FrancophonIA/ELRC3.0 huggingface dataset:
English: Fluconazole 200 mg QD (Day 1) then 100 mg QD
Danish: Svampemidler Fluconazol 200 mg x 1 (dag 1) derefter 100 mg x 1
English: Aptivus must be administered with low dose ritonavir to ensure its therapeutic effect (see section 4.2).
Danish: Aptivus skal gives sammen med en lavdosis ritonavir for at sikre en terapeutisk virkning (se pkt.
English: Aptivus co-administered with low dose ritonavir, has been associated with reports of clinical hepatitis and hepatic decompensation, including some fatalities.
Danish: Aptivus plus lavdosis ritonavir har været kædet sammen med rapportering om klinisk hepatitis og hepatisk dekompensering, nogen med dødelig udgang.
English: If indicated, elimination of unabsorbed tipranavir should be achieved by emesis or gastric lavage.
Danish: Hvis relevant kan elimination af uabsorberet tipranavir foretages vha. opkastning eller maveskylning.
English: Other HMG-CoA reductase inhibitors should be considered such as pravastatin, fluvastatin or rosuvastatin (see section 4.5).
Danish: Andre HMG-CoA-reduktasehæmmere bør overvejes, f.eks. pravastatin, fluvastatin eller rosuvastatin (se pkt.
English: Tipranavir pharmacokinetics have not been studied in patients with renal impairment.
Danish: Tipranavirs farmakokinetik er ikke undersøgt hos patienter med renal dysfunktion.
English: Patients should be monitored for opiate withdrawal syndrome.
Danish: Patienter bør monitoreres for opiatabstinens symptomer.
English: Nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs) Since there is no significant impact of nucleoside and nucleotide analogues on the P450 enzyme system no dosage adjustment of Aptivus is required when co-administered with these agents.
Danish: Nukleosid og nukleotid reverse transcriptasehæmmere (NRTI) Dosisjustering af Aptivus er ikke nødvendig ved samtidig behandling med nukleosid og nukleotid ananloger, da nukleosid og nukleotid ananloger ikke har nogen signifikant påvirkning på P450 enzymsystemet.
English: Analyses were conducted to assess virological outcome by the number of primary PI mutations (any change at protease codons 30, 32, 36, 46, 47, 48, 50, 53, 54, 82, 84, 88 and 90) present at baseline.
Danish: Der blev foretaget analyser med henblik på at vurdere det virologiske resultat på basis af antallet af primære proteasehæmmermutationer, der forelå ved baseline (enhver ændring ved proteasekodon 30, 32, 36, 46, 47, 48, 50, 53, 54, 82, 84, 88 og 90).
English: If you notice any of these symptoms please inform your child's doctor.
Danish: Hvis du bemærker et eller flere af disse symptomer, bør du fortælle det til dit barns læge.
English: Tipranavir maintains significant antiviral activity (< 4-fold resistance) against the majority of HIV-1 clinical isolates showing post-treatment decreased susceptibility to the currently approved protease inhibitors: amprenavir, atazanavir, indinavir, lopinavir, ritonavir, nelfinavir and saquinavir.
Danish: Tipranavir forbliver signifikant antiviralt (<4 gange resistens) over for størstedelen af hiv-1-kliniske isolater, som udviser nedsat følsomhed over for de godkendte proteasehæmmere: amprenavir, atazanavir, indinavir, lopinavir, ritonavir, nelfinavir og saquinavir.
English: Each bottle contains 120 soft capsules.
Danish: Hver beholder indeholder 120 kapsler.
English: The co-administration of tipranavir with vitamin E in the form of TPGS (d-alphatocopherol polyethylene glycol 1000 succinate) from 2,322 IU/m² upwards in rats resulted in a significant increase in effects on coagulation parameters, bleeding events and death.
Danish: Samtidig administration til rotter af tipranavir og vitamin E i formen TPGS (dalphatocopherolpolyethylenglycol 1000 succinat) med en mængde på minimum 2,322 IE/m resulterede i en signifikant øget påvirkning af koagulationsparametre, blødningsepisoder og død.
