FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop taking Synjardy for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Croatian: Prestanite nakratko uzimati Synjardy ako imate stanje koje može biti povezano s dehidracijom (značajan gubitak tjelesnih tekućina) kao što je jako povraćanje, proljev, vrućica, izloženost toplini ili ako pijete manje tekućine nego obično.
English: At baseline, 74% of patients were being treated with metformin, 48% with insulin, and 43% with a sulfonylurea.
Croatian: Na početku ispitivanja, 74 % bolesnika je bilo liječeno metforminom, 48 % inzulinom, a 43 % sulfonilurejom.
English: These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier´s gangrene which destroys the tissue under the skin.
Croatian: Ti simptomi mogu biti znak rijetke, no ozbiljne ili čak po život opasne infekcije koja se naziva nekrotizirajući fasciitis perineuma ili Fournierova gangrena koja uništava potkožno tkivo.
English: Comparison vs. met (95% CI)
Croatian: Usporedba naspram met (95 % CI)
English: Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see sections 4.3 and 4.4).
Croatian: Praćenje funkcije bubrega je nužno kako bi se spriječila laktacidoza povezana s metforminom, naročito u starijih bolesnika (vidjeti dijelove 4.3 i 4.4).
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: 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: Basal insulin dose (IU/day) at week 78
Croatian: Doza bazalnog inzulina (IU/dan) u 78. tjednu
English: The tablets are available in PVC/PVDC/aluminium perforated unit dose blisters.
Croatian: Tablete su dostupne u PVC/PVDC/aluminijskim perforiranim blisterima djeljivim na jedinične doze.
English: • iodinated contrast agents (medicines used during an X-ray, see section ‘Warnings and precautions'.
Croatian: • jodirana kontrastna sredstva (lijekove koji se primjenjuju tijekom rendgenskog snimanja, vidjeti dio ‘Upozorenja i mjere opreza').
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 26 % u usporedbi s uvjetima natašte.
English: In the EMPA-REG OUTCOME study, 10.1% of the patients were reported with cardiac failure at baseline.
Croatian: U ispitivanju EMPA-REG OUTCOME, 10,1 % bolesnika je bilo prijavljeno sa zatajenjem srca na početku ispitivanja.
English: Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment-β (HOMA-β) was noted.
Croatian: Zabilježeno je poboljšanje surogatnih biljega funkcije beta-stanica uključujući HOMA-β (engl.
English: During the initial 18 weeks the insulin dose was kept stable, but was adjusted to achieve a FPG <110 mg/dl in the following 60 weeks.
Croatian: Tijekom početnih 18 tjedana doza inzulina je bila stabilna, ali se prilagođavala u cilju postizanja razine glukoze natašte (FPG) < 110 mg/dl u slijedećih 60 tjedana.
English: • in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products
Croatian: • u kombinaciji s drugim lijekovima za liječenje šećerne bolesti u bolesnika u kojih nije postignuta dostatna regulacija metforminom i tim drugim lijekovima
English: Synjardy may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Croatian: Synjardy može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
English: Animal studies show that empagliflozin crosses the placenta during late gestation to a very limited extent but do not indicate direct or indirect harmful effects with respect to early embryonic development.
Croatian: Ispitivanja na životinjama pokazuju da empagliflozin prolazi kroz posteljicu tijekom kasne trudnoće u vrlo ograničenoj količini, ali ne ukazuju na izravne ili neizravne štetne učinke na rani embrionalni razvoj.
English: Drug-drug interactions involving the major CYP450 and UGT isoforms with empagliflozin and concomitantly administered substrates of these enzymes are therefore considered unlikely.
Croatian: Stoga se interakcije među lijekovima koje uključuju glavne izoforme enzima CYP450 i UGT s empagliflozinom i istodobno primijenjenim supstratima tih enzima ne smatraju vjerojatnim.
English: The observed increase in urine volume was not dose-dependent and is not clinically meaningful.
Croatian: Opaženo povećanje volumena mokraće nije bilo ovisno o dozi niti klinički značajno.
English: Based on the population pharmacokinetic analysis, the apparent terminal elimination half-life of empagliflozin was estimated to be 12.4 hours and apparent oral clearance was 10.6 l/hour.
Croatian: Na temelju farmakokinetičke analize populacije procijenjeno je da prividni terminalni poluvijek eliminacije empagliflozina iznosi 12,4 sati, a prividni oralni klirens 10,6 l/sat.
