FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited clinical experience in patients over the age of 75 years.
Slovenian: Kliničnih izkušenj pri bolnikih, starejših od 75 let, je malo.
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.
Slovenian: Zdravila Opsumit se ne sme uvesti pri bolnikih s hudo jetrno okvaro ali zvišanimi aminotransferazami (> 3-kratna ULN)) (glejte poglavji 4.2 in 4.3) in se ne priporoča pri bolnikih z zmerno jetrno okvaro.
English: Macitentan and its active metabolite do not have clinically relevant inhibitory or inducing effects on cytochrome P450 enzymes.
Slovenian: Macitentan in njegovi aktivni presnovki nimajo klinično pomembnega zaviralnega ali indukcijskega učinka na encime citokroma P450.
English: • That pregnant women must not take Opsumit;
Slovenian: • da nosečnice ne smejo jemati zdravila Opsumit;
English: Warfarin: Macitentan given as multiple doses of 10 mg once daily had no effect on exposure to S-warfarin (CYP2C9 substrate) or R-warfarin (CYP3A4 substrate) after a single dose of 25 mg warfarin.
Slovenian: Varfarin: Dajanje macitentana v več odmerkih po 10 mg enkrat na dan ni vplivalo na izpostavljenost S-varfarinu (substrat CYP2C9) ali R-varfarinu (substrat CYP3A4) po enem odmerku 25 mg varfarina.
English: Figure 1 Kaplan-Meier estimates of the first morbidity-mortality event in SERAPHIN
Slovenian: Slika 1 Ocena prvega dogodka obolevnosti - smrtnosti v študiji SERAPHIN po
English: Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Slovenian: Zdravilo Opsumit je kot samostojno zdravilo ali v kombinaciji indicirano za dolgotrajno zdravljenje pljučne arterijske hipertenzije (PAH) pri odraslih bolnikih s funkcionalnim razredom (FR) II do III po SZO.
English: How to store Opsumit 6.
Slovenian: Shranjevanje zdravila Opsumit 6.
English: Page 4 (inside centre)
Slovenian: Stran 4 (znotraj sredina)
English: LIST OF EXCIPIENTS Also contains lactose and soya bean lecithin (E322).
Slovenian: Vsebuje tudi laktozo in sojin lecitin (E322).
English: Caution should be exercised when macitentan is administered concomitantly with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir) (see section 4.5).
Slovenian: Previdnost je potrebna, ko se macitentan daje sočasno z močnimi zaviralci CYP3A4 (npr. itrakonazol, ketokonazol, vorikonazol, klaritromicin, telitromicin, nefazodon, ritonavir in sakvinavir) (glejte poglavje 4.5).
English: Each tablet contains 10 mg macitentan.
Slovenian: Ena tableta vsebuje 10 mg macitentan.
English: White high-density polyethylene (HDPE) bottles with child-resistant closure and a silica gel desiccant.
Slovenian: Bele plastenke iz polietilena visoke gostote (HDPE, high-density polyethylene) z za otroke varno zaporko s silikagelnim sušilnim sredstvom.
English: 7 Platelets
Slovenian: 7 Trombociti
English: There is limited experience with Opsumit in patients older than 75 years.
Slovenian: Izkušnje z zdravilom Opsumit pri bolnikih, starejših od 75 let, so omejene.
English: Your doctor will take blood test before you start treatment with Opsumit and during treatment to test:
Slovenian: Vaš zdravnik bo naročil krvne preiskave, preden se začnete zdraviti z zdravilom Opsumit in med zdravljenjem, s katerimi bo ugotovil:
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.
Slovenian: je treba bolniku povedati, da ga vzame čim prej, nato pa z naslednjim odmerkom nadaljuje ob načrtovanem času.
