FrancophonIA/ELRC3.0 huggingface dataset:
English: Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of insulin glargine.
Croatian: Prijavljene su medikacijske pogreške kada su umjesto inzulina glargina slučajno primijenjeni drugi inzulini, osobito kratkodjelujući inzulini.
English: Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Croatian: Inzulin i njegovi analozi snižavaju razinu glukoze u krvi potičući perifernu pohranu glukoze, osobito u mišiće kostura i masno tkivo te inhibirajući stvaranje glukoze u jetri.
English: Shelf life after first use
Croatian: Rok valjanosti nakon prve uporabe
English: HYPERGLYCAEMIA (high blood sugar levels) If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Croatian: HIPERGLIKEMIJA (visoka razina šećera u krvi) Ako Vam je razina šećera u krvi previsoka (hiperglikemija), možda niste injicirali dovoljno inzulina.
English: ------ NPH insulin
Croatian: NPH inzulinom.
English: Insulin receptor binding
Croatian: Vezanje za inzulinski receptor
English: If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Croatian: Ako dojite, obratite se svom liječniku za savjet jer će možda biti potrebno prilagoditi dozu inzulina i prehranu.
English: • If you cannot remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off.
Croatian: • Ako ne možete skinuti zatvarač brizgalice, nježno ga zakrećite naprijed-nazad, a zatim ga povucite ravno s brizgalice.
English: KwikPen Multipack: 10 (2 packs of 5) pens of 3 mL.
Croatian: KwikPen brizgalica Višestruko pakiranje: 10 (2 pakiranja po 5) brizgalica od 3 ml.
English: Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR.
Croatian: Bolesnici koji zbog postojanja protutijela na ljudski inzulin uzimaju visoke doze inzulina mogu imati bolji inzulinski odgovor uz ABASAGLAR.
English: Switch from other insulins to ABASAGLAR
Croatian: Prijelaz s drugih inzulina na ABASAGLAR
English: What you need to know before you use ABASAGLAR Do not use ABASAGLAR
Croatian: Što morate znati prije nego počnete primjenjivati lijek ABASAGLAR
English: It is unknown whether insulin glargine is excreted in human milk.
Croatian: Nije poznato izlučuje li se inzulin glargin u majčino mlijeko.
English: Do not use if it has been frozen.
Croatian: Ne smijete upotrijebiti ABASAGLAR ako je bio zamrznut.
English: Insulin glargine was administered once daily at bedtime and NPH human insulin was administered once or twice daily.
Croatian: Inzulin glargin primijenjen je jedanput na dan prije počinka, dok je ljudski NPH inzulin primijenjen jedanput ili dvaput na dan.
English: The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Croatian: Simptomi mogu uključivati crvenilo, neuobičajeno jaku bol prilikom injiciranja, svrbež, koprivnjaču, oticanje ili upalu.
English: Puerto Rico
Croatian: Portoriko
English: Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and glucose and ketone bodies in urine.
Croatian: Žeđ, povećana potreba za mokrenjem, umor, suha koža, crvenilo lica, gubitak teka, nizak krvni tlak, ubrzani otkucaji srca, pojava glukoze i ketonskih tijela u mokraći.
English: ABASAGLAR can be used in adolescents and children aged 2 years and above.
Croatian: ABASAGLAR se može primjenjivati u adolescenata i djece u dobi od 2 ili više godina.
English: Pens to be used with ABASAGLAR cartridges
Croatian: Brizgalice koje se koriste s ABASAGLAR ulošcima
English: If you think you may have a problem with ABASAGLAR KwikPen, consult your doctor, pharmacist or nurse.
Croatian: Smatrate li da postoji problem s brizgalicom ABASAGLAR KwikPen, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: This medicine contains less than 1 mmol (23 mg) sodium per dose, which means it is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, što znači da sadrži zanemarive količine natrija.
English: One hundred forty three of the patients treated with insulin glargine in this study continued treatment with insulin glargine in an uncontrolled extension study with mean duration of follow-up of 2 years.
