natgillin/translations-raw huggingface dataset:
I forskellige éndosisundersøgelser, ved 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.
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.
Propylenglycol, sorbitol, citronsyre, vandfri, natriumcitrat, natriumbenzoat, dinatriumedetat, vand, renset, saccharose, naturligt og kunstigt smagsstof (tyggegummi), orange farvestof E110.
12 purified water, sucrose, natural and artificial flavour (bubblegum), orange colour E110.
Aerius syrup leveres i flasker med 30, 50, 60, 100, 120, 150, 225 og 300 ml i type III ravgule glasflasker lukket med et børnesikkert polypropylenlåg.
Aerius syrup is supplied in bottles of 30, 50, 60, 100, 120, 150, 225, and 300 ml in type III amber glass bottles closed with a childproof polypropylene cap.
Lågene har en indsats lavet af Low Density Polyethylen (LDPE), polyethylen- skum, ethylenvinylacetat (EVA) og polyvinylidenchlorid (PvDC).
The caps have a liner made of Low Density Polyethylene (LDPE), polyethylene foam, ethylenevinylacetate (EVA), and polyvinylidene chloride (PvDC).
LDPE er produktkontaktoverfladen.
LDPE is the product contact surface.
Leveres med en hård, transparent, polystyrenmåleske, mærket 2, 5 ml og 5 ml, eller med en oral plastic målesprøjte med inddelinger på 2, 5 ml og 5 ml (kun for flasken på 150 ml).
Supplied with a rigid, transparent, polystyrene measuring spoon, calibrated at 2.5 ml and 5 ml, or with a plastic oral measuring syringe with graduations of 2.5 ml and 5 ml (for the 150 ml bottle only).
13 Dato for første tilladelse:
Date of first authorisation:
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Aerius 5 mg smeltetabletter
Aerius 5 mg oral lyophilisate
Hver Aerius smeltetablet indeholder 5 mg desloratadin.
Each dose of Aerius oral lyophilisate contains 5 mg desloratadine.
Smeltetablet
Oral lyophilisate
5. 1).
Adults and adolescents (12 years of age and over): one dose of Aerius oral lyophilisate placed in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
Aerius smeltetablet smelter øjeblikkeligt, og vand eller anden væske er ikke nødvendigt.
Aerius oral lyophilisate disperses instantly and water or other liquid is not needed.
Smeltetabletten kan indtages uafhængigt af måltider.
The dose can be taken regardless of mealtime.
Umiddelbart før brug skal blisteren åbnes med et forsigtigt træk, og smeltetabletten udtages uden at knuse den.
Immediately before use, the blister must be carefully peeled open and the dose of oral lyophilisate removed without crushing it.
Smeltetabletten lægges i munden, hvor den opløses øjeblikkeligt.
The dose of oral lyophilisate is placed in the mouth where it will disperse immediately.
I tilfælde af svær nyreinsufficiens bør Aerius anvendes med forsigtighed.
In the case of severe renal insufficiency, Aerius should be used with caution.
15 Dette lægemiddel indeholder aspartam 1, 75 mg per smeltetablet.
15 This product contains aspartame 1.75 mg per dose.
Aspartam er en kilde til phenylalanin, som kan være skadelig for personer med phenylketonuri.
Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
I kliniske undersøgelser ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, ved den anbefalede dosis på 5 mg daglig, blev bivirkninger med Aerius- tabletter rapporteret hos 3% flere patienter end hos dem, der behandledes med placebo.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Aerius tablets were reported in 3% of patients in excess of those treated with placebo.
16 Desloratadin fjernes ikke ved hæmodialyse; det vides ikke, om det fjernes ved peritoneal dialyse.
16 Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
I to enkeltdosis undersøgelser var Aerius smeltetablet vel tolereret på basis af kliniske laboratoriefund, fysiske undersøgelser, vitale sygdomstegn og EKG interval data.
In two single-dose trials, Aerius oral lyophilisate was well tolerated as documented by clinical laboratory findings, physical examinations, vital signs, and ECG interval data.
Ved den anbefalede dosis blev Aerius smeltetablet konstateret værende bioækvivalent med den almindelige tabletformulering af desloratadin.
At the recommended dose, Aerius oral lyophilisate was found to be bioequivalent to the conventional tablet formulation of desloratadine.
Effekten af Aerius smeltetablet forventes derfor at være den samme som med Aerius tabletformuleringen.
Therefore, the efficacy of Aerius oral lyophilisate is expected to be the same as with the Aerius tablet formulation.
I en klinisk farmakologiundersøgelse, i hvilken desloratadin blev indgivet i en dosering på 45 mg daglig (ni gange den terapeutiske dosis) i ti dage, sås ingen forlængelse af QTc intervallet.
In a clinical pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the clinical dose) for ten days, no prolongation of QTc interval was seen.
Ingen klinisk relevante ændringer i desloratadin plasmakoncentrationer 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.
I kontrollerede kliniske undersøgelser, var der ingen overhyppighed af døsighed sammenlignet med placebo ved den anbefalede dosis på 5 mg daglig.
In clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
Aerius- tabletter, givet i en enkelt daglig dosis på 7, 5 mg, påvirkede ikke den psykomotoriske præstationsevne i kliniske undersøgelser.
Aerius tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Hos patienter med allergisk rhinitis lindrede Aerius- tabletter effektivt symptomer såsom nysen, næseflåd og - kløe, samt øjenkløe, tåreflåd og rødme og kløe i ganen.
In 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 regulerede effektivt symptomerne i 24 timer.
Aerius tablets effectively controlled symptoms for 24 hours.
17 Aerius var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den totale score i rhino- konjunktivitis livskvalitetsspørgeskemaet.
17 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 enkeltdosis overkrydsningsundersøgelser af Aerius smeltetablet over for Aerius- tabletter var formuleringerne bioækvivalente.
In single-dose crossover studies of Aerius oral lyophilisate with Aerius tablets, the formulations were bioequivalent.
Tilstedeværelsen af føde havde ingen relevant indflydelse på AUC og Cmax af Aerius smeltetablet, mens tilstedeværelsen af føde forlænger Tmax for desloratadin fra 2, 5 til 4 timer og Tmax for 3- OH - desloratadin fra 4 til 6 timer.
The presence of food has no relevant influence on AUC and Cmax of Aerius oral lyophilisate while the presence of food prolongs Tmax for desloratadine from 2.5 to 4 hours and Tmax for 3-OH-desloratadine from 4 to 6 hours.
I en separat undersøgelse havde grapefrugtjuice ingen effekt på omsætningen af desloratadin.
In a separate study, grapefruit juice had no effect on the disposition of desloratadine.
18 5. 3 Prækliniske sikkerhedsdata
18 5.3 Preclinical safety data
Der sås ingen signifikant lokalirriterende effekt, når den hurtigt opløselige form blev undersøgt i en hamster slimhindeirritationstest.
No significant local irritant effect was observed when the rapidly-dissolving form was tested in a hamster cheek pouch mucous membrane irritation assay.
gelatine mannitol aspartam (E951) polacrilinkalium farvestof Opatint Red (indeholdende rød jernoxid (E172) og hypromellose (E464)) smagsstof Tutti- Frutti citronsyre, vandfri
gelatin mannitol aspartame (E951) polacrilin potassium Dye Opatint Red (containing red iron oxide (E172) and hypromellose (E464)) flavour Tutti-Frutti citric acid anhydrous
Aerius smeltetabletter leveres i enkeltdosis blisterkort af formstøbt blisterfilm med folielåg.
Aerius oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Materialerne af blisterkortet består af en polyvinylchlorid (PVC) film (produkt kontaktoverflade) med et inkorporeret aluminiumsfolielåg overtrukket med et vinyl varmeforseglet overtræk (produkt kontaktoverflade), som er varmeforseglet.
The materials of the blister consist of a polyvinyl chloride (PVC) film (product contact surface) with an incorporated aluminium foil lidding coated with a vinyl heat seal coat (product contact surface) which is heat sealed.
Pakninger med 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 eller 100 smeltetabletter.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 doses of oral lyophilisate.
Aerius 2, 5 mg smeltetabletter
Aerius 2.5 mg orodispersible tablets
Hver Aerius smeltetablet indeholder 2, 5 mg desloratadin.
Each dose of Aerius orodispersible tablet contains 2.5 mg desloratadine.
Smeltetabletter
Orodispersible Tablet
Lys rød, flad, rund, plettet tablet trykt med ” K ” på den ene side.
Light-red, flat-faced, round, speckled tablets, one side branded with “ K”
5. 1).
Children 6 to 11 years of age: one 2.5 mg Aerius orodispersible tablet placed in mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
5. 1).
Adults and adolescents (12 years of age and over): two 2.5 mg Aerius orodispersible tablets placed in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
21 4. 3 Kontraindikationer
4.3 Contraindications
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
21 4.4 Special warnings and precautions for use
Effekt og sikkerhed af Aerius 2, 5 mg smeltetabletter til børn under 6 år er ikke undersøgt.
Efficacy and safety of Aerius 2.5 mg orodispersible tablets in children under 6 years of age have not been established.
Dette lægemiddel indeholder 1, 4 mg phenylalanin per 2, 5 mg Aerius smeltetablet.
This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Aerius orodispersible tablet.
I kliniske undersøgelser blev desloratadin administreret til børn i syrupformuleringen.
In clinical trials, desloratadine in the syrup formulation was administered to a paediatric population.
Incidensen af bivirkninger totalt set var tilsvarende mellem desloratadin syrup og placebogrupperne og afveg ikke signifikant fra den sikkerhedsprofil, der er set hos voksne patienter.
The overall incidence of adverse events was similar between the desloratadine syrup and the placebo groups and did not differ significantly than the safety profile seen in adult patients.
22 Psykiske forstyrrelser Nervesystemet
22 Psychiatric disorders Nervous system disorders
Aerius smeltetablet var desuden veltolereret i en flerdosis undersøgelse.
In addition, Aerius orodispersible tablets were well tolerated in a multiple dose trial.
Ved den anbefalede dosis blev Aerius 5 mg smeltetablet fundet værende bioækvivalent med den konventionelle Aerius 5 mg tabletformulering af desloratadin.
At the recommended dose, Aerius 5 mg orodispersible tablet was found to be bioequivalent to the Aerius 5 mg conventional tablet and the Aerius 5 mg oral lyophilisate formulations of desloratadine.
Effekten af Aerius smeltetablet forventes derfor at være den samme som med Aerius tabletformuleringen.
Therefore, the efficacy of Aerius orodispersible tablet is expected to be the same as with the Aerius tablet formulation.
23 Desloratadin trænger ikke hurtigt ind i centralnervesystemet.
23 Desloratadine does not readily penetrate the central nervous system.
Aerius var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den totale 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 en række farmakokinetiske og kliniske undersøgelser nåede 6% af forsøgspersonerne en højere desloratadinkoncentration.
In a series of pharmacokinetic and clinical trials, 6% of the subjects reached a higher concentration of desloratadine.
Sikkerhedprofilen for forsøgspersonerne i begge polulationer var imidlertid ikke forskellig fra profilen for den almindelige population.
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 however the safety profile of these subjects was not different from that of the general population.
24 I en flerdose farmakokinetisk undersøgelse udført med tabletformuleringen hos raske voksne forsøgspersoner, blev fire personer fundet at være dårlige til at metabolisere desloratadin.
24 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.
I enkeltdosis overkrydsningsundersøgelser af Aerius 5 mg smeltetablet over for konventionelle Aerius 5 mg tabletter var formuleringerne bioækvivalente.
In single-dose crossover studies of Aerius 5 mg orodispersible tablets with Aerius 5 mg conventional tablets or Aerius 5 mg oral lyophilisate, the formulations were bioequivalent.
I forbindelse med dosisjusteringsundersøgelserne hos børn underbygger de farmakokinetiske data for Aerius smeltetabletter imidlertid brugen af 2, 5 mg dosen til børn i alderen 6 til 11 år.
Aerius 2.5 mg tablets has not been evaluated in paediatric patients however in conjunction with the dose finding studies in paediatrics, the pharmacokinetics data for Aerius orodispersible tablets supports the use of the 2.5 mg dose in paediatric patients 6 to 11 years of age.
Vand har ingen effekt på biotilgængeligheden for Aerius smeltetabletter.
Water had no affect on the bioavailability of Aerius orodispersible tablets.
Den samlede analyse af prækliniske og kliniske irritationsundersøgelser med smeltetabletten indikerer at det er usandsynligt at denne formulering indebærer nogen risiko for lokal irritation ved klinisk brug.
The collective analysis of preclinical and clinical irritation studies for the orodispersible tablet indicate that this formulation in unlikely to pose risk for local irritation with clinical use.
cellulose, mikrokrystallinsk stivelse, pregelatineret natriumstivelsesglycolat magnesiumstearat butyleret methacrylatcopolymer crospovidon natriumhydrogencarbonat citronsyre silica, kolloid vandfri jernoxid mannitol aspartam (E951) tutti- frutti aroma
microcrystalline cellulose pregelatinized starch sodium starch glycolate magnesium stearate butylated methacrylate copolymer crospovidone sodium hydrogen carbonate citric acid colloidal silicon dioxide ferric oxide mannitol aspartame (E951) flavour Tutti-Frutti
25 6. 2 Uforligeligheder
6.2 Incompatibilities 25 Not applicable.
Aerius smeltetabletter leveres i enkeltdosis blisterkort af formstøbt blisterfilm med folielåg.
Aerius orodispersible tablets are supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Materialerne af blisterkortet består af en formstøbt fire- lags aluminiumlaminat blisterfilm og et folielåg af lamineret aluminiumsfolie med papirbagside.
The blister materials consist of a four layer aluminum foil laminate cold form blister film and a paper backed laminated aluminum foil lidding film.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Hver Aerius smeltetablet indeholder 5 mg desloratadin.
Each dose of Aerius orodispersible tablet contains 5 mg desloratadine.
Lys rød, flad, rund, plettet tablet trykt med ” A ” på den ene side.
Light-red, flat-faced, round, speckled tablets, one side branded with “ A”
5. 1).
Adults and adolescents (12 years of age and over): one 5 mg Aerius orodispersible tablet placed in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
27 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
27 4.4 Special warnings and precautions for use
Effekt og sikkerhed af Aerius smeltetabletter til børn under 12 år er ikke undersøgt.
Efficacy and safety of Aerius orodispersible tablets in children under 12 years of age have not been established.
Dette lægemiddel indeholder 2, 9 mg phenylalanin per 5 mg Aerius smeltetablet.
This product contains 2.9 mg of phenylalanine per 5 mg dose of Aerius orodispersible tablet.
28 4. 9 Overdosering
28 4.9 Overdose
Aerius smeltetablet var desuden veltolereret i en flerdosis undersøgelse.
In addition, Aerius orodispersible tablets were well tolerated in a multiple-dose trial.
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.
Hos patienter med allergisk rhinitis lindrede Aerius- tabletter effektivt symptomer såsom nysen, næseflåd og - kløe, samt øjenkløe, tåreflåd og rødme og kløe i ganen.
29 In 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 regulerede
Aerius tablets effectively controlled symptoms for 24 hours.
Prævalensen af denne fænotype som er dårlig til at metabolisere var højere blandt voksne negroide end voksne kaukasere (hhv.
The prevalence of this poor metaboliser phenotype was greater among Black adults than Caucasian adults (18% vs.
18% og 2%), sikkerhedprofilen for disse forsøgspersoner var imidlertid ikke forskellig fra profilen for den almindelige population.
2%) however the safety profile of these subjects was not different from that of the general population.
I en flerdosis farmakokinetisk undersøgelse udført med tabletformuleringen hos raske voksne forsøgspersoner, blev fire personer fundet at være 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.
30 I enkeltdosis overkrydsningsundersøgelser af Aerius 5 mg smeltetablet over for konventionelle Aerius 5 mg tabletter var formuleringerne bioækvivalente.
30 In single-dose crossover studies of Aerius 5 mg orodispersible tablets with Aerius 5 mg conventional tablets or Aerius 5 mg oral lyophilisate, the formulations were bioequivalent.
Den samlede analyse af prækliniske og kliniske irritationsundersøgelser med smeltetabletten indikerer at det er usandsynligt at denne formulering indebærer nogen risiko for lokal irritation ved klinisk brug.
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.
31 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container
Materialerne af blisterkortet består af en formstøbt fire- lags aluminiumlaminat blisterfilm og et folielåg af lamineret aluminiumsfolie med papirbagside.
31 The blister materials consist of a four layer aluminum foil laminate cold form blister film and a paper backed laminated aluminum foil lidding film.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE / FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Aerius 0, 5 mg/ ml oral opløsning
Aerius 0.5 mg/ ml oral solution
Hver ml oral opløsning indeholder 0, 5 mg desloratadin.
Each ml of oral solution contains 0.5 mg desloratadine.
Dette lægemiddel indeholder 150 mg/ ml sorbitol.
This medicinal product contains 150 mg/ ml of sorbitol
2, 5 ml (1, 25 mg) Aerius oral opløsning en gang daglig.
2.5 ml (1.25 mg) Aerius oral solution once a day.
5 ml (2, 5 mg) Aerius oral opløsning en gang daglig.
5 ml (2.5 mg) Aerius oral solution once a day.
10 ml (5 mg) Aerius oral opløsning en gang daglig.
10 ml (5 mg) Aerius oral solution once a day.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
33 4.4 Special warnings and precautions for use
33 Effekt og sikkerhed af Aerius oral opløsning til børn under 1 år er ikke undersøgt.
Efficacy and safety of Aerius oral solution in children under 1 year of age have not been established.
Effekten af desloratadin hos børn < 2 år, der er dårlige til at metabolisere, er ikke undersøgt.
The effects of desloratadine in poor metabolisers < 2 years of age have not been studied.
Dette lægemiddel indeholder 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 sorbitol; thus, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
I kliniske undersøgelser i en pædiatrisk population blev desloratadin syrupformuleringen anvendt til ialt 246 børn i alderen 6 måneder til 11 år.
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.
Den samlede forekomst af bivirkninger hos børn i alderen 2 til 11 år var sammenlignelig for desloratadin - og placebogrupperne.
The overall incidence of adverse events in children 2 through 11 years of age was similar for the desloratadine and the placebo groups.
Der blev ikke set bivirkninger i en yderligere undersøgelse med forsøgspersoner mellem 6 og 11 år efter en enkelt 2, 5 mg dosis desloratadin oral opløsning.
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.
34 Psykiske forstyrrelser Nervesystemet
34 Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.
Hallucinationer Svimmelhed, somnolens, insomnia, psykomotorisk hyperaktivitet, anfald
Psychiatric disorders Nervous system disorders
Takykardi, hjertebanken
Hallucinations Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Effekten af Aerius oral opløsning er ikke vurderet i særlige undersøgelser hos børn.
Efficacy of Aerius oral solution has not been investigated in separate paediatric trials.
Sikkerheden ved Aerius syrup, som indeholder samme koncentration desloratadin, blev imidlertid påvist i tre pædiatriske undersøgelser.
However, the safety of Aerius syrup, which contains the same concentration of desloratadine, was demonstrated in three paediatric trials.