FrancophonIA/ELRC3.0 huggingface dataset:
English: Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Croatian: Liječenje pioglitazonom treba se prekinuti ako dođe do bilo kakvog pogoršanja srčanih simptoma.
English: Most minor reactions to insulins usually disappear in a few days to a few weeks.
Croatian: Većina blagih reakcija na inzulin obično nestane nakon nekoliko dana do nekoliko tjedana.
English: *determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values)
Croatian: *određena kao količina infundirane glukoze potrebna za održavanje stalne razine glukoze u plazmi (srednja vrijednost/sat)
English: The recovery of hypoglycaemia may be delayed because LUSDUNA has a long action.
Croatian: Oporavak od hipoglikemije može potrajati jer LUSDUNA ima dugotrajno djelovanje.
English: 2015DEC13 0AB1234
Croatian: 0AB1234
English: If you haven't been trained before, ask your doctor or nurse to show you how to use your pen.
Croatian: Ako još niste primili obuku, zamolite svog liječnika ili medicinsku sestru da Vam pokažu kako koristiti brizgalicu.
English: Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Croatian: Šećerna bolest je vrsta bolesti kod koje tijelo ne stvara dovoljno inzulina za kontrolu razine šećera u krvi.
English: If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Croatian: Ako ne možete gutati ili ako ste bez svijesti, trebat će Vam injekcija glukoze ili glukagona (lijeka koji povisuje razinu šećera u krvi).
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Croatian: Obavijestite liječnika što prije ako osjetite znakove zatajenja srca kao što je neuobičajen nedostatak zraka ili naglo povećanje tjelesne težine ili lokalizirano oticanje (edem).
English: Change the injection site with each injection to help prevent these skin changes.
Croatian: Promijenite mjesto injiciranja kod svake injekcije kako biste pomogli spriječiti takve promjene na koži.
English: Don't use your pen if it has been removed from the refrigerator for more than 28 days.
Croatian: Nemojte upotrijebiti brizgalicu ako je od njezina vađenja iz hladnjaka prošlo više od 28 dana.
English: Be familiar with your warning symptoms.
Croatian: Morate poznavati upozoravajuće simptome.
English: LUSDUNA is not the insulin of choice for the treatment of diabetic ketoacidosis.
Croatian: LUSDUNA nije inzulin izbora za liječenje dijabetičke ketoacidoze.
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Croatian: Promjene u jačini, nazivu (proizvođač), vrsti (obični, NPH, lente, dugodjelujući itd.), podrijetlu (životinjski, ljudski, analog ljudskog inzulina) i/ili načinu proizvodnje mogu dovesti do potrebe za promjenom doze.
English: The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence (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:
Croatian: Sljedeće nuspojave povezane s primjenom lijeka u kliničkim ispitivanjima navedene su prema MedDRA preporučenom pojmu prema klasifikaciji organskih sustava i u padajućem nizu prema učestalosti (vrlo često: ≥ 1/10; često: ≥ 1/100 i < 1/10; manje često: ≥ 1/1000 i < 1/100; rijetko: ≥ 1/10 000 i < 1/1000; vrlo rijetko: < 1/10 000).
English: Every time you inject you need to do a small test dose to make sure your pen is working.
Croatian: Prilikom svake injekcije morate provesti test s malom dozom kako biste bili sigurni da brizgalica radi ispravno.
English: • Do not select a dose or press the injection button without a needle attached.
Croatian: • Nemojte odabirati dozu ni pritiskati gumb za injiciranje bez pričvršćene igle.
English: Do not use Nexvue if it is damaged or not working properly; it has to be discarded and a new pen has to be used.
Croatian: Nexvue ako je oštećena ili ne radi ispravno; treba je zbrinuti i upotrijebiti novu brizgalicu.
English: Keep the needle straight so you do not damage the pen or needle.
Croatian: Držite iglu ravno da ne biste oštetili brizgalicu ili iglu.
English: Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people).
Croatian: Hipoglikemija (niska razina šećera u krvi) može biti vrlo ozbiljna i vrlo je česta kod liječenja inzulinom (može se javiti u više od 1 na 10 osoba).
