FrancophonIA/ELRC3.0 huggingface dataset:
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at Weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At Week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Croatian: U pedijatrijskih bolesnika s umjerenom do teškom Crohnovom bolešću, otvorena indukcijska doza adalimumaba bila je 160/80 mg ili 80/40 mg u nultom, odnosno drugom tjednu, ovisno o graničnoj vrijednosti za tjelesnu težinu od 40 kg.
English: • After proper training, the injection can be given by your child or given by another person, for example, a family member or friend.
Croatian: Nakon primjerene obuke, injekciju si možete dati sami, ili Vam je može dati druga osoba, primjerice član obitelji ili prijatelj.
English: At Week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 17.
Croatian: U četvrtom tjednu su ispitanici randomizirani u omjeru 1:1 na temelju njihove tjelesne težine u tom trenutku za liječenje niskom dozom ili standardnom dozom održavanja, kako je prikazano u Tablici 17.
English: First dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by an 80 mg dose (one 80 mg injection) two weeks later.
Croatian: Prva doza od 160 mg (dvije injekcije od 80 mg u jednom danu ili jedna injekcija od 80 mg na dan tijekom dva uzastopna dana), nakon koje dva tjedna kasnije slijedi doza od 80 mg (jedna injekcija od 80
English: At Week 16, more patients randomised to Humira 0.8 mg/kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg/kg eow or MTX.
Croatian: postigao je veći broj bolesnika randomiziranih za liječenje lijekom Humira u dozi od 0,8 mg/kg nego onih randomiziranih za primanje doze od 0,4 mg/kg svaki drugi tjedan ili za liječenje MTX-om.
English: If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
Croatian: Ako dobijete vrućicu koja ne prolazi, modrice ili ako jako lako krvarite ili izgledate jako blijedo, odmah nazovite liječnika.
English: The usual Humira dose for adults with ulcerative colitis is 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) at Week 0 and 80 mg (as two 40 mg injections in one day) at Week 2 and thereafter 40 mg every other week.
Croatian: Uobičajena početna doza lijeka Humira za odrasle bolesnike s ulceroznim kolitisom je 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana), nakon čega poslije dva tjedna slijedi doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu).
English: The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritisfrom 2 years of age is based on body weight (Table 1).
Croatian: Poliartikularni juvenilni idiopatski artritis u bolesnika u dobi od 2 i više godina Preporučena doza lijeka Humira za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom u dobi od 2 i više godina određuje se na temelju tjelesne težine (Tablica 1).
English: Packs of: 1 pre-filled syringe with needle guard (0.8 ml sterile solution) in a blister, and 1 alcohol pad.
Croatian: 1 napunjena štrcaljka sa štitnikom za iglu (0,8 ml sterilne otopine) u blisteru, i 1 jastučić natopljen alkoholom.
English: Humira 80 mg solution for injection in pre-filled pen is supplied as a sterile solution of 80 mg adalimumab dissolved in 0.8 ml solution.
Croatian: Humira 80 mg otopina za injekciju u napunjenoj brizgalici dolazi kao sterilna otopina s 80 mg adalimumaba otopljenog u 0,8 ml otopine.
English: PGA: Clear/minimal Percent of patients achieving PASI75 response was calculated as centreadjusted rate p<0.001, Humira vs. placebo
Croatian: 506 (62,2)b a Postotak bolesnika s rezultatom PASI 75 izražen kao stopa prilagođena istraživačkom centru b p<0,001, Humira naspram placeba
English: Table 19 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission Standard Dose 40/20 mg eow
Croatian: Tablica 19 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula Standardna doza 40/20 mg svaki drugi tjedan
English: At Week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 15.
Croatian: U četvrtom tjednu su ispitanici randomizirani u omjeru 1:1 na temelju njihove tjelesne težine u tom trenutku za liječenje niskom dozom ili standardnom dozom održavanja, kako je prikazano u Tablici 15.
English: Table 21 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission Standard Dose 40/20 mg eow
Croatian: Tablica 21 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula Standardna doza 40/20 mg svaki drugi tjedan
English: • arm or leg weakness;
Croatian: • slabost u rukama ili nogama,
English: Ltd Τηλ.
Croatian: često tahikardija
English: 2 alcohol pads
Croatian: 2 jastučića natopljena alkoholom
English: Humira 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Croatian: Humira 40 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica s jednokratnom dozom od 0,8 ml sadrži 40 mg adalimumaba.
English: Myocardial infarction arrhythmia,
Croatian: Nuspojava hipofosfatemija, dehidracija
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Croatian: mučnina i povraćanje često krvarenje u probavnom sustavu, dispepsija, gastroezofagusna refluksna bolest, sicca sindrom manje često pankreatitis, disfagija, edem lica
English: If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.
