FrancophonIA/ELRC3.0 huggingface dataset:
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction.
Danish: I tilfælde, hvor der er brug for et hurtigere respons af behandlingen, kan regimet 160 mg i uge 0 (dosis kan administreres som fire injektioner på en dag eller som to injektioner pr. dag i to på hinanden følgende dage), 80 mg i uge 2, anvendes med erkendelse af, at risikoen for bivirkninger er højere under induktionen.
English: Table 10: Maintenance of Clinical Remission and Response (Percent of Patients)
Danish: Tabel 10: Vedligeholdelse af Klinisk Remission og Respons (Procent af Patienter)
English: Methotrexate should be continued during treatment with Trudexa.
Danish: Der fortsættes med methotrexat under behandling med Trudexa.
English: Psoriatic arthritis clinical trials: elevations in ALT were more common in psoriatic arthritis patients (Studies VI-VII) compared with patients in rheumatoid arthritis clinical studies.
Danish: Psoriasisartritforsøg: Forhøjede ALAT-værdier forekom oftere hos patienter med psoriasisartrit (forsøg VI-VII) end hos patienter med reumatoid artrit i kliniske forsøg.
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I − V. In these trials, 11.9% of patients treated with Trudexa and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Danish: Patienter fik testet serumprøver for autoantistoffer på forskellige tidspunkter i reumatoid artrit forsøgne I-V. I disse havde 11,9% af de Trudexa-behandlede patienter og 8,1% af de placebo- og aktiv kontrolbehandlede patienter med negative antinukleære antistoftitere ved baseline positive titere efter 24 uger.
English: These trials included rheumatoid arthritis patients with short term and long standing disease as well as psoriatic arthritis, ankylosing spondylitis and Crohn's disease patients.
Danish: Disse forsøg omfattede både patienter med reumatoid artrit med kortere og længere sygdomsforløb og patienter med psoriasisartrit, ankyloserende spondylitis og Crohns sygdom.
English: In the twelve controlled trials, 16% of patients treated with Trudexa developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 10% of patients receiving placebo or active control.
Danish: I de tolv kontrollerede forsøg havde 16% af de patienter, som blev behandlet med Trudexa, reaktioner ved injektionsstedet (erythem og/eller kløe, blødning, smerter eller hævelse) sammenlignet med 10% af de patienter, som fik placebo eller aktiv kontrol.Reaktioner ved injektionsstedet gjorde det normalt ikke nødvendigt at indstille behandlingen med lægemidlet.
English: • Shortness of breath with exertion or upon lying down or swelling of the feet;
Danish: • Stakåndethed ved fysisk anstrengelse eller når De ligger ned, eller hævede fødder;
English: In patients with early rheumatoid arthritis (disease duration of less than 3 years) (Study V), elevations of ALT were more common in the combination arm (Trudexa /methotrexate) compared to the methotrexate monotherapy arm or the Trudexa monotherapy arm.
Danish: Hos patienter med tidlig reumatoid artrit (sygdomsvarighed på mindre end 3 år) (forsøg 5) forekom forhøjede ALAT-værdier oftere i kombinationsarmen (Trudexa/methotrexat) end i methotrexatmonoterapiarmen eller Trudexa-monoterapiarmen.
English: Trudexa has not been studied in these patient populations.
Danish: Trudexa er ikke undersøgt i disse patientpopulationer, hvor dosisanbefaling ikke kan gives.
English: In patients with ankylosing spondylitis antibodies were identified in 17/204 subjects (8.3%) treated with adalimumab.
Danish: Hos patienter med ankyloserende spondylitis blev der påvist antistoffer hos 17/204 patienter (8,3 %) behandlet med adalimumab.
English: Rare thyroid disorder (including goitre)
Danish: Sjælden thyreoideasygdom (herunder struma)
English: Trudexa/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 5).
Danish: Der blev observeret en significant mindre radiografisk progression hos Trudexa-/methotrexatpatienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 5).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)SUBCUTANEOUS USE Subkutan anvendelse
English: The observed rate of nonmelanoma skin cancers is approximately 9.0 per 1000 patient years, and the observed rate of lymphomas is approximately 1.2 per 1000 patient years.
