FrancophonIA/ELRC3.0 huggingface dataset:
English: The injection can be self-administered or given by another person, for example your child's doctor, his/her assistant or your child's home nurse.
Croatian: Injekciju može dati dijete samo sebi ili to može učiniti druga osoba, primjerice djetetov liječnik, njegov/njezin pomoćnik ili patronažna medicinska sestra.
English: The primary efficacy analysis of the study results showed no statistically significant difference between the group on teduglutide 0.10 mg/kg/day and the placebo group, while the proportion of subjects receiving the recommended teduglutide dose of 0.05 mg/kg/day achieving at least a 20% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different versus placebo (46% versus 6.3%, p<0.01).
Croatian: Primarna analiza djelotvornosti rezultata ispitivanja nije pokazala statistički značajnu razliku između skupina koje su primale 0,10 mg/kg/dan teduglutida i placebo, dok je udio bolesnika koji su primali preporučenu dozu teduglutida od 0,05 mg/kg/dan i postigli smanjenje parenteralne prehrane od barem 20% u tjednima 20 i 24 bio statistički značajno veći u odnosu na placebo (46% naspram 6,3%, p<0,01).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: 2.1 Remove the green flip-off button from the powder vial, wipe the top with an alcohol wipe and allow to dry.
Croatian: 2.1 Uklonite zeleni poklopac na podizanje s bočice s praškom, prebrišite vrh alkoholnom maramicom i pustite da se osuši.
English: Caution is needed if you are hypersensitive to tetracycline (see “Do not use Revestive” section).
Croatian: Potreban je oprez ako ste preosjetljivi na tetraciklin (pogledajte dio „Nemojte primjenjivati Revestive“).
English: Prior to initiating treatment with Revestive, faecal occult blood testing should be done for all children and adolescents.
Croatian: Prije nego što započne terapija lijekom Revestive, u sve djece i adolescenata treba provesti testiranje stolice na okultno krvarenje.
English: It is strongly recommended that every time Revestive is administered to a patient, the name and lot number of the product are recorded in order to maintain a link between the patient and the lot of the product.
Croatian: Izrazito se preporučuje da se pri svakoj primjeni lijeka Revestive zabilježi naziv i serijski broj lijeka, kako bi se sačuvala poveznica između bolesnika i serije lijeka.
English: You will also have a colonoscopy done (a procedure to see inside your colon and rectum to check for the presence of polyps (small abnormal growths) and have them removed) if you have unexplained blood in your bowel movements (stools).
Croatian: Također ćete morati obaviti kolonoskopiju (postupak koji se provodi da bi se vidjela unutrašnjost debelog crijeva i završnog dijela crijeva (rektuma) kako bi se provjerilo postoje li polipi (male abnormalne izrasline) te ih se odstranilo) ako u stolici imate krv neobjašnjenog uzroka.
English: 2.1 Remove the blue flip-off button from the powder vial, wipe the top with an alcohol wipe and allow to dry.
Croatian: 2.1 Uklonite plavi poklopac na podizanje s bočice s praškom, prebrišite vrh alkoholnom maramicom i pustite da se osuši.
English: The solution must not be used if it is cloudy or contains particulate matter.
Croatian: Otopina se ne smije koristiti ako je zamućena ili sadrži čestice.
English: Check with your child's doctor, pharmacist or nurse if you are not sure.
Croatian: Provjerite s djetetovim liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni.
English: At Week 16, the parenteral nutrition calories consumption continued to decrease with percentage mean changes from baseline of -39.15% (±39.08) compared to -0.87% (±9.25) for the standard of care cohort.
Croatian: U 16. tjednu, unos kalorija parenteralnom prehranom nastavio se smanjivati uz postotak srednje vrijednosti promjene u odnosu na početni od -39,15% (±39,08) u usporedbi s -0,87% (±9,25) u skupini na standardnoj skrbi.
English: The injection can be self-administered or given by another person, for example your doctor, his/her assistant or your home nurse.
Croatian: Injekciju si možete dati sami ili to može učiniti druga osoba, primjerice liječnik, njegov/njezin pomoćnik ili patronažna medicinska sestra.
