qanastek/EMEA-V3 huggingface dataset:
When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Meta r- riċetturi jiġu mblukkati, l- istamina ma tkunx tista 'tagħmel l- effett tagħha, u b' hekk jonqsu s- sintomi ta' l- allerġija.
How has Aerius been studied?
Kif ġie studjat Aerius?
Aerius has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
B' kollox saru tmien studji fuq Aerius li fihom ħadu sehem madwar 4, 800 pazjent adult u adoloxxenti b' rinite allerġika (inklużi erba 'studji dwar ir- rinite allerġika staġjonali, u żewġ studji f' pazjenti li kellhom ukoll l- ażma).
The effectiveness of Aerius was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
L- effikaċja ta 'Aerius tkejlet billi ġew studjati t- tibdiliet fis- sintomi (flissjoni, ħakk, għatis u konġestjoni ta' l- imnieħer) qabel u wara trattament ta 'bejn ġimagħtejn u erba' ġimgħat.
Aerius has also been studied in 416 patients with urticaria.
Aerius ġie studjat ukoll ma '416- il pazjent b' urtikarja.
The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.
L- effikaċja tkejlet bl- analiżi tat- tibdiliet fis - sintomi (il- ħakk, l- għadd u d- daqs tal- ħorriqijiet, it- tfixkil fl- irqad u fl- attivitajiet ta 'kuljum) qabel u wara trattament ta' sitt ġimgħat.
In all studies, the effectiveness of Aerius was compared with that of placebo (a dummy treatment).
Fl- istudji kollha, l- effikaċja ta 'Aerius tqabblet ma' dik ta 'plaċebo (trattament finta).
Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.
Ġew preżentati studji addizzjonali biex juru li l- mistura, is- soluzzjoni orali u l- pilloli li jinħallu fil- ħalq jiġu ttrattati bl- istess mod mill- ġisem bħall- pilloli, u biex juru li jistgħu jintużaw mit- tfal mingħajr periklu.
What benefit has Aerius shown during the studies?
X' benefiċċju wera Aerius matul l- istudji?
In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Aerius led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Fir- rinite allerġika, ir- riżultati kollha meħuda flimkien urew li trattament ta 'ġimagħtejn b' Aerius ta' 5 mg wassal għal tnaqqis medju fil- punteġġ tas- sintomi minn 25 għal 32% meta mqabbel mat- tnaqqis minn 12 għal 26% fil- pazjenti li kienu qed jingħataw plaċebo.
In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Aerius was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Fiż- żewġ studji dwar l- urtikarja, wara trattament ta 'sitt ġimgħat b' Aerius, it- tnaqqis fil- punteġġ tas- sintomi kien 58 u 67%, meta mqabbel ma' 40 u 33% f' pazjenti li kienu qed jieħdu plaċebo.
What is the risk associated with Aerius?
X' inhu r- riskju assoċjat ma 'Aerius?
In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
Fl- adulti u l- adoloxxenti, l- effetti sekondarji l- iktar komuni huma l- għeja (1. 2%), in- nixfa fil- ħalq (0. 8%) u l- uġigħ ta 'ras (0. 6%).
The side effects seen in children are similar.
Fit- tfal kien hemm effetti sekondarji simili.
In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%).
2. 3%).
For the full list of all side effects reported with Aerius, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Aerius, ara l - Fuljett ta' Tagħrif.
Aerius should not be used in people who may be hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Aerius m' għandux jittieħed minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għad- desloratadina, il- loratadina jew għal xi sustanza oħra.
Why has Aerius been approved?
Għaliex ġie approvat Aerius?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aerius’ s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Aerius fis- serħan mis- sintomi assoċjati mar- rinite allerġika jew ma' l- urtikarja huma akbar mir- riskji.
The Committee recommended that Aerius be given marketing authorisation.
Il- Kumitat irrakkomanda li Aerius jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Aerius:
Informazzjoni oħra dwar Aerius:
The European Commission granted a marketing authorisation valid throughout the European Union for Aerius to SP Europe on 15 January 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Aerius lil SP Europe fil- 15 ta 'Jannar 2001.
The marketing authorisation was renewed on 15 January 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 15 ta 'Jannar 2006.
The full EPAR for Aerius is available here.
L- EPAR sħiħ dwar Aerius jista 'jiġi kkonsultat hawn.
This summary was last updated in 04-2008.
