FrancophonIA/ELRC3.0 huggingface dataset:
English: All (10/10) patients with advanced fibrosis or cirrhosis at baseline (Ishak fibrosis score of 4, 5 or 6) had a ≥1 point decrease (median decrease from baseline was 1.5 points).
Danish: Alle (10/10) patienter med fremskreden fibrose eller cirrose ved baseline (Ishak fibrose-score på 4, 5 eller 6) havde ≥1 point fald (gennemsnitligt fald fra baseline var 1,5 point).
English: If you miss a dose of Entecavir Mylan, take it as soon as possible, and then take your next scheduled dose at its regular time.
Danish: Hvis du glemmer at tage en dosis af Entecavir Mylan, skal du tage den så hurtigt som muligt, og herefter tage næste dosis til sædvanlig tid.
English: Entecavir Mylan should not be used during pregnancy unless clearly necessary.
Danish: Entecavir Mylan bør ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
English: Take Entecavir Mylan as long as your doctor has told you.
Danish: Tag Entecavir Mylan lige så længe som lægen har foreskrevet.
English: Of these patients, 55/57 (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥1-point decrease in Ishak fibrosis score.
Danish: Af disse patienter opnåede 55/57 (96%) histologisk forbedring som tidligere defineret (se ovenstående), og 50/57 (88%) opnåede ≥ 1 point fald i Ishak fibrose-score.
English: Lactic acidosis and severe hepatomegaly with steatosis
Danish: Laktacidose og svær hepatomegali med steatose
English: For patients who are not able to swallow tablets, or for whom a dose reduction is recommended, other entecavir-containing products with more suitable formulations may be available.
Danish: Til patienter, som ikke er i stand til at synke tabletter eller hvor der anbefales dosisreduktion, findes der andre entecavir-holdige lægemidler i mere passende lægemiddelformer.
English: Through Week 240, 3 of the 10 patients experienced virologic breakthrough (≥1 log10 increase above nadir).
Danish: Til og med Uge 240 oplevede 3 ud af de 10 patienter virologisk svigt (≥1 log10 stigning over nadir).
English: By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
Danish: Ved at konkurrere med det naturlige substrat deoxyguanosin-TP, hæmmer entecavir-TP funktionelt de 3 aktiviteter af den virale polymerase: (1) priming af HBV-polymerase, (2) revers-transkription af den negative DNAstreng fra det prægenome messenger-RNA og (3) syntese af den positive HBV-DNA-streng.
English: The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAgnegative disease at the time of transplant.
Danish: Studiepopulationen bestod af 82% mænd, 39% var kaukasere og 37% asiatere, og gennemsnitsalderen var 49 år; 89% af patienterne havde HBeAg-negativ sygdom på transplantationstidspunktet.
English: No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammalian cell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Danish: Der sås ingen tegn på genotoksicitet i Ames mikrobielle mutagenicitetsassay, en genmutations-assay med pattedyrsceller og en transformations-assay med embryoceller fra syrisk hamster.
English: You should not take Entecavir Mylan to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced.
Danish: Du bør ikke tage Entecavir Mylan for at behandle din hepatitis-B-infektion, medmindre du samtidig også tager medicin mod hiv, idet virkningen af fremtidig hivbehandling kan blive nedsat.
English: By 48 weeks of post-treatment follow-up, a substantial number of HBeAg negative patients lost response.
Danish: Ved 48 ugers opfølgning efter behandling var respons nedsat hos et betragteligt antal HBeAg-negative patienter.
English: In the clinical trials entecavir treatment was discontinued if patients achieved a prespecified response.
Danish: I de kliniske studier blev behandling med entecavir seponeret, hvis patienterne oplevede et præspecificeret respons.
English: Entecavir is rapidly absorbed with peak plasma concentrations occurring between 0.5-1.5 hours.
Danish: Entecavir absorberes hurtigt, og maksimal plasmakoncentration nås efter 0,5-1,5 time.
English: Study 038 included 67 HBeAg positive and 1 HBeAg negative patients co-infected with HIV.
Danish: Studie 038 inkluderede 67 HBeAg-positive patienter og 1 HBeAg-negativ patient med samtidig hivinfektion.
English: Pharmacokinetic parameters in patients with moderate or severe hepatic impairment were similar to those in patients with normal hepatic function.
Danish: Farmakokinetiske parametre hos patienter med moderat eller svær leverinsufficiens svarede til dem hos patienter med normal leverfunktion.
English: For patients with baseline Ishak fibrosis score ≥2, 25/43 (58%) had a ≥2-point decrease.
