FrancophonIA/ELRC3.0 huggingface dataset:
English: The enzymes are taken from pig pancreas glands.
Croatian: Enzimi se dobivaju iz svinjske gušterače.
English: For infants below 1 year of age, give Enzepi just before each feed of formula or breast-milk.
Croatian: Za dojenčad mlađu od 1 godine, dajte lijek Enzepi neposredno prije svakog hranjenja zamjenskim mlijekom ili majčinim mlijekom.
English: Do not store Enzepi that has been sprinkled on food.
Croatian: Nemojte skladištiti lijek Enzepi koji je posut po hrani.
English: Study PR-011
Croatian: Ispitivanje PR-011
English: Then, enzymes catalyze the hydrolysis of fats to monoglycerides, glycerol, and free fatty acids, protein into peptides and amino acids, and starch into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.
Croatian: Zatim, enzimi kataliziraju hidrolizu masnoća na monogliceride, glicerol i slobodne masne kiseline, bjelančevina na peptide i aminokiseline te škroba na dekstrin i kratkolančane šećere poput maltoze i maltotrioze u dvanaesniku te proksimalnom tankom crijevu, a time djeluju kao probavni enzimi koje fiziološki luči gušterača.
English: A rare bowel condition called ‘fibrosing colonopathy', where the intestine is narrowed, has been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes.
Croatian: Rijetka bolest crijeva koja se naziva "fibrozirajuća kolonopatija", u kojoj su crijeva sužena, prijavljena je u bolesnika s cističnom fibrozom koji uzimaju velike doze enzima gušterače.
English: Cystic fibrosis patients
Croatian: Bolesnici s cističnom fibrozom
English: How much Enzepi to take
Croatian: Koliko lijeka Enzepi uzeti
English: Care should be taken to ensure that no medicinal product is retained in the mouth.
Croatian: Potrebno je paziti da lijek ne ostane u ustima.
English: Children (over 4 years of age), adolescents and adults (including elderly) The recommended starting dose for children over 4 years of age, adolescents (12 to 18 years) and adults is 500 lipase units per kg of body weight per meal.
Croatian: Djeca (starija od 4 godine), adolescenti i odrasli (uključujući starije osobe) Preporučena početna doza u djece starije od 4 godine, adolescenata (12 do 18 godina) i odraslih je 500 jedinica lipaze po kg tjelesne težine po obroku.
English: The most important serious adverse reactions observed with pancreatic enzyme medicinal products are anaphylactic reactions (see section 4.4) and fibrosing colonopathy (see section 4.4).
Croatian: Najvažnije ozbiljne nuspojave zabilježene s lijekovima od enzima gušterače su anafilaktičke reakcije (vidjeti dio 4.4) i fibrozirajuća kolonopatija (vidjeti dio 4.4).
English: Study PR-018
Croatian: Ispitivanje PR-018
English: Common (may affect up to 1 in 10 people): abdominal discomfort or bloating flatulence/passing wind diarrhoea headache.
Croatian: Često (mogu se javiti u do 1 na 10 osoba): nelagoda u trbuhu ili nadutost vjetrovi proljev glavobolja.
English: Patients were randomized to receive Enzepi from an opened capsule mixed and administered with apple juice (in a syringe nurser) or apple sauce (using a spoon) for 10 days of treatment, followed by a cross-over to the alternate mode of administration for an additional 10 days.
Croatian: Bolesnici su bili randomizirani u skupine koje su primale Enzepi iz otvorene kapsule promiješane i primijenjene sa sokom od jabuke (oralnom štrcaljkom za hranjenje) ili pireom od jabuke (žlicom) tijekom 10 dana liječenja, nakon čega je uslijedio prelazak na drukčiji način primjene tijekom drugih 10 dana.
English: Do not eat or open the desiccant sachets.
Croatian: Nemojte jesti niti otvarati vrećice sa sredstvom za sušenje.
English: The most important serious side effects seen with other pancreatic enzyme replacement medicines are ‘anaphylactic shock' and fibrosing colonopathy.
Croatian: Najvažnije ozbiljne nuspojave zapažene s drugim lijekovima za nadomjesno liječenje enzimima gušterače su "anafilaktički šok" i fibrozirajuća kolonopatija.
English: The mixture must not be stored.
Croatian: Mješavina se ne smije čuvati za kasnije.
