natgillin/translations-raw huggingface dataset:
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,
Efficacy endpoints included sub maximal exercise capacity, WHO functional class and Time to Clinical Worsening for all studies, and haemodynamics for STRIDE-1. 
Parametri za merjenje učinkovitosti so vključevali submaksimalno vadbeno zmogljivost, WHO funkcionalni razred in čas do kliničnega poslabšanja za vsa preskušanja, ter tudi hemodinamiko za STRIDE-1.
No clinical interaction study was performed with a substrate of CYP 2C8. 
Klinične raziskave interakcij na substratu CYP 2C8 niso bile opravljene.
A decrease in haemoglobin concentration by at least 1 g/dl was observed in 60% of patients treated with Thelin as compared to 32% of placebo-treated patients. 
Znižanje koncentracije hemoglobina za najmanj 1 g/dL so opazili pri 60 % bolnikov, ki so se zdravili z zdravilom Thelin, in 32 % bolnikov, ki so prejemali placebo.
Rare side effects (likely to affect less than 1 in 1000 people): 
Redki neželeni učinki (se verjetno pojavijo pri manj kot 1 od 1000 bolnikov) so:
Because treatment-associated elevations of AST and/or ALT are a marker for potential serious liver injury, liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals. 
Ker so zvišane vrednosti AST in/ali ALT v povezavi z zdravljenjem kazalnik potencialno resne jetrne okvare, morate vrednosti jetrnih aminotransferaz določiti pred uvedbo zdravljenja in nato v mesečnih časovnih presledkih.
Important information about some of the ingredients of Thelin Thelin tablets contain lactose monohydrate. 
Pomembne informacije o nekaterih sestavinah zdravila Thelin Tablete Thelin vsebujejo laktozo monohidrat.
Post marketing experience 
Izkušnje iz obdobja trženja
There are no human data regarding the use of sitaxentan sodium during pregnancy. 
Ni podatkov o uporabi natrijevega sitaksentanata pri nosečnicah.
If you stop taking Thelin Talk to your doctor before stopping treatment. 
Če ste prenehali jemati zdravilo Thelin Posvetujte se s svojim zdravnikom, preden prekinete zdravljenje.
Thelin was teratogenic at the lowest tested dose in rats, corresponding to exposures more than 30 times the human exposure. 
Zdravilo Thelin je bilo teratogeno pri najnižjem preskušenem odmerku, ki je bil pri podganah enakovreden 30-kratni izpostavitvi pri človeku.
Treatment Comparison of Change from Baseline in PVR, and CI at Week 12 by Functional Class - STRIDE 1: Sitaxentan 100 mg Versus Placebo 
Primerjava zdravljenja glede na osnovno vrednost PVR in CI v 12 tednu po funkcionalnem razredu - STRIDE-1: sitaksentan 100 mg glede na placebo
If you are intolerant to some sugars, contact your doctor before taking Thelin tablets. 
Če imate intoleranco za kakšne sladkorje, obvestite svojega zdravnika, preden začnete jemati tablete Thelin.
Elderly patients: No dosage adjustment is needed in patients over the age of 65 years. 
Starostniki: Pri bolnikih, starejših od 65 let, ni potrebno prilagoditi odmerka.
These survival estimates were similar in the subgroup of patients with PAH associated with CTD for the Thelin treated group (98%, 78% and 67% respectively). 
Ocene preživetja so podobne v podskupini bolnikov, zdravljenih z zdravilom Thelin, ki imajo PAH kot posledico bolezni vezivnega tkiva (98 %, 78% in 67%).
Following oral administration to healthy volunteers, sitaxentan sodium is highly metabolised. 
Po peroralnem dajanju zdravim prostovoljcem se je natrijev sitaksentanat zelo hitro presnovil.
Study results suggest that the dose of sildenafil does not need to be adjusted during concomitant administration with sitaxentan sodium. 
Rezultati raziskave kažejo, da odmerka sildanafila ni potrebno prilagoditi pri sočasni uporabi natrijevega sitaksentanata.
If you are able to get pregnant, you must use effective contraception while taking Thelin. 
Če lahko zanosite, morate med jemanjem zdravila Thelin uporabljati učinkovito kontracepcijo.
Thelin lowers the blood pressure by widening these vessels, so your heart can pump blood more effectively. 
Zdravilo Thelin niža krvni tlak s širjenjem teh žil, tako da lahko srce učinkoviteje črpa kri.
•That Thelin is teratogenic 
• da je zdravilo Thelin teratogeno;
Ask your pharmacist how to dispose of medicines you no longer require. 
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
Increased Liver Aminotransferases (see section 4.4) Elevations of AST and/or ALT are associated with sitaxentan sodium. 
Zvišane vrednosti jetrnih aminotransferaz (glejte poglavje 4.4) S natrijev sitaksentanat so povezane zvišane vrednosti AST in/ali ALT.
> 5 and ≤ 8 x ULN: Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised. 
> 5 in ≤ 8 × ZMN: Potrdite z drugo preiskavo jeter; če je stanje potrjeno, končajte zdravljenje in spremljajte vrednosti aminotransferaz najmanj vsaka 2 tedna, dokler se vrednosti ne normalizirajo.
Monobasic sodium phosphate (E339) 
Natrijev dihidrogenfosfat (E339)
In STRIDE-4, a statistically non-significant placebo-corrected mean improvement of 24.3 metres (p = 0.2078) was observed in the whole cohort. 
V preskušanju STRIDE-4 so pri celotni skupini ugotovili statistično neznačilno s placebom korigirano srednjo vrednost izboljšanja za 24,3 metrov (p=0,2078).
It is expected that a similar increase in anticoagulant effect will be seen with warfarin analogues, including acenocoumarol, fenprocoumon and fluindione. 
Pričakuje se, da do podobnega zvišanja antikoagulacijskega učinka pride pri analogih varfarina, vključujoč acenokumarol, fenprokumon in fluindion.
Testicular tubular atrophy was observed in rats, but not in mice or dogs. 
Pri podganah so opazili testikularno tubularno atrofijo, ne pa tudi pri miših ali psih.
Moreover, Clinical interaction studies with nelfinavir, a moderately potent OATP inhibitor, and pravastatin, a low affinity OATP inhibitor, did not result in clinically significant changes in sitaxentan plasma levels. 
Poleg tega klinične študije medsebojnega delovanja z nelfinavirjem, ki je zmerno močan zaviralec OATP, in pravastatinom, ki je zaviralec OATP z majhno afiniteto, niso pokazale klinično pomembnih sprememb koncentracije sitaksentana v plazmi.
Thelin is used to help lower blood pressure in the blood vessels when this pressure is raised in pulmonary arterial hypertension (PAH). 
Zdravilo Thelin pomaga pri zniževanju krvnega tlaka v žilah, če je krvni tlak zvišan zaradi pljučne arterijske hipertenzije (PAH).
As this could result in raised plasma levels of sitaxentan sodium, patients in need of the combination should be closely monitored for adverse events related to sitaxentan sodium (see section 4.5). 
Ker to lahko povzroči zvišane plazemske vrednosti natrijevega sitaksentanata, morate bolnike, ki potrebujejo to kombinacijo zdravil, natančno spremljati zaradi neželenih učinkov, povezanih z natrijevim sitaksentanatom (glejte poglavje 4.5).
Clearance of ciclosporin A was unchanged. 
Očistek ciklosporina A se ni spremenil.
General disorders and administration site conditions Fatigue, oedema (most commonly peripheral) 
Splošne težave in spremembe na mestu aplikacije Utrujenost, edemi (najpogosteje periferni)
Take special care with Thelin: 
Bodite posebno pozorni pri jemanju zdravila Thelin:
Sub-maximal exercise capacity: This was assessed by measuring distance walked in 6 minutes (6-minute walk test) at 12 weeks for STRIDE-1 and 18 weeks for STRIDE-2 and STRIDE-4. 
Z merjenjem razdalje, ki jo bolnik prehodi v 6 minutah (6-minutni test hoje), so določili submaksimalno vadbeno zmogljivost po 12 tednih v raziskavi STRIDE-1 in po 18 tednih v raziskavi STRIDE-2 in STRIDE-4.