FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Odmerek zdravila Enzepi je treba prilagoditi posamezniku na podlagi kliničnih simptomov, stopnje steatoreje, vsebnosti maščob v prehrani ali dejanske telesne mase.
English: It is also not known whether this medicinal product can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
Slovenian: Ni znano, ali lahko zdravilo škoduje plodu, če ga uporablja nosečnica, oziroma ali lahko vpliva na sposobnost razmnoževanja.
English: 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]).
Slovenian: 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]).
English: 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.
Slovenian: Ob obravnavanju tveganj in koristi tega zdravila je treba upoštevati ustrezno prehransko podporo, ki jo potrebuje nosečnica s pomanjkljivim eksokrinim delovanjem trebušne slinavke.
English: Inadequate hydration may predispose to/or aggravate constipation.
Slovenian: Neustrezna hidracija lahko povzroči nagnjenost k zaprtosti ali jo poslabša.
English: Cases of blood glucose fluctuations have been reported with Enzepi, most of them non-serious and recovered after diabetic treatment adjustment.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Če potresete zrnca Enzepi na hrano, pogoltnite mešanico ali jo dajte otroku takoj po tem, ko jo zmešate, in popijte kozarec vode ali soka.
English: Enzepi is a pancreatic enzyme replacement medicine for people whose bodies do not make enough of enzymes to digest food.
Slovenian: Enzepi je nadomestno encimsko zdravilo z encimi trebušne slinavke, namenjeno ljudem, katerih telo ne proizvaja dovolj lastnih encimov za prebavo hrane.
English: What Enzepi is and what it is used for What you need to know before you take Enzepi How to take Enzepi
Slovenian: Kaj je zdravilo Enzepi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Enzepi Kako jemati zdravilo Enzepi Možni neželeni učinki
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Enzepi contains a mixture of natural digestive enzymes which are used to digest food.
Slovenian: Zdravilo Enzepi vsebuje mešanico naravnih prebavnih encimov, ki se uporabljajo za prebavo hrane.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Velikost odmerka bo odvisna od: resnosti vaše bolezni, količine maščob v vašem blatu, vaše prehrane, vaše telesne mase.
English: It is unknown whether this medicinal product is excreted in human milk.
Slovenian: Ni znano, ali se to zdravilo izloča v materino mleko.
English: It is not known if Enzepi passes into your breast-milk.
Slovenian: Ni znano, ali zdravilo Enzepi prehaja v materino mleko.
English: 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.
Slovenian: 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.
English: Table 1 Analysis of coefficient of fat absorption over 72 hours (CFA72h) - completers population (study : PR005)
Slovenian: Preglednica 1 Analiza koeficienta absorpcije maščob v obdobju 72 ur (CFA-72h) - populacija, ki je zaključila obdobje zdravljenja (študija PR-005)
English: 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.
Slovenian: 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).
English: Care should be taken to ensure that no medicinal product is retained in the mouth.
Slovenian: Treba je paziti, da se nič zdravila ne zadržuje v ustih.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: It was a randomized, double-blind, active controlled, two-treatment, crossover study, comparing Enzepi to standard pancreatic enzyme treatment during 2 treatments periods.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Do not sprinkle the capsule contents directly into the formula or breast-milk.
Slovenian: Ne potresite vsebine kapsule neposredno v mlečno formulo ali materino mleko.
English: A total of 96 patients, aged 12 to 43 years, were randomized in the intent-to-treat population.
Slovenian: Skupno je bilo v populaciji z namenom zdravljenja randomiziranih 96 bolnikov, starih od 12 do 43 let.
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).
Slovenian: 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).
English: Not known (frequency cannot be estimated from the available data): abnormal/discoloured faeces (stools) or frequent bowel movements shortness of breath indigestion swelling, pain, soreness or irritation in the mouth tiredness or general feeling of being unwell (malaise) changes (increase or decrease) in blood glucose levels changes (increase or decrease) in body weight decreased appetite high uric acid level in the urine (hyperuricosuria) high uric acid level in the blood (hyperuricemia).
