natgillin/translations-raw huggingface dataset:
As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 lipase units/kg/day. 
Kot previdnostni ukrep mora neobičajne trebušne simptome ali spremembe trebušnih simptomov oceniti zdravnik, da se izključi možnost fibrozirajoče kolonopatije, zlasti če bolnik jemlje več kot 10.000 enot lipaze/kg/dan.
What Enzepi is and what it is used for 
Kaj je zdravilo Enzepi in za kaj ga uporabljamo
Clinical studies of Enzepi did not include sufficient numbers of subjects aged 65 and over to determine whether they respond different from younger subjects. 
Klinične študije z zdravilom Enzepi niso vključevale dovolj preskušancev, starih 65 let in več, da bi bilo mogoče ugotoviti, ali se odzivajo drugače kot mlajši.
The dose is measured in ‘lipase units'. 
Odmerek se meri v »enotah lipaze«.
Abnormal blood glucose levels 
Nenormalne ravni glukoze v krvi
Paediatric population below 1 year of age 
Pediatrična populacija, mlajša od 1 leta
Cystic fibrosis patients 
Bolniki s cistično fibrozo
During the study, patients were instructed to consume 100 g (± 15 g) of fat per day and to maintain a consistent dietary fat intake for meals and snacks. 
V študiji so bolniki dobili navodila, naj uživajo 100 g (± 15 g) maščob dnevno ter ohranjajo dosleden vnos maščob z obroki in prigrizki.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The capsule should be carefully opened to empty the content (granules). 
Kapsulo je treba previdno odpreti in izprazniti vsebino (zrnca).
Your child should take all the food mixture and should then drink enough liquid straight after to wash down all the medicine. 
Otrok mora pojesti vso mešanico s hrano in takoj zatem popiti dovolj tekočine, da poplakne vso količino zdravila.
Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially `sodium-free´. 
Natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, torej je praktično »brez natrija«.
It is important to ensure adequate hydration of patients at all times whilst dosing Enzepi. 
Pomembno je zagotoviti zadostno hidracijo bolnikov v celotnem obdobju odmerjanja zdravila Enzepi.
The primary efficacy endpoint was the percentage of “responders”, defined as those patients without steatorrhoea (<30% faecal fat content) and without signs and symptoms of malabsorption after one and two weeks of treatment with Enzepi. 
Primarni opazovani dogodek učinkovitosti je bil odstotek »odzivnih bolnikov«, opredeljenih kot bolnikov brez steatoreje (< 30 % vsebnosti maščob v blatu) ter brez znakov in simptomov malabsorpcije po enem ali dveh tednih zdravljenja z zdravilom Enzepi.
If you take more Enzepi than you should If you take more Enzepi than you should drink plenty of water and talk to your doctor as soon as possible. 
Če ste vzeli večji odmerek zdravila Enzepi, kot bi smeli Če ste vzeli večji odmerek zdravila Enzepi, kot bi smeli, spijte veliko količino vode in se čim prej posvetujte z zdravnikom.
The granules may be administered with a small amount of appropriate acidic food or directly into the mouth. 
Bolniku lahko daste zrnca z majhno količino ustrezne kisle hrane ali neposredno v usta.
The contents of the capsule should not be mixed directly into formula or breast-milk as this may diminish efficacy. 
Vsebina kapsule se ne sme zmešati neposredno v mlečno formulo ali materino mleko, ker bi to lahko zmanjšalo učinkovitost.
Carefully open the capsule and empty the granules on a small amount of acidic food (see above). 
Previdno odprite kapsulo in stresite zrnca na majhno količino kisle hrane (glejte zgoraj).
Adare Pharmaceuticals Srl Via Martin Luther King 13 20060 Pessano Con Bornago ITALY 
Adare Pharmaceuticals Srl Via Martin Luther King 13 20060 Pessano Con Bornago ITALIJA
Fertility No human data on the effect of Enzepi on fertility are available. 
Plodnost Na voljo ni nobenih podatkov o učinku zdravila Enzepi na plodnost pri ljudeh.
units For the full list of excipients, see section 6.1. 
enota Za celoten seznam pomožnih snovi glejte poglavje 6.1.
In clinical trials, 110 children with CF (cystic fibrosis) aged 1 month and older received Enzepi at a dose that ensured stabilization of symptoms. 
V kliničnih preskušanjih je 110 otrok s cistično fibrozo, starih 1 mesec in starejših, prejemalo zdravilo Enzepi v odmerku, ki je zagotavljal stabilizacijo simptomov.
