FrancophonIA/ELRC3.0 huggingface dataset:
English: The steady-state AUC of bosentan was 9% higher and the AUC of the active metabolite, Ro 48-5033, was 33% higher in patients with mild hepatic impairment than in healthy volunteers.
Croatian: njegovog aktivnog metabolita, Ro 48-5033, bila je 33% veća u bolesnika s blagim smanjenjem jetrene funkcije nego u zdravih dobrovoljaca.
English: Of the 22 patients stable at week 8, 6 improved at week 12/16 and 4 deteriorated compared with baseline.
Croatian: Od 22 bolesnika čije je stanje bilo stabilno nakon 8 tjedana u njih 6 došlo je do poboljšanja nakon 12/16 tjedana, a u 4 je došlo do pogoršanja u odnosu na početnu vrijednost.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
English: It is not known whether bosentan is excreted into human breast milk.
Croatian: Nije poznato izlučuje li se bosentan u majčino mlijeko.
English: Treatment with bosentan resulted in fewer new digital ulcers for the duration of therapy, compared with placebo.
Croatian: Kod liječenja bosentanom bilo je manje novih ulceracija prstiju nego kod placeba.
English: 56 film-coated tablets 112 film-coated tablets
Croatian: 56 filmom obloženih tableta 112 filmom obloženih tableta
English: Patients had primary pulmonary hypertension (10 patients) or PAH related to congenital heart diseases (9 patients) and were in WHO functional class II (n = 15, 79%) or class III (n = 4, 21%) at baseline.
Croatian: Obuhvaćeno je 10 bolesnika s primarnom plućnom hipertenzijom i 9 bolesnika s PAH-om povezanim s kongenitalnom srčanom bolesti koji su bili WHO funkcionalnog stupnja II (n = 15, 79%) ili stupnja III (n = 4, 21%) na početku studije.
English: These increases may be partly due to competitive inhibition of the elimination of bile salts from hepatocytes but other mechanisms, which have not been clearly established, are probably also involved in the occurrence of liver dysfunction.
Croatian: Povišenje jetrenih enzima dijelom može biti uzrokovano kompetitivnom inhibicijom eliminacije žučnih soli iz hepatocita, kao i drugim, još neutvrđenim mehanizmima poremećaja funkcije jetre.
English: Very common (may affect more than one in 10 people):
Croatian: Vrlo česte (mogu se pojaviti u više od 1 na 10 osoba):
English: In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, a decrease in haemoglobin concentration from baseline to below 10 g/dL was reported in 10.0% of patients.
Croatian: U analizi objedinjenih podataka 100 djece s PAH-om iz nekontroliranih pedijatrijskih studija FUTURE 1/2 i FUTURE 3/produžetak, zabilježeno je smanjenje koncentracije hemoglobina od početne vrijednosti na ispod 10 g/dl u 10,0% bolesnika.
English: Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline.
Croatian: Od 7 bolesnika kod kojih je došlo do pogoršanja nakon 8 tjedana, u njih 3 došlo je do poboljšanja nakon 12/16 tjedana, a u 4 je došlo do pogoršanja.
English: The benefit/risk balance of bosentan has not been established in patients with WHO class I functional status of PAH.
Croatian: Omjer koristi i rizika kod primjene bosentana nije ustanovljen u bolesnika s PAH-om WHO funkcionalnog stupnja I.
English: Palpitations1, 4
Croatian: Palpitacije1,4
English: Sildenafil: Co-administration of bosentan 125 mg twice daily (steady state) with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease in the sildenafil AUC and a 50% increase in the bosentan AUC.
Croatian: Sildenafil: istodobna primjena bosentana 125 mg dvaput dnevno (u stanju dinamičke ravnoteže) sa sildenafilom 80 mg tri puta dnevno (u stanju dinamičke ravnoteže) tijekom 6 dana u zdravih dobrovoljaca dovela je do smanjenja AUC-a kod sildenafila za 63% i povećanja AUC-a kod bosentana za 50%.