English: At 48-weeks in Phase III trials, rash of various types was observed in 15.5% males and 20.5% females receiving Aptivus coadministered with low dose ritonavir.
Danish: I et 48 ugers fase IIIstudie blev udslæt af forskellige typer observeret hos 15,5% af de mænd og 20,5% af de kvinder, der fik Aptivus sammen med en lav dosis af ritonavir.
English: If you suffer increased bleeding you should see your doctor immediately.
Danish: Hvis du får øget blødningstendens, skal du kontakte lægen straks.
English: At 48-weeks, a higher proportion of patients receiving tipranavirwithritonavir achieved a treatment response in comparison to the comparator protease inhibitor/ritonavir for nearly all of the possible combinations of genotypic resistance mutations (see table below).
Danish: Efter 48 uger nåede en større andel af de patienter, der fik tipranavir med ritonavir-behandling et behandlingsrespons sammenlignet med komparator proteasehæmmer/ritonavir for næsten alle mulige kombinationer af genotypisk resistensmutation (se tabel nedenfor).
English: Ritonavir acts by inhibiting hepatic cytochrome P450 CYP3A, the intestinal P-glycoprotein (P-gp) efflux pump and possibly intestinal cytochrome P450 CYP3A as well.
Danish: Ritonavir hæmmer det hepatiske cytokrom P450 CYP3A, udstrømningspumpen for P-glykoprotein (P-gp) i tarmen og muligvis også cytokrom P450 CYP3A i tarmen.
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with zidovudine or abacavir, results in a significant decrease in plasma concentration of these nucleoside reverse transcriptase inhibitors (NRTIs).
Danish: Samtidig behandling med Aptivus plus lavdosis ritonavir og zidovudin eller abacavir resulterer i et significant fald i plasmakoncentrationen af disse nucleoside reverse transcriptasehæmmere (NRTIs).
English: First-dose tipranavir/r:
Danish: Første-dosis tipranavir/r:
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-smittede patienter med svær immundefekt på tidspunktet for initieringen af den antiretrovirale kombinationsbehandling, kan der opstå en inflammatorisk reaktion over for asymptomatiske eller residuale opportunistiske patogener og forårsage alvorlige kliniske tilstande eller forværring af symptomerne.
English: It is recommended to prescribe tadalafil after at least 7 days of Aptivus with ritonavir dosing.
Danish: Tadalafil behandling bør startes efter mindst 7 dages behandling med Aptivus med ritonavir.
English: Total patients treated (N) 62 Events [N(%)]
Danish: Total antal behandlede patienter (N) Bivirkninger [N(%)] Diaré
English: Doses of ritonavir lower than 150 mg/m 2 twice daily, should not be used as they might alter the efficacy profile of the combination.
Danish: Der bør ikke ordineres ritonavir i doser på mindre end 150 mg/m 2 to gange daglig, da det kan ændre virkningsprofilen ved kombinationsbehandlingen.
English: Other medicines and Aptivus
Danish: Brug af anden medicin sammen med Aptivus
English: Failure to correctly co-administer tipranavir with ritonavir will result in reduced plasma levels of tipranavir that may be insufficient to achieve the desired antiviral effect.
Danish: Hvis tipranavir og ritonavir ikke gives korrekt sammen, resulterer det i nedsatte plasmakoncentrationer for tipranavir, som kan være utilstrækkelige til at opnå den ønskede antivirale virkning.
English: Nevertheless, the clinical data available from the RESIST trials did not suggest any significant alteration of the tipranavir with ritonavir safety profile when combined with enfuvirtide as compared to patients treated with tipranavir with ritonavir without enfuvirtide.
Danish: Dog viste kliniske data fra RESISTstudiet ingen signifikant ændring af sikkerhedsprofilen, når tipranavir med ritonavir gives med eller uden enfuvirtid.
English: Co-administration of Aptivus and agents that induce CYP3A and/or P-gp may decrease tipranavir concentrations and reduce its therapeutic effect (see list and details of considered agents, below).
