FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are having any vaccinations tell your doctor, or the person giving you the vaccine, that you are being treated with Arzerra.
Danish: Hvis du skal vaccineres, skal du fortælle lægen eller den person, der giver dig vaccinen, at du er i behandling med Arzerra.
English: Lonza Biologics plc 228 Bath Road Slough, Berks SL1 4DX United Kingdom
Danish: Lonza Biologics plc 228 Bath Road Slough, Berks SL1 4DX Storbritannien
English: Patients with a history of decreased pulmonary function may be at a greater risk for pulmonary complications from severe reactions and should be monitored closely during infusion of Arzerra.
Danish: Patienter, som tidligere har haft nedsat lungefunktion, kan have en større risiko for pulmonale komplikationer efter alvorlige reaktioner, og de skal overvåges nøje under infusionen af Arzerra.
English: Patients refractory to fludarabine and alemtuzumab n=95
Danish: Fludarabin- og alemtuzumab-refraktære patienter n=95
English: Approximately 90% of patients received 3-6 cycles of ofatumumab and 66% completed 6 cycles.
Danish: Ca. 90 % af patienterne fik 3-6 cyklusser med ofatumumab, og 66 % fuldførte 6 cyklusser.
English: The B-cell tumours include CLL (generally associated with lower levels of CD20 expression) and non-Hodgkin's lymphomas (where >90% of tumours have high levels of CD20 expression).
Danish: B-celletumorerne omfatter CLL (generelt kendetegnet ved, at cellerne udtrykker et lavere niveau CD20), og non-Hodgkin-lymfomer (hvor >90 % af tumorerne udtrykker CD20 på et højt niveau).
English: The results of this study demonstrated that Arzerra in combination with bendamustine is an effective therapy providing an ORR of 95% (95% CI: 85, 99) and a CR of 43%.
Danish: Resultaterne af dette studie viste, at Arzerra i kombination med bendamustin er en effektiv behandling, der giver en ORR på 95 % (95 % konfidensinterval: 85; 99) og CR på 43 %.
English: The usual dose of Arzerra for the first infusion is 300 mg.
Danish: Den sædvanlige dosis Arzerra ved den første infusion er 300 mg.
English: • 300 mg on day 1 followed 1 week later by
Danish: • 300 mg på dag 1 efterfulgt 1 uge senere af
English: 50 to 100 mg***
Danish: 50 til 100 mg***
English: What Arzerra contains - The active substance is ofatumumab.
Danish: Arzerra indeholder: - Aktivt stof: ofatumumab.
English: Pharmacotherapeutic group: antineoplasic agents, monoclonal antibodies, ATC code: L01XC10
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC10
English: Patients who had prior rituximab therapy, either as monotherapy or in combination with other medicinal products, responded to treatment with Arzerra at a similar rate to those who had not had prior rituximab therapy.
Danish: Patienter, der havde fået forudgående behandling med rituximab, enten som monoterapi eller i kombination med andre lægemidler, responderede på behandlingen med Arzerra med samme rate som de patienter, der ikke havde fået forudgående behandling med rituximab.
English: Previously untreated patients (ofatumumab + chlorambucil)
Danish: Tidligere ubehandlede patienter (ofatumumab + chlorambucil)
English: First and second infusions
Danish: Første og anden infusion
English: (Primary) endpoint
Danish: (Primært) endepunkt
English: These included improvements associated with constitutional symptoms, lymphadenopathy, organomegaly, or cytopenias (see Table 4).
Danish: De var blandt andet forbundet med konstitutionelle symptomer, lymfadenopati, organomegali eller cytopenier (se tabel 4).
English: In all patients with CLL, ofatumumab induces rapid and profound B-cell depletion, whether given as a single agent or in combination.
Danish: Hos alle patienter med CLL inducerer ofatumumab en hurtig og profund B-celle-depletion, uanset om det er givet alene eller i kombination.
English: If you have not been previously treated for CLL you will have a maximum of 13 infusions.