English: This medicinal product should not be used during breast feeding.
Croatian: Ovaj lijek se ne smije primjenjivati tijekom dojenja.
English: Based on the mode of action of SGLT2 inhibitors, osmotic diuresis accompanying therapeutic glucosuria may lead to a modest decrease in blood pressure (see section 5.1).
Croatian: Na temelju načina djelovanja inhibitora SGLT2, osmotska diureza, koja prati terapijsku glukozuriju, može dovesti do blagog sniženja krvnog tlaka (vidjeti dio 5.1).
English: Treatment with empagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Croatian: Liječenje empagliflozinom može se ponovno započeti kada se razine ketona vrate u normalu i stanje bolesnika stabilizira.
English: Compared to linagliptin 5 mg, both doses of empagliflozin plus linagliptin 5 mg provided statistically significant reductions in FPG and blood pressure.
Croatian: U usporedbi s linagliptinom 5 mg, obje doze empagliflozina plus linagliptin 5 mg dovele su do statistički značajnog sniženja vrijednosti FPG-a i krvnog tlaka.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Croatian: U brojnim slučajevima, stanje se očitovalo atipično, uz samo umjereno povišene vrijednosti glukoze u krvi, ispod 14 mmol/l (250 mg/dl).
English: Some responses were increased by the combination treatment, such as effects on renal physiology, electrolyte balance and acid/base state.
Croatian: Neki odgovori su se povećali uslijed kombiniranog liječenja, kao što su učinci na fiziologiju bubrega, ravnotežu elektrolita te acidobazni status.
English: • reduced body temperature and heartbeat
Croatian: • smanjena tjelesna temperatura i usporen rad srca
English: Empagliflozin and metformin
Croatian: Empagliflozin i metformin
English: If Fournier´s gangrene is suspected, Synjardy should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Croatian: Ako se sumnja na Fournierovu gangrenu, potrebno je prekinuti uzimanje lijeka Synjardy te hitno započeti s liječenjem (uključujući antibiotike i kirurški debridman).
English: It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Croatian: Pretpostavlja se da je farmakokinetika apsorpcije metformina nelinearne.
English: The glucosuria observed with empagliflozin is accompanied by mild diuresis which may contribute to sustained and moderate reduction of blood pressure.
Croatian: Glukozurija, koja je opažena uz empagliflozin, bila je praćena blagom diurezom, koja može doprinijeti trajnom i umjerenom snižavanju krvnog tlaka.
English: Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell;
Croatian: Simptomi uključuju bol u trbuhu, ubrzano i duboko disanje, pospanost ili Vam dah ima neobičan voćni miris;
English: Insulin and insulin secretagogues, such as sulphonylureas, may increase the risk of hypoglycaemia.
Croatian: Inzulin i inzulinski sekretagozi, poput sulfonilureje, mogu povećati rizik od hipoglikemije.
English: In this analysis, AUC was estimated to be 5.82%, 10.4%, and 17.3% lower in subjects with BMI of 30, 35, and 45 kg/m2, respectively, compared to subjects with a body mass index of 25 kg/m
Croatian: U ovoj analizi procijenjeno je da je AUC bio 5,82 %, 10,4 % i 17,3 % niži u ispitanika s ITM 30, 35 odnosno 45 kg/m2 u usporedbi s ispitanicima s indeksom tjelesne mase od 25 kg/m
English: There are no data from the use of this medicinal product or empagliflozin in pregnant women.
Croatian: Nema podataka o primjeni ovog lijeka ili empagliflozina u trudnica.
English: In the EMPA-REG OUTCOME study, empagliflozin reduced the risk of heart failure requiring hospitalization compared with placebo (empagliflozin 2.7 %; placebo 4.1 %; HR 0.65, 95 % CI 0.50,
Croatian: U ispitivanju EMPA-REG OUTCOME, empagliflozin je smanjio rizik od zatajenja srca koje zahtijeva hospitalizaciju u usporedbi s placebom (empagliflozin 2,7%; placebo 4,1%; HR 0,65; 95% CI 0,50;
English: Synjardy is a diabetes medicine that contains two active substances called empagliflozin and metformin.
Croatian: Synjardy je lijek za liječenje šećerne bolesti koji sadrži dvije djelatne tvari koje se nazivaju empagliflozin i metformin.