The number of responders (patients with less than 30% faecal fat content and without signs and symptoms of malabsorption) at baseline was 10/19 (52.6%), 13/19 (68.4%) after 1 week of treatment (stabilization) and 11/19 (57.9%) after the second week of open-label treatment with Enzepi. 
Število odzivnih bolnikov (bolniki z manj kot 30 % vsebnosti maščob v blatu ter brez znakov in simptomov malabsorpcije) je bilo ob izhodišču 10/19 (52,6 %), po 1 tednu zdravljenja (stabilizacija) 13/19 (68,4 %) in po drugem tednu odprtega zdravljenja z zdravilom Enzepi 11/19 (57,9 %).
Enzepi (N=83) 
Zdravilo Enzepi (N = 83)
The safety profile of Enzepi in the paediatric population was similar to that observed in adults. 
Varnostni profil zdravila Enzepi pri pediatrični populaciji je bil podoben kot pri odraslih.
Crushing, chewing, or mixing capsule contents with food or fluid with a pH greater than 5 or storing the food mixture (see below), can lead to a disruption of the protective gastro-resistant coating. 
Drobljenje, žvečenje ali mešanje vsebine kapsule s hrano ali tekočino z vrednostjo pH, višjo od 5, ali shranitev mešanice s hrano (glejte spodaj) lahko vpliva na zaščitno gastrorezistentno oblogo.
You and your doctor should decide if you will take Enzepi or breast-feed. 
Vi in vaš zdravnik se morata odločiti, ali boste jemali zdravilo Enzepi ali dojili.
As a risk to newborns/infants cannot be excluded, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Enzepi therapy taking into account the benefit of breast-feeding for the child and the benefit of continued Enzepi therapy for the breastfeeding woman. 
Ker tveganja za dojenega novorojenca/dojenčka ne moremo izključiti, se je treba odločiti med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Enzepi, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti nadaljevanja zdravljenja z zdravilom Enzepi za doječo mater.
Study EUR-1008-M 
Študija EUR-1008-M
The collection was performed in an approved, controlled environment that enabled supervised dietary intake and quantitative stool collection. 
Odvzem vzorcev je bil opravljen v odobrenem, nadzorovanem okolju, ki je omogočalo nadzorovan vnos s hrano in odvzem kvantitativnih vzorcev blata.
Infants (below 1 year of age) 
Dojenčki (mlajši od 1 leta)
Therefore, no reproductive or developmental toxicity is to be expected. 
Zato ni pričakovati škodljivih vplivov na sposobnost razmnoževanja ali razvoj.
Although, no preclinical investigations were carried out with Enzepi there is no evidence for any absorption of this medicinal product. 
Z zdravilom Enzepi sicer niso opravili nobenih predkliničnih raziskav, vendar ni dokazov o absorpciji tega zdravila.
The Enzepi soft food mixture should be swallowed immediately without chewing and followed with water or juice to ensure complete ingestion. 
Mešanico zdravila Enzepi z mehko hrano je treba takoj pogoltniti brez žvečenja in popiti vodo ali sok, da se zagotovi popolno zaužitje.
Maximum recommended dose 
Največji priporočeni odmerek
units 
enota
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. 
Če opazite katerega od naslednjih neželenih učinkov, nemudoma poiščite nujno zdravniško pomoč: srbenje, koprivnica ali izpuščaj; otečene oči, ustnice, dlani ali stopala; občutek vrtoglavice ali omedlevice; oteženo dihanje ali požiranje; omotica, kolaps ali izguba zavesti.
If you are breast-feeding or plan to breast-feed, or if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Če dojite ali nameravate dojiti, če ste noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Rarely, a more serious allergic reaction may include a feeling of warmth, dizziness and fainting, trouble breathing; these are symptoms of a severe, potentially life-threatening condition called ‘anaphylactic shock'. 
Redko lahko resnejša alergijska reakcija vključuje občutek toplote, omotico in izgubo zavesti ter težave z dihanjem; to so simptomi hudega, potencialno smrtno nevarnega stanja, ki se imenuje »anafilaktični šok«.
For both treatment periods, patients received a dose as close as possible to their stabilized existing pancreatic enzyme product dose on the first day. 
V obeh obdobjih zdravljenja so bolniki prvi dan prejeli odmerek, čim bolj podoben ustaljenemu odmerku encimov trebušne slinavke, ki so ga jemali do tedaj.
Enzyme doses expressed as lipase units/kg of body weight per meal must be reduced in older patients because they tend to ingest less fat per kilogram of body weight. 
Odmerki encimov, izraženi v enotah lipaze/kg telesne mase na obrok, morajo biti manjši pri starejših bolnikih, ker se nagibajo k zaužitju manj maščob na kilogram telesne mase.
