FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy endpoint was the mean difference in the coefficient of fat absorption (CFA-72h) between Enzepi and placebo treatment.
Slovenian: Primarni opazovani dogodek učinkovitosti je bila povprečna razlika v koeficientu absorpcije maščob (CFA72h) med zdravilom Enzepi in placebom.
English: Median (minimum - maximum)
Slovenian: Povzetek statističnih podatkov Srednja vrednost (SD) Mediana (najmanj - največ)
English: If you stop taking Enzepi
Slovenian: Če ste prenehali jemati zdravilo Enzepi
English: Overall, an improvement was observed from baseline to study completion for growth indices including weight-for-age, length-for-age, and weight-for-length percentiles.
Slovenian: Na splošno je bilo od izhodišča do zaključka študije opaziti izboljšanje indeksov rasti, vključno s percentili telesne mase glede na starost, višine glede na starost in telesne mase glede na višino.
English: Potential for hyperuricaemia
Slovenian: Možnost hiperurikemije
English: If you forget to take Enzepi
Slovenian: Če ste pozabili vzeti zdravilo Enzepi
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).
Slovenian: Veliki odmerki encimov trebušne slinavke so bili povezani s hiperurikozurijo in hiperurikemijo, zato jih je treba uporabljati previdno pri bolnikih z anamnezo protina, okvare ledvic ali hiperurikemije (glejte poglavje 4.4).
English: The enzymes are taken from pig pancreas glands.
Slovenian: Encimi so pridobljeni iz žlez trebušne slinavke prašičev.
English: Gastro-resistant granules are thoroughly mixed with chyme when the capsule dissolves in the stomach, without inactivating the acid-sensitive enzymes.
Slovenian: Ko se kapsula raztopi v želodcu, se gastrorezistentna zrnca temeljito zmešajo s himusom, ne da bi prišlo do inaktivacije kislinsko občutljivih encimov.
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).
Slovenian: Nadomestno zdravljenje z encimi trebušne slinavke pri pomanjkljivem eksokrinem delovanju trebušne slinavke zaradi cistične fibroze ali drugih bolezni (npr. kronični pankreatitis, odstranitev trebušne slinavke ali rak trebušne slinavke).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Enzepi Vsebina pakiranja in dodatne informacije
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).
Slovenian: Razmisliti je treba o spremljanju glukoze v krvi pri bolnikih s tveganjem za nenormalne ravni glukoze v krvi, ker lahko nadomestno zdravljenje z encimi trebušne slinavke vpliva na uravnavanje glukoze v krvi (glejte poglavje 4.8).
English: Fibrosing colonopathy
Slovenian: Fibrozirajoča kolonopatija
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.
Slovenian: - Druge sestavine zdravila so: o vsebina kapsul: premrežen natrijev karmelozat, hidrogenirano ricinusovo olje, koloidni brezvodni silicijev dioksid, mikrokristalna celuloza, magnezijev stearat, hipromelozaftalat, smukec, trietilcitrat; o ovoj kapsul:
English: Talk to your doctor or pharmacist before taking Enzepi if you have ever had gout, kidney disease, or high uric acid levels in your blood (hyperuricaemia) or in urine (hyperuricosuria), if you have abnormal blood glucose levels.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Enzepi se posvetujte z zdravnikom ali farmacevtom: če ste kdaj imeli protin, bolezen ledvic ali visoke ravni sečne kisline v krvi (hiperurikemija) ali urinu (hiperurikozurija); če imate nenormalne ravni glukoze v krvi.
English: The most relevant class effects of the pancreatic enzyme products include fibrosing colonopathy, hyperuricaemia/ hyperuricosuria and anaphylactic reactions.
Slovenian: Najpomembnejši učinki skupine zdravil, ki vsebujejo encime trebušne slinavke, vključujejo fibrozirajočo kolonopatijo, hiperurikemijo/hiperurikozurijo in anafilaktične reakcije.
English: Thus, Enzepi demonstrated both non-inferiority and equivalence to the comparator in fat absorption control (measured as CFA-72h) in adolescents and adults with CF-associated EPI.
Slovenian: Zdravilo Enzepi je torej izkazalo neinferiornost in enakovrednost s primerjalnim zdravilom pri nadzoru absorpcije maščob (izmerjenim kot CFA-72h) pri mladostnikih in odraslih s pomanjkljivim eksokrinim delovanjem trebušne slinavke zaradi cistične fibroze.
English: Administration should be followed by breast-milk or formula to ensure complete ingestion.
Slovenian: Po zdravilu mora bolnik dobiti materino mleko ali mlečno formulo, da se zagotovi popolno zaužitje.
