FrancophonIA/ELRC3.0 huggingface dataset:
English: After first opening: Do not refrigerate.
Croatian: Nakon prvog otvaranja: ne odlagati u hladnjak.
English: • If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.
Croatian: • Ako želite promijeniti Vašu uobičajenu prehranu, prvo porazgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom jer promjena prehrane može promijeniti Vašu potrebu za inzulinom.
English: The dose selector clicks differently when turned forwards, backwards or past the number of units left.
Croatian: Izbornik doze drugačije ‘klikne' kad se okreće unaprijed, unazad ili preko broja preostalih jedinica.
English: • danazol, for endometriosis
Croatian: • danazol, za endometriozu
English: The ratio between AUCGIR,0-12h,SS and AUCGIR,τ,SS was 0.5.
Croatian: Omjer između AUCGIR,0-12h,SS i AUCGIR,τ,SS bio je 0,5.
English: Important information Pay special attention to these notes as they are important for correct use of the pen.
Croatian: Posvetite posebnu pozornost ovim napomenama jer su važne za pravilnu uporabu brizgalice.
English: This should be kept in mind if treatment with the combination of pioglitazone and Tresiba is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka Tresiba.
English: If you use more Tresiba than you should
Croatian: Ako primijenite više lijeka Tresiba nego što ste trebali
English: Table 8 Results from DEVOTE
Croatian: Tablica 8 Rezultati iz ispitivanja DEVOTE
English: 1 Prepare your pen
Croatian: 1 Pripremite svoju brizgalicu
English: Do not touch the dose counter with your fingers.
Croatian: Ne dirajte brojčanik doze prstima.
English: Paediatric population The European Medicines Agency has waived the obligation to submit the results of trials with Tresiba in:
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Tresiba u:
English: After first opening: Do not store above 30°C.
Croatian: Nakon prvog otvaranja: ne čuvati na temperaturi iznad 30°C.
English: Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).
Croatian: Odmah obavijestite svog liječnika ako osjetite znakove zatajivanja srca kao što je neuobičajen nedostatak zraka, naglo povećanje tjelesne težine ili lokalizirano oticanje (edem).
English: Clear, colourless, neutral solution.
Croatian: Bistra, bezbojna, neutralna otopina.
English: Tresiba can be used in elderly, but if you are elderly, you may need to check your blood sugar level more often.
Croatian: Tresiba se može primjenjivati u starijih bolesnika, ali ako ste stariji možda ćete morati češće kontrolirati razinu šećera u krvi.
English: • Do not expose your pen to dust, dirt or liquid.
Croatian: • Ne izlažite svoju brizgalicu prašini, prljavštini ili tekućini.
English: You will need it after the injection to correctly remove the needle from the pen.
Croatian: Trebat će Vam nakon injiciranja kako bi pravilno skinuli iglu s brizgalice.
English: • Change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting (see section 4).
Croatian: • Svaki dan promijenite mjesto injiciranja unutar regije u koju injicirate radi smanjivanja opasnosti od stvaranja kvržica i ulegnuća na koži (vidjeti dio 4).
English: • Never share your pen with other people.
Croatian: • Nikada ne dijelite svoju brizgalicu s drugim osobama.
English: Let them know that if you pass out, they must:
Croatian: Ako se onesvijestite, recite im da moraju:
English: Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.5, 4.8 and 4.9).
Croatian: Hipoglikemija može nastupiti ako je doza inzulina prevelika u odnosu na potrebe za inzulinom (vidjeti dijelove 4.5, 4.8 i 4.9).
English: Never try to put the inner needle cap back on the needle.
Croatian: Nikada ne pokušajte vratiti unutarnji zatvarač igle natrag na iglu.
English: • not give you any food or drink because you may choke.
Croatian: • odmah zatražiti medicinsku pomoć • ne davati Vam nikakvu hranu ili piće jer biste se mogli ugušiti.
English: Do not count the pen clicks.
Croatian: Ne brojite broj ‘klikova' brizgalice.
English: If no drop appears, repeat steps 2A to 2C up to 6 times.
Croatian: Ako se kapljica ne pojavi, ponovite korake od 2A do 2C do 6 puta.
English: This helps you to ensure that you get your full insulin dose.
Croatian: Time ćete osigurati da dobijete punu dozu inzulina.
English: No metabolic effects are anticipated in the breast-fed newborn/infant.
Croatian: Ne očekuju se metabolički učinci u dojene novorođenčadi/dojenčadi.
