natgillin/translations-raw huggingface dataset:
The summary of opinion of the Committee for Orphan Medicinal Products for Thelin is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Thelin je na voljo tukaj.
The full EPAR for Thelin can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Thelin je na voljo tukaj.
Package size
EU/ 1/ 06/ 353/ 001
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
pretisni omot (PVC/ Aclar/ alu)
Oral use Oral use Oral use Oral use Oral use
pretisni omot (PVC/ Aclar/ alu)
blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) bottle (HDPE)
pretisni omot (PVC/ Aclar/ alu)
14 tablets 28 tablets 56 tablets 84 tablets 28 tablets
84 tablet
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI ZADEVAJO DRŽAVE ČLANICE
The MAH shall set up a surveillance programme to collect information on: the demographics of patients prescribed Thelin, any adverse reactions and reasons for discontinuation of Thelin.
Imetnik dovoljenja za promet bo vzpostavil program nadzorovanja, da zbere informacije o: demografiji bolnikov, ki jim je bil predpisan Thelin, neželenih učinkih in razlogih za ukinitev zdravljenja s Thelinom.
The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all doctors who intend to prescribe Thelin are provided with a physician information pack containing the following: • Product information • Physician information about Thelin • Patient information card • Partner of patient information card
Imetnik dovoljenja za promet se mora o podrobnostih sistema nadzorovane distribucije dogovoriti s pristojnimi nacionalnimi organi in mora program izvajati na nacionalni ravni, da zagotovi, da pred predpisovanjem zdravila, vsi zdravniki, ki nameravajo predpisovati Thelin, dobijo opisno dokumentacijo, ki vsebuje naslednje podatke:
The physician information about Thelin should contain the following key elements: • That Thelin is teratogenic o Use of effective contraception in women of child bearing age o Possible interaction with oral contraceptives and increased risk of thromboembolism o Need to advise female patients about teratogenicity, contraception, if necessary the need for pregnancy testing and what to do if they become pregnant o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
• da je Thelin teratogen o Ženske v rodni dobi morajo uporabljati učinkovita kontracepcijska sredstva. o Obstaja možnost medsebojnega delovanja s peroralnimi kontracepcijskimi sredstvi in povečana nevarnost tromboembolizma. o Bolnice morajo biti poučene o teratogenosti ter se z zdravnikom posvetovati o kontracepciji, testu za ugotavljanje nosečnosti in kaj storiti, če zanosijo. o Bolnice, ki zanosijo, je potrebno napotiti k specialistu za teratogenost ali zdravniku, ki ima izkušnje na področju teratogenosti, ter prositi zdravnika za diagnozo, drugo mnenje in nasvet.
• That Thelin is hepatotoxic o Need for liver function tests prior to and during treatment o Contraindication in patients with pre-existing hepatic impairment (Child-Pugh Class A- C). o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN): > 3 and ≤ 5 × ULN:
• da je Thelin hepatotoksičen o Potrebno je preverjati delovanje jeter pred in med zdravljenjem. o Kontraindikacija pri bolnikih z že obstoječo jetrno okvaro (stopnja A- C po Child - Pughu). o Če so jetrni encimi ≥ 3 × zgornje meje normalne vrednosti (ZMN), je potrebno bolnika natančno spremljati. > 3 in ≤ 5 × ZMN:
Confirm by another liver test within 2 weeks.
Potrdite z drugo preiskavo jeter v 2 tednih.
If confirmed, continue to monitor aminotransferases at least every 2 weeks.
Če je stanje potrjeno, nadaljujte spremljanje vrednosti aminotransferaz najmanj vsaka 2 tedna.
If the aminotransferase levels return to pre-treatment values, return to monthly liver testing. > 5 and ≤ 8 × ULN:
Če se vrednosti aminotransferaz vrnejo na vrednosti pred zdravljenjem, se vrnite na mesečne preiskave jeter. > 5 in ≤ 8 × ZMN:
Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Potrdite z drugo preiskavo jeter; če je stanje potrjeno, končajte zdravljenje in spremljajte vrednosti aminotransferaz najmanj vsaka 2 tedna, dokler se vrednosti ne normalizirajo.
If the aminotransferase levels return to pre-treatment values, reintroducing Thelin may be considered. > 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
Če se vrednosti aminotransferaz vrnejo na vrednosti pred zdravljenjem, pride v poštev ponovna uvedba zdravila Thelin. > 8 × ZMN: zdravljenje je treba končati in ponovna uvedba zdravila Thelin ne pride v poštev.
• 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 s Thelinom 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.