English: Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
Croatian: Prije uzimanja nekog lijeka, upitajte liječnika može li on utjecati na razinu šećera u krvi i što treba poduzeti bude li potrebno.
English: PEN LABEL -NEXVUE
Croatian: NALJEPNICA BRIZGALICE - NEXVUE
English: Read all of this leaflet carefully including the LUSDUNA Nexvue pre-filled pen Instructions for Use, before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu, uključujući upute za uporabu napunjene brizgalice LUSDUNA Nexvue, prije nego počnete primjenjivati ovaj lijek jer sadrže Vama važne podatke.
English: Don't run your pen under water.
Croatian: Nemojte stavljati brizgalicu pod mlaz vode.
English: - determine how much LUSDUNA per day you will need and at what time, - tell you when to check your blood sugar level, and whether you need to carry out urine tests, - tell you when you may need to inject a higher or lower dose of LUSDUNA.
Croatian: Vam je dnevno potrebno i u koje vrijeme, - Vam reći kada trebate provjeravati razinu šećera u krvi i trebate li napraviti pretrage mokraće, - Vam reći kada ćete možda trebati injicirati višu ili nižu dozu lijeka LUSDUNA.
English: Clean the area with an alcohol swab.
Croatian: Očistite područje alkoholnim tupferom.
English: The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring.
Croatian: Prelazak s jedne inzulinske terapije na drugu zahtijeva liječnički recept, liječnički nadzor i kontrolu razine šećera u krvi.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici brizgalice iza oznake ‘EXP'.
English: After the injection Be careful not to stick your finger with the needle.
Croatian: Nakon injekcije Pazite da se ne ubodete iglom u prst.
English: Insulin glargine is metabolised into 2 active metabolites M1 and M2 (see section 5.2).
Croatian: Inzulin glargin se metabolizira u 2 aktivna metabolita, M1 i M2 (vidjeti dio 5.2).
English: Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will
Croatian: Na temelju Vašeg načina života, rezultata pretraga razine šećera (glukoze) u krvi te ranije uporabe inzulina, Vaš liječnik će:
English: Do not use LUSDUNA - If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in
Croatian: Nemojte primjenjivati lijek LUSDUNA - ako ste alergični na inzulin glargin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Croatian: Miješanjem ili razrjeđivanjem može se promijeniti profil trajanja učinka/načina djelovanja lijeka, a miješanje može uzrokovati precipitaciju.
English: Select the dose
Croatian: Odaberite dozu
English: In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.
Croatian: U rijetkim slučajevima liječenje inzulinom također može uzrokovati privremeno nakupljanje vode u tijelu, uz oticanje potkoljenica i gležnjeva.
English: LUSDUNA with alcohol Your blood sugar levels may either rise or fall if you drink alcohol.
Croatian: LUSDUNA s alkoholom Razina šećera u krvi može se povisiti ili sniziti ako pijete alkohol.
English: Keep the pen straight, not at an angle or sideways.
Croatian: Držite brizgalicu ravno, a ne pod kutom ili ukoso.
English: This pen allows you to dial a dose between 1-60 units.
Croatian: Ova brizgalica omogućuje Vam odabir doze od 1 do 60 jedinica.
English: The medicinal product may be stored for a maximum of 28 days up to 30°C and away from direct heat or direct light.
Croatian: Lijek se može čuvati najviše 28 dana na temperaturi do 30°C, zaštićen od izvora izravne topline i izravne svjetlosti.
English: If your pen is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up.
Croatian: • Ako čuvate brizgalicu na hladnome, izvadite je 1 - 2 sata prije injiciranja kako bi se ugrijala.
English: These include:
Croatian: Oni obuhvaćaju:
English: If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink (lipoatrophy, may affect up to 1 in 100 people) or thicken (lipohypertrophy).
Croatian: Ako prečesto injicirate inzulin na istome mjestu na koži, potkožno masno tkivo na tom mjestu može se smanjiti (lipoatrofija, može se javiti u do 1 na 100 osoba) ili zadebljati (lipohipertrofija).
English: LUSDUNA is a biosimilar medicinal product.
Croatian: LUSDUNA je biosličan lijek.
