FrancophonIA/ELRC3.0 huggingface dataset:
English: Complicated urinary tract infection (e.g. pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
Croatian: Komplicirana infekcija mokraćnog sustava (npr. pijelonefritis ili urosepsa) javila se sa sličnom učestalošću u bolesnika liječenih empagliflozinom u usporedbi s placebom.
English: Symptoms include rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath;
Croatian: Simptomi uključuju brzi gubitak tjelesne težine, mučninu ili povraćanje, bol u trbuhu, brzo i duboko disanje, pospanost ili neobičan miris daha po voću;
English: In patients ≥75 years of age volume depletion events have been reported in a single patient treated with empagliflozin 25 mg as add-on to metformin therapy.
Croatian: ≥ 75 godina događaji deplecije volumena prijavljeni su u jednog bolesnika liječenog empagliflozinom25 mg kao dodatkom terapiji metforminom.
English: • in patients inadequately controlled on their maximally tolerated dose of metformin alone
Croatian: • u bolesnika u kojih nije postignuta zadovoljavajuća regulacija uz njihovu maksimalnu podnošljivu dozu metformina kao monoterapije
English: A total of 7052 patients with type 2 diabetes were treated in clinical studies to evaluate the safety of empagliflozin as add-on to metformin, of which 4740 patients were treated with empagliflozin as add-on to metformin.
Croatian: Ukupno je 7052 bolesnika s šećernom bolešću tipa 2 bilo liječeno u kliničkim ispitivanjima kojima se ocjenjivala sigurnost primjene empagliflozina kao dodatka metforminu, od čega je 4740 bolesnika bilo liječeno empagliflozinom kao dodatkom metforminu.
English: At Week 18, empagliflozin provided statistically significant improvement in HbA1c compared with placebo (Table 4).
Croatian: U 18. tjednu empagliflozin je doveo do statistički značajnog poboljšanja vrijednosti HbA1c u usporedbi s placebom (Tablica 4).
English: Other associated risk factors should be considered to avoid lactic acidosis such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic impairment and any condition associated with hypoxia (such as decompensated cardiac failure, acute myocardial infarction) (see section 4.3).
Croatian: Radi izbjegavanja laktacidoze potrebno je uzeti u obzir druge povezane faktore rizika poput slabo kontroliranog dijabetesa, ketoze, produljenog gladovanja, prekomjernog unosa alkohola, oštećenja funkcije jetre i bilo kojeg stanja povezanog s hipoksijom (poput dekompenziranog zatajenja srca, akutnog infarkta miokarda) (vidjeti dio 4.3).
English: • if you have “type 1 diabetes” - this type usually starts when you are young and your body does not produce any insulin;
Croatian: • ako imate „šećernu bolest tipa 1“ - ovaj tip bolesti obično se javlja u mlađoj životnoj dobi i kada
English: Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with renal failure or acute worsening of renal function.
Croatian: Prijavljeni slučajevi laktacidoze u bolesnika na metforminu prvenstveno su se pojavili u dijabetičara sa zatajenjem bubrega ili akutnim pogoršanjem funkcije bubrega.
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Croatian: Kombinacija čija primjena zahtijeva mjere opreza pri uporabi Glukokortikoidi (primijenjeni sistemskim ili lokalnim putem), beta-2 agonisti i diuretici imaju intrinzičnu hiperglikemijsku aktivnost.
English: Treatment with empagliflozin once daily resulted in statistically significant improvement in HbA1c, and 24 hour mean systolic and diastolic blood pressure as determined by ambulatory blood pressure monitoring (Table 6).
Croatian: Liječenje empagliflozinom jedanput dnevno rezultiralo je statistički značajnim poboljšanjem vrijednosti HbA1c i 24-satnog srednjeg sistoličkog i dijastoličkog krvnog tlaka utvrđenog ambulantnim praćenjem krvnog tlaka (Tablica 6).
English: Therapy should usually not be resumed earlier than 48 hours following surgery and only after renal function has been reevaluated and found to be normal.
Croatian: Liječenje se obično smije nastaviti 48 sati nakon kirurškog zahvata, te tek nakon što se funkcija bubrega ponovno ocijenila normalnom.
English: Stop taking Synjardy immediately and contact a doctor or the nearest hospital straight away.
Croatian: Odmah prestanite uzimati Synjardy i smjesta se obratite liječniku ili najbližoj bolnici.
