FrancophonIA/ELRC3.0 huggingface dataset:
English: Fiasp 100 units/mL solution for injection in pre-filled pen Store in a refrigerator (2°C-8°C).
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Čuvati u hladnjaku (2°C-8°C).
English: This makes sure that the insulin is flowing properly.
Croatian: Tako ćete biti sigurni da inzulin protječe kroz iglu.
English: • cool pale skin
Croatian: • hladna blijeda koža
English: Table 1 Dose adjustment Mealtime or bedtime blood sugar
Croatian: Tablica 1 Prilagodba doze Šećer u krvi u vrijeme obroka ili prije spavanja
English: Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent a relapse.
Croatian: Kako bi se spriječio relaps, po povratku svijesti bolesniku se preporučuje peroralni unos ugljikohidrata.
English: Patients with type 2 diabetes mellitus
Croatian: Bolesnici sa šećernom bolešću tipa 2
English: Blood glucose monitoring and insulin dose adjustment are recommended to achieve optimal glycaemic control.
Croatian: Za postizanje optimalne regulacije glikemije preporučuje se praćenje razine glukoze u krvi i prilagodba doze inzulina.
English: • To see precisely how much insulin is left, use the dose counter:
Croatian: • Da biste točno vidjeli koliko je inzulina preostalo, koristite brojčanik doze: Okrećite izbornik doze sve dok se brojčanik doze ne zaustavi.
English: postmeal Fiasp: 0.35→0.39 units/kg/day; and mealtime NovoRapid: 0.36→0.38 units/kg/day).
Croatian: 0,35→0,39 jedinica/kg/dan; te NovoRapid uz obrok: 0,36→0,38 jedinica/kg/dan).
English: The cartridge (Penfill) is designed to be used with Novo Nordisk reusable insulin pens and NovoFine Plus, NovoFine or NovoTwist injection needles for subcutaneous injection only.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u ulošku Primjena s inzulinskom brizgalicom za višekratnu uporabu Uložak (Penfill) je namijenjen uporabi s inzulinskim brizgalicama za višekratnu uporabu tvrtke Novo Nordisk i iglama za injekciju NovoFine Plus, NovoFine ili NovoTwist, te je prikladan samo za supkutane injekcije.
English: Fiasp should be injected up to 2 minutes before the start of the meal, with an option to inject up to 20 minutes after starting the meal.
Croatian: Fiasp se treba injicirati do 2 minute prije početka obroka, uz mogućnost injiciranja unutar 20 minuta nakon početka obroka.
English: Patients with type 1 diabetes mellitus
Croatian: Bolesnici sa šećernom bolešću tipa 1
English: phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid/sodium hydroxide (for pH adjustment) and water for injections
Croatian: POPIS POMOĆNIH TVARI fenol, metakrezol, glicerol, cinkov acetat, natrijev hidrogenfosfat dihidrat, argininklorid, nikotinamid (vitamin B3), kloridna kiselina/natrijev hidroksid (za podešavanje pH) i voda za injekcije
English: Pack sizes of 1, 5 or a multipack with 5 x (1 x 10 mL) vials.
Croatian: Veličine pakiranja od 1, 5 ili višestrukog pakiranja koje sadrži 5 (1 x 10 ml) bočica.
English: Fiasp 100 units/mL solution for injection in cartridge Store in a refrigerator (2°C-8°C).
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u ulošku Čuvati u hladnjaku (2°C-8°C).
English: Fiasp is presented as a clear, colourless and aqueous solution for injection in pre-filled pen.
Croatian: Fiasp je bistra, bezbojna i vodena otopina za injekciju u napunjenoj brizgalici.
English: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Bolesnikova sposobnost koncentracije i reagiranja može biti smanjena kao posljedica hipoglikemije.
English: 3 Always use a new needle for each injection to prevent contamination.
Croatian: Uvijek upotrijebite novu iglu za svaku injekciju kako biste spriječili onečišćenje.
