FrancophonIA/ELRC3.0 huggingface dataset:
English: • Ensuring you use the right type of insulin - always check the insulin label before each injection to avoid accidentally confusing Ryzodeg with other insulin products.
Croatian: • Provjerite koristite li odgovarajuću vrstu inzulina - uvijek provjerite naljepnicu na inzulinu prije svakog injiciranja kako biste izbjegli slučajnu zabunu između Ryzodeg inzulina i drugih inzulinskih pripravaka.
English: The efficacy and safety of Ryzodeg have been studied in a randomised controlled clinical trial in children and adolescents with diabetes mellitus type 1 for a period of 16 weeks (n=362).
Croatian: Djelotvornost i sigurnost lijeka Ryzodeg ispitivane su u randomiziranom, kontroliranom kliničkom ispitivanju provedenom u djece i adolescenata sa šećernom bolešću tipa 1 tijekom razdoblja od 16 tjedana (n=362).
English: Patients should not take an extra dose to make up for a missed dose.
Croatian: Bolesnik ne smije primijeniti dodatnu dozu kako bi nadoknadio izostavljenu dozu.
English: Total exposure of insulin degludec after single dose administration was, however, higher in children and adolescents than in adults with type 1 diabetes mellitus.
Croatian: Međutim, ukupna izloženost degludek inzulinu nakon primjene jedne doze bila je viša u djece i adolescenata nego u odraslih sa šećernom bolešću tipa 1.
English: Transferring a patient to another type, brand or manufacturer of insulin must be done under medical supervision and may result in the need for a change in dosage.
Croatian: Prijelaz s drugih inzulinskih pripravaka Prebacivanje bolesnika na drugu vrstu, naziv ili inzulin drugog proizvođača mora se provesti pod medicinskim nadzorom i može dovesti do potrebe za promjenom doze.
English: The pharmacodynamic effect of Ryzodeg is distinctively separated for the two components (Figure 1), and the resulting action profile reflects the individual components, the rapid-acting insulin aspart and the basal component insulin degludec.
Croatian: Farmakodinamički učinak lijeka Ryzodeg jasno je odvojen za dva sastojka (slika 1), a dobiveni profil djelovanja odražava pojedinačne sastojke, brzodjelujući aspart inzulin i bazalni sastojak, degludek inzulin.
English: The rates (events per patient-year of exposure) of confirmed hypoglycaemia (ISPAD 2009 definition: 46.23 vs 49.55) and nocturnal confirmed hypoglycaemia (5.77 vs 5.40) were comparable with Ryzodeg vs insulin detemir whereas the rate of severe hypoglycaemia (0.26 vs 0.07) was higher in the Ryzodeg arm although the difference was not statistically significant.
Croatian: Stope (događaji po bolesnik-godini izloženosti) potvrđene hipoglikemije (prema ISPAD definiciji iz 2009.: 46,23 naspram 49,55) i noćne potvrđene hipoglikemije (5,77 naspram 5,40) bile su usporedive u skupini koja je primala Ryzodeg i onoj koja je primala detemir inzulin, dok je stopa teške hipoglikemije bila viša u skupini koja je primala Ryzodeg (0,26 naspram 0,07) iako razlika nije bila statistički značajna.
English: Degradation of insulin degludec and insulin aspart is similar to that of human insulin; all metabolites formed are inactive.
Croatian: Razgradnja degludek inzulina i aspart inzulina slična je razgradnji humanog inzulina; svi nastali metaboliti su neaktivni.
English: • if the insulin does not appear clear and colourless.
Croatian: • Ako inzulin nije bistar i bezbojan.
English: Before you use Ryzodeg for the first time, your doctor or nurse will show you how to use it.
Croatian: Prije prve primjene lijeka Ryzodeg, Vaš liječnik ili medicinska sestra pokazat će Vam kako se koristi.
English: The recommended starting dose of Ryzodeg is 60-70% of the total daily insulin requirements in combination with short-/rapid-acting insulin at the remaining meals followed by individual dosage adjustments.
Croatian: Preporučena početna doza lijeka Ryzodeg iznosi 60-70% od ukupnih dnevnih potreba za inzulinom u kombinaciji s kratkodjelujućim/brzodjelujućim inzulinom uz ostale obroke, nakon čega slijedi individualna prilagodba doze.
