Kreon 25000 capsules gastro-resistant

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

pancreatin (lipase 25000PhEU, amylase 18000 PhEU, protease 1000 PhEU)

Beschikbaar vanaf:

Abbott Laboratories GmbH

ATC-code:

A09AA02 օրիգինալ դեղ

INN (Algemene Internationale Benaming):

pancreatin (lipase 25000PhEU, amylase 18000 PhEU, protease 1000 PhEU)

Dosering:

300mg (20/2x10/), in blister and (20) in plastic container

farmaceutische vorm:

capsules gastro-resistant

Eenheden in pakket:

300mg (20/2x10/), in blister and (20) in plastic container

Prescription-type:

OTC

Autorisatie-status:

Registered

Autorisatie datum:

2015-11-18

Productkenmerken

Abbott
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Kreon 10000
Kreon 25000
Kreon 40000
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule Kreon 10000 contains
150 mg Pancreatin (Pancreas Powder) corresponding to
Amylase 8000 Ph.Eur. units
Lipase 10000 Ph.Eur. units
Protease 600 Ph.Eur. units
1 capsule Kreon 25000 contains
300 mg Pancreatin (Pancreas Powder) corresponding to
Amylase 18000 Ph.Eur. units
Lipase 25000 Ph.Eur. units
Protease 1000 Ph.Eur. units
1 capsule Kreon 40000 contains
400 mg Pancreatin (Pancreas Powder) corresponding to
Amylase 25000 Ph.Eur. units
Lipase 40000 Ph.Eur. units
Protease 1600 Ph.Eur. units
Produced from porcine pancreatic tissue
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
(Hard Gelatin Capsules filled with Gastro-Resistant Pellets (=
Minimicrospheres™))
_DBP / DBP free formulation_
Kreon® 10000 and 40000: Bicoloured capsule with brown opaque cap and
transparent body
Kreon® 25000: Bicoloured capsule with Swedish orange opaque cap and
transparent body
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Violations of exocrine pancreas, accompanied by indigestion. In cystic
fibrosis to compensate for the lack
of exocrine pancreatic function.
Abbott
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SUMMARY OF PRODUCT CHARACTERISTICS
COMPANY CORE DATA
SHEET
[PANCREATIC
ENZYMES]
4.2 POSOLOGY 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.
The capsules should be swallowed intact, without crushing or chewing,
with enough fluid during or after
each meal or snack.
When swallowing of capsules is difficult (e.g. small children or
elderly patients), the capsules may be
carefully opened and the minimicrospheres added to acidic soft food
[pH < 5.5] that does not require
chewing,