FrancophonIA/ELRC3.0 huggingface dataset:
English: The following substances may increase the patient's insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Croatian: Sljedeće tvari mogu povećati bolesnikovu potrebu za inzulinom: oralni kontraceptivi, tiazidi, glukokortikoidi, hormoni štitnjače, simpatomimetici, hormon rasta i danazol.
English: Combination of NovoRapid with pioglitazone
Croatian: Kombinacija lijeka NovoRapid s pioglitazonom
English: What NovoRapid looks like and contents of the pack
Croatian: Kako NovoRapid izgleda i sadržaj pakiranja
English: Changing the site with each injection reduces the risk of developing such skin changes.
Croatian: Promjena mjesta injiciranja kod svake injekcije smanjuje rizik od takvih promjena na koži.
English: NovoRapid 100 units/ml solution for injection in vial NovoRapid Penfill 100 units/ml solution for injection in cartridge NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen NovoRapid PumpCart 100 units/ml solution for injection in cartridge
Croatian: NovoRapid 100 jedinica/ml otopina za injekciju u bočici NovoRapid Penfill 100 jedinica/ml otopina za injekciju u ulošku NovoRapid FlexPen 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici NovoRapid InnoLet 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici NovoRapid FlexTouch 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici NovoRapid PumpCart 100 jedinica/ml otopina za injekciju u ulošku
English: • Always check that the push-button is fully depressed and the dose selector is set to 0.
Croatian: • Uvijek provjerite je li potisni gumb pritisnut do kraja, a izbornik doze postavljen na 0.
English: • Put the pen cap back on your InnoLet to protect the insulin from light.
Croatian: • Vratite zatvarač brizgalice na InnoLet da biste zaštitili inzulin od svjetlosti.
English: The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs.
Croatian: Najbolja mjesta za injiciranje su područje trbuha (abdomena), nadlaktica ili prednja strana bedara.
English: What you need to know before you use NovoRapid
Croatian: Što morate znati prije nego počnete primjenjivati NovoRapid
English: Never try to put the inner needle cap back on the needle.
Croatian: Nikad nemojte pokušati vratiti unutarnji zatvarač igle natrag na iglu.
English: Before travelling between different time zones, the patient should seek the doctor's advice since this may mean that the patient has to take the insulin and meals at different times.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Prije putovanja u druge vremenske zone bolesnik treba potražiti savjet liječnika jer to može značiti da će bolesnik morati uzimati inzulin i obroke u druga doba dana.
English: Insulin mixtures should not be administered intravenously or used with a subcutaneous insulin infusion pump.
Croatian: Mješavine inzulina ne smiju se primjenjivati intravenski niti koristiti sa supkutanom inzulinskom infuzijskom pumpom.
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in the paediatric population do not indicate any differences to the broader experience in the general population.
Croatian: Na temelju podataka dobivenih nakon stavljanja lijeka na tržište i iz kliničkih ispitivanja, učestalost, vrsta i ozbiljnost nuspojava opaženih u pedijatrijskoj populaciji ne upućuju na bilo kakve razlike u odnosu na šire iskustvo u općoj populaciji.
English: If the insulin looks cloudy, do not use NovoRapid PumpCart.
Croatian: Ako inzulin izgleda mutno, nemojte upotrijebiti NovoRapid PumpCart.
English: • Always make sure you have a spare NovoRapid PumpCart available.
Croatian: • Pobrinite se da na raspolaganju uvijek imate rezervni NovoRapid PumpCart.
English: NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Croatian: NovoRapid je indiciran za liječenje šećerne bolesti u odraslih, adolescenata i djece u dobi od 1 i više godina.
English: ► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section
Croatian: ► ako ste alergični na aspart inzulin ili neki drugi sastojak ovog lijeka (vidjeti dio 6. Sadržaj pakiranja i druge informacije).
English: A clinical trial comparing safety and efficacy of insulin aspart vs. human insulin in the treatment of pregnant women with type 1 diabetes (322 exposed pregnancies (insulin aspart: 157; human insulin: 165)) did not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn.
Croatian: Kliničko ispitivanje usporedbe sigurnosti i djelotvornosti aspart inzulina u odnosu na humani inzulin u liječenju trudnica sa šećernom bolešću tipa 1 (322 izložene trudnoće (aspart inzulin: 157, humani inzulin: 165)) nije ukazalo na pojavu štetnih učinaka aspart inzulina na trudnoću ni na zdravlje fetusa/novorođenčeta.
