qanastek/EMEA-V3 huggingface dataset:
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.
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.
The effects of Neoclarityn 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.
Propylene glycol, sorbitol, citric acid anhydrous, sodium citrate, sodium benzoate, disodium edetate, purified water, sucrose, natural and artificial flavour (bubblegum), orange colour E110.
Propylene glycol, sorbitol, Anhydrous citric acid, Sodium citrate, Sodium benzoate, disodium edetate, ilma purifikat, sukrożju, togħma naturali u artifiċjali (bubble gum), kulur oranġjo E110.
Neoclarityn 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 Neoclarityn 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.
Supplied with a rigid, transparent, polystyrene measuring spoon, calibrated at 2.5 ml and 5 ml.
Jiġi b’ kuċċarina tal- kejl, iebsa, trasparenti, tal- polystyrene, ikkalibrata f’ 2. 5 ml u 5 ml.
Neoclarityn 5 mg oral lyophilisate
Neoclarityn 5 mg lajofiliżejt li jittieħed mill- ħalq
Each dose of Neoclarityn oral lyophilisate contains 5 mg desloratadine.
Kull doża ta ’ Neoclarityn lajofiliżejt li jittieħed mill- ħalq fiha 5 mg desloratadine.
Adults and adolescents (12 years of age and over): one dose of Neoclarityn 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 ’ Neoclarityn 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).
Neoclarityn oral lyophilisate disperses instantly and water or other liquid is not needed.
Neoclarityn lajofiliżejt li jittieħed mill- ħalq jinxtered mill- ewwel u ilma jew likwidu ieħor mhumiex neċessarji.
Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established.
L- effikaċja u s- sigurtà tal- pilloli Neoclarityn fit- tfal taħt it- tnax- il sena ma ġewx stabbiliti.
In the case of severe renal insufficiency, Neoclarityn should be used with caution.
F’ każ ta ’ insuffiċjenza renali severa, Neoclarityn għandu jintuża b’ attenzjoni.
4.6 Pregnancy and lactation
4. 5 Tqala u Treddigħ
4.8 Undesirable effects
4. 5 Effetti mhux mixtieqa
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 Neoclarityn 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’ Neoclarityn kien rappurtati fi 3% tal- pazjenti aktar minn dawk fuq plaċebo.
4.9 Overdose
16 4. 5 Doża eċċessiva
16 Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
Minn prova klinika b’ doża multipla, li fiha ingħataw sa 45 mg desloratadine (disa ’ darbiet id- doża klinika), ma kienx hemm effetti kliniċi rilevanti.
5.1 Pharmacodynamic properties
4. 5 Tagħrif farmakodinamiku
In two single-dose trials, Neoclarityn 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, Neoclarityn 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, Neoclarityn oral lyophilisate was found to be bioequivalent to the conventional tablet formulation of desloratadine.
Bid- doża rakkomandata, Neoclarityn lajofiliżejt li jittieħed mill- ħalq instabet li hija bioekwivalenti għall- formulazzjoni tal- pillola ta ’ desloratadine.
Therefore, the efficacy of Neoclarityn oral lyophilisate is expected to be the same as with the Neoclarityn tablet formulation.
Għaldaqstant, l- effikaċja ta ’ Neoclarityn lajofiliżejt li jittieħed mill- ħalq hija mistennija li tkun l- istess bħall Neoclarityn fil- formulazzjoni ta’ pillolaNeoclarityn.
Neoclarityn tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Neoclarityn mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg ma effettwax il - prestazzjonijiet psikomotriċi fi provi kliniċi.
In patients with allergic rhinitis, Neoclarityn 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.
17 F ’ pazjenti b’ rajnajtis allerġiku, il- pilloli Neoclarityn, 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.
Neoclarityn tablets effectively controlled symptoms for 24 hours.
Neoclarityn itaffi b’ mod effettiv s- sintomi għal 24 siegħa.
17 than 4 days per week or for less than 4 weeks.
Rajnajtis allerġiku intermittenti huwa definit bħala l- preżenza ta ’ sintomi għal anqas minn 4 ġranet fil- ġimgħa jew għal anqas minn 4 ġimgħat.
Neoclarityn 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 Neoclarityn 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.
5.2 Pharmacokinetic properties
4. 5 Tagħrif farmakokinetiku
In single-dose crossover studies of Neoclarityn oral lyophilisate with Neoclarityn tablets, the formulations were bioequivalent.
Fi studji crossover ta ’ Neoclarityn lajofiliżejt li jittieħed mill- ħalq ma ’ Neoclarityn pilloli, il - formulazzjonijiet kienu bijoekwivalenti.
