FrancophonIA/ELRC3.0 huggingface dataset:
English: Please refer to the trametinib SmPC (see section 4.4).
Croatian: Pogledajte sažetak opisa svojstava lijeka za trametinib (dio 4.4).
English: Date of first authorisation: 23 March 2018
Croatian: Datum prvog odobrenja: 23. ožujka 2018.
English: Time was treated as a categorical variable.
Croatian: Vrijeme se smatralo kategoričkom varijablom.
English: Elderly (≥ 65 years old)
Croatian: Starije osobe (≥ 65 godina)
English: In particular, tell your doctor:
Croatian: Osobito je važno da obavijestite svog liječnika:
English: Try to take it at the same time each day; this will help you remember to take it.
Croatian: Pokušajte uzimati lijek svaki dan u isto vrijeme; tako ćete se lakše sjetiti da ga trebate uzeti.
English: Children and adolescents below 18 years should not take this medicine.
Croatian: Djeca i adolescenti mlađi od 18 godina ne smiju uzimati ovaj lijek.
English: Patients should be monitored and treated appropriately.
Croatian: Bolesnike treba pratiti i liječiti na odgovarajući način.
English: • It is best to take your tablet with a meal.
Croatian: • Bilo bi najbolje da tabletu uzmete uz obrok.
English: Talk to your doctor for further instructions.
Croatian: Obratite se svom liječniku za daljnje upute.
English: • are 65 years or older
Croatian: • ako imate 65 ili više godina.
English: Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu (dvije doze u isto vrijeme) kako biste nadoknadili zaboravljenu dozu.
English: Subgroup analysis
Croatian: Analiza podskupina
English: If you are not sure, talk to your doctor before taking Segluromet.
Croatian: Ako niste sigurni, obratite se svom liječniku prije nego uzmete Segluromet.
English: Talk with your doctor about the best way to feed your baby if you take this medicine.
Croatian: Razgovarajte sa svojim liječnikom o najboljem načinu hranjenja svog djeteta dok uzimate ovaj lijek.
English: Effects of age, body weight, gender and race
Croatian: Učinci dobi, tjelesne težine, spola i rase
English: If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
Croatian: Ako ste trudni, razgovarajte sa svojim liječnikom o najboljem načinu kontroliranja razine šećera u krvi tijekom trudnoće.
English: Do not stop taking this medicine without talking to your doctor.
Croatian: Nemojte prestati uzimati ovaj lijek bez prethodnog razgovora sa svojim liječnikom.
English: Most of the events were mild or moderate and no serious case was reported.
Croatian: Događaji su većinom bili blage do umjerene težine i nije prijavljen nijedan ozbiljan slučaj.
English: No potential acute symptoms and signs of overdose were identified.
Croatian: Nisu utvrđeni mogući akutni simptomi i znakovi predoziranja.
English: * See Section 4.4.
Croatian: * Vidjeti dio 4.4.
English: Signs and symptoms of low blood sugar may include:
Croatian: Znakovi i simptomi niske razine šećera u krvi mogu uključivati:
English: Segluromet with alcohol
Croatian: Segluromet s alkoholom
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Croatian: Nije poznato je li ovaj lijek siguran i učinkovit kada ga uzimaju djeca i adolescenati mlađi od 18 godina.
English: Ask about ways to prevent dehydration.
Croatian: Pitajte liječnika kako možete spriječiti dehidraciju,
English: Patients should not take two doses of Segluromet at the same time.
Croatian: Bolesnici ne smiju uzeti dvije doze lijeka Segluromet u isto vrijeme.
English: Other medicines and Segluromet
Croatian: Drugi lijekovi i Segluromet
English: This may cause anaemia (low levels of red blood cells).
Croatian: To može uzrokovati anemiju (niske razine crvenih krvnih stanica)
English: • Swallow the tablet; if you have difficulties in swallowing the tablet can be broken or crushed.
Croatian: • Progutajte tabletu; ako imate poteškoća s gutanjem, tabletu možete prelomiti ili zdrobiti.
English: Hispanic or Latino patients comprised 15.6% to 34.5% of the population.
Croatian: Bolesnici hispanoameričkog ili latinoameričkog podrijetla činili su od 15,6% do 34,5% populacije.
English: However, if it is nearly time for your next dose, skip the missed dose and go back to your regular schedule.
Croatian: Međutim, ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu i nastavite uzimati lijek prema uobičajenom rasporedu.
English: • Your doctor will prescribe the right dose for you.
Croatian: • Liječnik će Vam propisati odgovarajuću dozu lijeka.
English: • if you have recently had a heart attack or have severe circulatory problems, such as ‘shock' or breathing difficulties.
Croatian: • ako ste nedavno imali srčani udar ili imate teške probleme s cirkulacijom, kao što su ‘šok' ili teškoće pri disanju,
English: (For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5 and 5.1.)
Croatian: (Za rezultate ispitivanja koji se odnose na kombinacije i učinke na regulaciju glikemije vidjeti dijelove 4.4, 4.5 i 5.1).
English: It is not known if Segluromet can harm your unborn baby.
Croatian: Nije poznato može li Segluromet naškoditi nerođenom djetetu.
English: • fast and deep breathing
Croatian: • ubrzano i duboko disanje,
English: The effects on kidney and bone did not fully reverse after the 1-month recovery period.
Croatian: Učinci na bubrege i kosti nisu se u potpunosti povukli nakon 1-mjesečnog razdoblja oporavka.
English: • if you have a severe infection or are dehydrated.
Croatian: • ako imate tešku infekciju ili ste dehidrirani,
English: Type 2 diabetes is a condition in which your body does not make enough insulin or the insulin that your body produces does not work as well as it should.
Croatian: Šećerna bolest tipa 2 je stanje u kojem Vaše tijelo ne proizvodi dovoljno inzulina ili inzulin koji Vaše tijelo proizvede ne djeluje kako bi trebao.
English: Your doctor may decide to temporarily or permanently stop your treatment with Segluromet.
Croatian: Vaš će liječnik možda odlučiti privremeno ili trajno prekinuti liječenje lijekom Segluromet.
English: , Vitamin B12 deficiency
Croatian: , deficijencija vitamina B12
English: This will lower your chance of having an upset stomach.
Croatian: Tako ćete smanjiti vjerojatnost nadražaja želuca.
English: During treatment with Segluromet, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Croatian: Tijekom liječenja lijekom Segluromet liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: • unusual sleepiness or tiredness
Croatian: • neuobičajena pospanost ili umor,
English: In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
Croatian: U slučaju sumnje na simptome, bolesnik treba prestati uzimati metformin i odmah potražiti medicinsku pomoć.
English: It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your healthcare professional.
Croatian: Važno je da redovito pregledavate svoja stopala i da se pridržavate svih drugih savjeta o njezi stopala i primjerenoj hidraciji koje su vam dali zdravsteni radnici.
English: GFR ml/min
Croatian: GFR u ml/min
English: Multipack: 196 (4 packs of 49) film-coated tablets
Croatian: Višestruko pakiranje: 196 (4 pakiranja od 49) filmom obloženih tableta
English: In this population, the incidence of severe hypoglycaemia was 0.4% in each group.
Croatian: U toj je populaciji incidencija teške hipoglikemije u svakoj skupini iznosila 0,4%.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, akutne toksičnosti, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
English: The clinical relevance of these decreases is unknown.
Croatian: Nije poznat klinički značaj tih smanjenja.
English: What Segluromet looks like and contents of the pack
Croatian: Kako Segluromet izgleda i sadržaj pakiranja
English: Serious diabetic ketoacidosis occurred rarely.
Croatian: Ozbiljna dijabetička ketoacidoza javljala se rijetko.
English: Patients and/or care-givers should be informed of the risk of lactic acidosis.
Croatian: Bolesnike i/ili njegovatelje treba informirati o riziku od laktacidoze.
English: Non-inferiority is declared when the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.
Croatian: Neinferiornost se smatrala dokazanom kada je gornja granica dvostranog intervala pouzdanosti (CI) od 95% za srednju vrijednost razlike iznosila manje od 0,3%.
English: Concomitant use not recommended
Croatian: Istodobna se primjena ne preporučuje
English: Includes: thirst and polydipsia.
