FrancophonIA/ELRC3.0 huggingface dataset:
English: 10 pre-filled syringes with separate needles
Croatian: 10 napunjenih štrcaljki sa zasebno priloženim iglama
English: 1 pre-filled syringe with separate needle
Croatian: 1 napunjena štrcaljka sa zasebno priloženom iglom
English: Serotype 14 2 µg
Croatian: serotipa 14
English: Prevenar - Pharmaceutical Form(s) and Strength(s)
Croatian: Sastav (koncentracija)
English: ATC code: A10AB05.
Croatian: ATK oznaka: A10AB05.
English: This is normal and has no effect on the dose you just received.
Croatian: To je normalno i ne utječe na dozu koju ste upravo primili.
English: Date of last renewal: 30 April 2009
Croatian: Datum posljednje obnove: 30. travnja 2009.
English: Absorption, distribution and elimination
Croatian: Apsorpcija, distribucija i eliminacija
English: They must not give you any food or drink due to risk of suffocation.
Croatian: Oni Vam ne smiju davati nikakvu hranu ni piće zbog rizika od gušenja.
English: These reactions are usually of transitory nature.
Croatian: Te su reakcije obično prolazne naravi.
English: Component of a multipack, cannot be sold separately.
Croatian: Dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Croatian: To može predstavljati rizik u situacijama u kojima su takve sposobnosti posebno važne (primjerice, vožnja ili upravljanje strojevima).
English: How much insulin is left?
Croatian: Koliko je inzulina preostalo?
English: Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.
Croatian: Nemojte davati ovaj lijek djeci mlađoj od 1 godine budući nisu provedena klinička ispitivanja u djece mlađe od 1 godine.
English: Dose counter stopped: 52 units left
Croatian: Brojčanik doze se zaustavio: preostale su 52 jedinice
English: NovoRapid dosing is individual and determined in accordance with the needs of the patient.
Croatian: Doziranje lijeka NovoRapid individualno je i određuje se u skladu s potrebama bolesnika.
English: The observed improvements in HbA1c and the safety profiles were comparable between all age groups.
Croatian: Opažena poboljšanja HbA1c i sigurnosni profili bili su usporedivi između svih dobnih skupina.
English: The risk of daytime hypoglycaemia was not significantly increased.
Croatian: Rizik od dnevnih hipoglikemija nije se značajno povećao.
English: • Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).
Croatian: • pijete alkohol (vidjeti Konzumiranje alkohola i primjena lijeka NovoRapid u dijelu 2).
English: Although stable over time, a certain amount of insulin will be initially adsorbed to the material of the infusion bag.
Croatian: Iako je stabilan tijekom vremena, određena količina inzulina inicijalno će se adsorbirati na materijal infuzijske vrećice.
English: NovoRapid which has been frozen must not be used.
Croatian: NovoRapid koji je bio zamrznut ne smije se primijeniti.
English: The trials included 167 children aged 1-5 years, 260 aged 6-11 and 285 aged 12-17.
Croatian: Ispitivanja su uključivala 167 djece u dobi od 1 do 5 godina, 260 djece u dobi od 6 do 11 godina i 285 djece u dobi od 12 do 17 godina.
English: • This medicinal product should never be mixed with any other medicinal products.
Croatian: • Ovaj se lijek nikada ne smije miješati s bilo kojim drugim lijekovima.
English: You should always measure your blood sugar regularly.
Croatian: Uvijek treba redovito mjeriti razinu šećera u krvi.
English: The duration of action is 3 to 5 hours.
Croatian: Djelovanje traje 3 do 5 sati.
English: The individual insulin requirement in adults and children is usually between 0.5 and 1.0 unit/kg/day.
Croatian: Individualna potreba za inzulinom u odraslih i djece obično se kreće u rasponu između 0,5 i 1,0 jedinica/kg/dan.
English: The safety and efficacy of NovoRapid in children below 1 year of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka NovoRapid u djece mlađe od 1 godine nisu ustanovljene.
English: However, Cmax differed between the age groups, stressing the importance of the individual titration of NovoRapid.
