FrancophonIA/ELRC3.0 huggingface dataset:
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 64 months, the median durations of MCyR and MMR had not yet been reached.
Danish: På tidspunktet for den opdaterede rapportering med minimumopfølgning på 64 måneder for alle igangværende patienter var de mediane varigheder af MCyR og MMR endnu ikke nået.
English: • Contraceptive advice for men and women Women of childbearing age being treated with Iclusig should avoid becoming pregnant.
Danish: • Råd om kontraception til mænd og kvinder Kvinder i den fertile alder, som behandles med Iclusig, bør undgå at blive gravide.
English: Patients should be tested for HBV infection before initiating treatment with Iclusig.
Danish: Patienten bør testes for HBV-infektion før initiering af behandling med Iclusig.
English: Management of toxicities
Danish: Styring af toksicitet
English: Table 5 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥ 2% of patients in any disease group from the Phase 2 Trial (N=449): minimum follow-up of 64 month for all ongoing patients Laboratory test
Danish: Tabel 5 Forekomst af klinisk relevante grad 3/4* laboratorieanomalier hos ≥ 2 % af patienter i alle sygdomsgrupper fra fase 2-forsøget (N=449): Minimumopfølgning på 64 måneder for alle igangværende patienter Laboratorieundersøgelser
English: in peripheral blood measured by quantitative reverse transcriptase polymerase chain reaction (qRT PCR).
Danish: transkriptet), i perifert blod målt ved kvantitativ revers-transkriptase-polymerase-kædereaktion (qRT PCR).
English: Factors other than dose may also contribute to this risk of arterial occlusion.
Danish: Andre faktorer end dosis bidrager muligvis til denne risiko for arteriel okklusion.
English: Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4%, neutropenia and anaemia < 1% each).
Danish: Seponering på grund af myelosuppression var sjælden (trombocytopeni 4 %, neutropeni og anæmi <1 % hver).
English: Very common insomnia
Danish: Meget almindelig Søvnløshed
English: When adjusted for exposure, the incidence of first arterial occlusive events was greatest in the first two years of follow-up and declined with decreasing daily dose intensity (following recommendation for prospective dose reduction).
Danish: Efter justering for eksponering var hyppigheden af første arterielle okklusive hændelser højst de første to år af opfølgningsperioden og faldt i takt med reduktion af daglig dosis (efter anbefaling om prospektiv dosisreduktion).
English: Some patients experienced more than one type of event.
Danish: Nogle patienter oplevede mere end én type bivirkning.
English: What you need to know before you take Iclusig Do not take Iclusig
Danish: Det skal du vide, før du begynder at tage Iclusig Tag ikke Iclusig
English: In the event of significant worsening, labile or treatment-resistant hypertension, treatment should be interrupted and evaluation for renal artery stenosis should be considered.
Danish: I tilfælde af signifikant forværret, labil eller behandlingsresistent hypertension skal behandlingen afbrydes og vurdering af nyrearteriestenose overvejes.
English: CP -CML patients who achieved MCyR or MMR response within the first year of treatment had statistically significantly improved progression-free (PFS) and overall survival (OS) compared to those patients who did not meet the treatment milestones.
Danish: CP-CML-patienter, som opnåede MCyR eller MMR inden for det første behandlingsår, havde statistisk signifikant forbedret progressionsfri (PFS) og generel overlevelse (OS) sammenlignet med de patienter, som ikke nåede milepælene for behandlingen.
English: • an appropriate response to the treatment is reached
Danish: • du har reageret passende på behandlingen
English: Table 11 shows these data for patients who achieved MCyR and MMR at 45 mg; similar data are available for patients who achieved MCyR and MMR at 30 mg.
Danish: Tabel 11 viser disse data for patienter, som opnåede MCyR og MMR med 45 mg; lignende data foreligger for patienter, som opnåede MCyR og MMR med 30 mg.