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): nenormalno blato/blato drugačne barve ali pogosto odvajanje blata, zasoplost, prebavne motnje, oteklina, bolečina, bolečnost ali draženje v ustih, utrujenost ali splošno slabo počutje, sprememba (zvišanje ali znižanje) ravni glukoze v krvi, sprememba (povečanje ali zmanjšanje) telesne mase, zmanjšan tek, visoka raven sečne kisline v urinu (hiperurikozurija), visoka raven sečne kisline v krvi (hiperurikemija).
English: Marketing Authorisation Holder Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate Coolock
Slovenian: Imetnik dovoljenja za promet z zdravilom Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate Coolock
English: In clinical trials, most of them were mild to moderate in severity.
Slovenian: V kliničnih preskušanjih so bili neželeni učinki večinoma blagi do zmerni.
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.
Slovenian: Bolniki so bili randomizirani za 10-dnevno prejemanje zdravila Enzepi iz odprte kapsule, zmešanega z jabolčnim sokom (v brizgi) ali jabolčno čežano (z uporabo žlice), ki mu je sledil prehod na drug način dajanja za dodatnih 10 dni.
English: Other medicines and Enzepi Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
English: Subjects achieved a mean CFA-72h of 84.08 with Enzepi and of 85.33 with comparator.
Slovenian: Preskušanci so dosegli povprečni koeficient CFA-72h 84,08 pri zdravilu Enzepi in 85,33 pri primerjalnem zdravilu.
English: Driving and using machines Enzepi does not affect your ability to drive or use tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Enzepi nima vpliva na sposobnost vožnje in upravljanja orodja ali strojev.
English: What Enzepi looks like and contents of the pack
Slovenian: Izgled zdravila Enzepi in vsebina pakiranja
English: Mean CFA-72h was 88% with Enzepi treatment compared to 63% with placebo treatment.
Slovenian: Povprečna vrednost CFA-72h je bila 88 % v skupini z zdravilom Enzepi v primerjavi s 63 % v skupini s placebom.
English: Enzepi capsules or its contents should not be crushed or chewed as they can cause irritation inside your mouth.
Slovenian: Kapsule Enzepi ali njihova vsebina se ne smejo zdrobiti ali žvečiti, saj bi lahko povzročile draženje v notranjosti ust.
English: Each patient's CFA-72h during placebo treatment was used as their no-treatment CFA-72h value.
Slovenian: CFA-72h vsakega bolnika med zdravljenjem s placebom so uporabili kot vrednost CFA-72h v odsotnosti zdravljenja.
English: Study PR-005
Slovenian: Študija PR-005
English: Do not store Enzepi that has been sprinkled on food.
Slovenian: Ne shranite zdravila Enzepi, ki ste ga posuli na hrano.
English: Gastro-resistant hard capsule.
Slovenian: gastrorezistentna trda kapsula
English: Your total daily dose should not exceed 2,500 lipase units per kg of body weight per meal (or 10,000 lipase units per kg of body weight per day).
Slovenian: Vaš celotni dnevni odmerek ne sme preseči 2.500 enot lipaze na kg telesne mase na obrok (ali 10.000 enot lipaze na kg telesne mase dnevno).
English: Children (between 1 and 4 years of age)
Slovenian: Otroci, stari od 1 do 4 let
English: For paediatric patients below 1 year of age, Enzepi must be administered immediately prior to each feed.
Slovenian: Pediatričnim bolnikom, mlajšim od 1 leta starosti, je treba dati zdravilo Enzepi tik pred vsakim hranjenjem.
English: Study PR-011
Slovenian: Študija PR-011
English: The primary efficacy endpoint was the coefficient of fat absorption over 72 hours (CFA-72h) which was calculated at the end of each treatment period, from the stools collected during the last 3 days of each treatment period.
Slovenian: Primarni opazovani dogodek učinkovitosti v študiji je bil koeficient absorpcije maščob v obdobju 72 ur (CFA-72h), ki je bil izračunan ob koncu vsakega obdobja zdravljenja iz vzorcev blata, odvzetih v zadnjih 3 dneh vsakega obdobja zdravljenja.
English: No preclinical investigations were carried out with Enzepi.
Slovenian: Z zdravilom Enzepi niso opravili nobenih predkliničnih raziskav.
