FrancophonIA/ELRC3.0 huggingface dataset:
English: Please also read the pump manual (user guide) that comes with your insulin pump.
Croatian: Molimo također pročitajte upute za uporabu pumpe (vodič za korisnika) koje dolaze zajedno s Vašom inzulinskom pumpom.
English: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia.
Croatian: Bolesnikova sposobnost koncentracije i reagiranja može biti smanjena kao posljedica hipoglikemije.
English: Before you use NovoRapid PumpCart in the pump you must have received a comprehensive instruction by your doctor or nurse.
Croatian: Prije nego primijenite NovoRapid PumpCart u pumpi morate dobiti opsežne upute od Vašeg liječnika ili medicinske sestre.
English: Make sure you have an alternative delivery method for your insulin available for injection under the skin (for example, a pen injector) in case the pump stops working.
Croatian: Budite sigurni da na raspolaganju imate neko drugo pomagalo za injiciranje inzulina pod kožu (primjerice, inzulinsku brizgalicu) u slučaju da pumpa prestane raditi.
English: NovoRapid (insulin aspart) can be used in pregnancy.
Croatian: NovoRapid (aspart inzulin) može se primjenjivati u trudnoći.
English: What you need to know before you use NovoRapid PumpCart Do not use NovoRapid PumpCart ► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
Croatian: Što morate znati prije nego počnete primjenjivati NovoRapid Nemojte primjenjivati NovoRapid ► ako ste alergični na aspart inzulin ili neki drugi sastojak ovog lijeka (vidjeti dio 6. Sadržaj pakiranja i druge informacije).
English: Always mix NovoRapid and the NPH insulin in the same sequence.
Croatian: Uvijek miješajte NovoRapid i NPH inzulin istim redoslijedom.
English: Normally you will inject your insulin in the front of your waist (abdomen).
Croatian: Obično ćete injicirati inzulin u područje trbuha (abdomena).
English: In case of hypoglycaemia or if hypoglycaemia is suspected NovoRapid must not be injected.
Croatian: U slučaju hipoglikemije ili sumnje na hipoglikemiju NovoRapid se ne smije injicirati.
English: NovoRapid can be used during pregnancy.
Croatian: NovoRapid se može koristiti u trudnoći.
English: Bolus (meal-time) insulin requirements: NovoRapid will start to lower your blood sugar within 1020 minutes after you start a bolus delivery (see section 3, How to use NovoRapid PumpCart, for more information about how to adjust your bolus dose).
Croatian: Bolus (za vrijeme obroka) potrebe za inzulinom: NovoRapid počinje snižavati razinu šećera u krvi unutar 10-20 minuta nakon što započnete bolus primjenu (za više informacija o tome kako prilagoditi Vašu bolus dozu vidjeti dio 3.
English: The cartridge may contain a minor amount of air in the form of small bubbles.
Croatian: Uložak može sadržavati malu količinu zraka u obliku mjehurića.
English: Adverse reactions observed in patients using NovoRapid are mainly due to the pharmacologic effect of insulin.
Croatian: Nuspojave opažene u bolesnika liječenih lijekom NovoRapid uglavnom su posljedica farmakološkog učinka inzulina.
English: ► Keep the needle under your skin for at least 6 seconds to make sure you have injected all the insulin.
Croatian: ► Zadržite iglu pod kožom najmanje 6 sekundi da budete sigurni da ste injicirali sav inzulin.
English: • Sulphonamides (used to treat infections).
Croatian: • sulfonamide (koriste se za liječenje infekcija).
English: To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.
Croatian: Kako biste imali koristi od inzulinske infuzije te uočili moguću neispravnost u radu inzulinske pumpe, preporučuje se redovito mjeriti razinu šećera u krvi.
English: For intravenous use, infusion systems with NovoRapid 100 units/ml at concentrations from 0.05 unit/ml to 1.0 unit/ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose including 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at room temperature for 24 hours.
Croatian: Za intravensku primjenu, infuzijski sustavi s lijekom NovoRapid 100 jedinica/ml u koncentraciji od 0,05 jedinica/ml do 1,0 jedinica/ml aspart inzulina u infuzijskoj otopini 0,9% natrijeva klorida, 5% dekstroze ili 10% dekstroze, uključujući 40 mmol/l kalijeva klorida, u polipropilenskim infuzijskim vrećicama, stabilni su 24 sata na sobnoj temperaturi.
