FrancophonIA/ELRC3.0 huggingface dataset:
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: <1/10,000).
Croatian: Tablični prikaz nuspojava Sljedeće nuspojave povezane s primjenom lijeka zabilježene u kliničkim ispitivanjima popisane su u nastavku kao MedDRA preporučeni pojmovi 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:
English: Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Croatian: Sljedeći simptomi ukazuju na nisku razinu šećera u mozgu: glavobolje, jaka glad, mučnina, povraćanje, umor, pospanost, poremećaji spavanja, nemir, agresivno ponašanje, poteškoće s koncentracijom, slabije reakcije, depresija, smetenost, poremećaji govora (ponekad potpun gubitak sposobnosti govora), poremećaji vida, drhtanje, paraliza, trnci (parestezije), utrnulost i trnci u području usta, omaglica, gubitak samokontrole, nesposobnost vođenja brige o samome sebi, konvulzije, gubitak svijesti.
English: You may need to talk about: - the availability of your insulin in the country you are visiting, - supplies of insulin etc.
Croatian: Možda ćete morati porazgovarati o: - dostupnosti inzulina u zemlji koju posjećujete
English: - determine how much ABASAGLAR 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 ABASAGLAR.
Croatian: - Vam reći kada trebate provjeravati razinu šećera u krvi i trebate li napraviti pretrage mokraće - Vam reći kada ćete možda trebati injicirati veću ili manju dozu lijeka ABASAGLAR
English: • Store the pen you are currently using at room temperature [below 30 ° C] and away from heat and light.
Croatian: • Čuvajte brizgalicu koju trenutno koristite na sobnoj temperaturi [ispod 30°C], zaštićenu od topline i svjetlosti.
English: Physiological concentrations of endogenous IGF-1 may activate the mitogenicproliferative pathway; however, the therapeutic concentrations found in insulin therapy, including in ABASAGLAR 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 u liječenju inzulinom, uključujući liječenje lijekom ABASAGLAR, znatno su niže od farmakoloških koncentracija potrebnih za aktivaciju IGF-1 metaboličkog puta.
English: After subcutaneous injection in diabetic patients, insulin glargine is rapidly metabolised at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Croatian: Nakon supkutane injekcije u bolesnika sa šećernom bolešću, inzulin glargin se brzo metabolizira na karboksilnim krajevima beta lanca, pri čemu nastaju dva aktivna metabolita: M1 (21A-Gly-inzulin) i M2 (21A-Gly-des-30B-Thr-inzulin).
English: Do not refrigerate or freeze.
Croatian: Ne odlagati u hladnjak i ne zamrzavati.
English: Combination of ABASAGLAR with pioglitazone
Croatian: Kombinacija lijeka ABASAGLAR s pioglitazonom
English: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Croatian: Bolesnikova sposobnost koncentracije i reagiranja može biti umanjena zbog hipoglikemije ili hiperglikemije ili, primjerice, zbog oštećenja vida.
English: With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary.
Croatian: Zbog poboljšane metaboličke regulacije i posljedičnog povećanja osjetljivosti na inzulin možda će biti potrebna daljnja prilagodba režima doziranja.
English: PLEASE READ THESE INSTRUCTIONS BEFORE USE
Croatian: PRIJE UPORABE PROČITAJTE OVE UPUTE
English: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Croatian: Izražena promjena u regulaciji glikemije može uzrokovati privremen poremećaj vida zbog privremene promjene napetosti i refrakcijskog indeksa leće.
English: They can spread around the injection site.
Croatian: Ove se reakcije mogu proširiti oko mjesta injiciranja.
English: If you notice signs of your blood sugar being too low (hypoglycaemia), take the action to increase your blood sugar levels inmediately.
Croatian: Ako primijetite simptome niske razine šećera u krvi (hipoglikemija), odmah poduzmite mjere da povisite razinu šećera u krvi.
English: • Skin and allergic reactions at the injection site
Croatian: • Kožne i alergijske reakcije na mjestu injiciranja
English: Hypoglycaemia (very common), in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.4).
Croatian: Hipoglikemija (vrlo često), koja je općenito najčešća nuspojava inzulinske terapije, može nastupiti ako je doza inzulina previsoka u odnosu na potrebu za inzulinom (vidjeti dio 4.4).
English: If you have any questions or problems with your ABASAGLAR KwikPen, contact your healthcare professional for assistance.
Croatian: U slučaju bilo kakvih pitanja ili poteškoća s brizgalicom ABASAGLAR KwikPen, obratite se za pomoć zdravstvenom djelatniku.
English: Pack of 5
Croatian: Pakiranje od 5
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 rizične čimbenike za razvoj zatajenja srca.
English: Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
Croatian: Inzulin inhibira lipolizu u adipocitima, inhibira proteolizu i povećava sintezu proteina.
