FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table.
Danish: Frekvenserne for bivirkninger, der er rapporteret ud over placebo i kliniske studier, og andre bivirkninger, der er rapporteret efter markedsføring, fremgår af nedenstående tabel.
English: The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride (PVC) film (product contact surface) with an aluminium foil lidding coated with a vinyl heat seal coat (product contact surface) which is heat sealed.
Danish: Blistermaterialet består af en polychlortrifluorethylen (PCTFE)/Polyvinylchloride (PVC) film (produkt kontaktoverflade) med et aluminiumsfolielåg overtrukket med et vinyl varmeforseglet overtræk (produkt kontaktoverflade), som er varmeforseglet.
English: These symptoms include itching and hives.
Danish: Symptomerne indbefatter kløe og kløende udslæt.
English: Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient's disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
Danish: Intermitterende allergisk rhinitis (tilstedeværelse af symptomer i mindre end 4 dage per uge eller i mindre end 4 uger) bør behandles ud fra vurdering af patientens sygehistorie, og behandlingen kan afbrydes efter symptomerne er forsvundet og genoptages ved tilbagevenden.
English: The efficacy of Aerius tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Danish: Virkningen af Aerius-tabletter er ikke blevet tydeligt vist i studier med unge patienter mellem 12 og 17 år.
English: ● yellowing of the skin and/or eyes
Danish: ● usædvanlig mathedsfølelse ● huden og/eller øjnene får en gullig farve
English: 1 film-coated tablet 2 film-coated tablets 3 film-coated tablets 5 film-coated tablets 7 film-coated tablets 10 film-coated tablets 14 film-coated tablets 15 film-coated tablets 20 film-coated tablets 21 film-coated tablets 30 film-coated tablets 50 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Danish: 1 filmovertrukket tablet 2 filmovertrukne tabletter 3 filmovertrukne tabletter 5 filmovertrukne tabletter 7 filmovertrukne tabletter 10 filmovertrukne tabletter 14 filmovertrukne tabletter 15 filmovertrukne tabletter 20 filmovertrukne tabletter 21 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
English: Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Danish: Svimmelhed, døsighed, insomni, psykomotorisk hyperaktivitet, krampeanfald
English: Taking Aerius is not recommended if you are pregnant or nursing a baby.
Danish: Det frarådes, at du tager Aerius, hvis du er gravid, eller hvis du ammer dit spædbarn.
English: The overall safety profile of these subjects was not different from that of the general population.
Danish: Den overordnede sikkerhedsprofil hos disse patienter var ikke forskellig fra den generelle befolkning.
English: The dose of orodispersible tablet is placed in the mouth where it will disperse immediately.
Danish: Læg smeltetabletten i munden, hvor den smelter øjeblikkeligt.
English: Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Danish: Abdominalsmerter, kvalme, opkastning, dyspepsi, diarré
English: Aerius tablets contain lactose.
Danish: Aerius-tabletter indeholder lactose.
English: In separate single dose studies, at the recommended doses, paediatric patients had comparable AUC and Cmax values of desloratadine to those in adults who received a 5 mg dose of desloratadine syrup.
Danish: I éndosisstudier med de anbefalede doser, havde pædiatriske patienter AUC og Cmax værdier af desloratadin, som var sammenlignelige med værdierne hos voksne, der fik en 5 mg dosis desloratadin syrup.
English: Before using, carefully peel open the blister and remove the dose of orodispersible tablet without crushing it. Place it in your mouth and it will disperse immediately.
Danish: Umiddelbart før brug skal blisteren åbnes med et forsigtigt træk, og smeltetabletten udtages uden at knuse den. Smeltetabletten lægges i munden, hvor den opløses øjeblikkeligt.
English: Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and for more than 4 weeks.
Danish: Vedvarende allergisk rhinitis er defineret som tilstedeværelse af symptomer i 4 dage eller mere per uge og i mere end 4 uger.
English: In a series of pharmacokinetic and clinical trials, 6 % of the subjects reached a higher concentration of desloratadine.
Danish: I en række farmakokinetiske og kliniske studier nåede 6 % af patienterne en højere koncentration af desloratadin.
English: This medicinal product contains sorbitol; thus, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Dette lægemiddel indeholder sorbitol og bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/-galactosemalabsorption eller sucrase-isomaltasemangel.
