Creon Micro

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Pancreatin 60.12mg (3,600 Ph. Eur. u/Amylase, 5,000 Ph. Eur. u/Lipase and 200 Ph. Eur. u/Protease)

Доступна с:

Viatris Limited

ИНН (Международная Имя):

Pancreatin 60.12 mg (3,600 Ph. Eur. u/Amylase, 5,000 Ph. Eur. u/Lipase and 200 Ph. Eur. u/Protease)

дозировка:

60.12 mg

Фармацевтическая форма:

Modified release granules

состав:

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

Штук в упаковке:

Bottle, glass, with LDPE stopper and dosing scoop, 20 g

класс:

General sale

Тип рецепта:

General sale

Производитель:

Abbott Laboratories GmbH

Терапевтические показания :

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).

Обзор продуктов:

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

Дата Авторизация:

2011-03-15

тонкая брошюра

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

Характеристики продукта

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