English: Keep using this medicine for as long as your doctor prescribes it for you.
Croatian: Nastavite primjenjivati ovaj lijek sve dok Vam ga liječnik propisuje.
English: In a phase 1 study the effect of hepatic impairment on the pharmacokinetics of teduglutide following subcutaneous administration of 20 mg teduglutide was investigated.
Croatian: U ispitivanju faze 1 ispitan je utjecaj oštećenja funkcije jetre na farmakokinetiku teduglutida nakon supkutane primjene 20 mg teduglutida.
English: Treatment with teduglutide resulted in a 2.5 l/week reduction in parenteral nutrition requirements (from a pre-treatment baseline of 9.6 litres) versus 0.9 l/week (from a pre-treatment baseline of 10.7 litres) for placebo at 24 weeks.
Croatian: Liječenje teduglutidom rezultiralo je smanjenjem potrebe za parenteralnom prehranom za 2,5 l/tjedno (od 9,6 litara prije početka liječenja) naspram 0,9 l/tjedno (od 10,7 litara prije početka liječenja) za placebo nakon 24 tjedana.
English: How to use Revestive
Croatian: Kako primjenjivati Revestive
English: The solution must be injected subcutaneously into a cleaned area on the abdomen, or if this is not possible, on the thigh (see section 4.2 Method of administration) using a thin needle for subcutaneous injection.
Croatian: Otopinu treba primijeniti potkožno u čisto područje na trbuhu ili, ako to nije moguće, u bedro (vidjeti u dijelu 4.2 pod Način primjene) koristeći tanku iglu za potkožnu injekciju.
English: Powder and solvent for solution for injection 1 vial of powder containing 5 mg teduglutide 1 pre-filled syringe containing 0.5 ml of solvent 28 vials of powder containing 5 mg teduglutide 28 pre-filled syringes containing 0.5 ml of solvent
Croatian: Prašak i otapalo za otopinu za injekciju 1 bočica s praškom koja sadrži 5 mg teduglutida 1 napunjena štrcaljka koja sadrži 0,5 ml otapala 28 bočica s praškom koje sadrže 5 mg teduglutida 28 napunjenih štrcaljki koje sadrže 0,5 ml otapala
English: The recommended dose of Revestive in children and adolescents (aged 1 to 17 years) is 0.05 mg/kg body weight once daily.
Croatian: Preporučena doza lijeka Revestive u djece i adolescenata (u dobi od 1 do 17 godina) iznosi 0,05 mg/kg tjelesne težine jedanput dnevno.
English: It is strongly recommended that every time your child receives a dose of Revestive, the name and lot number of the product are recorded in order to maintain a record of the lots used.
Croatian: Izrazito se preporučuje da svaki put kad Vaše dijete primi dozu lijeka Revestive zabilježite naziv i serijski broj lijeka kako bi se vodila evidencija o primijenjenoj seriji lijeka.
English: Renal elimination was confirmed in a study investigating pharmacokinetics in subjects with renal impairment.
Croatian: Eliminacija putem bubrega potvrđena je u ispitivanju farmakokinetike kod ispitanika s oštećenom funkcijom bubrega.
English: Two (2) patients on the recommended teduglutide dose were weaned off parenteral nutrition by Week 24.
Croatian: U 2 bolesnika koja su primala preporučenu dozu teduglutida, parenteralna prehrana bila je ukinuta do 24. tjedna.
English: Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS).
Croatian: Lijek Revestive indiciran je za liječenje bolesnika od navršene 1 godine nadalje sa sindromom kratkog crijeva (SKC).
English: Revestive contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Revestive sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Treatment should be initiated under the supervision of a medical professional with experience in the treatment of paediatric SBS.
Croatian: Liječenje treba započeti pod nadzorom zdravstvenog radnika s iskustvom u liječenju SKC-a u pedijatrijskih bolesnika.
English: The recommended daily dose for your child is 0.05 mg per kg body weight.
Croatian: Preporučena dnevna doza za Vaše dijete je od 0,05 mg po kilogramu tjelesne težine.
English: The doctor will take special care and monitor your child's small bowel function and monitor for signs and symptoms indicating problems with the gallbladder, bile ducts and pancreas.
