FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, the mean (SD) blood-to-plasma concentration ratio is 0.58 (0.02) and the mean (CV%) apparent volume of distribution (Vz/F) of encorafenib is 226 L (32.7%).
Danish: Efter en enkelt oral dosis af 100 mg [14C]-encorafenib hos raske forsøgsdeltagere er den gennemsnitlige (SD) blodplasmakoncentrationsratio 0,58 (0,02), og encorafenibs gennemsnitlige (CV %) tilsyneladende distributionsvolumen (Vz/F) er 226 l (32,7 %).
English: Facial paresis was generally reversible and led to treatment discontinuation in 0.9% (2/217).
Danish: Ansigtsparese var normalt reversibelt og førte til seponering af behandlingen hos 0,9 % (2/217).
English: What you need to know before you take Braftovi 3.
Danish: Det skal du vide, før du begynder at tage Braftovi 3.
English: Co-administration of encorafenib with a CYP3A4 inducer was not assessed in a clinical study; however, a reduction in encorafenib exposure is likely and may result in compromised efficacy.
Danish: Samtidig administration af encorafenib og en CYP3A4-induktor er ikke blevet vurderet i et klinisk studie; det er imidlertid sandsynligt, at eksponeringen for encorafenib vil være nedsat, hvilket kan resultere i nedsat virkning.
English: In the 4-week and 13-week rat toxicity studies, clinical signs, reduced body weight reduced epididymides and prostate weights and microscopic findings in testes, epididymides, stomach and skin were noted.
Danish: I toksicitetsstudier hos rotter af 4 og 13 ugers varighed blev der set kliniske tegn, reduceret kropsvægt, reduceret epididymis- og prostatavægt samt mikroskopifund i testikler, epididymis, mave og hud.
English: Encorafenib should be withheld for up to 4 weeks.
Danish: Encorafenib skal seponeres i op til 4 uger.
English: If you have liver or kidney problems, your doctor may start you on a lower dose.
Danish: Hvis du har lever- eller nyreproblemer, vil lægen eventuelt starte behandlingen med en lavere dosis.
English: 27 patients (5%) had received prior checkpoint inhibitors (antiPD1/PDL1 or ipilimumab) (8 patients in Combo 450 arm (4%); 7 patients in vemurafenib arm (4%); 12 patients in Enco 300 arm (6%) including 22 patients in the metastatic setting (6 patients in Combo 450 arm; 5 patients in vemurafenib arm; 11 patients in Enco 300 arm) and 5 patients in the adjuvant setting (2 patients in Combo 450 arm; 2 patients in vemurafenib arm; 1 patient in Enco 300 arm).
Danish: 27 patienter (5 %) havde fået forudgående behandling med checkpoint-hæmmere (anti-PD1/PDL1 eller ipilimumab) (8 patienter i Combo 450-armen (4 %); 7 patienter i vemurafenib-armen (4 %); 12 patienter i Enco 300-armen (6 %)), herunder 22 patienter med metastaser (6 patienter i Combo 450-armen; 5 patienter i vemurafenib-armen; 11 patienter i Enco 300-armen) og 5 patienter, som fik adjuverende behandling, (2 patienter i Combo 450-armen; 2 patienter i vemurafenib-armen; 1 patient i Enco 300-armen).
English: Co-administration of moderate (diltiazem) and strong (posaconazole) CYP3A4 inhibitors with single doses of encorafenib in healthy volunteers resulted in a 2 and 3-fold increase in the area under the concentration-time curve (AUC), respectively and in 44.6% and 68.3% increase in maximum encorafenib concentration (Cmax) respectively.
Danish: Samtidig administration af moderate (diltiazem) og stærke (posaconazol) CYP3A4-hæmmere og enkeltdoser af encorafenib hos raske frivillige resulterede i en hhv. 2- og 3-foldig stigning i arealet under koncentrations-tidskurven (AUC) og i en hhv. 44,6 % og 68,3 % stigning i maksimal encorafenibkoncentration (Cmax).
English: Visual impairment, including blurred vision and reduced visual acuity, occurred in 21.5% (59/274) of patients.
Danish: Synsnedsættelse, herunder sløret syn og nedsat synsstyrke, forekom hos 21,5 % (59/274) af patienterne.