English: Tresiba has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see section 5.2).
Croatian: Tresiba je primijenjena u djece i adolescenata u dobi do 18 godina radi ispitivanja farmakokinetičkih svojstava (vidjeti dio 5.2).
English: • sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline, for asthma
Croatian: • simpatomimetike, poput epinefrina (adrenalina), salbutamola ili terbutalina, za astmu
English: • in insulin infusion pumps.
Croatian: • u inzulinskim infuzijskim pumpama.
English: Total exposure after a single dose was, however, higher in children and adolescents than in adults with type 1 diabetes mellitus.
Croatian: Međutim, ukupna izloženost nakon jedne doze bila je viša u djece i adolescenata nego u odraslih sa šećernom bolešću tipa 1.
English: • Pioglitazone used together with insulin, see ‘Pioglitazone' below.
Croatian: • Uzimanje pioglitazona zajedno s inzulinom, vidjeti dolje ‘Pioglitazon'.
English: • Check that the insulin in your pen is clear and colourless.
Croatian: • Provjerite da je inzulin u Vašoj brizgalici bistar i bezbojan.
English: In both treatment arms, children aged 6-11 years had a numerically higher rate of confirmed hypoglycaemia than in the other age groups.
Croatian: U obje terapijske skupine djeca u dobi 6-11 godina imala su brojčano višu stopu potvrđenih hipoglikemija nego u drugim dobnim skupinama.
English: Results from subgroup analyses (e.g. sex, diabetes duration, CV risk group and previous insulin regimen) was aligned with the primary analysis.
Croatian: Rezultati analiza po podskupinama (npr. spol, trajanje šećerne bolesti, skupina s KV rizikom i prethodni inzulinski režim) u skladu su s primarnom analizom.
English: The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in human plasma.
Croatian: Afinitet degludek inzulina za albumine u serumu odgovara vezivanju na proteine plazme od >99% u humanoj plazmi.
English: Non-clinical data reveal no safety concerns for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, kancerogenosti i reproduktivne toksičnosti.
English: Avoiding too low blood sugar (hypoglycaemia) is particularly important for the health of your baby.
Croatian: Izbjegavanje preniske razine šećera u krvi (hipoglikemije) posebno je važno za zdravlje Vašeg djeteta.
English: Tresiba is to be dosed in accordance with the individual patient's needs.
Croatian: Tresiba se treba dozirati sukladno individualnim potrebama bolesnika.
English: If you forget a dose, inject the missed dose when discovering the mistake, ensuring a minimum of 8 hours between doses.
Croatian: Ako ste zaboravili primijeniti jednu dozu, injicirajte izostavljenu dozu čim utvrdite pogrešku, pazeći da između dvije doze protekne najmanje 8 sati.
English: In rats, insulin degludec was secreted in milk; the concentration in milk was lower than in plasma.
Croatian: U štakora se degludek inzulin izlučivao u mlijeko; koncentracija u mlijeku bila je niža od one u plazmi.
English: If you discover that you missed your previous dose when it is time to take your next regular scheduled dose, do not inject a double dose, but resume your once-daily dosing schedule.
Croatian: Ako primijetite da ste izostavili prethodnu dozu u vrijeme kada trebate primijeniti sljedeću redovnu dozu, nemojte injicirati dvostruku dozu, već nastavite sa svojim uobičajenim rasporedom doziranja jednom dnevno.
English: Insulins and analogues for injection, long-acting.
Croatian: Inzulini i analozi za injiciranje, dugodjelujući.
English: The MAH shall agree on the final text of the Direct Healthcare Professional Communication letter and the content of the patient brochure together with a communication plan, with the National Competent Authority in each Member State prior to distribution of the educational pack in the Member State.
Croatian: Nositelj odobrenja mora dogovoriti konačan tekst Izravnog pisma zdravstvenim radnicima i sadržaj Brošure za bolesnike, kao i komunikacijski plan, s nacionalnim nadležnim tijelom u svakoj zemlji članici prije distribucije edukacijskog paketa u zemlji članici.
English: Antibody development was sparse and had no clinical impact.
Croatian: Do razvoja protutijela je dolazilo rijetko i nije imalo kliničkog utjecaja.
English: %: Percentage of subjects with a first EAC confirmed event relative to the number of randomised subjects.
Croatian: %: Postotak ispitanika s prvim događajem koji je potvrdilo Povjerenstvo za ocjenu događaja u odnosu na broj randomiziranih ispitanika.