English: Treatment with bosentan was associated with a reduction in the rate of clinical worsening, defined as a composite of symptomatic progression, hospitalisation for PAH and death, compared with placebo (proportional risk reduction 77%, 95% confidence interval [CI] 20-94%, p = 0.0114).
Croatian: koju zajednički određuju napredovanje simptoma, hospitalizacija zbog PAH-a i smrt (smanjenje rizika za 77%, 95% interval pouzdanosti [CI] 20-94%, p = 0,0114).
English: No specific study has been performed in patients with pulmonary hypertension and concomitant left ventricular dysfunction.
Croatian: Nije provedena posebna studija u bolesnika s PAH-om i istodobnim zatajenjem lijevog ventrikula.
English: • Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function)
Croatian: • Ciroza (stvaranje ožiljaka) jetre, zatajenje jetre (teški poremećaj funkcije jetre)
English: Data on other CYP3A4 inducers, e.g., carbamazepine, phenobarbital, phenytoin and St. John's wort are lacking, but their concomitant administration is expected to lead to reduced systemic exposure to bosentan.
Croatian: Premda nema podataka o drugim induktorima CYP3A4, poput karbamazepina, fenobarbitala, fenitoina i gospine trave, očekuje se smanjeno sistemsko izlaganje bosentanu kod njegove istodobne primjene s navedenim lijekovima.
English: Twenty-six patients continued to receive bosentan in the 24-week open-label extension phase (AC-052-409) of the BREATHE-5 study (mean duration of treatment = 24.4 ± 2.0 weeks) and, in general, efficacy was maintained.
Croatian: (AC-052-409) ispitivanja BREATHE-5 (srednje trajanje liječenja = 24,4 ± 2,0 tjedna), i općenito je djelotvornost bila održana.
English: In healthy subjects, bosentan displays dose- and time-dependent pharmacokinetics.
Croatian: U zdravih osoba farmakokinetika bosentana ovisna je o dozi i vremenu.
English: Change from BL; mean (SD)
Croatian: srednja vrijednost (SD) Promjena u odnosu na BL; srednja vrijednost (SD)
English: ((Front cover))
Croatian: ((Prednja stranica))
English: In study AC-052-401, during 16 weeks of double-blind therapy, patients in the bosentan group developed a mean of 1.4 new digital ulcers vs 2.7 new digital ulcers in the placebo group (p = 0.0042).
Croatian: U studiji AC-052-401 tijekom 16 tjedana dvostruko slijepe terapije u bolesnika koji su dobivali bosentan pojavilo se u prosjeku 1,4 novih ulceracija prstiju u odnosu na 2,7 novih ulceracija prstiju u skupini koja je dobivala placebo (p = 0,0042).
English: • One patient in the bosentan group had treatment failure (need for ECMO as per protocol definition), which was declared based on increasing Oxygenation Index values within 8 h after the first study drug dose.
Croatian: (potrebe za ECMO prema definiciji protokola) koji je utvrđen na temelju rastućih vrijednosti oksigenacijskog indeksa unutar 8 sati od davanja prve doze ispitivanog lijeka.
English: The co-primary endpoints were percentage change from baseline in pulmonary vascular resistance (PVR) and change from baseline in 6-minute walk distance to Month 6 versus placebo.
Croatian: Ko-primarne mjere ishoda bile su postotak promjene plućnog krvožilnog otpora (PVR) i promjena u udaljenosti prijeđenoj šestominutnim hodanjem nakon šest mjeseci u odnosu na stanje prije liječenja, u usporedbi s placebom.
English: Inside your pack of STAYVEER tablets you will find a Patient Alert Card. You should complete this card and take it to your doctor at your next visit so that your doctor or gynaecologist can assess whether you need additional or alternative reliable contraceptive methods.
Croatian: Trebate je popuniti i uzeti je sa sobom kada idući put idete liječniku kako bi Vaš liječnik ili ginekolog ocijenio trebate li dodatnu ili drugu pouzdanu kontracepcijsku metodu.