English: Opsumit 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 (> 3 × ULN); see sections 4.3 and
Slovenian: Zdravila Opsumit se ne sme uvesti pri bolnikih s hudo jetrno okvaro ali s klinično pomembno zvišanimi jetrnimi aminotransferazami (več kot trikratna zgornja normalna meja (> 3 × ULN (Upper Limit of Normal)); glejte poglavji 4.3 in 4.4).
English: For more information on Opsumit, please read carefully the patient information leaflet.
Slovenian: Za več informacij o zdravilu natančno preberite navodilo za uporabo.
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).
Slovenian: Macitentan in njegov aktivni presnovek v klinično pomembnih koncentracijah nista zaviralca jetrne ali ledvične iztočne črpalke, vključno s proteinom odpornosti na več zdravil (P-gp, MDR-1), prenašalci več zdravil in prenašalci toksinske ekstruzije (MATE1 in MATE2-K).
English: Cartons containing 1 bottle of 30 film-coated tablets.
Slovenian: Škatle vsebujejo po 1 plastenko s 30 filmsko obloženimi tabletami.
English: • Anaemia (low number of red blood cells) or reduced haemoglobin
Slovenian: • anemija (nizko število rdečih krvnih celic) ali zmanjšanje ravni hemoglobina
English: Macitentan is only excreted after extensive metabolism.
Slovenian: Izločanje Macitentan se izloča le po obsežni presnovi.
English: Exposure to macitentan was decreased by 21%, 34%, and 6% and, for the active metabolite by 20%, 25%, and 25% in subjects with mild, moderate or severe hepatic impairment, respectively.
Slovenian: Izpostavljenost macitentanu se je pri osebah z blago jetrno okvaro znižala za 21 %, z zmerno za 34 % in s hudo za 6 %, aktivnemu presnovku pa za 20 % pri blagi jetrni okvari, za 25 % pri zmerni in za 25 % pri hudi.
English: The Patient Reminder Card for patients prescribed Opsumit should include the following key elements:
Slovenian: Opozorilna kartica za bolnika, ki jim je bilo predpisano zdravilo Opsumit, mora vsebovati naslednje ključne elemente:
English: OUTER CARTON/BOTTLE
Slovenian: ZUNANJA ŠKATLA/PLASTENKA
English: Page 3 (inside left)
Slovenian: Stran 3 (znotraj levo)
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.
Slovenian: Pri 742 bolnikih s simptomatsko PAH, ki so bili randomizirani v eno od treh skupin zdravljenja (placebo [N = 250], 3 mg [N = 250] ali 10 mg [N = 242] macitentana enkrat na dan), so opravili multicentrično, dvojno slepo, s placebom kontrolirano, od dogodkov odvisno študijo izidov zdravljenja 3. faze, z vzporednimi skupinami, (AC-055-302/SERAPHIN), za ocenitev dolgoročnega učinka na obolevnost ali smrtnost.
English: Elevations > 5 × ULN occurred in 2.5% of patients on macitentan 10 mg versus 2% of patients on placebo.
Slovenian: Zvišanja > 5 × ULN so se pojavila pri 2,5 % bolnikov, ki so prejemali macitentan 10 mg, v primerjavi z 2 % bolnikov, ki so prejemali placebo.
English: Several members of the CYP2C family, namely CYP2C8, CYP2C9 and CYP2C19, as well as CYP3A4, are involved in the formation of these metabolites.
Slovenian: V nastajanju teh presnovkov sodeluje več članov družine CYP2C, in sicer CYP2C8, CYP2C9 in CYP2C19, pa tudi CYP3A4.
English: After 2 years of treatment, testicular tubular atrophy was seen in rats at 4-fold the human exposure.
Slovenian: Po 2 letih zdravljenja so pri podganah opazili testikularno tubularno atrofijo pri izpostavljenosti, ki je bila 4-krat večja kot pri ljudeh.
English: You can take Opsumit with or without food.
Slovenian: Zdravilo Opsumit lahko jemljete s hrano ali brez nje.
English: • yellowing of your skin or the whites of your eyes (jaundice)
Slovenian: • rumeno obarvanost kože ali beločnic (zlatenico)
English: Opsumit contains lactose, lecithin from soya and sodium Opsumit contains a sugar called lactose.
Slovenian: Zdravilo Opsumit vsebuje laktozo, sojin lecitin in natrij Zdravilo Opsumit vsebuje sladkor, imenovan laktoza.
English: Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Na podlagi farmakokinetičnih (FK) podatkov odmerka pri bolnikih z blago, zmerno ali hudo jetrno okvaro ni treba prilagajati (glejte poglavji 4.4 in 5.2).
English: • fever
Slovenian: • vročino
English: The combination of macitentan with strong CYP3A4 inducers should be avoided (see section 4.4).
Slovenian: Kombinaciji macitentana z močnimi induktorji CYP3A4 se je treba izogniti (glejte poglavje 4.4).
English: This card contains important safety information you need to be aware of when receiving treatment withOpsumit.
Slovenian: Za zdravljenje pljučne arterijske hipertenzije Ta kartica vsebuje pomembne informacije, ki jih morate poznati, ko se zdravite z zdravilom Opsumit.
English: PHARMACEUTICAL FORM AND CONTENTS 15 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 15 filmsko obloženih tablet
English: Opsumit is contraindicated during breastfeeding (see section 4.3).
Slovenian: Zdravilo Opsumit je kontraindicirano med dojenjem (glejte poglavje 4.3).
English: If you have kidney problems, talk to your doctor before using Opsumit.
Slovenian: Če imate težave z ledvicami, se pred uporabo zdravila Opsumit posvetujte z zdravnikom.
English: There is no clinically relevant effect of age, sex or ethnic origin on the pharmacokinetics of macitentan and its active metabolite.
Slovenian: Starost, spol ali etična pripadnost nimajo klinično pomembnega učinka na farmakokinetiko macitentana in njegovega aktivnega presnovka.
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.
Slovenian: O zmanjšanju koncentracije hemoglobina na manj kot 10 g/dl glede na izhodišče so poročali pri 8,7 % bolnikov, zdravljenih z macitentanom 10 mg, in 3,4 % bolnikov, zdravljenih s placebom.
English: Haemoglobin concentration
Slovenian: Koncentracije hemoglobina
English: All patients were followed up to end-of-study (EOS) for vital status.
Slovenian: Pri vseh bolnikih so spremljali življenjski status do konca študije.
English: The MAH shall ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Opsumit are provided with a Prescriber Kit containing the following:
Slovenian: Opsumit vsi zdravstveni delavci, ki nameravajo zdravilo predpisovati in/ali izdajati, imeli na voljo komplet za zdravnike, ki bo vseboval naslednje:
English: Liver enzyme tests should be obtained prior to initiation of Opsumit.
Slovenian: Pred uvedbo zdravila Opsumit je treba pridobiti rezultate preiskav jetrnih encimov.
English: The number of deaths of all causes up to EOS on macitentan 10 mg was 35 versus 44 on placebo (HR 0.77; 97.5% CI: 0.46 to 1.28).
Slovenian: Število smrti iz vseh vzrokov do konca študije z macitentanom 10 mg je bila 35 v primerjavi s 44 na placebu (HR 0,77; 97,5 % IZ: 0,46 do 1,28).
English: HR a (97.5% CI)
Slovenian: (97,5-% IZ)
English: Treatment comparison: macitentan 10 mg vs placebo
Slovenian: Primerjava zdravljenja: macitentan 10 mg v primerjavi s placebom
English: • Leukopenia (decreased white blood cell counts)
Slovenian: • levkopenija (zmanjšane ravni belih krvnih celic)
English: • That women of childbearing potential must use reliable contraception;
Slovenian: • da morajo ženske v rodni dobi uporabljati učinkovito kontracepcijo;
English: The benefit/risk balance of macitentan has not been established in patients with WHO class I functional status of pulmonary arterial hypertension.
Slovenian: Razmerja med koristmi in tveganje macitentana pri bolnikih s funkcionalnim razredom pljučne arterijske hipertenzije I po SZO niso ugotavljali.
English: There is no experience with the use of macitentan in patients undergoing dialysis, therefore Opsumit is not recommended in this population (see sections 4.2 and 5.2).
Slovenian: Z uporabo zdravila Opsumit pri bolnikih na dializi ni izkušenj, zato se macitentan v tej populaciji ne priporoča (glejte poglavji 4.2 in 5.2).
English: • nefazodone (used to treat depression),
Slovenian: • nefazodon (zdravilo, ki se uporablja za zdravljenje depresije),
English: If a patient is hypersensitive to soya, Opsumit must not be used (see section 4.3).
Slovenian: Bolniki, preobčutljivi na sojo, zdravila Opsumit ne smejo uporabljati (glejte poglavje 4.3).
English: • ritonavir, saquinavir (used to treat HIV infections),
Slovenian: • ritonavir, sakvinavir (zdravili, ki se uporabljata za zdravljenje okužb s HIV),
English: However, there is no clinical experience with the use of macitentan in PAH patients with moderate or severe hepatic impairment.
Slovenian: Vendar pa kliničnih izkušenj z uporabo macitentana pri bolnikih s PAH z zmerno ali hudo jetrno okvaro ni.
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.
Slovenian: Drugo poslabšanje PAH je bilo opredeljeno kot prisotnost vseh treh naslednjih komponent: trajno zmanjšanje prehojene razdalje v 6 minutah (6MWD, 6-minute walk distance) za vsaj 15 % od izhodišča;
English: Approximately 52%, 46%, and 2% of patients were in WHO FC II, III, and IV, respectively.
Slovenian: Glede na FR po SZO je približno 52 % bolnikov je sodilo v razred II, 46 % v razred III in 2 % v razred IV.
English: If any of these apply to you, please tell your doctor.
Slovenian: Če karkoli od zgoraj naštetega velja za vas, to povejte zdravniku.
English: This increase is not considered clinically relevant (see sections 4.2 and 4.4).
Slovenian: Zvišanje ni bilo ocenjeno kot klinično pomembno (glejte poglavji 4.2 in 4.4).
English: prostanoid initiation n (%)
Slovenian: prostanoida n (%)
English: • Breastfeeding (see section 4.6).
Slovenian: • Dojenje (glejte poglavje 4.6).
English: This decrease is not considered clinically relevant (see sections 4.2 and 4.4).
Slovenian: Znižanje ni bilo ocenjeno kot klinično pomembno (glejte poglavji 4.2 in 4.4).
English: Macitentan was teratogenic in rabbits and rats at all doses tested.
Slovenian: Macitentan je bil pri kuncih in podganah v vseh testiranih odmerkih teratogen.
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.
Slovenian: Ciklosporin A: Sočasno zdravljenje s ciklosporinom A 100 mg dvakrat na dan, kombiniranim zaviralcem CYP3A4 in OATP, v stanju dinamičnega ravnovesja ni spremenila izpostavljenosti macitentanu in njegovemu aktivnemu presnovku v klinično pomembnem obsegu.
English: Concomitant use with strong CYP3A4 inducers
Slovenian: Sočasna uporaba z močnimi zaviralci CYP3A4
English: Opsumit contains lecithin derived from soya.
Slovenian: Zdravilo Opsumit vsebujejo lecitin, pridobljen iz soje.
English: • Nasopharyngitis (inflammation of the throat and nasal passages)
Slovenian: • nazofaringitis (vnetje žrela in nosnih poti)
English: How to take Opsumit
Slovenian: Kako jemati zdravilo Opsumit
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.
Slovenian: V dveh dvojno slepih kliničnih študijah pri bolnikih z razjedami prstov, povezanih s sistemsko sklerozo, so bile incidence neželenih učinkov perifernega edema v razponu od 13,4 % do 16,1 % za skupino z macitentanom 10 mg in od 6,2 % do 4,5 % v skupini s placebom.
English: Opsumit is contraindicated during pregnancy and in women of childbearing potential who are not using reliable contraception (see section 4.3).
Slovenian: Zdravilo Opsumit je kontraindicirano med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije (glejte poglavje 4.3).
English: Opsumit widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Slovenian: Zdravilo Opsumit pljučne arterije razširi in s tem srcu olajša črpanje krvi skoznje.
English: 2 Hypotension has been associated with the use of ERAs including macitentan.
Slovenian: 2 Z uporabo ERA, vključno z macitentanom, povezujejo hipotenzijo.
English: • regular monitoring of haemoglobin levels;
Slovenian: • rednem spremljanju ravni hemoglobina; • rednem spremljanju delovanja jeter;
English: The use of Opsumit is not recommended in patients undergoing dialysis (see sections 4.4 and 5.2).
Slovenian: Uporaba zdravila Opsumit se ne priporoča pri bolnikih, ki se zdravijo z dializo (glejte poglavji 4.4 in 5.2).
English: Be sure to discuss any questions you may have with your doctor.
Slovenian: O morebitnih vprašanjih se morate posvetovati z zdravnikom.
English: EN
Slovenian: SI
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).
Slovenian: Kombinaciji macitentana z močnimi induktorji CYP3A4 (npr. rifampicin, šentjanževka, karbamazepin in fenitoin) se je treba izogniti (glejte poglavje 4.5).
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.
Slovenian: Incidenca zvišanja aminotransferaz (ALT/AST) > 3 × ULN je bila v dvojno slepi študiji pri bolnikih s PAH 3,4 % pri macitentanu 10 mg in 4,5 % pri placebu.
English: Therefore you must not take Opsumit if you are pregnant and you must also not become pregnant while taking Opsumit.
Slovenian: če ste noseči, prav tako pa ne smete zanositi v času jemanja zdravila.
English: Testicular tubular dilatation was observed in chronic toxicity studies with male rats and dogs with safety margins of 11.6 and 5.8, respectively.
Slovenian: V študijah kronične toksičnosti so pri podganjih samcih in psih opazili testikularno tubularno dilatacijo z varnostno mejo 11,6 pri podganah oz. 5,8 pri psih.
English: • Women of childbearing potential who are not using reliable contraception (see sections 4.4 and
Slovenian: • Ženske v rodni dobi, ki ne uporabljajo učinkovite kontracepcije (glejte poglavji 4.4 in 4.6).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag Int
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Janssen-Cilag Int
English: Decrease in haemoglobin concentrations has been associated with endothelin receptor antagonists (ERAs) including macitentan (see section 4.8).
Slovenian: Zdravljenje z antagonisti receptorja endotelina, vključno z macitentanom, je povezano z zmanjšanjem koncentracij hemoglobina (glejte poglavje 4.8).
English: Idiopathic or heritable PAH was the most common aetiology in the study population (57%), followed by PAH due to connective tissue disorders (31%), PAH associated with corrected simple congenital heart disease (8%), and PAH associated with other aetiologies (medicinal products and toxins [3%] and HIV [1%]).
Slovenian: zaradi bolezni vezivnega tkiva (31 %), PAH, povezana z zdravljeno preprosto prirojeno boleznijo srca (8 %) in PAH, povezana z drugimi vzroki (zdravila in toksini [3 %] in HIV [1 %]).
English: Cases of anaemia requiring blood cell transfusion have been reported with macitentan and other ERAs.
Slovenian: Z macitentanom in drugimi ERA so poročali o primerih anemije, zaradi katere je bilo potrebno zdravljenje s transfuzijo krvnih celic.
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.
Slovenian: Bolniki, zdravljeni z macitentanom 10 mg, so dosegli mediano zmanjšanje za 36,5 % (97,5 % IZ: 21,7 do 49,2 %) pljučnega žilnega upora in zvišanje za 0,58 l/min/m2 (97,5 % IZ: 0,28 do 0,93 l/min/m2) v srčnem indeksu v primerjavi s placebom.
