FrancophonIA/ELRC3.0 huggingface dataset:
English: • The selectivity of ambrisentan for the ETA over the ETB receptor is expected to retain ETB receptor mediated production of the vasodilators nitric oxide and prostacyclin.
Croatian: • Zbog selektivnosti ambrisentana za ETA receptore u odnosu na ETB receptore, očekuje se održano stvaranje vazodilatatora - dušikovog oksida i prostaciklina, posredovano ETB receptorima.
English: Volibris tablets contain a colouring called Allura red AC Aluminium Lake (E129) which can cause allergic reactions (see section 4).
Croatian: Volibris tablete sadržavaju boju Allura red AC Aluminium Lake (E129) koja može izazvati alergijske reakcije (pogledajte dio 4).
English: Contains lactose, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).
Croatian: Sadrži laktozu, lecitin (soja) (E322) i boju Allura red AC Aluminium Lake (E129).
English: Ambrisentan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced.
Croatian: Liječenje ambrisentanom se ne smije započeti u žena reproduktivne dobi ukoliko rezultat prethodno učinjenog testa na trudnoću nije negativan i ukoliko žena ne koristi pouzdane metode kontracepcije.
English: This slight increase in sildenafil Cmax is not considered clinically relevant (see section
Croatian: Blagi porast Cmax za sildenafil se ne smatra klinički značajnim (vidjeti dio 4.5).
English: Therefore ambrisentan must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (>3xULN); see sections 4.3 and 4.4).
Croatian: Zbog toga se terapija ambrisentanom ne smije započinjati u bolesnika s teškim oštećenjem jetre ili klinički značajnim povišenjem jetrenih aminotransferaza (više od 3 puta iznad gornje granice normalnih vrijednosti (>3 x GGN); vidjeti dijelove 4.3 i 4.4).
English: The distribution of ambrisentan into red blood cells is low, with a mean blood:plasma ratio of 0.57 and 0.61 in males and females, respectively.
Croatian: Raspodjela ambrisentana u eritrocite je mala; srednji omjer distribucije između krvi i plazme iznosi 0,57 za muškarce i 0,61 za žene.
English: Patients started on ambrisentan 5 mg and tadalafil 20 mg, and were titrated to 40 mg tadalafil at week 4 and 10 mg ambrisentan at week 8, unless there were tolerability issues.
Croatian: Bolesnici su započeli liječenje ambrisentanom u dozi od 5 mg i tadalafilom u dozi od 20 mg, nakon čega je doza tadalafila titrirana do 40 mg u 4. tjednu, a doza ambrisentana do 10 mg u 8. tjednu, pod uvjetom da nije bilo nikakvih problema s podnošljivošću.
English: Volibris 10 mg film-coated tablets EU/1/08/451/003
Croatian: Volibris 10 mg filmom obložene tablete EU/1/08/451/003
English: These effects occurred at exposures approximately 1.8 to 7 times human paediatric exposures at 10 mg (age 9 to 15 years), based on AUC.
Croatian: Ti su se učinci pojavili pri izloženosti približno 1,8 do 7 puta većoj od pedijatrijske izloženosti u ljudi (dob od
English: INFORMATION IN BRAILLE volibris 5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU volibris 5 mg
English: EU/1/08/451/004 30 film-coated tablets
Croatian: EU/1/08/451/002 30 filmom obloženih tableta
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Nuspojave unutar skupine iste učestalosti navedene su u padajućem slijedu prema ozbiljnosti.
English: That women of reproductive potential must use effective contraception; The need for monthly pregnancy tests;
Croatian: - Informaciju o potrebi provođenja mjesečnih testova na trudnoću;
English: Adverse reactions identified from 12 week placebo controlled clinical trial data are included below by system organ class and frequency.
Croatian: Nuspojave identificirane u placebom kontroliranim kliničkim ispitivanjima u trajanju od 12 tjedana navedene su prema organskim sustavima i učestalosti.
English: Treatment must be initiated by a physician experienced in the treatment of PAH.