English: The primary efficacy endpoint was the mean difference in the coefficient of fat absorption (CFA-72h) between Enzepi and placebo treatment.
Croatian: Primarna mjera ishoda djelotvornosti bila je srednja vrijednost razlike u koeficijentu apsorpcije masnoće (CFA-72 h) između liječenja lijekom Enzepi i placebom.
English: High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricaemia, and should be used with caution in patients with a history of gout, renal impairment or hyperuricaemia (see section 4.4).
Croatian: Visoke doze lijekova od enzima gušterače vezane su uz hiperurikozuriju i hiperuricemiju i trebaju se koristiti uz oprez u bolesnika koji u anamnezi imaju giht, oštećenje funkcije bubrega ili hiperuricemiju (vidjeti dio 4.4).
English: Do not sprinkle the capsule contents directly into the formula or breast-milk.
Croatian: Nemojte posipati sadržaj kapsule izravno u zamjensko mlijeko ili majčino mlijeko.
English: Pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).
Croatian: Nadomjesno liječenje enzimima gušterače u egzokrinoj insuficijenciji gušterače zbog cistične fibroze ili ostalih stanja (npr. kronični pankreatitis, nakon pankreatektomije ili kod raka gušterače).
English: Study PR-011 was an open-label crossover study in 15 patients, ages 1 to 11 months, with EPI due to CF.
Croatian: Ispitivanje PR-011 bilo je otvoreno ispitivanje s križnom zamjenom skupina u 15 bolesnika u dobi od 1 do 11 mjeseci s EPI-jem uslijed CF-a.
English: Do not mix the Enzepi granules with water, milk, breast-milk, formula feeds, flavoured milk or hot food.
Croatian: Ne miješati Enzepi granule s vodom, mlijekom, majčinim mlijekom, zamjenskim mlijekom, aromatiziranim mlijekom ili vrućom hranom.
English: The most relevant class effects of the pancreatic enzyme products include fibrosing colonopathy, hyperuricaemia/ hyperuricosuria and anaphylactic reactions.
Croatian: Najrelevantniji učinci skupine lijekova od enzima gušterače uključuju fibrozirajuću kolonopatiju, hiperuricemiju/hiperurikozuriju i anafilaktičke reakcije.
English: Study PR-005
Croatian: Ispitivanje PR-005
English: This can result in early release of the enzymes in the oral cavity, irritation of the mucous membranes and may lead to loss of enzyme activity.
Croatian: To može rezultirati ranim otpuštanjem enzima u usnoj šupljini, nadraženošću sluznice i može dovesti do gubitka aktivnosti enzima.
English: However as pancreatic enzymes are not absorbed from the gastrointestinal tract, no systemic toxicity is expected following oral administration of pancreas powder.
Croatian: Međutim, budući da se enzimi gušterače ne apsorbiraju iz probavnog trakta, nakon peroralne primjene praška gušterače ne očekuje se sistemska toksičnost.
English: The maximum recommended total dose is 2,500 lipase units/kg of body weight per meal (or 10,000 lipase units/kg of body weight per day), or 4,000 lipase units/g fat ingested per day.
Croatian: Najveća preporučena ukupna doza je 2500 jedinica lipaze/kg tjelesne težine po obroku (ili 10 000 jedinica lipaze/kg tjelesne težine na dan), ili 4000 jedinica lipaze/g unesene masnoće na dan.
English: 25,000 Ph. Eur.
Croatian: 25 000 Ph.
English: Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and as a result in some cases colonic strictures (see sections 4.2 and 4.4).
Croatian: Kronično visoke doze lijekova od enzima gušterače bile su povezane s fibrozirajućom kolonopatijom i u nekim slučajevima s njoj posljedičnim suženjem kolona (vidjeti dijelove 4.2 i 4.4).
English: Fibrosing colonopathy
Croatian: Fibrozirajuća kolonopatija
English: How to take Enzepi
Croatian: Kako uzimati Enzepi
English: The CFA-72h was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured.
Croatian: CFA-72 h je bio utvrđen uzimanjem uzoraka stolice tijekom 72 sata tijekom oba liječenja, kada je mjereno i izlučivanje masnoće i unos masnoća.
English: If you have severe stomach pain, trouble passing stools (constipation), nausea or vomiting, tell your doctor straightaway.
