natgillin/translations-raw huggingface dataset:
blister (Aclar/ PVC, alu)
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)
30 tabletter
30 ml 50 ml 60 ml 100 ml 120 ml 150 ml 225 ml 300 ml
EU/ 1/ 00/ 157/ 012
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
Azomyr
1/ 3 EU/ 1/ 00/ 157/ 032 EU/ 1/ 00/ 157/ 033 EU/ 1/ 00/ 157/ 034 EU/ 1/ 00/ 157/ 035 EU/ 1/ 00/ 157/ 036 EU/ 1/ 00/ 157/ 037 EU/ 1/ 00/ 157/ 038 EU/ 1/ 00/ 157/ 039 EU/ 1/ 00/ 157/ 040 EU/ 1/ 00/ 157/ 041 EU/ 1/ 00/ 157/ 042 EU/ 1/ 00/ 157/ 043 EU/ 1/ 00/ 157/ 044 EU/ 1/ 00/ 157/ 045 EU/ 1/ 00/ 157/ 046 EU/ 1/ 00/ 157/ 047 EU/ 1/ 00/ 157/ 048 EU/ 1/ 00/ 157/ 049 EU/ 1/ 00/ 157/ 050 EU/ 1/ 00/ 157/ 051 EU/ 1/ 00/ 157/ 052 EU/ 1/ 00/ 157/ 053 EU/ 1/ 00/ 157/ 054 EU/ 1/ 00/ 157/ 055 EU/ 1/ 00/ 157/ 056 EU/ 1/ 00/ 157/ 057 EU/ 1/ 00/ 157/ 058
Filmovertrukne tabletter
Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr
Oral anvendelse
5 mg 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
blister (Aclar/ PVC, alu)
Oral lyophilisate 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
50 tabletter
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 Oral use
EU/ 1/ 00/ 157/ 013
blister (PVC/ Alu) 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)
Azomyr
30 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
EU/ 1/ 00/ 157/ 014
EU/ 1/ 00/ 157/ 059
EU/ 1/ 00/ 157/ 015
EU/ 1/ 00/ 157/ 060
EU/ 1/ 00/ 157/ 016
EU/ 1/ 00/ 157/ 061
1/ 3 EU/ 1/ 00/ 157/ 017
2/ 3 EU/ 1/ 00/ 157/ 062
EU/ 1/ 00/ 157/ 018
EU/ 1/ 00/ 157/ 063
EU/ 1/ 00/ 157/ 019
EU/ 1/ 00/ 157/ 064
EU/ 1/ 00/ 157/ 020
EU/ 1/ 00/ 157/ 065
225 ml
150 ml
EU/ 1/ 00/ 157/ 021
EU/ 1/ 00/ 157/ 066
300 ml
225 ml
EU/ 1/ 00/ 157/ 066 EU/ 1/ 00/ 157/ 067
EU/ 1/ 00/ 157/ 067
Azomyr Azomyr
Azomyr
0, 5 mg/ ml 0, 5 mg/ ml
0.5 mg/ ml
Oral anvendelse Oral anvendelse
Oral use
flaske (glas) + måleske flaske (glas) + måleske
bottle (glass) + spoon (plastic)
225 ml 300 ml
300 ml
1 flaske 1 flaske
1 bottle
Azomyr er indiceret til symptomlindring i forbindelse med:
Azomyr is indicated for the relief of symptoms associated with:
Effekt og sikkerhed af Azomyr- tabletter til børn under 12 år er ikke undersøgt.
Efficacy and safety of Azomyr tablets in children under 12 years of age have not been established.
5. 2).
In the case of severe renal insufficiency, Azomyr should be used with caution (see section 5.2).
5. 1).
In a clinical pharmacology trial Azomyr taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Brug af Azomyr under graviditet kan derfor ikke anbefales.
The use of Azomyr during pregnancy is therefore not recommended.
Desloratadin udskilles i modermælk; anvendelse af Azomyr anbefales derfor ikke hos ammende kvinder.
Desloratadine is excreted into breast milk, therefore the use of Azomyr is not recommended in breast- feeding women.
I kliniske undersøgelser ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, ved den anbefalede dosis på 5 mg daglig, blev bivirkninger med Azomyr rapporteret hos 3% flere patienter end hos dem, der behandledes med placebo.
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.
Azomyr, givet i en enkelt daglig dosis på 7, 5 mg, påvirkede ikke den psykomotoriske præstationsevne i kliniske undersøgelser.