English: Animal studies with the combination of empagliflozin and metformin or with metformin alone have shown reproductive toxicity at higher doses of metformin only (see section
Croatian: Ispitivanja na životinjama s kombinacijom empagliflozina i metformina ili samim metforminom pokazala su reproduktivnu toksičnost samo pri višim dozama metformina (vidjeti dio 5.3).
English: Due to the mechanism of action, decreased renal function will result in reduced glycaemic efficacy of empagliflozin.
Croatian: Zbog mehanizma djelovanja empagliflozina, smanjena funkcija bubrega rezultirat će smanjenom glikemijskom djelotvornošću empagliflozina.
English: In addition, Synjardy can be used as an alternative to taking both empagliflozin and metformin as single tablets.
Croatian: Uz to se Synjardy može primjenjivati kao alternativa uzimanju empagliflozina i metformina kao pojedinačnih tableta.
English: Hypoglycaemia (when used with sulphonylurea or insulin)
Croatian: Hipoglikemija (u kombiniranoj primjeni sa sulfonilurejom ili inzulinom)
English: No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea and as add-on to linagliptin and metformin.
Croatian: Niti jedan bolesnik nije imao događaj teške hipoglikemije u kombinaciji s metforminom i sulfonilurejom i kao dodatak linagliptinu i metforminu.
English: Your doctor may ask you to stop taking Synjardy until you have recovered.
Croatian: Vaš liječnik može zatražiti prekid primjene lijeka Synjardy sve dok se ne oporavite;
English: • in patients already being treated with the combination of empagliflozin and metformin as separate tablets.
Croatian: • u bolesnika koji se već liječe kombinacijom empagliflozina i metformina kao odvojenim tabletama.
English: Synjardy is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
Croatian: Synjardy je indiciran za liječenje odraslih osoba sa šećernom bolešću tipa 2 kao dodatak dijeti i tjelovježbi:
English: Most toxicity was consistent with secondary pharmacology related to urinary glucose loss and electrolyte imbalances including decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism and gluconeogenesis, urinary changes such as polyuria and glucosuria, and microscopic changes including mineralisation in kidney and some soft and vascular tissues.
Croatian: Većina toksičnosti je bila konzistentna sa sekundarnom farmakologijom povezanom s gubitkom glukoze putem mokraće i neravnotežom elektrolita uključujući smanjenu tjelesnu težinu i tjelesnu masnoću, povećanu konzumaciju hrane, proljev, dehidraciju, sniženu vrijednost glukoze u serumu i povišene vrijednosti drugih serumskih parametara koji odražavaju povećani metabolizam proteina i glukoneogenezu, promjene u mokraći poput poliurije i glukozurije, te mikroskopske promjene uključujući mineralizaciju u bubregu kao i nekim mekim i vaskularnim tkivima.
English: Empagliflozin should not be initiated.
Croatian: Primjena empagliflozina ne smije se započeti.
English: Renal clearance of metformin is >400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Croatian: Bubrežni klirens metformina je > 400 ml/min. što ukazuje da se metformin uklanja putem glomerularne filtracije i tubularne sekrecije.
English: • medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib).
Croatian: • lijekove koji mogu promijeniti količinu metformina u Vašoj krvi, osobito ako imate smanjenu funkciju bubrega (kao što su verapamil, rifampicin, cimetidin, dolutegravir, ranolazin, trimetoprim, vandetanib, izavukonazol, krizotinib, olaparib).
English: SGLT2 prevents glucose (blood sugar) from being lost in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys.
Croatian: SGLT2 sprječava gubitak glukoze (šećera u krvi) putem mokraće tako što apsorbira glukozu u krvotok dok se krv filtrira u bubrezima.
English: The population pharmacokinetic analysis showed that the apparent oral clearance of empagliflozin decreased with a decrease in creatinine clearance leading to an increase in drug exposure.
Croatian: Farmakokinetička analiza populacije pokazala je da se prividni oralni klirens empagliflozina smanjio sa smanjenjem klirensa kreatinina, dovodeći do povećanja izloženosti lijeku.
English: Available animal data have shown excretion of empagliflozin and metformin in milk.
Croatian: Dostupni podaci u životinja pokazali su da se empagliflozin i metformin izlučuju u mlijeko.