Danish: Blandt patienter med baseline Ishak fibrose-score ≥2, havde 25/43 (58%) ≥2 point fald.
English: Talk to your doctor or pharmacist before taking Entecavir Mylan if you have ever had problems with your kidneys, tell your doctor.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Entecavir Mylan hvis du tidligere har haft problemer med nyrerne, skal du fortælle din læge det.
English: uncommon: rash, alopecia
Danish: ikke almindelig: udslæt, alopeci
English: (Year 1), after week 58 through week 102 (Year 2), after week 102 through week 156 (Year 3), after week 156 through week 204 (Year 4), or after week 204 through week 252 (Year 5).
Danish: Uge 58 (År 1), efter uge 58 til og med uge 102 (År 2) eller efter uge 102 til og med uge 156 (År 3), efter uge 156 til og med uge 204 (År 4) eller efter uge 204 til og med uge 252 (År 5).
English: The population pharmacokinetic analysis covering patients in the age range 16-75 years did not identify age as significantly influencing entecavir pharmacokinetics.
Danish: Den populations-farmakokinetiske analyse, der dækker patienter i aldersgruppen 16-75 år, kunne ikke påvise, at alder i signifikant grad påvirkede entecavirs farmakokinetik.
English: Entecavir Mylan belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Danish: Entecavir Mylan tilhører en gruppe medicin, der kan forårsage lactacidose (ophobning af mælkesyre i blodet) og forstørret lever.
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation (see section 4.4).
Danish: Serum-ALAT og HBV-DNA-niveauer bør følges regelmæssigt efter seponering af behandlingen (se pkt.
English: common: increased transaminases
Danish: almindelig: forhøjede aminotransferaser
English: Severe Managed with CAPD (n = 4)
Danish: Svær Behandlet med CAPD (n = 4)
English: The entecavir-TP Ki for HBV DNA polymerase is 0.0012 μM.
Danish: Entecavir-TP Ki for HBV-DNA polymerase er 0,0012 μM.
English: Patients were randomized (2:1) to receive blinded treatment with entecavir 0.015 mg/kg up to 0.5 mg/day (N = 120) or placebo (N = 60).
Danish: Patienterne blev randomiseret (2:1) til blindet behandling med entecavir 0,015 mg/kg op til 0,5 mg/dag (N = 120) eller placebo (N = 60).
English: There is a dose-proportionate increase in Cmax and AUC values following multiple doses ranging from 0.1-1 mg. Steady-state is achieved between 610 days after once daily dosing with ≈ 2 times accumulation.
Danish: Der er en dosisproportional stigning i Cmax og AUC-værdier efter gentagne doser på 0,1-1 mg. Steady-state opnås 6 - 10 dage efter én gang daglig dosering med ≈ 2 gange akkumulering.
English: Resistance and specific precaution for lamivudine-refractory patients
Danish: Resistens og specifikke forsigtighedsregler for lamivudin-refraktære patienter
English: Entecavir Mylan can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Danish: Entecavir Mylan kan anvendes til mennesker, hvis lever er skadet, men stadig fungerer ordentligt (kompenseret leversygdom) og til mennesker, hvis lever er skadet og ikke fungerer ordentligt (inkompenseret leversygdom).
English: Gender/age
Danish: Køn/alder
English: The population pharmacokinetic analysis did not identify race as significantly influencing entecavir pharmacokinetics.
Danish: Den populations-farmakokinetiske analyse viste ikke, at race i signifikant grad påvirkede entecavirs farmakokinetik.
English: common: vomiting, diarrhoea, nausea, dyspepsia
Danish: almindelig: opkastning, diarré, kvalme, dyspepsi
English: Entecavir Mylan can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Danish: Entecavir Mylan kan anvendes til børn, hvis lever er skadet, men stadig fungerer ordentligt (kompenseret leversygdom).
English: If your doctor instructs you to take Entecavir Mylan on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Danish: Hvis lægen har sagt, at du skal tage Entecavir Mylan på tom mave, betyder det mindst 2 timer efter et måltid og mindst 2 timer før næste måltid.
English: In addition, high exposures of entecavir had no relevant adverse effects on γ polymerase or mitochondrial DNA synthesis in HepG2 cells (Ki >160 µM).
Danish: Dertil kommer, at høj eksponering af entecavir ikke havde relevante bivirkninger på γ-polymerase eller mitochondriel DNA-syntese i HepG2-celler (Ki > 160 μM).
English: Paediatric patients with body weight of at least 32.6 kg, should be administered a daily dose of one 0.5 mg tablet with or without food.