A dose adjustment may be necessary. 
Morda bo treba prilagoditi odmerek.
EUR-1008-M was conducted in 34 patients with EPI due to CF, 26 of whom were children, including 8 children aged 7 to 11 years, and 18 adolescents aged 12 to 17 years. 
Študija EUR-1008-M je bila opravljena pri 34 bolnikih s pomanjkljivim eksokrinim delovanjem trebušne slinavke zaradi cistične fibroze, od katerih je bilo 26 otrok, vključno z 8 otroki, starimi od 7 do 11 let, ter 18 mladostniki, starimi od 12 do 17 let.
An allergic reaction could include itching, hives or rash. 
Alergijska reakcija lahko vključuje srbenje, koprivnico ali izpuščaj.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1113/001-016 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/16/1113/001-016
Do not mix with water, milk, breast-milk, formula, flavoured milk or hot food. 
Ne mešajte z vodo, mlekom, materinim mlekom, mlečno formulo, aromatiziranim mlekom ali toplo hrano.
The capsules should be swallowed whole and take them with a drink of water or juice. 
Kapsule je treba pogoltniti cele in jih vzeti s kozarcem vode ali soka.
These include lipases for digesting fat, proteases for digesting protein and amylases for digestions carbohydrates. 
Vključujejo lipaze za prebavo maščob, proteaze za prebavo beljakovin in amilaze za prebavo ogljikovih hidratov.
Model-based statistics are from a mixed effects linear model using CFA-72h as the response variable, fixed effect factors for treatment, period and treatment sequence, and subject within treatment sequence as a random effect. 
Statistični podatki na podlagi modela izhajajo iz linearnega modela mešanih učinkov, kjer je bil koeficient CFA-72h uporabljen kot spremenljivka odziva, zdravljenje, obdobje in zaporedje zdravljenja kot stalni učinki ter preskušanec v zaporedju zdravljenja kot slučajni učinek.
What you need to know before you take Enzepi 
Kaj morate vedeti, preden boste vzeli zdravilo Enzepi
Enzepi is designed to release most of the enzymes in vivo at pH greater than 5.5. 
Zdravilo Enzepi je zasnovano tako, da in vivo sprosti večino encimov pri vrednosti pH, višji od 5,5.
Immediately give them milk, formula or breast-milk to drink to ensure the granules are completely swallowed and none remain in your child's mouth. 
Takoj mu dajte mleko, formulo ali materino mleko, da bo zrnca popolnoma pogoltnil in del odmerka ne bo ostal v otrokovih ustih.
Porcine derived pancreatic enzyme products contain purines that may increase blood uric acid levels. 
Zdravila z encimi trebušne slinavke prašičjega izvora vsebujejo purine, ki lahko zvišajo ravni sečne kisline v krvi.
Enzepi should not be crushed or chewed or mixed in foods having a pH greater than 5. 
Zdravilo Enzepi se ne sme zdrobiti ali žvečiti ali zmešati s hrano z vrednostjo pH, višjo od 5.
Pancreatic enzyme medicinal products do not cause pharmacokinetic and pharmacodynamic interactions based on their pharmacology, as they are not absorbed from the gastrointestinal tract. 
Zdravila z encimi trebušne slinavke ne povzročajo farmakokinetičnih in farmakodinamičnih interakcij na podlagi farmakoloških značilnosti, saj se ne absorbirajo iz prebavil.
Study EUR 1009-M 
Študija EUR-1009-M
Ask your doctor about other foods you can sprinkle Enzepi granules on. 
Posvetujte se z zdravnikom o drugih živilih, na katera lahko potresete zrnca zdravila Enzepi.
How much Enzepi to take 
Koliko zdravila Enzepi morate jemati
Enzepi should always be taken with a meal or snack. 
Zdravilo Enzepi je vedno treba vzeti z obrokom ali prigrizkom.
The mean faecal fat content was similar at baseline (24.8%), after stabilization (27.0%) and after the second week of open-label treatment 
Povprečna vsebnost maščob v blatu je bila podobna ob izhodišču (24,8 %), po stabilizaciji (27,0 %) in po drugem tednu odprtega zdravljenja (27,3 %).
Patients were randomized to receive Enzepi or matching placebo for 6 to 7 days of treatment, followed by cross-over to the alternate treatment for an additional 6 to 7 days. 
Bolniki so bili randomizirani za prejemanje zdravila Enzepi ali ujemajočega se placeba v obdobju zdravljenja od 6 do 7 dni, čemur je sledil prehod na nadomestno zdravilo za dodatnih 6 do 7 dni.