English: Other medicines and LUSDUNA
Croatian: Drugi lijekovi i LUSDUNA
English: You can give from 1 to 60 units in a single injection.
Croatian: Jednom injekcijom možete primijeniti od 1 do 60 jedinica.
English: Read about this in the Package leaflet supplied in every carton.
Croatian: Pročitajte o tome u uputi o lijeku, koja dolazi u svakom pakiranju.
English: Only use needles that are compatible for use with Nexvue (see “Nexvue Instructions for Use”).
Croatian: Koristite samo igle koje su prikladne za uporabu s brizgalicom Nexvue (pogledajte ‘Upute za uporabu brizgalice Nexvue').
English: You need to see the window clearly during the injection.
Croatian: Tijekom injekcije morate imati jasan pogled na prozorčić.
English: Very rare side-effects (may affect up to1 in 10,000 people) In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba) U vrlo rijetkim slučajevima mogu nastupiti poremećaj osjeta okusa (disgeuzija) i bol u mišićima (mialgija).
English: Do not reuse the needle; throw it away safely following the directions.
Croatian: Igla se ne smije ponovno upotrijebiti; zbrinite je na siguran način, u skladu s uputama.
English: These units are exclusive to insulin glargine and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1).
Croatian: Ove se jedinice odnose isključivo na inzulin glargin te nisu istovjetne internacionalnim jedinicama (IU) ni jedinicama koje se koriste za izražavanje jačine drugih inzulinskih analoga (vidjeti dio 5.1).
English: What LUSDUNA is and what it is used for What you need to know before you use LUSDUNA
Croatian: Što je LUSDUNA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek LUSDUNA
English: Also, be sure to remove the needle before disposing of the pen.
Croatian: Isto tako, svakako uklonite iglu prije odlaganja brizgalice.
English: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Croatian: Primarno djelovanje inzulina, uključujući inzulin glargin, jest regulacija metabolizma glukoze.
English: Severe allergic reactions (rare, may affect up to 1 in 1,000 people) - the signs may include largescale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angioedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating.
Croatian: Teške alergijske reakcije (rijetke, mogu se javiti u do 1 na 1000 osoba) - znakovi mogu uključivati proširene kožne reakcije (osip i svrbež po cijelom tijelu), teško oticanje kože ili sluznica (angioedem), nedostatak zraka, pad krvnog tlaka s ubrzanim otkucajima srca i znojenjem.
English: You may need to talk about: - the availability of your insulin in the country you are visiting, - supplies of insulin, syringes etc., - correct storage of your insulin while travelling, - timing of meals and insulin administration while travelling, - the possible effects of changing to different time zones, - possible new health risks in the countries to be visited, - what you should do in emergency situations when you feel unwell or become ill.
Croatian: Možda ćete morati porazgovarati o: - dostupnosti inzulina u zemlji koju posjećujete, - zalihama inzulina, štrcaljkama i dr., - ispravnom čuvanju inzulina za vrijeme putovanja, - rasporedu uzimanja obroka i inzulina za vrijeme putovanja, - mogućim utjecajima promjene vremenskih zona, - mogućim novim rizicima po zdravlje u zemljama koje namjeravate posjetiti, - tome što trebate učiniti u hitnim slučajevima ako se ne osjećate dobro ili obolite.
English: • Always attach a new needle before each use.
Croatian: • Uvijek pričvrstite novu iglu prije svake uporabe.
English: In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Croatian: U bolesnika s proliferativnom retinopatijom, osobito ako nije liječena fotokoagulacijom, teške epizode hipoglikemije mogu rezultirati prolaznom amaurozom.
English: Is the insulin clear, colourless and free of particles?
Croatian: Je li inzulin bistar, bezbojan i bez čestica?
English: If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Croatian: Ako niste sigurni uzimate li neki od tih lijekova, upitajte svog liječnika ili ljekarnika.
English: • Always perform the safety test before each injection.
Croatian: • Uvijek provedite test sigurnosti prije svake injekcije.
English: Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy, including in LUSDUNA therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
Croatian: Fiziološke koncentracije endogenog IGF-1 proteina mogu aktivirati mitogeno-proliferativni put; međutim, terapijske koncentracije koje se postižu pri terapiji inzulinom, uključujući i terapiju lijekom LUSDUNA, su znatno niže od farmakoloških koncentracija potrebnih za aktivaciju IGF-1 metaboličkog puta.