English: Any waste material should be disposed of in accordance with local requirements.
Croatian: Otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: However, the patient's ability to concentrate and react may be impaired as a result of hypoglycaemia.
Croatian: Međutim, bolesnikova sposobnost koncentracije i reagiranja može biti smanjena kao posljedica hipoglikemije.
English: • acetylsalicylic acid (and other salicylates), for pain and mild fever
Croatian: • acetilsalicilatnu kiselinu (i druge salicilate), za bol i blagu vrućicu
English: Other medicines and Tresiba
Croatian: Drugi lijekovi i Tresiba
English: Patients in the Tresiba arm included 43 children aged 1-5 years, 70 children aged 6-11 years and 61 adolescents aged 12-17 years.
Croatian: Skupina bolesnika koji su primali lijek Tresiba uključivala je 43 djece u dobi od 1-5 godina, 70 djece u dobi 6-11 godina i 61 adolescenta u dobi 12-17 godina.
English: If you experience eye problems, talk to your doctor.
Croatian: Ako Vam se jave problemi s vidom, porazgovarajte sa svojim liječnikom.
English: • Do not try to repair your pen or pull it apart.
Croatian: • Ne pokušavajte popraviti brizgalicu niti je rastaviti.
English: 26 weeks of treatment
Croatian: Liječenje u trajanju od 26 tjedana
English: Your insulin dose may need to be changed during pregnancy and after delivery.
Croatian: Možda će biti potrebno promijeniti Vašu dozu inzulina tijekom trudnoće i nakon poroda.
English: • Eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case).
Croatian: • Uzmite tablete glukoze ili drugi međuobrok bogat šećerom poput slatkiša, keksa ili voćnog soka (za svaki slučaj, uvijek nosite sa sobom tablete glukoze ili međuobrok bogat šećerom).
English: • Always carry an extra pen and new needles with you in case of loss or damage.
Croatian: • Uvijek nosite dodatnu brizgalicu i nove igle sa sobom, za slučaj da izgubite ili oštetite one koje koristite.
English: • Turn the dose selector to select the dose you need, as directed by your doctor or nurse.
Croatian: • Okrenite izbornik doze kako biste odabrali potrebnu dozu, kako Vam je pokazao Vaš liječnik ili medicinska sestra.
English: The recommended daily starting dose is 10 units followed by individual dosage adjustments.
Croatian: Preporučena početna dnevna doza je 10 jedinica nakon čega slijedi individualna prilagodba doze.
English: Transferring a patient to another type, brand or manufacturer of insulin must be done under medical supervision and may result in the need for a change in dosage.
Croatian: Prebacivanje bolesnika na drugu vrstu, naziv ili inzulin drugog proizvođača mora se provesti pod medicinskim nadzorom i može dovesti do potrebe za promjenom doze.
English: Tap the top of the pen gently a few times to let any air bubbles rise to the top.
Croatian: Lagano kucnite prstom po vrhu brizgalice nekoliko puta kako bi se mjehurići zraka skupili na vrhu.
English: • you experience difficulty in breathing
Croatian: • poteškoće s disanjem
English: Nocturnal
Croatian: Noćne
English: Do not place the used needle in household waste.
Croatian: Ne bacajte iskorištenu iglu u kućni otpad.
English: A specific overdose for insulin cannot be defined.
Croatian: Specifično predoziranje inzulinom nije moguće definirati.
English: Important information about some of the ingredients of Tresiba This medicine contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Važne informacije o nekim sastojcima lijeka Tresiba Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi.
English: The dose counter shows the number of units regardless of strength and no dose conversion should be done when transferring a patient to a new strength.
Croatian: Brojčanik doze pokazuje broj jedinica bez obzira na jačinu i nije potrebno preračunavanje doze pri prebacivanju bolesnika na novu jačinu.
English: • you have used an injection of glucagon
Croatian: • ste primijenili injekciju glukagona
English: Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule.
Croatian: Bolesnicima koji zaborave jednu dozu preporučuje se da je primijene čim to primijete te da se nakon toga vrate uobičajenom rasporedu doziranja jednom dnevno.
English: OTHER Novo Nordisk A/S
Croatian: DRUGO Novo Nordisk A/S
English: Tresiba must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).
Croatian: Tresiba se ne smije izvlačiti iz uloška napunjene brizgalice u štrcaljku (vidjeti dio 4.4).
English: If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
Croatian: Ako imate simptome niske razine šećera u krvi, odmah poduzmite korake kako biste povećali razinu šećera u krvi.
