FrancophonIA/ELRC3.0 huggingface dataset:
English: This pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the pen.
Croatian: Ne preporučuje se da ovu brizgalicu koriste slijepe ili slabovidne osobe bez pomoći osobe koja je obučena za pravilnu uporabu brizgalice.
English: What ABASAGLAR looks like and contents of the pack
Croatian: Kako ABASAGLAR izgleda i sadržaj pakiranja
English: • Prepare your skin as recommended by your healthcare professional.
Croatian: • Pripremite kožu onako kako Vam je preporučio zdravstveni djelatnik.
English: • The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
Croatian: • Upute o rukovanju iglama ne predstavljaju zamjenu za lokalne propise ni upute zdravstvenih djelatnika ili ustanova.
English: - If you normally need to give 2 injections for your full dose, be sure to give your second injection.
Croatian: Ako si obično morate dati 2 injekcije da biste primijenili cijelu dozu, obavezno primijenite drugu injekciju.
English: Common Uncommon Rare Very rare
Croatian: Vrlo često Često Manje često Rijetko Vrlo rijetko
English: Needles are not included in the pack.
Croatian: Igle nisu uključene u pakiranje.
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia.
Croatian: Neophodno je da bolesnice s otprije postojećim ili gestacijskim dijabetesom održavaju dobru metaboličku kontrolu tijekom trudnoće kako bi se spriječili štetni ishodi povezani s hiperglikemijom.
English: Push the dose knob in until it stops, and “0” is seen in the dose window.
Croatian: Pritišćite gumb za doziranje sve dok se ne zaustavi i dok se u prozorčiću za odabir doze ne prikaže "0".
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: Pharmacokinetics in children aged 2 to less than 6 years with type 1 diabetes mellitus was assessed in one clinical study (see section 5.1).
Croatian: Farmakokinetika u djece u dobi od 2 do manje od 6 godina sa šećernom bolešću tipa 1 ocijenjena je u jednom kliničkom ispitivanju (vidjeti dio 5.1).
English: • Always check the number in the Dose Window to make sure you have dialled the correct dose.
Croatian: • Uvijek provjerite broj u prozorčiću za odabir doze kako biste bili sigurni da ste odabrali točnu dozu.
English: ABASAGLAR is not the insulin of choice for the treatment of diabetic ketoacidosis.
Croatian: ABASAGLAR nije inzulin izbora za liječenje dijabetičke ketoacidoze.
English: • It is normal to see a small amount of insulin left in the pen that you cannot inject.
Croatian: • Normalno je da se u brizgalici vidi mala količina preostalog inzulina koju ne možete injicirati.
English: Most minor reactions to insulins usually disappear in a few days to a few weeks.
Croatian: Većina blagih reakcija na inzulin obično nestaje za nekoliko dana ili tjedana.
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 (lijek koji povisuje razinu šećera u krvi).
English: Talk to your doctor, pharmacist or nurse before using ABASAGLAR.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek ABASAGLAR.
English: Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Croatian: Bolesnici sa šećernom bolešću tipa 1 moraju nastaviti redovito uzimati barem male količine ugljikohidrata, čak i kada nisu u stanju jesti ili jedu vrlo malo, ili kad povraćaju i sl., a nikada ne smiju sasvim izostaviti inzulin.
English: You should see insulin at the tip of the needle.
Croatian: Trebali biste vidjeti inzulin na vrhu igle.
English: Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Croatian: Pažljivo slijedite upute o doziranju, kontroli (pretrage krvi i mokraće), prehrani i tjelesnoj aktivnosti (fizički rad i tjelovježba) o kojima ste razgovarali sa svojim liječnikom.
English: If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Croatian: Ako se uoče normalne ili snižene vrijednosti glikiranog hemoglobina, mora se uzeti u obzir mogućnost pojave opetovanih, neprepoznatih (posebice noćnih) epizoda hipoglikemije.
English: The use of ABASAGLAR may be considered during pregnancy, if clinically needed.
Croatian: Može se razmotriti primjena lijeka ABASAGLAR tijekom trudnoće, ako je klinički opravdano.
English: In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
Croatian: U mnogim slučajevima indicirane su pretrage mokraće na ketone, a često je potrebno prilagoditi dozu inzulina.
English: Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
Croatian: Oprez: Umjetni zaslađivači i hrana zaslađena umjetnim zaslađivačima (primjerice dijetalni napici) ne pomažu u liječenju hipoglikemije.
English: Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Croatian: Neprestano mijenjanje mjesta injiciranja unutar preporučenih područja može pomoći u ublažavanju ili sprečavanju takvih reakcija.
English: Not all of these pens may be marketed in your country.
Croatian: Neke od tih brizgalica možda se neće nalaziti na tržištu u Vašoj zemlji.
English: Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.
Croatian: Možda će biti potrebne prilagodbe doze lijeka, rasporeda obroka ili tjelesne aktivnosti.
English: Do not use if it is cloudy, coloured, or has particles or clumps in it.
Croatian: Nemojte ga upotrijebiti ako je mutan, obojen ili ako sadrži čestice ili grudice.
English: - You may have dust, food, or liquid inside the pen.
Croatian: - Možda u brizgalici ima prašine, hrane ili tekućine.
English: Your blood sugar level may either rise or fall if you take:
Croatian: Razina šećera u krvi može porasti ili pasti ako uzimate:
English: Read the instructions for use before you start taking ABASAGLAR and each time you get another ABASAGLAR KwikPen.
Croatian: Pročitajte upute za uporabu prije nego što počnete primjenjivati lijek ABASAGLAR i svaki put kad dobijete novu brizgalicu ABASAGLAR KwikPen.
English: If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Croatian: Ako je inzulinska brizgalica oštećena ili ne radi ispravno (zbog mehaničkih oštećenja), treba je zbrinuti i upotrijebiti novu inzulinsku brizgalicu.
English: Secondary endpoints included all-cause mortality and a composite microvascular outcome.
Croatian: Sekundarne mjere ishoda uključivale su smrtnost zbog bilo kojega uzroka i kompozitni mikrovaskularni ishod.
English: The plunger only moves a little with each injection and you may not notice that it moves.
Croatian: Klip se sa svakom injekcijom samo neznatno pomiče, pa možda nećete ni primijetiti da se pomaknuo.
English: EXP Discard 28 days after first use.
Croatian: EXP Zbrinuti 28 dana nakon prve uporabe.
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 bilo kojeg lijeka pitajte liječnika može li on utjecati na razinu šećera u krvi i što treba poduzeti bude li potrebno.
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 tjednima liječenja to smanjenje mora se barem djelomično nadoknaditi povećanjem doze inzulina u vrijeme obroka, a nakon tog početnog razdoblja doziranje je potrebno individualno prilagoditi.
English: ABASAGLAR is a biosimilar medicinal product.
Croatian: ABASAGLAR je biosličan lijek.
English: • If you do not prime before each injection, you may get too much or too little insulin.
Croatian: • Ako ne provjerite protok inzulina prije svake injekcije, možete primijeniti previše ili premalo inzulina.
English: Change the injection site with each injection to help prevent these skin changes.
Croatian: Promjenite mjesto injiciranja kod svake injekcije kako bi spriječili takve promjene na koži.
English: Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Croatian: Neposredno nakon poroda potreba za inzulinom naglo pada (povećan rizik od hipoglikemije).
English: • Do not try to change your dose while injecting.
Croatian: • Nemojte pokušavati promijeniti dozu za vrijeme injiciranja.
English: Light grey with green ring on the end
Croatian: svjetlosiv sa zelenim prstenom na rubu
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 inzulina (proizvođač), vrsti (obični, NPH, lente, dugodjelujući itd.), podrijetlu (životinjski, ljudski, analog ljudskog inzulina) i/ili načinu proizvodnje mogu rezultirati potrebom za promjenom doze.
English: Store below 30 º C.
Croatian: Čuvati na temperaturi ispod 30°C.
English: Use this medicine exactly as your doctor has told you.
Croatian: Primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
English: The dose regimen (dose and timing) should be individually adjusted.
Croatian: Režim doziranja (dozu i vrijeme primjene) potrebno je prilagoditi pojedinom bolesniku.
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: Što prije obavijestite liječnika ako primijetite znakove srčanog zatajenja kao što je neuobičajen nedostatak zraka, naglo povećanje tjelesne težine ili lokalizirano oticanje (edem).
English: Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.
Croatian: Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italija
English: ABASAGLAR is injected under the skin.
Croatian: ABASAGLAR se daje injekcijom pod kožu.
English: Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Croatian: Pazite da alkohol, druga sredstva za dezinfekciju ili neke druge tvari ne onečiste inzulin.
English: - If you do not see “0” in the dose window, do not redial.
Croatian: Ako ne vidite '0' u prozorčiću za odabir doze, nemojte ponovno odmjeriti dozu.
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 dovesti do prolazne amauroze.
English: • Inject your insulin as your healthcare professional has shown you.
Croatian: • Injicirajte inzulin onako kako Vam je pokazao Vaš zdravstveni djelatnik.
English: * Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Croatian: * Inzulin glargin proizvodi se tehnologijom rekombinantne DNK na bakteriji Escherichia coli.
English: Only use needles that are compatible for use with ABASAGLAR KwikPen (see “ABASAGLAR KwikPen Instructions for Use”).
Croatian: Koristite samo igle koje su prikladne za uporabu s brizgalicom ABASAGLAR KwikPen (vidjeti "Upute za uporabu brizgalice ABASAGLAR KwikPen").