Azomyr given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Effekten af Azomyr- tabletter er ikke blevet tydeligt vist i undersøgelser med unge patienter mellem 12 og 17 år.
The efficacy of Azomyr tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Azomyr var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den total score i rhino- konjunktivitis livskvalitetsspørgeskemaet.
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 effektivt til at lindre kløe og mindske størrelsen og antallet af kløende udslæt ved slutningen af det første doseringsinterval.
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.
Behandling med Azomyr reducerede også signifikant påvirkningen af søvn og daglig funktionsevne, målt ved en fire- points skala, der anvendtes for at vurdere disse parametre.
Treatment with Azomyr also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Azomyr leveres i enkeltdosisblisterpakninger af formstøbt blisterfilm med folielåg.
Azomyr is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
DATO FOR ÆNDRING AF TEKSTEN 6 Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Azomyr 0, 5 mg/ ml syrup
Azomyr 0.5 mg/ ml syrup
5. 1).
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).
4. 4) og at der ikke er nogen resultater, der understøtter brug af Azomyr til behandling af infektiøs rhinitis.
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.
2, 5 ml (1, 25 mg) Azomyr syrup en gang daglig.
2.5 ml (1.25 mg) Azomyr syrup once a day.
5 ml (2, 5 mg) Azomyr syrup en gang daglig.
5 ml (2.5 mg) Azomyr syrup once a day.
10 ml (5 mg) Azomyr syrup en gang daglig.
10 ml (5 mg) Azomyr syrup once a day.
Effekt og sikkerhed af Azomyr syrup til børn under 1 år er ikke undersøgt.
Efficacy and safety of Azomyr syrup in children under 1 year of age have not been established.
Sikkerheden af Azomyr syrup hos børn i alderen 2 til 11 år som er dårlige til at metabolisere, er den samme som for børn som har en normal evne til at metabolisere.
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.
Effekten af Azomyr syrup hos børn < 2 år, der er dårlige til at metabolisere, er ikke undersøgt.
The effects of Azomyr syrup in poor metabolisers < 2 years of age have not been studied.
5. 1).
No clinically relevant interactions were observed in clinical trials with Azomyr tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
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).
Desloratadin udskilles i modermælk; anvendelse af Azomyr anbefales derfor ikke hos ammende kvinder.
Desloratadine is excreted into breast milk, therefore the use of Azomyr is not recommended in breastfeeding women.
I kliniske undersøgelser i en pædiatrisk population blev Azomyr syrup anvendt til ialt 246 børn i alderen 6 måneder til 11 år.
In clinical trials in a paediatric population, Azomyr syrup was administered to a total of 246 children aged 6 months through 11 years.
Den samlede forekomst af bivirkninger hos børn i alderen 2 til 11 år var sammenlignelig for Azomyr syrup - og placebogrupperne.
The overall incidence of adverse events in children 2 through 11 years of age was similar for the Azomyr syrup and the placebo groups.
Ved den anbefalede dosis i kliniske undersøgelser omfattende voksne og unge ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, blev bivirkninger med Azomyr rapporteret hos 3% flere patienter end hos dem, der behandledes med placebo.
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.
Psykiske forstyrrelser Nervesystemet
9 Psychiatric disorders Nervous system disorders
Effekten af Azomyr syrup er ikke vurderet i særlige undersøgelser hos børn.
Efficacy of Azomyr syrup has not been investigated in separate paediatric trials.
Sikkerheden ved Azomyr syrup blev påvist i tre pædiatriske undersøgelser.
Safety of Azomyr syrup was demonstrated in three paediatric trials.
Desloratadin trænger ikke hurtigt ind i centralnervesystemet.
10 Desloratadine does not readily penetrate the central nervous system.
Azomyr- tabletter, givet i en enkelt daglig dosis på 7, 5 mg til voksne og unge, påvirkede ikke den psykomotoriske præstationsevne i kliniske undersøgelser.
Azomyr tablets given at a single daily dose of 7.5 mg to adults and adolescents did not affect psychomotor performance in clinical trials.
Effekten af Azomyr syrup er ikke blevet undersøgt i pædiatriske undersøgelser hos børn under 12 år.
Efficacy of Azomyr syrup has not been investigated in paediatric trials in children less than 12 years of age.
Hos voksne og unge patienter med allergisk rhinitis lindrede Azomyr- tabletter effektivt symptomer såsom nysen, næseflåd og - kløe, samt øjenkløe, tåreflåd og rødme samt kløe i ganen.
