FrancophonIA/ELRC3.0 huggingface dataset:
English: • Always perform the safety test before each injection (see Step 3).
Croatian: • Prije svake injekcije uvijek treba provesti test sigurnosti (vidjeti 3.korak).
English: Most of the cases were related to handling errors or pump system failure.
Croatian: Većina ovih slučajeva bila je povezana s pogrešnim rukovanjem ili kvarom pumpnog sustava.
English: Patients must be educated to use proper injection techniques.
Croatian: Bolesnike se mora poučiti ispravnim tehnikama davanja injekcije.
English: What Apidra is and what it is used for What you need to know before you use Apidra How to use Apidra
Croatian: Što je Apidra i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Apidra
English: Special caution must be taken when removing and disposing the needle.
Croatian: Potreban je poseban oprez pri skidanju i uklanjanju igle.
English: You must use the pen as described in these Instructions for use.
Croatian: Brizgalicu morate koristiti kao što je opisano u Uputama za uporabu.
English: If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates.
Croatian: Ako imate šećernu bolest tipa 1 (šećernu bolest ovisnu o inzulinu), nemojte prestati primjenjivati inzulin te i dalje uzimajte dovoljno ugljikohidrata.
English: There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Croatian: Nema dovoljno kliničkih podataka o primjeni lijeka Apidra u djece mlađe od 6 godina.
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Croatian: Morate ih poznavati kako biste ispravno odgovorili na promjene razine šećera u krvi i spriječili da postane previsoka ili preniska.
English: Absorption from deltoid sites was in-between (see section 4.2).
Croatian: Apsorpcija iz deltoidne regije bila je između tih vrijednosti (vidjeti dio 4.2).
English: These conditions can happen when there are problems with the infusion pump or when the pump system is used incorrectly.
Croatian: Ova stanja mogu se pojaviti kada postoje problemi s pumpom za infuziju ili kada se pumpni sustav nepravilno koristi.
English: The frequency of hyperglycaemia cannot be estimated.
Croatian: Učestalost hiperglikemije ne može se procijeniti.
English: It may also be given intravenously by healthcare professionals under close supervision by a doctor.
Croatian: Može se primijeniti i u venu ako ga primjenjuje zdravstveni djelatnik pod strogim nadzorom liječnika.
English: GLUCOSE - mg/dL
Croatian: GLUKOZA - mg/dL
English: Figure 1: Average glucose-lowering effect over 6 hours in 20 patients with type 1 diabetes mellitus.
Croatian: Slika 1: Prosječni učinak na sniženje razine glukoze tijekom 6 sati u 20 bolesnika sa šećernom bolešću tipa 1.
English: Injection should be given immediately after mixing.
Croatian: Injekcija se mora primijeniti odmah po miješanju.
English: Combination of Apidra with pioglitazone
Croatian: Kombinacija Apidre s pioglitazonom
English: Interim subcutaneous injections with Apidra may be required.
Croatian: U međuvremenu mogu biti potrebne supkutane injekcije lijeka Apidra.
English: The potency of this preparation is stated in units.
Croatian: Jačina ovoga lijeka izražena je u jedinicama.
English: Immediately after delivery, insulin requirements decline rapidly.
Croatian: Neposredno nakon poroda potrebe za inzulinom naglo se smanjuju.
English: Insulin glulisine is produced by recombinant DNA technology in Escherichia coli.
Croatian: Inzulin glulizin proizveden je tehnologijom rekombinantne DNK na bakteriji Escherichia coli.
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 osjetite znakove srčanog zatajivanja kao što je neuobičajen nedostatak zraka ili naglo povećanje tjelesne težine ili lokalizirano oticanje (edem).
English: The absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra-subject variability (11% CV).
Croatian: Apsolutna bioraspoloživost (70%) inzulina glulizina bila je podjednaka kod svih mjesta injiciranja i imala je malu intraindividualnu varijabilnost (11% CV).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 September 2004
Croatian: Datum prvog odobrenja: 27. rujna 2004.
English: Change the infusion set and reservoir at least every 48 hours using aseptic technique.
Croatian: Mijenjajte komplet za infuziju i spremnik najmanje svakih 48 sati aseptičkom tehnikom.