English: Rare - Peripheral neuropathy (painful neuropathy)
Croatian: Poremećaji živčanog sustava Rijetko - periferna neuropatija (bolna neuropatija)
English: In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Croatian: U rijetkim slučajevima, prisustvo takvih inzulinskih protutijela može zahtijevati prilagodbu doze inzulina kako bi se korigirala sklonost hiperglikemiji ili hipoglikemiji.
English: In a basal-bolus treatment regimen 50-70% of this requirement may be provided by NovoRapid and the remainder by intermediate-acting or long-acting insulin.
Croatian: U bazal-bolus inzulinskoj terapiji 50-70% te potrebe može se nadoknaditi lijekom NovoRapid, a ostatak srednjedugodjelujućim ili dugodjelujućim inzulinom.
English: I Select the dose you need.
Croatian: I Odaberite potrebnu dozu.
English: If refrigerated, keep away from the cooling element.
Croatian: Ako ga čuvate u hladnjaku, držite ga dalje od rashladnih dijelova.
English: The maximum effect is exerted between 1 and 3 hours after injection.
Croatian: Maksimalni učinak postiže se između 1 i 3 sata nakon injiciranja.
English: NovoRapid PumpCart is for use in a pump and covers your total daily insulin needs: both your all day (basal) and meal-time (bolus) insulin needs.
Croatian: NovoRapid PumpCart namijenjen je za uporabu u pumpi i pokriva Vaše ukupne dnevne potrebe za inzulinom, zajedno Vaše cjelodnevne (bazalne) potrebe i potrebe za inzulinom za vrijeme obroka (bolus).
English: • Always carry an extra pen and new needles with you, in case of loss or damage.
Croatian: • Uvijek sa sobom nosite rezervnu brizgalicu i dodatne igle za slučaj gubitka ili oštećenja.
English: Important information about some of the ingredients of NovoRapid
Croatian: Važne informacije o nekim sastojcima lijeka NovoRapid
English: It must not be used with other devices not designed for NovoRapid PumpCart, as this may result in incorrect insulin dosing and subsequent hyper- or hypoglycaemia.
Croatian: Ne smije se koristiti s drugim pomagalima koja nisu namijenjena uporabi s uloškom NovoRapid PumpCart jer to može uzrokovati netočno doziranje inzulina i posljedično tome hiperglikemiju ili hipoglikemiju.
English: NovoRapid must be protected from excessive heat and light.
Croatian: NovoRapid se mora zaštititi od prevelike topline i svjetlosti.
English: NovoRapid can be used in adolescents and children aged 1 year and above instead of soluble human insulin when a rapid onset of effect is preferred.
Croatian: NovoRapid se može primjenjivati u adolescenata i djece u dobi od 1 i više godina umjesto otopine humanog inzulina kada je potreban brz početak djelovanja.
English: Uncommon - Urticaria, rash, eruptions Very rare - Anaphylactic reactions*
Croatian: Manje često - urtikarija, osip, erupcije Vrlo rijetko - anafilaktičke reakcije*
English: In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin.
Croatian: U testovima in vitro, uključujući vezivanje na inzulinska i IGF-1 receptorska mjesta i utjecaj na stanični rast, aspart inzulin se ponašao vrlo slično humanom inzulinu.
English: The efficacy and safety of NovoRapid given as bolus insulin in combination with either insulin detemir or insulin degludec as basal insulin has been studied for up to 12 months, in two randomised controlled clinical trials in adolescents and children aged 1 to less than 18 years (n=712).
Croatian: Djelotvornost i sigurnost primjene lijeka NovoRapid kao bolus inzulina, u kombinaciji s detemir inzulinom ili degludek inzulinom kao bazalnim, ispitivane su do 12 mjeseci, u dva randomizirana kontrolirana klinička ispitivanja u adolescenata i djece u dobi od 1 do manje od 18 godina (n=712).
English: This medicinal product must not be diluted or mixed with other medicinal products except for mixing with NPH (Neutral Protamine Hagedorn) insulin in a syringe for subcutaneous use, or with infusion fluids as described in section 4.2.
Croatian: Ovaj lijek se ne smije razrjeđivati ni miješati s drugim lijekovima osim s NPH (neutralni protamin Hagedorn) inzulinom u štrcaljki za supkutanu primjenu ili s otopinama za infuziju, kako je opisano u dijelu 4.2.
English: Patients using CSII should be comprehensively instructed in the use of the pump system and use the correct reservoir and tubing for the pump (see section 6.6).
