qanastek/EMEA-V3 huggingface dataset:
Desloratadine is excreted into breast milk, therefore the use of Azomyr 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 in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Azomyr 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’ Azomyr kien rappurtati fi 3% tal - pazjenti aktar minn dawk fuq plaċebo.
Azomyr given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Azomyr mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg ma effettwax il - prestazzjonijiet psikomotriċi fi provi kliniċi.
In patients with allergic rhinitis, Azomyr 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, Azomyr, 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.
Azomyr effectively controlled symptoms for 24 hours.
Azomyr itaffi b’ mod effettiv s- sintomi għal 24 siegħa.
The efficacy of Azomyr tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
L- effikaċja tal- pilloli Azomyr ma ntwerietx b’ mod ċar fi provi bi pazjenti adolexxenti minn 12 sa 17- il sena.
Azomyr 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 Azomyr 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.
4 In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Azomyr 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, Azomyr kien effettiv biex iserraħ il- ħakk u jnaqqas id- daqs u n- numru ta ’ ħbiebes fl- aħħar ta ’ l- ewwel intervall tad- dożaġġ.
Treatment with Azomyr also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Kura b’ Azomyr 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.
Azomyr is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
Azomyr issibu ġo folja għal kull doża li tikkonsisti f’ rita llaminata tal- folji magħluqa bil- fojl.
Azomyr 0.5 mg/ ml syrup
Azomyr 0. 5 mg/ ml mistura
Azomyr 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).
Azomyr 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 Azomyr.
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 Azomyr huwa tajjeb għal kura ta ’ rajnajtis ta ’ l- infezzjoni.
2.5 ml (1.25 mg) Azomyr syrup once a day.
2. 5 ml (1. 25 mg) Azomyr mistura darba kuljum.
5 ml (2.5 mg) Azomyr syrup once a day.
5 ml (2. 5 mg) Azomyr mistura darba kuljum.
10 ml (5 mg) Azomyr syrup once a day.
Adulti u adolexxenti (minn 12- il sena ‘ l fuq): 10 ml (5 mg) Azomyr mistura darba kuljum.
Efficacy and safety of Azomyr syrup in children under 1 year of age have not been established.
L- effikaċja u s- sigurtà tal- mistura Azomyr fi tfal li għandhom anqas minn sena ma ġewx stabbiliti.
The safety of Azomyr 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 Azomyr 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.
No clinically relevant interactions were observed in clinical trials with Azomyr 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, Azomyr tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Fi prova farmakoloġika klinika, pilloli Azomyr 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 Azomyr 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, Azomyr 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 Azomyr 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.
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 Azomyr 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’ Azomyr kien rappurtati fi
Efficacy of Azomyr syrup has not been investigated in separate paediatric trials.
L- effikaċja tal- mistura Azomyr ma ġietx investigata fi provi pedjatriċi separati.
Safety of Azomyr syrup was demonstrated in three paediatric trials.
Żewġ studji pedjatriċi wrew is- sigurtà tal- mistura Azomyr.
Azomyr 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 Azomyr mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg lill- adulti u adolexxenti ma effettwax il- prestazzjonijiet psikomotriċi fi provi kliniċi.
Efficacy of Azomyr syrup has not been investigated in paediatric trials in children less than 12 years of age.
L- effikaċja tal - ’ mistura Azomyr ma ġiext investigata fi provi pedjatriċi fi tfal ta ’ taħt it- 12- il sena.
In adult and adolescent patients with allergic rhinitis, Azomyr 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 Azomyr, 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.
Azomyr 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 Azomyr 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.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Azomyr 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, Azomyr 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’ Azomyr tejjbet
Treatment with Azomyr also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
11 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.
The effects of Azomyr 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.
Azomyr 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 Azomyr 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.
Azomyr 5 mg oral lyophilisate
Azomyr 5 mg lajofiliżejt li jittieħed mill- ħalq
Each dose of Azomyr oral lyophilisate contains 5 mg desloratadine.
Kull doża ta ’ Azomyr lajofiliżejt li jittieħed mill- ħalq fiha 5 mg desloratadine.
Adults and adolescents (12 years of age and over): one dose of Azomyr 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 ’ Azomyr 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).
Azomyr oral lyophilisate disperses instantly and water or other liquid is not needed.
Azomyr lajofiliżejt li jittieħed mill- ħalq jinxtered mill- ewwel u ilma jew likwidu ieħor mhumiex neċessarji.
Efficacy and safety of Azomyr tablets in children under 12 years of age have not been established.
L- effikaċja u s- sigurtà tal- pilloli Azomyr fit- tfal taħt it- tnax- il sena ma ġewx stabbiliti.
In the case of severe renal insufficiency, Azomyr should be used with caution.
F’ każ ta ’ insuffiċjenza renali severa, Azomyr għandu jintuża b’ attenzjoni.
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 Azomyr 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’ Azomyr kien rappurtati fi 3% tal- pazjenti aktar minn dawk fuq plaċebo.
In two single-dose trials, Azomyr 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, Azomyr 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, Azomyr oral lyophilisate was found to be bioequivalent to the conventional tablet formulation of desloratadine.
Bid- doża rakkomandata, Azomyr lajofiliżejt li jittieħed mill- ħalq instabet li hija bioekwivalenti għall - formulazzjoni tal- pillola ta ’ desloratadine.
Therefore, the efficacy of Azomyr oral lyophilisate is expected to be the same as with the Azomyr tablet formulation.
Għaldaqstant, l- effikaċja ta ’ Azomyr lajofiliżejt li jittieħed mill- ħalq hija mistennija li tkun l- istess bħall Azomyr fil- formulazzjoni ta’ pillolaAzomyr.
Azomyr tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Azomyr mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg ma effettwax il - prestazzjonijiet psikomotriċi fi provi kliniċi.
In patients with allergic rhinitis, Azomyr 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 Azomyr, 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.
Azomyr tablets effectively controlled symptoms for 24 hours.
17 Azomyr itaffi b’ mod effettiv s- sintomi għal 24 siegħa.
17 Azomyr 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 Azomyr 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.
In single-dose crossover studies of Azomyr oral lyophilisate with Azomyr tablets, the formulations were bioequivalent.
Fi studji crossover ta ’ Azomyr lajofiliżejt li jittieħed mill- ħalq ma ’ Azomyr pilloli, il- formulazzjonijiet kienu bijoekwivalenti.
The presence of food has no relevant influence on AUC and Cmax of Azomyr 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 Azomyr filwaqt li meta jkun hemm l- ikel, it- AzomyrTmax ta ’ desloratadine titwal minn 2. 5 għal 4 sigħat u t- Tmax għal 3 - OH- desloratadine minn 4 għal 6 sigħat.
5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is - sigurtà tal- mediċina
18 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.
Azomyr oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Azomyr lajofiliżejt li jittieħed mill- ħalq issibu ġo folja għal kull doża li tikkonsisti f’ rita llaminata tal - folji magħluqha bil- fojl.
Azomyr 2.5 mg orodispersible tablets
Azomyr 2. 5 mg pilloli li jinħallu fil- ħalq
Each dose of Azomyr orodispersible tablet contains 2.5 mg desloratadine.
Kull doża ta ’ Azomyr pillola li tinħall fil- ħalq fiha 2. 5 mg desloratadine.
Children 6 to 11 years of age: one 2.5 mg Azomyr 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 Azomyr 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 Azomyr 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 Azomyr 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).
Efficacy and safety of Azomyr 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 Azomyr 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 Azomyr orodispersible tablet.
Dan il- prodott fih 1. 4 mg phenylalanine għal kull doża ta ’ 2. 5 mg ta ’ pillola li tinħall fil- ħalq Azomyr.
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 Azomyr 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 Azomyr kien rappurtati fi 3% tal- pazjenti aktar minn dawk fuq plaċebo.
In addition, Azomyr orodispersible tablets were well tolerated in a multiple dose trial.
Minbarra hekk, il- pilloli li jinħallu fil- ħalq Azomyr, kienu jifilħu għalihom tajjeb fi prova b’ ħafna dożi.
At the recommended dose, Azomyr 5 mg orodispersible tablet was found to be bioequivalent to the Azomyr 5 mg conventional tablet and the Azomyr 5 mg oral lyophilisate formulations of desloratadine.
Bid- doża rakkomandata, il- pillola li tinħall fil- ħalq Azomyr 5 mg instabet li hija bioekwivalenti għall - pillola konvenzjonali Azomyr 5 mg u l- formulazzjonijiet lajofilizzati orali ta ’ desloratadine, Azomyr 5 mg.
Therefore, the efficacy of Azomyr orodispersible tablet is expected to be the same as with the Azomyr tablet formulation.
Għaldaqstant, l- effikaċja tal- pillola li tinħall fil- ħalq Azomyr hija mistennija li tkun l- istess bħall Azomyr fil- formulazzjoni ta’ pillola.
Azomyr tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Il- pilloli Azomyr mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg ma effettwax il- prestazzjonijiet psikomotriċi fi provi kliniċi.
In patients with allergic rhinitis, Azomyr 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 Azomyr 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.
Azomyr tablets effectively controlled symptoms for 24 hours.
Il - pilloli Azomyr ikkontrollaw is- sintomi b’ mod effettiv għal 24 siegħa.
Azomyr was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Azomyr 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 single-dose crossover studies of Azomyr 5 mg orodispersible tablets with Azomyr 5 mg conventional tablets or Azomyr 5 mg oral lyophilisate, the formulations were bioequivalent.
Fi studji crossover ta ’ pilloli li jinħallu fil- ħalq Azomyr 5 mg ma ’ pilloli konvenzjonali Azomyr 5 mg jew lajofilzzat orali Azomyr 5 mg, il- formulazzjonijiet kienu bioekwivalenti.
Azomyr 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 Azomyr orodispersible tablets supports the use of the 2.5 mg dose in paediatric patients 6 to 11 years of age.
Il- pilloli Azomyr 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 Azomyr 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 Azomyr 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 Azomyr 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.
Water had no affect on the bioavailability of Azomyr orodispersible tablets.
L- ilma ma kellux effett fuq il- biodisponibilità tal- pilloli li jinħallu fil- ħalq Azomyr.
Azomyr orodispersible tablets are supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Il- pilloli li jinħallu fil- ħalq Azomyr jiġu f’ dożi individwali ġo folji mgħamula minn folja laminata b’ fojl b’ kisja ta ’ rita biex tgħalaq.
Azomyr 5 mg orodispersible tablets
Azomyr 5 mg pilloli li jinħallu fil- ħalq
Each dose of Azomyr orodispersible tablet contains 5 mg desloratadine.
Kull doża ta ’ Azomyr pillola li tinħall fil- ħalq fiha 5 mg desloratadine.
Adults and adolescents (12 years of age and over): one 5 mg Azomyr 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 Azomyr 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).
Efficacy and safety of Azomyr orodispersible tablets in children under 12 years of age have not been established.
L- effikaċja u s- sigurtà tal- pilloli li jinħallu fil- ħalq Azomyr fi tfal taħt it- 12- il sena ma ġewx stabbiliti.
In the case of severe renal insufficiency, Azomyr should be used with caution.
27 F’ każ ta ’ insuffiċjenza renali severa, Azomyr għandu jintuża b’ attenzjoni.
This product contains 2.9 mg of phenylalanine per 5 mg dose of Azomyr orodispersible tablet.
Dan il- prodott fih 2. 9 mg phenylalanine għal kull doża ta ’ 5 mg ta ’ pillola li tinħall fil- ħalq Azomyr.
In addition, Azomyr orodispersible tablets were well tolerated in a multiple-dose trial.
Minbarra hekk, il- pilloli li jinħallu fil- ħalq Azomyr, kienu jifilħu għalihom tajjeb fi prova b’ ħafna dożi.
29 In patients with allergic rhinitis, Azomyr 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 Azomyr 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.
30 In single-dose crossover studies of Azomyr 5 mg orodispersible tablets with Azomyr 5 mg conventional tablets or Azomyr 5 mg oral lyophilisate, the formulations were bioequivalent.
Fi studji crossover ta ’ pilloli li jinħallu fil- ħalq Azomyr 5 mg ma ’ pilloli konvenzjonali Azomyr 5 mg jew lajofilzzat orali Azomyr 5 mg, il- formulazzjonijiet kienu bioekwivalenti.
The presence of food has no relevant influence on AUC and Cmax of Azomyr 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 Azomyr 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.
Azomyr 0.5 mg/ ml oral solution
Azomyr 0. 5 mg/ ml soluzzjoni orali
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 Azomyr.
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 Azomyr huwa tajjeb għal kura ta ’ rajnajtis ta ’ l- infezzjoni.
2.5 ml (1.25 mg) Azomyr oral solution once a day.
2. 5 ml (1. 25 mg) Azomyr soluzzjoni orali darba kuljum.
5 ml (2.5 mg) Azomyr oral solution once a day.
5 ml (2. 5 mg) Azomyr soluzzjoni orali darba kuljum.
10 ml (5 mg) Azomyr oral solution once a day.
10 ml (5 mg) Azomyr soluzzjoni orali darba kuljum.
Efficacy and safety of Azomyr oral solution in children under 1 year of age have not been established.
L- effikaċja u s- sigurtà tas- soluzzjoni orali Azomyr fi tfal li għandhom anqas minn sena ma ġewx stabbiliti.
Desloratadine is excreted into breast milk, therefore the use of Azomyr is not recommended in breastfeeding women.
Desloratidine joħroġ fil- ħalib tas- sider, għaldaqstant l- użu ta ’ desloratidine mhuwiex irrakkomandat f’ nisa li qed ireddgħu.
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 Azomyr 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 Azomyr kien rappurtati fi 3% tal- pazjenti aktar minn dawk fuq plaċebo.
Efficacy of Azomyr oral solution has not been investigated in separate paediatric trials.
L- effikaċja tas- soluzzjoni orali Azomyr ma ġietx investigata fi provi pedjatriċi separati.
However, the safety of Azomyr syrup, which contains the same concentration of desloratadine, was demonstrated in three paediatric trials.
Iżda, is- sigurtà tal- mistura Azomyr, li fiha l- istess konċentrazzjoni ta ’ desloratadine, intweriet fi tliet provi fit- tfal.
In adult and adolescent patients with allergic rhinitis, Azomyr 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 Azomyr 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.
Azomyr effectively controlled symptoms for 24 hours.
Il- pilloli Azomyr ikkontrollaw is- sintomi b’ mod effettiv għal 24 siegħa.
Azomyr 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 Azomyr kienu effettivi biex iserrħu il- problemi relatati ma ’ rajnajtis allerġiku ta ’ l- istaġun kif jidher mill- punteġġ totali tal- kwestjonarju fuq il- kwalità tal- ħajja b’ rajno- konġunktivite.
As Azomyr oral solution contains the same concentration of desloratadine, no bioequivalence study was required and it is expected to be equivalent to the syrup and tablet.
Peress li s- soluzzjoni orali għandha l- istess konċentrazzjoni ta ’ desloratadine, ma kienx hemm bżonn li jsir studju ta ’ bioekwivalenza għax hu mistenni li jkun l- istess għall- mistura u għall- pillola.
Azomyr oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/ R) screw closure having a multi-ply polyethylene- faced liner.
Azomyr soluzzjoni orali, jiġi fi fliexken tal- ħġieġ kannella jagħti fl- oranġjo tat- Tip III ta ’ daqsijiet ta ’ 30, 50, 60, 100, 120, 150, 225 u 300 ml magħluq bi plastik reżistenti għat- tfal (C/ R) b’ kisi b’ ħafna faċċaturi ta ’ ply polythylene.
Azomyr 5 mg film-coated tablets desloratadine
Azomyr 5 mg pillola miksija b’ rita desloratadine
Azomyr 5 mg tablet desloratadine
Azomyr pillola 5 mg desloratadine
Azomyr 0.5 mg/ ml syrup desloratadine
Azomyr 0. 5 mg/ ml mistura desloratadine
Azomyr 5 mg oral lyophilisate desloratadine
Azomyr 5 mg ta ’ lajofiliżejt li jittieħed mill- ħalq desloratadine
Azomyr 2.5 mg orodispersible tablets desloratadine
Azomyr 2. 5 mg pilloli li jinħallu fil- ħalq desloratadine
Azomyr 2.5 mg orodispersible tablet
Azomyr 2. 5 mg pillola li tinħall mill- ħalq
Azomyr 5 mg orodispersible tablets desloratadine
Azomyr 5 mg pillola li tinħall fil- ħalq desloratadine
60 EXP
JIS
Azomyr 5 mg orodispersible tablet
Azomyr 5 mg pillola li tinħall mill- ħalq
Azomyr 0.5 mg/ ml oral solution desloratadine
Azomyr 0. 5 mg/ ml soluzzjoni orali desloratadine
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA
Azomyr 5 mg film-coated tablets desloratadine
Azomyr 5 mg pilloli miksija b’ rita desloratadine
What Azomyr is and what it is used for 2.
X’ inhu Azomyr u għalxiex jintuża 2.
Before you take Azomyr 3.
Qabel ma tieħu Azomyr 3.
How to take Azomyr 4.
Kif għandek tieħu Azomyr 4.
How to store Azomyr 6.
Kif taħżen Azomyr 6.
WHAT AZOMYR IS AND WHAT IT IS USED FOR
X’ INHU AZOMYR U GĦALXIEX JINTUŻA
Azomyr is an antiallergy medicine that does not make you drowsy.
Azomyr hija mediċina kontra ta ’ l- allerġija li ma traqdekx.
Azomyr relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Azomyr ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal- passaġġi fl- imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
Azomyr is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Azomyr tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
BEFORE YOU TAKE AZOMYR
QABEL MA TIEĦU AZOMYR
Do not take Azomyr
Tieħux Azomyr
- if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Azomyr or
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine jew sustanzi oħra ta ’
to loratadine.
Azomyr jew għal loratadine.
Azomyr is indicated for adults and adolescents (12 years of age and older).
Azomyr jintuża għall- adulti u l- adolexxenti (minn tnax- il sena ’ l fuq).
Take special care with Azomyr
Oqgħod attent ħafna b’ Azomyr
If this applies to you, or if you are not sure, please check with your doctor before taking Azomyr.
Jekk dan jgħodd għalik jew jekk m’ intix ċert/ a, jekk jogħġbok aċċerta ruħek mat- tabib tiegħek qabel tieħu Azomyr.
Taking other medicines There are no known interactions of Azomyr with other medicines.
Meta tieħu mediċini oħra M’ hemmx tgħarif dwar interazzjonijiet ta ’ Azomyr ma ’ mediċini oħra.
Taking Azomyr with food and drink Azomyr may be taken with or without a meal.
Meta tieħu Azomyr ma ’ l- ikel u max- xorb Azomyr jista jittieħed ma ’ l- ikel jew waħdu.
If you are pregnant or nursing a baby, taking Azomyr is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ Azomyr mhux irrakkomandat.
Driving and using machines At the recommended dose, Azomyr is not expected to cause you to be drowsy or less alert.
Sewqan u tħaddim ta ’ magni Bid- doża rrakkomandata, Azomyr mhux mistenni li jraqqdek jew inaqqaslek il- ħila biex tirreaġixxi.
Important information about some of the ingredients of Azomyr Azomyr tablets contain lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Azomyr Il- pilloli Azomyr fihom lactose.
HOW TO TAKE AZOMYR
KIF GĦANDEK TIEĦU AZOMYR
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu Azomyr.
If you take more Azomyr than you should Take Azomyr only as it is prescribed for you.
Jekk tieħu Azomyr aktar milli suppost Ħu Azomyr biss kif ordnawlek.
However, if you take more Azomyr than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar Azomyr milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
If you forget to take Azomyr If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.
Jekk tinsa tieħu Azomyr Jekk tinsa tieħu id- doża fil- ħin, ħudha malli tiftakar, imbagħad erġa ’ lura għall- iskeda regolari tiegħek.
Like all medicines, Azomyr can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Azomyr jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Azomyr tqiegħed fuq is- suq, każijiet ta’ Azomyrreazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes, u nefħa) u raxx kienu rappurtati rari ħafna.
HOW TO STORE AZOMYR
KIF TAĦŻEN AZOMYR
Do not use Azomyr after the expiry date which is stated on the carton and blister.
Tużax Azomyr wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
What Azomyr contains
X’ fih Azomyr
What Azomyr looks like and contents of the pack
Id- Dehra ta ’ Azomyr u l- kontenuti tal- pakkett
Azomyr 5 mg film-coated tablets are packed in unit dose blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 or 100 tablets.
Azomyr pilloli ta ’ 5 mg miksija b’ rita huma ppakkjati f’ folji b’ doża individwali f’ pakketti ta ’ 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 jew 100 pillola.
Suomi/ Finland PL 86/ PB 86 FIN-02151 Espoo/ Esbo Puh/ Tel: + 358-(0)20-7570 300
Suomi/ Finland PL 86/ PB 86 FIN- 02201 Espoo/ Esbo Puh/ Tel: + 358 - (0) 20- 7570 300
71 Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: +357-22 757188
70 Κύπρος Οδός Αγίου Νικολάου, 8 CY- 1055 Λευκωσία Τηλ: +357- 22 757188
Azomyr 0.5 mg/ ml syrup desloratadine
Azomyr 0. 5 mg/ ml mistura desloratadina
Azomyr syrup is an antiallergy medicine that does not make you drowsy.
Il- mistura Azomyr hija mediċina ta ’ kontra l- allerġija li ma traqdekx.
Azomyr syrup relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Il- mistura Azomyr ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal- passaġġi fl - imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
Azomyr syrup is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Il- mistura Azomyr tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
of Azomyr, in particular colouring agent E110.
sustanzi oħra ta ’ Azomyr, b’ mod speċjali għall- kulur E110.
Azomyr syrup is indicated for children 1 through 11 years of age, adolescents (12 years of age and older), and adults, including the elderly.
Il- mistura Azomyr jintuża għat- tfal bejn is- sentejn u l- ħdax- il sena, l- adolexxenti (minn tnax- il sena ‘ l fuq), u l- adulti, inklużi l- anzjani.
73 Taking Azomyr with food and drink Azomyr may be taken with or without a meal.
72 Meta tieħu Azomyr ma ’ l- ikel u max- xorb Azomyr jista jittieħed ma ’ l- ikel jew mingħajr ikel.
If you are pregnant or nursing a baby, taking Azomyr syrup is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ il mistura Azomyr mhux irrakkomandat.
Important information about some of the ingredients of Azomyr You should not take Azomyr syrup if you are allergic to the colouring agent E110.
Tagħrif importanti dwar xi sustanzi ta ’ Azomyr M’ għandekx tieħu l- mistura Azomyr jekk int allerġiku għal- kulur E110.
Azomyr syrup contains sucrose and sorbitol.
Il- mistura Azomyr fiha sukrożju u sorbitol.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr syrup.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu Azomyr mistura.
If you take more Azomyr than you should Take Azomyr syrup only as it is prescribed for you.
Jekk tieħu Azomyr aktar milli suppost Ħu il- mistura Azomyr biss kif ordnawlek.
However, if you take more Azomyr syrup than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar il- mistura Azomyr milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
Like all medicines, Azomyr syrup can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, il- mistura Azomyr jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In most children and adults, side effects with Azomyr were about the same as with a dummy solution or tablet.
Fil- parti l- kbira tat- tfal u adulti, l- effetti sekondarji b’ Azomyr kienu rrapurtati kważi daqs
During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Azomyr tqiegħed fuq is- suq, każijiet ta’ Azomyrrejazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes, u nefħa) u raxx kienu rappurtati rari ħafna.
Do not use Azomyr after the expiry date which is stated on the bottle.
Tużax Azomyr wara d- data ta ’ skadenza li tidher fuq il- flixkun.
Azomyr syrup is available in bottles of 30, 50, 60, 100, 120, 150, 225, and 300 ml, with a childproof cap.
Il- mistura Azomyr jiġi fi fliexken ta ’ 30, 50, 60, 100, 120, 150, 225, u 300 ml, b’ tapp li ma jinfetaħx mit- tfal.
77 PACKAGE LEAFLET:
76 FULJETT TA ’ TAGĦRIF:
Azomyr 5 mg oral lyophilisate desloratadine
Azomyr 5 mg lajofiliżejt li jittieħed mill- ħalq desloratadine
What Azomyr oral lyophilisate is and what it is used for 2.
X’ inhu Azomyr lajofiliżejt li jittieħed mill- ħalq u għalxiex jintuża 2.
Before you take Azomyr oral lyophilisate 3.
Qabel ma tieħu Azomyr lajofiliżejt li jittieħed mill- ħalq 3.
How to take Azomyr oral lyophilisate 4.
Kif għandek tieħu Azomyr lajofiliżejt li jittieħed mill- ħalq 4.
How to store Azomyr oral lyophilisate 6.
Kif taħżen Azomyr lajofiliżejt li jittieħed mill- ħalq 6.
WHAT AZOMYR ORAL LYOPHILISATE IS AND WHAT IT IS USED FOR
X’ INHU AZOMYR LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ U GĦALXIEX JINTUŻA
Azomyr oral lyophilisate is an antiallergy medicine that does not make you drowsy.
Azomyr lajofiliżejt li jittieħed mill- ħalq huwa mediċina ta ’ kontra l- allerġija li ma traqdekx.
Azomyr oral lyophilisate relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Azomyr lajofiliżejt li jittieħed mill- ħalq ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal- passaġġi fl- imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
Azomyr oral lyophilisate is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Azomyr lajofiliżejt li jittieħed mill- ħalq tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
BEFORE YOU TAKE AZOMYR ORAL LYOPHILISATE
QABEL MA TIEĦU AZOMYR LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ
Do not take Azomyr oral lyophilisate
Tieħux Azomyr lajofiliżejt li jittieħed mill- ħalq
- if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of Azomyr
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine jew sustanzi oħra ta ’
oral lyophilisate, or to loratadine.
Azomyr jew għal loratadine.
Azomyr oral lyophilisate is indicated for adults and adolescents (12 years of age and older).
Azomyr lajofiliżejt li jittieħed mill- ħalq huwa intiż għall- adulti u l- adolexxenti (minn tnax- il sena u ‘ l fuq).
Take special care with Azomyr oral lyophilisate
Oqgħod attent ħafna b’ Azomyr
78 Taking Azomyr oral lyophilisate with food and drink Azomyr oral lyophilisate does not need to be taken with water or liquid.
77 Meta tieħu Azomyr lajofiliżejt li jittieħed mill- ħalq ma ’ l- ikel u max- xorb Azomyr lajofiliżejt li jittieħed mill- ħalq m’ għandhiex bżonn tittieħed ma ’ l- ilma jew x likwidu.
Additionally, Azomyr oral lyophilisate may be taken with or without a meal.
Minbarra hekk, Azomyr lajofiliżejt li jittieħed mill- ħalq tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
Important information about some of the ingredients of Azomyr oral lyophilisate This product contains aspartame 1.75 mg/ dose.
Tagħrif importanti dwar xi sustanzi ta ’ Azomyr lajofiliżejt li jittieħed mill- ħalq Dan il- prodott fih aspartame 1. 75 mg/ doża.
HOW TO TAKE AZOMYR ORAL LYOPHILISATE
KIF GĦANDEK TIEĦU AZOMYR LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ
Adults and adolescents (12 years of age and older): take one dose of Azomyr oral lyophilisate once a day.
Adulti u adolexxenti (minn tnax- il sena ‘ l fuq): ħu doża waħda ta ’ Azomyr lajofiliżejt li jittieħed mill - ħalq darba kuljum.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr oral lyophilisate.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu Azomyr lajofiliżejt li jittieħed mill- ħalq.
If you take more Azomyr oral lyophilisate than you should Take Azomyr oral lyophilisate only as prescribed for you.
Jekk tieħu Azomyr lajofiliżejt li jittieħed mill- ħalq aktar milli suppost Ħu Azomyr lajofiliżejt li jittieħed mill- ħalq biss kif ordnawlek.
However, if you take more Azomyr oral lyophilisate than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar Azomyr lajofiliżejt li jittieħed mill- ħalq milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
If you forget to take Azomyr oral lyophilisate If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.
Jekk tinsa tieħu Azomyr lajofiliżejt li jittieħed mill- ħalq Jekk tinsa tieħu id- doża fil- ħin, ħudha malli tiftakar, imbagħad erġa ’ lura għall- iskeda regolari tiegħek.
79 During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
78 Meta Azomyr tqiegħed fuq is- suq, każijiet ta’ Azomyrreazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes, u nefħa) u raxx kienu rappurtati rari ħafna.
HOW TO STORE AZOMYR ORAL LYOPHILISATE
KIF TAĦŻEN AZOMYR LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ
Do not use Azomyr oral lyophilisate after the expiry date which is stated on the carton and blister.
Tużax Azomyr lajofiliżejt li jittieħed mill- ħalq wara d- data ta ’ skadenza li tidher fuq il- kartuna u l - folja.
Tell your pharmacist if you notice any change in the appearance of Azomyr oral lyophilisate.
Għid lill- ispiżjar jekk tara xi tibdil fid- dehra ta ’ Azomyr lajofiliżejt li jittieħed mill- ħalq.
What Azomyr oral lyophilisate contains
X’ fih Azomyr lajofiliżejt li jittieħed mill- ħalq
What Azomyr oral lyophilisate looks like and contents of the pack
Id- Dehra ta ’ Azomyr lajofiliżejt li jittieħed mill- ħalq u l- kontenuti tal- pakkett
Azomyr oral lyophilisate is packed in unit dose blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, and 100 doses of oral lyophilisate.
Azomyr lajofiliżejt li jittieħed mill- ħalq huwa pakkjat f’ folji b’ doża individwali ġo pakketti ta ’ 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, u 100 doża.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
79 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
82 PACKAGE LEAFLET:
81 FULJETT TA ’ TAGĦRIF:
What Azomyr orodispersible tablet is and what it is used for 2.
X’ inhi Azomyr pillola li tinħall fil- ħalq u għalxiex jintuża 2.
Before you take Azomyr orodispersible tablet 3.
Qabel ma tieħu Azomyr pillola li tinħall fil- ħalq 3.
How to take Azomyr orodispersible tablet 4.
Kif għandek tieħu Azomyr pillola li tinħall fil- ħalq 4.
How to store orodispersible tablet 6.
Kif taħżen Azomyr pillola li tinħall fil- ħalq 6.
WHAT AZOMYR ORODISPERSIBLE TABLET IS AND WHAT IT IS USED FOR
X’ INHI AZOMYR PILLOLA LI TINAĦALL FIL- ĦALQ U GĦALXIEX JINTUŻA
Azomyr orodispersible tablet is an antiallergy medicine that does not make you drowsy.
Azomyr pillola li tinħall fil- ħalq hija mediċina kontra l- allerġiji li ma traqdekx.
Azomyr orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Azomyr pillola li tinħall fil- ħalq ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal - passaġġi fl- imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
Azomyr orodispersible tablet is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Azomyr pillola li tinħall fil- ħalq tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
BEFORE YOU TAKE AZOMYR ORODISPERSIBLE TABLET
QABEL MA TIEĦU AZOMYR PILLOLA LI TINĦALL FIL- ĦALQ
Do not take Azomyr orodispersible tablet:
Tieħux Azomyr pillola li tinħall fil- ħalq
- if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of Azomyr
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine, jew sustanzi oħra ta ’
orodispersible tablet, or to loratadine.
Azomyr pillola li tinħall fil- ħalq, jew għal loratadine.
Azomyr 2.5 mg orodispersible tablet is indicated for adults and children (6 years of age and older).
Azomyr 2. 5 mg pillola li tinħall fil- ħalq tintuża għall- adulti u tfal (minn 6 snin ‘ l fuq).
Take special care with Azomyr orodispersible tablet
Oqgħod attent ħafna b’ Azomyr pillola li tinħall fil- ħalq
83 Taking Azomyr orodispersible tablet with food and drink Azomyr orodispersible tablet does not need to be taken with water or liquid.
82 Meta tieħu Azomyr pillola li tinħall fil- ħalq ma ’ l- ikel u max- xorb Azomyr pillola li tinħall fil- ħalq m’ għandhiex bżonn tittieħed ma ’ l- ilma jew x likwidu.
Additionally, Azomyr orodispersible tablet may be taken with or without a meal.
Minbarra hekk, Azomyr pillola li tinħall fil- ħalq tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
If you are pregnant or nursing a baby taking Azomyr is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ Azomyr mhux irrakkomandat.
Important information about some of the ingredients of Azomyr orodispersible tablet This product contains aspartame.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Azomyr pillola li tinħall fil- ħalq Dan il- prodott fih aspartame.
HOW TO TAKE AZOMYR ORODISPERSIBLE TABLET
KIF GĦANDEK TIEĦU AZOMYR PILLOLA LI TINĦALL FIL- HALQ
Children 6 to 11 years of age: take one 2.5 mg Azomyr orodispersible tablet once a day.
Tfal ta ’ 6 sa 11- il sena: ħu pillola 2. 5 mg Azomyr li tinħall fil- ħalq ta ’ darba kuljum.
Adults and adolescents (12 years of age and older): take two 2.5 mg Azomyr orodispersible tablets once a day.
Adulti u adolexxenti (12- il sena ‘ l fuq): ħu pillola waħda ta ’ 5 mg Azomyr pillola li tinħall fil- ħalq darba kuljum.