English: • SoloStar must never be used if it is damaged or if the patient is not sure if it is working properly.
Croatian: • SoloStar se nikad ne smije upotrijebiti ako je oštećen ili ako bolesnik nije siguran da ispravno radi.
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens (see section 4.2 and 6.6).
Croatian: Ovi ulošci ne smiju se upotrebljavati niti s jednom drugom brizgalicom za višekratnu primjenu jer je preciznost doziranja utvrđena samo s navedenim brizgalicama (vidjeti dijelove 4.2 i 6.6).
English: • Never use SoloStar if it is damaged or if you are not sure that it is working properly.
Croatian: • Nikad ne upotrebljavajte SoloStar ako je oštećen ili ako niste sigurni da ispravno radi.
English: Changes in strength, brand (manufacturer), type (regular, neutral protamine Hagedorn [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, neutralni protamin Hagedorn [NPH], lente, dugodjelujući itd.), podrijetlu (životinjski, ljudski, analog ljudskog inzulina) i/ili načinu proizvodnje mogu rezultirati potrebom za promjenom doze.
English: Since Apidra is a solution, it does not require resuspension before use.
Croatian: Budući da je Apidra otopina, nije ju potrebno resuspendirati prije uporabe.
English: In controlled clinical studies in adults, insulin glulisine did not show differences in safety and efficacy in subgroup analyses based on race and gender.
Croatian: U kontroliranim kliničkim ispitivanjima u odraslih nisu zabilježene razlike s obzirom na sigurnost i djelotvornost inzulina glulizina u analizama podskupina prema spolu i rasi.
English: Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will determine how much Apidra you will need.
Croatian: Temeljem Vašeg načina života, rezultata pretraga razine šećera (glukoze) u krvi te ranije uporabe inzulina, Vaš liječnik će odrediti kolika doza lijeka Apidra
English: The infusion set and reservoir used with Apidra must be changed at least every 48 hours using aseptic technique.
Croatian: Set za infuziju i spremnik koji se koriste s lijekom Apidra moraju se mijenjati najmanje svakih 48 sati uz primjenu aseptičke tehnike.
English: Continuous subcutaneous infusion pump Refer to section 4.2 and 4.4 for advice.
Croatian: Pumpa za kontinuiranu supkutanu infuziju Za savjet pogledati dijelove 4.2 i 4.4.
English: Always have available an alternative insulin delivery system for injection under the skin (see section 3 under “How to handle an infusion pump system” and “What to do if the pump system fails or when the pump is used incorrectly”).
Croatian: Uvijek imajte na raspolaganju alternativni sustav za primjenu inzulina injekcijom pod kožu (vidjeti dio 3 pod 'Kako rukovati pumpom za infuziju' i 'Što učiniti u slučaju kvara pumpe ili ako je pumpa nepravilno korištena').
English: The primary activity of insulins and insulin analogues, including insulin glulisine, is regulation of glucose metabolism.
Croatian: Primarno djelovanje inzulina i inzulinskih analoga, uključujući inzulin glulizin, je regulacija metabolizma glukoze.
English: Apidra contains metacresol
Croatian: Apidra sadrži metakrezol
English: Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Croatian: Bol u trbuhu, brzo i duboko disanje, pospanost ili čak gubitak svijesti mogu biti znakovi teškog stanja (ketoacidoza) koje je nastalo zbog manjka inzulina
English: Read carefully all of this leaflet including the Instructions for Use of Apidra SoloStar, pre-filled pen, before using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu, uključujući Upute za uporabu napunjene brizgalice Apidra SoloStar, prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: Instructions for proper use
Croatian: Upute za pravilnu uporabu
English: If you think you may have a problem with Apidra, have it checked by your doctor or pharmacist.
Croatian: Smatrate li da postoji problem s lijekom Apidra, neka ga provjeri liječnik ili ljekarnik.
English: Treatment of adults, adolescents and children 6 years or older, with diabetes mellitus, where treatment with insulin is required.
Croatian: Liječenje odraslih, adolescenata i djece u dobi od 6 ili više godina koji boluju od šećerne bolesti i potrebno im je liječenje inzulinom.
English: Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
Croatian: Beta-blokatori poput drugih simpatolitičkih lijekova (kao što su klonidin, gvanetidin i rezerpin) mogu oslabiti ili sasvim potisnuti prve upozoravajuće simptome koji Vam pomažu prepoznati hipoglikemiju.
