natgillin/translations-raw huggingface dataset:
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.
Compared with placebo treatment, Thelin resulted in statistically significant improvement in pulmonary vascular resistance (PVR) and cardiac index (CI) after 12 weeks of treatment (see below).
V primerjavi s placebom je zdravljenje z zdravilom Thelin po 12 tednih statistično pomembno izboljšalo pljučno vaskularno odpornost (PVR - pulmonary vascular resistance) in srčni indeks (CI - cardiac index) (glejte spodaj).
Thelin did not affect fertility in males and females.
Zdravilo Thelin ni vplivalo na plodnost pri samcih in samicah.
•That Thelin is hepatotoxic and they will need to attend for regular blood tests
• da je zdravilo Thelin hepatotoksično in da morajo bolniki redno prihajati na krvne preiskave;
• That treatment with Thelin often causes a decrease in haemoglobin and related red cell parameters o Need for full blood count prior to use and monitoring at clinically appropriate intervals
• da zdravljenje z zdravilom Thelin pogosto povzroči znižanje hemoglobina in sorodnih parametrov rdečih krvnih celic o Pred začetkom jemanja je potrebno narediti krvno sliko in bolnika spremljati v klinično primernih intervalih.
In all cases, INR should be monitored on a regular schedule.
o Vrednosti INR je potrebno skrbno spremljati.
Oral contraceptives (substrate of CYP3A4/5): Concomitant administration of Thelin and OrthoNovum 1/35 (1 mg norethindrone/ 0.035 mg ethinyl estradiol) resulted in increases in exposure to ethinyl estradiol (substrate of CYP3A4/5) and norethindrone (CYP3A4/5) of 59 % and 47%, respectively.
Peroralna kontracepcijska sredstva (substrati CYP3A4/5): Sočasna uporaba zdravil Thelin in Ortho-Novum 1/35 (1 mg noretindrona/ 0,035 mg etinilestradiola) je povečala izpostavljenost etinilestradiolu (ki je substrat CYP3A4/5) za 59 % in noretindronu (CYP3A4/5) za 47 %.
What Thelin is and what it is used for Before you take Thelin How to take Thelin Possible side effects How to store Thelin Further information
Kaj je zdravilo Thelin in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Thelin Kako jemati zdravilo Thelin Možni neželeni učinki
Subjects receiving warfarin achieve therapeutic anticoagulation (International Normalised Ratio [INR] target) with lower doses of the anticoagulant in the presence of sitaxentan sodium.
Preiskovanci, ki prejemajo varfarin v prisotnosti natrijevega sitaksentanata, dosežejo terapevtsko antikoagulacijo (ciljno mednarodno normalizirano razmerje - International Normalised Ratio (INR) target) z nižjimi odmerki antikoagulacijskega sredstva.
Thelin may affect your liver.
Zdravilo Thelin lahko vpliva na jetra.
When administered with a high fat meal, the rate of absorption (Cmax) of Thelin was decreased by 43% and the Tmax delayed (2-fold increase) compared to fasted conditions, but the extent of absorption was the same.
Pri dajanju z obrokom, ki vsebuje veliko maščob, se v primerjavi s teščim stanjem hitrost absorpcije (Cmax) zdravila Thelin zmanjša za 43 %, Tmax pa zakasni (dvakratno povečanje), vendar je obseg absorpcije enak.
Dosage in renal impairment: No dose adjustment is required in patients with renal impairment.
Bolniki z ledvično okvaro: Pri bolnikih z ledvično okvaro ni potrebno prilagoditi odmerka.
Sitaxentan sodium caused teratogenicity in rats (see section 5.3).
Natrijev sitaksentanat je povzročil teratogene učinke pri podganah (glejte poglavje 5.3).
Do not take more than one tablet each day.
Vendar ne vzemite dveh tablet v istem dnevu.
Sitaxentan sodium was detected in the plasma of breast fed pups from female rats treated with sitaxentan sodium, indicating that sitaxentan sodium was present in the breast milk.
Natrijev sitaksentanat so odkrili v plazmi dojenih mladičev podgan, katerim so dajali natrijev sitaksentanat, kar kaže, da je natrijev sitaksentanat prisoten v materinem mleku.
Pulmonary arterial hypertension is the term used when the heart struggles to pump blood to the lungs.
Izraz pljučna arterijska hipertenzija pomeni, da srce težko črpa kri v pljuča.