English: The pancreatic enzymes in Enzepi are gastro-resistant to minimise destruction or inactivation in gastric acid.
Slovenian: Encimi trebušne slinavke v zdravilu Enzepi so gastrorezistentni, kar je namenjeno zmanjšanju njihovega uničevanja ali inaktivacije v želodčni kislini.
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.
Slovenian: Pediatrični bolniki, stari 4 leta ali več, in odrasli (vključno s starejšimi bolniki) Za otroke, stare 4 leta ali več, mladostnike in odrasle je priporočeni začetni odmerek 500 enot lipaze/kg telesne mase na obrok.
English: Capsule content (gastro-resistant granules) Croscarmellose sodium Hydrogenated castor oil Colloidal anhydrous silica Microcrystalline cellulose Magnesium stearate
Slovenian: premrežen natrijev karmelozat hidrogenirano ricinusovo olje koloidni brezvodni silicijev dioksid mikrokristalna celuloza magnezijev stearat hipromelozaftalat smukec trietilcitrat
English: How to take Enzepi
Slovenian: Kako jemati zdravilo Enzepi
English: Allergan Norden AB Tlf: + 4580884560
Slovenian: Danmark Allergan Norden AB Tlf: + 4580884560
English: After first opening: 6 months when stored below 25°C.
Slovenian: Po prvem odprtju: 6 mesecev pri temperaturi do 25 °C.
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.
Slovenian: Pri dojenčkih, mlajših od 1 leta starosti, je priporočeni začetni odmerek 5.000 enot lipaze na 120 ml formule ali materinega mleka.
English: units protease:
Slovenian: proteaza:
English: Propylene glycol Indigotine (E132)
Slovenian: Črnilo šelak propilenglikol indigotin (E132)
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.
Slovenian: Nato encimi v dvanajstniku in proksimalnem tankem črevesu katalizirajo hidrolizo maščob v monogliceride, glicerol in proste maščobne kisline, beljakovin v peptide in aminokisline ter škroba v dekstrine in kratkoverižne sladkorje, kot sta maltoza in maltotrioza, pri čemer delujejo kot prebavni encimi, ki jih naravno izloča trebušna slinavka.
English: Study PR-011 was an open-label crossover study in 15 patients, ages 1 to 11 months, with EPI due to CF.
Slovenian: Študija PR-011 je bila odprta navzkrižna študija pri 15 bolnikih, starih od 1 do 11 mesecev, s pomanjkljivim eksokrinim delovanjem trebušne slinavke zaradi cistične fibroze.
English: The dose of Enzepi was adjusted during the 12month study as the patient's grew and gained weight.
Slovenian: Med 12-mesečno študijo so odmerek zdravila Enzepi prilagajali glede na rast in pridobivanje telesne mase bolnikov.
English: Tel: + 32 2 709 21 64 (Nederlands) Tél : + 32 2 709 21 58 (Français)
Slovenian: Tel: + 32 2 709 21 64 (Nederlands)
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.
Slovenian: Priporočeni začetni odmerek pri otrocih, starih od 1 do 4 let, je 1.000 enot lipaze/kg telesne mase ob vsakem obroku.
English: The most important serious side effects seen with other pancreatic enzyme replacement medicines are ‘anaphylactic shock' and fibrosing colonopathy.
Slovenian: Najpomembnejša resna neželena učinka, o katerih so poročali pri uporabi drugih zdravil z encimi trebušne slinavke, sta »anafilaktični šok« in fibrozirajoča kolonopatija.
English: Blood glucose decreased Blood glucose increased Weight decreased Weight increased
Slovenian: Preiskave znižanje ravni glukoze v krvi, zvišanje ravni glukoze v krvi, zmanjšanje telesne mase, povečanje telesne mase
English: Additionally for Enzepi 40,000 units gastro-resistant granules Indigotine (E132)
Slovenian: Dodatno pri zdravilu Enzepi 40.000 enot gastrorezistentna zrnca indigotin (E132)
English: If you have severe stomach pain, trouble passing stools (constipation), nausea or vomiting, tell your doctor straightaway.
Slovenian: Če imate hude bolečine v trebuhu, težko odvajate blato (zaprtost), vam je slabo ali bruhate, takoj obvestite svojega zdravnika.
English: not less than 270 units*
Slovenian: 270 enot*.
English: Nordmark Arzneimittel GmbH & Co. KG Pinnauallee 4
Slovenian: Nordmark Arzneimittel GmbH & Co.
English: Patients were transitioned to Enzepi from their usual PEP (pancreatic enzyme product) treatment.
