FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be informed of the characteristic symptom of acute pancreatitis.
Croatian: Bolesnike treba upozoriti na karakterističan simptom akutnog pankreatitisa.
English: 7a Choose your injection site (Figure P).
Croatian: 7a Odaberite mjesto za injiciranje (slika P).
English: Inspect, and continue to swirl the pen until all the powder is dissolved.
Croatian: Pregledajte brizgalicu i nastavite je vrtjeti sve dok se sav prašak ne otopi.
English: • if you have ever had pancreatitis (inflammation of the pancreas).
Croatian: • ako ste ikada imali pankreatitis (upalu gušterače).
English: • because your body does not make enough insulin to control the level of sugar in your blood or
Croatian: • Vaše tijelo ne proizvodi dovoljno inzulina za kontrolu razine šećera u krvi ili
English: • if you have a serious problem with emptying your stomach (gastroparesis) or if you have severe bowel disease (severe gastrointestinal disease).
Croatian: • ako imate ozbiljne tegobe s pražnjenjem želuca (gastroparezu) ili tešku bolest crijeva (tešku bolest probavnog sustava).
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Istraživanja na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: What if I leave my pen with the needle attached (Step 5), and then come back to finish the next step much later?
Croatian: Što ako ostavim brizgalicu nakon što pričvrstim iglu (5. korak) i zatim se mnogo kasnije vratim da bih dovršio sljedeći korak?
English: DO NOT use the pen if the injection button does not pop out.
Croatian: NEMOJTE upotrijebiti brizgalicu ako dugme za injiciranje ne iskoči.
English: In the event of a suspected overdose, the appropriate supportive clinical care should be instituted, as dictated by the subject's clinical status.
Croatian: U slučaju sumnje na predoziranje, treba uvesti odgovarajuće potporno kliničko liječenje u skladu s kliničkim statusom bolesnika.
English: Figure A * Injection Button is inside the pen until the pen is ready for injection.
Croatian: Slika A *Dugme za injiciranje nalazi se unutar brizgalice sve dok nije spremna za injekciju.
English: If it has been more than 8 hours since the medicine was mixed in Step 2, throw away the pen and use another pen.
Croatian: Ako je od miješanja lijeka u 2. koraku prošlo više od 8 sati, bacite brizgalicu i upotrijebite drugu.
English: Choice of other medicinal products and dose selection should be considered accordingly, as adverse reactions may continue and efficacy may, at least partly, persist until albiglutide levels decline.
Croatian: U skladu s time treba razmatrati odabir drugih lijekova i doza, jer se nuspojave mogu nastaviti, a djelovanje lijeka potrajati, barem djelomično, sve dok se razine albiglutida ne snize.
English: Japanese patients showed approximately 30 to 40% higher exposures than Caucasians, likely attributable to lower body weight.
Croatian: Japanaca je izloženost bila približno 30 do 40% veća nego u bijelaca, što se vjerojatno može pripisati manjoj tjelesnoj težini.
English: Talk to your doctor if you are taking acarbose and Eperzan at the same time.
Croatian: Obratite se svom liječniku ako istodobno uzimate akarbozu i Eperzan.
English: The AUC of simvastatin acid was increased by 36% and Cmax was increased by approximately 100%.
Croatian: AUC simvastatinske kiseline povećao se za 36%, a Cmax za približno 100%.
English: Instruct the patient to read the full Instructions for Use (IFU) including the Questions and Answers before starting the therapy and refer back to the IFU each time before injecting the dose.
Croatian: Uputite bolesnika da pročita Upute za uporabu u potpunosti, uključujući Pitanja i odgovore, prije početka liječenja te da ih ponovno koristi svaki puta prije injiciranja doze.
English: This can cause your needle to block, you should continue from Step 5 to Step 6 right away.
Croatian: To može uzrokovati začepljenje igle; nakon 5. koraka trebate odmah prijeći na 6. korak.
English: Eperzan helps your body to increase the production of insulin when your blood sugar is high.