Croatian: Liječnik će obratiti posebnu pozornost i pratiti funkciju tankog crijeva Vašega djeteta te nadzirati dijete kako bi uočio moguće znakove i simptome koji ukazuju na teškoće sa žučnim mjehurom, žučnim vodovima ili gušteračom.
English: Revestive is used to treat adults, children and adolescents (aged 1 year and above) with Short Bowel Syndrome.
Croatian: Revestive se koristi za liječenje odraslih, djece i adolescenata (od navršene 1 godine nadalje) sa sindromom kratkog crijeva.
English: The injection volume per body weight when using the 5 mg strength vial is provided in Table 2 below.
Croatian: Volumeni injekcije prema tjelesnoj težini kad se upotrebljava bočica jačine 5 mg navedeni su u nastavku u tablici 2.
English: In another phase 3 double-blind, placebo-controlled study in patients with SBS, who required parenteral nutrition, patients received a 0.05 mg/kg/day dose (n=35), a 0.10 mg/kg/day dose (n=32) of teduglutide or placebo (n=16) for up to 24 weeks.
Croatian: U drugom dvostruko slijepom, placebom kontroliranom ispitivanju faze 3 na bolesnicima sa SKC-om, koji su ovisili o parenteralnoj prehrani, ispitanici su primali 0,05 mg/kg/dan (n=35) ili 0,10 mg/kg/dan (n=32) teduglutida ili placebo (n=16) do 24 tjedna.
English: Use this medicine exactly as your doctor has told you.
Croatian: Primijenite ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
English: Your doctor will take special care and monitor your small bowel function and monitor for signs and symptoms indicating problems with your gallbladder, bile ducts and pancreas.
Croatian: Liječnik će obratiti posebnu pozornost i pratiti funkciju tankog crijeva te nadzirati znakove i simptome koji ukazuju na teškoće sa žuči, žučnim vodovima ili gušteračom.
English: In a phase 1 study, the effect of renal impairment on the pharmacokinetics of teduglutide following subcutaneous administration of 10 mg teduglutide was investigated.
Croatian: U ispitivanju faze 1 ispitan je utjecaj oštećenja funkcije bubrega na farmakokinetiku teduglutida nakon supkutane primjene 10 mg teduglutida.
English: At the end of study, 21 (70%), 18 (60%) and 18 (60%) of the 30 completers achieved a reduction of 1, 2, or 3 days per week in parenteral support, respectively.
Croatian: Na kraju ispitivanja, od 30 ispitanika koji su završili ispitivanje njih 21 (70%), 18 (60%) i 18 (60%) postiglo je smanjenje od 1 dana, 2 dana odnosno 3 dana tjedno na parenteralnoj potpori.
English: The recommended daily dose is 0.05 mg per kg body weight.
Croatian: Preporučena dnevna doza je 0,05 mg po kilogramu tjelesne težine.
English: Based on subject diary data, 18 (69.2%) subjects in the 0.05 mg/kg/day group achieved the primary endpoint of ≥20% reduction in PN/IV volume at end of treatment, compared to baseline; in the SOC arm, 1 (11.1%) subject achieved this endpoint.
Croatian: Na temelju podataka iz dnevnika koje su vodili ispitanici, njih 18 (69,2%) u skupini liječenoj dozom od 0,05 mg/kg na dan postiglo je primarni ishod od ≥20% smanjenja volumena parenteralne/intravenske prehrane (PN/IV) na kraju liječenja u usporedbi s onim na početku; u skupini na standardnoj skrbi, ovu mjeru ishoda postigao je 1 ispitanik (11,1%).
English: 5 mg strength Volume to be injected
Croatian: Jačina 5 mg Volumen injekcije
English: Three (3) doses of teduglutide, 0.0125 mg/kg/day (n=8), 0.025 mg/kg/day (n=14), and 0.05 mg/kg/day (n=15), were investigated for 12 weeks.
Croatian: Tijekom 12 tjedana ispitivane su 3 doze teduglutida: 0,0125 mg/kg/dan (n=8), 0,025 mg/kg/dan (n=14) i 0,05 mg/kg/dan (n=15).
English: Congestive heart failure has been observed in clinical trials.