Danish: Pædiatriske patienter med en kropsvægt på mindst 32,6 kg skal have en daglig dosis på en 0,5 mg tablet med eller uden mad.
English: There are no recommendations for entecavir in children less than 2 years of age or weighing less than 10 kg.
Danish: Der er ingen dosisanbefalinger for entecavir til børn under 2 år eller børn, der vejer under 10 kg.
English: Resistance is mediated by reduced inhibitor binding to the altered HBV reverse transcriptase, and resistant HBV exhibits reduced replication capacity in cell culture.
Danish: Resistens medieres ved nedsat hæmmerbinding til den ændrede HBV-revers transkriptase, og resistent HBV udviser nedsat replikationskapacitet i cellekulturer.
English: In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Danish: Hos patienter med kompenseret leversygdom ledsages disse stigninger i serum-ALAT generelt ikke af stigninger i serumbilirubin eller hepatisk inkompensation.
English: • compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Danish: • kompenseret leversygdom og tegn på aktiv virusreplikation, vedvarende forhøjet serum alaninaminotransferase (ALAT) og histologisk påvist aktiv inflammation og/eller fibrose.
English: There are limited data on patients co-infected with HIV who have low CD4 cell counts (<200 cells/mm3).
Danish: Der er begrænsede data vedrørende patienter med samtidig hiv-infektion, som har lave CD4-tal (<200 celler/mm3).
English: This finding was not observed in repeat-dose studies in other species, including monkeys administered entecavir daily for 1 year at exposures ≥100 times those in humans.
Danish: Dette fund blev ikke observeret i studier med gentagne doser til andre arter, inklusive aber, der fik entecavir dagligt i 1 år i doser ≥ 100 gange den humane dosis.
English: Tablet core: microcrystalline cellulose, crospovidone, lactose monohydrate (see section 2, “Entacavir Mylan contains lactose”), magnesium stearate
Danish: Tabletkerne: Mikrokrystallinsk cellulose, crospovidon, lactosemonohydrat (se afsnit 2 “Entecavir Mylan indeholder lactose”), magnesiumstearat
English: Mutations in the HBV polymerase that encode lamivudine-resistance substitutions may lead to the subsequent emergence of secondary substitutions, including those associated with entecavir associated resistance (ETVr).
Danish: Mutationer i den HBV-polymerase, der koder for lamivudin-resistens-substitutioner, kan forårsage sekundære substitutioner, inklusive entecavir-associerede resistens-substitutioner (ETVr).
English: Entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
Danish: Entecavir er ikke et substrat af og virker ikke inducerende eller hæmmende på CYP450enzymsystemet.
English: The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV-infected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV.
Danish: Sikkerhed og virkning af entecavir blev også undersøgt i et aktivt kontrolleret klinisk studie med 191 HBV-inficerede patienter med inkompenseret leversygdom og i et klinisk studie med 68 patienter, der var co-inficerede med HBV og hiv.
English: All 61 patients had HBsAg loss post-transplantation, and 2 of these later became HBsAg positive despite maintaining undetectable HBV DNA (<6 IU/ml).
Danish: Alle 61 patienter var HBsAg-negative efter transplantationen, og 2 af patienterne blev senere HBsAgpositive på trods af ikke-detekterbart HBV-DNA (<6 IE/ml).
English: Entecavir inhibited HBV DNA synthesis (50% reduction, EC50) at a concentration of 0.004 µM in human HepG2 cells transfected with wild-type HBV.
Danish: Entecavir hæmmer HBV-DNA-syntese (50% reduktion, EC50) ved en koncentration på 0,004 μM i humane HepG2-celler transficeret med vild-type HBV.
English: Exacerbations after discontinuation of treatment
Danish: Eksacerbationer efter seponering af behandling
English: HIV variants containing the M184V substitution showed loss of susceptibility to entecavir (see section 4.4).
Danish: hiv-varianter, der indeholder M184V-substitutionen, viste tab af følsomhed mod entecavir (se pkt.
English: Entecavir-TP is a weak inhibitor of cellular DNA polymerases α, β, and δ with Ki values of 18 to 40 µM.
Danish: Entecavir-TP er en svag hæmmer af cellulær DNA-polymerase α, β og δ med Ki-værdier på 18-40 μM.
English: A higher rate of serious hepatic adverse events (regardless of causality) has been observed in patients with decompensated liver disease, in particular in those with Child-Turcotte-Pugh (CTP) class C disease, compared with rates in patients with compensated liver function.