English: The mechanism of action of empagliflozin is independent of beta cell function and insulin pathway and this contributes to a low risk of hypoglycaemia.
Croatian: Mehanizam djelovanja empagliflozina neovisan je o funkciji beta-stanica i inzulinskom putu, što doprinosi niskom riziku od hipoglikemije.
English: Because of how this medicine works, your urine will test positive for sugar while you are taking this medicine.
Croatian: Vaše mokraće će biti pozitivan na šećer tijekom uzimanja ovog lijeka.
English: • Acute conditions with the potential to alter renal function such as: dehydration, severe infection,
Croatian: • Akutna stanja koja mogu promijeniti funkciju bubrega poput: dehidracije, teške infekcije, šoka.
English: Stop taking Synjardy and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Croatian: Prestanite uzimati Synjardy i odmah se obratite liječniku ili otiđite u najbližu bolnicu ako osjetite neke od simptoma laktacidoze, jer to stanje može dovesti do kome.
English: An urge to pass urine or more frequent urination may be due to the way Synjardy works, but they can also be signs of urinary tract infection.
Croatian: Osjećaj nagona za mokrenjem ili češće mokrenje mogu se javiti zbog načina djelovanja lijeka Synjardy, ali oni ujedno mogu biti i znakovi infekcije mokraćnog sustava.
English: The observed effect of food on empagliflozin and metformin is not considered to be clinically relevant.
Croatian: Opaženi učinak hrane na empagliflozin i metformin nije se smatrao klinički značajnim.
English: After oral administration, empagliflozin was rapidly absorbed with peak plasma concentrations occurring at a median tmax of 1.5 hours post-dose.
Croatian: Nakon peroralne primjene, empagliflozin se brzo apsorbirao, s pojavom vršnih koncentracija u plazmi pri medijanu tmax od 1,5 sati nakon primijene doze.
English: Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with medicinal products that are P-gp substrates.
Croatian: Na temelju in vitro ispitivanja, smatra se da nije vjerojatno da empagliflozin izaziva interakcije s lijekovima koji predstavljaju P-gp supstrate.
English: These symptoms could be a sign of “diabetic ketoacidosis”a rare, but serious, sometines life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Croatian: Ovi simptomi mogu biti znak „dijabetičke ketoacidoze“rijetkog, ali ozbiljnog i ponekad po život opasnog problema koji se može javiti uz šećernu bolest zbog povišenih razina „ketonskih tijela“ u mokraći ili krvi što je vidljivo u nalazima pretraga.
English: PVC/PVDC/aluminium perforated unit dose blisters.
Croatian: PVC/PVDC/aluminijski perforirani blisteri djeljivi na jedinične doze.
English: Empagliflozin administered during the period of organogenesis was not teratogenic.
Croatian: Empagliflozin, koji se primjenjivao tijekom razdoblja organogeneze, nije imao teratogeni učinak.
English: The frequencies of urinary tract infections were low for male patients and were balanced across treatment groups.
Croatian: Učestalosti infekcija mokraćnog sustava bile su niske u muških bolesnika te uravnotežena među liječenim skupinama.
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 izloženosti maksimalne preporučene doze empagliflozina, odnosno metformina.
English: The difference in frequency was less pronounced in male patients.
Croatian: Razlika u učestalosti za muške bolesnike bila je slabije izražena.
English: A total of 12245 patients with type 2 diabetes were treated in clinical studies to evaluate the safety of empagliflozin as add-on to metformin, of which 8199 patients were treated with empagliflozin as add-on to metformin either alone or in addition to a sulfonylurea, pioglitazone, or insulin.
Croatian: Ukupno je 12 245 bolesnika s šećernom bolešću tipa 2 bilo liječeno u kliničkim ispitivanjima kojima se ocjenjivala sigurnost primjene empagliflozina kao dodatka metforminu, od čega je 8199 bolesnika bilo liječeno empagliflozinom kao dodatak metforminu, bilo da je dodan sam ili kao dodatak uz sulfonilureju, pioglitazon ili inzulin.
English: • if you have a severe infection such as an infection affecting your lung or bronchial system or your kidney.
Croatian: • ako imate tešku infekciju kao što je infekcija koja pogađa pluća ili bronhe ili pak bubrege.
English: The most commonly reported adverse events in clinical trials were hypoglycaemia in combination with insulin and/or sulphonylurea, urinary tract infections, genital tract infections and increased urination (see description of selected side effects).