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: - The even numbers are printed on the dial.
Croatian: - Na brojčaniku su otisnuti parni brojevi.
English: Before using ABASAGLAR solution for injection in pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).
Croatian: Prije uporabe ABASAGLAR otopine za injekciju u napunjenoj brizgalici, morate pažljivo pročitati upute za uporabu koje se nalaze u uputi o lijeku (vidjeti dio 6.6).
English: • Select a new needle.
Croatian: • Odaberite novu iglu.
English: The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, randomised, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12% of participants) or type 2 diabetes mellitus treated with ≤1 antidiabetic oral agent (88% of participants).
Croatian: Outcome Reduction with Initial Glargine INtervention) bilo je multicentrično, randomizirano ispitivanje faktorijalnog dizajna 2x2, provedeno na 12 537 sudionika s visokim kardiovaskularnim rizikom i poremećajem razine glukoze natašte ili narušenom tolerancijom glukoze (12% sudionika) ili šećernom bolešću tipa 2 liječenom ≤ 1 oralnim antidijabetikom (88% ispitanika).
English: • Always use a new needle for each injection to help prevent infections and blocked needles.
Croatian: • Uvijek upotrijebite novu iglu za svaku injekciju kako biste spriječili infekcije i začepljenje igle.
English: A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.
Croatian: Brojne tvari utječu na metabolizam glukoze i mogu zahtijevati prilagodbu doze inzulina glargina.
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Croatian: U starijih osoba progresivno pogoršanje bubrežne funkcije može dovesti do stalnog smanjivanja potrebe za inzulinom.
English: Read all of this leaflet carefully including the Instructions for Use of the ABASAGLAR KwikPen pre-filled pen, before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu, uključujući upute za uporabu napunjene brizgalice ABASAGLAR KwikPen, prije nego počnete primjenjivati ovaj lijek jer sadrže Vama važne podatke.
English: Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Croatian: U rijetkim slučajevima inzulin može uzrokovati retenciju natrija i edem, osobito ako je ranija slaba regulacija metabolizma poboljšana intenziviranom inzulinskom terapijom.
English: Please consult your doctor for further information.
Croatian: Za dodatne informacije obratite se svom liječniku.
English: The cartridges should only be used in conjunction with a Lilly reusable insulin pen and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.
Croatian: Ulošci se smiju koristiti samo s inzulinskom brizgalicom za višekratnu uporabu tvrtke Lilly i ne smiju se koristiti ni s jednom drugom brizgalicom za višekratnu uporabu jer nije utvrđena preciznost doziranja s drugim brizgalicama.
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 duljinu djelovanja inzulina glargina može utjecati tjelesna aktivnost i drugi čimbenici.
English: In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety and efficacy in insulin glargine-treated patients compared to the entire study population.
Croatian: U kliničkim ispitivanjima, analize podskupina prema dobi i spolu nisu ukazale na razlike u sigurnosti i djelotvornosti u bolesnika liječenih inzulinom glarginom u odnosu na cjelokupnu populaciju ispitanika.
English: Severe allergic reactions to insulins may become life-threatening.
Croatian: Teške alergijske reakcije na inzulin mogu postati opasne po život.
English: Light grey with green colour bars
Croatian: svjetlosive s prugama zelene boje
English: If your dose is more than 60 80 units, you will need to give yourself more than one injection.
Croatian: Vaša doza iznosi više od 60 80 jedinica, morat ćete si dati više od jedne injekcije.
English: Lilly France S.A.S., rue du Colonel Lilly, F-67640 Fegersheim, France.
Croatian: Lilly France S.A.S., rue du Colonel Lilly, F-67640 Fegersheim, Francuska.
English: ABASAGLAR is available in packs containing 5 pre-filled pens and in multipacks comprising 2 cartons, each containing 5 pre-filled pens.
Croatian: ABASAGLAR je dostupan u pakiranjima of 5 napunjenih brizgalica, te u višestrukom pakiranju koje se sastoji od dvije kutije, svaka kutija sadrži 5 napunjenih brizgalica.
English: How to recognise your ABASAGLAR KwikPen:
Croatian: Kako ćete prepoznati brizgalicu ABASAGLAR KwikPen:
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: Pri učestalom injiciranju inzulina na isto mjesto na koži, potkožno masno tkivo na tom mjestu može se stanjiti (lipoatrofija, može se javiti u do 1 na 100 osoba) ili zadebljati (lipohipertrofija).
English: At baseline, participants had a median HbA1c value of 6.4% and median on-treatment HbA1c values ranged from 5.9 to 6.4% in the insulin glargine group, and 6.2% to 6.6% in the standard care group throughout the duration of follow-up.
Croatian: Sudionici su na početku ispitivanja imali medijan vrijednosti HbA1c od 6,4%, dok se medijan vrijednosti HbA1c tijekom liječenja kretao u rasponu od 5,9 do 6,4% u skupini koja je primala inzulin glargin te od 6,2 do 6,6% u skupini koja je primala standardno liječenje tijekom čitavoga razdoblja praćenja.
English: • If your dose is more than 6080 units, you will need to give more than one injection.
Croatian: • Ako Vaša doza iznosi više od 60 80 jedinica, morat ćete primijeniti više od jedne injekcije.
English: Do not try to inject your insulin by turning the dose knob.
Croatian: Nemojte pokušavati injicirati inzulin okretanjem gumba za doziranje.
English: • The pen will not let you dial more than the number of units left in the pen.
Croatian: • Brizgalica ne dopušta da se odmjeri doza veća od broja jedinica preostalih u brizgalici.
English: Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Croatian: Dugoročno poboljšanje regulacije glikemije smanjuje rizik od progresije dijabetičke retinopatije.
English: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or
Croatian: - injicirati količinu koja je preostala u brizgalici, a zatim upotrijebiti novu brizgalicu da biste injicirali ostatak doze, ili - uzeti novu brizgalicu i njome injicirati cijelu dozu.
English: Prolonged or severe hypoglycaemic episodes may be life-threatening.
Croatian: Produljene ili teške epizode hipoglikemije mogu biti opasne po život.
English: EXP Discard pen 28 days after first use.
Croatian: EXP Brizgalicu zbrinuti 28 dana nakon prve uporabe.
English: If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked.
Croatian: Ako je potrebno, češće mjerite razinu šećera u krvi jer Vam to može pomoći u prepoznavanju blagih epizoda hipoglikemije koje biste inače previdjeli.
English: Problems with the insulin pen?
Croatian: Problemi s inzulinskom brizgalicom?
English: In patients with type 2 diabetes mellitus, ABASAGLAR can also be given together with orally active antidiabetic medicinal products.
Croatian: U bolesnika sa šećernom bolešću tipa 2 ABASAGLAR se može primjenjivati i zajedno s oralnim antidijabeticima.
English: Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Croatian: Pentamidin (koristi se za liječenje nekih infekcija uzrokovanih parazitima) može uzrokovati hipoglikemiju, nakon koje ponekad može uslijediti hiperglikemija.
English: Instead, regular insulin administered intravenously is recommended in such cases.
Croatian: Umjesto njega se u takvim slučajevima preporučuje intravenska primjena običnog inzulina.
English: Careful monitoring of glucose control is essential.
Croatian: Vrlo je važno pomno kontrolirati razinu glukoze.
English: Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.
Croatian: Kada se inzulin glargin injicira jedanput na dan, stanje dinamičke ravnoteže postiže se 2-4 dana nakon prve doze.
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: Adolescents and children aged 2 years and older The safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older (see section 5.1).
Croatian: Sigurnost i djelotvornost inzulina glargina ustanovljene su u adolescenata i djece u dobi od 2 ili više godina (vidjeti dio 5.1).
English: To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with ABASAGLAR should reduce their dose by approximately 20%.
Croatian: Kako bi se smanjio rizik od hipoglikemije, bolesnici koji mijenjaju režim liječenja bazalnim inzulinom s liječenja inzulinom glarginom od 300 jedinica/ml jedanput na dan na liječenje lijekom ABASAGLAR jedanput na dan trebaju smanjiti dozu za približno 20%.
English: Due to more sustained basal insulin supply with insulin glargine, less nocturnal but more early morning hypoglycaemia can be expected.
Croatian: Zbog ravnomjernije opskrbe bazalnim inzulinom kod primjene inzulina glargina može se očekivati manje noćnih, no više ranojutarnjih epizoda hipoglikemije.
English: If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).
Croatian: Ako vam je šećer u krvi prenizak (hipoglikemija), slijedite upute za hipoglikemiju (vidjeti uokvireni tekst na kraju ove upute o lijeku).
English: You will NOT receive your insulin by turning the dose knob.
Croatian: NEĆETE primiti inzulin okretanjem gumba za doziranje.
English: In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.
Croatian: Općenito su nuspojave u djece i adolescenata u dobi od 18 ili manje godina slične onima u odraslih.
English: Correspondingly, the incidences of nocturnal hypoglycaemia were 32 % in the insulin glargine / lispro group vs. 52 % in the NPH / regular group.
Croatian: Sukladno tome, incidencija noćne hipoglikemije iznosila je 32% u skupini koja je primala inzulin glargin/lispro, naspram 52% u skupini koja je primala NPH/običan inzulin.
English: There is no experience with the use of ABASAGLAR in children below the age of 2 years.
Croatian: Nema iskustva s primjenom lijeka ABASAGLAR u djece mlađe od 2 godine.
English: In case of insufficient glucose control or a tendency to hyperglycaemic or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Croatian: U slučaju nedostatne regulacije glukoze ili sklonosti epizodama hiperglikemije ili hipoglikemije, prije razmatranja prilagodbe doze mora se procijeniti pridržava li se bolesnik propisanog režima doziranja i mjesta primjene injekcije, primjenjuje li pravilnu tehniku injiciranja te sve ostale važne čimbenike.
English: The time course of action of insulin and insulin analogues such as insulin glargine may vary considerably in different individuals or within the same individual
Croatian: Trajanje djelovanja inzulina i inzulinskih analoga, poput inzulina glargina, može se značajno razlikovati između različitih osoba, odnosno u iste osobe.
English: Choose your injection site.
Croatian: Odaberite mjesto za injiciranje.
English: Dose Knob with green ring
Croatian: Gumb za doziranje sa zelenim prstenom
English: - You should use a new needle for each injection and repeat the priming step.
Croatian: - Za svaku injekciju morate upotrijebiti novu iglu i ponoviti korak provjere protoka inzulina.
English: Each cartridge contains 3 mL of solution for injection (equivalent to 300 units) and they are available in packs of 5 and 10 cartridges.
Croatian: Jedan uložak sadrži 3 ml otopine za injekciju (što odgovara 300 jedinica), a dostupna su pakiranja od 5 i 10 uložaka.
English: Label
Croatian: OZNAČIVANJE
English: Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
Croatian: Primjena inzulina može uzrokovati stvaranje protutijela na inzulin (tvari koje djeluju protiv inzulina).
English: However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Croatian: Međutim, intenziviranje inzulinskog liječenja te naglo poboljšanje regulacije glikemije može biti povezano s privremenim pogoršanjem dijabetičke retinopatije.
English: In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 5.1).
Croatian: U rijetkim slučajevima prisutnost tih protutijela na inzulin može uvjetovati prilagodbu doze inzulina kako bi se umanjila sklonost hiperglikemiji odnosno hipoglikemiji (vidjeti dio 5.1).
English: Participants were randomised (1:1) to receive insulin glargine (n=6,264), titrated to reach FPG ≤95 mg/dL (5.3 mM), or standard care (n=6,273).
Croatian: (1:1) da primaju inzulin glargin (n=6 264), titriran kako bi se postigla razina glukoze u plazmi natašte od ≤ 95 mg/dl (5,3 mM), ili standardno liječenje (n=6 273).
English: Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Croatian: Poseban oprez i pojačana kontrola razina glukoze u krvi preporučuju se u bolesnika u kojih epizode hipoglikemije mogu biti klinički posebno važne, poput bolesnika sa značajnom stenozom koronarnih arterija ili krvnih žila koje opskrbljuju mozak (rizik od srčanih ili cerebralnih komplikacija hipoglikemije) te bolesnika s proliferativnom retinopatijom, naročito ako nije liječena fotokoagulacijom (rizik od prolazne amauroze uslijed hipoglikemije).
English: The ABASAGLAR cartridges are to be used only in Lilly insulin pens to ensure you get the correct dose.
Croatian: ABASAGLAR ulošci smiju se upotrebljavati samo s inzulinskim brizgalicama tvrtke Lilly kako bi se osigurala primjena točne doze.
English: Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat.
Croatian: Simptomi koji Vam govore da razina šećera u krvi previše ili prebrzo pada su: znojenje, ljepljiva koža, tjeskoba, ubrzani otkucaji srca, visok krvni tlak, osjećaj lupanja srca i nepravilan srčani ritam.
English: Glycohaemoglobin and glucose variabilities were comparable in both treatment groups.
Croatian: Varijabilnosti u vrijednostima glikiranog hemoglobina i glukoze bile su usporedive u obje liječene skupine.
English: The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor.
Croatian: Ukupna terapijska koncentracija inzulina (inzulina glargina i njegovih metabolita) utvrđena u bolesnika sa šećernom bolešću tipa 1 bila je značajno niža od koncentracije potrebne za dostizanje polovice maksimalnog zasićenja IGF-1 receptora i posljedičnu aktivaciju mitogeno-proliferativnog puta koji se inicira putem IGF-1 receptora.
English: A 24-week parallel group study was conducted in 125 children with type 1 diabetes mellitus aged 2 to 6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or twice daily as basal insulin.
Croatian: Provedeno je 24-tjedno ispitivanje s paralelnim skupinama koje je obuhvatilo 125 djece sa šećernom bolešću tipa 1 u dobi od 2 do 6 godina, u kojemu se uspoređivalo djelovanje inzulina glargina primijenjenog jedanput na dan ujutro u odnosu na NPH inzulin primijenjen jedanput ili dvaput na dan kao bazalni inzulin.