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.
Azomyr- tabletter lindrede effektivt generne ved sæsonbetonet allergisk rhinitis, vist ved den totale score i rhino- konjunktivitis livskvalitetsspørgeskemaet.
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.
I to placebokontrollerede seks- ugers undersøgelser hos patienter med kronisk idiopatisk urticaria var Azomyr effektivt til at lindre kløe og mindske størrelsen og antallet af kløende udslæt ved slutningen af det første doseringsinterval.
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.
I en række farmakokinetiske og kliniske undersøgelser nåede 6% af patienterne en højere koncentration af desloratadin.
11 In a series of pharmacokinetic and clinical trials, 6% of the subjects reached a higher concentration of desloratadine.
Effekten af Azomyr syrup hos patienter < 2 år med dårlig metaboliseringsgrad er ikke undersøgt.
The effects of Azomyr syrup in poor metabolizers < 2 years of age have not been studied.
Propylenglycol, sorbitol, citronsyre, vandfri, natriumcitrat, natriumbenzoat, dinatriumedetat, vand, renset, saccharose, naturligt og kunstigt smagsstof (tyggegummi), orange farvestof E110.
Propylene glycol, sorbitol, citric acid anhydrous, sodium citrate, sodium benzoate, disodium edetate, purified water, sucrose, natural and artificial flavour (bubblegum), orange colour E110.
Azomyr syrup leveres i flasker med 30, 50, 60, 100, 120, 150, 225 og 300 ml i type III ravgule glasflasker lukket med et børnesikkert polypropylenlåg.
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.
Leveres med en hård, transparent, polystyrenmåleske, mærket 2, 5 ml og 5 ml.
Supplied with a rigid, transparent, polystyrene measuring spoon, calibrated at 2.5 ml and 5 ml.
Azomyr 5 mg smeltetabletter
Azomyr 5 mg oral lyophilisate
Hver Azomyr smeltetablet indeholder 5 mg desloratadin.
Each dose of Azomyr oral lyophilisate contains 5 mg desloratadine.
5. 1).
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).
Azomyr smeltetablet smelter øjeblikkeligt, og vand eller anden væske er ikke nødvendigt.
Azomyr oral lyophilisate disperses instantly and water or other liquid is not needed.
I tilfælde af svær nyreinsufficiens bør Azomyr anvendes med forsigtighed.
In the case of severe renal insufficiency, Azomyr should be used with caution.
I kliniske undersøgelser ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, ved den anbefalede dosis på 5 mg daglig, blev bivirkninger med Azomyr- tabletter rapporteret hos 3% flere patienter end hos dem, der behandledes med placebo.
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.
I to enkeltdosis undersøgelser var Azomyr smeltetablet vel tolereret på basis af kliniske laboratoriefund, fysiske undersøgelser, vitale sygdomstegn og EKG interval data.
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.
Ved den anbefalede dosis blev Azomyr smeltetablet konstateret værende bioækvivalent med den almindelige tabletformulering af desloratadin.
At the recommended dose, Azomyr oral lyophilisate was found to be bioequivalent to the conventional tablet formulation of desloratadine.
Effekten af Azomyr smeltetablet forventes derfor at være den samme som med Azomyr tabletformuleringen.
Therefore, the efficacy of Azomyr oral lyophilisate is expected to be the same as with the Azomyr tablet formulation.
Azomyr- tabletter, givet i en enkelt daglig dosis på 7, 5 mg, påvirkede ikke den psykomotoriske præstationsevne i kliniske undersøgelser.
Azomyr tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Hos patienter med allergisk rhinitis lindrede Azomyr- tabletter effektivt symptomer såsom nysen, næseflåd og - kløe, samt øjenkløe, tåreflåd og rødme og kløe i ganen.
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.
Azomyr- tabletter regulerede effektivt symptomerne i 24 timer.
Azomyr tablets effectively controlled symptoms for 24 hours.
17 Azomyr var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den totale score i rhino- konjunktivitis livskvalitetsspørgeskemaet.
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.
I enkeltdosis overkrydsningsundersøgelser af Azomyr smeltetablet over for Azomyr- tabletter var formuleringerne bioækvivalente.
In single-dose crossover studies of Azomyr oral lyophilisate with Azomyr tablets, the formulations were bioequivalent.
Tilstedeværelsen af føde havde ingen relevant indflydelse på AUC og Cmax af Azomyr smeltetablet, mens tilstedeværelsen af føde forlænger Tmax for desloratadin fra 2, 5 til 4 timer og Tmax for 3- OH - desloratadin fra 4 til 6 timer.
