FrancophonIA/ELRC3.0 huggingface dataset:
English: The two active substances in Qtern work in different ways to help control the level of sugar in your blood and remove excess sugar from your body via your urine.
Croatian: Dvije djelatne tvati u lijeku Qtern djeluju na različit način kako bi pomogle u kontroli razine šećera u krvi i uklanjanju viška šećera iz tijela kroz mokraću.
English: The volume of distribution of saxagliptin was 205 l.
Croatian: Volumen distribucije saksagliptina iznosio je 205 l.
English: The clinical relevance of the skin lesions is not known and skin lesions have not been observed in humans.
Croatian: Klinički značaj kožnih lezija nije poznat i one nisu primijećene kod ljudi.
English: Such studies have been conducted with the individual active substances.
Croatian: Takva su ispitivanja provedena s pojedinačnim djelatnim tvarima.
English: Efficacy parameter
Croatian: Parametar djelotvornosti
English: Patients should be advised of the characteristic symptoms of heart failure, and to immediately report such symptoms.
Croatian: Bolesnike treba upozoriti na karakteristične simptome zatajenja srca i reći im da takve simptome moraju odmah prijaviti.
English: In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Croatian: U slučaju predoziranja, potrebno je započeti prikladne mjere liječenja u skladu sa bolesnikovim kliničkim statusom.
English: Urinary uric acid excretion was also increased transiently (for 3-7 days) and accompanied by a sustained reduction in serum uric acid concentration.
Croatian: Izlučivanje mokraćne kiseline mokraćom također se privremeno povećalo (tijekom 3 - 7 dana), a bilo je praćeno održanim smanjenjem koncentracije mokraćne kiseline u serumu.
English: Sequential add-on clinical trials Study MB102129
Croatian: Klinička ispitivanja sekvencijskog dodavanja Ispitivanje MB102129
English: Patients with signs and symptoms of urinary tract infections should be evaluated and promptly treated, if indicated (see section 4.8).
Croatian: Bolesnike sa znakovima i simptomima infekcije mokraćnih putova potrebno je odmah procijeniti i liječiti, ako je to indicirano (vidjeti dio 4.8)
English: D, oedema peripheral
Croatian: D, periferni edem
English: If pregnancy is detected, treatment with Qtern should be discontinued.
Croatian: Ako se ustanovi trudnoća, liječenje lijekom Qtern mora se prekinuti.
English: How much to take - The recommended dose is one tablet a day.
Croatian: - Preporučena doza je jedna tableta dnevno.
English: What you need to know before you take Qtern
Croatian: Što morate znati prije nego počnete uzimati Qtern
English: Females had approximately 25% higher systemic-exposure values for saxagliptin, this difference is considered not clinically relevant.
Croatian: Žene su imale otprilike 25% veću vrijednost sistemske izloženosti saksagliptina, ta razlika se ne smatra klinički značajnom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Qtern in all subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Qtern u svim podskupinama pedijatrijske populacije u liječenju šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Dapagliflozin: There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Croatian: Dapagliflozin: Nije bilo klinički značajnih razlika u sistemskoj izloženosti između bijelaca, crnaca i azijata.
English: CALENDAR BLISTERS
Croatian: KALENDARSKI BLISTERI
English: Laboratory findings
Croatian: Laboratorijske pretrage
English: Frequencies of all uncommon adverse reactions were based on the individual mono-components data.
Croatian: Učestalost svih manje čestih nuspojava bazirala se na podacima za individualne monokomponentne.
English: Qtern has no or negligible influence on the ability to drive and use machines.
Croatian: Qtern ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Dapagliflozin: A meta-analysis of cardiovascular events in the clinical program was performed.
Croatian: Dapagliflozin: Provedena je meta-analiza kardiovaskularnih događaja u kliničkom programu.
English: Saxagliptin: Elderly patients (65-80 years) had about 60 % higher saxagliptin AUC than young patients (18-40 years).
Croatian: Saksagliptin: Kod starijih je bolesnika (65 - 80 godina) AUC saksagliptina bio približno 60% veći nego kod mlađih bolesnika (18 - 40 godina).
English: - if you have very high levels of sugar in your blood which may make you dehydrated (lose too much body fluid).
Croatian: - ako imate vrlo visoke razine šečera u krvi koje mogu dovesti do dehidracije (prekomjernog gubitka tjelesne tekućine).