English: There are no specific data available concerning overdoses with insulin glulisine.
Croatian: Nema specifičnih podataka koji se odnose na predoziranje inzulinom glulizinom.
English: If you think you may have a problem with SoloStar, please consult your Health Care Professional.
Croatian: Smatrate li da postoji problem s brizgalicom SoloStar, obratite se zdravstvenom djelatniku.
English: The distribution and elimination of insulin glulisine and regular human insulin after intravenous administration is similar with volumes of distribution of 13 l and 22 l and half-lives of 13 and 18 minutes, respectively.
Croatian: Distribucija i eliminacija inzulina glulizina i običnog ljudskog inzulina nakon intravenske primjene su podjednake, s volumenom distribucije od 13 l odnosno 22 l i poluvijekom od 13 odnosno 18 minuta.
English: What you need to know before you use Apidra
Croatian: Što morate znati prije nego počnete primjenjivati lijek Apidra
English: Pump or infusion set problems or using the pump incorrectly can result in you not getting enough insulin.
Croatian: Problemi s pumpom ili setom za infuziju ili nepravilno korištenje pumpe mogu uzrokovati da ne dobijete dovoljno inzulina.
English: Hypoglycaemia can become severe and may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Croatian: Hipoglikemija može postati teška i izazvati nesvjesticu i/ili konvulzije te rezultirati prolaznim ili trajnim slabljenjem moždane funkcije ili čak smrću.
English: If your blood sugar level starts to rise, contact your doctor, pharmacist or nurse as soon as possible.
Croatian: Ako razina šećera u Vašoj krvi počne rasti, što prije kontaktirajte svog liječnika, ljekarnika ili medicinsku sestru.
English: Continuous subcutaneous insulin infusion
Croatian: Kontinuirana supkutana infuzija inzulina
English: Apidra can be administered intravenously.
Croatian: Apidra se može primjenjivati intravenski.
English: The mean residence time of insulin glulisine was shorter (98 min) than for regular human insulin (161 min) (see figure 3).
Croatian: Prosječno vrijeme zadržavanja za inzulin glulizin bilo je kraće (98 min) u odnosu na obični ljudski inzulin (161 min) (vidjeti sliku 3).
English: Rare reported side effect (may affect up to 1 in 1,000 people) • Skin changes at the injection site (lipodystrophy)
Croatian: Rijetko prijavljene nuspojave (mogu se javiti u 1 na 1000 osoba) Kožne promjene na mjestu injiciranja (lipodistrofija)
English: The dose of Apidra should be individually adjusted.
Croatian: Dozu lijeka Apidra treba prilagoditi pojedinom bolesniku.
English: In this study, the majority of patients (79%) mixed their short acting insulin with NPH insulin immediately prior to injection and 58% of subjects used oral hypoglycaemic agents at randomization and were instructed to continue to use them at the same dose.
Croatian: U ovom je ispitivanju većina bolesnika (79%) miješala kratkodjelujući inzulin s NPH inzulinom neposredno prije injiciranja, a 58% bolesnika je u trenutku randomizacije koristilo oralne hipoglikemike te su dobili uputu da ih nastave uzimati u istoj dozi.
English: Figure 1A
Croatian: Slika 1A
English: In insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favours more rapid absorption.
Croatian: Zamjena aminokiseline asparagina ljudskog inzulina na poziciji B3 lizinom i lizina na poziciji B29 glutaminskom kiselinom potiče bržu apsorpciju inzulina glulizina.
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, u bolesnika je potrebno pratiti znakove i simptome zatajivanja srca, porasta tjelesne težine i edema.
English: It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration.
Croatian: Nije poznato izlučuje li se inzulin glulizin u majčino mlijeko u ljudi, ali inzulin u načelu ne prelazi u mlijeko i ne apsorbira se nakon oralne primjene.
English: It is important that patients follow the Apidra specific instructions when using Apidra.
Croatian: Važno je da bolesnici slijede specifične upute za lijek Apidra prilikom njegovog korištenja.
English: Apidra can be administered intravenously, which should be carried out by healthcare professionals.
