Kraj: Armenia
Język: angielski
Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pancreatin (lipase, amylase, protease)
KRKA d.d.
A09AA02
pancreatin (lipase, amylase, protease)
20000U+ 12000U+ 900U
tablets gastro-resistant, coated
(10/1x10/) and (30/3x10/) in blister
OTC
Registered
2019-09-09
I 1.3.1 panzynorm forte N I SPC, Labeling and Package Leaflet AM JIHCToK-BKJIa,lJJ>IIII l1H, aMHJIa3bI 12000 E,ll; E Przeczytaj cały dokument, rrpOTea3bI 900 E,ll; E . _BcnoM02ameJlbHbZe_ _8eUjecm8a:_ JIaKT03a MOHOrH,IJ;paT, ueJIJIIOJI03a MHKPOKPHCTaJIJIHQeCKa5I, KpOCrrOBH.LJ:OH, KpeMHH5I .LJ:HOKCH.LJ: KOJIJIOH.LJ:HbIH 6e3BO,IJ;HbIH, MarH:IDI cTeapaT, rHrrpOMeJIJI03a, MeTaKpHJIOBOH KHCJIOThI H 3THJIaKpHJlaTa COIIOJIHMep (1: 1), TPH3TMJIUHTpaT, THTaHa ,nHOKCH,n (E 171), TaJIbK, CHMeTHKOH 3MYJIbCH.H, apoMaTH3aTop BaHHJIHH 54 286 C, apoMaTH3aTop 6epraMoT 54253 T, MaKporOJI 6000, KapMeJIJI03a HaTpH.H H rroJIHcop6aT 80. JIEKAPCTBEHHAH epMeHTHble rrperrapaTbI. Ko,n ATX A09AA02. $apMaKOHOrHqeCKHeCBO~CTBa I1aH3HHopM q,opTe 20 000 BOCCTaHaBJIHBaeT .LJ:eq,HUHT rraHKpeaTHQeCKHX cpepMeHToB, YBeJIHQHBaeT KaTa60JIHQeCKHH MeTa6oJIH3M H YJIYQIIIaeT KJIHHHQecKYIO KapTHHY MaJIb.LJ:Hrecnm. I1perrapaT IIOBblillaeT YCBoeHHe Bcex BH,IJ;OBIIH~H, YJIyrIIIIaeT rrHTaHHe 60JIbHOrO, rrpe,nyrrpe)l(.LJ:aeTHJIH YMeHbillaeT cTeaTopelO H CHMIITOMhI, 06YCJIOBJIeHHhle MaJIb.LJ:HreCTHeH. I1aHKpeaTHH cIIoco6cTByeT YMeHbIIIeHHIO 60JIH rrpH XpOHHQeCKOM rraHKpeaTHTe. SmPCPIL136620 2 30.07.2019 - U dated: 26.08.2019 1.3.1 Panzynorm forte N SPC, Labeling and Package Leaflet AM NOKA3AHLFH ,[.(NHNPLFMEHEHIFH He,llOCTaTOqHOCTbBHeillHeceKpeTopHoi1: CPYHKl.Ufl1rro,ll:>KeJIY,llOqHoi1: :>KeJIe3bI. CNOCO6 NPLFMEHEHIFH IF
1.3.l Panzynorm forte N SPC, Labeling and Package gastro-resistant tablets - - Leaflet 1. NAME OF THE MEDICINAL PRODUCT PanzynormO forte 20000 gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains pancreatin from porcine pancreas with enzymatic activity: 20 000 Ph. Eur. Units of lipase (Lipasum), 12 000 Ph. Eur. Units of amylase (Amylasum), 900 Ph. Eur. Units of protease (Proteasum) For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablets: white to slightly grey in colour, round, slightly biconvex. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Panzynorm forte 20000 is indicated in chronic exocrine pancreatic insufficiency. 4.2 Posology and method of administration Dosage should be individualized. Treatment should be initiated with low doses: one capsule three times daily, during the main meals. If the symptoms of pancreatic enzyme deficiency persist, the dosage may be gradually increased. One to two tablets during the main meals (three times daily) are usually sufficient. Ifnecessary, the patient may also take one tablet during snacks. The doses may also be higher, however, the patient should take the lowest dose necessary to eliminate the symptoms, which is particularly important in patients with cystic fibrosis. Smaller doses are usually sufficient in children. 4.3 Contraindications panzynorm forte 20000 is contraindicated in hypersensitivity to proteins of porcine origin or to any of the other ingredients of the drug. panzynorm forte 20000 should not be taken by patients with acute pancreatitis or acute attack of chronic pancreatitis. Panzynorm forte 20000 should not be taken by children with cystic fibrosis under 15 years of age. 4.4 Special warnings and special precautions for use The coating of the tablet prevents _the_ active pancreatic enzymes from damaging the oral mucous membrane and protects the enzymes from gastric juice. Patients should swallow the tablets whole, without chewing them. In rare patients with cystic fibro Przeczytaj cały dokument