Danish: Samtidig administration af Aptivus og midler, der inducerer CYP3A og/eller P-gp kan sænke tipranavirkoncentrationerne og nedsætte den terapeutiske virkning (se liste og beskrivelse af relevante midler herunder).
English: Ergot derivatives Dihydroergotamine Ergonovine Ergotamine Methylergonovine No interaction study performed
Danish: Sekalealkaloider Dihydroergotamin Ergonovin Ergotamin Methylergonovin Der er ikke udført interaktionsstudier.
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Danish: Patienter, der tager østrogen som hormonerstatning, skal monitoreres klinisk for tegn på østrogenmangel.
English: Caution should be used when prescribing carbamazepine, phenobarbital, and phenytoin.
Danish: Der bør udvises forsigtighed ved ordination af carbamazepin, fenobarbital og fenytoin.
English: The most abundant urinary metabolite, at 11.0% of urine radioactivity (0.5% of dose) was a glucuronide conjugate of tipranavir.
Danish: 11,0% af radioaktiviteten (0,5% af dosis) var et glucuronid-konjugat fra tipranavir.
English: Black printing ink Propylene glycol Black iron oxide (E172) Polyvinyl acetate phthalate Macrogol
Danish: Propylenglycol Sort jernoxid (E172) Polyvinylacetatphthalat Macrogol
English: Aptivus in combination with low dose ritonavir may cause changes in your heart rhythm and the electrical activity of your heart.
Danish: Aptivus plus lavdosis ritonavir kan forårsage ændringer i hjerterytmen og i den elektriske aktivitet i hjertet.
English: Aptivus also contains macrogolglycerol ricinoleate which may cause stomach upset and diarrhoea.
Danish: Aptivus indeholder også makrogolglycerol-ricinoleat, som kan give maveproblemer og diare.
English: Contains macrogolglycerol ricinoleate, sorbitol and ethanol (see package leaflet for further information)
Danish: LISTE OVER HJÆLPESTOFFER Indeholder makrogolglycerol-ricinoleat, sorbitol og ethanol (se indlægsseddel)
English: H2-receptor antagonists No interaction study performed
Danish: H2-receptorantagonister Der er ikke udført interaktionsstudier.
English: Aptivus may lead to a loss of effectiveness of some medicines including: - methadone, meperidine (pethidine), used as morphine substitutes
Danish: Aptivus kan medføre, at nedenstående medicin mister eller får nedsat virkning: - metadon, meperidin (petidin), morfin-erstatning.
English: The clinical implications of these findings are not known.
Danish: Den kliniske relevans af disse fund er ikke kendt.
English: If Aptivus has been prescribed for your child, please note that all information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
Danish: Hvis Aptivus er ordineret til dit barn, så bemærk venligst, at denne information er beregnet til dit barn.
English: Also the use of the alpha-1 adrenoceptor antagonist alfuzosin, and sildenafil when used for the treatment of pulmonary arterial hypertension.
Danish: Ligeledes α-1-antagonisten alfuzosin samt sildenafil til behandling af pulmonal arteriel hypertension.
English: However, it is unknown whether the combination of tipranavir with ritonavir might cause a larger increase in trazodone exposure.
Danish: Det vides dog ikke om kombinationen af tipranavir med ritonavir kan forårsage en større forøgelse af trazodoneksponering.
English: Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.
Danish: Aptivus bør kun anvendes i kombinationsbehandling med antiretroviale lægemidler hos patienter, hvor der ikke er nogen anden terapeutisk mulighed.
English: If your child has liver disease or hepatitis, their doctor will decide if they need additional testing.
Danish: Hvis dit barn har en leversygdom eller hepatitis, vil dit barns læge vurdere, om dit barn har brug for ekstra studier.
English: Through 48 weeks of treatment, the proportion of patients in the tipranavir with ritonavir arm compared to the comparator PI/ritonavir arm with HIV-1 RNA < 400 copies/ml was 30% and 14% respectively, and with HIV-1 RNA < 50 copies/ml was 23% and 10% respectively.
Danish: Gennem 48 ugers behandling var andelen af patienter i tipranavir med ritonavir-gruppen i forhold til komparator-proteasehæmmer/ritonavir-gruppen med hiv-1 RNA < 400 viruspartikler/ml henholdsvis 30% og 14%, og med hiv-1 RNA < 50 viruspartikler/ml henholdsvis 23% og 10%.
English: Rabeprazole plasma concentrations might decrease as a result of induction of CYP2C19 by tipranavir/r.
Danish: Plasmakoncentrationen af rabeprazol kan reduceres som følge af tipranavir/r induktion af CYP2C19.
English: Ethinyl oestradiol Cmax ↓ 52% Ethinyl oestradiol AUC ↓ 43% Mechanism unknown Norethindrone Cmax ↔ Norethindrone AUC ↑ 27% Tipranavir ↔
Danish: Ethinyl-estradiol Cmax ↓ 52% Ethinyl-estradiol AUC ↓ 43% Ukendt mekanisme Norethisteron Cmax ↔ Norethisteron AUC ↑ 27% Tipranavir ↔
English: Tipranavir is a substrate, an inducer and an inhibitor of cytochrome P450 CYP3A.
Danish: Tipranavir er et substrat, der inducerer og hæmmer cytokrom P450 CYP3A.
English: Concomitant use of tipranavir, co-administered with low dose ritonavir, and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Danish: Samtidig anvendelse af tipranavir plus lavdosis ritonavir og fluticason eller andre glukokortikoider, der metaboliseres af CYP3A4 anbefales ikke, medmindre den potentielle fordel ved behandlingen opvejer risikoen for systemiske kortikosteroid-effekter, herunder Cushings syndrom og adrenal suppression (se pkt.
English: In general, caution should be exercised in the administration and monitoring of Aptivus in older people reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy (see section 4.4).
Danish: Generelt skal der udvises forsigtighed, når der gives Aptivus til ældre patienter, grundet den højere frekvens af nedsat lever-, nyre- og hjertefunktion og anden samtidig sygdom eller behandling (se pkt.
English: Drugs by therapeutic area
Danish: Lægemidler inddelt efter terapeutisk område
English: 600/100 mg BID
Danish: 600/100 mg x 2
English: 25-O-desacetylrifabutin AUC ↑ 21 fold
Danish: 25-O-desacetylrifabutin AUC ↑ 21 gange
English: Integrase strand transfer inhibitors Raltegravir 400 mg BID Raltegravir Cmax ↔ Raltegravir AUC 0-12↔ Raltegravir C12: ↓ 45%
Danish: Integrasehæmmere af genoverførelse Raltegravir 400 mg x 2 Raltegravir Cmax ↔ Raltegravir AUC 0-12↔ Raltegravir C12: ↓ 45%
English: General disorders and administration site conditions common fatigue uncommon pyrexia, influenza like illness, malaise * see section Description of selected adverse reactions “Bleeding” for source of information
Danish: Ikke almindelig pyreksi, influenzalignende symptomer, utilpashed *se afsnittet Beskrivelse af udvalgte bivirkninger “Blødning” for mere information
English: Limited data are currently available for the use of Aptivus, co-administered with low dose ritonavir, in patients co-infected with hepatitis B or C. Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reaction.
Danish: Der foreligger begrænsede data vedrørende brugen af Aptivus plus lavdosis ritonavir til patienter smittede med hepatitis B eller C. Patienter med kronisk hepatitis B eller C, som behandles med antiretroviral kombinationsbehandling, har øget risiko for svære og potentielt fatale leverbivirkninger.
English: Rosuvastatin 10 mg QD Rosuvastatin Cmax ↑ 123% Rosuvastatin AUC ↑ 37%
Danish: Rosuvastatin 10 mg x 1 Rosuvastatin Cmax ↑ 123% Rosuvastatin AUC ↑ 37%
English: At least one primary protease gene mutation from among 30N, 46I, 46L, 48V, 50V, 82A, 82F, 82L, 82T, 84V or 90M had to be present at baseline, with not more than two mutations on codons 33, 82, 84 or 90.
Danish: Mindst en primær proteasegenmutation blandt 30N, 46I, 46L, 48V, 50V, 82A, 82F, 82L, 82T, 84V eller 90M skulle være til stede ved baseline men ikke mere end to mutationer på kodon 33, 82, 84 eller 90.
English: There was an average decrease in susceptibility of 2-fold wild type (WT) for tipranavir, 12-fold WT for amprenavir, 55-fold WT for atazanavir, 41-fold WT for indinavir, 87-fold WT for lopinavir, 41fold WT for nelfinavir, 195-fold WT for ritonavir, and 20-fold WT for saquinavir.
Danish: Der var et gennemsnitligt fald i følsomhed for 2 gange vildtype over for tipranavir, 12 gange vildtype over for amprenavir, 55 gange vildtype over for atazanavir, 41 gange vildtype over for indinavir, 87 gange vildtype over for lopinavir, 41 gange vildtype over for nelfinavir, 195 gange vildtype over for ritonavir og 20 gange vildtype over for saquinavir.
English: Adverse events of nausea, dizziness, hypotension and syncope have been observed following coadministration of trazodone and ritonavir in this study.
Danish: I dette studie så man bivirkninger som kvalme, svimmelhed, hypotension og synkope ved samtidig administration af trazodon og ritonavir.
English: An interaction study in women between tipranavir, co-administered with low dose ritonavir, and ethinyl oestradiol/norethindrone demonstrated a high frequency of non-serious rash.
Danish: Et interaktionsstudie med kvinder mellem tipranavir plus lavdosis ritonavir og ethinylestradiol/norethindron viste stor hyppighed af ikke-alvorligt udslæt.
English: What you need to know before your child takes Aptivus
Danish: Det skal du vide, før dit barn begynder at tage Aptivus
English: - sildenafil, vardenafil, tadalafil (medicines used to produce and maintain an erection).
Danish: - sildenafil, vardenafil, tadalafil (medicin mod rejsningsbesvær).
English: The ritonavir-boosted PI was chosen from among saquinavir, amprenavir, indinavir or lopinavir/ritonavir.
Danish: Den ritonavir-boostede proteasehæmmer blev valgt blandt saquinavir, amprenavir, indinavir og lopinavir/ritonavir.
English: A 5 ml oral syringe and adapter is supplied for dosing.
Danish: En 5 ml doseringssprøjte og adaptor følger med.
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Aptivus/ritonavir is required (see section 4.4).
Danish: Reduktion af colchicindosis eller afbrydelse af colchicinbehandling anbefales hos patienter med normal nyre- og leverfunktion, hvis behandling med Aptivus/ritonavir er nødvendig (se pkt.
English: Lansoprazole Pantoprazole Rabeprazole No interaction study performed
Danish: Lansoprazol Pantoprazol Rabeprazol Der er ikke udført Interationsstudier.
English: Tipranavir, co-administered with low dose ritonavir, is expected to decrease meperidine concentrations and increase normeperidine metabolite concentrations.
Danish: Tipranavir plus lavdosis ritonavir forventes at reducere meperidinkoncentrationer og øge normeperidinmetabolitkoncentrationer.
English: In such cases no dosage adjustment of zidovudine can be recommended (see section
Danish: I sådanne tilfælde anbefales ingen dosisjustering af zidovudin (se pkt.
English: Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir (see section 4.5).
Danish: Naturlægemidler indeholdende perikon (Hypericum perforatum) pga. risiko for nedsættelse af plasmakoncentrationen og nedsat klinisk effekt af tipranavir (se pkt.
English: Your child will always have to take Aptivus in combination with other antiretroviral medicines.
Danish: Dit barn skal altid tage Aptivus sammen med andre antiretrovirale lægemidler.
English: Concentrations of cyclosporin, tacrolimus, or sirolimus cannot be predicted when co-administered with tipranavir co-administered with low dose ritonavir, due to conflicting effect of tipranavir, coadministered with low dose ritonavir, on CYP 3A and P-gp.
Danish: Koncentrationer af ciclosporin, tacrolimus eller sirolimus kan ikke forudsiges, når det gives sammen med tipranavir og lavdosis ritonavir, som følge af den modsatrettede virkning af tipranavir plus lavdosis ritonavir på CYP3A og P-gp.
English: emtricitabine: If you are taking emtricitabine your kidney function should be checked before initiation of Aptivus.
Danish: - emtricitabin: Hvis du tager emtricitabin bør din lever funktion undersøges før du starter på
English: The comparator regimen included a ritonavir-boosted PI (also individually defined) plus an OBR.
Danish: Komparatorbehandlingen omfattede en ritonavir-boostet proteasehæmmer (også defineret for hver enkelt) plus en optimeret baggrundsbehandling.
English: Virological response to tipranavir with ritonavir therapy has been evaluated using a tipranavirassociated mutation score based on baseline genotype in RESIST-1 and RESIST-2 patients.
Danish: - Mutationer i forbindelse med tipranavir-resistens Virologisk respons over for tipranavir med ritonavir-behandling er vurderet ud fra en tipranavirrelateret mutationsscore baseret på baseline genotype hos patienter, der deltog i RESIST-1 og RESIST-2.
English: You must not breast-feed your baby because it is possible that the baby can become HIV-infected through the breast milk.
Danish: Du må ikke amme, da barnet kan blive smittet med hivinfektionen via mælken.
English: The clinical relevance of the reduced loperamide plasma concentration is unknown.
Danish: Den kliniske relevans af den reducerede plasmakoncentration af loperamid er ukendt.
English: Most frequently reported moderate or severe adverse reactions in paediatric patients age 2 to < 12 years (reported in 2 or more children, Trial 1182.14, 48 weeks analyses, Full Analysis Set).
Danish: De hyppigste moderate til alvorlige bivirkninger hos pædiatriske patienter i alderen fra 2 til 12 år (rapporteret hos 2 eller flere børn i studie 1182.14, 48-ugers analyse, komplet analysesæt).
English: Most frequently reported moderate or severe adverse reactions in paediatric patients aged 12 to 18 years who took Aptivus capsules (reported in 2 or more children, Trial 1182.14, week 48 analyses, Full Analysis Set).
Danish: De hyppigste moderate til alvorlige bivirkninger hos pædiatriske patienter i alderen fra 12 til 18 år, som fik Aptivus kapsler (rapporteret hos 2 eller flere børn i studie 1182.14, 48-ugers analyse, komplet analysesæt).
English: Your doctor will carefully consider whether to treat you with combinations of Aptivus and protease inhibitors.
Danish: Lægen vil vurdere, om du skal behandles med en kombination af Aptivus og proteasehæmmere.
English: If your child has: - high liver function tests results - hepatitis B or C infection your child is at increased risk of severe and potentially fatal liver damage while taking Aptivus.
Danish: Hvis dit barn har - forhøjede resultater af leverfunktionstest - hepatitis B eller C-infektion (leverbetændelse) er der en øget risiko, for alvorlig eller evt. dødelig leverskade i den periode, hvor dit barn tager Aptivus.
English: Patients receiving rifabutin with Aptivus, co-administered with low dose ritonavir, should be closely monitored for emergence of adverse events associated with rifabutin therapy.
Danish: Patienter, der får rifabutin og Aptivus plus lavdosis ritonavir, skal monitoreres tæt for at se, om der opstår bivirkninger, der kan forbindes med rifabutinbehandlingen.
English: Among all randomised and treated patients, the median change from baseline in HIV-1 RNA at the last measurement up to Week 48 was -0.64 log10 copies/ml in patients receiving tipranavir with ritonavir versus -0.22 log10 copies/ml in the comparator PI/ritonavir arm.
Danish: Blandt alle randomiserede og behandlede patienter var median ændringen fra baseline i hiv-1 RNA ved sidste måling op til uge 48 -0,64 log10 viruspartikler/ml hos patienter, der havde fået tipranavir med ritonavir i modsætning til -0,22 log10 viruspartikler/ml i komparator-proteasehæmmer/ritonavir-gruppen.
English: The most serious adverse reactions include hepatic impairment and liver toxicity.
Danish: De alvorligste bivirkninger omfatter nedsat leverfunktion og levertoksicitet.