Croatian: 4.2 Doziranje i način primjene Liječenje mora započeti liječnik s iskustvom u liječenju PAH-a.
English: Most cases of peripheral oedema in clinical studies with ambrisentan were mild to moderate in severity, although it may occur with greater frequency and severity in patients ≥65 years.
Croatian: većina je perifernih edema bila blaga do umjerena, ali oni mogu biti češći i teži u bolesnika u dobi
English: Volibris tablets contain the azo colouring agent Allura red AC Aluminium Lake (E129), which can cause allergic reactions.
Croatian: Volibris tablete sadrže azo-boju Allura red AC Aluminium Lake (E129), koja može uzrokovati alergijske reakcije.
English: 2 The frequency of headache appeared higher with 10 mg ambrisentan.
Croatian: 2 učestalost glavobolja je veća pri primjeni 10 mg ambrisentana
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means that it is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: The measure included: death, lung transplantation, hospitalisation for PAH, atrial septostomy, addition of other PAH therapeutic agents and early escape criteria.
Croatian: PAH-a, septostomija atrija, dodavanje drugih lijekova za PAH i kriteriji ranog uzmaka.
English: • whether you have anaemia • whether your liver is working properly.
Croatian: • radi li Vaša jetra ispravno.
English: Therapy that is recommended at the severe stage of the disease (e.g. epoprostenol) should be considered if the clinical condition deteriorates.
Croatian: Ukoliko dođe do pogoršanja kliničkog stanja, treba razmisliti o primjeni (npr. epoprostenola) kao preporučene terapije ovog teškog stadija bolesti.
English: The placebo-adjusted improvement in mean 6MWD at week 12 in patients in the 10 mg group in ARIES-1 was 51.4 m (95% CI: 26.6 to 76.2; p <0.001).
Croatian: Placebom prilagođeno srednje poboljšanje 6MWD u 12-tom tjednu, u bolesnika na 10 mg u ARIES-1 je iznosilo 51,4 m (95% CI: 26,6 do 76,2; p<0,001).
English: Talk to your doctor before taking this medicine if you have:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete ovaj lijek:
English: Secondary Endpoints (change from baseline to week 24)
Croatian: Sekundarne mjere ishoda (promjena od početka ispitivanja do
English: The effects of 12 days dosing with ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of oral contraceptive containing ethinyl estradiol (35 μg) and norethindrone (1 mg) were studied in healthy female volunteers.
Croatian: Ispitivan je utjecaj 12-dnevne primjene ambrisentana (10 mg jednom dnevno) na farmakokinetiku pojedinačne doze oralnih kontraceptiva koji sadržavaju etinilestradiol (35 μg) i noretindron (1 mg) na zdravim dobrovoljkama.
English: How to store Volibris
Croatian: Kako čuvati Volibris
English: Volibris tablets contain less than 1 mmol sodium (23 mg), which is essentially ‘sodium-free'.
Croatian: Volibris tablete sadrže manje od 1 mmol (23 mg) natrija, tj. zanemarive količine natrija.
English: Therefore the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Croatian: Na temelju tih promjena, doza ambrisentana treba biti ograničena na 5 mg jednom dnevno kada je u istovremenoj primjeni sa ciklosporinom A (vidjeti dio 4.2).
English: This may be due to the inhibition by cyclosporine A of transporters and metabolic enzymes involved in the pharmacokinetics of ambrisentan.
Croatian: To je vjerojatno posljedica inhibicije transportera i metaboličkih enzima uključenih u farmakokinetiku ambrisentana od strane ciklosporina A. Stoga, doza ambrisentana kod istovremene upotrebe sa ciklosporinom
English: Treatment with combination therapy resulted in a 50% risk reduction (hazard ratio [HR] 0.502; 95% CI: 0.348 to 0.724; p=0.0002) of the composite clinical failure endpoint up to final assessment visit when compared to the pooled monotherapy group [Figure 1 and Table 1].