English: Before using Nexvue, the instructions for use included in the pack must be read carefully (see section 6.6).
Croatian: Nexvue moraju se pažljivo pročitati upute za uporabu koje su priložene u pakiranju lijeka (vidjeti dio 6.6).
English: Dial a 2-unit test dose Dial a test dose of two units by turning the dial until the black line points to “2”.
Croatian: Odmjerite testnu dozu od 2 jedinice Odmjerite testnu dozu od dvije jedinice okretanjem izbornika doze sve dok crna linija ne pokaže ‘2'.
English: Although LUSDUNA contains the same active substance as other medicines containing insulin glargine 300 units/ml, these medicines are not interchangeable.
Croatian: Iako LUSDUNA sadrži istu djelatnu tvar kao i drugi lijekovi koji sadrže inzulin glargin jačine 300 jedinica/ml, ovi lijekovi nisu međusobno zamjenjivi.
English: There were no differences between insulin glargine and standard care for the two co-primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Croatian: Nisu primijećene razlike između inzulina glargina i standardnog liječenja za dva koprimarna ishoda; za bilo koju mjeru ishoda koja je sastavnica navedenih ishoda; ili za smrtnost zbog bilo kojeg uzroka niti za kompozitni mikrovaskularni ishod.
English: During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.
Croatian: U prvim se tjednima liječenja to smanjenje mora barem djelomično nadoknaditi povećanjem doze inzulina koji se uzima u vrijeme obroka, a nakon toga režim doziranja treba prilagoditi pojedinom bolesniku.
English: Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise hypoglycaemia.
Croatian: Beta-blokatori, poput drugih simpatolitičkih lijekova (kao što su klonidin, gvanetidin i rezerpin), mogu oslabiti ili sasvim potisnuti prve upozoravajuće simptome koji Vam pomažu prepoznati hipoglikemiju.
English: Manufacturer NV Organon Molenstraat 110 5342 CC Oss The Netherlands
Croatian: Proizvođač NV Organon Molenstraat 110 5342 CC Oss Nizozemska
English: It is completely soluble at the acidic pH of the LUSDUNA injection solution (pH 4).
Croatian: Potpuno je topljiv u kiselom mediju kakav je LUSDUNA otopina za injekciju (pH 4).
English: Mean dose of insulin glargine by study end was 0.42 U/kg.
Croatian: Srednja vrijednost doze inzulina glargina na kraju ispitivanja bila je 0,42 jedinice/kg.
English: OUTER CARTON - Packs of 1 and 5
Croatian: KUTIJA - Pakiranja od 1 i 5
English: Double-check that you set the right dose before injecting.
Croatian: Provjerite još jednom jeste li odmjerili točnu dozu prije nego što je injicirate.
English: More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Croatian: Teže epizode popraćene komom, napadajem ili neurološkim oštećenjem mogu se liječiti intramuskularnom/supkutanom primjenom glukagona ili intravenskom primjenom koncentrirane glukoze.
English: Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
Croatian: Takve okolnosti mogu dovesti do teške hipoglikemije (i mogućeg gubitka svijesti) prije nego što bolesnik postane svjestan hipoglikemije.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e., essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: In patients with type 2 diabetes mellitus, LUSDUNA can also be given together with oral antidiabetic medicinal products.
Croatian: U bolesnika sa šećernom bolešću tipa 2, LUSDUNA se može primjenjivati zajedno s oralnim antidijabeticima.
English: Before you inject, make sure that the dose window is facing you.
Croatian: Prije nego što injicirate lijek, provjerite je li prozorčić za prikaz doze okrenut prema Vama.
English: For information on how to care for your pen, see section “Caring for your pen”.
Croatian: Za informacije o tome kako održavati brizgalicu pogledajte dio ‘Održavanje brizgalice'.
English: This pen is only for your use.
Croatian: Ova je brizgalica namijenjena samo za Vašu uporabu.
English: • Do not put it back in the refrigerator or freeze.
