FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean treatment difference between Symkevi and placebo-treated patients for absolute change in ppFEV1 through the average of Week 4 and Week 8 was 4.4 percentage points (95% CI: 1.1, 7.8).
Croatian: Srednja vrijednost terapijske razlike između bolesnika liječenih lijekom Symkevi i onih koji su primali placebo u apsolutnoj promjeni vrijednosti ppFEV1 do prosječne vrijednosti na kraju 4. tjedna i 8. tjedna iznosila je 4,4 postotna boda (95% CI: 1,1; 7,8).
English: Symkevi 100 mg/150 mg film-coated tablets tezacaftor/ivacaftor
Croatian: Symkevi 100 mg/150 mg filmom obložene tablete tezacaftorum/ivacaftorum
English: CFQ-R respiratory domain score Baseline value
Croatian: Rezultat u respiratornoj domeni upitnika CFQ-R Početna vrijednost
English: • Redness inside the ear
Croatian: • začepljenost uha
English: Examples of moderate CYP3A inhibitors include:
Croatian: Primjeri umjerenih inhibitora CYP3A:
English: Patients who received Symkevi in combination with ivacaftor in Study 1 and continued on treatment showed sustained improvements in ppFEV1 through 48 weeks [within-group change=-0.8 (0.8) percentage points from Study 3 baseline].
Croatian: U bolesnika koji su u ispitivanju 1 primali Symkevi u kombinaciji s ivakaftorom i koji su nastavili s tim liječenjem, poboljšanje vrijednosti ppFEV1 zadržalo se do kraja 48. tjedna [promjena unutar skupine = -0,8 (0,8) postotnih bodova od početne vrijednosti u ispitivanju 3].
English: Ivacaftor 150 mg tablet *Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days.
Croatian: *Nastaviti doziranje tabletama tezakaftora od 100 mg / ivakaftora od 150 mg ili ivakaftora od 150 mg naizmjenično svaki drugi dan.
English: Symkevi 100 mg/150 mg film-coated tablets
Croatian: NAZIV LIJEKA Symkevi 100 mg/150 mg filmom obložene tablete
English: For CFQ-R respiratory domain score (a measure of respiratory symptoms relevant to patients with CF including cough, sputum production, and difficulty breathing) the percentage of subjects with at least a
Croatian: U rezultatu respiratorne domene upitnika CFQ-R (mjera respiratornih simptoma relevantnih za bolesnike s cističnom fibrozom koji uključuju kašalj, stvaranje sputuma i otežano disanje), postotak ispitanika s povećanjem za najmanje 4 boda od početne vrijednosti (minimalna klinički važna razlika) iznosio je u 24. tjednu 51,1% za Symkevi i 35,7% za placebo.
English: Ivacaftor 1.28 (0.440) 9.3 (1.7) *AUC0-24h for tezacaftor and AUC0-12h for ivacaftor
Croatian: *AUC0-24h za tezakaftor i AUC0-12h za ivakaftor
English: The tablets are for oral use.
Croatian: Tablete se uzimaju na usta.
English: Symkevi in combination with ivacaftor has been studied with pitavastatin, an OATP1B1 substrate, and was found to have no clinically relevant effect on the exposure of pitavastatin (1.24 fold increased exposure based on AUC).
Croatian: Ustanovljeno je da nema klinički važan učinak na izloženost pitavastatinu (na temelju AUC-a izloženost se povećala 1,24 puta).