English: Part 1 of Study CMEK162B2301 demonstrated a statistically significant improvement in PFS in the patients treated with Combo 450 compared with patients treated with vemurafenib.
Danish: I Del 1 af Studie CMEK162B2301 blev der påvist en statistisk signifikant forbedring i PFS hos de patienter, der blev behandlet med Combo 450, i forhold til de patienter, der blev behandlet med vemurafenib.
English: Closer monitoring of encorafenib related toxicities in patients with mild hepatic impairment is recommended, including clinical examination and liver function tests, with assessment of ECGs as clinically appropriate during treatment.
Danish: Det anbefales at udføre tættere monitorering af encorafinib-relaterede toksiciteter hos patienter med let nedsat leverfunktion, herunder klinisk undersøgelse og leverfunktionstest med vurdering af ekg efter, hvad der er klinisk relevant under behandlingen.
English: The involvement of several uptake transporter families (OCT1, OATP1B1, OATP1B3 and OATPB1) was investigated in vitro using relevant transporter inhibitors.
Danish: Flere forskellige optagelsestransportørfamilier (OCT1, OATP1B1, OATP1B3 og OATPB1) er blevet undersøgt in vitro ved brug af relevante transportørhæmmere.
English: Encorafenib is moderately (86.1%) bound to human plasma proteins in vitro.
Danish: Encorafenibs bindingsgrad til humane plasmaproteiner in vitro er moderat (86,1 %).
English: The median (range) encorafenib terminal half-life (T1/2) was 6.32 h (3.74 to 8.09 h).
Danish: Medianværdien (interval) for encorafenibs terminale halveringstid (T1/2) var 6,32 t (3,74 til 8,09 t).
English: Concomitant agents that are substrates of UGT1A1 (e.g. raltegravir, atorvastatin, dolutegravir) may have increased exposure and should be therefore administered with caution.
Danish: Eksponeringen for stoffer, som er substrater for UGT1A1 (f.eks. raltegravir, atorvastatin, dolutegravir), kan være forøget, og samtidig administration bør derfor ske med forsigtighed.
English: Administration of encorafenib should be undertaken with caution at a reduced dose of 300 mg once daily in patients with mild hepatic impairment (Child-Pugh Class A).
Danish: Encorafenib bør administreres med forsigtighed i en reduceret dosis på 300 mg én gang dagligt hos patienter med let nedsat leverfunktion (Child-Pugh klasse A).
English: Encorafenib should be maintained and supportive measures such as topical therapy should be instituted.
Danish: Encorafenib skal fortsættes, og understøttende tiltag såsom topikal behandling skal iværksættes.
English: In patients treated with Combo 450 (n = 274), 194 patients (70.8%) were <65 years old, 65 patients (23.7%) were 65 -74 years old and 15 patients (5.5%) were aged > 75.
Danish: Blandt de patienter, der blev behandlet med Combo 450 (n=274), var 194 patienter (70,8 %) < 65 år, 65 patienter (23,7 %) var 65-74 år, og 15 patienter (5,5 %) var > 75 år.
English: The pharmacokinetics of encorafenib have been shown to be approximatively dose linear after single and multiples doses.
Danish: Farmakokinetikken af encorafenib har vist sig at være stort set dosislineær efter enkelte og gentagne doser.
English: In case of vomiting after administration of encorafenib, the patient should not take an additional dose and should take the next scheduled dose.
Danish: I tilfælde af opkastning efter administration af encorafenib skal patienten ikke tage en ekstra dosis men blot tage næste dosis som planlagt.
English: There are no data from the use of encorafenib in pregnant women.
Danish: Der er ingen eller utilstækkelige data fra anvendelse af encorafenib til gravide kvinder.
English: For new primary non-cutaneous RAS mutation-positive malignancies: it should be considered to discontinue encorafenib and binimetinib permanently.
Danish: Nye primære ikke-kutane RAS-mutationspositive maligniteter: Permanent seponering af encorafenib og binimetinib bør overvejes.
English: There are no data on the effects of encorafenib on fertility in humans.
Danish: Der foreligger ingen data vedrørende encorafenibs virkninger på fertiliteten hos mennesker.
