FrancophonIA/ELRC3.0 huggingface dataset:
English: With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary.
Croatian: Zbog poboljšane metaboličke regulacije i posljedičnog povećanja inzulinske osjetljivosti, možda će biti potrebna daljnja prilagodba režima doziranja.
English: The Nexvue pen delivers LUSDUNA in increments of 1 unit up to a maximum single dose of 60 units.
Croatian: Brizgalicom Nexvue lijek LUSDUNA se može dozirati u koracima od 1 jedinice do najveće pojedinačne doze od 60 jedinica.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Croatian: Farmakoterapijska skupina: Pripravci za liječenje šećerne bolesti; inzulini i analozi za injiciranje, dugog djelovanja.
English: Check the cartridge to make sure the insulin is clear, colourless and free of particles.
Croatian: Pregledajte uložak kako biste se uvjerili da je inzulin bistar, bezbojan i da ne sadrži čestice.
English: At baseline, participants had a median HbA1c value of 6.4 % and median on-treatment HbA1c values ranged from 5.9 to 6.4 % in the insulin glargine group, and 6.2 % to 6.6 % in the standard care group throughout the duration of follow-up.
Croatian: Sudionici su na početku ispitivanja imali medijan vrijednosti HbA1c od 6,4%, dok se medijan vrijednosti HbA1c tijekom liječenja kretao u rasponu od 5,9 do 6,4% u skupini koja je primala inzulin glargin te od 6,2 do 6,6% u skupini koja je primala standardno liječenje tijekom čitavoga razdoblja praćenja.
English: It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Croatian: Smije se koristiti samo ako je otopina bistra, bezbojna, vodenaste konzistencije i bez vidljivih krutih čestica.
English: The time course of action of insulin and insulin analogues such as insulin glargine may vary considerably in different individuals or within the same individual.
Croatian: Trajanje djelovanja inzulina i inzulinskih analoga, poput inzulina glargina, može se značajno razlikovati između različitih osoba, odnosno kod iste osobe.
English: Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
Croatian: Liječenje inzulinom može potaknuti tijelo na stvaranje protutijela na inzulin (tvari koje djeluju protiv inzulina).
English: After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of micro-precipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/time profile with a prolonged duration of action.
Croatian: Nakon injekcije u potkožno tkivo, kisela se otopina neutralizira i stvaraju se mikroprecipitati iz kojih se neprestano otpuštaju male količine inzulina glargina, što osigurava ravnomjerni, predvidljivi profil koncentracija/vrijeme, bez vršnih koncentracija i s produljenim djelovanjem.
English: Needles and alcohol swabs are not included.
Croatian: Igle i alkoholni tupferi nisu uključeni u pakiranje.
English: • You can clean the outside of your pen by wiping it with a damp cloth.
Croatian: • Vanjski dio brizgalice možete očistiti tako da ga obrišete vlažnom krpom.
English: This kills germs that might make you sick.
Croatian: Tako ćete uništiti sve mikroorganizme zbog kojih biste se mogli razboljeti.
English: The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicentre, randomised, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12 % of participants) or type 2 diabetes mellitus treated with ≤ 1 antidiabetic oral agent (88 % of participants).
Croatian: Outcome Reduction with Initial Glargine INtervention) bilo je multicentrično, randomizirano ispitivanje faktorijalnog dizajna 2x2, provedeno u 12 537 ispitanika s visokim kardiovaskularnim rizikom i poremećajem razine glukoze natašte ili narušenom tolerancijom glukoze (12% ispitanika) ili šećernom bolešću tipa 2 liječenom ≤ 1 oralnim antidijabetikom (88% ispitanika).
English: Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Croatian: U rijetkim slučajevima inzulin može uzrokovati retenciju natrija i edem, pogotovo ako je ranija slaba regulacija metabolizma poboljšana intenziviranom inzulinskom terapijom.
English: One hundred forty three of the patients treated with insulin glargine in this study continued treatment with insulin glargine in an uncontrolled extension study with mean duration of follow-up of 2 years.