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference LS mean (95% CI) P value nominal P<0.0001±
Croatian: n/N Srednja vrijednost promjene unutar skupine dobivena metodom najmanjih kvadrata (95% CI) Srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata (95% CI) P vrijednost nominalni P<0,0001±
English: Medicinal products affecting the pharmacokinetics of tezacaftor and ivacaftor CYP3A inducers
Croatian: Lijekovi koji utječu na farmakokinetiku tezakaftora i ivakaftora
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference versus placebo LS mean (95% CI) P value
Croatian: n/N Srednja vrijednost (SD) n/N Srednja vrijednost promjene unutar skupine dobivena metodom najmanjih kvadrata (95% CI) Srednja vrijednost terapijske razlike naspram placeba dobivena metodom najmanjih kvadrata (95% CI) P vrijednost
English: Baseline value
Croatian: ITM Početna vrijednost
English: Tezacaftor 100 mg/ivacaftor 150 mg tablet Ivacaftor 150 mg tablet
Croatian: Jutarnja doza tezakaftor 100 mg/ivakaftor 150 mg tableta ivakaftor 150 mg tableta
English: Symkevi 100 mg/150 mg tablets tezacaftor/ivacaftor
Croatian: NAZIV LIJEKA Symkevi 100 mg/150 mg tablete tezacaftorum/ivacaftorum
English: Drug
Croatian: Učestalost
English: Absolute change from baseline through Week 24 (points)**
Croatian: Apsolutna promjena od početka ispitivanja do kraja 24. tjedna (bodovi)**
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Odstupanja rezultata laboratorijskih pretraga
English: Adolescents TEZ 100 mg qd/IVA 150 mg q12h Adults
Croatian: Adolescenti TEZ 100 mg svaki dan / IVA 150 mg svakih 12 sati
English: Side effects seen with Symkevi in combination with ivacaftor: Very common side effects
Croatian: Nuspojave opažene uz Symkevi u kombinaciji s ivakaftorom: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba)
English: Average absolute change from baseline through Week 24 (percentage points)**
Croatian: Prosječna apsolutna promjena od početka ispitivanja do kraja 24. tjedna (postotni bodovi)**
English: Food or drink containing grapefruit or Seville oranges should be avoided during treatment (see section 4.5).
Croatian: Tijekom liječenja potrebno je izbjegavati hranu i pića koja sadrže grejpfrut ili naranče sorte Seville
English: No ivacaftor 150 mg dose
Croatian: 150 mg ivakaftora.
English: In Study 1 (patients homozygous for the F508del mutation), the treatment difference between Symkevi in combination with ivacaftor and placebo in mean absolute change from baseline in sweat chloride through Week 24, was -10.1 mmol/L (95% CI: -11.4, -8.8; nominal P<0.0001*).
Croatian: U ispitivanju 1 (bolesnici homozigoti za mutaciju F508del), terapijska razlika između lijeka Symkevi u kombinaciji s ivakaftorom i placeba u srednjoj vrijednosti apsolutne promjene koncentracije klorida u znoju od početka ispitivanja do kraja 24. tjedna iznosila je -10,1 mmol/l (95% CI: -11,4; -8,8;
English: Medicinal products affected by tezacaftor and ivacaftor CYP2C9 substrates
Croatian: Supstrati CYP2C9
English: • Breast mass
Croatian: • upala dojki
English: CFTR activity were represented: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L,
Croatian: Ispitivanje u bolesnika s cističnom fibrozom koji su bili heterozigoti za mutaciju F508del i drugu mutaciju povezanu s rezidualnom aktivnošću proteina CFTR (ispitivanje 2) U 244 bolesnika uključena u ispitivanje 2 bile su zastupljene sljedeće mutacije povezane s rezidualnom aktivnošću CFTR-a koje potpadaju pod indikaciju: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference LS mean (95% CI) P value
Croatian: n/N Srednja vrijednost (SD) n/N Srednja vrijednost promjene unutar skupine dobivena metodom najmanjih kvadrata (95% CI) Srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata (95% CI) P vrijednost
English: Starting dose: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily.
Croatian: Početna doza: jedna tableta tezakaftora od 100 mg /
English: TEZ 100 mg qd/IVA 150 mg q12h
Croatian: TEZ 100 mg svaki dan / IVA 150 mg svakih 12 sati
English: Hypromellose (E464) Hydroxypropyl cellulose (E463) Titanium dioxide (E171) Talc (E553b)
Croatian: Film-ovojnica tablete hipromeloza (E464) hidroksipropilceluloza (E463)
English: Oropharyngeal pain, Nasal congestion very common
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja orofaringealni bol, kongestija nosa vrlo često kongestija sinusa, crvenilo ždrijela često
English: Nasopharyngitis very common
Croatian: Infekcije i infestacije nazofaringitis vrlo često
English: Evening No dose adjustment No ivacaftor 150 mg dose
Croatian: Večernja doza ivakaftor 150 mg tableta
English: The mean absolute change (SE) from baseline in ppFEV1 was 11.7 (1.2) percentage points in the Symkevi in combination with ivacaftor group, 7.6 (1.2) percentage points in the ivacaftor group and -0.4 (1.2) percentage points in the placebo group in Study 2.