Croatian: Ako dobijete vrućicu koja ne prolazi, blage modrice ili ako jako lako krvarite ili izgledate jako blijedo, odmah nazovite liječnika.
English: At Week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 25.
Croatian: U četvrtom tjednu su ispitanici randomizirani u omjeru 1:1 na temelju njihove tjelesne težine u tom trenutku za liječenje niskom dozom ili standardnom dozom održavanja, kako je prikazano u Tablici 25.
English: • tremor;
Croatian: • vrtoglavica,
English: Pad
Croatian: Vata
English: Tel: +386 (1)32 08 060
Croatian: AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060
English: Humira 40 mg Weekly
Croatian: Humira 40 mg svaki tjedan Placebo
English: PsA Study II
Croatian: Ispitivanje PsA II
English: Humira showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to Week 12 compared to placebo.
Croatian: Physical Component Score, PCS) upitnika SF-36 u usporedbi s placebom.
English: Table 27 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission Standard Dose 40/20 mg eow
Croatian: Tablica 27 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula Standardna doza 40/20 mg svaki drugi tjedan
English: Do not use the product after the month and year shown.
Croatian: Lijek se ne smije upotrijebiti nakon navedenog roka valjanosti.
English: Liver failure
Croatian: • zatajenje jetre
English: When needed (for example, when you are travelling), a single Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Croatian: Ako je potrebno (primjerice, ako putujete), pojedinačna napunjena brizgalica otopine lijeka Humira može se čuvati na sobnoj temperaturi (do 25°C) najviše do 14 dana - pazite da je zaštitite od svjetlosti.
English: • children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye
Croatian: • odraslih osoba s nezaraznim uveitisom kod kojega upala zahvaća stražnji dio oka • djece u dobi od 2 i više godina s kroničnim nezaraznim uveitisom kod kojega upala zahvaća prednji dio oka
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo (See Table 22).
Croatian: Klinički odgovor Rezultati iz obaju ispitivanja pokazali su statistički značajno smanjenje rizika od neuspjeha liječenja u bolesnika liječenih lijekom Humira u odnosu na one koji su primali placebo (vidjeti Tablicu 22).
English: Muscle spasms (including blood creatine phosphokinase increased)
Croatian: • niska razina kalcija u krvi • niska razina fosfata u krvi
English: Beyond 16 weeks, patients with inadequate response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Croatian: U bolesnika u kojih nije postignut zadovoljavajući odgovor na lijek Humira u dozi od 40 mg svaki drugi tjedan nakon 16 tjedana, možda će biti korisno povećati doziranje na 40 mg lijeka svaki tjedan ili 80 mg svaki drugi tjedan.
English: Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Croatian: Humira 40 mg otopina za injekciju u napunjenoj štrcaljki dolazi kao sterilna otopina s 40 mg adalimumaba otopljenog u 0,8 ml otopine.
English: The third group received 40 mg of Humira every other week with placebo injections on alternate weeks.
Croatian: Druga je dobivala 20 mg lijeka Humira svaki tjedan tijekom 52 tjedna, dok je treća skupina svaki tjedan naizmjenično dobivala 40 mg lijeka Humira ili injekcije placeba (jedan tjedan 40 mg lijeka Humira, drugi tjedan placebo).
English: • expiry (EXP) date has passed
Croatian: • ako je istekao navedeni rok valjanosti (Rok valjanosti, EXP)
English: Keep the pre-filled syringe in its outer carton in order to protect from light.
Croatian: Napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: In addition cases of non-melanoma skin cancer have been observed in patients taking Humira.
Croatian: • U bolesnika koji primjenjuju lijek Humira zamijećeni su i slučajevi nemelanomskog raka kože.
English: Humira 40 mg solution for injection in pre-filled syringe Each 0.4 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Croatian: Humira 40 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka s jednokratnom dozom od 0,4 ml sadrži 40 mg adalimumaba.
English: ANNEX I
Croatian: Tablica 11
English: In patients with Crohn's disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5.5 g/ml during the induction period.
Croatian: Humira u nultom tjednu i zatim 40 mg u 2. tjednu postignute su najniže serumske koncentracije adalimumaba od približno 5,5 μg/ml.
English: Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml solution.
Croatian: Humira 40 mg otopina za injekciju u napunjenoj brizgalici dolazi kao sterilna otopina s 40 mg adalimumaba otopljenog u 0,4 ml otopine.
English: paleness
Croatian: Imunogenost
English: • 2 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 2 napunjene štrcaljke (0,8 ml sterilne otopine), svaka s 1 jastučićem natopljenim alkoholom, u blisteru.
English: It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Croatian: Važno je da kažete liječniku ako se u djeteta pojave simptomi infekcije kao što su vrućica, rane, osjećaj umora i problemi sa zubima.