English: Glucose Infusion Rate (mg/(kg*min))
Croatian: Brzina infuzije glukoze (mg/(kg*min))
English: 4 Inject your dose
Croatian: 4 Injicirajte svoju dozu
English: This medicinal product has no or negligible influence on the ability to drive and use machines.
Croatian: Ovaj lijek ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Cardiovascular evaluation
Croatian: Kardiovaskularna procjena
English: Solution for injection (FlexTouch)
Croatian: Otopina za injekciju (FlexTouch)
English: • Eye disorder - fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder.
Croatian: • Poremećaj vida - naglo poboljšanje regulacije šećera u krvi može dovesti do privremenog pogoršanja poremećaja vida u osoba oboljelih od šećerne bolesti.
English: Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
Croatian: Degludek inzulin veže se specifično na receptore humanog inzulina i ima iste farmakološke učinke kao i humani inzulin.
English: Some medicines affect your blood sugar level, this may mean your insulin dose has to be changed.
Croatian: Neki lijekovi utječu na razinu šećera u krvi, to može značiti da je potrebno promijeniti Vašu dozu inzulina.
English: To avoid dosing errors and potential overdose, patients and healthcare professionals should never use a syringe to draw the medicinal product from the cartridge in the pre-filled pen.
Croatian: Kako bi izbjegli pogreške pri doziranju i moguće predoziranje, bolesnici i zdravstveni radnici nikada ne smiju štrcaljkom izvlačiti lijek iz uloška koji se nalazi u napunjenoj brizgalici.
English: • Periodic Safety Update Reports (PSUR)
Croatian: • Periodička izvješća o neškodljivosti (PSUR)
English: With insulin preparations, allergic reactions may occur.
Croatian: Kod primjene inzulinskih pripravaka, mogu se javiti alergijske reakcije.
English: There is no difference in the pharmacokinetics of insulin degludec between elderly and younger adult patients, between races or between healthy subjects and patients with renal or hepatic impairment.
Croatian: Ne postoje razlike u farmakokinetici degludek inzulina između starijih i mlađih odraslih bolesnika, između rasa ili između zdravih osoba i bolesnika s oštećenjem bubrega ili jetre.
English: • Never share your pen or your needles with other people.
Croatian: • Nikada ne dijelite svoju brizgalicu ili igle s drugim osobama.
English: What you need to know before you use Tresiba
Croatian: Što morate znati prije nego počnete primjenjivati lijek Tresiba
English: Adverse reactions listed below are based on clinical trial data and classified according to MedDRA System Organ Class.
Croatian: Dolje navedene nuspojave temelje se na podacima iz kliničkih ispitivanja i prikazane su prema MedDRA klasifikaciji organskih sustava.
English: Make sure to have a minimum of 8 hours between the doses.
Croatian: Pripazite da između dvije doze protekne najmanje 8 sati.
English: It must not be refilled.
Croatian: Ne smije se ponovno puniti.
English: • If severe low blood sugar is not treated over time, it can cause brain damage.
Croatian: • Ako se teški oblik niske razine šećera u krvi ne liječi, s vremenom može uzrokovati oštećenje mozga.
English: Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
Croatian: Bolesnicima koji su slijepi ili slabovidni mora se objasniti da uvijek zatraže pomoć druge osobe koja ima dobar vid i koja je naučila koristiti inzulinsko pomagalo.
English: *Produced in Saccharomyces cerevisiae by recombinant DNA technology.
Croatian: *Proizveden tehnologijom rekombinantne DNK u Saccharomyces cerevisiae.
English: Patients must visually verify the dialled units on the dose counter of the pen.
Croatian: Bolesnici moraju vizualno provjeriti odabrane jedinice na brojčaniku doze na brizgalici.
English: If there is still no drop, change the needle and repeat steps 2A to 2C once more.
Croatian: promijenite iglu i ponovite korake od 2A do 2C još jednom.
English: See your doctor if they do not disappear after a few weeks.
Croatian: Ako ne nestanu nakon nekoliko tjedana, posjetite liječnika.
English: Listed below are the most common medicines which may affect your insulin treatment.
Croatian: U nastavku su navedeni najčešći lijekovi koji mogu utjecati na Vaše liječenje inzulinom.
English: Tresiba is to be used once daily with mealtime insulin and requires subsequent individual dosage adjustments.
Croatian: Tresiba se primjenjuje jednom dnevno s inzulinom uz obrok i zahtijeva naknadne individualne prilagodbe doze.