Croatian: • Nemojte je vraćati u hladnjak ni zamrzavati.
English: NPH insulin
Croatian: NPH inzulin
English: OUTER CARTON (with blue box) multipack - 10 (2 x 5)
Croatian: KUTIJA (s plavim okvirom) višestrukog pakiranja - 10 (2 x 5)
English: As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.
Croatian: Kao i kod svih inzulina, na trajanje djelovanja inzulina glargina mogu utjecati tjelesna aktivnost i drugi čimbenici.
English: IGF-1 receptor binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
Croatian: Vezanje za IGF-1 receptor: Afinitet inzulina glargina za ljudski IGF-1 receptor približno je 5 do 8 puta veći nego afinitet ljudskog inzulina (ali približno 70 do 80 puta manji nego afinitet IGF-1 proteina), dok se metaboliti M1 i M2 vezuju za IGF-1 receptor s nešto manjim afinitetom nego ljudski inzulin.
English: • This pen is only for your use.
Croatian: • Ova je brizgalica namijenjena samo za Vašu uporabu.
English: Clean the cartridge head with an alcohol swab.
Croatian: Očistite glavu uloška alkoholnim tupferom.
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor foeto/neonatal toxicity of insulin glargine.
Croatian: Opsežni podaci (više od 1000 trudnoća) ukazuju da inzulin glargin nema specifične štetne učinke na trudnoću niti ne uzrokuje specifične malformacije i da nema feto/neonatalni toksični učinak.
English: Empty pens must never be reused and must be properly discarded.
Croatian: Prazne brizgalice nikada se ne smiju ponovno upotrijebiti i moraju se zbrinuti sukladno propisima.
English: 5 pre-filled pens of 3 mL.
Croatian: 5 napunjenih brizgalica od 3 ml.
English: LUSDUNA and medicinal products containing insulin glargine 300 units/mL are not bioequivalent and are not directly interchangeable.
Croatian: LUSDUNA i lijekovi koji sadrže inzulin glargin jačine 300 jedinica/ml nisu bioekvivalentni i nisu izravno međusobno zamjenjivi.
English: If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.
Croatian: U slučaju primjene ove kombinacije, potrebno je nadzirati bolesnike zbog moguće pojave znakova i simptoma zatajenja srca, porasta tjelesne težine i edema.
English: LUSDUNA must not be mixed with any other insulin or diluted.
Croatian: LUSDUNA se ne smije miješati s drugim inzulinima niti razrjeđivati.
English: It may take up to five tries.
Croatian: Ovaj ćete korak možda morati ponoviti do pet puta.
English: Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock, and may be life-threatening.
Croatian: Takve reakcije na inzulin (uključujući inzulin glargin) ili na pomoćne tvari mogu, primjerice, biti povezane s generaliziranim kožnim reakcijama, angioedemom, bronhospazmom, hipotenzijom i šokom te mogu biti po život opasne.
English: Date out of the refrigerator: Write-in space for placing date the pen was out of refrigerator.
Croatian: Datum vađenja iz hladnjaka: Prostor za upis datuma kada je brizgalica izvađena iz hladnjaka.
English: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
Croatian: Prijavljeni su slučajevi zatajenja srca kod primjene pioglitazona u kombinaciji s inzulinom, osobito u bolesnika koji su imali čimbenike rizika za razvoj zatajenja srca.
English: Over the course of this 6-year study, 42 % of the insulin glargine group did not experience any hypoglycaemia.
Croatian: Tijekom ovog 6-godišnjeg ispitivanja, u 42% ispitanika u skupini koja je primala inzulin glargin nije zabilježen niti jedan događaj hipoglikemije.
English: Children There is no experience with the use of LUSDUNA in children below the age of 2 years.
Croatian: Djeca Nema iskustva s primjenom lijeka LUSDUNA u djece mlađe od 2 godine.
English: Pre-filled pens in use or carried as a spare may be stored for a maximum of 28 days up to 30°C and away from direct heat and direct light.
Croatian: Napunjene brizgalice u uporabi ili rezervne brizgalice mogu se čuvati najviše 28 dana na temperaturi do najviše 30°C, zaštićene od izvora izravne topline i izravne svjetlosti.