Croatian: Eperzan pomaže tijelu povećati proizvodnju inzulina kada su razine šećera u krvi visoke.
English: Results at 104 weeks are presented in Table 3.
Croatian: Rezultati nakon 104 tjedna liječenja prikazani su u Tablici
English: A decrease in halflife of simvastatin and simvastatin acid from ~7 hours to 3.5 hours was observed.
Croatian: Primijećeno je smanjenje poluvijeka simvastatina i simvastatinske kiseline sa ~7 sati na 3,5 sati.
English: Small air bubbles are okay and do not need to rise to the top.
Croatian: Mali mjehurići zraka ne predstavljaju problem i ne moraju isplivati na površinu.
English: What if I do not attach the needle at Step 5?
Croatian: Što ako ne pričvrstim iglu u 5. koraku?
English: This is to make sure the medicine has dissolved.
Croatian: Tako ćete biti sigurni da se lijek otopio.
English: After discontinuation, the effect of Eperzan may continue as plasma levels of albiglutide decline slowly over about 3 to 4 weeks.
Croatian: Nakon prekida liječenja učinci lijeka Eperzan mogu potrajati jer se razine albiglutida u plazmi smanjuju polako tijekom približno 3 do 4 tjedna.
English: This will help mix the medicine.
Croatian: To će olakšati miješanje lijeka.
English: Clean Empty Cup Clock/Timer
Croatian: Čista, prazna čaša Sat/mjerač vremena
English: You may give both injections in the same body area (for example, your stomach area), but you should not give the injections very close together.
Croatian: Obje injekcije možete primijeniti na istome području na tijelu (primjerice, na područje trbuha), ali mjesta na koja injicirate lijekove ne smiju biti preblizu jedno drugome.
English: Always use this medicine exactly as your doctor, nurse or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik, medicinska sestra ili ljekarnik.
English: Use within 8 hours of reconstitution.
Croatian: Upotrijebiti unutar 8 sati nakon pripreme za primjenu.
English: Eperzan should not be used for treatment of diabetic ketoacidosis.
Croatian: Eperzan se ne smije primjenjivati za liječenje dijabetičke ketoacidoze.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Eperzan in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Eperzan u jednoj ili više podskupina pedijatrijske populacije za liječenje šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Hold Upright and Twist to 3
Croatian: Držite uspravno i zakrenite na broj 3
English: What Eperzan contains - The active substance is albiglutide.
Croatian: Što Eperzan sadrži - Djelatna tvar je albiglutid.
English: Simvastatin AUC was decreased by 40% and simvastatin Cmax was increased by 18%.
Croatian: AUC simvastatina smanjio se za 40%, a Cmax povećao za 18%.
English: If you are pregnant or breast-feeding, if you think you may be pregnant, or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku, medicinskoj sestri ili ljekarniku za savjet prije nego primijenite ovaj lijek.
English: Each pen injector should be used by one person only and is for single use.
Croatian: Svaku brizgalicu smije koristiti samo jedna osoba, a namijenjena je za jednokratnu uporabu.
English: Your doctor will decide if you can use Eperzan, and will explain the symptoms of pancreatitis (see ‘Conditions you need to look out for'
Croatian: Liječnik će odlučiti možete li primjenjivati Eperzan te će Vam objasniti simptome pankreatitisa (pogledajte „Stanja na koja trebate obratiti pažnju“ u dijelu 4.).
English: If necessary you can change the day of the week on which you use Eperzan, as long as it is at least 4 days since your last dose.
Croatian: Ako je to potrebno, možete promijeniti dan u tjednu kada primjenjujete Eperzan, pod uvjetom da je od primjene posljednje doze prošlo najmanje 4 dana.
English: If you use more Eperzan than you should
Croatian: Ako primijenite više lijeka Eperzan nego što ste trebali
English: • If stored in the refrigerator, allow the pen to sit at room temperature for 15 minutes before starting
Croatian: • Ako ste brizgalicu čuvali u hladnjaku, pričekajte 15 minuta da se ugrije na sobnu temperaturu prije nego što započnete s 1. korakom.