English: The recommended dose of Braftovi is 6 capsules of 75 mg once daily (corresponding to a daily dose of 450 mg).
Danish: Den anbefalede dosis af Braftovi er 6 kapsler à 75 mg én gang dagligt (svarende til en total daglig dosis på 450 mg).
English: Therefore, concomitant administration of encorafenib with strong CYP3A4 inhibitors should be avoided (due to increased encorafenib exposure and potential increase in toxicity, see section 5.2).
Danish: Derfor bør samtidig administration af encorafenib og stærke CYP3A4-hæmmere undgås (på grund af øget eksponering for encorafenib og potentielt øget toksicitet, se pkt.
English: Encorafenib may decrease the efficacy of hormonal contraceptives (see section 4.5).
Danish: Encorafenib kan nedsætte virkningen af hormonelle kontraceptiva (se pkt.
English: The most common AEs reported with a higher incidence in patients aged ≥ 65 years compared to patients aged < 65 years included diarrhoea, pruritus, GGT and blood phosphatase alkaline elevation.
Danish: De mest almindelige AE'er rapporteret med en højere hyppighed hos patienter ≥ 65 år sammenlignet med patienter < 65 år omfattede diarré, kløe, GGT og forhøjet alkalisk fosfatase i blodet.
English: Encorafenib is both an inhibitor and inducer of CYP3A4.
Danish: Encorafenib er både en hæmmer og induktor af CYP3A4.
English: In the event of an overdose, encorafenib treatment should be interrupted and renal function must be monitored as well as adverse reactions.
Danish: I tilfælde af overdosering bør behandlingen med encorafenib afbrydes, og der bør iværksættes monitorering af nyrefunktionen og bivirkninger.
English: - Kidney problems: Braftovi can alter your kidney activity (often abnormal blood tests, more rarely dehydration and vomiting).
Danish: - Nyreproblemer: Braftovi kan påvirke din nyrefunktion (ofte uregelmæssige blodprøveresultater, sjældnere dehydrering og opkastning).
English: Agents that are substrates of renal transporters OAT1, OAT3, OCT2 (such as furosemide, penicillin) or agents that are substrates of the hepatic transporters OATP1B1, OATP1B3, OCT1 (such as atorvastatin, bosentan) or substrates of BCRP (such as methotrexate, rosuvastatin) or substrates of P-gp (e.g. posaconazole) may have increased exposure and should be therefore co-administered with caution.
Danish: Eksponeringen for stoffer, som er substrater for nyretransportørerne OAT1, OAT3, OCT2 (såsom furosemid, penicillin), eller stoffer, som er substrater for levertransportørerne OATP1B1, OATP1B3, OCT1 (såsom atorvastatin, bosentan) eller substrater for BCRP (såsom methotrexat, rosuvastatin) eller substrater af P-gp (f.eks. posaconazol), kan være forøget, og samtidig administration bør derfor ske med forsigtighed.
English: Ophthalmic lesions were partially reversible and consisted of a separation or detachment in the retina between the outer rods and cones layer and retinal pigmented epithelium at the central macula at the fovea.
Danish: De oftalmiske læsioner var delvist reversible og bestod af retinaseparation ellerløsning mellem de ydre stave og taplag og retinalt pigmentepitel i den gule plet i fovea.
English: In the sub-acute 28-day and sub-chronic 13-week rat toxicology studies, encorafenib treatment at 20 mg/kg/d (dose level approximately 8 times the human exposure at the recommended dose) resulted in decreased testes and epididymis weights with tubular degeneration and oligospermia.
Danish: I et subakut og et subkronisk toksikologistudie hos rotter af henholdsvis 28 dages varighed og 13 ugers varighed resulterede behandling med encorafenib 20 mg/kg/dag (dosisniveau, der er cirka 8 gange højere end eksponeringen hos mennesker med den anbefalede dosis) i reduceret testikel- og epididymisvægt med tubulær degeneration og oligospermi.
English: Encorafenib should be permanently discontinued and a follow up with ophthalmologic monitoring should be performed.
Danish: Encorafenib skal seponeres permanent, og der skal foretages en opfølgning med oftalmologisk kontrol.