Croatian: Adolescenti s cističnom fibrozom koji su bili heterozigoti za mutaciju F508del i drugu mutaciju povezanu s rezidualnom aktivnošću proteina CFTR U ispitivanju 2, srednja vrijednost apsolutne promjene (SE) od početne vrijednosti ppFEV1 iznosila je 11,7 (1,2) postotnih bodova u skupini liječenoj lijekom Symkevi u kombinaciji s ivakaftorom, 7,6 (1,2) postotnih bodova u skupini liječenoj ivakaftorom i -0,4 (1,2) postotnih bodova u skupini koja je primala placebo.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kongestija sinusa često
English: Race
Croatian: Spol
English: Cataracts
Croatian: Katarakta
English: Breast inflammation, Gynaecomastia, Nipple disorder, Nipple pain uncommon
Croatian: Poremećaji reproduktivnog sustava i dojki kvržica u dojci često upala dojki, ginekomastija, poremećaj bradavica, bol u bradavicama manje često
English: Transaminase elevations very common
Croatian: Poremećaji jetre i žuči povišenje transaminaza vrlo često
English: Tell your doctor straight away if you have any of these symptoms.
Croatian: Ako imate neki od ovih simptoma, odmah obavijestite svog liječnika.
English: Tablet film coat
Croatian: Jedna tableta tezakaftora od
English: --1 Modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50*, Modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50*.
Croatian: --1 Modificirani živi BVDV-1* necitopatogeni roditeljski soj KE-9: 104,0-106,0 TCID50** Modificirani živi BVDV-2* necitopatogeni roditeljski soj NY-3: 104,0-106,0 TCID50**
English: ** Tissue culture infectious dose 50%
Croatian: * infektivna doza za kulturu tkiva 50%
English: 100 mg / 150 mg Film-coated tablet Oral use blister (PCTFE/PVC/alu)
Croatian: Blister (PCTFE/PVC/Al)
English: The recommended dose is 14 mg once a day.
Croatian: Preporučena doza je 14 mg na dan.
English: The study lasted for up to two years.
Croatian: Ispitivanje je trajalo do dvije godine.
English: The results of the study were inconclusive.
Croatian: Rezultati ispitivanja bili su nejasni.
English: Treatment lasted for up to about three years (152 weeks).
Croatian: Najduže liječenje iznosilo je oko tri godine (152 tjedna).
English: Aubagio teriflunomide
Croatian: Aubagio teriflunomid
English: • serious infections;
Croatian: • ozbiljnim infekcijama;
English: The full EPAR for Aubagio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za Aubagio nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Women who can become pregnant must not take Aubagio without using reliable contraceptive measures.
Croatian: Žene koje bi mogle zatrudnjeti ne smiju uzimati Aubagio bez korištenja pouzdane kontracepcije.
English: Aubagio is available as tablets (14 mg).
Croatian: Aubagio je dostupan u obliku tableta (14 mg).
English: • severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
Croatian: • teškim stanjem imunodeficijencije, kao što je sindrom stečene imunodeficijencije (AIDS);
English: In general, headache, diarrhoea, nausea and alopecia are mild to moderate, resolve with time and do not usually lead to treatment being stopped.
Croatian: Općenito, glavobolja, proljev, mučnina i alopecija su blagi do umjereni, nestanu s vremenom i obično ne dovode do prekida liječenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aubagio on 26 August 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Aubagio na snazi u Europskoj uniji od 26. kolovoza 2013.
English: • poor bone marrow function or low blood cell counts (red cells, white cells or platelets);
Croatian: • slabom funkcijom koštane srži ili s niskim brojem krvnih stanica (crvene krvne stanice, bijele krvne stanice ili trombociti);
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Aubagio'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 Aubagio nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: It is used to treat adults with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Croatian: Koristi se za liječenje odraslih osoba s multiplom sklerozom (MS), bolesti kod koje upala uništava zaštitnu ovojnicu oko živaca.
English: Other information about Aubagio
Croatian: Ostale informacije o lijeku Aubagio
English: This is a summary of the European public assessment report (EPAR) for Aubagio.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aubagio.
English: The most commonly reported side effects with Aubagio (which may affect more than 1 in 10 people) are headache, diarrhoea, increased liver enzymes, nausea (feeling sick), and alopecia (hair loss).
Croatian: Najčešće nuspojave lijeka Aubagio (koje se mogu javiti u više od 1 na 10 osoba) su glavobolja, proljev, povišeni jetreni enzimi, mučnina (osjećaj slabosti) i alopecija (gubitak kose).
English: Although the effects were modest, they were considered to be significant and similar to other MS treatments, although there were no conclusive results available from a direct comparison with interferon beta-1a.
