FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients tolerating empagliflozin whose eGFR is persistently below 60 ml/min/1.73 m2 or CrCl <60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily.
Croatian: U bolesnika koji podnose empagliflozin i čiji je eGFR perzistentno ispod 60 ml/min/1,73 m ili klirens kreatinina <60 ml/min, potrebno je prilagoditi ili zadržati dozu empagliflozina na 10 mg jedanput dnevno.
English: Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by coadministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Croatian: Ispitivanja interakcija sugeriraju da istodobna primjena s metforminom, glimepiridom, pioglitazonom, sitagliptinom, linagliptinom, varfarinom, verapamilom, ramiprilom, simvastatinom, torasemidom i hidroklorotiazidom nije utjecala na farmakokinetiku empagliflozina.
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%
Croatian: Bolesnici (%) s postignutim HbA1c <7% s početnom vrijednošću HbA1c ≥7%
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg tablets Empagliflozin
Croatian: NAZIV LIJEKA Jardiance 10 mg tablete empagliflozin
English: NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg tablets Empagliflozin
Croatian: NAZIV LIJEKA Jardiance 25 mg tablete empagliflozin
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% at week 52
Croatian: Bolesnici (%) s postignutim HbA1c <7% s početnom vrijednošću HbA1c ≥7% u 52. tjednu
English: It is important to stay on the diet and exercise program recommended by your doctor while taking Jardiance.
Croatian: Važno je, tijekom uzimanja lijeka Jardiance, pridržavati se dijete i provoditi tjelovježbu prema preporuci Vašeg liječnika.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of empagliflozin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 10 mg empagliflozina.
English: Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Croatian: Promjena od početne vrijednosti Razlika od placeba (97,5% CI)
English: Empagliflozin should not be initiated in patients with an eGFR <60 ml/min/1.73 m2 or
Croatian: Terapija empagliflozinom ne smije se započeti u bolesnika s eGFR<60 ml/min/1,73 m2 ili klirensom kreatinina <60 ml/min.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg of empagliflozin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 25 mg empagliflozina.
English: Your doctor may want to lower the dose of these other medicines,
Croatian: - Vaš liječnik može zatražiti da uzimate drugi lijek.
English: Renal impairment Jardiance should not be initiated in patients with an eGFR below 60 ml/min/1.73 m2 or
Croatian: Oštećenje bubrežne funkcije Terapija lijekom Jardiance ne smije se započeti u bolesnika s eGFR ispod 60 ml/min/1,73 m2 ili klirensom kreatinina <60 ml/min.
English: 45-60 ml/min/1.73 m2 and 7.7% of 30-45 ml/min/1.73 m
Croatian: 45 ml/min./1,73 m
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Mean adjusted for baseline value Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure LOCF, values after antihypertensive rescue censored * p-value <0.0001
Croatian: LOCF) prije primjene pomoćne terapije za postizanje zadovoljavajuće glikemije (engl. glycaemic rescue) Srednja vrijednost prilagođena za početnu vrijednost Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde * p<0,0001
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Mean adjusted for baseline value Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure * p<0.0001
Croatian: Last observation carried forward, LOCF) prije primjene pomoćne terapije za postizanje zadovoljavajuće glikemije (engl. glycaemic rescue) Srednja vrijednost prilagođena za početnu vrijednost Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Croatian: Promjena od početne vrijednosti Razlika od placeba (95% CI)
English: HbA1c (%) Baseline (mean) Change from baseline Comparison vs. empa (95% CI)
Croatian: Promjena od početne vrijednosti Usporedba naspram empa (95% CI)
English: Body Weight (kg) Baseline (mean) Change from baseline
Croatian: Tjelesna težina (kg) Početna vrijednost (srednja vrijednost)
English: Fertility
Croatian: Dizurija
English: What Jardiance contains - The active substance is empagliflozin.