Slovenian: Bolniki so prešli na zdravilo Enzepi z običajnega zdravljenja z encimi trebušne slinavke.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja*
English: *Symptoms of allergic reactions.
Slovenian: * simptomi alergijskih reakcij ** učinki skupine zdravil
English: Mouth irritation
Slovenian: Draženje ust
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).
Slovenian: Pri bolnikih s tveganjem za nenormalne ravni glukoze v krvi lahko nadomestno zdravljenje z encimi trebušne slinavke vpliva na uravnavanje glukoze v krvi (glejte poglavje 4.4).
English: What Enzepi contains - The active substance is pancreas powder of porcine origin.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Enzepi - Zdravilna učinkovina je uprašeni pankreas prašičjega izvora.
English: Frequency, type and severity of adverse reactions were similar in elderly people with pancreatic exocrine insufficiency as compared to adults.
Slovenian: Pri starejših ljudeh s pomanjkljivim eksokrinim delovanjem trebušne slinavke so bile pogostnost, vrsta in resnost neželenih učinkov podobne kot pri odraslih.
English: Caution must be exercised when prescribing Enzepi to patients with a history of gout, renal impairment, or hyperuricaemia.
Slovenian: Pri predpisovanju zdravila Enzepi bolnikom z anamnezo protina, okvare ledvic ali hiperurikemije je potrebna previdnost.
English: All patients consumed a high-fat diet (greater than or equal to 100 grams of fat per day) during the treatment period.
Slovenian: Med zdravljenjem so vsi bolniki uživali hrano z visoko vsebnostjo maščob (najmanj 100 gramov maščobe dnevno).
English: 20 gastro-resistant hard capsules 50 gastro-resistant hard capsules 100 gastro-resistant hard capsules 200 gastro-resistant hard capsules
Slovenian: 20 gastrorezistentnih trdih kapsul 50 gastrorezistentnih trdih kapsul 100 gastrorezistentnih trdih kapsul 200 gastrorezistentnih trdih kapsul
English: - proteolytic activity:
Slovenian: - proteolitična aktivnost:
English: How to store Enzepi
Slovenian: Shranjevanje zdravila Enzepi
English: Pancreatic enzymes are not absorbed from the gastrointestinal tract.
Slovenian: Encimi trebušne slinavke se ne absorbirajo iz prebavil.
English: The CFA-72h was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured.
Slovenian: Koeficient CFA-72h so pri obeh zdravljenjih določili z odvzemanjem vzorcev blata v obdobju 72 ur ter z merjenjem izločenih in zaužitih maščob.
English: Capsule shell Hypromellose Carrageenan (E407) Potassium chloride Titanium dioxide (E171) Carnauba wax Purified water
Slovenian: Ovoj kapsul hipromeloza karagenan (E407) kalijev klorid titanov dioksid (E171) karnauba vosek prečiščena voda
English: 28 days, followed by a cross-over to the alternate treatment for a second 28 day period.
Slovenian: V prvem obdobju zdravljenja so bolniki 28 dni prejemali zdravilo Enzepi ali primerjalno zdravilo, nato so prešli na nadomestno zdravilo za dodatno 28-dnevno obdobje.
English: Enzepi is supplied in plastic (HDPE) bottles with desiccant sachets, closed with a lined polypropylene childresistant closure and a peel-off sealing liner.
Slovenian: Zdravilo Enzepi je na voljo v plastenkah (HDPE), ki vsebujejo vrečice s sušilom, zaprtih z obloženo polipropilensko za otroke varno zaporko in odstranljivo tesnilno oblogo.
English: HDPE bottle containing desiccant sachets, closed with a lined polypropylene childresistant closure and a peel-off sealing liner.
Slovenian: Plastenka iz HDPE z vrečicami sušilnega sredstva, zaprta z obloženo polipropilensko za otroke varno zaporko in odstranljivo tesnilno oblogo.
English: 25,000 units*,
Slovenian: 25.000 enot*,
English: Additionally for Enzepi 10,000 units gastro-resistant granules Yellow iron oxide (E172)
Slovenian: Dodatno pri zdravilu Enzepi 10.000 enot gastrorezistentna zrnca rumeni železov oksid (E172)
English: 40,000 units*,
Slovenian: 40.000 enot*,
English: EUR 1009-M was an open-label, single arm study in 19 patients, ages 1 to 6 years, with EPI due to CF.
Slovenian: Študija EUR-1009-M je bila odprta študija z eno skupino pri 19 bolnikih, starih od 1 do 6 let, s pomanjkljivim eksokrinim delovanjem trebušne slinavke zaradi cistične fibroze.
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
Slovenian: Enzepi 5.000 enot gastrorezistentne trde kapsule Enzepi 10.000 enot gastrorezistentne trde kapsule Enzepi 25.000 enot gastrorezistentne trde kapsule Enzepi 40.000 enot gastrorezistentne trde kapsule
English: - amylolytic activity:
Slovenian: - amilolitična aktivnost:
English: However as pancreatic enzymes are not absorbed from the gastrointestinal tract, no systemic toxicity is expected following oral administration of pancreas powder.
Slovenian: Vendar po peroralnem jemanju uprašenega pankreasa ni pričakovati sistemske toksičnosti, ker se encimi trebušne slinavke ne absorbirajo iz prebavil.
English: Potential for irritation to oral mucosa
Slovenian: Možnost draženja ustne sluznice
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains: lipase:
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje: lipaza:
English: Data generated in the CF population with EPI can be extrapolated to the other causes of EPI such as chronic pancreatitis, post pancreatectomy or pancreatic cancer.
Slovenian: Podatki, pridobljeni pri populaciji s cistično fibrozo s pomanjkljivim eksokrinim delovanjem trebušne slinavke, se lahko upoštevajo tudi pri pomanjkljivem eksokrinem delovanju trebušne slinavke zaradi drugih vzrokov, kot so kronični pankreatitis, odstranitev trebušne slinavke ali rak trebušne slinavke.
English: not less than 130 units*
Slovenian: 130 enot*.
English: Hyperuricaemia/ hyperuricosuria** Decreased appetite
Slovenian: Presnovne in prehranske motnje hiperurikemija/hiperurikozurija**, zmanjšan tek
English: 5,000 units*,
Slovenian: 5.000 enot*,
English: not less than 270 Ph. Eur.
Slovenian: 270 enot po Ph. Eur..
English: 40,000 Ph. Eur.
Slovenian: 40.000 enot po Ph.
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.
Slovenian: Pri otrocih, starih od 1 do manj kot 4 let, je priporočeni začetni odmerek 1.000 enot lipaze/kg telesne mase na obrok.
English: 10,000 units*,
Slovenian: 10.000 enot*,
English: 25,000 Ph. Eur.
Slovenian: 25.000 enot po Ph.
English: Rarely, anaphylactic reactions have been reported with pancreatic enzyme products with different formulations of the same active ingredient (pancreas powder).
Slovenian: Pri uporabi zdravil z encimi trebušne slinavke v različnih formulacijah iste učinkovine (uprašenega pankreasa) so redko poročali o anafilaktičnih reakcijah.
English: units amylolytic activity:
Slovenian: amilolitična aktivnost:
English: not less than 3,200 units*
Slovenian: 3.200 enot*,
English: lipolytic activity:
Slovenian: lipolitična aktivnost:
English: It is only in the duodenum, which has a different environment with a pH value greater than 5, that these digestive enzymes are released from the granules.
Slovenian: Ti prebavni encimi se sprostijo iz granul šele v dvanajstniku, ki ima drugačno okolje in vrednost pH, višjo od 5.
English: units proteolytic activity:
Slovenian: proteolitična aktivnost:
English: Do not chew the capsules.
Slovenian: Kapsule je treba pogoltniti cele.
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.
Slovenian: Pri bolnikih s cistično fibrozo, ki so jemali velike odmerke zdravil s pankreatinom, so poročali o strikturah ileocekalnega predela in debelega črevesa (fibrozirajoča kolonopatija).
English: Do not eat or open the desiccant sachets.
Slovenian: Vrečic s sušilom ne smete pojesti ali odpreti.
English: INFORMATION IN BRAILLE Enzepi 25,000
Slovenian: PODATKI V BRAILLOVI PISAVI Enzepi 25.000
English: INFORMATION IN BRAILLE Enzepi 40,000
Slovenian: PODATKI V BRAILLOVI PISAVI Enzepi 40.000
English: not less than 650 units*
Slovenian: 650 enot*.
English: INFORMATION IN BRAILLE Enzepi 5,000
Slovenian: PODATKI V BRAILLOVI PISAVI Enzepi 5.000
English: Dispose of any accidentally crushed capsule.
Slovenian: Kapsule, ki so se po nesreči zdrobile, zavrzite.
English: not less than 3,200 Ph. Eur.
Slovenian: 3.200 enot po Ph.
English: not less than 7,800 units*
Slovenian: 7.800 enot*,
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.
Slovenian: Zaradi preprečitve draženja ustne sluznice je treba paziti, da se zdravilo Enzepi ne zdrobi ali žveči ali zadržuje v ustih.
