FrancophonIA/ELRC3.0 huggingface dataset:
English: Cyclosporine A: Concomitant treatment with cyclosporine A 100 mg twice daily, a combined CYP3A4 and OATP inhibitor, did not alter the steady-state exposure to macitentan and its active metabolite to a clinically relevant extent.
Croatian: Ciklosporin A: Istovremena primjena ciklosporina A 100 mg dva puta dnevno, kombiniranog inhibitora CYP3A4 i OATP, nije promijenila izloženost macitentanu i njegovom aktivnom metabolitu u stanju dinamičke ravnoteže do klinički relevantne mjere.
English: Strong CYP3A4 inducers: Concomitant treatment with rifampicin 600 mg daily, a potent inducer of CYP3A4, reduced the steady-state exposure to macitentan by 79% but did not affect the exposure to the active metabolite.
Croatian: Snažni induktori CYP3A4: Istodobna primjena rifampicina u dozi od 600 mg dnevno, snažnog induktora CYP3A4, smanjila je izloženost macitentanu u stanju dinamičke ravnoteže za 79%, ali nije utjecala na izloženost aktivnom metabolitu.
English: Hypotension2
Croatian: Često hipotenzija2
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for BLISTERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za BLISTERE
English: Opsumit is contraindicated during breastfeeding (see section 4.3).
Croatian: Opsumit je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: The incidence of aminotransferase elevations (ALT/AST) > 3 × ULN was 3.4% on macitentan 10 mg and 4.5% on placebo in a double-blind study in patients with PAH.
Croatian: Incidencija povišenja aminotransferaza (ALT/AST) > 3 × GGN iznosila je 3,4% za skupinu koja je primala macitentan 10 mg i 4,5% za skupinu koja je primala placebo u dvostruko slijepom ispitivanju u bolesnika s PAH-om.
English: Aminotransferase elevations4
Croatian: Često povišene vrijednosti aminotransferaza4
English: The cytochrome P450 enzymes CYP3A4, CYP2C8, CYP2C9, and CYP2C19 are involved in the metabolism of macitentan and formation of its metabolites (see section 5.2).
Croatian: Enzimi citokroma P450 kao što su CYP3A4, CYP2C8, CYP2C9 i CYP2C19 uključeni su u metabolizam macitentana i nastanak njegovih metabolita (vidjeti dio 5.2).
English: Opsumit is not to be initiated in patients with severe hepatic impairment or elevated aminotransferases (> 3 × ULN) (see sections 4.2 and 4.3), and is not recommended in patients with moderate hepatic impairment.
Croatian: Terapiju lijekom Opsumit ne smije se započinjati u bolesnika s teškim oštećenjem jetre ili povišenim aminotransferazama (> 3 × GGN) (vidjeti dijelove 4.2 i 4.3) te se ne preporučuje u bolesnika s umjerenim oštećenjem jetre.
English: • fast heart rate, palpitations
Croatian: • ubrzan puls, osjećaj lupanja srca
English: Opsumit contains lecithin derived from soya.
Croatian: Opsumit sadrži lecitin dobiven od soje.
English: Macitentan and its active metabolite are not inhibitors of hepatic or renal efflux pumps at clinically relevant concentrations, including the multi-drug resistance protein (P-gp, MDR-1) and multidrug and toxin extrusion transporters (MATE1 and MATE2-K).
Croatian: Macitentan i njegov aktivni metabolit nisu inhibitori jetrenih ili bubrežnih efluksnih pumpi pri klinički relevantnim koncentracijama, uključujući protein rezistencije na više lijekova (engl. multidrug resistance protein; P-gp, MDR-1) i ekstruzijske transportere više lijekova i toksina (MATE1 i MATE2-K).
English: The combination of macitentan with strong CYP3A4 inducers should be avoided (see section 4.4).
Croatian: Kombinaciju macitentana sa snažnim induktorima CYP3A4 treba izbjegavati (vidjeti dio 4.4).
English: Page 3 (inside left)
Croatian: Stranica 3 (unutarnja lijeva strana)
English: Microcrystalline cellulose (E460i)
Croatian: Jezgra tablete laktoza hidrat celuloza, mikrokristalična (E460i)
English: A decrease from baseline in haemoglobin concentration to below 10 g/dL was reported in 8.7% of patients treated with macitentan 10 mg and 3.4% of placebo-treated patients.