Croatian: U usporedbi s objedinjenim podacima iz skupina liječenih monoterapijom, liječenje kombiniranom terapijom smanjilo je rizik od kompozitne mjere ishoda - kliničkog neuspjeha - za 50% (omjer hazarda [engl. hazard ratio, HR]: 0,502; 95% CI: 0,348 - 0,724; p = 0,0002) do posljednjeg kontrolnog posjeta [Slika 1 i Tablica 1].
English: Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).
Croatian: klasificiranom prema Svjetskoj zdravstvenoj organizaciji (SZO) u funkcionalni razred II do III, što uključuje i primjenu u kombiniranom liječenju (vidjeti dio 5.1).
English: There is limited experience with ambrisentan in individuals with severe renal impairment (creatinine clearance <30 ml/min); therapy should be initiated cautiously in this subgroup and particular care taken if the dose is increased to 10 mg ambrisentan.
Croatian: ml/min); terapiju treba započeti oprezno u ovoj podskupini, a naročito treba paziti ako se doza ambrisentana poveća na 10 mg.
English: Breast-feeding It is not known if Volibris is transferred to breast milk.
Croatian: Nije poznato izlučuje li se Volibris u majčino mlijeko.
English: Each tablet contains approximately 95 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.11 mg of Allura red AC Aluminium Lake (E129).
Croatian: Jedna tableta sadrži približno 95 mg laktoze (u obliku hidrata), približno 0,25 mg lecitina (soja) (E322) i približno 0,11 mg boje Allura red AC Aluminium Lake (E129).
English: Steady-state administration of ambrisentan in healthy volunteers had no clinically relevant effects on the single-dose pharmacokinetics of digoxin, a substrate for Pgp (see section 5.2).
Croatian: Primjena ambrisentana u stanju dinamičke ravnoteže u zdravih dobrovoljaca nije imala klinički značajan učinak na farmakokinetiku pojedinačne doze digoksina (supstrat Pgp-a) (vidjeti dio 5.2).
English: The mean age of all patients was 54 years (SD 15; range 18-75 years of age).
Croatian: Srednja vrijednost dobi svih bolesnika bila je 54 godine (standardno odstupanje: 15; raspon:
English: The Cmax and AUC(0-∞) were slightly decreased for ethinyl estradiol (8% and 4%, respectively), and slightly increased for norethindrone (13% and 14 %, respectively).
Croatian: Uočeno je blago smanjenje Cmax za 8 % te AUC(0-∞) za 4 % kod etinilestradiola i povećanje Cmax za 13% te AUC(0-∞) za 14% kod noretindrona.
English: If you take too many tablets you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that could cause light-headedness: → Ask your doctor or pharmacist for advice if you take more tablets than prescribed.
Croatian: Ako uzmete previše tableta, veća je vjerojatnost pojave nuspojava poput glavobolje, crvenila praćenog osjećajem vrućine, omaglice, mučnine ili niskog krvnog tlaka koji može izazvati ošamućenost.
English: Each tablet contains approximately 90 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.45 mg of Allura red AC Aluminium Lake (E129).
Croatian: Jedna tableta sadrži približno 90 mg laktoze (u obliku hidrata), približno 0,25 mg lecitina (soja) (E322) i približno 0,45 mg boje Allura red AC Aluminium Lake (E129).
English: Package leaflet: Information for the user Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets ambrisentan
Croatian: Uputa o lijeku: Informacije za korisnika Volibris 5 mg filmom obložene tablete Volibris 10 mg filmom obložene tablete ambrisentan
English: Secondary endpoints Secondary endpoints were tested:
Croatian: Sekundarne mjere ishoda Ispitivale su se i sekundarne mjere ishoda: Tablica 2
English: Very common
Croatian: vrlo često2
English: The effects of repeat dosing of cyclosporine A (100 - 150 mg twice daily) on the steady-state pharmacokinetics of ambrisentan (5 mg once daily), and the effects of repeat dosing of ambrisentan (5 mg once daily) on the steady-state pharmacokinetics of cyclosporine A (100 - 150 mg twice daily)
Croatian: U zdravih dobrovoljaca je ispitivan učinak ponavljajućeg doziranja ciklosporina A (100-150 mg dva puta dnevno) na farmakokinetiku ambrisentana (5 mg jednom dnevno) u stanju dinamičke ravnoteže, i učinke ponavljajućeg doziranja ambrisentana (5 mg jednom dnevno) na farmakokinetiku ciklosporina
English: Volibris 5 mg film-coated tablets Each tablet contains 5 mg of ambrisentan.
