FrancophonIA/ELRC3.0 huggingface dataset:
English: Subsequently, patients were allowed to up-titrate their insulin dose to no higher than the pre-randomisation dose.
Croatian: Nakon toga je bolesnicima bilo dopušteno postupno povećavati dozu inzulina, no ne na dozu višu od one koju su primjenjivali prije randomizacije.
English: The results of the in vitro and in vivo protein binding studies suggest that there is no clinically relevant interaction between insulin detemir and fatty acids or other protein bound medicinal products.
Croatian: Rezultati ispitivanja vezanja za proteine in vitro i in vivo ukazuju da ne postoji klinički značajna interakcija između detemir inzulina i masnih kiselina ili drugih lijekova koji se vežu na proteine.
English: The dose selector returns to 0.
Croatian: Izbornik doze se vraća na 0.
English: Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Croatian: Neprestano mijenjanje mjesta injiciranja unutar određenog područja može pomoći u ublažavanju ili sprječavanju takvih reakcija.
English: The 39% of patients not achieving target were randomised to have Levemir once-daily added or continue on liraglutide+metformin for 52 weeks.
Croatian: Preostalih 39% bolesnika koji nisu postigli ciljne vrijednosti randomizirano je tako da su dodatno primali Levemir jednom dnevno ili su nastavili liječenje liraglutidom+metforminom tijekom 52 tjedna.
English: The trial started with a 12-week run-in period with liraglutide+metformin, where 61% reached an HbA1c <7%.
Croatian: Ispitivanje je započelo 12-tjednim razdobljem uvodnog liječenja liraglutidom+metforminom, u kojemu je 61% bolesnika postiglo HbA1c
English: You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks.
Croatian: Možete ga nositi uza se i čuvati na sobnoj temperaturi (ispod 30°C) do 6 tjedana.
English: In children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake and physical activities in order to minimise the risk of hypoglycaemia.
Croatian: U djece treba biti na oprezu kako bi se doze inzulina (posebno u bazal-bolus režimima) prilagodile unosu hrane i fizičkim aktivnostima te tako umanjio rizik od hipoglikemije.
English: ► Inject the insulin under your skin.
Croatian: Injicirajte inzulin pod svoju kožu.
English: If your blood sugar is low or high, it might affect your concentration and ability to react and therefore also your ability to drive a car 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 automobila ili rukovanja strojem.
English: After an increase in insulin antibodies during the first year, the insulin antibodies decreased during the second year to a level slightly higher than pre-trial level.
Croatian: Nakon povećanja broja inzulinskih protutijela tijekom prve godine, razina inzulinskih protutijela se tijekom druge godine smanjila do razine koja je bila nešto viša nego prije uključivanja u ispitivanje.
English: What to do if you experience high blood sugar: ► If you get any of 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 potražite medicinski savjet.
English: This is part of a multipack of 10 pens and not for sale as individual pens
Croatian: Ovo je dio višestrukog pakiranja od 10 brizgalica i nije predviđeno za pojedinačnu prodaju.
English: When changing basal insulin to Levemir, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimise the risk of hypoglycaemia (see section 4.4).
Croatian: Kada se prethodno primijenjen bazalni inzulin mijenja u Levemir, smanjenje doze bazalnog i bolus inzulina treba razmotriti individualno kako bi se smanjio rizik od hipoglikemije (vidjeti dio 4.4).
English: ► If you are treated with Levemir Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Croatian: Ako se liječite lijekom Levemir Penfill i još jednim inzulinom u Penfill ulošku, morate koristiti dva pomagala za primjenu inzulina, po jedan za svaku vrstu inzulina.
English: When adjusting dose in order to improve glucose control, patients should be advised to be aware of signs of hypoglycaemia.
Croatian: Kod prilagodbe doze radi poboljšanja regulacije glikemije bolesnicima treba savjetovati da budu svjesni znakova hipoglikemije.
English: Levemir must not be administered intravenously, as it may result in severe hypoglycaemia.
Croatian: Levemir se ne smije primjenjivati intravenski jer to može rezultirati teškom hipoglikemijom.
English: No metabolic effects of ingested insulin detemir on the breast-fed newborn/infant are anticipated since insulin detemir, as a peptide, is digested into amino acids in the human gastrointestinal tract.
Croatian: Ne očekuje se metabolički učinak progutanog detemir inzulina u dojene novorođenčadi/dojenčadi jer se detemir inzulin, kao peptid, u ljudskom gastrointestinalnom traktu probavlja u aminokiseline.
