natgillin/translations-raw huggingface dataset:
This was tested for low-dose nifedipine only.
To je bilo testirano le za nizke odmerke nifedipina.
The estimates may have been influenced by the initiation of new or additional PAH therapies, which occurred in 24% of patients at one year.
Na ocene so lahko vplivale uvedbe novih ali dodatnih postopkov zdravljenja PAH, kar se je zgodilo pri 24 % bolnikov po 1 letu.
• Try to take the tablet at the same time each day to help you remember.
• Tableto vzemite vedno ob isti uri, da si boste lažje zapomnili.
Bottle Label (fix-a form)
Nalepka na plastenki (fix-a form)
The degree of binding is independent of concentration in the clinically relevant range.
Stopnja vezave je neodvisna od koncentracije v klinično pomembnem območju.
Potential effects in humans are unknown.
Možni učinki pri ljudeh niso znani.
For more details on liver problems, see ‘Testing for liver problems' in section 2.
Za več podatkov o težavah z jetri glejte „Preiskave za težave z jetri“ v poglavju 2.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Zdravljenje lahko uvede in spremlja le zdravnik, ki ima izkušnje z zdravljenjem PAH.
This may lead to hepatic failure, which can be fatal, and highlights the need for regular monitoring of transaminases and bilirubin.
To lahko povzroči odpoved jeter, lahko s smrtnim izidom, in poudarja potrebo po rednem spremljanju vrednosti transaminaz in bilirubina.
The change in AUC was not considered clinically significant.
Sprememba AUC se ne šteje za klinično pomembno.
Tell your doctor at once if you are or plan to become pregnant in the near future.
Nemudoma obvestite svojega zdravnika, če ste noseči ali če načrtujete zanositev v bližnji prihodnosti.
Pharmacotherapeutic group: Other antihypertensives, ATC code: C02KX03
Farmakoterapevtska skupina: Drugi antihipertenzivi, oznaka ATC: C02KX03
In the event of overdose, symptomatic and supportive measures should be employed.
V primeru prevelikega odmerjanja je potrebno začeti simptomatsko in podporno zdravljenje.
Your doctor may recommend monthly pregnancy tests while you are taking Thelin.
Vaš zdravnik vam lahko priporoči mesečno testiranje nosečnosti v času jemanja zdravila Thelin.
OTHER CONDITIONS
DRUGI POGOJI
It is recommended that haemoglobin concentrations be checked prior to treatment, after 1 and 3 months, and every 3 months thereafter.
Priporočljivo je, da koncentracije hemoglobina preverite pred zdravljenjem, nato po 1 in 3 mesecih, zatem pa vsake 3 mesece.
The dose of these medicines may need to be adjusted by your doctor.
Vaš zdravnik bo morda moral prilagoditi odmerek teh zdravil.
Interaction with sildenafil may be serious if hypotension occurs beyond a safe level.
Interakcija s sildenafilom je lahko resna, če pride do hipotenzije pod varnim območjem.
Aminotransferase levels must then be checked within 3 days after re-introduction, then again after a further 2 weeks, and thereafter according to the recommendations above.
Vrednosti aminotransferaz morate preveriti v 3 dneh po ponovni uvedbi, nato po dodatnih 2 tednih, kasneje pa po zgornjih priporočilih.
Do not breast-feed if you are taking this medicine, it is not known if it passes into breast milk.
Ne dojite med jemanjem tega zdravila, saj ni znano, ali prehaja v materino mleko.
Improvements in functional class were observed across all studies (STRIDE-1, STRIDE-2 & STRIDE-4).
Izboljšanje v funkcionalnih razredih so opazili pri vseh študijah (STRIDE-1, STRIDE-2 in STRIDE-4).
This specific group had a higher risk (19%; N = 10/53) of developing elevations in ALT and/or AST > 3 x ULN indicating that appropriate care should be exercised when initiating sitaxentan in this patient population.