Contains lactose monohydrate
Vsebuje laktoza monohidrat
Among patients with PAH associated with CTD in STRIDE-1 and STRIDE-2, a statistically significant difference versus placebo was observed (37.73 metres, p < 0.05).
V skupini bolnikov s PAH povezano boleznijo vezivnega tkiva so v preskušanjih STRIDE-1 in STRIDE-2 opazili statistično pomembno razliko v primerjavi s placebom (37,73 metrov, p<0,05).
• cramp in muscles
• krči v mišicah,
If necessary, pregnancy testing should be undertaken (see Section
Če je potrebno, naj se izvede test nosečnosti (glejte poglavje 4.6.
Rash (various types and presentations)
Izpuščaj (različnih vrst in kliničnih oblik)
In placebo-controlled studies, marked decreases in haemoglobin (> 15% decrease from baseline with value < lower limit of normal) were observed in 7% of patients treated with Thelin (N = 149) and 3% of placebo-treated patients (N = 155).
V raziskavah, nadzorovanih s placebom, so izrazito znižanje vrednosti hemoglobina (>15 % znižanje od izhodiščnih vrednosti z vrednostjo < spodnje meje normalne vrednosti) opazili pri 7 % bolnikov, ki so se zdravili z zdravilom Thelin (N = 149), in 3 % bolnikov, ki so prejemali placebo (N = 155).
Due to possible teratogenicity, Thelin must not be initiated in women of child-bearing potential unless they practise reliable contraception.
Zaradi možne teratogenosti se zdravila Thelin ne sme uvajati pri ženskah v rodni dobi, če ne uporabljajo zanesljive kontracepcije.
Thelin increases the plasma levels of Vitamin K antagonists such as warfarin, acenocoumarol and fenprocoumon (see section 4.5).
Zdravilo Thelin zviša plazemske vrednosti antagonistov vitamina K, npr. varfarina, acenokumarola in fenprokumona (glejte poglavje 4.5).
PVC/ACLAR/paper-backed aluminium blisters containing 14 tablets.
Pretisni omoti iz aluminija in s podlago iz PVC/ACLAR/papirja, ki vsebujejo po 14 tablet.
If liver transferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, anorexia, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in total bilirubin > 2x ULN, treatment should be stopped and re-introduction of Thelin is not to be considered.
Če zvišanje vrednosti jetrnih transferaz spremljajo klinični simptomi okvare jeter (npr. slabost, bruhanje, neješčnost, zvišana telesna temperatura, abdominalne bolečine, zlatenica ali nenavadna letargija ali utrujenost) ali če se raven skupnega bilirubina zviša > 2 × ZMN, je potrebno zdravljenje prekiniti in zdravljenja z zdravilom Thelin ne smete ponovno uvesti.
In PAH and heart failure, in the absence of endothelin receptor antagonism, elevated ET-1 concentrations are strongly correlated with the severity and prognosis of these diseases.
Zvišane koncentracije ET-1 pri PAH in srčnem popuščanju ter v odsotnosti antagonizma receptorja za endotelin so močno povezane z resnostjo in prognozo teh bolezni.
Predominant actions of ET-1 binding to ETA are vasoconstriction and vascular remodelling, while binding to ETB results in ET-1 clearance, and vasodilatory/ antiproliferative effects due in part to nitric oxide and prostacyclin release.
Ko se ET-1 veže na ETA, sta posledici v glavnem vazokonstrikcija in vaskularno remodeliranje, vezava ET-1 na ETB pa povzroči očistek ET-1 in vazodilatorne/antiproliferativne učinke, ki so deloma posledica sproščanja dušikovega oksida in prostaciklina.
Symptomatic hepatitis
Simptomatski hepatitis redki
No data are available with Thelin in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
Ni podatkov o uporabi zdravila Thelin pri bolnikih s pljučno hipertenzijo, ki je povezana s pljučno veno-okluzivno boleznijo.
Thelin should be used with caution if you are taking or begin to take Vitamin K antagonists (e.g. warfarin, acenocoumarol, fenprocoumon or fluindione).
Zdravilo Thelin morate jemati previdno, če jemljete ali ste začeli jemati antagoniste vitamina K (npr. varfarin, acenokumarol, fenprokumon ali fluindion).
In these studies, the study medicine was added to patients' current therapy, which could have included a combination of digoxin, anticoagulants, diuretics, oxygen, and vasodilators (eg, calcium channel blockers, ACE inhibitors).