Danish: Hvis du ikke tidligere er blevet behandlet for CLL, vil du maksimalt få 13 infusioner.
English: Ofatumumab has a small volume of distribution, with mean Vss values ranging from 1.7 to 8.1 l across studies, dose levels, and infusion number.
Danish: Ofatumum ab har et lavt fordelingsvolumen med gennemsnitlige Vss-værdier i intervallet fra 1,7 til 8,1 l på tværs af forsøg, dosisniveauer og antallet af infusioner.
English: Patients with evidence of prior HBV infection should be monitored for clinical and laboratory signs of hepatitis or HBV reactivation during treatment with and for 6-12 months following the last infusion of Arzerra.
Danish: Patienter med tegn på tidligere HBV-infektion skal monitoreres for kliniske og laboratoriemæssige tegn på hepatitis eller HBV-reaktivering under behandlingen og 6-12 måneder efter den sidste infusion af Arzerra.
English: Medicines of this type (monoclonal antibodies) can cause infusion reactions when they are injected into the body.
Danish: Medicin af denne type (monoklonale antistoffer) kan give infusionsreaktioner, når de sprøjtes ind i kroppen.
English: Very common side effects that may show up in your blood tests:
Danish: Meget almindelige bivirkninger, der kan ses i dine blodprøver:
English: The effect of ofatumumab on patients with prolonged QT intervals (e.g. acquired or congenital) is unknown.
Danish: Virkningen af ofatumumab hos patienter med forlængede QT-intervaller (dvs. erhvervet eller medfødt) er ikke kendt.
English: The ORR was 49% in patients refractory to fludarabine and alemtuzumab (see Table 3 for a summary of the efficacy data from the study).
Danish: ORR var 49 % hos patienter, der var refraktære over for behandling med fludarabin og alemtuzumab (se tabel 3 for oversigt over effektdata fra studiet).
English: All patients should be screened for HBV infection by measuring HBsAg and anti-HBc before initiation of Arzerra treatment.
Danish: Alle patienter bør screenes for HBV-infektion ved at måle HBsAg og anti-HBc inden initiering af behandling med Arzerra.
English: Arzerra contains sodium
Danish: Arzerra indeholder natrium
English: Seven percent of patients had ≥Grade 3 infusion-related reactions at any time during treatment.
Danish: Syv procent af patienterne havde på et eller andet tidspunkt i behandlingsforløbet ≥grad 3 infusionsrelaterede reaktioner.
English: Store the diluted infusion solution between 2C and 8 C and use within 24 hours.
Danish: Den fortyndede infusionsvæske skal opbevares ved temperaturer mellem 2 C - 8 C og bruges inden for 24 timer.
English: Arzerra was administered as monotherapy to 223 patients with refractory CLL (study Hx-CD20-406).
Danish: Arzerra blev administreret som monoterapi til 223 patienter med refraktær CLL (studie Hx-CD20406).
English: If an anaphylactic reaction occurs, Arzerra should be immediately and permanently discontinued and appropriate medical treatment should be initiated.
Danish: Hvis en anafylaktisk reaktion opstår, skal Arzerra straks og permanent seponeres, og passende medicinsk behandling skal påbegyndes.
English: 36 patients had a normal karyotype and chromosomal aberrations were detected in 174 patients; there were 47 patients with 17p deletion, 73 patients with 11q deletion, 23 patients with trisomy 12q, and 31 patients with 13q deletion as the sole aberration.
Danish: 36 patienter havde en normal karyotype, og der blev påvist kromosomaberrationer hos 174 patienter; der var 47 patienter med 17p-deletion, 73 patienter med 11q-deletion, 23 patienter med trisomi 12q og 31 patienter med 13q-deletion som den eneste aberration.
English: Intravenous administration of ofatumumab to pregnant cynomolgus monkeys at 100 mg/kg once weekly from days 20 to 50 of gestation did not elicit maternal or foetal toxicity or teratogenicity.