Croatian: Pad u odnosu na početne vrijednosti u koncentraciji hemoglobina na ispod 10 g/dl prijavljen je u 8,7% bolesnika liječenih macitentanom 10 mg i 3,4% bolesnika liječenih placebom.
English: It is unknown whether macitentan is excreted in human milk.
Croatian: Nije poznato izlučuje li se macitentan u majčino mlijeko u ljudi.
English: Elevations of liver aminotransferases (AST, ALT) have been associated with PAH and with endothelin receptor antagonists (ERAs).
Croatian: Povišenje jetrenih aminotransferaza (AST, ALT) povezano je s PAH-om i antagonistima receptora endotelina (ERA, engl. endothelin receptor antagonists).
English: The Patient Reminder Card for patients prescribed Opsumit should include the following key elements:
Croatian: Kartica-podsjetnik za bolesnike kojima je propisan Opsumit mora sadržavati sljedeće ključne elemente:
English: It is not known if Opsumit is transferred to breast milk.
Croatian: Nije poznato prelazi li Opsumit u majčino mlijeko.
English: • ritonavir, saquinavir (used to treat HIV infections),
Croatian: • ritonavir, sakvinavir (koriste se za liječenje HIV infekcije),
English: • Nasal congestion (blocked nose)
Croatian: • kongestija nosa (začepljen nos)
English: • whether you have anaemia (a reduced number of red blood cells)
Croatian: • imate li anemiju (smanjeni broj crvenih krvnih stanica)
English: Carcinogenicity studies of 2 years' duration did not reveal a carcinogenic potential at exposures 18fold and 116-fold the human exposure in rats and mice, respectively.
Croatian: Dvogodišnja ispitivanja kancerogenosti u miševa i štakora, nisu otkrila kancerogeni potencijal pri izloženosti 18 puta većoj odnosno 116 puta većoj od izloženosti kod ljudi.
English: Morbiditymortality event b
Croatian: Događaj morbiditetamortaliteta b Smrt c n (%)
English: Macitentan and its active metabolite are not inhibitors of hepatic or renal uptake transporters at clinically relevant concentrations, including the organic anion transporting polypeptides (OATP1B1 and OATP1B3).
Croatian: Macitentan i njegov aktivni metabolit nisu inhibitori jetrenih ili bubrežnih membranskih unosnih transportera pri kliničkim značajnim koncentracijama uključujući polipeptide za prijenos organskih aniona (OATP1B1 i OATP1B3).
English: Administration of macitentan to female rats from late pregnancy through lactation at maternal exposures 5-fold the human exposure, caused reduced pup survival and impairment of the reproductive capability of the offspring, which was exposed to macitentan during late intrauterine life and via the milk during the suckling period.
Croatian: 5 puta većoj od izloženosti kod ljudi uzrokovala je smanjeno preživljavanje mladunčadi i oštećenje sposobnosti razmnožavanja podmlatka izloženog macitentanu tijekom kasne faze boravka u maternici i putem mlijeka tijekom perioda sisanja.
English: 3 Oedema/fluid retention has been associated with the use of ERAs including macitentan.
Croatian: 3 Edem/retencija tekućine povezana je s primjenom ERA-ova, uključujući macitentan.
English: At clinically relevant concentrations, macitentan and its active metabolite do not interact with proteins involved in hepatic bile salt transport, i.e., the bile salt export pump (BSEP) and the sodium-dependent taurocholate co-transporting polypeptide (NTCP).
Croatian: Pri klinički relevantnim koncentracijama, macitentan i njegov aktivni metabolit ne stupaju u interakciju s proteinima u jetri koji su uključeni u transport žučnih soli, tj. s pumpom za izlučivanje žučnih soli (BSEP) te o natriju ovisnim kotransportnim polipeptidima za taurokolat (NTCP).
English: The recommended dose of Opsumit is one 10 mg tablet, once a day.
Croatian: Preporučena doza lijeka Opsumit je jedna tableta od 10 mg, jednom na dan.
English: Other worsening of PAH was defined as the presence of all of the three following components: a sustained decrease in 6-minute walk distance (6MWD) of at least 15% from baseline; worsening of PAH symptoms (worsening of WHO FC or right heart failure); and need for new treatment for PAH.