English: After a 4-14 days screening period on their usual PEP, patients received Enzepi at individually titrated doses ranging between 2,300 and 10,000 lipase units per kg body weight per day, with a mean of approximately 5,000 lipase units per kg body weight per day (not to exceed 2,500 lipase units per kilogram per meal) for 14 days.
Slovenian: Po 4- do 14-dnevnem opazovalnem obdobju, v katerem so prejemali običajno zdravljenje z encimi trebušne slinavke, so bolniki 14 dni prejemali zdravilo Enzepi v odmerkih, prilagojenih posamezniku, v razponu od 2.300 do 10.000 enot lipaze na kg telesne mase dnevno, s povprečjem približno 5.000 enot lipaze na kg telesne mase dnevno (odmerek ni presegel 2.500 enot lipaze na kilogram telesne mase na obrok).
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.
Slovenian: To lahko povzroči predčasno sproščanje encimov v ustni votlini, draženje sluznice in izgubo encimske aktivnosti.
English: It is not known if Enzepi will affect your ability to get pregnant or if it harms your unborn baby.
Slovenian: Ni znano, ali lahko zdravilo Enzepi vpliva na zmožnost zanositve ali škoduje še nerojenemu otroku.
English: Enzepi has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Enzepi nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Enzepi should be taken during meals or snacks, with a drink of water or juice.
Slovenian: Zdravilo Enzepi je treba jemati med obroki ali prigrizki, s kozarcem vode ali soka.
English: Care should be taken to ensure that Enzepi is not retained in the mouth.
Slovenian: Paziti je treba, da se zdravilo Enzepi ne zadržuje v ustih.
English: Enzepi belongs to the family of pancreatic enzyme products and contains a defined amount of lipase, amylase and protease that have been extracted from porcine pancreas and purified using a process designed to inactivate viruses.
Slovenian: Zdravilo Enzepi spada v družino zdravil z encimi trebušne slinavke in vsebuje določeno količino lipaze, amilaze in proteaze, pridobljenih iz trebušne slinavke prašičev in prečiščenih s postopkom za inaktivacijo virusov.
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.
Slovenian: Največji priporočeni skupni odmerek je 2.500 enot lipaze/kg telesne mase na obrok (ali 10.000 enot lipaze/kg telesne mase dnevno) ali 4.000 enot lipaze/g zaužite maščobe dnevno.
English: Then, starting on the second day, the dose of assigned treatment could be changed (titrated up and/or titrated down) to stabilize the symptoms of EPI.
Slovenian: Od drugega dneva se je odmerek dodeljenega zdravila lahko spremenil (postopoma povečal ali zmanjšal) zaradi stabilizacije simptomov pomanjkljivega eksokrinega delovanja trebušne slinavke.
English: The supportive EUR-1008-M, conducted in the US, was a randomized, double-blind, placebo-controlled, crossover study of 34 patients, ages 7 to 23 years, with EPI due to CF.
Slovenian: Podporna študija EUR-1008-M, opravljena v ZDA, je bila randomizirana, dvojno slepa, s placebom nadzorovana navzkrižna študija s 34 bolniki, starimi od 7 do 23 let, s pomanjkljivim eksokrinim delovanjem trebušne slinavke zaradi cistične fibroze.
English: Make sure the medicine and food mixture is swallowed completely and that no granules are left in your or your child's mouth.
Slovenian: Pogoltniti je treba vso mešanico zdravila in hrane ter paziti, da zrnca ne ostanejo v vaših ali otrokovih ustih.
English: Steatorrhoea was assessed from the faecal fat content measured by spot faecal fat testing on Days 11 and 18 compared with baseline (under usual PEPs).
Slovenian: Steatorejo so ocenili po vsebnosti maščob v blatu, izmerjeni z naključnim testiranjem maščob v blatu na 11. in 18. dan v primerjavi z izhodiščem (ko je potekalo običajno zdravljenje z encimi trebušne slinavke).
English: Adverse reactions associated with pancreas powder obtained from clinical studies, post-marketing surveillance and some additional class effects are tabulated below.
Slovenian: Neželeni učinki, povezani z uprašenim pankreasom, ugotovljeni v kliničnih študijah in obdobju trženja, ter nekateri dodatni učinki, značilni za to skupino zdravil, so našteti v spodnji preglednici.