Danish: Intravenøs administration af ofatumumab til drægtige cynomolgusaber i doser på 100 mg/kg én gang om ugen fra dag 20 til dag 50 i drægtighedsperioden udløste hverken maternel eller føtal toksicitet eller teratogenicitet.
English: Age ≥75 years (n=119) Co-morbidity 0 or 1 (n=126) Co-morbidity 2 or more (n=321) ECOG 0, 1 (n=411) ECOG 2 (n=35)
Danish: Alder ≥75 år (n=119) Komorbiditet 0 eller 1 (n=126) Komorbiditet 2 eller flere (n=321) ECOG 0, 1 (n=411) ECOG 2 (n=35)
English: Age was not found to be a significant factor for ofatumumab pharmacokinetics in a cross-study population pharmacokinetic analysis of patients ranging in age from 21 to 87 years of age.
Danish: Alderen viste sig ikke at have signifikant indflydelse på ofatumumabs farmakokinetik i en farmakokinetisk cross-study-populationsanalyse hos patienter i alderen 21-87 år.
English: Table 3 Summary of response to Arzerra in patients with refractory CLL
Danish: Tabel 3 Oversigt over respons på Arzerra hos patienter med refraktær CLL
English: 268 (23%) of the 1,168 patients experienced ≥Grade 3 infections.
Danish: 268 (23 %) ud af de 1.168 patienter fik infektioner ≥grad 3.
English: Tell your doctor immediately if you have memory loss, trouble thinking, difficulty with walking or loss of vision.
Danish: Fortæl det straks til lægen, hvis du oplever hukommelsestab, koncentrationsbesvær, får svært ved at gå eller oplever synstab.
English: Ofatumumab is eliminated in two ways: a target-independent route like other IgG molecules and a target-mediated route which is related to binding to B-cells.
Danish: Ofatumumab elimineres ad to veje: en vej, der er uafhængig af målcellen, som det også er tilfældet med andre IgG-molekyler, samt en målcelle-medieret vej, der er relateret til bindingen til B-celler.
English: Arzerra must not be mixed with, or administered as an infusion with other medicinal products or intravenous solutions.
Danish: Arzerra må hverken blandes eller administreres som en infusion med andre lægemidler eller intravenøse opløsninger.
English: Based on available safety and efficacy data in the elderly, no dose adjustment is required (see section 5.2).
Danish: Baseret på de foreliggende data om sikkerhed og effekt er dosisjustering ikke nødvendig hos ældre (se pkt.
English: The excretion of ofatumumab in milk has not been studied in animals.
Danish: Udskillelsen af ofatumumab i mælk er ikke blevet undersøgt hos dyr.
English: Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Danish: Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Tyskland
English: Pre-medication attenuates infusion-related reactions but these may still occur, predominantly during the first infusion.
Danish: Præmedicinering modvirker infusionsrelaterede reaktioner, men de kan stadig forekomme, hovedsageligt under den første infusion.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIG FOR BATCHFRIGIVELSE
English: Arzerra treatment should not be initiated in patients with evidence of current hepatitis B infection (HBsAg positive) until the infection has been adequately treated.
Danish: Behandling med Arzerra bør ikke iværksættes hos patienter med tegn på nuværende hepatitis B-infektion (HBsAg-positiv), før infektionen er blevet tilfredsstillende behandlet.
English: Your doctor may test the amount of electrolytes, such as magnesium and potassium, in your blood before and during your treatment with Arzerra.
Danish: Lægen kan undersøge mængden af elektrolytter i dit blod, såsom magnesium og kalium, før og under behandling med Arzerra.
English: 101 International Drive Portsmouth, NH 03801-2815 United States
Danish: Lonza Biologics, Inc. 101 International Drive Portsmouth, NH 03801-2815 USA
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Patients should be closely monitored during administration of ofatumumab for the onset of infusionrelated reactions, including cytokine release syndrome, particularly during the first infusion.