• Effect of Thelin on bleeding o Interaction with warfarin and vitamin K antagonists leading to an increased INR o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium o Need for regular monitoring of INR o Be aware of the potential for haemorrhage and investigate as appropriate o Increased risk of epistaxis and gingival bleeding
• da Thelin vpliva na krvavenje o Medsebojno delovanje z varfarinom in antagonisti vitamina K, ki lahko pripeljejo do povišane vrednosti INR.
2 • That there is an interaction with ciclosporin A which may lead to higher blood concentration of Thelin and hence an increased risk of adverse reactions.
2 Pred začetkom zdravljenja s sitaksentanat je potrebno zmanjšati uveljavljeni odmerek o antagonistov vitamina K.
• That the safety database of Thelin is limited and physicians are encouraged to enrol patients in a surveillance programme to increase knowledge about the incidence of important adverse drug reactions (ADRs).
• da je baza podatkov o varnosti Thelina omejena, zato so zdravniki vabljeni, da bolnike vključijo v program nadzorovanja in s tem poglobijo znanje o incidenci pomembnih neželenih učinkov zdravila (ADRs).
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 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 hkratna zdravljenja, o razloge za ukinitev, o neželene učinke ○ vsi resni neželeni učinki, ○ povišani jetrni encimi na > 3 x 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 (nepričakovani neželeni učinki).
The Patient information card should include the following information • That Thelin is teratogenic • The need to ensure that women of child bearing age are using effective contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued • The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant. • That Thelin is hepatotoxic and they will need to attend for regular blood tests • The need to tell their doctor about any adverse events • The need to tell their doctor that they are taking Thelin
Podatki o zdravilu za bolnika morajo vsebovati naslednje informacije: • da je Thelin teratogen; • da morajo ženske v rodni dobi uporabljati učinkovito kontracepcijsko sredstvo in da morajo bolnice svoje zdravnike obvestiti o možnosti zanositve preden jim zdravnik izda nov recept; • da morajo bolnice svojega zdravnika nemudoma obvestiti o morebitni nosečnosti; • da je Thelin hepatotoksičen in da morajo bolniki redno prihajati na krvne preiskave; • da morajo bolniki obvestiti svojega zdravnika o neželenih učinkih; • da morajo bolniki svojim zdravnikom povedati, da jemljejo Thelin.
Partner of patient information card should include the following information: • That Thelin is teratogenic and that women of child bearing age must use effective contraception
Podatki o zdravilu za bolnikovega partnerja morajo vsebovati naslednje informacije: • da je Thelin teratogen in da morajo ženske v rodni dobi uporabljati učinkovito kontracepcijsko sredstvo.
Each film-coated tablet contains 100 mg sitaxentan sodium.
Ena filmsko obložena tableta vsebuje 100 mg natrijev sitaksentanat.
Also contains 166.3mg of lactose monohydrate.
Vsebuje tudi 166, 3 mg laktoze monohidrata.
Film-coated tablet Capsule shaped yellow-to-orange film-coated tablets, debossed with T-100 on one side.
filmsko obložena tableta Rumene do oranžne filmsko obložene tablete v obliki kapsule z vrezanim napisom T- 100 na eni strani.
It may be taken with or without food and without regard to the time of day.
Ura jemanja ni pomembna.
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.
Zato lahko upoštevate možnost zdravljenja še dodatnih 12 tednov.
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).
Discontinuation of treatment There is limited experience with abrupt discontinuation of sitaxentan sodium.
Prekinitev zdravljenja Izkušnje z nenadno prekinitvijo zdravljenja s natrijev sitaksentanat so omejene.
Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x Upper Limit of Normal (ULN)) (see section 4.3).
Zdravilo Thelin je kontraindicirano za zdravljenje bolnikov, ki imajo pred začetkom zdravljenja zvišane vrednosti jetrnih aminotransferaz (> 3 x zgornja meja normalne vrednosti (ZMN)) (glejte poglavje 4. 3).
2 Use in children and adolescents (< 18 years).
2 Otroci in mladostniki (< 18 let):
Mild to severe hepatic impairment (Child-Pugh Class A-C).
Blaga do huda jetrna okvara (Child- Pugh razred A- C).
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) > 3x ZMN).
Concomitant administration with ciclosporin A (see section 4.5).
Sočasno dajanje ciklosporina A (glejte poglavje 4. 5).
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.
Transfer to a therapy that is recommended at the severe stage of the disease (eg, epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Če se klinično stanje poslabša, morate preučiti možnosti zamenjave zdravljenja z zdravljenjem, ki je priporočeno za hudo stopnjo bolezni (npr. epoprostenol) (glejte poglavje 4. 2).
Elevations of AST and/ or ALT associated with Thelin occur both early and late in treatment, usually progress slowly, and are typically asymptomatic.
Ponavadi napredujejo počasi in so tipično asimptomatske.
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 s natrijev sitaksentanat.
