FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease.
Danish: Patienterne kan opleve træthed, hovedpine, ændring i mental tilstand, abdominalsmerter, ændret afføringsmønster og hypotension eller uspecifikke symptomer, der kan minde om andre ætiologier, f.eks. hjernemetastaser eller underliggende sygdom.
English: Signs and symptoms of hepatitis may include eye or skin yellowing (jaundice), pain on the right side of your stomach area, tiredness.
Danish: Tegn og symptomer på hepatitis kan være gulfarvning af øjnene eller huden (gulsot), smerter i den højre side af maven, træthed.
English: The study included adult patients with confirmed unresectable Stage III or Stage IV melanoma.
Danish: Studiet inkluderede voksne patienter med bekræftet, inoperabelt stadie III- eller IV-melanom.
English: METHOD AND ROUTE(S) OF ADMINISTRATION IV use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) i.v.
English: It contains 2.3 mg sodium per ml of concentrate.
Danish: YERVOY indeholder 2,3 mg natrium pr. ml koncentrat.
English: Clinical and pharmacokinetic data with pre-existing severe renal impairment are limited; the potential need for dose adjustment cannot be determined.
Danish: Kliniske og farmakokinetiske data for eksisterende alvorligt nedsat nyrefunktion er begrænsede; det potentielle behov for dosisjustering kan ikke fastlægges.
English: Efficacy Results in CA184178 Ipilimumab 3 mg/kg N= 4
Danish: Effektresultater i CA184178 Ipilimumab 3 mg/kg N=4
English: Post authorisation efficacy study (PAES): In order to further elucidate the contribution of ipilimumab to the efficacy and toxicity of the combination regimen of nivolumab and ipilimumab, the MAH should conduct and submit the results of a randomised, clinical study comparing the efficacy and safety of the combination of nivolumab and ipilimumab to nivolumab monotherapy in previously untreated adult patients with intermediate/poorrisk advanced renal cell carcinoma and with an appropriate spectrum of PDL1 expression levels.
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For yderligere at belyse ipilimumabs bidrag til effekt og toksicitet af kombinationsregimet med nivolumab og ipilimumab skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne fra et randomiseret klinisk studie, hvor effekt og sikkerhed af kombinationen af nivolumab og ipilimumab sammenlignes med nivolumab som monoterapi hos tidligere ubehandlede voksne patienter med fremskredent renalcellekarcinom i mellem- eller højrisikogruppen, og med et passende spektrum af PD-L1-ekspressionsniveauer.
English: Rare (may affect up to 1 in 1000 people) severe and possibly fatal peeling of the skin (toxic epidermal necrolysis) loosening of membrane at the back of the eye (serous retinal detachment)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1000 personer) alvorlig og muligvis dødelig afskalning af huden (toksisk epidermal nekrolyse) løsning af hinde bagerst i øjet (serøs nethindeløsning)
English: If severe (Grade 3 or 4), these reactions may require immediate systemic high-dose corticosteroid therapy and discontinuation of ipilimumab (see section 4.2).
Danish: Hvis disse bivirkninger er svære (Grad 3 eller 4), kan det være nødvendigt med omgående systemisk højdosis kortikosteroid-behandling og seponering af ipilimumab (se pkt.
English: Sequential administration with vemurafenib
Danish: Sekventiel administration af vemurafenib
English: Please refer to the package leaflet of nivolumab in order to understand the use of this medicine.
Danish: Du skal læse indlægssedlen for nivolumab, så du kender dette lægemiddel.
English: The following side effects have been reported with ipilimumab in combination with nivolumab:
Danish: Følgende bivirkninger er blevet rapporteret, når ipilimumab er givet i kombination med nivolumab:
English: YERVOY must be stored in a refrigerator (2°C to 8°C).
Danish: YERVOY skal opbevares i køleskab (2 °C til 8 °C).
English: Patients should be monitored for signs and symptoms of hepatitis such as transaminase and total bilirubin elevations.
Danish: Patienterne bør monitoreres for tegn og symptomer på hepatitis, f.eks. forhøjet aminotransferase og total-bilirubin.
English: When administered in combination with nivolumab, the CL of ipilimumab was unchanged in the presence of anti-ipilimumab antibodies and there was no evidence of altered toxicity profile.
Danish: Når det blev administreret i kombination med nivolumab var ipilimumabs CL uændret ved tilstedeværelse af anti-ipilimumab-antistoffer, og der var ikke tegn på ændret toksicitetsprofil.
English: In other patients with a history of autoimmune disease, ipilimumab should be used with caution after careful consideration of the potential risk-benefit on an individual basis.