English: Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
Croatian: U bolesnika u kojih je znatno poboljšana regulacija glikemije, primjerice intenziviranjem inzulinske terapije, mogu se promijeniti uobičajeni upozoravajući simptomi hipoglikemije te ih o tome treba primjereno savjetovati.
English: Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy.
Croatian: Mjesto injiciranja unutar istog područja treba stalno mijenjati kako bi se smanjio rizik od lipodistrofije.
English: In addition the data from a clinical trial including 27 women with gestational diabetes randomised to treatment with insulin aspart vs. human insulin (insulin aspart: 14; human insulin: 13) showed similar safety profiles between treatments.
Croatian: Dodatno, podaci iz kliničkog ispitivanja koje je uključilo 27 žena s gestacijskim dijabetesom koje su bile randomizirane na aspart inzulin ili humani inzulin (aspart inzulin: 14, humani inzulin: 13) pokazali su sličan sigurnosni profil u objema skupinama.
English: Since NovoRapid should be administered in immediate relation to a meal, the rapid onset of action should be considered in patients with concomitant diseases or treatment where a delayed absorption of food might be expected.
Croatian: Budući da se NovoRapid treba primjenjivati neposredno uz obrok, u bolesnika koji boluju od popratne bolesti ili su podvrgnuti liječenju kod kojeg se može očekivati usporena apsorpcija hrane, potrebno je imati u vidu njegov brz početak djelovanja.
English: How to use NovoRapid PumpCart Dose and when to take your insulin
Croatian: Kako primjenjivati NovoRapid Doza i kada trebate primijeniti inzulin
English: Compared to soluble human insulin the faster onset of action of NovoRapid is maintained regardless of the injection site.
Croatian: U usporedbi s otopinom humanog inzulina, brži početak djelovanja lijeka NovoRapid održan je bez obzira na mjesto injiciranja.
English: D Screw the needle straight onto the pen.
Croatian: D Navijte iglu ravno na brizgalicu.
English: • Keeping the needle upwards, press the push-button and the dose selector returns to 0.
Croatian: • Držeći iglu prema gore, pritisnite potisni gumb i izbornik doze vraća se na 0.
English: It should normally be used in combination with intermediate-acting or long-acting insulin.
Croatian: Obično bi se trebao primjenjivati u kombinaciji sa srednjedugodjelujućim ili dugodjelujućim inzulinom.
English: Administration in a pump system will require a comprehensive instruction by your healthcare professional.
Croatian: Za primjenu uz pomoć pumpe potrebne su detaljne upute koje će Vam dati zdravstveni radnik.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga. a) Sažetak ozbiljnih i vrlo čestih nuspojava
English: Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.
Croatian: Zatražite pomoć osobe koja dobro vidi i koja je naučila kako koristiti FlexTouch napunjenu brizgalicu.
English: NovoRapid produces a more rapid onset of action compared to soluble human insulin, together with a lower glucose concentration, as assessed within the first four hours after a meal.
Croatian: NovoRapid ima brži početak djelovanja i znatnije snižava koncentraciju glukoze u krvi u usporedbi s otopinom humanog inzulina, kako je utvrđeno unutar prva četiri sata nakon obroka.
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in the elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Croatian: Na temelju podataka dobivenih nakon stavljanja lijeka na tržište i iz kliničkih ispitivanja, učestalost, vrsta i ozbiljnost nuspojava opaženih u starijih bolesnika i bolesnika s oštećenjem bubrega ili jetre ne upućuju na bilo kakve razlike u odnosu na šire iskustvo u općoj populaciji.
English: • Do not refill NovoRapid PumpCart.
Croatian: • Nemojte ponovno puniti NovoRapid PumpCart.
English: • Caregivers must be very careful when handling used needles - to reduce the risk of needle injury and cross-infection.
Croatian: • Osobe koje skrbe za bolesnika moraju biti vrlo oprezne pri rukovanju rabljenim iglama kako bi smanjile rizik od ozljede iglom i prijenosa infekcije.
English: Infusion sites should be rotated.
Croatian: Treba mijenjati mjesta infuzije.
English: Data from two randomised controlled clinical trials (322 and 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn when compared to human insulin (see section 5.1).
Croatian: Podaci iz dva randomizirana kontrolirana klinička ispitivanja (322 i 27 izloženih trudnoća) ne ukazuju na pojavu štetnih učinaka aspart inzulina na trudnoću ni na zdravlje fetusa/novorođenčeta u usporedbi s humanim inzulinom
English: Inject the air into the vial containing the NPH insulin and pull out the needle.