Croatian: Sto četrdeset i tri (143) bolesnika liječena inzulinom glarginom u ovom ispitivanju nastavila su liječenje inzulinom glarginom u nekontroliranom produžetku ispitivanja sa srednjom vrijednošću trajanja praćenja od 2 godine.
English: Correspondingly, the incidences of nocturnal hypoglycaemia were 32 % in the insulin glargine / lispro group versus 52 % in the NPH / regular group.
Croatian: Sukladno tome, incidencija noćne hipoglikemije iznosila je 32% u skupini koja je primala inzulin glargin/lispro, naspram 52% u skupini koja je primala NPH/obični inzulin.
English: Simply re-cap the pen, and store it without the needle for your next injection.
Croatian: Jednostavno vratite zatvarač na brizgalicu i čuvajte je bez pričvršćene igle za sljedeću injekciju.
English: Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Croatian: Primjeri simptoma koji ukazuju na nisku razinu šećera u mozgu: glavobolje, jaka glad, mučnina, povraćanje, umor, pospanost, poremećaji spavanja, nemir, agresivno ponašanje, poteškoće s koncentracijom, slabije reakcije, depresija, smetenost, poremećaji govora (ponekad potpun gubitak sposobnosti govora), poremećaji vida, drhtavica, paraliza, trnci (parestezije), utrnulost i trnci u području usta, omaglica, gubitak samokontrole, nesposobnost vođenja brige o sebi, konvulzije, gubitak svijesti.
English: Write the date you removed your pen from the refrigerator on the label.
Croatian: Na naljepnicu zapišite datum kada ste izvadili brizgalicu iz hladnjaka.
English: In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal.
Croatian: U randomiziranom, kontroliranom kliničkom ispitivanju, pedijatrijski bolesnici (u dobi od 6 do 15 godina) sa šećernom bolešću tipa 1 (n=349) bili su tijekom 28 tjedana liječeni bazal-bolus inzulinskim režimom, u kojemu se prije svakog obroka primjenjivao običan ljudski inzulin.
English: INTERMEDIATE CARTON (without blue box) component of a multipack - 5 pens
Croatian: UNUTARNJA KUTIJA (bez plavog okvira) koja je sastavni dio višestrukog pakiranja5 brizgalica
English: If you dial the wrong dose, just dial backwards until the correct number lines up with the black line on the window.
Croatian: Ako odmjerite pogrešnu dozu, jednostavno okrećite izbornik doze unatrag sve dok se točan broj ne poravna s crnom linijom na prozorčiću.
English: In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Croatian: Osim toga, pod utjecajem simpatolitika, poput beta blokatora, klonidina, gvanetidina i rezerpina, znakovi adrenergičke proturegulacije mogu oslabjeti ili potpuno izostati.
English: Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of insulin glargine.
Croatian: Prijavljene su medikacijske pogreške slučajne primjene drugih inzulina, osobito kratkodjelujućih inzulina, umjesto inzulina glargina.
English: Make sure the pens are away from the freezer compartment or a freezer pack.
Croatian: Pobrinite se da se brizgalice nalaze podalje od zamrzivača ili rashladnog uloška.
English: Injection sites must be rotated within a given injection area from one injection to the next to prevent injection site reactions (see section 4.8).
Croatian: Mjesto injiciranja mora se promijeniti kod svake injekcije unutar preporučenog područja davanja kako bi se spriječile reakcije na mjestu injiciranja (vidjeti dio 4.8).
English: Complaints of injection site reactions (injection site reaction, injection site pain) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
Croatian: Pritužbe na reakcije na mjestu injiciranja (reakcija na mjestu injiciranja, bol na mjestu injiciranja) i kožne reakcije (osip, koprivnjača) prijavljene su relativno češće u djece i adolescenata u dobi od 18 ili manje godina nego u odraslih.
English: Inner needle cap must be removed before injecting the dose.
Croatian: Unutarnji zatvarač igle mora se skinuti prije injiciranja doze.
English: Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia (see section 4.4).
