FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision must be made whether to discontinue breast-feeding or to discontinue from nivolumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med nivolumab seponeres, idet der tages hensyn til fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: PD-L1 Expression nivolumab investigator's choice OS by tumour PD-L1 expression Number of events (number of patients)
Danish: PD-L1-ekspression nivolumab investigators valg OS i forhold til PD-L1-tumorekspression Antal hændelser (antal patienter)
English: Of the 811 treated patients, 103 (13%) had an ECOG performance score of 2, 686 (85%) were < 75 years old and 125 (15%) were ≥ 75 years old.
Danish: Af de 811 behandlede patienter havde 103 (13 %) en ECOG-performance-score på 2, 686 (85 %) var < 75 år, og 125 (15 %) var ≥ 75 år.
English: It is very important for you to keep all your appointments to receive OPDIVO.
Danish: Det er meget vigtigt, at du overholder alle dine aftaler om behandling med OPDIVO.
English: No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Danish: Der blev ikke rapporteret nogen generelle forskelle i sikkerhed og virkning mellem ældre (≥ 65 år) og yngre patienter (< 65 år).
English: Years from most recent transplant to first dose of study therapy, median (min-max) a 18/80 (22.5%) of the patients in CA209205 Cohort B presented B-Symptoms at baseline.
Danish: År fra seneste transplantation til første dosis af studiebehandlingen, median (min-maks) a 18/80 (22,5 %) af patienterne i CA209205 kohorte B udviste B-symptomer ved baseline.
English: Table 17 summarises results of ORR and OS by tumour PD-L1 expression.
Danish: Tabel 17 opsummerer resultaterne for ORR og OS i forhold til PD-L1-tumorekspression.
English: Solid organ transplant rejection
Danish: Afstødning af et transplanteret fast organ
English: Probability of Survival
Danish: Sandsynlighed for overlevelse
English: Nivolumab or nivolumab in combination with ipilimumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy.
Danish: Behandling med nivolumab eller nivolumab i kombination med ipilimumab bør ikke genoptages, mens patienten får immunsuppressive doser af kortikosteroid eller anden immunsuppressiv behandling.
English: If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up to 24 hours [a maximum of 8 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light].
Danish: Hvis OPDIVO ikke anvendes straks, kan den opbevares i køleskab (2°C-8°C) og beskyttet mod lys i op til 24 timer [højst 8 timer ud af de 24 timer ved stuetemperatur (20°C-25°C) og dagslys].
English: Nivolumab baseline CL in adjuvant melanoma patients was approximately 40% lower and steady state CL approximately 20 % lower relative to advanced melanoma.
Danish: Nivolumabs CL ved baseline hos patienter behandlet for adjuverende melanom var cirka 40 % lavere, og CL ved steady state var cirka 20 % lavere i forhold til fremskredent melanom.
English: Each vial contains either 40 mg (in 4 mL), 100 mg (in 10 mL) or 240 mg (in 24 mL) of nivolumab.
Danish: Et hætteglas indeholder enten 40 mg (i 4 ml), 100 mg (i 10 ml) eller 240 mg (i 24 ml) nivolumab.
English: Vogt-Koyanagi-Harada syndromeh Cardiac disorders
Danish: Vogt-Koyanagi-Harada syndromh
English: Median duration of response was 13.2 months (95% CI: 8.2, NE)
Danish: Medianresponsvarighed var 13,2 måneder (95 % CI: 8.2; NE)
English: The following side effects have been reported with nivolumab in combination with ipilimumab:
Danish: Følgende bivirkninger er blevet rapporteret med nivolumab i kombination med ipilimumab:
English: EU/1/15/1014/001 40 mg vial EU/1/15/1014/002 100 mg vial EU/1/15/1014/003 240 mg vial
Danish: EU/1/15/1014/001 40 mg hætteglas EU/1/15/1014/002 100 mg hætteglas EU/1/15/1014/003 240 mg hætteglas
English: Fatal cases have been reported in completed or ongoing clinical studies b
Danish: Der er rapporteret dødelige tilfælde i afsluttede eller igangværende kliniske studier.
English: There are no data on the use of nivolumab in combination with ipilimumab in patients with only a non clear-cell histology in first line RCC.
Danish: Der foreligger ingen data fra anvendelse af nivolumab i kombination med ipilimumab hos førstelinje RCC-patienter med kun en non-clear cell-histologi.
English: Uncommon metabolic acidosis
Danish: Ikke almindelig metabolisk acidose
English: Shortness of breath (dyspnoea)
Danish: Åndenød (dyspnø)
English: Not Availableb
Danish: Ikke tilgængeligb
English: The study included patients (18 years or older) with previously untreated, advanced or metastatic renal cell carcinoma with a clear-cell component.
