FrancophonIA/ELRC3.0 huggingface dataset:
English: This is normal and what is left of the tablet after all the medicine has been released.
Croatian: To je normalna pojava, a radi se o dijelovima tablete koji preostanu nakon što se iz nje otpusti sav lijek.
English: Your kidney function will be checked at least once every year or more frequently if you are elderly or if you have worsening kidney function.
Croatian: Liječnik će Vam kontrolirati rad bubrega najmanje jednom godišnje, a možda i češće ako ste starija osoba ili ako Vam se pogoršava bubrežna funkcija.
English: What you need to know before you take Qtrilmet
Croatian: Što morate znati prije nego počnete uzimati Qtrilmet
English: Therapeutic experience in patients 65 years and older is limited, and very limited in patients 75 years and older.
Croatian: Iskustvo s liječenjem bolesnika u dobi od 65 i više godina je ograničeno, dok je kod bolesnika u dobi od 75 i više godina vrlo ograničeno.
English: Surgery and operations
Croatian: Kirurški zahvati i operacije
English: Qtrilmet is not recommended for children and adolescents under 18 years of age because it has not been studied in these patients.
Croatian: Primjena lijeka Qtrilmet ne preporučuje se kod djece i adolescenata mlađih od 18 godina jer se lijek nije ispitivao kod tih bolesnika.
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: The treatment groups were proportionally well balanced with regard to demographics, subject characteristics, disease characteristics, and medical history.
Croatian: Liječene skupine bile su proporcionalno dobro ujednačene s obzirom na demografske podatke, značajke bolesnika, značajke bolesti i anamnezu.
English: The dose should be taken as two tablets orally, once daily at the same time of the day, with food.
Croatian: Dozu treba uzimati peroralno, kao dvije tablete jedanput na dan, svaki dan u isto vrijeme, uz hranu.
English: If pancreatitis is suspected, this medicinal product should be discontinued; if acute pancreatitis is confirmed, it should not be restarted.
Croatian: Posumnja li se na pankreatitis, treba prekinuti primjenu ovog lijeka; ako se akutni pankreatitis potvrdi, liječenje ovim lijekom ne smije se ponovno započinjati.
English: What Qtrilmet is and what it is used for What you need to know before you take Qtrilmet How to take Qtrilmet
Croatian: Što je Qtrilmet i za što se koristi Što morate znati prije nego počnete uzimati Qtrilmet
English: If you need major surgery, you must stop taking Qtrilmet during and for some time after the operation.
Croatian: Ako se trebate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati Qtrilmet tijekom i još neko vrijeme nakon operacije.
English: In case of suspected symptoms, the patient should stop taking Qtrilmet and seek immediate medical attention.
Croatian: U slučaju sumnje na simptome, bolesnik treba prestati uzimati Qtrilmet i odmah potražiti liječničku pomoć.
English: Consideration of such etiology is recommended if a patient presents with megaloblastic anaemia.
Croatian: Preporučuje se razmotriti tu etiologiju ako bolesnik pokazuje znakove megaloblastične anemije.
English: Like for all diabetic patients it is important to counsel patients on routine preventative foot care.
Croatian: Kao i kod svih drugih bolesnika sa šećernom bolešću, važno je savjetovati bolesnike o rutinskoj, preventivnoj njezi stopala.
English: To control your diabetes, you need to follow your doctor's advice on diet and exercise, even when you are taking this medicine.
Croatian: Da biste šećernu bolest držali pod kontrolom, morate se pridržavati liječnikovih savjeta o prehrani (dijeti) i tjelovježbi, čak i dok uzimate ovaj lijek.
English: Combinations requiring precautions for use
Croatian: Kombinacije kod kojih je potreban oprez
English: The majority of patients in this study had a baseline HbA1c of > 8% (see Table 4).
Croatian: Većina bolesnika u tom ispitivanju imala je početnu vrijednost HbA1c > 8% (vidjeti Tablicu 4).
English: A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital malformations.
Croatian: Ograničena količina podataka o primjeni metformina kod trudnica ne ukazuje na povećan rizik od prirođenih malformacija.
English: Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Croatian: Liječenje treba privremeno prekinuti kod bolesnika koji su hospitalizirani zbog velikih kirurških zahvata ili ozbiljne akutne bolesti.
English: The most effective method to remove lactate and metformin is haemodialysis.
Croatian: Najučinkovitija metoda uklanjanja laktata i metformina je hemodijaliza.
English: Modified-release tablet (tablet).
Croatian: Tableta s prilagođenim oslobađanjem (tableta).
English: Laboratory findings
Croatian: Laboratorijski nalazi
English: The mean Vd ranged between 63-276 L.
Croatian: Srednji volumen distribucije (Vd) kretao se između 63 l i 276 l.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Croatian: Kod bolesnika s povećanim rizikom od daljnje progresije oštećenja bubrežne funkcije i kod starijih osoba funkciju bubrega treba ocjenjivati i češće, npr. svakih 3 - 6 mjeseci.
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: The volume of distribution of saxagliptin was 205 L.
Croatian: Volumen distribucije saksagliptina iznosio je 205 l.
English: Proportion of patients achieving HbA1c < 7%
Croatian: Udio bolesnika koji su postigli HbA1c < 7%
English: Due to the limited therapeutic experience with this medicinal product in patients 75 years and older, initiation of therapy is not recommended in this population.
Croatian: Zbog ograničenog terapijskog iskustva s primjenom ovog lijeka kod bolesnika u dobi od 75 i više godina, ne preporučuje se uvoditi ga u liječenje u toj populaciji.
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 Azijaca.
English: Risk of volume depletion with this medicinal product should also be taken into account (see sections 4.4 and 5.2).
Croatian: Treba uzeti u obzir i rizik od deplecije volumena kod primjene ovog lijeka (vidjeti dijelove 4.4 i 5.2).
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 napomenuti da takve simptome moraju odmah prijaviti.
English: Do not stop taking Qtrilmet without talking to your doctor first.
Croatian: Nemojte prestati uzimati Qtrilmet ako prethodno o tome niste razgovarali s liječnikom.
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: 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.
Croatian: Dugoročno liječenje metforminom povezano je sa smanjenjem apsorpcije vitamina B12, što u vrlo rijetkim slučajevima može dovesti do klinički značajnog manjka vitamina B12.
English: No metabolites have been identified in humans.
Croatian: Kod ljudi nisu pronađeni njegovi metaboliti.
English: It does not stimulate insulin secretion and therefore, does not produce hypoglycaemia.
Croatian: Ne stimulira lučenje inzulina i stoga ne izaziva hipoglikemiju.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Qtrilmet 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 Qtrilmet u svim podskupinama pedijatrijske populacije u liječenju šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If Fournier's gangrene is suspected, Qtrilmet should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Croatian: Posumnja li se na Fournierovu gangrenu, treba prekinuti primjenu lijeka Qtrilmet i odmah započeti s liječenjem (uključujući antibiotike i kirurški debridman).
English: Females had approximately 25% higher systemic-exposure values for saxagliptin, this difference is considered not clinically relevant.
Croatian: Žene su imale približno 25% veće vrijednosti sistemske izloženosti saksagliptinu, ali se ta razlika ne smatra klinički značajnom.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Croatian: Metformin povećava prijenosni kapacitet specifičnih tipova membranskih prijenosnika glukoze (GLUT-1 i GLUT-4).
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Qtrilmet before or at the time of the injection.
Croatian: Ako trebate primiti injekciju kojom se u krvotok ubrizgava kontrastno sredstvo koje sadrži jod, primjerice za potrebe rendgenskog snimanja ili oslikavanja, morate prestati uzimati Qtrilmet prije ili u vrijeme primjene injekcije.
English: It is taken on its own, or it can be combined with a different type of diabetes medicine called a sulphonylurea.
Croatian: Može se uzimati sam ili u kombinaciji s jednom drugom vrstom lijeka za šećernu bolest, koji se zove sulfonilureja.
English: Mean absolute lymphocyte counts remained stable with daily dosing up to 102 weeks in duration.
Croatian: Srednja vrijednost apsolutnog broja limfocita bila je stabilna kod svakodnevne primjene tijekom do 102 tjedna.
English: Because elderly patients (≥ 65 years) are more likely to have decreased renal function, this medicinal product should be used with caution as age increases.
Croatian: Budući da kod starijih bolesnika (≥ 65 godina) postoji veća vjerojatnost smanjene bubrežne funkcije, ovaj lijek treba primjenjivati uz oprez s porastom dobi.
English: Use in patients at risk for volume depletion, hypotension, and/or electrolyte imbalances
Croatian: Primjena kod bolesnika kod kojih postoji rizik od deplecije volumena, hipotenzije i/ili neravnoteže elektrolita
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 vratili nakon ponovnog uvođenja istog ili drugog inhibitora DPP-4.
English: Qtrilmet with alcohol
Croatian: Qtrilmet s alkoholom
English: Thereafter, glimepiride/placebo dose were kept constant, except for down-titration to prevent hypoglycaemia.
Croatian: Nakon toga se doza glimepirida/placeba održavala stabilnom, osim smanjivanja radi sprječavanja hipoglikemije.
English: There was no effect of food on Cmax and Tmax of metformin.
Croatian: Hrana nije utjecala na Cmax i Tmax metformina.
English: If it is less than 12 hours since you should have taken your daily dose, take a dose of Qtrilmet as soon as you remember.
Croatian: - Ako je prošlo manje od 12 sati od propuštene dnevne doze, uzmite dozu lijeka Qtrilmet čim se sjetite.
English: Qtrilmet must be discontinued at the time of surgery with general, spinal or epidural anaesthesia.
Croatian: Primjena lijeka Qtrilmet mora se prekinuti u vrijeme kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: Use of alternative methods to monitor glycaemic control is advised.
Croatian: Preporučuje se korištenje drugih metoda za praćenje regulacije glikemije.
English: Avoid excessive alcohol intake while taking Qtrilmet since this may increase the risk of lactic acidosis (see “Warnings and precautions” and “Do not take Qtrilmet if you”).
Croatian: Izbjegavajte prekomjeran unos alkohola tijekom liječenja lijekom Qtrilmet jer to može povećati rizik od laktacidoze (pogledajte odlomke ‘Upozorenja i mjere opreza' i ‘Nemojte uzimati Qtrilmet').
English: Other medicines and Qtrilmet
Croatian: Drugi lijekovi i Qtrilmet
English: Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Croatian: Ponovno uvođenje liječenja inhibitorima SGLT2 kod bolesnika koji su doživjeli DKA tijekom prethodnog liječenja inhibitorom SGLT2 se ne preporučuje, osim ako nije utvrđen i razriješen neki drugi jasan precipitirajući faktor.
English: Food has relatively modest effects on the pharmacokinetics of dapagliflozin in healthy subjects.
Croatian: Hrana ima relativno skroman učinak na farmakokinetiku dapagliflozina kod zdravih ispitanika.
English: If no adequate strength of Qtrilmet is available, individual mono-components should be used instead of the modified-release combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Qtrilmet, umjesto kombinacije s prilagođenim oslobađanjem treba koristiti pojedinačne sastavnice.
English: Qtrilmet contains lactose (milk sugar).
Croatian: Qtrilmet sadrži laktozu (mliječni šećer).
English: Qtrilmet has no or negligible influence on the ability to drive and use machines.
Croatian: Qtrilmet ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Qtrilmet should be discontinued if a serious hypersensitivity reaction is suspected.
Croatian: Primjenu lijeka Qtrilmet treba prekinuti u slučaju sumnje na ozbiljnu reakciju preosjetljivosti.
English: Metformin: Plasma protein binding is negligible.
Croatian: Metformin: Vezivanje za proteine u plazmi je zanemarivo.
English: Saxagliptin and its major metabolite are removed by haemodialysis (23% of dose over four hours).
Croatian: Saksagliptin i njegov glavni metabolit uklanjaju se hemodijalizom (23% doze tijekom četiri sata).
English: The safety and efficacy in patients with type 1 diabetes have not been established and Qtrilmet should not be used in patients with type 1 diabetes.
Croatian: Budući da sigurnost i djelotvornost kod bolesnika sa šećernom bolešću tipa 1 nisu ustanovljene, Qtrilmet se ne smije koristiti kod bolesnika sa šećernom bolešću tipa 1.
English: Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people) Qtrilmet may cause a very rare, but very serious side effect called lactic acidosis.
Croatian: - laktacidoza, koja se javlja vrlo rijetko (može se javiti u do 1 na 10 000 osoba) Qtrilmet može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se zove laktacidoza.
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 kardiovaskularnu bolest (osim hipertenzije), dok je njih 67,9% imalo hipertenziju.
English: When driving or using machines, it should be taken into account that dizziness has been reported in studies with saxagliptin.
Croatian: Kod upravljanja vozilima ili rada sa strojevima treba uzeti u obzir da je u ispitivanjima saksagliptina prijavljena omaglica.
English: To avoid overdose, do not continue taking the separate tablets of these medicines as well as Qtrilmet.
Croatian: Da biste izbjegli predoziranje, nemojte uz Qtrilmet nastaviti uzimati i zasebne tablete tih lijekova.
English: The majority of events were considered non-serious, mild or moderate in intensity, and resolved.
Croatian: Većina događaja nije se smatrala ozbiljnima, bila je blage ili umjerene težine te se povukla.
English: Qtrilmet dose is taken orally once daily at the same time of the day with food to reduce the gastrointestinal adverse reactions associated with metformin.
Croatian: Doza lijeka Qtrilmet uzima se peroralno jedanput na dan, svaki dan u isto vrijeme, uz hranu, kako bi se ublažile gastrointestinalne nuspojave povezane s metforminom.
English: While a causal relationship between dapagliflozin and bladder cancer is unlikely (see sections 4.8 and 5.3), as a precautionary measure, Qtrilmet 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 Qtrilmet kod bolesnika koji se istodobno liječe pioglitazonom.
English: You may see some remains of the tablet shell in your stools.
Croatian: U stolici ćete možda vidjeti ostatke ovojnice tablete.
English: Frequencies of all uncommon adverse reactions were based on the individual mono-components data.
Croatian: Učestalost svih manje čestih nuspojava temeljila se na podacima za pojedinačne sastavnice.
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: dugotrajnu i jaku bol u abdomenu.
English: Metformin: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Croatian: Metformin: Bubrežni klirens metformina iznosi > 400 ml/min, što ukazuje na to da se metformin eliminira glomerularnom filtracijom i tubularnom sekrecijom.
English: When the patient plans to become pregnant, and during pregnancy, it is recommended that diabetes is not treated with this medicinal product, but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus associated with abnormal blood glucose levels.
Croatian: Kad bolesnica planira zatrudnjeti i tijekom trudnoće preporučuje se ne liječiti šećernu bolest ovim lijekom, već inzulinom održavati razine glukoze u krvi što bliže normalnim vrijednostima, kako bi se smanjio rizik od malformacija ploda povezanih s abnormalnim razinama glukoze u krvi.
English: Metformin No clinically relevant interaction has been identified.
Croatian: Metformin Nije utvrđena nijedna klinički važna interakcija.
English: The numerical imbalance of breast, bladder, and prostate tumours must be considered with caution; it will be further investigated in post-authorisation studies.
Croatian: Nesrazmjeran broj tumora dojke, mokraćnog mjehura i prostate mora se pažljivo razmotriti i dodatno će se istražiti u ispitivanjima nakon dobivanja odobrenja za stavljanje lijeka u promet.
English: In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), Qtrilmet should be temporarily discontinued and contact with a health care professional is recommended.
Croatian: U slučaju dehidracije (težak proljev ili povraćanje, vrućica ili smanjen unos tekućine) preporučuje se privremeno prekinuti primjenu lijeka Qtrilmet i obratiti se zdravstvenom radniku.
English: The remaining 219 patients started to take 5 mg saxagliptin 16 weeks ahead of the study start.
Croatian: Ostalih 219 bolesnika počelo je uzimati saksagliptin u dozi od 5 mg 16 tjedana prije početka ispitivanja.
English: Patients and/or care-givers should be informed on the risk of lactic acidosis.
Croatian: Bolesnike i/ili njegovatelje treba upozoriti na rizik od laktacidoze.
English: These may be symptoms of another rare, but very serious, sometimes life-threatening condition called diabetic ketoacidosis.
Croatian: To mogu biti simptomi još jednog rijetkog, ali vrlo ozbiljnog i ponekad po život opasnog stanja koje se zove dijabetička ketoacidoza.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/litres.
Croatian: U brojnim se slučajevima stanje očitovalo atipično, uz samo umjereno povišene vrijednosti glukoze u krvi, ispod 14 mmol/l.
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 presatkom organa ili dijagnozom sindroma humane imunodeficijencije, nisu se ispitivali u sklopu kliničkog programa razvoja saksagliptina.
English: CV deaths were balanced across the treatment groups.
Croatian: Broj slučajeva smrti zbog KV uzroka bio je podjednak u obje liječene skupine.
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 dispoziciju saksagliptina.
English: Non-clinical studies of either metformin, saxagliptin or dapagliflozin revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity or carcinogenicity.
Croatian: Neklinička ispitivanja provedena za metformin, saksagliptin ili dapagliflozin ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti ili kancerogenosti.
English: For patients receiving Qtrilmet, 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 Qtrilmet, 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: When starting or using such products in combination with metformin, close monitoring of renal function is necessary.
Croatian: Kad se ti lijekovi uvode ili primjenjuju u kombinaciji s metforminom potrebno je pažljivo pratiti bubrežnu funkciju.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Qtrilmet.
Croatian: Ako niste sigurni, razgovarajte s liječnikom, ljekarnikom ili medicinskom sestrom prije nego što uzmete Qtrilmet.
English: Lactic acidosis, a very rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis.
Croatian: Laktacidoza, vrlo rijetka ali ozbiljna metabolička komplikacija, najčešće se javlja pri akutnom pogoršanju bubrežne funkcije ili kod kardiorespiratorne bolesti ili sepse.
English: Follow the recommendations for skin care from your doctor or nurse.
Croatian: Pridržavajte se preporuka za njegu kože koje su Vam dali liječnik ili medicinska sestra.
English: If renal function falls below GFR < 60 mL/min, treatment should be discontinued.
Croatian: Ako se bubrežna funkcija pogorša do vrijednosti GFR-a < 60 ml/min, liječenje treba prekinuti.
English: No benefit was observed for MACE or all-cause mortality.
Croatian: Nije primijećena korist s obzirom na pojavu MACE događaja ili smrti zbog bilo kojeg uzroka.
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 ‘EXP'.
English: Also, it may be dangerous to drive or use machines if your blood sugar levels fall too low (hypoglycaemia), which can cause shaking, sweating, fast heartbeat, change in vision, headache and confusion.
Croatian: Isto tako, može biti opasno upravljati vozilima ili raditi sa strojevima ako Vam razine šećera u krvi padnu prenisko (hipoglikemija), što može uzrokovati drhtanje, znojenje, ubrzano kucanje srca, promjene vida, glavobolju i smetenost.