qanastek/EMEA-V3 huggingface dataset:
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 attivitajiet ta ’ kuljum limitati mis- sintomi.
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.
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.
Kura b’ Aerius tejjbet ukoll
Treatment with Aerius also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
11 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 desloratadine administration in adults and adolescents.
Il- konċentrazzjonijiet fil- plażma ta ’ desloratadine ikunu jistgħu jitkejjlu fi żmien 30 minuta minn meta jingħata f ’ adulti u adolexxenti.
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 prevalence of this poor metaboliser phenotype was comparable for adult (6%) and
F’ serje ta ’ provi farmakokinetiċi u kliniċi, 6% ta ’ l- individwi kisbu konċentrazzjoni ogħla ta ’ desloratadine.
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.
Il- prevalenza ta ’ dan il- finotajp ta ’ metabolizzatur batut seta ’ jitqabbel ma ’ l- individwi adulti (6%) u dawk pedjatriċi minn 2 - sa 11- il sena (6%), u ogħla fis- Suwed (18% adulti, 16% pedjatriċi) milli fil- Kawkażi (2% fl- adulti, 3% pedjatriċi) madankollu fiż- żewġ popolazzjonijiet il - profil ta ’ sigurtà ta ’ dawn l- individwi ma kienx differenti minn dak tal- popolazzjoni ġenerali.
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.
Fi studju farmakokinetiku b’ ħafna dożi li sar bil- formulazzjoni tal- pillola f’ individwi adulti b’ saħħithom, erba ’ individwi instabu li kienu metabolizzaturi dgħajjfa ta ’ desloratadine.
These subjects had a Cmax concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.
Dawn l - individwi kellhom konċentrazzjoni Cmax kważi 3- darbiet ogħla wara madwar 7 sigħat b’ half- life fil - fażi terminali ta ’ madwar 89 siegħa.
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.
Dehru parametri farmakokinetiċi simili fi studju farmakokinetiku b’ ħafna dożi li sar bil- formulazzjoni tal- mistura f’ individwi li huma metabolizzaturi dgħajfin pedjatriċi minn sentejn sa 11- il sena li kienu dijanjostikati b’ rajnajtis allerġiku.
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.
L- esponiment għal desloratadine kien madwar 6- darniet ogħla u s - Cmax kien madwar 3 sa 4 darbiet ogħla ma ’ 3- 6 sigħat b’ half life terminali ta ’ madwar 120 siegħa.
Exposure was the same in adult and paediatric poor metabolisers when treated with age-appropriate doses.
L - esponiment kien l- istess fl- adulti u metabolizzaturi dgħajfin pedjatriċi meta kkurati b’ dożi xierqa għall- età tagħhom.
The overall safety profile of these subjects was not different from that of the general population.
Il- profil ta ’ sigurtà globali f’ dawn l- individwi ma kienx differenti minn dak tal - popolazzjoni ġenerali.
The effects of Aerius syrup in poor metabolizers < 2 years of age have not been studied.
L- effetti ta ’ desloratadine f’ metabolizzaturi dgħajfin ta ’ anqas minn sentejn ma kienux studjati.
There is no evidence of clinically relevant active substance accumulation following once daily adult and adolescent dosing of desloratadine (5 mg to 20 mg) for 14 days.
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.
In a single dose, crossover study of desloratadine, the tablet and the syrup formulations were found to be bioequivalent.
Fi studju b’ doża waħda, crossover ta ’ desloratadine, il- formulazzjonijiet tal- pillola u l- mistura nstabu li kienu bioekwivalenti.
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.
Fi studji separati b’ doża waħda, bid- dożi rakkomandati, pazjenti pedjatriċi kellhom valuri ta ’ l- AUC u Cmax ta ’ desloratadine komparabbli ma ’ dawk ta ’ l- adulti li rċevew doża ta ’ 5 mg tal- mistura desloratadine.
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’ dożi waħdiet ta ’ 7. 5 mg desloratadine, ma kienx hemm effett ta ’ l- ikel (kolazzjon għoli fix - xaħam, b’ valur għoli ta ’ kaloriji) fuq id- dispożizzjoni ta ’ desloratadine.
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.
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.