Croatian: Ubrizgajte zrak u bočicu s NPH inzulinom i izvucite iglu.
English: Before using NovoRapid PumpCart in a pump, you must have thorough training in the use of the pump and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump.
Croatian: Prije nego počnete primjenjivati NovoRapid PumpCart u pumpi morate imati cjelovitu edukaciju o primjeni pumpe i informacijama o svim aktivnostima koje morate poduzeti u slučaju bolesti, previsoke ili preniske razine šećera u krvi ili neispravnosti pumpe.
English: When you are using an insulin pump
Croatian: Kada primjenjujete inzulinsku pumpu
English: A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human insulin.
Croatian: Posljedica farmakodinamike brzodjelujućih inzulinskih analoga jest da, ako nastupi hipoglikemija, to se može dogoditi ranije nakon injiciranja nego što je to slučaj kod otopine humanog inzulina.
English: The insulin will work more quickly if injected into the front of your waist.
Croatian: Inzulin će djelovati brže ako se injicira u trbuh.
English: Dispose of it carefully, and put the pen cap back on after every use.
Croatian: Pažljivo bacite iglu u otpad i vratite zatvarač brizgalice natrag na brizgalicu nakon svake uporabe.
English: Please proceed to the information in ‘Instructions on how to use NovoRapid PumpCart prefilled cartridge'.
Croatian: Prijeđite na informacije sadržane u „Upute za uporabu napunjenog uloška NovoRapid PumpCart“.
English: The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Croatian: Učinak aspart inzulina na snižavanje razine glukoze u krvi posljedica je olakšanog ulaska glukoze nakon vezanja inzulina na receptore na mišićnim i masnim stanicama te istovremene inhibicije otpuštanja glukoze iz jetre.
English: FlexTouch - without blue box)
Croatian: FlexTouch - bez plavog okvira)
English: Substances added to NovoRapid may cause degradation of insulin aspart.
Croatian: Tvari koje se dodaju lijeku NovoRapid mogu izazvati razgradnju aspart inzulina.
English: The relative differences in the pharmacodynamic properties (GIRmax,AUCGIR, 0-120 min) between insulin aspart and soluble human insulin in the elderly were similar to those seen in healthy subjects and in younger patients with diabetes.
Croatian: Relativne razlike u farmakodinamičkim svojstvima (GIRmax, AUCGIR, 0-120 min) između aspart inzulina i otopine humanog inzulina u starijih bolesnika bile su slične onima u zdravih ispitanika te u mlađih bolesnika sa šećernom bolešću.
English: Drinking alcohol and taking NovoRapid
Croatian: Konzumiranje alkohola i primjena lijeka NovoRapid
English: You can select up to 80 units per dose.
Croatian: U jednoj dozi možete odabrati najviše 80 jedinica.
English: Otherwise the liquid may leak out which can cause inaccurate dosing.
Croatian: Ako to ne učinite, tekućina može istjecati, što može rezultirati pogrešnim doziranjem.
English: Do not touch the needle or the cap.
Croatian: Nemojte dotaknuti iglu niti zatvarač.
English: Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
Croatian: Istraživanja su također pokazala da je disocijacija vezanja na inzulinske receptore aspart inzulina jednaka kao i kod humanog inzulina.
English: What to do if you experience low blood sugar: ► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice) and adjust insulin delivery or stop your pump.
Croatian: Što učiniti ako osjetite nisku razinu šećera u krvi: ► Ako osjetite nisku razinu šećera u krvi, uzmite tablete glukoze ili pojedite neki međuobrok bogat šećerom (primjerice, slatkiše, kekse, voćni sok) i prilagodite primjenu inzulina ili zaustavite pumpu.
English: NovoRapid is for injection under the skin (subcutaneously) or for continuous infusion in a pump system.
Croatian: NovoRapid je namijenjen injiciranju pod kožu (supkutano) ili za primjenu kontinuiranom infuzijom uz pomoć pumpe.
English: A clinical trial comparing preprandial soluble human insulin with postprandial insulin aspart was performed in small children (20 patients aged 2 to less than 6 years, studied for 12 weeks, among those four were younger than 4 years old) and a single dose PK/PD trial was performed in children (612 years) and adolescents (13-17 years).