English: Table 1 Adverse reactions reported in placebo-controlled studies System organ class
Croatian: Nuspojave prijavljene u placebom kontroliranim ispitivanjima
English: For metformin, AUC decreased by 12% and Cmax decreased by 26% compared to fasting conditions.
Croatian: Za metformin vrijednost AUC se smanjila za 12 %, a vrijednost Cmax se smanjila za
English: This may induce metformin accumulation and may increase the risk for lactic acidosis.
Croatian: To može inducirati nakupljanje metformina i može povećati rizik od laktacidoze.
English: The most commonly reported adverse events in clinical trials were hypoglycaemia in combination with insulin and/or sulphonylurea, urinary tract infections,
Croatian: Najčešće prijavljeni štetni događaji u kliničkim ispitivanjima bili su hipoglikemija u kombinaciji s inzulinom i/ili sulfonilurejom, infekcije mokraćnog sustava, infekcije genitalnog trakta i pojačano mokrenje
English: Therefore, this medicinal product must be discontinued prior to, or at the time of the test and not be reinstituted until at least 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further (see section 4.5).
Croatian: Stoga je potrebno prekinuti primjenu ovog lijeka prije ili u vrijeme pretrage, te se lijek smije ponovno uvesti najmanje 48 sati nakon toga i tek nakon što se funkcija bubrega ponovo ocijenila i nije se dodatno pogoršala (vidjeti dio 4.4).
English: 1 LOCF, values after taking antidiabetic rescue therapy censored
Croatian: 1 LOCF, cenzurirane vrijednosti nakon uzimanja pomoćne antidijabetičke terapije (engl. antidiabetic rescue therapy)
English: The frequency of patients with hypoglycaemic events was similar for empagliflozin and placebo as add-on to metformin.
Croatian: Učestalost bolesnika s hipoglikemijskim događajima bila je slična uz empagliflozin i placebo kao dodatkom metforminu.
English: Biotransformation Metformin is excreted unchanged in the urine.
Croatian: Metformin se luči u nepromijenjenom obliku u urin.
English: Empagliflozin daily resulted in a statistically significant reduction in body weight, systolic and diastolic blood pressure and a statistically significantly lower proportion of patients with hypoglycaemic events compared to glimepiride (2.5% for empagliflozin, 24.2% for glimepiride, p<0.0001).
Croatian: Svakodnevna primjena empagliflozina rezultirala je statistički značajnim smanjenjem tjelesne težine, sistoličkog i dijastoličkog krvnog tlaka te statistički značajnim nižim udjelom bolesnika s hipoglikemijskim događajima u usporedbi s glimepiridom (2,5 % za empagliflozin, 24,2 %
English: • changes the way things taste
Croatian: • svrbež • promjena osjeta okusa
English: Add-on to pioglitazone + metformin therapyb Placebo
Croatian: Dodatak terapiji pioglitazonom +/- metforminb Placebo
English: Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) If you take Synjardy with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is increased.
Croatian: Obratite se svom liječniku što je prije moguće ako primijetite sljedeće nuspojave: Niska razina šećera u krvi (hipoglikemija), vrlo često (može se javiti u više od 1 na 10 osoba) Ako uzimate Synjardy s drugim lijekom koji može izazvati nisku razinu šećera u krvi, poput sulfonilureje ili inzulina, rizik od nastanka niske razine šećera u krvi je veći.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Synjardy Lijek čuvajte izvan pogleda i dohvata djece.
English: Increased urination1, 2
Croatian: Pojačano mokrenje1, 2
English: Table 6 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressurea
Croatian: Rezultati djelotvornosti u 12. tjednu placebom kontroliranog ispitivanja empagliflozina u bolesnika sa šećernom bolešću tipa 2 i nekontroliranim krvnim tlakoma
English: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting or alcohol intake, body fluid deficit (dehydration) due to severe diarrhoea or vomiting, liver problems and any medical conditions in which a region of the body is deprived with a lack of oxygen supply (such as acute severe heart diseases).
Croatian: Rizik od razvoja laktacidoze također se povećava uz nekontrolirani dijabetes, produljeno gladovanje ili unos alkohola, nedostatak tjelesne tekućine (dehidraciju) uslijed teške dijareje ili povraćanja, probleme s jetrom ili druga medicinska stanja u kojima dio tijela nije dostatno opskrbljen kisikom (kao što su to akutne teške bolesti srca).