English: The recommended dose is 30 mg once a week, injected on the same day each week.
Croatian: Preporučena doza je 30 mg jedanput tjedno, a injicira se svaki tjedan istoga dana.
English: • reduced appetite
Croatian: • smanjeni apetit
English: Injection Button*
Croatian: Dugme za injiciranje*
English: Wait 15 Minutes
Croatian: Pričekajte 15 minuta
English: If you have heard and felt the injection button “click” and slowly counted to 5 before pulling the needle out of your skin, you should have received the full dose of your medicine.
Croatian: Ako ste čuli i osjetili ‘klik' kada ste pritisnuli dugme za injiciranje i brojili do 5 prije izvlačenja igle iz kože, trebali ste primiti cijelu dozu lijeka.
English: These findings are consistent with lactational ileus syndrome which has been previously reported in mice.
Croatian: Ti nalazi odgovaraju sindromu laktacijskog ileusa, koji je prethodno prijavljen u miševa.
English: Eperzan should not be used during pregnancy, and is not recommended in women of childbearing potential not using effective contraception.
Croatian: Eperzan se ne smije primjenjivati u trudnoći, a ne preporučuje se niti u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju.
English: IMPORTANT: You may hear a “click” when you first start twisting the cartridge from [2] to [3].
Croatian: VAŽNO: Možda ćete čuti ‘klik' odmah kad počnete zakretati uložak iz broja [2] u broj [3].
English: Therapeutic proteins such as albiglutide are catabolised by widely distributed proteolytic enzymes, which are not restricted to hepatic tissue; therefore, changes in hepatic function are unlikely to have any effect on the elimination of Eperzan (see section 4.2).
Croatian: Terapijski proteini poput albiglutida kataboliziraju se posredstvom široko rasprostranjenih proteolitičkih enzima, koji nisu ograničeni samo na jetreno tkivo; stoga nije izgledno da bi promjene jetrene funkcije mogle utjecati na eliminaciju lijeka Eperzan (vidjeti dio 4.2).
English: DO NOT rest the back of the device (where the injection button is exposed) on a flat surface while removing needle caps.
Croatian: NEMOJTE osloniti donji dio brizgalice (gdje se nalazi dugme za injiciranje) na ravnu površinu dok skidate zatvarače igle.
English: If you need to give yourself both at the same time, use two separate injections.
Croatian: Ako oba lijeka morate primijeniti u isto vrijeme, injicirajte svaki zasebno.
English: The clinical experience in patients >75 years is very limited (see section 5.2).
Croatian: ≥ 75 godina je vrlo ograničeno (vidjeti dio 5.2).
English: DO NOT shake the pen to avoid foaming, which may affect your dose.
Croatian: NEMOJTE tresti brizgalicu kako biste izbjegli pjenjenje, koje može utjecati na dozu.
English: The most serious adverse reaction in clinical trials was acute pancreatitis (see section 4.4).
Croatian: Najozbiljnija nuspojava u kliničkim ispitivanjima bio je akutni pankreatitis (vidjeti dio 4.4).
English: Lift Pen from Skin
Croatian: Podignite brizgalicu s kože
English: Sixty seven percent of patients were Caucasian, 15% African American/African heritage and 11% Asian; 26% of patients were Hispanic/Latino.
Croatian: Šezdeset i sedam posto bolesnika bili su bijelci, 15% Afroamerikanci/osobe afričkoga podrijetla, 11% Azijati, a 26%
English: Most patients with severe hypoglycaemic events in clinical studies were receiving concurrent sulphonylurea or insulin and none required hospitalisation or led to withdrawal of treatment.
Croatian: Većina bolesnika koji su u kliničkim ispitivanjima imali događaj teške hipoglikemije istodobno je primala sulfonilureju ili inzulin, a niti jednoj osobi nije bila potrebna hospitalizacija niti prekid liječenja.