Croatian: Ako imate jaku bol u trbuhu, poteškoće sa stolicom (zatvor), mučninu ili povraćanje, odmah obavijestite svog liječnika.
English: The capsules should be swallowed whole and take them with a drink of water or juice.
Croatian: Kapsule se trebaju progutati cijele s vodom ili sokom.
English: Adverse reactions associated with pancreas powder obtained from clinical studies, post-marketing surveillance and some additional class effects are tabulated below.
Croatian: Nuspojave vezane uz prašak gušterače zabilježene u kliničkim ispitivanjima, tijekom praćenja lijeka nakon stavljanja u promet i neki dodatni učinci skupine navedeni su u nastavku.
English: Gastro-resistant hard capsule.
Croatian: Želučanootporna tvrda kapsula.
English: o Printing ink: shellac, propylene glycol, indigotine (E132).
Croatian: o Tinta za označivanje: šelak, propilenglikol, indigotin (E132).
English: Care should be taken to ensure that Enzepi is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.
Croatian: Potrebno je paziti da se Enzepi ne drobi ili žvače ili zadržava u ustima, kako bi se spriječila nadraženost sluznice usta.
English: 10,000 Ph. Eur.
Croatian: 10 000 Ph.
English: Enzepi capsules or the granules inside them should not be crushed or chewed and the capsules or the granules inside them should not be held in your or your child's mouth.
Croatian: Kapsule Enzepi ili granule u njima ne smiju se drobiti niti žvakati; kapsule ili granule u njima ne smijete držati u ustima, niti ih Vaše dijete smije držati u ustima.
English: - The other ingredients are: o Capsule content: croscarmellose sodium, hydrogenated castor oil, colloidal anhydrous silica, cellulose microcrystalline, magnesium stearate, hypromellose phthalate, talc, triethyl citrate.
Croatian: - Drugi sastojci su: o Sadržaj kapsule: umrežena karmelozanatrij, hidrogenizirano ricinusovo ulje, bezvodni koloidni silicijev dioksid, mikrokristalična celuloza, magnezijev stearat, hipromelozaftalat, talk, trietilcitrat.
English: How to store Enzepi
Croatian: Kako čuvati Enzepi
English: The recommended starting dose for children between 1 and 4 years of age is 1,000 lipase units per kg of body weight with each meal.
Croatian: Preporučena početna doza u djece između 1 i 4 godine je 1000 jedinica lipaze po kg tjelesne težine uz svaki obrok.
English: Pancreatic enzymes are not absorbed from the gastrointestinal tract.
Croatian: Enzimi gušterače ne apsorbiraju se iz probavnog trakta.
English: Paediatric population aged 4 years or older and adults (including elderly) For children aged 4 years or older, adolescents and adults the recommended starting dose is 500 lipase units/kg of body weight per meal.
Croatian: Pedijatrijska populacija u dobi od 4 ili više godina i odrasli (uključujući starije osobe) Za djecu u dobi od 4 godine ili više, adolescente i odrasle preporučena početna doza je 500 jedinica lipaze/kg tjelesne težine po obroku.
English: Allergan Norden AB Tlf: + 4580884560
Croatian: Danmark Allergan Norden AB Tlf: + 4580884560
English: It is not known if Enzepi passes into your breast-milk.
Croatian: Nije poznato izlučuje li se Enzepi u majčino mlijeko.
English: What Enzepi contains - The active substance is pancreas powder of porcine origin.
Croatian: Sadržaj pakiranja i druge informacije Što Enzepi sadrži - Djelatna tvar je prašak gušterače svinjskog podrijetla.
English: not less than 650 units*
Croatian: ne manje od 650 jedinica*
English: not less than 3,200 Ph. Eur.
Croatian: ne manje od 3200 Ph.
English: The recommended starting dose for infants below 1 year of age is 5,000 lipase units per 120 ml of formula milk or breast-milk.
Croatian: Preporučena početna doza u dojenčadi mlađe od 1 godine je 5000 jedinica lipaze po 120 ml zamjenskog mlijeka ili majčinog mlijeka.
English: If you notice any of the following seek urgent medical attention straightaway: itching, hives or rash swollen eyes, lips, hands or feet feeling lightheaded or faint trouble breathing or swallowing dizziness, collapse or unconsciousness.