English: • Turn the dose selector back until the dose counter shows 0.
Croatian: • Okrećite izbornik doze unazad sve dok brojčanik doze ne dođe na 0.
English: • Pull off the pen cap.
Croatian: • Skinite zatvarač brizgalice.
English: As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naïve patients with type 1 diabetes.
Croatian: Kao općenito pravilo za izračun početne ukupne dnevne doze inzulina u bolesnika sa šećernom bolešću tipa 1 koji prethodno nisu liječeni inzulinom mogu se koristiti 0,2 do 0,4 jedinice inzulina po kilogramu tjelesne težine.
English: Dose adjustment mmol/L
Croatian: Prilagodba doze mmol/l mg/dl
English: • feeling sleepy or tired
Croatian: • osjećaj pospanosti ili umora
English: Fiasp administered postmeal showed non-inferior glycaemic control compared to NovoRapid mealtime (ETD: 0.13% [-0.01; 0.26]95% CI).
Croatian: Fiasp primijenjen nakon obroka ostvario je neinferiornu regulaciju glikemije u usporedbi s lijekom NovoRapid primijenjenim uz obrok (procijenjena razlika između liječenja: 0,13% [-0,01; 0,26]95% CI).
English: Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin.
Croatian: Vaša brizgalica je napunjena inzulinska brizgalica s mogućnošću odabira doze, koja sadrži 300 jedinica inzulina.
English: • Before breakfast - dose should be adjusted according to the blood sugar level before lunch the previous day.
Croatian: • Doza prije doručka treba se prilagoditi u skladu s razinom šećera u krvi prije ručka prethodnog dana.
English: • if the vial has not been stored correctly (see section 5 ‘How to store Fiasp').
Croatian: • ako uložak nije ispravno čuvan (pogledajte dio 5 „Kako čuvati Fiasp“).
English: Fiasp administered postmeal resulted in higher 1-hour postmeal glucose increment and comparable 2-hour postmeal glucose increment to NovoRapid dosed at mealtime (Table 3).
Croatian: Fiasp primijenjen nakon obroka postigao je veće povećanje glukoze 1 sat nakon obroka i usporedivo povećanje glukoze 2 sata nakon obroka u usporedbi s lijekom NovoRapid primijenjenim uz obrok (Tablica 3).
English: Monitoring of blood glucose is necessary during insulin infusion.
Croatian: Tijekom infuzije inzulina nužno je praćenje razine glukoze u krvi.
English: Do not rub the area.
Croatian: Ne trljajte mjesto injiciranja.
English: return the vial to your supplier.
Croatian: vratite bočicu u ljekarnu.
English: The pre-filled pen can provide a dose of 1-80 units in one injection in steps of 1 unit.
Croatian: Odmjeravanjem 1 jedinice, napunjenom brizgalicom mogu se primijeniti doze u rasponu od 1 do 80 jedinica.
English: Adult: Fiasp should be injected right before (0-2 minutes) the start of the meal, with an option to inject up to 20 minutes after starting the meal.
Croatian: Odrasli: Fiasp se treba injicirati neposredno prije početka obroka (0-2 minute), uz mogućnost injiciranja unutar 20 minuta nakon početka obroka.
English: • thyroid hormones - for thyroid problems
Croatian: • hormone štitnjače - za probleme sa štitnjačom
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (Cartridge (Penfill))
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (uložak (Penfill))
English: Fiasp administered at mealtime provided significantly lower 1-hour and 2-hour postmeal glucose increment compared to NovoRapid administrated at mealtime.
Croatian: Fiasp koji je primijenjen uz obrok doveo je do značajno manjeg povećanja glukoze 1 i 2 sata nakon obroka u usporedbi s lijekom NovoRapid primijenjenim uz obrok.
English: Fiasp 100 units/mL solution for injection in pre-filled pen Needles and pre-filled pens must not be shared.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Igle i napunjene brizgalice ne smiju se dijeliti.