English: If you stop taking Qtern
Croatian: Ako prestanete uzimati Qtern
English: In patients where DKA is suspected or diagnosed, treatment with Qtern should be discontinued immediately.
Croatian: U bolesnika kod kojih se sumnja na DKA ili je ista dijagnosticirana, liječenje lijekom Qtern treba odmah prekinuti.
English: UNIQUE IDENTIFIER HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: - Necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus.
Croatian: - Nekrotizirajući fasciitis perineuma ili Fournierova gangrena, ozbiljna infekcija mekog tkiva genitalija ili područja između genitalija i anusa.
English: Diabetic skin lesions (skin damage such as sores or ulcers) are a common complication of diabetes.
Croatian: Dijabetičke kožne lezije (kožna oštećenja poput ranica ili čireva) česta su komplikacija šećerne bolesti.
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome have not been studied in the saxagliptin clinical programme.
Croatian: Imunokompromitirani bolesnici, kao što su bolesnici s presađenim organom ili dijagnozom sindroma humane imunodeficijencije, nisu se ispitivali u sklopu kliničkog programa saksagliptina.
English: The effect in HbA1c observed at Week 24 was sustained at Week 52.
Croatian: Učinak na HbA1c primijećen u 24. tjednu bio je održan i u 52. tjednu.
English: Use in patients treated with pioglitazone
Croatian: Primjena kod bolesnika liječenih pioglitazonom
English: Like for all diabetic patients it is important to counsel patients on routine preventative foot care.
Croatian: Kao i kod svih bolesnika sa dijabetesom važno je savjetovati bolesnike o rutinskoj, preventivnoj njezi stopala.
English: Actions of both medicinal products are regulated by the plasma glucose level.
Croatian: Djelovanje oba ova lijeka regulira se prema vrijednostima glukoze u plazmi.
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: In the clinical program, 34.4% of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9% had hypertension.
Croatian: U kliničkom je programu na početku liječenja 34,4% ispitanika u anamnezi imalo neku kardiovaskularnu bolest (isključujući hipertenziju), a njih 67,9% imalo je hipertenziju.
English: - If it is less than 12 hours since you should have taken your dose, take a dose of Qtern as soon as you remember.
Croatian: - Ako je prošlo manje od 12 sati od propuštene doze uzmite dozu lijeka Qtern čim se sjetite.
English: Qtern should be discontinued if a serious hypersensitivity reaction is suspected.
Croatian: Primjena lijeka Qtern mora se prekinuti u slučaju sumnje na tešku reakciju preosjetljivosti.
English: Non-clinical studies of either saxagliptin or dapagliflozin revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity or carcinogenicity.
Croatian: Neklinička ispitivanja provedena za saksagliptin ili dapagliflozin ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti ili kancerogenosti.
English: - Low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) if used with other diabetes medicines known to cause hypoglycaemia.
Croatian: - Niska razina šećera u krvi (hipoglikemija), koja se javlja vrlo često (može se javiti u više od 1 na 10 osoba) ako se ovaj lijek uzima s drugim lijekovima za šećernu bolest za koje se zna da uzrokuju hipoglikemiju.
English: Mean absolute lymphocyte counts remained stable with daily dosing up to 102 weeks in duration.
Croatian: Srednja vrijednost apsolutnog broja limfocita ostala je stabilna uz svakodnevnu primjenu lijeka u trajanju do 102 tjedna.
English: Proportion of patients achieving HbA1c < 7 %
Croatian: Udio bolesnika koji su postigli HbA1c < 7%
English: Patients should be informed of the characteristic symptoms of acute pancreatitis; persistent, severe abdominal pain.
Croatian: Bolesnike treba upozoriti na karakteristične simptome akutnog pankreatitisa: perzistentnu i jaku bol u abdomenu.
English: While a causal relationship between dapagliflozin and bladder cancer is unlikely (see sections 4.8 and 5.3), as a precautionary measure, Qtern is not recommended for use in patients concomitantly treated with pioglitazone.
Croatian: Iako uzročna povezanost između dapagliflozina i raka mokraćnog mjehura nije vjerojatna (vidjeti dijelove 4.8 i 5.3), kao mjera opreza ne preporučuje se primjenjivati Qtern kod bolesnika koji se istodobno liječe pioglitazonom.