Croatian: Kliničko ispitivanje u kojemu se uspoređivala otopina humanog inzulina primijenjena prije obroka s aspart inzulinom primijenjenim nakon obroka provedeno je u male djece (20 bolesnika u dobi od 2 do 6 godina; ispitivanje je trajalo 12 tjedana; četvero djece je bilo mlađe od 4 godine), a ispitivanje farmakokinetike/farmakodinamike jedne doze provedeno je u djece (6-12 godina) i adolescenata (13-17 godina).
English: Patients transferred to NovoRapid from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products.
Croatian: Bolesnicima koji su prešli na NovoRapid s druge vrste inzulina možda će biti potreban veći broj injekcija dnevno ili različita doza nego kod primjene njihovih uobičajenih inzulinskih pripravaka.
English: Always store NovoRapid without the needle attached.
Croatian: Uvijek spremite NovoRapid bez nataknute igle.
English: The patient should be advised to discard the needle after each injection.
Croatian: Bolesniku treba savjetovati da nakon svakog injiciranja iglu baci u otpad.
English: Clinical trials in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal hypoglycaemia with insulin aspart compared with soluble human insulin.
Croatian: Klinička ispitivanja provedena u bolesnika sa šećernom bolešću tipa 1 pokazala su smanjenje rizika od noćnih hipoglikemija uz aspart inzulin u usporedbi s otopinom humanog inzulina.
English: A mean maximum plasma concentration of 492±256 pmol/l was reached 40 (interquartile range: 30-40) minutes after a subcutaneous dose of 0.15 unit/kg bodyweight in type 1 diabetic patients.
Croatian: U bolesnika sa šećernom bolešću tipa 1 srednja maksimalna koncentracija u plazmi od 492±256 pmol/l postiže se za 40 minuta (interkvartilni raspon 30-40 minuta) nakon supkutane doze od 0,15 jedinica/kg tjelesne težine.
English: • Always make sure that a drop appears at the needle tip before injection (picture 1B).
Croatian: • Prije injiciranja uvijek provjerite je li se na vrhu igle pojavila kapljica inzulina (slika 1B).
English: NovoRapid can only be mixed with NPH (Neutral Protamine Hagedorn) insulin in a syringe for subcutaneous use.
Croatian: NovoRapid se smije miješati samo s NPH (neutralni protamin Hagedorn) inzulinom u štrcaljki za supkutanu primjenu.
English: If any of these applies, do not use NovoRapid.
Croatian: Ako se nešto od toga odnosi na Vas, nemojte primjenjivati NovoRapid.
English: What NovoRapid PumpCart looks like and contents of the pack
Croatian: Kako NovoRapid PumpCart izgleda i sadržaj pakiranja
English: • NovoRapid PumpCart must be protected from excessive heat and light during storage and use.
Croatian: • NovoRapid PumpCart mora biti zaštićen od prekomjerne topline i svjetlosti tijekom čuvanja i uporabe.
English: When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Croatian: Kad bolesnici prelaze s jedne vrste inzulinskoga pripravka na drugu, rani upozoravajući simptomi hipoglikemije mogu se promijeniti ili postati manje izraženi nego tijekom liječenja s prethodnom vrstom inzulina.
English: When necessary, NovoRapid can be given soon after a meal.
Croatian: Kad je potrebno, NovoRapid se može primijeniti ubrzo nakon obroka.
English: METHOD AND ROUTES OF ADMINISTRATION Needles are not included
Croatian: NAČIN I PUTEVI PRIMJENE LIJEKA Igle nisu priložene.
English: In two long-term open label trials in patients with type 1 diabetes comprising 1070 and 884 patients, respectively, NovoRapid reduced glycated haemoglobin by 0.12 [95% C.I.
Croatian: U dva dugotrajna, otvorena ispitivanja u bolesnika sa šećernom bolešću tipa 1, u koja je bilo uključeno 1070, odnosno 884 bolesnika, NovoRapid je snizio glikirani hemoglobin za 0,12 postotnih bodova [95% C.I. 0,03; 0,22], odnosno za 0,15 postotnih bodova [95% C.I.
English: Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
Croatian: Držite FlexPen iglom okrenutom prema gore te nekoliko puta lagano kucnite prstom po ulošku kako bi se mjehurići zraka skupili na vrhu uloška.
English: Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Croatian: Vaš InnoLet je jednostavna, kompaktna napunjena brizgalica, kojom se odmjeravanjem po 1 jedinice mogu birati doze u rasponu od 1 do 50 jedinica.
