FrancophonIA/ELRC3.0 huggingface dataset:
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 vezanja inzulina glargina za ljudski receptor IGF-1 proteina je otprilike 5 do 8 puta veći nego afinitet ljudskog inzulina (ali približno 70 do 80 puta manji nego afinitet IGF-1 proteina), dok je afinitet vezanja metabolita M1 i M2 za IGF-1 receptor nešto manji nego afinitet ljudskog inzulina.
English: Sanofi S.p.A., Via Valcanello, 4 03012 Anagni (FR), Italy.
Croatian: Sanofi S.p.A., ViaValcanello, 4 03012 Anagni (FR), Italija
English: Perform a Safety test
Croatian: 3. korak Provođenje testa sigurnosti
English: Not all of these pens may be marketed in your country (see section 4.2 and 6.6)
Croatian: Neke od navedenih brizgalica možda se neće nalaziti na tržištu u Vašoj zemlji (vidjeti dijelove 4.2 i
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 dovesti do retencije natrija i edema, pogotovo ako je ranija slaba regulacija metabolizma poboljšana intenziviranom inzulinskom terapijom.
English: B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
Croatian: Prilikom stavljanja iglu držite u ravnini s brizgalicom i pričvrstite je za brizgalicu (navijte ili gurnite na brizgalicu, ovisno o vrsti igle).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/
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 vrijednosti trajanja praćenja od 2 godine.
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 NPH inzulinom.
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 primjene i djelotvornosti u bolesnika liječenih inzulinom glarginom u odnosu na cjelokupnu populaciju ispitanika.
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: 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 smanjiti (lipoatrofija, može se javiti u manje od 1 na 100 osoba) ili zadebljati (lipohipertrofija).
English: Lantus can be used in adolescents and children aged 2 years and above.
Croatian: Lantus se može koristiti u adolescenata i djece u dobi od 2 ili više godina.
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 Lantus should reduce their dose by approximately 20%.
Croatian: Kako bi se smanjio rizik od hipoglikemije, bolesnici koji mijenjaju svoj režim uzimanja bazalnog inzulina s uzimanja inzulina glargina 300 jedinica/ml jednom dnevno na režim uzimanja lijeka Lantus jednom dnevno, trebaju smanjiti svoju dozu za približno 20%.
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, prisustvo tih protutijela na inzulin može uvjetovati prilagodbu doze inzulina kako bi se umanjila sklonost hiperglikemiji odnosno hipoglikemiji (vidjeti dio 5.1).
English: Shelf-life after first use of the cartridge or pen
Croatian: Rok valjanosti nakon prve uporabe uloška ili brizgalice
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 podjednake onima u odraslih.
English: Protect your SoloStar from dust and dirt.
Croatian: Zaštitite svoj SoloStar od prašine i prljavštine.
English: In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal.
Croatian: U randomiziranom, kontroliranom kliničkom ispitivanju pedijatrijski bolesnici (u dobi od 6 do 15 godina) sa šećernom bolešću tipa 1 (n = 349) bili su tijekom 28 tjedana na bazal-bolus režimu liječenja inzulinom, u kojoj je prije svakog obroka primijenjen obični ljudski inzulin.
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 5,9-6,4% u skupini koja je primala inzulin glargin te od 6,2-6,6% u skupini koja je primala standardno liječenje tijekom čitavoga razdoblja praćenja.
English: If you stop using Lantus
Croatian: Ako prestanete primjenjivati Lantus
English: INSTRUCTION FOR USE
Croatian: UPUTE ZA UPORABU
English: *determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values)
Croatian: Kraj razdoblja promatranja *količina infundirane glukoze potrebna za održanje stalne razine glukoze u plazmi (srednja vrijednost/sat)
English: Lantus should not be administered intravenously.
Croatian: Lantus se ne smije primjenjivati intravenski.
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, posebice u skeletnu muskulaturu i masno tkivo te inhibirajući stvaranje glukoze u jetri.
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 postupnog i ravnomjernog smanjenja potrebe za inzulinom.
English: This pen is only for your use.
Croatian: Ova je brizgalica samo za Vašu upotrebu.
English: Pack sizes of 1, 2, 5 and 10 vials of 5 ml or 1 vial of 10 ml.
Croatian: Pakiranja od 1, 2, 5 i 10 bočica od 5 ml, odnosno 1 bočice od 10 ml.
English: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Croatian: Liječenje Blage epizode hipoglikemije obično se mogu liječiti oralnim uzimanjem ugljikohidrata.
English: After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of micro-precipitates 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, bez vršnih koncentracija i s produljenim djelovanjem.
English: In case of insufficient glucose control or a tendency to hyper- 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 kontrole glukoze ili sklonosti hiperglikemiji odnosno hipoglikemiji, prije razmatranja prilagodbe doze mora se procijeniti pridržava li se bolesnik propisanog režima doziranja i mjesta injiciranja, pravilne tehnike injiciranja te sve ostale važne čimbenike.
English: A. Remove the protective seal from a new needle.
Croatian: Uklonite zaštitni zatvarač s nove igle.
English: Lantus is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Croatian: Lantus se koristi za liječenje šećerne bolesti u odraslih, adolescenata i djece u dobi od 2 i više godina.
English: If you think you may have a problem with SoloStar, consult your doctor, pharmacist or nurse.
Croatian: Smatrate li da postoji problem s brizgalicom SoloStar, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Croatian: No, intenziviranje inzulinskog liječenja te naglo poboljšanje regulacije glikemije može biti povezano s privremenim pogoršanjem dijabetičke retinopatije.
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 aminoacids in the human gastrointestinal tract.
Croatian: Ne očekuje se metabolički učinak progutanog inzulina glargina u dojene novorođenčadi/dojenčadi jer se inzulin glargin, s obzirom da je peptid, u ljudskom probavnom sustavu probavlja u aminokiseline.
English: For more information, see the box at the end of this leaflet.
Croatian: Za više informacija, pogledajte okvir na kraju ove upute.
English: If you are concerned that your SoloStar may be damaged, use a new one.
Croatian: Vaš SoloStar možda oštećen, uklonite ga i upotrijebite novi.
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 halfmaximal 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 metabolita) nađena 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: • Adolescents and children aged 2 years and older patients Safety and efficacy of Lantus have been established in adolescents and children aged 2 years and older (see section 5.1).
Croatian: Sigurnost primjene i djelotvornost lijeka Lantus ustanovljene su u adolescenata i djece u dobi od 2 ili više godina (vidjeti dio 5.1).
English: The following related adverse reactions from clinical investigations are listed below 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: < 1/10; manje često: ≥ 1/1000 i < 1/100; rijetko: ≥ 1/10 000 i < 1/1000; vrlo rijetko: < 1/10 000).
English: TEXT TO APPEAR ON THE ALUMINIUM FOIL WHICH IS USED FOR SEALING TRANSPARENT PLASTIC TRAY CONTAINING THE CARTRIDGE
Croatian: TEKST NA ALUMINIJSKOJ FOLIJI KOJOM JE ZATVOREN PROZIRNI PLASTIČNI
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 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.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone (oral anti-diabetic medicine used to treat type 2 diabetes mellitus) 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 (oralni antidijabetik za liječenje šećerne bolesti tipa 2) i inzulinom, došlo je do razvoja srčanog zatajenja.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Lantus Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
Croatian: Kako biste točno očitali dozu, držite brizgalicu vodoravno, tako da je igla na lijevoj, a izbornik doze na desnoj strani,
English: D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
Croatian: Kucnite po spremniku inzulina kako bi se mjehurići zraka popeli prema igli.
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 heart beat and sweating.
Croatian: Teške alergijske reakcije (rijetke, mogu se javiti u manje od 1 na 1000 osoba) - znakovi mogu uključivati raširene kožne reakcije (osip i svrbež po cijelom tijelu), jako oticanje kože ili sluznice (angioedem), nedostatak zraka, pad krvnog tlaka s ubrzanim otkucajima srca i znojenjem.
English: No new safety signals were observed in this study.
Croatian: U ovom ispitivanju nisu otkriveni novi signali u vezi sa sigurnošću primjene lijeka.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA
English: Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Lantus.
Croatian: Bolesnici koji zbog postojanja protutijela na ljudski inzulin uzimaju visoke doze inzulina mogu imati bolji terapijski odgovor na Lantus.
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: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane hipoglikemija
English: A large amount of data on pregnant women (more than 1000 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 iznesenih trudnoća) izloženim inzulinu glarginu nakon stavljanja lijeka u promet ukazuje na to da inzulin glargin ne pokazuje specifične štetne učinke na trudnoću te da ne uzrokuje specifične malformacije niti feto/neonatalnu toksičnost.
English: Lantus must not be mixed with any other insulin or diluted.
Croatian: Lantus se ne smije miješati s drugim inzulinima niti razrjeđivati.
English: B. Dispose of the needle safely, as instructed by your doctor, pharmacist or nurse.
Croatian: Uklonite iglu na siguran način, kako su Vas uputili Vaš liječnik, ljekarnik ili medicinska sestra.
English: Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH.
Croatian: Inzulin glargin analog je ljudskog inzulina male topljivosti pri neutralnom pH.
English: The prolonged duration of action of Lantus is dependent on its injection into subcutaneous tissue.
Croatian: Produljeno djelovanje lijeka Lantus ovisi o injiciranju u potkožno tkivo.
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 ili nepravilan srčani ritam.
English: In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products.
Croatian: U bolesnika sa šećernom bolešću tipa 2, Lantus se može primjenjivati zajedno s oralnim antidijabeticima.
English: There is no experience with the use of Lantus in children below the age of 2 years.
Croatian: Nema iskustva s primjenom lijeka Lantus u djece mlađe od 2 godine.
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 hypo- or hyperglycaemia (see section 4.4).
Croatian: Dozu će možda trebati prilagoditi i ako, primjerice, dođe do promjena tjelesne težine ili životnih navika bolesnika, ako se promijeni vrijeme primjene doze inzulina ili nastupe druge okolnosti zbog kojih se povećava sklonost hipoglikemiji odnosno hiperglikemiji (vidjeti dio 4.4).
English: Hydrochloric acid (for pH adjustment) Polysorbate 20
Croatian: Kloridna kiselina (za prilagodbu pH) Polisorbat 20
English: Sodium hydroxide (for pH adjustment) Water for injections
Croatian: Natrijev hidroksid (za prilagodbu pH) Voda za injekcije
English: If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.
Croatian: potrebno je nadzirati bolesnike i pratiti pojavu znakova i simptoma zatajivanja srca, porasta tjelesne težine i edema.
English: If you think you may have a problem with Lantus, have it checked by your doctor or pharmacist.
Croatian: Smatrate li da postoji problem s lijekom Lantus, neka ga provjeri liječnik ili ljekarnik.
English: Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.
Croatian: Pažljivo slijedite upute o doziranju, kontroli (pretrage krvi i mokraće), prehrani i tjelesnoj aktivnosti (fizički rad i tjelovježba) te tehnici injiciranja, o kojima ste razgovarali sa svojim liječnikom.
English: Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Croatian: Poremećaji metabolizma i prehrane Teški napadaji hipoglikemije, posebno ako se ponavljaju, mogu uzrokovati neurološka oštećenja.
English: Lantus contains insulin glargine.
Croatian: Lantus sadrži inzulin glargin.
English: When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).
Croatian: Kad se prelazi s liječenja inzulinom srednje dugog ili dugog djelovanja na liječenje lijekom Lantus možda će biti potrebno prilagoditi dozu bazalnog inzulina i drugih antidijabetika pri istodobnoj primjeni (dozu i vrijeme primjene dodatnih običnih inzulina ili brzodjelujućih inzulinskih analoga,
English: The Lantus Solostar is grey with a purple injection button.
Croatian: Lantus SoloStar je sive boje s ljubičastim dugmetom za injiciranje.
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 versus 4.1 mM.
Croatian: HbA1c u odnosu na početne vrijednosti bile su podjednake u obje terapijske 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/obični inzulin, sa srednjom najnižom vrijednošću od 5,4 mM, naspram 4,1 mM.
English: Sími: +354 535 7000
Croatian: Vistor hf. Sími: +354 535 7000
English: Before first use, the pre-filled pen must be stored at room temperature for 1 to 2 hours.
Croatian: Prije prve uporabe napunjena se brizgalica mora držati na sobnoj temperaturi 1 do 2 sata.
English: Insulin glargine has a long and steady blood-sugar-lowering action.
Croatian: Inzulin glargin ima dugotrajan i ravnomjeran učinak snižavanja razine šećera u krvi.
English: Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, 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: Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: - corticosteroids (such as "cortisone" used to treat inflammation),
Croatian: Lijekovi koji mogu uzrokovati povišenje razine šećera u krvi (hiperglikemiju) obuhvaćaju: - kortikosteroide (poput kortizona, koriste se za liječenje upale),
English: Insulin receptor binding: 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: Vezanje za inzulinski receptor: 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: • Contamination and/or infection,
Croatian: Tako ćete spriječiti: • onečišćenje i/ili infekciju
English: Before using SoloStar, the instructions for use included in the package leaflet must be read carefully (see section 6.6).
Croatian: Prije uporabe brizgalice SoloStar moraju se pažljivo pročitati upute za uporabu koje su sastavni dio upute o lijeku (vidjeti dio 6.6).
English: The pen containing a cartridge or the pens in use must not be stored in the refrigerator.
Croatian: Brizgalica koja sadrži uložak ili brizgalice u uporabi ne smiju se odlagati u hladnjak.
English: Switch from insulin glargine 300 units/ml to Lantus Lantus and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable.
Croatian: Lantus i Toujeo (inzulin glargin 300 jedinica/ml) nisu bioekvivalentni i nisu izravno međusobno zamjenjivi.
English: 5 ml vial, cartridge, SoloStar pre-filled pen Zinc chloride
Croatian: Bočica od 5 ml, uložak, SoloStar napunjena brizgalica Cinkov klorid
English: Shelf-life after first use of the vial
Croatian: Rok valjanosti nakon prve uporabe bočice