Dan is- sommarju kien aġġornat l- aħħar fi:
EU Number
Numru ta ’ l- EU EU/ 1/ 00/ 160/ 001
Invented name
Qawwa 5 mg
Pharmaceutical Form
Lajofiliżejt orali
Route of Administration
folji (Aclar/ PVC, alu)
Packaging
2 pilloli
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
folji (Aclar/ PVC, alu)
5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
5 pilloli
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Lajofiliżejt orali
blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu)
Użu orali
1 tablet 2 tablets 3 tablets 5 tablets 7 tablets 10 tablets 14 tablets 15 tablets 20 tablets 21 tablets 30 tablets 50 tablets 100 tablets
folji (Aclar/ PVC, alu)
EU/ 1/ 00/ 160/ 014 EU/ 1/ 00/ 160/ 015 EU/ 1/ 00/ 160/ 016 EU/ 1/ 00/ 160/ 017 EU/ 1/ 00/ 160/ 018 EU/ 1/ 00/ 160/ 019 EU/ 1/ 00/ 160/ 020 EU/ 1/ 00/ 160/ 021 EU/ 1/ 00/ 160/ 022 EU/ 1/ 00/ 160/ 023 EU/ 1/ 00/ 160/ 024 EU/ 1/ 00/ 160/ 025 EU/ 1/ 00/ 160/ 026 EU/ 1/ 00/ 160/ 027 EU/ 1/ 00/ 160/ 028 EU/ 1/ 00/ 160/ 029 EU/ 1/ 00/ 160/ 030 EU/ 1/ 00/ 160/ 031 EU/ 1/ 00/ 160/ 032
10 pilloli
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
EU/ 1/ 00/ 160/ 007
0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
Aerius
Syrup Syrup Syrup Syrup Syrup Syrup Syrup Syrup Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate
5 mg
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Lajofiliżejt orali
bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu)
Użu orali
30 ml 50 ml 60 ml 100 ml 120 ml 150 ml 225 ml 300 ml
folji (Aclar/ PVC, alu)
1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 2 3 5 7 10 14 15 20 21 30
14- il pillola
EU/ 1/ 00/ 160/ 033 EU/ 1/ 00/ 160/ 034
EU/ 1/ 00/ 160/ 008
Oral lyophilisate Oral lyophilisate
Lajofiliżejt orali
Oral use Oral use
Lajofiliżejt orali
blister (PVC/ Alu) blister (PVC/ Alu)
folji (Aclar/ PVC, alu)
50 100
50 pillola
EU/ 1/ 00/ 160/ 035
EU/ 1/ 00/ 160/ 013
bottle (glass)
flixkun (ħġieġ)
EU/ 1/ 00/ 160/ 036 EU/ 1/ 00/ 160/ 037 EU/ 1/ 00/ 160/ 038 EU/ 1/ 00/ 160/ 039 EU/ 1/ 00/ 160/ 040 EU/ 1/ 00/ 160/ 041 EU/ 1/ 00/ 160/ 042 EU/ 1/ 00/ 160/ 043 EU/ 1/ 00/ 160/ 044 EU/ 1/ 00/ 160/ 045 EU/ 1/ 00/ 160/ 046 EU/ 1/ 00/ 160/ 047 EU/ 1/ 00/ 160/ 048 EU/ 1/ 00/ 160/ 049 EU/ 1/ 00/ 160/ 050 EU/ 1/ 00/ 160/ 051 EU/ 1/ 00/ 160/ 052 EU/ 1/ 00/ 160/ 053 EU/ 1/ 00/ 160/ 054 EU/ 1/ 00/ 160/ 055 EU/ 1/ 00/ 160/ 056 EU/ 1/ 00/ 160/ 057 EU/ 1/ 00/ 160/ 058 EU/ 1/ 00/ 160/ 059 EU/ 1/ 00/ 160/ 060
EU/ 1/ 00/ 160/ 024
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
Aerius
5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
5 mg
Film-coated tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
Lajofiliżejt orali
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali
blister (Aclar/ PVC, alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu)
folja (PVC/ Alu)
90 tablets 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets
3
EU/ 1/ 00/ 160/ 061
EU/ 1/ 00/ 160/ 025
0.5 mg/ ml
5
Oral solution
Użu orali
bottle (glass) + spoon (plastic)
folja (PVC/ Alu)
1 bottle
flixkun 1, siringa 1 90 pillola
bottle (glass) + spoon (plastic)
flixkun (ħġieġ) + kuċċarina (plastik)
EU/ 1/ 00/ 160/ 063
2/ 3 EU/ 1/ 00/ 160/ 063
bottle (glass) + syringe (plastic)
flixkun (ħġieġ) + siringa (plastik)
Aerius 5 mg film-coated tablets
Aerius 5 mg pilloli miksija b’ rita
Each tablet contains 5 mg desloratadine.
Kull pillola fiha 5 mg desloratadine.
Film-coated tablets
Pilloli miksija b’ rita
Aerius is indicated for the relief of symptoms associated with:
Aerius jintuża biex jittaffew is- sintomi assoċjati ma ’:
- allergic rhinitis (see section 5.1)
- rajnajtis allerġiku (ara sezzjoni 5. 1)
- urticaria (see section 5.1)
- urtikarja (ara sezzjoni 5. 1)
Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
Adulti u adolexxenti (minn tnax- il sena ’ l fuq): pillola waħda kuljum, ma ’ l- ikel jew waħidha, biex jittaffu s- sintomi assoċjati ma ’ rajnajtis allerġiku (inkluż rajnajtis allerġiku intermittenti u dak persistenti) u urtikarja (ara sezzjoni 5. 1).
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).
Hemm esperjenza limitata dwar l- effikaċja minn prova klinika bl- użu ta ’ desloratadine f’ adolexxenti minn 12 sa 17- il sena (ara sezzjonijiet 4. 8 u 5. 1).
