FrancophonIA/ELRC3.0 huggingface dataset:
English: Pancreatic enzyme medicinal products do not cause pharmacokinetic and pharmacodynamic interactions based on their pharmacology, as they are not absorbed from the gastrointestinal tract.
Croatian: Lijekovi od enzima gušterače ne uzrokuju farmakokinetičke i farmakodinamičke interakcije na temelju njihove farmakologije jer ne apsorbiraju u probavnom traktu.
English: Gastro-resistant granules are thoroughly mixed with chyme when the capsule dissolves in the stomach, without inactivating the acid-sensitive enzymes.
Croatian: Želučanootporne granule temeljito se miješaju s himusom kada se kapsule otope u želucu, bez inaktiviranja enzima osjetljivih na kiselinu.
English: Inadequate hydration may predispose to/or aggravate constipation.
Croatian: Neodgovarajuća hidracija može bolesnika predisponirati za/ili pogoršati konstipaciju.
English: The safety profile of Enzepi in the paediatric population was similar to that observed in adults.
Croatian: Sigurnosni profil lijeka Enzepi u pedijatrijskoj populaciji bio je sličan onom zapaženom u odraslih.
English: Abnormal blood glucose levels
Croatian: Abnormalne razine glukoze u krvi
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.
Croatian: Srednja vrijednost razlike u CFA-72 h bila je 26 postotnih točaka veća kod liječenja lijekom Enzepi uz 95%-tni interval pouzdanosti od (19, 32) i p<0,001.
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.
Croatian: Najčešće nuspojave prijavljene s lijekom Enzepi bile su gastrointestinalne tegobe [bol u abdomenu (16%); flatulencija (12%); distenzija abdomena (7%); proljev i povraćanje (6%); konstipacija (5%); mučnina (3%)] i glavobolja koja se javljala u oko 6% bolesnika.
English: For both treatment periods, patients received a dose as close as possible to their stabilized existing pancreatic enzyme product dose on the first day.
Croatian: U oba razdoblja liječenja bolesnici su dobili dozu što bližu njihovoj stabiliziranoj dozi postojećeg lijeka od enzima gušterače na prvi dan.
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).
Croatian: Ako Vi ili Vaše dijete imate poteškoća s gutanjem kapsula Enzepi, pažljivo otvorite kapsule i posipajte sadržaj (granule) na malu količinu kisele hrane kao što je voćni pire (jabuka/kruška), jogurt, ili sok (naranča/ananas/jabuka).
English: 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.
Croatian: Statistike na bazi modela dobivene su iz linearnog modela miješanog učinka koji koristi CFA-72 h kao varijablu odgovora, čimbenike fiksnog učinka kod liječenja, razdoblja i sekvence liječenja te ispitanika unutar sekvence liječenja kao nasumični učinak.
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.
Croatian: Samo se u dvanaesniku, koji ima različito okruženje s vrijednošću pH većom od 5, probavni enzimi oslobađaju iz granula.
English: Enzepi contains a mixture of natural digestive enzymes which are used to digest food.
Croatian: Enzepi sadrži mješavinu prirodnih probavnih enzima koji služe za probavu hrane.
English: 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.
Croatian: Drobljenje, žvakanje ili miješanje sadržaja kapsule s hranom ili tekućinama čiji je pH veći od 5, ili čuvanje mješavine hrane (vidjeti u nastavku), može prouzročiti narušavanje zaštitne želučanootporne ovojnice.
English: Frequency, type and severity of adverse reactions were similar in elderly people with pancreatic exocrine insufficiency as compared to adults.
Croatian: Učestalost, vrsta i težina nuspojava bile su slične u starijih osoba s egzokrinom insuficijencijom gušterače u usporedbi s odraslima.
English: Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially `sodium-free´.
Croatian: Natrij Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Patients were transitioned to Enzepi from their usual PEP (pancreatic enzyme product) treatment.
Croatian: Bolesnici su prebačeni na Enzepi sa svojeg uobičajenog lijeka od pankreasnog enzima (PEP, engl. pancreatic enzyme product).
English: For paediatric patients below 1 year of age, Enzepi must be administered immediately prior to each feed.
Croatian: Za pedijatrijske bolesnike mlađe od 1 godine, Enzepi se mora primijeniti netom prije svakog hranjenja.
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.
Croatian: Enzepi je namijenjen odraslima, adolescentima, djeci i dojenčadi s "egzokrinom insuficijencijom gušterače", stanjem koje otežava tijelu razgradnju i probavu hrane.
English: Although, no preclinical investigations were carried out with Enzepi there is no evidence for any absorption of this medicinal product.
Croatian: Iako nisu provedena pretklinička ispitivanja s lijekom Enzepi, nema dokaza o apsorpciji ovog lijeka.