English: The increases in creatinine were generally transient during continuous treatment or reversible after discontinuation of treatment.
Croatian: Tijekom kontinuiranog liječenja, povećanja kreatinina su uglavnom bila prolazna ili su bila reverzibilna nakon prekida liječenja.
English: In addition, elderly patients are more likely to be treated with anti-hypertensive medicinal products that may cause volume depletion and/or changes in renal function [e.g. angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB)].
Croatian: Osim toga, kod starijih bolesnika postoji veća vjerojatnost liječenja antihipertenzivima koji mogu uzrokovati depleciju volumena i/ili promjene funkcije bubrega (npr. inhibitorima angiotenzin-konvertirajućeg enzima (ACE-I) i blokatorima receptora angiotenzina II tipa 1 (ARB)).
English: Based on very limited experience in patients 75 years and older, initiation of Qtern therapy is not recommended in this population (see sections 4.4 and 5.2).
Croatian: S obzirom na vrlo ograničeno iskustvo s primjenom kod bolesnika u dobi od 75 ili više godina, ne preporučuje se započinjati liječenje lijekom Qtern u toj populaciji (vidjeti dijelove 4.4 i 5.2).
English: Not all pack sizes may be marketed in your country.
Croatian: Na tržištu u Vašoj zemlji ne moraju se nalaziti sve veličine pakiranja.
English: Saxagliptin and its major metabolite are removed by haemodialysis (23% of dose over four hours).
Croatian: Saksagliptin i njegovi glavni metaboliti uklanjaju se hemodijalizom (23% doze tijekom 4 sata).
English: Patients experienced relief of symptoms after discontinuation of the medicinal product and some experienced recurrence of symptoms with reintroduction of the same or another DPP-4 inhibitor.
Croatian: Bolesnicima su se simptomi ublažili nakon prekida primjene lijeka, a kod nekih su se povratili nakon ponovnog uvođenja istog ili drugog inhibitora DPP-4.
English: This may be used to treat fungal infections.
Croatian: On se može koristiti za liječenje gljivičnih infekcija. - diltiazem.
English: Dapagliflozin: There is no clinically meaningful increase in exposure based on age alone in subjects up to 70 years old.
Croatian: Dapagliflozin: Ne dolazi do klinički značajnog povećanja izloženosti temeljenog isključivo na dobi kod ispitanika u dobi do 70 godina.
English: You should call your doctor, pharmacist or nurse immediately if you experience any of these symptoms.
Croatian: Morate odmah obavijestiti svog liječnika, ljekarnika ili medicinsku sestru ako primijetite bilo koji od tih simptoma.
English: The most commonly reported adverse reaction related to renal function was serum creatinine increases, the majority of which were transient and reversible (see section 4.8).
Croatian: Najčešće prijavljena nuspojava povezana s funkcijom bubrega bila je povišenje vrijednosti kreatinina u serumu, koje je u većini slučajeva bilo prolazno i reverzibilno (vidjeti dio 4.8).
English: Taking this medicine can cause blood sugar levels to fall too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Croatian: Uzimanje ovog lijeka može izazvati preveliki pad razine šećera u krvi (hipoglikemiju), što može dovesti do pojave simptoma poput drhtanja, znojenja i promjena vida te utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Maternal toxicity was evident only at the highest dose tested, and limited to transient reductions in body weight and food consumption at dose.
Croatian: Toksičnost za majku primijećena je samo kod najveće ispitivane doze, a bila je ograničena na prolazna smanjenja tjelesne težine i unosa hrane pri toj dozi.
English: Saxagliptin was not teratogenic at any doses evaluated in rats or rabbits.
Croatian: Saksagliptin nije bio teratogen ni u jednoj dozi ispitivanoj kod štakora ili kunića.
English: If Fournier's gangrene is suspected, Qtern 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 Qtern te hitno započeti s liječenjem (uključujući antibiotike i kirurški debridman).
English: If a dose is missed and it is < 12 hours until the next dose, the missed dose should be skipped and the next dose taken at the usual time.
Croatian: Ako bolesnik propusti uzeti dozu, a do sljedeće je preostalo < 12 sati, propuštenu dozu bi trebalo preskočiti i sljedeću dozu treba uzeti u uobičajeno vrijeme.
English: Onset of symptoms following initiation of therapy may be rapid or may occur after longer periods of treatment.
