natgillin/translations-raw huggingface dataset:
At that time, the RMS concluded that Casodex (bicalutamide) 150 mg should not be used in the treatment of ‘localised' prostate cancer, however, it was concluded that the benefit/risk balance remained positive for selected patients in ‘locally advanced' prostate cancer, as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. 
Takrat je referenčna država članica zaključila, da zdravila Casodex (bikalutamid) 150 mg ne bi smeli uporabljati za zdravljenje „lokaliziranega“ raka prostate, vendar pa je zaključila tudi, da je razmerje med koristmi in tveganji ostalo pozitivno za izbrane bolnike z „lokalno napredovalim“ rakom prostate in pri uporabi za takojšnje zdravljenje bodisi samostojno ali kot adjuvans k zdravljenju z radikalno prostatektomijo ali radioterapijo.
The aim of the study should be to estimate the incidence of heart failure, cardiovascular morbidity and mortality in patients with prostate cancer, compared to the general population. 
Cilj te študije bi moral biti ocenjevanje pojavnosti odpovedi srca, kardiovaskularne obolevnosti in smrtnosti pri bolnikih z rakom prostate v primerjavi s splošno populacijo.
The aim of the study is to estimate the incidence of heart failure, cardiovascular morbidity and mortality in patients with prostate cancer, compared to the general population. 
Cilj te študije je oceniti pojavnost odpovedi srca, kardiovaskularne obolevnosti in smrtnosti pri bolnikih z rakom prostate v primerjavi s splošno populacijo.
4.1 Therapeutic indications [Invented name] 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1). 
[Izmišljeno ime zdravila] 150 mg je indiciran bodisi kot monoterapija ali kot adjuvantna terapija poleg radikalne prostatektomije ali radioterapije pri bolnikih z lokalno napredovalim rakom prostate z visokim tveganjem za napredovanje bolezni (glejte poglavje 5.1).
The results should be reported to the RMS and the NCAs where bicalutamide 150 mg is authorised. 
O rezultatih mora poročati RMS in nacionalnim pristojnim organom, kjer je bikalutamid 150 mg odobren.
How can the company rule out any role of bicalutamide 150 mg in the increased mortality due to heart failure in the Casodex arm of the EPC trial? 
Kako lahko družba izključi kakršnokoli vlogo bikalutamida 150 mg v povišani smrtnosti zaradi odpovedi srca v skupini, ki je v preizkušanju za zgodnji rak prostate prejemala zdravilo Casodex?
The SPC has been amended accordingly and notes in section 5.1 that, for patients with locally advanced disease “A reduction in risk of objective disease progression… was most evident in those at highest risk of disease progression. 
Povzetek glavnih značilnosti zdravila je bil ustrezno dopolnjen, tako da poglavje 5.1 vsebuje opombo, da je bilo pri bolnikih z lokalno napredovalo boleznijo „znižanje tveganja objektivnega napredovanja bolezni... najbolj očitno pri tistih, katerih tveganje za napredovanje bolezni je bilo največje.
In view of this, the benefit-risk profile for the use of CASODEX is not considered favourable in this group of patients. 
Razmerje med koristjo in tveganjem uporabe zdravila CASODEX v tej skupini zato velja za neugodno.
0.56 (0.40 to 0.78) 
0,56 (0,40 do 0,78)
Locally advanced prostate cancer refers to larger tumours or tumours with spread to lymph nodes, but not involving spread to other organs. 
Izraz lokalno napredovali rak prostate se nanaša na velike tumorje, ki so se razširili na bezgavke, ne pa tudi na druge organe.
Further, the study should include prostate cancer subgroups to include those on bicalutamide, and those treated with LHRH analogues, orchidectomy, and other hormonal therapies. 
Poleg tega bi morala študija vključevati podskupine bolnikov z rakom prostate, vključno s tistimi, ki prejemajo bikalutamid, in tistimi, ki se zdravijo z LHRH analogi, so prestali orhidektomijo in druge hormonske načine zdravljenja.
However, the EPC study was positive for the primary progression free survival (PFS) endpoint, both overall and in the locally advanced subgroups. 
