FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults and adolescents aged 16 years and over, the recommended starting dose is 1,500 mg per square metre of body surface area, given over two hours on days one, three and five, repeated every 21 days.
Croatian: U odraslih osoba i adolescenata u dobi od 16 godina i starijih, preporučena početna doza lijeka je 1 500 mg po četvornom metru tjelesne površine.
English: No patient was older than 85 years.
Croatian: Niti jedan bolesnik nije bio stariji od 85 godina.
English: Possible signs are listed in section 4, ‘Possible side effects'.
Croatian: Mogući znakovi su navedeni u dijelu 4, „Moguće nuspojave“.
English: Your doctor may decide to temporarily or permanently stop your treatment with this medicine.
Croatian: Vaš liječnik može odlučiti privremeno ili trajno prekinuti liječenje ovim lijekom.
English: This medicine is not recommended for children and adolescents under 18 years, because it has not been studied in these patients.
Croatian: Ovaj lijek se ne preporučuje djeci i adolescentima mlađim od 18 godina, jer lijek nije ispitan u ovih bolesnika.
English: The clinical relevance of this finding remains uncertain.
Croatian: Klinička značajnost ovog otkrića ostaje nejasna.
English: Each side of the tablet is 8 mm long.
Croatian: Svaka strana tablete je dugačka 8 mm.
English: Number of patients analysed
Croatian: Broj analiziranih bolesnika
English: Systemic exposure of each metabolite was less than 10 % of total drug-related material.
Croatian: Sistemska izloženost svakom metabolitu je iznosila manje od 10% ukupnog materijala povezanog s lijekom.
English: The signs of too low blood sugar may include:
Croatian: Znakovi pretjerano niske razine šećera u krvi mogu uključivati:
English: In this case, do not continue taking any one of those tablets separately, if your are taking this medicine.
Croatian: U tom slučaju nemojte nastaviti s odvojenim uzimanjem bilo koje od tih tableta ako uzimate ovaj lijek.
English: What to do if you forget to take a tablet depends on how long it is until your next dose:
Croatian: Što učiniti ako ste zaboravili uzeti tabletu ovisi o tome koliko vremena je preostalo do sljedeće doze.
English: Diet and exercise can help your body to use its blood sugar better.
Croatian: Dijeta i tjelovježba mogu pomoći tijelu da što bolje iskoristi šećer u krvi.
English: Seen rarely • sore in the mouth
Croatian: Zabilježeno rijetko • afte u ustima
English: If you take more of this medicine than you should, immediately talk to a doctor or go to a hospital.
Croatian: Ako uzmete više ovog lijeka nego što ste trebali, odmah se javite liječniku ili otiđite u bolnicu.
English: There is very little experience in patients aged 75 years or older.
Croatian: Postoji vrlo malo iskustva u bolesnika u dobi od 75 godina ili više.
English: The incidence of confirmed hypoglycaemic events was low (< 1,5 %).
Croatian: Incidencija potvrđenih hipoglikemijskih događaja je bila niska (< 1,5%).
English: Do not stop taking this medicine without first consulting your doctor.
Croatian: Ne prekidajte uzimanje ovog lijeka bez prethodnog savjetovanja s liječnikom.
English: The metformin dose should be continued.
Croatian: Potrebno je nastaviti dozu metformina.
English: It does this by blocking a protein called DPP-4.
Croatian: To čini blokiranjem proteina nazvanog DPP-4.
English: Do not drive or use any tools or machines, if you experience any of these symptoms while taking Glyxambi.
Croatian: Nemojte voziti ili koristiti druge alate ili strojeve, ako iskusite bilo koji od tih simptoma tijekom uzimanja lijeka Glyxambi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2016
Croatian: Datum prvog odobrenja: 11. studeni 2016.
English: In clinical trials, patients were treated for up to 24 or 52 weeks.
Croatian: U kliničkim ispitivanjima bolesnici su bili liječeni do 24 ili 25 tjedana.
English: • if you have or have had a disease of the pancreas.
Croatian: • ako imate ili ste imali bolest gušterače;
English: Therefore, assessment of renal function is recommended:
Croatian: Stoga se preporučuje procjena funkcije bubrega:
English: Both tumours are common in rats and are unlikely to be relevant to humans.
Croatian: Oba tumora su česta u štakora i vjerojatno nisu relevantni za ljude.
English: Empagliflozin is mainly excreted unchanged.
Croatian: Empagliflozin se uglavnom izlučuje nepromijenjen.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Croatian: Bolesnike je potrebno obavijestiti o karakterističnim simptomima akutnog pankreatitisa.