The presence of food has no relevant influence on AUC and Cmax of Neoclarityn 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 Neoclarityn filwaqt li meta jkun hemm l- ikel, it- NeoclaritynTmax 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
4. 5 Tagħrif ta ’ qabel l- użu kliniku dwar is - sigurtà tal- mediċina
Neoclarityn oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Neoclarityn lajofiliżejt li jittieħed mill- ħalq issibu ġo folja għal kull doża li tikkonsisti f’ rita llaminata tal- folji magħluqha bil- fojl.
6.6 Special precautions for disposal
19 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Neoclarityn 2.5 mg orodispersible tablets
Neoclarityn 2. 5 mg pilloli li jinħallu fil- ħalq
Each dose of Neoclarityn orodispersible tablet contains 2.5 mg desloratadine.
Kull doża ta ’ Neoclarityn pillola li tinħall fil- ħalq fiha 2. 5 mg desloratadine.
Children 6 to 11 years of age: one 2.5 mg Neoclarityn 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 Neoclarityn 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 Neoclarityn 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 Neoclarityn 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).
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents12 through 17 years of age (see sections 4.8 and 5.1).
Hemm esperjenza limitata dwar l- effikaċja minn prova klinika bl- użu ta ’ desloratadine f’ adolexxenti minn 12 sa 17- il sena (ara sezzjonijiet 4. 8 u 5. 1).
Efficacy and safety of Neoclarityn 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 Neoclarityn 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 Neoclarityn orodispersible tablet.
Dan il- prodott fih 1. 4 mg phenylalanine għal kull doża ta ’ 2. 5 mg ta ’ pillola li tinħall fil- ħalq Neoclarityn.
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 Neoclarityn 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 Neoclarityn kien rappurtati fi 3% tal- pazjenti aktar minn dawk fuq plaċebo.
In addition, Neoclarityn orodispersible tablets were well tolerated in a multiple dose trial.
Minbarra hekk, il- pilloli li jinħallu fil- ħalq Neoclarityn, kienu jifilħu għalihom tajjeb fi prova b’ ħafna dożi.
At the recommended dose, Neoclarityn 5 mg orodispersible tablet was found to be bioequivalent to the Neoclarityn 5 mg conventional tablet and the Neoclarityn 5 mg oral lyophilisate formulations of desloratadine.
Bid- doża rakkomandata, il- pillola li tinħall fil- ħalq Neoclarityn 5 mg instabet li hija bioekwivalenti għall- pillola konvenzjonali Neoclarityn 5 mg u l- formulazzjonijiet lajofilizzati orali ta ’ desloratadine, Neoclarityn 5 mg.
Therefore, the efficacy of Neoclarityn orodispersible tablet is expected to be the same as with the Neoclarityn tablet formulation.
Għaldaqstant, l- effikaċja tal- pillola li tinħall fil- ħalq Neoclarityn hija mistennija li tkun l- istess bħall Neoclarityn fil- formulazzjoni ta’ pillola.
Neoclarityn tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Il- pilloli Neoclarityn mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg ma effettwax il- prestazzjonijiet psikomotriċi fi provi kliniċi.
In a single dose study performed in adults, desloratadine 5 mg did not affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks related to flying.
Fi prova b’ doża waħda li seħħet fl- adulti, desloratadine 5 mg ma effettwax il- miżuri standard tal- prestazzjoni tat- titjir fl- ajru inkluż żieda fin - ngħas jew il- ħila biex jiġu eżegwiti proċeduri relatati mat- titjir fl- ajru.
In patients with allergic rhinitis, Neoclarityn 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 Neoclarityn 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.
Neoclarityn tablets effectively controlled symptoms for 24 hours.
Il - pilloli Neoclarityn ikkontrollaw is- sintomi b’ mod effettiv għal 24 siegħa.
Neoclarityn was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Neoclarityn 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 Neoclarityn 5 mg orodispersible tablets with Neoclarityn 5 mg conventional tablets or Neoclarityn 5 mg oral lyophilisate, the formulations were bioequivalent.
Fi studji crossover ta ’ pilloli li jinħallu fil- ħalq Neoclarityn 5 mg ma ’ pilloli konvenzjonali Neoclarityn 5 mg jew lajofilzzat orali Neoclarityn 5 mg, il- formulazzjonijiet kienu bioekwivalenti.
Neoclarityn 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 Neoclarityn orodispersible tablets supports the use of the 2.5 mg dose in paediatric patients 6 to 11 years of age.
Il - pilloli Neoclarityn 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 Neoclarityn 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 Neoclarityn 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 Neoclarityn 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 Neoclarityn orodispersible tablets.