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance dose studied in both these studies was 125 mg twice daily.
Croatian: Nakon 4 tjedna primanja bosentana 62,5 mg dvaput dnevno, doza održavanja bila je 125 mg dvaput dnevno u obje studije.
English: In patients between 3 months and 2 years the daily exposure was 7,879 ng·h/mL; AUCτ was 3,939 ng·h/mL (CV: 72%).
Croatian: U bolesnika starosti između 3 mjeseca i 2 godine dnevna izloženost bila je 7879 ng•h/mL; AUCτ je bila 3939 ng•h/mL (CV: 72%).
English: However, some patients who show no response after 8 weeks of treatment with STAYVEER may respond favourably after an additional 4 to 8 weeks of treatment.
Croatian: STAYVEEROM mogu pozitivno reagirati nakon dodatnih 4 do 8 tjedana liječenja.
English: Rifampicin: Co-administration in 9 healthy subjects for 7 days of bosentan 125 mg twice daily with rifampicin, a potent inducer of CYP2C9 and CYP3A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case.
Croatian: Rifampicin: istodobna primjena u 9 zdravih osoba kroz 7 dana bosentana 125 mg dvaput dnevno s rifampicinom, jakim induktorom CYP2C9 i CYP3A4, smanjila je koncentracije bosentana u plazmi za 58%, a u pojedinim slučajevima i za gotovo 90%.
English: Treatment with bosentan has been associated with dose-dependent elevations in liver aminotransferases and decreases in haemoglobin concentration (see section 4.4).
Croatian: Liječenje bosentanom povezano je s povišenjem vrijednosti jetrenih aminotransferaza ovisnim o dozi i smanjenjem koncentracije hemoglobina (vidjeti dio 4.4).
English: In the patients above 2 years (n = 22) the daily exposure was 8,820 ng·h/mL; AUCτ was 4,410 ng·h/mL (CV: 58%).
Croatian: U bolesnika starijih od 2 godine (n = 22) dnevna izloženost bila je 8820 ng•h/mL; AUCτ je bila 4410 ng•h/mL (CV: 58%).
English: Bosentan is metabolised by CYP2C9 and CYP3A4.
Croatian: Bosentan metaboliziraju CYP2C9 i CYP3A4.
English: Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 122 (study AC-052-401 [RAPIDS-1]) and 190 (study AC-052-331 [RAPIDS-2]) adult patients with systemic sclerosis and digital ulcer disease (either ongoing digital ulcers or a history of digital ulcers within the previous year).
Croatian: Sistemska skleroza s bolešću ulceracije prstiju Dvije randomizirane, dvostruko slijepe, multicentrične, placebom kontrolirane studije provedene su na 122 (studija AC-052-401 [RAPIDS-1]) i 190 (studija AC-052-331 [RAPIDS-2]) odrasla bolesnika sa sistemskom sklerozom i bolešću ulceracija prstiju (trenutačno prisutne ulceracije ili postojanje ulceracija u anamnezi unatrag godine dana).
English: If any of these apply to you, tell your doctor.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obratite se svom liječniku.
English: Efficacy in adult patients with pulmonary arterial hypertension Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 32 (study AC-052-351) and 213 (study AC-052-352 [BREATHE-1]) adult patients with WHO functional class III-IV PAH (primary pulmonary hypertension or pulmonary hypertension secondary mainly to scleroderma).
Croatian: Djelotvornost kod odraslih bolesnika s plućnom arterijskom hipertenzijom Dvije randomizirane, dvostruko slijepe, multicentrične, placebom kontrolirane studije provedene su na 32 (studija AC-052-351) i 213 (studija AC-052-352 [BREATHE-1]) odrasla bolesnika s PAH-om
English: In a juvenile rat toxicity study, where rats were treated from Day 4 post partum up to adulthood, decreased absolute weights of testes and epididymides, and reduced number of sperm in epididymides were observed after weaning.