Croatian: Prilagodba doze također može biti potrebna, primjerice, ako dođe do promjene tjelesne težine ili životnih navika bolesnika, ako se promijeni vrijeme primjene doze inzulina ili nastupe druge okolnosti zbog kojih se povećava sklonost hipoglikemiji odnosno hiperglikemiji (vidjeti dio 4.4).
English: If it does not work, you will need to try with a new needle.
Croatian: Ako inzulin i dalje ne izlazi, morat ćete pokušati ponovno s novom iglom.
English: How to handle Nexvue Nexvue is a pre-filled disposable pen containing insulin glargine.
Croatian: Kako rukovati brizgalicom Nexvue Nexvue je napunjena brizgalica za jednokratnu uporabu koja sadrži inzulin glargin.
English: QR code linking to the instructions for use to be included.
Croatian: Uključiti QR kod koji vodi do uputa za uporabu.
English: To reduce the risk of hypoglycaemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/mL to a once daily regimen with LUSDUNA should reduce their dose by approximately 20%.
Croatian: Kako bi se smanjio rizik od hipoglikemije, bolesnici koji mijenjaju svoj bazalni inzulinski režim s režima liječenja s inzulinom glarginom jačine 300 jedinica/ml jedanput na dan na režim liječenja lijekom LUSDUNA jedanput na dan, trebaju smanjiti svoju dozu za približno 20%.
English: LUSDUNA should not be administered intravenously.
Croatian: LUSDUNA se ne smije primjenjivati intravenski.
English: Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heartbeat, high blood pressure, palpitations and irregular heartbeat.
Croatian: Primjeri simptoma koji Vam govore da razina šećera u krvi previše ili prebrzo pada su: znojenje, ljepljiva koža, tjeskoba, ubrzani otkucaji srca, visok krvni tlak, osjećaj lupanja srca i nepravilni otkucaji srca.
English: Discard pen 28 days after removal from refrigerator.
Croatian: Baciti brizgalicu 28 dana nakon vađenja iz hladnjaka.
English: Clinical study safety data are not available for children under 2 years.
Croatian: Nema dostupnih podataka iz kliničkih ispitivanja o sigurnosti primjene u djece mlađe od 2 godine.
English: - The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (for pH adjustment) (see section 2 “Important information about some of the ingredients of LUSDUNA”), hydrochloric acid (for pH adjustment) and water for injections.
Croatian: - Drugi sastojci su: cinkov klorid, metakrezol, glicerol, natrijev hidroksid (za prilagodbu pH) (pogledajte dio 2. ‘Važne informacije o nekim sastojcima lijeka LUSDUNA'), kloridna kiselina (za prilagodbu pH) i voda za injekcije.
English: Due to more sustained basal insulin supply with insulin glargine, less nocturnal but more early morning hypoglycaemia can be expected.
Croatian: Zbog ravnomjernije opskrbe bazalnim inzulinom kod primjene inzulina glargina, može se očekivati manje noćnih no više ranojutarnjih epizoda hipoglikemije.
English: What you need to know before you use LUSDUNA
Croatian: Što morate znati prije nego počnete primjenjivati lijek LUSDUNA
English: • If you use more than one type of medicine, make sure you have the right medicine before
Croatian: • Ako primjenjujete više od jedne vrste lijeka, prije injiciranja provjerite imate li pravi lijek.
English: Check your insulin
Croatian: Pregledajte inzulin
English: Each pen contains 3 mL of solution for injection, equivalent to 300 units.
Croatian: Jedna brizgalica sadrži 3 ml otopine za injekciju, što odgovara 300 jedinica.
English: If you use more than one type of medicine, make sure you have the right medicine before injecting.
Croatian: Ako primjenjujete više od jedne vrste lijeka, prije injiciranja uvjerite se da imate pravi lijek.
English: Deliver the dose by pressing the injection button until you see 0 and a green stripe appears in the window.
Croatian: Dozu ćete primijeniti tako da pritisnete gumb za injiciranje i držite ga pritisnutim sve dok se u prozorčiću ne prikažu 0 i zelena linija.
