FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment was well tolerated as documented by clinical laboratory tests, vital signs, and ECG interval data, including QTc.
Danish: Behandling var veltolereret, vist ved kliniske laboratorieundersøgelser, vitale sygdomstegn og data for EKG-interval, inklusive QTc.
English: If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Danish: Hvis du glemmer at tage din medicin til tiden, så tag den snarest muligt og vend derefter tilbage til din sædvanlige medicineringsplan.
English: Common in children less than 2 years of age: the following may affect up to 1 in 10 children
Danish: Almindelige hos børn under 2 år: følgende kan forekomme hos op til 1 ud af 10 børn
English: Do not take a double dose to make up for forgotten individual doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for glemte individuelle doser.
English: Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
Danish: Desloratadin fjernes ikke ved hæmodialyse; det vides ikke, om det fjernes ved peritoneal dialyse.
English: Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1receptor antagonist activity.
Danish: Desloratadin er en ikke-sederende, langtidsvirkende histaminantagonist med selektiv perifer H1receptorantagonist aktivitet.
English: When Aerius should be used
Danish: Hvornår Aerius skal bruges
English: No significant differences were found in the psychomotor test results between desloratadine and placebo groups, whether administered alone or with alcohol.
Danish: Der blev ikke fundet signifikante forskelle i de psykomotoriske testresultater mellem desloratadin- og placebogrupperne, hvad enten det blev indgivet alene eller sammen med alkohol.
English: ● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium
Danish: ● øget hudfølsomhed over for sollys, selv i overskyet vejr, og over for ultraviolet (UV) lys, f.eks. UV-lys i et solarium
English: Tachycardia, palpitations QT prolongation
Danish: Takykardi, palpitationer Forlænget QT-interval
English: However, the safety of desloratadine syrup formulation, which contains the same concentration of desloratadine as Aerius oral solution, was demonstrated in three paediatric trials.
Danish: Sikkerheden af desloratadin syrup-formuleringen, som indeholder samme koncentration af desloratadin som Aerius oral opløsning, blev imidlertid påvist i tre pædiatriske studier.
English: These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells.
Danish: Disse omfatter hæmning af frigørelsen af proinflammatoriske cytokiner såsom IL-4, IL-6, IL-8 og IL-13 fra humane mastceller/basofile, og ligeledes hæmning af ekspressionen af adhæsionsmolekylet P-selectin på endothelceller.
English: Headache Insomnia
Danish: Hovedpine Insomni
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/ neonatal toxicity of desloratadine.
Danish: Data fra et stort antal gravide kvinder (flere end 1.000 gravide forsøgspersoner) indikerer hverken misdannelser eller føtal/neonatal toksicitet i forbindelse med desloratadin.
English: Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
Danish: Aspartam er en kilde til phenylalanin, som kan være skadeligt for personer med phenylketonuri.
English: In each trial, the effects were sustained over the 24 hour dosing interval.
Danish: I hvert studie var virkningerne vedvarende over 24 timers doseringsintervallet.
English: The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
Danish: Manglende karcinogent potentiale blev vist i studier med desloratadin og loratadin.
English: Phenylalanine may be harmful for people with phenylketonuria.
Danish: Phenylalanin kan være skadelig for personer med phenylketonuri.
English: Common Very rare
Danish: Almindelig Meget sjælden
English: The safety of desloratadine in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.
Danish: Sikkerheden af desloratadin hos børn i alderen 2 til 11 år som er dårlige til at metabolisere, er den samme som for børn som har en normal evne til at metabolisere.
English: As Aerius oral solution contains the same concentration of desloratadine, no bioequivalence study was required and it is expected to be equivalent to the syrup and tablet.
Danish: Da Aerius oral opløsning indeholder samme koncentration af desloratadin, var et bioækvivalensstudie ikke nødvendigt, og den orale opløsning forventes at være ækvivalent med syruppen og tabletten.
English: Aerius tablets effectively controlled symptoms for 24 hours.
Danish: Aerius-tabletter regulerede effektivt symptomerne i 24 timer.
English: In clinical trials in a paediatric population, the desloratadine syrup formulation was administered to a total of 246 children aged 6 months through 11 years.
Danish: I kliniske studier i en pædiatrisk population blev desloratadin syrup anvendt til i alt 246 børn i alderen 6 måneder til 11 år.
English: Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be more easily recruited prospectively.
Danish: Kronisk idiopatisk urticaria er blevet undersøgt som en klinisk model for urticarialidelser, da den patofysiologi der ligger til grund herfor er tilsvarende uanset ætiologi, og fordi kroniske patienter lettere kan rekrutteres prospektivt.
English: Use caution when taking Aerius with alcohol.
Danish: Du skal udvise forsigtighed, hvis du tager Aerius sammen med alkohol.
English: An improvement in pruritus of more than 50 % was observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with placebo.
Danish: En forbedring af kløe på mere end 50 % blev set hos 55 % af patienterne behandlet med desloratadin sammenlignet med 19 % af patienter behandlet med placebo.
English: What Aerius is Aerius contains desloratadine which is an antihistamine.
Danish: Hvad Aerius er Aerius indeholder desloratadin, som er et antihistamin.
English: The bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
Danish: Biotilgængeligheden for desloratadin var dosisproportional over området 5 mg til 20 mg.
English: Excipient(s) with known effect: This medicine contains mannitol and aspartame (E951).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Dette lægemiddel indeholder mannitol og aspartam (E951).
English: Desloratadine has been identified in breastfed newborns/infants of treated women.
Danish: Desloratadin er blevet sporet hos behandlede kvinders ammede nyfødte/spædbørn.
English: The overall incidence of adverse events in children 2 through 11 years of age was similar for the desloratadine and the placebo groups.
Danish: Den samlede forekomst af bivirkninger hos børn i alderen 2 til 11 år var sammenlignelig for desloratadin- og placebogrupperne.
English: Talk to your doctor, pharmacist or nurse before taking Aerius: - if you have poor kidney function.
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før du tager Aerius: - hvis du har dårlig nyrefunktion.
English: Therefore, the efficacy of Aerius orodispersible tablet is expected to be the same as with the Aerius tablet formulation.
Danish: Virkningen af Aerius smeltetablet forventes derfor at være den samme som med Aerius tabletformuleringen.
English: Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and aggression.
Danish: Andre bivirkninger, der blev rapporteret i perioden efter markedsføring hos pædiatriske patienter med frekvensen ”Ikke kendt”, var forlænget QT-interval, arytmi, bradykardi, unormal adfærd og aggression.
English: In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Aerius was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Danish: I to placebokontrollerede seks-ugers studier hos patienter med kronisk idiopatisk urticaria var Aerius effektivt til at lindre kløe og mindske størrelsen og antallet af kløende udslæt ved slutningen af det første doseringsinterval.
English: Water had no effect on the bioavailability of Aerius orodispersible tablets.
Danish: Vand har ingen indflydelse på biotilgængeligheden for Aerius smeltetabletter.
English: Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.
Danish: Selvom de fleste mennesker ikke oplever døsighed, frarådes det at beskæftige sig med aktiviteter, der kræver mental årvågenhed, for eksempel køre bil og betjene maskiner, indtil din reaktion på dette lægemiddel er fastlagt.
English: If you forget to take Aerius orodispersible tablet If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Danish: Hvis du har glemt at tage Aerius smeltetabletter Hvis du glemmer at tage din medicin til tiden, så tag den snarest muligt og vend derefter tilbage til din sædvanlige medicineringsplan.
English: If you forget to take Aerius
Danish: Hvis du har glemt at tage Aerius
English: The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency.
Danish: Graden af akkumulation for desloratadin var i overensstemmelse med dets halveringstid (cirka 27 timer) og doseringshyppigheden på en gang daglig.
English: Water or other liquid is not needed to swallow the dose.
Danish: Vand eller anden væske er ikke nødvendigt for at sluge smeltetabletten.
English: In infants and toddlers aged 6 to 23 months, the most frequent adverse reactions reported in excess of placebo were diarrhoea (3.7 %), fever (2.3 %) and insomnia (2.3 %).
Danish: Hos spædbørn og småbørn i alderen 6 til 23 måneder var de hyppigste reaktioner, der er rapporteret oftere end ved placebo, diarré (3,7 %), feber (2,3 %) og søvnløshed (2,3 %).
English: After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system.
Danish: Efter peroral indgift blokerer desloratadin selektivt perifere histamin H1receptorer, fordi stoffet hindres i at trænge ind i centralnervesystemet.
English: Desloratadine plasma concentrations can be detected within 30 minutes of administration.
Danish: Desloratadin plasmakoncentrationer kan påvises inden for 30 minutter efter indgift.
English: Non-clinical studies conducted with desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine.
Danish: Prækliniske studier udført med desloratadin og loratadin viste, at der ikke var nogle kvalitative eller kvantitative forskelle i toksicitetsprofilen mellem desloratadin og loratadin ved sammenlignelig eksponering i forhold til desloratadin.
English: ● hallucinations
Danish: • hallucinationer
English: However, common side effects in children less than 2 years of age were diarrhoea, fever and insomnia while in adults, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
Danish: Imidlertid sås der hos børn yngre end 2 år de almindelige bivirkninger diarré, feber og søvnløshed, mens der hos voksne blev rapporteret træthed, mundtørhed og hovedpine lidt oftere end ved en placebotablet.
English: Thus, since the course of allergic rhinitis/chronic idiopathic urticaria and the profile of desloratadine are similar in adults and paediatric patients, desloratadine efficacy data in adults can be extrapolated to the paediatric population.
Danish: Da forløbet af allergisk rhinitis/kronisk idiopatisk urticaria og profilen af desloratadin således er ens hos voksne og pædiatriske patienter, kan data for desloratadins virkning hos voksne overføres til den pædiatriske population.
English: Exposure was the same in adult and paediatric poor metabolisers when treated with age-appropriate doses.
Danish: Eksponeringen var den samme hos voksne og børn med dårlig metaboliseringsgrad, når de blev behandlet med aldersspecifikke doser.
English: During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Danish: Under markedsføringen af Aerius er tilfælde af alvorlige allergiske reaktioner (vejrtrækningsbesvær, hiven efter vejret, kløe, kløende udslæt og hævelse) blevet rapporteret meget sjældent.
English: In addition to the established classifications of seasonal and perennial, allergic rhinitis can alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to the duration of symptoms.
Danish: Udover de etablerede klassifikationer sæsonbetinget og helårs allergisk rhinitis, kan allergisk rhinitis alternativt opdeles i intermitterende allergisk rhinitis og vedvarende allergisk rhinitis afhængig af symptomernes varighed.
English: As a precautionary measure, it is preferable to avoid the use of Aerius during pregnancy.
Danish: For en sikkerheds skyld bør Aerius undgås under graviditet.
English: As with other antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non-responsive to antihistamines was excluded.
Danish: Som i andre antihistaminstudier ved kronisk idiopatisk urticaria blev de få patienter, der var identificeret som ikke-responderende på antihistaminer, ekskluderet.
English: The collective analysis of preclinical and clinical irritation studies for the orodispersible tablet indicate that this formulation is unlikely to pose risk for local irritation with clinical use.
Danish: Den samlede analyse af prækliniske og kliniske irritationsstudier med smeltetabletten indikerer, at det er usandsynligt at denne formulering indebærer nogen risiko for lokal irritation ved klinisk brug.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aerius therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Hvorvidt amningen skal fortsættes eller om behandlingen med Aerius skal seponeres/undlades skal vurderes ud fra afvejning af barnets fordele ved amning og kvindens fordele ved behandling.
English: However, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
Danish: Træthed, mundtørhed og hovedpine blev imidlertid rapporteret hyppigere end ved en placebotablet.
English: The dose must be taken as soon as the blister has been opened.
Danish: Smeltetabletten skal indtages straks efter, at blisteren er blevet åbnet.
English: Contains propylene glycol and sorbitol.
Danish: Indeholder propylenglycol og sorbitol.
English: You can take this medicine with or without food.
Danish: Du kan tage din medicin med eller uden mad.
English: Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours.
Danish: Desloratadin bliver godt absorberet med maksimumkoncentration opnået efter cirka 3 timer; terminalfase halveringstiden er cirka 27 timer.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Aerius findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.
Danish: Bivirkningsprofilen set i forbindelse med overdosering post-marketing er sammenlignelig med bivirkningsprofilen set med terapeutiske doser, men bivirkningerne kan være mere udtalte.
English: Adverse reactions seen with Aerius
Danish: Bivirkninger set med Aerius
English: In a separate study, grapefruit juice had no effect on the disposition of desloratadine.
Danish: I et separat studie havde grapefrugtjuice ingen indflydelse på metaboliseringen af desloratadin.
English: In a single dose study performed in adults, desloratadine 5 mg did not affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks related to flying.
Danish: I et enkeltdosisstudie hos voksne påvirkede desloratadin 5 mg hverken standardtestmålingerne for præstationsevne ved flyvning, herunder forværring af subjektiv søvnighed, eller flyvningsrelaterede opgaver.
English: Approximately 6 % of adults and children 2- to 11-year old are phenotypic poor metabolisers of desloratadine and exhibit a higher exposure (see section 5.2).
Danish: Omkring 6 % af voksne og børn i alderen 2 til 11 år er fænotypisk dårlige til at metabolisere desloratadin og udviser højere eksponering (se pkt.
English: The exposure (AUC) to desloratadine was about 6-fold higher and the Cmax was about 3 to 4 fold higher at 3-6 hours with a terminal half-life of approximately 120 hours.
Danish: Eksponering (AUC) for desloratadin var omkring 6 gange højere og Cmax var omkring 3 til 4 gange højere ved 3-6 timer med en halveringstid i terminalfasen på cirka 120 timer.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: De prækliniske data viser ingen speciel risiko for mennesker på basis af konventionelle studier af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet samt reproduktionsog udviklingstoksicitet.
English: Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine administration in adults and adolescents.
Danish: Desloratadin plasmakoncentrationer kan påvises inden for 30 minutter efter indgift hos voksne og unge.
English: In both studies, changes in exposure (AUC and Cmax) of desloratadine and 3-hydroxydesloratadine were not clinically relevant.
Danish: Ændringerne i eksponering (AUC og Cmax) for desloratadin og 3-hydroxydesloratadin var ikke klinisk relevante i nogen af studierne.
English: The pharmacokinetics of desloratadine in patients with chronic renal insufficiency (CRI) was compared with that of healthy subjects in one single-dose study and one multiple dose study.
Danish: Farmakokinetikken for desloratadin hos patienter med kronisk nyreinsufficiens (CRI) og raske personer blev sammenlignet i et enkeltdosisstudie og et flerdosisstudie.
English: Since histamine release is a causal factor in all urticarial diseases, desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
Danish: Da der er en sammenhæng mellem frigivelse af histamin og alle urticarialidelser, forventes det, at desloratadin giver effektiv symptomlindring ved andre urticarialidelser udover kronisk idiopatisk urticaria, som det anbefales i kliniske vejledninger.
English: In an additional study, no adverse events were seen in subjects between 6 and 11 years of age following a single 2.5 mg dose of desloratadine oral solution.
Danish: Der blev ikke set bivirkninger i et yderligere studie med forsøgspersoner mellem 6 og 11 år efter en enkelt 2,5 mg dosis desloratadin oral opløsning.