English: Patients should be monitored for signs or symptoms consistent with heart failure and they should be treated as clinically indicated, including interruption of Iclusig.
Danish: Patienter skal overvåges for tegn og symptomer, der er forenelige med hjerteinsufficiens, og skal behandles som klinisk indiceret, herunder seponering af Iclusig.
English: Defined as a ≤ 0.1% ratio of BCR-ABL to ABL transcripts on the International Scale (IS) (ie, ≤ 0.1% BCR-ABLIS; patients must have the b2a2/b3a2 (p210) transcript),
Danish: Defineret som et ≤ 0,1 % forhold af BCR-ABL til ABL-transkripter på den internationale skala (IS) (dvs. ≤ 0,1 % BCR-ABLIS; patienter skal have b2a2/b3a2- (p210)
English: • recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Danish: • genopblussen (reaktivering) af hepatitis B-infektion, hvis du tidligere har haft hepatitis B (leverbetændelse type B)
English: A statistically significant increased incidence of squamous cell carcinoma of the clitoral gland was observed at that dose.
Danish: Der blev observeret en statistisk signifikant øget forekomst af pladecellekarcinom i glans clitoridis med denne dosis.
English: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 93055 Regensburg Germany
Danish: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 93055 Regensburg Tyskland
English: Data from the phase 2 trial are available on the maintenance of response (MCyR and MMR) in all CPCML patients who underwent dose reduction for any reason.
Danish: Der foreligger data fra fase 2-forsøget om opretholdelse af respons (MCyR og MMR) hos alle CPCML-patienter, hvor dosis af en eller anden grund blev reduceret.
English: In this kind of leukaemia, some of the DNA (genetic material) has become rearranged to form an abnormal chromosome, the Philadelphia chromosome.
Danish: I denne form for leukæmi, omdannes noget af DNA (arvemateriale) til et unormalt kromosom, Philadelphiakromosomet.
English: The probability of all patients with CP CML maintaining MCyR and MMR did not change further when the analysis was extended out to 5 years.
Danish: Sandsynligheden for opretholdelse af MCyR og MMR for alle patienter med CP-CML ændredes ikke, da analysen blev udvidet til 5 år.
English: Additionally, after approximately 2 years of follow-up, all patients who were still taking a 45 mg daily dose were recommended to undergo a dose reduction, even in the absence of adverse events, in response to the continued occurrence of vascular occlusive events in the clinical trial.
Danish: Efter ca. 2 års opfølgning blev alle patienter, som stadig fik en daglig dosis på 45 mg, desuden anbefalet at reducere dosis, også selvom de ikke havde bivirkninger, som reaktion på den fortsatte forekomst af vaskulære okklusive hændelser i det kliniske forsøg.
English: Ponatinib did not exhibit genotoxic properties when evaluated in the standard in vitro and in vivo systems.
Danish: Ponatinib havde ingen genotoksiske egenskaber, da det blev vurderet i standard in vitro- og in vivo-systemerne.
English: For the overall CP-CML disease group, the probability of survival at 2, 3, 4, and 5 years is estimated as 86.0%, 81.2%, 76.9%, and 73.3%, respectively, as shown in Figure 1.
Danish: For CP-CML-sygdomsgruppen generelt estimeres sandsynligheden for overlevelse efter hhv. 2, 3, 4 og 5 år at være 86,0 %, 81,2 %, 76,9 % og 73,3 %, som vist i figur 1.
English: Intrinsic factors affecting ponatinib pharmacokinetics No specific studies have been performed to evaluate the effects of gender, age, race, and body weight on ponatinib pharmacokinetics.
Danish: Reelle faktorer, der påvirker ponatinibs farmakokinetik Der er ikke udført specifikke studier for at vurdere virkningerne af køn, alder, race og legemsvægt på ponatinibs farmakokinetik.
English: Although plasma ponatinib exposures increased to steady-state levels with continuous dosing, a population pharmacokinetic analysis predicts a limited increase in apparent oral clearance within the first two weeks of continuous dosing, which is not considered clinically relevant.
