FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma concentrations of drugs principally metabolized by CYP2C9 may be increased during sitaxentan sodium co-administration.
Danish: Plasmakoncentrationen af lægemidler, der hovedsagligt metaboliseres af CYP2C9, kan være forhøjet ved samtidig anvendelse af sitaxentannatrium.
English: The 18 week STRIDE-2 trial, conducted in 246 patients, included 4 treatment arms: placebo once daily, Thelin 50 mg once daily, Thelin 100 mg once daily, and open-label bosentan twice daily (efficacy-rater blinded, administered according to the approved package insert).
Danish: STRIDE-2forsøget på 18 uger foretaget med 246 patienter omfattede 4 behandlingsarme: placebo én gang dagligt; Thelin 50 mg én gang dagligt, Thelin 100 mg én gang dagligt, og åbent bosentan to gange dagligt (effekten vurderet blindet, indgivet i henhold til godkendt indlægsseddel).
English: Rash (various types and presentations)
Danish: Udslæt (forskellige former)
English: 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.
Danish: Sitaxentannatrium blev påvist i plasma fra rotteunger, som havde diet hos hunrotter behandlet med sitaxentannatrium, hvilket indikerer, at sitaxentannatrium var til stede i brystmælken.
English: Gingival bleeding, flushing
Danish: Gingival blødning, rødmen
English: • If you could get pregnant or are pregnant (please read the section “Pregnancy and breast-feeding”
Danish: • Hvis De er i den fødedygtige alder eller er gravid (læs afsnittet ‘Graviditet og Amning'
English: 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.
Danish: STRIDE-1, som omfattede 178 patienter, sammenlignede 2 orale doser af Thelin (100 mg én gang dagligt og 300 mg én gang dagligt) med placebo under 12 ugers behandling.
English: Thelin should be used with caution if you are taking or begin to take Vitamin K antagonists (e.g. warfarin, acenocoumarol, fenprocoumon or fluindione).
Danish: Thelin bør anvendes med forsigtighed, hvis De tager eller begynder at tage vitamin K-antagonister (f.eks. warfarin, acenocoumarol, phenprocoumon eller fluindion).
English: In an open-label hypertension study, 10 patients received 480 mg twice daily (approximately a 10-fold increase in daily dose compared to the MRHD) for up to 2 weeks.
Danish: I et åbent hypertensionsforsøg fik 10 patienter 480 mg 2 gange dagligt (dvs. en cirka 10 gange højere daglig dosis sammenlignet med den maksimalt anbefalede humane dosis) i op til 2 uger.
English: 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).
Danish: I fase 2 og 3 orale forsøg hos patienter med PAH blev forhøjelse af ALAT og/eller ASAT > 3 ULN observeret hos 5 % af patienterne, der blev behandlet med placebo (N=155) og hos 7 % af patienterne behandlet med Thelin 100 mg (N=887).
English: 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.
Danish: Derudover resulterede kliniske interaktionsforsøg med nelfinavir, en moderat potent OATP-hæmmer, og pravastatin, en OATP-hæmmer med lav affinitet, ikke i klinisk signifikante ændringer i sitaxentans plasmakoncentration.
English: Do not breast-feed if you are taking this medicine, it is not known if it passes into breast milk.
Danish: De må ikke amme, mens De tager Thelin, da det ikke vides, om det udskilles i modermælken.
English: Thelin comes in blister packs of 14, 28, 56, and 84 tablets and bottles of 28 tablets.
Danish: Thelin findes i blisterkort med 14, 28, 56 og 84 tabletter og beholder med 28 tabletter.
English: 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.
Danish: (Cmax) af Thelin reduceret med 43 % og Tmax forsinket (dobbelt forøgelse) sammenlignet med fastende tilstand, men graden af absorption var den samme.
English: 28 film-coated tablets
Danish: 28 filmovertrukne tabletter.
English: Dosage in renal impairment: No dose adjustment is required in patients with renal impairment.
Danish: Dosering ved nedsat nyrefunktion: Der kræves ikke dosisjustering hos patienter med nedsat nyrefunktion.
English: Treatment with Thelin was associated with a dose-related decrease in haemoglobin (see section 4.8).
