Kreon 10000 capsules gastro-resistant

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pancreatin (lipase 10000PhEU, amylase 8000 PhEU, protease 600 PhEU)

Available from:

Abbott Laboratories GmbH

ATC code:

A09AA02 օրիգինալ դեղի առաջին դեղաձև, դեղաչափ և թողարկման ձև

INN (International Name):

pancreatin (lipase 10000PhEU, amylase 8000 PhEU, protease 600 PhEU)

Dosage:

150mg (20/2x10/) in blister, (20) in plastic container

Pharmaceutical form:

capsules gastro-resistant

Units in package:

150mg (20/2x10/) in blister, (20) in plastic container

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-11-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
Abbott
Confidential Information
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This information is confidential
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 in Kreon Minimicrospheres
®
granules, gastro-
resistant 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 in Kreon Minimicrospheres
®
granules, gastro-
resistant 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 in Kreon Minimicrospheres
®
granules, gastro-
resistant 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 (Kreon
Minimicrospheres
®
))
_DBP / DBP free formulation _
Kreon
®
10000 and Kreon
®
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.
SUMMARY OF PRODUCT CHARACTERISTICS
Abbott
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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 c