English: Dose-adjustments are recommended to be based on fasting plasma glucose measurements.
Croatian: Preporučuje se prilagoditi dozu na temelju izmjerenih vrijednosti glukoze u plazmi natašte.
English: • Ryzodeg is given as an injection under the skin (subcutaneous injection).
Croatian: • Ryzodeg se primjenjuje potkožnom (supkutanom) injekcijom.
English: Few severe hypoglycaemic episodes were reported in each group; the observed rate of severe hypoglycaemia within the Ryzodeg arm was higher for subjects aged 2-5 years compared to subjects aged 6-11 years or 12-17 years (0.42 vs 0.21 and 0.21 respectively).
Croatian: U obje je skupine prijavljen malen broj epizoda teške hipoglikemije; opažena stopa teške hipoglikemije u skupini koja je primala Ryzodeg bila je viša među ispitanicima u dobi od 2-5 godina u usporedbi s ispitanicima u dobi od 6-11 ili 12-17 godina (0,42 naspram 0,21 odnosno 0,21).
English: eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin without talking to your doctor.
Croatian: Previsoka razina šećera u krvi može nastupiti ako: jedete više ili vježbate manje nego obično; pijete alkohol; dobijete infekciju ili vrućicu; niste primijenili dovoljno inzulina; primjenjujete manje inzulina nego što Vam je potrebno; zaboravite primijeniti inzulin ili prestanete primjenjivati inzulin bez prethodnog razgovora s liječnikom.
English: End of trial
Croatian: Na kraju ispitivanja
English: The trial had a median duration of 2 years and compared the cardiovascular safety of insulin degludec vs insulin glargine (100 units/mL) in 7,637 patients with type 2 diabetes mellitus at high risk of cardiovascular events.
Croatian: Ispitivanje je imalo medijan trajanja od 2 godine te se uspoređivala kardiovaskularna sigurnost degludek inzulina u odnosu na glargin inzulin (100 jedinica/ml) u 7637 bolesnika sa šećernom bolešću tipa 2 i visokim rizikom od kardiovaskularnih događaja.
English: Seven multinational, randomised, controlled, open-label, treat-to-target clinical studies of between 26 and 52 weeks' duration were conducted exposing a total of 1,761 patients with diabetes mellitus (1 study involving 362 patients in type 1 diabetes mellitus and 6 studies involving 1,399 patients in type 2 diabetes mellitus) to Ryzodeg.
Croatian: Klinička djelotvornost i sigurnost Provedeno je sedam multinacionalnih, randomiziranih, kontroliranih, otvorenih kliničkih ispitivanja s titracijom do postizanja ciljnih vrijednosti u trajanju od 26 do 52 tjedna, u kojima je lijeku Ryzodeg ukupno bio izložen 1761 bolesnik sa šećernom bolešću (1 ispitivanje u kojem su sudjelovala 362 bolesnika sa šećernom bolešću tipa 1 i 6 ispitivanja u kojima je sudjelovalo 1399 bolesnika sa šećernom bolešću tipa 2).
English: Pregnancy There is no clinical experience with the use of this medicinal product in pregnant women.
Croatian: Nema kliničkog iskustva s primjenom ovog lijeka u trudnica.
English: • The other ingredients are glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections (see section 2).
Croatian: • Drugi sastojci su glicerol, metakrezol, fenol, natrijev klorid, cinkov acetat, kloridna kiselina i natrijev hidroksid (za podešavanje pH) i voda za injekcije (vidjeti dio 2).
English: Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Croatian: Otopina za injekciju (FlexTouch) Višestruko pakiranje: 10 (2 pakiranja po 5) napunjenih brizgalica od 3 ml
English: Ryzodeg must not be added to infusion fluids.
Croatian: Ryzodeg se ne smije dodavati u infuzijske otopine.
English: Combination of pioglitazone and insulin medicinal products Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac failure.
Croatian: Prijavljeni su slučajevi zatajivanja srca kod primjene pioglitazona u kombinaciji s inzulinom, osobito u bolesnika koji su imali rizične faktore za razvoj zatajivanja srca.