English: Table 5 Treatment effect for the primary composite endpoint, its components and mortality
Croatian: Tablica 5 Učinak liječenja za primarnu kompozitnu mjeru ishoda, njezine komponente i mortalitet
English: • prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
Croatian: • prije započinjanja istodobne terapije bilo kojim lijekom koji može imati negativan učinak na funkciju bubrega.
English: Your doctor will need to change your treatment.
Croatian: Liječnik će morati promijeniti Vaše liječenje.
English: • inflamed nose or throat (nasopharyngitis)
Croatian: • upala nosa ili grla (nazofaringitis)
English: Loss of body fluid (dehydration), seen uncommonly The signs of dehydration are not specific, but may include:
Croatian: Gubitak tjelesne tekućine (dehidracija), zabilježen manje često Znakovi dehidracije nisu specifični, ali mogu uključivati:
English: • If it is 12 hours or more until your next dose, take Glyxambi as soon as you remember.
Croatian: • Ako do sljedeće doze ima 12 ili više sati, uzmite Glyxambi čim se sjetite.
English: The absolute bioavailability of linagliptin is approximately 30 %.
Croatian: Apsolutna bioraspoloživost linagliptina je oko 30%.
English: Frequency categories are defined as 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) and not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Overall, the effects on HbA1c reduction observed at 24 weeks were sustained at week 52.
Croatian: Ukupno, učinci na smanjenje vrijednosti HbA1c opaženi u 24. tjednu bili su održani u 52. tjednu.
English: The safety profile of Glyxambi did not differ in the elderly.
Croatian: Sigurnosni profil lijeka Glyxambi nije se razlikovao u starijih osoba.
English: Use in patients at risk for volume depletion
Croatian: Primjena u bolesnika s rizikom od deplecije volumena
English: What Glyxambi is and what it is used for
Croatian: Što je Glyxambi i za što se koristi
English: Glyxambi tablets are for oral use and can be taken with or without a meal at any time of the day at regular intervals.
Croatian: Tablete lijeka Glyxambi namijenjenje su za peroralnu primjenu i mogu se uzimati sa ili bez obroka u bilo koje doba dana u redovitim intervalima.
English: Elderly subjects (65 to 80 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Croatian: Stariji ispitanici (65 do 80 godina) imali su usporedive koncentracije linagliptina u plazmi, u usporedbi s mlađim osobama.
English: Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili primijetite znakove neovlaštenog otvaranja.
English: Glyxambi showed a similar food effect as the individual active substances.
Croatian: Glyxambi je pokazao sličan učinak uz hranu kao i pojedinačne djelatne tvari.
English: Your doctor may limit your dose or decide to use an alternative medicine.
Croatian: Liječnik može ograničiti Vašu dozu ili se odlučiti za primjenu drugog lijeka.
English: The observed increase in urine volume was not dose-dependent.
Croatian: Opaženo povećanje volumena mokraće nije bilo ovisno o dozi.
English: Table 6 Major adverse cardiovascular events (MACE) and mortality by treatment group in the CAROLINA study
Croatian: Tablica 6 Veliki štetni kardiovaskularni događaji (MACE) i mortalitet po liječenoj skupini u ispitivanju CAROLINA
English: • prior to Glyxambi initiation and periodically during treatment, i.e. at least yearly,
Croatian: • prije započinjanja terapije lijekom Glyxambi i periodično tijekom liječenja, tj. barem jedanput godišnje,
English: Based on these studies there is no concern for carcinogenicity in humans.
Croatian: Ova ispitivanja ne daju razloga za zabrinutost u smislu kancerogenosti u ljudi.
English: A significantly higher incidence of malignant lymphomas only in female mice at the highest dose (>200-times human exposure) is not considered relevant for humans.
Croatian: Značajno veća incidencija malignih limfoma samo na ženkama miševa, pri najvišim dozama (> 200 puta više od izloženosti u ljudi), ne smatra se značajnom za ljude.
English: The genital tract infections were mild and moderate in intensity, none was severe in intensity.
Croatian: Infekcije genitalnog trakta bile su blage ili umjerene u intenzitetu, niti jedna nije bila teškog inteziteta.
English: Warnings and precautions Talk to your doctor, before taking this medicine, and during treatment:
Croatian: Obratite se svom liječniku prije nego uzmete ovaj lijek, kao i tijekom liječenja:
English: • if you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid.
Croatian: • ako primijetite mjehuriće na koži, to može biti znak stanja pod imenom bulozni pemfigoid.
English: • Do not take a double dose of this medicine to make up for a forgotten dose.
Croatian: • Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu ovog lijeka.