English: Finger Grip
Croatian: infekcije zglobova
English: • anxiety;
Croatian: • utrnulost,
English: Paraesthesias (including hypoesthesia), migraine, nerve root compression
Croatian: migrena, kompresija korijena živca
English: Humira 40 mg eow N=109
Croatian: Humira 40 mg svaki drugi tjedan N=109
English: • 6 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 6 napunjenih štrcaljki (0,8 ml sterilne otopine), svaka s 1 jastučićem natopljenim alkoholom, u blisteru.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo (See Table 24).
Croatian: Klinički odgovor Rezultati iz obaju ispitivanja pokazali su statistički značajno smanjenje rizika od neuspjeha liječenja u bolesnika liječenih lijekom Humira u odnosu na one koji su primali placebo (vidjeti Tablicu 24).
English: Anaphylaxis
Croatian: anemija
English: 1 sterile vial adapter
Croatian: 1 sterilni nastavak za bočicu
English: Throwing away supplies
Croatian: OTPADNIH MATERIJALA KOJI POTJEČU
English: Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Croatian: Jedna bočica s jednokratnom dozom od 0,8 ml sadrži 40 mg adalimumaba.
English: Paediatric plaque psoriasis Age or body weight
Croatian: Plak psorijaza u djece Dob ili tjelesna težina
English: Adverse Reaction administration site conditions*
Croatian: Opći poremećaji i reakcije na mjestu primjene*
English: • 4 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 4 napunjene štrcaljke (0,8 ml sterilne otopine), svaka s 1 jastučićem natopljenim alkoholom, u blisteru.
English: If your child takes Humira the risk of getting lymphoma, leukemia, or other cancers may increase.
Croatian: Rizik obolijevanja od limfoma, leukemije ili drugih tumora može se povećati ako Vaše dijete primjenjuje lijek Humira.
English: • 6 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 6 napunjenih štrcaljki (0,4 ml sterilne otopine), svaka s 1 jastučićem natopljenim alkoholom, u blisteru.
English: • 2 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 2 napunjene brizgalice (0,4 ml sterilne otopine), svaka s 1 jastučićem natopljenim alkoholom, u blisteru.
English: The safety and efficacy of Humira were studied in adult patients with chronic plaque psoriasis ( 10% BSA involvement and Psoriasis Area and Severity Index (PASI)  12 or  10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Croatian: Psoriasis Area and Severity Index, PASI] ≥ 12 ili ≥ 10) koji su bili kandidati za sistemsku terapiju ili fototerapiju u randomiziranim, dvostruko slijepim ispitivanjima.
English: Your child should not take Humira with medicines containing the following active substances due to increased risk of serious infection:
Croatian: Zbog povećanog rizika od ozbiljne infekcije, Vaše dijete ne smije primjenjivati lijek Humira s drugim lijekovima koji sadrže sljedeće djelatne tvari:
English: Plum Activator Button
Croatian: Bordo tipka za aktivaciju
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at Week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at Week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Croatian: U slučaju da postoji potreba za bržim odgovorom na terapiju, terapija se može započeti dozom od 160 mg u nultom tjednu (primijenjenom u obliku četiri injekcije od 40 mg u jednom danu ili kao dvije injekcije od 40 mg na dan kroz dva uzastopna dana) i 80 mg u drugom tjednu (primijenjenom u obliku dvije injekcije od
English: If a faster response is required, your child's doctor may prescribe an initial dose of 160 mg initially (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik djetetu može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: When needed (for example, when you are travelling), a single Humira pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Croatian: Ako je potrebno (primjerice, ako putujete), pojedinačna napunjena štrcaljka otopine lijeka Humira može se čuvati na sobnoj temperaturi (do 25°C) najviše do 14 dana - pazite da je zaštitite od svjetlosti.
English: • liver failure;
Croatian: • proboj crijeva,
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of Humira in paediatric patients with plaque psoriasis.
Croatian: U ispitivanju faze III u kojem se Humira primjenjivala u pedijatrijskih bolesnika s plak psorijazom,
English: • fatty liver;
Croatian: • masna jetra,
English: Humira 80 mg solution for injection in pre-filled pen Each 0.8 ml single dose pre-filled pen contains 80 mg of adalimumab.
Croatian: Humira 80 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica s jednokratnom dozom od 0,8 ml sadrži 80 mg adalimumaba.
English: • 4 pre-filled pens (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 4 napunjene brizgalice (0,8 ml sterilne otopine), svaka s 1 jastučićem natopljenim alkoholom, u blisteru.
English: • Adolescent hidradenitis suppurativa
Croatian: • gnojnog hidradenitisa u adolescenata
English: • 4 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 4 napunjene brizgalice (0,4 ml sterilne otopine), svaka s 1 jastučićem natopljenim alkoholom, u blisteru.