V omenjenih raziskavah so preučevano zdravilo dodali bolnikovi obstoječi terapiji, ki je lahko vključevala kombinacijo digoksina, antikoagulacijskih sredstev, diuretikov, kisika in vazodilatorjev
Liver aminotransferase elevations may reverse spontaneously while continuing treatment with sitaxentan sodium.
Zvišane vrednosti jetrnih aminotransferaz se lahko vrnejo v normalno območje spontano v nadaljevanju zdravljenja z natrijevim sitaksentanatom.
Thelin comes in blister packs of 14, 28, 56, and 84 tablets and bottles of 28 tablets.
Zdravilo Thelin je na voljo v pretisnih omotih s 14, 28, 56 in 84 tabletami ter plastenkah z 28 tabletami.
HOW TO TAKE THELIN
KAKO JEMATI ZDRAVILO THELIN
Thelin should not be used during pregnancy unless clearly necessary ie, in case no alternative treatment options are available.
Zdravilo Thelin ne smete uporabljati med nosečnostjo, razen če je nujno potrebno, tj. če ni na voljo drugega načina zdravljenja.
The influence of liver impairment on the pharmacokinetics of sitaxentan sodium has not been evaluated.
Okvara jetrne funkcije Vpliv okvare jeter na farmakokinetiko natrijevega sitaksentanata ni raziskan.
At high doses, dose-related increases in prothrombin time (PT) and activated partial thromboplastin time (APTT) were also seen, most prominently in rats, and coagulopathy (bleedings) in rats and dogs, but not mice.
Pri visokih odmerkih so zlasti pri podganah opazili od odmerka odvisno podaljšanje protrombinskega časa (PČ) in aktiviranega parcialnega tromboplastinskega časa (APTČ), pri podganah in psih pa koagulopatijo (krvavitve), česar niso opazili pri miših.
Thelin 100 mg film-coated tablets
Thelin 100 mg filmsko obložene tablete
Pulmonary veno-occlusive disease (PVOD)
Pljučno veno-okluzivna bolezen
Consequently, should signs of pulmonary oedema occur when Thelin is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered.
Če se pojavijo znaki pljučnega edema pri bolnikih s pljučno hipertenzijo, ki jemljejo zdravilo Thelin, je treba upoštevati možnost povezane veno-okluzivne bolezni.
Thelin tablets contain lactose monohydrate.
Tablete Thelin vsebujejo laktozo monohidrat.
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalcev odgovornih za sproščanje serije
The placebo-corrected increases in walk distance in the whole cohort compared to baseline were 35 metres (p = 0.006; ANCOVA) and 31 metres (p < 0.05; ANCOVA), respectively.
Po korekciji s skupino bolnikov, ki je prejemala placebo, je bila prehojena razdalja v celi skupini v primerjavi z izhodiščem v prvi raziskavi daljša za 35 metrov (p=0,006; ANCOVA), v drugi raziskavi pa daljša za 31 metrov (p<0,05; ANCOVA).
There is no specific experience with the management of Thelin overdose.
Specifičnih izkušenj o obravnavi prevelikega odmerjanja zdravila Thelin ni.
•The need to tell their doctor about any adverse events
• da morajo bolniki obvestiti svojega zdravnika o neželenih učinkih;
Administration of Thelin to female rats from late-pregnancy through lactation reduced pup survival, and caused testis tubular aplasia and delayed vaginal opening at the lowest exposure tested (17-45 times the human exposure).
Dajanje zdravila Thelin podganjim samicam od pozne brejosti ter skozi dojenje je pri najnižjem preskušenem odmerku (17-45-kratni izpostavitvi pri človeku) zmanjšalo preživetje mladičev in povzročilo testikularno tubularno aplazijo ter zakasnjeno odpiranje nožnice.
Liver aminotransferases increase, bilirubin increase (associated with liver aminotransferase increase)
Bolezni jeter, žolčnika in žolčevodov Zvišanje jetrnih aminotransferaz, zvišanje bilirubina (povezano z zvišanjem jetrnih aminotransferaz)
Warfarin (vitamin K antagonist, substrate of CYP2C9): Concomitant treatment with sitaxentan sodium resulted in a 2.4 fold increase in S-warfarin exposure.
Varfarin (antagonist vitamina K, substrat CYP2C9): Sočasno zdravljenje z natrijevim sitaksentanatom je povzročilo 2,4-kratno zvišanje izpostavitve S-varfarinu.
Sitaxentan sodium is rapidly absorbed following oral administration.
Natrijev sitaksentanat se hitro absorbira po peroralni uporabi.