Ta specifična skupina je imela večje tveganje (19 %, n = 10/53) za zvišanje ALT in/ali AST > 3 × ZMN, kar kaže, da je v primeru uvedbe sitaksentana v tej populaciji bolnikov potrebna ustrezna skrb.
Approximately 50-60% of an oral dose is excreted in the urine with the remainder eliminated in the faeces.
Približno 50-60 % peroralnega odmerka se izloči z urinom, preostali del pa z blatom.
WHAT THELIN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO THELIN IN ZA KAJ GA UPORABLJAMO
The usual dose is a 100 mg tablet once a day.
Običajen odmerek je ena 100 mg tableta enkrat na dan.
Additionally, PAH also is characterized by reduced nitric oxide activity.
Poleg tega je za PAH značilno tudi zmanjšanje aktivnosti dušikovega oksida.
If a marked decrease in haemoglobin concentration occurs, further evaluation should be undertaken to determine the cause and need for specific treatment.
Če pride do izrazitega znižanja koncentracije hemoglobina, morate z dodatnimi preiskavami določiti vzrok in ugotoviti, ali je potrebno specifično zdravljenje.
Safety of Thelin has been evaluated in clinical trials of more than 1200 patients with PAH, as well as post-marketing safety data.
Varnost zdravila Thelin so ocenili v kliničnih preskušanjih pri več kot 1.200 bolnikih s PAH in tudi na podlagi podatkov o varnosti zdravila iz obdobja trženja.
Therefore, especially in women who smoke, there is an increased risk for thromboembolism.
Zato imajo zlasti kadilke zvišano tveganje za tromboembolijo.
Therefore, at higher doses of nifedipine, an increase in exposure cannot be excluded.
Zato pri večjih odmerkih nifedipina ni mogoče izključiti večje izpostavitve le temu.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Bolniki z redkimi dednimi težavami intolerance galaktoze, pomanjkljivostjo laktaze Lapp ali malabsorpcije glukoze-galaktoze ne smejo jemati tega zdravila.
A total of 145 patients were treated with sitaxentan sodium 100 mg and their long term survival status was assessed for a minimum of 3 years.
Z zdravilom Thelin 100 mg je bilo zdravljenih skupno 145 bolnikov in njihovo dolgoročno preživetje so ocenjevali najmanj 3 leta.
• If you are allergic (hypersensitive) to sitaxentan sodium or any of the other ingredients in these tablets;
• Če ste alergični na (preobčutljivi za) natrijev sitaksentanat ali katerokoli sestavino zdravila v teh tabletah.
Liver function abnormalities have been associated with PAH.
Nenormalnosti jetrne funkcije so povezane s PAH.
• If you have raised levels of some liver enzymes (detected by blood tests);
• Če imate zvišane ravni določenih jetrnih encimov (ki se določajo s preiskavo krvi).
In the case of clinical deterioration despite Thelin treatment for at least 12 weeks, alternative therapies should be considered.
V primeru kliničnega poslabšanja kljub zdravljenju z zdravilom Thelin najmanj 12 tednov, morate preučiti možnosti alternativnih načinov zdravljenja.
The significance of these findings for humans is unknown.
Pomen teh odkritij za človeka ni znan.
A NOAEL has not been established.
Vrednosti NOAEL niso določili.
A known undesirable effect is dizziness, which could influence the ability to drive or use machines.
Znan neželen učinek je omotica, ki lahko vpliva na sposobnost vožnje in upravljanja s stroji.
The effect of Thelin on the outcome of the disease is unknown.
Učinek zdravila Thelin na izid bolezni ni znan.
The mechanism of liver toxicity is not fully documented and it might vary between endothelin receptor antagonists.
Mehanizem hepatotoksičnosti ni povsem dokumentiran in se med različnimi antagonisti receptorja za endotelin lahko razlikuje.
Two randomized, double-blind, multi-centre, placebo-controlled trials were conducted to demonstrate efficacy.
Za dokaz učinkovitosti sta bili opravljeni dve randomizirani, dvojno slepi, multicentrični preskušanji, ki sta bili kontrolirani s placebom.