English: N: Number of subjects with a first EAC confirmed event during trial.
Croatian: N: Broj ispitanika s prvim događajem tijekom ispitivanja koji je potvrdilo Povjerenstvo za ocjenu događaja.
English: There is no clinically relevant difference in the pharmacodynamics of this medicinal product between elderly and younger adult patients.
Croatian: Nema klinički relevantne razlike u farmakodinamici ovog lijeka između starijih i mlađih odraslih bolesnika.
English: This medicinal product must not be used in insulin infusion pumps.
Croatian: Ovaj lijek se ne smije koristiti u inzulinskim infuzijskim pumpama.
English: • the local reactions spread to other parts of your body
Croatian: Znakovi ozbiljne alergijske reakcije su: • širenje lokalnih reakcija na druge dijelove Vašeg tijela
English: This may lead to too high blood sugar level.
Croatian: To može dovesti do previsoke razine šećera u krvi.
English: Do not make any dose re-calculation.
Croatian: Nemojte vršiti nikakvo preračunavanje doze.
English: This medicinal product is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day.
Croatian: Ovaj lijek je bazalni inzulin za supkutanu primjenu jednom dnevno, u bilo koje doba dana, po mogućnosti u isto vrijeme svakoga dana.
English: It is therefore recommended that the patient always carries glucose-containing products.
Croatian: Stoga se bolesniku preporučuje da sa sobom uvijek nosi proizvode koji sadrže šećer.
English: Detailed instructions for use are provided on the other side of this leaflet.
Croatian: Detaljne upute za uporabu nalaze se na poleđini ove upute.
English: When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
Croatian: Kad je brizgalica prazna, bacite je u otpad bez nataknute igle, sukladno uputama Vašeg liječnika, medicinske sestre, ljekarnika ili u skladu s lokalnim propisima.
English: An updated RMP should be submitted: - At the request of the European Medicines Agency; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Ažurirani RMP treba dostaviti: - na zahtjev Europske agencije za lijekove; - prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Always remove the needle after each injection and store your pen without the needle attached.
Croatian: Uvijek skinite iglu nakon svakog injiciranja i spremite brizgalicu bez pričvršćene igle.
English: You can carry your Tresiba cartridge (Penfill) with you and keep it at room temperature (not above 30°C) for up to 8 weeks.
Croatian: Tresiba uložak (Penfill) možete nositi sa sobom i čuvati na sobnoj temperaturi (ne iznad 30°C) do 8 tjedana.
English: Primary analysis (3-point MACE) CV Death
Croatian: Primarna analiza (trokomponentni MACE) Smrt zbog KV uzroka
English: They may increase or decrease your blood sugar level.
Croatian: Oni mogu povećati ili smanjiti razinu šećera u krvi.
English: This medicinal product must not be administered intramuscularly as it may change the absorption.
Croatian: Ovaj lijek se ne smije primjenjivati intramuskularno jer to može promijeniti apsorpciju.
English: If the dose counter stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
Croatian: Ako se brojčanik doze zaustavi prije nego što se vrati do 0, nije primijenjena cijela doza, zbog čega bi razina šećera u krvi mogla postati previsoka.
English: On occasions when administration at the same time of the day is not possible, Tresiba allows for flexibility in the timing of insulin administration (see section 5.1).
Croatian: U slučajevima kada primjena u isto doba dana nije moguća, Tresiba omogućuje fleksibilnost vremena primjene inzulina (vidjeti dio 5.1).
English: Caution: One step equals 2 units - the pen shows the dose
Croatian: Oprez: jedan stupanj su 2 jedinice - brizgalica pokazuje dozu.
English: Fertility Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility.
Croatian: Ispitivanja reprodukcije na životinjama s degludek inzulinom ne ukazuju na bilo kakve štetne učinke na plodnost.
English: Octreotide and lanreotide: used to treat a rare condition involving too much growth hormone (acromegaly).
Croatian: Oktreotid i lanreotid: koji se koriste za liječenje rijetke bolesti koju karakterizira suvišak hormona rasta (akromegalija).
English: In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet (see section 6.6).
Croatian: U slučaju začepljenja igle, bolesnici moraju slijediti naputke navedene u uputama za uporabu koje dolaze s uputom o lijeku (vidjeti dio 6.6).
English: • Pull the needle and pen straight up from your skin.
Croatian: • Izvucite iglu i brizgalicu ravno iz kože.