Danish: Den fundne hyppighed af ikke-melanom hudkræft er cirka 9,0 pr. 1000 patient-år og den fundne hyppighed af lymfomer er cirka 1,2 pr. 1000 patient-år.
English: Psoriatic arthritis and ankylosing spondylitis
Danish: Psoriasisartrit og ankyloserende spondylitis
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY BACKING TEXT
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS PAKKE TEKST
English: • nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances;
Danish: • nervesygdomme (såsom dissemineret sklerose og betændelse i synsnerven), smagsforstyrrelser,
English: Hepatobiliary Disorders reactivation of hepatitis B
Danish: Sygdomme i lever og galdeveje reaktivering af hepatitis B
English: In patients with psoriatic arthritis, adalimumab antibodies were identified in 38/376 subjects (10%) treated with adalimumab.
Danish: Hos patienter med psoriasis artrit blev der påvist adalimumab antistoffer hos 38/376 patienter (10 %) behandlet med adalimumab.
English: Doses of 20, 40 or 80 mg of Trudexa or placebo were given every other week for 24 weeks.
Danish: Doser på 20, 40 eller 80 mg Trudexa eller placebo blev givet hver anden uge i 24 uger.
English: • Remove cap from needle syringe, being careful not to touch the needle or let it touch any surface.
Danish: • Fjern hætten fra kanylesprøjten, og sørg for ikke at berøre kanylen eller at lade den røre nogen overflade.
English: Adverse events of the haematologic system, including medically significant cytopoenia (e.g. thrombocytopaenia, leucopaenia) have been infrequently reported with Trudexa.
Danish: Hæmatologiske bivirkninger herunder klinisk signifikant cytopeni (f.eks. thrombocytopeni, leukopeni) er rapporteret i sjældne tilfælde efter behandling med Trudexa.
English: • If you develop symptoms of heart failure (shortness of breath or swelling of the feet) seek medical attention immediately.
Danish: • Hvis De udvikler symptomer på hjerteinsufficiens (stakåndethed eller hævede fødder), bør De omgående søge lægehjælp.
English: Trudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Danish: Trudexa er indiceret til behandling af aktiv og progressiv psoriasisartrit hos voksne patienter, hvor responset på forudgående behandling med sygdomsmodificerende antireumatiske lægemidler har været utilstrækkelig.
English: Patients were randomised to 40 mg of Trudexa or placebo every other week for 24 weeks.
Danish: Patienterne blev randomiseret til 40 mg Trudexa eller placebo hver anden uge i 24 uger.
English: Uncommon (≥ 1/1000 and< 1/100 patients):
Danish: Usædvanlige (≥ 1/1000 og< 1/100 patienter):
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.4 per 1000 patient years, respectively (see section 4.4).
Danish: Den rapporterede hyppighed af ikke-melanom hudkræft og lymfomer er henholdsvis cirka 0,2 og 0,4 pr. 1000 patient-år (se pkt.
English: • muscle weakness;
Danish: • muskel-svaghed;
English: Ankylosing spondylitis is an inflammatory disease of the spine.
Danish: Ankyloserende spondylitis er en inflammatorisk sygdom i rygsøjlen.
English: • If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
Danish: • Hvis De udvikler symptomer, der tyder på en infektion, f.eks. feber, vedvarende hoste, vægttab eller sløvhed, bør De omgående søge lægehjælp.
English: Neoplasms benign and malignant (including cysts and polyps)
Danish: Godartede, ondartede og uspecificerede svulster (herunder cyster og polypper)
English: ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between Trudexa and placebo at Weeks 2, 12 and 24 a ASsessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Danish: ***,** Statistisk signifikant på<0,001, <0,01 for alle sammenligning mellem Trudexa og placebo ved uge 2, 12 og a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
English: It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.
Danish: Det er vigtigt at informere lægen, hvis De får symptomer som feber, sår, træthedsfornemmelse eller tandproblemer.
English: Trudexa has been studied both in rheumatoid arthritis and psoriatic arthritis patients taking Trudexa as monotherapy and those taking concomitant methotrexate.
Danish: Trudexa er blevet undersøgt hos patienter med reumatoid artrit og psoriasis artrit, der udelukkende blev behandlet med Trudexa, og hos patienter, der også samtidigt tog methotrexat.
