Nchi: Armenia
Lugha: Kiingereza
Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
multienzymes (lipase, amylase, protease)
Laboratoires Mayoly Spindler
A09AA02 օրիգինալ դեղ
multienzymes (lipase, amylase, protease)
25000U+22500U+1250U (20) glass bottle, (50) glass bottle, (100) glass bottle
capsules hard
25000U+22500U+1250U (20) glass bottle, (50) glass bottle, (100) glass bottle
OTC
Registered
2015-07-03
ii;::l iij tr:v1lc. a.g,.&g_ ' SUMMARY OF PRODUCT CHARACTERISTICS 1) NAME OF TIIE MEDICINAL PRODUCT EUROBIOL 25 00q U, gastro-resistant capsule, hard. l; i 2) QUALTTATIyE AND QUANTTTATTVE COMPOSTTTON Porcine pancfeas p{wder* ...............2j4.050 - 32t9.875 mg ij:l i t j: For one capsule. ,l *Qraritity conesbon4irig to an en4ymatic activity of Lipolytic activity .......i............. ....... 25 000 Ph. Eur. U Arnylolytic 4ctivity ............ 22 50A Ph. Eur. U Proteolytio For a full list of excipients, see section 6.1. 3) PHARMACEUTICAL FORM Gastro-resistant capsule, hard. i 4) CLINTCAI,PARTTCULARS 4.1. Therapeutic indications Treatment of exocrine pancreatic insufficiency in adults and children during : - cystic fibrgsis; , - documentdd chrbniq pancreatitis (especially the presence ofpancreatic calcifications), in tire presence of steatorrhotia 2 6 gl24 h; - ceph4lic oitotal.pancreatic resections. 4.2. Posology and method of administration Posology 'Ihe optimal posology must be determined and modulated over time depending on diet ancl patient's digestive status, i.e. nurrber ofstools and steatorrhoea. The usual daify posology is: - infants un{it the age of I8 months: 2 capsules ch{ldren: 4 capqules adflts: 6 cppiules EUROBIOL !e ddruinistered in 2 or 3 daily doses, taken during meals. Page'J-14 4.4. Spqciaiyainjnsgland precautions for use Special;Warninqq Colonic strictures.have been observed in other counhies, in children with cystic fibrosis, during the use of high deiily doses of pancreatic enzyme replacement therapy, presented in ihe gastro-resistant form. In all cases,,idosep lyere at lpast 4 times higher than the doses usually recommended in France. il r ; r:ri Ensurb tliat stEatorrhoea is ) 6 g/24 h before prescribing EUROBIOL 25 000 U in patients with docurnented chronic pancreatitis. ll;,,:'l I. The rlsk of infectious disease due to transmission of infectious agents camot be totally excluded during adminishation of medicinal products containing animal pancreas powder extracts. These, pancreatic extract Soma hati kamili