L- ilma ma kellux effett fuq il- biodisponibilità tal- pilloli li jinħallu fil- ħalq Neoclarityn.
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)
6.2 Incompatibilities 25 Not applicable.
25 Togħma ta ’ Tutti- Frutti
6.3 Shelf life
6. 2 Inkompatibilitajiet
Neoclarityn orodispersible tablets are supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Il- pilloli li jinħallu fil- ħalq Neoclarityn jiġu f’ dożi individwali ġo folji mgħamula minn folja laminata b’ fojl b’ kisja ta ’ rita biex tgħalaq.
Neoclarityn 5 mg orodispersible tablets
Neoclarityn 5 mg pilloli li jinħallu fil- ħalq
Each dose of Neoclarityn orodispersible tablet contains 5 mg desloratadine.
Kull doża ta ’ Neoclarityn pillola li tinħall fil- ħalq fiha 5 mg desloratadine.
Adults and adolescents (12 years of age and over): one 5 mg Neoclarityn 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 Neoclarityn 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).
27 4.4 Special warnings and precautions for use
27 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Efficacy and safety of Neoclarityn orodispersible tablets in children under 12 years of age have not been established.
L- effikaċja u s- sigurtà tal- pilloli li jinħallu fil- ħalq Neoclarityn fi tfal taħt it- 12- il sena ma ġewx stabbiliti.
This product contains 2.9 mg of phenylalanine per 5 mg dose of Neoclarityn orodispersible tablet.
Dan il- prodott fih 2. 9 mg phenylalanine għal kull doża ta ’ 5 mg ta ’ pillola li tinħall fil- ħalq Neoclarityn.
28 4.9 Overdose
28 4. 9 Doża eċċessiva
In addition, Neoclarityn orodispersible tablets were well tolerated in a multiple-dose trial.
Minbarra hekk, il- pilloli li jinħallu fil- ħalq Neoclarityn, kienu jifilħu għalihom tajjeb fi prova b’ ħafna dożi.
29 In patients with allergic rhinitis, Neoclarityn 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.
29 F’ pazjenti b’ rajnajtis allerġiku, il- pilloli Neoclarityn 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.
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.
Desloratadine ma
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.
30 jimpedixxix CYP3A4 in vivo, u studji in vitro urew li l- prodott mediċinali ma jimpedixxix CYP2D6 u la huwa sottostrat u l- anqas inibitur tal- glajkoproteina- P.
30 In single-dose crossover studies of Neoclarityn 5 mg orodispersible tablets with Neoclarityn 5 mg conventional tablets or Neoclarityn 5 mg oral lyophilisate, the formulations were bioequivalent.
Fi studji crossover ta ’ pilloli li jinħallu fil- ħalq Neoclarityn 5 mg ma ’ pilloli konvenzjonali Neoclarityn 5 mg jew lajofilzzat orali Neoclarityn 5 mg, il- formulazzjonijiet kienu bioekwivalenti.
6.5 Nature and contents of container
31 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Neoclarityn 0.5 mg/ ml oral solution
Neoclarityn 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 Neoclarityn.
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 Neoclarityn huwa tajjeb għal kura ta ’ rajnajtis ta ’ l- infezzjoni.
2.5 ml (1.25 mg) Neoclarityn oral solution once a day.
2. 5 ml (1. 25 mg) Neoclarityn soluzzjoni orali darba kuljum.
5 ml (2.5 mg) Neoclarityn oral solution once a day.
5 ml (2. 5 mg) Neoclarityn soluzzjoni orali darba kuljum.
10 ml (5 mg) Neoclarityn oral solution once a day.
10 ml (5 mg) Neoclarityn soluzzjoni orali darba kuljum.
Efficacy and safety of Neoclarityn oral solution in children under 1 year of age have not been established.
L- effikaċja u s- sigurtà tas- soluzzjoni orali Neoclarityn fi tfal li għandhom anqas minn sena ma ġewx stabbiliti.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breastfeeding women.
Desloratidine joħroġ fil- ħalib tas- sider, għaldaqstant l- użu ta ’ desloratidine mhuwiex irrakkomandat f’ nisa li qed ireddgħu.
The most frequent of adverse
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 -
34 events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).
34 pilloli Neoclarityn 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.
L- aktar effetti avversi frekwenti li kienu rappurtati aktar minn dak tal- plaċebo kienu għeja (1. 2%), ħalq xott (0. 8%) u uġigħ ta ’ ras (0. 6%).
Elevations of liver enzymes, increased bilirubin, hepatitis
Effetti mhux mixtieqa oħrajn li ġew rappurtati rari ħafna fil- perijodu ta ’ wara t- tqegħid fis- suq huma elenkati fit- tabella li ġejja.
Musculoskeletal and connective tissue disorders General disorders
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 Disturbi ġenerali
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Reazzjonijiet ta ’ sensitività eċċessiva (bħall anafilassi, anġjoedima, qtugħ ta ’ nifs, ħakk, raxx u urtikarja)
Efficacy of Neoclarityn oral solution has not been investigated in separate paediatric trials.
L- effikaċja tas- soluzzjoni orali Neoclarityn ma ġietx investigata fi provi pedjatriċi separati.
However, the safety of Neoclarityn syrup, which contains the same concentration of desloratadine, was demonstrated in three paediatric trials.
Iżda, is - sigurtà tal- mistura Neoclarityn, li fiha l- istess konċentrazzjoni ta ’ desloratadine, intweriet fi tliet provi fit- tfal.
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.
Thus, since the course of allergic rhinitis/ chronic idiopathic urticaria and the profile of desloratadine are similar in adults and paediatric patients, desloratadine efficacy data in adults can be extrapolated to the paediatric population.
Għalhekk, peress li l- mod kif jiżviluppaw rajnajtis allerġiku/ urtikarja idjopatika kronika kif ukoll minħabba li l - profil ta ’ desloratadine huwa simili f’ pazjenti adulti u f' dawk pedjatriċi, it- tagħrif dwar l- effikaċja fl - adulti jista ’ jintuża bħala mudell għall- popolazzjoni pedjatrika.
In a multiple dose clinical trial, in adults and adolescents, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was
Fi prova
In a clinical pharmacology trial, in adults and adolescents, in which desloratadine was administered to adults at a dose of 45 mg daily (nine times the clinical dose) for ten days, no prolongation of QTc interval was seen.
35 klinika farmakoloġika, li fiha ingħata desloratadine b’ doża ta ’ 45 mg kuljum (disa ’ darbiet id- doża klinika) għal għaxart ijiem, ma kienx hemm żieda fit- tul ta ’ l- intervall QTc.
In a single dose study performed in adults, desloratadine 5 mg did not affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks related to flying.
Fi prova b’ doża waħda li seħħet fl- adulti, desloratadine 5 mg ma effettwax il- miżuri standard tal - prestazzjoni tat- titjir fl- ajru inkluż żieda fin- ngħas jew il- ħila biex jiġu esegwiti proċeduri relatati mat - titjir fl- ajru.
In adult and adolescent patients with allergic rhinitis, Neoclarityn 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 Neoclarityn 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.
Neoclarityn effectively controlled symptoms for 24 hours.
Il- pilloli Neoclarityn ikkontrollaw is- sintomi b’ mod effettiv għal 24 siegħa.
The efficacy of Neoclarityn tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
L - effikaċja tal- pilloli Neoclarityn ma ntwerietx b’ mod ċar fi provi bi pazjenti adolexxenti minn 12 sa 17- il sena.
Neoclarityn 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 Neoclarityn 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.
36 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours.
36 wara madwar 3 sigħat; il- half- life fl- aħħar fażi hija madwar 27 siegħa.
As Neoclarityn 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.
Neoclarityn 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.
Neoclarityn 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.
38 Date of first authorisation:
Data ta ’ l- ewwel awtorizzazzjoni:
BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 TABLETS
KAXXA TA ’ 5, 6, 10, 12, 15, 18, 20, 30, 50, 100 DOŻI/ A TA ’ PILLOLA WAĦDA
Neoclarityn 5 mg film-coated tablets desloratadine
Neoclarityn 5 mg pillola miksija b’ rita desloratadine
1 film-coated tablet 2 film-coated tablets 3 film-coated tablets 5 film-coated tablets 7 film-coated tablets 10 film-coated tablets 14 film-coated tablets 15 film-coated tablets 20 film-coated tablets 21 film-coated tablets 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
Pillola 1 miksija b’ rita 2 pilloli miksijin b’ rita 3 pilloli miksijin b’ rita 5 pilloli miksijin b’ rita 7 pilloli miksijin b’ rita 10 pilloli miksijin b’ rita 14- il pillola miksija b’ rita 15- il pillola miksija b’ rita 20 pillola miksija b’ rita 21 pillola miksija b’ rita 30 pillola miksija b’ rita 50 pillola miksija b’ rita 100 pillola miksija b’ rita
1 tablet 2 tablets 3 tablets 5 tablets 7 tablets 10 tablets 14 tablets 15 tablets 20 tablets 21 tablets 30 tablets 50 tablets 100 tablets
Pillola 1 2 pilloli 3 pilloli 5 pilloli 7 pilloli 10 pilloli 14- il pillola 15- il pillola 20 pillola 21 pillola 30 pillola 50 pillola 100 pillola
45 16.
45 16.
Neoclarityn 5 mg tablet desloratadine
Neoclarityn pillola 5 mg desloratadine
Neoclarityn 0.5 mg/ ml syrup desloratadine
Neoclarityn 0. 5 mg/ ml mistura desloratadine
syrup 30 ml with 1 spoon 50 ml with 1 spoon 60 ml with 1 spoon 100 ml with 1 spoon 120 ml with 1 spoon 150 ml with 1 spoon 225 ml with 1 spoon 300 ml with 1 spoon
mistura 30 ml b’ kuċċarina 1 50 ml b’ kuċċarina 1 60 ml b’ kuċċarina 1 100 ml b’ kuċċarina 1 120 ml b’ kuċċarina 1 150 ml b’ kuċċarina 1 225 ml b’ kuċċarina 1 300 ml b’ kuċċarina 1
30 ml with 1 spoon 50 ml with 1 spoon 60 ml with 1 spoon 100 ml with 1 spoon 120 ml with 1 spoon 150 ml with 1 spoon 225 ml with 1 spoon 300 ml with 1 spoon
30ml b’ kuċċarina 1 50 ml b’ kuċċarina 1 60 ml b’ kuċċarina 1 100 ml b’ kuċċarina 1 120 ml b’ kuċċarina 1 150 ml b’ kuċċarina 1 225 ml b’ kuċċarina 1 300 ml b’ kuċċarina 1
Neoclarityn 5 mg oral lyophilisate desloratadine
Neoclarityn 5 mg ta ’ lajofiliżejt li jittieħed mill- ħalq desloratadine
Neoclarityn 2.5 mg orodispersible tablets desloratadine
Neoclarityn 2. 5 mg pilloli li jinħallu fil- ħalq desloratadine
56 EXP
JIS
Neoclarityn 2.5 mg orodispersible tablet
Neoclarityn 2. 5 mg pillola li tinħall mill- ħalq
57 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
57 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
58 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Neoclarityn 5 mg orodispersible tablets desloratadine
Neoclarityn 5 mg pillola li tinħall fil- ħalq desloratadine
59 EXP
JIS
Neoclarityn 5 mg orodispersible tablet
Neoclarityn 5 mg pillola li tinħall mill- ħalq
60 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
60 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
61 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Neoclarityn 0.5 mg/ ml oral solution desloratadine
Neoclarityn 0. 5 mg/ ml soluzzjoni orali desloratadine
oral solution 30 ml with 1 spoon 50 ml with 1 spoon 60 ml with 1 spoon 100 ml with 1 spoon 120 ml with 1 spoon 150 ml with 1 spoon 150 ml with 1 oral syringe 225 ml with 1 spoon 300 ml with 1 spoon
soluzzjoni orali 30 ml b’ kuċċarina waħda 50 ml b’ kuċċarina waħda 60 ml b’ kuċċarina waħda 100 ml b’ kuċċarina waħda 120 ml b’ kuċċarina waħda 150 ml b’ kuċċarina waħda 150 ml b ’ siringa waħda għall- ħalq 225 ml b’ kuċċarina waħda 300 ml b’ kuċċarina waħda
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
63 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
66 PACKAGE LEAFLET:
66 FULJETT TA ’ TAGĦRIF:
Neoclarityn 5 mg film-coated tablets desloratadine
Neoclarityn 5 mg pilloli miksija b’ rita desloratadine
What Neoclarityn is and what it is used for 2.
X’ inhu Neoclarityn u għalxiex jintuża 2.
Before you take Neoclarityn 3.
Qabel ma tieħu Neoclarityn 3.
How to take Neoclarityn 4.
Kif għandek tieħu Neoclarityn 4.
How to store Neoclarityn 6.
Kif taħżen Neoclarityn 6.
WHAT NEOCLARITYN IS AND WHAT IT IS USED FOR
X’ INHU NEOCLARITYN U GĦALXIEX JINTUŻA
Neoclarityn is an antiallergy medicine that does not make you drowsy.
Neoclarityn hija mediċina kontra ta ’ l- allerġija li ma traqdekx.
Neoclarityn relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Neoclarityn ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal- passaġġi fl- imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
Neoclarityn is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Neoclarityn tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
BEFORE YOU TAKE NEOCLARITYN
QABEL MA TIEĦU NEOCLARITYN
Do not take Neoclarityn
Tieħux Neoclarityn
- if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine jew sustanzi oħra ta ’
Neoclarityn or to loratadine.
Neoclarityn jew għal loratadine.
Neoclarityn is indicated for adults and adolescents (12 years of age and older).
Neoclarityn jintuża għall- adulti u l- adolexxenti (minn tnax- il sena ’ l fuq).
Take special care with Neoclarityn
Oqgħod attent ħafna b’ Neoclarityn
If this applies to you, or if you are not sure, please check with your doctor before taking Neoclarityn.
Jekk dan jgħodd għalik jew jekk m’ intix ċert/ a, jekk jogħġbok aċċerta ruħek mat- tabib tiegħek qabel tieħu Neoclarityn.
Taking other medicines There are no known interactions of Neoclarityn with other medicines.
Meta tieħu mediċini oħra M’ hemmx tgħarif dwar interazzjonijiet ta ’ Neoclarityn ma ’ mediċini oħra.
Taking Neoclarityn with food and drink Neoclarityn may be taken with or without a meal.
Meta tieħu Neoclarityn ma ’ l- ikel u max- xorb Neoclarityn jista jittieħed ma ’ l- ikel jew waħdu.
Pregnancy and breast-feeding 67 Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast- feeding.
67 Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina waqt it- tqala u t- treddigħ.
If you are pregnant or nursing a baby, taking Neoclarityn is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ Neoclarityn mhux irrakkomandat.
Driving and using machines At the recommended dose, Neoclarityn is not expected to cause you to be drowsy or less alert.
Sewqan u tħaddim ta ’ magni Bid- doża rrakkomandata, Neoclarityn mhux mistenni li jraqqdek jew inaqqaslek il- ħila biex tirreaġixxi.
Important information about some of the ingredients of Neoclarityn Neoclarityn tablets contain lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Neoclarityn Il- pilloli Neoclarityn fihom lactose.
HOW TO TAKE NEOCLARITYN
KIF GĦANDEK TIEĦU NEOCLARITYN
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 Neoclarityn.
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 Neoclarityn.
If you take more Neoclarityn than you should Take Neoclarityn only as it is prescribed for you.
Jekk tieħu Neoclarityn aktar milli suppost Ħu Neoclarityn biss kif ordnawlek.
However, if you take more Neoclarityn than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar Neoclarityn milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
If you forget to take Neoclarityn 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 Neoclarityn Jekk tinsa tieħu id- doża fil- ħin, ħudha malli tiftakar, imbagħad erġa ’ lura għall- iskeda regolari tiegħek.
Like all medicines, Neoclarityn can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Neoclarityn jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In adults, side effects were about the same as with a dummy tablet.
Fl- adulti, l- effetti sekondarji kienu rrapurtati kważi daqs kemm ikun hemm b’ pillola finta.
During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Neoclarityn tqiegħed fuq is- suq, każijiet ta’ Neoclaritynreazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes, u nefħa) u raxx kienu rappurtati rari ħafna.
Cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation and abnormal liver function tests have also been reported very rarely.
Każijiet ta ’ palpitazzjonijie, qalb tħabbat magħaġġla, uġigħ fl- istonku, dardir (tħossok ħażin), rimettar, stonku mqalleb, dijarea, sturdament, ngħas, nuqqas ta ’ rqad, uġigħ fil- muskoli, alluċinazzjonijiet, aċċessjonijiet, tħossok bla sabar u tiċċaqlaq aktar, infjammazzjoni tal- fwied u testijiet tal- funzjoni tal - fwied anormali kienu wkoll irrappurtati rari ħafna.
HOW TO STORE NEOCLARITYN
KIF TAĦŻEN NEOCLARITYN
Do not use Neoclarityn after the expiry date which is stated on the carton and blister.
Tużax Neoclarityn wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
What Neoclarityn contains
X’ fih Neoclarityn
What Neoclarityn looks like and contents of the pack
Id- Dehra ta ’ Neoclarityn u l- kontenuti tal- pakkett
Neoclarityn 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.
Neoclarityn 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.
Taś mowa 7 PL-02-677 Warszawa Tel.: + 48-(0)22 478 41 50
PL- 02- 677 Warszawa Tel.: + 48 - (0) 22 478 41 50
71 PACKAGE LEAFLET:
71 FULJETT TA ’ TAGĦRIF:
Neoclarityn 0.5 mg/ ml syrup desloratadine
Neoclarityn 0. 5 mg/ ml mistura desloratadina
Neoclarityn syrup is an antiallergy medicine that does not make you drowsy.
Il- mistura Neoclarityn hija mediċina ta ’ kontra l- allerġija li ma traqdekx.
Neoclarityn 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 Neoclarityn ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal- passaġġi fl - imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
Neoclarityn syrup is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Il- mistura Neoclarityn tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
of Neoclarityn, in particular colouring agent E110.
sustanzi oħra ta ’ Neoclarityn, b’ mod speċjali għall- kulur E110.
Neoclarityn 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 Neoclarityn 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.
Taking Neoclarityn with food and drink Neoclarityn may be taken with or without a meal.
72 Meta tieħu Neoclarityn ma ’ l- ikel u max- xorb Neoclarityn jista jittieħed ma ’ l- ikel jew mingħajr ikel.
72 Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast- feeding.
Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina waqt it- tqala u t- treddigħ.
If you are pregnant or nursing a baby, taking Neoclarityn syrup is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ il mistura Neoclarityn mhux irrakkomandat.
Important information about some of the ingredients of Neoclarityn You should not take Neoclarityn syrup if you are allergic to the colouring agent E110.
Tagħrif importanti dwar xi sustanzi ta ’ Neoclarityn M’ għandekx tieħu l- mistura Neoclarityn jekk int allerġiku għal- kulur E110.
Neoclarityn syrup contains sucrose and sorbitol.
Il- mistura Neoclarityn 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 Neoclarityn 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 Neoclarityn mistura.
If you take more Neoclarityn than you should Take Neoclarityn syrup only as it is prescribed for you.
Jekk tieħu Neoclarityn aktar milli suppost Ħu il- mistura Neoclarityn biss kif ordnawlek.
However, if you take more Neoclarityn syrup than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar il- mistura Neoclarityn milli suppost, għamel kuntatt mat - tabib jew l- spiżjar tiegħek.
Like all medicines, Neoclarityn syrup can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, il- mistura Neoclarityn jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In most children and adults, side effects with Neoclarityn were about the same as with a dummy solution or tablet.
Fil- parti l- kbira tat- tfal u adulti, l- effetti sekondarji b’ Neoclarityn kienu rrapurtati kważi
During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Neoclarityn tqiegħed fuq is- suq, każijiet ta’ Neoclaritynrejazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes, u nefħa) u raxx kienu rappurtati rari ħafna.
Cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation and abnormal liver function tests have also been reported very rarely.
Każijiet ta ’ palpitazzjonijiet, qalb tħabbat magħaġġla, uġigħ fl- istonku, dardir (tħossok ħażin), rimettar, stonku mqalleb, dijarea, sturdament, ngħas, nuqqas ta ’ rqad, uġigħ fil- muskoli, alluċinazzjonijiet, aċċessjonijiet, tħossok bla sabar u tiċċaqlaq aktar, infjammazzjoni tal- fwied u testijiet tal- funzjoni tal - fwied anormali kienu wkoll irrappurtati rari ħafna.
Do not use Neoclarityn after the expiry date which is stated on the bottle.
Tużax Neoclarityn wara d- data ta ’ skadenza li tidher fuq il- flixkun.
Neoclarityn syrup is available in bottles of 30, 50, 60, 100, 120, 150, 225, and 300 ml, with a childproof cap.
Il- mistura Neoclarityn jiġi fi fliexken ta ’ 30, 50, 60, 100, 120, 150, 225, u 300 ml, b’ tapp li ma jinfetaħx mit- tfal.
A measuring spoon is provided, marked for doses of 2.5 ml and 5 ml.
Jiġi b’ kuċċarina tal- kejl, ikkalibrati għal dożi ta ’ 2. 5 ml u 5 ml.
75 Ísland Hörgatún 2 IS-210 Garðabær Sími: + 354 535 70 00
75 76 Ísland Hörgatún 2 IS- 210 Garðabær Sími: + 354 535 70 00
76 PACKAGE LEAFLET:
77 FULJETT TA ’ TAGĦRIF:
Neoclarityn 5 mg oral lyophilisate desloratadine
Neoclarityn 5 mg lajofiliżejt li jittieħed mill- ħalq desloratadine
What Neoclarityn oral lyophilisate is and what it is used for 2.
X’ inhu Neoclarityn lajofiliżejt li jittieħed mill- ħalq u għalxiex jintuża 2.
Before you take Neoclarityn oral lyophilisate 3.
Qabel ma tieħu Neoclarityn lajofiliżejt li jittieħed mill- ħalq 3.
How to take Neoclarityn oral lyophilisate 4.
Kif għandek tieħu Neoclarityn lajofiliżejt li jittieħed mill- ħalq 4.
How to store Neoclarityn oral lyophilisate 6.
Kif taħżen Neoclarityn lajofiliżejt li jittieħed mill- ħalq 6.
WHAT NEOCLARITYN ORAL LYOPHILISATE IS AND WHAT IT IS USED FOR
X’ INHU NEOCLARITYN LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ U GĦALXIEX JINTUŻA
Neoclarityn oral lyophilisate is an antiallergy medicine that does not make you drowsy.
Neoclarityn lajofiliżejt li jittieħed mill- ħalq huwa mediċina ta ’ kontra l- allerġija li ma traqdekx.
Neoclarityn 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).
Neoclarityn 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).
Neoclarityn oral lyophilisate is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Neoclarityn lajofiliżejt li jittieħed mill- ħalq tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
BEFORE YOU TAKE NEOCLARITYN ORAL LYOPHILISATE
QABEL MA TIEĦU NEOCLARITYN LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ
Do not take Neoclarityn oral lyophilisate
Tieħux Neoclarityn lajofiliżejt li jittieħed mill- ħalq
- if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine jew sustanzi oħra ta ’
Neoclarityn oral lyophilisate, or to loratadine.
Neoclarityn jew għal loratadine.
Neoclarityn oral lyophilisate is indicated for adults and adolescents (12 years of age and older).
Neoclarityn lajofiliżejt li jittieħed mill- ħalq huwa intiż għall- adulti u l- adolexxenti (minn tnax- il sena u ‘ l fuq).
Take special care with Neoclarityn oral lyophilisate
Oqgħod attent ħafna b’ Neoclarityn
77 Taking Neoclarityn oral lyophilisate with food and drink Neoclarityn oral lyophilisate does not need to be taken with water or liquid.
78 Meta tieħu Neoclarityn lajofiliżejt li jittieħed mill- ħalq ma ’ l- ikel u max- xorb Neoclarityn lajofiliżejt li jittieħed mill- ħalq m’ għandhiex bżonn tittieħed ma ’ l- ilma jew x likwidu.
Additionally, Neoclarityn oral lyophilisate may be taken with or without a meal.
Minbarra hekk, Neoclarityn lajofiliżejt li jittieħed mill- ħalq tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
Important information about some of the ingredients of Neoclarityn oral lyophilisate This product contains aspartame 1.75 mg/ dose.
Tagħrif importanti dwar xi sustanzi ta ’ Neoclarityn lajofiliżejt li jittieħed mill- ħalq Dan il- prodott fih aspartame 1. 75 mg/ doża.
HOW TO TAKE NEOCLARITYN ORAL LYOPHILISATE
KIF GĦANDEK TIEĦU NEOCLARITYN LAJOFILIŻEJT LI JITTIEĦED MILL - ĦALQ
Adults and adolescents (12 years of age and older): take one dose of Neoclarityn oral lyophilisate once a day.
Adulti u adolexxenti (minn tnax- il sena ‘ l fuq): ħu doża waħda ta ’ Neoclarityn 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 Neoclarityn 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 Neoclarityn lajofiliżejt li jittieħed mill- ħalq.
If you take more Neoclarityn oral lyophilisate than you should Take Neoclarityn oral lyophilisate only as prescribed for you.
Jekk tieħu Neoclarityn lajofiliżejt li jittieħed mill- ħalq aktar milli suppost Ħu Neoclarityn lajofiliżejt li jittieħed mill- ħalq biss kif ordnawlek.
However, if you take more Neoclarityn oral lyophilisate than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar Neoclarityn lajofiliżejt li jittieħed mill- ħalq milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
If you forget to take Neoclarityn 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 Neoclarityn lajofiliżejt li jittieħed mill- ħalq Jekk tinsa tieħu id- doża fil- ħin, ħudha malli tiftakar, imbagħad erġa ’ lura għall- iskeda regolari tiegħek.
However, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
Madankollu, għejja, ħalq xott u uġigħ ta ’ ras kienu rappurtati b’ mod aktar frekwenti minn dawk li jkun
78 During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Neoclarityn tqiegħed fuq is- suq, każijiet ta’ Neoclaritynreazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes, u nefħa) u raxx kienu rappurtati rari ħafna.
HOW TO STORE NEOCLARITYN ORAL LYOPHILISATE
KIF TAĦŻEN NEOCLARITYN LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ
Do not use Neoclarityn oral lyophilisate after the expiry date which is stated on the carton and blister.
Tużax Neoclarityn 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 Neoclarityn oral lyophilisate.
Għid lill- ispiżjar jekk tara xi tibdil fid- dehra ta ’ Neoclarityn lajofiliżejt li jittieħed mill- ħalq.
What Neoclarityn oral lyophilisate contains
X’ fih Neoclarityn lajofiliżejt li jittieħed mill- ħalq
What Neoclarityn oral lyophilisate looks like and contents of the pack
Id- Dehra ta ’ Neoclarityn lajofiliżejt li jittieħed mill- ħalq u l- kontenuti tal- pakkett