English: • glaucoma;
Danish: • glaukom;
English: Patients in steroid-free remission for >=90 daysa * p < 0.001 for Trudexa versus placebo pairwise comparisons of proportions ** p < 0.02 for Trudexa versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Danish: >=90 dagea * p<0,001 for Trudexa vs. placebo parvise sammenligninger af forholdet ** p<0,02 for Trudexa vs. placebo parvise sammenligninger af forholdet a Af dem som modtog kortikosteroider ved baseline
English: Uncommon arrhythmias, tachycardia, palpitations
Danish: Usædvanlig arytmier, takykardi, palpitationer
English: • flu like symptoms, chest pain, swelling of the feet.
Danish: • influenza-lignende symptomer, brystsmerter, hævede fødder.
English: There is limited safety experience in patients undergoing arthroplasty while receiving Trudexa.
Danish: Der er begrænset erfaring med sikkerhed for patienter, som får artroplastik under behandling med Trudexa.
English: Study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had insufficient efficacy to methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexateintolerant) every week and whose methotrexate dose remained constant at 12.5 to 25 mg every week.
Danish: Forsøg III evaluerede 619 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor methotrexat i doser på 12,5 til 25 mg (10 mg ved methotrexat-intolerans) hver uge havde haft utilstrækkelig effekt, og hvor methotrexat-dosen forblev konstant på 12,5 til 25 mg hver uge.
English: Rare hepatic necrosis, hepatitis
Danish: Almindelig forhøjede leverenzymer Sjælden hepatisk nekrose, hepatitis
English: In cases where a more rapid response is required your doctor may prescribe a dose of 160 mg at week 0 (as 4 injections in one day or 2 injections per day for two consecutive days), 80 mg (2 injections) at week 2, and thereafter as 40 mg (1 injection) every other week.
Danish: I tilfælde, hvor der kræves et hurtigere respons, kan Deres læge ordinere en dosis på 160 mg i uge 0 (som 4 injektioner på en dag eller 2 injektioner pr. dag i to på hinanden følgende dage), 80 mg (2 injektioner) i uge 2, og derefter 40 mg (1 injektion) hver anden uge.
English: − If you have any further questions, please ask your doctor or pharmacist.
Danish: - Hvis De har yderligere spørgsmål, bedes De kontakte Deres læge eller apotek.
English: Clinical remission results remained relatively constant irrespective of previous TNF antagonist exposure.
Danish: Vedligeholdelse af remission- og respons-raterne er vist i Tabel 10. Raterne for klinisk remission forblev forholdvis konstante uanset tidligere TNF-antagonist-eksposition.
English: Dates of Trudexa treatment:
Danish: Trudexa-behandlingsdatoer:
English: Common dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias)
Danish: Almindelig omtågethed (herunder vertigo), hovedpine, forstyrrelse af nerve-følsomhed (herunder paræstesi)
English: Study VI
Danish: Forsøg VI
English: Uncommon opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, wound infection, skin infection (including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot)
Danish: Usædvanlig sepsis, opportunistiske infektioner (såsom tuberkulose eller histoplasmose) abscesser, ledinfektion, sårinfektion, hudinfektion (herunder cellulitis og impetigo), , superficielle svampeinfektioner (herunder i hud, negle og fødder)
English: • asthma, shortness of breath;
Danish: • astma, forpustethed;
English: Rare lymphoma, solid organ tumours (including breast, ovarian, testicular), squamous cell carcinoma of the skin
Danish: Sjælden lymfomer, faste organtumorer (herunder i bryst, ovarie og testikler), spinocellulært karcinom
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.
Danish: Det er vigtigt, at De informerer lægen, hvis De har symptomer på infektioner, f.eks. feber, sår, træthedsfornemmelse, tandproblemer.
English: Uncommon neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia, , lymphadenopathy, leucocytosis
Danish: Almindelig Usædvanlig lymfopeni neutropeni (herunder agranulocytosis), leukopeni, , trombocytopeni, anæmi, lymfadenopati, leukocytose
English: CLASSIC I and GAIN induction of remission and response rates are presented in Table 9.
Danish: Tabel 9 viser rater for induktion af remission og respons i CLASSIC I og GAIN.