English: Cartridge (type I colourless glass) with a plunger (bromobutyl rubber) and aluminium combi-seal fitted with a bi-layered bromobutyl rubber and polyisoprene rubber flat disc containing 3 mL of solution.
Croatian: Uložak (bezbojno staklo tipa I) s klipom (bromobutilna guma) i aluminijskim kombiniranim zatvaračem opremljenim dvoslojnom ravnom pločicom od bromobutilne gume i poliizoprenske gume, koji sadrži 3 ml otopine.
English: However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Croatian: No, intenziviranje inzulinske terapije praćeno naglim poboljšanjem regulacije glikemije može biti povezano s privremenim pogoršanjem dijabetičke retinopatije.
English: What LUSDUNA looks like and contents of the pack LUSDUNA 100 units/mL solution for injection in a pre-filled pen is a clear and colourless solution.
Croatian: Kako LUSDUNA izgleda i sadržaj pakiranja LUSDUNA 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici je bistra i bezbojna otopina.
English: • LUSDUNA contains a medicine called insulin glargine.
Croatian: • LUSDUNA sadrži lijek koji se zove inzulin glargin.
English: Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Croatian: Inzulin i njegovi analozi snižavaju razinu glukoze u krvi potičući periferni unos glukoze, posebice u skeletnu muskulaturu i masno tkivo, te inhibirajući stvaranje glukoze u jetri.
English: Safety and efficacy of insulin glargine have not been established in children below the age of 2 years.
Croatian: Sigurnost i djelotvornost inzulina glargina nisu ustanovljene u djece mlađe od 2 godine.
English: Combination of LUSDUNA with pioglitazone
Croatian: Kombinacija lijeka LUSDUNA i pioglitazona
English: LUSDUNA can be used in adolescents and children aged 2 years and above.
Croatian: LUSDUNA se može koristiti u adolescenata i djece u dobi od 2 ili više godina.
English: If the pen won't let you dial your full dose, there may not be enough insulin left in the pen.
Croatian: Ako ne možete odmjeriti punu dozu, možda u brizgalici nije preostalo dovoljno inzulina.
English: Clean your injection site
Croatian: Očistite mjesto injiciranja
English: Recap the pen after use in order to protect from light.
Croatian: Vratiti zatvarač na brizgalicu nakon uporabe radi zaštite od svjetlosti.
English: Check to make sure insulin comes out of the pen.
Croatian: Provjerite izlazi li inzulin iz brizgalice.
English: • Skin and allergic reactions at the injection site These signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Croatian: • Kožne i alergijske reakcije na mjestu injiciranja Znakovi mogu uključivati crvenilo, neuobičajeno jaku bol prilikom injiciranja, svrbež, koprivnjaču, oticanje ili upalu.
English: Throw away the needle safely, as instructed by your doctor, pharmacist or nurse.
Croatian: Zbrinite iglu na siguran način, u skladu s uputama liječnika, ljekarnika ili medicinske sestre.
English: The prolonged duration of action of insulin glargine is dependent on its injection into subcutaneous tissue.
Croatian: Produljeno djelovanje inzulina glargina ovisi o njegovom injiciranju u potkožno tkivo.
English: Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Croatian: Poseban oprez i pojačana kontrola glukoze u krvi preporučuju se u bolesnika u kojih epizode hipoglikemije mogu biti klinički posebno značajne, poput bolesnika sa značajnom stenozom koronarnih arterija ili krvnih žila koje opskrbljuju mozak (rizik od srčanih ili cerebralnih komplikacija hipoglikemije) te bolesnika s proliferativnom retinopatijom, naročito ako nije liječena fotokoagulacijom (rizik od prolazne amauroze uslijed hipoglikemije).
English: Press to inject into the air
Croatian: Pritisnite da biste injicirali dozu u zrak
English: Driving and using machines Your ability to concentrate or react may be reduced if: - you have hypoglycaemia (low blood sugar levels), - you have hyperglycaemia (high blood sugar levels), - you have problems with your sight.
Croatian: Vaša sposobnost koncentracije i reagiranja može biti oslabljena: - ako imate hipoglikemiju (nisku razinu šećera u krvi), - ako imate hiperglikemiju (visoku razinu šećera u krvi), - ako imate problema s vidom.