Croatian: Kako Jardiance izgleda i sadržaj pakiranja
English: Table 9: Results at 24 week in a placebo-controlled study of empagliflozin in renally impaired type 2 diabetes patients
Croatian: Rezultati u 24. tjednu u placebom kontroliranom ispitivanju empagliflozina u bolesnika s oštećenjem bubrežne funkcije i šećernom bolešću tipa 2 Placebo Empagliflozin 10 mg
English: HbA1c (%) at week 78 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Croatian: HbA1c (%) u 78. Tjednu Početna vrijednost (srednja vrijednost)
English: HbA1c (%) at week 18 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Croatian: HbA1c (%) u 18. Tjednu Početna vrijednost (srednja vrijednost)
English: 5 ml (80 microgram/ml)
Croatian: 5 ml (80 mikrogram/ml)
English: EU/1/10/643/001
Croatian: EU/1/10/643/001 Rapiscan mikrograma
English: Annex I List of medicinal products and presentations
Croatian: Prilog I Popis naziva i farmaceutskih oblika
English: Astellas Pharma Co. Ltd
Croatian: Astellas Pharma Co.
English: DicloFlex 4% uz ādas izsmidzināms aerosols, šķīdums
Croatian: DicloFlex 4% uz âdas izsmidzinâms aerosols, đíîdums
English: This overview was last updated in 02-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 02.2019.
English: Further information on Volibris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/volibris.
Croatian: Više informacija o lijeku Volibris nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/volibris
English: The main measure of effectiveness was the proportion of patients who died or whose disease got worse.
Croatian: Glavno mjerilo djelotvornosti bio je udio bolesnika koji su umrli ili čija se bolest pogoršala.
English: Volibris is available as tablets (5 and 10 mg).
Croatian: Volibris je dostupan u obliku tableta (5 i 10 mg).
English: Because it might be able to cause birth defects, Volibris must not be used in pregnant women or in women who could become pregnant unless they are using reliable contraception.
Croatian: Budući da bi mogao izazvati oštećenja ploda, Volibris se ne smije primjenjivati u trudnica ili žena koje bi mogle zatrudnjeti, osim ako ne upotrebljavaju pouzdanu kontracepciju.
English: The main measure of effectiveness was the change in the distance the patients could walk in 6 minutes after 12 weeks of treatment.
Croatian: Glavno mjerilo djelotvornosti bila je promjena udaljenosti koju je bolesnik mogao prehodati u roku od šest minuta nakon 12 tjedana liječenja.
English: Results showed that Volibris was more effective than placebo at improving exercise capacity (the ability to carry out physical activity).
Croatian: Rezultati su pokazali da je Volibris bio učinkovitiji od placeba u poboljšavanju fizičke kondicije za tjelovježbu (sposobnosti bavljenja fizičkom aktivnošću).
English: Overall, in the two studies taken together, the patients could walk an average of around 345 m in 6 minutes at the start of the study.
Croatian: Sveukupno, u dva istovremeno provedena ispitivanja bolesnici su mogli prehodati u prosjeku oko 345 m tijekom šest minuta na početku ispitivanja.
English: When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Volibris should be 5 mg a day and the patient should be closely monitored by their doctor.
Croatian: Kada se primjenjuje s ciklosporinom (lijekom koji smanjuje aktivnost imunosnog sustava), doza lijeka Volibris trebala bi biti 5 mg dnevno, a bolesnika bi pozorno trebao nadzirati njegov liječnik.
English: What measures are being taken to ensure the safe and effective use of Volibris?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Volibris?
English: The increased dose of 10 mg is recommended when the medicine is used with tadalafil (another medicine for PAH).
Croatian: Povećana doza od 10 mg preporučuje se kada se lijek primjenjuje s tadalafilom (drugim lijekom protiv PAH-a).
English: The company that markets Volibris will provide a patient card containing important information on the medicine's side effects and the need to avoid pregnancy during treatment.
Croatian: Tvrtka koja lijek Volibris stavlja u promet osigurat će karticu za bolesnike s važnim informacijama o nuspojavama lijeka i o potrebi izbjegavanja trudnoće tijekom terapije.