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.
If AST and/ or ALT are > 3 x ULN prior to initiation of therapy, use of Thelin is contraindicated (see section 4.3).
Če so pred začetkom zdravljenja vrednosti AST in/ ali ALT > 3 x ZMN, je uporaba zdravila Thelin kontraindicirana (glejte poglavje 4. 3).
The mechanism of liver toxicity is not fully documented and it might vary between endothelin antagonists.
Mehanizem hepatotoksičnosti ni povsem dokumentiran in se med različnimi antagonisti endotelina lahko razlikuje.
Appropriate care should be exercised when initiating Sitaxentan in patients who discontinued other endothelin receptor antagonists due to liver enzyme abnormalities (see section 4.8).
V primeru uvedbe sitaksentana pri bolnikih, ki so nehali uporabljati druge antagoniste receptorjev endotelina, zaradi nepravilnosti pri jetrnih encimih, je potrebna ustrezna skrb (glejte poglavje 4. 8).
Recommendations in case of treatment-emergent ALT/ AST elevations:
Priporočila v primeru zvišanja vrednosti ALT/ AST med zdravljenjem:
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:
3 > 3 and ≤  5 x ULN:
> 3 in ≤ 5x ZMN
If confirmed, continue to monitor aminotransferases at least every 2 weeks.
Če se vrednosti
If the aminotransferase levels return to pre-treatment values, return to monthly liver testing.
3 aminotransferaz vrnejo na vrednosti pred zdravljenjem, zopet začnite z mesečnimi jetrnimi preiskavami.
> 5 and ≤ 8 x ULN:
≥ 5x in ≤ 8 x ZMN
Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Če je stanje potrjeno, prekinite zdravljenje in spremljajte vrednosti aminotransferaz najmanj vsaka 2 tedna, dokler se ne normalizirajo.
> 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
> 8 x ZMN:
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 x ZMN, je potrebno zdravljenje prekiniti in zdravljenja z zdravilom Thelin ne smete ponovno uvesti.
Re-introduction must follow the guidelines detailed in section 4.2.
Pri ponovni uvedbi zdravljenja morate upoštevati smernice iz poglavja 4. 2.
Pre-existing liver impairment Studies in patients with pre-existing liver impairment have not been conducted.
Obstoječa jetrna okvara Raziskave na bolnikih z obstoječo jetrno okvaro niso bile opravljene.
Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x ULN, see section 4.3).
Zdravilo Thelin je kontraindicirano za zdravljenje bolnikov, ki imajo pred začetkom zdravljenja zvišane vrednosti jetrnih amintransferaz (> 3× ZMN, glejte poglavje 4. 3).
Bleeding There is an increased risk of bleeding with Thelin, mainly in the form of epistaxis and gingival bleeding.
Krvavitve Pri jemanju zdravila Thelin se poveča tveganje za krvavitve, ki se večinoma kažejo kot krvavitve iz nosa in krvavitve iz dlesni.
Vitamin K antagonists Thelin increases the plasma levels of Vitamin K antagonists such as warfarin, acenocoumarol and fenprocoumon (see section 4.5).
Antagonisti vitamina K Zdravilo Thelin zviša plazemske vrednosti antagonistov vitamina K, npr. varfarina, acenokumarola in fenprokumona (glejte poglavje 4. 5).
Drugs which inhibit Organic Anion Transporting Polypeptides (OATP) The extent of interaction with potent OATP inhibitors (e. g. some statins, proteinase inhibitors, tuberculostatics) is unknown.
Zdravila, ki zavirajo polipetpdide za prenos organskih anionov (OATP - Organic Anion Transporting Polypeptides) Obseg interakcije z močnimi zaviralci OATP (npr. statini, zaviralci proteaz, tuberkulostatiki) ni znan.
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).
Oral contraceptive agents Thelin increases oestrogen exposure when given concomitantly with oral contraceptive agents (see Section 4.5).
Peroralni kontraceptivi Pri sočasni uporabi s peroralnimi kontracepcijskimi sredstvi Thelin poveča izpostavitev estrogenu (glejte poglavje 4. 5).
Pregnancy Due to possible teratogenicity, Thelin must not be initiated in women of child-bearing potential unless they practise reliable contraception.
Nosečnost Zaradi možne teratogenosti se zdravila Thelin ne sme uvajati pri ženskah v rodni dobi, če ne uporabljajo zanesljive kontracepcije.
If necessary, pregnancy testing should be undertaken (see Section 4.6).
Vendar so poročali, da je pri uporabi vazodilatatorjev (v glavnem
4 Pulmonary veno-occlusive disease (PVOD) No data are available with Thelin in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
4 prostaciklina) pri teh bolnikih v posameznih primerih prišlo do življenjsko ogrožajočega pljučnega edema.
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.
Haemoglobin concentration Treatment with Thelin was associated with a dose-related decrease in haemoglobin (see section 4.8).
Koncentracija hemoglobina Zdravljenje z zdravilom Thelin je povezano z znižanjem vrednosti hemoglobina, ki je odvisno od odmerka (glejte poglavje 4. 8).
Most of this decrease of haemoglobin concentration was detected during the first few weeks of treatment and haemoglobin levels stabilized by 4 weeks of Thelin treatment.
Vrednosti hemoglobina so se stabilizirale do 4. tedna zdravljenja z zdravilom Thelin.
Excipients Thelin tablets contain lactose monohydrate.
Pomožne snovi Tablete Thelin vsebujejo laktozo monohidrat.
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.
Sitaxentan sodium is metabolised in the liver by cytochrome P450 CYP2C9 and CYP3A4/ 5 isoenzymes.
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Sitaxentan sodium is an inhibitor of CYP2C9 and, to a lesser extent, CYP2C19, CYP3A4/ 5 and CYP2C8.
Natrijev sitaksentanat se v jetrih presnavlja z izoencimi CYP2C9 in CYP3A4/ 5 citokroma P450. Natrijev sitaksentanat je zaviralec CYP2C9 in v manjši meri tudi CYP2C19, CYP3A4/ 5 ter CYP2C8.
Co-administration with drugs metabolized by CYP2C19 or CYP3A4/ 5 is not expected to result in clinically significant drug interactions.
Ni pričakovati, da bi sočasna uporaba zdravil, ki jih presnavlja CYP2C19 ali CYP3A4/ 5, povzročila klinično pomembno interakcijo med zdravili.
Sitaxentan sodium does not affect the p-glycoprotein transporter, but it is postulated to be a substrate of OATP transporter proteins.
se predvideva, da je substrat transportnih beljakovin OATP.
Organic Anion Transporting Polypeptides (OATP) Inhibitors:
Zaviralci OATP - polipetpdidov za prenos organskih anionov:
Co-administration with ciclosporin A, a potent OATP inhibitor, resulted in a 6-fold increase in Cmin and a 67% increase in AUC of sitaxentan therefore the use of Thelin in patients receiving systemic ciclosporin A is contraindicated (see section 4.3).
Zato je zdravilo Thelin kontraindicirano pri bolnikih, ki prejemajo sistemsko zdravljenje s ciklosporinom A (glejte poglavje 4. 3).
Fluconazole (inhibitor of CYP2C19, CYP2C9 and CYP3A4/ 5):
Flukonazol (zaviralec CYP2C19, CYP2C9 in CYP3A4/ 5):
Co-administration of Thelin and fluconazole had no effect on the clearance of sitaxentan sodium.
Sočasna uporaba zdravila Thelin in flukonazola ni vplivala na očistek natrijevega sitaksentanata.
Ketoconazole (substrate and inhibitor of CYP3A4/ 5):
Ketokonazol (substrat in zaviralec CYP3A4/ 5):
Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or ketoconazole.
Sočasna uporaba z zdravilom Thelin ni klinično pomembno spremenila očistka natrijevega sitaksentanata in ketokonazola.
Nelfinavir (substrate of CYP3A4/ 5, CYP2C19):
Nelfinavir (substrat CYP3A4/ 5, CYP2C19):
Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or nelfinavir.
Sočasna uporaba z zdravilom Thelin ni klinično pomembno spremenila očistka natrijevega sitaksentanata in nelfinavirja.
5 Effects of Thelin on other medicinal products
5 Učinki zdravila Thelin na druga zdravila
Warfarin (vitamin K antagonist, substrate of CYP2C9):
Varfarin (antagonist vitamina K, substrat CYP2C9):
Concomitant treatment with sitaxentan sodium resulted in a 2.4 fold increase in S-warfarin exposure.
Sočasno zdravljenje z natrijevim sitaksentanatom je povzročilo 2, 4- kratno zvišanje izpostavitve S- varfarinu.
When initiating vitamin K antagonist therapy in a patient taking sitaxenten 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.
In patients already taking a vitamin K antagonist, it is recommended that the dose of the vitamin K antagonist be reduced when starting sitaxentan sodium.
Pri bolnikih, ki že jemljejo antagonist vitamina K, je priporočljivo, da se ob uvedbi natrijevega sitaksentanata zniža odmerek antagonista vitamina K.
In all cases, INR should be monitored on a regular schedule.
V vseh primerih je potrebno INR redno preverjati.
Oral contraceptives (substrate of CYP3A4/ 5):
Peroralna kontracepcijska sredstva (substrati CYP3A4/ 5):
Concomitant administration of Thelin and Ortho- Novum 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.
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%.