Croatian: Simptomi mogu nastupiti ubrzo nakon početka liječenja ili nakon duljih razdoblja liječenja.
English: At 24 weeks, reductions in serum uric acid concentrations ranged from -48.3 to -18.3 micromoles/l (-0.87 to -0.33 mg/dl).
Croatian: U 24. tjednu se smanjenje koncentracije mokraćne kiseline u serumu kretalo između -48,3 i -18,3 mikromola/l (-0,87 do -0,33 mg/dl).
English: There were no clinically relevant differences observed in saxagliptin pharmacokinetics between males and females.
Croatian: Nisu primijećene klinički značajne razlike u farmakokinetici saksagliptina između muškaraca i žena.
English: The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within the approximate 1-month recovery period.
Croatian: Proširenje bubrežne nakapnice i tubula primijećeno kod mladih životinja nije se u potpunosti povuklo u razdoblju oporavka u trajanju od približno mjesec dana.
English: No benefit was observed for MACE or all-cause mortality.
Croatian: Nije primijećena korist s obzirom na pojavu MACE ili smrti zbog bilo kojeg uzroka.
English: The recommended dose is one 5 mg saxagliptin/10 mg dapagliflozin tablet once daily (see sections 4.5 and 4.8).
Croatian: Preporučena doza je jedna tableta od 5 mg saksagliptina/10 mg dapagliflozina jedanput na dan (vidjeti dijelove 4.5 i 4.8).
English: Considering the short latency between first drug exposure and tumour diagnosis, a causal relationship to any specific tumour type is considered unlikely.
Croatian: S obzirom na kratkotrajnu latenciju između prvog izlaganja lijeku i dijagnosticiranja tumora, smatra se da uzročna povezanost s bilo kojom specifičnom vrstom tumora nije vjerojatna.
English: For patients receiving Qtern, in case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended.
Croatian: Kod bolesnika koji primaju Qtern, a kod kojih istodobno postoje stanja koja mogu dovesti do deplecije volumena, preporučuje se pažljivo praćenje statusa volumena (npr. fizikalni pregled, mjerenje krvnog tlaka, laboratorijske pretrage, uključujući određivanje vrijednosti hematokrita) i elektrolita.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/litres (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: Qtern is not expected to affect you being able to drive a car or use any tools or machines.
Croatian: Ne očekuje se da će Qtern imati utjecaja na Vašu sposobnost upravljanja vozilima ili rukovanje bilo kojim alatima ili strojevima.
English: - if you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension).
Croatian: - ako uzimate lijekove za snižavanje krvnog tlaka (antihipertenzive) i ranije ste patili od niskog krvnog tlaka (hipotenzije).
English: • Prior to initiation of this medicinal product and at least yearly, thereafter (see sections 4.2, 4.8, 5.1 and 5.2).
Croatian: • prije početka liječenja ovim lijekom i barem jednom godišnje nakon toga (vidjeti dijelove 4.2, 4.8, 5.1 i 5.2)
English: No episodes of major hypoglycaemia were reported, and no subject discontinued the study treatment due to hypoglycaemia.
Croatian: Nije prijavljena nijedna epizoda teške hipoglikemije i nijedan ispitanik nije prekinuo ispitivano liječenje zbog hipoglikemije.
English: Treatment with dapagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Croatian: Liječenje dapagliflozinom može se ponovno započeti kada se razine ketona vrate u normalu i stanje bolesnika stabilizira.
English: Qtern contains lactose (milk sugar).
Croatian: Qtern sadrži laktozu (mliječni šećer).
English: Indigo carmine aluminium lake (E132)
Croatian: Tinta za označivanje šelak boja Indigo carmine aluminium lake (E132)
English: The safety and efficacy of dapagliflozin in patients with type 1 diabetes have not been established and Qtern should not be used for treatment of patients with type 1 diabetes.
Croatian: Sigurnost i djelotvornost dapagliflozina u bolesnika sa šećernom bolešću tipa 1 nisu ustanovljene te se Qtern ne smije primjenjivati u liječenju bolesnika sa šećernom bolešću tipa
English: The majority of events were considered non-serious, mild or moderate in intensity, and resolved.
Croatian: Većina događaja smatrani su ne-ozbiljnim, blagog do umjerenog intenziteta koji su se povukli.
English: Thus, changes in blood protein levels in various disease states (e.g. renal or hepatic impairment) are not expected to alter the disposition of saxagliptin.