English: The median time to definitive 10% deterioration in the FACT-M score was not reached in the Combo 450 arm and was 22.1 months (95% CI: 15.2, NE) in the vemurafenib arm with a HR for the difference of 0.46 (95% CI: 0.29, 0.72).
Danish: Mediantiden til definitiv 10 % forværring i FACT-M-scoren blev ikke nået i Combo 450-armen og var 22,1 måneder (95 % CI 15,2; NE) i vemurafenib-armen med en HR for forskellen på 0,46 (95 % CI 0,29; 0,72).
English: No patients discontinued treatment due to anaemia, 1.5% (4/274) required dose interruption or dose modification.
Danish: Ingen patienter fik seponeret behandlingen på grund af anæmi; hos 1,5 % (4/274) var det nødvendigt at pausere behandlingen eller ændre dosis.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Danish: FARMAKOLOGISKE EGENSKABER 5.1 Farmakokinetiske egenskaber
English: Elderly patients No dose adjustment is required for patients aged 65 years and older (see section 5.2).
Danish: Ældre patienter Det er ikke nødvendigt at justere dosis hos patienter på 65 år og derover (se pkt.
English: Your doctor will examine your eyes for any problems with your sight while you are taking Braftovi.
Danish: Lægen vil undersøge dine øjne, hvis du får nye eller forværrede synsproblemer, mens du tager Braftovi.
English: Haemorrhagei Hypertension *
Danish: Blødningi Hypertension *
English: Neuropathy peripheral* Dysgeusia*
Danish: Hovedpine Perifer neuropati* Dysgeusi
English: PFS as assessed by investigators (investigator assessment) was a supportive analysis.
Danish: (investigatorvurdering) var en understøttende analyse.
English: Gamma-glutamyl transferase (GGT) increased*
Danish: Forhøjet gamma-glutamyltransferase (GGT)*
English: Encorafenib 450 mg in combination with binimetinib (n = 274)
Danish: Encorafenib 450 mg i kombination med binimetinib (n=274)
English: Encorafenib suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, D and K).
Danish: Encorafenib hæmmer RAF/MEK/ERKsignalvejen i tumorceller, der udtrykker forskellige muterede former af BRAF-kinase (V600E, D og K).
English: Study CMEK162B2301, Part 2:
Danish: Studie CMEK162B2301, Del 2:
English: Skin hyperpigmentation*
Danish: Hyperpigmentering af huden*
English: The risk of haemorrhage may be increased with concomitant use of anticoagulant and antiplatelet therapy.
Danish: Risikoen for blødning kan være højere ved samtidig brug af antikoagulantia og trombocythæmmende lægemidler.
English: The median time to onset of the first event of facial paresis was 0.3 months (range 0.1 to 12.1 months).
Danish: Mediantiden til starten på den første hændelse med ansigtsparese var 0,3 måneder (interval 0,1 til 12,1 måneder).
English: Dermatologic evaluations should be performed prior to initiation of therapy with encorafenib in combination with binimetinib, every 2 months while on therapy and for up to 6 months following discontinuation of the combination.
Danish: Der bør gennemføres dermatologiske vurderinger inden opstart af behandling med encorafenib i kombination med binimetinib, hver 2. måned under behandlingen og i op til 6 måneder efter seponering af kombinationen.
English: The incidence of Grade 3 or 4 elevation was 0.7% (2/274).
Danish: Forekomsten af stigninger af grad 3 eller 4 var 0,7 % (2/274).
English: A similar proportion of patients in each treatment arm received subsequent treatment with checkpoint inhibitors, mainly pembrolizumab, nivolumab and ipilimumab (34.4% Combo 450 arm, 36.1% encorafenib arm, 39.8% vemurafenib arm).
Danish: En ensartet andel af patienterne i hver behandlingsarm fik efterfølgende behandling med checkpointhæmmere, primært pembrolizumab, nivolumab og ipilimumab (34,4 % i Combo 450-armen, 36,1 % i encorafenib-armen, 39,8 % i vemurafenib-armen).
English: No dosing recommendation can be made in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Danish: Der kan ikke gives anbefalinger vedrørende dosering til patienter med moderat (Child-Pugh klasse B) eller svært (Child-Pugh klasse C) nedsat leverfunktion.