Croatian: svrbež, koprivnjača ili osip oticanje očiju, usana, šaka ili stopala osjećaj ošamućenosti ili nesvjestica poteškoće s disanjem ili gutanjem omaglica, kolaps ili gubitak svijesti.
English: not less than 130 Ph. Eur.
Croatian: ne manje od 130 Ph.
English: not less than 410 units*
Croatian: ne manje od 410 jedinica*
English: not less than 270 units*
Croatian: ne manje od 270 jedinica*.
English: Enzepi is supplied in plastic (HDPE) bottles with desiccant sachets, closed with a lined polypropylene childresistant closure and a peel-off sealing liner.
Croatian: Enzepi je dostupan u plastičnim (HDPE) bocama s vrećicama sredstva za sušenje, zatvorenima polipropilenskim zatvaračem sigurnim za djecu i odvojivom pokrovnom folijom.
English: Hyperuricaemia/ hyperuricosuria** Decreased appetite
Croatian: Poremećaji metabolizma i prehrane hiperuricemija/hiperurikozurija** smanjeni apetit
English: Consideration should be given to blood glucose monitoring in patients at risk of abnormal blood glucose levels as glycaemic control may be affected by administration of pancreatic enzyme replacement therapy (see section 4.8).
Croatian: Potrebno je uzeti u obzir praćenje glukoze u krvi u bolesnika s rizikom od abnormalnih razina glukoze u krvi jer primjena nadomjesne terapije enzimima gušterače može utjecati na regulaciju glikemije (vidjeti dio 4.8).
English: not less than 130 units*
Croatian: ne manje od 130 jedinica*
English: Caution must be exercised when prescribing Enzepi to patients with a history of gout, renal impairment, or hyperuricaemia.
Croatian: Potreban je oprez prilikom propisivanja lijeka Enzepi u bolesnika koji u anamnezi imaju giht, oštećenje funkcije bubrega ili hiperuricemiju.
English: Paediatric population between 1 and less than 4 years of age For children between 1 and less than 4 years of age the recommended starting dose is 1,000 lipase units/kg of body weight per meal.
Croatian: Pedijatrijska populacija između 1 i manje od 4 godine Za djecu između 1 i manje od 4 godine preporučena početna doza je 1000 jedinica lipaze/kg tjelesne težine po obroku.
English: In patients at risk of abnormal blood glucose levels glycaemic control may be affected by administration of pancreatic enzyme replacement therapy (see section 4.4).
Croatian: U bolesnika s rizikom od abnormalnih razina glukoze u krvi, na regulaciju glikemije može utjecati primjena nadomjesne terapije enzimima gušterače (vidjeti dio 4.4).
English: not less than 410 Ph. Eur.
Croatian: ne manje od 410 Ph.
English: EUR 1009-M was an open-label, single arm study in 19 patients, ages 1 to 6 years, with EPI due to CF.
Croatian: Ispitivanje EUR 1009-M bilo je otvoreno ispitivanje s jednom skupinom bolesnika od 19 bolesnika u dobi od 1 do 6 godina s EPI-jem uslijed CF-a.
English: not less than 650 Ph. Eur.
Croatian: ne manje od 650 Ph.
English: Nordmark Arzneimittel GmbH & Co. KG Pinnauallee 4
Croatian: Nordmark Arzneimittel GmbH & Co.
English: These include lipases for digesting fat, proteases for digesting protein and amylases for digestions carbohydrates.
Croatian: Oni uključuju lipaze za probavu masnoća, proteaze za probavu bjelančevina i amilaze za probavu ugljikohidrata.
English: The pancreatic enzymes in Enzepi are gastro-resistant to minimise destruction or inactivation in gastric acid.
Croatian: Enzimi gušterače u lijeku Enzepi su želučanootporni kako bi se smanjila njihova razgradnja ili inaktivacija želučanom kiselinom.
English: not less than 3,200 units*
Croatian: ne manje od 3200 jedinica*
English: not less than 270 Ph. Eur.
Croatian: ne manje od 270 Ph.
English: HDPE bottle containing desiccant sachets, closed with a lined polypropylene childresistant closure and a peel-off sealing liner.
Croatian: Boca od polietilena visoke gustoće (HDPE) koja sadrži vrećice sa sredstvom za sušenje, zatvorena polipropilenskim zatvaračem sigurnim za djecu i odvojivom pokrovnom folijom.