Croatian: Iako su učinci skromni, smatraju se značajnima i sličnima drugim načinima liječenja multiple skleroze, iako nije bilo dostupnih jasnih rezultata iz izravne usporedbe s interferonom beta-1a.
English: It is not intended to provide practical advice on how to use Aubagio.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Aubagio.
English: Regarding its safety, side effects were similar to the immunosuppressant leflunomide, as leflunomide is converted into teriflunomide in the body.
Croatian: U pogledu sigurnosti, nuspojave su slične imunosupresivnom lijeku leflunomidu, jer se leflunomid u tijelu pretvara u teriflunomid.
English: What measures are being taken to ensure the safe and effective use of Aubagio?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Aubagio?
English: Aubagio is a medicine that contains the active substance teriflunomide.
Croatian: Aubagio je lijek koji sadrži djelatnu tvar teriflunomid.
English: The pack will also include information on a registry the company will set up to collect data on babies born to women treated with Aubagio, as well as a patient reminder card with key safety information for patients.
Croatian: Paket će također sadržavati informacije o registru koji će napraviti tvrtka radi prikupljanja podataka o djeci koju su rodile žene liječene lijekom Aubagio, kao i karticu za podsjećanje bolesnika s ključnim sigurnosnim informacijama za bolesnike.
English: What is Aubagio and what is it used for?
Croatian: Što je Aubagio i za što se koristi?
English: Aubagio must not be used in patients with:
Croatian: Aubagio se ne smije primjenjivati u bolesnika s:
English: Aubagio has been studied in four main studies involving over 2,700 adults with relapsing-remitting MS.
Croatian: Aubagio je ispitivan u četiri glavna ispitivanja koja su uključivala više od 2700 odraslih osoba s relapsno-remitirajućom multiplom sklerozom.
English: In MS, the body's immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths.
Croatian: Kod multiple skleroze imunosni sustav tijela ne radi ispravno i napada dijelove središnjeg živčanog sustava (mozak i leđnu moždinu), što uzrokuje upalu koja oštećuje ovojnice živaca.
English: Why is Aubagio approved?
Croatian: Zašto je Aubagio odobren?
English: However, the rate of relapse was 23.4% with Aubagio compared with 15.4% with interferon beta-1a.
Croatian: Međutim, stopa relapsa bila je 23,4% za Aubagio u usporedbi s 15,4% za interferon beta-1a.
English: Aubagio must also not be used in pregnant women or during breast-feeding.
Croatian: Aubagio se također ne smije primjenjivati na trudnicama ili dojiljama.
English: • severe kidney disease that requires dialysis;
Croatian: • teškim bolestima bubrega koje zahtijevaju dijalizu;
English: Aubagio is given by mouth which was considered to be an advantage over other medicines such as interferon beta-1a.
Croatian: Aubagio se uzima kroz usta što se smatra prednošću pred drugim lijekovima kao što je interferon beta-1a.
English: A risk management plan has been developed to ensure that Aubagio is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Aubagio.
English: In addition, the company that markets Aubagio must ensure that all healthcare professionals who are expected to use Aubagio receive an information pack containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment.
Croatian: Uz to, tvrtka koja proizvodi Aubagio mora se pobrinuti da svi zdravstveni djelatnici za koje se smatra da će koristiti lijek Aubagio dobe informativni paket s važnim sigurnosnim informacijama, uključujući podatke o testovima i nadzoru koji se mora provoditi nad bolesnicima prije i nakon početka liječenja.
English: What are the risks associated with Aubagio?
Croatian: Koji su rizici povezani s lijekom Aubagio?
English: The exact way teriflunomide works in MS is not known but it is thought to reduce the number of lymphocytes which form part of the immune system and are involved in the inflammation process.
Croatian: Točan način djelovanja teriflunomida na multiplu sklerozu nije poznat, ali smatra se da smanjuje broj limfocita koji tvore dio imunosnog sustava i koji su uključeni u upalni proces.
English: The studies also looked at the effect of Aubagio on the changes in the patients' level of disability and showed that the risk of disability getting worse was reduced by 30% in comparison with placebo after around two and a half years (132 weeks) of treatment.
Croatian: Ispitivanja su istraživala i učinak lijeka Aubagio na promjene u razini onesposobljenosti bolesnika i pokazala su da se rizik od pogoršavanja onesposobljenosti smanjio za 30% u usporedbi s placebom nakon otprilike dvije godine i šest mjeseci (132 tjedna) liječenja.
English: Aubagio can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of MS.