Croatian: U kliničkim ispitivanjima opaženo je kongestivno zatajenje srca.
English: Very common (may affect more than 1 in 10 people): - Respiratory tract infection (any infection of the sinuses, throat, airways or lungs) - Headache - Stomach pain, bloated stomach, feeling sick (nausea), swelling of stoma (an artificial opening for waste removal), vomiting - Reddening, pain or swelling at the site of the injection
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): - infekcije dišnog sustava (bilo kakva infekcija sinusa, grla, dišnih puteva ili pluća) - glavobolja - bol u trbuhu, nadutost trbuha, mučnina, oticanje stome (umjetnog otvora za pražnjenje stolice),
English: Ten (10) subjects were weaned off their parenteral support while on teduglutide treatment for 30 months.
Croatian: Parenteralna potpora ukinuta je kod 10 ispitanika tijekom liječenja teduglutidom u trajanju od 30 mjeseci.
English: Congestive heart failure
Croatian: Srčani poremećaji kongestivno zatajenje
English: The doctor will choose the dose that is right for your child, depending on their body weight.
Croatian: Liječnik će na temelju djetetove tjelesne težine odrediti dozu koja mu je primjerena.
English: Three (3) paediatric subjects in the 0.05 mg/kg group achieved the additional endpoint of enteral autonomy by week 24.
Croatian: U troje (3) pedijatrijskih ispitanika u skupini liječenoj dozom od 0,05 mg/kg postignut je dodatni ishod tj. potpuno ukidanje parenteralne potpore do 24. tjedna.
English: Colonoscopy/sigmoidoscopy is required if there is evidence of unexplained blood in the stool.
Croatian: Ako se u stolici pronađe krv neobjašnjenog uzroka, potrebna je kolonoskopija/sigmoidoskopija.
English: In case of a significant deterioration of the cardiovascular disease, the need for continued treatment with Revestive should be reassessed.
Croatian: U slučaju značajnog pogoršanja kardiovaskularne bolesti, treba procijeniti potrebu za daljnjim liječenjem lijekom Revestive.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta lijek treba primijeniti odmah, osim ako način rekonstitucije ne isključuje rizik od kontaminacije mikrobima.
English: Includes the following preferred terms: Injection site haematoma, Injection site erythema, Injection site pain, Injection site swelling and Injection site haemorrhage.
Croatian: Uključuje sljedeće preporučene pojmove: hematom na mjestu primjene injekcije, eritem na mjestu primjene injekcije, bol na mjestu primjene injekcije, oticanje na mjestu primjene injekcije i krvarenje na mjestu primjene injekcije.
English: - Do not use Revestive if you notice that the solution is cloudy or contains particulate matter.
Croatian: - Revestive se ne smije primijeniti ako primijetite da je otopina zamućena ili sadrži čestice.
English: The mean reduction of weekly parenteral nutrition volume was 4.9 l/week (52% reduction from baseline) after one year of continuous teduglutide treatment.
Croatian: Srednje smanjenje tjednog volumena parenteralne prehrane iznosilo je nakon jednogodišnje kontinuirane primjene teduglutida 4,9 l/tjedan (52% manje nego na početku terapije).
English: 4.2 Clean the intended site of injection on your child's skin with an alcohol swab, using a circular motion, working outwards.
Croatian: 4.2 Mjesto na koži djeteta koje ste odabrali za davanje injekcije očistite alkoholnom maramicom, kružnim pokretima prema van.
English: 1.1 Take the pre-filled syringe with the solvent and flip off the top part of the white plastic cap on the pre-filled syringe so that it is ready for the reconstitution needle to be attached.
Croatian: 1.1 Uzmite napunjenu štrcaljku s otapalom i uklonite gornji dio bijelog plastičnog zatvarača na napunjenoj štrcaljki kako biste na nju mogli postaviti iglu za pripremu otopine.
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Croatian: Nuspojave su u nastavku navedene prema MedDRA klasifikaciji organskih sustava i učestalosti.
