natgillin/translations-raw huggingface dataset:
bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu)
blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu)
30 ml 50 ml 60 ml 100 ml 120 ml 150 ml 225 ml 300 ml
1 2 3 5 7 10 14 15 20 21 30 50 100
1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 2 3 5 7 10 14 15 20 21 30
15 tabletti
1/ 3 EU/ 1/ 00/ 161/ 033 EU/ 1/ 00/ 161/ 034 EU/ 1/ 00/ 161/ 035 EU/ 1/ 00/ 161/ 036 EU/ 1/ 00/ 161/ 037 EU/ 1/ 00/ 161/ 038 EU/ 1/ 00/ 161/ 039 EU/ 1/ 00/ 161/ 040 EU/ 1/ 00/ 161/ 041 EU/ 1/ 00/ 161/ 042 EU/ 1/ 00/ 161/ 043 EU/ 1/ 00/ 161/ 044 EU/ 1/ 00/ 161/ 045 EU/ 1/ 00/ 161/ 046 EU/ 1/ 00/ 161/ 047 EU/ 1/ 00/ 161/ 048 EU/ 1/ 00/ 161/ 049 EU/ 1/ 00/ 161/ 050 EU/ 1/ 00/ 161/ 051 EU/ 1/ 00/ 161/ 052 EU/ 1/ 00/ 161/ 053 EU/ 1/ 00/ 161/ 054 EU/ 1/ 00/ 161/ 055 EU/ 1/ 00/ 161/ 056 EU/ 1/ 00/ 161/ 057 EU/ 1/ 00/ 161/ 058
2/ 4 EU/ 1/ 00/ 161/ 040
Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
Neoclarityn
5 mg 5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
2, 5 mg
Oral lyophilisate Oral lyophilisate Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
Suus dispergeeruv tablett
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Suukaudne
blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu)
blister (PVC/ OPA/ alu)
50 100 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets
18 tabletti
EU/ 1/ 00/ 161/ 059
EU/ 1/ 00/ 161/ 041
Oral solution
Neoclarityn
30 ml
30 tabletti
EU/ 1/ 00/ 161/ 060
EU/ 1/ 00/ 161/ 043
50 ml
50 tabletti
1 bottle
Suukaudne
EU/ 1/ 00/ 161/ 061
EU/ 1/ 00/ 161/ 054
EU/ 1/ 00/ 161/ 062
EU/ 1/ 00/ 161/ 058
2/ 3 EU/ 1/ 00/ 161/ 063
EU/ 1/ 00/ 161/ 063
Neoclarityn 5 mg film-coated tablets
Neoclarityn 5 mg õhukese polümeerkilega kaetud tabletid
Neoclarityn is indicated for the relief of symptoms associated with:
Neoclarityn on näidustatud järgmiste haiguste sümptomaatiliseks raviks:
Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established.
Neoclarityn tablettide efektiivsus ja ohutus alla 12- aastastel lastel ei ole tõestatud.
In the case of severe renal insufficiency, Neoclarityn should be used with caution (see section 5.2).
Raske neerupuudulikkuse korral tuleb Neoclarityn’ t kasutada ettevaatusega (vt lõik 5. 2).
2 4.5 Interaction with other medicinal products and other forms of interaction
2 4. 5 Koostoimed teiste ravimitega ja muud koostoimed
In a clinical pharmacology trial Neoclarityn taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Kliinilise farmakoloogia uuringus ei potentseerinud Neoclarityn samaaegselt manustatuna alkoholi toimet (vt lõik 5. 1).
The use of Neoclarityn during pregnancy is therefore not recommended.
Seetõttu on Neoclarityn’ e kasutamine raseduse ajal mittesoovitav.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breast-feeding women.
Desloratadiin eritub rinnapiima ja seetõttu ei ole Neoclarityn’ e kasutamine rinnaga toitvatel naistel soovitatav.
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 were reported in 3% of patients in excess of those treated with placebo.