Croatian: Aubagio se izdaje samo na liječnički recept te liječenje mora započeti i nadzirati liječnik koji je iskusan u liječenju multiple skleroze.
English: The risk of serious side effects affecting the liver and bone marrow was considered manageable and adequately addressed by risk minimisation measures.
Croatian: Smatra se da je moguće odgovoriti na rizik ozbiljnih nuspojava koje utječu na jetru i koštanu srž i da je to pitanje prikladno riješeno mjerama za smanjivanje rizika.
English: The fourth study involving 324 patients compared the effects of Aubagio with interferon beta-1a (another treatment for MS) on the rate of treatment failure, by looking at the time until patients had their first relapse or permanently stopped their treatment.
Croatian: Četvrto ispitivanje s 324 bolesnika uspoređivalo je učinke lijeka Aubagio s interferonom beta-1a (druga terapija za multiplu sklerozu) na stopu neuspješnog liječenja, s obzirom na vrijeme do prvog relapsa bolesnika ili trajnog prekida liječenja.
English: One study involving 179 patients compared the effects of Aubagio with placebo (a dummy treatment) on the number of active lesions (developing areas of damage) in the brain detected by a brain scan.
Croatian: Jedno ispitivanje s 179 bolesnika uspoređivalo je učinke lijeka Aubagio s placebom (liječenje bez djelatne tvari) na broj aktivnih lezija (oštećena područja koja se razvijaju) na mozgu utvrđenih snimanjem mozga.
English: Two studies involving 2,257 patients compared the effects of Aubagio with placebo in reducing the number of relapses per patient per year (called the ‘annualised relapse rate').
Croatian: Dva ispitivanja s 2257 bolesnika uspoređivala su učinke lijeka Aubagio s placebom na smanjenje broja relapsa po bolesniku u godini dana (nazvano "godišnja stopa relapsa").
English: Aubagio was found to be more effective than placebo: after around 9 months (36 weeks), the number of active lesions was around 1 per scan in patients who were taking Aubagio compared with around 2.7 in patients taking placebo.
Croatian: Ustanovilo se da je lijek Aubagio djelotvorniji od placeba: nakon otprilike 9 mjeseci (36 tjedana) broj aktivnih lezija bio je oko 1 po snimci kod bolesnika koji su uzimali Aubagio i oko 2,7 kod bolesnika koji su uzimali placebo.
English: The active substance in Aubagio, teriflunomide, blocks an enzyme called ‘dihydro-orotate dehydrogenase' which is necessary for cells to multiply.
Croatian: Djelatna tvar u lijeku Aubagio, teriflunomid, blokira enzim dihidroorotat dehidrogenazu koji je potreban za diobu stanica.
English: Aubagio was found to be more effective than placebo: in patients taking Aubagio, relapses were reduced by around 30% more than in patients taking placebo (the annualised relapse rate was 0.35 for Aubagio compared with 0.53 for placebo).
Croatian: Ustanovilo se da je lijek Aubagio djelotvorniji od placeba: kod bolesnika koji su uzimali Aubagio relapsi su smanjeni za oko 30% više u odnosu na bolesnike koji su uzimali placebo (godišnja stopa relapsa bila je 0,35 za Aubagio u usporedbi s 0,53 za placebo).
English: For more information about treatment with Aubagio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Aubagio pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of MS.
Croatian: Smanjenje broja limfocita ublažava upalu, što pomaže pri kontroli simptoma multiple skleroze.
English: In studies, Aubagio was shown to reduce relapses and delay the progression of disability in patients with relapsingremitting MS.
Croatian: Ispitivanja su pokazala da Aubagio smanjuje relapse i odgađa napredovanje onesposobljenosti kod bolesnika s relapsno-remitirajućom multiplom sklerozom.
English: Overall, no conclusion could be reached from this study on any differences between Aubagio and interferon beta-1a for MS treatment.
Croatian: Općenito, iz ovog se ispitivanja nije moglo doći do zaključka o razlikama između liječenja multiple skleroze lijekom Aubagio i interferonom beta-1a.
English: Aubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Croatian: Aubagio se koristi kod vrste multiple skleroze koja se naziva relapsno-remitirajuća multipla skleroza, a koju karakteriziraju napadaji simptoma (relapsi) nakon kojih slijedi razdoblje oporavka (remisije).
English: • severe liver disease;
Croatian: • teškom bolešću jetre;
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aubagio, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Aubagio nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: How does Aubagio work?
Croatian: Kako Aubagio djeluje?