Croatian: 143 bolesnika liječena inzulinom glarginom u ovom ispitivanju nastavila su liječenje inzulinom glarginom u nekontroliranom produžetku ispitivanja sa srednjom vrijednošću trajanja praćenja od
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Croatian: U nekih bolesnika koji dugo boluju od šećerne bolesti tipa 2 i imaju srčanu bolest ili su imali moždani udar, a liječeni su pioglitazonom i inzulinom, došlo je do razvoja srčanog zatajenja.
English: In clinical pharmacology studies, intravenous insulin glargine and human insulin have been shown to be equipotent when given at the same doses.
Croatian: U kliničkim farmakološkim ispitivanjima pokazalo se da su intravenski primijenjen inzulin glargin i ljudski inzulin ekvipotentni kada se daju u istim dozama.
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose lowering effect of insulin.
Croatian: Beta blokatori, klonidin, soli litija odnosno alkohol mogu pojačati ili oslabiti učinak inzulina na snižavanje razine glukoze u krvi.
English: A new needle must be attached before each use.
Croatian: Prije svake uporabe morate pričvrstiti novu iglu.
English: Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
Croatian: Pentamidin može uzrokovati hipoglikemiju, nakon koje ponekad može uslijediti hiperglikemija.
English: Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypoglycaemia or hyperglycaemia (see section 4.4).
Croatian: Dozu će možda trebati prilagoditi i ako, primjerice, dođe do promjene tjelesne težine ili životnih navika bolesnika, ako se promijeni vrijeme primjene doze inzulina ili ako nastupe druge okolnosti zbog kojih se povećava sklonost hipoglikemiji odnosno hiperglikemiji (vidjeti dio 4.4).
English: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Croatian: Liječenje šećerne bolesti u odraslih, adolescenata i djece u dobi od 2 ili više godina.
English: - 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: - 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 ako obolite
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:
Croatian: Lijekovi koji mogu uzrokovati pad razine šećera u krvi (hipoglikemiju) obuhvaćaju:
English: - beta-blockers (used to treat high blood pressure), - clonidine (used to treat high blood pressure), - lithium salts (used to treat psychiatric disorders).
Croatian: - beta-blokatore (koriste se za liječenje visokog krvnog tlaka) - klonidin (koristi se za liječenje visokog krvnog tlaka) - soli litija (koriste se za liječenje psihijatrijskih poremećaja)
English: - If you still do not think you received the full amount you dialled for your injection, do not start over or repeat that injection.
Croatian: - Ako i dalje mislite da niste primili cijelu dozu koju ste odmjerili za injekciju,
English: 2, rue du Colonel Lilly F-67640 Fegersheim France
Croatian: Lilly France S.A.S. 2, rue du Colonel Lilly F-67640 Fegersheim Francuska
English: ABASAGLAR is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Croatian: ABASAGLAR se koristi za liječenje šećerne bolesti u odraslih, adolescenata i djece u dobi od 2 i više godina.
English: - A drop of insulin at the needle tip is normal.
Croatian: - Kap inzulina na vrhu igle je normalna pojava.
English: No metabolic effects of ingested insulin glargine on the breast-fed newborn/infant are anticipated since insulin glargine as a peptide is digested into amino acids in the human gastrointestinal tract.
Croatian: Ne očekuju se metabolički učinci progutanog inzulina glargina u dojene novorođenčadi/dojenčadi jer se inzulin glargin, s obzirom da je peptid, u ljudskom probavnom sustavu probavlja u aminokiseline.
English: Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
Croatian: Intravenska primjena uobičajene supkutane doze može izazvati tešku hipoglikemiju.
English: The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycaemic events with insulin glargine [insulin glargine: NPH rate ratio (95% CI) = 1.18 (0.97-1.44)].
Croatian: Primarni cilj ispitivanja dokazati da inzulin glargin nije inferioran u odnosu na NPH u svim slučajevima hipoglikemije - nije postignut, a zabilježen je trend povećanja broja slučajeva hipoglikemije u skupini koja je primala inzulin glargin [omjer inzulin glargin: NPH (95% CI) = 1,18 (0,97-1,44)].
English: - The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2 “Important information about some of the ingredients of ABASAGLAR”), hydrochloric acid and water for injections.
Croatian: - Drugi sastojci su: cinkov oksid, metakrezol, glicerol, natrijev hidroksid (vidjeti dio 2 "Važne informacije o nekim sastojcima lijeka ABASAGLAR"), kloridna kiselina i voda za injekcije.
English: The ABASAGLAR cartridges are to be used only in conjunction with a Lilly reusable insulin pen (see section 4.4).
Croatian: ABASAGLAR ulošci smiju se koristiti samo s inzulinskom brizgalicom za višekratnu uporabu tvrtke Lilly (vidjeti dio 4.4).
English: - The active substance is insulin glargine.
Croatian: - Djelatna tvar je inzulin glargin.
English: In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
Croatian: U kliničkom su ispitivanju simptomi hipoglikemije odnosno odgovori proturegulacijskih hormona bili podjednaki nakon intravenske primjene inzulina glargina odnosno ljudskog inzulina i u zdravih dobrovoljaca i u bolesnika sa šećernom bolešću tipa 1.
English: • Unscrew the capped needle and dispose of it as directed by your healthcare professional.
Croatian: • Odvijte zatvorenu iglu i bacite je u otpad prema uputama zdravstvenog djelatnika.
English: Figure 1 above shows the activity profiles over time of insulin glargine and NPH insulin.
Croatian: Slika 1 gore prikazuje profil djelovanja inzulina glargina i NPH inzulina tijekom vremena.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of microprecipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/time profile with a prolonged duration of action.
Croatian: Nakon injekcije u potkožno tkivo, kisela otopina se neutralizira i stvaraju se mikroprecipitati iz kojih se neprestano otpuštaju male količine inzulina glargina, što osigurava ravnomjernu, predvidljivu koncentraciju lijeka kroz vrijeme,
English: In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high.
Croatian: U svakom slučaju, možda će biti potrebno prilagoditi dozu inzulina kako biste izbjegli preniske ili previsoke razine šećera u krvi.
English: Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins (see section 4.4).
Croatian: Prije svake injekcije uvijek se mora provjeriti naljepnica na inzulinu kako ne bi došlo do medikacijskih pogrešaka zbog zamjene inzulina glargina i drugih inzulina (vidjeti dio 4.4).
English: If you stop using ABASAGLAR
Croatian: Ako prestanete primjenjivati lijek ABASAGLAR
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 najdulje 28 dana na temperaturi do 30°C, zaštićen od izvora topline i izravne svjetlosti.
English: HbA1c changes from baseline were similar between treatment groups; however blood glucose values recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular group, with a mean nadir of 5.4 mM vs. 4.1 mM.
Croatian: Promjene u koncentraciji HbA1c u odnosu na početne vrijednosti bile su podjednake u obje liječene skupine; međutim, razine glukoze u krvi zabilježene tijekom noći bile su značajno više u skupini koja je primala inzulin glargin/inzulin lispro nego u skupini koja je primala NPH/običan inzulin, sa srednjom najnižom vrijednošću od 5,4 mM, naspram 4,1 mM.
English: These cartridges are for use with a Lilly 3 mL pen only.
Croatian: Ovi ulošci namijenjeni su za primjenu samo s brizgalicom od 3 ml tvrtke Lilly.
English: For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available.
Croatian: Nema dostupnih kliničkih podataka o trudnicama izloženima inzulinu glarginu u kontroliranim kliničkim ispitivanjima.
English: ABASAGLAR KwikPen (“Pen”) is a disposable pen containing 300 units (3 mL) of insulin glargine.
Croatian: ABASAGLAR KwikPen je brizgalica za jednokratnu uporabu koja sadrži 300 jedinica (3 ml) inzulina glargina.
English: ABASAGLAR must not be mixed with any other insulin or medicinal products or diluted.
Croatian: ABASAGLAR se ne smije miješati s drugim inzulinima ili lijekovima niti razrjeđivati.
English: No significant difference was seen in the progression of diabetic retinopathy when insulin glargine was compared to NPH insulin.
Croatian: Nije opažena značajna razlika u progresiji dijabetičke retinopatije kad se inzulin glargin uspoređivao s
English: Store in original package in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: • Change (rotate) your injection site for each injection.
Croatian: • Promijenite mjesto injiciranja kod svake injekcije.
English: If you forget to use ABASAGLAR
Croatian: Ako ste zaboravili primijeniti lijek ABASAGLAR
English: ABASAGLAR comes in a special cartridge to be used only in a Lilly insulin pen.
Croatian: ABASAGLAR se nalazi u posebnom ulošku koji se koristi isključivo u inzulinskoj brizgalici tvrtke Lilly.
English: The prolonged duration of action of insulin glargine is dependent on its injection into subcutaneous tissue.
Croatian: Produljeno djelovanje inzulina glargina ovisi o injiciranju u potkožno tkivo.
English: The instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
Croatian: Moraju se pažljivo slijediti upute za uporabu brizgalice, umetanje uloška, pričvršćivanje igle te primjenu injekcije inzulina.
English: Insulin glargine has a long and steady blood-sugar-lowering action.
Croatian: Inzulin glargin dugotrajno i ravnomjerno snižava razinu šećera u krvi.
English: Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH.
Croatian: Inzulin glargin je analog ljudskog inzulina male topivosti pri neutralnom pH.
English: Serious hypoglycaemia may cause brain damage and may be life-threatening.
Croatian: Ozbiljna hipoglikemija može uzrokovati oštećenje mozga te može biti opasna po život.
English: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Croatian: Liječenje Blage epizode hipoglikemije obično se mogu liječiti peroralnim uzimanjem ugljikohidrata.
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 na brizgalici iza oznake „EXP“.
English: - If you have missed a dose of ABASAGLAR or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia).
Croatian: Ako ste propustili dozu lijeka ABASAGLAR ili ako niste injicirali dovoljno inzulina, razina šećera u krvi može postati previsoka (hiperglikemija).
English: What should you do if you experience hyperglycaemia?
Croatian: Što trebate učiniti u slučaju hiperglikemije?
English: The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.
Croatian: Produljeno djelovanje supkutano primijenjenog inzulina glargina može odgoditi oporavak od hipoglikemije.
English: Step 8:
Croatian: 8. korak :
English: Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Croatian: Predoziranje inzulinom može uzrokovati tešku, a katkada i dugotrajnu te po život opasnu hipoglikemiju.
English: Pen Needle Parts (Needles Not Included)
Croatian: Dijelovi igle za brizgalicu (pakiranje ne sadrži igle)
English: • Pull off the inner needle shield and throw it away.
Croatian: • Skinite unutarnji zatvarač igle i bacite ga u otpad.
English: The rates of severe hypoglycaemia (affected participants per 100 participant years of exposure) were 1.05 for insulin glargine and 0.30 for standard care group and the rates of confirmed non-severe hypoglycaemia were 7.71 for insulin glargine and 2.44 for standard care group.
Croatian: Stopa teške hipoglikemije (broj pogođenih sudionika na 100 sudionik-godina izloženosti) iznosila je 1,05 u skupini koja je primala inzulin glargin i 0,30 u skupini koja je primala standardno liječenje, dok je stopa potvrđene hipoglikemije koja se nije smatrala teškom iznosila 7,71 u skupini koja je primala inzulin glargin te 2,44 u skupini koja je primala standardno liječenje.
English: Refer to the instructions for using the pen.
Croatian: Pridržavajte se uputa za uporabu brizgalice.
English: This medicinal product contains less than 1 mmol sodium (23 mg) 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: • Push the capped needle straight onto the pen and twist the needle on until it is tight.
Croatian: • Nataknite zatvorenu iglu ravno na brizgalicu i čvrsto navijte iglu.
English: • KwikPen compatible needle (BD [Becton, Dickinson and Company] pen needles recommended).
Croatian: [Becton, Dickinson and Company]).
English: At the last on-treatment visit, there was a mean increase in body weight from baseline of 1.4 kg in the insulin glargine group and a mean decrease of 0.8 kg in the standard care group.
Croatian: Pri posljednjoj kontroli tijekom liječenja zabilježeno je srednje povećanje tjelesne težine od 1,4 kg u odnosu na početnu vrijednost u skupini koja je primala inzulin glargin te srednje smanjenje od 0,8 kg u odnosu na početnu vrijednost u skupini koja je primala standardno liječenje.
English: The longer duration of action of subcutaneous insulin glargine is directly related to its slower rate of absorption and supports once daily administration.
Croatian: Dulje djelovanje supkutano primijenjenog inzulina glargina izravno je povezano sa sporijom apsorpcijom, što podupire primjenu lijeka jedanput na dan.
English: In vitro studies indicate that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin.
Croatian: Ispitivanja in vitro upućuju na to da je afinitet vezanja inzulina glargina i njegovih metabolita M1 i M2 na ljudski inzulinski receptor sličan afinitetu ljudskog inzulina.
English: A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin (each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients aged 12 to 18 years was also performed.
Croatian: Također je provedeno ispitivanje s križnom zamjenom skupina u kojemu je uspoređena primjena inzulina glargina i inzulina lispro s primjenom NPH i običnog ljudskog inzulina (svaka terapija primjenjivala se 16 tjedana nasumičnim redoslijedom), u 26 adolescenata sa šećernom bolešću tipa 1,
English: Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide, water for injections
Croatian: Pomoćne tvari: cinkov oksid, metakrezol, glicerol, kloridna kiselina i natrijev hidroksid, voda za injekcije
English: • To prime your pen, turn the dose knob to select 2 units.
Croatian: • Kako biste provjerili protok inzulina u brizgalici, okrenite gumb za doziranje i odmjerite 2 jedinice.
English: • Pull off the paper tab from the outer needle shield.
Croatian: • Skinite papirnati pokrov s vanjskog zatvarača igle.
English: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Croatian: U bolesnika s oštećenjem jetrene funkcije potrebe za inzulinom mogu biti smanjene zbog smanjenog kapaciteta glukoneogeneze te smanjenog metabolizma inzulina.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava disgeuzija
English: Cartridges in use (in the insulin pen) or carried as a spare may be stored for a maximum of 28 days up to 30°C and away from direct heat or direct light.
Croatian: Ulošci u uporabi (u inzulinskoj brizgalici) ili rezervni ulošci mogu se čuvati najdulje 28 dana na temperaturi do 30°C, zaštićeni od izvora topline i izravne svjetlosti.
English: • Eye reactions
Croatian: • Poremećaji oka
English: - If you see “0” in the dose window, you have received the full amount you dialled.
Croatian: • Provjerite broj u prozorčiću - Ako vidite '0' u prozorčiću za odabir doze, primili ste cijelu odmjerenu dozu.
English: What should you do if you experience hypoglycaemia?
Croatian: Što trebate učiniti u slučaju hipoglikemije?
English: There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of insulin glargine.
Croatian: Nema klinički značajne razlike u koncentracijama inzulina niti glukoze u serumu nakon primjene inzulina glargina u abdomen, deltoidni mišić ili bedro.
English: If your blood sugar level falls too low, you may pass out (become unconscious).
Croatian: Ako Vam se razina šećera u krvi previše snizi, možete se onesvijestiti (izgubiti svijest).
English: ABASAGLAR contains insulin glargine, an insulin analogue and has a prolonged duration of action.
Croatian: ABASAGLAR sadrži inzulin glargin, koji je inzulinski analog s produljenim djelovanjem.
English: If you think you may have a problem with ABASAGLAR, have it checked by your doctor or pharmacist.
Croatian: Smatrate li da postoji problem s lijekom ABASAGLAR, neka ga provjeri liječnik ili ljekarnik.
English: For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Croatian: Za informacije o liječenju hiperglikemije pogledajte uokvireni tekst na kraju ove upute o lijeku.