Kljub temu pa je bila študija pozitivno ovrednotena na primarni točki preživetja brez napredovanja bolezni, tako v celoti kot tudi pri podskupinah z lokalnim napredovanjem bolezni.
BG - Bulgaria AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire, LU1 3LU, UK 
BG - Bolgarija AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire, LU1 3LU, UK
Further, the study will include prostate cancer subgroups to include those on Casodex (bicalutamide), and those treated with luteinizing hormone-releasing hormone (LHRH) analogues, orchidectomy, and other hormonal therapies. 
Poleg tega bo študija vključevala podskupine bolnikov z rakom prostate, vključno s tistimi, ki prejemajo zdravilo Casodex (bikalutamid), in tistimi, ki se zdravijo z analogi LHRH, orhidektomijo in drugimi hormonskimi načini zdravljenja.
The lack of broad consensus in the standard of care for early prostate cancer makes it difficult to study. 
Ker širše soglasje glede standardne nege zgodnjega raka prostate ne obstaja, je taka študija zelo otežena.
B-1180 Brussel 
B-1180
PT - Portugal Generis Farmacêutica, S.A. Office Park da Beloura - Edifício 4 
PT - Portugalska Generis Farmacêutica, S.A. Office Park da Beloura - Edifício 4 Quinta da Beloura 2710-444 Sintra
Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing. 
Zato se lahko zdravniki odločijo, da je optimalna medicinska strategija pri bolniku z majhnim tveganjem za napredovanje bolezni (zlasti v adjuvantnih okoliščinah po radikalni prostatektomiji) odložitev hormonskega zdravljenja, dokler se ne pojavijo znaki napredovanja bolezni.
- The CHMP concluded that the benefit/risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable. 
- CHMP je zaključil, da je pri zdravilih, ki vsebujejo biklautamid 150 mg, in ob dogovorjeni omejeni indikaciji razmerje med koristmi in tveganji ugodno.
Reports concerning pregnancy in partners of patients taking bicalutamide 
odpoved srca odpoved jeter intersticijsko bolezen pljuč raka na prsih poročila o nosečnosti partneric bolnikov, ki jemljejo bikalutamid
EL - Greece Genepharm SA 18th klm Marathon Ave 153 44 Pallini Attiki 
18th klm Marathon Ave 44 Pallini Attiki
Deaths (%) in placebo patients 
Smrti (%) pri bolnikih na placebu
It is acknowledged that overall there is no statistically significant survival benefit in locally advanced prostate cancer. 
Znano je, da pri lokalno napredovalem raku prostate niso opazili statistično značilnega koristnega učinka na preživetje.
Progression-free survival in locally advanced disease by therapy sub-group 
Preživetje brez napredovanja pri lokalno napredovali bolezni po terapevtskih podskupinah
A new pharmacoepidemiological study will be undertaken as part of an agreed Risk Management Plan (RMP), a post-opinion commitment to get a better understanding of cardiovascular risk. 
Za boljše razumevanje kardiovaskularnih tveganj se bo kot del dogovorjenega načrta za obvladovanje tveganja začela izvajati farmakoepidemiološka študija za boljše razumevanje kardiovaskularnega tveganja, kot se je po pridobljenem mnenju odbora zavezal imetnik.
PT - Portugal Farma-APS, Produtos Farmacêuticos, S.A. 
PT - Portugalska Farma-APS, Produtos Farmacêuticos, S.A. Rua João de Deus, 19
It is difficult to obtain overall survival data in patients with early prostate cancer due to its insidious course. 
Zaradi zahrbtnosti bolezni je podatke o celotnem preživetju bolnikov z zgodnjim rakom prostate težko dobiti.
27472 Cuxhaven, Germany 
Heinz-Lohmann-Strasse 5 27472 Cuxhaven, Germany tableta
Events (%) in placebo patients 
Dogodki (%) pri bolnikih na placebu
HU - Hungary AstraZeneca KFt. Park u. 3 
HU - Madžarska AstraZeneca KFt.
Albert-Schweitzer Gasse 3 
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3
Events (%) in Casodex patients 
Dogodki (%) pri bolnikih, ki so prejemali zdravilo Casodex
SL - Slovenia AstraZeneca UK Limited 
SL - Slovenija AstraZeneca UK Limited filmsko obložena
Member State Marketing Authorisation Holder 
Država članica Imetnik dovoljenja za promet z zdravilom Izmišljeno ime
Section 5.1 of the SPC was amended to note that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, might be to defer hormonal therapy until signs that the disease is progressing. 
Poglavje 5.1 Povzetka glavnih značilnosti zdravila je bilo dopolnjeno z opozorilom, da je odložitev hormonskega zdravljenja do pojava znakov, ki nakazujejo na napredovanje bolezni, najboljša strategija zdravljenja bolnikov z majhnim tveganjem za napredovanje bolezni, še posebej če se ga namerava uporabiti kot adjuvans po radikalni prostatektomiji.
RO-Romania AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire, 
RO - Romunija AstraZeneca UK Ltd 600 Capability Green Luton, Bedfordshire LU1 3LU, United Kingdom
SK - Slovakia AstraZeneca UK Limited Silk Road Business Park Macclesfield 
SK - Slovaška AstraZeneca UK Limited Silk Road Business Park Macclesfield
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS Whereas 
RAZLOGI ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
NV AstraZeneca SA 110 rue E. Van Ophem B-1180 Bruxelles Belgium 
LU - Luksemburg NV AstraZeneca SA rue E. Van Ophem
LV - Latvia AstraZeneca UK Limited Silk Road Business Park Macclesfield 
AstraZeneca UK Limited Silk Road Business Park Macclesfield
Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.” Section 5.1 of the SPC also includes a summary of the efficacy results from the EPC study. 
Zato se klinični zdravniki lahko odločijo, da je odložitev hormonskega zdravljenja do pojava znakov, ki nakazujejo na napredovanje bolezni, najboljša strategija zdravljenja za bolnike z majhnim tveganjem za napredovanje bolezni, še posebej če se načrtuje uporaba kot adjuvans po radikalni prostatektomiji“.
Overall survival in locally advanced disease by therapy sub-group Analysis population Deaths (%) in CASODEX patients 
Analizirana populacija Smrti (%) pri bolnikih na zdravilu CASODEX
Progression-free survival in locally advanced disease by therapy sub-group Analysis population Events (%) in CASODEX patients 
Preživetje brez napredovanja bolezni pri lokalno napredovalem raku po zdravljenih podskupinah
112 (4 x 28) tablets (multipack) 
112 (4 x 28) tablet (večkratno pakiranje)
MA (EU) number (Invented) name 
Številka dovoljenja za promet (EU)
Immediate Packaging Pack size 
Pot uporabe Primarna ovojnina Pakiranje
Route of Administration 
Lastniško ime Jakost
0.6 ml (10 mg/ml) 1 pre-filled syringe + on body injector (Onpro kit) 
1 napolnjena injekcijska brizga + injektor, ki se pritrdi na telo (komplet Onpro)
Solution for injection Subcutaneous use pre-filled syringe (glass) without blister 
Za subkutano uporabo napolnjena injekcijska brizga (steklena) brez pretisnega omota
Solution for injection Subcutaneous use Pre-filled syringe (glass) with on body-injector (Onpro kit) 
Za subkutano uporabo napolnjena injekcijska brizga (steklena) z injektorjem, ki se pritrdi na telo (komplet Onpro)
Solution for injection Subcutaneous use pre-filled syringe (glass) with needle guard 
Za subkutano uporabo napolnjena injekcijska brizga (steklena) s ščitnikom igle
Solution for injection Subcutaneous use pre-filled syringe (glass) 
Za subkutano uporabo napolnjena injekcijska brizga (steklena)
Blister (PVC/alu foil) 
Pretisni omot (PVC/alufolija)
MA (EU) number 
Številka postopka EMA Številka (EU) dovoljenja za promet
Bottle (HDPE) 
Steklenica (polietilenska)
60 tablets 
300 mg Filmsko obložene tablete
20mg/mL Oral solution Oral use 
60 tablet mg/ml
1 bottle + 1 dosing syringe + 1 adapter 
Steklenica, plastični nastavek za steklenico, peroralna odmerna brizga
Film-coated tablet 
Peroralna raztopina
This will make it easier for you to do more activities. 
Zaradi tega boste lažje opravili več aktivnosti.