Croatian: Međutim, Cmax se razlikovao po dobnim skupinama, što naglašava važnost individualne titracije lijeka NovoRapid.
English: For example, when it is difficult to dose the child in relation to meals.
Croatian: Primjerice, kad je teško odrediti kada djetetu dati dozu inzulina s obzirom na obroke.
English: This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects).
Croatian: To može smanjiti rizik od stvaranja kvržica ili ulegnuća na koži (vidjeti dio 4. Moguće nuspojave).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, reproduktivne i razvojne toksičnosti.
English: This should be kept in mind if treatment with the combination of pioglitazone and NovoRapid is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka NovoRapid.
English: rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti na temelju dostupnih podataka).
English: If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Croatian: Ako ste slijepi ili slabovidni i ne možete pročitati što piše na brojčaniku doze na brizgalici, nemojte koristiti ovu brizgalicu bez tuđe pomoći.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: ► If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid).
Croatian: ► ako nije ispravno čuvan ili je bio zamrznut (vidjeti dio 5. Kako čuvati NovoRapid PumpCart).
English: Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults.
Croatian: Aspart inzulin se brzo apsorbirao u obje dobne skupine, sa sličnim tmax kao i u odraslih.
English: You can turn the dose selector forwards or backwards.
Croatian: Izbornik doze možete okretati unaprijed ili unazad.
English: Dose button
Croatian: Potisni gumb
English: ► If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections.
Croatian: ► ako putujete u inozemstvo, putovanje kroz vremenske zone može utjecati na Vaše potrebe za inzulinom i na vrijeme injiciranja.
English: NovoRapid can be used in elderly patients.
Croatian: NovoRapid se može koristiti u starijih bolesnika.
English: Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester.
Croatian: Potrebe za inzulinom obično se smanjuju tijekom prvog tromjesečja, a postupno povećavaju u drugom i trećem tromjesečju trudnoće.
English: During use: Use within 4 weeks
Croatian: Tijekom uporabe: upotrijebiti unutar 4 tjedna.
English: What NovoRapid is and what it is used for
Croatian: Što je NovoRapid i za što se koristi
English: What to do in case of pump failure
Croatian: Što učiniti u slučaju neispravnosti pumpe
English: See also Serious allergic reactions above.
Croatian: Vidjeti i Ozbiljna alergijska reakcija u prethodnom odjeljku.
English: In picture A the bottom of the plunger is hidden behind the white label band as it should be.
Croatian: A donji dio klipa skriven je iza bijele trakice, kako i treba biti.
English: See a) Summary of serious and very common side effects in section 4.
Croatian: Vidjeti a) Sažetak ozbiljnih i vrlo čestih nuspojava u dijelu 4.
English: If no drop appears, repeat steps F to H up to 6 times.
Croatian: Ako se kapljica ne pojavi, ponovite korake F do H najviše 6 puta.
English: When necessary, you can take the bolus dose just after you have finished eating.
Croatian: Kad je potrebno, bolus dozu možete primijeniti odmah nakon što ste završili s obrokom.
English: However, the NovoRapid dose may need to be adjusted.
Croatian: Međutim, možda će biti potrebno prilagoditi dozu lijeka NovoRapid.
English: If you experience any problems contact your doctor.
Croatian: Ako iskusite bilo kakve probleme obratite se svom liječniku.
English: The dose selector clicks differently when turned forwards, backwards or past the number of units left.
Croatian: Izbornik doze ima drugačiji zvuk kad se okreće unaprijed, unazad, odnosno preko broja preostalih jedinica.
English: Start by checking your pen to make sure that it contains NovoRapid 100 units/ml, then look at the illustrations to the right to get to know the different parts of your pen and needle.
Croatian: Započnite tako što ćete provjeriti brizgalicu kako biste se uvjerili da sadrži NovoRapid 100 jedinica/ml, a zatim pogledajte slike na desnoj strani da se upoznate s različitim dijelovima brizgalice i igle.
English: AUC, Cmax and CL/F were similar in patients with reduced hepatic function compared with subjects with normal hepatic function.
Croatian: AUC, Cmax i CL/F bili su slični u bolesnika sa smanjenom jetrenom funkcijom, u usporedbi s ispitanicima s normalnom jetrenom funkcijom.
English: • NovoRapid PumpCart should be kept out of reach of others, especially children.
Croatian: • NovoRapid PumpCart treba čuvati izvan dohvata drugih osoba, osobito djece.
English: See c) Effects from diabetes in section 4.
Croatian: Vidjeti c) Učinci šećerne bolesti u dijelu 4.
English: ► If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very common side effects in section 4).
Croatian: ► ako sumnjate da počinje hipoglikemija (niska razina šećera u krvi) (vidjeti a) Sažetak ozbiljnih i vrlo čestih nuspojava u dijelu 4).
English: If you try to put it back on, you may accidentally stick yourself with the needle.
Croatian: Ako ga pokušate vratiti, možete se nehotice ubosti iglom.
English: The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units.
Croatian: Potentnost inzulinskih analoga, uključujući aspart inzulin, izražava se u jedinicama, dok se potentnost humanog inzulina izražava u internacionalnim jedinicama.
English: If you need more insulin than the units left in your pen, you can split your dose between two pens.
Croatian: Ako trebate više inzulina nego što ga je preostalo u brizgalici, dozu možete podijeliti na dvije brizgalice.
English: • Always check that NovoRapid PumpCart looks the way it should (picture A).
Croatian: • Uvijek provjerite izgleda li NovoRapid PumpCart kako bi trebao (slika A).
English: ► If you are ill, carry on taking your insulin and consult your doctor.
Croatian: ► ako ste bolesni, nastavite s primjenom inzulina i posavjetujte se s liječnikom.
English: Always use your insulin and adjust your dose exactly as your doctor has told you.
Croatian: Uvijek primijenite inzulin i prilagodite dozu točno onako kako Vam je rekao Vaš liječnik.
English: Modern insulin products are improved versions of human insulin.
Croatian: Moderni inzulinski pripravci poboljšane su verzije humanog inzulina.
English: *Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Croatian: *Aspart inzulin proizveden je iz Saccharomyces cerevisiae tehnologijom rekombinantne DNK.
English: Always use your insulin and adjust your basal (all-day) and bolus (meal time) doses exactly as your doctor has told you.
Croatian: Uvijek primijenite inzulin i prilagodite bazalnu (cjelodnevnu) i bolus (za vrijeme obroka) dozu točno onako kako Vam je rekao Vaš liječnik.
English: It is best to measure your blood sugar level regularly to get the maximum benefit of insulin delivery, and to make sure the pump is working properly.
Croatian: Najbolje je redovito mjeriti razinu šećera u krvi kako bi se dobila maksimalna korist od primjene inzulina i kako biste osigurali da pumpa radi ispravno.
English: If you use only one type of insulin
Croatian: Ako koristite samo jednu vrstu inzulina
English: 6.6 Special precautions for disposal and other handling Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Ovaj lijek se ne smije upotrijebiti ako primijetite da otopina nije bistra, bezbojna i vodena.
English: Stop when the right number of units lines up with the dose pointer.
Croatian: Zaustavite se kad ispravan broj jedinica bude u ravnini s pokazivačem doze.
English: If no drop appears after these new attempts, change the needle and repeat steps F to H once more.
Croatian: Ako se nakon tih dodatnih pokušaja kapljica inzulina ne pojavi, promijenite iglu i još jednom ponovite korake F do H.
English: NovoRapid can be used in children and adolescents aged 1 year and above in preference to soluble human insulin when a rapid onset of action might be beneficial, for example, in the timing of the injections in relation to meals (see sections 5.1 and 5.2).
Croatian: NovoRapid se može primjenjivati u djece i adolescenata u dobi od 1 i više godina umjesto otopine humanog inzulina kada brži početak djelovanja može biti koristan, primjerice, pri usklađivanju vremena davanja inzulina s obrocima (vidjeti dijelove 5.1 i 5.2).
English: Measure your blood sugar if possible and rest.
Croatian: Ako možete, izmjerite razinu šećera u krvi, a zatim se odmarajte.
English: Do not use the pen if a drop of insulin still does not appear.
Croatian: Nemojte koristiti brizgalicu ako se kapljica inzulina još uvijek ne pojavi.
English: Before you set or change the basal rate, carefully read the pump manual (user guide).
Croatian: Prije nego što namjestite ili promijenite udio bazalnog inzulina, pažljivo pročitajte upute za uporabu pumpe (upute za korisnika).
English: Just before use, roll the NPH insulin between your hands until the liquid is uniformly white and cloudy.
Croatian: Neposredno prije primjene provaljajte NPH inzulin među dlanovima dok tekućina ne postane jednoliko bijela i mutna.
English: • Check the label to make sure that it is NovoRapid PumpCart.
Croatian: • Provjerite naljepnicu kako biste bili sigurni da je to NovoRapid PumpCart.
English: Multipack: 2 x (5 x 3 ml)
Croatian: Višestruko pakiranje: 2 x (5 x 3 ml).
English: This could interrupt the injection.
Croatian: Time biste mogli prekinuti primjenu injekcije.
English: For storage conditions of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja lijeka vidjeti u dijelu 6.3.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim ažuriranim verzijama RMP-a.
English: No apparent effect of creatinine clearance values on AUC, Cmax, CL/F and tmax of insulin aspart was found.
Croatian: Nije bilo vidljivog utjecaja vrijednosti klirensa kreatinina na AUC, Cmax, CL/F i tmax aspart inzulina.
English: Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening.
Croatian: Ozbiljna alergijska reakcija na NovoRapid ili neki od njegovih sastojaka (sistemska alergijska reakcija) je vrlo rijetka nuspojava, ali može biti opasna po život.
English: The maximum effect occurs between 1 and 3 hours after the bolus delivery and the effect lasts for 3 to 5 hours.
Croatian: Maksimalan učinak postiže se između 1 i 3 sata nakon bolus primjene, a učinak traje 3 do 5 sati.
English: Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints.
Croatian: Otečeni zglobovi: Kad počnete primjenjivati inzulin, nakupljanje vode može uzrokovati oticanje oko gležnjeva i drugih zglobova.
English: • Follow the steps described in section 1 and 2 to prepare and insert a new NovoRapid PumpCart into your pump.
Croatian: • Slijedite korake opisane u poglavljima 1 i 2 za pripremanje i umetanje novog uloška NovoRapid
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: Changes in strength, brand (manufacturer), type, origin (animal, human insulin or human insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose.
Croatian: Promjene u jačini, nazivu inzulina (proizvođač), vrsti, podrijetlu (životinjski, humani inzulin ili analog humanog inzulina) i/ili načinu proizvodnje (rekombinantna DNK u odnosu na inzulin životinjskog podrijetla) mogu rezultirati potrebom za promjenom doze.
English: The intra-individual variability in time to maximum concentration is significantly less for NovoRapid than for soluble human insulin, whereas the intraindividual variability in Cmax for NovoRapid is larger.
Croatian: Intraindividualna varijabilnost u vremenu potrebnom da se postigne maksimalna koncentracija značajno je manja za NovoRapid nego za otopinu humanog inzulina, dok je intraindividualna varijabilnost u Cmax veća za NovoRapid.
English: • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
Croatian: • simpatomimetike (poput epinefrina [adrenalina] ili salbutamola, terbutalina koji se koriste za liječenje astme)
English: After stabilisation of patient's blood glucose adjustment of the dose should be considered (see sections 4.8 and 4.9).
Croatian: Nakon što u bolesnika dođe do stabilizacije glikemije treba razmotriti prilagodbu doze (vidjeti dijelove 4.8 i 4.9).
English: Treatment with NovoRapid helps to prevent complications from your diabetes.
Croatian: Liječenje lijekom NovoRapid pomaže spriječiti komplikacije šećerne bolesti.
English: If you stop the pump, the insulin effect will last for 3 to 5 hours.
Croatian: Ako zaustavite pumpu, djelovanje inzulina trajat će 3-5 sati.
English: Frequency categories are defined according to the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Croatian: Za učestalost pojavljivanja korištena je sljedeća kategorizacija: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko
English: If you are given glucagon, you will need glucose or a sugar snack as soon as you are conscious.
Croatian: Ako Vam je injiciran glukagon, trebat ćete uzeti glukozu ili međuobrok bogat šećerom čim se probudite iz nesvjestice.
English: The pharmacodynamic profile of insulin aspart in children was similar to that seen in adults.
Croatian: Farmakodinamički profil aspart inzulina u djece bio je sličan onom u odraslih.
English: c) Effects from diabetes
Croatian: c) Učinci šećerne bolesti
English: If you change the basal insulin setting the change will start to affect you within 10-20 minutes.
Croatian: Ako promijenite postavke za bazalni inzulin, promjena će utjecati na Vas unutar 10-20 minuta.
English: If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
Croatian: Ako imate smanjenu funkciju bubrega ili jetre, ili ste stariji od 65 godina, trebate češće kontrolirati razinu šećera u krvi i s liječnikom razgovarati o promjenama doze inzulina.
English: Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar.
Croatian: Recite ljudima u svojoj okolini da imate šećernu bolest te koje su moguće posljedice, uključujući rizik od nesvjestice (gubitka svijesti) zbog niske razine šećera u krvi.
English: NovoRapid will start to lower your blood sugar 10-20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3-5 hours.
Croatian: NovoRapid počinje snižavati razinu šećera u krvi 10-20 minuta nakon što ga injicirate, maksimalan učinak postiže se između 1 i 3 sata nakon injiciranja, a učinak traje 3-5 sati.
English: • Before inserting the needle, use soap and water to clean your hands and the skin where the needle is inserted to avoid any infection at the infusion site.
Croatian: • Prije uvođenja igle operite ruke i kožu na mjestu uvođenja igle vodom i sapunom kako ne bi došlo do infekcije na mjestu infuzije.
English: Anaphylactic reactions:
Croatian: Anafilaktičke reakcije:
English: Mixing two types of insulins
Croatian: Miješanje dvije vrste inzulina
English: What NovoRapid is and what it is used for What you need to know before you use NovoRapid How to use NovoRapid
Croatian: Što je NovoRapid i za što se koristi Što morate znati prije nego počnete primjenjivati NovoRapid
English: ► When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
Croatian: ► Kad simptomi niske razine šećera u krvi nestanu ili Vam se stabilizira razina šećera u krvi, nastavite liječenje inzulinom kao obično.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by physicians or other healthcare staff.
Croatian: • Teške epizode hipoglikemije, u kojima bolesnik ostane bez svijesti, mogu se liječiti glukagonom (0,5 do 1 mg) koji intramuskularno ili supkutano daje osoba upoznata s načinom primjene glukagona ili glukozom koju intravenski daje liječnik ili drugi zdravstveni radnik.
English: If in doubt, take the full dose with a new pen.
Croatian: Ako niste sigurni, primijenite cijelu dozu novom brizgalicom.
English: After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Croatian: Nakon poroda potrebe za inzulinom obično se brzo vraćaju na one prije trudnoće.
English: • Check the expiry date, which is stated on the label and the carton.
Croatian: • Provjerite rok valjanosti, koji je naveden na naljepnici i kutiji.
English: There are no restrictions on treatment with NovoRapid during breast-feeding.
Croatian: Nema ograničenja za liječenje lijekom NovoRapid tijekom dojenja.
English: What NovoRapid contains
Croatian: Što NovoRapid sadrži
English: Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Croatian: Neki lijekovi utječu na razinu šećera u krvi, što može značiti da će trebati promijeniti dozu inzulina.
English: ► If you are treated with NovoRapid Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Croatian: ► Ako se liječite lijekom NovoRapid Penfill i još jednim inzulinom u Penfill ulošku, morate koristiti dva pomagala za primjenu inzulina, po jedan za svaku vrstu inzulina.
English: Subcutaneous injection in the abdominal wall ensures a faster absorption than other injection sites.
Croatian: Supkutano injiciranje u trbušnu stijenku osigurava bržu apsorpciju nego druga mjesta injiciranja.