Cartons contain 14, 28, 56, or 84 tablets.
Škatle vsebujejo 14, 28, 56 ali 84 tablet.
If INR is not properly monitored and increased exposure to vitamin K antagonists remains undetected, severe or life-threatening bleeding episodes may occur.
Če INR ne nadziramo ustrezno in ostane povečana izpostavitev antagonistom vitamina K neodkrita, se lahko pojavijo hude ali smrtno nevarne krvavitve.
Re-introduction must follow the guidelines detailed in section 4.2.
Pri ponovni uvedbi zdravljenja morate upoštevati smernice iz poglavja 4.2.
Do not take Thelin:
Ne jemljite zdravila Thelin:
This blood test will be done before treatment, then one month and three months after you start taking Thelin tablets.
Te preiskave boste opravili pred zdravljenjem, nato pa en mesec in tri mesece po začetku jemanja tablet zdravila Thelin.
Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom
Pfizer Limited Sandwich Kent CT13 9NJ Velika Britanija
Excipients: Also contains 166.3mg of lactose monohydrate.
Pomožne snovi: Vsebuje tudi 166,3 mg laktoze monohidrata.
Based on results of the population pharmacokinetic analysis and pooled pharmacokinetic data over several studies, it was found that gender, race, and age do not clinically significantly affect the pharmacokinetics of sitaxentan sodium.
Na osnovi rezultatov populacijske analize farmakokinetike in združenih farmakokinetičnih podatkov iz več raziskav so ugotovili, da spol, rasa in starost klinično pomembno ne vplivajo na farmakokinetiko natrijevega sitaksentanata.
Thelin is a potent (Ki 0.43 nM) and highly selective ETA antagonist (approximately 6,500-fold more selective for ETA as compared to ETB).
Zdravilo Thelin je močen (Ki 0,43 nM) in izredno selektiven antagonist ETA (približno 6.500-krat bolj selektiven za ETA v primerjavi z ETB).
If you miss a period or think you may be pregnant, contact your doctor right away.
Če ne dobite menstruacije ali če menite, da ste noseči, nemudoma obvestite svojega zdravnika.
Use in patients using other medicines:
Bolniki, ki jemljejo druga zdravila:
Mild to severe hepatic impairment (Child-Pugh Class A-C).
Blaga do huda jetrna okvara (Child-Pugh razred A-C).
However, at doses of 300 mg or higher, non-linear pharmacokinetics result in disproportionately higher plasma concentrations of sitaxentan sodium.
Vendar pri odmerkih 300 mg ali več nelinearna farmakokinetika povzroči nesorazmerno visoke plazemske koncentracije natrijevega sitaksentanata.
If you forget to take Thelin
Če ste pozabili vzeti zdravilo Thelin
Reproduction toxicity has been evaluated in rats only.
Vpliv na sposobnost razmnoževanja je bil raziskan le pri podganah.
EU/1/06/353/001 (14 film-coated tablets in blisters) EU/1/06/353/002 (28 film-coated tablets in blisters) EU/1/06/353/003 (56 film-coated tablets in blisters) EU/1/06/353/004 (84 film-coated tablets in blisters)
EU/1/06/353/001 (14 filmsko obloženih tablet v pretisnih omotih) EU/1/06/353/002 (28 filmsko obloženih tablet v pretisnih omotih) EU/1/06/353/003 (56 filmsko obloženih tablet v pretisnih omotih) EU/1/06/353/004 (84 filmsko obloženih tablet v pretisnih omotih)
Marketing authorisation holder: Pfizer Limited
Imetnik dovoljenja za promet: Pfizer Limited
Sitaxentan sodium is more than 99% protein bound to plasma proteins, predominantly albumin.
Natrijev sitaksentanat je v več kot 99 % vezano na plazemske beljakovine, poglavitno na albumin.
Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity.
Zdravljenje bolnikov s pljučno arterijsko hipertenzijo (PAH), ki so uvrščeni v funkcionalni razred III po WHO, za izboljšanje vadbene zmogljivosti.
In both STRIDE-1 and STRIDE-2 trials, treatment with Thelin resulted in a significant increase in exercise capacity.
V obeh preskušanjih STRIDE-1 in STRIDE-2 je zdravljenje z zdravilom Thelin povzročilo statistično pomembno zvišanje vadbene zmogljivosti.
Adverse events reported during the post-marketing period to date have been similar to those reported in clinical trials.
Neželeni učinki, doslej opisani v obdobju trženja , so bili podobni neželenim učinkom, opisanim v kliničnih preskušanjih.
Thelin was not carcinogenic when administered to rats for 97-99 weeks or when administered to p53(+/-) transgenic mice for 6 months.
Niso odkrili karcinogenih učinkov pri dajanju zdravila Thelin podganam 97-99 tednov in transgenim mišim p53(+/-) 6 mesecev.
In this total population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96%, 85% and 78% respectively.
V tej populaciji je Kaplan-Meierjeva ocena preživetja po 1, 2 in 3 letih zdravljenja z natrijevim sitaksentanatom 96 %, 85% in 78%.
These changes in sildenafil plasma concentrations were not considered clinically significant.
Te spremembe plazemskih koncentracij sildenafila se ne štejejo za klinično pomembne.
Testing for liver problems
Preiskave za težave z jetri
If you notice any of these signs:
Če opazite kateregakoli od naslednjih znakov:
Less than 1% of the dose is excreted as unchanged active ingredient.
V nespremenjeni obliki se izloči manj kot 1 % odmerka zdravilne učinkovine.
Sitaxentan sodium does not penetrate into erythrocytes and does not appear to cross the blood-brain barrier.
Natrijev sitaksentanat ne vstopa v eritrocite in izgleda, da ne prehaja krvno-možganske pregrade.
In PAH patients, peak plasma concentrations are generally achieved within 1-4 hours.
Pri bolnikih s PAH so bile najvišje plazemske koncentracije ponavadi dosežene v 1 do 4 urah.
Elevated aminotransferases prior to initiation of treatment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x ULN).
Zvišane vrednosti aminotransferaz pred začetkom zdravljenja (aspartat-aminotransferaza (AST) in/ali alanin-aminotransferaza (ALT) > 3 × ZMN).
High-density polyethylene (HDPE) bottles containing 28 tablets.
Plastenke iz polietilena visoke gostote (HDPE) vsebujejo 28 tablet.
For oral use Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo.
Effects of Thelin on other medicinal products
Učinki zdravila Thelin na druga zdravila
Studies in patients with pre-existing liver impairment have not been conducted.
Raziskave na bolnikih z obstoječo jetrno okvaro niso bile opravljene.
It is unknown whether or not sitaxentan sodium is excreted into human milk.
Ni znano, ali se natrijev sitaksentanat izloča v človeškem materinem mleku.
• If you are taking Ciclosporin A (used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver or kidney transplants);
• Če jemljete ciklosporin A (uporablja se za zdravljenje luskavice in revmatoidnega artritisa ter za preprečevanje zavrnitve presajenih jeter ali ledvic).
The efficacy and safety of Thelin co-administration with other treatments for PAH (eg, epoprostenol, sildenafil, iloprost) has not been studied in controlled clinical trials.
Učinkovitost in varnost zdravila Thelin pri sočasnem jemanju drugih zdravil za zdravljenje PAH (npr. epoprostenol, sildenafil, iloprost) nista bili preučeni v kontroliranih kliničnih preskušanjih.
• If you are taking a statin (e.g. pravastatin or simvastatin).
• Če jemljete statin (npr. prevastatin ali simvastatin).
Re-introduction of treatment with Thelin should only be considered if the potential benefits of treatment with Thelin outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Ponovno uvedbo zdravljenja z zdravilom Thelin preučite le, če so potencialni koristni učinki zdravljenja z zdravilom Thelin večji od potencialnih tveganj in če so vrednosti jetrnih aminotransferaz v območju vrednosti pred zdravljenjem.
However, patients completing STRIDE-2 were eligible to enrol in open-label studies (STRIDE-2X and STRIDE-3).
Vendar so bili bolniki, ki so zaključili preskušanje STRIDE-2, primerni za vključitev v odprto preskušanje (STRIDE-2X in STRIDE-3).
• If you could get pregnant or are pregnant (please read the section “Pregnancy and breast-feeding”
• Če lahko zanosite ali če ste noseči (preberite poglavje „Nosečnost in dojenje“ v nadaljevanju).
ET-1 actions are mediated through endothelin A receptors (ETA), present on smooth muscle cells, and endothelin B receptors (ETB), present on endothelial cells.
ET-1 deluje preko receptorja za endotelin A (ETA), ki se nahaja na celicah gladkega mišičja, in receptorja za endotelin B (ETB), ki se nahaja na endotelnih celicah.
Driving and using machines Do not drive or use any tools or machines if you feel dizzy.
Vpliv na sposobnost upravljanja vozil in strojev Ne vozite avtomobila oziroma ne upravljajte z orodji ali stroji, če ste omotični.
Like all medicines, Thelin can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Thelin neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
14 film-coated tablets in blisters 28 film-coated tablets in blisters 56 film-coated tablets in blisters 84 film-coated tablets in blisters
14 filmsko obloženih tablet v pretisnih omotih 28 filmsko obloženih tablet v pretisnih omotih 56 filmsko obloženih tablet v pretisnih omotih 84 filmsko obloženih tablet v pretisnih omotih
However, a number of patients who showed no response by week 12 of treatment with Thelin responded favourably by week 24, so an additional 12 weeks of treatment may be considered.
Vendar je bil pri številnih bolnikih, ki se niso odzvali na zdravljenje z zdravilom Thelin do 12. tedna, odziv do 24. tedna ugoden.
Blood and lymphatic system disorders Haemoglobin decrease (rarely resulting in anaemia), haematocrit decrease
Bolezni krvi in limfatičnega sistema Znižanje hemoglobina (ki redko povzroči anemijo), znižanje hematokrita občasni
Endothelin-1 (ET-1) is a potent vascular paracrine and autocrine peptide in the lung, and can also promote fibrosis, cell proliferation, cardiac hypertrophy, and remodelling and is pro-inflammatory.
Endotelin-1 (ET-1) je močen vaskularni parakrin in avtokrin peptid v pljučih, ki lahko tudi spodbuja fibrozo, razmnoževanje celic, srčno hipertrofijo in remodeliranje ter podpira vnetja.
Liver function:
Jetrna funkcija:
Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.
Učinkovitost je bila pokazana za primarno pljučno hipertenzijo in pljučno hipertenzijo, povezano z boleznimi vezivnega tkiva.
Patients had moderate to severe (NYHA/WHO functional class II-IV) PAH resulting from idiopathic pulmonary arterial hypertension (IPAH, also known as primary pulmonary hypertension), connective tissue disease (CTD), or congenital heart disease (CHD).
Bolniki so imeli zmerno do hudo (funkcionalni razred II-IV po NYHA/WHO) PAH, ki je nastala iz idiopatske pljučne arterijske hipertenzije (IPAH, imenovano tudi primarna pljučna hipertenzija), bolezni vezivnega tkiva ali kongenitalne srčne bolezni.
If you realise you have taken more Thelin tablets than your doctor has recommended (or if someone else has taken some of your Thelin tablets), contact your doctor straight away.
Če ste vzeli večji odmerek zdravila Thelin, kot bi smeli Če ugotovite, da ste vzeli več tablet zdravila Thelin, kot vam je naročil zdravnik (ali če je vaše tablete zdravila Thelin vzel kdo drug), nemudoma obvestite svojega zdravnika.
Patients with pre-existent hepatic disease and patients using nonconventional PAH treatments (eg, iloprost) were excluded.