The dosage of Enzepi should be individualised based on clinical symptoms, the degree of steatorrhoea present, the fat content of the diet, or actual body weight. 
Odmerek zdravila Enzepi je treba prilagoditi posamezniku na podlagi kliničnih simptomov, stopnje steatoreje, vsebnosti maščob v prehrani ali dejanske telesne mase.
It is also not known whether this medicinal product can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. 
Ni znano, ali lahko zdravilo škoduje plodu, če ga uporablja nosečnica, oziroma ali lahko vpliva na sposobnost razmnoževanja.
For patients who are unable to swallow capsules whole, the capsules may be carefully opened and the contents mixed (without crushing) with small amounts of acidic soft food of pH 5 or less (e.g., fruit puree [apple/ pear], yoghurt, juice [orange/pineapple/apple]). 
Za bolnike, ki ne morejo pogoltniti cele kapsule, se lahko kapsule previdno odprejo in vsebina zmeša (brez drobljenja) z majhno količino kisle mehke hrane z vrednostjo pH 5 ali nižjo (npr. sadna kaša [jabolko/hruška], jogurt, sok [pomaranča/ananas/jabolko]).
The risk and benefit of this medicinal product should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. 
Ob obravnavanju tveganj in koristi tega zdravila je treba upoštevati ustrezno prehransko podporo, ki jo potrebuje nosečnica s pomanjkljivim eksokrinim delovanjem trebušne slinavke.
Inadequate hydration may predispose to/or aggravate constipation. 
Neustrezna hidracija lahko povzroči nagnjenost k zaprtosti ali jo poslabša.
Cases of blood glucose fluctuations have been reported with Enzepi, most of them non-serious and recovered after diabetic treatment adjustment. 
Pri uporabi zdravila Enzepi so poročali o primerih nihanja ravni glukoze v krvi, vendar večinoma niso bila resna in so se popravila po prilagoditvi antidiabetičnega zdravljenja.
The most common adverse reactions reported with Enzepi were gastrointestinal complaints [abdominal pain (16%); flatulence (12%); abdominal distention (7%); diarrhoea and vomiting (6%); constipation (5%); nausea (3%)], and headache occurring in approximately 6% of patients. 
Najpogostejši neželeni učinki, o katerih so poročali pri zdravilu Enzepi, so bile prebavne motnje [bolečina v trebuhu (16 %); flatulenca (12 %); napihnjenost trebuha (7%); driska in bruhanje (6 %); zaprtost (5 %); navzea (3 %)] in glavobol, ki se pojavlja pri približno 6 % bolnikov.
If you still have fatty stools (smelly, loose, oily, pale stools) or other stomach or gut problems (gastrointestinal symptoms), talk to your doctor as your dose may need to be adjusted again. 
Če imate še vedno mastno blato (smrdljivo, mehko, mastno, bledo blato) ali druge težave z želodcem ali črevesjem (simptomi prebavil), se posvetujte s svojim zdravnikom, saj bo morda treba vaš odmerek ponovno prilagoditi.
If you sprinkle the Enzepi granules on food, swallow the mixture or give it to your child straight after you have mixed it, followed by a drink of water or juice. 
Če potresete zrnca Enzepi na hrano, pogoltnite mešanico ali jo dajte otroku takoj po tem, ko jo zmešate, in popijte kozarec vode ali soka.
Enzepi is a pancreatic enzyme replacement medicine for people whose bodies do not make enough of enzymes to digest food. 
Enzepi je nadomestno encimsko zdravilo z encimi trebušne slinavke, namenjeno ljudem, katerih telo ne proizvaja dovolj lastnih encimov za prebavo hrane.
What Enzepi is and what it is used for What you need to know before you take Enzepi How to take Enzepi 
Kaj je zdravilo Enzepi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Enzepi Kako jemati zdravilo Enzepi Možni neželeni učinki
The mean difference in CFA-72h was 26 percentage points greater with Enzepi treatment with a 95% Confidence Interval of (19, 32) and p<0.001. 
Povprečna razlika v koeficientu CFA-72h je bila pri zdravilu Enzepi za 26 odstotnih točk višja pri 95-odstotnem intervalu zaupanja (19, 32) in vrednosti p < 0,001.
If you have cystic fibrosis and you are taking pancreatic enzymes exceeding10,000 lipase units per kilogram body weight per day and have unusual abdominal symptoms (such as severe stomach pain, trouble passing stools, nausea or vomiting) or changes in abdominal symptoms, tell your doctor straightaway. 