English: Other information about Volibris
Croatian: Ostale informacije o lijeku Volibris
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Volibris 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 Volibris također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Patients with class III disease and those with PAH caused by connective tissue disease gained a greater benefit from the 10 mg dose than from the 5 mg dose.
Croatian: Bolesnici s klasom III bolesti i oni s PAH-om uzrokovanim bolešću vezivnog tkiva imali su veću korist od doze od 10 mg nego od doze od 5 mg.
English: Over a three-year period the likelihood of the disease getting worse was 32% with the combined treatment and 44% with a single medicine.
Croatian: U razdoblju od tri godine vjerojatnost za pogoršanje bolesti bila je 32 % s kombiniranim liječenjem i 44 % s monoterapijom.
English: It must not be used in patients with idiopathic pulmonary fibrosis (long-term disease in which hard fibrous tissue continuously forms in the lungs), with or without secondary pulmonary hypertension (high blood pressure in the lungs).
Croatian: Ne smije se primjenjivati u bolesnika s idiopatskom plućnom fibrozom (dugoročnom bolešću u kojoj se u plućima neprestano stvara tvrdo vlaknasto tkivo),ili sa sekundarnom plućnom hipertenzijom (visokim krvnim tlakom u plućima) ili bez nje.
English: What is Volibris and what is it used for?
Croatian: Što je Volibris i za što se primjenjuje?
English: As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult.
Croatian: Posljedica je toga smanjena količina kisika koja može ući u krv u plućima, što otežava fizičku aktivnost.
English: An overview of Volibris and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Volibris i zašto je odobren u EU-u
English: As for all medicines, data on the use of Volibris are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Volibris kontinuirano se prate.
English: Volibris received a marketing authorisation valid throughout the EU on 21 April 2008.
Croatian: Volibris je dobio odobrenje za stavljanje u promet koje je na snazi na prostoru EU-a od 21. travnja
English: Results showed that 18% of patients (46 out of 253) given combination treatment died or their disease got worse compared with 31% (77 out of 247) given either Volibris or tadalafil alone.
Croatian: Rezultati su pokazali da je 18 % bolesnika (46 od 253) koji su primili kombinaciju lijekova umrlo ili im se bolest pogoršala u usporedbi s 31 % (77 od 247) bolesnika koji su primili Volibris ili tadalafil kao monoterapiju.
English: The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Croatian: Volibris se primjenjuje u bolesnika s klasom bolesti II ili III. „Klasa” se odnosi na težinu bolesti: „klasa II” uključuje blago ograničenje fizičke aktivnosti, a „klasa III” odnosi se na veća ograničenja fizičke aktivnosti.
English: The European Medicines Agency decided that Volibris' benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Volibris nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
English: Side effects reported with Volibris are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Volibris pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: After 12 weeks of treatment, patients taking 5 mg Volibris once a day could walk an average of 36 m more while patients taking placebo had got worse and could walk 9 m less.
Croatian: Nakon 12 tjedana terapije bolesnici koji su uzimali 5 mg lijeka Volibris jedanput dnevno mogli su u prosjeku prehodati 36 m više, dok su bolesnici koji su uzimali placebo bili lošije te su prehodali 9 m manje.
English: Volibris must not be used in people who are hypersensitive (allergic) to soya, ambrisentan or any of the other ingredients.
Croatian: Volibris se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na soju, ambrisentan ili bilo koji drugi sastojak lijeka.
English: Volibris is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).
Croatian: Volibris je lijek koji se primjenjuje kao monoterapija ili u kombinaciji s drugim lijekovima za liječenje odraslih koji boluju od plućne arterijske hipertenzije (PAH).
English: Various doses of Volibris (2.5, 5 and 10 mg) have been compared with placebo (a dummy treatment) in two main studies involving a total of 394 patients with PAH, most of whom had class II or III disease that was of unknown cause or caused by connective tissue disease.
Croatian: Različite doze lijeka Volibris (2,5; 5 i 10 mg) uspoređene su s placebom (prividnim liječenjem) u dvama glavnim ispitivanjima koja su uključivala ukupno 394 bolesnika s PAH-om, od kojih je većina imala klasu II ili klasu III bolesti čiji uzrok nije bio poznat ili je bila uzrokovana bolešću vezivnog tkiva.