English: Albiglutide is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Croatian: Albiglutid je protein kod kojega se očekuje metabolizam degradacijom u male peptide i pojedinačne aminokiseline posredstvom sveprisutnih proteolitičkih enzima.
English: If you have attached the needle, EPERZAN should be used right away.
Croatian: Ako ste pričvrstili iglu, EPERZAN morate primijeniti odmah.
English: Eperzan has no or negligible influence on the ability to drive or use machines.
Croatian: Eperzan ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: These types of gastrointestinal events may lead to dehydration, and worsen renal function.
Croatian: Te vrste gastrointestinalnih događaja mogu uzrokovati dehidraciju i dodatno narušiti bubrežnu funkciju.
English: You have Type 2 diabetes either:
Croatian: Imate šećernu bolest tipa 2 zbog toga što:
English: Adverse reactions from phase III studies during the entire treatment periods and postmarketing reports
Croatian: Nuspojave iz ispitivanja faze III prijavljivane tijekom čitavih razdoblja liječenja i iz izvještaja nakon stavljanja lijeka u promet
English: After mixing, wait 30 minutes before injection
Croatian: Nakon miješanja pričekajte 30 minuta prije injekcije.
English: Possible hypersensitivity reactions including angioedema, erythema, generalised pruritus and rash with dyspnoea, have been reported with albiglutide.
Croatian: Moguće reakcije preosjetljivosti koje uključuju angioedem, eritem, generalizirani pruritus i osip s dispnejom, prijavljene su s albiglutidom.
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance.
Croatian: Kada samo dijeta i tjelovježba ne omogućuju dovoljno dobru regulaciju glikemije u bolesnika u kojih se primjena metformina ne smatra prikladnom zbog kontraindikacija ili nepodnošenja.
English: It must not be administered intravenously or intramuscularly.
Croatian: Ne smije se primjenjivati intravenski niti intramuskularno.
English: Although most patients with injection site reactions were antibody negative (~85%), injection site reactions were reported more frequently for antibody positive (41%, N = 116) than antibody negative patients (14%, N = 1,927).
Croatian: Iako je većina bolesnika s reakcijama na mjestu injekcije bila negativna na protutijela (~85%), reakcije na mjestu injekcije češće su prijavljivane u bolesnika pozitivnih na protutijela (41%, N = 116) nego u onih negativnih na protutijela (14%, N = 1927).
English: The majority of the observed reduction in fasting plasma glucose occurs after a single dose, consistent with the pharmacokinetic profile of albiglutide.
Croatian: Glavnina primijećenog smanjenja razine glukoze u plazmi natašte događa se nakon primjene jednokratne doze, što je sukladno farmakokinetičkom profilu albiglutida.
English: The day of weekly administration can be changed if necessary as long as the last dose was administered 4 or more days previously.
Croatian: Ako je potrebno, dan tjedne primjene može se promijeniti, pod uvjetom da je posljednja doza primijenjena prije 4 ili više dana.
English: With the clear cartridge pointing up, gently swirl the pen for one minute.
Croatian: S prozirnim uloškom usmjerenim prema gore, nježno vrtite brizgalicu jednu minutu.
English: Based on the results of population pharmacokinetic analyses that included Caucasian, African American/African, Asian and Hispanic/Non-Hispanic patients, race and ethnicity had no clinically meaningful effect on the pharmacokinetics of Eperzan clearance.
Croatian: S obzirom na rezultate populacijskih farmakokinetičkih analiza koje su uključivale bijelce, Afroamerikance/Afrikance, Azijate, Hispanoamerikance te bolesnike koji nisu hispanoameričkog podrijetla, rasa i etničko podrijetlo nisu klinički značajno utjecali na farmakokinetiku klirensa lijeka
English: Patients treated with albiglutide should be advised of the potential risk of dehydration, and take precautions to avoid fluid depletion.
Croatian: Bolesnike liječene albiglutidom potrebno je upozoriti na mogući rizik od dehidracije te poduzeti mjere opreza radi sprječavanja gubitka tekućine.
English: Eperzan has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and therefore it is not recommended in these patients.
Croatian: Eperzan nije ispitivan u bolesnika s teškom bolešću probavnog sustava, uključujući tešku gastroparezu, pa se njegova primjena u tih bolesnika ne preporučuje.
English: Wait 30 Minutes
Croatian: Pričekajte 30 minuta
English: Hold the pen upright before attaching the needle.
Croatian: Držite brizgalicu uspravno prije nego što pričvrstite iglu.
English: Seeing small air bubbles remaining is normal and you can still use the pen.
Croatian: Normalno je da u ulošku preostanu mali mjehurići zraka pa možete upotrijebiti brizgalicu.
English: Eperzan must not be injected into a vein (intravenously) or into a muscle (intramuscularly).
Croatian: Eperzan se ne smije injicirati u venu (intravenski) niti u mišić (intramuskularno).
English: Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Croatian: Primjena agonista GLP-1 receptora povezuje se s rizikom od razvoja akutnog pankreatitisa.
English: Based on the results of population pharmacokinetic analyses, there is no clinically relevant effect of gender on clearance.
Croatian: S obzirom na rezultate populacijskih farmakokinetičkih analiza, spol nema klinički značajnog učinka na klirens.
English: There is no experience in patients with NYHA class III-IV cardiac failure.
Croatian: Nema iskustva u liječenju bolesnika sa zatajenjem srca NYHA stupnja III-IV.
English: Anticipated symptoms of an overdose may be severe nausea, vomiting or headache.
Croatian: Očekivani simptomi predoziranja mogu biti jaka mučnina, povraćanje ili glavobolja.
English: 9a Pull the needle out of your skin (Figure U).
Croatian: 9a Izvucite iglu iz kože (Slika U).
English: After reconstitution, continue to follow the steps in the instructions for use to attach the needle, prime the pen injector and administer the injection.
Croatian: Nakon rekonstitucije nastavite slijediti korake navedene u uputama za uporabu kako biste pričvrstili iglu, provjerili protok lijeka u brizgalici i primijenili injekciju.
English: After mixing, wait 15 minutes before injection
Croatian: Nakon miješanja pričekajte 15 minuta prije injekcije.
English: If you use too much Eperzan, contact a doctor or pharmacist for advice.
Croatian: Ako primijenite previše lijeka Eperzan, obratite se liječniku ili ljekarniku za savjet.
English: This dose was associated with an increased frequency of nausea, vomiting, and headache.
Croatian: Ta je doza bila povezana s povećanom učestalošću mučnine, povraćanja i glavobolje.
English: Caution is advised if used concomitantly with albiglutide (see section 4.8).
Croatian: Preporučuje se oprez pri istodobnoj primjeni s albiglutidom (vidjeti dio 4.8).
English: When Eperzan is added to existing metformin therapy, the current metformin dose can be continued unchanged.
Croatian: Kada se Eperzan dodaje postojećoj terapiji metforminom, dotadašnja doza metformina ne mora se mijenjati.
English: Remaining cartons must be stored at 2C to 8C until required.
Croatian: Preostale kutije moraju se čuvati na temperaturi od 2°C do 8°C dok ne budu potrebne.
English: After this time, pens should be used or thrown away.
Croatian: Nakon tog se razdoblja brizgalice moraju upotrijebiti ili baciti.
English: What you need to know before you use Eperzan
Croatian: Što morate znati prije nego počnete primjenjivati Eperzan
English: As long as the needle has not been attached, the pen can be used for up to 8 hours from the time Step 2 was started.
Croatian: Ako niste pričvrstili iglu, brizgalicu možete upotrijebiti unutar 8 sati nakon započinjanja 2. koraka.
English: A pen cannot be re-used.
Croatian: Ista se brizgalica ne može ponovno upotrijebiti.
English: Do not use this medicine after the expiry date which is stated on the pen and the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na brizgalici i kutiji iza oznake 'EXP'.