English: Constipation Abdominal distension Flatulence
Slovenian: eritematozni izpuščaj, pruritus
English: not less than 7,800 Ph. Eur.
Slovenian: 7.800 enot po Ph.
English: Additionally for Enzepi 25,000 units gastro-resistant granules Yellow iron oxide (E172)
Slovenian: Dodatno pri zdravilu Enzepi 25.000 enot gastrorezistentna zrnca rumeni železov oksid (E172) indigotin (E132)
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:
Slovenian: Enzepi 25.000 enot gastrorezistentne trde kapsule Ena kapsula vsebuje 209,3 mg uprašenega pankreasa z naslednjimi stopnjami encimske aktivnosti: - lipolitična aktivnost:
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:
Slovenian: Enzepi 10.000 enot gastrorezistentne trde kapsule Ena kapsula vsebuje 83,7 mg uprašenega pankreasa z naslednjimi stopnjami encimske aktivnosti: - lipolitična aktivnost:
English: not less than 4,800 Ph. Eur.
Slovenian: 4.800 enot po Ph.
English: After first opening, the medicine may be stored for a maximum of 6 months below 25°C in its tightly closed container.
Slovenian: Po prvem odprtju plastenke lahko zdravilo hranite največ 6 mesecev pri temperaturi do 25 °C v trdno zaprtem vsebniku.
English: One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities:
Slovenian: Ena kapsula vsebuje 83,7 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti:
English: Enzepi 5,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water.
Slovenian: Enzepi 5000 enot: hipromeloza, karagenan (E407), kalijev klorid, titanov dioksid (E171), karnauba vosek, voda;
English: not less than 130 Ph. Eur.
Slovenian: 130 enot po Ph. Eur..
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.
Slovenian: Kapsule zdravila Enzepi ali zrnca iz njihove notranjosti se ne smejo drobiti ali žvečiti.
English: Keep the bottle tightly closed and the desiccant in the bottle in order to protect from moisture.
Slovenian: Plastenko shranjujte tesno zaprto in ne odstranite sušilnega sredstva za zagotovitev zaščite pred vlago.
English: Enzepi 40,000 units gastro-resitant hard capsules One capsule contains 334.9 mg of pancreas powder including the following enzymatic activites: - lipolytic activity:
Slovenian: Enzepi 40.000 enot gastrorezistentne trde kapsule Ena kapsula vsebuje 334,9 mg uprašenega pankreasa z naslednjimi stopnjami encimske aktivnosti: - lipolitična aktivnost:
English: Enzepi 10,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, yellow iron oxide (E172).
Slovenian: Enzepi 10.000 enot: hipromeloza, karagenan (E407), kalijev klorid, titanov dioksid (E171), karnauba vosek, voda, rumeni železov oksid (E172);
English: 5,000 Ph. Eur.
Slovenian: 5.000 enot po Ph.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - 25,000 unit strength
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA - Jakost 25.000 enot
English: One capsule contains 209.3 mg of pancreas powder of porcine origin including the following enzymatic activities:
Slovenian: Ena kapsula vsebuje 209,3 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti:
English: not less than 4,800 units*
Slovenian: 4.800 enot*,
English: INFORMATION IN BRAILLE Enzepi 10,000
Slovenian: PODATKI V BRAILLOVI PISAVI Enzepi 10.000
English: Enzepi 25,000 units gastro-resistant hard capsules
Slovenian: Enzepi 25.000 enot gastrorezistentne trde kapsule
English: Capsules should be swallowed whole and not chewed or crushed.
Slovenian: Ne smejo se žvečiti ali drobiti.
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost, splošno slabo počutje
English: 10,000 Ph. Eur.
Slovenian: 10.000 enot po Ph.
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.
Slovenian: Pri bolnikih s cistično fibrozo, ki so prejemali velike odmerke encimov trebušne slinavke, so poročali o redki bolezni z zoženjem črevesa, ki se imenuje fibrozirajoča kolonopatija.
English: Enzepi 5,000 units gastro-resistant hard capsules One capsule contains 39.8 mg of pancreas powder including the following enzymatic activities: - lipolytic activity:
Slovenian: Enzepi 5.000 enot gastrorezistentne trde kapsule Ena kapsula vsebuje 39,8 mg uprašenega pankreasa z naslednjimi stopnjami encimske aktivnosti: - lipolitična aktivnost:
English: not less than 1,600 Ph. Eur.
Slovenian: 1.600 enot po Ph.
English: One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic activities:
Slovenian: Ena kapsula vsebuje 334,9 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti:
English: not less than 650 Ph. Eur.
Slovenian: 650 enot po Ph. Eur..