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.
Rajnajtis allerġiku intermittenti (meta s- sintomi joħorġu għal anqas minn 4 ijiem fil- ġimgħa jew għal anqas minn 4 ġimgħat) għandha tkun maniġġjata skond l- evalwazzjoni tal- passat mediku tal- pazjent u l- kura għandha titwaqqaf wara li s- sintomi jgħaddu u terġa ’ tinbeda meta jerġgħu jitfaċċaw.
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.
F’ rajnajtis allerġiku persistenti (meta s- sintomi joħorġu għal 4 ijiem jew aktar fil- ġimgħa u għal aktar minn 4 ġimgħat), jista ’ jkun konsiljat lill- pazjenti li l- kura tibqa għaddejja waqt il- perijodi ta ’ esponiment għall- allerġen.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Sensittività eċċessiva għas- sustanza attiva, jew għal xi sustanzi mhux attivi, jew għal loratadine.
Efficacy and safety of Aerius tablets in children under 12 years of age have not been established.
L- effikaċja u s- sigurtà tal- pilloli Aerius fi tfal taħt it- tnax- il sena ma ġewx stabbiliti.
In the case of severe renal insufficiency, Aerius should be used with caution (see section 5.2).
F’ każ ta ’ insuffiċjenza renali severa, Aerius għandu jintuża b’ attenzjoni (ara sezzjoni 5. 2).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Pazjenti bi problemi erditarji rari ta ’ intolleranza għal galactose, deffiċjenza ta ’ Lapp lactase jew malassorbiment ta ’ glucose- galactose m’ għandhomx jieħdu din il- mediċina.
2 4.5 Interaction with other medicinal products and other forms of interaction
2 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
Ma dehrux interazzjonijiet klinikament rilevanti waqt provi kliniċi bil- pilloli desloratadine li fihom ingħataw erythromycin jew ketoconazole fl- istess ħin (ara sezzjoni 5. 1).
In a clinical pharmacology trial Aerius taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Fi prova farmakoloġika klinika, pilloli Aerius li ttieħdu flimkien ma ’ alkoħol ma żiedux l- effetti li jxekklu l- prestazzjoni ta ’ l- alkoħol (ara sezzjoni 5. 1).
Desloratadine was not teratogenic in animal studies.
Desloratidine ma kienx teratoġeniku fi studji fuq annimali.
The safe use of the medicinal product during pregnancy has not been established.
Ma ġiex stabbilit li l- użu tal- prodott mediċinali waqt it- tqala ma jagħmilx ħsara.
The use of Aerius during pregnancy is therefore not recommended.
L- użu ta ’ Aerius waqt it- tqala għaldaqstant mhuwiex irrakkomandat.
Desloratadine is excreted into breast milk, therefore the use of Aerius is not recommended in breast- feeding women.
Desloratidine joħroġ fil- ħalib tas- sider, għaldaqstant l- użu ta ’ desloratidine mhuwiex rakkomandat f’ nisa li qed ireddgħu.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving desloratadine.
Fi provi kliniċi li evalwaw il- ħila ta ’ sewqan, ma kienx hemm xekkil f’ pazjenti li kienu qed jirċievu desloratidine.
However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Madankollu, il- pazjenti għandhom ikunu infurmati li rari ħafna xi nies ħassewhom bi ngħas, b’ mod li setgħa jeffettwa l- ħila tagħhom biex isuqu jew iħaddmu magni.
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 were reported in 3% of patients in excess of those treated with placebo.
Fi provi kliniċi ta ’ medda ta ’ indikazzjonijiet fosthom rajnajtis allerġiku u urtikarja idjopatika kronika, bid- doża rakkomandata ta ’ 5 mg kuljum, l- effetti mhux mixtieqa b’ Aerius kien rappurtati fi 3% tal - pazjenti aktar minn dawk fuq plaċebo.
The most frequent of adverse events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).
L- aktar effetti avversi frekwenti li kienu rappurtati aktar minn dak tal- plaċebo kienu għejja (1. 2%), ħalq xott (0. 8%), u uġigħ ta ’ ras (0. 6%).
In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9% of patients treated with desloratadine and 6.9% of patients receiving placebo.
Fi prova klinika li fiha ħadu sehem 578 pazjenti adolexxenti, minn 12 sa 17- il sena, l- aktar każ avers komuni kien uġigħ ta ’ ras, li seħħ f’ 5. 9% tal- pazjenti ikkurati b’ desloratadine u 6. 9% tal- pazjenti li kienu qed jirċievu plaċebo.
Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.
Effetti mhux mixtieqa oħrajn li ġew rappurtati rari ħafna fil- perijodu ta ’ wara t- tqegħid fis - suq huma elenkati fit- tabella li ġejja.
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Disturbi psikjatriċi Alluċinazzjonijiet Disturbi fis- sistema nervuża Sturdament, sonnolenza, nuqqas ta ’ rqad, iperattività psikomotorjali, aċċessjonijiet Disturbi fil- qalb Takikardja, u taħbit mgħaġġel tal- qalb Disturbi gastro- intestinali Uġigħ addominali, dardir, rimettar, dispepsja, dijarrea Disturbi fil- fwied u fil- marrara Żjieda fl- enżimi tal- fwied, żieda fil- bilirubin, epatite Disturbi muskolu- skeletrali u tal- connective Majalġja tissue Disturbi ġenerali Reazzjonijiet ta ’ sensittività eċċessiva (bħal reazzjonijiet anafilattiċi, anġjoedema, ħakk, raxx u urtikarja)
In the event of overdose, consider standard measures to remove unabsorbed active substance.
F’ każ ta ’ doża eċċessiva, qies miżuri standard sabiex tneħħi is- sustanza attiva mhux assorbita.
Symptomatic and supportive treatment is recommended.
Kura sintomatika u ta ’ support hija rrakkomandata.
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.
Minn prova klinika b’ doża multipla, li fiha ingħataw sa 45 mg desloratadine (disa ’ darbiet id- doża klinika), ma kienx hemm effetti kliniċi rilevanti.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
Desloratadine ma jiġix eliminat bil- emodijaliżi; mhux magħruf jekk jiġix eliminat b’ dijaliżi tal - peritonew.
Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code:
Kategorija farmakoterapewtika: anti- istamini - antagonista H1, Kodiċi ATC:
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity.
Desloratadine huwa antagonist ta ’ istamina li ma jħeddilx u li jaħdem fit- tul b’ attività agonista għar - riċettur- H1 periferali b’ mod selettiv.
After oral administration, desloratadine selectively blocks peripheral histamine H1- receptors because the substance is excluded from entry to the central nervous system.
Wara li jingħata b’ mod orali, desloratidine jimblokka ir- riċetturi - H1 b’ mod selettiv għaliex is- sustanza ma titħalliex tidħol fi- sistema nervuża ċentrali.
Desloratadine has demonstrated antiallergic properties from in vitro studies.
Fi studji in vitro, desloratadine wera karatteristiċi kontra l- allerġiji.
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.
Dawn kienu jinkludu t- tfixkil tal - ħelsien ta ’ ċitokini li jgħinu l- infjammazzjoni bħal IL- 4, IL- 6, IL- 8 u IL- 13 miċ- ċelluli mast/ bażofili tal- bniedem, kif ukoll tfixkil fl- espressjoni tal- molekula ta ’ adeżjoni P- selectin fuq iċ- ċelluli endoteljali.
The clinical relevance of these observations remains to be confirmed.
Ir- rilevanza klinika ta ’ dawn l- osservazzjonijiet għad trid tiġi kkonfermata.
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.
Fi prova klinika b’ ħafna dożi, li fiha sa 20 mg desloratadine ingħata kuljum għal 14- il ġurnata, ma kienx hemm effett kardjovaskulari klinikament jew statistikament rilevanti.
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.
Fi prova klinika farmakoloġika, li fiha ingħata desloratadine b’ doża ta ’ 45 mg kuljum (disa ’ darbiet id- doża klinika) għal għaxart ijiem, ma kienx hemm żieda fit- tul ta ’ l- intervall QTc.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose ketoconazole and erythromycin interaction trials.
Ma dehrux tibdiliet kliniċi rilevanti tal- konċentrazzjonijiet fil- plażma ta ’ desloratadine bi provi ta ’ interazzjoni b’ ħafna dożi, ma’ ketoconazole u erythromycin.
Desloratadine does not readily penetrate the central nervous system.
Desloratadine ma jippenetrax malajr fis- sistema nervuża ċentrali.
In controlled clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
Fi provi kliniċi bid- doża rakkomandata ta ’ 5 mg kuljum, il- każijiet ta ’ dawk li qabadhom ngħas żejjed ma kienux aktar meta mqabbla mal- plaċebo.
Aerius given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Aerius mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg ma effettwax il - prestazzjonijiet psikomotriċi fi provi kliniċi.
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.
Fi prova b’ doża waħda li seħħet fl- adulti, desloratadine 5 mg ma effettwax il- miżuri standard tal- prestazzjoni tat- titjir fl- ajru inkluż żieda fin- ngħas jew il- ħila biex jiġu eżegwiti proċeduri relatati mat- titjir fl- ajru.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced impairment in performance or increase in sleepiness.
Fi provi kliniċi farmakoloġiċi, l- għotja flimkien ma ’ alkoħoliċi ma żiedux l- effetti li jxekklu l - prestazzjoni ta ’ l- alkoħol jew żieda fin- ngħas.
No significant differences were found in the psychomotor test results between desloratadine and placebo groups, whether administered alone or with alcohol.
Ma kienx hemm differenzi sinjifikanti bejn ir- riżultati ta ’ testijiet psikomotorjali fil- gruppi ta ’ desloratadine u plaċebo, kemm meta kien mogħti waħdu kif ukoll ma ’ l- alkoħol.
In patients with allergic rhinitis, Aerius was effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
F’ pazjenti b ’ rajnajtis allerġiku, Aerius, kien effettiv biex iserrħu sintomi bħal għatis, tnixxija mill - imnieħer, u hakk, kif ukoll ħakk, dmugħ u ħmura fl- għajnejn, u ħakk fis- saqaf tal- ħalq.
Aerius effectively controlled symptoms for 24 hours.
Aerius itaffi b’ mod effettiv s- sintomi għal 24 siegħa.
The efficacy of Aerius tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
L- effikaċja tal- pilloli Aerius ma ntwerietx b’ mod ċar fi provi bi pazjenti adolexxenti minn 12 sa 17- il sena.
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.
Minbarra l- klassifikazzjonijiet stabbiliti ta ’ l- istaġun u perenni, rajnajtis allerġiku jista ’ minflok ikun klassifikat bħala rajnajtis allerġiku intermittenti u rajnajtis allerġiku persistenti skond kemm idumu s - sintomi.
Intermittent allergic rhinitis is defined as the presence of symptoms for less than 4 days per week or for less than 4 weeks.
Rajnajtis allerġiku intermittenti huwa definit bħala l- preżenza ta ’ sintomi għal anqas minn 4 ġranet fil- ġimgħa jew għal anqas minn 4 ġimgħat.
Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and for more than 4 weeks.
Rajnajtis allerġiku persistenti huwa definit bħala l- preżenza ta ’ sintomi għal 4 ġranet jew aktar fil- ġimgħa u għal aktar minn 4 ġimgħat.
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.
4 Aerius kien effettiv biex iserraħ il- problemi relatati ma ’ rajnajtis allerġiku ta ’ l- istaġun kif jidher mil - punteġġ totali tal- kwestjonarju fuq il- kwalità tal- ħajja b’ rajno- konġunktivite.
The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.
L- akbar titjib deher fil - qasam ta ’ problemi prattiċi u attivitaiet ta ’ kuljum limitati mis- sintomi.
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.
Urtikarja idjopatika kronika kienet studjata bħala mudell kliniku għall- kundizzjonijiet bl- urtikarja, peress li l- patofiżjoloġija warajhom hija simili, irrispettivament mill- etjoloġija, u peress li pazjenti kroniċi jistgħu jiġu ngaġġati aktar faċilment b’ mod prospettiv.
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.
Peress illi l- ħelsien ta ’ histamine huwa l- fattur li jikkawża l- mard kollu li jinvolvi l- urtikarja, desloratadine huwa mistenni li jkun effettiv biex jipprovdi serħan mis- sintomi għall- kundizzjonijiet oħra li jinvolvu l- urtikarja, minbarra urtikarja idjopatika kronika, hekk kif qed jingħata parir fil- linji gwida kliniċi.
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.
F’ żewġ provi kkontrollati bi plaċebo li damu sitt ġimgħat f’ pazjenti b’ urtikarja kronika idjopatika, Aerius kien effettiv biex iserraħ il- ħakk u jnaqqas id- daqs u n- numru ta ’ ħbiebes fl- aħħar ta ’ l- ewwel intervall tad- dożaġġ.
In each trial, the effects were sustained over the 24 hour dosing interval.
F’ kull prova, l- effetti nżammu tul l- 24 siegħa bejn doża u oħra.
As with other antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non- responsive to antihistamines was excluded.
Bħal provi oħra b’ anti- istaminiċi f’ urtikarja idjopatika kronika, il- minoranza tal- pazjenti li kienu identifikati bħala li ma wrewx rispons għall- anti- istaminiċi kienu esklużi.
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.
Titjib fil- ħakk ta ’ aktar minn 50% deher f’ 55% tal- pazjenti kkurati b’ desloratadine imqabbla ma ’ 19% kkurati bi plaċebo.
Treatment with Aerius also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Kura b’ Aerius tejjbet ukoll b’ mod sinjifikanti in- nuqqas ta ’ rqad u funzjoni ta ’ matul il- jum, kif imkejjel bi skala b’ erba ’ punti li tintuża biex tevalwa dawn il- varjanti.
Desloratadine plasma concentrations can be detected within 30 minutes of administration.
Il- konċentrazzjonijiet fil- plażma ta ’ desloratadine ikunu jistgħu jitkejjlu fi żmien 30 minuta minn meta jingħata.
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours.
Desloratadine jiġi assorbit tajjeb u l- ogħla konċentrazzjoni tinkiseb wara madwar 3 sigħat; il - half- life fl- aħħar fażi hija madwar 27 siegħa.
The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency.
Il- grad ta ’ akkumulu ta ’ desloratadine kien jaqbel mal - half- life tiegħu (madwat 27 siegħa) u l- frekwenza ta ’ dożaġġ ta ’ darba kuljum.
The bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
Il- biodisponibilità ta ’ desloratadine kienet proporzjonali mad- doża fuq il- medda ta ’ 5 mg sa 20 mg.
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.
Fi studju farmakokinetiku fejn il- karatteristiċi demografiċi tal- pazjenti kienu jaqblu ma ’ dawk tal - popolazzjoni ġenerali b’ rajnajtis allerġiku ta ’ l- istaġun, 4% tas- suġġetti akkwistaw konċentrazzjoni ogħla ta ’ desloratadine.
This percentage may vary according to ethnic background.
Dan il- persentaġġ jista ’ jvarja skond l- isfond etniku tal- pazjent.
Maximum desloratadine concentration was about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.
Il - konċentrazzjoni massima ta ’ desloratadine kienet daqs 3 darbiet aktar għolja wara madwar 7 sigħat u l- fażi terminali iddum madwar 89 siegħa biex tonqos bin- nofs.
The safety profile of these subjects was not different from that of the general population.
Il- profil ta ’ sigurtà f’ dawn is- suġġetti ma kienx differenti minn dik tal- popolazzjoni ġenerali.
Desloratadine is moderately bound (83% - 87%) to plasma proteins.
Desloratadine jintrabat b’ mod moderat (83% - 87%) mal- proteini tal- plażma.
There is no evidence of clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days.
M’ hemmx evidenza ta ’ akkumulu tal- mediċina li jista ’ jkollu rilevanza klinika wara li jingħata dożaġġ ta ’ desloratadine darba kuljum (5 mg sa 20 mg) għal 14- il ġurnata.
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.
L- enżima responsabbli għal metaboliżmu ta ’ desloratadine għadha ma ġietx identifikata, u għalhekk, xi interazzjonijiet ma ’ xi prodotti mediċinali oħra ma jistgħux jiġu esklużi għal kollox.
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.
Desloratadine ma jimpedixxix CYP3A4 in vivo, u studji in vitro urew li l- prodott mediċinali ma jimpedixxix CYP2D6 u la huwa sottostrat u l- anqas inibitur tal- glajkoproteina- P.
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.
Fi prova b’ doża waħda fejn intużat doża ta ’ 7. 5 mg desloratadine, ma kien hemm l- ebda effett fuq id - dispożizzjoni ta ’ desloratadine mill- ikel (kolazzjon b’ livell għoli ta ’ xaħam u kaloriji).
In another study, grapefruit juice had no effect on the disposition of desloratadine.
Fi studju ieħor, il- meraq tal- grejpfrut ma kellu l- ebda effett fuq id- dispożizzjoni ta ’ desloratadine.
Desloratadine is the primary active metabolite of loratadine.
Desloratadine huwa l- metabolu attiv ewlieni ta ’ loratadine.
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.
Studji ta ’ qabel l- użu kliniku li saru b’ desloratadine u loratadine urew li m’ hemmx differenzi mill- lat kwalitattiv jew kwantitattiv fil- profil ta ’ tossiċità ta ’ desloratadine u loratadine f’ livelli komparabbli ta ’ esponiment għal desloratadine.
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.
Informazzjoni li mhiex klinika b’ desloratadine, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, effett tossiku fuq is- sistema
The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
In- nuqqas ta ’ potenzjal li jikkawża l- kanċer kien intwera bi studji li saru b’ desloratadine u loratadine.
Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc.
Kisja tal- pillola:
Tablet coating: film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.
(li fiha lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), kisja ċara (li fiha hypromellose, macrogol 400), carnauba wax, white wax.
Aerius is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
Aerius issibu ġo folja għal kull doża li tikkonsisti f’ rita llaminata tal- folji magħluqa bil- fojl.
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.
Il - materjali tal- folja jikkonsistu f’ rita tal- polychlorotrifluoroethylene (PCTFE) / Polyvinyl Chloride (PVC) (il- wiċċ li jmiss mal- prodott) b’ għatu tal- fojl ta ’ l- aluminju mgħotti b’ rita tal- vinyl imwaħħla billi tiġi imsaħħna (il- wiċċ li jmiss mal- prodott) li hija magħluqa billi tiġi imsaħħna.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 tablets.
Pakketti ta ’ 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 pillola.
15 January 2001 Date of last renewal:
15 Jannar 2001 Data ta ’ l- aħħar tiġdid:
15 January 2006
15 Jannar 2006
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/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Aerius 0.5 mg/ ml syrup
Aerius 0. 5 mg/ ml mistura
Each ml of syrup contains 0.5 mg desloratadine.
Kull ml ta ’ mistura fih 0. 5 mg desloratadine.
Syrup
Mistura
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).
Aerius jista ’ jittieħed mingħajr ma jingħata każ għall- ħin ta ’ l- ikel għas- serħan mis- sintomi assoċjati ma ’ rajnajtis allerġiku (inkluż rajnajtis allerġiku intermittenti u dak persistenti) u urtikarja (ara sezzjoni 5. 1).
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.
Min jordna din il- mediċina għandu jżomm f’ rasu li ħafna mill- każijiet ta ’ rajnajtis taħt is- sentejn ikunu ġejjin min infezzjoni (ara sezzjoni 4. 4) u m’ hemmx tagħrif li juri li Aerius huwa tajjeb għal kura ta ’ rajnajtis ta ’ l- infezzjoni.
Children 1 through 5 years of age:
Tfal bejn 1 u 5 snin:
2.5 ml (1.25 mg) Aerius syrup once a day.
2. 5 ml (1. 25 mg) Aerius mistura darba kuljum.
Children 6 through 11 years of age:
Tfal minn 6 sa 11- il sena:
5 ml (2.5 mg) Aerius syrup once a day.
5 ml (2. 5 mg) Aerius mistura darba kuljum.
10 ml (5 mg) Aerius syrup once a day.
Adulti u adolexxenti (minn 12- il sena ‘ l fuq): 10 ml (5 mg) Aerius mistura darba kuljum.
4.4 Special warnings and precautions for use
8 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Efficacy and safety of Aerius syrup in children under 1 year of age have not been established.
L- effikaċja u s- sigurtà tal- mistura Aerius fi tfal li għandhom anqas minn sena ma ġewx stabbiliti.
8 In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis.
Fi tfal li għandhom anqas minn sentejn, id- dijanjożi ta ’ rajnajtis allerġiku hija partikolarment diffiċli biex tagħrafha minn forom oħra ta ’ rajnajtis.
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.
Għandhom jitqiesu jekk ikunux ħielsa minn infezzjoni tat- tratt respiratorju ta ’ fuq jew anormalitajiet strutturali, kif ukoll il passat tal- pazjent, eżamijiet fiżiċi, u testijiet tal- laboratorju u tal- ġilda xierqa.
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).
Madwar 6% ta ’ l- adulti u tfal ta ’ etajiet bejn 2 u 11- il sena huma metabolizzaturi dgħajfin ta ’ desloratadine b’ mod finotipiku u juru esponiment ogħla (ara sezzjoni 5. 2).
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.
Is- sigurtà ta ’ desloratadine fi tfal ta ’ etajiet bejn 2 u 11- il sena li huma metabolizzaturi dgħajfin hija l- istess bħal dik fi tfal li huma metabolizzaturi normali.
The effects of Aerius syrup in poor metabolisers < 2 years of age have not been studied.
L- effetti ta ’ desloratadine f’ metabolizzaturi dgħajfin li għandhom < sentejn ma ġewx studjati.
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.
Dan il- prodott mediċinali fih sukrożju u sorbitol; għalhekk pazjenti li jbatu minn problemi rari ereditarji ta ’ intolleranza għall- fruktożju, problemi biex jassorbu l- glukożju- galaktożju, jew insuffiċjenza ta ’ sukrażi- iżomaltażi m’ għandhomx jieħdu din il- mediċina.
This medicinal product contains the colouring agent E110 which may cause allergic reactions.
Dan il- prodott mediċinali fih sustanza tal- kulur E110 li tista ’ tikkawża reazzjonijiet allerġiċi.
No clinically relevant interactions were observed in clinical trials with Aerius tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
Ma dehrux interazzjonijiet klinikament rilevanti waqt provi kliniċi bil- pilloli desloratadine li fihom ingħataw erythromycin jew ketoconazole fl- istess ħin (ara sezzjoni 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).
Fi prova farmakoloġika klinika, pilloli Aerius li ttieħdu flimkien ma ’ alkoħol ma żiedux l- effetti li jxekklu l- prestazzjoni ta ’ l- alkoħol (ara sezzjoni 5. 1).
Desloratadine is excreted into breast milk, therefore the use of Aerius is not recommended in breastfeeding women.
Desloratidine joħroġ fil- ħalib tas- sider, għaldaqstant l- użu ta ’ desloratidine mhuwiex rakkomandat f’ nisa li qed ireddgħu.
In clinical trials in a paediatric population, Aerius syrup was administered to a total of 246 children aged 6 months through 11 years.
Fi provi kliniċi f’ popolazzjoni pedjatrika, il- formulazzjoni ta ’ mistura ta ’ desloratadine ingħatat b’ kollox lill- 246 tifel u tifla ta ’ etajiet minn 6 xhur sa 11- il sena.
The overall incidence of adverse events in children 2 through 11 years of age was similar for the Aerius syrup and the placebo groups.
L- inċidenza globali ta ’ każijiet avversi fi tfal minn sentejn sa 11- il sena kienet simili għal gruppi fuq desloratadine u dawk fuq plaċebo.
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%).
Fi trabi żgħar u toddlers ta ’ etajiet minn 6 sa 23 xahar, l- aktar każijiet avversi rrappurtati iżjed ta ’ spiss mill- plaċebo kienu dijarea (3. 7%), deni (2. 3%) u nuqqas ta ’ rqad (2. 3%).
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.
Fi provi kliniċi ta ’ medda ta ’ indikazzjonijiet fosthom rajnajtis allerġiku u urtikarja idjopatika kronika, bid- doża rakkomandata ta ’ 5 mg kuljum, l- effetti mhux mixtieqa b’ Aerius kien rappurtati fi
Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.
Effetti mhux mixtieqa oħrajn li ġew rappurtati rari ħafna fil- perijodu ta ’ wara t- tqegħid fis- suq huma elenkati fit - tabella li ġejja.
Psychiatric disorders
Disturbi psikjatriċi Alluċinazzjonijiet Disturbi fis- sistema nervuża Sturdament, sonnolenza, nuqqas ta ’ rqad, iperattività psikomotorjali, aċċessjonijiet Disturbi fil- qalb Takikardja, u taħbit mgħaġġel tal- qalb Disturbi gastro- intestinali Uġigħ addominali, dardir, rimettar, dispepsja, dijarrea Disturbi fil- fwied u fil- marrara Żjieda fl- enżimi tal- fwied, żieda fil- bilirubin, epatite Disturbi muskolu- skeletrali u tal- connective Majalġja tissue Disturbi ġenerali Reazzjonijiet ta ’ sensittività eċċessiva (bħal reazzjonijiet anafilattiċi, anġjoedema, ħakk, raxx u urtikarja)
9
4. 9 Doża eċċessiva
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.
Minn prova klinika b’ doża multipla, li fiha ingħataw sa 45 mg desloratadine (disa ’ darbiet id- doża klinika), ma kienx hemm effetti kliniċi rilevanti.
Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code:
Kategorija farmakoterapewtika: anti- istamini antagonista H1, Kodiċi ATC:
Efficacy of Aerius syrup has not been investigated in separate paediatric trials.
L- effikaċja tal- mistura Aerius ma ġietx investigata fi provi pedjatriċi separati.
Safety of Aerius syrup was demonstrated in three paediatric trials.
Żewġ studji pedjatriċi wrew is- sigurtà tal- mistura Aerius.
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).
Tfal bejn sena u 11- il sena, li kienu kandidati għal terapija b’ anti istaminiku irċevew doża ta ’ 1. 25 mg (minn sena sa 5 snin) desloratadine kuljum jew 2. 5 mg (minn 6 sa 11- il sena).
Treatment was well tolerated as documented by clinical laboratory tests, vital signs, and ECG interval data, including QTc.
Il- kura ma għamlet l- ebda ħsara kif deher minn testijiet tal- laboratorju kliniku, sinjali vitali, u dejta ta ’ l- intervall ECG, inkluż QTc.
When given at the recommended doses, the plasma concentrations of desloratadine (see section 5.2) were comparable in the paediatric and adult populations.
10 popolazzjonijiet pedjatriċi ma dawk adulti.
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.
Għalhekk, peress li l- mod kif jiżviluppaw rajnajtis allerġiku/ urtikarja idjopatika kronika kif ukoll minħabba li l- profil ta ’ desloratadine huwa simili f’ pazjenti adulti u f' dawk pedjatriċi, it- tagħrif dwar l- effikaċja fl- adulti jista ’ jintuża bħala mudell għall- popolazzjoni pedjatrika.
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.
Fi prova klinika, f ’ adulti u adolexxenti, b’ ħafna dożi, li fiha sa 20 mg desloratadine ingħata kuljum għal 14- il ġurnata, ma kienx hemm effett kardjovaskulari klinikament jew statistikament rilevanti.
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.
Fi prova klinika farmakoloġika f ’ adulti u adolexxenti, li fiha ingħata desloratadine b’ doża ta ’ 45 mg kuljum (disa ’ darbiet id- doża klinika) għal għaxart ijiem, ma kienx hemm żieda fit- tul ta ’ l- intervall QTc.
In controlled clinical trials, at the recommended dose of 5 mg daily for adults and adolescents, there was no excess incidence of
Fi provi kliniċi bid- doża rakkomandata ta ’ 5 mg kuljum għall- adulti u adolexxenti, il- każijiet ta ’ dawk li qabadhom ngħas żejjed ma kienux aktar meta mqabbla mal- plaċebo.
Aerius tablets given at a single daily dose of 7.5 mg to adults and adolescents did not affect psychomotor performance in clinical trials.
Il- pilloli Aerius mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg lill- adulti u adolexxenti ma effettwax il- prestazzjonijiet psikomotriċi fi provi kliniċi.
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.
Fi prova b’ doża waħda li seħħet fl- adulti, desloratadine 5 mg ma effettwax il- miżuri standard tal - prestazzjoni tat- titjir fl- ajru inkluż żieda fin- ngħas jew il- ħila biex jiġu eżegwiti proċeduri relatati mat - titjir fl- ajru.
In clinical pharmacology trials in adults, co-administration with alcohol did not increase the alcohol- induced impairment in performance or increase in sleepiness.
Fi provi kliniċi farmakoloġiċi, l- għotja flimkien ma ’ alkoħoliċi ma żiedux l- effetti li jxekklu l - prestazzjoni ta ’ l- alkoħol jew żieda fin- ngħas.
Efficacy of Aerius syrup has not been investigated in paediatric trials in children less than 12 years of age.
L- effikaċja tal - ’ mistura Aerius ma ġiext investigata fi provi pedjatriċi fi tfal ta ’ taħt it- 12- il sena.
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.
F ’ pazjenti adulti u adolexxenti b’ rajnajtis allerġiku, il- pilloli Aerius, kienu effettivi biex iserrħu sintomi bħal għatis, tnixxija mill- imnieħer u ħakk, kif ukoll ħakk, dmugħ u ħmura fl- għajnejn, u ħakk fis- saqaf tal- ħalq.
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.
Il- pilloli Aerius kienu effettivi biex iserrħu il- problemi relatati ma ’ rajnajtis allerġiku ta ’ l- istaġun kif jidher mil- punteġġ totali tal- kwestjonarju fuq il- kwalità tal- ħajja b’ rajno- konġunktivite.