Danish: Der er set en højere forekomst af alvorlige leverbivirkninger (uanset kausalitet) hos patienter med inkompenseret leversygdom, især hos patienter med Child-Turcotte-Pugh (CTP) klasse C sygdom, sammenlignet med patienter med kompenseret leverfunktion.
English: As an alternative, in case the oral solution is not available, the dose can be adjusted by increasing the dosage interval, as detailed in the table.
Danish: Hvis oral opløsning ikke er tilgængelig, kan dosis alternativt justeres ved at øge dosisintervallet, som vist i tabellen.
English: The median EC50 value for entecavir against LVDr HBV (rtL180M and rtM204V) was 0.026 µM (range 0.010-0.059 µM).
Danish: Gennemsnitlig EC50-værdi for entecavir mod LVDr HBV (rtL180M og rtM204V) er 0,026 μM (0,010-0,059 μM).
English: The demonstration of benefit is based on histological, virological, biochemical, and serological responses after 48 weeks of treatment in active-controlled clinical trials of 1,633 adults with chronic hepatitis B infection, evidence of viral replication and compensated liver disease.
Danish: Påvisning af benefit er baseret på histologisk, virologisk, biokemisk og serologisk respons efter 48 ugers behandling i aktivt kontrollerede kliniske studier med 1.633 voksne med kronisk hepatitis Binfektion, dokumenteret virusreplikation og kompenseret leversygdom.
English: The safety and efficacy of entecavir 1 mg once daily were assessed in a single-arm study in 65 patients who received a liver transplant for complications of chronic HBV infection and had HBV DNA <172 IU/ml (approximately 1000 copies/ml) at the time of transplant.
Danish: Sikkerheden og virkningen af entecavir 1 mg en gang dagligt blev vurderet i et enkelt-arm-studie med 65 patienter, som gennemgik en levertransplantation på grund af komplikationer ved kronisk HBVinfektion, og som havde HBV-DNA <172 IE/ml (ca. 1.000 kopier/ml) på tidspunktet for transplantationen.
English: Entecavir exposure in HBV-infected liver transplant recipients on a stable dose of cyclosporine A or tacrolimus (n = 9) was ≈ 2 times the exposure in healthy subjects with normal renal function.
Danish: Entecavir eksponering hos HBV-inficerede levertransplanterede patienter i behandling med stabil dosis ciclosporin A eller tacrolimus (n = 9) var ≈ 2 gange eksponeringen hos raske frivillige med normal nyrefunktion.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Patients with lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients without lamivudine resistance.
Danish: Patienter med lamivudin-resistent HBV har højere risiko for efterfølgende at udvikle entecavir-resistens end patienter uden lamivudinresistens.
English: HBeAg Seroconversion
Danish: HBeAg-serokonvertering
English: These trials provide experience in 195 HBeAg-positive nucleosidetreatment-naïve subjects treated with entecavir for a median duration of 99 weeks.
Danish: Disse studier tilvejebringer erfaring fra 195 nukleosidnaive, HBeAg-positive forsøgspersoner, som behandles med entecavir i gennemsnitlig 99 uger.
English: Patients in response were followed for an additional 24 weeks off-treatment.
Danish: Patienter der responderede blev fulgt i yderligere 24 uger efter seponering af behandling.
English: Entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours.
Danish: Entecavir, en guanosinnukleosidanalog med aktivitet mod HBV-polymerase, fosforyleres effektivt til den aktive trifosfat-form (TP), som har en intracellulær halveringstid på 15 timer.
English: Entecavir was superior to adefovir dipivoxil on the primary efficacy endpoint of mean change from baseline in serum HBV DNA by PCR at week 24.
Danish: Entecavir var superior til adefovirdipivoxil mht. det primære effekt endepunkt - gennemsnitlig ændring fra baseline i serumHBV-DNA ved PCR i uge 24.
English: Administration of 0.5 mg entecavir with a standard high-fat meal (945 kcal, 54.6 g fat) or a light meal (379 kcal, 8.2 g fat) resulted in a minimal delay in absorption (1-1.5 hour fed vs. 0.75 hour fasted), a decrease in Cmax of 44-46%, and a decrease in AUC of 18-20%.
Danish: Administration af 0,5 mg entecavir med et fedtrigt standardmåltid (945 kcal, 54,6 g fedt) eller et let måltid (379 kcal, 8,2 g fedt) forårsagede en minimal forsinkelse i absorption (1-1,5 time efter fødeindtagelse versus 0,75 time fastende), et fald i Cmax på 44-46% samt et fald i AUC på 18-20%.