English: It is unknown whether this medicinal product is excreted in human milk.
Croatian: Nije poznato izlučuje li se lijek u majčino mlijeko.
English: Additionally for Enzepi 40,000 units gastro-resistant granules Indigotine (E132)
Croatian: Dodatno za Enzepi 40 000 jedinica želučanootporne granule indigotin (E132)
English: not less than 7,800 Ph. Eur.
Croatian: ne manje od 7800 Ph.
English: Mouth irritation
Croatian: Nadražena usta
English: Enzepi 5,000 units gastro-resistant hard capsules Enzepi 10,000 units gastro-resistant hard capsules Enzepi 25,000 units gastro-resistant hard capsules Enzepi 40,000 units gastro-resistant hard capsules
Croatian: Enzepi 5000 jedinica želučanootporne tvrde kapsule Enzepi 10 000 jedinica želučanootporne tvrde kapsule Enzepi 25 000 jedinica želučanootporne tvrde kapsule Enzepi 40 000 jedinica želučanootporne tvrde kapsule gušterača, prašak
English: - proteolytic activity:
Croatian: - proteolitička aktivnost:
English: units
Croatian: Eur. jedinica
English: Administration should be followed by breast-milk or formula to ensure complete ingestion.
Croatian: Nakon primjene granula treba slijediti davanje majčinog mlijeka ili zamjenskog mlijeka kako bi se osiguralo potpuno gutanje.
English: No preclinical investigations were carried out with Enzepi.
Croatian: Nisu provedene nekliničke pretrage s lijekom Enzepi.
English: Capsule content (gastro-resistant granules) Croscarmellose sodium Hydrogenated castor oil Colloidal anhydrous silica Microcrystalline cellulose Magnesium stearate
Croatian: Sadržaj kapsule (želučanootporne granule) karmelozanatrij, umrežena ricinusovo ulje, hidrogenizirano silicijev dioksid, koloidni, bezvodni celuloza, mikrokristalična magnezijev stearat hipromelozaftalat talk trietilcitrat
English: Additionally for Enzepi 10,000 units gastro-resistant granules Yellow iron oxide (E172)
Croatian: Dodatno za Enzepi 10 000 jedinica želučanootporne granule željezov oksid, žuti (E172)
English: 25,000 units*
Croatian: 25 000 jedinica*
English: 20 gastro-resistant hard capsules 50 gastro-resistant hard capsules 100 gastro-resistant hard capsules 200 gastro-resistant hard capsules
Croatian: 20 želučanootpornih tvrdih kapsula 50 želučanootpornih tvrdih kapsula 100 želučanootpornih tvrdih kapsula 200 želučanootpornih tvrdih kapsula
English: 25,000 units*,
Croatian: 25 000 jedinica*,
English: After first opening, the medicine may be stored for a maximum of 6 months below 25°C in its tightly closed container.
Croatian: Nakon prvog otvaranja, lijek se može čuvati najviše 6 mjeseci na temperaturi ispod 25 °C u čvrsto zatvorenom spremniku.
English: not less than 7,800 units*
Croatian: ne manje od 7800 jedinica*
English: 28 days, followed by a cross-over to the alternate treatment for a second 28 day period.
Croatian: Tijekom prvog razdoblja liječenja, bolesnici su dobili Enzepi ili usporedni lijek tijekom 28 dana, nakon čega je uslijedio prelazak na drukčije liječenje tijekom drugih 28 dana.
English: Keep the bottle tightly closed and the desiccant in the bottle in order to protect from moisture.
Croatian: Bocu čuvati čvrsto zatvorenu, sa sredstvom za sušenje u boci radi zaštite od vlage.
English: not less than 4,800 units*
Croatian: ne manje od 4800 jedinica*
English: 40,000 units*
Croatian: 40 000 jedinica*
English: 40,000 units*,
Croatian: 40 000 jedinica*,
English: lipolytic activity:
Croatian: lipolitička aktivnost:
English: 5,000 units*,
Croatian: 5000 jedinica*,
English: Capsule shell Hypromellose Carrageenan (E407) Potassium chloride Titanium dioxide (E171) Carnauba wax Purified water
Croatian: Ovojnica kapsule hipromeloza karagenan (E407) kalijev klorid titanijev dioksid (E171) karnauba vosak pročišćena voda.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja*
English: not less than 1,600 Ph. Eur.