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 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
De prækliniske data for desloratadin viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og reproduktionstoksicitet.
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.
Azomyr smeltetabletter leveres i enkeltdosis blisterkort af formstøbt blisterfilm med folielåg.
Azomyr oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Azomyr 2, 5 mg smeltetabletter
Azomyr 2.5 mg orodispersible tablets
Hver Azomyr smeltetablet indeholder 2, 5 mg desloratadin.
Each dose of Azomyr orodispersible tablet contains 2.5 mg desloratadine.
5. 1).
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).
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).
Effekt og sikkerhed af Azomyr 2, 5 mg smeltetabletter til børn under 6 år er ikke undersøgt.
Efficacy and safety of Azomyr 2.5 mg orodispersible tablets in children under 6 years of age have not been established.
Dette lægemiddel indeholder 1, 4 mg phenylalanin per 2, 5 mg Azomyr smeltetablet.
This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Azomyr orodispersible tablet.
Azomyr smeltetablet var desuden veltolereret i en flerdosis undersøgelse.
In addition, Azomyr orodispersible tablets were well tolerated in a multiple dose trial.
Ved den anbefalede dosis blev Azomyr 5 mg smeltetablet fundet værende bioækvivalent med den konventionelle Azomyr 5 mg tabletformulering af desloratadin.
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.
Effekten af Azomyr smeltetablet forventes derfor at være den samme som med Azomyr tabletformuleringen.
Therefore, the efficacy of Azomyr orodispersible tablet is expected to be the same as with the Azomyr tablet formulation.
Azomyr var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den totale score i rhino- konjunktivitis livskvalitetsspørgeskemaet.
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.
I enkeltdosis overkrydsningsundersøgelser af Azomyr 5 mg smeltetablet over for konventionelle Azomyr 5 mg tabletter var formuleringerne bioækvivalente.
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.
I forbindelse med dosisjusteringsundersøgelserne hos børn underbygger de farmakokinetiske data for Azomyr smeltetabletter imidlertid brugen af 2, 5 mg dosen til børn i alderen 6 til 11 år.
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.
Vand har ingen effekt på biotilgængeligheden for Azomyr smeltetabletter.
Water had no affect on the bioavailability of Azomyr orodispersible tablets.
cellulose, mikrokrystallinsk stivelse, pregelatineret natriumstivelsesglycolat magnesiumstearat butyleret methacrylatcopolymer crospovidon natriumhydrogencarbonat citronsyre silica, kolloid vandfri jernoxid mannitol aspartam (E951)
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
25 tutti- frutti aroma
6.2 Incompatibilities 25 Not applicable.
Azomyr smeltetabletter leveres i enkeltdosis blisterkort af formstøbt blisterfilm med folielåg.
Azomyr orodispersible tablets are supplied in unit dose blisters comprised of laminate blister film with foil lidding.
EU/ 1/ 00/ 157/ 037- 048
EU/ 1/ 00/ 157/ 035-046
Hver Azomyr smeltetablet indeholder 5 mg desloratadin.
Each dose of Azomyr orodispersible tablet contains 5 mg desloratadine.
5. 1).
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).
Effekt og sikkerhed af Azomyr smeltetabletter til børn under 12 år er ikke undersøgt.
Efficacy and safety of Azomyr orodispersible tablets in children under 12 years of age have not been established.
Dette lægemiddel indeholder 2, 9 mg phenylalanin per 5 mg Azomyr smeltetablet.
This product contains 2.9 mg of phenylalanine per 5 mg dose of Azomyr orodispersible tablet.
Azomyr smeltetablet var desuden veltolereret i en flerdosis undersøgelse.
In addition, Azomyr orodispersible tablets were well tolerated in a multiple-dose trial.
Hos patienter med allergisk rhinitis lindrede Azomyr- tabletter effektivt symptomer såsom nysen, næseflåd og - kløe, samt øjenkløe, tåreflåd og rødme og kløe i ganen.
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.
Azomyr- tabletter regulerede
Azomyr tablets effectively controlled symptoms for 24 hours.
30 I enkeltdosis overkrydsningsundersøgelser af Azomyr 5 mg smeltetablet over for konventionelle Azomyr 5 mg tabletter var formuleringerne bioækvivalente.
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.
EU/ 1/ 00/ 157/ 049- 060
EU/ 1/ 00/ 157/ 047-058