Danish: Studiet inkluderede patienter (18 år eller ældre) med tidligere ubehandlet, fremskredent eller metastatisk renalcellekarcinom med en clear cell-komponent.
English: Baseline characteristics were balanced between groups except for the proportions of patients who had a history of brain metastasis (19% and 13% in the nivolumab group and chemotherapy group, respectively) and patients with LDH greater than ULN at baseline (51% and 35%, respectively).
Danish: Baseline-karakteristika var velbalancerede grupperne imellem undtagen andelen af patienter, som havde hjernemetastaser i anamnesen (19 % og 13 % i henholdsvis nivolumabgruppen og kemoterapigruppen) og patienter med LDH ved baseline, som var højere end ULN (henholdsvis 51 % og 35 %).
English: Primary analysis Minimum follow-up: 10.6 months
Danish: Primær analyse Minimum opfølgning: 10,6 måneder
English: Subsequent systemic therapy was received by 31.8%, 44.3%, and 62.2% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Danish: Efterfølgende systemisk behandling blev modtaget af 31,8 %, 44,3 % og 62,2 % af patienterne i henholdsvis kombinations-armen, nivolumab-armen og ipilimumab-armen.
English: Uncommon bronchitis bronchitis, aseptic meningitis
Danish: Ikke almindelig bronkitis bronkitis, aseptisk meningitis
English: Resolution occurred in 64 patients (45.4%).
Danish: Resolution forekom hos 64 patienter (45,4 %).
English: Not Reached (1.9+, 12.0+)
Danish: Ikke nået (1,9+, 12,0+)
English: Pre-study tumour tissue specimens were systematically collected prior to randomisation in order to conduct pre-planned analyses of efficacy according to tumour PD-L1 expression.
Danish: Vævsprøver fra tumor før studiet blev systematisk indsamlet før randomisering for at kunne udføre forudplanlagte analyser af virkning i forhold til PD-L1-tumorekspression.
English: Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumour responses in metastatic melanoma.
Danish: Kombineret nivolumab (anti-PD-1) og ipilimumab (anti-CTLA-4) medieret hæmning resulterer i forbedret anti-tumorrespons ved metastatisk melanom.
English: 99.79% CI 95% CI
Danish: 99,79 % CI 95 % CI p-værdi
English: • patients with prior therapy for melanoma (except patients with surgery, adjuvant radiotherapy after neurosurgical resection for lesions of the central nervous system, and prior adjuvant interferon completed ≥ 6 months prior to randomisation),
Danish: • patienter der tidligere har modtaget behandling for melanom (bortset fra patienter der har modtaget kirurgiske indgreb, adjuverende strålebehandling efter neurokirurgisk resektion for læsioner i centralnervesystemet, og tidligere adjuverende interferon færdigbehandlet ≥ 6 måneder inden randomisering),
English: Cases of myotoxicity (myositis, myocarditis, and rhabdomyolysis), some with fatal outcome, have been reported with nivolumab or nivolumab in combination with ipilimumab.
Danish: Tilfælde af myotoksicitet (myositis, myocarditis og rabdomyolyse), herunder tilfælde med dødelig udgang, er rapporteret med nivolumab og nivolumab i kombination med ipilimumab.
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: In a post-hoc analysis of the 80 patients in CA209205 Cohort B, 37 had no response to prior brentuximab vedotin treatment.
Danish: I en post-hoc-analyse af de 80 patienter i CA209205 kohorte B, havde 37 ikke noget respons på forudgående behandling med brentuximab vedotin.
English: PD-L1 Expression nivolumab docetaxel ORR by tumour PD-L1 expression Minimum follow-up: 13.2 months
Danish: PD-L1-ekspression nivolumab docetaxel ORR i forhold til PD-L1-tumorekspression Minimum opfølgning: 13,2 måneder
English: Permanent discontinuation of treatment was required in a greater proportion of patients receiving nivolumab in combination with ipilimumab than in those receiving nivolumab monotherapy.
Danish: Permanent seponering af behandlingen var nødvendig hos en større andel af de patienter, der fik nivolumab i kombination med ipilimumab, end hos de patienter, der fik nivolumab-monoterapi.
English: Uncommon (may affect up to 1 in 100 people) Bronchitis
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) Bronkitis
English: Patients with mild or moderate infusion reaction may receive nivolumab or nivolumab in combination with ipilimumab with close monitoring and use of premedication according to local treatment guidelines for prophylaxis of infusion reactions.