English: To see precisely how much insulin is left use the dose counter: Turn the dose selector until the dose counter stops.
Croatian: Da biste vidjeli koliko je točno inzulina preostalo, upotrijebite brojčanik doze: Okrećite izbornik doze sve dok se brojčanik doze ne zaustavi.
English: GIRmax** *Area under the curve ** Glucose Infusion Rate p-value <0.001 for all comparisons with Levemir
Croatian: GIRmax** *površina ispod krivulje ** količina infundirane glukoze p-vrijednost < 0,001 za sve usporedbe s lijekom Levemir
English: In case of hypoglycaemia or if hypoglycaemia is suspected, Levemir must not be injected.
Croatian: U slučaju hipoglikemije ili sumnje na hipoglikemiju, Levemir se ne smije injicirati.
English: Very rare - Anaphylactic reactions*
Croatian: Vrlo rijetko - anafilaktičke reakcije*
English: There were no major hypoglycaemic episodes.
Croatian: Nije bilo slučajeva teške epizode hipoglikemije.
English: Concomitant antidiabetic treatment may need to be adjusted (dose and/or timing of oral antidiabetic medicinal products or concurrent short/rapid-acting insulin medicinal products).
Croatian: Možda će biti potrebno prilagoditi popratnu terapiju šećerne bolesti (dozu i/ili vrijeme primjene oralnih antidijabetika ili popratnih kratkodjelujućih/brzodjelujućih inzulinskih pripravaka).
English: When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the dose and timing of administration may be necessary (see section 4.4).
Croatian: Pri prijelazu s drugih srednjedugodjelujućih ili dugodjelujućih inzulinskih pripravaka možda će biti potrebno prilagoditi dozu i vrijeme primjene lijeka (vidjeti dio 4.4).
English: This could interrupt the injection.
Croatian: Time biste mogli privremeno prekinuti primjenu injekcije.
English: Efficacy and safety data for adolescent patients with type 2 diabetes mellitus have been extrapolated from data for children, adolescent and adult patients with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus.
Croatian: Podaci o djelotvornosti i sigurnosti u adolescentnih bolesnika sa šećernom bolešću tipa 2 ekstrapolirani su iz podataka za djecu, adolescente i odrasle bolesnike sa šećernom bolešću tipa 1 te odrasle bolesnike sa šećernom bolešću tipa
English: Talk to your doctor, nurse or pharmacist for advice.
Croatian: Obratite se svom liječniku, medicinskoj sestri ili ljekarniku za savjet.
English: After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.8 and 4.9).
Croatian: Nakon što se bolesnikova razina glukoze u krvi stabilizira, treba razmotriti prilagodbu doze (vidjeti dijelove 4.8. i
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 June 2004
Croatian: Datum prvog odobrenja: 1. lipnja 2004.
English: Addition of Levemir provided a further reduction of HbA1c from 7.6% to 7.1% after 52 weeks.
Croatian: Dodatak lijeka Levemir omogućio je daljnje snižavanje HbA1c sa 7,6% na 7,1% nakon
English: There were no clinically relevant differences in pharmacokinetic properties between young children, children, adolescents and adults.
Croatian: Nisu utvrđene klinički značajne razlike u farmakokinetičkim svojstvima između male djece, djece, adolescenata i odraslih.
English: There are limited data in patients with severe hypoalbuminaemia.
Croatian: Podaci za bolesnike s teškom hipoalbuminemijom su ograničeni.
English: You can select doses from 1 to 60 units in increments of 1 unit.
Croatian: 1 jedinice mogu se birati doze u rasponu od 1 do 60 jedinica.
English: During use or when carried as a spare: The product can be stored for a maximum of 6 weeks.
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: lijek se smije čuvati najviše 6 tjedana.
English: Levemir was the basal insulin product for 33% (n=147) of the patients (97.3% using metformin).
Croatian: Levemir je kao bazalni inzulin primjenjivalo ukupno 33% (n=147) bolesnika (od kojih je 97,3% uzimalo i metformin).
English: Levemir + liraglutide + metformin n=160
Croatian: Randomizirani na Levemir + liraglutid + metformin n=160
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); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Za učestalost pojavljivanja korištena je sljedeća kategorizacija: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100);
English: Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy.
Croatian: Mjesto injiciranja unutar istog područja treba stalno mijenjati kako bi se umanjio rizik od lipodistrofije.
English: Post-marketing data from an additional 250 outcomes from pregnant women exposed to Levemir indicate no adverse effects of insulin detemir on pregnancy and no malformative or foetal/neonatal toxicity of insulin detemir.