English: • Before lunch - dose should be adjusted according to the blood sugar level before dinner the previous day.
Croatian: • Doza prije ručka treba se prilagoditi u skladu s razinom šećera u krvi prije večere prethodnog dana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (Cartridge (Penfill))
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (uložak (Penfill))
English: Read the package leaflet before use Subcutaneous use
Croatian: Prije uporabe pročitajte uputu o lijeku Za supkutanu primjenu
English: Close glucose monitoring is recommended during the transfer from other mealtime insulins and in the initial weeks thereafter.
Croatian: Tijekom prijelaza s drugih inzulina koji se uzimaju uz obrok i u prvim tjednima nakon toga preporučuje se pomno pratiti razine glukoze.
English: One pre-filled pen contains 300 units of insulin aspart in 3 mL solution.
Croatian: Jedna napunjena brizgalica sadrži 300 jedinica aspart inzulina u 3 ml otopine.
English: A drop of insulin may appear at the needle tip.
Croatian: Na vrhu igle može se pojaviti kapljica inzulina.
English: Paper tab
Croatian: Papirnati pokrov
English: Fiasp 100 units/mL solution for injection in cartridge Needles and cartridges must not be shared.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u bočici Igle i štrcaljke ne smiju se dijeliti.
English: One vial contains 1,000 units of insulin aspart in 10 mL solution.
Croatian: Jedna bočica sadrži 1000 jedinica aspart inzulina u 10 ml otopine.
English: How to use Fiasp
Croatian: Kako primjenjivati Fiasp
English: Disodium phosphate dihydrate Arginine hydrochloride Nicotinamide (vitamin B3) Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari fenol metakrezol glicerol cinkov acetat natrijev hidrogenfosfat dihidrat argininklorid nikotinamid (vitamin B3) kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: NovoRapid mealtime + insulin detemir
Croatian: NovoRapid uz obrok + inzulin detemir
English: Fiasp 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Otopina za injekciju (FlexTouch).
English: 2 Remove the protective cap from the vial.
Croatian: Uklonite zaštitni zatvarač s bočice.
English: Converting from another mealtime insulin can be done on a unit-to-unit basis.
Croatian: Prijelaz s drugog inzulina koji se uzima uz obrok može se provesti uzimajući jednak broj jedinica.
English: Fiasp 100 units/mL solution for injection in pre-filled pen One pre-filled pen contains 300 units of insulin aspart in 3 mL solution.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 300 jedinica aspart inzulina u 3 ml otopine.
English: B Severe hypoglycaemia (episode requiring assistance of another person) or blood glucose (BG) confirmed hypoglycaemia defined as episodes confirmed by plasma glucose < 3.1 mmol/L irrespective of symptoms C Statistically significant in favour of Fiasp
Croatian: (GK) definirane kao epizode potvrđene glukozom u plazmi <3,1 mmol/l bez obzira na simptome C Statistički značajno u korist lijeka Fiasp
English: EU/1/16/1160/006 10 pens of 3 mL
Croatian: EU/1/16/1160/011 10 uložaka od 3 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (Pre-filled pen (FlexTouch))
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BRIZGALICI (napunjena brizgalica (FlexTouch))
English: EU/1/16/1160/009 5 vials of 10 mL
Croatian: EU/1/16/1160/008 5 bočica od 10 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (VIAL)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (BOČICA)
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING CARTON FOR MULTIPACK (Pre-filled pen (FlexTouch) - without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA ZA VIŠESTRUKO PAKIRANJE (napunjena brizgalica (FlexTouch) - bez plavog okvira)
English: One cartridge contains 300 units of insulin aspart in 3 mL solution.
Croatian: Jedan uložak sadrži 300 jedinica aspart inzulina u 3 ml otopine.
English: • Press and hold in the dose button until the dose counter returns to 0.