English: Patients should be instructed to seek medical advice if signs/symptoms (e.g., persistent cough, wasting/weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with Trudexa.
Danish: Patienter bør instrueres i at søge læge, hvis der opstår sygdomstegn/symptomer, der tyder på tuberkuloseinfektion (f.eks. vedvarende hoste, tæring/vægttab, lav temperatur), under eller efter behandling med Trudexa.
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Danish: Se punkt 4.4 og 5.1 vedrørende kombination med andre sygdomsmodificerende antireumatiske lægemidler end methotrexat.
English: There is limited safety experience of surgical procedures in patients treated with Trudexa.
Danish: Der er begrænset erfaring med sikkerhed efter kirurgiske indgreb hos patienter i behandling med Trudexa.
English: A loading dose of 160 mg Trudexa on week 0 followed by 80 mg Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ml during the induction period.
Danish: Ved et induktionsregime på 160 mg Trudexa i uge 0 fulgt af 80 mg Trudexa i uge 2 blev opnået laveste serum-adalimumab-koncentrationer på ca. 12 µg/ml i induktions-perioden.
English: Slowly pull the plunger back to draw solution into the syringe.
Danish: Træk langsomt stemplet tilbage, så opløsningen kommer ind i sprøjten.
English: Each prefilled pen comes with 1 alcohol pad.
Danish: Hver fyldt pen leveres med 1 alkoholserviet.
English: Table 2 Undesirable Effects in Postmarketing Surveillance and Phase IV Clinical Studies
Danish: Tabel 2 Uønskede virkninger iovervågning efter markedsføring og kliniske fase IV-forsøg
English: Impaired renal and/or hepatic function
Danish: Svækket nyre- og/eller leverfunktion
English: ASAS 50 Week 2
Danish: ASAS 50 Uge 2
English: Again, do NOT touch the needle or let it touch any surface.
Danish: Rør IKKE kanylen og lad den ikke røre noget.
English: Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Danish: Forsøg I evaluerede 271 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel, hvor methotrexat i doser på 12,5 til 25 mg (10 mg ved methotrexat-intolerans) hver uge havde haft utilstrækkelig effekt, og hvor methotrexat-dosen forblev konstant på 10 til 25 mg hver uge.
English: You are advised to avoid becoming pregnant and must use adequate contraception while using Trudexa and for at least 5 months after the last Trudexa treatment.
Danish: De rådes til at undgå at blive gravid og at bruge passende prævention under behandling med Trudexa og mindst 5 måneder efter den sidste behandling med Trudexa.
English: For Trudexa, no clinical data on exposed pregnancies are available
Danish: Der foreligger ikke kliniske data om eksponering for Trudexa under graviditet.
English: Crohn's disease is an inflammatory disease of the digestive tract.
Danish: Crohns sygdom er en inflammatorisk sygdom i mavetarmkanalen.
English: The additional adverse reactions in Table 2 have been reported from postmarketing surveillance or Phase IV clinical trials:
Danish: I tabel 2 ses de yderligere bivirkninger, som er rapporteret fra overvågning efter markedsføring eller kliniske fase IV-forsøg:
English: • Wash your hands thoroughly • Set up the following items on a clean surface o One vial of Trudexa for injection o One syringe with fixed needle o Two alcohol pads
Danish: • Vask hænderne grundigt • Læg følgende ting på et rent underlag o Et hætteglas med Trudexa til injektion o En sprøjte med fastgjort kanyle
English: Week 2 Week 12 Week 24
Danish: Uge 12 Uge 24
English: The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Danish: Sikkerhed og effekt af Trudexa er undersøgt i randomiserede, dobbelt-blinde, placebo-kontrollerede forsøg i over 1400 patienter med moderat til svær aktiv Crohns sygdom (Crohns sygdomsaktivitetsindeks (CDAI) ≥ 220 og ≤ 450).
English: Skin and subcutaneous tissue disorders cutaneous vasculitis
Danish: Sygdomme i hud og subkutant væv kutan vaskulitis
English: Common musculoskeletal pain
Danish: Almindelig smerter i skeletmuskulaturen
English: Blood and the lymphatic system disorders
Danish: Sygdomme i blod- og lymfesystem
English: ASAS 70 Week 2
Danish: ASAS 70 Uge 2
English: The usual dose for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab given every other week as a single dose.