English: Why is Volibris approved?
Croatian: Zašto je Volibris odobren?
English: It causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the flow of blood to the lungs.
Croatian: To uzrokuje visoki krvni tlak u žilama koje prenose krv iz srca u pluća te smanjuje dotok krvi u pluća.
English: By blocking the effect of endothelin, Volibris allows the vessels to expand, helping to lower the blood pressure and improving symptoms.
Croatian: Blokiranjem učinka endotelina Volibris omogućuje opuštanje (širenje) žila, što pomaže u snižavanju krvnog tlaka i poboljšanju simptoma.
English: What are the risks associated with Volibris?
Croatian: Koji su rizici povezani s lijekom Volibris?
English: The risk of the disease getting worse or the patient dying within a year was 11% in patients given the combination treatment and 24% in those given a single medicine (Volibris or tadalafil).
Croatian: Rizik od pogoršanja bolesti ili smrti unutar godine dana iznosio je 11 % u bolesnika koji su primili kombinaciju lijekova, a 24 % u bolesnika koji su primili samo jedan lijek (Volibris ili tadalafil).
English: Volibris contains the active substance ambrisentan.
Croatian: Volibris sadrži djelatnu tvar ambrisentan.
English: It must not be used in patients who are breastfeeding, who have severe liver problems or who have high levels of liver enzymes in the blood.
Croatian: Ne smije se primjenjivati u bolesnica koje su dojilje, bolesnika koji imaju ozbiljne probleme s jetrom ili visoke razine jetrenih enzima u krvi.
English: In addition, treatment with a combination of Volibris (10 mg) and tadalafil has been compared with either Volibris or tadalafil alone in another main study involving 605 patients with PAH.
Croatian: Nadalje, terapija kombinacijom lijeka Volibris (10 mg) i tadalafila uspoređena je s Volibrisom ili tadalafilom kao monoterapijom u drugom glavnom ispitivanju koje je obuhvaćalo 605 bolesnika s PAHom.
English: For more information about using Volibris, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Volibris pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The active substance in Volibris, ambrisentan, blocks the receptors for a hormone called endothelin, which causes blood vessels to become narrow.
Croatian: Djelatna tvar lijeka Volibris, ambrisentan, blokira receptore za hormon naziva endotelin, što uzrokuje sužavanje krvnih žila.
English: Volibris can only be obtained with a prescription and treatment must be started by a doctor who has experience in the treatment of PAH.
Croatian: Volibris se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju PAH-a.
English: Treatment is started at a dose of 5 mg once a day and the doctor may increase it to 10 mg daily depending on response and any side effects experienced by the patient.
Croatian: Terapiju lijekom Volibris započinje se dozom od 5 mg jedanput dnevno koju liječnik može povećati na 10 mg dnevno ovisno o reakciji bolesnika i nuspojavama koje bolesnik može razviti.
English: The most common side effects with Volibris (seen in more than 1 patient in 10) are headache (including sinus headache and migraine), peripheral oedema (swelling, especially of the ankles and feet) and fluid retention.
Croatian: Najčešće nuspojave lijeka Volibris (koje se mogu javiti u više od 1 na 10 bolesnika) jesu glavobolja (uključujući sinusnu glavobolju i migrenu), periferni edem (oticanje, najčešće gležnjeva i stopala) te zadržavanje tekućine.
English: Volibris has been shown to be effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Croatian: Volibris se pokazao učinkovitim za liječenje PAH-a bez utvrđenog uzroka te PAH-a uzrokovanog bolešću vezivnog tkiva.
English: What benefits of Volibris have been shown in studies?
Croatian: Koje su koristi od lijeka Volibris utvrđene u ispitivanjima?
English: How does Volibris work?
Croatian: Kako djeluje Volibris?
English: For the full list of side effects with Volibris, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Volibris potražite u uputi o lijeku.