Croatian: • Pritisnite gumb za doziranje i držite ga pritisnutim sve dok se brojčanik doze ne vrati na 0.
English: Fiasp postmeal + insulin detemir
Croatian: Fiasp uz obrok + inzulin detemir
English: Each cartridge contains 3 mL of solution.
Croatian: Svaki uložak sadrži 3 ml otopine.
English: See your reusable pen manual for further instructions.
Croatian: Za dodatne informacije pročitajte upute za uporabu brizgalice za višekratnu uporabu.
English: Hold the dose button down until the dose counter shows 0.
Croatian: Gumb za doziranje držite pritisnutim dok se brojčanik doze ne vrati na 0.
English: 1 mL of the solution contains 100 units of insulin aspart* (equivalent to 3.5 mg).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 ml otopine sadrži 100 jedinica aspart inzulina* (što odgovara 3,5 mg).
English: Always use the dose counter and the dose pointer to see how many units you have selected before injecting the insulin.
Croatian: Prije injiciranja inzulina, uvijek pogledajte brojčanik doze i pokazivač doze kako biste provjerili koliko ste jedinica odabrali.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (Pre-filled pen (FlexTouch))
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (napunjena brizgalica (FlexTouch))
English: One cartridge contains 300 units of insulin aspart in 3 mL solution 1 mL solution contains 100 units of insulin aspart (equivalent to 3.5 mg)
Croatian: Jedna napunjena brizgalica sadrži 300 jedinica aspart inzulina u 3 ml otopine Jedan ml otopine sadrži 100 jedinica aspart inzulina (što odgovara 3,5 mg)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (VIAL - with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA (BOČICA - s plavim okvirom)
English: Fiasp is recommended to be administered prior to the meal (0-2 minutes), with the flexibility to administer up to 20 minutes after starting the meal in situations, when there is uncertainty about the meal intake.
Croatian: Preporučuje se primjenjivati Fiasp prije obroka (0-2 minute), ali se u situacijama kada postoji neizvjesnost oko unosa obroka može primijeniti i do 20 minuta nakon početka obroka.
English: Fiasp 100 units/mL solution for injection in cartridge Cartridge (type 1 glass), with a plunger (halobutyl) and a stopper (halobutyl/polyisoprene) in a carton.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u ulošku Uložak (staklo tipa 1) s klipom (halobutil) i čepom (halobutil/poliizopren) u kutiji.
English: Each vial contains 10 mL of solution.
Croatian: Svaka bočica sadrži 10 ml otopine.
English: Fiasp 100 units/mL solution for injection in vial One vial contains 1,000 units of insulin aspart in 10 mL solution.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u bočici Jedna bočica sadrži 1000 jedinica aspart inzulina u 10 ml otopine.
English: Fiasp 100 units/mL solution for injection in cartridge One cartridge contains 300 units of insulin aspart in 3 mL solution.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u ulošku Jedan uložak sadrži 300 jedinica aspart inzulina u 3 ml otopine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACK (Pre-filled pen (FlexTouch) - with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA VIŠESTRUKO PAKIRANJE (napunjena brizgalica (FlexTouch) - s plavim okvirom)
English: Fiasp is a mealtime insulin.
Croatian: Kada primjenjivati Fiasp Fiasp je inzulin koji se uzima uz obrok.
English: • Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer cap.
Croatian: • Na ravnoj površini uvedite vrh igle u vanjski zatvarač igle.
English: How to store Fiasp
Croatian: Kako čuvati Fiasp
English: Administration with a syringe
Croatian: Primjena uz pomoć štrcaljke
English: • feeling sick
Croatian: • gubitak teka
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING CARTON FOR MULTIPACK (VIAL - without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA ZA VIŠESTRUKO PAKIRANJE (BOČICA- bez plavog okvira)
English: Children: Fiasp should be injected right before (0-2 minutes) the start of the meal, with the possibility to inject up to 20 minutes after starting the meal in situations, when there is uncertainty about how the child will eat.