English: • 6 pre-filled pens (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 6 napunjenih brizgalica (0,8 ml sterilne otopine), svaka s 1 jastučićem natopljenim alkoholom, u blisteru.
English: Not known
Croatian: U ispitivanju
English: • 6 pre-filled pens (0.4 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 6 napunjenih brizgalica (0,4 ml sterilne otopine), svaka s 1 jastučićem natopljenim alkoholom, u blisteru.
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik Vam može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan u dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 1, P < 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Croatian: Adalimumab je značajno odgodio vrijeme do neuspjeha liječenja u odnosu na placebo (vidjeti Sliku 1, P < 0,0001 iz log-rang testa).
English: Eye disorders
Croatian: oticanje očiju
English: Humira 40 mg solution for injection in pre-filled pen is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Croatian: Humira 40 mg otopina za injekciju u napunjenoj brizgalici dolazi kao sterilna otopina s 40 mg adalimumaba otopljenog u 0,8 ml otopine.
English: Suomi/Finland AbbVie Oy
Croatian: Suomi/Finland
English: Cerebrovascular accident
Croatian: • moždani udar
English: Keep Humira out of the sight and reach of children.
Croatian: Čuvajte lijek Humira izvan pogleda i dohvata djece.
English: Crohn's disease in adults and children
Croatian: Crohnova bolest u djece
English: • 2 pre-filled syringes with automatic needle guard (0.4 ml sterile solution), each with 1 alcohol pad, in a blister.
Croatian: • 2 napunjene štrcaljke s automatskim štitnikom za iglu (0,4 ml sterilne otopine), svaka s 1
English: • itchy rash
Croatian: • tjeskoba
English: In monotherapy, some patients who experience a decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Croatian: U slučaju monoterapije, u nekih bolesnika u kojih je došlo do slabljenja odgovora na liječenje lijekom Humira u dozi od 40 mg svaki drugi tjedan možda će biti korisno povećati doziranje adalimumaba na
English: Humira 40 mg solution for injection in pre-filled pen adalimumab
Croatian: Humira 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
English: Clinical Response Clinical Remission Mucosal Healing
Croatian: Indukcija kliničke remisije i kliničkog odgovora
English: Content (concentration)
Croatian: Sastav (koncentr acija)
English: 1 dose (0.5 ml): Hepatitis A virus (inactivated)1,2
Croatian: 1 doza (0,5 ml) sadrži: inaktivirani virus hepatitisa
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Croatian: 10 mikrograma proizveden na humanim diploidnim (MRC-5) stanicama adsorbiran na aluminijev hidroksid, hidratizirani
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Croatian: Al proizveden tehnologijom rekombinantne DNK na stanicama kvasca (Saccharomyces cerevisiae) adsorbiran na aluminijev fosfat
English: Hepatitis B surface antigen3,4
Croatian: 360 ELISA jedinica površinski antigen virusa hepatitisa B
English: 10 micrograms
Croatian: 0,025 miligrama
English: 1 pre-filled syringe without needle
Croatian: 1 napunjena štrcaljka bez igle
English: EMA procedure number
Croatian: Broj (EU) odobrenja
English: (Invented) name Strength Pharmaceutical form Route of administration
Croatian: (Zaštićeno) ime Doza
English: This means it has a long duration of action.
Croatian: To znači da dulje djeluje.
English: The study in children lasted 16 weeks.
Croatian: Ispitivanja provedena na djeci trajala su 16 tjedana.
English: The full EPAR for Ryzodeg can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Ryzodeg nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: All the studies in adults lasted six months, but one was extended to one year.
Croatian: Sva su ispitivanja provedena na odraslima trajala šest mjeseci, a jedno je produljeno na jednu godinu.
English: The dose of Ryzodeg is determined individually for each patient.
Croatian: Doza lijeka Ryzodeg određuje se pojedinačno za svakog bolesnika.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ryzodeg on 21 January 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Ryzodeg u promet koje vrijedi na prostoru Europske unije od 21. siječnja 2013.
English: What measures are being taken to ensure the safe and effective use of Ryzodeg?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ryzodeg?
English: Other information about Ryzodeg
Croatian: Ostale informacije o lijeku Ryzodeg
English: Ryzodeg is injected once or twice a day, at mealtimes.
Croatian: Ryzodeg se ubrizgava jedanput ili dvaput dnevno uz obrok.
English: Because the dose requirements in young children may not be stable and because they cannot express symptoms of hypoglycaemia, Ryzodeg is not suitable for children aged under 2 years.
Croatian: Budući da zahtjevi koji se odnose na doziranje u male djece nisu stabilni i budući da ona ne mogu izraziti simptome hipoglikemije, lijek Ryzodeg nije primjeren za djecu ispod navršene 2. godine života.