Danish: Selv om plasmaeksponeringen af ponatinib øgedes til steady state-niveau ved kontinuerlig dosering, forudsiger en populationsfarmakokinetisk analyse en begrænset stigning i den tilsyneladende orale clearance inden for de første to uger med kontinuerlig dosering; dette anses ikke for at være klinisk relevant.
English: Before initiating Iclusig, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med Iclusig bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: Inform your doctor immediately if you experience these symptoms.
Danish: Kontakt lægen med det samme, hvis du får disse symptomer.
English: In a cell-based accelerated mutagenesis assay, no mutation in BCR-ABL was detected that could confer resistance to 40 nM ponatinib.
Danish: I en cellebaseret accelereret mutagenese-undersøgelse blev der ikke konstateret nogen mutation i BCR-ABL, som kunne påvise resistens over for 40 nM ponatinib.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 July 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 1. juli 2013 Dato for seneste fornyelse: 8. februar 2018
English: In the phase 2 trial, dose reductions were recommended following adverse events; in addition in October 2013 new recommendations for prospective dose reduction in all CP-CML patients in the absence of adverse events were introduced in this trial with the aim of reducing the risk of vascular occlusive events.
Danish: I fase 2-forsøget blev dosisreduktion anbefalet efter bivirkninger; endvidere blev der i oktober 2013 indført nye anbefalinger for prospektiv dosisreduktion hos alle CP-CML-patienter uden bivirkninger i dette forsøg med henblik på at reducere risikoen for vaskulære okklusive bivirkninger.
English: Caution should be exercised with concurrent use of Iclusig and moderate and strong CYP3A inhibitors and moderate and strong CYP3A inducers (see section 4.5).
Danish: Der skal udvises forsigtighed ved samtidig brug af Iclusig og moderate og stærke CYP3A-hæmmere samt moderate og stærke CYP3A-induktorer (se pkt.
English: Age Median, years (range) Gender, n (%) Male Race, n (%) Asian Black/African American White Other ECOG Performance Status, n (%) ECOG=0 or 1 Disease history Median time from diagnosis to first dose, years (range) Resistant to Prior TKI Therapy a *, n (%)
Danish: Alder Median, år (interval) Køn, n (%) Mand Race, n (%) Asiatisk Sort/afrikansk-amerikansk Hvid Andet ECOG Performance Status n (%) ECOG=0 eller 1 Anamnese Mediantid fra diagnose til første dosis, år (interval) Resistent over for tidligere TKI-behandlinga*, n (%) Tidligere TKI-behandling- antal regimer, n (%)
English: The anti-leukaemic activity of Iclusig was also evaluated in a phase 1 dose escalation study that included 65 CML and Ph+ ALL patients; the study is completed.
Danish: Iclusigs anti-leukæmiske aktivitet blev også evalueret i et fase 1-dosiseskaleringsstudie, hvor 65 patienter med CML og Ph+ ALL deltog; studiet er afsluttet.
English: Of the CP-CML patients with no mutation detected at entry, 49% (66/136) achieved a MCyR.
Danish: Ud af de CP-CML-patienter uden konstateret mutation ved indtræden i forsøget opnåede 49 % (66/136) et MCyR.
English: Posterior Reversible Encephalopathy Syndrome
Danish: Posteriort reversibelt encefalopati-syndrom
English: • you have a liver disorder.
Danish: • du har en leversygdom.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE24
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, protein-kinase-hæmmere, ATC-kode: L01XE24
English: At doses of 15 mg or greater, 32 of 34 patients (94%) demonstrated a ≥ 50% reduction of CRK-like (CRKL) phosphorylation, a biomarker of BCR-ABL inhibition, in peripheral blood mononuclear cells.
Danish: Ved doser på 15 mg eller derover viste 32 ud af 34 patienter (94 %) en ≥ 50 % reduktion af CRK-lignende (CRKL)-fosforylering, en biomarkør for BCR-ABL-hæmning, i perifere mononukleære celler i blod.
English: No human data on the effect of ponatinib on fertility are available.
Danish: Der foreligger ingen data vedrørende indvirkningen af ponatinib på human fertilitet.
English: A MCyR at the 3-month landmark correlated strongly and statistically significantly with PFS and OS (p<0.0001 and p=0.0006, respectively).
Danish: Et MCyR ved pejlemærket 3 måneder korrelerede stærkt og statistisk signifikant med PFS og OS (hhv. p<0,0001 og p=0,0006).
English: Incyte Biosciences Distribution B.V. Paasheuvelweg 25
Danish: Incyte Biosciences Distribution B.V.
English: Patients with estimated creatinine clearance of ≥ 50 mL/min should be able to safely receive Iclusig with no dosage adjustment.
Danish: Patienter med estimeret kreatinin-clearance på ≥ 50 ml/min bør uden risiko kunne tage Iclusig, uden der er foretaget dosisjustering.
English: Following a single oral dose of [14C]-labeled ponatinib, approximately 87% of the radioactive dose is recovered in the faeces and approximately 5% in the urine.
Danish: Efter oral enkeltdosis af [14C]-mærket ponatinib kunne ca. 87 % af den radioaktive dosis genfindes i fæces og ca. 5 % i urin.
English: In a patient suspected of developing an arterial occlusive event or a venous thromboembolism, Iclusig should be immediately interrupted.
Danish: Hvis det mistænkes, at en patient er ved at udvikle en arteriel okklusiv hændelse eller venøs tromboemboli, skal Iclusig omgående seponeres.
English: The risk of arterial occlusive events is likely to be dose-related.
Danish: Risikoen for arterielle okklusive hændelser er sandsynligvis dosisrelateret.
English: • narrowing of the blood vessels, poor blood circulation, sudden increase in blood pressure
Danish: • forsnævring af blodkarrene, dårligt kredsløb, pludselig forhøjelse af blodtrykket
English: If lipase elevations are accompanied by abdominal symptoms, Iclusig should be withheld and patients evaluated for evidence of pancreatitis (see section 4.2).
Danish: Hvis lipaseforhøjelser er ledsaget af abdominale symptomer, skal Iclusig seponeres, og patienterne skal undersøges for tegn på pancreatitis (se pkt.
English: In preclinical mutagenesis studies, 40 nM was determined as the concentration of ponatinib sufficient to inhibit viability of cells expressing all tested BCR-ABL mutants by > 50% (including T315I) and suppress the emergence of mutant clones.
Danish: I prækliniske mutagenese-studier blev 40 nM fastlagt som koncentrationen af ponatinib, som var tilstrækkelig til at hæmme levedygtigheden af celler, der eksprimerer alle testede BCR-ABL-mutanter med > 50 % (herunder T315I) og undertrykke udviklingen af mutante kloner.
English: Patients should be advised not to swallow the desiccant canister found in the bottle.
Danish: Patienterne bør informeres om, at de ikke må synke den dåse med tørremiddel, som findes i flasken.
English: The 0.8 mg/kg/day dose in females resulted in a plasma exposure level generally lower or equivalent to the human exposure at the range of dose from 15 mg to 45 mg daily.
Danish: Dosen på 0,8 mg/kg/dag til hunrotter medførte et plasmaeksponeringsniveau, som generelt var lavere end eller svarende til human eksponering i dosisintervallet 15 mg til 45 mg dagligt.
English: • The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 4000, polyvinyl alcohol, titanium dioxide (E171).
Danish: • Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, natriumstivelsesglycolat, silica (kolloid vandfri), magnesiumstearat, talkum, macrogol 4000, polyvinylalkohol, titandioxid (E171).
English: Iclusig should be continued at the same dose
Danish: Fortsæt Iclusig med samme dosis
English: Co-administration of strong CYP3A4 inducers such as carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, and St. John's Wort with ponatinib should be avoided, and alternatives to the CYP3A4 inducer should be sought, unless the benefit outweighs the possible risk of ponatinib underexposure.
Danish: Samtidig administration af potente CYP3A4-induktorer som f.eks. carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin og perikon med ponatinib bør undgås, og alternativer til CYP3A4-induktorer bør søges, medmindre fordelen opvejer den mulige risiko for undereksponering af ponatinib.
English: Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity studies.
Danish: Iclusig er vurderet i studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, reproduktionstoksicitet, fototoksicitet og karcinogenicitet.
English: With a minimum follow-up of 64 months, 3.4% (9/267) of CP-CML patients experienced transformation of their disease to AP-CML or BP-CML.
Danish: Med en minimumopfølgning på 64 måneder oplevede 3,4 % (9/267) af CP-CML-patienterne transformation af deres sygdom til AP-CML eller BP-CML.
English: Statistical significance was achieved in the correlation of PFS and OS with a MCyR at the 12-month landmark (p=<0.0001 and p=0.0012, respectively).
Danish: Statistisk signifikans blev opnået i korrelationen mellem PFS og OS med et MCyR ved pejlemærket 12 måneder (hhv. p=<0,0001 og p=0,0012).
English: Unchanged ponatinib accounted for 24% and < 1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites.
Danish: Uomdannet ponatinib stod for hhv. 24 % og < 1 % af den administrerede dosis i fæces og urin, mens resten af dosis bestod af metabolitter.
English: PRES is a neurological disorder that can present with signs and symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances.
Danish: PRES er en neurologisk lidelse, som kan optræde med tegn og symptomer i form af krampeanfald, hovedpine, nedsat opmærksomhed, ændrede mentale evner, synstab og andre visuelle og neurologiske forstyrrelser.
English: Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triple-bond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase.
Danish: Ponatinib er en potent pan-BCR-ABL-hæmmer med strukturelle elementer, herunder en tredobbelt kulstof-kulstof-binding, som muliggør høj affinitetsbinding til naturligt forekommende BCR-ABL og mutante former for ABL-kinase.
English: The most common serious adverse reactions >2% (treatment-emergent frequencies) were pneumonia (7.3%), pancreatitis (5.8%), abdominal pain (4.7%), atrial fibrillation (4.5%), pyrexia (4.5%), myocardial infarction (4.0%), peripheral arterial occlusive disease (3.8%), anaemia (3.8%), angina pectoris (3.3%), platelet count decreased (3.1%), febrile neutropenia (2.9%), hypertension (2.9%), coronary artery disease (2.7%), cardiac failure congestive (2.4%), cerebrovascular accident (2.4%), sepsis (2.4%), cellulitis (2.2%), acute kidney injury (2.0%), urinary tract infection (2.0%) and lipase increased (2.0%).
Danish: De hyppigste alvorlige bivirkninger > 2 % (behandlingsrelaterede hyppigheder) var pneumoni (7,3 %), pancreatitis (5,8 %), abdominalsmerter (4,7 %), atrieflimren (4,5 %), pyreksi (4,5 %), myokardieinfarkt (4,0 %), perifer arteriel okklusiv sygdom (3,8 %), anæmi (3,8 %), angina pectoris (3,3 %), nedsat trombocyttal (3,1 %), febril neutropeni (2,9 %), hypertension (2,9 %), koronararteriesygdom (2,7 %), kongestiv hjerteinsufficiens (2,4 %), cerebrovaskulær hændelse (2,4 %), sepsis (2,4 %), cellulitis (2,2 %), akut nyreskade (2,0 %), urinvejsinfektion (2,0 %) og forhøjet lipase (2,0 %).
English: With once-daily dosing, plasma exposures of ponatinib are increased by approximately 1.5-fold between first dose and steady state conditions.
Danish: Med en dosis én gang dagligt øges plasmaeksponeringerne for ponatinib ca. 1,5 gang mellem første dosis og steady state tilstande.
English: Evidence for pre- and post-implantation loss of embryos was reported in female rats and ponatinib may therefore impair female fertility.
Danish: Der blev rapporteret evidens for tab af embryoer før og efter implantation hos hunrotter, og ponatinib kan derfor forringe fertiliteten hos hunner.
English: Iclusig should be interrupted immediately in case of arterial occlusion.
Danish: Iclusig skal omgående seponeres i tilfælde af arteriel okklusion.
English: In vitro data showed no difference in plasma protein binding in plasma samples of healthy subjects and hepatically impaired (mild, moderate and severe) subjects.
Danish: In vitro-data viste ingen forskel i plasmaproteinbinding i plasmaprøver fra raske forsøgspersoner og patienter med nedsat leverfunktion (let, moderat og svært).
English: Treatment-emergent hypertension (including hypertensive crisis) occurred in Iclusig-treated patients.
Danish: Behandlingsrelateret hypertension (herunder hypertensiv krise) er forekommet hos Iclusig-behandlede patienter.
English: Iclusig has not been studied at doses above 30 mg in patients with hepatic impairment (Childs-Pugh Classes A, B & C).
Danish: Iclusig er ikke undersøgt ved doser over 30 mg hos patienter med nedsat leverfunktion (Child-Pughklasse A, B og C).
English: Iclusig use may be resumed at the same, or a reduced dose, after the event is resolved or controlled.
Danish: Behandlingen med Iclusig kan genoptages med den samme eller en nedsat dosis, når bivirkningen er ophørt eller under kontrol.
English: The geometric mean (CV%) Cmax and AUC(0-τ) exposures achieved for ponatinib 45 mg daily at steady state were 77 ng/mL (50%) and 1296 ng•hr/mL (48%), respectively.
Danish: De geometriske gennemsnitlige (CV %) Cmax- og AUC(0-τ)-eksponeringer, opnået for ponatinib 45 mg dagligt ved steady state, var hhv. 77 ng/ml (50 %) og 1296 ng•t/ml (48 %).
English: Table 4 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class
Danish: Tabel 4 Bivirkninger observeret hos CML- og Ph+ ALL-patienter - hyppighed er rapporteret efter forekomst af behandlingsopståede bivirkninger Systemorganklasse
English: For CP-CML patients overall (N=267), as well as for CP-CML R/I Cohort A patients (N=203) and T315I Cohort B patients (N=64), the median OS has not yet been reached.
Danish: For CP-CML-patienter generelt (N=267) samt for CP-CML R/I kohorte A-patienter (N=203) og T3151 kohorte B-patienter (N=64) er median OS endnu ikke nået.
English: Reducing the dose of Iclusig to 15 mg should be considered for CP-CML patients who have achieved a major cytogenetic response taking the following factors into account in the individual patient assessment: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels (see sections 4.4 and 5.1).
Danish: Reduktion af dosis til 15 mg Iclusig bør overvejes til CP-CML-patienter, der har opnået major cytogenetisk respons, idet følgende faktorer tages i betragtning ved vurdering af den enkelte patient: kardiovaskulær risiko, bivirkninger ved ponatinib-behandling, tid til cytogenetisk respons og BCR-ABL-transkriptniveau (se pkt.
English: 6.6 Special precautions for disposal and other handling Disposal
Danish: 6.6 Regler for bortskaffelse og anden håndtering
English: • diarrhoea, vomiting, nausea
Danish: • diarré, opkastning, kvalme
English: Patients should be warned to immediately report suspected skin reactions, especially if associated with blistering, peeling, mucosal involvement or systemic symptoms.
Danish: Patienterne skal advares om straks at indberette formodede hudreaktioner, især hvis de er forbundet med blæredannelse, afskalning, omfatter slimhinderne eller systemiske symptomer.
English: • blood infection
Danish: • blodforgiftning