Croatian: postpartalnog dana sve do odrasle dobi, nakon odvikavanja je zabilježena smanjena apsolutna težina testisa i epididimisa i smanjen broj spermija u epididimisima.
English: STAYVEER”
Croatian: STAYVEEROM.
English: Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about STAYVEER ask your doctor.
Croatian: Ako imate pitanja o lijeku STAYVEER, pitajte svog liječnika.
English: The safety profile of the combination was not different from the one expected with each component and the combination therapy was well tolerated in children and adults.
Croatian: Sigurnost primjene kombinacije lijekova nije se razlikovala od sigurnosti primjene svakog lijeka zasebno.
English: CARTON WITH 56 TABLETS
Croatian: PAKIRANJE S 56 TABLETA
English: Blood tests for liver function
Croatian: Krvne pretrage za funkciju jetre
English: These cases reinforce the importance of strict adherence to the monthly schedule for monitoring of liver function for the duration of treatment with STAYVEER (see section 4.4).
Croatian: Ti slučajevi pojačavaju važnost točnog pridržavanja mjesečnog rasporeda praćenja funkcije jetre tijekom liječenja
English: At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone.
Croatian: U stanju dinamičke ravnoteže koncentracije bosentana u plazmi bile su 3 do 4 puta više nego kod primjene samog bosentana.
English: This was a double-blind, placebo-controlled, randomised study in pre-term or term neonates (gestational age 36-42 weeks) with PPHN.
Croatian: FUTURE 4 je bila dvostruko slijepa, placebom kontrolirana, randomizirana studija u nedonoščadi ili donošene novorođenčadi (gestacijske dobi 36-42 tjedna) s PPHN.
English: When co-administered, initial trough concentrations of bosentan were approximately 30-fold higher than those measured after bosentan alone.
Croatian: Kod istodobne primjene početne najniže koncentracije bosentana bile su 30 puta više od onih koje su izmjerene nakon primjene samog bosentana.
English: In patients with evidence of the presence of cholestasis, the exposure to the active metabolite may be increased.
Croatian: Izloženost aktivnom metabolitu može se povećati kod bolesnika kod kojih je dokazano prisustvo kolestaze.
English: PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Croatian: PVC/PE/PVDC/aluminij blisteri sadrže 14 filmom obloženih tableta.
English: STAYVEER 62.5 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Croatian: STAYVEER 62,5 mg filmom obložene tablete PVC/PE/PVDC/aluminij blisteri koji sadrže 14 filmom obloženih tableta.
English: Treatment with bosentan has been associated with dose-related decreases in haemoglobin concentration (see section 4.8).
Croatian: Liječenje bosentanom povezano je sa smanjenjem koncentracije hemoglobina ovisnim o dozi (vidjeti dio 4.8).
English: Pulmonary veno-occlusive disease
Croatian: Okluzivna bolest plućnih vena
English: Recommended dose Adult
Croatian: Preporučena doza
English: 5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo.
Croatian: Edem ili retencija tekućine prijavljeni su u 13,2% bolesnika koji su dobivali bosentan i 10,9% bolesnika koji su dobivali placebo.
English: • Some patients taking STAYVEER have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Croatian: Kod nekih bolesnika koji uzimaju STAYVEER utvrđeni su abnormalni testovi funkcije jetre te anemija (snižena koncentracija hemoglobina).
English: It is important that you have these regular blood tests as long as you are taking STAYVEER.
Croatian: Važno je da tijekom uzimanja STAYVEERA provodite redovite krvne pretrage.
English: Pulmonary arterial hypertension patients with concomitant left ventricular failure
Croatian: Bolesnici s plućnom arterijskom hipertenzijom i istodobnim zatajenjem lijevog ventrikula
English: Anaemia, haemoglobin decrease, (see section 4.4)
Croatian: Anemija, smanjenje koncentracije hemoglobina, (vidjeti dio 4.4)
English: A Patient Alert Card providing important safety information that patients need to be aware of before and during treatment with STAYVEER is included in the pack.