Če imate cistično fibrozo in jemljete encime trebušne slinavke, ki presegajo 10.000 enot lipaze na kilogram telesne mase dnevno, in imate neobičajne trebušne simptome (kot so hude bolečine v trebuhu, težave pri odvajanju blata, siljenje na bruhanje ali bruhanje) ali spremembe trebušnih simptomov, o tem nemudoma obvestite zdravnika.
Enzepi contains a mixture of natural digestive enzymes which are used to digest food. 
Zdravilo Enzepi vsebuje mešanico naravnih prebavnih encimov, ki se uporabljajo za prebavo hrane.
If you sprinkle the Enzepi granules on food, give the medicine and food mixture to your child right away and do not store Enzepi that is sprinkled on food. 
Če potresete zrnca zdravila Enzepi na hrano, takoj dajte mešanico hrane in zdravila otroku ter ne shranite zdravila Enzepi, ki ste ga posuli na hrano.
Your doctor will adjust your dose which will depend on: the severity of your illness, how much fat is in your stools, your diet, your weight. 
Velikost odmerka bo odvisna od: resnosti vaše bolezni, količine maščob v vašem blatu, vaše prehrane, vaše telesne mase.
It is unknown whether this medicinal product is excreted in human milk. 
Ni znano, ali se to zdravilo izloča v materino mleko.
It is not known if Enzepi passes into your breast-milk. 
Ni znano, ali zdravilo Enzepi prehaja v materino mleko.
Enzepi is for use by adults, adolescents, children and infants with ‘exocrine pancreatic insufficiency', a condition that makes the body less able to break down and digest food. 
Zdravilo Enzepi je namenjeno uporabi pri odraslih, mladostnikih, otrocih in dojenčkih s »pomanjkljivim eksokrinim delovanjem trebušne slinavke«, boleznijo, ki poslabša razgradnjo in prebavo hrane v telesu.
Table 1 Analysis of coefficient of fat absorption over 72 hours (CFA72h) - completers population (study : PR005) 
Preglednica 1 Analiza koeficienta absorpcije maščob v obdobju 72 ur (CFA-72h) - populacija, ki je zaključila obdobje zdravljenja (študija PR-005)
An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Care should be taken to ensure that no medicinal product is retained in the mouth. 
Treba je paziti, da se nič zdravila ne zadržuje v ustih.
Crushing, chewing or holding the Enzepi capsules in your or your child's mouth may cause irritation in your or your child's mouth or change the way Enzepi works in your or your child's body. 
Drobljenje, žvečenje ali zadrževanje kapsul zdravila Enzepi v vaših ali otrokovih ustih lahko povzroči draženje v ustih ali spremeni način delovanja zdravila Enzepi v telesu.
If you or your child have trouble swallowing Enzepi capsules, open carefully the capsules and sprinkle the contents (granules) on a small amount of acidic food such as fruit puree (apple/ pear), yoghurt, or juice (orange/pineapple/apple). 
Če imate vi ali vaš otrok težave s požiranjem kapsul zdravila Enzepi, previdno odprite kapsule in potresite vsebino (zrnca) na majhno količino kisle hrane, kot so sadna kaša (jabolko/hruška), jogurt ali sok (pomaranča/ananas/jabolko).
It was a randomized, double-blind, active controlled, two-treatment, crossover study, comparing Enzepi to standard pancreatic enzyme treatment during 2 treatments periods. 
To je bila randomizirana, dvojno slepa, aktivno nadzorovana navzkrižna študija z dvema zdraviloma, v kateri so primerjali zdravilo Enzepi s standardnim zdravilom z encimi trebušne slinavke v dveh obdobjih zdravljenja.
The short-term efficacy and safety of Enzepi were assessed in clinical studies in paediatric patients, ages 1 to 17 years, with EPI due to CF. 
Kratkoročno učinkovitost in varnost zdravila Enzepi so ocenili v kliničnih študijah pri pediatričnih bolnikih, starih od 1 do 17 let, s pomanjkljivim eksokrinim delovanjem trebušne slinavke zaradi cistične fibroze.
Do not sprinkle the capsule contents directly into the formula or breast-milk. 
Ne potresite vsebine kapsule neposredno v mlečno formulo ali materino mleko.
A total of 96 patients, aged 12 to 43 years, were randomized in the intent-to-treat population. 
Skupno je bilo v populaciji z namenom zdravljenja randomiziranih 96 bolnikov, starih od 12 do 43 let.
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). 
To bi lahko vplivalo na zaščitno gastrorezistentno oblogo in povzročilo predčasno sproščanje encimov, draženje ustne sluznice in/ali izgubo encimske aktivnosti (glejte poglavje 4.2).