Croatian: Apidra se može primijeniti intravenski, što mora učiniti zdravstveni djelatnik.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti; inzulini i analozi za injiciranje, brzog djelovanja.
English: Read and follow the instructions that come with your insulin infusion pump.
Croatian: Pročitajte i slijedite upute priložene uz infuzijsku pumpu za inzulin.
English: Never use the solution if it has become cloudy or contains particles; use it only if it is clear and colourless.
Croatian: Nikada nemojte primijeniti otopinu ako se zamutila ili sadrži čestice; upotrijebite je samo ako je bistra i bezbojna.
English: If your blood sugar level is too high, this tells you that you may need more insulin than you have injected.
Croatian: Previsoka razina šećera u krvi upućuje na to da Vam treba više inzulina nego što ste injicirali.
English: If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.
Croatian: Ako se na vrhu igle ne pojavljuje inzulin, treba ponoviti 3. korak još dva puta dok se na vrhu igle ne pojavi inzulin.
English: These units are exclusive to Apidra 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 lijek Apidra i nisu istovjetne internacionalnim jedinicama (IU) ili jedinicama koje se koriste za izražavanje jačine drugih inzulinskih analoga (vidjeti dio 5.1).
English: These instructions may differ from general pump manual instructions.
Croatian: Ove se upute mogu razlikovati od općih uputa u priručniku za inzulinsku pumpu.
English: Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2).
Croatian: Supkutana injekcija u abdominalnu stijenku osigurava nešto bržu apsorpciju nego ostala mjesta predviđena za injiciranje (vidjeti dio 5.2).
English: If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.
Croatian: Ako prijeđete s nekog drugog inzulina na inzulin glulizin, liječnik će Vam možda morati prilagoditi dozu.
English: The pharmacokinetic and pharmacodynamic properties of insulin glulisine were investigated in children (7-11 years) and adolescents (12-16 years) with type 1 diabetes mellitus.
Croatian: Farmakokinetička i farmakodinamička svojstva inzulina glulizina ispitana su u djece (7-11 godina) i adolescenata (12-16 godina) sa šećernom bolešću tipa 1.
English: After injection, the site of injection should not be massaged.
Croatian: Mjesto injekcije se ne smije masirati nakon injiciranja.
English: However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2).
Croatian: Ipak, potrebe za inzulinom mogu biti smanjene u slučaju oštećenja bubrega (vidjeti dio 5.2).
English: Hypoglycaemia, the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
Croatian: Hipoglikemija, najčešća nuspojava liječenja inzulinom, može nastupiti ako je doza inzulina previsoka u odnosu na potrebu za inzulinom.
English: Pen needle (not included)
Croatian: Igla za brizgalicu (nije uključena)
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 oštećenom jetrenom funkcijom potrebe za inzulinom mogu biti smanjene zbog smanjenog kapaciteta glukoneogeneze i smanjenog metabolizma inzulina.
English: • Metabolism and nutrition disorders
Croatian: • Poremećaji metabolizma i prehrane
English: Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Croatian: Na mjestu injiciranja može doći do lipodistrofije kao posljedice nemijenjanja mjesta injiciranja unutar određenog područja.
English: This helps prevent contamination and/or infection, entry of air into the insulin reservoir and leakage of insulin.
Croatian: Tako će se spriječiti onečišćenje i/ili infekcija te ulazak zraka u spremnik s inzulinom i istjecanje inzulina.
English: Insulin glulisine was rapidly absorbed in both age groups, with similar Tmax and Cmax as in adults (see section 4.2).
Croatian: U obje se skupine inzulin glulizin brzo apsorbirao, pri čemu su vrijednosti Tmax i Cmax bile podjednake onima u odraslih bolesnika (vidjeti dio 4.2).
English: Injection button
Croatian: Dugme za injiciranje
English: You should always have an alternative insulin delivery system available for injection under the skin in case the pump system fails.
Croatian: Uvijek trebate imati dostupan alternativni sustav za primjenu inzulina injekcijom pod kožu u slučaju kvara pumpnog sustava.
English: What to do if the pump system fails or when the pump is used incorrectly
Croatian: Što učiniti u slučaju kvara pumpe ili ako je pumpa nepravilno korištena
English: • Skin and subcutaneous tissue disorders
Croatian: • Poremećaji kože i potkožnog tkiva
English: These could be symptoms of severe cases of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
Croatian: To mogu biti simptomi ozbiljnih slučajeva generalizirane alergijske reakcije na inzulin, uključujući anafilaktičku reakciju, koja može ugroziti život.
English: Figure 1B
Croatian: Slika 1B
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, iza koje ponekad može uslijediti hiperglikemija.
English: Step 6 Remove and discard the needle
Croatian: 6. korak Skidanje i uklanjanje igle
English: Apidra should be given by subcutaneous injection shortly (0-15 min) before or soon after meals or by continuous subcutaneous pump infusion.
Croatian: Apidra se treba primijeniti supkutanom injekcijom neposredno (0-15 minuta) prije ili ubrzo nakon obroka ili kontinuiranom supkutanom infuzijom uz pomoć inzulinske pumpe.
English: GLULISINE - pre REGULAR - pre
Croatian: GLULIZIN - prije OBIČNI - prije
English: Recommended safety measures for removal and disposal of needles must be followed (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Croatian: Moraju se slijediti preporučene mjere za sigurno skidanje i uklanjanje igala (npr. tehnika zatvaranja jednom rukom) kako bi se umanjio rizik od slučajnog uboda iglom i prijenosa zaraznih bolesti.
English: Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable between 15°C and 25°C for 48 hours (see section 6.6).
Croatian: Inzulin glulizin za intravensku primjenu u koncentraciji od 1 jedinice/ml stabilan je 48 sati na temperaturi između 15°C i 25°C (vidjeti dio 6.6).
English: Always remove the needle after each injection and store SoloStar without a needle attached.
Croatian: Nakon svake injekcije uvijek skinite iglu i SoloStar čuvajte bez pričvršćene igle.
English: The label on the pen should be checked to make sure it contains the correct insulin.
Croatian: Treba provjeriti oznaku na brizgalici kako bi se osiguralo da sadrži ispravnu vrstu inzulina.
English: Hypoglycaemia (low blood sugar) can be very serious.
Croatian: Hipoglikemija (niska razina šećera u krvi) može biti vrlo ozbiljna.
English: Refer to the manufacturer's instructions for using the pen.
Croatian: Pogledajte upute proizvođača za uporabu brizgalice.
English: Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable at room temperature for 48 hours.
Croatian: Inzulin glulizin za intravensku primjenu u koncentraciji od 1 jedinice/ml stabilan je 48 sati na sobnoj temperaturi.
English: Administered immediately before a test meal, insulin glulisine provided better postprandial control than regular human insulin, as in adults (see section 5.1).
Croatian: Primijenjen neposredno prije testnog obroka, inzulin glulizin ostvario je bolju postprandijalnu regulaciju u odnosu na obični ljudski inzulin, jednako kao u odraslih bolesnika (vidjeti dio 5.1).
English: Prior to each injection a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Croatian: Prije svake injekcije mora se provesti test sigurnosti kako bi se provjerilo rade li brizgalica i igla ispravno te uklonili mjehurići zraka.
English: Prompt identification and correction of the cause of hyperglycaemia or ketosis or diabetic ketoacidosis is necessary.
Croatian: Nužna je pravovremena identifikacija i uklanjanje uzroka hiperglikemije ili ketoze ili dijabetičke ketoacidoze.
English: Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 mg to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a healthcare professional.
Croatian: Teške epizode hipoglikemije u kojima bolesnik ostane bez svijesti mogu se liječiti glukagonom (0,5 do 1 mg) koji intramuskularno ili supkutano daje osoba upoznata s načinom primjene glukagona, ili glukozom koju intravenski daje zdravstveni djelatnik.
English: Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening.
Croatian: Teški slučajevi generalizirane alergije, uključujući anafilaktičke reakcije, mogu biti opasni po život.
English: Special patient groups If you have liver or kidney problems, speak to your doctor as you may need a lower dose.
Croatian: Ako imate tegoba s jetrom ili bubrezima, razgovarajte sa svojim liječnikom jer ćete možda trebati manju dozu inzulina.
English: INFORMATION IN BRAILLE Apidra SoloStar
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Apidra SoloStar
English: Step 5 Inject the dose
Croatian: 5. korak Injiciranje doze