Danish: Patienter, der oplever lette eller moderate infusionsreaktioner, kan få nivolumab eller nivolumab i kombination med ipilimumab under nøje overvågning og med anvendelse af præmedicinering i henhold til gældende retningslinjer for profylakse mod infusionsreaktioner.
English: Efficacy by BRAF status: Objective responses to nivolumab (according to the definition of the coprimary endpoint) were observed in patients with or without BRAF mutation-positive melanoma.
Danish: Effekt i forhold til BRAF-status: Objektivt repons på nivolumab (i henhold til definitionen på de to primære endepunkter) blev observeret hos patienter med eller uden BRAF mutationspositivt melanom.
English: Administer the OPDIVO infusion intravenously over a period of 30 or 60 minutes depending on the dose.
Danish: OPDIVO-infusion administreres intravenøst over en periode på 30 eller 60 minutter alt afhængig af dosis.
English: If not used immediately, chemical and physical in-use stability of OPDIVO has been demonstrated for 24 hours at 2ºC to 8ºC protected from light and a maximum of 8 hours at 20°C-25°C and room light (this 8-hour period of the total 24 hours should be inclusive of the product administration period).
Danish: Hvis OPDIVO ikke anvendes straks, er der påvist kemisk og fysisk stabilitet under anvendelse i 24 timer ved 2°C-8°C og beskyttet mod lys og i højst 8 timer ved 20°-25°C og dagslys (de 8 timer af de i alt 24 timer er inklusive administrationsperioden).
English: In addition, CA209037 excluded patients who have had a Grade 4 adverse reaction that was related to anti-CTLA-4 therapy (see section 5.1).
Danish: Derudover udelukkede CA209037 patienter, som havde haft en grad 4 bivirkning, der var relateret til anti-CTLA-4-behandling (se pkt.
English: 95% CI: 1.4, 17.9 OS by tumour PD-L1 expression Minimum follow-up: 13.2 months Number of events (number of patients)
Danish: 95 % CI: 1,4; 17,9 OS i forhold til PD-L1-tumorekspression Minimum opfølgning: 13,2 måneder Antal hændelser (antal patienter)
English: Most immune-related adverse reactions improved or resolved with appropriate management, including initiation of corticosteroids and treatment modifications (see section 4.2).
Danish: De fleste immunrelaterede bivirkninger forbedredes eller forsvandt med passende behandling, herunder kortikosteroidbehandling og behandlingsmodifikationer (se pkt.
English: Table 22: Updated efficacy results in patients with relapsed/refractory classical Hodgkin lymphoma from longer follow up of study CA209205
Danish: Tabel 22: Opdaterede effektresultater hos patienter med recidiverende/refraktær klassisk Hodgkins lymfom fra den længere opfølgningsperiode i studie CA209205
English: Additional data from 100 patients from CA209205 Cohort C who received brentuximab before and/or after ASCT are also presented.
Danish: Yderligere data fra 100 patienter fra CA209205 kohorte C, som fik brentuximab før og/eller efter ASCT er også vist.
English: Urothelial Carcinoma
Danish: Urothelialt karcinom
English: Post authorisation efficacy study (PAES): The MAH should submit the addendum to the CA209205 Final CSR reporting the OS data and data from the discontinuation schedule in Cohort C.
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende addendummet for den endelige CA209205 CSR med rapportering af OS-data og data fra seponeringsskemaet i Kohorte C.
English: Increased acid levels in the blood
Danish: Forhøjet syreindhold i blodet
English: If symptoms or signs of SJS or TEN appear, treatment with nivolumab or nivolumab in combination with ipilimumab should be discontinued and the patient referred to a specialised unit for assessment and treatment.
Danish: Hvis der opstår symptomer eller tegn på SJS eller TEN, skal behandling med nivolumab eller nivolumab i kombination med ipilimumab seponeres og patienten henvises til en specialafdeling til vurdering og behandling.
English: In the nivolumab group there were two patients with CRs and seven patients with PRs who had tumour PD-L1 expression < 1%.
Danish: I nivolumab-gruppen var der to patienter med CR og syv patienter med PR, der havde PD-L1tumorekspression < 1 %.
English: Results of a post-hoc, exploratory multivariate analysis indicated that nivolumab-treated patients with poorer prognostic features and/or aggressive disease when combined with lower (e.g., < 50%) or no tumour PD-L1 expression may be at higher risk of death within the first 3 months.
Danish: Resultaterne af en post-hoc eksplorativ multivariatanalyse indikerede, at nivolumab-behandlede patienter med dårlige prognostiske faktorer og/eller aggressiv sygdom kombineret med lav (f.eks. < 50 %) eller ingen PD-L1-tumorekspression kan have en højere risiko for død inden for de første 3 måneder.