English: In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high caloric breakfast) on the disposition of desloratadine.
Danish: I et studie med enkeltdosering på 7,5 mg desloratadin var der ingen påvirkning af fødeindtagelse (morgenmad med højt fedtindhold og højt kalorieindhold) på omsætningen af desloratadin.
English: Excipient(s) with known effect: This medicine contains lactose.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Dette lægemiddel indeholder lactose.
English: Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) Asthenia
Danish: Overfølsomhedsreaktioner (såsom anafylaksi, angioødem, dyspnø, kløe, udslæt og urticaria) Asteni
English: Immediately before use, the blister must be carefully peeled open and the dose of orodispersible tablet removed without crushing it.
Danish: Før brug åbnes blisterpakningen forsigtigt, og smeltetabletten udtages uden at knuse den.
English: Do not use this medicine if you notice any change in the appearance of the tablets.
Danish: Tag ikke lægemidlet, hvis du bemærker ændringer i tabletternes udseende.
English: At the recommended dose, Aerius 5 mg orodispersible tablet was found to be bioequivalent to the Aerius 5 mg conventional tablet formulation of desloratadine.
Danish: Ved den anbefalede dosis blev Aerius 5 mg smeltetablet fundet værende bioækvivalent med den konventionelle Aerius 5 mg tabletformulering af desloratadin.
English: Elevations of liver enzymes, increased bilirubin, hepatitis Jaundice
Danish: Forhøjede leverenzymer, forhøjet bilirubin, hepatitis Gulsot
English: ● pounding or irregular heartbeat
Danish: • hjertebanken eller uregelmæssig hjerterytme
English: In a single dose, crossover study of desloratadine, the tablet and the syrup formulations were found to be bioequivalent.
Danish: I et éndosis overkrydsningsstudie af desloratadin blev tablet- og syrup -formuleringerne fundet at være bioækvivalente.
English: The cold form blister film is composed of polyvinyl chloride (PVC) film adhesively laminated to an oriented polyamide (OPA) film, adhesively laminated to aluminum foil, adhesively laminated to polyvinyl chloride (PVC) film.
Danish: Den formstøbte blisterfilm består af polyvinylchlorid (PVC) film, som er lamineret til en polyamid film (OPA), lamineret til aluminiumsfolie, lamineret med polyvinylchlorid (PVC) film.
English: Fertility There are no data available on male and female fertility.
Danish: Frugtbarhed Der er ingen information tilgængelig om virkningen på frugtbarheden hos mænd og kvinder.
English: Aerius oral solution contains sorbitol.
Danish: Aerius oral opløsning indeholder sorbitol.
English: Aerius oral solution contains sorbitol
Danish: Aerius oral opløsning indeholder sorbitol
English: In single-dose crossover studies of Aerius 5 mg orodispersible tablets with Aerius 5 mg conventional tablets, the formulations were bioequivalent.
Danish: I enkeltdosis overkrydsningsstudier af Aerius 5 mg smeltetablet over for konventionelle Aerius 5 mg tabletter var formuleringerne bioækvivalente.
English: If you forget to take Aerius oral solution
Danish: Hvis du har glemt at tage Aerius oral opløsning
English: BOTTLE OF 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML
Danish: FLASKE INDEHOLDENDE 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML
English: There is no evidence of clinically relevant active substance accumulation following once daily adult and adolescent dosing of desloratadine (5 mg to 20 mg) for 14 days.
Danish: Der er ikke noget, der tyder på klinisk relevant akkumulering af det aktive stof efter dosering til unge og voksne en gang daglig med desloratadin (5 mg til 20 mg) i 14 dage.
English: In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Danish: Ved vedvarende allergisk rhinitis (tilstedeværelse af symptomer i 4 dage eller mere om ugen og i mere end 4 uger) kan fortsat behandling foreslås til patienterne under perioder med allergeneksponering.
English: Aerius was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Danish: Aerius var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den totale score i rhino-konjunktivitis livskvalitetsspørgeskemaet.
English: The prevalence of this poor metaboliser phenotype was greater among Black adults than Caucasian adults (18 % vs. 2 %) however the safety profile of these subjects was not different from that of the general population.
Danish: Prævalensen af denne fænotype som er dårlig til at metabolisere var højere blandt voksne negroide end voksne kaukasere (hhv. 18 % og 2 %), sikkerhedprofilen for disse forsøgspersoner var imidlertid ikke forskellig fra profilen for den almindelige population.
English: Fatigue Fever
Danish: Træthed Feber
English: Adults During the marketing of Aerius, the following side effects were reported as:
Danish: Voksne Efter markedsføring af Aerius er følgende bivirkninger blevet rapporteret:
English: Aerius orodispersible tablet with food, drink and alcohol Aerius orodispersible tablet does not need to be taken with water or liquid.
Danish: Brug af Aerius smeltetabletter sammen med mad, drikke og alkohol Aerius smeltetabletter behøver ikke at blive taget med vand eller væske.
English: Additionally, Aerius orodispersible tablet may be taken with or without a meal.
Danish: Herudover kan Aerius smeltetabletter tages med eller uden mad.
English: If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.
Danish: Hvis din allergiske snue er forbigående (tilstedeværelse af symptomer i mindre end 4 dage per uge eller i mindre end 4 uger), vil din læge anbefale dig en behandlingsplan, som vil afhænge af vurderingen af din sygdomshistorie.
English: During the marketing of Aerius, the following side effects were reported as:
Danish: Efter markedsføring af Aerius er følgende bivirkninger blevet rapporteret:
English: Aerius oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/R) screw closure having a multi-ply polyethylenefaced liner.
Danish: Aerius oral opløsning leveres i flasker med 30, 50, 60, 100, 120, 150, 225 og 300 ml i type III ravgule glasflasker lukket med et børnesikkert polypropylenskruelåg med en indsats af multi-ply polyethylen.
English: Aerius contains lactose
Danish: Aerius indeholder lactose
English: Do not use this medicine if you notice any change in the appearance of the oral solution.
Danish: Tag ikke lægemidlet, hvis du bemærker ændringer i den orale opløsnings udseende.
English: In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult subjects, four subjects were found to be poor metabolisers of desloratadine.
Danish: I et flerdosis farmakokinetisk studie udført med tabletformuleringen hos raske voksne forsøgspersoner, blev fire personer fundet at være dårlige til at metabolisere desloratadin.
English: The safety profile of these subjects was not different from that of the general population.
Danish: Sikkerhedsprofilen for disse forsøgspersoner var ikke forskellig fra profilen for den almindelige population.
English: The effects of desloratadine in poor metabolisers < 2 years of age have not been studied.
Danish: Virkningen af desloratadin hos børn < 2 år, der er dårlige til at metabolisere, er ikke undersøgt.
English: Name and address of the manufacturer responsible for batch release for film-coated tablets
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse af filmovertrukne tabletter
English: No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose, ketoconazole and erythromycin interaction trials.
Danish: Ingen klinisk relevante ændringer i desloratadin plasmakoncentrationer blev set i flerdosis, ketoconazol og erythromycin interaktionsstudier.
English: The prevalence of this poor metaboliser phenotype was comparable for adult (6 %) and paediatric subjects 2- to 11-year old (6 %), and greater among Blacks (18 % adult, 16 % paediatric) than Caucasians (2 % adult, 3 % paediatric) in both populations.
Danish: Prævalencen af denne fænotype med dårlig metaboliseringsgrad var sammenlignelig for voksne (6 %) og pædiatriske patienter i alderen 2 til 11 år (6 %) og højere for negroide (18 % for voksne, 16 % for børn) end kaukasere (2 % for voksne, 3 % for børn) i begge populationer.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakning og blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose ketoconazole and erythromycin interaction trials.
Danish: Ingen klinisk relevante ændringer i desloratadin plasmakoncentrationerne blev set i flerdosis ketoconazol og erythromycin interaktionsstudier.
English: If you take more Aerius oral solution than you should Take Aerius oral solution only as it is prescribed for you.
Danish: Hvis du har taget for meget Aerius oral opløsning Tag udelukkende Aerius oral opløsning således, som det er ordineret til dig.
English: There is no evidence of clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days.
Danish: Der er ikke noget, der tyder på klinisk relevant lægemiddelakkumulering efter dosering en gang daglig med desloratadin (5 mg til 20 mg) i 14 dage.
English: Dry mouth Diarrhoea
Danish: Mundtørhed Diarré
English: Aerius 2.5 mg orodispersible tablet is light red, speckled, and round with “K” branded on one side.
Danish: Aerius 2,5 mg smeltetabletter er lys rød, plettet og rund med ”K” trykt på den ene side.
English: In clinical studies in adults, side effects were about the same as with a dummy tablet.
Danish: I kliniske studier med voksne var bivirkningerne nogenlunde de samme som ved en placebotablet.
English: Aerius tablets were effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Danish: Aerius-tabletter lindrede effektivt generne ved sæsonbetonet allergisk rhinitis, vist ved den totale score i rhino-konjunktivitis livskvalitetsspørgeskemaet.
English: Do not use this medicine if you notice any change in the appearance of Aerius orodispersible tablet.
Danish: Tag ikke lægemidlet, hvis du bemærker ændringer i udseendet af Aerius smeltetabletter.
English: This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Aerius orodispersible tablet.
Danish: Dette lægemiddel indeholder 1,4 mg phenylalanin per 2,5 mg Aerius smeltetablet.
English: The blister materials consist of a four layer aluminum foil laminate cold form blister film and a paper backed laminated aluminum foil lidding film.
Danish: Blistermaterialet består af en formstøbt fire-lags aluminiumlaminat blisterfilm og et folielåg af lamineret aluminiumsfolie med papirbagside.
English: Swallow the tablet whole.
Danish: Tabletten skal sluges hel.
English: Other medicines and Aerius
Danish: Brug af anden medicin sammen med Aerius
English: Use in children and adolescents Do not give this medicine to children less than 1 year of age.
Danish: Børn og unge Giv ikke dette lægemiddel til børn under 1 år.
English: If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.
Danish: Hvis din allergiske snue er vedvarende (tilstedeværelse af symptomer i 4 dage eller mere per uge og i mere end 4 uger), vil din læge måske anbefale dig en længerevarende behandling.
English: Aerius is supplied in blisters comprised of laminate blister film with foil lidding.
Danish: Aerius leveres i blistre af formstøbt blisterfilm med folielåg.
English: In a clinical pharmacology trial, Aerius tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Danish: I et klinisk farmakologisk studie forstærkede Aerius-tabletter indtaget sammen med alkohol ikke alkohols præstationshæmmende virkninger (se pkt.
English: Aerius 5 mg orodispersible tablet is light red, speckled, and round with “A” branded on one side.
Danish: Aerius 5 mg smeltetabletter er lys rød, plettet og rund med ”A” trykt på den ene side.
English: If you take more Aerius orodispersible tablet than you should Take Aerius orodispersible tablet only as prescribed for you.
Danish: Hvis du har taget for mange Aerius smeltetabletter Tag udelukkende Aerius smeltetabletter således, som det er ordineret til dig.
English: Children 1 through 5 years of age: 2.5 ml (1.25 mg) Aerius oral solution once a day.
Danish: Børn i alderen 1 til 5 år: 2,5 ml (1,25 mg) Aerius oral opløsning en gang daglig.
English: This product contains 2.9 mg of phenylalanine per 5 mg dose of Aerius orodispersible tablet.
Danish: Dette lægemiddel indeholder 2,9 mg phenylalanin per 5 mg Aerius smeltetablet.
English: Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc.
Danish: Tabletkernen: calciumhydrogenphosphatdihydrat, mikrokrystallinsk cellulose, majsstivelse, talkum.
English: The recommended dose is 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.
Danish: Den anbefalede dosis er 2,5 ml (½ skefuld á 5 ml) oral opløsning en gang daglig.
English: What you need to know before you take Aerius
Danish: Det skal du vide, før du begynder at tage Aerius
English: There is limited clinical trial efficacy experience with the use of desloratadine in children 6 through 11 years of age (see section 5.2).
Danish: Der er begrænset erfaring med klinisk virkning ved brug af desloratadin hos børn mellem 6 og 11 år (se afsnit 5.2).
English: Aerius is an antiallergy medicine that does not make you drowsy.
Danish: Aerius er et lægemiddel mod allergi, som ikke gør dig døsig.