Allergilise riniidi ja kroonilise idiopaatilise urtikaaria kliinilistes uuringutes on Neoclarityn' e kasutamisel soovitatud annuses 5 mg ööpäevas kõrvaltoimeid tekkinud 3% sagedamini kui platseeboga ravitud patsientidel.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
3 Desloratadiin ei ole hemodialüüsiga elimineeritav; peritoneaaldialüüsiga elimineeritavuse kohta andmed puuduvad.
Neoclarityn given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Kliinilistes uuringutes ei mõjutanud ühekordse annusena 7, 5 mg manustatud Neoclarityn psühhomotoorset võimekust.
In patients with allergic rhinitis, Neoclarityn was effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Allergilise riniidi patsientidel vähendasid Neoclarityn tabletid efektiivselt järgmisi sümptomeid: aevastamine, vesine nohu, nina sügelus, silmade sügelemine, pisaravool ja punetus, suulae sügelus.
Neoclarityn effectively controlled symptoms for 24 hours.
Neoclarityn tabletid kontrollisid sümptomeid efektiivselt 24 tundi.
The efficacy of Neoclarityn tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Noorukitel vanuses 12 kuni 17 aastat läbiviidud uuringutes ei ole Neoclarityn tablettide efektiivsus selgelt tõestatud.
Since histamine release is a causal factor in all urticarial diseases, desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
Kuna kõiki urtikaarseid haigusi põhjustavaks faktoriks on histamiini vabanemine,
4 In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
4 siis vastavalt kliinilistele ravijuhistele on desloratadiin tõenäoliselt efektiivne ka teiste urtikaarsete seisundite leevendamisel lisaks kroonilise idiopaatilise urtikaaria sümptomitele.
Treatment with Neoclarityn also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Ravi Neoclarityn’ ega vähendas ühtlasi märkimisväärselt unehäireid ja päevaste tegevuste häiritust, mida hinnati 4- punktilises skaalas.
Neoclarityn is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
Neoclarityn on saadaval üheannuselises alumiiniumfooliumiga kaetud lamineeritud blistris.
EU/ 1/ 00/ 161/ 001-013
EU/ 1/ 00/ 161/ 001- 013
Neoclarityn 0.5 mg/ ml syrup
Neoclarityn 0, 5 mg/ ml siirup
Neoclarityn 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).
Neoclarityn’ t võib võtta sõltumata toidukordadest allergilise riniidi (sealhulgas vahelduv ja püsiv allergiline riniit) ja urtikaariaga seostatavate sümptomite leevendamiseks (vt lõik 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 Neoclarityn.
Ravimit ordineerides tuleb arvestada sellega, et alla 2 aastastel lastel on riniit enamikel juhtudel infektsioosse päritoluga (vt lõik 4. 4) ja puuduvad andmed, mis toetaksid infektsioosse riniidi ravi Neoclarityn’ ega.
2.5 ml (1.25 mg) Neoclarityn syrup once a day.
2, 5 ml (1, 25 mg) Neoclarityn siirupit üks kord päevas.
5 ml (2.5 mg) Neoclarityn syrup once a day.
5 ml (2, 5 mg) Neoclarityn siirupit üks kord päevas.
10 ml (5 mg) Neoclarityn syrup once a day.
10 ml (5 mg) Neoclarityn siirupit üks kord päevas.
Efficacy and safety of Neoclarityn syrup in children under 1 year of age have not been established.
Neoclarityn siirupi efektiivsus ja ohutus alla 1- aastastel lastel ei ole tõestatud.
8 In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis.
8 Alla 2- aastaste laste diagnoosimisel on allergilist riniiti raske eristada teistest riniidi vormidest.
The safety of Neoclarityn syrup in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.
Neoclarityn siirupi ohutus 2… 11- aastastel nõrga metabolisatsiooniga lastel on sama, mis normaalse metabolismiga lastel.
The effects of Neoclarityn syrup in poor metabolisers < 2 years of age have not been studied.