English: Over 2,300 patients have received Eperzan in 8 placebo- or active-controlled phase III studies.
Croatian: Više od 2300 bolesnika primilo je Eperzan u 8 ispitivanja faze III kontroliranih placebom ili aktivnim lijekom.
English: After I give my medicine, there is some liquid still seen in the clear cartridge.
Croatian: Nakon što primijenim lijek, u prozirnom ulošku se i dalje vidi mala količina tekućine.
English: DO NOT use pen if there are still particles in the liquid.
Croatian: NEMOJTE upotrijebiti brizgalicu ako u tekućini još ima čestica.
English: You will mix them together by twisting the pen.
Croatian: Pomiješat ćete ih zakretanjem brizgalice.
English: If the needle is attached before Step 5, some of the medicine may be lost during mixing.
Croatian: Ako se igla pričvrsti prije 5. koraka, pri miješanju može doći do gubitka određene količine lijeka.
English: If you think this applies to you, don't use Eperzan until you have checked with your doctor, nurse or pharmacist.
Croatian: Ako mislite da se ovo odnosi na Vas, nemojte primijeniti Eperzan dok se ne posavjetujete sa svojim liječnikom, medicinskom sestrom ili ljekarnikom.
English: It is unknown whether the reduced offspring body weight was caused by a direct albiglutide effect on the offspring or secondary to effects on the dam.
Croatian: Nije poznato je li smanjena tjelesna težina mladunčadi posljedica izravnog učinka albiglutida na mladunčad ili je to posljedica učinka lijeka na majku.
English: Stop taking Eperzan.
Croatian: Prestanite primjenjivati Eperzan.
English: When using Eperzan with insulin, each medicinal product must be administered as a separate injection.
Croatian: Kada se Eperzan primjenjuje zajedno s inzulinom, svaki se lijek mora primijeniti zasebnom injekcijom.
English: Use each pen only once.
Croatian: Svaka brizgalica smije se upotrijebiti samo jedanput.
English: IMPORTANT: Make sure you have waited 30 minutes before continuing onto step 4.
Croatian: VAŽNO: Obavezno pričekajte 30 minuta prije nego što prijeđete na 4. korak.
English: Each pen contains a white to yellow powder and a colourless solvent in separate compartments.
Croatian: Jedna brizgalica sadrži prašak bijele do žute boje i bezbojno otapalo u zasebnim odjeljcima.
English: Albiglutide is a recombinant fusion protein consisting of two copies of a 30-amino acid sequence of modified human glucagon-like peptide 1 genetically fused in series to human albumin.
Croatian: Albiglutid je rekombinantni fuzijski protein koji se sastoji od dviju kopija slijeda od 30 aminokiselina koje tvore modificirani ljudski glukagonu nalik peptid-1, koji je genetskim putem serijski spojen za ljudski albumin.
English: Choose Injection Site
Croatian: Odaberite mjesto za injiciranje
English: Eperzan has not been studied in combination with prandial insulin, dipeptidyl peptidase-4 (DPP-4) inhibitors, or sodium/glucose cotransporter 2 (SGLT2) inhibitors.
Croatian: Eperzan nije ispitivan u kombinaciji s prandijalnim inzulinom, inhibitorima dipeptidil-peptidaze 4 (DPP-4) niti inhibitorima suprijenosnika natrija/glukoze 2 (SGLT2).
English: Eperzan should not be used while you're pregnant.
Croatian: Eperzan se ne smije primjenjivati tijekom trudnoće.
English: Albiglutide also produced dose-dependent increases in serum calcitonin levels in a 21-day study in mice, suggesting that thyroid tumours in rodents are a theoretical possibility for albiglutide as well.
Croatian: Albiglutid je također uzrokovao o dozi ovisna povećanja koncentracija kalcitonina u serumu u 21-dnevnom ispitivanju na miševima, što ukazuje na to da su tumori u glodavaca teoretski mogući i kod primjene albiglutida.