Croatian: 6-minutnoj udaljenosti hodanja (6MWD) od najmanje 15% od početne vrijednosti; pogoršanje simptoma PAH-a (pogoršanje funkcionalne klase SZO ili zatajenje desnog srca); te im je potrebno novo liječenje PAH-a.
English: • Urinary tract infection (bladder infection)
Croatian: • infekcija mokraćnog sustava (infekcija mokraćnog mjehura)
English: Exercise capacity was evaluated as a secondary endpoint.
Croatian: Simptomatske mjere ishoda Funkcionalni kapacitet procijenjen je kao sekundarna mjera ishoda.
English: What Opsumit looks like and contents of the pack Opsumit 10 mg tablets are white to off-white, biconvex, round, film-coated tablets with “10” on both sides.
Croatian: Opsumit 10 mg tablete su bijele do gotovo bijele, bikonveksne, okrugle, filmom obložene tablete s oznakom „10” na obje strane.
English: PHARMACEUTICAL FORM AND CONTENTS 15 film-coated tablets
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ 15 filmom obloženih tableta
English: • Women of childbearing potential who are not using reliable contraception (see sections 4.4 and
Croatian: • Žene reproduktivne dobi koje ne primjenjuju pouzdane kontracepcijske metode (vidjeti dijelove 4.4 i 4.6).
English: The pharmacokinetics of macitentan in PAH patients were not influenced by the severity of the disease.
Croatian: Farmakokinetika macitentana u bolesnika s PAH-om nije bila pod utjecajem težine bolesti.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag Int
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Janssen-Cilag Int
English: Laboratory abnormalities
Croatian: Nenormalni laboratorijski nalazi
English: This causes people to feel tired, dizzy, and short of breath.
Croatian: To uzrokuje umor, omaglicu i nedostatak zraka kod ljudi.
English: In placebo-controlled studies, macitentan-related decreases in haemoglobin concentration were not progressive, stabilised after the first 4-12 weeks of treatment and remained stable during chronic treatment.
Croatian: U placebom kontroliranim ispitivanjima, s macitentanom povezani padovi koncentracije hemoglobina nisu bili progresivni te su se stabilizirali nakon prvih 4 do
English: Caution should be exercised when macitentan is administered concomitantly with strong CYP3A4 inhibitors (see section 4.4).
Croatian: Treba postupati oprezno kod istodobne primjene macitentana sa snažnim inhibitorima CYP3A4 (vidjeti dio 4.4).
English: Opsumit should be used with caution in this age group.
Croatian: Opsumit u toj dobnoj skupini treba primijeniti s oprezom.
English: However, there is no clinical experience with the use of macitentan in PAH patients with moderate or severe hepatic impairment.
Croatian: Međutim, nema kliničkog iskustva s upotrebom macitentana u bolesnika s PAH-om s umjerenim ili teškim oštećenjem funkcije jetre.
English: The combination of macitentan with strong CYP3A4 inducers (e.g., rifampicin, St. John's wort, carbamazepine, and phenytoin) should be avoided (see section 4.5).
Croatian: Kombinaciju macitentana s jakim induktorima CYP3A4 (primjerice, s rifampicinom, gospinom travom, karbamazepinom i fenitoinom) treba izbjegavati (vidjeti dio 4.5).
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Croatian: 4.2 Doziranje i način primjene Liječenje treba započeti i nadzirati samo liječnik s iskustvom u liječenju PAH-a.
English: The use of Opsumit is not recommended in patients undergoing dialysis (see sections 4.4 and 5.2).
Croatian: Primjena lijeka Opsumit se ne preporučuje u bolesnika koji su na dijalizi (vidjeti dijelove 4.4 i 5.2).
English: • Prescribing checklists;
Croatian: • Popis provjere kod propisivanja;
English: • Bronchitis (inflammation of the airways)
Croatian: • bronhitis (upala dišnih putova)
English: No nasal cavity findings were noted in the 3-month mouse toxicity study or in rat and dog studies.