10 August 2006 
10 Avgust 2006.
For your own safety, it is very important that you have regular blood tests. 
Zaradi vaše lastne varnosti je zelo pomembno, da redno opravljate krvne preiskave.
These may be signs that your liver is not working properly. 
To so lahko znaki, da vaša jetra ne delujejo pravilno.
24 months 
24 mesecev.
• If you are a child or adolescent under 18 years old. 
• Če ste otrok ali mladostnik, mlajši od 18 let.
The terminal elimination half-life (t½) is 10 hours. 
Končni razpolovni čas izločanja (t½) je 10 ur.
It is important to have these tests every month during treatment, even if you do not have any symptoms at all. 
Pomembno je, da se te preiskave opravijo vsak mesec zdravljenja, čeprav nimate nobenih simptomov.
Swallow the tablet whole with water. 
Pogoltnite celo tableto skupaj z vodo.
Therefore an interaction with such a drug cannot be excluded. 
Zato interakcije s takšnim zdravilom ne moremo izključiti.
Use in children and adolescents (< 18 years). 
Otroci in mladostniki (< 18 let):
Your doctor will advise you about suitable contraception. 
Vaš zdravnik vam bo svetoval o najbolj primerni metodi kontracepcije.
Patients in need of the combination should be closely monitored. 
Bolnike, ki potrebujejo takšno kombinacijo, je treba natančno nadzirati.
• If you have or have had a serious liver problem; 
• Če imate ali ste imeli resne težave z jetri.
The absolute bioavailability of Thelin is between 70 and 100%. 
Absolutna biološka uporabnost zdravila Thelin je med 70 in 100 %.
Thelin is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy. 
Zdravilo Thelin ni priporočljivo za otroke in mladostnike, mlajše od 18 let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti.
If you cannot reach your doctor, go to the nearest hospital and take the pack with you. 
Če zdravnika ne morete obvestiti takoj, pojdite v najbližjo bolnišnico in vzemite škatlo s seboj.
Functional Class 
Funkcionalni razred
If necessary, pregnancy testing should be undertaken. 
Če je potrebno, naj se izvede test nosečnosti.
Do not take Thelin if you are taking Ciclosporin A. 
Ne jemljite zdravila Thelin, če jemljete ciklosporin A.
Re-introduction of treatment: 
Ponovna uvedba zdravljenja:
The reduction in mean pulmonary artery pressure of 3 mmHg (6%) was not statistically significant. 
Znižanje povprečnega tlaka pljučne arterije za 3 mmHg (6 %) ni bilo statistično pomembno.
Frequencies are reported as very common ( 1/10), common (> 1/100, < 1/10), uncommon (> 1/1,000,  1/100), rare (> 1/10,000,  1/1,000), and very rare ( 1/10,000). 
Pogostnosti neželenih učinkov so navedene kot zelo pogosti (1/10), pogosti (>1/100, <1/10), občasni (>1/1000, 1/100), redki (>1/10000, 1/1000) in zelo redki (1/10000).
Steady state in volunteers is reached within about 6 days. 
Pri prostovoljcih je bilo stanje dinamičnega ravnovesja doseženo v približno 6 dneh.
Refer to section 4.3. 
Glejte poglavje 4.3.
• yellow colouring of the skin and eyes (jaundice) Talk to your doctor immediately. 
• rumeno obarvanje kože in oči (zlatenica), nemudoma obvestite svojega zdravnika.
• pain in the stomach (abdominal pain) 
• bolečine v trebuhu (abdominalne bolečine),
The advice of a hepatologist is recommended. 
Priporočljivo je mnenje hepatologa.
It does not matter whether you take it with or without food. 
Ni pomembno, ali tableto vzamete s hrano ali brez.
To be written in braille at time of manufacture. 
Se izpiše v Braillovi pisavi ob izdelavi.
• If you are taking a high dose of nifedipine. 
• Če jemljete visoke odmerke nifedipina.
During clinical trials, these changes were usually reversible when monitoring and discontinuation guidelines were followed. 
V kliničnih preskušanjih so bile te spremembe ponavadi reverzibilne ob upoštevanju smernic za spremljanje in prekinitev zdravljenja.
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.
General description 
Splošni opis
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.