Croatian: Volibris 5 mg filmom obložene tablete Jedna tableta sadrži 5 mg ambrisentana.
English: Therefore ambrisentan should not be initiated in patients with severe hepatic impairment or clinically significant elevated hepatic aminotransferases (>3xULN) (see sections 4.3 and 4.4).
Croatian: Stoga se ne preporučuje uvođenje ambrisentana u bolesnika s teškim oštećenjem jetre ili klinički značajnim porastom jetrenih aminotransferaza (>3 x GGN) (vidjeti dio 4.3 i 4.4).
English: Combination with tadalafil
Croatian: Kombinacija s tadalafilom
English: 9 Rash includes rash erythematous, rash generalised, rash papular and rash pruritic
Croatian: 9 osip uključuje eritemski osip, generalizirani osip, papularni osip i pruritički osip
English: The incidence of peripheral oedema was increased when ambrisentan was dosed in combination with tadalafil (45% adverse event frequency), compared to the incidence of peripheral oedema when ambrisentan and tadalafil were given as monotherapy (38% and 28%, respectively).
Croatian: incidencija perifernog edema bila je povećana (učestalost štetnog događaja: 45%) u odnosu na incidenciju perifernog edema kada su se ambrisentan i tadalafil primjenjivali u monoterapiji
English: Hypotension (low blood pressure) This can cause light-headedness.
Croatian: Hipotenzija (nizak krvni tlak)
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 5.2).
Croatian: Bolesnike na terapiji ambrisentanom se treba pozorno pratiti na početku terapije s rifampicinom (vidjeti dijelove 4.4 i 5.2)
English: Taking out a tablet
Croatian: Vađenje tablete iz pakiranja
English: In ARIES-2, ambrisentan (combined dose group) significantly delayed the time to clinical worsening of PAH compared to placebo (p<0.001), the hazard ratio demonstrated an 80% reduction (95% CI: 47% to 92%).
Croatian: U ARIES-2, ambrisentan je (grupa s kombiniranom dozom) značajno usporio vrijeme do nastupa kliničkog pogoršanja PAH-a u odnosu na placebo (p<0,001), omjer hazarda je pokazao
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/451/001 10 film-coated tablets EU/1/08/451/002 30 film-coated tablets 13.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/451/003 10 filmom obloženih tableta EU/1/08/451/004 30 filmom obloženih tableta 13. BROJ SERIJE
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GlaxoSmithKline (Ireland) Limited
English: If clinically significant fluid retention develops during therapy with ambrisentan, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as ambrisentan or underlying heart failure, and the possible need for specific treatment or discontinuation of ambrisentan therapy.
Croatian: Ukoliko se razvije klinički značajna retencija tekućine za vrijeme terapije ambrisentanom, sa ili bez posljedičnog porasta tjelesne težine, potrebna je daljnja procjena kako bi se utvrdio razlog, npr.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
English: The safety findings observed with long-term ambrisentan exposure in this study were generally consistent with those observed in the 12 week placebo-controlled studies.
Croatian: Rezultati o sigurnosti zamijećeni pri dugotrajnoj izloženosti ambrisentanu u ovom ispitivanju bili su općenito u skladu s rezultatima zamijećenima u
English: Following initial doses of rifampicin, a transient increase in ambrisentan AUC(0-τ) (121% and 116% after first and second doses of rifampicin, respectively) was observed, presumably due to a rifampicin-mediated OATP inhibition.