Croatian: ne manje od 1600 Ph.
English: * Ph. Eur.
Croatian: * Ph. Eur. jedinica
English: not less than 1,600 units*
Croatian: ne manje od 1600 jedinica*
English: Look into your child's mouth to make sure that all the medicine has been swallowed.
Croatian: Provjerite da u ustima Vašeg djeteta nije ostalo neprogutanog lijeka.
English: 10,000 units*
Croatian: 10 000 jedinica*
English: - amylolytic activity:
Croatian: - amilolitička aktivnost:
English: 5,000 units*
Croatian: 5000 jedinica*
English: 10,000 units*,
Croatian: 10 000 jedinica*,
English: units amylolytic activity:
Croatian: Eur. jedinica amilolitička aktivnost:
English: Propylene glycol Indigotine (E132)
Croatian: Tinta za označivanje šelak propilenglikol indigotin (E132) 6.2 Inkompatibilnosti
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains: lipase:
Croatian: TVARI Jedna kapsula sadrži: lipazu:
English: Potential for irritation to oral mucosa
Croatian: Mogućnost nadraženosti sluznice usta
English: Additionally for Enzepi 25,000 units gastro-resistant granules Yellow iron oxide (E172)
Croatian: Dodatno za Enzepi 25 000 jedinica želučanootporne granule željezov oksid, žuti (E172) indigotin (E132)
English: units proteolytic activity:
Croatian: Eur. jedinica proteolitička aktivnost:
English: INFORMATION IN BRAILLE Enzepi 40,000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Enzepi 40 000
English: INFORMATION IN BRAILLE Enzepi 25,000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Enzepi 25 000
English: Hard capsule with a green opaque cap and a white opaque body, printed with “Enzepi 25” and containing light-brown gastro-resistant granules.
Croatian: Tvrda kapsula sa zelenom neprozirnom kapicom i bijelim neprozirnim tijelom, s otisnutim "Enzepi 25", koja sadrži svijetlosmeđe želučanootporne granule.
English: Anaphylactic reaction** Drug hypersensitivity/ Hypersensitivity
Croatian: preosjetljivost na lijek/ preosjetljivost
English: Enzepi 25,000 units gastro-resistant hard capsules
Croatian: Enzepi 25 000 jedinica želučanootporne tvrde kapsule
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING BOTTLE LABEL - 5,000 unit strength
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE - Jačina 5000 jedinica
English: Enzepi 10,000 units gastro-resistant hard capsules One capsule contains 83.7 mg of pancreas powder including the following enzymatic activites: - lipolytic activity:
Croatian: Enzepi 10 000 jedinica želučanootporne tvrde kapsule Jedna kapsula sadrži 83,7 mg praška gušterače uključujući sljedeće enzimske aktivnosti: - lipolitička aktivnost:
English: Enzepi 25,000 units gastro-resistant hard capsules One capsule contains 209.3 mg of pancreas powder including the following enzymatic activites: - lipolytic activity:
Croatian: Enzepi 25 000 jedinica želučanootporne tvrde kapsule Jedna kapsula sadrži 209,3 mg praška gušterače uključujući sljedeće enzimske aktivnosti: - lipolitička aktivnost:
English: These actions can disrupt the protective gastro-resistant coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity (see section 4.2).
Croatian: Enzepi se ne smije drobiti, žvakati niti miješati s hranom čiji je pH veći od 5. Time bi se mogla narušiti zaštitna želučanootporna ovojnica što rezultira ranim otpuštanjem enzima, nadraženošću sluznice usta i/ili gubitkom aktivnosti enzima (vidjeti dio 4.2).
English: Tel: +48 22 256 3700
Croatian: Allergan Sp. z o.o. Tel: +48 22 256 3700
English: Тел.
Croatian: Tel.:
English: Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations.
Croatian: U bolesnika s cističnom fibrozom koji uzimaju velike doze pripravaka pankreatina prijavljena su suženja ileocekuma i debelog crijeva (fibrozirajuća kolonopatija).
English: One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities:
Croatian: Jedna kapsula sadrži 39,8 mg praška gušterače svinjskog podrijetla uključujući sljedeće enzimske aktivnosti: