FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Segluromet (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system and problems with the gut such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.
Croatian: Najčešće nuspojave lijeka Segluromet (koje se mogu pojaviti u više od 1 na 10 bolesnika) jesu gljivične infekcije vagine i druge infekcije ženskog reproduktivnog sustava te problemi s probavom kao što su mučnina, povraćanje, proljev, bolovi u trbuhu i gubitak apetita.
English: What measures are being taken to ensure the safe and effective use of Segluromet?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Segluromet?
English: Other information about Segluromet
Croatian: Ostale informacije o lijeku Segluromet
English: As for all medicines, data on the use of Segluromet is continuously monitored.
Croatian: Kao i za sve lijekove, podaci o uporabi lijeka Segluromet stalno se prate.
English: Why is Segluromet authorised in the EU?
Croatian: Zašto je Segluromet odobren u EU-u?
English: A lower dose of ertugliflozin 5 mg was less effective.
Croatian: Manja doza ertugliflozina (5 mg) bila je manje djelotvorna.
English: What is Segluromet and what is it used for?
Croatian: Što je Segluromet i za što se koristi?
English: It must also not be used in patients with severe kidney problems or certain heart, circulatory, breathing or liver problems and in patients who drink alcohol to excess.
Croatian: Ne smije se koristiti ni u bolesnika s ozbiljnim problemima s bubrezima ili određenim problemima sa srcem, cirkulacijom, disanjem ili jetrom te u bolesnika koji prekomjerno uživaju u alkoholu.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Segluromet have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Segluromet nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: • patients who are already taking ertugliflozin and metformin as separate tablets.
Croatian: • bolesnika koji već uzimaju ertugliflozin i metformin kao zasebne tablete.
English: The studies looked mainly at effects on levels of HbA1c (a measure of blood glucose) after 6 months or one year of treatment.
Croatian: U ispitivanjima su se uglavnom ispitivali učinci na razine HbA1c (mjera glukoze u krvi) 6 mjeseci ili jednu godinu nakon liječenja.
English: The result is a high level of glucose in the blood.
Croatian: To dovodi do visoke razine glukoze u krvi.
English: It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.
Croatian: To radi blokiranjem proteina u bubrezima (pod nazivom SGLT2) koji obično glukozu iz bubrega vraća u krv.
English: Segluromet can also help some patients lose weight.
Croatian: Segluromet može pomoći i u gubitku tjelesne težine.
English: An overview of Segluromet and why it is authorised in the EU
Croatian: Pregled lijeka Segluromet i zašto je odobren u EU-u
English: The dose of Segluromet may be reduced or it may be stopped if the kidneys are not working well enough.
Croatian: Doza lijeka Segluromet može se smanjiti ili se primjena lijeka može prekinuti ako bubrezi ne funkcioniraju dovoljno dobro.
English: Segluromet can only be obtained with a prescription.
Croatian: Segluromet se izdaje samo na liječnički recept.
English: Four main studies in over 3,600 patients with type 2 diabetes have shown that adding ertugliflozin to metformin helps lower glucose levels when metformin is not working well enough.
Croatian: Četiri glavna ispitivanja u kojima je sudjelovalo više od 3 600 osoba koje boluju od dijabetesa tipa 2 pokazala su da dodavanje ertugliflozina metforminu pomaže smanjiti razinu glukoze kada metformin ne djeluje dovoljno dobro.
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Croatian: Dijabetes tipa 2 bolest je pri kojoj tijelo ne proizvodi dovoljno inzulina za kontrolu razine glukoze u krvi ili pri kojoj se tijelo ne može učinkovito koristiti inzulinom.
English: The strength of Segluromet tablet to use depends on how well the patient's glucose levels are controlled.
Croatian: Odluka o jačini tablete Segluromet koju treba primjenjivati ovisi o tome koliko je dobro kontrolirana razina glukoze u bolesnika.
English: What are the risks associated with Segluromet?
Croatian: Koji su rizici povezani s lijekom Segluromet?
English: Segluromet is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes.
Croatian: Segluromet je lijek koji se koristi za kontroliranje razine glukoze (šećera) u krvi u odraslih osoba koje boluju od dijabetesa tipa
English: Side effects reported with Segluromet are carefully evaluated and any necessary action taken to protect patients.
Croatian: Zabilježene nuspojave lijeka Segluromet pažljivo se procjenjuju te se poduzimaju sve potrebne mjere opreza za zaštitu bolesnika.
English: HbA1c levels fell by a further 0.5 points when both medicines were added to metformin.
Croatian: Razina HbA1c smanjila se za dodatnih 0,5 bodova kada su oba lijeka dodana metforminu.
English: For more information about using Segluromet, see the package leaflet or contact your doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Segluromet pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Segluromet must not be used in patients with uncontrolled diabetes with severe symptoms that lead to high acid levels in the blood.
Croatian: Segluromet se ne smije primjenjivati u bolesnika s nekontroliranim dijabetesom i ozbiljnim simptomima koji uzrokuju povišene razine kiseline u krvi.
English: Metformin, on the other hand, works mainly by blocking glucose production in the body and by reducing the absorption of glucose in the gut.
Croatian: Međutim, metformin djeluje uglavnom blokiranjem proizvodnje glukoze u tijelu i smanjenjem apsorpcije glukoze u crijevima.
English: Steglatro is not as effective in patients with moderate kidney impairment and should therefore not be started in such patients.
Croatian: Segluromet nije jednako učinkovit u bolesnika s umjerenim oštećenjem bubrega te se stoga ne smije primjenjivati u takvih bolesnika.
English: • A second study found that adding ertugliflozin to a combination of sitagliptin (another diabetes medicine) and metformin was more effective than placebo.
Croatian: • U drugom je ispitivanju utvrđeno da je dodavanje ertugliflozina kombinaciji sitagliptina (drugi lijek protiv dijabetesa) i metformina bilo djelotvornije od placeba.
English: How is Segluromet used?
Croatian: Kako se Segluromet koristi?
English: Studies showed that Segluromet can help lower glucose levels in patients whose metformin treatment is not working well enough, including those taking another diabetes medicine in addition to metformin.
Croatian: Ispitivanja pokazuju da Segluromet može pomoći u smanjivanju razine glukoze u krvi bolesnika koji ne reagiraju dovoljno dobro na liječenje metforminom, uključujuću one koji uzimaju drugi antidijabetik uz metformin.
English: At the start of the studies, patients' HbA1c was above 7 percentage points.
Croatian: Na početku ispitivanja HbA1c bolesnika bio je veći od 7 postotnih bodova.
English: The two active substances in Segluromet, ertugliflozin and metformin, work in different ways to lower glucose levels.
Croatian: Dvije djelatne tvari lijeka Segluromet, ertugliflozin i metformin, djeluju na različite načine da bi smanjile razinu glukoze u krvi.
English: Ertugliflozin helps to lower blood glucose by making the patient pass out glucose in the urine.
Croatian: Ertugliflozin pomaže smanjiti razinu glukoze u krvi izlučivanjem glukoze kroz mokraću bolesnika.
English: • The first study found that in patients taking a combination of ertugliflozin and metformin, HbA1c levels fell by around 0.8 points, compared with reductions of 0.03 when placebo (a dummy treatment) was added to metformin.
Croatian: • U prvom je ispitivanju utvrđeno da su se razine HbA1c u bolesnika koji su uzimali kombinaciju ertugliflozina i metformina smanjile za približno 0,8 bodova u usporedbi sa smanjenjem od 0,03 boda u bolesnika koji su uzimali placebo (prividno liječenje) u kombinaciji s metforminom.
English: HbA1c levels fell by between 0.8 and 0.9 percentage points when ertugliflozin was added, compared with a fall of 0.1 with placebo
Croatian: Razine HbA1c smanjile su se za 0,8 do 0,9 posto nakon dodavanja ertugliflozina u odnosu na smanjenje od 0,1 posto koje je uslijedilo nakon dodavanja placeba
English: In this study, HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride.
Croatian: U tom se ispitivanju razina HbA1c smanjila za 0,6 bodova nakon primjene ertugliflozina te za 0,7 bodova nakon primjene glimepirida.
English: • The fourth study found that, in patients taking metformin, adding ertugliflozin was as effective as adding sitagliptin with HbA1c levels falling by around 1 point with both treatments.
Croatian: • U četvrtom ispitivanju utvrđeno je da je dodavanje ertugliflozina u bolesnika koji su uzimali metformin bilo jednako djelotvorno kao dodavanje sitagliptina jer se razina HbA1c smanjila za približno 1 bod u oba liječenja.
English: • A third study found that a combination of ertugliflozin at a 15 mg dose with metformin was about as effective as a combination of metformin with another diabetes medicine, glimepiride.
Croatian: • U trećem je ispitivanju utvrđeno da je kombinacija 15 mg ertugliflozina i metformina bila otprilike jednako djelotvorna kao i kombinacija metformina i glimepirida, drugog lijeka protiv dijabetesa.
English: What benefits of Segluromet have been shown in studies?
Croatian: Koje su koristi lijeka Segluromet utvrđene u ispitivanjima?
English: • patients whose glucose levels are not well controlled with the highest dose of metformin they can take
Croatian: • bolesnika s razinom glukoze u krvi koja se ne može kontrolirati na odgovarajući način primjenom najveće doze metformina
English: • patients on the highest dose of metformin they can take who are also taking another diabetes medicine
Croatian: • bolesnika koji primjenjuju najveću moguću dozu metformina te još jedan lijek protiv dijabetesa
English: How does Segluromet work?
Croatian: Kako djeluje Segluromet?
English: For the full list of side effects of Segluromet, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Segluromet potražite u uputi o lijeku.
English: Finally, in addition to lowering glucose levels, studies showed that adding ertugliflozin to metformin helped patients reduce bodyweight.
Croatian: Konačno, ispitivanja su pokazala da dodavanje ertugliflozina metforminu ne samo da smanjuje razinu glukozu u krvi, nego i pomaže bolesnicima da izgube tjelesnu težinu.
English: What is Uptravi and what is it used for?
Croatian: Što je Uptravi i za što se koristi?
English: The full EPAR for Uptravi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Uptravi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Overall, 24.4% (140 out of 574) of patients treated with Uptravi either died or showed signs of worsening disease compared with 36.4% (212 out of 582) of patients treated with placebo.
Croatian: Sveukupno je 24,4 % (140 od 574) bolesnika liječenih lijekom Uptravi preminulo ili razvilo simptome pogoršanja bolesti u usporedbi s 36,4 % (212 od 582) bolesnika liječenih placebom.
English: Uptravi is available as tablets (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms).
Croatian: Uptravi je dostupan u obliku tableta (od 200, 400, 600, 800, 1000, 1200, 1400 i 1600 mikrograma).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Uptravi on 12 May 2016.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Uptravi na snazi u Europskoj uniji od 12. svibnja 2016.
English: What measures are being taken to ensure the safe and effective use of Uptravi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Uptravi?
English: The main measure of effectiveness was based on the number of patients whose disease worsened or who died during treatment or shortly after treatment had ended.
Croatian: Glavno mjerilo djelotvornosti temeljilo se na broju bolesnika čija se bolest pogoršala ili onih koji su preminuli tijekom ili ubrzo nakon okončanja terapije.
English: This summary was last updated in 06-2017.
Croatian: Sažetak je posljednji put ažuriran u 06. 2017.
English: Uptravi selexipag
Croatian: Uptravi seleksipag
English: Patients may tolerate treatment better if they take their tablets with food and take the first tablet of an increased dose in the evening rather than the morning.
Croatian: Bolesnici mogu bolje podnositi liječenje ako tablete uzimaju s hranom te ako prvu povećanu dozu uzmu navečer, a ne ujutro.
English: The ‘class' reflects the severity of the disease: ‘class II' involves slight limitation of physical activity while ‘class III' involves marked limitation of physical activity.
Croatian: „Stupanj” se odnosi na težinu bolesti: „stupanj II” uključuje blago ograničenje fizičke aktivnosti, a „stupanj III” veća ograničenja fizičke aktivnosti.
English: If the patient cannot tolerate an increased dose, the doctor may have to reduce it.
Croatian: Ako bolesnik ne podnosi povećanu dozu, liječnik će je možda morati smanjiti.
English: Why is Uptravi approved?
Croatian: Zašto je lijek Uptravi odobren?
English: What are the risks associated with Uptravi?
Croatian: Koji su rizici povezani s lijekom Uptravi?
English: Compared with other medicines in the same class which are given into a vein, Uptravi has the advantage of being given by mouth.
Croatian: U usporedbi s drugim lijekovima u istom razredu koji se daju u venu, Uptravi ima prednost jer se uzima na usta.
English: Although the CHMP noted a small apparent increase in the rate of death for patients taking Uptravi when compared with placebo, they considered that this was due to chance or to the way the study was designed and therefore did not impact the benefits or risks of the medicine.
Croatian: Iako je CHMP zabilježio niži vidljiv porast stope smrtnosti bolesnika koji su uzimali Uptravi u usporedbi s placebom, smatrao je da se radi o slučajnosti ili o načinu na koji je ispitivanje osmišljeno, te da stoga nije utjecao na koristi i rizike od lijeka.
English: This is a summary of the European public assessment report (EPAR) for Uptravi.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Uptravi.
English: Patients with PAH currently have very limited treatment options; therefore there is a high unmet medical need.
Croatian: Bolesnici s PAH-om trenutačno imaju vrlo ograničene mogućnosti liječenja i stoga brojne medicinske potrebe nisu zadovoljene.
English: These effects are mild or moderate and are most frequently seen while the dose of Uptravi is being increased.
Croatian: Te su nuspojave blage ili umjerene i najčešće se javljaju pri povećanju doze lijeka Uptravi.
English: Treatment should be started at a dose of 200 micrograms twice a day, approximately 12 hours apart.
Croatian: Liječenje treba započeti dozom od 200 mikrograma dvaput dnevno s razmakom od otprilike 12 sati.
English: The benefits of Uptravi for PAH were shown in one main study involving 1,156 patients with PAH.
Croatian: Koristi od lijeka Uptravi za liječenje PAH-a utvrđene su u jednom glavnom ispitivanju na 1156 bolesnika s PAH-om.
English: Other information about Uptravi
Croatian: Ostale informacije o lijeku Uptravi
English: The company will provide educational materials for the healthcare professionals who will prescribe and dispense the medicine to help them prescribe the medicine correctly and avoid medication errors.
Croatian: Tvrtka će dostaviti materijale za obuku zdravstvenim radnicima koji će propisivati i izdavati lijek kao pomoć pri pravilnom propisivanju lijeka te za izbjegavanje medikacijskih pogrešaka.
English: If stopping treatment with Uptravi, the dose should be reduced gradually.
Croatian: Ako se prekida terapija lijekom Uptravi, doza se mora postepeno smanjivati.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Uptravi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Uptravi nadmašuju s njime povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: It is not intended to provide practical advice on how to use Uptravi.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Uptravi.
English: For patients with other heart problems, Uptravi must only be used under close medical supervision.
Croatian: U bolesnika s drugim srčanim problemima lijek Uptravi smije se koristiti samo pod izravnim liječničkim nadzorom.
English: The diary contains boxes for the patient to mark the number and strength of tablets they take each day.
Croatian: Dnevnik sadrži rubrike u koje bolesnici trebaju unijeti broj i jačinu tableta koje svakodnevno uzimaju.
English: The dose is then increased weekly, as long as it is tolerated, to a maximum of 1,600 micrograms twice daily, which is then continued afterwards.
Croatian: Doza se zatim povećava svakog tjedna dok god je bolesnik podnosi do maksimalne doze od 1600 mikrograma dva puta dnevno s kojim se potom nastavlja terapija.
English: Uptravi can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Croatian: Uptravi se izdaje samo na recept, a terapiju mora započeti i pratiti samo liječnik s iskustvom u liječenju PAH-a.
English: Uptravi must not be taken at the same time as medicines, such as gemfibrozil, that are strong blockers (inhibitors) of the liver enzyme CYP2C8.
Croatian: Uptravi se ne smije uzimati istovremeno s lijekovima poput gemfibrozila, koji su snaži blokatori (inhibitori) jetrenog enzima CYP2C8.
English: Patients were given either Uptravi or placebo (a dummy treatment) for around 70 weeks.
Croatian: Bolesnici su primali ili lijek Uptravi ili placebo (prividno liječenje) tijekom 70-tak tjedana.
English: The most common side effects with Uptravi (which may affect more than 1 in 10 people) are headache, diarrhoea, nausea and vomiting, jaw pain, myalgia (muscle pain), pain in the limbs, arthralgia (joint pain) and flushing.
Croatian: Najčešće nuspojave lijeka Uptravi (koje se mogu javiti u više od 1 na 10 osoba) su glavobolja, proljev, mučnina i povraćanje, bol u vilici, mijalgija (bol u mišićima), bol u udovima, artralgija (bol u zglobovima) i navala crvenila.
English: It can be used in combination with other medicines called endothelin receptor antagonists (ERA) or phosphodiesterase type-5 (PDE-5) inhibitors or on its own for patients for whom these medicines are not suitable.
Croatian: Može se koristiti u kombinaciji s drugim lijekovima naziva antagonisti endotelinskih receptora (ERA) ili inhibitori fosfodiesteraze tipa 5 (PDE-5) ili kao monoterapija u bolesnika za koje ti lijekovi nisu prikladni.
English: It must also not be used in patients who have had a stroke within the last 3 months.
Croatian: Ne smije se koristiti u bolesnika koji su preboljeli moždani udar unutar prethodna tri mjeseca.
English: Uptravi is used in patients with functional class II or III PAH.
Croatian: Uptravi se koristi u bolesnika s funkcijskim stupnjem II ili III PAH-a.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Uptravi have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Uptravi nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The active substance in Uptravi, selexipag, is a ‘prostacyclin receptor agonist'.
Croatian: Djelatna tvar lijeka seleksipag, je „agonist receptora prostaciklina”.
English: Uptravi contains the active substance selexipag.
Croatian: Uptravi sadrži djelatnu tvar seleksipag.
English: Regarding safety, the side effects with Uptravi are considered acceptable.
Croatian: U pogledu sigurnosti, smatra su nuspojave lijeka Uptravi prihvatljive.
English: Patients with moderately reduced liver function should start with 200 micrograms once daily.
Croatian: Bolesnici s umjereno oslabljenom funkcijom jetre terapiju trebaju započeti dozom od 200 mikrograma jednom dnevno.
English: Any prescriber of Uptravi will have to register first with the company that markets Uptravi before being able to prescribe it.
Croatian: Osobe koje propisuju lijek Uptravi morat će se prvo registrirati pri tvrtki koja ga stavlja u promet prije njegova propisivanja.
English: Uptravi is a medicine used to treat adults with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Croatian: Uptravi je lijek koji se primjenjuje u liječenju odraslih osoba od plućne arterijske hipertenzije (PAHabnormalno visok krvni tlak u plućnim arterijama).
English: Patients with severely reduced liver function should not take Uptravi.
Croatian: Bolesnici sa znatno oslabljenom funkcijom jetre ne smiju uzimati lijek Uptravi.
English: This means that it works in a similar way to prostacyclin, a naturally occurring substance that regulates blood pressure by attaching to receptors in the muscles of blood vessel walls, causing the vessels to relax and widen.
Croatian: To znači da djeluje na sličan način kao prostaciklin, prirodna tvar koja regulira krvni tlak vezivanjem na receptore u mišićima na stijenkama krvnih žila, što uzrokuje opuštanje i širenje krvnih žila.
English: Uptravi must not be used in patients who have had a heart attack within the last 6 months, severe coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle) or unstable angina (a severe type of chest pain).
Croatian: Uptravi se ne smije primjenjivati u bolesnika koji su preboljeli srčani udar unutar zadnjih šest mjeseci, onima s teškom koronarnom bolešću srca (bolest srca u kojoj su začepljene žile koje srčani mišić opskrbljuju krvlju) ili s nestabilnom anginom (teškim oblikom boli u prsima).
English: It must not be used in patients with severe arrhythmias (unstable heartbeat) or defects in the heart valves.
Croatian: Ne smije se primjenjivati u bolesnika s ozbiljnim aritmijama (nestabilnim pulsom) ili s oštećenjima srčanih zalisaka.
English: By attaching to prostacyclin receptors, Uptravi also widens the blood vessels and so lowers the pressure inside them, improving symptoms of the disease.
Croatian: Vezivanjem na receptore prostaciklina, Uptravi također širi krvne žile čime se u njima snižava tlak, što ublažava simptome bolesti.
English: What benefits of Uptravi have been shown in studies?
Croatian: Koje su koristi od lijeka Uptravi utvrđene u ispitivanjima?
English: For practical information about using Uptravi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Uptravi bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: These materials will also include a guide and diary to be given to patients to help them keep track of the number of tablets to take and explain how doses should be increased.
Croatian: Ti će materijali također sadržavati vodič i dnevnik koji se daje bolesnicima za vođenje evidencije o dozama lijeka koje moraju uzimati te s informacijama o načinu povećanja doza.