English: Pharmacokinetics were generally similar in healthy subjects and in patients with type 2 diabetes.
Croatian: Farmakokinetika je općenito bila slična u zdravih ispitanika i u bolesnika sa šećernom bolešću tipa 2.
English: Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, fertility and early embryonic development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti, plodnosti i ranog embrionalnog razvoja.
English: An urge to pass urine or more frequent urination may be due to the way this medicine works, but as they can also be signs of urinary tract infection, if you note an increase in such symptoms, you should also contact your doctor.
Croatian: Osjećaj nagona za mokrenjem ili češće mokrenje mogu se javiti zbog načina djelovanja ovog lijeka, ali budući da oni ujedno mogu biti znakovi infekcije mokraćnog sustava, ako primijetite povećanje ovih simptoma, morate se obratiti svom liječniku.
English: Safety and efficacy of Glyxambi in paediatric patients below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Glyxambi u pedijatrijskih bolesnika mlađih od 18 godina nisu još ustanovljene.
English: Your doctor may need to change your treatment.
Croatian: Liječnik će možda trebati promijeniti Vaše liječenje.
English: Therefore, Glyxambi is not recommended for use in this population.
Croatian: Stoga se Glyxambi ne preporučuje za primjenu u toj populaciji.
English: A double dose should not be taken to compensate for a forgotten dose.
Croatian: Ne smije se uzeti dvostruka doza kako bi se nadoknadila zaboravljena doza.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER (perforated)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER BLISTER (perforirani)
English: No clinically relevant effect of Cmax and Tmax changes is expected; therefore linagliptin may be administered with or without food.
Croatian: Ne očekuje se klinički značajan učinak promjena u Cmax i Tmax; stoga se linagliptin može primjenjivati sa ili bez hrane.
English: Before you start treatment with Glyxambi and regularly during treatment, your doctor will check how well your kidneys are working.
Croatian: Prije početka liječenja lijekom Glyxambi kao i redovito tijekom liječenja, liječnik će provjeravati koliko dobro rade
English: SGLT2 is highly expressed in the kidney, whereas expression in other tissues is absent or very low.
Croatian: SGLT2 je značajno eksprimiran u bubregu, dok u drugim tkivima nije prisutan ili je vrlo nizak.
English: Use with medicinal products known to cause hypoglycaemia
Croatian: Primjena s lijekovima koji uzrokuju hipoglikemiju
English: Use of dipeptidyl peptidase-4 (DPP-4) inhibitors has been associated with a risk of developing acute pancreatitis.
Croatian: Primjena inhibitora dipeptidil-peptidaze-4 (DPP-4) povezana je s rizikom od razvoja akutnog pankreatitisa.
English: Adverse reactions marked with an asterisk (*) are further discussed in section “Description of selected adverse reactions” below.
Croatian: Nuspojave označene zvjezdicom (*) dodatno su razrađene u dijelu „Opis izabranih nuspojava“ u nastavku.
English: • if you are 75 years old or older as starting this medicine above 75 years is not recommended .
Croatian: • ako imate 75 ili više godina, jer se ne preporučuje započinjanje liječenja ovim lijekom u bolesnika starijih od 75 godina.
English: • You can take Glyxambi with or without food.
Croatian: • Glyxambi možete uzimati sa ili bez hrane.
English: Co-administration with known inducers of UGT enzymes should be avoided because of a risk of decreased efficacy of empagliflozin.
Croatian: Potrebno je izbjegavati istodobnu primjenu s poznatim induktorima UGT enzima zbog rizika od smanjene djelotvornosti empagliflozina.
English: If you have type 2 diabetes, your pancreas may not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively.
Croatian: Ako imate šećernu bolest tipa 2, Vaša gušterača možda ne stvara dovoljno inzulina za regulaciju razine glukoze u krvi, a Vaše tijelo ne može učinkovito koristiti vlastiti inzulin.
English: No dosage adjustment is necessary for Glyxambi based on body mass index.
Croatian: Nije potrebno prilagođavanje doze za Glyxambi na osnovi indeksa tjelesne mase.
English: Contact a doctor or the nearest hospital straight away as these symptoms could be a sign of “diabetic ketoacidosis” - a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Croatian: Odmah se javite liječniku ili u najbližu bolnicu, jer ovi simptomi mogu biti znak „dijabetičke ketoacidoze“ - problema koji se može javiti uz šećernu bolest zbog povišenih razina „ketonskih tijela“ u mokraći ili krvi, što je vidljivo u nalazima pretraga.
English: Therefore, special attention should be given to their volume intake in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE inhibitors).
Croatian: Stoga je potrebno naročito paziti na njihov unos volumena u slučaju istodobne primjene lijekova koji mogu dovesti do deplecije volumena (npr. diuretici, ACE inhibitori).
English: Oral 2-year carcinogenicity studies in rats and mice revealed no evidence of carcinogenicity in rats or male mice.
Croatian: Dvogodišnja ispitivanja kancerogenosti oralne doze na štakorima i miševima nisu dala dokaze kancerogenosti u štakora ili mužjaka miševa.
English: • laboratory blood tests may show changes in blood fat levels, an increase in the amount of red blood cells (increase in haematocrit), and changes related to kidney function (decrease in filtration rate and increase in blood creatinine)
Croatian: • laboratorijske pretrage krvi mogu pokazati promjene u razinama masti u krvi, povećanje broja crvenih krvnih stanica (povišeni hematokrit) i promjene povezane s funkcijom bubrega
English: This results in high levels of sugar in your blood, which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs.
Croatian: To rezultira visokim razinama šećera u krvi što može dovesti do medicinskih problema poput bolesti srca, bolesti bubrega, sljepoće i slabe cirkulacije u udovima.
English: What Glyxambi looks like and contents of the pack
Croatian: Kako Glyxambi izgleda i sadržaj pakiranja
English: One patient administered Glyxambi experienced a confirmed (investigator-defined), major hypoglycaemic event (defined as an event requiring assistance) in the active- or placebo-controlled trials (overall frequency 0,1 %).
Croatian: Jedan bolesnik koji je primao Glyxambi imao je potvrđeni (definirano od strane ispitivača) teški hipoglikemijski događaj (definiran kao događaj koji zahtijeva asistenciju) u aktivno ili placebom kontroliranim ispitivanjima (ukupna učestalost 0,1%).
English: The most serious adverse reactions were ketoacidosis (< 0.1%), pancreatitis (0.2%), hypersensitivity (0.6%), and hypoglycaemia (2.4%) (see section 4.4).
Croatian: Najozbiljnije nuspojave su bile ketoacidoza (< 0,1%), pankreatitis (0,2%), preosjetljivost (0,6%) i hipoglikemija (2,4%) (vidjeti dio 4.4).
English: The inter subject and residual variabilities for empagliflozin oral clearance were 39.1 % and 35.8 %, respectively.
Croatian: Interindividualne i rezidualne varijabilnosti za oralni klirens empagliflozina iznosile su 39,1% odnosno 35,8%.
English: Linagliptin binds selectively to DPP-4 and exhibits a > 10,000-fold selectivity versus DPP-8 or DPP-9 activity in vitro.
Croatian: Linagliptin se selektivno veže na DPP-4 i pokazuje > 10 000 puta veću selektivnost naspram aktivnosti DPP-8 ili DPP-9 in vitro.
English: No major metabolites of empagliflozin were detected in human plasma and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O-glucuronide).
Croatian: U humanoj plazmi nisu pronađeni glavni metaboliti empagliflozina, a najzastupljeniji metaboliti bila su tri konjugata glukuronida (2-, 3-, i 6-O-glukuronid).
English: Empagliflozin cardiovascular outcome (EMPA-REG OUTCOME) study
Croatian: Ispitivanje kardiovaskularnog ishoda uz primjenu empagliflozina (EMPA-REG OUTCOME)
English: In particular, you should tell your doctor if you are using the following medicines:
Croatian: Osobito je važno obavijestiti liječnika ako primjenjujete sljedeće lijekove:
English: Diabetic ketoacidosis (DKA)
Croatian: Dijabetička ketoacidoza (DKA)
English: The frequency of reported nocturia was comparable between placebo and empagliflozin (< 1 %).
Croatian: Učestalost prijavljene nokturije je bila usporediva između placeba i empagliflozina (< 1%).
English: Effects related to the individual active substances are described below.
Croatian: Učinci povezani s pojedinačnim djelatnim tvarima opisani su u nastavku.
English: Liver, kidneys and gastrointestinal tract are the principal target organs of toxicity in mice and rats.
Croatian: Jetra, bubrezi i gastrointestinalni trakt najvažniji su ciljni organi toksičnosti u miševa i štakora.
English: No drug interaction studies have been performed with Glyxambi and other medicinal products; however, such studies have been conducted with the individual active substances.
Croatian: Nisu provedena ispitivanja interakcija s lijekom Glyxambi i drugim lijekovima; međutim, takva ispitivanja provedena su s pojedinačnim djelatnim tvarima.
English: Systemic exposure of empagliflozin increased in a dose proportional manner.
Croatian: Sistemska izloženost empagliflozinu povećala se proporcionalno dozi.
English: GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels.
Croatian: GLP-1 i GIP povećavaju biosintezu inzulina i sekreciju iz beta-stanica gušterače u prisustvu normalnih i povišenih razina glukoze u krvi.
English: • to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control
Croatian: • za poboljšanje kontrole glikemije kada metformin i/ili sulfonilureja (SU) te samo jedna od monokomponenti lijeka Glyxambi ne omogućuju odgovarajuću kontrolu glikemije.
English: Linagliptin binds very effectively to DPP-4 in a reversible manner and thus leads to a sustained increase and a prolongation of active incretin levels.
Croatian: Linagliptin se veže vrlo učinkovito na DPP-4 na reverzibilan način, čime dolazi do održanog povećanja i produljenja razina aktivnih inkretina.
English: Initiation of therapy with Glyxambi in this population is not recommended (see section 4.2).
Croatian: Započinjanje terapije lijekom Glyxambi u ovoj populaciji se ne preporučuje (vidjeti dio 4.2).
English: Talk to your doctor in case you suffer from severe hepatic impairment.
Croatian: Obratite se svom liječniku ako patite od teškog oštećenja jetrene funkcije.
English: For FPG, baseline FPG is also included.
Croatian: Za FPG također je uključena početna vrijednost FPG.
English: C]-empagliflozin solution to healthy volunteers, approximately 96 % of the drug-related radioactivity was eliminated in faeces (41 %) or urine (54 %).
Croatian: C]-empagliflozina u zdravih dobrovoljaca, oko 96% radioaktivnosti povezane s lijekom bilo je eliminirano putem fecesa (41%) ili urina (54%).
English: Insulin and sulphonylureas may increase the risk of hypoglycaemia.
Croatian: Inzulin i sulfonilureje mogu povećati rizik od hipoglikemije.
English: Blood creatinine increased/Glomerular filtration rate decreased
Croatian: Povišena razina kreatinina u krvi/snižena brzina glomerularne filtracije
English: Body Weight-24 weeks
Croatian: Tjelesna težina-24 tjedna
English: General toxicity studies in rats up to 13 weeks were performed with the combination of empagliflozin and linagliptin.
Croatian: Ispitivanja opće toksičnosti u štakora u trajanju do 13 tjedana provedena su s kombinacijom empagliflozina i linagliptina.
English: Talk to your doctor if you have kidney problems.
Croatian: Obratite se svom liječniku ako imate problema s bubrezima.
English: Treatment with Glyxambi should not be started in patients above the age of 75.
Croatian: Liječenje lijekom Glyxambi ne smije se započeti u bolesnika starijih od 75 godina.
English: Empagliflozin exposure is increased in patients with severe hepatic impairment and therapeutic experience in such patients is limited (see section 5.2).
Croatian: Izloženost empagliflozinu je povećana u bolesnika s teškim oštećenjem jetrene funkcije, a terapijsko iskustvo u tih bolesnika je ograničeno (vidjeti dio 5.2).
English: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring and institute clinical measures as required.
Croatian: U slučaju predoziranja, prikladno je primijeniti uobičajene suportivne mjere, npr. uklanjanje neapsorbiranog lijeka iz gastrointestinalnog trakta, uz kliničko praćenje te primjenu kliničkih mjera prema potrebi.
English: The amount of glucose removed by the kidney through this glucuretic mechanism is dependent upon the blood glucose concentration and GFR.
Croatian: Količina glukoze koju bubreg uklanja pomoću tog glukuretskog mehanizma ovisna je o koncentraciji glukoze u krvi i GFR-u.
English: At high concentrations, where DPP-4 is fully saturated, 70-80 % of linagliptin was bound to other plasma proteins than DPP-4, hence 30-20 % were unbound in plasma.
Croatian: Pri visokim koncentracijama, gdje je DPP-4 potpuno zasićen, 70-80% linagliptina se veže na druge proteine plazme osim DPP-4, stoga je 30-20% ostalo nevezano u plazmi.
English: • if you develop symptoms of acute pancreatitis, like persistent, severe abdominal pain.
Croatian: • ako razvijete simptome akutne upale gušterače, poput stalne jake boli u trbuhu.
English: No increased risk of CV death or all-cause mortality was observed.
Croatian: Nije bio uočen povećani rizik od kardiovaskularne smrti ili mortaliteta svih uzroka.
English: Therefore, clinically relevant interactions would not be expected with other P-glycoprotein / CYP3A4 inhibitors.
Croatian: Stoga se ne očekuju klinički značajne interakcije s drugim inhibitorima P-glikoproteina / CYP3A4.