Croatian: Djeca: Fiasp se treba injicirati neposredno prije početka obroka (0-2 minute), ali se u situacijama kada postoji neizvjesnost oko unosa djetetovog obroka može primijeniti i do 20 minuta nakon početka obroka.
English: Vial (type 1 glass) closed with a halobutyl/polyisoprene rubber disc and a protective plastic cap in order to obtain a tamper-proof container in a carton.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u bočici Bočica (staklo tipa 1) zatvorena pločicom od halobutilne/poliizoprenske gume i zaštitnim plastičnim zatvaračem s evidencijom otvaranja u kutiji.
English: 3 Select your dose • Make sure the dose counter shows 0 before you start.
Croatian: • Prije početka provjerite da je brojčanik doze postavljen na 0.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (VIAL)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (BOČICA)
English: 5 After your injection
Croatian: Nakon injiciranja
English: One vial contains 1,000 units of insulin aspart in 10 mL solution 1 mL solution contains 100 units of insulin aspart (equivalent to 3.5 mg)
Croatian: NAVOĐENJE DJELATNE TVARI Jedna bočica sadrži 1000 jedinica aspart inzulina u 10 ml otopine Jedan ml otopine sadrži 100 jedinica aspart inzulina (što odgovara 3,5 mg)
English: The patient should discard the needle after each injection.
Croatian: Nakon svakog injiciranja, bolesnik treba baciti iglu u otpad.
English: One pre-filled pen contains 300 units of insulin aspart in 3 mL solution 1 mL solution contains 100 units of insulin aspart (equivalent to 3.5 mg)
Croatian: NAVOĐENJE DJELATNE TVARI Jedan uložak sadrži 300 jedinica aspart inzulina u 3 ml otopine Jedan ml otopine sadrži 100 jedinica aspart inzulina (što odgovara 3,5 mg)
English: • feeling confused
Croatian: • učestalo mokrenje
English: The pre-filled pen (FlexTouch) is designed to be used with NovoFine Plus, NovoFine or NovoTwist injection needles.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Primjena pomoću napunjene brizgalice (FlexTouch) Napunjena brizgalica (FlexTouch) namijenjena je za uporabu s iglama za injekciju NovoFine Plus, NovoFine ili NovoTwist.
English: Solution for injection FlexTouch
Croatian: NAČIN PRIMJENE LIJEKA FlexTouch
English: Throw away the needle after each injection.
Croatian: Nakon svakog injiciranja iglu bacite u otpad.
English: Always keep the vial in the carton in order to protect from light.
Croatian: Uložak uvijek čuvati u kutiji radi zaštite od svjetlosti.
English: Fiasp 100 units/mL solution for injection in vial Solution for injection.
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u bočici Otopina za injekciju.
English: • Pre-breakfast dose should be adjusted according to the pre-lunch SMPG the previous day
Croatian: • Doza prije doručka treba se prilagoditi u skladu sa samostalno izmjerenom glukozom u plazmi prije ručka prethodnog dana
English: Fiasp is presented as a clear, colourless and aqueous solution for injection in a vial.
Croatian: Kako Fiasp izgleda i sadržaj pakiranja Fiasp je bistra, bezbojna i vodena otopina za injekciju u ulošku.
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Fiasp
English: Usual warning symptoms may disappear in patients with long-standing diabetes.
Croatian: U osoba koje dugo boluju od šećerne bolesti uobičajeni upozoravajući simptomi hipoglikemije mogu nestati.
English: Always keep the cartridge in the carton in order to protect from light.
Croatian: Bočicu uvijek čuvati u kutiji radi zaštite od svjetlosti.
English: Fiasp 100 units/mL solution for injection in cartridge Solution for injection (Penfill).
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u ulošku Otopina za injekciju (Penfill).