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.
Slovenian: Zdravilo Opsumit 10 mg tablete so bele do belkaste, bikonveksne, okrogle, filmsko obložene tablete z vtisnjeno oznako ”10” na obeh straneh.
English: Caution should be exercised when macitentan is administered concomitantly with strong CYP3A4 inhibitors (see section 4.4).
Slovenian: Previdnost je potrebna pri sočasni uporabi macitentana z močnimi zaviralci CYP3A4 (glejte poglavje 4.4).
English: It is important that you report immediately to your prescribing doctor pregnancy or any side effects that may occur during treatment with Opsumit.
Slovenian: Pomembno je, da zdravnika, ki vam je zdravilo predpisal, takoj obvestite o morebitni nosečnosti ali katerem koli neželenem učinku,
English: Worsening of PAH n (%) i.v./s.c.
Slovenian: Poslabšanje PAH n (%)
English: Opsumit contains lactose.
Slovenian: Zdravilo Opsumit vsebuje laktozo.
English: • Nasal congestion (blocked nose)
Slovenian: • kongestija nosu (zamašen nos)
English: • whether you have anaemia (a reduced number of red blood cells)
Slovenian: • ali imate anemijo (zmanjšano število rdečih krvnih celic)
English: Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells.
Slovenian: Macitentan kaže veliko afiniteto do receptorjev ET v celicah gladkih mišic pljučnih arterij pri človeku in vzdržuje njihovo zasedenost.
English: Elevations of liver aminotransferases (AST, ALT) have been associated with PAH and with endothelin receptor antagonists (ERAs).
Slovenian: S PAH in z antagonisti receptorjev endotelina (ERA, endothelin receptor antagonists) je povezano zvišanje jetrnih aminotransferaz (AST, ALT).
English: Opsumit may harm the development of the foetus.
Slovenian: Nosečnost Zdravilo lahko škoduje razvoju zarodka.
English: 1Data derived from pooled placebo-controlled studies.
Slovenian: Podatki iz združenih, s placebom nadzorovanih študij
English: Adverse reactions associated with macitentan obtained from this clinical study are tabulated below.
Slovenian: ki so jih pridobili v tej klinični študiji, so predstavljeni v spodnji preglednici.
English: Opsumit® 10 mg macitentan film-coated tablets
Slovenian: Opsumit® 10 mg macitentan filmsko obložene tablete
English: Exposure to macitentan and its active metabolite was increased by 1.3- and 1.6-fold, respectively, in patients with severe renal impairment.
Slovenian: Izpostavljenost macitentanu se je pri bolnikih s hudo okvaro ledvic zvišala za 1,3-krat in njegovemu aktivnemu presnovku za 1,6-krat.
English: Increased liver weight and hepatocellular hypertrophy were observed in mice, rats and dogs after treatment with macitentan.
Slovenian: Pri miših, podganah in psih so po zdravljenju z macitentanom opazili povečanje mase jeter in hepatocelično hipertrofijo.
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).
Slovenian: Zdravljenje z macitentanom 10 mg je v 6. mesecu privedlo do 74 % večje možnosti izboljšanja FR po SZO v primerjavi s placebom (razmerje tveganj 1,74; 97,5 % IZ: 1,10 do 2,74; p = 0,0063).
English: The development of testicular tubular atrophy in male animals was observed after treatment with macitentan (see section 5.3).
Slovenian: Po zdravljenju z macitentanom so pri samcih živali opazili razvoj testikularne tubularne atrofije (glejte poglavje 5.3).
English: Morbiditymortality event b
Slovenian: Dogodek obolevnostismrnostib
English: whether you have anaemia (a reduced number of red blood cells)
Slovenian: ali imate anemijo (zmanjšano število rdečih krvnih celic)