English: Similar pharmacokinetic parameters were observed in a multiple-dose pharmacokinetic study conducted with the syrup formulation in paediatric poor metaboliser subjects 2- to 11-year old diagnosed with allergic rhinitis.
Danish: Lignende farmakokinetiske parametre blev fundet i et flerdosis farmakokinetisk studie, udført med syrup-formuleringen til pædiatriske patienter i alderen 2 til 11 år med dårlig metaboliseringsgrad og diagnosen allergisk rhinitis.
English: Children, 1-11 years of age, who were candidates for antihistamine therapy received a daily desloratadine dose of 1.25 mg (1 through 5 years of age) or 2.5 mg (6 through 11 years of age).
Danish: Børn i alderen 1-11 år, som havde behov for antihistaminbehandling, fik en daglig desloratadin dosis på 1,25 mg (i alderen 1 til 5 år) eller 2,5 mg (i alderen 6 til 11 år).
English: Efficacy of Aerius syrup has not been investigated in paediatric trials in children less than 12 years of age.
Danish: Virkningen af Aerius syrup er ikke undersøgt i pædiatriske studier med børn under 12 år.
English: Clinical efficacy and safety In a multiple dose trial, Aerius orodispersible tablets were well tolerated.
Danish: Klinisk virkning og sikkerhed I et flerdosisstudie var Aerius smeltetabletter veltolereret.
English: Excipient(s) with known effect: This medicinal product contains 150 mg/ml of sorbitol
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Dette lægemiddel indeholder 150 mg/ml sorbitol.
English: In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis.
Danish: Diagnosen allergisk rhinitis er specielt vanskelig at skelne fra andre typer af rhinitis hos børn under 2 år.
English: In clinical studies with Aerius, the following side effects were reported as:
Danish: I kliniske studier med Aerius er følgende bivirkninger blevet rapporteret som:
English: Common: the following may affect up to 1 in 10 people
Danish: Almindelige: følgende kan forekomme hos op til 1 ud af 10 personer
English: The overall incidence of adverse reactions was similar between the desloratadine syrup and the placebo groups and did not differ significantly than the safety profile seen in adult patients.
Danish: Incidensen af bivirkninger totalt set var sammenlignelig i grupperne, der fik henholdsvis desloratadin-syrup og placebo, og afveg ikke signifikant fra den sikkerhedsprofil, der er set hos voksne patienter.
English: Very rare: the following may affect up to 1 in 10,000 people
Danish: Meget sjældne: følgende kan forekomme hos op til 1 ud af 10.000 personer
English: In a pharmacokinetic trial in which patient demographics were comparable to those of the general seasonal allergic rhinitis population, 4 % of the subjects achieved a higher concentration of desloratadine.
Danish: I et farmakokinetisk studie, i hvilket patientdemografika var sammenlignelige med dem for den almindeligt forekommende sæsonbetinget allergisk rhinitis population, opnåede 4 % af forsøgspersonerne en højere koncentration af desloratadin.
English: Intermittent allergic rhinitis is defined as the presence of symptoms for less than 4 days per week or for less than 4 weeks.
Danish: Intermitterende allergisk rhinitis er defineret som tilstedeværelse af symptomer i mindre end 4 dage per uge eller i mindre end 4 uger.
English: Nevertheless, as there is individual variation in response to all medicinal products, it is recommended that patients are advised not to engage in activities requiring mental alertness, such as driving a car or using machines, until they have established their own response to the medicinal product.
Danish: Da der kan være individuel respons på alle lægemidler, bør patienterne frarådes at beskæftige sig med aktiviteter, der kræver mental årvågenhed, for eksempel køre bil og betjene maskiner, indtil den enkeltes respons på lægemidlet er klarlagt.
English: The most frequent of adverse events reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Danish: De hyppigste bivirkninger, rapporteret oftere end ved placebo var træthed (1,2 %), mundtørhed (0,8 %) og hovedpine (0,6 %).