English: common: fatigue
Danish: almindelig: træthed
English: Mean change from baselinec,e HBsAg lossb
Danish: Gennemsnitlig ændring fra baselinec,e Tab af HBsAgb
English: HBV DNA <50 IU/mL and HBeAg seroconversiona HBV DNA <50 IU/mLa HBeAg seroconversiona ALT normalisationa HBV DNA <50 IU/mLa
Danish: HBV-DNA <50 IU/ml og HBeAg-serokonverteringa HBV-DNA <50 IU/mla HBeAg-serokonverteringa ALAT-normaliseringa HBV-DNA <50 IU/mla
English: For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
Danish: For både kompenseret og inkompenseret leversygdom er denne indikation baseret på data fra kliniske studier hos nukleosid-naive patienter med HBeAg-positiv og HBeAg-negativ HBV-infektion.
English: Dose adjustment is recommended for patients with creatinine clearance <50 ml/min, including those on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Danish: Dosisjustering anbefales hos patienter med kreatinin-clearance < 50 ml/min, inklusive patienter i hæmodialyse eller i vedvarende ambulant peritonealdialyse (CAPD).
English: b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58
Danish: b Inkluderer patienter med mindst én HBV-DNA-måling under behandling ved PCR ved eller efter uge 24 til og med
English: In clinical studies in patients with compensated liver disease, the most common adverse reactions of any severity with at least a possible relation to entecavir were headache (9%), fatigue (6%), dizziness (4%) and nausea (3%).
Danish: I kliniske studier med patienter med kompenseret leversygdom var de almindeligste bivirkninger af alle sværhedsgrader, og hvor en forbindelse med entecavir var mulig, hovedpine (9%), træthed (6%), svimmelhed (4%) og kvalme (3%).
English: See leaflet for further information 4.
Danish: Se indlægssedlen for flere oplysninger.
English: Response criteria were HBV virological suppression (HBV DNA <0.7 MEq/ml by bDNA) and loss of HBeAg (in HBeAg positive patients) or ALT <1.25 times ULN (in HBeAg negative patients).
Danish: Responskriterier var HBV-virologisk suppression (HBV-DNA <0,7 MEq/ml ved bDNA) og tab af HBeAg (hos HBeAg-positive patienter) eller ALAT <1,25 gange ULN (hos HBeAg-negative patienter).
English: Renal function should be carefully evaluated before and during entecavir therapy in liver transplant recipients receiving cyclosporine or tacrolimus (see section 5.2).
Danish: Nyrefunktionen skal vurderes omhyggelig inden og under behandling med entecavir hos levertransplanterede patienter, der får ciclosporin eller tacrolimus (se pkt.
English: Entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady-state of about 75% of the dose.
Danish: Entecavir elimineres primært via nyrerne, hvor omkring 75% af dosis ved steady-state kan genfindes som uomdannet lægemiddel i urinen.
English: At baseline, patients had a mean CTP score of 8.59 and 26% of patients were CTP class C. The mean baseline Model for End Stage Liver Disease (MELD) score was 16.23.
Danish: Patienterne havde et gennemsnitligt CTP-tal på 8,59 ved baseline, og 26% af patienterne var i CTP-klasse C. Den gennemsnitlige score for Model for End Stage Liver Disease (MELD) ved baseline var 16,23.
English: The effect of age on the pharmacokinetics of entecavir was evaluated comparing elderly subjects in the age range 65-83 years (mean age females 69 years, males 74 years) with young subjects in the age range 20-40 years (mean age females 29 years, males 25 years).
Danish: Effekt af alder på entecavirs farmakokinetik er vurderet ved at sammenligne ældre patienter i aldersgruppen 65-83 år (gennemsnitsalder for kvinder 69 år, for mænd 74 år) med yngre patienter i aldersgruppen 20-40 år (gennemsnitsalder for kvinder 29 år, for mænd 25 år).
English: Uncommon (at least 1 in 1,000 patients): rash, hair loss.
Danish: Ikke almindelig (kan forekomme hos mindst 1 ud af 1.000 patienter): udslæt, hårtab.
English: Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Danish: Entecavir Mylan er også indiceret til behandling af kronisk HBV-infektion hos nukleosid-naive pædiatriske patienter fra 2 til < 18 år med kompenseret leversygdom, som har tegn på aktiv virusreplikation og vedvarende forhøjet serum-ALAT eller histologisk påvist moderat til svær inflammation og/eller fibrose.
English: rare: anaphylactoid reaction
Danish: sjælden: anafylaktoid reaktion