Croatian: Nakon početnih doza rifampicina pronađen je prolazni porast AUC(0-τ) ambrisentana (121% u prvoj i
English: The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p<0.001) for the 5 mg group, in
Croatian: Placebom prilagođeno poboljšanje srednjeg 6MWD u 12-tom tjednu, u usporedbi s početnim je iznosilo 30,6 m (95% CI: 2,9 do 58,3; p=0,008) u ispitivanju ARIES-1, i 59,4 m (95% CI: 29,6 do 89,3; p<0,001) u ARIES-2, za grupe ispitanika na 5 mg ispitivanog lijeka.
English: You can take Volibris with or without food.
Croatian: Volibris možete uzeti neovisno o obroku.
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 4.5).
Croatian: Bolesnike na terapiji ambrisentanom trebalo bi na početku liječenja rifampicinom pomno pratiti (vidjeti dijelove 4.4 i 4.5).
English: Uncommon3,8
Croatian: 4.8 Nuspojave
English: Inflammation and changes in the nasal cavity epithelium have been seen in rodents after chronic administration at exposures below the therapeutic levels in humans.
Croatian: Tijekom kronične primjene ambrisentana, zamijećene su upala i promjene epitela sluznice nosne šupljine u glodavaca, pri izloženosti koje su bile ispod terapijskih razina u ljudi.
English: No clinically meaningful effects on the pharmacokinetics of ambrisentan or sildenafil were seen during a drug-drug interaction study in healthy volunteers, and the combination was well tolerated.
Croatian: Tijekom ispitivanja interakcija lijekova na zdravim dobrovoljcima, nije nađen klinički značajan učinak na farmakokinetiku ambrisentana ili sildenafila, a kombinacija je bila dobro podnošena.
English: Ambrisentan does not undergo significant renal metabolism or renal clearance (excretion).
Croatian: Oštećenje bubrega Ambrisentan se značajno ne metabolizira niti se uklanja bubregom (izlučuje).
English: Volibris 5 mg film-coated tablet (tablet) is a pale pink, square, convex tablet engraved with ‘GS' on one face and ‘K2C' on the other.
Croatian: Volibris 5 mg filmom obložena tableta (tableta) je blijedo ružičasta, četvrtasta, ispupčena tableta s utisnutim oznakama „GS“ na jednoj i „K2C“ na drugoj strani tablete.
English: Ambrisentan monotherapy
Croatian: Doziranje Monoterapija ambrisentanom
English: Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets
Croatian: Volibris 5 mg filmom obložene tablete Volibris 10 mg filmom obložene tablete
English: Marketing Authorisation Holder GlaxoSmithKline (Ireland) Limited 12 Riverwalk
Croatian: Nositelj odobrenja za stavljanje lijeka u promet GlaxoSmithKline (Ireland) Limited 12 Riverwalk
English: Volibris 10 mg film-coated tablet (tablet) is a deep pink, oval, convex tablet engraved with ‘GS' on one face and ‘KE3' on the other.
Croatian: Volibris 10 mg filmom obložena tableta (tableta) je tamno ružičasta, ovalna, ispupčena tableta s utisnutim oznakama „GS“ na jednoj i „KE3“ na drugoj strani tablete.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg ambrisentan
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 10 mg ambrisentana
English: Cases consistent with autoimmune hepatitis, including possible exacerbation of underlying autoimmune hepatitis, hepatic injury and hepatic enzyme elevations potentially related to therapy have been observed with ambrisentan (see sections 4.8 and 5.1).
Croatian: Zapaženi su slučajevi koji odgovaraju autoimunom hepatitisu, uključujući moguće egzacerbacije podležećeg autoimunog hepatitisa, oštećenje jetre i porast jetrenih enzima potencijalno vezan uz liječenje ambrisentanom
English: This is due to the heart not pumping out enough blood, causing shortness of breath, extreme tiredness and swelling in the ankles and legs.