Danish: Den almindelige dosis til voksne med reumatoid artrit, psoriasisartrit og ankyloserende spondylitis er 40 mg adalimumab hver anden uge som enkeltdosis.
English: In Study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Trudexa/methotrexate combination therapy versus methotrexate monotherapy and Trudexa monotherapy at week 52, which was maintained through week 104.
Danish: I forsøg V var forbedringen i HAQ funktionsevneindeks og den fysiske komponent fra SF 36 større (p<0,001) for Trudexa/methotrexat-kombinationsterapi end for methotrexat-monoterapi og Trudexamonoterapi efter 52 uger.
English: If any side effects get serious, if you have any unusual effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig, hvis De oplever en usædvanlig reaktion, eller hvis De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De oplyse Deres læge eller apotek herom.
English: Rheumatoid arthritis clinical trials: in controlled rheumatoid arthritis clinical trials (Studies I − IV), elevations of ALT were similar in patients receiving adalimumab or placebo.
Danish: Reumatoid artrit-forsøg: I de kontrollerede kliniske reumatoid artrit-forsøg (forsøg I-IV) var forhøjelsen i ALAT-værdierne hos patienter behandlet med adalimumab og placebo ens.
English: After cleaning, do not touch the stopper with your hands.
Danish: Rør ikke proppen med hænderne efter rengøring.
English: Uncommon menstrual cycle and uterine bleeding disorders
Danish: Usædvanlig forstyrrelser i menstruationscyklus og blødning fra livmoder
English: Very Common injection site reaction (including pain, swelling, redness or pruritus)
Danish: Meget almindelig reaktioner på injektionsstedet (herunder smerter, hævelser, rødme eller kløe)
English: Thereafter, patients enrolled in an open-label extension phase in which 40 mg of Trudexa was administered every other week up to 60 months.
Danish: Derefter blev patienterne optaget i et åbent forlængelsesforsøg hvor 40 mg Trudexa blev administreret hver anden uge i op til 60 måneder.
English: If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: - Hvis en bivirkning bliver alvorlig eller, De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: The third group received 40 mg of Trudexa every other week with placebo injections on alternate weeks.
Danish: Den tredje gruppe fik 40 mg Trudexa hver anden uge og placeboinjektioner i de øvrige uger.
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride
Danish: Natriumdihydrogenfosfatdihydrat Dinatriumfosfatdihydrat
English: 80/40 mg N = 75
Danish: Trudexa 80/40 mg N = 75
English: In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.
Danish: Ved behandling med Trudexa alene kan det være en fordel for visse patienter, der oplever faldende respons, at øge dosis til 40 mg adalimumab hver uge.
English: Uncommon tinnitus, ear discomfort (including pain and swelling)
Danish: Usædvanlig tinnitus, øre-ubehag (herunder smerte og hævelse)
English: The rate (95% confidence interval) of non-melanoma skin cancers was 7.6 (4.7, 12.4) per 1000 patient-years among Trudexa-treated patients and 2.0 (0.5, 8.2) per 1000 patient-years among control patients.
Danish: Hyppigheden (95 % konfidensinterval) af ikke-melanom hudkræft var 7,6 (4,7, 12,4) pr. 1000 patient-år blandt Trudexa-behandlede patienter og 2,0 (0,5, 8,2) pr. 1000 patient-år blandt kontrolpatienterne.
English: • Look at the expiry date on the syringe.
Danish: • Kontrollér udløbsdatoen på hætteglasset.
English: HOW TO STORE TRUDEXA
Danish: HVORDAN DE OPBEVARER TRUDEXA
English: • With the needle still in the vial, turn the vial upside down at eye level.
Danish: • Når kanylen sidder i hætteglasset, vendes hætteglasset på hovedet i øjenhøjde.
English: Additional Adverse Reactions from Postmarketing Surveillance or Phase IV Clinical Trials
Danish: Yderligere bivirkninger fra overvågning efter markedsføring og kliniske fase IV-forsøg
English: • ear discomfort;
Danish: • øre-ubehag;
English: • injection site reactions (including pain, swelling, redness or itching).
Danish: • reaktion ved injektionsstedet (herunder smerter, hævelse, rødme eller kløe).