English: Special care before injection
Croatian: Posebna upozorenja prije injekcije
English: You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Croatian: U normalnim okolnostima trebali biste moći prepoznati kada Vam šećer u krvi previše pada, tako da možete primjereno djelovati.
English: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
Croatian: Vrijeme nastupa hipoglikemije ovisi o načinu djelovanja inzulina koji se primjenjuju te se stoga može promijeniti kada se mijenja režim liječenja.
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 te je vrlo česta kod liječenja inzulinom (može se javiti u više od 1 na 10 osoba).
English: Your insulin dose may need to be changed during pregnancy and after giving birth.
Croatian: Možda će biti potrebno promijeniti dozu inzulina tijekom trudnoće i nakon poroda.
English: Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Croatian: Miješanjem ili razrjeđivanjem može se promijeniti trajanje/način djelovanja lijeka, a miješanje može uzrokovati precipitaciju.
English: Throw the pen away and get a new pen.
Croatian: Bacite brizgalicu i nabavite novu.
English: - The odd numbers, after the number 1, are shown as full lines.
Croatian: - Neparne brojeve, nakon broja jedan,
English: Hold the dose knob in and count to 5 slowly.
Croatian: Držite gumb za doziranje pritisnutim i polako izbrojite do 5.
English: Before use:
Croatian: Prije uporabe:
English: For storage conditions after first opening of this medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja lijeka vidjeti u dijelu 6.3.
English: • Do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen.
Croatian: • Nemojte koristiti brizgalicu ako je istekao rok valjanosti naveden na naljepnici ili ako je prošlo više od 28 dana otkako ste je počeli koristiti.
English: Before use
Croatian: Prije uporabe
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Croatian: Prebacivanje bolesnika na drugu vrstu inzulina ili inzulin drugog proizvođača treba provesti pod strogim liječničkim nadzorom.
English: • Ask your healthcare professional about options to dispose of the pens and sharps container properly.
Croatian: • Pitajte zdravstvenog djelatnika na koje načine možete propisno odložiti brizgalice i spremnik za oštre predmete.
English: Do NOT inject ABASAGLAR in a vein, since this will change its action and may cause hypoglycaemia.
Croatian: ABASAGLAR se NE SMIJE injicirati u venu jer će to promijeniti djelovanje lijeka i može uzrokovati hipoglikemiju.
English: It is completely soluble at the acidic pH of the ABASAGLAR injection solution (pH 4).
Croatian: Potpuno je topljiv u kiselom mediju kakav je ABASAGLAR otopina za injekciju (pH 4).
English: The recovery of hypoglycaemia may be delayed because ABASAGLAR has a long action.'
Croatian: Oporavak od hipoglikemije može potrajati jer ABASAGLAR ima dugotrajno djelovanje.
English: • Store unused pens in the refrigerator at 2 ° C to 8 ° C.
Croatian: • Neupotrijebljene brizgalice čuvajte u hladnjaku na temperaturi od 2°C do 8°C.
English: Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine.
Croatian: Koncentracije su stoga bile sukladne vremenskom profilu farmakodinamičke aktivnosti inzulina glargina.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
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 može uzrokovati i privremeno nakupljanje vode u tijelu, uz oticanje potkoljenica i gležnjeva.
English: The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring.
Croatian: Prijelaz s jednog inzulina na drugi zahtijeva liječnički recept, medicinski nadzor i praćenje razine šećera u krvi.
English: * Determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values)
Croatian: *količina infundirane glukoze potrebna za održavanje stalne razine glukoze u plazmi (srednja vrijednost/sat)
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: 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, bolesnike je potrebno nadzirati kako bi se uočili eventualni znakovi i simptomi zatajenja srca, porast tjelesne težine i edemi.
English: ABASAGLAR should look clear and colourless.
Croatian: ABASAGLAR mora biti bistar i bezbojan.
English: • Skin changes at the injection site
Croatian: • Kožne promjene na mjestu injiciranja
English: - Do not remove the pen label.
Croatian: Nemojte skidati naljepnicu s brizgalice.
English: Supplies needed to give your injection:
Croatian: Pribor potreban za primjenu injekcije:
English: - If you still do not see insulin, change the needle and repeat the priming steps.
Croatian: - Ako i dalje ne vidite inzulin, zamijenite iglu i ponovite korake za provjeru protoka inzulina.
English: Pack of 5 and 10
Croatian: Pakiranja od 5 i 10
English: This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Croatian: To može dovesti do teške hiperglikemije (vrlo visoke razine šećera u krvi) i ketoacidoze (tijelo razgrađuje mast umjesto šećera pa dolazi do nakupljanja kiseline u krvi).
English: ABASAGLAR should not be administered intravenously.
Croatian: ABASAGLAR se ne smije primjenjivati intravenski.