English: Encorafenib should be withheld for up to 4 weeks
Danish: Encorafenib skal pauseres i op til 4 uger.
English: EU/1/18/1314/001 28 hard capsules EU/1/18/1314/003 112 hard capsules
Danish: EU/1/18/1314/001 28 hårde kapsler EU/1/18/1314/003 112 hårde kapsler
English: Medicinal product interactions
Danish: Interaktion med andre lægemidler
English: Patients had histologically confirmed cutaneous or unknown primary melanoma but those with uveal or mucosal melanoma were excluded.
Danish: Patienterne havde histologisk bekræftet kutant eller ukendt primært melanom, men patienter med melanomer i uvea eller slimhinder blev udelukket.
English: - Liver problems: Braftovi can cause abnormal blood tests related to how your liver works (raised levels of liver enzymes).
Danish: - Leverproblemer: Braftovi kan give uregelmæssige blodprøveresultater med hensyn til, hvordan din lever virker (forhøjede niveauer af leverenzymer).
English: EU/1/18/1314/002 42 hard capsules EU/1/18/1314/004 168 hard capsules
Danish: EU/1/18/1314/002 42 hårde kapsler EU/1/18/1314/004 168 hårde kapsler
English: Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse reactions that may affect their ability to drive and use machines (see sections 4.4 and 4.8).
Danish: Patienter bør rådes til ikke at føre motorkøretøj eller anvende maskiner, hvis de oplever synsforstyrrelser eller andre bivirkninger, der kan påvirke deres evne til at føre motorkøretøj og betjene maskiner (se pkt.
English: The embryo-foetal development study in rabbits indicated that encorafenib induced foetal toxicity with lower foetal weights and transitory changes in skeletal development.
Danish: Et studie af den embryoføtale udvikling hos kaniner viste, at encorafenib forårsagede føtal toksicitet med lavere fostervægt og forbigående forandringer i den skeletale udvikling.
English: Fertility studies were not conducted with encorafenib.
Danish: Der er ikke udført fertilitetsstudier med encorafenib.
English: Braftovi 75 mg hard capsules encorafenib This medicine is subject to additional monitoring.
Danish: Braftovi 75 mg kapsler, hårde encorafenib Dette lægemiddel er underlagt supplerende overvågning.
English: Braftovi 50 mg hard capsules EU/1/18/1314/001 28 hard capsules EU/1/18/1314/003 112 hard capsules Braftovi 75 mg hard capsules EU/1/18/1314/002 42 hard capsules EU/1/18/1314/004 168 hard capsules
Danish: Braftovi 50 mg kapsler, hårde EU/1/18/1314/001 28 hårde kapsler EU/1/18/1314/003 112 hårde kapsler Braftovi 75 mg kapsler, hårde EU/1/18/1314/002 42 hårde kapsler EU/1/18/1314/004 168 hårde kapsler
English: Across pooled combination studies of encorafenib and binimetinib at the recommended doses and a single-agent encorafenib study, results suggest that encorafenib has the potential to result in small increases in QTc interval (see section 5.1).
Danish: De samlede kombinationsstudier med encorafenib og binimetinib i de anbefalede doser og et monoterapistudie med encorafenib tyder på, at encorafenib potentielt kan forårsage små stigninger i QTc-intervallet (se pkt.
English: An interim OS analysis of Study CMEK162B2301 Part 1, (cut-off date 07 November 2017) demonstrated a statistically significant improvement in OS for Combo 450 compared with vemurafenib (see Table 6 and Figure 2).
Danish: En interim OS-analyse af Studie CMEK162B2301 Del 1, (skæringsdato 7. november 2017) viste en statistisk significant forbedring i OS for Combo 450 sammenlignet med vemurafenib (se tabel 6 og figur 2).
English: Most events were Grade 1-2, with Grade 3 reported in 0.4% (1/274) of patients and no event led to discontinuation.
Danish: De fleste hændelser var af grad 1-2, mens grad 3 blev rapporteret hos 0,4 % (1/274) af patienterne, og ingen hændelser førte til seponering.
English: The most common adverse reactions (>25%) occurring in patients treated with encorafenib 300 mg administered with binimetinib were fatigue, nausea and diarrhoea.