English: Discard the needle after each injection
Croatian: Nakon svakog injiciranja iglu baciti u otpad
English: Fiasp 100 units/mL solution for injection in vial insulin aspart
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u ulošku aspart inzulin
English: Insulin scale Insulin window
Croatian: Prozorčić inzulina
English: Obesity
Croatian: Dojenje
English: Fiasp 100 units/mL solution for injection in pre-filled pen insulin aspart
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici aspart inzulin
English: Keep the cartridge in the carton in order to protect from light.
Croatian: Zatvarač držati na brizgalici radi zaštite od svjetlosti.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION
Croatian: OZNAČIVANJE I UPUTA O LIJEKU
English: Please read these instructions carefully before using your FlexTouch pre-filled pen.
Croatian: Prije uporabe FlexTouch napunjene brizgalice, pozorno pročitajte ove upute.
English: Needle
Croatian: Igla
English: Fiasp (0.41→0.39 units/kg/day), postmeal Fiasp (0.43→0.42 units/kg/day) and mealtime NovoRapid
Croatian: Promjene u medijanu ukupne doze bazalnog inzulina od početka ispitivanja do kraja ispitivanja bile su usporedive za Fiasp primijenjen uz obrok (0,41→0,39 jedinica/kg/dan), Fiasp primijenjen nakon obroka (0,43→0,42 jedinica/kg/dan) i NovoRapid primijenjen uz obrok (0,43→0,43 jedinica/kg/dan).
English: Fiasp 100 units/mL solution for injection in vial
Croatian: Fiasp 100 jedinica/ml otopina za injekciju u bočici
English: This means that this medicine is essentially ‘sodium-free'.
Croatian: To znači da lijek sadrži zanemarive količine natrija.
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: Estimated rate ratio
Croatian: Procijenjeni omjer stopa
English: Keep the cartridge in the outer carton in order to protect from light
Croatian: Uložak čuvati u vanjskoj kutiji radi zaštite od svjetlosti
English: Renal impairment
Croatian: Skala inzulina
English: Hepatic impairment
Croatian: • ubrzani otkucaji srca
English: • Pre-dinner dose should be adjusted according to the bedtime SMPG the previous day
Croatian: • Doza prije večere treba se prilagoditi u skladu sa samostalno izmjerenom glukozom u plazmi prije spavanja prethodnog dana
English: Keep the cartridge in the outer carton in order to protect from light.
Croatian: Uložak čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: • Hold the pen with the needle pointing up.
Croatian: • Brizgalicu držite iglom okrenutom prema gore.
English: Initiation
Croatian: Pretilost
English: Keep the cap on the pen in order to protect from light
Croatian: Zatvarač držati na brizgalici radi zaštite od svjetlosti
English: Keep the vial in the carton in order to protect from light.
Croatian: Uložak čuvati u kutiji radi zaštite od svjetlosti.
English: Dose selector
Croatian: Izbornik doze
English: • Pre-lunch dose should be adjusted according to the pre-dinner SMPG the previous day
Croatian: • Doza prije ručka treba se prilagoditi u skladu sa samostalno izmjerenom glukozom u plazmi prije večere prethodnog dana
English: Contents of the pack and other information What Fiasp contains
Croatian: Što Fiasp sadrži
English: GENERAL CLASSIFICATION FOR SUPPLY
Croatian: Za supkutanu primjenu
English: EU/1/16/1160/010 5 cartridges of 3 mL EU/1/16/1160/011 10 cartridges of 3 mL
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1160/010 5 uložaka od 3 ml
English: • Read the manual that comes with your reusable pen.
Croatian: • Pročitajte upute za uporabu brizgalice za višekratnu uporabu.
English: EU/1/16/1160/007 1 vial of 10 mL EU/1/16/1160/008 5 vials of 10 mL
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1160/007 1 bočica od 10 ml
English: • fast heartbeat
Croatian: • suha usta