English: The intravascular administration of iodinated contrast materials in radiologic studies can lead to renal failure.
Croatian: Intravaskularna primjena jodiranih kontrastnih materijala u radiološkim ispitivanjima može dovesti do zatajenja bubrega.
English: In case of conditions that may lead to fluid loss (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving Synjardy.
Croatian: gastrointestinalna bolest) preporučuje se pažljivo praćenje volumnog statusa (npr. liječnički pregled, kontrola krvnog tlaka, laboratorijske pretrage uključujući hematokrit) i elektrolita.
English: Special caution should be exercised in situations where renal function may become impaired, for example in case of dehydration, or when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID).
Croatian: Potreban je poseban oprez u situacijama kada je moguće oštećenje funkcije bubrega, na primjer u slučaju dehidracije ili kada se počinje antihipertenzivna ili diuretska terapija ili kada se počinje terapija nesteroidnim protuupalnim lijekom.
English: Due to its mechanism of action, patients taking Synjardy will test positive for glucose in their urine.
Croatian: Bolesnici koji uzimaju Synjardy zbog njegovog će mehanizma djelovanja imati pozitivan nalaz glukoze u mokraći.
English: Due to the metformin component, co-administration of anaesthesia can increase the risk of side effects.
Croatian: Zbog metformina istodobna primjena anestezije može povećati rizik od nuspojava.
English: In patients with mild, moderate or severe renal impairment (creatinine clearance <30 - <90 ml/min) and patients with kidney failure/end stage renal disease (ESRD), AUC of empagliflozin increased by approximately 18%, 20%, 66%, and 48%, respectively compared to subjects with normal renal function.
Croatian: < 90 ml/min.) i bolesnika sa zatajenjem bubrega/terminalnim stadijem bolesti bubrega, AUC empagliflozina se povećao za približno 18 %, 20 %, 66 % odnosno 48 % u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: Difference from glimepiride1 (97.5% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy b Up to 4 mg glimepiride
Croatian: Razlika od glimepirida1 (97,5 % CI) aPotpuni skup za analizu (engl. full analysis set, FAS) s prenošenjem posljednjih opažanja dalje (engl. last observation carried forward, LOCF) prije primjene pomoćne terapije za postizanje zadovoljavajuće glikemije (engl. glycaemic rescue)
English: Special caution should be paid to situations where renal function may become impaired, for example in case of dehydration (severe diarrhoea or vomiting), or when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID).
Croatian: Potreban je poseban oprez u situacijama kada je moguće oštećenje funkcije bubrega, na primjer u slučaju dehidracije (teška dijareja ili povraćanje) ili kada se počinje antihipertenzivna ili diuretska terapija te kada se počinje terapija nesteroidnim protuupalnim lijekom.
English: Volume depletion1, 2
Croatian: Deplecija volumena1,
English: Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and
Croatian: Ovaj lijek se ne smije primjenjivati u bolesnika s oštećenjem jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
English: Urinary tract infection1, 2
Croatian: Infekcija mokraćnog sustava1, 2
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Croatian: Srednji plazmatski AUC i Cmax u stanju dinamičke ravnoteže iznosili su 1870 nmol.h i 259 nmol/l uz empagliflozin 10 mg te 4740 nmol.h i 687 nmol/l uz empagliflozin 25 mg primijenjenim jedanput dnevno.
English: A greater proportion of patients treated with empagliflozin and with a baseline HbA1c ≥7.0% achieved a target HbA1c of <7% compared to placebo (Table 5).
Croatian: Veći udio bolesnika liječenih empagliflozinom s početnom vrijednošću HbA1c ≥ 7,0 % postigao je ciljnu vrijednost < 7 % u usporedbi s placebom (tablica 5).
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away.
Croatian: Odmah prestanite uzimati ovaj lijek i odmah se obratite liječniku ili se javite u najbližu bolnicu.
English: 2 Identified adverse reactions of empagliflozin monotherapy 3 Identified adverse reactions of metformin monotherapy 4 Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia)
Croatian: 4 Dugotrajno liječenje metforminom bilo je povezano sa smanjenom apsorpcijom vitamina B12 što vrlo rijetko može rezultirati klinički značajnom deficijencijom vitamina B12 (npr. megaloblastična anemija).