Croatian: Stoga se ne očekuje da bi promjene razine proteina u krvi kod različitih bolesti (primjerice oštećenja bubrežne ili jetrene funkcije) mogle promijeniti raspoloživost saksagliptina.
English: In a separate pre-specified subgroup analysis, mean reductions from baseline in HbA1c were generally greater for patients with higher baseline HbA1c values.
Croatian: U zasebnoj unaprijed specificiranoj analizi podskupina, srednje vrijednosti sniženja HbA1c od početne vrijednosti općenito su bile veće kod bolesnika koji su imali više početne vrijednosti HbA1c.
English: Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema).
Croatian: Simptomi mogu uključivati (između ostaloga) sve veći nedostatak zraka, brz porast tjelesne težine i oticanje stopala (edem stopala).
English: Do not take Qtern if any of the above apply to you.
Croatian: Nemojte uzeti Qtern ako se bilo što od navedenoga odnosi na Vas.
English: Saxagliptin: In a pool of 5 placebo-controlled studies, a small decrease in absolute lymphocyte count was observed, approximately 100 cells/microl relative to placebo.
Croatian: Saksagliptin: U objedinjenoj analizi 5 placebo kontroliranih ispitivanja, opaženo je malo smanjenje apsolutnog broja limfocita, otprilike 100 stanica/µl u odnosu na placebo.
English: Serum creatinine was further evaluated in those patients with events related to decreased renal function, and most observed increases in creatinine were ≤ 0.5 mg/dl from baseline.
Croatian: Serumski kreatinin dodatno je procijenjen u onih bolesnika sa događajima koji su povezani sa smanjenom bubrežnom funkcijom, i najzapaženija povećanja kreatinina bila su ≤ 0.5 mg/dl u odnosu na početak liječenja.
English: These symptoms could be a sign of “diabetic ketoacidosis” - a rare but serious, sometimes 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, ponekad i opasnog po život problema koji se može javiti uz šećernu bolest zbog povišenih razina „ketonskih tijela“ u mokraći ili krvi, što je vidljivo u nalazima pretraga.
English: Stop taking Qtern and see a doctor straight away if you notice any of the following serious side effects:
Croatian: Prestanite uzimati Qtern i odmah se obratite liječniku ako se pojavi bilo koja od navedenih ozbiljnih nuspojava:
English: Available epidemiological data for pioglitazone suggest a small increased risk of bladder cancer in diabetic patients treated with pioglitazone.
Croatian: Dostupni epidemiološki podaci za pioglitazon ukazuju na blago povećan rizik od raka mokraćnog mjehura kod bolesnika sa šećernom bolešću koji se liječe pioglitazonom.
English: The primary safety (non-inferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischemic stroke.
Croatian: Primarna mjera ishoda za sigurnost (neinferiornost) i djelotvornost (superiornost) bila je objedinjena mjera ishoda koju je činilo vrijeme do prve pojave bilo kojeg od sljedećih velikih KV štetnih događaja (engl. major adverse CV events, MACE): smrti zbog KV uzroka, infarkta miokarda bez smrtnog ishoda ili ishemijskog moždanog udara bez smrtnog ishoda.
English: HbA1c (%) at week 24
Croatian: HbA1c (%) u 24. tjednu
English: Compilation of reported adverse reactions for Qtern
Croatian: Kompilacija prijavljenih nuspojava lijeka Qtern
English: The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78 %.
Croatian: Apsolutna bioraspoloživost dapagliflozina nakon peroralne primjene doze od 10 mg iznosi 78%.
English: Qtern must not be used in patients who have had any serious hypersensitivity reaction to a DPP-4 inhibitor or a SGLT2 inhibitor (see section 4.3).
Croatian: Qtern se ne smije primjenjivati kod bolesnika koji su imali bilo kakvu ozbiljnu reakciju preosjetljivosti na inhibitor DPP-4 ili inhibitor SGLT-2 (vidjeti dio 4.3).
English: Do not use this medicine after the expiry date, which is stated on the blister and carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake "Rok valjanosti" ili "EXP".
English: “Type 2 diabetes mellitus” is the type of diabetes that usually starts when you are older.
Croatian: Šećerna bolest tipa 2 je vrsta šećerne bolesti koja se obično javlja u starijoj dobi.