natgillin/translations-raw huggingface dataset:
Treatment comparison: macitentan 10 mg vs placebo
Usporedba terapija: macitentan 10 mg naspram placeba
In the presence of strong CYP3A4 inducers reduced efficacy of macitentan could occur.
U prisutnosti jakih induktora CYP3A4 može doći do smanjenja djelotvornosti macitentana.
Testicular tubular atrophy, and minimal effects on reproductive variables and sperm morphology were recorded at exposures 3.8-fold the human exposure.
Atrofija tubula testisa i minimalni učinci na reproduktivne varijable kao i na morfologiju sperme uočeni su pri izloženosti 3,8 većoj od one kod ljudi.
The exposure to the active metabolite in patients, which is approximately 5-fold less potent than macitentan, was approximately 1.3-fold higher than in healthy subjects.
Izloženost aktivnom metabolitu, koji je približno 5 puta manje potentan od macitentana, u bolesnika bila je približno 1,3 puta veća nego kod zdravih ispitanika.
However, undesirable effects may occur (e.g., headache, hypotension) that may influence the ability to drive and use machines (see section
Međutim, mogu se javiti nuspojave (npr. glavobolja, hipotenzija) koje bi mogle utjecati na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
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Sildenafil: At steady-state, the exposure to sildenafil 20 mg three times a day was increased by 15% during concomitant administration of macitentan 10 mg once daily.
Sildenafil: U stanju dinamičke ravnoteže, izloženost sildenafilu od 20 mg tri puta dnevno povećana je za 15% tijekom istovremene primjene macitentana 10 mg jednom dnevno.
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).
Na temelju farmakokinetičkih (PK) podataka, nije potrebna prilagodba doze u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
• That women of childbearing potential must use reliable contraception;
• Žene u reproduktivnoj dobi moraju koristiti pouzdanu kontracepciju;
Macitentan and its active metabolite are not relevant substrates of OATP1B1 and OATP1B3, but enter the liver by passive diffusion.
Macitentan i njegov aktivni metabolit nisu relevantni supstrati OATP1B1 i OATP1B3, ali ulaze u jetru pasivnom difuzijom.
Opsumit widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Opsumit širi plućne arterije što olakšava srcu pumpanje krvi kroz njih.
Pharmacotherapeutic group: anti-hypertensives, anti-hypertensives for pulmonary arterial hypertension.
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: antihipertenzivi, antihipertenzivi za plućnu arterijsku hipertenziju.
How to take Opsumit
Kako uzimati Opsumit
Leukopenia6
Često leukopenija6
In the period between end-of-treatment (EOT) and EOS, patients could receive open-label macitentan 10 mg or alternative PAH therapy.
U razdoblju između kraja liječenja i dovršetka ispitivanja, bolesnici su mogli primiti otvoreno liječenje macitentanom 10 mg ili zamjensku terapiju za PAH.
Macitentan and its active metabolite do not have clinically relevant inhibitory or inducing effects on cytochrome P450 enzymes.
Macitentan i njegov aktivni metabolit nemaju klinički značajne inhibitorne ili induktivne učinke na enzime citokroma P450.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ako vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
• The importance of telling patients to report immediately any possible pregnancy that occurs during Opsumit use.
• Važnost upućivanja bolesnice da prijavi svaku moguću trudnoću do koje dođe tijekom primjene lijeka Opsumit.
OUTER CARTON/BOTTLE
KUTIJA/ BOCA
Keep this medicine out of the sight and reach of children.
Kako čuvati Opsumit Lijek čuvajte izvan pogleda i dohvata djece.
Exposure to macitentan and its active metabolite was increased by 1.3- and 1.6-fold, respectively, in patients with severe renal impairment.
Izloženost macitentanu i njegovom aktivnom metabolitu povećana je za 1,3 odnosno 1,6 puta u bolesnika s teškim oštećenjem funkcije bubrega.
In both species there were cardiovascular and mandibular arch fusion abnormalities.
U obje vrste uočeni su kardiovaskularni poremećaji te nenormalna fuzija mandibularnog luka.
Sildenafil, a CYP3A4 substrate, did not affect the pharmacokinetics of macitentan, while there was a 15% reduction in the exposure to the active metabolite of macitentan.
Sildenafil, supstrat CYP3A4, nije utjecao na farmakokinetiku macitentana dok je istovremeno bila prisutna redukcija u izloženosti aktivnom metabolitu od 15%.
No dose adjustment is required in patients over the age of 65 years (see section 5.2).
U bolesnika starijih od 65 godina nije potrebna prilagodba doze (vidjeti dio 5.2).