English: Colorectal polyp Colonic stenosis Flatulence Intestinal obstruction Pancreatic duct stenosis Pancreatitis Small intestinal stenosis
Croatian: Poremećaji probavnog sustava distenzija abdomena bol u abdomenu mučnina povraćanje kolorektalni polip stenoza debelog crijeva flatulencija opstrukcija crijeva stenoza gušteračnog voda pankreatitis stenoza tankog crijeva duodenalni polip želučani polip
English: The powder in the vial must then be dissolved by adding all the solvent from the pre-filled syringe.
Croatian: Prašak u bočici treba otopiti dodavanjem cijelog sadržaja otapala iz napunjene štrcaljke.
English: Materials provided in the pack: - 1 or 28 vials with 5 mg teduglutide as a powder - 1 or 28 pre-filled syringes with solvent
Croatian: Sadržaj pakiranja: - 1 ili 28 bočica s 5 mg teduglutida u obliku praška - 1 ili 28 napunjenih štrcaljki s otapalom
English: The mean decrease from baseline at Week 12 in the number of days/week on parenteral nutrition, in the ITT population based on physician-prescribed data, was -1.36 (±2.37) days/week corresponding to a percentage decrease of -24.49% (±42.46).
Croatian: U 12. tjednu, u populaciji predviđenoj za liječenje, srednja vrijednost smanjenja u broju dana po tjednu na parenteralnoj prehrani u odnosu na početni broj na temelju podataka o parenteralnoj prehrani koju su propisali liječnici, iznosio je -1,36 (±2,37) dana po tjednu, što je odgovaralo postotku smanjenja od -24,49% (±42,46).
English: Uncommon (may affect up to 1 in 100 people) - Polyps (small abnormal growths) in your child's small bowel
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): - polipi (male neprirodne izrasline) u tankom crijevu Vašega djeteta.
English: If you inject more Revestive than you are told to by your child's doctor, you should contact the doctor, pharmacist or nurse.
Croatian: Ako ubrizgate više lijeka Revestive nego što Vam je rekao djetetov liječnik, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: 2.2 Uncap the reconstitution needle on the assembled pre-filled syringe with solvent without touching the tip of the needle.
Croatian: 2.2 Uklonite poklopac s igle za pripremu otopine na sastavljenoj napunjenoj štrcaljki s otapalom bez da dodirujete vrh igle.
English: Contact the doctor or the emergency unit if your child experiences yellowing of the skin and the whites in the eyes, itching, dark urine and light-coloured stools or pain in the upper right side or middle of the stomach area
Croatian: Javite se liječniku ili u hitnu medicinsku službu ako se Vašem djetetu pojavi žutilo kože i bjeloočnica, svrbež, tamna boja mokraće i svijetla boja stolice ili bol u gornjem desnom ili srednjem dijelu trbuha.
English: Contact your doctor or the emergency unit if you experience yellowing of the skin and the whites in the eyes, itching, dark urine and light-coloured stools or pain in the upper right side or middle of the stomach area
Croatian: Javite se liječniku ili u hitnu medicinsku službu ako se pojavi žutilo kože i bjeloočnica, svrbež, tamna boja mokraće i svijetla boja stolice ili bol u gornjem desnom ili srednjem dijelu trbuha.
English: Revestive is a powder and solvent for solution for injection (5 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Croatian: Revestive je prašak i otapalo za otopinu za injekciju (5 mg teduglutida u bočici, 0,5 ml otapala u napunjenoj štrcaljki).
English: 1.25 mg strength Volume to be injected
Croatian: Jačina 1,25 mg Volumen injekcije
English: - Do not use Revestive after the expiry date which is stated on the carton, the vial and the pre-filled syringe.
Croatian: - Revestive se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, bočici i napunjenoj štrcaljki.
English: Revestive is a powder and solvent for solution for injection (1.25 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Croatian: Revestive je prašak i otapalo za otopinu za injekciju (1,25 mg teduglutida u bočici, 0,5 ml otapala u napunjenoj štrcaljki).
English: 1.1 Take the pre-filled syringe with solvent and flip off the top part of the white plastic cap so that it is ready for the reconstitution needle to be attached.
Croatian: 1.1 Uzmite napunjenu štrcaljku s otapalom i uklonite gornji dio bijelog plastičnog zatvarača kako biste na nju mogli postaviti iglu za pripremu otopine.