Danish: Behandling med Thelin var forbundet med et dosisrelateret fald i hæmoglobin (se pkt.
English: 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.
Danish: 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.
English: Monobasic sodium phosphate (E339)
Danish: Natriumdihydrogenphosphatdihydrat (E339)
English: Thelin tablets contain lactose monohydrate.
Danish: Thelintabletter indeholder lactosemonohydrat.
English: 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.
Danish: 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.
English: • Try to take the tablet at the same time each day to help you remember.
Danish: • Prøv at tage tabletten på samme tidspunkt hver dag, så De ikke så nemt glemmer det. Slug tabletten hel med vand.
English: No data are available with Thelin in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
Danish: Der foreligger ingen data om brugen af Thelin hos patienter med pulmonal hypertension i forbindelse med pulmonal veneokklusiv sygdom.
English: 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).
Danish: Der bør tages relevante forholdsregler, når sitaxentanbehandling initieres hos patienter, der har afbrudt behandling med andre endothelinreceptor-antagonister pga. leverenzymabnormiteter (se pkt.
English: Co-administration with drugs metabolized by CYP2C19 or CYP3A4/5 is not expected to result in clinically significant drug interactions.
Danish: Samtidig administration med lægemidler, der metaboliseres af CYP2C19 eller CYP3A4/5, forventes ikke at resultere i klinisk signifikante lægemiddelinteraktioner.
English: 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.
Danish: Ved fravær af endothelinreceptor-antagonisme er forhøjede ET-1-koncentrationer stærkt korreleret med sværhedsgraden af PAH og hjertesvigt og prognosen for disse sygdomme.
English: Therefore, especially in women who smoke, there is an increased risk for thromboembolism.
Danish: Der er derfor en forøget risiko for tromboembolisme.
English: 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.
Danish: Denne specifikke gruppe havde en større risiko (19 %; N=10/53) for udvikling af ALAT-stigning og/eller ASAT-stigning > 3 x ULN.
English: Headaches (some severe),
Danish: Det vides ikke,
English: INR increase (with concomitant vitamin K antagonist therapy).
Danish: Stigning i INR (ved samtidig behandling med vitamin K-antagonist).
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Omeprazole (substrate of CYP2C19): Concomitant administration of Thelin with omeprazole increased the omeprazole AUC0-24 by 30%; Cmax was unchanged.
Danish: Omeprazol (CYP2C19-substrat): Samtidig administration af Thelin og omeprazol øgede omeprazols AUC0-24 med 30 %; Cmax var uændret.
English: 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.
Danish: 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.
English: 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.
Danish: Hvis der forekommer tegn på lungeødem under Thelinbehandling hos patienter med pulmonal hypertension, bør muligheden for associeret veneokklusiv sygdom overvejes.
English: Film-coated tablet Capsule shaped yellow-to-orange film-coated tablets, debossed with T-100 on one side.
Danish: Gule til orange, kapselformede filmovertrukne tabletter, præget med T-100 på den ene side.
English: 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.
Danish: Sildenafil (CYP3A4-substrat): En enkeltdosis af sildenafil på 100 mg indgivet samtidig med Thelin øgede sildenafils Cmax og AUC∞ med henholdsvist 18 % og 28 %.
English: Thelin increases the plasma levels of Vitamin K antagonists such as warfarin, acenocoumarol and fenprocoumon (see section 4.5).
Danish: Thelin forhøjer plasmaniveauerne af vitamin K-antagonister, såsom warfarin, acenocoumarol og fenprocoumon (se pkt.
English: • If you are breast-feeding (please read the section ‘Pregnancy and breast-feeding' below);
Danish: • Hvis De ammer (læs afsnittet ”Graviditet og amning” nedenfor).
English: 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.
Danish: 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.
English: Efficacy endpoints included sub maximal exercise capacity, WHO functional class and Time to Clinical Worsening for all studies, and haemodynamics for STRIDE-1.
Danish: 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.
English: Ask your pharmacist how to dispose of medicines you no longer require.
Danish: Spørg på apoteket, hvordan De skal aflevere medicinrester.
English: • Liver damage
Danish: • Leverskader
English: Common side effects (likely to affect more than 1 in every 100 people):
Danish: Almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 personer):
English: Due to possible teratogenicity, Thelin must not be initiated in women of child-bearing potential unless they practise reliable contraception.
Danish: Pga. mulig teratogenicitet må behandling ikke påbegyndes hos kvinder i den fertile alder, medmindre de anvender sikker kontraception.
English: • unusual tiredness
Danish: • usædvanlig træthed
English: • feeling and/or being sick, difficulty in passing stools, stomach ache, indigestion and diarrhoea
Danish: • Kvalme, opkastning, forstoppelse, mavepine, fordøjelsesbesvær og diaré
English: 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.
Danish: In vitro-forsøg med menneskelige levermikrosomer eller primære hepatocytter viser, at sitaxentannatrium hæmmer CYP2C9, og i mindre grad CYP 2C8, CYP2C19 og CYP3A4/5.
English: Adverse events reported during the post-marketing period to date have been similar to those reported in clinical trials.
Danish: Disse bivirkninger er de samme som dem, der blev rapporteret i de kliniske forsøg.
English: Do not take Thelin:
Danish: Tag ikkeThelin:
English: 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.
Danish: 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).
English: Each film-coated tablet contains 100 mg sitaxentan sodium.
Danish: Hver filmovertrukken tablet indeholder 100 mg sitaxentannatrium.
English: Rare side effects (likely to affect less than 1 in 1000 people):
Danish: Sjældne bivirkninger (det sker hos mellem 1 og 10 ud af 1000 patienter):
English: Driving and using machines Do not drive or use any tools or machines if you feel dizzy.
Danish: Kør ikke bil eller motorcykel og lad være med at cykle, hvis De føler Dem svimmel.
English: Nifedipine (substrate of CYP3A4/5): The clearance of nifedipine was not clinically significantly changed when given concomitantly with Thelin.
Danish: Nifedipin (CYP3A4/5-substrat): Nifedipins clearance var ikke klinisk signifikant ændret ved indgivelse samtidig med Thelin.
English: Concomitant administration with ciclosporin A (see section 4.5).
Danish: Samtidig behandling med ciclosporin (se pkt.
English: Oral contraceptive agents
Danish: Orale kontraceptiva:
English: When initiating vitamin K antagonist therapy in a patient taking sitaxentan sodium, it is recommended to start at the lowest available dose.
Danish: 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.
English: Medicinal product subject to restricted medical prescription.
Danish: Lægemidlet må kun udleveres efter begrænset recept.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Danish: Thelin bør derfor ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Fluconazole (inhibitor of CYP2C19, CYP2C9 and CYP3A4/5): Co-administration of Thelin and fluconazole had no effect on the clearance of sitaxentan sodium.
Danish: Fluconazol (CYP2C19- og CYP2C9-, og CYP3A4/5-hæmmer): Samtidig administration af Thelin og fluconazol havde ingen effekt på clearance af sitaxentannatrium.
English: 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.
Danish: Thelin 100 mg filmovertrukne tabletter er gule til orange, kapselformede, filmovertrukne tabletter, , som er præget med T-100 på den ene side.
English: Tablet core:
Danish: Hæmoglobinkoncentration:
English: Elevations of AST and/or ALT associated with Thelin occur both early and late in treatment, usually progress slowly, and are typically asymptomatic.
Danish: Forhøjelse af ASAT og/eller ALAT forbundet med Thelin forekommer både tidligt og sent i behandlingen.
English: Prothrombin time (PT) increase (with concomitant vitamin K antagonist therapy).
Danish: Stigning i protrombintid (PT) (ved samtidig behandling med vitamin Kantagonist).
English: General disorders and administration site conditions Fatigue, oedema (most commonly peripheral)
Danish: Almene symptomer og reaktioner på administrationsstedet Træthed, ødemer (sædvanligvis perifere)
English: Contains lactose monohydrate
Danish: Indeholder lactosemonohydrat.
English: Sitaxentan sodium is metabolised in the liver by cytochrome P450 CYP2C9 and CYP3A4/5 isoenzymes.
Danish: Sitaxentannatrium metaboliseres i leveren af cytochrom P450-, CYP2C9- og CYP3A4/5-isoenzymer.
English: Liver function:
Danish: Leverfunktion:
English: The overall mean decrease in haemoglobin concentration for Thelin -treated patients was 0.5 g/dl (change to end of treatment).
Danish: Det samlede gennemsnitlige fald i hæmoglobinkoncentration var 0,5 g/dl (ændring fra start til behandlingsafslutning) for patienter behandlet med Thelin.
English: 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
Danish: Det skal De vide, før De begynder at tage Thelin Sådan skal De tage Thelin Bivirkninger
English: 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)
Danish: EU/1/06/353/002 (28 filmovertrukne tabletter i blisterkort).
English: • 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
Danish: 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.
English: Testing for anaemia
Danish: Test for blodmangel (anæmi)
English: Stearic acid (E570b) Hypromellose (E464) Cellulose, microcrystalline (E460) Titanium dioxide (E171) Yellow iron oxide dehydrate (E172) Red iron oxide dehydrate (E172) Talc (E553b)
Danish: Stearinsyre (E570b) Hypromellose (E464) Cellulose, mikrokrystallinsk (E460) Titandioxid (E171) Gul jernoxid-dehydrat (E172) Rød jernoxid-dehydrat (E172) Talcum (E553b)
English: Sitaxentan sodium is an inhibitor of CYP2C9 and, to a lesser extent, CYP2C19, CYP3A4/5 and CYP2C8.
Danish: Sitaxentannatrium er en hæmmer af CYP2C9 og i mindre grad af CYP2C19, CYP3A4/5 og CYP 2C8.
English: • The active substance is sitaxentan sodium.
Danish: Thelin indeholder • Aktivt stof: sitaxentannatrium.
English: 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).
Danish: 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.
English: HOW TO TAKE THELIN
Danish: SÅDAN SKAL DE TAGE THELIN
English: Each tablet contains 100 mg of sitaxentan sodium
Danish: Hver tablet indeholder 100 mg sitaxentannatrium
English: 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.
Danish: Graden af interaktion med potente OATP-hæmmere (f.eks. visser statiner, proteinasehæmmere, tuberkulostatika) er ukendt.
English: 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).
Danish: 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.
English: • yellow colouring of the skin and eyes (jaundice) Talk to your doctor immediately.
Danish: • gulfarvning af hud og det hvide i øjnene (gulsot)
English: • 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).
Danish: • At Thelin er hepatotoksisk o Nødvendigheden af leverfunktionstests før og i løbet af behandlingen.
English: PVC/ACLAR/paper-backed aluminium blisters
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS PVC/ACLAR/ aluminiumblister med papirbagbeklædning
English: 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
Danish: 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.
English: Thelin 100 mg film-coated tablets
Danish: Thelin 100 mg filmovertrukne tabletter
English: It is unknown whether or not sitaxentan sodium is excreted into human milk.
Danish: om sitaxentannatrium udskilles i rmælk hos mennesker.
English: • 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).
Danish: o Filmovertrækket indeholder stearinsyre (E570b), hypromellose (E464), mikrokrystallinsk cellulose (E460), titandioxid (E171), gul jernoxid-dehydrat (E172), rød jernoxid-dehydrat (E172), og talcum (E553b).
English: o Contraindication in patients with elevated direct bilirubin > 2 x ULN prior to initiation of treatment.
Danish: o Kontraindikation hos patienter med forhøjet direkte bilirubin inden påbegyndelse af behandlingen (> 2 x ULN ).
English: In vitro, sitaxentan sodium is metabolized by CYP2C9 and CYP3A4/5.
Danish: Sitaxentannatrium metaboliseres in vitro af CYP2C9 og CYP3A4/5.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller på apoteket.
English: 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.
Danish: Aminotransferaseniveauer skal derefter kontrolleres inden for 3 dage efter genoptagelse af behandling.
English: Elevated direct bilirubin > 2 x ULN prior to initiation of treatment.
Danish: Forhøjet direkte bilirubin inden påbegyndelse af behandling (> 2 x ULN).