English: How is Volibris used?
Croatian: Kako se Volibris primjenjuje?
English: The risk of such reactions decreases in subsequent infusions.
Croatian: Rizik od takvih reakcija smanjuje se tijekom sljedećih infuzija.
English: The full EPAR for Truxima can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/truxima.
Croatian: Cjeloviti EPAR za lijek Truxima nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/truxima.
English: Truxima received a marketing authorisation valid throughout the EU on 17 February 2017.
Croatian: Lijek Truxima dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 17. veljače 2017.
English: What is Truxima and what is it used for?
Croatian: Što je Truxima i za što se koristi?
English: Truxima (rituximab)
Croatian: Truxima (rituksimab)
English: Depending on the condition being treated, patients may also receive other medicines as well.
Croatian: Ovisno o bolesti koja se liječi, bolesnici mogu primiti i druge lijekove.
English: It must also not be used in patients with a severe infection or a severely weakened immune system.
Croatian: Ne smiju ga upotrebljavati ni bolesnici s teškom upalom ili jako oslabljenim imunosnim sustavom.
English: This means that Truxima is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: To znači da je Truxima vrlo sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: In addition, the two medicines had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Truxima and 73% (43 of 59 patients) with MabThera.
Croatian: Nadalje, ta dva lijeka imaju usporedive učinke na simptome artritisa: udio bolesnika s 20 % poboljšanja u ocjeni simptoma (ACR20) nakon 24 tjedna primjene lijeka Truxima iznosio je 74 % (114 od 155 bolesnika), u odnosu na 73 % (43 od 59 bolesnika) koji su uzimali lijek MabThera.
English: What measures are being taken to ensure the safe and effective use of Truxima?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Truxima?
English: Why is Truxima authorised in the EU?
Croatian: Zašto je lijek Truxima odobren u EU-u?
English: This overview was last updated in 07-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 7. 2019.
English: An overview of Truxima and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Truxima i zašto je odobren u EU-u
English: In addition, the medicine should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Croatian: Osim toga, lijek je potrebno davati pod pomnim nadzorom iskusnog zdravstvenog radnika i na mjestu u kojem su izravno dostupni odjeli za oživljavanje bolesnika.
English: The most common serious side effects are infusion reactions, infections (which may affect more than half of all patients) and heart-related problems.
Croatian: Najčešće ozbiljne nuspojave su reakcije na infuziju, infekcije (koje se mogu javiti u više od polovice svih bolesnika) i srčani problemi.
English: Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine to prevent fever).
Croatian: Prije svake infuzije bolesniku je potrebno dati antihistaminik (kako bi se spriječile alergijske reakcije) i antipiretik (lijek protiv vrućice).
English: Truxima is a ‘biosimilar medicine'.
Croatian: Truxima je „biosličan lijek”.
English: Because Truxima is a biosimilar medicine, the studies on effectiveness and safety carried out for MabThera do not need to be repeated for Truxima.
Croatian: Budući da je lijek Truxima biosličan lijek, ispitivanja učinkovitosti i sigurnosti provedena za lijek MabThera nije potrebno ponavljati za lijek Truxima.
English: Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare severe infection known as progressive multifocal leukoencephalopathy (PML).
Croatian: Druge ozbiljne nuspojave uključuju ponovnu aktivaciju hepatitisa B (ponovno javljanje virusne upale jetre zbog hepatitisa B) i rijetku ozbiljnu upalu poznatu kao progresivna multifokalna leukoencefalopatija (PML).
English: Other information about Truxima
Croatian: Ostale informacije o lijeku Truxima
English: ‘Autoimmune' means that the disease is caused by the immune system (the body's natural defences) attacking the body's own cells.
Croatian: je bolest uzrokovana napadom imunosnog sustava (prirodne obrane tijela) na stanice vlastitog tijela.
English: Side effects reported with Truxima are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Truxima pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Truxima?
Croatian: Koji su rizici povezani s lijekom Truxima?
English: Truxima can only be obtained with a prescription.
Croatian: Truxima se izdaje samo na recept.