Macitentan has been administered as a single dose of up to 600 mg to healthy subjects.
Macitentan je davan zdravim ispitanicima kao pojedinačna doza do 600 mg.
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).
Potreban je oprez kad se macitentan primjenjuje istovremeno s jakim inhibitorima CYP3A4 (primjerice, s itrakonazolom, ketokonazolom, vorikonazolom, klaritromicinom, telitromicinom, nefazodonom, ritonavirom i sakvinavirom) (vidjeti dio 4.5).
Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells.
Macitentan pokazuje visoki afinitet i održivu zauzetost ET receptora u stanicama glatkih mišića arterija mišića.
• To provide patients with appropriate information regarding the safe use of the product;
• Bolesnicima dati odgovarajuće informacije o sigurnoj primjeni lijeka;
This decrease is not considered clinically relevant (see sections 4.2 and 4.4).
Ovo smanjenje nije se smatralo klinički značajnim (vidjeti dijelove 4.2 i 4.4).
• nefazodone (used to treat depression),
• nefazodon (koristi se za liječenje depresije),
White high-density polyethylene (HDPE) bottles with child-resistant closure and a silica gel desiccant.
Bijele boce od polietilena visoke gustoće (HDPE) sa zaštitnim zatvaračem sigurnim za djecu i sredstvom za sušenje od silika gela.
All events were confirmed by an independent adjudication committee, blinded to treatment allocation.
Svi su događaji potvrđeni od strane neovisnog povjerenstva za procjenu koje nije raspolagalo podacima o vrsti terapije koja je dodijeljena pojedinim skupinama bolesnika.
It is important that you report immediately to your prescribing doctor pregnancy or any side effects that may occur during treatment with Opsumit.
Važno je da svom liječniku koji Vam je propisao lijek odmah prijavite trudnoću ili bilo koju nuspojavu koja se može javiti tijekom liječenja lijekom Opsumit.
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
Terapija Opsumitom se ne smije započinjati u bolesnika s teškim oštećenjem funkcije jetre ili klinički značajno povišenim jetrenim aminotransferazama (više od 3 puta od gornje granice normale (> 3 × GGN); vidjeti dijelove 4.3 i 4.4).
• regular monitoring of haemoglobin levels;
• redovitim praćenjem razina hemoglobina;
Testicular tubular dilatation was observed in chronic toxicity studies with male rats and dogs with safety margins of 11.6 and 5.8, respectively.
Dilatacija tubula testisa uočena je u ispitivanjima kronične toksičnosti kod mužjaka štakora i pasa sa sigurnosnom granicom od 11,6 odnosno 5,8.
LIST OF EXCIPIENTS Also contains lactose and soya bean lecithin (E322).
3. POPIS POMOĆNIH TVARI Sadrži također laktozu i sojin lecitin (E322).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg macitentan.
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 10 mg macitentana.
Exposure to macitentan in patients with PAH was approximately 1.2-fold greater than in healthy subjects.
Izloženost macitentanu u bolesnika s PAH-om bila je približno 1,2 puta veća nego kod zdravih ispitanika.
• Pregnancy (see section 4.6).
• Dojenje (vidjeti dio 4.6).
Haemodynamic parameters were assessed in a subset of patients (placebo [N = 67], macitentan 10 mg [N = 57]) after 6 months of treatment.
Hemodinamski parametri procijenjeni su na podskupini bolesnika (placebo [N = 67] te na onima koji su primali macitentan 10 mg [N = 57] nakon 6 mjeseci liječenja.
Macitentan may lead to more reduction of blood pressure and decrease in haemoglobin in patients with kidney problems.
Macitentan može dovesti do sniženja krvnog tlaka i smanjenja hemoglobina u bolesnika s oštećenjem bubrega.
The safety of macitentan in children and adolescents below 18 years has not yet been established.
Sigurnost macitentana u djece i adolescenata s nenavršenih 18 godina nisu još ustanovljene.
If any of these apply to you, please tell your doctor.
Ako se išta od navedenog odnosi na Vas, molimo obavijestite svog liječnika.
Each tablet contains 10 mg macitentan.
Jedna tableta sadrži 10 mg macitentana.
After 2 years of treatment, testicular tubular atrophy was seen in rats at 4-fold the human exposure.
2 godine liječenja, atrofija tubula testisa uočena je u štakora pri 4 puta većoj izloženosti od one kod ljudi.
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).
Nema iskustva s primjenom macitentana u bolesnika koji su na dijalizi pa se stoga Opsumit ne preporučuje u ovoj populaciji (vidjeti dijelove 4.2 i 5.2).
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.