Croatian: Podaci nakon stavljanja lijeka na tržište koji su obuhvatili dodatnih 250 ishoda u trudnica izloženih lijeku Levemir, ukazuju da detemir inzulin nema štetnih učinaka na trudnoću te da ne uzrokuje malformacije ili da nema feto/neonatalni toksični učinak.
English: In the study versus insulin glargine, Levemir was allowed to be administered once or twice daily whereas insulin glargine was to be administered once a day, 55% of the Levemir treated patients completed the 52 weeks of treatment on the twice daily regimen.
Croatian: U ispitivanju u kojemu se Levemir uspoređivao s glargin inzulinom, pri čemu se Levemir mogao primjenjivati jednom ili dva puta dnevno, dok se glargin inzulin morao davati jednom dnevno, 55% bolesnika liječenih lijekom Levemir dovršilo je 52-tjedno liječenje uz doziranje dva puta dnevno.
English: The number of live born children of women becoming pregnant after randomisation were 50 (83%) for Levemir and 55 (89%) for NPH.
Croatian: Broj živorođene djece u žena koje su zatrudnjele nakon randomizacije bio je 50 (83%) u skupini koja je primala Levemir i 55 (89%) u skupini koja je primala NPH.
English: • Whenever the risk management system is modified, especially as the results 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: • 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: Adverse reactions observed in patients using Levemir are mainly due to the pharmacologic effect of insulin.
Croatian: Nuspojave opažene u bolesnika liječenih lijekom Levemir uglavnom su posljedica farmakološkog učinka inzulina.
English: Levemir can be used alone as the basal insulin or in combination with bolus insulin.
Croatian: Levemir se može koristiti u monoterapiji kao bazalni inzulin ili u kombinaciji s bolus inzulinom.
English: • Hold InnoLet with the needle upwards and tap the cartridge gently with your finger a few times (picture B) to make any air bubbles collect at the top of the cartridge.
Croatian: • InnoLet držite iglom okrenutom prema gore te nekoliko puta lagano kucnite prstom po ulošku (slika B) kako bi se mjehurići zraka skupili na vrhu uloška.
English: The terminal half-life after subcutaneous administration is determined by the rate of absorption from the subcutaneous tissue.
Croatian: Terminalni poluvijek nakon supkutane primjene određen je brzinom apsorpcije iz potkožnog tkiva.
English: If any of these applies, do not use Levemir.
Croatian: Ako se nešto od toga odnosi na Vas, nemojte primjenjivati Levemir.
English: • Deliver the dose by pressing the push-button fully down (picture D).
Croatian: • Injicirajte dozu tako da potisni gumb pritisnete do kraja (slika D).
English: Levemir is not to be used in insulin infusion pumps.
Croatian: Levemir se ne smije koristiti u inzulinskim infuzijskim pumpama.
English: Levemir is a modern insulin (insulin analogue) with a long-acting effect.
Croatian: Levemir je moderni inzulin (inzulinski analog) s dugotrajnim djelovanjem.
English: At the beginning of the insulin treatment, refraction anomalies and oedema may occur; these reactions are usually of transitory nature.
Croatian: Na početku inzulinske terapije mogu se javiti refrakcijske anomalije i edem, koji su obično prolazne naravi.
English: See also Serious allergic reaction above.
Croatian: Ozbiljna alergijska reakcija u prethodnom odjeljku.
English: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Denmark
Croatian: Hallas Allé DK-4400 Kalundborg Danska
English: Insulin detemir is distributed more slowly to peripheral target tissues compared to NPH insulin.
Croatian: Detemir inzulin se u periferna ciljna tkiva raspodjeljuje sporije nego NPH inzulin.
English: Substances added to Levemir may cause degradation of insulin detemir, e.g. if the medicinal product contains thiols or sulphites.
Croatian: Tvari koje se dodaju lijeku Levemir mogu izazvati razgradnju detemir inzulina, primjerice ako lijek sadrži tiole ili sulfite.
English: A 26-week, double blind, randomised clinical trial was conducted to investigate the efficacy and safety of adding liraglutide (1.8 mg) vs. placebo in patients with type 2 diabetes inadequately controlled on basal insulin with or without metformin.
Croatian: Provedeno je 26-tjedno, dvostruko slijepo, randomizirano kliničko ispitivanje kako bi se ispitale djelotvornost i sigurnost dodavanja liraglutida (1,8 mg) naspram placeba u bolesnika sa šećernom bolešću tipa 2 koji nisu postigli odgovarajuću kontrolu bazalnim inzulinom s metforminom ili bez njega.
English: Levemir FlexPen/Levemir InnoLet/Levemir FlexTouch 1 ml of the solution contains 100 units insulin detemir* (equivalent to 14.2 mg).
Croatian: Levemir FlexPen/Levemir InnoLet/Levemir FlexTouch 1 ml otopine sadrži 100 jedinica detemir inzulina* (što odgovara 14,2 mg).
English: (5%) for Levemir and 11 (7%) for NPH with 3 (4%) major malformations for Levemir and 3 (2%) for NPH.
Croatian: Učestalost prirođenih malformacija iznosila je 4 (5%) uz Levemir i 11 (7%) uz NPH, sa 3 (4%) teške malformacije uz Levemir i 3 (2%) uz NPH.
English: It is unknown whether insulin detemir is excreted in human milk.
Croatian: Nije poznato izlučuje li se detemir inzulin u majčino mlijeko.
English: Levemir is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes).
Croatian: Levemir se koristi za snižavanje visoke razine šećera u krvi u odraslih, adolescenata i djece u dobi od 1 ili više godina koji imaju dijabetes (šećernu bolest).
English: Levemir dose adjustment
Croatian: Prilagodba doze lijeka Levemir
English: Dose proportionality in pharmacodynamic response (maximum effect, duration of action, total effect) is observed after subcutaneous administration.
Croatian: Nakon supkutane primjene opaža se da je farmakodinamički odgovor (maksimalan učinak, trajanje djelovanja, ukupan učinak) proporcionalan dozi.
English: The time action profile of Levemir is statistically significantly less variable and therefore more predictable than for NPH (Neutral Protamine Hagedorn) insulin as seen from the within-subject Coefficients of Variation (CV) for the total and maximum pharmacodynamic effect in Table 1.
Croatian: Profil vremenskog djelovanja lijeka Levemir statistički je značajno manje varijabilan te stoga predvidljiviji od profila NPH (Neutral Protamin Hagedorn) inzulina, što se vidi po intraindividualnim koeficijentima varijacije (CV) ukupnog i maksimalnog farmakodinamičkog učinka u Tablici 1. Tablica 1: Intraindividualna varijabilnost profila vremenskog djelovanja lijeka Levemir i NPH inzulina
English: EXP During use: Use within 6 weeks
Croatian: Rok valjanosti Tijekom uporabe: upotrijebiti unutar 6 tjedana.
English: These combined mechanisms of protraction provide a more reproducible absorption and action profile of insulin detemir compared to NPH insulin.
Croatian: Kombinacijom ovih mehanizama produžavanja djelovanja omogućena je bolja ponovljivost apsorpcije i profila djelovanja detemir inzulina u odnosu na NPH inzulin.
English: Make sure you can see the dose counter.
Croatian: Provjerite vidite li brojčanik doze.
English: B. Check that the insulin in your pen is clear and colourless.
Croatian: Provjerite je li inzulin u brizgalici bistar i bezbojan.
English: • your doctor has switched you from one type or brand of insulin to another, or
Croatian: • Vam je liječnik promijenio vrstu inzulina ili ste započeli s primjenom inzulina drugog proizvođača, ili
English: In these patients, addition of liraglutide resulted in a greater decline in HbA1c compared to addition of placebo (to 6.93% vs. to 8.24%), a greater decline in fasting plasma glucose (to 7.20 mmol/l vs. to 8.13 mmol/l), and a greater decline in body weight (-3.47 kg vs. -0.43 kg).
Croatian: HbA1c u usporedbi s dodavanjem placeba (na 6,93% naspram na 8,24%), većim padom razine glukoze u plazmi natašte (na 7,20 mmol/l naspram na 8,13 mmol/l) te većim padom tjelesne težine (-3,47 kg naspram -0,43 kg).
English: Combination of Levemir with pioglitazone
Croatian: Kombinacija lijeka Levemir s pioglitazonom
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in the paediatric population do not indicate any differences to the broader experience in the general diabetes population.
Croatian: Na temelju podataka dobivenih nakon stavljanja lijeka na tržište i iz kliničkih ispitivanja, učestalost, vrsta i ozbiljnost nuspojava opaženih u pedijatrijskoj populaciji ne upućuju na razlike u odnosu na šire iskustvo u općoj populaciji oboljelih od šećerne bolesti.
English: Levemir can be used with meal-related rapid acting insulin medicines.