Croatian: Zatajenje srca Zatajenje srca posljedica je toga što srce ne pumpa dovoljno krvi, što uzrokuje nedostatak zraka,
English: 6 Cases of worsening dyspnoea of unclear aetiology have been reported shortly after starting ambrisentan therapy.
Croatian: 6 slučajevi pogoršanja dispneje nepoznate etiologije, zabilježeni su kratko nakon početka terapije ambrisentanom 7 incidencija nazalne kongestije bila je ovisna o dozi tijekom terapije ambrisentanom
English: Hepatic transaminases increased Common3
Croatian: porast vrijednosti jetrenih transaminaza
English: • feeling sick (nausea)
Croatian: • osjećaj mučnine • povraćanje
English: 4 Data derived from routine pharmacovigilance surveillance 5 Most of the reported cases of cardiac failure were associated with fluid retention.
Croatian: 5 većina prijavljenih slučajeva zatajenja srca bila je povezana s retencijom tekućine.
English: Volibris contains the active substance ambrisentan.
Croatian: Što je Volibris i za što se koristi Volibris sadrži djelatnu tvar ambrisentan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg ambrisentan
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 5 mg ambrisentana
English: Monotherapy pooled
Croatian: Objedinjene monoterapije
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/451/003 10 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/451/001 10 filmom obloženih tableta
English: Your doctor may need to adjust your dose of Volibris if you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis).
Croatian: Ako započinjete terapiju ciklosporinom A (lijek koji se koristi nakon transplantacije organa ili za liječenje psorijaze), liječnik će možda trebati prilagoditi dozu lijeka Volibris.
English: Deep-pink, oval, convex, film-coated tablet with “GS” debossed on one side and “KE3” on the other side.
Croatian: Tamno ružičaste, ovalne, konveksne, filmom obložene tablete s utisnutim „GS“ na jednoj i „KE3“ na drugoj strani tablete.
English: NAME OF THE MEDICINAL PRODUCT Volibris 10 mg tablets ambrisentan
Croatian: NAZIV LIJEKA Volibris 10 mg tablete ambrisentan
English: Volibris 5 mg film-coated tablets EU/1/08/451/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Volibris 5 mg filmom obložene tablete EU/1/08/451/001
English: Don't stop taking Volibris without your doctor's advice Volibris is a treatment that you will need to keep on taking to control your PAH.
Croatian: Volibris je terapija koju morate uzimati kako biste kontrolirali PAH.
English: NAME OF THE MEDICINAL PRODUCT Volibris 5 mg tablets ambrisentan
Croatian: NAZIV LIJEKA Volibris 5 mg tablete ambrisentan
English: adverse event frequency), compared to the incidence of anaemia when ambrisentan and tadalafil were given as monotherapy (7% and 11%, respectively).
Croatian: Kada se ambrisentan primjenjivao u kombinaciji s tadalafilom, incidencija anemije bila je povećana (učestalost štetnog događaja: 15%) u odnosu na incidenciju anemije kada su se ambrisentan i tadalafil primjenjivali u monoterapiji (7% odnosno 11%).
English: • high temperature (fever)
Croatian: • povišenu tjelesnu temperaturu (vrućicu) • bol u trbuhu (abdomenu)
English: Pack sizes with unit dose blisters of 10x1 or 30x1 film-coated tablets.
Croatian: Pakiranja s 10x1 ili 30x1 filmom obloženom tabletom u blisterima djeljivima na jedinične doze.
English: Volibris 10 mg film-coated tablets
Croatian: Volibris 10 mg filmom obložene tablete
English: Mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in hemoglobin concentrations persisted for up to 4 years of treatment with ambrisentan in the long-term open-label extension of the pivotal Phase 3 clinical studies.
Croatian: Srednje smanjenje od početne vrijednosti (u rasponu od 0,9 do 1,2 g/dl) u koncentracijama hemoglobina održalo se do
English: This is a common side effect that may affect up to one in 10 people
Croatian: Ovo je česta nuspojava koja se može javiti u do 1 na