English: 4.2 Clean the intended site of injection on your skin with an alcohol swab, using a circular motion, working outwards.
Croatian: 4.2 Mjesto na koži koje ste odabrali za davanje injekcije očistite alkoholnom maramicom, kružnim pokretima prema van.
English: Respiratory tract infection*
Croatian: Infekcije i infestacije infekcije dišnog sustava*
English: No dose adjustment is necessary for paediatric patients with mild renal impairment.
Croatian: Nije potrebna prilagodba doze u pedijatrijskih bolesnika s blagim oštećenjem bubrega.
English: If a polyp is found, adherence to current polyp follow-up guidelines is recommended.
Croatian: Vidjeti također dio 5.1. Ako se pronađe polip, preporučuje se slijediti važeće smjernice o praćenju polipa.
English: Common (may affect up to 1 in 10 people): - Flu (influenza) or flu-like symptoms - Decreased appetite - Swelling of hands and/or feet - Problems sleeping, anxiety - Cough, shortness of breath - Polyps (small abnormal growths) in your child's large bowel - Passing gas (flatulence) - Narrowing or blockage of your child's pancreatic duct, which may cause inflammation of the pancreas - Inflammation of the gallbladder
Croatian: Često (mogu se javiti u do 1 na 10 osoba): - gripa ili simptomi slični gripi - smanjeni apetit - oticanje šaka i/ili stopala - teškoće sa spavanjem, tjeskoba - kašalj, nedostatak zraka - polipi (male neprirodne izrasline) u debelom crijevu Vašega djeteta - vjetrovi (flatulencija) - suženje ili začepljenost gušteračnog voda Vašega djeteta što može prouzročiti upalu gušterače - upala žučnog mjehura.
English: The recommended dose of Revestive is 0.05 mg/kg body weight once daily.
Croatian: Preporučena doza lijeka Revestive je 0,05 mg/kg tjelesne težine jedanput dnevno.
English: Results below correspond to the ITT population at the recommended dose of 0.05 mg/kg/day.
Croatian: Niže prikazani rezultati odnose se na populaciju predviđenu za liječenje koja je primala preporučenu dozu od 0,05 mg/kg na dan.
English: Powder and solvent for solution for injection 28 vials of powder containing 1,25 mg teduglutide 28 pre-filled syringes containing 0.5 ml of solvent
Croatian: Prašak i otapalo za otopinu za injekciju 28 bočica praška koje sadrže 1,25 mg teduglutida 28 napunjenih štrcaljki koje sadrže 0,5 ml otapala
English: 2.4 Leave the reconstitution needle and empty syringe in the vial.
Croatian: 2.4 Iglu za pripremu otopine i praznu štrcaljku ostavite u bočici.
English: 2.3 Taking the powder vial, insert the reconstitution needle attached to the assembled pre-filled syringe into the centre of the rubber stopper and gently push the plunger all the way down to inject all the solvent into the vial.
Croatian: 2.3 Uzmite bočicu s praškom, umetnite iglu za pripremu otopine pričvršćenu na sastavljenoj napunjenoj štrcaljki kroz sredinu gumenog čepa i nježno do kraja pritisnite klip kako biste ubrizgali sav sadržaj otapala u bočicu.
English: Concomitant medicinal products
Croatian: Istodobno uzimanje lijekova
English: The mean change in parenteral nutrition volume from baseline at Week 12 in the ITT population, based on physician-prescribed data, was -2.57 (±3.56) l/week, correlating to a -39.11% (±40.79) mean decrease, compared to 0.43 (±0.75) l/week, correlating to a 7.38% (±12.76) increase in the standard of care cohort.
Croatian: Na temelju podataka o parenteralnoj prehrani koju su propisali liječnici, srednja vrijednost promjene u volumenu parenteralne prehrane od početka do 12. tjedna u populaciji predviđenoj za liječenje (ITT) iznosila je -2,57 (±3,56) l tjedno, što odgovara srednjoj vrijednosti smanjenja od -39,11% (±40,79), u usporedbi s 0,43 (±0,75) l tjedno što odgovara povećanju od 7,38% (±12,76) u skupini na standardnoj skrbi.