natgillin/translations-raw huggingface dataset:
Hallucinationer Svimmelhed, somnolens, insomnia, psykomotorisk hyperaktivitet, anfald
Hallucinations Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Hjertes Mave- tarmkanalen
Cardiac disorders Gastrointestinal disorders
Takykardi, hjertebanken Mavepine, kvalme, opkastning, dyspepsi, diarré
Tachycardia, palpitations Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Knogler, led, muskler og bindevæv Almene symptomer
Musculoskeletal and connective tissue disorders General disorders
Myalgi Overfølsomhedsreaktioner (såsom anafylaksi, angioødem, dyspnø, kløe, udslæt og urticaria)
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
På grundlag af en flerdosis klinisk undersøgelse, i hvilken op til 45 mg desloratadin blev indgivet (ni gange den terapeutiske dosis), sås ingen klinisk relevante virkninger.
Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
Antihistaminer – H1 antagonist, ATC- kode:
Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code:
Desloratadin er en ikke- sederende, langtidsvirkende histaminantagonist med selektiv perifer H1 - receptorantagonist aktivitet.
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity.
Efter peroral indgift blokerer desloratadin selektivt perifere histamin H1 - receptorer, fordi stoffet hindres i at trænge ind i centralnervesystemet.
After oral administration, desloratadine selectively blocks peripheral histamine H1- receptors because the substance is excluded from entry to the central nervous system.
Desloratadin har vist antiallergiske egenskaber i in vitro undersøgelser.
Desloratadine has demonstrated antiallergic properties from in vitro studies.
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.
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.
I en flerdosis klinisk undersøgelse, i hvilken op til 20 mg desloratadin blev indgivet daglig i 14 dage, blev der ikke observeret nogle statistisk eller klinisk relevante kardiovaskulære virkninger.
In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
Ingen klinisk relevante ændringer i desloratadin plasmakoncentrationerne blev set i flerdosis ketoconazol og erythromycin interaktionsundersøgelser.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose ketoconazole and erythromycin interaction trials.
Aerius, givet i en enkelt daglig dosis på 7, 5 mg, påvirkede ikke den psykomotoriske præstationsevne i kliniske undersøgelser.
Aerius given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
I en enkeltdosisundersøgelse hos voksne påvirkede desloratadin 5 mg hverken standardtestmålingerne for præstationsevne ved flyvning, herunder forværring af subjektiv søvnighed, eller flyvningsrelaterede opgaver.
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.
I kliniske farmakologiundersøgelser gav samtidig indgift med alkohol ikke en øgning af den alkoholinducerede forringelse af præstationsevnen eller øget søvnighed.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced impairment in performance or increase in sleepiness.
Der blev ikke fundet signifikante forskelle i de psykomotoriske testresultater mellem desloratadin - og placebogrupperne, hvad enten det blev indgivet alene eller sammen med alkohol.
No significant differences were found in the psychomotor test results between desloratadine and placebo groups, whether administered alone or with alcohol.
Effekten af Aerius- tabletter er ikke blevet tydeligt vist i undersøgelser med unge patienter mellem 12 og 17 år.
The efficacy of Aerius tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Aerius var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den total score i rhino- konjunktivitis livskvalitetsspørgeskemaet.
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.
I to placebokontrollerede seks- ugers undersøgelser hos patienter med kronisk idiopatisk urticaria var
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.
4 Aerius effektivt til at lindre kløe og mindske størrelsen og antallet af kløende udslæt ved slutningen af det første doseringsinterval.
4 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.
I hver undersøgelse var virkningerne vedvarende over 24 timers doseringsintervallet.
In each trial, the effects were sustained over the 24 hour dosing interval.
Som i andre antihistaminundersøgelser ved kronisk idiopatisk urticaria blev de få patienter, der var identificeret som ikke- responderende på antihistaminer, ekskluderet.
As with other antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non- responsive to antihistamines was excluded.
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.
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.
Behandling med Aerius reducerede også signifikant påvirkningen af søvn og daglig funktionsevne, målt ved en fire- points skala, der anvendtes for at vurdere disse parametre.
Treatment with Aerius also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
I en farmakokinetisk undersøgelse, i hvilken patientdemografika var sammenlignelige med dem for den almindeligt forekommende sæsonbetinget allergisk rhinitis population, opnåede 4% af forsøgspersonerne en højere koncentration af desloratadin.
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.
Desloratadin er moderat bundet (83% - 87%) til plasmaproteiner.
Desloratadine is moderately bound (83% - 87%) to plasma proteins.
Enzymet, der er ansvarlig for metaboliseringen af desloratadin, er ikke blevet identificeret endnu, og nogle interaktioner med andre lægemidler kan derfor ikke fuldstændigt udelukkes.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products can not be fully excluded.
Desloratadin hæmmer ikke CYP3A4 in vivo, og in vitro undersøgelser har vist, at lægemidlet ikke hæmmer CYP2D6 og hverken er et substrat for eller en hæmmer af P- glycoprotein.
Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
I en undersøgelse med enkeltdosering på 7, 5 mg desloratadin var der ingen påvirkning af fødeindtagelse (morgenmad med højt fedtindhold og højt kalorieindhold) på omsætningen af desloratadin.
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.
I en anden undersøgelse havde grapefrugtjuice ingen indflydelse på omsætningen af desloratadin.
In another study, grapefruit juice had no effect on the disposition of desloratadine.
De prækliniske data for desloratadin viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og reproduktionstoksicitet.
Non-clinical data with desloratadine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction.
Aerius leveres i enkeltdosisblisterpakninger af formstøbt blisterfilm med folielåg.
Aerius is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
Materialet af blisteren består af en polychlortrifluorethylen (PCTFE) / Polyvinylchloride (PVC) film (produkt kontaktoverflade) med et aluminiumsfolielåg overtrukket med et vinyl varmeforseglet overtræk (produkt kontaktoverflade), som er varmeforseglet.
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.
SP Europe Rue de Stalle 73 B- 1180 Bruxelles Belgien
SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium
15. januar 2001 Dato for seneste fornyelse:
15 January 2001 Date of last renewal:
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
DATE OF REVISION OF THE TEXT 6 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Aerius 0, 5 mg/ ml syrup
Aerius 0.5 mg/ ml syrup
Hver ml syrup indeholder 0, 5 mg desloratadin.
Each ml of syrup contains 0.5 mg desloratadine.
Syrup
Syrup
5. 1).
Aerius may be taken without regard to mealtime for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
4. 4) og at der ikke er nogen resultater, der understøtter brug af Aerius til behandling af infektiøs rhinitis.
The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin (see section 4.4) and there are no data supporting the treatment of infectious rhinitis with Aerius.
2, 5 ml (1, 25 mg) Aerius syrup en gang daglig.
2.5 ml (1.25 mg) Aerius syrup once a day.
5 ml (2, 5 mg) Aerius syrup en gang daglig.
5 ml (2.5 mg) Aerius syrup once a day.
Voksne og unge (i alderen 12 år og derover):
In adults and adolescents (12 years of age and over):
10 ml (5 mg) Aerius syrup en gang daglig.
10 ml (5 mg) Aerius syrup once a day.
8 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use
Effekt og sikkerhed af Aerius syrup til børn under 1 år er ikke undersøgt.
Efficacy and safety of Aerius syrup in children under 1 year of age have not been established.
Diagnosen allergisk rhinitis er specielt vanskelig at skelne fra andre typer af rhinitis hos børn under 2 år.
8 In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis.
Udelukkelse af øvre luftvejsinfektion eller strukturelle abnormaliteter bør, såvel som sygehistorie, fysiske undersøgelser og relevante laboratorie - og hudprøver, tages i betragtning.
The absence of upper respiratory tract infection or structural abnormalities, as well as patient history, physical examinations, and appropriate laboratory and skin tests should be considered.
5. 2).
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).
Sikkerheden af Aerius syrup 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.
The safety of Aerius syrup in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.
Effekten af Aerius syrup hos børn < 2 år, der er dårlige til at metabolisere, er ikke undersøgt.
The effects of Aerius syrup in poor metabolisers < 2 years of age have not been studied.
Dette lægemiddel indeholder saccharose og sorbitol; patienter med sjældne arvelige lidelser med fruktoseintolerance, dårlig absorption af glucose- galactose eller sukrase- isomaltosemangel bør derfor ikke tage denne medicin.
This medicinal product contains sucrose and sorbitol; thus, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Dette lægemiddel indeholder farvestoffet E110, som kan medføre allergiske reaktioner.
This medicinal product contains the colouring agent E110 which may cause allergic reactions.
5. 1).
No clinically relevant interactions were observed in clinical trials with Aerius tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
5. 1).
In a clinical pharmacology trial, Aerius tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Desloratadin udskilles i modermælk; anvendelse af Aerius anbefales derfor ikke hos ammende kvinder.
Desloratadine is excreted into breast milk, therefore the use of Aerius is not recommended in breastfeeding women.
I kliniske undersøgelser i en pædiatrisk population blev Aerius syrup anvendt til ialt 246 børn i alderen 6 måneder til 11 år.
In clinical trials in a paediatric population, Aerius syrup was administered to a total of 246 children aged 6 months through 11 years.
Den samlede forekomst af bivirkninger hos børn i alderen 2 til 11 år var sammenlignelig for Aerius syrup - og placebogrupperne.
The overall incidence of adverse events in children 2 through 11 years of age was similar for the Aerius syrup and the placebo groups.
Hos spædbørn og småbørn i alderen 6 til 23 måneder var de hyppigste bivirkninger, rapporteret oftere end ved placebo, diarré (3, 7%), feber (2, 3%) og søvnløshed (2, 3%).
In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhoea (3.7%), fever (2.3%) and insomnia (2.3%).
Ved den anbefalede dosis i kliniske undersøgelser omfattende voksne og unge ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, blev bivirkninger med Aerius rapporteret hos 3% flere patienter end hos dem, der behandledes med placebo.
At the recommended dose, in clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, undesirable effects with Aerius were reported in 3% of patients in excess of those treated with placebo.
De hyppigste bivirkninger, rapporteret oftere end ved placebo var træthed (1, 2%), mundtørhed (0, 8%) og hovedpine
The most frequent of adverse events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).
Andre uønskede reaktioner, der blev rapporteret meget sjældent under markedsføringen er anført i den følgende tabel.
Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.
Psykiske forstyrrelser Nervesystemet
Psychiatric disorders
Hallucinationer Svimmelhed, somnolens, insomnia, psykomotorisk hyperaktivitet, anfald
Hallucinations
Hjerte
9
Takykardi, hjertebanken
Nervous system disorders
Mave- tarmkanalen
Cardiac disorders Gastrointestinal disorders
Mavepine, kvalme, opkastning, dyspepsi, diarré
Tachycardia, palpitations Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
På grundlag af en flerdosis klinisk undersøgelse, hos voksne og unge, i hvilken op til 45 mg desloratadin blev indgivet (ni gange den terapeutiske dosis), sås ingen klinisk relevante virkninger.
Based on a multiple dose clinical trial in adults and adolescents, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
Effekten af Aerius syrup er ikke vurderet i særlige undersøgelser hos børn.
Efficacy of Aerius syrup has not been investigated in separate paediatric trials.
Sikkerheden ved Aerius syrup blev påvist i tre pædiatriske undersøgelser.
Safety of Aerius syrup was demonstrated in three paediatric trials.
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).
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).
Behandling var veltolereret, vist ved kliniske laboratorieundersøgelser, vitale sygdomstegn og EKG intervaldata, inklusive QTc.
Treatment was well tolerated as documented by clinical laboratory tests, vital signs, and ECG interval data, including QTc.
5. 2) sammenlignelige for den pædiatriske population og voksenpopulationen.
When given at the recommended doses, the plasma concentrations of desloratadine (see section 5.2) were comparable in the paediatric and adult populations.
Da forløbet af allergisk rhinitis/ kronisk idiopatisk urticaria og profilen af desloratadin således er ens hos voksne og pædiatriske patienter, kan data for desloratadins effekt hos voksne overføres til den pædiatriske population.
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.
I en flerdosis klinisk undersøgelse, hos voksne og unge, i hvilken op til 20 mg desloratadin blev indgivet daglig i 14 dage, blev der ikke observeret nogen statistisk eller klinisk relevant kardiovaskulær virkning.
In a multiple dose clinical trial, in adults and adolescents, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
10 desloratadin blev indgivet i en dosering på 45 mg daglig (9 gange den kliniske dosering) i ti dage, sås ingen forlængelse af QTc intervallet.
In a clinical pharmacology trial, in adults and adolescents, in which desloratadine was administered to adults at a dose of 45 mg daily (nine times the clinical dose) for ten days, no prolongation of QTc interval was seen.
I kontrollerede kliniske undersøgelser, hos voksne og unge var der ingen overhyppighed af døsighed sammenlignet med placebo ved den anbefalede dosis på 5 mg daglig.
In controlled clinical trials, at the recommended dose of 5 mg daily for adults and adolescents, there was no excess incidence of
Aerius- tabletter, givet i en enkelt daglig dosis på 7, 5 mg til voksne og unge, påvirkede ikke den psykomotoriske præstationsevne i kliniske undersøgelser.
Aerius tablets given at a single daily dose of 7.5 mg to adults and adolescents did not affect psychomotor performance in clinical trials.
I kliniske farmakologiundersøgelser hos voksne gav samtidig indgift med alkohol ikke en øgning af den alkoholinducerede forringelse af præstationsevnen eller øget søvnighed.
In clinical pharmacology trials in adults, co-administration with alcohol did not increase the alcohol- induced impairment in performance or increase in sleepiness.
Effekten af Aerius syrup er ikke blevet undersøgt i pædiatriske undersøgelser hos børn under 12 år.
Efficacy of Aerius syrup has not been investigated in paediatric trials in children less than 12 years of age.
Hos voksne og unge patienter med allergisk rhinitis lindrede Aerius- tabletter effektivt symptomer såsom nysen, næseflåd og - kløe, samt øjenkløe, tåreflåd og rødme samt kløe i ganen.
In adult and adolescent patients with allergic rhinitis, Aerius tablets were effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Aerius- tabletter lindrede effektivt generne ved sæsonbetonet allergisk rhinitis, vist ved den totale score i rhino- konjunktivitis livskvalitetsspørgeskemaet.
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.
I to placebokontrollerede seks- ugers undersøgelser 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.
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.
Graden af akkumulation for desloratadin var i
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours.
11 overensstemmelse med dets halveringstid (cirka 27 timer) og doseringshyppigheden på en gang daglig.
The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency.
I en række farmakokinetiske og kliniske undersøgelser nåede 6% af patienterne en højere koncentration af desloratadin.
In a series of pharmacokinetic and clinical trials, 6% of the subjects reached a higher concentration of desloratadine.
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 sorte (18% for voksne, 16% for børn) end kaukasiske (2% for voksne, 3% for børn) i begge populationer.
11 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.
I et flerdosis farmakokinetisk undersøgelse udført med tabletter og raske voksne personer, var fire personer dårlige til at metabolisere desloratadin.
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.
Lignende farmakokinetiske parametre blev fundet i et flerdosis farmakokinetisk undersøgelse, udført med syrup til pædiatriske patienter i alderen 2 til 11 år med dårlig metaboliseringsgrad og diagnosen allergisk rhinitis.
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.
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.
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.
Effekten af Aerius syrup hos patienter < 2 år med dårlig metaboliseringsgrad er ikke undersøgt.
The effects of Aerius syrup in poor metabolizers < 2 years of age have not been studied.
I en éndosis overkrydsningsundersøgelse af desloratadin blev tablet - og syrupformuleringerne fundet værende bioækvivalente.
In a single dose, crossover study of desloratadine, the tablet and the syrup formulations were found to be bioequivalent.