Croatian: Bolesnici koji primjenjuju KSII trebaju dobiti jasne upute o uporabi pumpe te koristiti odgovarajući spremnik i kateter za pumpu (vidjeti dio 6.6).
English: • If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d'Orléans F-28000 Chartres, France.
Croatian: • Ako su druga i treća oznaka H7 ili T6, proizvođač je Novo Nordisk Production SAS, 45 Avenue d'Orléans, F-28000 Chartres, Francuska.
English: If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.
Croatian: U slučaju primjene ove kombinacije, u bolesnika valja pratiti znakove i simptome zatajivanja srca, porasta tjelesne težine i edema.
English: NPH (Neutral Protamine Hagedorn) insulin is the only type of insulin that can be mixed with NovoRapid and the mixture must be injected immediately under your skin (subcutaneously).
Croatian: NPH (neutralni protamin Hagedorn) inzulin jedina je vrsta inzulina koja se smije miješati s lijekom NovoRapid, a mješavina se mora odmah injicirati pod kožu (supkutano).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 September 1999
Croatian: Datum prvog odobrenja: 7. rujna 1999.
English: Follow the pump manual (user guide).
Croatian: Slijedite upute za uporabu pumpe (vodič za korisnika).
English: Adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class.
Croatian: Dolje navedene nuspojave temelje se na podacima iz kliničkih ispitivanja i prikazane su prema MedDRA učestalosti i klasifikaciji organskih sustava.
English: EXP/ During use in pump: Use within 7 days
Croatian: Tijekom uporabe u pumpi: upotrijebiti unutar 7 dana.
English: The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control (see section 4.8, Description of selected adverse reactions).
Croatian: Učestalost hipoglikemija varira ovisno o populaciji bolesnika, shemi doziranja i stupnju regulacije glikemije (vidjeti dio 4.8, Opis odabranih nuspojava).
English: If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others.
Croatian: Ako je razina šećera u krvi niska ili visoka, to može utjecati na koncentraciju i sposobnost reagiranja pa time i na sposobnost vožnje ili rukovanja strojem.
English: When the pen contains less than 80 units, the dose counter stops at the number of units left.
Croatian: Ako je u brizgalici ostalo manje od 80 jedinica, brojčanik doze će se zaustaviti na broju preostalih jedinica.
English: Your bolus (meal-time) insulin needs to be adjusted based on your blood sugar measurement and food intake.
Croatian: Vaša bolus (za vrijeme obroka) potreba za inzulinom mora biti prilagođena na temelju mjerenja šećera u krvi i unosa hrane.
English: NovoRapid is generally taken immediately before a meal.
Croatian: NovoRapid se uobičajeno primjenjuje neposredno prije obroka.
English: • If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Croatian: • Ako su druga i treća oznaka S6, P5, K7, R7, VG, FG ili ZF, proizvođač je Novo Nordisk A/S,
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i NovoRapid Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Do not refill your InnoLet.
Croatian: Nemojte ponovno puniti svoj InnoLet.
English: 0.26] percentage points compared to human insulin; a difference of limited clinical significance.
Croatian: 0,05; 0,26] u usporedbi s humanim inzulinom; ograničen je klinički značaj te razlike.
English: C Take a new disposable needle, and tear off the paper tab.
Croatian: C Uzmite novu jednokratnu iglu i otrgnite papirnatu naljepnicu.
English: If necessary NovoRapid can be given directly into a vein but this must only be done by physicians or other healthcare staff.
Croatian: Ako je potrebno, NovoRapid možete primiti izravno u venu, ali to smije učiniti samo liječnik ili neki drugi zdravstveni radnik.
English: ► Inject the insulin under the skin.
Croatian: Injicirajte inzulin pod kožu.
English: In patients with hepatic impairment, absorption rate was decreased and more variable, resulting in delayed tmax from about 50 min in subjects with normal hepatic function to about 85 min in patients with moderate and severe hepatic impairment.
Croatian: U bolesnika s oštećenjem jetre apsorpcija je bila smanjena i varijabilnija, rezultirajući kasnijim tmax od približno 50 minuta u ispitanika s normalnom funkcijom jetre do približno 85 minuta u bolesnika s umjereno i teško oštećenom funkcijom jetre.
English: What NovoRapid PumpCart is and what it is used for
Croatian: Što je NovoRapid PumpCart i za što se koristi
English: The insulin concentrations returned to baseline about 4 to 6 hours after dose.
Croatian: Koncentracija inzulina vraća se na početnu oko 4 do 6 sati nakon primjene.
English: When you change the infusion set (tubing and needle), be sure to change the site for inserting the needle (injection site).
Croatian: Kada promijenite infuzijski set (cjevčicu i iglu) pripazite da promijenite mjesto uvođenja igle (mjesto injiciranja).
English: Never inject directly into a vein (intravenously) or muscle (intramuscularly).
Croatian: Nikada ne injicirajte izravno u venu (intravenski) ili mišić (intramuskularno).
English: Dose and when to take your insulin
Croatian: Doza i kada trebate primijeniti inzulin
English: The absorption rate was somewhat slower in type 2 diabetic patients, resulting in a lower Cmax (352±240 pmol/l) and later tmax (60 (interquartile range: 50-90) minutes).
Croatian: Brzina apsorpcije je nešto sporija u bolesnika sa šećernom bolešću tipa 2, što za posljedicu ima niži Cmax (352±240 pmol/l) i kasniji tmax (60 minuta; interkvartilni raspon 50-90 minuta).
English: b) List of other side effects
Croatian: b) Popis ostalih nuspojava
English: In NovoRapid substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with soluble human insulin.
Croatian: U lijeku NovoRapid zamjena aminokiseline prolina aspartnom kiselinom na položaju B28 umanjuje tendenciju stvaranja heksamera, što je opaženo kod otopine humanog inzulina.
English: If you suspect NovoRapid PumpCart is damaged, take it back to your supplier.
Croatian: Ako sumnjate da je NovoRapid PumpCart oštećen, vratite ga u ljekarnu.
English: Especially in children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake, physical activities and current blood glucose level in order to minimise the risk of hypoglycaemia.
Croatian: Treba voditi računa da doze inzulina (osobito u bazal-bolus terapiji) odgovaraju unosu hrane, fizičkoj aktivnosti i trenutnoj razini glukoze u krvi, osobito u djece, kako bi se rizik od hipoglikemije sveo na najmanju moguću mjeru.
English: Make sure that you receive your full dose by using the right injection technique.
Croatian: Kako biste bili sigurni da ste primili cijelu dozu inzulina, primijenite pravilnu tehniku injiciranja.
English: After the dose counter has returned to 0, leave the needle under the skin for at least 6 seconds to make sure that you get your full dose.
Croatian: Nakon što se brojčanik doze vrati na 0, ostavite iglu pod kožom još najmanje 6 sekundi, kako biste bili sigurni da ste primili cijelu dozu.
English: NovoRapid can be used in adolescents and children aged 1 year and above.
Croatian: NovoRapid se može primjenjivati u adolescenata i djece u dobi od 1 i više godina.
English: NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes).
Croatian: NovoRapid se koristi za snižavanje visoke razine šećera u krvi u odraslih, adolescenata i djece u dobi od 1 i više godina koji imaju dijabetes (šećernu bolest).
English: Make sure the needle is on tight.
Croatian: Provjerite je li igla dobro pričvršćena.
English: • Hold your InnoLet with the needle upwards and tap the cartridge gently with your finger a few times (picture 1B) to make any air bubbles collect at the top of the cartridge.
Croatian: • Držite InnoLet iglom okrenutom prema gore te nekoliko puta lagano kucnite prstom po ulošku (slika 1B) kako bi se mjehurići zraka skupili na vrhu uloška.
English: NovoRapid vial/NovoRapid Penfill/NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch
Croatian: NovoRapid bočica/NovoRapid Penfill/NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid
English: If it shows 80, at least 80 units are left in your pen.
Croatian: Ako pokazuje 80, u brizgalici je preostalo najmanje 80 jedinica.
English: Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirements.
Croatian: Popratne bolesti, posebice infekcije i stanja praćena vrućicom, obično povećavaju bolesnikovu potrebu za inzulinom.
English: Removing the needle
Croatian: Odstranjivanje igle
English: Due to the faster onset of action, NovoRapid should generally be given immediately before a meal.
Croatian: S obzirom na brži početak djelovanja NovoRapid bi uobičajeno trebalo primjenjivati neposredno prije obroka.
English: You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Croatian: Možete se brže probuditi iz nesvjestice ako Vam netko tko to zna injicira hormon glukagon.
English: Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding fertility.
Croatian: Ispitivanja na životinjama vezana uz reprodukciju nisu pokazala bilo kakve razlike između aspart inzulina i humanog inzulina s obzirom na plodnost.
English: For use in an infusion pump system
Croatian: Za primjenu u infuzijskoj pumpi
English: NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect.
Croatian: NovoRapid je moderni inzulin (inzulinski analog) s brzodjelujućim učinkom.
English: How to store NovoRapid PumpCart Contents of the pack and other information
Croatian: Moguće nuspojave Kako čuvati NovoRapid PumpCart Sadržaj pakiranja i druge informacije
English: The time to maximum concentration is, on average, half of that for soluble human insulin.
Croatian: Vrijeme do postizanja maksimalne koncentracije iznosi u prosjeku polovicu vremena potrebnog kod primjene otopine humanog inzulina.
English: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life threatening.
Croatian: Generalizirane reakcije preosjetljivosti (uključujući generalizirani kožni osip, svrbež, znojenje, gastrointestinalne poremećaje, angioneurotski edem, poteškoće s disanjem, palpitacije i pad krvnog tlaka) javljaju se vrlo rijetko, ali mogu biti opasne po život.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV NovoRapid bočica
English: Due to this short action NovoRapid should normally be taken in combination with intermediate-acting or long-acting insulin preparations.
Croatian: Zbog njegova kratkog djelovanja NovoRapid se obično primjenjuje u kombinaciji sa srednjedugodjelujućim ili dugodjelujućim inzulinskim pripravcima.
English: Needles, syringes, cartridges, pre-filled pens and infusion sets must not be shared.
Croatian: Igle, štrcaljke, ulošci, napunjene brizgalice i infuzijski setovi ne smiju se dijeliti s drugim osobama.
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between NovoRapid and other insulin products.
Croatian: Bolesnicima se mora objasniti da prije svakog injiciranja uvijek provjere naljepnicu na inzulinu, kako bi izbjegli slučajne zamjene lijeka NovoRapid i drugih inzulinskih pripravaka.
English: The pharmacokinetic and pharmacodynamic properties of NovoRapid were investigated in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes.
Croatian: Farmakokinetička i farmakodinamička svojstva lijeka NovoRapid ispitivana su u djece (6-12 godina) i adolescenata (13-17 godina) sa šećernom bolešću tipa
English: Talk with your doctor, nurse or pharmacist for advice.
Croatian: Obratite se svom liječniku, medicinskoj sestri ili ljekarniku za savjet.
English: ► If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor.
Croatian: ► Ako imate tako nisku razinu šećera u krvi da se onesvijestite, ako Vam je bila potrebna injekcija glukagona ili ako često imate nisku razinu šećera u krvi, obratite se svom liječniku.
English: • Monoamine oxidase inhibitors (MAOI) (used to treat depression)
Croatian: • inhibitore monoaminooksidaze (MAO inhibitore) (koriste se za liječenje depresije)
English: What to do if you experience high blood sugar: ► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
Croatian: Što učiniti ako osjetite visoku razinu šećera u krvi: ► Ako primijetite neki od gore navedenih znakova, izmjerite razinu šećera u krvi i ako možete, provjerite ketone u urinu, a zatim odmah zatražite medicinski savjet.
English: B Check that the insulin in your pen is clear and colourless.
Croatian: B Provjerite je li inzulin u brizgalici bistar i bezbojan.
English: NovoRapid should be drawn into the syringe before you draw your NPH insulin.
Croatian: NovoRapid treba uvući u štrcaljku prije NPH inzulina.
English: If necessary, NovoRapid can be administered intravenously which should be carried out by physicians or other healthcare staff.
Croatian: Ako je potrebno, NovoRapid se može primijeniti i intravenski, što trebaju činiti liječnici ili drugi zdravstveni radnici.
English: • Dispose of the empty NovoRapid PumpCart cartridge and the used infusion set as instructed by your doctor or nurse.
Croatian: • Bacite u otpad prazan uložak NovoRapid PumpCart i upotrijebljen infuzijski set prema uputama liječnika ili medicinske sestre.
English: A decreased absorption rate was observed in elderly patients, resulting in a later tmax (82 (interquartile range: 60-120) minutes), whereas Cmax was similar to that observed in younger patients with type 2 diabetes and slightly lower than in patients with type 1 diabetes.
Croatian: U starijih bolesnika opažena je smanjena apsorpcija, što je rezultiralo kasnijim tmax (82 minute; interkvartilni raspon 60-120 minuta), dok je Cmax bio sličan onom u mlađih bolesnika sa šećernom bolešću tipa 2 i nešto niži nego u bolesnika sa šećernom bolešću tipa 1.