Croatian: Levemir se može koristiti s brzodjelujućim inzulinskim lijekovima koji se primjenjuju uz obrok.
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Levemir and other insulin products.
Croatian: Bolesnicima se mora objasniti da prije svakog injiciranja uvijek provjere naljepnicu na inzulinu, kako bi izbjegli slučajne zamjene lijeka Levemir i drugih inzulinskih pripravaka.
English: Glycaemic control (HbA1c) with Levemir was comparable to NPH insulin, with a lower risk of nocturnal hypoglycaemia and no associated weight gain.
Croatian: Regulacija glikemije (HbA1c) uz Levemir bila je usporediva s NPH inzulinom, uz manji rizik za noćnu hipoglikemiju i bez porasta tjelesne težine.
English: Insert the needle into your skin as your doctor or nurse has shown you.
Croatian: Zabodite iglu pod kožu kako Vam je pokazao liječnik ili medicinska sestra.
English: • The active substance is insulin detemir.
Croatian: • Djelatna tvar je detemir inzulin.
English: When Levemir is used in combination with tablets for diabetes and/or in combination with injectable anti-diabetic products, other than insulin, Levemir should be administered once a day.
Croatian: Kad se Levemir koristi u kombinaciji s tabletama protiv šećerne bolesti i/ili u kombinaciji s lijekovima za liječenje šećerne bolesti koji se injiciraju, a nisu inzulini, Levemir treba primijeniti jednom dnevno.
English: If administered twice daily, steady state will occur after 2-3 dose administrations.
Croatian: Kod primjene dva puta dnevno stanje dinamičke ravnoteže postiže se nakon primjene 2-3 doze.
English: ► If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses.
Croatian: ► Ako dojite, posavjetujte se s liječnikom jer će možda biti potrebno promijeniti doze inzulina.
English: When Levemir is used as part of a basal-bolus insulin regimen, Levemir should be administered once or twice daily depending on patients' needs.
Croatian: Kad se Levemir primjenjuje u sklopu bazal-bolus inzulinske terapije, Levemir treba primijeniti jednom ili dva puta dnevno, ovisno o bolesnikovim potrebama.
English: Other medicines and Levemir
Croatian: Drugi lijekovi i Levemir
English: For patients who require twice daily dosing to optimise blood sugar control, the evening dose can be administered in the evening or at bedtime.
Croatian: U bolesnika kojima je za optimalnu kontrolu šećera u krvi potrebno doziranje dva puta dnevno, večernja se doza može primijeniti navečer ili prije odlaska na spavanje.
English: Uncommon - Allergic reactions, potentially allergic reactions, urticaria, rash, eruptions*
Croatian: Manje često - alergijske reakcije, potencijalno alergijske reakcije, urtikarija, osip, erupcije*
English: Change in body weight from baseline (kg)
Croatian: Promjena tjelesne težine u odnosu na početnu (kg)
English: There is no experience with the use of Levemir in children below the age of 1 year.
Croatian: Nema iskustva s primjenom lijeka Levemir u djece mlađe od 1 godine.
English: Dispose of it carefully, and put the pen cap back on after every use.
Croatian: Pažljivo bacite iglu u otpad i vratite zatvarač na brizgalicu nakon svake uporabe.
English: However, when used in combination with oral antidiabetic medicinal products, three clinical studies have shown a frequency of common (2.2% of allergic reactions and potentially allergic reactions have been observed).
Croatian: Međutim, kada se koristi u kombinaciji s oralnim antidijabeticima, u tri je klinička ispitivanja učestalost bila česta (zabilježeno je 2,2%
English: No pharmacokinetic or pharmacodynamic interactions were observed between liraglutide and Levemir when administering a single dose of Levemir 0.5 units/kg with liraglutide 1.8 mg at steady state in patients with type 2 diabetes.
Croatian: Nisu opažene farmakokinetičke niti farmakodinamičke interakcije između liraglutida i lijeka Levemir nakon primjene jednokratne doze lijeka Levemir od 0,5 jedinica/kg i 1,8 mg liraglutida u stanju dinamičke ravnoteže u bolesnika sa šećernom bolešću tipa
English: Levemir is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region.
Croatian: Levemir se primjenjuje supkutanom injekcijom u trbušnu stijenku, bedro, nadlakticu, deltoidno ili glutealno područje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (FlexTouch)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA (FlexTouch)
English: During use or when carried as a spare: Levemir Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Croatian: Tijekom uporabe ili kada lijek nosite kao rezervni: Levemir Penfill koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.