English: P-value is derived from a log-rank test stratified by prior maintenance therapy and line of therapy; the corresponding O'Brien-Fleming efficacy boundary significance level is 0.0408.
Danish: P-værdi er udledt af en log-rank test stratificeret efter tidligere vedligeholdelsesbehandling og behandlingsforløb; det tilsvarende O'Brien-Fleming-signifikansniveau for effektgrænse er 0,0408.
English: Baseline characteristics were generally balanced between the two groups.
Danish: Baseline-karakteristika var generelt velbalancerede mellem de to grupper.
English: b 25/100 (25%) of the patients in CA209205 Cohort C presented B-Symptoms at baseline.
Danish: b. 25/100 (25 %) af patienterne i CA209205 kohorte C udviste B-symptomer ved baseline.
English: No Grade 5 nephritis or renal dysfunction was reported in these studies.
Danish: Ingen grad 5 nefritis eller nedsat nyrefunktion blev rapporteret i disse studier.
English: Subsequent immunotherapy (including anti-PD1 therapy, anti-CTLA-4 antibody, or other immunotherapy) was received by 14.6%, 29.1%, and 44.1% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Danish: Efterfølgende immunterapi (inklusive anti-PD1-terapi, anti-CTLA-4 antistof, eller anden immunterapi) blev givet til 14,6 %, 29,1 % og 44,1 % af patienterne i henholdsvis kombinations-armen, nivolumab-armen og ipilimumabarmen.
English: Melanoma (advanced or adjuvant treatment)
Danish: Melanom (behandling af fremskredent melanom eller adjuverende behandling)
English: Adjuvant treatment of melanoma
Danish: Adjuverende behandling af melanom
English: Table 26: Efficacy results (CA209275)a nivolumab (n = 270)
Danish: Tabel 26: Effektresultater (CA209275)a nivolumab (n = 270)
English: Frequencies are defined as: 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 post-marketing data).
Danish: Hyppighederne er defineret som: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data efter markedsføring).
English: The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed ORR and PFS. Additional prespecified subgroup analyses were conducted to evaluate the efficacy of tumour PD-L1 expression at predefined levels of 1%, 5% and 10%.
Danish: Vigtige sekundære effektparametre var investigatorvurderet ORR og PFS. Der blev udført yderligere analyser af præspecificerede undergrupper for at vurdere virkningen af PD-L1-tumorekspression ved prædefinerede niveauer på 1 %, 5 % og 10 %.
English: Apparently meaningful symptom improvement (MID = 2 point change in FKSI-DRS score; p < 0.001) and time to improvement (HR = 1.66 (1.33,2.08), p < 0.001) were significantly better for patients on the nivolumab arm.
Danish: Tilsyneladende var betydelig symptombedring (MID = 2 point ændring i FKSIDRS-score; p < 0,001) og tid til bedring (HR = 1,66 (1,33;2,08), p < 0,001) signifikant bedre hos patienterne i nivolumab-armen.
English: Frequencies are defined as: 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 post-marketing data).
Danish: Hyppighederne er defineret som: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data efter markedsføring).
English: Fluid in the lungs
Danish: Væske i lungerne
English: Quantifiable tumour PD-L1 expression was measured in 79% of patients in the nivolumab group and 77% of patients in the docetaxel group.
Danish: Kvantificerbar PD-L1-tumorekspression blev målt hos 79 % af patienterne i nivolumab-gruppen og hos 77 % af patienterne i docetaxel-gruppen.
English: Adverse reactions reported in the pooled dataset for patients treated with nivolumab monotherapy (n = 2578) are presented in Table 5.
Danish: Bivirkninger, der blev rapporteret i det puljede datasæt for patienter behandlet med nivolumab-monoterapi (n = 2578), er vist i tabel 5.
English: These may be signs of inflammation of the lungs (pneumonitis or interstitial lung disease).
Danish: Det kan være tegn på en betændelseslignende reaktion (inflammation) i lungerne (pneumonitis eller interstitiel lungesygdom).
English: Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis or Stevens-Johnson syndrome)
Danish: Alvorlig og muligvis dødelig afskalning af huden (toksisk epidermal nekrolyse eller StevensJohnsons syndrom)
English: Resolution occurred in 117 patients (42.9%).
Danish: Resolution forekom hos 117 patienter (42,9 %).
English: There are no data on adjuvant treatment in patients with melanoma with the following risk factors (see sections 4.5 and 5.1
Danish: Der foreligger ingen data omkring adjuverende behandling hos melanompatienter med de følgende risikofaktorer (se pkt.