English: For infants below 1 year of age the recommended starting dose is 5,000 lipase units per meal (generally 120 ml of milk) (see section Method of administration).
Slovenian: Pri dojenčkih, mlajših od 1 leta starosti, je priporočeni začetni odmerek 5.000 enot lipaze na obrok (običajno 120 ml mleka) (glejte poglavje Način uporabe).
English: Repeated high doses of pancreatic enzyme replacement medicines can also cause scarring or thickening of the bowel wall that can lead to blockage of the intestines, a condition called fibrosing colonopathy.
Slovenian: Ponavljajoči se veliki odmerki nadomestnih encimskih zdravil z encimi trebušne slinavke lahko povzročijo tudi brazgotinjenje ali zadebelitev črevesne stene, ki lahko pripeljejo do zapore črevesa (bolezni, ki se imenuje fibrozirajoča kolonopatija).
English: enzymes, Enzyme preparations, ATC code: A09AA02
Slovenian: Farmakoterapevtska skupina: digestivi, vključno z encimi; encimska zdravila; oznaka ATC: A09AA02 Mehanizem delovanja
English: Pack size: one bottle of 20, 50, 100 or 200 gastro-resistant hard capsules.
Slovenian: Velikosti pakiranj: plastenka z 20, 50, 100 ali 200 gastrorezistentnimi trdimi kapsulami.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew the capsules.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Kapsul ne žvečite.
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).
Slovenian: Najpomembnejši resni neželeni učinki, opaženi pri zdravilih z encimi trebušne slinavke, so anafilaktične reakcije (glejte poglavje 4.4) in fibrozirajoča kolonopatija (glejte poglavje 4.4).
English: For infants below 1 year of age, give Enzepi just before each feed of formula or breast-milk.
Slovenian: Dojenčkom, mlajšim od 1 leta starosti, dajte zdravilo Enzepi tik pred vsakim obrokom mlečne formule ali materinega mleka.
English: The efficacy of Enzepi has been evaluated in one active-comparator study and one placebo-controlled study conducted in 130 patients with EPI (exocrine pancreatic insufficiency) associated with CF.
Slovenian: Učinkovitost zdravila Enzepi so ocenili v eni študiji z aktivno primerjalno učinkovino in v eni študiji, nadzorovani s placebom, pri 130 bolnikih s pomanjkljivim eksokrinim delovanjem trebušne slinavke, povezanim s cistično fibrozo.
English: Study PR-018
Slovenian: Študija PR-018
English: Common (may affect up to 1 in 10 people): abdominal discomfort or bloating flatulence/passing wind diarrhoea headache.
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 oseb): neprijeten občutek v trebuhu ali napihnjenost, napenjanje/vetrovi, driska, glavobol.
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.
Slovenian: Otroci, starejši od 4 let, mladostniki in odrasli (vključno s starejšimi) Priporočeni začetni odmerek za otroke, starejše od 4 let, mladostnike (stare od 12 do 18 let) in odrasle je 500 enot lipaze/kg telesne mase na obrok.
English: Anaphylactic reaction** Drug hypersensitivity/ Hypersensitivity
Slovenian: Bolezni imunskega sistema anafilaktična reakcija**, preobčutljivost za zdravilo/ preobčutljivost
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).
Slovenian: Kronični veliki odmerki zdravil z encimi trebušne slinavke so bili povezani s fibrozirajočo kolonopatijo in posledično v nekaterih primerih z zoženjem debelega črevesa (glejte poglavji 4.2 in 4.4).
English: Do not mix the Enzepi granules with water, milk, breast-milk, formula feeds, flavoured milk or hot food.
Slovenian: Zrnc zdravila Enzepi ne mešajte z vodo, mlekom, materinim mlekom, mlečno formulo, aromatiziranim mlekom ali toplo hrano.
English: Nevertheless, undersirable effects on the breastfed newborn/infant are not anticipated since systemic exposure in breast-feeding women to the pancreatic enzymes present in Enzepi is not expected.
Slovenian: Kljub temu ni pričakovati neželenih učinkov na dojenega novorojenca/dojenčka, saj pri doječi materi ne bo prišlo do sistemske izpostavljenosti encimom trebušne slinavke, ki jih vsebuje zdravilo Enzepi.