Croatian: Nisu zabilježene nikakve promjene na nosnoj šupljini u tromjesečnom ispitivanju toksičnosti u miševa ili štakora i pasa.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ 30 filmom obloženih tableta
English: • Pharyngitis (inflammation of the throat)
Croatian: • faringitis (upala grla)
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu se javiti kod do 1 na 10 osoba)
English: Concomitant use with strong CYP3A4 inducers
Croatian: Istovremena primjena s jakim induktorima CYP3A4
English: Treatment with macitentan 10 mg at Month 6 led to a 74% higher chance of WHO FC improvement relative to placebo (risk ratio 1.74; 97.5% CI: 1.10 to 2.74; p = 0.0063).
Croatian: Liječenje macitentanom 10 mg u 6. mjesecu uzrokovalo je 74% veću šansu za poboljšanje u funkcionalnoj klasi SZO u odnosu na placebo (omjer rizika 1,74; 97,5% CI 1,10 do 2,74; p = 0,0063).
English: Patients treated with macitentan 10 mg achieved a median reduction of 36.5% (97.5% CI: 21.7 to 49.2%) in pulmonary vascular resistance and an increase of 0.58 L/min/m2 (97.5% CI: 0.28 to 0.93 L/min/m2) in cardiac index compared to placebo.
Croatian: 10 mg postigli su medijan smanjenja od 36,5% (97,5% CI 21,7 do 49,2%) plućne vaskularne rezistencije te porasta od 0,58% L/min/m2 (97,5% CI 0,28 do 0,93 L/min/m2) kardijalnog indeksa u usporedbi s placebom.
English: In two double-blind clinical studies in patients with digital ulcers associated with systemic sclerosis, the incidences of peripheral oedema AEs ranged from 13.4% to 16.1% in the macitentan 10 mg groups and from 6.2% to 4.5% in the placebo groups.
Croatian: U dvostruko slijepom kliničkom ispitivanju bolesnika s digitalnim ulceracijama povezanim sa sistemskom sklerozom, incidencije nuspojava perifernog edema u skupinama koje su liječene macitentanom 10 mg iznosile su 13,4% do 16,1%, odnosno 6,2% do 4,5%
English: All patients were followed up to end-of-study (EOS) for vital status.
Croatian: Svim bolesnicima kontroliran je vitalni status do dovršetka ispitivanja.
English: A multicenter, double-blind, placebo-controlled, parallel-group, event-driven, Phase 3 outcome study (AC-055-302/SERAPHIN) was conducted in 742 patients with symptomatic PAH, who were randomised to three treatment groups (placebo [N = 250], 3 mg [N = 250] or 10 mg [N = 242] of macitentan once daily), to assess the long-term effect on morbidity or mortality.
Croatian: Djelotvornost u bolesnika s plućnom arterijskom hipertenzijom Multicentrično, dvostruko slijepo, placebom kontrolirano, ispitivanje ishoda faze III, u paralelnim skupinama s fokusom na događaj (AC-055-302/SERAPHIN) provedeno je u 742 bolesnika sa simptomatskim PAH-om koji su bili nasumično raspodijeljeni u tri različite skupine za liječenje
English: Treatment with macitentan 10 mg resulted in a 45% risk reduction (hazard ratio [HR] 0.55; 97.5% CI: 0.39 to 0.76; logrank p < 0.0001) of the composite morbidity-mortality endpoint up to EOT when compared to placebo [Figure 1 and Table 1].
Croatian: Liječenje macitentanom 10 mg uzrokovalo je 45% smanjenje rizika (omjer hazarda [HR] 0,55; 97,5% CI 0,39 do 0,76; logrank p < 0,0001) kompozitne mjere ishoda morbiditeta/mortaliteta do kraja liječenja kad je provedena usporedba s placebom [slika 1 i tablica 1].
English: There is no clinically relevant effect of age, sex or ethnic origin on the pharmacokinetics of macitentan and its active metabolite.
Croatian: Utjecaj dobi, spola ili etničkog podrijetla na farmakokinetiku macitentana i njegovog aktivnog metabolita nije klinički značajan.
English: • Patient reminder cards.
Croatian: • Kartice-podsjetnik za bolesnika.
English: Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease (see section 5.1).
Croatian: PAH povezan s bolestima vezivnog tkiva i PAH povezan s korigiranom jednostavnom urođenom srčanom manom (vidjeti dio 5.1).
