natgillin/translations-raw huggingface dataset:
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)
pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ OPA/ alu)
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
1 2 3 5 7 10 14 15 20 21 30 50 100 5 tablet
EU/ 1/ 00/ 157/ 059
EU/ 1/ 00/ 157/ 037
0.5 mg/ ml
12 tablet
Oral solution
EU/ 1/ 00/ 157/ 039
Oral use
20 tablet
EU/ 1/ 00/ 157/ 060
EU/ 1/ 00/ 157/ 043
EU/ 1/ 00/ 157/ 061
EU/ 1/ 00/ 157/ 050
Oral solution
EU/ 1/ 00/ 157/ 051
1 bottle
90 tablet
2/ 3 EU/ 1/ 00/ 157/ 062
EU/ 1/ 00/ 157/ 058
100 ml
100 tablet
bottle (glass) + syringe (plastic)
steklenička (steklo) + žlička (plastika)
Azomyr is indicated for the relief of symptoms associated with:
Azomyr je indiciran za lajšanje simptomov:
Efficacy and safety of Azomyr tablets in children under 12 years of age have not been established.
Pri otrocih, mlajših od 12 let, še niso ugotovili učinkovitosti in varnosti Azomyr tablet.
In the case of severe renal insufficiency, Azomyr should be used with caution (see section 5.2).
V primeru hude ledvične insuficience morate zdravilo Azomyr uporabljati previdno (glejte poglavje 5. 2).
In a clinical pharmacology trial Azomyr taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
(glejte poglavje 5. 1).
The use of Azomyr during pregnancy is therefore not recommended.
Varnost zdravila Azomyr v času nosečnosti še ni bila ugotovljena, zato ne priporočamo njegove uporabe v času nosečnosti.
Desloratadine is excreted into breast milk, therefore the use of Azomyr is not recommended in breast- feeding women.
Desloratadin se izloča v materino mleko, zato ne priporočamo uporabe zdravila Azomyr pri doječih materah.
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.
V kliničnih preskušanjih pri različnih indikacijah za uporabo zdravila, vključno z alergijskim rinitisom in kronično idiopatsko urtikarijo so pri priporočenem odmerku 5 mg na dan o neželenih učinkih zdravila Azomyr poročali pri 3% bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
Azomyr given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
V kliničnih preskušanjih zdravilo Azomyr v enem dnevnem odmerku 7, 5 mg ni vplivalo na psihomotorične sposobnosti bolnikov.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced impairment in performance or increase in sleepiness.
V kliničnih farmakoloških preskušanjih sočasna uporaba zdravila Azomyr z alkoholom ni okrepila škodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
Azomyr effectively controlled symptoms for 24 hours.
Azomyr učinkovito obvladuje te simptome za čas 24 ur.
The efficacy of Azomyr tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Učinkovitosti zdravila Azomyr tablete niso jasno dokazali v preskušanjih pri mladostnikih, starih od 12 do 17 let.
The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.
Azomyr je učinkovito ublažil težave, povezane s sezonskim alergijskim rinitisom, kar so pokazali skupni rezultati vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom Največje izboljšanje so ugotavljali v zvezi s praktičnimi problemi in pri dnevnih dejavnostih, ki jih sicer ovirajo simptomi te bolezni.
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.
V dveh s placebom kontroliranih šesttedenskih preskušanjih pri bolnikih s kronično idiopatsko urtikarijo je Azomyr učinkovito blažil srbenje in zmanjšal velikost in število izpuščajev koprivnice že do konca prvega intervala odmerjanja.
Treatment with Azomyr also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Zdravljenje z zdravilom Azomyr je tudi bistveno zmanjšalo motnje spanja in dnevnih dejavnosti bolnika čez dan, kar so ugotavljali na podlagi meritev s štiritočkovno lestvico za oceno teh spremenljivk.
Azomyr is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
Azomyr je na voljo v laminatnih pretisnih omotih za enojni odmerek, ki ga sestavljata film pretisnega, omota in folija, ki ga prekriva.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 tablets.
Škatle po 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 ali 100 tablet.
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).
Zdravilo Azomyr lahko bolnik jemlje ne glede na obroke za lajšanje simptomov, povezanih z alergijskim rinitisom (vključno z intermitentnim in perzistentnim alergijskim rinitisom) in za zdravljenje urtikarije (glejte poglavje 5. 1).
The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin (see section 4.4) and there are no data supporting the treatment of infectious rhinitis with Azomyr.
Zdravnik, ki predpiše zdravilo, naj se zaveda, da je pri otrocih, mlajših od 2 let, večina primerov rinitisa infekcijskega izvora (glejte poglavje 4. 4) in da ni nobenih podatkov, ki bi govorili v prid zdravljenju infekcijskega rinitisa z zdravilom Azomyr.
2.5 ml (1.25 mg) Azomyr syrup once a day.
2, 5 ml (1, 25 mg) sirupa Azomyr enkrat na dan.
5 ml (2.5 mg) Azomyr syrup once a day.
5 ml (2, 5 mg) sirupa Azomyr enkrat na dan.
10 ml (5 mg) Azomyr syrup once a day.
10 ml (5 mg) sirupa Azomyr enkrat na dan.
Efficacy and safety of Azomyr syrup in children under 1 year of age have not been established.
Pri otrocih, mlajših od 1 leta, še niso ugotovili učinkovitosti in varnosti Azomyr sirupa.
The effects of Azomyr syrup in poor metabolisers < 2 years of age have not been studied.
Učinkov zdravila Azomyr sirup pri otrocih, mlajših od 2 let, ki slabo presnavljajo zdravilo, niso raziskovali.
No clinically relevant interactions were observed in clinical trials with Azomyr tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
V kliničnih preskušanjih tablet Azomyr, v katerih so bolniki sočasno jemali tudi eritromicin ali ketokonazol, niso opažali nobenih klinično pomembnih interakcij med zdravili (glejte poglavje 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).
(glejte poglavje 5. 1).
Desloratadine is excreted into breast milk, therefore the use of Azomyr is not recommended in breastfeeding women.
Desloratadin se izloča v materino mleko, zato ne priporočamo uporabe zdravila Azomyr pri doječih materah.
In clinical trials in a paediatric population, Azomyr syrup was administered to a total of 246 children aged 6 months through 11 years.
V kliničnih preskušanjih pri pediatrični populaciji so zdravilo Azomyr sirup dajali skupaj 246 otrokom, starim od 6 mesecev do 11 let.
The overall incidence of adverse events in children 2 through 11 years of age was similar for the Azomyr syrup and the placebo groups.
Skupna incidenca neželenih učinkov pri otrocih, starih od 2 do 11 let, ki so prejemali zdravilo Azomyr, je bila podobna skupni incidenci pri skupini, ki je prejemala 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.
V kliničnih preskušanjih pri različnih indikacijah za uporabo zdravila, vključno z alergijskim rinitisom in kronično idiopatsko urtikarijo, so pri priporočenem odmerku na dan o neželenih učinkih zdravila Azomyr poročali pri 3% bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
9 Psychiatric disorders Nervous system disorders
9 Halucinacije Psihiatrične motnje
Efficacy of Azomyr syrup has not been investigated in separate paediatric trials.
Učinkovitosti zdravila Azomyr sirup niso raziskovali v ločenih pediatričnih preskušanjih.
Safety of Azomyr syrup was demonstrated in three paediatric trials.
V treh preskušanjih pri pediatričnih bolnikih so dokazali varnost zdravila Azomyr sirup.
10 Desloratadine does not readily penetrate the central nervous system.
Desloratadin ne prehaja zlahka v osrednji živčni sistem.
Azomyr tablets given at a single daily dose of 7.5 mg to adults and adolescents did not affect psychomotor performance in clinical trials.
V kliničnih preskušanjih zdravilo Azomyr pri enkratnem dnevnem odmerku 7, 5 mg pri odraslih in mladostnikih ni vplivalo na psihofizične sposobnosti bolnikov.
In clinical pharmacology trials in adults, co-administration with alcohol did not increase the alcohol- induced impairment in performance or increase in sleepiness.
V kliničnih farmakoloških preskušanjih pri odraslih sočasna uporaba zdravila Azomyr z alkoholom ni okrepila škodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
Efficacy of Azomyr syrup has not been investigated in paediatric trials in children less than 12 years of age.
Učinkovitosti zdravila Azomyr sirup niso proučili v pediatričnih preskušanjih pri otrocih, mlajših od 12 let.
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.
Azomyr tablete so učinkovito ublažile težave, povezane s sezonskim alergijskim rinitisom, kar je pokazal skupni rezultat vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom.
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.
V dveh s placebom kontroliranih šesttedenskih preskušanjih pri bolnikih s kronično idiopatsko urtikarijo je Azomyr učinkovito blažil srbenje in zmanjšal velikost in število izpuščajev koprivnice že do konca prvega intervala odmerjanja.
An improvement in pruritus of more than 50% was observed in 55% of patients treated with desloratadine compared with 19% of patients treated with placebo.
11 kot 50% izboljšanje srbenja, v primerjavi z 19% bolnikov, zdravljenih s placebom.
Treatment with Azomyr also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Zdravljenje z zdravilom Azomyr je tudi bistveno zmanjšalo motnje spanja in dnevnih dejavnosti, kar so ugotavljali na podlagi meritev s štiritočkovno lestvico za oceno teh spremenljivk.
11 In a series of pharmacokinetic and clinical trials, 6% of the subjects reached a higher concentration of desloratadine.
V vrsti farmakokinetičnih in kliničnih preskušanj je 6% preiskovancev doseglo večje koncentracije desloratadina.
The effects of Azomyr syrup in poor metabolizers < 2 years of age have not been studied.
Učinkov zdravila Azomyr sirup pri bolnikih, mlajših od 2 let, ki slabo presnavljajo zdravilo, niso raziskovali.
Propylene glycol, sorbitol, citric acid anhydrous, sodium citrate, sodium benzoate, disodium edetate, purified water, sucrose, natural and artificial flavour (bubblegum), orange colour E110.
Propilenglikol, sorbitol, brezvodna citronska kislina, natrijev citrat, natrijev benzoat, dinatrijev edetat, prečiščena voda, saharoza, naravna in umetna aroma (za žvečilne gumije), oranžno barvilo E110
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.
Azomyr sirup je na voljo v stekleničkah po 30, 50, 60, 100, 120, 150, 225 in 300 ml iz rjavega stekla tipa III, zaprtih z za otroke varno polipropilensko zaporko.
Supplied with a rigid, transparent, polystyrene measuring spoon, calibrated at 2.5 ml and 5 ml.
Zdravilu je priložena trdna, prosojna polistirenska odmerna žlička, umerjena na 2, 5 ml in 5 ml.
EU/ 1/ 00/ 157/ 014-021
13 EU/ 1/ 00/ 157/ 014- 021
Azomyr 5 mg oral lyophilisate
Azomyr 5 mg peroralni liofilizat
Each dose of Azomyr oral lyophilisate contains 5 mg desloratadine.
Vsak odmerek zdravila Azomyr peroralni liofilizat vsebuje 5 mg desloratadina.
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).
Odrasli in mladostniki (stari 12 let ali več): bolnik naj si da en odmerek zdravila Azomyr peroralni liofilizat v usta enkrat na dan za lajšanje simptomov, povezanih z alergijskim rinitisom (vključno z intermitentnim in perzistentnim alergijskim rinitisom) in za zdravljenje urtikarije (glejte poglavje 5. 1).
Azomyr oral lyophilisate disperses instantly and water or other liquid is not needed.
Azomyr peroralni liofilizat se v ustih dispergira v trenutku in ni potrebno pitje vode ali drugih tekočin.
In the case of severe renal insufficiency, Azomyr should be used with caution.
V primeru hude ledvične insuficience morate zdravilo Azomyr uporabljati previdno.
No clinically relevant interactions were observed in clinical trials with Azomyr tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
V kliničnih preskušanjih, v katerih so bolniki sočasno s tabletami Azomyr jemali tudi eritromicin ali ketokonazol, niso opažali klinično pomembnih interakcij med zdravili (glejte poglavje 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).
V klinični farmakološki raziskavi pri sočasnem jemanju tablet Azomyr in uživanju alkohola ni bilo okrepljenih škodljivih učinkov alkohola (glejte poglavje 5. 1).
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.