Danish: Hos andre patienter med autoimmun sygdom i anamnesen bør ipilimumab anvendes med forsigtighed efter en omhyggelig og individuel vurdering af risici og fordele.
English: YERVOY must not be administered as an intravenous push or bolus injection.
Danish: YERVOY må ikke administreres intravenøst som hurtig bolus (”push injection”) eller bolusinjektion.
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency (including secondary adrenocortical insufficiency), hypophysitis (including hypopituitarism), diabetes mellitus, and diabetic ketoacidosis have been observed with ipilimumab in combination with nivolumab (see section 4.8).
Danish: Svære endokrinopatier, herunder hypotyroidisme, hypertyroidisme, binyrebarkinsufficiens (herunder sekundær adrenokortikal insufficiens), hypofysitis (herunder hypopituitarisme), diabetes mellitus og diabetisk ketoacidose, er observeret med ipilimumab i kombination med nivolumab (se pkt.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken og etiketten på hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: If resolution occurs, resume therapy.d
Danish: Hvis remission, genoptages behandling.d
English: Permanent discontinuation of treatment was required in a greater proportion of patients receiving ipilimumab in combination with nivolumab than in those receiving nivolumab monotherapy.
Danish: Permanent seponering af behandlingen var nødvendig hos en større andel af de patienter, der fik ipilimumab i kombination med nivolumab, end hos de patienter, der fik nivolumab-monoterapi.
English: YERVOY should not be used in children younger than 12 years of age.
Danish: YERVOY bør ikke anvendes til børn under 12 år.
English: It is not known whether ipilimumab gets into breast milk.
Danish: Man ved ikke, om ipilimumab udskilles i mælken.
English: Other moderate adverse reactionsc a
Danish: Andre moderate bivirkningerc a
English: The improvement in OS was similar between ipilimumab with nivolumab and nivolumab monotherapy in patients with high tumour PD-L1 expression (PD-L1 ≥ 1%).
Danish: Forbedringen af OS var sammenlignelig mellem ipilimumab med nivolumab og nivolumab som monoterapi hos patienter med høj PD-L1-tumorekspression (PD-L1 ≥ 1 %).
English: Patients who had not received prior systemic anticancer therapy for unresectable or metastatic melanoma were enrolled.
Danish: Patienter, som ikke tidligere havde fået systemisk cancerbehandling for inoperabelt eller metastatisk melanom, blev inkluderet i studiet.
English: Patients were randomized in a 3:1:1 ratio to receive ipilimumab 3 mg/kg + an investigational gp100 peptide vaccine (gp100), ipilimumab 3 mg/kg monotherapy, or gp100 alone.
Danish: Patienterne blev randomiseret i forholdet 3:1:1 til at få ipilimumab 3 mg/kg + en gp100 peptid testvaccine (gp100), ipilimumab 3 mg/kg monoterapi eller kun gp100.
English: Patients with ocular/uveal melanoma were excluded from clinical trials of melanoma.
Danish: Patienter med okulært/uvealt melanom blev udelukket fra kliniske melanom-forsøg.
English: Any unused medicinal product or waste material should be discarded in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: The Marketing Authorisation Holder shall agree the format and content of the above material with the National Competent Authority prior to launch in the Member State.
Danish: Forud for markedsføring af lægemidlet i hver medlemsstat skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om indholdet og udformningen af ovenstående materiale.
English: Overall survival compared between Ipilimumab 10 mg/kg and 3 mg/kg groups showed HR = 0.84 (95% CI: 0.70, 0.99; P-value = 0.04).
Danish: Sammenligning af samlet overlevelse (OS) mellem grupperne, der fik ipilimumab 10 mg/kg og 3 mg/kg viste HR = 0,84 (95 % CI: 0,70; 0,99; P-værdi = 0,04).
English: Neurologic: New onset or worsening severe motor or sensory neuropathy
Danish: Nyopstået eller forværret svær motorisk eller sensorisk neuropati
English: - Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes).
Danish: - sukkersyge (diabetes) (symptomer omfatter overdreven tørst, kraftigt øget urinproduktion, øget appetit med vægttab, træthed, sløvhed, svaghedsfølelse, nedtrykthed, irritabilitet og generel utilpashed) eller diabetisk ketoacidose (syrestoffer i blodet som følge af diabetes).
English: Before you are given YERVOY, tell your doctor if you are taking any medicines that suppress your immune system, such as corticosteroids.
Danish: Brug af anden medicin sammen med YERVOY Fortæl det til lægen, inden du får YERVOY hvis du tager medicin, der hæmmer immunsystemet, som f.eks. kortikosteroider.
English: - inflammation of the liver (hepatitis) that can lead to liver failure.
Danish: - leverbetændelse (hepatitis) som kan medføre leversvigt.
English: Histiocytosis haematophagic has been reported in relation to ipilimumab therapy.
Danish: Hæmatofagisk histiocytose er blevet rapporeret i forbindelse med ipilimumab-terapi.
English: When YERVOY is given alone for the treatment of skin cancer, the recommended dose is 3 mg of ipilimumab per kilogram of your body weight.
Danish: Når YERVOY gives alene til behandling af hudkræft, er den anbefalede dosis 3 mg ipilimumab pr. kilogram kropsvægt.
English: Patients with a mild to moderate (Grade 1 or 2) rash may remain on ipilimumab therapy with symptomatic treatment (e.g. antihistamines).
Danish: Patienter med lette til moderate (Grad 1 eller 2) udslæt kan fortsætte med ipilimumab med symptomatisk behandling (f.eks. antihistaminer).
English: Ipilimumab is most commonly associated with adverse reactions resulting from increased or excessive immune activity.
Danish: Ipilimumab er som oftest forbundet med bivirkninger, der skyldes øget eller overdreven immunaktivitet.
English: A Phase 3, double-blind study enrolled patients with previously treated or untreated unresectable Stage III or Stage IV melanoma.
Danish: Et fase 3 dobbelt-blindet studie inkluderede patienter med tidligere behandlet eller ubehandlet inoperabelt Stadie III eller Stadie IV melanom.
English: Children and adolescents YERVOY should not be used in children below 12 years of age.
Danish: Børn og unge YERVOY bør ikke anvendes til børn under 12 år.
English: For patients with significant LFT elevations that are refractory to corticosteroid therapy, addition of an alternative immunosuppressive agent to the corticosteroid regimen may be considered.
Danish: Hos patienter med signifikant forhøjede levertal, som er refraktære over for kortikosteroid‑behandling, kan det overvejes at tilføje et supplerende immunosuppressivt middel.
English: The pharmacokinetics of ipilimumab was studied in 785 patients with advanced melanoma who received induction doses ranging from 0.3 to 10 mg/kg administered once every 3 weeks for 4 doses.
Danish: Ipilimumabs farmakokinetik blev undersøgt hos 785 patienter med fremskredent melanom, som fik induktionsdoser fra 0,3 til 10 mg/kg administreret en gang hver 3. uge til i alt 4 doser.
English: ** ipilimumab in combination with nivolumab for the first 4 doses then followed by nivolumab monotherapy in RCC.
Danish: ** ipilimumab i kombination med nivolumab for de første 4 doser, derefter efterfulgt af nivolumab som monoterapi ved RCC.
English: Ipilimumab in combination with nivolumab is used to treat advanced melanoma (a type of skin cancer) in adults advanced renal cell carcinoma (advanced kidney cancer) in adults
Danish: Ipilimumab i kombination med nivolumab anvendes til behandling af fremskredent melanom (en bestemt type hudkræft) hos voksne fremskredent renalcellekarcinom (fremskreden nyrekræft) hos voksne
English: Transfer the concentrate into a sterile, evacuated glass bottle or intravenous bag (PVC or non-PVC).
Danish: TRIN 2 Overfør koncentratet til en steril, tom glasflaske eller intravenøs pose (PVC eller non-PVC).
English: Neutralising antibodies against ipilimumab were not detected.
Danish: Der blev ikke fundet neutraliserende antistoffer mod ipilimumab.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been rarely reported with Ipilimumab in clinical studies and during postmarketing use.
Danish: Lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS) er i sjældne tilfælde rapporteret med ipilimumab i kliniske studier og under anvendelse efter markedsføring.
English: The YERVOY infusion should not be infused at the same time in the same intravenous line with other agents.
Danish: YERVOY infusionen må ikke infunderes samtidig med andre lægemidler i samme intravenøse slange.
English: Adrenal insufficiency, hyperthyroidism, and hypothyroidism of any severity were each reported in 2% of patients.
Danish: Binyrebarkinsufficiens, hypertyroidisme og hypotyroidisme uanset sværhedsgrad blev rapporteret hos 2 % af patienterne.
English: The types of irARs were consistent with the adult experience, with the most commonly reported irARs across all groups in the categories of gastrointestinal (0 [3 mg/kg], 62.5% [5 mg/kg], and 44.4% [10 mg/kg]), hepatic function (0 [3 mg/kg], 75.0% [5 mg/kg], 33.3% [10 mg/kg]), and skin (0 [3 mg/kg], 25.0% [5 mg/kg], 33.3% [10 mg/kg]) events.
Danish: De oftest rapporterede irAR'er på tværs af alle grupper var hændelser i kategorierne mave-tarm-kanal (0 [3 mg/kg], 62,5 % [5 mg/kg], og 44,4 % [10 mg/kg]), leverfunktion (0 [3 mg/kg], 75,0 % [5 mg/kg], 33,3 % [10 mg/kg]), og hud (0 [3 mg/kg], 25,0 % [5 mg/kg], 33,3 % [10 mg/kg]).
English: 40 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium).
Danish: 40 ml koncentrat i et hætteglas (Type I-glas) med en prop (coated butylgummi) og et flip-off låg (aluminium).
English: DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
Danish: DRESS viser sig som udslæt med eosinofili forbundet med en eller flere af følgende kendetegn: feber, lymfadenopati, ansigtsødem og påvirkning af indre organer (lever, nyrer, lunger).
English: Immune-related endocrinopathy observed in clinical trials was generally controlled with hormone replacement therapy.
Danish: Immunrelateret endokrinopati, som blev observet i kliniske forsøg, blev generelt behandlet med hormonsubstitutionsbehandling.
English: The other ingredients are Tris-hydrochloride, sodium chloride (see section 2 "YERVOY contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Danish: Øvrige indholdsstoffer: Tris-hydrochlorid, natriumchlorid (se afsnit 2 ”YERVOY indeholder natrium”), mannitol (E421), pentetatsyre, polysorbat 80, natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: Patients without liver metastasis who had a baseline AST > 2.5 x ULN, patients with liver metastasis who had a baseline AST > 5 x ULN, and patients with a baseline total bilirubin ≥ 3 x ULN were also excluded.
Danish: Patienter uden levermetastaser, som havde en ASAT > 2,5 x ULN ved behandlingsstart, patienter med levermetastaser, som havde en ASAT > 5 x ULN ved behandlingsstart og patienter med en total‑bilirubin ≥ 3 x ULN ved behandlingsstart blev også ekskluderet.
English: Patients must be treated according to institutional guidelines for management of sensory neuropathy, and intravenous corticosteroids (e.g. methylprednisolone 2 mg/kg/day) should be initiated immediately.
Danish: Patienter skal behandles i overensstemmelse med lokale retningslinjer for behandling af sensorisk neuropati, og intravenøs behandling med kortikosteroider (f.eks. methylprednisolon 2 mg/kg/dag) bør straks initieres.
English: Grade 4 rash or Grade 3 pruritus
Danish: Grad 4 udslæt eller Grad 3 pruritus
English: The frequencies of serious adverse reactions in the 10 mg/kg and 3 mg/kg groups were 37% and 18%, with the 3 most common serious adverse reactions being diarrhea (10.7% vs 5.5%), colitis (8.0% vs 3.0%), and hypophysitis (4.4% vs 1.9%).
Danish: Frekvensen af alvorlige bivirkninger i grupperne, der fik 10 mg/kg og 3 mg/kg, var hhv. 37 % og 18 %, hvoraf de tre mest almindelige alvorlige bivirkninger var diarré (hhv. 10,7 % og 5,5 %), colitis (hhv. 8,0 % og 3,0 %) og hypofysitis (hhv. 4,4 % og 1,9 %).
English: 10 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium).
Danish: 10 ml koncentrat i et hætteglas (Type I-glas) med en prop (coated butylgummi) og et flip-off låg (aluminium).
English: The safety and efficacy of YERVOY have not been studied in patients with renal impairment.
Danish: YERVOYs sikkerhed og virkning er ikke undersøgt hos patienter med nedsat leverfunktion.
English: The median duration of time from initial diagnosis to randomisation was 0.4 years in both the ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg and sunitinib groups.
Danish: Mediantiden fra initial diagnosticering til randomisering var 0,4 år i både gruppen med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg og i sunitinibgruppen.
English: Caution should be used when considering the use of ipilimumab or ipilimumab in combination with nivolumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on a prior cancer immune stimulatory therapy).
Danish: Der skal udvises forsigtighed, hvis brugen af ipilimumab eller ipilimumab i kombination med nivolumab overvejes til en patient, der har oplevet en alvorlig eller livstruende hudrelateret bivirkning under tidligere immunstimulerende cancerbehandling.
English: Do not use YERVOY after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke YERVOY efter den udløbsdato, der står på æsken og etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Patients with a history of autoimmune disease (other than vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism), including those who require systemic immunosuppressive therapy for pre-existing active autoimmune disease or for organ transplantation graft maintenance, were not evaluated in clinical trials.
Danish: Patienter med autoimmun sygdom i anamnesen (med undtagelse af vitiligo og tilstrækkeligt kontrollerede endokrine mangeltilstande som f.eks. hypotyroidisme), herunder patienter, som har behov for systemisk immunosuppressiv behandling af eksisterende aktiv autoimmun sygdom eller til forebyggelse af organafstødning efter organtransplantation, blev ikke undersøgt i kliniske forsøg.
English: In intermediate/poor-risk patients, OS benefit was observed in the ipilimumab in combination with nivolumab arm vs. sunitinib regardless of tumour PD-L1 expression.
Danish: Hos mellem- eller højrisikopatienter blev OS-fordel observeret i ipilimumab i kombination med nivolumab-armen versus sunitinib uanset PD-L1-tumorekspressionsniveau.
English: Among 128 patients who discontinued ipilimumab in combination with nivolumab due to adverse reaction after 18 months of follow-up, median PFS was 16.7 months (95% CI: 10.2, NA).
Danish: Hos de 128 patienter, hvor ipilimumab i kombination med nivolumab blev seponeret på grund af bivirkninger efter en opfølgningsperiode på 18 måneder, var median-PFS 16,7 måneder (95 % CI: 10,2; N.A.).
English: In patients receiving ipilimumab at a higher than recommended dose in combination with dacarbazine, immune-related hepatotoxicity occurred more frequently than in patients receiving ipilimumab 3 mg/kg monotherapy.
Danish: Hos patienter, der fik ipilimumab i højere doser end anbefalet og i kombinatin med dacarbazin, forekom immunrelateret heptatotoksicitet oftere end hos patienter, der fik ipilimumab 3 mg/kg som monoterapi.
English: Summary of Adverse Events after up to Four Doses of 3, 5 and 10 mg/kg, All Treated Patients
Danish: Resume af bivirkninger efter op til fire doser på 3, 5 og 10 mg/kg.
English: Number of Subjects at Risk Nivolumab + Ipilimumab
Danish: Antal forsøgspersoner i risikogruppe Nivolumab + ipilimumab
English: Immune-related adverse reactions, which can be severe or life-threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems.
Danish: Immunrelaterede bivirkninger, som kan være svære eller livstruende, kan omfatte mave‑tarmkanal, lever, hud, nervesystemet, det enokrine system eller andre organsystemer.
English: Clinical and pharmacokinetic data with pre-existing moderate hepatic impairment are limited; the potential need for dose adjustment cannot be determined.
Danish: Kliniske og farmakokinetiske data for eksisterende moderat nedsat leverfunktion er begrænsede; det potentielle behov for dosisjustering kan ikke fastlægges.
English: Long term survival benefit of treatment with ipilimumab (at 3mg/kg) is demonstrated through a pooled analysis of OS data from clinical trials in patients with previously treated and treatment naive advanced melanoma (N = 965).
Danish: Langtidsoverlevelse ved behandling med ipilimumab (ved 3 mg/kg) er påvist i en puljet analyse af OS-data fra kliniske forsøg med patienter med tidligere behandlet og behandlingsnaivt fremskredent melanom (N = 965).
English: Withhold dose until an adverse reaction resolves to Grade 1 or Grade 0 (or returns to baseline).
Danish: Udsæt dosis indtil bivirkning svinder til Grad 1 eller Grad 0 (eller vender tilbage til samme niveau som ved behandlingsstart).
English: Uncommon diabetic ketoacidosisc, diabetes mellitusc diabetic ketoacidosisc, hypopituitarism Metabolism and nutrition disorders
Danish: Ikke almindelig diabetisk ketoacidosec, diabetes mellitusc diabetisk ketoacidosec, hypopituitarisme Metabolisme og ernæring
English: The safety data for patients with unresectable or metastatic melanoma, treated with ipilimumab (3 mg/kg, with a minimum of 3 year follow-up) and enrolled in multi-national, prospective, observational study CA184143 (N= 1151) were similar to what has been reported in ipilimumab clinical trials for advanced melanoma.
Danish: Sikkerhedsdata for patienter med inoperabelt eller metastatisk melanom, behandlet med ipilimumab (3 mg/kg, med en opfølgningsperiode på minimum 3 år) og inkluderet i det multinationale, prospektive observationsstudie CA184143 (N= 1.151), var sammenlignelige med det, der er blevet rapporteret i kliniske forsøg med ipilimumab til fremskredent melanom.
English: Severe elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin or symptoms of hepatotoxicity
Danish: Svær forhøjelse af aspartataminotransferase (ASAT), alaninaminotransferase (ALAT) eller total-bilirubin eller symptomer på hepatotoksicitet