natgillin/translations-raw huggingface dataset:
I et åbent PAH-forsøg blev der rapporteret om et fatalt tilfælde af leversvigt efter kronisk dosering af 600 mg sitaxentan dagligt givet som 300 mg 2 gange dagligt.
In an open-label PAH study, one fatal case of hepatic failure has been reported after chronic dosing of sitaxentan at 600 mg/day administered as 300 mg bid.
Natriumdihydrogenphosphatdihydrat (E339)
Monobasic sodium phosphate (E339)
Thelintabletter indeholder lactosemonohydrat.
Thelin tablets contain lactose monohydrate.
I 99-ugers forsøg sås der derimod en dosisrelateret, lettere forøget incidens af minimal til mild fokal atrofi ved doser, der yder 29 til 94 gange den menneskelige eksponering.
In the 26-week study, moderate to marked diffuse seminiferous tubular atrophy was present at a very low incidence, whereas in the 99-week study there was a dose-related, slightly increased incidence of minimal to mild focal atrophy at doses providing 29 to 94 times the human exposure.
• Prøv at tage tabletten på samme tidspunkt hver dag, så De ikke så nemt glemmer det. Slug tabletten hel med vand.
• Try to take the tablet at the same time each day to help you remember.
Der foreligger ingen data om brugen af Thelin hos patienter med pulmonal hypertension i forbindelse med pulmonal veneokklusiv sygdom.
No data are available with Thelin in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
Der bør tages relevante forholdsregler, når sitaxentanbehandling initieres hos patienter, der har afbrudt behandling med andre endothelinreceptor-antagonister pga. leverenzymabnormiteter (se pkt.
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).
Samtidig administration med lægemidler, der metaboliseres af CYP2C19 eller CYP3A4/5, forventes ikke at resultere i klinisk signifikante lægemiddelinteraktioner.
Co-administration with drugs metabolized by CYP2C19 or CYP3A4/5 is not expected to result in clinically significant drug interactions.
Ved fravær af endothelinreceptor-antagonisme er forhøjede ET-1-koncentrationer stærkt korreleret med sværhedsgraden af PAH og hjertesvigt og prognosen for disse sygdomme.
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.
Der er derfor en forøget risiko for tromboembolisme.
Therefore, especially in women who smoke, there is an increased risk for thromboembolism.
Denne specifikke gruppe havde en større risiko (19 %; N=10/53) for udvikling af ALAT-stigning og/eller ASAT-stigning > 3 x ULN.
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.
Det vides ikke,
Headaches (some severe),
Stigning i INR (ved samtidig behandling med vitamin K-antagonist).
INR increase (with concomitant vitamin K antagonist therapy).
A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
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Der er set tilfælde af samtidige stigninger i niveaerne af aminotransferaser (ALAT og/eller ASAT) > 8 x ULN og total-bilirubin > 2 x ULN efter administration af sitaxentannatrium.
Cases of concurrent elevations of transaminases (ALT and/or AST) > 8 x ULN and total bilirubin > 2 x ULN have been reported following administration of sitaxentan sodium.
ET-1koncentrationen er forhøjet i plasma og lungevæv hos patienter, der lider af pulmonal arteriel hypertension (PAH), såvel som andre kardiovaskulære sygdomme og bindevævssygdomme, inklusive sklerodermi, akut og kronisk hjerteinsufficiens, myokardieiskæmi, systemisk hypertension og aterosklerose.
ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension (PAH), as well as other cardiovascular disorders and connective tissue diseases, including scleroderma, acute and chronic heart failure, myocardial ischaemia, systemic hypertension, and atherosclerosis, suggesting a pathogenic role of ET-1 in these diseases.
Omeprazol (CYP2C19-substrat): Samtidig administration af Thelin og omeprazol øgede omeprazols AUC0-24 med 30 %; Cmax var uændret.
Omeprazole (substrate of CYP2C19): Concomitant administration of Thelin with omeprazole increased the omeprazole AUC0-24 by 30%; Cmax was unchanged.
I placebo-kontrollerede forsøg af PAH med den anbefalede dosis var den mest almindelige bivirkning, som blev vurderet til muligvis at være relateret til Thelin, hovedpine hos 15 % af patienterne, og perifert ødem og nasal kongestion, hver hos 9 % af patienterne.
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.
Hvis der forekommer tegn på lungeødem under Thelinbehandling hos patienter med pulmonal hypertension, bør muligheden for associeret veneokklusiv sygdom overvejes.
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.
Gule til orange, kapselformede filmovertrukne tabletter, præget med T-100 på den ene side.
Film-coated tablet Capsule shaped yellow-to-orange film-coated tablets, debossed with T-100 on one side.
Sildenafil (CYP3A4-substrat): En enkeltdosis af sildenafil på 100 mg indgivet samtidig med Thelin øgede sildenafils Cmax og AUC∞ med henholdsvist 18 % og 28 %.
Sildenafil (substrate of CYP3A4): A single dose of sildenafil 100 mg coadministered with Thelin increased Cmax and AUC∞ of sildenafil by 18% and 28%, respectively.
Thelin forhøjer plasmaniveauerne af vitamin K-antagonister, såsom warfarin, acenocoumarol og fenprocoumon (se pkt.
Thelin increases the plasma levels of Vitamin K antagonists such as warfarin, acenocoumarol and fenprocoumon (see section 4.5).
• Hvis De ammer (læs afsnittet ”Graviditet og amning” nedenfor).
• If you are breast-feeding (please read the section ‘Pregnancy and breast-feeding' below);
Graden af interaktion med andre OATP-hæmmere (visse HMG CoA-reduktasehæmmere, f.eks. atorvastatin, proteasehæmmere, f.eks. ritonavir, tuberkulostatika, f.eks. rifamycin) er ikke kendt, men kan resultere i en stigning i sitaxentans plasmakoncentration.
The extent of interaction with other OATP inhibitors (some HMG CoA reductase inhibitors eg, atorvastatin, protease inhibitors eg, ritonavir, tuberculostatics eg, rifamycin) is unknown but could result in raised plasma levels of sitaxentan.
Effektendepunkter inkluderede nedsat maksimal fysisk funktionsevne, WHO-funktionsklasse og tiden til klinisk forværring (Time to Clinical Worsening) i alle studier og hæmodynamiske parametre i STRIDE-1.
Efficacy endpoints included sub maximal exercise capacity, WHO functional class and Time to Clinical Worsening for all studies, and haemodynamics for STRIDE-1.
Spørg på apoteket, hvordan De skal aflevere medicinrester.
Ask your pharmacist how to dispose of medicines you no longer require.
• Leverskader
• Liver damage
Almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 personer):
Common side effects (likely to affect more than 1 in every 100 people):
Pga. mulig teratogenicitet må behandling ikke påbegyndes hos kvinder i den fertile alder, medmindre de anvender sikker kontraception.
Due to possible teratogenicity, Thelin must not be initiated in women of child-bearing potential unless they practise reliable contraception.
• usædvanlig træthed
• unusual tiredness
• Kvalme, opkastning, forstoppelse, mavepine, fordøjelsesbesvær og diaré
• feeling and/or being sick, difficulty in passing stools, stomach ache, indigestion and diarrhoea
In vitro-forsøg med menneskelige levermikrosomer eller primære hepatocytter viser, at sitaxentannatrium hæmmer CYP2C9, og i mindre grad CYP 2C8, CYP2C19 og CYP3A4/5.
In vitro studies using human liver microsomes or primary hepatocytes show that sitaxentan sodium inhibits CYP2C9, and, to a lesser extent, CYP 2C8, CYP2C19 and CYP3A4/5.
Disse bivirkninger er de samme som dem, der blev rapporteret i de kliniske forsøg.
Adverse events reported during the post-marketing period to date have been similar to those reported in clinical trials.
Tag ikkeThelin:
Do not take Thelin:
Kontakt straks lægen, skadestuen eller apoteket, hvis De har taget flere Thelintabletter, end der står her, eller flere end lægen har foreskrevet (eller hvis andre personer har taget nogen af Thelintabletterne).
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.
Hver filmovertrukken tablet indeholder 100 mg sitaxentannatrium.
Each film-coated tablet contains 100 mg sitaxentan sodium.
Sjældne bivirkninger (det sker hos mellem 1 og 10 ud af 1000 patienter):
Rare side effects (likely to affect less than 1 in 1000 people):
Kør ikke bil eller motorcykel og lad være med at cykle, hvis De føler Dem svimmel.
Driving and using machines Do not drive or use any tools or machines if you feel dizzy.
Nifedipin (CYP3A4/5-substrat): Nifedipins clearance var ikke klinisk signifikant ændret ved indgivelse samtidig med Thelin.
Nifedipine (substrate of CYP3A4/5): The clearance of nifedipine was not clinically significantly changed when given concomitantly with Thelin.
Samtidig behandling med ciclosporin (se pkt.
Concomitant administration with ciclosporin A (see section 4.5).
Orale kontraceptiva:
Oral contraceptive agents
Ved indledning af behandling med vitamin K-antagonister hos patienter, som tager sitaxentannatrium, anbefales det at begynde ved den lavest mulige dosis af vitamin Kantagonisten.
When initiating vitamin K antagonist therapy in a patient taking sitaxentan sodium, it is recommended to start at the lowest available dose.
Lægemidlet må kun udleveres efter begrænset recept.
Medicinal product subject to restricted medical prescription.
Thelin bør derfor ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Fluconazol (CYP2C19- og CYP2C9-, og CYP3A4/5-hæmmer): Samtidig administration af Thelin og fluconazol havde ingen effekt på clearance af sitaxentannatrium.
Fluconazole (inhibitor of CYP2C19, CYP2C9 and CYP3A4/5): Co-administration of Thelin and fluconazole had no effect on the clearance of sitaxentan sodium.
Thelin 100 mg filmovertrukne tabletter er gule til orange, kapselformede, filmovertrukne tabletter, , som er præget med T-100 på den ene side.
What Thelin tablets look like and contents of the pack Thelin 100 mg film-coated tablets are yellow-to-orange, capsule-shaped tablets, marked with T-100 on one side.
Hæmoglobinkoncentration:
Tablet core:
Forhøjelse af ASAT og/eller ALAT forbundet med Thelin forekommer både tidligt og sent i behandlingen.
Elevations of AST and/or ALT associated with Thelin occur both early and late in treatment, usually progress slowly, and are typically asymptomatic.
Stigning i protrombintid (PT) (ved samtidig behandling med vitamin Kantagonist).
Prothrombin time (PT) increase (with concomitant vitamin K antagonist therapy).
Almene symptomer og reaktioner på administrationsstedet Træthed, ødemer (sædvanligvis perifere)
General disorders and administration site conditions Fatigue, oedema (most commonly peripheral)
Indeholder lactosemonohydrat.
Contains lactose monohydrate
Sitaxentannatrium metaboliseres i leveren af cytochrom P450-, CYP2C9- og CYP3A4/5-isoenzymer.
Sitaxentan sodium is metabolised in the liver by cytochrome P450 CYP2C9 and CYP3A4/5 isoenzymes.
Leverfunktion:
Liver function:
Det samlede gennemsnitlige fald i hæmoglobinkoncentration var 0,5 g/dl (ændring fra start til behandlingsafslutning) for patienter behandlet med Thelin.
The overall mean decrease in haemoglobin concentration for Thelin -treated patients was 0.5 g/dl (change to end of treatment).
Det skal De vide, før De begynder at tage Thelin Sådan skal De tage Thelin Bivirkninger
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
EU/1/06/353/002 (28 filmovertrukne tabletter i blisterkort).
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)
o Behov for dosisreduktion af vitamin K-antagonister efter initiering af o Start behandling med vitamin K-antagonister i reduceret dosis, hvis patienten er i o Vær opmærksom på risikoen for hæmoragi og undersøg det, der er relevant o Forøget risiko for epistaxis og gingival blødning.
• 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
Test for blodmangel (anæmi)
Testing for anaemia
Stearinsyre (E570b) Hypromellose (E464) Cellulose, mikrokrystallinsk (E460) Titandioxid (E171) Gul jernoxid-dehydrat (E172) Rød jernoxid-dehydrat (E172) Talcum (E553b)
Stearic acid (E570b) Hypromellose (E464) Cellulose, microcrystalline (E460) Titanium dioxide (E171) Yellow iron oxide dehydrate (E172) Red iron oxide dehydrate (E172) Talc (E553b)
Sitaxentannatrium er en hæmmer af CYP2C9 og i mindre grad af CYP2C19, CYP3A4/5 og CYP 2C8.
Sitaxentan sodium is an inhibitor of CYP2C9 and, to a lesser extent, CYP2C19, CYP3A4/5 and CYP2C8.
Thelin indeholder • Aktivt stof: sitaxentannatrium.
• The active substance is sitaxentan sodium.
Organisk anion-transport-polypeptid (OATP)-hæmmere: Samtidig administration af Thelin og ciclosporin, der er en potent OATP-hæmmer, resulterede i en stigning på 6-gange i sitaxentans Cmin og en stigning på 67 % i sitaxentans AUC.
Organic Anion Transporting Polypeptides (OATP) Inhibitors: 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).
SÅDAN SKAL DE TAGE THELIN
HOW TO TAKE THELIN
Hver tablet indeholder 100 mg sitaxentannatrium
Each tablet contains 100 mg of sitaxentan sodium
Graden af interaktion med potente OATP-hæmmere (f.eks. visser statiner, proteinasehæmmere, tuberkulostatika) er ukendt.
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.
Thelin er kontraindiceret til patienter med forhøjede leveraminotransferaser inden påbegyndelse af behandling (> 3 x øvre normalgrænse (ULN)) eller med forhøjet direkte bilirubin inden påbegyndelse af behandling (> 2 x ULN) (se pkt.
Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin > 2 x ULN prior to initiation of treatment (see section 4.3).
• gulfarvning af hud og det hvide i øjnene (gulsot)
• yellow colouring of the skin and eyes (jaundice) Talk to your doctor immediately.
• At Thelin er hepatotoksisk o Nødvendigheden af leverfunktionstests før og i løbet af behandlingen.
• 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).
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS PVC/ACLAR/ aluminiumblister med papirbagbeklædning
PVC/ACLAR/paper-backed aluminium blisters
Thelin er kontraindiceret hos patienter med forhøjede levertransferaser inden påbegyndelse af behandling (> 3 x ULN) eller med forhøjet direkte bilirubin inden påbegyndelse af behandling (> 2 x ULN), se pkt.
Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x ULN), or with elevated direct bilirubin > 2 x ULN prior to initiation of treatment, see section
Thelin 100 mg filmovertrukne tabletter
Thelin 100 mg film-coated tablets
om sitaxentannatrium udskilles i rmælk hos mennesker.
It is unknown whether or not sitaxentan sodium is excreted into human milk.
o Filmovertrækket indeholder stearinsyre (E570b), hypromellose (E464), mikrokrystallinsk cellulose (E460), titandioxid (E171), gul jernoxid-dehydrat (E172), rød jernoxid-dehydrat (E172), og talcum (E553b).
• The film-coat contains stearic acid (E570b), hypromellose (E464), microcrystalline cellulose (E460), titanium dioxide (E171), yellow iron oxide dehydrate (E172), red iron oxide dehydrate (E172) and talc (E553b).
o Kontraindikation hos patienter med forhøjet direkte bilirubin inden påbegyndelse af behandlingen (> 2 x ULN ).
o Contraindication in patients with elevated direct bilirubin > 2 x ULN prior to initiation of treatment.
Sitaxentannatrium metaboliseres in vitro af CYP2C9 og CYP3A4/5.
In vitro, sitaxentan sodium is metabolized by CYP2C9 and CYP3A4/5.
Er De i tvivl, så spørg lægen eller på apoteket.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Aminotransferaseniveauer skal derefter kontrolleres inden for 3 dage efter genoptagelse af behandling.
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.
Forhøjet direkte bilirubin inden påbegyndelse af behandling (> 2 x ULN).
Elevated direct bilirubin > 2 x ULN prior to initiation of treatment.
Thelin 100 mg filmovertrukne tabletter Sitaxentannatrium
Thelin 100 mg film-coated tablets Sitaxentan sodium
• Øvrige indholdsstoffer: o Tabletkernen indeholder mikrokrystallinsk cellulose (E460),lactosemonohydrat, hypromellose (E464), natriumstivelsesglycolat, magnesiumstearat (E470b) vandfri dinatriumphosphat (E339), ascorbylpalmitat (E304), dinatriumedetat, natriumdihydrogenphosphatdihydrat (E339).
• The tablet core contains cellulose, microcrystalline (E460), lactose monohydrate, hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), anhydrous disodium phosphate (E339), ascorbyl palmitate (E304), disodium edetate and monobasic sodium phosphate (E339).
Endothelin-1 (ET-1) er et potent vaskulært parakrint og autokrint peptid i lungen.
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.
○ Alle alvorlige bivirkninger ○ Stigning i leverenzymer til > 3 x ULN ○ Forhøjet direkte bilirubin > 2 x ULN ○ Anæmi ○ Hæmoragi ○ Graviditet og udfald ○ Lungeødem (forbundet med veneokklusiv sygdom) ○Formodede interaktioner ○Uventede bivirkninger i henhold til produktresumé.
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.
84 filmovertrukne tabletter i blisterkort.
14 film-coated tablets in blisters 28 film-coated tablets in blisters 56 film-coated tablets in blisters 84 film-coated tablets in blisters
Ketoconazol (CYP3A4/5-substrat og -hæmmer): Samtidig administration af Thelin og ketoconazol forårsagede ikke en klinisk siginifikant ændring af hverken sitaxentannatriums eller ketoconazols clearance.
Ketoconazole (substrate and inhibitor of CYP3A4/5): Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or ketoconazole.
• Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
• If any side effect becomes serious, or if you notice any side effects not listed in this leaflet,
Hvis aminotransferaseniveauerne vender tilbage til niveauerne inden indledning af behandlingen, bør genoptagelse af den initiale dosering ud fra betingelserne beskrevet nedenfor overvejes.
If the aminotransferase levels return to pre-treatment values, consider resuming the initial treatment schedule according to the conditions described below.
Tal med lægen, inden De begynder at tage Thelin, hvis nogen af ovenstående punkter gælder for Dem.
If any of these apply to you, tell your doctor before you start taking Thelin.
Henvend Dem til Deres læge eller apotek, hvis De har yderligere spørgsmål.
Check with your doctor or pharmacist if you are not sure.
Kvinder i den fertile alder:
Women of child-bearing potential
acenocoumarol, phenprocoumon eller fluindion) for at forebygge blodpropper.
• If you are taking or begin to take anticoagulants (e.g. warfarin, acenocoumarol, fenprocoumon or fluindione) to prevent blood clots.
Hvis aminotransferasenivauerne returnerer til værdierne inden behandling, kan genoptagelse af Thelinbehandling overvejes i henhold til omstændighederne beskrevet nedenfor.
If the aminotransferase levels return to pre-treatment values, consider reintroducing Thelin according to the conditions described below.
Funktionsklasse
Functional Class
Brug af Thelin er kontraindiceret, hvis ASAT og/eller ALAT er > 3 x ULN, inden behandling påbegyndes eller hvis direkte bilirubin er > 2 x ULN (se pkt.
If AST and/or ALT are > 3 x ULN prior to initiation of therapy, or direct bilirubin is > 2 x ULN, use of sitaxentan is contraindicated (see section 4.3)
• Rødmen
• flushed
• Muskelkramper
• cramp in muscles
bilag I: Produktresumé; pkt.
(See Annex I: Summary of Product Characteristics, section 4.2)
Nelfinavir (CYP2C19- og CYP3A4/5-substrat): Samtidig administration af Thelin og nelfinavir forårsagede ikke en klinisk signifikant ændring i clearance af sitaxentannatrium eller af nelfinavir.
Nelfinavir (substrate of CYP3A4/5, CYP2C19): Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or nelfinavir.
Dosering ved nedsat leverfunktion:
Dosage in hepatic impairment:
Ved høje doser sås endvidere dosisrelaterede stigninger i protrombintid (PT) og aktiveret delvis tromboplastintid (APTT).
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.
Kontakt lægen før De tager Thelin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
If you are intolerant to some sugars, contact your doctor before taking Thelin tablets.
Natriumstivelsesglycolat Magnesiumstearat (E470b) Dinatriumphosphat, vandfri (E339) Ascorbylpalmitat (E304) Dinatriumedetat
Cellulose, microcrystalline (E460) Lactose monohydrate Hypromellose (E464) Sodium starch glycolate Magnesium stearate (E470b) Disodium phosphate, anhydrous (E339) Ascorbyl palmitate (E304) Disodium edetate
Ved bekræftelse skal behandlingen afbrydes, og aminotransferaseniveauer monitoreres mindst hver fjortende dag, indtil niveauerne normaliseres.
> 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.
Forhøjet ASAT og/eller ALAT er forbundet med sitaxentannatrium.
Increased Liver Aminotransferases (see section 4.4) Elevations of AST and/or ALT are associated with sitaxentan sodium.