English: Table 10: Response rate at week 12 - all response evaluable patients and by subgroup (CA209172)
Danish: Tabel 10: Responsrate i uge 12 - alle patienter med evaluerbart respons og ud fra undergruppe (CA209172)
English: In an exploratory post-hoc analysis using a non-validated assay, both tumour cell PD-L1 expression and tumour-associated immune cell (TAIC) PD-L1 expression were analysed in relation to the magnitude of treatment effect of nivolumab compared to investigator's choice.
Danish: I en eksplorativ post-hoc-analyse, hvor der blev anvendt en ikke-valideret analyse, blev både PD-L1tumorcelleekspression og PD-L1-tumor-associeret immuncelle (TAIC)-ekspression analyseret med hensyn til omfanget af behandlingsvirkning af nivolumab sammenlignet med investigators valg.
English: PVC infusion sets
Danish: PVC-infusionssæt
English: Among 131 patients who discontinued the combination due to adverse reaction after 28 months of follow-up, the ORR was 71% (93/131) with 20% (26/131) achieving a complete response and median OS was not reached.
Danish: Blandt de 131 patienter hvor kombinationen blev seponeretpå grund af bivirkninger efter en opfølgningsperiode på 28 måneder var ORR 71 % (93/131), hvoraf 20 % (26/131) opnåede komplet respons og median-OS var ikke blevet nået.
English: A total of 945 patients were randomised to receive nivolumab in combination with ipilimumab (n = 314), nivolumab monotherapy (n = 316), or ipilimumab monotherapy (n = 315).
Danish: I alt 945 patienter blev randomiseret til at få enten nivolumab i kombination med ipilimumab (n = 314), nivolumab-monoterapi (n = 316) eller ipilimumab-monoterapi (n = 315).
English: Temporary and reversible non-infectious inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis)
Danish: Midlertidig og reversibel ikke-smitsom inflammation af de beskyttende hinder, der omgiver hjernen og rygmarven (aseptisk meningitits)
English: The majority (75%) of patients had M1c stage disease at study entry.
Danish: Størstedelen (75 %) af patienterne havde sygdomsstadie M1c ved inklusion i studiet.
English: Patients with tumour PD-L1 expression by all predefined expression levels in the nivolumab group demonstrated greater likelihood of improved survival compared to docetaxel, whereas survival was similar to docetaxel in patients with low or no tumour PD-L1 expression.
Danish: Patienter med PD-L1-tumorekspression ved alle prædefinerede ekspressionsniveauer i nivolumabgruppen viste større sandsynlighed for forbedret overlevelse sammenlignet med docetaxel, hvorimod overlevelsen var den samme som i docetaxel-gruppen ved lav eller ingen PD-L1-tumorekspression.
English: Symptomatic Grade 2 or 3 hypothyroidism, hyperthyroidism, hypophysitis,
Danish: Symptomatisk grad 2 eller 3 hypotyroidisme, hypertyroidisme, hypofysitis
English: Patients with ocular/uveal melanoma were excluded from pivotal clinical trials of melanoma.
Danish: Patienter med okulært/uvealt melanom blev udelukket fra pivotale kliniske melanom-studier.
English: Anaemia is a composite term which includes, among other causes, haemolytic anaemia and autoimmune anaemia.
Danish: Anæmi er et sammensat udtryk, som blandt andet omfatter hæmolytisk anæmi og autoimmun anæmi.
English: Additionally, for patients who experienced an event, Table 7 presents the percentage of patients who required high-dose corticosteroids (at least 40 mg daily prednisone equivalents) by dosing regimen.
Danish: Ydermere viser tabel 7 procenter for de patienter, der fik en bivirkning og havde brug for behandling med højdosis-kortikosteroid (mindst ækvivalent med 40 mg prednison dagligt) ud fra dosisregime.
English: In non-squamous NSCLC, a higher number of deaths within 3 months was observed in nivolumab compared to docetaxel.
Danish: Ved ikke-planocellulær NSCLC blev der observeret flere dødsfald inden for 3 måneder med nivolumab sammenlignet med docetaxel.
English: PHARMACEUTICAL FORM AND CONTENTS Sterile concentrate
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Sterilt koncentrat
English: Median durations of response were 31.9 months (range: 1.4+-31.9) and 12.8 months (range: 1.3+-13.6+), respectively.
Danish: Medianresponsvarighed var henholdsvis 31,9 måneder (1,4+-31,9) og 12,8 måneder (1,3+-13,6+).
English: Signs and symptoms may include abnormal kidney function tests, or decreased volume of urine.
Danish: Tegn og symptomer kan være unormale prøveresultater for nyrefunktionen eller nedsat urinmængde.