Effects of other medicinal products on Thelin
Učinki drugih zdravil na zdravilo Thelin
In phase 2 and 3 oral studies in patients with PAH, elevations in ALT and/or AST > 3 ULN were observed in 5% of placebo-treated patients (N = 155) and 7% of Thelin 100 mg-treated patients (N = 887).
V fazah 2 in 3 raziskav peroralne oblike pri bolnikih s pljučno arterijsko hipertenzijo so zvišanje vrednosti ALT in/ali AST > 3 ZMN zabeležili pri 5 % bolnikov, ki so jemali placebo (N=155) in pri 7 % bolnikov, ki so jemali zdravilo Thelin 100 mg (N=887).
• bleeding from the gums
• krvavitve iz dlesni
Digoxin (substrate of p-Glycoprotein): Concomitant administration of Thelin did not alter the pharmacokinetics of digoxin indicating no effect on the p-glycoprotein transporter
Digoksin (substrat p-glikoproteina): Sočasna uporaba zdravila Thelin ne spremeni farmakinetike digoksina, kar kaže, da ni vpliva na transporter p-glikoproteina.
Recommendations in case of treatment-emergent ALT/AST elevations: If ALT/AST measurements rise to the following levels then changes to the monitoring or treatment are given:
Če se vrednosti ALT/AST zvišajo na navedene vrednosti, potem se priporočajo naslednje spremembe spremljanja ali zdravljenja:
If you miss a dose, take the missed dose as soon as you remember but do not take two tablets in one day.
Če ste pozabili vzeti odmerek, vzemite pozabljeni odmerek, ko se spomnite.
STRIDE-1, which included 178 patients, compared 2 oral doses of Thelin (100 mg once daily and 300 mg once daily) with placebo during 12 weeks of treatment.
V preskušanju STRIDE-1, kjer je bilo vključenih 178 bolnikov, so primerjali 2 peroralna odmerka zdravila Thelin (100 mg enkrat dnevno in 300 mg enkrat dnevno) s placebom v 12 tednih zdravljenja.
The most common metabolic products are at least 10 times less potent as ETA antagonists than sitaxentan sodium in a standard in vitro test of activity.
Najpogostejši presnovni produkti so bili v standardnem in vitro testu aktivnosti najmanj 10-krat manj učinkoviti antagonisti ETA kot natrijev sitaksentanat.
• When new information is received that may impact on the current Safety Specification,
• kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja
The information collected should include: o Anonymised patient details - age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Elevated direct bilirubin > 2 ×ULN o Anaemia o Haemorrhage o Pregnancy and outcome o Pulmonary oedema (associated with veno-occlusive disease) o Suspected interactions o Unexpected ADRs according to the SPC.
Zbrani podatki morajo vsebovati: o anonimizirane podatke o bolniku - starost, spol in etiologijo PAH, o sočasna zdravljenja, o razloge za ukinitev, o neželene učinke, ○ vsi resni neželeni učinki, ○ povišani jetrni encimi na > 3 × ZMN, ○ povišani direktni bilirubin > 2 × ZMN, ○ anemija, ○ krvavitev, ○ nosečnost in izid, ○ pljučni edem (povezan z vensko-okluzivno boleznijo), ○ možna medsebojna delovanja, ○neželeni učinki, ki niso navedeni v povzetku glavnih značilnosti zdravila
At the recommended dose during placebo-controlled trials in pulmonary arterial hypertension PAH, the most common adverse drug reactions considered to be at least possibly related to Thelin treatment were headache in 15% of patients, and peripheral oedema and nasal congestion, each in 9% of patients.
V preskušanjih, nadzorovanih s placebom, so bili pri bolnikih s pljučno arterijsko hipertenzijo (PAH), ki so jemali priporočeni odmerek, najpogostejši neželeni učinki, ki so lahko povezani z zdravljenjem z zdravilom Thelin, glavobol pri 15 % bolnikov in periferni edem ter zamašen nos, vsak pri 9 % bolnikov.
Oral contraceptive agents
Peroralni kontraceptivi
When initiating vitamin K antagonist therapy in a patient taking sitaxentan sodium, it is recommended to start at the lowest available dose.
Pri uvedbi zdravljenja z antagonisti vitamina K pri bolnikih, ki jemljejo natrijev sitaksentanat, je priporočljivo začeti z najnižjim odmerkom, ki je na voljo.
Concomitant administration with ciclosporin A (see section 4.5).
Sočasno dajanje ciklosporina A (glejte poglavje 4.5).