English: When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with LUSDUNA, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).
Croatian: Kad se prelazi s liječenja inzulinom srednje dugog ili dugog djelovanja na liječenje lijekom LUSDUNA možda će biti potrebno promijeniti dozu bazalnog inzulina i prilagoditi liječenje drugim istodobno primijenjenim antidijabeticima (dozu i vrijeme primjene dodatnih običnih inzulina ili brzodjelujućih inzulinskih analoga, odnosno dozu oralnih antidijabetika).
English: The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor.
Croatian: Ukupna terapijska koncentracija inzulina (inzulina glargina i metabolita) nađena u bolesnika sa šećernom bolešću tipa 1 bila je značajno niža od koncentracije potrebne za dostizanje polovice maksimalnog zasićenja IGF-1 receptora i posljedičnu aktivaciju mitogeno-proliferativnog puta koji se inicira putem IGF-1 receptora.
English: If you stop using LUSDUNA
Croatian: Ako prestanete primjenjivati lijek LUSDUNA
English: Only use needles that are compatible for use with your pen (see section “Parts of your pen” below).
Croatian: Koristite samo igle koje su prikladne za uporabu s Vašom brizgalicom (pogledajte dio ‘Dijelovi brizgalice' u nastavku).
English: LUSDUNA is injected under the skin.
Croatian: LUSDUNA se daje injekcijom pod kožu.
English: In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Croatian: U slučaju nedostatne kontrole glukoze ili sklonosti epizodama hiperglikemije odnosno hipoglikemije, prije razmatranja prilagodbe doze mora se procijeniti pridržava li se bolesnik propisanog režima liječenja i mjesta injiciranja te pravilne tehnike injiciranja, kao i sve ostale važne čimbenike.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone (oral anti-diabetic medicine used to treat type 2 diabetes mellitus) and insulin experienced the development of heart failure.
Croatian: U nekih bolesnika koji dugo boluju od šećerne bolesti tipa 2 i imaju srčanu bolest ili su imali moždani udar, a liječeni su pioglitazonom (oralni antidijabetik za liječenje šećerne bolesti tipa 2) i inzulinom, došlo je do razvoja zatajenja srca.
English: Carefully read the instructions for use included in the package before using Nexvue.
Croatian: Pažljivo pročitajte upute za uporabu uključene u pakiranje prije nego što upotrijebite Nexvue.
English: A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin (each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients aged 12 to 18 years was also performed.
Croatian: Provedeno je i ukriženo ispitivanje, u kojemu se uspoređivala primjena inzulina glargina plus inzulin lispro s primjenom NPH inzulina plus obični ljudski inzulin (svako liječenje primjenjivalo se 16 tjedana, nasumičnim redoslijedom) u 26 adolescenata sa šećernom bolešću tipa 1 u dobi od 12 do 18 godina.
English: 1 pre-filled pen of 3 mL 5 pre-filled pens of 3 mL
Croatian: 1 napunjena brizgalica od 3 ml 5 napunjenih brizgalica od 3 ml
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Croatian: Beta blokatori, klonidin, soli litija odnosno alkohol mogu ili pojačati ili oslabiti učinak inzulina na snižavanje razine glukoze u krvi.
English: LUSDUNA is only suitable for injection just under the skin.
Croatian: Lijek LUSDUNA je prikladan samo za ubrizgavanje neposredno pod kožu.
English: Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with LUSDUNA.
Croatian: Bolesnici koji zbog postojanja protutijela na ljudski inzulin uzimaju visoke doze inzulina mogu imati bolji terapijski odgovor na inzulin uz lijek LUSDUNA.
English: The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤ 18 years of age) than in adults.
Croatian: Prijave nuspojava nakon stavljanja lijeka u promet uključivale su relativno češće reakcije na mjestu injiciranja (bol na mjestu injiciranja, reakcija na mjestu injiciranja) i kožne reakcije (osip, urtikarija) u djece i adolescenata (≤ 18 godina) nego u odraslih.