Opsumit je, kao monoterapija ili u kombinaciji, indiciran za dugotrajno liječenje odraslih bolesnika s plućnom arterijskom hipertenzijom (PAH) klasificiranom prema kriterijima Svjetske zdravstvene organizacije (SZO) kao funkcionalna klasa II do III.
Very common side effects (may affect more than 1 in 10 people)
Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba)
Based on PK data, no dose adjustment is required in patients with renal impairment.
Na temelju PK podataka, nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega.
If you have kidney problems, talk to your doctor before using Opsumit.
Ako imate problema s bubrezima, obavijestite svog liječnika prije primjene lijeka Opsumit.
4 Liver aminotransferases
Jetrene aminotransferaze
• The need for regular blood tests because Opsumit causes a decrease in haemoglobin;
• Potreba za redovitim krvnim pretragama, jer Opsumit uzrokuje pad hemoglobina
Adverse reactions associated with macitentan obtained from this clinical study are tabulated below.
Nuspojave povezane s macitentanom dobivene iz ovih kliničkih ispitivanja navedene su u tablici u nastavku.
Macitentan was teratogenic in rabbits and rats at all doses tested.
Macitentan se pokazao teratogen u kunića i štakora pri svim ispitanim dozama.
Hypersensitivity reactions (e.g., angioedema, pruritus, rash)1
Manje često reakcije preosjetljivosti (npr. angioedem, svrbež, osip)1
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.
Izloženost macitentanu bila je smanjena za 21%, 34% i 6% te za aktivni metabolit za 20%, 25% te za
Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of effects such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation.
Endotelin (ET)-1 i njegovi receptori (ETA i ETB) posreduju različite učinke poput vazokonstrikcije,
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Opsumit is contraindicated during pregnancy and in women of childbearing potential who are not using reliable contraception (see section 4.3).
Opsumit je kontraindiciran tijekom trudnoće i kod žena reproduktivne dobi koje ne koriste pouzdanu kontracepciju (vidjeti dio 4.3).
Your doctor will take blood test before you start treatment with Opsumit and during treatment to test:
Vaš liječnik će provesti krvne pretrage prije početka liječenja lijekom Opsumit i tijekom liječenja kako bi ispitao:
Macitentan induced minimal to slight mucosal hyperplasia and inflammatory infiltration in the submucosa of the nasal cavity in the mouse carcinogenicity study at all doses.
Macitentan je inducirao minimalnu do blagu hiperplaziju sluznice i upalnu infiltraciju podsluznice nosne šupljine u ispitivanjima kancerogenosti na miševima u svim dozama.
The pharmacokinetics of macitentan and its active metabolite have mainly been documented in healthy subjects.
5.2 Farmakokinetička svojstva Farmakokinetika macitentana i njegovog aktivnog metabolita uglavnom je proučavana na zdravim ispitanicima.
Elevations > 5 × ULN occurred in 2.5% of patients on macitentan 10 mg versus 2% of patients on placebo.
Povišenja > 5 × GGN dogodila su se u 2,5% bolesnika koji su primali macitentan 10 mg naspram 2% bolesnika koji su primali placebo.
2 Hypotension has been associated with the use of ERAs including macitentan.
2 Hipotenzija je povezana s primjenom ERA-ova, uključujući macitentan.
- The other ingredients are lactose monohydrate (see section 2 “Opsumit contains lactose, lecithin from soya and sodium"), microcrystalline cellulose (E460i), povidone, sodium starch glycolate Type A (see section 2 “Opsumit contains lactose, lecithin from soya and sodium”), magnesium stearate (E572), polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soya bean lecithin (E322) (see section 2 “Opsumit contains lactose, lecithin from soya and sodium") and xanthan gum (E415).
„Opsumit sadrži laktozu, sojin lecitin i natrij“), magnezijev stearat (E572), polisorbat 80 (E433), poli(vinilni alkohol) (E1203), titanijev dioksid (E171), talk (E553b), sojin lecitin (E322) (vidjeti dio 2 „Opsumit sadrži laktozu, sojin lecitin i natrij“) i ksantanska guma (E415).
Opsumit contains lactose.
Opsumit sadrži laktozu.
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.
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.
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.
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.
Hypotension2
Često hipotenzija2
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for BLISTERS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za BLISTERE
Opsumit is contraindicated during breastfeeding (see section 4.3).
Opsumit je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
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.
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.
Aminotransferase elevations4
Često povišene vrijednosti aminotransferaza4
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).
Enzimi citokroma P450 kao što su CYP3A4, CYP2C8, CYP2C9 i CYP2C19 uključeni su u metabolizam macitentana i nastanak njegovih metabolita (vidjeti dio 5.2).