Bolnike z obstoječo boleznijo jeter in bolnike z nekonvencionalnim zdravljenjem PAH (npr. iloprost) so izključili.
Dose-dependent malformations of the head, mouth, face and large blood vessels occurred.
Pojavile so se malformacije glave, gobca, obraza in velikih žil.
The efficacy of Thelin as monotherapy has not been established in patients with NYHA/WHO functional class IV PAH.
Učinkovitost zdravila Thelin kot monoterapije ni dokazana pri bolnikih s PAH funkcionalnega razreda IV po NYHA/WHO.
• yellowing of the skin or eyes ( jaundice) and persistent nausea and/or vomiting may indicate changes in liver function
• porumenelost kože ali oči (zlatenica) ter dolgotrajna slabost v želodcu in/ali bruhanje so lahko znaki spremenjenega delovanja jeter
In vitro and in vivo tests on genetic toxicology did not provide any evidence for a clinically relevant genotoxic potential.
V in vitro in in vivo preskusih genetske toksikologije niso našli dokazov za klinično pomembno genotoksičnost.
Sitaxentan sodium does not affect the p-glycoprotein transporter, but it is postulated to be a substrate of OATP transporter proteins.
Natrijev sitaksentanat ne vpliva na transporter p-glikoprotein temveč se predvideva, da je substrat transportnih beljakovin OATP.
Given a theoretical higher risk for thromboembolism, traditional concomitant use of vitamin K antagonists should be considered.
Glede na teoretično večje tveganje za pojav tromboembolije pride v poštev običajna sočasna uporaba antagonistov vitamina K.
Increases in the vitamin K antagonist dose should be done in small increments to reach an appropriate target INR.
Zviševanje odmerka antagonista vitamina K je potrebno opraviti v majhnih korakih, dokler ne dosežete ciljnega INR.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2.0, predstavljeni v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 5 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
Following this, the test will continue to be done every three months to check for anaemia (a reduced amount of red blood cells).
Nato boste preiskave za slabokrvnost (zmanjšano število rdečih krvničk v krvi) opravljali vsake tri mesece.
If any of the side effects become serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
• feeling tired
• utrujenost,
• Anaemia (low blood count)
• anemija (majhno število rdečih krvnih celic)
The most common adverse effects at this dose were headache, nausea, and vomiting.
Najpogostejši neželeni učinki pri tem odmerku so bili glavobol, slabost in bruhanje.
These medicines may interfere with the effect of Thelin.
Ta zdravila lahko motijo delovanje zdravila Thelin.
Higher doses did not confer additional benefit sufficient to offset the increased risk of adverse reactions, particularly liver injury (see section 4.4).
Višji odmerki niso povečali koristnih učinkov v primerjavi s povečanim tveganjem neželenih učinkov, zlasti okvar jeter (glejte poglavje 4.4).
In an open-label hypertension study, 10 patients received 480 mg twice daily (approximately a 10-fold increase in daily dose compared to the MRHD) for up to 2 weeks.
V odprti raziskavi hipertenzije je 10 bolnikov prejemalo 480 mg dvakrat dnevno (približno 10-krat večji dnevni odmerek kot najvišji priporočeni odmerek za človeka (MRHD)) do 2 tedna.
There was no change in Cmax or AUC for the active metabolite, n-desmethylsildenafil.
Nista pa bili spremenjeni vrednosti Cmax in AUC aktivnega presnovka, n-desmetilsildenafila.
Very common side effects (likely to affect more than 1 in 10 patients): • headache
Zelo pogosti neželeni učinki (pri več kot 1 od 10 bolnikov) so: • glavobol.
The Sitaxentan population also included patients (N = 53) who had discontinued another endothelin receptor antagonist due to liver function abnormalities.
Populacija, ki je dobivala sitaksentan, je vključevala tudi bolnike (n = 53), ki so zaradi nepravilnosti jetrnega delovanja nehali uporabljati kakšen drug antagonist endotelinskih receptorjev.
• blocked nose and nosebleeds
• zamašen nos in krvavitve iz nosu,