Neoclarityn siirupi toimet nõrga metabolisatsiooniga < 2 aastastel ei ole uuritud.
No clinically relevant interactions were observed in clinical trials with Neoclarityn tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
Kliinilistes uuringutes ei ole täheldatud kliinilise tähendusega koostoimeid Neoclarityn tablettide samaaegsel manustamisel erütromütsiini või ketokonasooliga (vt lõik 5. 1).
In a clinical pharmacology trial, Neoclarityn tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Kliinilise farmakoloogia uuringus ei potentseerinud Neoclarityn tabletid samaaegselt manustatuna alkoholi toimet (vt lõik 5. 1).
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breastfeeding women.
Desloratadiin eritub rinnapiima ja seetõttu ei ole Neoclarityn’ e kasutamine rinnaga toitvatel naistel soovitatav.
In clinical trials in a paediatric population, Neoclarityn syrup was administered to a total of 246 children aged 6 months through 11 years.
Pediaatrilise populatsiooni kliinilistes uuringutes manustati Neoclarityn siirupit kokku 246 lapsele vanuses 6 kuud kuni 11 aastat.
The overall incidence of adverse events in children 2 through 11 years of age was similar for the Neoclarityn syrup and the placebo groups.
2... 11- aastastel lastel esinenud kõrvaltoimete sagedus oli Neoclarityn siirupi ja platseebo rühmas sarnane.
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 Neoclarityn were reported in 3% of patients in excess of those treated with placebo.
Allergilise riniidi ja kroonilise idiopaatilise urtikaaria kliinilistes uuringutes on Neoclarityn’ e kasutamisel soovitatud annuses kõrvaltoimeid tekkinud 3% sagedamini kui platseeboga ravitud patsientidel.
9 Psychiatric disorders Nervous system disorders
9 hüperaktiivsus, krambid Südame häired
Hallucinations Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Tahhükardia, südame kloppimine
Efficacy of Neoclarityn syrup has not been investigated in separate paediatric trials.
Neoclarityn siirupi efektiivsust ei ole lastel eraldi uuritud.
Safety of Neoclarityn syrup was demonstrated in three paediatric trials.
Neoclarityn siirupi ohutus on näidatud kolmes laste uuringus.
10 Desloratadine does not readily penetrate the central nervous system.
Desloratadiin tungib kesknärvisüsteemi halvasti.
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.
Kliinilistes uuringutes ei mõjutanud täiskasvanutele ja noorukitele ühekordse 7, 5 mg
In clinical pharmacology trials in adults, co-administration with alcohol did not increase the alcohol- induced impairment in performance or increase in sleepiness.
Ühekordne desloratadiini 5 mg annus täiskasvanutel ei mõjutanud lennuki juhtimise suutlikkuse standardnäitajaid, sh. ei suurenenud unisus ega halvenenud lendamisega seotud ülesannete täitmine.
Efficacy of Neoclarityn syrup has not been investigated in paediatric trials in children less than 12 years of age.
Pediaatrilistes uuringutes ei ole Neoclarityn siirupi efektiivsust noorematel kui 12 aastastel lastel uuritud.
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.
Allergilise riniidiga noorukitel ja täiskasvanud patsientidel vähendasid Neoclarityn tabletid efektiivselt järgmisi sümptomeid: aevastamine, vesine nohu, nina sügelus, silmade sügelemine, pisaravool ja punetus, suulae sügelus.
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.
Rinokonjunktiviidi patsientide elukvaliteedi küsitluse kohaselt leevendasid Neoclarityn tabletid efektiivselt sesoonse allergilise riniidi talumist.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Kahes platseebo- kontrollitud 6- nädalases kroonilise idiopaatilise urtikaaria uuringus vähendas Neoclarityn efektiivselt sügelust ja kuplade suurust ning arvu juba esimese ravipäeva lõpuks.
11 In a series of pharmacokinetic and clinical trials, 6% of the subjects reached a higher concentration of desloratadine.
