Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pancreatin (lipase 10000PhEU, amylase 8000 PhEU, protease 600 PhEU)
Abbott Laboratories GmbH
A09AA02 օրիգինալ դեղի առաջին դեղաձև, դեղաչափ և թողարկման ձև
pancreatin (lipase 10000PhEU, amylase 8000 PhEU, protease 600 PhEU)
150mg (20/2x10/) in blister, (20) in plastic container
capsules gastro-resistant
150mg (20/2x10/) in blister, (20) in plastic container
OTC
Registered
2020-11-19
SUMMARY OF PRODUCT CHARACTERISTICS Abbott Confidential Information 1/8 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 Confidential Information 2/8 This information is confidential 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 Pročitajte cijeli dokument