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.
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.
• fast heart rate, palpitations
• ubrzan puls, osjećaj lupanja srca
Opsumit contains lecithin derived from soya.
Opsumit sadrži lecitin dobiven od soje.
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).
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).
The combination of macitentan with strong CYP3A4 inducers should be avoided (see section 4.4).
Kombinaciju macitentana sa snažnim induktorima CYP3A4 treba izbjegavati (vidjeti dio 4.4).
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Microcrystalline cellulose (E460i)
Jezgra tablete laktoza hidrat celuloza, mikrokristalična (E460i)
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.
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.
It is unknown whether macitentan is excreted in human milk.
Nije poznato izlučuje li se macitentan u majčino mlijeko u ljudi.
Elevations of liver aminotransferases (AST, ALT) have been associated with PAH and with endothelin receptor antagonists (ERAs).
Povišenje jetrenih aminotransferaza (AST, ALT) povezano je s PAH-om i antagonistima receptora endotelina (ERA, engl. endothelin receptor antagonists).
The Patient Reminder Card for patients prescribed Opsumit should include the following key elements:
Kartica-podsjetnik za bolesnike kojima je propisan Opsumit mora sadržavati sljedeće ključne elemente:
It is not known if Opsumit is transferred to breast milk.
Nije poznato prelazi li Opsumit u majčino mlijeko.
• ritonavir, saquinavir (used to treat HIV infections),
• ritonavir, sakvinavir (koriste se za liječenje HIV infekcije),
• Nasal congestion (blocked nose)
• kongestija nosa (začepljen nos)
• whether you have anaemia (a reduced number of red blood cells)
• imate li anemiju (smanjeni broj crvenih krvnih stanica)
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.
Dvogodišnja ispitivanja kancerogenosti u miševa i štakora, nisu otkrila kancerogeni potencijal pri izloženosti 18 puta većoj odnosno 116 puta većoj od izloženosti kod ljudi.
Morbiditymortality event b
Događaj morbiditetamortaliteta b Smrt c n (%)
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).
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).
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.
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.
3 Oedema/fluid retention has been associated with the use of ERAs including macitentan.
3 Edem/retencija tekućine povezana je s primjenom ERA-ova, uključujući macitentan.
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).
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).
The recommended dose of Opsumit is one 10 mg tablet, once a day.
Preporučena doza lijeka Opsumit je jedna tableta od 10 mg, jednom na dan.
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.
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.
• Urinary tract infection (bladder infection)
• infekcija mokraćnog sustava (infekcija mokraćnog mjehura)
Exercise capacity was evaluated as a secondary endpoint.
Simptomatske mjere ishoda Funkcionalni kapacitet procijenjen je kao sekundarna mjera ishoda.
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.
Opsumit 10 mg tablete su bijele do gotovo bijele, bikonveksne, okrugle, filmom obložene tablete s oznakom „10” na obje strane.
PHARMACEUTICAL FORM AND CONTENTS 15 film-coated tablets
4. FARMACEUTSKI OBLIK I SADRŽAJ 15 filmom obloženih tableta
• Women of childbearing potential who are not using reliable contraception (see sections 4.4 and
• Žene reproduktivne dobi koje ne primjenjuju pouzdane kontracepcijske metode (vidjeti dijelove 4.4 i 4.6).
The pharmacokinetics of macitentan in PAH patients were not influenced by the severity of the disease.
Farmakokinetika macitentana u bolesnika s PAH-om nije bila pod utjecajem težine bolesti.
NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag Int
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Janssen-Cilag Int
Laboratory abnormalities
Nenormalni laboratorijski nalazi
This causes people to feel tired, dizzy, and short of breath.
To uzrokuje umor, omaglicu i nedostatak zraka kod ljudi.
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.
U placebom kontroliranim ispitivanjima, s macitentanom povezani padovi koncentracije hemoglobina nisu bili progresivni te su se stabilizirali nakon prvih 4 do
Caution should be exercised when macitentan is administered concomitantly with strong CYP3A4 inhibitors (see section 4.4).
Treba postupati oprezno kod istodobne primjene macitentana sa snažnim inhibitorima CYP3A4 (vidjeti dio 4.4).
Opsumit should be used with caution in this age group.
Opsumit u toj dobnoj skupini treba primijeniti s oprezom.
However, there is no clinical experience with the use of macitentan in PAH patients with moderate or severe hepatic impairment.
Međutim, nema kliničkog iskustva s upotrebom macitentana u bolesnika s PAH-om s umjerenim ili teškim oštećenjem funkcije jetre.