Danish: Under administration af ofatumumab skal patienten monitoreres tæt for tegn på infusionsrelaterede reaktioner, herunder cytokinfrigivelsessyndrom, særligt under den første infusion.
English: • memory loss, trouble with thinking, and difficulty with walking or loss of vision (possible symptoms of progressive multifocal leukoencephalopathy)
Danish: • hukommelsestab, koncentrationsbesvær og vanskeligheder med at gå eller tab af syn (mulige symptomer på progressiv multifokal leukoencefalopati)
English: CIRS-G ≤10 (n=310) CIRS-G >10 (n=137) CrCl <70 ml/min (n=214) CrCl ≥70 ml/min (n=227) 17p or 11q deletion (n=90) IGHV mutated (≤98%) (n=177) IGHV unmutated (>98%) (n=227) β2M ≤3500 μg/l (n=109) β2M >3500 μg/l (n=322) ZAP-70 positive (n=161) ZAP-70 intermediate (n=160) ZAP-70 negative (n=100) IGHV mutated & ZAP-70 negative (n=60)
Danish: CIRS-G ≤ 10 (n=310) CIRS-G >10 (n=137) CrCl <70 ml/min (n=214) CrCl ≥70 ml/min (n=227) 17p- eller 11q-deletion (n=90) IGHV muteret (≤98 %) (n=177) IGHV ikke-muteret (>98 %) (n=227) β2M ≤3500 μg/l (n=109) β2M >3500 μg/l (n=322) ZAP-70 positiv (n=161) ZAP-70 intermediær (n=160) ZAP-70 negativ (n=100) IGHV muteret & ZAP-70 negativ (n=60)
English: HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive.
Danish: HBV-reaktivering er defineret som en brat stigning i HBV-replikation, hvilket viser sig som en hurtig stigning i serum-HBV-DNA eller ved fund af HBsAg hos en person, der tidligere var HBsAg-negativ og anti-HBc-positiv.
English: Therefore, the concomitant use of these agents with ofatumumab should be avoided.
Danish: Derfor bør brugen af disse vacciner undgås sammen med ofatumumab.
English: The antibody in Arzerra recognises a substance on the surface of lymphocytes and causes the lymphocyte to die.
Danish: Antistoffet i Arzerra genkender et stof på lymfocytternes overflade og dræber lymfocytterne.
English: Medicines of this type (monoclonal antibodies) can cause infusion-related reactions, which are occasionally severe, and can cause death.
Danish: Medicin af denne type (monoklonale antistoffer) kan medføre infusionsrelaterede reaktioner, der i nogle tilfælde er alvorlige og kan forårsage dødsfald.
English: ------Chlorambucil (N=226) Median 13.1 months____Ofatumumab + Chlorambucil (N=221)
Danish: ------Chlorambucil (N=226) Median 13,1 måneder ____Ofatumumab + Chlorambucil (N=221) Median 22,4 måneder
English: These patients also experienced comparable clinical improvement, in terms of the efficacy endpoints and haematological parameters detailed above, to patients refractory to both fludarabine and alemtuzumab.
Danish: Disse patienter havde også sammenlignelige, kliniske forbedringer, i form af effekt-endepunkter og hæmatologiske parametre (uddybet ovenfor), sammenlignet med patienter, der var refraktære over for både fludarabin og alemtuzumab.
English: The PFS in the monotherapy Arzerra arm was comparable to the results seen with Arzerra monotherapy in study Hx-CD20-406.
Danish: PFS i armen med Arzerra-monoterapi var sammenlignelig med de resultater, som blev set med Arzerra-monoterapi i studiet Hx-CD20-406.
English: Reactivation of HBV replication is often followed by hepatitis, i.e. increase in transaminase levels and, in severe cases, increase in bilirubin levels, liver failure, and death.
Danish: Reaktivering af HBV-replikation er ofte efterfulgt af hepatitis, dvs. stigning i aminotransferase-niveauer og i alvorlige tilfælde stigning i bilirubin-niveau, leversvigt og død.