Croatian: U pakiranje lijeka uključena je Kartica s upozorenjima za bolesnika koja sadrži važne sigurnosne informacije kojih bolesnici moraju biti svjesni prije i tijekom liječenja lijekom STAYVEER.
English: 2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo.
Croatian: Reakcije preosjetljivosti prijavljene su u 9,9% bolesnika koji su dobivali bosentan i u 9,1% bolesnika koji su dobivali placebo.
English: Warnings and precautions Tests your doctor will do before treatment
Croatian: Nalazi koje će Vaš liječnik zatražiti prije liječenja
English: In the FUTURE-4 study including 13 neonates with PPHN treated with bosentan 2 mg/kg twice daily for less than 10 days (range 0.5-10.0 days), there were no cases of liver aminotransferases ≥ 3 × ULN
Croatian: U FUTURE-4 studiji koja je uključila 13 novorođenčadi s PPHN-om liječene bosentanom u dozi od 2 mg/kg dvaput dnevno kraće od 10 dana (raspon 0,5-10,0 dana) nije bilo slučajeva s porastom razine jetrenih aminotransferaza ≥ 3 × GGN tijekom liječenja, ali se pojavio jedan slučaj hepatitisa 3 dana nakon završetka liječenja bosentanom.
English: The plasma concentrations of bosentan were not affected by concomitant simvastatin.
Croatian: Istodobna primjena simvastatina nije utjecala na koncentracije bosentana u plazmi.
English: Adverse events of liver abnormalities and anaemia/haemoglobin decrease occurred in 9% and 5% of patients, respectively.
Croatian: Štetan događaj poremećaja funkcije jetre javio se u 9%, a anemija/smanjenje razine hemoglobina u 5% bolesnika.
English: Warfarin: Co-administration of bosentan 500 mg twice daily for 6 days decreased the plasma concentrations of both S-warfarin (a CYP2C9 substrate) and R-warfarin (a CYP3A4 substrate) by 29% and 38%, respectively.
Croatian: Varfarin: istodobnom primjenom bosentana 500 mg dvaput dnevno tijekom 6 dana smanjila se koncentracija u plazmi S-varfarina (supstrat za CYP2C9) i R-varfarina (supstrat CYP3A4) za 29%,
English: A 2-year carcinogenicity study in mice showed an increased combined incidence of hepatocellular adenomas and carcinomas in males, but not in females, at plasma concentrations about 2 to 4 times the plasma concentrations achieved at the therapeutic dose in humans.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Dvogodišnja studija kancerogenosti na miševima pokazala je povećanu kombiniranu učestalost hepatocelularnih adenoma i karcinoma u mužjaka, ali ne i ženki, kod koncentracija u plazmi koje su 2 do 4 puta veće od onih koje se postižu kod terapijskih doza u ljudi.
English: Patients were treated with bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily for a further 12 weeks.
Croatian: Bolesnici su dobivali bosentan 62,5 mg dvaput dnevno tijekom 4 tjedna, a potom 125 mg dvaput dnevno tijekom daljnjih 12 tjedana.
English: Some patients taking STAYVEER were found to have abnormal liver function tests.
Croatian: Neki bolesnici koji su uzimali STAYVEER, imali su promijenjene nalaze jetrene funkcije.
English: STAYVEER 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Croatian: STAYVEER 125 mg filmom obložene tablete PVC/PE/PVDC/aluminij blisteri koji sadrže 14 filmom obloženih tableta.
English: Glibenclamide: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of glibenclamide (a CYP3A4 substrate) by 40%, with potential significant decrease of the hypoglycaemic effect.
Croatian: Glibenklamid: istodobna primjena bosentana 125 mg dvaput dnevno tijekom 5 dana smanjila je koncentraciju glibenklamida u plazmi (supstrat za CYP3A4) za 40%, s mogućim značajnim smanjenjem hipoglikemijskog učinka.
English: In adult patients, STAYVEER treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Croatian: Kod odraslih bolesnika, liječenje STAYVEEROM treba započeti dozom od 62,5 mg dvaput dnevno u trajanju od 4 tjedna i potom povećati na dozu održavanja od 125 mg dvaput dnevno.
English: In study AC-052-365 (FUTURE 1), dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
Croatian: U studiji AC-052-365 (FUTURE 1) 36 djece s PAH-om u dobi od 2 do 11 godina primalo je tablete za oralnu suspenziju.
English: The aetiology of PAH, according to Dana Point classification, included idiopathic PAH (46%), heritable PAH (3%), associated PAH after corrective cardiac surgery (38%), and PAH related to congenital heart disease associated with systemic-topulmonary shunts, including Eisenmenger syndrome (13%).
Croatian: PAH (46%), nasljedni PAH (3%), udruženi PAH nakon korektivne operacije srca (38%) te PAH
English: STAYVEER treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Croatian: Liječenje STAYVEEROM treba započeti dozom od 62,5 mg dvaput dnevno u trajanju od 4 tjedna i potom povećati na dozu održavanja od 125 mg dvaput dnevno.
English: The accumulation of bosentan in hepatocytes leading to cytolysis with potentially severe damage of the liver, or an immunological mechanism, are not excluded.
Croatian: Nije isključen ni imunološki mehanizam niti nakupljanje bosentana u hepatocitima koje dovodi do citolize s potencijalnim teškim oštećenjem jetre.
English: However, there was no evidence of bosentan affecting thyroid function (thyroxine, TSH) in humans.
Croatian: Kod ljudi nije dokazan utjecaj bosentana na funkciju štitnjače (tiroksin, TSH).
English: Package leaflet: Information for the user STAYVEER 62.5 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za korisnika STAYVEER 62,5 mg filmom obložene tablete bosentan
English: Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and STAYVEER has not been studied in man but co-administration of tacrolimus or sirolimus and STAYVEER may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant STAYVEER may reduce the plasma concentrations of tacrolimus and sirolimus.
Croatian: Takrolimus, sirolimus: istodobna primjena takrolimusa ili sirolimusa sa STAYVEEROM nije ispitana u ljudi, ali istodobna primjena takrolimusa ili sirolimusa sa STAYVEEROM kao i kod ciklosporina
English: Skin and subcutaneous disorders Common
Croatian: Poremećaji kože i potkožnog tkiva
English: On day 9, plasma concentrations of bosentan were approximately 5-fold higher than with bosentan administered alone.
Croatian: Deveti dan koncentracije bosentana u plazmi bile su približno 5 puta više od onih izmjerenih nakon primjene bosentana samostalno.
English: Concomitant use of STAYVEER and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Croatian: Istodobna primjena s drugim lijekovima Kontraindicirana je istodobna primjena STAYVEERA s ciklosporinom A (vidjeti dio 4.3 i 4.5).
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava Često
English: Simvastatin: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate) and its active β-hydroxy acid metabolite by 34% and 46%, respectively.
Croatian: Simvastatin: istodobna primjena bosentana 125 mg dvaput dnevno tijekom 5 dana dovela je do smanjenja koncentracija simvastatina u plazmi (susptrat CYP3A4) te njegovog aktivnog β-hidroksikiselinskog metabolita za 34%, odnosno 46%.
English: Cartons contain 56 or 112 film-coated tablets.
Croatian: Kutije sadrže 56 ili 112 filmom obloženih tableta.
English: Oral use Read the package leaflet before use
Croatian: Prije uporabe pročitajte uputu o lijeku
English: Consequently, should signs of pulmonary oedema occur when STAYVEER is administered in patients with PAH, the possibility of associated venoocclusive disease should be considered.
Croatian: STAYVEERA u bolesnika s PAH-om, treba razmotriti mogućnost okluzivne bolesti vena.
English: Signs that your liver may not be working properly include:
Croatian: Znakovi oštećenja funkcije jetre uključuju: