FrancophonIA/ELRC3.0 huggingface dataset:
English: - the risks of CRS and serious neurologic adverse reactions, associated with YESCARTA - the need to report the symptoms to their treating doctor immediately - the need to remain in the proximity of the location where YESCARTA was received for at least 4 weeks following YESCARTA infusion - the need to carry the patient alert card at all times
Danish: For at informere og forklare patienterne om risiciene for CRS og andre alvorlige neurologiske bivirkninger forbundet med YESCARTA nødvendigheden af omgående at rapportere symptomerne til deres behandlende læge nødvendigheden af at blive nær klinikken, hvor YESCARTA blev givet, i mindst 4 uger efter infusion af YESCARTA nødvendigheden af altid at medbringe patientinformationskortet
English: This medicine contains genetically-modified cells.
Danish: Dette lægemiddel indeholder genetisk modificerede celler.
English: • For autologous use only.
Danish: • Udelukkende til autolog anvendelse.
English: Pregnancy after YESCARTA therapy should be discussed with the treating physician.
Danish: Graviditet efter behandling med YESCARTA skal diskuteres med den behandlende læge.
English: At the 24-month follow-up analysis, these 3 patients remained in CR at 30 to 35 months after YESCARTA infusion.
Danish: Ved 24-måneders opfølgningsanalysen udviste disse 3 patienter stadig CR 30 til 35 måneder efter infusion af YESCARTA.
English: In addition, administer dexamethasone 10 mg intravenously with the first dose of tocilizumab and repeat dose every 6 hours.
Danish: Administrér endvidere dexamethason 10 mg intravenøst med den første dosis tocilizumab og gentag dosen hver 6. time.
English: The most significant and frequently occurring adverse reactions were CRS (93%), encephalopathy (58%), and infections (39%).
Danish: De mest signifikante og hyppigst forekommende bivirkninger var CRS (93 %), encefalopati (58 %) og infektioner (39 %).
English: Monitor patients life-long for secondary malignancies.
Danish: Monitorér patienterne hele livet for sekundære maligniteter.
English: • Prime the tubing with 0.9% sodium chloride solution (0.154 mmol sodium per mL) prior to infusion.
Danish: • Skyl slangerne med 0,9 % natriumchloridopløsning (0,154 mmol natrium pr. ml) inden infusion.
English: 6 month OS (%) [95% CI] 9 month OS (%) [95% CI] 12 month OS (%) [95% CI]
Danish: OS efter 6 måneder (%) [95% KI] OS efter 9 måneder (%) [95% KI] OS efter 12 måneder (%) [95% KI] OS efter 24 måneder (%) [95% KI]
English: • Chills, extreme tiredness, weakness, dizziness, headache, cough, shortness of breath, or rapid heartbeat, which may be symptoms of a condition known as cytokine release syndrome.
Danish: • Kulderystelser, ekstrem træthed, svaghed, svimmelhed, hovedpine, hoste, åndenød eller hurtig puls, som kan være symptomer på en tilstand, der kaldes cytokin release syndrom.
English: Grade 3 or higher unspecified pathogen, bacterial, and viral infections occurred in 19%, 9%, and 6% of patients respectively.
Danish: grad 3 eller højere uspecificerede patogene, bakterielle og virale infektioner forekom hos hhv. 19 %, 9 % og 6 % af patienterne.
English: A causal relationship between spinal cord lesions and axicabtagene ciloleucel was confirmed, based on the evidence from two clinical trial cases; one case with an event of quadriplegia (in the setting of myelitis) and second case with events of muscular weakness and leukoencephalopathy, and one spontaneous case report with an event of spinal cord oedema.
Danish: En årsagssammenhæng mellem rygmarvslæsioner og axicabtagene ciloleucel blev bekræftet på baggrund af evidensen fra to tilfælde i kliniske studier, hvoraf det ene tilfælde var en hændelse med tetraplegi (i forbindelse med myelitis) og det andet tilfælde var hændelser med muskelsvækkelse og leukoencefalopati, samt én spontan indberetning af et tilfælde med rygmarvsødem.
English: These include the use of tocilizumab (if concurrent CRS) and/or corticosteroids for moderate, severe, or life-threatening neurologic adverse reactions as summarised in Table 2.
Danish: Disse inkluderer anvendelse af tocilizumab (i tilfælde af samtidig CRS) og/eller kortikosteroider til behandling af moderate, alvorlige eller livstruende neurologiske bivirkninger, som opsummeret i Tabel 2.
English: This sequence of events leads to apoptosis and necrosis of CD19-expressing target cells.
Danish: Denne signaleringskaskade fører til apoptose og nekrose af målceller, som udtrykker CD19.
English: In the primary analysis, based on the mITT population (minimum follow up of 6 months) the ORR was 72% and the complete response (CR) rate was 51%, as determined by an independent review committee.
Danish: I den primære analyse, der var baseret på mITT-populationen (minimum opfølgning på 6 måneder), var ORR 72 %, og raten af fuldstændigt respons (CR) var 51 %, vurderet af en uafhængig bedømmelseskomité.
English: After you are given YESCARTA
Danish: Efter du har fået YESCARTA
English: The 24-month analysis had a median follow-up of 27.1 months.
Danish: 24-måneders analysen havde en gennemsnitlig opfølgning på 27,1 måned.
English: Oxygen requirement less than 40% FiO2 or hypotension responsive to fluids or low dose of one vasopressor or Grade 2 organ toxicity (b).
Danish: Iltbehov er mindre end 40 % FiO2, eller hypotension er responsiv over for væske, eller en lavdosis af én vasopressor, eller grad 2 organtoksicitet (b).
English: The median dose was 2.0 x 106 anti-CD19 CAR T cells/kg.
Danish: Den gennemsnitlige dosis var 2,0 x 106 anti-CD19 CAR T-celler/kg.
English: Dysphagia*
Danish: Dysfagi*
English: The other ingredients (excipients) are: Cryostor CS10, sodium chloride, human albumin.
Danish: Øvrige indholdsstoffer (hjælpestoffer): Cryostor CS10, natriumchorid, humant albumin.
English: YESCARTA is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
Danish: YESCARTA er indiceret til behandling af voksne patienter med recidiveret eller refraktært diffust storcellet B-celle lymfom (DLBCL) og primært mediastinalt storcellet B-celle lymfom (PMBCL) efter to eller flere andre systemiske behandlinger.
English: Tumour necrosis factor (TNF) antagonists are not recommended for management of YESCARTA-associated CRS.
Danish: Antagonister for tumornekrosefaktor (TNF) anbefales ikke til behandling af CRS forbundet med YESCARTA.
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
English: • Check that the patient information on the cassette label matches that on the bag label.
Danish: • Kontrollér at patientens information på etiketten på kassetten matcher informationen på etiketten på posen.
English: Median AUCDay 0-28 in responding patients (N = 71) was 253% of the corresponding level in nonresponders (N = 25) (562.0 days x cells/μL versus 222.0 days x cells/μL).
Danish: Gennemsnitlig AUCDag 0-28 hos patienter med respons (N = 71) var 253 % af det tilsvarende niveau hos ikke-responderende patienter (N = 25) (562,0 dage x celler/mikrol versus 222,0 dage x celler/mikrol).
English: Serious adverse reactions that may be associated with CRS included acute kidney injury, atrial fibrillation, ventricular tachycardia, cardiac arrest, cardiac failure, capillary leak syndrome, hypotension, hypoxia, and HLH/MAS.
Danish: Alvorlige bivirkninger, der kan være forbundet med CRS, inkluderede akut nyreskade, atrieflimren, ventrikeltakykardi, hjertestop, hjertesvigt, kapillær lækagesyndrom, hypotension, hypoxi og HLH/MAS.
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Danish: Ikke anvendt lægemiddel skal bortskaffes i overensstemmelse med lokale retningslinjer vedrørende biosikkerhed.
English: Non-interventional post-authorisation safety study (PASS): In order to assess the safety profile including long term safety in patients with B-lymphocyte malignancies treated with axicabtagene ciloleucel in the post marketing setting, the applicant should conduct and submit a study based on a registry.
Danish: Ikke-interventionelle sikkerhedsstudier efter tilladelse til markedsføring (PASS): Ansøgeren skal udføre og indsende et studie baseret på et register med henblik på at vurdere sikkerhedsprofilen, inklusive den langsigtede sikkerhed hos patienter med B-lymfocytmaligniteter, der er behandlet med axicabtagene ciloleucel efter markedsføring.
English: The DOR was longer in patients who achieved CR compared to patients with a best response of PR (Table 5).
Danish: DOR var længere hos patienter, som opnåede CR, sammenlignet med patienter, hvis bedste respons var PR (Tabel 5).
English: Of the 55 patients who achieved CR, 7 patients had SD and 10 had PR at their initial tumour assessment and converted to CR as late as 12 months after YESCARTA infusion.
Danish: Af de 55 patienter, som opnåede CR, havde 7 patienter SD, og 10 havde PR ved deres første tumorvurdering og konverterede til CR så sent som 12 måneder efter infusion af YESCARTA.
English: Administer dexamethasone 10 mg intravenously every 6 hours.
Danish: Administrér dexamethason 10 mg intravenøst hver 6. time.
English: Serious adverse reactions including encephalopathy (22%), aphasia (4%), delirium (4%), and seizures (1%) have been reported in patients administered YESCARTA.
Danish: Alvorlige bivirkninger, herunder encefalopati (22 %), afasi (4 %), delirium (4 %), og krampeanfald (1 %), er blevet rapporteret hos patienter, som har fået YESCARTA.
English: Ethylene-vinyl acetate cryostorage bag with sealed addition tube and two available spike ports, containing approximately 68 mL of cell dispersion.
Danish: Ethylen-vinylacetat frysepose med forseglet tillægsslange og to tilgængelige studser indeholdende cirka 68 ml celledispersion.
English: • After the entire content of the bag is infused, rinse the tubing at the same infusion rate with 0.9% sodium chloride solution (0.154 mmol sodium per mL) to ensure all YESCARTA is delivered.
Danish: • Efter infusion af hele posens indhold, skylles slangen med 0,9 % natriumchloridopløsning (0,154 mmol natrium pr. ml) ved samme infusionshastighed for at sikre, at al YESCARTA er indgivet.
English: The median time to onset was 2 days (range: 1 to 12 days) and the median duration was 7 days (range: 2 to 29 days).
Danish: Den gennemsnitlige tid til symptomstart var 2 dage (mellem 1 og 12 dage) og den gennemsnitlige varighed var 7 dage (interval: 2 til 29 dage).
English: Duration of Responsea, median (range) in months
Danish: Varighed af responsa, gennemsnit (tidsinterval) i måneder
English: Prolonged cytopenias
Danish: Langvarige cytopenier
English: The median time to response was 1.0 months (range: 0.8 to 6.3 months).
Danish: Den gennemsnitlige tid til respons var 1,0 måned (tidsinterval: 0,8 til 6,3 måneder).
English: The most common serious adverse reactions included encephalopathy (22%), unspecified pathogen infections (16%), bacterial infections (6%), febrile neutropenia (6%), viral infections (5%), and pyrexia (5%).
Danish: De mest almindelige alvorlige bivirkninger inkluderede encefalopati (22 %), uspecificerede patogene infektioner (16 %), bakterielle infektioner (6 %), febril neutropeni (6 %), virale infektioner (5 %) og pyreksi (5 %).
English: The stability of YESCARTA upon completion of thawing is up to 3 hours at room temperature (20 ˚C to 25 °C).
Danish: Stabiliteten af YESCARTA efter fuld optøning er op til 3 timer ved stuetemperatur (20 °C - 25 °C).
English: - have had hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
Danish: - Har haft infektion med hepatitis B-, hepatitis C- eller human immundefekt virus- (hiv).
English: In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.
Danish: I tilfælde af febril neutropeni, evalueres patienten for infektioner og behandles med bredspektrede antibiotika, væske og anden støttende behandling, som medicinsk indiceret.
English: One sterile infusion bag.
Danish: En steril infusionspose.
English: 6229 EV Maastricht The Netherlands
Danish: 6229 EV Maastricht Nederlandene
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer).
English: Oxygen requirement greater than or equal to 40% FiO2 or hypotension requiring high-dose or multiple vasopressors or Grade 3 organ toxicity or Grade 4 transaminitis.
Danish: Iltbehov større end eller svarende til 40 % FiO2, eller hypotension der kræver en højdosis eller flere forskellige vasopressorer, eller grad 3 organtoksicitet, eller grad 4 transaminitis.
English: There is limited experience with YESCARTA in patients exposed to prior CD19-directed therapy.
Danish: Der er begrænset erfaring med YESCARTA hos patienter, der er eksponeret for tidligere CD19-rettet behandling.
English: Your healthcare professional handling YESCARTA will therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases and will follow local biosafety guidelines to clean up or dispose of any material that has been in contact with YESCARTA.
Danish: Det sundhedspersonale, der håndterer YESCARTA, vil derfor tage passende forholdsregler (bruge handsker og øjenværn) for at undgå en mulig overførsel af smitsomme sygdomme og vil følge lokale retningslinjer for biosikkerhed, når de skal rengøre eller bortskaffe materiale, der har været i kontakt med YESCARTA.
English: Gently mix the contents of the bag to disperse clumps of cellular material.
Danish: Omryst forsigtigt posens indhold for at opløse klumper af cellemateriale.
English: A minimum of four doses of tocilizumab for use in the event of cytokine release syndrome (CRS) and emergency equipment must be available prior to infusion of YESCARTA.
Danish: Der skal være mindst fire doser tocilizumab og nødudstyr til rådighed i tilfælde af cytokin release syndrom (CRS) inden infusion af YESCARTA.
English: 6229EV Maastricht The Netherlands
Danish: 6229EV Maastricht Nederlandene
English: YESCARTA was administered as a single infusion at a target dose of 2 x 106 anti-CD19 CAR T cells/kg after lymphodepleting chemotherapy regimen of 500 mg/m2 intravenous cyclophosphamide and 30 mg/m2 intravenous fludarabine on the 5th, 4th, and 3rd day before YESCARTA.
Danish: YESCARTA blev administreret som en enkelt infusion med en måldosis på 2 x 106 anti-CD19 CAR T-celler/kg efter lymfocytdepleterende kemoterapibehandling med 500 mg/m2 intravenøs cyclophosphamid og 30 mg/m2 intravenøs fludarabin på 5., 4. og 3. dagen inden behandling med YESCARTA.
English: The median anti-CD19 CAR T cell Cmax level in responders (N = 71) was 216% higher compared to the corresponding level in nonresponders (N = 25) (43.6 cells/μL versus 20.2 cells/μL).
Danish: Det gennemsnitlige anti-CD19 CAR T-celle Cmax niveau hos responderende patienter (N = 71) var 216 % højere sammenlignet med det tilsvarende niveau hos ikke-responderende patienter (N = 25) (43,6 celler/mikrol versus 20,2 celler/mikrol).
English: Following anti-CD19 CAR T-cell engagement with CD19 expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signalling cascades that lead to T-cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines.
Danish: Når anti-CD19 CAR T-cellerne binder til kræftcellerne, som udtrykker CD19, aktiverer de co-stimulerende domæner CD28 og CD3-zeta downstream signaleringsveje, som medfører T-celle-aktivering, proliferation, erhvervelse af effektorfunktioner samt udskillelse af inflammatoriske cytokiner og kemokiner.
English: Any unused medicine or waste material must be disposed of in accordance with local biosafety guidelines.
Danish: Ikke anvendt lægemiddel eller affaldsmateriale skal bortskaffes i overensstemmelse med lokale retningslinjer vedrørende biosikkerhed.
English: • After the first 10 days following the infusion, the patient should be monitored at the physician's discretion.
Danish: • Efter de første 10 dage efter infusionen skal patienten monitoreres efter lægens skøn.
English: Cardiac arrest Cardiac failure
Danish: Hjertestop Hjertesvigt
English: • The YESCARTA bag must not be removed from the cassette if the information on the patientspecific label does not match the intended patient.
Danish: • Posen med YESCARTA må ikke tages ud af kassetten, hvis oplysningerne på den patientspecifikke etiket ikke matcher den tilsigtede patient.
English: Do not infuse YESCARTA if the information on the patient-specific label does not match the intended patient.
Danish: YESCARTA må ikke indgives, hvis oplysningerne på den patientspecifikke etiket ikke matcher den tiltænkte patient.
English: At the 12-month follow-up analysis, 3 patients remained in CR 24 months after YESCARTA infusion.
Danish: Ved 12-måneders opfølgningsanalysen udviste 3 patienter stadig CR 24 måneder efter infusion af YESCARTA.
English: Serious infections have been very commonly observed with YESCARTA (see section 4.8).
Danish: Alvorlige infektioner er blevet observeret til at være meget almindelige med YESCARTA (se pkt.
English: Dehydration Decreased appetite Hypophosphataemia Hyponatraemia Weight decrease
Danish: Dehydrering Nedsat appetit Hypofosfatæmi Hyponatriæmi Vægttab
English: Monitor blood counts after YESCARTA infusion.
Danish: Monitorér blodtal efter infusion af YESCARTA.
English: YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy.
Danish: YESCARTA (axicabtagene ciloleucel) er en genetisk modificeret autolog T-celle-immunterapi målrettet mod CD19.
English: A single dose of YESCARTA contains 2 x 106 CAR-positive viable T cells per kg of body weight (or maximum of 2 x 108 CAR-positive viable T cells for patients 100 kg and above) in approximately 68 mL dispersion in an infusion bag.
Danish: En enkelt dosis YESCARTA indeholder 2 x 106 CAR-positive, levedygtige T-celler pr. kg legemsvægt (eller maksimum 2 x 108 CAR-positive, levedygtige T-celler til patienter, der vejer 100 kg og derover) i cirka 68 ml dispersion i en infusionspose.
English: See section 4.4 for management guidance.
Danish: 4.4 for vejledning vedrørende behandling.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (kan påvirke op til 1 ud af 10 personer).
English: The median time to response was 1.0 months (range: 0.8 to 12.2 months).
Danish: Gennemsnitstiden til respons var 1,0 måned (tidsinterval: 0,8 til 12,2 måneder).
English: - Headache, depressed level of consciousness, difficulty in speaking, agitation, shaking.
Danish: Hovedpine, reduceret bevidsthedsniveau, talebesvær, ophidselse, rysten.
English: Cytokine Release Syndrome Hypogammaglobulinaemia
Danish: Cytokin release syndrom Hypogammaglobulinæmi
English: YESCARTA contains genetically modified human blood cells.
Danish: YESCARTA indeholder genetisk modificerede humane blodceller.
English: Administer methylprednisolone 1000 mg intravenously per day with first dose of tocilizumab and continue methylprednisolone 1000 mg intravenously per day for 2 more days; if improves, then manage as above.
Danish: Administrér methylprednisolon 1000 mg intravenøst dagligt med den først dosis tocilizumab og fortsæt methylprednisolon 1000 mg intravenøst dagligt i yderligere 2 dage; ved bedring behandles som beskrevet ovenfor.
English: Local biosafety guidelines should be followed for unused medicine or waste material.
Danish: Gældende lokale retningslinjer vedrørende biosikkerhed skal følges med hensyn til ikke anvendt lægemiddel eller affaldsmateriale.
English: During the 30 to 60 minutes before you are given YESCARTA you may be given other medicines.
Danish: Du kan få andre lægemidler inden for de 30 til 60 minutter, før du får YESCARTA.
English: - Shortness of breath, cough.
Danish: Åndenød, hoste.
English: Kite Pharma EU B.V. Tufsteen 1
Danish: Kite Pharma EU B.V.
English: Package leaflet: Information for the patient YESCARTA 0.4 - 2 x 108 cells dispersion for infusion axicabtagene ciloleucel (CAR+ viable T cells) This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten YESCARTA, 0,4 - 2 x 108 celler infusionsvæske, dispersion axicabtagene ciloleucel (CAR+ levedygtige T-celler) Dette lægemiddel er underlagt supplerende overvågning.
English: The most common Grade 3 or higher adverse reactions included encephalopathy (31%), unspecified pathogen infections (19%), CRS (11%), bacterial infection (9%), aphasia (7%), viral infection (6%), delirium (6%), hypotension (6%), and hypertension (6%).
Danish: De mest almindelige bivirkninger af grad 3 eller højere inkluderede encefalopati (31 %), uspecificeret patogen infektioner (19 %), CRS (11 %), bakteriel infektion (9 %), afasi (7 %), viral infektion (6 %), delirium (6 %), hypotension (6 %) og hypertension (6 %).
English: Treatment algorithms have been developed to ameliorate some of the CRS symptoms experienced by patients on YESCARTA.
Danish: Behandlingsalgoritmer er blevet udviklet for at modvirke nogle af CRS-symptomerne, som patienter i behandling med YESCARTA kan opleve.
English: Studies of YESCARTA in patients with hepatic and renal impairment were not conducted.
Danish: Der blev ikke udført studier med YESCARTA hos patienter med nedsat lever- og nyrefunktion.
English: The most common signs or symptoms associated with CRS included pyrexia (83%), hypotension (44%), tachycardia (24%), hypoxia (23%), and chills (20%).
Danish: De mest almindelige tegn og symptomer forbundet med CRS inkluderede pyreksi (83 %), hypotension (44 %), takykardi (24 %), hypoxi (23 %) og kulderystelser (20 %).
English: Lonza Netherlands B.V. Oxfordlaan 70
Danish: Lonza Netherlands B.V.
English: CRS has been known to be associated with end organ dysfunction (e.g., hepatic, renal, cardiac, and pulmonary).
Danish: CRS vides at være forbundet med organsvigt (f.eks. lever, nyrer, hjerte og lunger).
English: There is no experience of use of YESCARTA in patients with primary CNS lymphoma.
Danish: Der er ingen erfaringer med YESCARTA til patienter med primært CNS-lymfom.
English: Healthcare professionals handling YESCARTA should take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Danish: Sundhedspersonale, der håndterer YESCARTA, skal tage hensigtsmæssige forholdsregler (bruge handsker og øjenværn) for at undgå mulig overførsel af smitsomme sygdomme.
English: • Once the patient ID is confirmed, remove the YESCARTA bag from the cassette.
Danish: • Når patientens ID er bekræftet, tages posen med YESCARTA ud af kassetten.
English: For special precautions for disposal, see section 6.6.
Danish: For særlige forholdsregler ved bortskaffelse, se pkt.
English: The PRAC considers that the product information of axicabtagene ciloleucel containing products should be amended to reflect the risk of dysphagia associated with axicabtagene ciloleucel therapy.
Danish: PRAC vurderer, at produktinformationen for præparater, der indeholder axicabtagene ciloleucel, skal opdateres for at afspejle risikoen for dysfagi i forbindelse med behandling med axicabtagene ciloleucel.
English: The pregnancy status of women of child bearing potential must be verified before starting YESCARTA treatment.
Danish: Graviditetsstatus hos fertile kvinder skal bekræftes inden start af behandling med YESCARTA.
English: • Verify that the patient's identity (ID) matches the patient identifiers on the YESCARTA cassette.
Danish: • Kontrollér at patientens identitet (ID) matcher patientens identifikatorer på YESCARTAkassetten.
English: Prolonged (still present at Day 30 or with an onset at Day 30 or beyond) Grade 3 or higher neutropenia, thrombocytopenia, and anaemia occurred in 26%, 24%, and 10% of patients, respectively.
Danish: Langvarig (som stadig er til stede efter dag 30 eller med start på dag 30 eller senere) grad 3 eller højere neutropeni, trombocytopeni og anæmi forekom hos hhv. 26 %, 24 % og 10 % af patienterne.