English: PFS benefit with the addition of Arzerra was observed in all patients, including those with poor-risk biological features (such as 17p or 11q deletion, unmutated IGHV, β2M >3500 μg/l, and ZAP-70 expression).
Danish: PFS-fordele ved tilføjelse af Arzerra blev set hos alle patienter, inklusive dem med biologiske kendetegn for dårlig prognose (såsom 17p- eller 11q-deletion, ikke-muteret IGHV, β2M>3500 μg/l og ZAP-70-ekspression).
English: The ORR in this group was 43% (95.3% CI: 33, 53).
Danish: ORR i denne gruppe var 43 % (95,3 % konfidensinterval: 33, 53).
English: Arzerra was also given to a group of patients (n=112) with bulky lymphadenopathy (defined as at least one lymph node >5 cm) who were also refractory to fludarabine.
Danish: Arzerra blev også givet til en gruppe af patienter (n=112) med lymfadenopati med stor tumorbyrde (defineret som mindst én lymfeknude på >5 cm), som var refraktære over for fludarabin.
English: Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule.
Danish: Ofatumumab er et humant, monoklonalt antistof (IgG1), der binder sig specifikt til en bestemt epitop, som er lokaliseret i både de små og store ekstracellulære loops på CD20-molekylet.
English: The response rate in patients with prior rituximab therapy was 38% (95% CI: 23, 61).
Danish: Responsraten hos patienter i forudgående behandling med rituximab var 38 % (95 % konfidensinterval: 23, 61).
English: Arzerra is administered by intravenous infusion; therefore, absorption is not applicable.
Danish: Arzurra administreres som intravenøs infusion, og absorptionen er derfor ikke relevant.
English: The duration of response was 16 weeks (CI: 13, 19) and the time to next CLL therapy was 52.4 weeks (CI: 36.9 - non-estimable).
Danish: Responsvarigheden var 16 uger (konfidensinterval: 13, 19 uger), og tiden til den næste CLL-behandling var 52,4 uger (konfidensinterval: 36,9 - kan ikke estimeres).
English: The median CIRS score was 7 (range: 4 to 17), 36% of patients had CrCL <70 ml/min, 93% of patients had ECOG 0 or 1.
Danish: Den mediane CIRS-score var 7 (interval: 4 til 17), 36 % af patienterne havde CrCL <70 ml/min, 93 % af patienterne havde ECOG 0 eller 1.
English: Ofatumumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Danish: Ofatumumab er et protein, som forventes at blive metaboliseret ved nedbrydning til små peptider og individuelle aminosyrer af ubikvitære, proteolytiske enzymer.
English: • shingles, cold sores (possible symptoms of herpes viral infection that can potentially be severe).
Danish: • helvedesild, forkølelsessår (mulige symptomer på en herpesinfektion, som potentielt kan være alvorlig).
English: Arzerra should be permanently discontinued in patients who develop an anaphylactic reaction to the medicinal product.
Danish: Arzerra bør seponeres permanent hos patienter, der udvikler en anafylaktisk reaktion på lægemidlet.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Peripheral B-cell counts decreased after the first ofatumumab infusion in patients with haematological malignancies.
Danish: Antallet af perifere B-celler faldt efter den første infusion af ofatumumab hos patienter med hæmatologiske maligniteter.
English: Baseline disease characteristics and prognostic markers were balanced between treatment arms and representative of a relapsed CLL population.
Danish: Sygdomskarakteristika og prognostiske markører ved baseline var afbalancerede mellem de 2 behandlingsarme og repræsentative for en population med recidiverende CLL.
English: Limited data are available in the heterogeneous non-white population and in patients with an ECOG performance status of PS = 2.
Danish: Begrænsede data er tilgængelige for den heterogene ikke-hvide population og for patienter med ECOG- performancestatus på PS=2.
English: Management of TLS includes correction of electrolyte abnormalities, monitoring of renal function, maintenance of fluid balance and supportive care.
Danish: TLS behandles blandt andet ved korrektion af elektrolytabnormiteter, monitorering af nyrefunktionen, opretholdelse af væskebalancen og understøttende behandling.
English: Arzerra is for intravenous infusion and must be diluted prior to administration.
Danish: Arzerra er beregnet til intravenøs infusion og skal fortyndes før administration.
English: The overall safety profile of ofatumumab is based on data from 1,168 patients in clinical trials in CLL (see section 5.1).
Danish: Den samlede bivirkningsprofil for ofatumumab er baseret på data fra 1.168 patienter med CLL i kliniske studier (se pkt.
English: • if you have lung disease,
Danish: • hvis du har en lungesygdom.
English: The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumours.
Danish: CD20-molekylet er et transmembrant phosphoprotein, der udtrykkes på B-lymfocytter fra præ-B-lymfocytstadiet til stadiet, hvor B-lymfocytterne er modne, samt på B-celletumorer.
English: Arzerra should be discontinued in patients who experience serious or life-threatening cardiac arrhythmias.
Danish: Arzerra skal seponeres hos patienter, der får alvorlige eller livstruende hjertearytmier.
English: Adverse reactions reported in patients treated with ofatumumab as monotherapy and with ofatumumab in combination with chemotherapy, are listed below by MedDRA body system organ class and by frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Danish: Bivirkningerne, som blev set hos patienter behandlet med ofatumumab som monoterapi og ofatumumab i kombination med kemoterapi, er anført nedenfor efter systemorganklasse og hyppighed i henhold til MedDRA. Der benyttes følgende hyppigheder i henhold til følgende konvention: meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Patients who present with abdominal pain, especially early in the course of ofatumumab therapy, should be evaluated and appropriate treatment instituted.
Danish: Patienter, der får abdominalsmerter, især tidligt i behandlingsforløbet med ofatumumab, skal undersøges, og der skal iværksættes passende behandling.
English: Figure 1 Kaplan-Meier estimates of IRC-assessed PFS in previously untreated CLL
Danish: Figur 1 Kaplan-Meier estimater af IRC-vurderet PFS i tidligere ubehandlet CLL
English: Study OMB115991 evaluated the efficacy of Arzerra in combination with bendamustine in 44 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment.
Danish: Studie OMB115991 vurderede effekten af Arzerra i kombination med bendamustin hos 44 patienter med tidligere ubehandlet CLL, der var vurderet uegnede til fludarabinbaseret behandling.
English: Insufficient data exist regarding the safety of resuming Arzerra in patients who develop HBV reactivation.
Danish: Der foreligger ikke tilstrækkelige data vedrørende sikkerheden ved at genoptage Arzerra hos patienter, der har udviklet HBVreaktivering.
English: Table 4 Summary of clinical improvement with a minimum duration of 2 months in refractory patients with abnormalities at baseline
Danish: Tabel 4 Oversigt over kliniske forbedringer med en varighed på mindst to måneder hos refraktære patienter med abnormiteter ved udgangsniveauet
English: None of the patients had an increase of QTc to >500 msec. A concentration dependent increase in QTc was not detected.
Danish: Ingen af patienterne havde stigninger i QTc til >500 ms. Der blev ikke fundet en koncentrationsafhængig sammenhæng i QTc-forlængelserne.
English: Risk factors for TLS include a high tumour burden, high concentrations of circulating cells (≥25,000/mm hypovolaemia, renal insufficiency, elevated pre-treatment uric acid levels and elevated lactate dehydrogenase levels.
Danish: Risikofaktorerne for TLS omfatter stor tumorbyrde, høje koncentrationer af cirkulerende celler (25.000/mm hypovolæmi, nyreinsufficiens, forhøjet niveau af urinsyre før behandlingen og forhøjet niveau af lactatdehydrogenase.