English: With Ryzodeg, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely.
Croatian: Kod primjene lijeka Ryzodeg, preosjetljivost (koja se očituje oticanjem jezika i usana, proljevom, mučninom, umorom i svrbežom) i urtikarija rijetko su prijavljene.
English: If you stop using Ryzodeg
Croatian: Ako prestanete primjenjivati Ryzodeg
English: There is no clinical experience with Ryzodeg during breast-feeding.
Croatian: Nema kliničkog iskustva s primjenom lijeka Ryzodeg tijekom dojenja.
English: DEVOTE was a randomised, double-blind, and event-driven clinical trial focusing on insulin degludec, the long-acting component of Ryzodeg.
Croatian: Ispitivanje DEVOTE bilo je randomizirano, dvostruko slijepo kliničko ispitivanje vođeno događajima, usredotočeno na degludek inzulin, dugodjelujuću sastavnicu lijeka Ryzodeg.
English: • Basal insulin called insulin degludec, this has a long blood sugar-lowering effect.
Croatian: • Bazalni inzulin pod nazivom degludek inzulin, on ima produljeni učinak na snižavanje razine šećera u krvi.
English: Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Ryzodeg.
Croatian: Reakcije na mjestu injiciranja (uključujući hematom na mjestu injiciranja, bol, krvarenje, eritem, čvoriće, oticanje, promjenu boje, svrbež, toplinu i oteklinu na mjestu injiciranja) javile su se u bolesnika liječenih lijekom Ryzodeg.
English: EU/1/12/806/001 1 pen of 3 mL EU/1/12/806/002 1 pen of 3 mL and 7 NovoFine needles EU/1/12/806/003 1 pen of 3 mL and 7 NovoTwist needles EU/1/12/806/004 5 pens of 3 mL
Croatian: EU/1/12/806/001 1 brizgalica od 3 ml EU/1/12/806/002 1 brizgalica od 3 ml i 7 NovoFine igala EU/1/12/806/003 1 brizgalica od 3 ml i 7 NovoTwist igala EU/1/12/806/004 5 brizgalica od 3 ml
English: The total and maximum glucose-lowering effects of Ryzodeg increase linearly with increasing doses.
Croatian: Učinci lijeka Ryzodeg na snižavanje ukupne i najviše razine glukoze linearno se povećavaju povećanjem doza.
English: It is unknown whether insulin degludec/insulin aspart is excreted in human milk.
Croatian: Nije poznato izlučuje li se degludek inzulin/aspart inzulin u majčino mlijeko u ljudi.
English: An efficacy and safety evaluation for adolescent patients with type 2 diabetes mellitus has been made using data from adolescent and adult patients with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus.
Croatian: Napravljena je procjena djelotvornosti i sigurnosti za adolescente koji boluju od šećerne bolesti tipa 2 koristeći podatke adolescenata i odraslih koji boluju od šećerne bolesti tipa 1 te odraslih bolesnika sa šećernom bolešću tipa
English: In type 1 diabetes mellitus, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Croatian: U šećernoj bolesti tipa 1 neliječena hiperglikemija može dovesti do dijabetičke ketoacidoze, koja može biti smrtonosna.
English: The pharmacokinetic properties of insulin degludec in children (1-11 years) and adolescents (1218 years) were at steady state comparable to those observed in adults with type 1 diabetes mellitus.
Croatian: Farmakokinetička svojstva degludek inzulina u djece (1-11 godina) i adolescenata (12-18 godina) su u stanju dinamičke ravnoteže bila usporediva s onima zapaženima u odraslih sa šećernom bolešću tipa
English: How to store Ryzodeg
Croatian: Kako primjenjivati Ryzodeg
English: This medicinal product is to be used once daily at mealtime in combination with short-/rapid-acting insulin at the remaining meals followed by individual dosage adjustments.
Croatian: Ovaj lijek se treba koristiti jednom dnevno u vrijeme obroka, u kombinaciji s kratkodjelujućim/brzodjelujućim inzulinom uz ostale obroke, nakon čega slijedi individualna prilagodba doze.
English: Primary analysis (3-point MACE) CV Death
Croatian: Primarna analiza (trokomponentni MACE)
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Ryzodeg and other insulin products.
Croatian: Bolesnicima se mora objasniti da prije svakog injiciranja uvijek provjere naljepnicu na inzulinu radi izbjegavanja slučajne zamjene lijeka Ryzodeg i drugih inzulinskih pripravaka.
English: Hypoglycaemia Rate (per patient year of exposure) Severe
Croatian: Stopa hipoglikemije (za izloženost po bolesnik-godina)
English: Ryzodeg showed a lower rate of nocturnal hypoglycaemia compared to IGlar o.d. plus IAsp during 26 weeks (0.42 vs 0.76 estimated rates per patient year of exposure) and 38 weeks (0.51 vs 0.83 estimated rates per patient year of exposure).
Croatian: Uz Ryzodeg je zabilježena niža stopa noćne hipoglikemije u usporedbi s IGlar j.d. plus IAsp tijekom 26 tjedana (0,42 naspram 0,76 procijenjene stope za izloženost po bolesnik-godina) i 38 tjedana (0,51 naspram 0,83 procijenjene stope za izloženost po bolesnikgodina).
English: Ryzodeg allows for flexibility in the timing of insulin administration as long as it is dosed with the main meal(s).
Croatian: Fleksibilno vrijeme doziranja Ryzodeg omogućuje fleksibilnost vremena primjene inzulina sve dok se dozira uz glavni obrok
English: Ryzodeg dosed once daily with the main meal plus insulin aspart for the remaining meals showed similar reduction in HbA1c at week 16 and no differences in FPG and SMPG compared to comparator insulin detemir dosed once or twice daily plus mealtime insulin aspart.
Croatian: Ryzodeg primijenjen jednom dnevno uz glavni obrok plus aspart inzulin primijenjen uz preostale obroke ostvarili su slično smanjenje HbA1c u 16. tjednu bez razlika u razinama glukoze u plazmi natašte i razinama glukoze u plazmi kod samostalnog mjerenja u usporedbi s komparatorom detemir inzulinom primijenjenim jednom ili dvaput dnevno plus aspart inzulinom primijenjenim uz obroke.
English: Before you use Ryzodeg for the first time, your doctor or nurse will show you how to use the pre-filled pen.
Croatian: Prije prve primjene lijeka Ryzodeg, Vaš liječnik ili medicinska sestra pokazat će Vam kako se koristi napunjena brizgalica.
English: The pharmacokinetic properties of Ryzodeg in type 1 diabetes mellitus were investigated in children (6-11 years) and adolescents (12-18 years) and compared to adults after single dose administration.
Croatian: Farmakokinetička svojstva lijeka Ryzodeg kod šećerne bolesti tipa 1 ispitivana su u djece (6-11 godina) i adolescenata (12-18 godina) i uspoređena s odraslima nakon primjene jedne doze.
English: Ryzodeg (o.d.)1
Croatian: Ryzodeg (d.d.)1
English: Ryzodeg can be administered once daily at mealtime in combination with short-/rapid-acting insulin at the remaining meals.
Croatian: Ryzodeg se može primjenjivati jednom dnevno u vrijeme obroka, u kombinaciji s kratkodjelujućim/brzodjelujućim inzulinom uz preostale obroke.
English: Ryzodeg may be associated with higher occurrence of severe hypoglycaemia compared to a basal-bolus regimen in the paediatric population, particularly in children 2 to 5 years old (see section 5.1).
Croatian: Ryzodeg može biti povezan s češćom pojavom teške hipoglikemije u usporedbi s bazal-bolus režimom u pedijatrijskoj populaciji, osobito u djece u dobi od
English: A lower rate of nocturnal hypoglycaemia (defined as episodes between midnight and 6 a.m. confirmed by plasma glucose < 3.1 mmol/L or by patient needing third party assistance) was observed with Ryzodeg relative to IGlar (Table 1).
Croatian: Niža stopa noćnih hipoglikemija (definirane kao epizode u vremenu od ponoći do 6 sati ujutro, potvrđene vrijednošću glukoze u plazmi <3,1 mmol/l ili time što je bolesniku bila potrebna pomoć druge osobe) zabilježena je kod primjene lijeka Ryzodeg u usporedbi s IGlar (Tablica 1).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Važne informacije o nekim sastojcima lijeka Ryzodeg Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi.
English: As Ryzodeg contains a rapid-acting mealtime insulin (insulin aspart), prandial glycaemic control at the dosing meal is improved relative to administering basal insulin only; see trial results in Table 1.
Croatian: Budući Ryzodeg sadrži brzodjelujući inzulin koji se primjenjuje uz obrok (aspart inzulin), regulacija prandijalne glikemije kod primjene doze uz obrok poboljšana je u usporedbi s primjenom samog bazalnog inzulina; vidjeti rezultate ispitivanja u Tablici
English: • Please also read the manual that comes with your insulin delivery system.
Croatian: • Pročitajte i upute za uporabu koje su priložene uz Vaše pomagalo za primjenu inzulina.
English: One (1) unit of this insulin corresponds to 1 international unit of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart.
Croatian: Jedna (1) jedinica ovog inzulina odgovara 1 internacionalnoj jedinici humanog inzulina, 1 jedinici glargin inzulina,
English: Difference: -1.14 [-1.53;-0.76]
Croatian: Razlika: -1,14 [-1,53; -0,76]
English: Glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections
Croatian: glicerol, metakrezol, fenol, natrijev klorid, cinkov acetat, kloridnu kiselinu i natrijev hidroksid (za podešavanje pH) i vodu za injekcije.
English: 3 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose < 3.1 mmol/L or by the patient needing third party assistance.
Croatian: 3 Potvrđena hipoglikemija definirana je kao epizoda potvrđena razinom glukoze u plazmi <3,1 mmol/l ili time što je bolesniku potrebna pomoć druge osobe.
English: Always keep Ryzodeg Penfill in the outer carton when you are not using it in order to protect from light.
Croatian: Uvijek držite Ryzodeg Penfill u vanjskoj kutiji kad ga ne koristite, radi zaštite od svjetlosti.
English: This assessment supports the use of Ryzodeg in adolescent patients with type 2 diabetes mellitus.
Croatian: Ta ocjena podupire primjenu lijeka Ryzodeg u adolescenata sa šećernom bolešću tipa 2.
English: There is no experience with the use of this medicine in children below the age of 2 years.
Croatian: Nema iskustva s primjenom ovog lijeka u djece mlađe od 2 godine.
English: Pack sizes of 1 (with or without needles), 5 (without needles) and multipack containing 10 (2 packs of 5) (without needles) pre-filled pens.
Croatian: Veličine pakiranja: 1 (sa ili bez igala), 5 (bez igala) ili višestruko pakiranje koje sadrži 10 (2 pakiranja po 5) (bez igala) napunjenih brizgalica.
English: Figure 1: Pharmacodynamics, single dose - Mean glucose infusion rate profile - Patients with type 1 diabetes - 0.8 U/kg Ryzodeg - Trial 3539
Croatian: - Prosječni profil brzine infuzije glukoze - Bolesnici sa šećernom bolešću tipa 1 - 0,8 U/kg lijeka Ryzodeg - Ispitivanje 3539
English: Total exposure with Ryzodeg increases proportionally with increasing dose of the basal component (insulin degludec) and the mealtime component (insulin aspart) in type 1 and type 2 diabetes mellitus.
Croatian: Uz primjenu lijeka Ryzodeg, ukupna izloženost se proporcionalno povećava povećanjem doze bazalnog sastojka (degludek inzulina) i sastojka koji se primjenjuje uz obrok (aspart inzulin) u šećernoj bolesti tipa 1 i tipa 2.
English: When using Ryzodeg once-daily, changing to twice daily should be considered when higher doses are needed, e.g. to avoid hypoglycaemia.
Croatian: Kada se Ryzodeg primjenjuje jednom dnevno, ako su potrebne veće doze, npr. da bi se izbjegla hipoglikemija, treba razmotriti prelazak na primjenu dva puta dnevno.
English: In patients with type 1 diabetes mellitus, treatment with Ryzodeg o.d. plus IAsp for the remaining meals demonstrated similar glycaemic control (HbA1c and fasting plasma glucose) with a lower rate of nocturnal hypoglycaemia compared to a basal/bolus regimen with IDet plus IAsp at all meals (Table
Croatian: U bolesnika sa šećernom bolešću tipa 1, liječenje lijekom Ryzodeg j.d. zajedno s IAsp uz ostale obroke pokazuje sličnu regulaciju glikemije (HbA1c i glukoza u plazmi natašte) uz nižu stopu noćnih hipoglikemija u usporedbi s bazal/bolus liječenjem s IDet zajedno s IAsp uz sve obroke (Tablica 3).
English: After first opening: Can be stored in a refrigerator (2°C - 8°C).
Croatian: Nakon prvog otvaranja: može se čuvati u hladnjaku (2°C-8°C).
English: The steady-state pharmacokinetic properties of the insulin degludec component of Ryzodeg were investigated using a population pharmacokinetic analysis in children down to 1 year of age.
Croatian: Farmakokinetička svojstva degludek inzulina, kao sastavnice lijeka Ryzodeg, u stanju dinamičke ravnoteže ispitivana su primjenom populacijske farmakokinetičke analize u djece starije od 1 godine.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Ryzodeg Lijek čuvajte izvan pogleda i dohvata djece.
English: The pre-filled pen can provide a dose of 1-80 units in one injection in steps of 1 unit.
Croatian: Napunjena brizgalica može isporučiti dozu od 1-80 jedinica po injekciji u stupnjevima od 1 jedinice.
English: Substances added to Ryzodeg may cause degradation of insulin degludec and/or insulin aspart.
Croatian: Tvari dodane lijeku Ryzodeg mogu izazvati razgradnju degludek inzulina i/ili aspart inzulina.
English: The basal component of Ryzodeg (insulin degludec) forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose-lowering effect.
Croatian: Bazalni sastojak lijeka Ryzodeg (degludek inzulin) tvori topive multiheksamere nakon supkutane injekcije, što rezultira stvaranjem depoa iz kojega se degludek inzulin neprestano i sporo apsorbira u cirkulaciju što dovodi do ravnomjernog i stabilnog učinka na snižavanje glukoze.
English: Elderly, race, renal and hepatic impairment
Croatian: Starije osobe, rasna pripadnost, oštećenje bubrega i jetre
English: The rapid absorption characteristics of the well-established insulin aspart are maintained by Ryzodeg.
Croatian: Svojstva brze apsorpcije dobro poznatog aspart inzulina zadržana su u lijeku Ryzodeg.
English: • Use with the main meal(s); you can change the time of dosing as long as Ryzodeg is dosed with the largest meal(s).
Croatian: • Primijenite ga uz glavni obrok (glavne obroke);možete promijeniti vrijeme doziranja sve dok
English: • Too low blood sugar (hypoglycaemia)
Croatian: • Preniska razina šećera u krvi (hipoglikemija)
English: What to do if you get too high blood sugar
Croatian: Što učiniti ako osjetite prenisku razinu šećera u krvi
English: 5 After your injection • Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
Croatian: • Uvedite vrh igle u vanjski zatvarač igle na ravnoj površini ne dodirujući iglu ili vanjski zatvarač igle.
English: Non-inferiority in HbA1c change from baseline to end-of-trial was confirmed in 6 of the 7 studies against all comparators when treating patients to target, whereas non-inferiority was not confirmed in one study (comparing IDegAsp b.i.d.
Croatian: Neinferiornost promjene HbA1c, od početne vrijednosti do vrijednosti na kraju ispitivanja potvrđena je u 6 od 7 ispitivanja u odnosu na sve usporedne lijekove pri liječenju bolesnika titracijom do postizanja ciljnih vrijednosti, dok u jednom ispitivanju provedenom kod šećerne bolesti tipa 2 (u kojem se
English: was compared with IDeg o.d. plus IAsp (2-4 daily injections) in patients with type 2 diabetes mellitus treated with basal insulin in need of treatment intensification with mealtime insulin.
Croatian: Ryzodeg d.d. uspoređivao se s IDeg j.d. plus IAsp (2-4 injekcije dnevno) u bolesnika sa šećernom bolešću tipa 2 koji su se liječili bazalnim inzulinom i kojima je bilo potrebno intenziviranje liječenja inzulinom koji se primjenjuje uz obrok.