English: Pack size: one bottle of 20, 50, 100 or 200 gastro-resistant hard capsules.
Croatian: Veličine pakiranja: jedna boca sa 20, 50, 100 ili 200 želučanootpornih tvrdih kapsula.
English: The Enzepi soft food mixture should be swallowed immediately without chewing and followed with water or juice to ensure complete ingestion.
Croatian: Mješavinu kašaste hrane s lijekom Enzepi treba progutati odmah bez žvakanja i zatim popiti vodu ili sok kako bi se osiguralo potpuno gutanje.
English: Rarely, anaphylactic reactions have been reported with pancreatic enzyme products with different formulations of the same active ingredient (pancreas powder).
Croatian: Rijetko su prijavljivane anafilaktičke reakcije s lijekovima od enzima gušterače s različitim formulacijama istog djelatnog sastojka (prašak gušterače).
English: **Class effects
Croatian: **Učinci skupine
English: Enzepi is a pancreatic enzyme replacement medicine for people whose bodies do not make enough of enzymes to digest food.
Croatian: Enzepi je lijek za nadomjesno liječenje enzimima gušterače u osoba čija tijela ne proizvode dovoljno vlastitih enzima za probavu hrane.
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.
Croatian: Kratkotrajna djelotvornost i sigurnost lijeka Enzepi procijenjene su u kliničkim ispitivanjima u pedijatrijskih bolesnika, u dobi od 1 do 17 godina, s EPI-jem uslijed CF-a.
English: Subjects achieved a mean CFA-72h of 84.08 with Enzepi and of 85.33 with comparator.
Croatian: Ispitanici su postigli srednju vrijednost CFA-72 h od 84,08 s lijekom Enzepi i 85,33 s lijekom usporedbe.
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.
Croatian: Ako imate cističnu fibrozu i uzimate enzime gušterače u količini većoj od 10 000 jedinica lipaze po kilogramu tjelesne težine na dan i imate neobične abdominalne simptome (kao što je jaka bol u trbuhu, poteškoće sa stolicom, mučninu ili povraćanje) ili promjene simptoma vezanih uz trbuh, odmah obavijestite svog liječnika.
English: The contents of the capsule should not be mixed directly into formula or breast-milk as this may diminish efficacy.
Croatian: Sadržaj kapsule ne smije se promiješati izravno u zamjensko mlijeko ili majčino mlijeko jer bi to moglo smanjiti djelotvornost.
English: Care should be taken to ensure that Enzepi is not retained in the mouth.
Croatian: Potrebno je paziti da Enzepi ne ostane u ustima.
English: Infants (below 1 year of age)
Croatian: Dojenčad (mlađa od 1 godine)
English: Fertility No human data on the effect of Enzepi on fertility are available.
Croatian: Plodnost Nisu dostupni podaci o utjecaju lijeka Enzepi na plodnost u ljudi.
English: An allergic reaction could include itching, hives or rash.
Croatian: Alergijska reakcija može uključivati svrbež, koprivnjaču ili osip.
English: 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.
Croatian: Odmah mu dajte piti mlijeko, zamjensko mlijeko ili majčino mlijeko da granule potpuno proguta i ništa ne ostane u ustima Vašeg djeteta.
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.
Croatian: Doziranje lijeka Enzepi treba prilagoditi svakom bolesniku pojedinačno na temelju kliničkih simptoma, stupnja postojeće steatoreje, sadržaja masnoća u prehrani, ili stvarnoj tjelesnoj težini.
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.
Croatian: Ako pospete granule Enzepi na hranu, odmah dajte mješavinu lijeka i hrane Vašem djetetu i ne čuvajte za kasnije Enzepi koji je posut po hrani.
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.
Croatian: Enzepi pripada skupini lijekova od enzima gušterače i sadrži određenu količinu lipaze, amilaze i proteaze koje su dobivene iz svinjske gušterače i pročišćene korištenjem postupka koji je namijenjen inaktiviranju virusa.
English: Enzepi has no influence on the ability to drive and use machines.
Croatian: Enzepi ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Nakon razdoblja probira od 414 dana na njihovom uobičajenom PEP-u, bolesnici su primili Enzepi u pojedinačno titriranim dozama u rasponu između 2300 i 10 000 jedinica lipaze po kg tjelesne težine na dan, s aritmetičkom sredinom od 5000 jedinica lipaze po kg tjelesne težine na dan (ne smije se prekoračiti 2500 jedinica lipaze po kilogramu po obroku) tijekom 14 dana.