English: If the patient misses a dose of Opsumit, the patient should be told to take it as soon as possible and then take the next dose at the regularly scheduled time.
Croatian: potrebno mu je reći da ju uzme što prije, a zatim da uzme sljedeću dozu prema redovitom rasporedu.
English: The development of testicular tubular atrophy in male animals was observed after treatment with macitentan (see section 5.3).
Croatian: Nakon liječenja macitentanom uočen je razvoj atrofije tubula testisa u mužjaka životinja (vidjeti dio 5.3).
English: Package leaflet: information for the user Opsumit 10 mg film-coated tablets macitentan
Croatian: Uputa o lijeku: Informacije za korisnika Opsumit 10 mg filmom obložene tablete macitentan
English: Signs that your liver may not be working properly include: nausea (urge to vomit) vomiting fever (high temperature) pain in your stomach (abdomen) jaundice (yellowing of your skin or the whites of your eyes) dark-coloured urine itching of your skin lethargy or fatigue (unusual tiredness or exhaustion) flu-like syndrome (joint and muscle pain with fever)
Croatian: žuticu (žutilo kože i bjeloočnica) tamno obojanu mokraću svrbež kože letargiju ili umor (neuobičajeni umor ili iscrpljenost) sindrom nalik gripi (bol u zglobovima i mišićima s vrućicom)
English: Approximately 52%, 46%, and 2% of patients were in WHO FC II, III, and IV, respectively.
Croatian: 52% bolesnika bili su u SZO funkcionalnoj klasi II, 46% ih je bilo u SZO funkcionalnoj klasi III, a 2% u SZO funkcionalnoj klasi IV.
English: Efficacy of macitentan 10 mg on the primary endpoint was consistent across subgroups of age, sex, ethnic origin, geographical region, aetiology, by monotherapy or in combination with another PAH therapy and by WHO FC (I/II and III/IV).
Croatian: Djelotvornost macitentana 10 mg kao primarna mjera ishoda bila je konzistentna širom podskupina po dobi, spolu, etničkom podrijetlu, zemljopisnoj regiji, etiologiji, monoterapiji ili kombinaciji s drugim
English: In a long-term doubleblind study in patients with PAH, hypotension was reported for 7.0% and 4.4% of patients on macitentan 10 mg and placebo, respectively.
Croatian: U dugoročnom dvostruko slijepom ispitivanju u bolesnika s PAH-om, hipotenzija je prijavljena za 7,0% bolesnika koji su primali 10 mg macitentana i 4,4% bolesnika koji su primali placebo.
English: • Hypersensitivity to the active substance, soya or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar, soju ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Trudnoća (vidjeti dio 4.6).
English: Concomitant use with strong CYP3A4 inhibitors
Croatian: Istovremena primjena s jakim inhibitorima CYP3A4
English: See package leaflet for further information
Croatian: Vidjeti uputu o lijeku za dodatne informacije
English: • flu-like syndrome (joint and muscle pain with fever)
Croatian: • neuobičajeni umor ili iscrpljenost (letargiju ili umor) • sindrom nalik gripi (bol u zglobovima i mišićima s vrućicom)
English: Opsumit treatment should only be initiated in women of childbearing potential when the absence of pregnancy has been verified, appropriate advice on contraception provided, and reliable contraception is practised (see sections 4.3 and 4.6).
Croatian: Liječenje lijekom Opsumit smije se započeti u žena reproduktivne dobi samo kada je potvrđeno da nisu trudne, kada su primile odgovarajući savjet o kontracepciji te primjenjuju pouzdanu metodu kontracepcije (vidjeti dijelove 4.3 i 4.6).
English: The benefit/risk balance of macitentan has not been established in patients with WHO class I functional status of pulmonary arterial hypertension.
Croatian: Omjer koristi i rizika macitentana nije ustanovljen u bolesnika s plućnom arterijskom hipertenzijom funkcionalne klase I prema SZO.
English: Initiation of Opsumit is not recommended in patients with severe anaemia.
Croatian: bolesnika s teškom anemijom ne preporučuje se započinjanje liječenja lijekom Opsumit.
English: Uncommon side effects (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu se javiti kod 1 na 100 osoba)
English: • Leukopenia (decreased white blood cell counts)
Croatian: • leukopenija (snižene vrijednosti leukocita)
English: In a longterm double-blind study in patients with PAH, the incidence of oedema AEs in the macitentan 10 mg and placebo treatment groups was 21.9% and 20.5%, respectively.
Croatian: U dugotrajnom dvostruko slijepom ispitivanju bolesnika s PAH-om, incidencija nuspojava edema u skupini koja je liječena macitentanom od 10 mg i skupini koja je primala placebo iznosila je 21,9% odnosno 20,5%.
English: Worsening of PAH n (%) i.v./s.c.
Croatian: Pogoršanje PAH-a n (%)
English: If you are allergic to soya, do not use this medicine (see section 2 ‘Do not take Opsumit').
Croatian: Ako ste alergični na soju, nemojte koristiti ovaj lijek
English: If you take Opsumit together with other medicines including those listed below, the effects of Opsumit or the other medicines might be altered.
Croatian: Učinci lijeka Opsumit ili drugih lijekova mogu se promijeniti ako uzimate lijek Opsumit zajedno s drugim lijekovima uključujući one navedene u nastavku.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
Croatian: 5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku
English: There is limited experience with Opsumit in patients older than 75 years.
Croatian: U bolesnika starijih od 75 godina iskustvo s lijekom Opsumit je ograničeno.
English: In a double-blind study in patients with idiopathic pulmonary fibrosis, the incidence of peripheral oedema AEs in the macitentan and placebo treatment groups was 11.8% and 6.8%, respectively.
Croatian: U dvostruko slijepom ispitivanju bolesnika s idiopatskom plućnom fibrozom (IPF), incidencija nuspojava perifernog edema u skupini koja je liječena macitentanom i skupini koja je primala placebo iznosila je 11,8% odnosno 6,8%.
English: The risk of PAH related death or hospitalisation for PAH up to EOT was reduced by 50% (HR 0.50; 97.5% CI: 0.34 to 0.75; logrank p < 0.0001) in patients receiving macitentan 10 mg (50 events) compared to placebo (84 events).
Croatian: Rizik od smrti povezane s PAH-om ili hospitalizacije zbog PAH-a do kraja liječenja smanjen je za 50% (HR 0,50; 97,5% CI 0,34 do 0,75; logrank p < 0,0001) u bolesnika koji su primali macitentan
English: There is no clinical experience with the use of macitentan in PAH patients with severe renal impairment.
Croatian: Nema kliničkog iskustva s primjenom macitentana u bolesnika s PAH-om s teškim oštećenjem bubrega.
English: Ketoconazole: In the presence of ketoconazole 400 mg once daily, a strong CYP3A4 inhibitor, exposure to macitentan increased approximately 2-fold.
Croatian: U prisutnosti ketokonazola u dozi od 400 mg jednom dnevno, snažnog inhibitora
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a mean decrease in haemoglobin versus placebo of 1 g/dL.
Croatian: U dvostruko slijepom ispitivanju na bolesnicima s PAH-om, macitentan 10 mg povezan je s prosječnim padom koncentracije hemoglobina naspram placeba od 1 g/dl.
English: Slightly increased pre- and post-implantation loss, decreased mean number of pups, and decreased testis and epididymis weights, were observed at exposures 7-fold the human exposure.
Croatian: Kod izloženosti sedam puta većoj od izloženosti kod ljudi uočeni su preimplantacijski i postimplantacijski gubitak embrija, smanjen prosječan broj mladunčadi i smanjena težina testisa i epididimisa.
English: Opsumit® 10 mg macitentan film-coated tablets
Croatian: Opsumit 10 mg macitentan filmom obložene tablete
English: Macitentan and its active metabolite ACT-132577 are well distributed into tissues as indicated by an apparent volume of distribution (Vss/F) of approximately 50 L and 40 L for macitentan and ACT-132577, respectively.
Croatian: (Vss/F) od približno 50 L za macitentan odnosno 40 L za ACT-132577.
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean platelet count of 17 × 109/L, versus a mean decrease of 11 × 109/L in placebo-treated patients.
Croatian: U dvostruko slijepom ispitivanju u bolesnika s PAH-om, macitentan od 10 mg povezan je s padom prosječnog broja trombocita od 17 × 109/L naspram prosječnog pada od 11 × 109/L u bolesnika liječenih placebom.