English: Iron oxide black (E172) Iron oxide red (E172)
Croatian: talk željezov oksid, crni (E172) željezov oksid, crveni (E172) 6.2 Inkompatibilnosti
English: Table 3: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformina
Croatian: Rezultati djelotvornosti u 104. tjednu u aktivno kontroliranom ispitivanju u kojem se uspoređivao empagliflozin naspram glimepirida kao dodatak metforminua
English: A total of 4704 patients with type 2 diabetes were treated in 7 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 1109 patients received empagliflozin 10 mg and 1863 received empagliflozin 25 mg as add-on to metformin therapy.
Croatian: Ukupno je bilo liječeno 4 704 bolesnika s šećernom bolešću tipa 2 u 7 dvostruko slijepih, placebom ili aktivno kontroliranih kliničkih ispitivanja u minimalnom trajanju od 24 tjedna, od kojih je 1 109 bolesnika primalo empagliflozin 10 mg, a njih 1 863 empagliflozin 25 mg kao dodatak terapiji metforminom.
English: * p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Croatian: (engl. antihypertensive rescue) * p-vrijednost< 0,0001 za neinferiornost i p-vrijednost = 0,0153 za superiornost ** p-vrijednost < 0,0001
English: Due to the mechanism of action, decreased renal function will result in reduced efficacy of empagliflozin.
Croatian: Zbog mehanizma djelovanja empagliflozina, smanjena funkcija bubrega rezultirat će smanjenjem njegove djelotvornosti.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Table 5 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformina
Croatian: Rezultati djelotvornosti u 18. i 78. tjednu u placebom kontroliranom ispitivanju empagliflozina kao dodatka bazalnom inzulinu s metforminoma
English: Table 2: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapya
Croatian: Rezultati djelotvornosti 24-tjednih placebom kontroliranih ispitivanja Dodatak terapiji metforminoma
English: • difficulty breathing
Croatian: • teški umor • otežano disanje
English: Liver function tests abnormalities3 Hepatitis3
Croatian: Abnormalni nalazi pretrage jetrene funkcije3
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently in metformin-treated patients who received empagliflozin 10 mg (4.0%) and empagliflozin 25 mg (3.9%) compared to placebo (1.3%), and were reported more frequently for empagliflozin compared to placebo in female patients.
Croatian: Vaginalna monilijaza, vulvovaginitis, balanitis i druge genitalne infekcije Vaginalna monilijaza, vulvovaginitis, balanitis i druge genitalne infekcije češće su bile prijavljene u bolesnika liječenih metforminom koji su primali empagliflozin 10 mg (4,0 %) i empagliflozin 25 mg
English: No major metabolites of empagliflozin were detected in human plasma, as defined by at least 10% of total drug-related material, and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O-glucuronide).
Croatian: ukupnog materijala povezanog s lijekom, a najzastupljeniji metaboliti bila su tri konjugata glukuronida (2-, 3-, i 6-O-glukuronid).
English: An increased frequency was noted when empagliflozin given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5% and placebo: 8.4%) or as add-on to metformin and insulin (empagliflozin 10 mg: 31.3%, empagliflozin 25 mg: 36.2% and placebo: 34.7%).
Croatian: Povećana učestalost je zabilježena kada je empagliflozin primjenjivan kao dodatak metforminu i sulfonilureji (empagliflozin 10 mg: 16,1 %, empagliflozin 25 mg: 11,5 %, placebo: 8,4 %) ili kao dodatak metforminu ili inzulinu (empagliflozin 10 mg: 31,3 %, empagliflozin 25 mg: 36,2 %, placebo 34,7 %).
English: However, only hypochloremia was considered adverse at exposures of approximately 9- and 3-times the clinical AUC exposure of the maximum recommended dose of empagliflozin and metformin, respectively.
Croatian: Međutim, samo se hipokloremija smatrala štetnom pri izloženosti od približno 9 i 3 puta većoj od kliničke AUC
English: If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma.
Croatian: Ako se to dogodi Vama, potrebno Vam je hitno bolničko liječenje, jer laktacidoza može dovesti do kome.
English: The overall frequency of urinary tract infection adverse events was higher in metformin-treated patients who received empagliflozin 10 mg (8.8%) compared to empagliflozin 25 mg (6.6%) or placebo (7.8%).
Croatian: Infekcije mokraćnog sustava Sveukupna učestalost infekcija mokraćnog sustava prijavljenih kao štetni događaji bila je veća u bolesnika liječenih metforminom koji su primali empagliflozin od 10 mg (8,8 %) u usporedbi s bolesnicima koji su primali empagliflozin 25 mg (6,6 %) ili placebo (7,8 %).
English: * p-value <0.0001 ** p-value ≤0.025
Croatian: * p-vrijednost < 0,0001 ** p-vrijednost ≤ 0,025
English: Administration of empagliflozin 25 mg resulted in a higher proportion of patients achieving HbA1c goal of less than 7% and fewer patients needing glycaemic rescue compared to empagliflozin 10 mg and placebo.
Croatian: Primjena empagliflozina 25 mg rezultirala je većim udjelom bolesnika koji su postigli ciljne vrijednosti HbA1c niže od 7 % i manjim brojem bolesnika koji su trebali dodatno liječenje u cilju postizanja zadovoljavajuće glikemije (engl. glycaemic rescue) u usporedbi s primjenom empagliflozina 10 mg i placeba.
English: Add-on to metformin and a sulphonylurea therapya Placebo
Croatian: Dodatak terapiji metforminom i sulfonilurejoma Placebo
English: Metformin is excreted by the kidney.
Croatian: Metformin se izlučuje putem bubrega.
English: Following administration of a dose of 850 mg metformin hydrochloride, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 minute prolongation of the time to peak plasma concentration were observed.
Croatian: Nakon primjene doze od 850 mg metforminklorida uočena je 40 % niža vršna koncentracija u plazmi, 25 %-tno smanjenje vrijednosti
English: Table 4: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add-on to multiple daily doses of insulin with concomitant metformin therapy
Croatian: Rezultati djelotvornosti u 18. i 52. tjednu u placebom kontroliranom ispitivanju empagliflozina kao dodatka višekratnim dnevnim dozama inzulina uz istodobnu terapiju metforminom.
English: Treatment with iodinated contrast agent can reduce your kidney function and increase the risk of side effects due to the metformin component.
Croatian: Uzimanje jodiranog kontrastnog sredstva može smanjiti Vašu funkciju bubrega i povećati rizik od nuspojava zbogmetformina.
English: In subjects with mild, moderate, and severe hepatic impairment according to the Child-Pugh classification, AUC of empagliflozin increased approximately by 23%, 47%, and 75% and Cmax by approximately 4%, 23%, and 48%, respectively, compared to subjects with normal hepatic function.
Croatian: empagliflozina se povećao za približno 23 %, 47 % odnosno 75 %, a Cmax za približno 4 %, 23 % odnosno 48 % u usporedbi s ispitanicima s normalnom funkcijom jetre.
English: Treatment with empagliflozin in combination with metformin with or without other antidiabetic medicinal products (pioglitazone, sulfonylurea, DPP-4 inhibitors, and insulin) led to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, systolic and diastolic blood pressure.
Croatian: sulfonilureje, inhibitora enzima DPP-4 i inzulina) dovelo je do klinički značajnih poboljšanja vrijednosti HbA1c, glukoze u plazmi natašte (engl. fasting plasma glucose, FPG), tjelesne težine, te sistoličkog i dijastoličkog krvnog tlaka.
English: Interaction studies conducted in healthy volunteers suggest that the pharmacokinetics of empagliflozin were not influenced by co-dministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Croatian: Ispitivanja interakcija provedenih u zdravih dobrovoljaca sugeriraju da istodobna primjena s metforminom, glimepiridom, pioglitazonom, sitagliptinom, linagliptinom, varfarinom, verapamilom, ramiprilom, simvastatinom, torasemidom i hidroklortiazidom nije utjecala na farmakokinetiku empagliflozina.
English: The overall frequency of urinary tract infection reported as adverse event was higher in patients treated with empagliflozin 10 mg on a background of metformin compared to patients treated with placebo or empagliflozin 25 mg on a background of metformin (see section 4.8).
Croatian: Sveukupna učestalost infekcija mokraćnog sustava prijavljenih kao štetni događaj bila je veće u bolesnika koji su liječeni empagliflozinom 10 mg uz osnovnu terapiju metforminom u usporedbi s bolesnicima koji su primali placebo ili liječeni empagliflozinom 25 mg uz osnovnu terapiju metforminom (vidjeti dio 4.8).