12 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 riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
Propylene glycol, sorbitol, citric acid anhydrous, sodium citrate, sodium benzoate, disodium edetate,
Propylene glycol, sorbitol, Anhydrous citric acid, Sodium citrate, Sodium benzoate, disodium edetate, ilma purifikat, sukrożju, togħma naturali u artifiċjali (bubble gum), kulur oranġjo E110.
Store in the original package.
Aħżen fil- kontenitur oriġinali.
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.
Il- mistura Aerius issibha fi fliexken ta ’ 30, 50, 60, 100, 120, 150, 225, u 300 ml ġo fliexken tal- ħġieġ ambra tip III magħluqa b’ tapp tal- polipropajlin li ma jinfetaħx mit- tfal.
The caps have a liner made of Low Density Polyethylene (LDPE), polyethylene foam, ethylenevinylacetate (EVA), and polyvinylidene chloride (PvDC).
It- tappijiet għandhom kisja ta ’ Politajlin ta ’ Densità Baxxa (Low Density Polyethylene) (LDPE), fowm tal - polyethylene, ethylenevinyl acetate( EVA), u l - polyvinylidene chloride (PvDC).
LDPE is the product contact surface.
LDPE huwa l- wiċċ li jmiss mal- prodott.
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).
Għall- pakkett ta ’ 150 ml, hemm kuċċarina tal- kejl jew b’ siringa waħda għall- ħalq bil- kejl, immarkati għad- dożi tat - 2. 5 ml u 5 ml.
Aerius 5 mg oral lyophilisate
Aerius 5 mg lajofiliżejt li jittieħed mill- ħalq
Each dose of Aerius oral lyophilisate contains 5 mg desloratadine.
Kull doża ta ’ Aerius lajofiliżejt li jittieħed mill- ħalq fiha 5 mg desloratadine.
PHARMACEUTICAL form
GĦAMLA FARMAĊEWTIKA
Oral lyophilisate
Lajofiliżejt li jittieħed mill- ħalq
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).
Adulti u adolexxenti (minn tnax- il sena ’ l fuq): doża waħda ta ’ Aerius lajofiliżejt li jittieħed mill- ħalq titpoġġa fil- ħalq darba kuljum biex jittaffu s- sintomi assoċjati ma ’ rajnajtis allerġiku (inkluż rajnajtis allerġiku intermittenti u dak persistenti) u urtikarja (ara sezzjoni 5. 1).
Aerius oral lyophilisate disperses instantly and water or other liquid is not needed.
Aerius lajofiliżejt li jittieħed mill- ħalq jinxtered mill- ewwel u ilma jew likwidu ieħor mhumiex neċessarji.
The dose can be taken regardless of mealtime.
Id- doża m’ hemmx għalfejn tittieħed skond il- ħin tal- ikel.
Immediately before use, the blister must be carefully peeled open and the dose of oral lyophilisate removed without crushing it.
Eżatt qabel ma ’ tintuża, il- folja għandha tinfetaħ bir- reqqa u d- doża tal- lajofiliżejt li tittieħed mill- ħalq titneħħa mingħajr ma tgħaffiġha.
The dose of oral lyophilisate is placed in the mouth where it will disperse immediately.
Id- doża tal- lajofiliżejt li tittieħed mill- ħalq titpoġġa fil - ħalq fejn hi tinfirex immedjatament.
Water or other liquid is not needed to swallow the dose.
Ilma jew likwidu ieħor mhumiex neċessarji biex tibla ’ d- doża.
The dose must be taken as soon as the blister has been opened.
Id- doża għandha tittieħed hekk kif tinfetaħ il- folja.
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 fit- tfal taħt it- tnax- il sena ma ġewx stabbiliti.
In the case of severe renal insufficiency, Aerius should be used with caution.
F’ każ ta ’ insuffiċjenza renali severa, Aerius għandu jintuża b’ attenzjoni.
15 This product contains aspartame 1.75 mg per dose.
15 Dan il- prodott fih 1. 75 mg aspartima f’ kull doża.
Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
Aspartima hu sors ta ’ phenylalanine, li jista’ jkun ta ’ ħsara għal min għandu finajlketonurja.
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.
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.
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.
4.9 Overdose
16 4. 9 Doża eċċessiva
16 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.
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.
F’ żewġ provi b’ dożi ta ’ darba, Aerius lajofiliżejt orali kienu jifilħu għalih tajjeb kif huwa dokumentat bis- sejbiet tal- laboratorju kliniku, eżamijiet fiżiċi, sinjali vitali, u dejta ta ’ l- intervall ECG.
At the recommended dose, Aerius oral lyophilisate was found to be bioequivalent to the conventional tablet formulation of desloratadine.
Bid- doża rakkomandata, Aerius lajofiliżejt li jittieħed mill- ħalq instabet li hija bioekwivalenti għall - formulazzjoni tal- pillola ta ’ desloratadine.
Therefore, the efficacy of Aerius oral lyophilisate is expected to be the same as with the Aerius tablet formulation.
Għaldaqstant, l- effikaċja ta ’ Aerius lajofiliżejt li jittieħed mill- ħalq hija mistennija li tkun l- istess bħall Aerius fil- formulazzjoni ta’ pillola.
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.
In 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 tablets 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 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 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 effectively controlled symptoms for 24 hours.
17 Aerius itaffi b’ mod effettiv s- sintomi għal 24 siegħa.
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.
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.
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 tlett darbiet aktar għolja wara madwar seba ’ 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 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 subtrat u l- anqas inibitur tal- glajkoproteina- P.
In single-dose crossover studies of Aerius oral lyophilisate with Aerius tablets, the formulations were bioequivalent.
Fi studji crossover ta ’ Aerius lajofiliżejt li jittieħed mill- ħalq ma ’ Aerius pilloli, il- formulazzjonijiet kienu bijoekwivalenti.
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.
18 Il- preżenza ta ’ l- ikel ma teffettwax b’ mod relevanti l- AUC u Cmax tal- lajofilizzat orali Aerius filwaqt li meta jkun hemm l- ikel, it- Tmax ta ’ desloratadine titwal minn 2. 5 għal 4 sigħat u t- Tmax għal 3- OH - desloratadine minn 4 għal 6 sigħat.
In a separate study, grapefruit juice had no effect on the disposition of desloratadine.
Fi studju separat, il- meraq tal- grejfrut ma kellu l- ebda effett fuq id - dispożizzjoni ta ’ desloratadine.
18 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is - sigurtà tal- mediċina
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 riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
No significant local irritant effect was observed when the rapidly-dissolving form was tested in a hamster cheek pouch mucous membrane irritation assay.
Ma deherx effett irritanti sinifikanti meta l - forma li tinħall malajr kienet ittestjata b’ essej għall- irritazzjoni tal- membrana mukuża tal- borża ta ’ ħaddejn il- ħamster.
gelatin mannitol aspartame (E951) polacrilin potassium Dye Opatint Red (containing red iron oxide (E172) and hypromellose (E464)) flavour Tutti-Frutti citric acid anhydrous
gelatin mannitol aspartame (E951) polacrilin potassium Kulur Opatint Aħmar (li fih red iron oxide (E172) u hypromellose( E464)) Togħma tat- Tutti- Frutti citric acid anhydrous
Not applicable.
Ma jgħoddx f’ dan il - każ.
Aerius oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Aerius lajofiliżejt li jittieħed mill- ħalq issibu ġo folja għal kull doża li tikkonsisti f’ rita llaminata tal - folji magħluqha bil- fojl.
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.
Il materjali tal- folja jikkonsistu f’ rita tal- polyvinyl chloride (PVC) (il- wiċċ li jmiss mal- prodott) b’ għatu tal- fojl ta ’ l- aluminju inkorporat miksi b’ rita tal- vinyl imwaħħla billi tissaħħan (il - wiċċ li jmiss il- prodott) li hija magħluqa billi tissaħħan.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 doses of oral lyophilisate.
Pakketti ta ’ 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 dożi ta ’ lajofiliżejt li jittieħed mill- ħalq.
Aerius 2.5 mg orodispersible tablets
Aerius 2. 5 mg pilloli li jinħallu fil- ħalq
Each dose of Aerius orodispersible tablet contains 2.5 mg desloratadine.
Kull doża ta ’ Aerius pillola li tinħall fil- ħalq fiha 2. 5 mg desloratadine.
Orodispersible Tablet
Pillola li tinħall fil- ħalq
Light-red, flat-faced, round, speckled tablets, one side branded with “ K”
Pilloli ħomor ċari, b’ wiċċ ċatt, tondi, ittikkjati, b’ naħa minnhom markata b ’ “ K ”
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).
Pillola Aerius li tinħall fil- ħalq waħda ta ’ 2. 5 mg li titqiegħed fil- ħalq darba kuljum biex jittaffu s- sintomi assoċjati ma ’ rajnajtis allerġiku (inkluż rajnajtis allerġiku intermittenti u dak persistenti) u urtikarja (ara sezzjoni 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).
Adulti u adolexxenti (12- il sena jew akbar): żewġ pilloli Aerius li jinħallu fil- ħalq ta ’ 2. 5 mg li jitqiegħedu fil- ħalq darba kuljum biex jittaffu s- sintomi assoċjati ma ’ rajnajtis allerġiku (inkluż rajnajtis allerġiku intermittenti u dak persistenti) u urtikarja (ara sezzjoni 5. 1).
The dose can be taken regardless of mealtime.
Id- doża tista ’ tittieħed irrispettivament mill- ħin ta ’ l- ikel.
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 immaniġġjata skond l- evalwazzjoni tal- passat mediku tal- pazjent u l- kura għandha titwaqqaf wara li s- sintomi jgħaddu u terġa ’ tinbeda meta jerġgħu jitfaċċaw.
Immediately before use, the blister must be carefully peeled open and the dose of orodispersible tablet removed without crushing it.
Eżatt qabell- użu, il- folja għandha titqaxxar b’ kawtela biex tinfetaħ u d- doża tal- pillola li tinħall fil - ħaql titneħħa mingħajr ma tgħaffiġha.
The dose of orodispersible tablet is placed in the mouth where it will disperse immediately.
Id- doża tal- pillola li tinħall fil- ħalq titqiegħed fil- ħalq fejn ser tinħall mill- ewwel.
Water or other liquid is not needed to swallow the dose.
M’ hemmx bżonn li tixrob l- ilma jew likwidi oħra biex tibla ’ d- doża.
The dose must be taken as soon as the blister has been opened.
Id- doża għandha tittieħed malli tinfetaħ il- folja.
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 2.5 mg orodispersible tablets in children under 6 years of age have not been established.
L- effikaċja u s- sigurtà tal- pilloli li jinħallu fil- ħalq Aerius 2. 5 mg fi tfal taħt is- 6 snin ma ġewx stabiliti.
This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Aerius orodispersible tablet.
Dan il- prodott fih 1. 4 mg phenylalanine għal kull doża ta ’ 2. 5 mg ta ’ pillola li tinħall fil- ħalq Aerius.
Phenylalanine may be harmful for people with phenylketonuria.
Phenylalanine jista ’ jgħamel il- ħsara f’ pazjenti li jbatu minn fenajlkitonurja.
In clinical trials, desloratadine in the syrup formulation was administered to a paediatric population.
Fi provi kliniċi, desloratidine f’ għamla ta ’ mistura ngħata lill- popolazzjoni pedjatrika.
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.
Il- frekwenza ta ’ effetti avversi ġenerali kienu l- istess bejn il- grupp li ngħata l- mistura desloratidine u dak tal- plaċebo u ma kienx differenti b’ mod sinifikanti mill- profil ta ’ sigurtà li deher fil- pazjenti adulti.
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.
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 tal- pilloli 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%).
22 Psychiatric disorders Nervous system disorders
22 Alluċinazzjonijiet Disturbi psikjatriċi Sturdament, ngħas, nuqqas ta ’ rqad, iperattività Disturbi fis- sistema nervuża psikomotorjali, aċċessjonijiet Takikardja, palpitazzjonijiet Disturbi fil- qalb Uġigħ addominali, dardir, rimettar, dispepsja, diareja Disturbi gastro- intestinali Enzimi tal- fwied għoljin, bilirubin għoli, epatite Disturbi fil- fwied u fil- marrara Majalġja Disturbi muskolu- skeletrali u tal- connective tissue Reazzjonijiet ta ’ sensitività eċċessiva (bħall Disturbi ġenerali anafilassi, anġjoedima, qtugħ ta ’ nifs, ħakk, raxx u urtikarja)
Hepatobiliary disorders
4. 9 Doża eċċessiva
Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code:
Kategorija farmakoterapewtika: anti- istaminiċi – antagonist H1, Kodiċi ATC:
In addition, Aerius orodispersible tablets were well tolerated in a multiple dose trial.
Minbarra hekk, il- pilloli li jinħallu fil- ħalq Aerius, kienu jifilħu għalihom tajjeb fi prova b’ ħafna dożi.
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.
Bid- doża rakkomandata, il- pillola li tinħall fil- ħalq Aerius 5 mg instabet li hija bioekwivalenti għall - pillola konvenzjonali Aerius 5 mg u l- formulazzjonijiet lajofilizzati orali ta ’ desloratadine, Aerius 5 mg.
Therefore, the efficacy of Aerius orodispersible tablet is expected to be the same as with the Aerius tablet formulation.
Għaldaqstant, l- effikaċja tal- pillola li tinħall fil- ħalq Aerius hija mistennija li tkun l- istess bħall Aerius fil- formulazzjoni ta’ pillola.
23 Desloratadine does not readily penetrate the central nervous system.
23 Desloratadine ma jippenetrax malajr fis- sistema nervuża ċentrali.
Aerius tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Il- pilloli Aerius mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg ma effettwax il - prestazzjonijiet psikomotriċi fi provi kliniċi.
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.
F’ pazjenti 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 effectively controlled symptoms for 24 hours.
Il- pilloli Aerius ikkontrollaw is- sintomi b’ mod effettiv għal 24 siegħa.
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 ikklassifikat bħala rajnajtis allerġiku intermittenti u rajnajtis allerġiku persistenti skond kemm idumu s- sintomi.
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.
Aerius kien effettiv biex iserraħ il- problemi relatati ma ’ rajnajtis allerġiku ta ’ l- istaġun kif jidher mill - punteġġ totali tal- kwestjonarju fuq il- kwalità tal- ħajja b’ rajno- konġunktivite.
In a series of pharmacokinetic and clinical trials, 6% of the subjects reached a higher concentration of desloratadine.
F’ serje ta ’ provi farmakokinetiċi u kliniċi, 6% ta ’ l- individwi kisbu konċentrazzjoni ogħla ta ’ desloratadine.
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.
Madankollu fiż- żewġ popolazzjonijiet il - profil ta ’ sigurtà ta ’ dawn l- individwi ma kienx differenti minn dak tal- popolazzjoni ġenerali.
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.
24 Fi studju farmakokinetiku b’ ħafna dożi li sar bil- formulazzjoni tal- pillola f’ individwi adulti b’ saħħithom, erba ’ individwi nstabu li kienu metabolizzaturi dgħajjfa ta ’ desloratadine.
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- enzima risponsabbli għal metaboliżmu ta ’ desloratadine għadha ma ġietx identifikata, u għalhekk, xi interazzjonijiet ma ’ xi prodotti mediċinali oħra ma jistgħux jiġu esklużi għal kollox.
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.
Fi studji crossover ta ’ pilloli li jinħallu fil- ħalq Aerius 5 mg ma ’ pilloli konvenzjonali Aerius 5 mg jew lajofilzzat orali Aerius 5 mg, il- formulazzjonijiet kienu bioekwivalenti.
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.
Il- pilloli Aerius 2. 5 mg ma ġewx evalwati f’ pazjenti pedjatriċi madankollu b’ relazzjoni ma ’ l- istudji dwar is- sejbiet tad- doża f’ pedjatriċi, id- dejta farmakokinetiċi għall- pilloli li jinħallu fil- ħalq Aerius jiffavorixxu l- użu tad- doża ta ’ 2. 5 mg fil- pazjenti pedjatriċi bejn 6 u 11- il sena.
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.
Il- preżenza ta ’ l- ikel ma teffettwax b’ mod rilevanti l- AUC u Cmax tal- lajofilizzat orali Aerius filwaqt li meta jkun hemm l- ikel, it- Tmax ta ’ desloratadine titwal minn 2. 5 għal 4 sigħat u t- Tmax għal 3- OH- desloratadine minn 4 għal 6 sigħat.
In a separate study, grapefruit juice had no effect on the disposition of desloratadine.
Fi studju separat, il- meraq tal- grejfrut ma kellu l- ebda effett fuq id- dispożizzjoni ta ’ desloratadine.
Water had no affect on the bioavailability of Aerius orodispersible tablets.
L- ilma ma kellux effett fuq il- biodisponibilità tal- pilloli li jinħallu fil- ħalq Aerius.
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.
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.
L- analiżi kollettiva ta ’ studji fuq l - irritazzjoni ta ’ qabel l- użu kliniku kif ukoll dawk kliniċi għall- pillola li tinħall fil- ħalq juru li din il - formulazzjoni mhux probabbli li jkollha riskju li tikkawża irritazzjoni lokali bl- użu kliniku.
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
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) Togħma ta ’ Tutti- Frutti
6.2 Incompatibilities 25 Not applicable.
25 6. 2 Inkompatibilitajiet
Store in the original package.
Aħżen fil- pakett oriġinali.
Aerius orodispersible tablets are supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Il- pilloli li jinħallu fil- ħalq Aerius jiġu f’ dożi individwali ġo folji mgħamula minn folja laminata b’ fojl b’ kisja ta ’ rita biex tgħalaq.
The blister materials consist of a four layer aluminum foil laminate cold form blister film and a paper backed laminated aluminum foil lidding film.
Il- materjali tal- folji mgħamula minn erba ’ saffi ta ’ fojl ta ’ aluminium laminat fil- forma kiesħa għar - rita tal- folji u fojl ta ’ l- aluminium miksi b’ karta laminata minn wara b’ kisja ta ’ rita biex tgħalaq.
The cold form blister film is composed of polyvinyl chloride (PVC) film adhesively laminated to an oriented polyamide (OPA) film, adhesively laminated to aluminum foil, adhesively laminated to polyvinyl chloride (PVC) film.
Ir- rita fil- forma kiesħa tal- folja hija mgħamula minn rita ta ’ polyvinyl chloride (PVC) laminata b’ kolla ma ’ rita ta ’ polyamide orjentat (OPA), laminat b’ kolla ma ’ fojl ta ’ l- aluminum, laminat b’ kolla ma ’ rita ta ’ polyvinyl chloride (PVC).
Packs of 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 orodispersible tablets.
Pakketti ta ’ 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 u 100 pilloli li jinħallu fil- ħalq.
Aerius 5 mg orodispersible tablets
Aerius 5 mg pilloli li jinħallu fil- ħalq
Each dose of Aerius orodispersible tablet contains 5 mg desloratadine.
Kull doża ta ’ Aerius pillola li tinħall fil- ħalq fiha 5 mg desloratadine.
Light-red, flat-faced, round, speckled tablets, one side branded with “ A”
Pilloli ħomor ċari, b’ wiċċ ċatt, tondi, ittikkjati, b’ naħa minnhom markata b ’ “ A ”
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).
Adulti u adolexxenti (12- il sena jew akbar): pillola Aerius li tinħall fil- ħalq ta ’ 5 mg li titqiegħed fil - ħalq darba kuljum biex ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (inkluż rajnajtis allerġiku intermittenti u dak persistenti) u urtikarja (ara sezzjoni 5. 1).
Immediately before use, the blister must be carefully peeled open and the dose of orodispersible tablet removed without crushing it.
Eżatt qabell- użu, il- folja għandha titqaxxar b’ kawtela biex tinfetaħ u d- doża tal- pillola li tinħall fil - ħalq titneħħa mingħajr ma tgħaffiġha.
27 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Efficacy and safety of Aerius orodispersible tablets in children under 12 years of age have not been established.
L- effikaċja u s- sigurtà tal- pilloli li jinħallu fil- ħalq Aerius fi tfal taħt it- 12- il sena ma ġewx stabbiliti.
In the case of severe renal insufficiency, Aerius should be used with caution.
27 F’ każ ta ’ insuffiċjenza renali severa, Aerius għandu jintuża b’ attenzjoni.
This product contains 2.9 mg of phenylalanine per 5 mg dose of Aerius orodispersible tablet.
Dan il- prodott fih 2. 9 mg phenylalanine għal kull doża ta ’ 5 mg ta ’ pillola li tinħall fil- ħalq Aerius.
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Alluċinazzjonijiet Disturbi psikjatriċi Sturdament, ngħas, nuqqas ta ’ rqad, iperattività Disturbi fis- sistema nervuża psikomotorjali, aċċessjonijiet Takikardja, palpitazzjonijiet Disturbi fil- qalb Uġigħ addominali, dardir, rimettar, dispepsja, diareja Disturbi gastro- intestinali Enzimi tal- fwied għoljin, bilirubin għoli, epatite Disturbi fil- fwied u fil- marrara Majalġja Disturbi muskolu- skeletrali u tal- connective tissue Reazzjonijiet ta ’ sensitività eċċessiva (bħall Disturbi ġenerali anafilassi, anġjoedima, qtugħ ta ’ nifs, ħakk, raxx u urtikarja)
28 4.9 Overdose
4. 9 Doża eċċessiva
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.
28 Minn prova klinika b’ doża multipla, li fiha ingħataw sa 45 mg desloratadine (disa ’ darbiet id- doża klinika), ma kienx hemm effetti kliniċi rilevanti.
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 jgħinuim 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.
In addition, Aerius orodispersible tablets were well tolerated in a multiple-dose trial.
Minbarra hekk, il- pilloli li jinħallu fil- ħalq Aerius, kienu jifilħu għalihom tajjeb fi prova b’ ħafna dożi.
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.
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.
F’ pazjenti 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.
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.
29 Minbarra l- klassifikazzjonijiet stabbiliti ta ’ l- istaġun u perenni, rajnajtis allerġiku jista ’ minflok ikun ikklassifikat bħala rajnajtis allerġiku intermittenti u rajnajtis allerġiku persistenti skond kemm idumu s- sintomi.
2%) however the safety profile of these subjects was not different from that of the general population.
Il- prevalenza ta ’ dan il- finotajp ta ’ metabolizzatur batut kienet ogħla f’ adulti Suwed milli f’ adulti Kawkażi (18% vs 2%) madankollu fiż- żewġ popolazzjonijiet il- profil ta ’ sigurtà ta ’ dawn l- individwi ma kienx differenti minn dak tal- popolazzjoni ġenerali.
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.
Fi studju farmakokinetiku b’ ħafna dożi li sar bil- formulazzjoni tal- pillola f’ individwi adulti b’ saħħithom, erba ’ individwi nstabu li kienu metabolizzaturi dgħajjfa ta ’ desloratadine.
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.
Fi studji crossover ta ’ pilloli li jinħallu fil- ħalq Aerius 5 mg ma ’ pilloli konvenzjonali Aerius 5 mg jew lajofilzzat orali Aerius 5 mg, il- formulazzjonijiet kienu bioekwivalenti.
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.
30 Il- preżenza ta ’ l- ikel ma teffettwax b’ mod rilevanti l- AUC u Cmax tal- lajofilizzat orali Aerius filwaqt li meta jkun hemm l- ikel, it- Tmax ta ’ desloratadine titwal minn 2. 5 għal 4 sigħat u t- Tmax għal 3- OH- desloratadine minn 4 għal 6 sigħat.
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.
L- analiżi kollettiva ta ’ studji fuq l - irritazzjoni ta ’ qabel l- użu kliniku kif ukoll dawk kliniċi għall- pillola li tinħall fil- ħalq juru li din il - formulazzjoni mhux probabbli li jkollha riskju li tikkawża irritazzjoni lokali bl- użu kliniku.
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.
Il- materjali tal- folji mgħamula minn erba ’ saffi ta ’ fojl ta ’ aluminium laminat fil- forma kiesħa għar - rita tal- folji u fojl ta ’ l- aluminium miksi b’ karta laminata minn wara b’ kisja ta ’ rita biex tgħalaq.
The cold form blister film is composed of polyvinyl chloride (PVC) film adhesively laminated to an oriented polyamide (OPA) film, adhesively laminated to aluminum foil, adhesively laminated to polyvinyl chloride (PVC) film.
31 Ir- rita fil- forma kiesħa tal- folja hija mgħamula minn rita ta ’ polyvinyl chloride (PVC) laminata b’ kolla ma ’ rita ta ’ polyamide orjentat (OPA), laminat b’ kolla ma ’ fojl ta ’ l- aluminum, laminat b’ kolla ma ’ rita ta ’ polyvinyl chloride (PVC).
Aerius 0.5 mg/ ml oral solution
Aerius 0. 5 mg/ ml soluzzjoni orali
Each ml of oral solution contains 0.5 mg desloratadine.
Kull ml ta ’ soluzzjoni orali fih 0. 5 mg desloratadine.
This medicinal product contains 150 mg/ ml of sorbitol
Dan il- prodott mediċinali fih 150 mg/ ml ta ’ sorbitol
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 jkun jaf li ħafna mill- każi 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 minn sena 1 sa 5 snin:
2.5 ml (1.25 mg) Aerius oral solution once a day.
2. 5 ml (1. 25 mg) Aerius soluzzjoni orali darba kuljum.
Children 6 through 11 years of age:
Tfal minn 6 snin sa 11- il sena:
5 ml (2.5 mg) Aerius oral solution once a day.
5 ml (2. 5 mg) Aerius soluzzjoni orali darba kuljum.
In adults and adolescents (12 years of age and over):
F’ adulti u adolexxenti (minn 12- il sena ’ l fuq):
10 ml (5 mg) Aerius oral solution once a day.
10 ml (5 mg) Aerius soluzzjoni orali darba kuljum.
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.
33 4.4 Special warnings and precautions for use
33 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Efficacy and safety of Aerius oral solution in children under 1 year of age have not been established.
L- effikaċja u s- sigurtà tas- soluzzjoni orali Aerius fi tfal li għandhom anqas minn sena ma ġewx stabbiliti.
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 xorta 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.
Wieħed għandu jati kas jekk ikollhomx infezzjoni tat- tratt respiratorju ta ’ fuq jew anormalitajiet strutturali, kif ukoll l- istorja tal- pazjent, eżamijiet fiżiċi, u testijiet xierqa tal- laboratorju u tal- ġilda.
The safety of desloratadine in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.
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 desloratadine 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 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 sorbitol; għalhekk, pazjenti li għandhom mard rari li jintiret ta ’ intolleranza għal fructose, malassorbiment ta ’ glucose- galactose jew insuffiċjenza ta ’ sucrase - isomaltase m’ għandhomx jieħdu din il- mediċina.
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 irrakkomandat f’ nisa li qed ireddgħu.
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.
Fi provi kliniċi fit- tfal, il- formulazzjoni ta ’ mistura ta ’ desloratadine ingħatat b’ kollox lil 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 desloratadine and the placebo groups.
L- inċidenza globali ta ’ każi avversi fi tfal minn sentejn sa 11- il sena kienet simili għal gruppi fuq desloratadine u dawk fuq plaċebo.
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.
Fi studju ieħor, ma dehrux każi avversi f’ individwi ta ’ etajiet bejn 6 u 11- il sena wara doża waħda ta ’ 2. 5 mg ta ’ soluzzjoni orali ta ’ desloratadine.
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 li saru f’ adulti u adolexxenti fuq medda ta ’ indikazzjonijiet fosthom rajnajtis allerġiku u urtikarja idjopatika kronika, bid- doża rakkomandata ta ’ 5 mg kuljum, l- effetti mhux mixtieqa tal - pilloli 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
34 Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.
34 frekwenti li kienu rappurtati aktar minn dak tal- plaċebo kienu għeja (1. 2%), ħalq xott (0. 8%) u uġigħ ta ’ ras (0. 6%).
Musculoskeletal and connective tissue disorders General disorders
Effetti mhux mixtieqa oħrajn li ġew rappurtati rari ħafna fil- perijodu ta ’ wara t- tqegħid fis- suq huma elenkati fit- tabella li ġejja.
Efficacy of Aerius oral solution has not been investigated in separate paediatric trials.
L- effikaċja tas- soluzzjoni orali Aerius ma ġietx investigata fi provi pedjatriċi separati.
However, the safety of Aerius syrup, which contains the same concentration of desloratadine, was demonstrated in three paediatric trials.
Iżda, is- sigurtà tal- mistura Aerius, li fiha l- istess konċentrazzjoni ta ’ desloratadine, intweriet fi tliet provi fit- tfal.
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.
Meta ingħata bid- dożi rrakkomandati, il- konċentrazzjonijiet ta ’ desloratadine fil- plażma (ara sezzjoni 5. 2) kienu komparabbli fil- popolazzjonijiet pedjatriċi ma ’ dawk adulti.
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 b’ ħafna dożi f’ adulti u adolexxenti, 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
Fi prova