English: Eat a meal or snack within 10 minutes of the bolus dose to avoid low blood sugar.
Croatian: Unutar 10 minuta od bolus doze pojedite obrok ili međuobrok da izbjegnete nisku razinu šećera u krvi.
English: • Check that the insulin in NovoRapid PumpCart is clear and colourless.
Croatian: • Provjerite je li inzulin u ulošku NovoRapid PumpCart bistar i bezbojan.
English: Before use of NovoRapid in the pump system, you must have received a comprehensive instruction in the use and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump system.
Croatian: Prije primjene lijeka NovoRapid u pumpi morali ste dobiti detaljne upute o načinu uporabe kao i informacije o tome što učiniti u slučaju bolesti, previsoke ili preniske razine šećera u krvi ili kvara pumpe.
English: NovoRapid is a rapid-acting insulin analogue.
Croatian: NovoRapid je brzodjelujući inzulinski analog.
English: • NovoRapid PumpCart contains 1.6 ml insulin aspart solution, equivalent to 160 units.
Croatian: • NovoRapid PumpCart sadrži 1,6 ml otopine aspart inzulina, što odgovara 160 jedinica.
English: When transferring from other insulin medicinal products, adjustment of the NovoRapid dose and the dose of the basal insulin may be necessary.
Croatian: Pri prijelazu s drugih inzulinskih pripravaka možda će biti potrebno prilagoditi dozu lijeka NovoRapid i dozu bazalnog inzulina.
English: Insulin aspart is equipotent to soluble human insulin on a molar basis.
Croatian: Aspart inzulin ima jednaku potentnost kao i otopina humanog inzulina na molarnoj osnovi.
English: See How and where to inject below for information.
Croatian: Za detalje, vidjeti odjeljak Kako i gdje injicirati u daljnjem tekstu.
English: FlexTouch - with blue box)
Croatian: FlexTouch - s plavim okvirom)
English: Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar.
Croatian: Unutar 10 minuta od injiciranja pojedite obrok ili međuobrok da izbjegnete nisku razinu šećera u krvi.
English: Please refer to the package leaflet where detailed instructions for use are provided.
Croatian: Pogledajte uputu o lijeku u kojoj se nalaze detaljni naputci za primjenu.
English: ► Infusion sets (tubing and needle) and NovoRapid PumpCart must not be shared.
Croatian: Infuzijski set (cjevčica i igla) i NovoRapid PumpCart ne smiju se dijeliti s drugim osobama.
English: Continuous rotation of the injection site within a given area reduces the risk of developing these reactions.
Croatian: Neprestano mijenjanje mjesta injiciranja unutar određenog područja smanjuje rizik od razvoja ovih reakcija.
English: NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.
Croatian: NovoRapid ima brz početak djelovanja; stoga, ako se hipoglikemija pojavi, može se pojaviti ranije nakon injiciranja nego što je to slučaj s otopinom humanog inzulina.
English: Turn the vial and syringe upside down and draw up the prescribed dose of NovoRapid.
Croatian: Preokrenite bočicu i štrcaljku i navucite propisanu dozu lijeka NovoRapid.
English: During use: Store below 30°C.
Croatian: Tijekom uporabe: čuvati na temperaturi ispod 30°C.
English: Make sure you can see the dose counter.
Croatian: Pobrinite se da vam je vidljiv brojčanik doze.
English: Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides.
Croatian: Sljedeće tvari mogu smanjiti bolesnikovu potrebu za inzulinom: oralni antidijabetici, inhibitori monoaminooksidaze (MAO inhibitori), beta-blokatori, inhibitori angiotenzin konvertirajućeg enzima (ACE inhibitori), salicilati, anabolički steroidi i sulfonamidi.
English: Be very careful to calculate correctly if splitting your dose.
Croatian: Ako dijelite dozu na dvije brizgalice, jako pazite da točno izračunate kako ćete je podijeliti.
English: Check the name and coloured label on your NovoRapid FlexTouch pen to make sure that it contains the type of insulin you need.
Croatian: Provjerite naziv i boju naljepnice na svojoj NovoRapid FlexTouch brizgalici kako biste bili sigurni da sadrži vrstu inzulina koju trebate.
English: ► If the insulin does not appear clear and colourless.
Croatian: ► ako inzulin nije bistar i bezbojan.
English: 5 x 3 ml pre-filled pens.
Croatian: 5 x 3 ml napunjene brizgalice.