Croatian: Uključuje žeđ i polidipsiju.
English: SGLT2 inhibitors should be used with caution in these patients.
Croatian: Inhibitore SGLT2 u tih bolesnika treba primjenjivati uz oprez.
English: Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycaemic agents.
Croatian: Njegovi farmakološki mehanizmi djelovanja razlikuju se od drugih skupina oralnih antihiperglikemika.
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: U bolesnika s povećanim rizikom od daljnje progresije oštećenja funkcije bubrega i u starijih osoba, funkciju bubrega treba ocjenjivati i češće, npr. svakih 3 - 6 mjeseci.
English: • increased levels of “ketone bodies” in your urine or blood
Croatian: • povišene razine ‘ketonskih tijela' u mokraći ili krvi,
English: • The dose of Segluromet that you take will depend on your condition and the amount of ertugliflozin and metformin needed to control your blood sugar.
Croatian: • Doza lijeka Segluromet koju ćete uzimati ovisit će o Vašem stanju te količini ertugliflozina i metformina koja je potrebna za regulaciju šećera u krvi.
English: • Metformin belongs to a group of medicines called biguanides.
Croatian: • Metformin pripada skupini lijekova koji se zovu bigvanidi.
English: The safety and efficacy of Segluromet in children under 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Segluromet u djece mlađe od 18 godina nisu ustanovljene.
English: Necrotising fasciitis of the perineum or Fournier's gangrene (not known, cannot be estimated from the available data)
Croatian: Nekrotizirajući fasciitis perineuma ili Fournierova gangrena (nepoznato, ne može se procijeniti iz dostupnih podataka)
English: Do not use this medicine if the packaging is damaged or shows signs of tampering.
Croatian: Ovaj se lijek ne smije upotrijebiti ako je pakiranje oštećeno ili se vide znakovi otvaranja.
English: • might be at risk of dehydration (for example, if you are taking medicines that increase urine production [diuretics] lower blood pressure or if you are over 65 years old).
Croatian: • ako bi mogao postojati rizik od dehidracije (primjerice, ako uzimate lijekove koji povećavaju proizvodnju mokraće [diuretike] ili snižavaju krvni tlak ili ako ste stariji od 65 godina).
English: In case of swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage form.
Croatian: U slučaju poteškoća s gutanjem, tablete se mogu prelomiti ili zdrobiti jer se radi o formulaciji s trenutnim oslobađanjem.
English: Alu/PVC/PA/Alu blisters.
Croatian: Al/PVC/PA/Al blisteri.
English: • change in taste
Croatian: • promjena osjeta okusa
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 Segluromet before or at the time of the injection.
Croatian: Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvotok, na primjer, radi rendgenskog snimanja ili oslikavanja, morate prestati uzimati Segluromet prije ili u vrijeme injekcije.
English: Talk to your doctor, pharmacist, or nurse before and while taking Segluromet, if you:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije i za vrijeme uzimanja lijeka Segluromet:
English: • Segluromet can be used alone or with some other medicines that lower blood sugar.
Croatian: • Segluromet se može uzimati samostalno ili u kombinaciji s nekim drugim lijekovima koji snižavaju razinu šećera u krvi.
English: As an underlying mechanism has not been established, risk factors, apart from general risk factors, for amputation are unknown.
Croatian: Budući da podležeći mehanizam nije utvrđen, čimbenici rizika za amputaciju, osim općih čimbenika rizika, nisu poznati.
English: Elderly patients may be at an increased risk of volume depletion.
Croatian: Stariji bolesnici mogu imati povećan rizik od deplecije volumena.
English: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Croatian: O tome treba informirati bolesnika i češće pratiti razinu glukoze u krvi, osobito na početku liječenja takvim lijekovima.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Segluromet.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Segluromet.
English: This finding was attributed to carbohydrate malabsorption leading to altered calcium homeostasis and was not considered relevant to human risk.
Croatian: Taj se nalaz pripisao malapsorpciji ugljikohidrata koja je izmijenila homeostazu kalcija, i nije se smatrao relevantnim za rizik kod ljudi.
English: GFR should be assessed before treatment initiation and regularly thereafter (see section 4.2).
Croatian: Treba ocijeniti GFR prije početka liječenja i redovito nakon toga (vidjeti dio 4.2).
English: Ertugliflozin is a potent, selective, and reversible inhibitor of SGLT2.
Croatian: Ertugliflozin je potentan, selektivan i reverzibilan inhibitor SGLT2.
English: Renal clearance is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination.
Croatian: Bubrežni klirens približno je 3,5 puta veći nego klirens kreatinina, što ukazuje na to da je glavni put eliminacije metformina tubularna sekrecija.
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 (e.g., megaloblastic anaemia).
Croatian: Dugoročno liječenje metforminom povezano je sa smanjenjem apsorpcije vitamina B12, što vrlo rijetko može dovesti do klinički značajne deficijencije vitamina B12 (npr. megaloblastične anemije).
English: • Take one tablet twice daily.
Croatian: • Uzmite jednu tabletu dvaput na dan.
English: Since human kidney maturation occurs in utero and during the first 2 years of life when exposure from breast-feeding may occur, a risk to newborns/infants cannot be excluded.
Croatian: Budući da ljudski bubrezi sazrijevaju in utero i tijekom prve dvije godine života, kada može doći do izlaganja lijeku dojenjem, ne može se isključiti rizik za novorođenčad/dojenčad.
English: Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see section 4.4).
Croatian: Laktacidoza je prijavljena u približno 32% slučajeva predoziranja metforminom (vidjeti dio 4.4).
English: If needed, dose adjustment of metformin may be considered as OCT inhibitors/inducers may alter the efficacy of metformin.
Croatian: Ako je potrebno, može se razmotriti prilagodba doze metformina jer inhibitori/induktori OCT-a mogu izmijeniti djelotvornost metformina.
English: What you need to know before you take Segluromet
Croatian: Što morate znati prije nego počnete uzimati Segluromet
English: Repeat-dose oral toxicity studies were conducted in mice, rats, and dogs for up to 13, 26, and 39 weeks, respectively.
Croatian: Ispitivanja toksičnosti ponovljenih peroralnih doza provedena su u miševa, štakora i pasa, a trajala su do 13, 26 odnosno 39 tjedana.
English: • if you are allergic to ertugliflozin or metformin or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na ertugliflozin, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.),
English: Your doctor will decide when you must stop and when to restart your treatment with Segluromet.
Croatian: Liječnik će odlučiti kada morate prekinuti i kada možete nastaviti liječenje lijekom Segluromet.
English: Combinations requiring precautions for use
Croatian: Kombinacije kod kojih je potreban oprez pri primjeni
English: Segluromet should be taken orally twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Croatian: Segluromet treba uzimati peroralno dvaput na dan s hranom kako bi se smanjile gastrointestinalne nuspojave povezane s metforminom.
English: The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Croatian: Poželjno je podijeliti maksimalnu dnevnu dozu metformina na 2 - 3 dnevne doze.
English: Contact your doctor as soon as possible if you notice the following side effects:
Croatian: Obratite se svom liječniku što je prije moguće ako primijetite bilo koju od sljedećih nuspojava:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Segluromet 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 Segluromet u svim podskupinama pedijatrijske populacije u liječenju dijabetesa tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: This can lead to serious medical problems, like heart disease, kidney disease, blindness and poor circulation.
Croatian: To može dovesti do ozbiljnih zdravstvenih tegoba kao što su bolest srca, bolest bubrega, sljepoća i loša cirkulacija.
English: These data reflect exposure of 1,029 patients to ertugliflozin with a mean exposure duration of approximately 25 weeks.
Croatian: Ti podaci odražavaju izloženost 1029 bolesnika ertugliflozinu, uz srednju vrijednost trajanja izloženosti od približno 25 tjedana.
English: Therefore, haemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdose is suspected.
Croatian: Dakle, hemodijaliza može biti korisna za uklanjanje akumuliranog lijeka u bolesnika u kojih se sumnja na predoziranje metforminom.
English: Hypotension/Volume depletion
Croatian: Hipotenzija/deplecija volumena
English: Ketoacidosis is a condition in which substances called ‘ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma.
Croatian: Ketoacidoza je stanje u kojem se tvari koje se nazivaju „ketonska tijela“ nakupljaju u krvi i mogu dovesti do dijabetičke pretkome.
English: p< 0.001 compared to control group.
Croatian: p < 0,001 u odnosu na kontrolnu skupinu.
English: There were no clinically meaningful differences in the ertugliflozin Cmax values among the different renal function groups.
Croatian: Nije bilo klinički značajnih razlika u vrijednostima Cmax ertugliflozina između skupina s različitim stupnjevima funkcije bubrega.
English: Contact a doctor or the nearest hospital straight away if you have any of the following serious side effects:
Croatian: Odmah se javite liječniku ili otiđite u najbližu bolnicu ako imate bilo koju od sljedećih ozbiljnih nuspojava:
English: Based on a population pharmacokinetic analysis, age, body weight, gender, and race do not have a clinically meaningful effect on the pharmacokinetics of ertugliflozin.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, dob, tjelesna težina, spol i rasa nemaju klinički značajnog učinka na farmakokinetiku ertugliflozina.
English: , Haemoglobin increased ß,1
Croatian: , povišene vrijednosti hemoglobina ß,1
English: • Metformin works by inhibiting sugar (glucose) production in the liver.
Croatian: • Metformin djeluje tako da sprječava proizvodnju šećera (glukoze) u jetri.
English: If you need to have major surgery you must stop taking Segluromet during and for some time after the procedure.
Croatian: Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati Segluromet tijekom zahvata i još neko vrijeme nakon zahvata.
English: The most commonly reported adverse reactions across the clinical program were vulvovaginal mycotic infection, and other female genital mycotic infections.
Croatian: Najčešće prijavljene nuspojave u cjelokupnom programu kliničkih ispitivanja bile su vulvovaginalna gljivična infekcija i druge genitalne gljivične infekcije u žena.
English: There is no information regarding the presence of ertugliflozin in human milk, the effects on the breast-fed infant, or the effects on milk production.
Croatian: Nema informacija o prisutnosti ertugliflozina u majčinom mlijeku, učincima na dojenče ni učincima na proizvodnju mlijeka.
English: Treatment with Segluromet may be restarted when the ketone values are normal and the patient's condition has stabilised.
Croatian: Liječenje lijekom Segluromet može se ponovno započeti kada se razine ketona vrate u normalu i stanje bolesnika stabilizira.
English: The mean daily dose of glimepiride was 3.0 mg (see Table 5).
Croatian: Srednja vrijednost dnevne doze glimepirida iznosila je 3,0 mg (vidjeti Tablicu 5).
English: In patients where DKA is suspected or diagnosed, treatment with Segluromet should be discontinued immediately.
Croatian: U bolesnika u kojih se posumnja na DKA ili se DKA dijagnosticira, liječenje lijekom Segluromet potrebno je odmah prekinuti.
English: Segluromet must be discontinued at the time of surgery under general, spinal, or epidural anaesthesia.
Croatian: Primjena lijeka Segluromet mora se prekinuti u vrijeme kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: It is not known if DKA is more likely to occur with higher doses of ertugliflozin.
Croatian: Nije poznato je li vjerojatnost nastupa DKA veća kod primjene viših doza ertugliflozina.
English: A serious soft tissue infection of the genitals or the area between the genitals and the anus (see section “Warnings and precautions” for symptoms).
Croatian: Ozbiljna infekcija mekog tkiva genitalija ili područja između genitalija i anusa (za simptome, pogledajte dio „Upozorenja i mjere opreza”).
English: Ertugliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters.
Croatian: Ertugliflozin je supstrat prijenosnika P-glikoproteina (P-gp) i proteina rezistencije raka dojke (engl. breast cancer resistance protein, BCRP).
English: • hepatitis (a liver problem)
Croatian: • hepatitis (tegobe s jetrom)
English: Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours.
Croatian: Nakon peroralne primjene približno 90% apsorbirane doze eliminira se putem bubrega unutar prva 24 sata, uz poluvrijeme eliminacije iz plazme od približno 6,2 sata.
English: The recommended dose is one tablet twice daily.
Croatian: Preporučena doza je jedna tableta dvaput na dan.