English: Table 1 Analysis of coefficient of fat absorption over 72 hours (CFA72h) - completers population (study : PR005)
Croatian: Tablica 1 Analiza koeficijenta apsorpcije masti tijekom 72 sata (CFA-72 h) - Populacija koja je sudjelovala u ispitivanju do kraja (Ispitivanje PR-005)
English: Dispose of any accidentally crushed capsule.
Croatian: Bacite slučajno zdrobljene kapsule.
English: The mean faecal fat content was similar at baseline (24.8%), after stabilization (27.0%) and after the second week of open-label treatment
Croatian: Srednji sadržaj fekalne masnoće bio je sličan na početku ispitivanja (24,8%), nakon stabilizacije (27,0%) i nakon drugog tjedna otvorenog liječenja (27,3%).
English: Mean CFA-72h was 88% with Enzepi treatment compared to 63% with placebo treatment.
Croatian: Srednji CFA-72 h bio 88% kod liječenja lijekom Enzepi u usporedbi sa 63% kod liječenja placebom.
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]).
Croatian: Za bolesnike koji ne mogu progutati cijele kapsule, one se mogu pažljivo otvoriti i sadržaj promiješati (bez drobljenja) s malom količinom kisele kašaste hrane čiji je pH 5 ili manje (npr. voćni pire [jabuka/kruška], jogurt, sok [naranča/ananas/jabuka]).
English: If you forget to take Enzepi
Croatian: Ako ste zaboravili uzeti Enzepi
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.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Enzepi: ako ste ikada imali giht, bolest bubrega, ili visoke razine mokraćne kiseline u krvi (hiperuricemija) ili u mokraći (hiperurikozurija), ako imate abnormalne razine glukoze u krvi.
English: It was a randomized, double-blind, active controlled, two-treatment, crossover study, comparing Enzepi to standard pancreatic enzyme treatment during 2 treatments periods.
Croatian: Bilo je randomizirano, dvostruko slijepo, kontrolirano aktivnim lijekom, s dva lijeka i križnom zamjenom skupina, u kojem je lijek Enzepi uspoređen sa standardnim liječenjem enzimima gušterače tijekom 2 razdoblja liječenja.
English: Make sure the medicine and food mixture is swallowed completely and that no granules are left in your or your child's mouth.
Croatian: Osigurajte se da ste mješavinu lijeka i hrane potpuno progutali i da Vam u ustima ili u ustima Vašeg djeteta nisu ostale granule.
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.
Croatian: Ako još imate masnu stolicu (stolica koja zaudara, mekana, uljana, blijeda stolica) ili druge probleme sa želucem ili crijevima (probavni simptomi), razgovarajte sa svojim liječnikom jer možda treba ponovno prilagoditi dozu.
English: Twelve patients completed both assigned treatment arms and were evaluated.
Croatian: Procijenjeno je dvanaest bolesnika koji su dovršili obje dodijeljene terapijske skupine.
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.
Croatian: Suportivno ispitivanje EUR-1008-M, provedeno u SAD-u bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje s križnom zamjenom skupina provedeno na 34 bolesnika u dobi od 7 do 23 godina s EPI-jem uslijed CF-a.
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.
Croatian: Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
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).
Croatian: Steatoreja je procijenjena iz sadržaja fekalne masnoće izmjerene „spot“ testom masnoće u stolici na 11. i 18. dan u usporedbi s početnom vrijednosti (pod uobičajenim PEP-om).
English: All patients consumed a high-fat diet (greater than or equal to 100 grams of fat per day) during the treatment period.
Croatian: Svi su bolesnici konzumirali hranu koja sadrži visok postotak masnoća (veći ili jednak 100 grama masnoće na dan) tijekom razdoblja liječenja.
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.
Croatian: Primarna mjera ishoda djelotvornosti bila je koeficijent apsorpcije masnoća tijekom 72 sata (CFA-72 h) koji je izračunat na kraju svakog razdoblja liječenja, iz uzoraka stolice uzetih tijekom posljednjih 3 dana svakog razdoblja liječenja.
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.
Croatian: Usprkos tomu, ne očekuju se neželjeni učinci na dojenu novorođenčad/dojenčad budući da se ne očekuje sistemska izloženost dojilja enzimima gušterače prisutnima u lijeku Enzepi.
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.
Croatian: Ako posipate granule na hranu, progutajte smjesu ili dajte je Vašem djetetu odmah nakon što ste je promiješali, nakon toga popijte vodu ili sok.
English: Each patient's CFA-72h during placebo treatment was used as their no-treatment CFA-72h value.
Croatian: CFA72 h svakog bolesnika tijekom liječenja placebom korišten je kao njihova vrijednost CFA-72 h bez liječenja.
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).
