Creon 10,000

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

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.

Saatavilla:

Viatris Limited

INN (Kansainvälinen yleisnimi):

Pancreatin 150 mg (amylase 8,000 Ph Eur U, lipase 10,000 Ph Eur U, total protease 600 Ph Eur U.)

Annos:

150 mg

Lääkemuoto:

Modified release capsule

Koostumus:

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

Kpl paketissa:

Bottle, plastic, HDPE bottle with tamper evident PP twist-off closure, 100 capsules

luokka:

General sale

Prescription tyyppi:

General sale

Valmistaja:

Abbott Laboratories GmbH

Käyttöaiheet:

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).

Tuoteyhteenveto:

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

Valtuutus päivämäärä:

1998-08-03

Pakkausseloste

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

Valmisteyhteenveto

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