English: 5 orodispersible tablets 6 orodispersible tablets 10 orodispersible tablets 12 orodispersible tablets 15 orodispersible tablets 18 orodispersible tablets 20 orodispersible tablets 30 orodispersible tablets 50 orodispersible tablets 60 orodispersible tablets 90 orodispersible tablets 100 orodispersible tablets
Danish: 5 smeltetabletter 6 smeltetabletter 10 smeltetabletter 12 smeltetabletter 15 smeltetabletter 18 smeltetabletter 20 smeltetabletter 30 smeltetabletter 50 smeltetabletter 60 smeltetabletter 90 smeltetabletter 100 smeltetabletter
English: Do not use this medicine after the expiry date which is stated on the bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In clinical trials, desloratadine in the syrup formulation was administered to a paediatric population.
Danish: I kliniske studier blev desloratadin administreret til børn i syrup-formuleringen.
English: In clinical studies in most children and adults, side effects with Aerius were about the same as with a dummy solution or tablet.
Danish: Hos de fleste børn og voksne var bivirkningerne i kliniske studier med Aerius nogenlunde de samme som ved en placeboopløsning eller placebotablet.
English: In the multiple-dose study, steady state was reached after Day 11, and compared to healthy subjects the exposure to desloratadine was ~1.5-fold greater in subjects with mild to moderate CRI and ~2.5-fold greater in subjects with severe CRI.
Danish: I flerdosisstudiet blev steady state nået efter dag 11, og eksponeringen for desloratadin var ~1,5 gange højere hos patienter med mild til moderat CRI og ~2,5 gange højere hos patienter med svær CRI sammenlignet med raske personer.
English: Use in children and adolescents Do not give this medicine to children less than 6 years of age.
Danish: Børn og unge Giv ikke dette lægemiddel til børn under 6 år.
English: Name and address of the manufacturer responsible for batch release for oral solution
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse af oral opløsning
English: There is limited clinical trial efficacy experience with the use of desloratadine in children 1 through 11 years of age and adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Danish: Der er begrænset erfaring med klinisk virkning ved brug af desloratadin til børn mellem 1 og 11 år samt unge mellem 12 og 17 år (se afsnit 4.8 og 5.1).
English: 30 ml with 1 spoon 50 ml with 1 spoon 60 ml with 1 spoon 100 ml with 1 spoon 120 ml with 1 spoon 150 ml with 1 spoon 150 ml with 1 oral syringe 225 ml with 1 spoon 300 ml with 1 spoon
Danish: oral opløsning 30 ml med en måleske 50 ml med en måleske 60 ml med en måleske 100 ml med en måleske 120 ml med en måleske 150 ml med en måleske 150 ml med en oral sprøjte 225 ml med en måleske 300 ml med en måleske
English: For the 150 ml package, a measuring spoon or an oral measuring syringe is provided, marked for doses of 2.5 ml and 5 ml.
Danish: Til 150 ml pakningen leveres en måleske eller en oral målesprøjte med inddelinger på 2,5 og 5 ml.
English: There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Danish: Der er begrænset erfaring med klinisk virkning ved brug af desloratadin til unge mellem 12 og 17 år (se afsnit 4.8 og 5.1).
English: Aerius with food, drink and alcohol Aerius may be taken with or without a meal.
Danish: Brug af Aerius sammen med mad, drikke og alkohol Aerius kan tages med eller uden mad.
English: How to take Aerius
Danish: Sådan skal du tage Aerius
English: If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.
Danish: Stop med at tage medicinen og søg straks akut lægehjælp, hvis du får nogle af disse alvorlige bivirkninger.
English: All packages except the 150 ml package are supplied with a measuring spoon marked for doses of 2.5 ml and 5 ml.
Danish: Alle pakninger på nær 150 ml pakningen leveres med en måleske med dosisindelinger på 2,5 ml og 5 ml.
English: Take the dose immediately after removal from the blister.
Danish: Tag tabletterne, så snart du har taget dem ud af blisterpakningen.
English: How Aerius works
Danish: Sådan virker Aerius
English: ● restlessness with increased
Danish: • rastløshed med øget kropsbevægelse
English: Efficacy of Aerius oral solution has not been investigated in separate paediatric trials.
Danish: Virkningen af Aerius oral opløsning er ikke vurderet i særlige studier hos børn.