný Name):

Pancreatic extract

Forma lieku:

Capsule, enteric

Zloženie:

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

Spôsob podávania:

Oral

Počet v balení:

100

Typ predpisu:

Not scheduled. Not considered by committee

Terapeutické indikácie:

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)

Prehľad produktov:

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

Stav Autorizácia:

Registered

Dátum Autorizácia:

2009-03-26

Príbalový leták

CREON
® 10,000, CREON
®
25,000, CREON
® 35,000,
CREON
® 40,000
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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

Súhrn charakteristických

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