Danish: De mest almindelige bivirkninger (> 25 %) hos patienter, der fik encorafenib 300 mg i kombination med binimetinib, var træthed, kvalme og diarré.
English: Your doctor will check that your heart is working properly before and during your treatment with these medicines.
Danish: Lægen vil undersøge dit hjerte før og under behandlingen med disse lægemidler for at sikre, at det fungerer korrekt.
English: Talk to your doctor immediately if you have any symptoms of heart problems such as feeling dizzy, tired, lightheaded, if you have shortness of breath, if you feel like your heart is pounding, racing, beating irregularly, or if you have swelling in the legs.
Danish: Tal straks med lægen, hvis du har symptomer på hjerteproblemer, som f.eks. at du føler dig svimmel, træt, omtumlet, hvis du har åndenød, hvis du føler, at dit hjerte hamrer, slår hurtigt eller uregelmæssigt, eller hvis du får hævede ben.
English: The occurrence of QTc prolongation can be managed with dose reduction, interruption or discontinuation with correction of abnormal electrolytes and control of risk factors (see section 4.2).
Danish: QTc-forlængelse kan håndteres med dosisreduktion, pausering eller seponering ledsaget af korrigering af elektrolytforstyrrelser og kontrol af risikofaktorer (se pkt.
English: While encorafenib is a relatively potent reversible inhibitor of UGT1A1, no differences in binimetinib exposure have been observed clinically when binimetinib was co-administered with encorafenib.
Danish: Selvom encorafenib er en relativt potent reversibel UGT1A1-hæmmer, er der ikke set nogen forskel i eksponeringen for binimetinib ved klinisk samtidig administration af binimetinib og encorafenib.
English: How to take Braftovi How much to take
Danish: Sådan skal du tage Braftovi Så meget skal du tage
English: Encorafenib is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Encorafenib bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: The median relative dose intensity (RDI) for Combo 450 was 100% for encorafenib and 99.6% for binimetinib; the median RDI was 86.2% for Enco 300 and 94.5% for vemurafenib.
Danish: Medianværdien af den relative dosisintensitet (RDI) for Combo 450 var 100 % for encorafenib og 99,6 % for binimetinib; median-RDI var 86,2 % for Enco 300 og 94,5 % for vemurafenib.
English: If not improved within 6 weeks, ophthalmic monitoring should be repeated and encorafenib should be permanently discontinued.
Danish: • Hvis der ikke ses bedring i løbet af 6 uger, skal oftalmisk kontrol gentages, og encorafenib skal seponeres permanent.
English: Pancreatic enzyme elevation, mostly asymptomatic, was reported in the pooled Combo 450 population.
Danish: Der blev rapporteret om tilfælde af øgede pankreasenzymer, oftest asymptomatiske, i den samlede Combo 450-population.
English: For new primary cutaneous malignancies: No dose modifications are required for encorafenib.
Danish: Nye primære kutane maligniteter: Det er ikke nødvendigt at justere encorafenib-dosen.
English: Other skin cancers: Treatment with Braftovi may result in a different type of skin cancer such as cutaneous squamous cell carcinoma.
Danish: Andre former for hudkræft: Behandling med Braftovi kan resultere i udvikling af andre typer af hudkræft, såsom kutant planocellulært karcinom.
English: Talk to your doctor, pharmacist or nurse before taking Braftovi, about all of your medical conditions, particularly if you have any of the following: - heart problems including alteration of the electrical activity of your heart (QT interval prolongation) - bleeding problems or if you are taking medicines that may cause bleeding - eye problems - liver or kidney problems
Danish: Inden du begynder at tage Braftovi, skal du tale med lægen, apotekspersonalet eller sundhedspersonalet om alle dine helbredsproblemer, især hvis du har: - hjerteproblemer, herunder ændring i hjertets elektriske aktivitet (QT-forlængelse) - blødningsproblemer eller om du bruger medicin, der kan forårsage blødning - øjenproblemer - lever- eller nyreproblemer
English: • Grade 4
Danish: • Grad 4
English: Blood creatinine increased* Amylase increased Lipase increased
Danish: Forhøjet kreatinin i blodet* Forhøjet amylase Forhøjet lipase