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 (vidjeti opis odabranih nuspojava).
English: Multiple-dose study: After repeated doses of 500 mg twice daily for 7 days in paediatric patients the peak plasma concentration (Cmax) and systemic exposure (AUC0-t) were approximately 33% and 40% lower, respectively, compared to diabetic adults who received repeated doses of 500 mg twice daily for 14 days.
Croatian: Ispitivanje višekratne doze: Nakon ponovljenih doza od 500 mg dvaput dnevno tijekom 7 dana u pedijatrijskih bolesnika, vršna koncentracija u plazmi (Cmax) i sistemska izloženost (AUC0-t) bile su približno 33 % odnosno 40 % niže u usporedbi s odraslim dijabetičarima koji su primali ponovljene doze od 500 mg dvaput dnevno tijekom 14 dana.
English: The reduction of cardiovascular death was comparable for empagliflozin 10 mg and 25 mg (see Figure 1) and confirmed by an improved overall survival (Table
Croatian: Smanjenje kardiovaskularne smrti je bilo usporedivo za empagliflozin 10 mg i 25 mg (Slika 1) te potvrđeno poboljšanim ukupnim preživljenjem (Tablica 9).
English: Empagliflozin does not inhibit human uptake transporters such as OAT3, OATP1B1, and OATP1B3 in vitro at clinically relevant plasma concentrations and, as such, drug-drug interactions with substrates of these uptake transporters are considered unlikely.
Croatian: Empagliflozin ne inhibira humane prijenosnike za unos poput OAT3, OATP1B1 i OATP1B3 in vitro pri klinički značajnim koncentracijama u plazmi, te se, kao takve, interakcije među lijekovima sa supstratima tih prijenosnika za unos ne smatraju vjerojatnima.
English: Table 4: Efficacy results at 24 week comparing empagliflozin in combination with metformin to the individual components Empagliflozin 10 mg
Croatian: Tablica 4: Rezultati djelotvornosti u 24. tjednu za empagliflozin u kombinaciji s metforminom u usporedbi s pojedinačnim komponentama Empagliflozin 10 mg
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Croatian: Laktacidoza je hitno medicinsko stanje te se mora bolnički liječiti.
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with empagliflozin in NYHA class III-IV.
Croatian: New York Heart Association) klasifikaciji je ograničeno, te u kliničkim ispitivanjima ne postoje iskustva primjene empagliflozina u bolesnika III-IV stupnja prema NYHA klasifikaciji.
English: If this happens to you, you may need immediate hospital treatment, as lactic acidosis can lead to coma.
Croatian: Vam se to dogodi, potrebno Vam je hitno bolničko liječenje, jer laktacidoza može dovesti do kome.
English: Metformin partitions into erythrocytes.
Croatian: Metformin se razdjeljuje u eritrocite.
English: A paediatric Phase 1 study examined the pharmacokinetics and pharmacodynamics of empagliflozin (5 mg, 10 mg and 25 mg) in children and adolescents ≥10 to <18 years of age with type 2 diabetes mellitus.
Croatian: U pedijatrijskom ispitivanju faze 1 istražila se farmakokinetika i farmakodinamika empagliflozina (5 mg, 10 mg i 25 mg) u djece i adolescenata u dobi od ≥ 10 do < 18 godina sa šećernom bolešću tipa
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Croatian: Metformin je bigvanid s antihiperglikemijskim učincima, koji snižava bazalnu i postprandijalnu razinu glukoze u plazmi.
English: The effect of empagliflozin on urinary glucose excretion is associated with osmotic diuresis, which could affect hydration status of patients age 75 years and older.
Croatian: Učinak empagliflozina na izlučivanje glukoze mokraćom povezan je s osmotskom diurezom, koja može utjecati na hidracijski status u bolesnika u dobi od 75 i više godina.
English: The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability using the recommended daily dose of 10 mg or 25 mg of empagliflozin, while not exceeding the maximum recommended daily dose of metformin.
Croatian: Doziranje je potrebno prilagoditi pojedinom bolesniku na temelju trenutnog režima, učinkovitosti i podnošljivosti liječenja primjenjujući preporučenu dnevnu dozu od 10 mg ili 25 mg empagliflozina, pri čemu se ne smije prekoračiti maksimalna preporučena dnevna doza metformina.