Reas farmakokineetilistes ja kliinilistes uuringutes saavutasid 6% uuritavatest kõrgema desloratadiini kontsentratsiooni.
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.
11 2… 11- aastaste laste (6%) hulgas ning mõlema populatsiooni puhul kõrgem mustadel (18% täiskasvanutest, 16% lastest) kui valgetel (2% täiskasvanutest, 3% lastest).
The effects of Neoclarityn syrup in poor metabolizers < 2 years of age have not been studied.
Neoclarityn siirupi toimet nõrga metabolisatsiooniga < 2 aastastel ei ole uuritud.
Propylene glycol, sorbitol, citric acid anhydrous, sodium citrate, sodium benzoate, disodium edetate, purified water, sucrose, natural and artificial flavour (bubblegum), orange colour E110.
Propüleenglükool, sorbitool, veevaba sidrunhape, naatriumtsitraat, naatriumbensoaat, dinaatriumedetaat, destilleeritud vesi, sahharoos,
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.
Pudel on III tüüpi merevaigu- kollasest klaasist ja lastekindla polüpropüleenist korgiga.
EU/ 1/ 00/ 161/ 014-021
EU/ 1/ 00/ 161/ 014- 021
Neoclarityn 5 mg oral lyophilisate
Neoclarityn 5 mg peroraalne lüofilisaat
Each dose of Neoclarityn oral lyophilisate contains 5 mg desloratadine.
Neoclarityn peroraalse lüofilisaadi iga annus sisaldab 5 mg desloratadiini.
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).
Neoclarityn peroraalse lüofilisaadi üks annus asetada suhu üks kord ööpäevas allergilise riniidi (sealhulgas vahelduv ja püsiv allergiline riniit) ja urtikaariaga seostatavate sümptomite leevendamiseks (vt lõik 5. 1).
Neoclarityn oral lyophilisate disperses instantly and water or other liquid is not needed.
Neoclarityn peroraalne lüofilisaat lahustub koheselt ja vesi või muu vedelik ei ole vajalik.
In the case of severe renal insufficiency, Neoclarityn should be used with caution.
Raske neerupuudulikkuse korral tuleb Neoclarityn’ t kasutada ettevaatusega.
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.
Allergilise riniidi ja kroonilise idiopaatilise urtikaaria kliinilistes uuringutes on Neoclarityn tablettide kasutamisel soovitatud annuses 5 mg ööpäevas kõrvaltoimeid tekkinud 3% sagedamini kui platseeboga ravitud patsientidel.
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.
15 Kliinilises uuringus ei ilmnenud desloratadiini manustamisel annuses kuni 45 mg (9- kordne terapeutiline annus) kliiniliselt olulisi kõrvaltoimeid.
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.
Ühekordse annusega tehtud kahes uuringus oli Neoclarityn peroraalne lüofilisaat kliiniliste laborinäitajate, füüsilise läbivaatuse, vitaalsuse ja EKG intervalli andmete kohaselt hästi talutav.
At the recommended dose, Neoclarityn oral lyophilisate was found to be bioequivalent to the conventional tablet formulation of desloratadine.
Soovitavas annuses oli Neoclarityn peroraalne lüofilisaat bioekvivalentne desloratadiini tavapärase tabletivormiga.
Therefore, the efficacy of Neoclarityn oral lyophilisate is expected to be the same as with the Neoclarityn tablet formulation.
Seetõttu on Neoclarityn peroraalse lüofilisaadi oodatav efektiivsus võrdne Neoclarityn tabletiga.
Neoclarityn tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Kliinilistes uuringutes ei mõjutanud ühekordse annusena 7, 5 mg manustatud Neoclarityn tabletid psühhomotoorset võimekust.
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.
Allergilise riniidi patsientidel vähendasid Neoclarityn tabletid efektiivselt järgmisi sümptomeid: aevastamine, vesine nohu, nina sügelus, silmade sügelemine, pisaravool ja punetus, suulae sügelus.
Neoclarityn tablets effectively controlled symptoms for 24 hours.
Neoclarityn tabletid kontrollisid sümptomeid efektiivselt 24 tundi.
Intermittent allergic rhinitis is defined as the presence of symptoms for less
Allergilist riniiti loetakse vahelduvaks, kui sümptomid ilmnevad vähem kui 4
17 than 4 days per week or for less than 4 weeks.
16 päeval nädalas või vähem kui 4 nädalat.
In single-dose crossover studies of Neoclarityn oral lyophilisate with Neoclarityn tablets, the formulations were bioequivalent.
Ühekordse annusega Neoclarityn peroraalse lüofilisaadi ja Neoclarityn tablettide ristuuringus olid ravimvormid bioekvivalentsed.
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.
Desloratadiini Tmax pikeneb toidu mõjul 2, 5 kuni 4 tundi ja 3- OH- desloratadiini Tmax 4 kuni 6 tundi.
18 5.3 Preclinical safety data
17 5. 3 Prekliinilised ohutusandmed
Neoclarityn oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Neoclarityn peroraalne lüofilisaat on saadaval üheannuselises alumiiniumfooliumiga kaetud lamineeritud blistris.
EU/ 1/ 00/ 161/ 022-034
EU/ 1/ 00/ 161/ 022- 034
Neoclarityn 2.5 mg orodispersible tablets
Neoclarityn 2, 5 mg suus dispergeeruvad tabletid
Each dose of Neoclarityn orodispersible tablet contains 2.5 mg desloratadine.
Iga Neoclarityn suus dispergeeruv tablett sisaldab 2, 5 mg desloratadiini.
For a full list of excipients, see section 6.1.
Neoclarityn Abiainete täielik loetelu vt lõik 6. 1.
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).
6 kuni 11- aastased lapsed: üks 2, 5 mg Neoclarityn suus dispergeeruv tablett asetada suhu üks kord ööpäevas allergilise riniidi (sealhulgas vahelduv ja püsiv allergiline riniit) ja urtikaariaga seostatavate sümptomite leevendamiseks (vt lõik 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).
Täiskasvanud ja 12- aastased ning vanemad noorukid: kaks 2, 5 mg Neoclarityn suus dispergeeruvat tabletti asetada suhu üks kord ööpäevas allergilise riniidi (sealhulgas vahelduv ja püsiv allergiline riniit) ja kroonilise idiopaatilise urtikaariaga seostatavate sümptomite leevendamiseks (vt lõik 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).
Kliinilistest uuringutest saadud andmed desloratadiini kasutamise kohta noorukitel vanuses 12 kuni 17 aastat on piiratud (vt lõik 4. 8 ja 5. 1).
Efficacy and safety of Neoclarityn 2.5 mg orodispersible tablets in children under 6 years of age have not been established.
Neoclarityn 2, 5 mg suus dispergeeruvate tablettide efektiivsus ja ohutus alla 6- aastastel lastel ei ole tõestatud.
This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Neoclarityn orodispersible tablet.
See ravim sisaldab 1, 4 mg fenüülalaniini 2, 5 mg Neoclarityn suus dispergeeruva tableti kohta.
22 Psychiatric disorders Nervous system disorders
Psühhiaatrilised häired
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.
Ühekordse annusega tehtud kahes uuringus oli Neoclarityn suukaudne lüofilisaat kliiniliste laborinäitajate, füüsilise läbivaatuse, vitaalsuse ja EKG intervalli andmete kohaselt hästi talutav.
In addition, Neoclarityn orodispersible tablets were well tolerated in a multiple dose trial.
Lisaks olid Neoclarityn suus dispergeeruvad tabletid hästi talutavad mitmekordsete annustega läbiviidud uuringus.
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.
Soovitavas annuses oli Neoclarityn 5 mg suus dispergeeruv tablett bioekvivalentne desloratadiini teiste ravimvormidega, nagu Neoclarityn 5 mg tavapärase tabletivormiga ning Neoclarityn 5 mg peroraalse lüofilisaadiga.