English: For further details on handling, see section 6.6.
Croatian: Za dodatne informacije o rukovanju vidjeti dio 6.6.
English: It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Croatian: Preporučuje se da odmah nakon uzimanja glukoze izmjerite razinu šećera u krvi kako biste provjerili imate li zaista hipoglikemiju.
English: In general, the safety profile for children and adolescents (≤ 18 years of age) is similar to the safety profile for adults.
Croatian: Općenito je sigurnosni profil lijeka u djece i adolescenata (≤ 18 godina) sličan sigurnosnom profilu u odraslih bolesnika.
English: In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem.
Croatian: U takvim slučajevima može se razviti teška hipoglikemija (možete se čak i onesvijestiti) prije nego što postanete svjesni problema.
English: In use:
Croatian: U uporabi:
English: In use
Croatian: U uporabi
English: Mean dose of insulin glargine by study end was 0.42 U/kg.
Croatian: Srednja doza inzulina glargina na kraju ispitivanja bila je 0,42 U/kg.
English: The first co-primary efficacy outcome was the time to the first occurrence of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, and the second co-primary efficacy outcome was the time to the first occurrence of any of the first co-primary events, or revascularisation procedure (coronary, carotid, or peripheral), or hospitalisation for heart failure.
Croatian: Prvi od dvaju primarnih ishoda djelotvornosti bilo je vrijeme do prve pojave smrti zbog kardiovaskularnog uzroka, nesmrtonosnog infarkta miokarda ili nesmrtonosnog moždanog udara, a drugi od dvaju primarnih ishoda djelotvornosti bilo je vrijeme do prve pojave bilo kojeg događaja povezanoga s prvim primarnim ishodom ili do postupka revaskularizacije (koronarnih, karotidnih ili perifernih krvnih žila) ili hospitalizacije zbog zatajenja srca.
English: • Check the pen to make sure you are taking the right type of insulin.
Croatian: • Provjerite brizgalicu kako biste bili sigurni da imate ispravan inzulin.
English: Insulin glargine did not alter the relative risk for CV disease and CV mortality when compared to standard of care.
Croatian: Inzulin glargin nije promijenio relativan rizik od kardiovaskularne bolesti i kardiovaskularne smrtnosti u usporedbi sa standardnim liječenjem.
English: Your blood sugar levels may either rise or fall if you drink alcohol.
Croatian: Razine šećera u krvi mogu se povisiti ili sniziti ako pijete alkohol.
English: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Croatian: Primarno djelovanje inzulina, uključujući inzulin glargin, je regulacija metabolizma glukoze.
English: • Priming your pen means removing the air from the needle and cartridge that may collect during normal use and ensures that the pen is working correctly.
Croatian: • Provjerom protoka inzulina uklanja se zrak iz igle i uloška koji se može nakupiti tijekom normalne uporabe i time se osigurava da će brizgalica pravilno raditi.
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 feto/neonatal toxicity of insulin glargine.
Croatian: Velika količina podataka o trudnicama (više od 1000 ishoda trudnoća) ukazuje na to da inzulin glargin nema specifičnih štetnih učinaka na trudnoću te da ne uzrokuje specifične malformacije niti feto/neonatalnu toksičnost.
English: Important information about some of the ingredients of ABASAGLAR
Croatian: Važne informacije o nekim sastojcima lijeka ABASAGLAR
English: • Pull the needle out of your skin.
Croatian: • Izvucite iglu iz kože.
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) ili jedinicama koje se koriste za izražavanje jačine drugih inzulinskih analoga (vidjeti dio 5.1).
English: Severe allergic reactions (rare, may affect up to 1 in 1,000 people) - the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating.
Croatian: Teške alergijske reakcije (rijetko, javljaju se kod do 1 na 1000 osoba) - znakovi mogu uključivati široki raspon kožnih reakcija (osip i svrbež po cijelom tijelu), jako oticanje kože ili sluznica (angioedem), nedostatak zraka, pad krvnog tlaka s ubrzanim otkucajima srca i znojenjem.
English: Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.
Croatian: Većina blagih reakcija na inzulin na mjestu injiciranja obično se povlači za nekoliko dana do nekoliko tjedana.
English: Switch from insulin glargine 300 units/ml to ABASAGLAR ABASAGLAR and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable.
Croatian: Prijelaz s inzulina glargina od 300 jedinica/ml na ABASAGLAR ABASAGLAR i Toujeo (inzulin glargin od 300 jedinica/ml) nisu bioekvivalentni i nisu izravno zamjenjivi.
English: • Labels:
Croatian: • Naljepnice:
English: Clinical study safety data are not available for children under 2 years.
Croatian: Nema podataka iz kliničkih ispitivanja o sigurnosti primjene u djece mlađe od 2 godine.