Croatian: Nepoznate (učestalost se ne može procijeniti iz dostupnih podataka): abnormalna stolica/promijenjena boja stolice ili česta stolica nedostatak zraka probavne tegobe oticanje, bol, bolnost ili nadraženost usta umor ili opće loše osjećanje (malaksalost) promjene (povećanje ili smanjenje) razina glukoze u krvi promjene (povećanje ili smanjenje) tjelesne težine smanjen apetit visoka razina mokraćne kiseline u mokraći (hiperurikozurija) visoka razina mokraćne kiseline u krvi (hiperuricemija).
English: o Capsule shell :
Croatian: o Ovojnica kapsule:
English: Driving and using machines Enzepi does not affect your ability to drive or use tools or machines.
Croatian: Upravljanje vozilima i strojevima Enzepi ne utječe na Vašu sposobnost upravljanja vozilima ili rada na strojevima.
English: After first opening: 6 months when stored below 25°C.
Croatian: Nakon prvog otvaranja: 6 mjeseci na temperaturi ispod 25 °C.
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.
Croatian: Podaci generirani u populaciji s CF-om koja ima EPI mogu se ekstrapolirati na druge uzroke EPI-ja poput kroničnog pankreatitisa, stanja nakon pankreatektomije ili kod raka gušterače.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „Rok valjanosti“.
English: enzymes, Enzyme preparations, ATC code: A09AA02
Croatian: Farmakoterapijska skupina: Digestivi, uključujući enzime, enzimski pripravci, ATK oznaka: A09AA02
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).
Croatian: Vaša ukupna dnevna doza ne bi smjela prekoračiti 2500 jedinica lipaze po kg tjelesne težine po obroku (ili 10 000 jedinica lipaze po kg tjelesne težine na dan).
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.
Croatian: Stoga je Enzepi pokazao neinferiornost i ekvivalenciju u odnosu na lijek usporedbe po pitanju reguliranja apsorpcije masnoća (izmjereno kao CFA-72 h) u adolescenata i odraslih s EPI-jem povezanim s CF-om.
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.
Croatian: Sveukupno, opaženo je poboljšanje od početka do dovršetka ispitivanja što se tiče indeksa rasta, uključujući percentile vrijednosti težina-dob, duljina-dob i težina-duljina.
English: Marketing Authorisation Holder Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate Coolock
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate Coolock
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.
Croatian: Ponovljene velike doze lijeka za nadomjesno liječenje enzimima gušterače mogu također prouzročiti ožiljkaste promjene ili zadebljenja crijevne stijenke, što može dovesti do začepljenja crijeva, stanja koje se naziva fibrozirajuća kolonopatija.
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).
Croatian: Za dojenčad mlađu od 1 godine preporučena početna doza je 5000 jedinica lipaze po obroku (općenito 120 ml mlijeka) (vidjeti dio Način primjene).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1113/001-016
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1113/001-016
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.
Croatian: Bolesnici su bili randomizirani u skupinu koja je dobivala Enzepi ili odgovarajući placebo tijekom 6 do 7 dana liječenja, nakon čega je uslijedio prelazak na drukčije liječenje tijekom dodatnih 6 do 7 dana.
English: Enzepi should be taken during meals or snacks, with a drink of water or juice.
Croatian: Enzepi treba uzimati tijekom obroka ili međuobroka s vodom ili sokom.
English: Enzepi capsules or its contents should not be crushed or chewed as they can cause irritation inside your mouth.
Croatian: Enzepi kapsule ili njihov sadržaj ne smiju se zdrobiti niti žvakati jer bi to moglo prouzročiti nadraženost u ustima.
English: If you stop taking Enzepi
Croatian: Ako prestanete uzimati Enzepi
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.
Croatian: Djelotvornost lijeka Enzepi procijenjena je u jednom ispitivanju s aktivnim lijekom usporedbe (komparatorom) i u jednom placebom kontroliranom ispitivanju provedenom u 130 bolesnika s EPI-jem (egzokrinom insuficijencijom gušterače) povezanim s CF-om.
English: Do not mix with water, milk, breast-milk, formula, flavoured milk or hot food.
Croatian: Ne miješati s vodom, mlijekom, majčinim mlijekom, zamjenskim mlijekom, aromatiziranim mlijekom ili vrućom hranom.
English: Porcine derived pancreatic enzyme products contain purines that may increase blood uric acid levels.
Croatian: Lijekovi dobiveni od svinjskog enzima gušterače sadrže purine koji mogu povećati razine mokraćne kiseline u krvi.
English: units For the full list of excipients, see section 6.1.
Croatian: Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Blood glucose decreased Blood glucose increased Weight decreased Weight increased
Croatian: Pretrage snižena razina glukoze u krvi povišena razina glukoze u krvi smanjenje tjelesne težine povećanje tjelesne težine