V kliničnih preskušanjih pri nizu indikacij za uporabo zdravila, vključno z alergijskim rinitisom in kronično idiopatsko urtikarijo, so pri priporočenem odmerku 5 mg na dan o neželenih učinkih tablet Azomyr poročali pri 3% bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
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.
V dveh preskusih uporabe enkratnih odmerkov so bolniki dobro prenašali zdravilo Azomyr peroralni liofilizat, kar je razvidno iz kliničnih laboratorijskih izvidov, pregleda telesa, vitalnih znakov in podatkov o EKG intervalih.
At the recommended dose, Azomyr oral lyophilisate was found to be bioequivalent to the conventional tablet formulation of desloratadine.
Ugotovili so, da je zdravilo Azomyr peroralni liofilizat v priporočenem odmerku bioekvivalenten običajni formulaciji desloratadina v obliki tablet.
Therefore, the efficacy of Azomyr oral lyophilisate is expected to be the same as with the Azomyr tablet formulation.
Zato je pričakovana učinkovitost zdravila Azomyr peroralni liofilizat enaka učinkovitosti tablet Azomyr.
Azomyr tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
V kliničnih preskušanjih tablete Azomyr pri enkratnem dnevnem odmerku 7, 5 mg niso vplivale na psihofizične sposobnosti bolnikov.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced impairment in performance or increase in sleepiness.
V kliničnih farmakoloških preskušanjih sočasna uporaba zdravila Azomyr z alkoholom ni okrepila šlodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
Azomyr tablets effectively controlled symptoms for 24 hours.
17 Tablete Azomyr učinkovito obvladujejo te simptome za čas 24 ur.
In addition to the established classifications of seasonal and perennial, allergic rhinitis can alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to the duration of symptoms.
Azomyr Poleg že uveljavljene klasifikacije, po kateri alergijski rinitis delimo na sezonski in celoletni alergijski rinitis, ga lahko na drug način, to je na podlagi trajanja simptomov, razvrščamo tudi na intermitentni alergijski rinitis in perzistentni alergijski rinitis.
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.
Azomyr je učinkovito ublažil težave, povezane s sezonskim alergijskim rinitisom, kar so pokazali skupni rezultati vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom.
In single-dose crossover studies of Azomyr oral lyophilisate with Azomyr tablets, the formulations were bioequivalent.
V navzkrižnih študijah primerjave enkratnega odmerka zdravil Azomyr peroralni liofilizat in Azomyr tablet sta se ti dve formulaciji izkazali za bioekvivalentni.
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 Prisotnost hrane nima pomembnejšega vpliva na vrednost AUC in Cmax za zdravilo Azomyr peroralni liofilizat, podaljša pa Tmax desloratadina z 2, 5 na 4 ure in Tmax 3- OH- desloratadina s 4 na 6 ur.
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.
Predklinični podatki o desloratadinu na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Azomyr oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Azomyr peroralni liofilizat je na voljo v laminatnih pretisnih omotih za enojni odmerek, ki ga sestavljata film pretisnega omota in folija. ki ga prekriva.
Azomyr 2.5 mg orodispersible tablets
Azomyr 2, 5 mg orodisperzibilne tablete
Each dose of Azomyr orodispersible tablet contains 2.5 mg desloratadine.
Vsaka orodisperzibilna tableta vsebuje 2, 5 mg desloratadina.
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).
Otroci (stari 6 do 11 let): eno 2, 5 mg orodisperzibilno tableto Azomyr enkrat na dan za lajšanje simptomov, povezanih z alergijskim rinitisom (vključno z intermitentnim in perzistentnim alergijskim rinitisom) in za zdravljenje urtikarije (glejte poglavje 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).
Odrasli in mladostniki (stari 12 let ali več): dve 2, 5 mg orodisperzibilni tableti Azomyr enkrat na dan za lajšanje simptomov, povezanih z alergijskim rinitisom (vključno z intermitentnim in perzistentnim alergijskim rinitisom) in za zdravljenje urtikarije (glejte poglavje 5. 1).
Efficacy and safety of Azomyr 2.5 mg orodispersible tablets in children under 6 years of age have not been established.
Pri otrocih, mlajših od 6 let, še niso ugotovili učinkovitosti in varnosti Azomyr 2, 5 mg orodisperzibilnih tablet.
This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Azomyr orodispersible tablet.
Azomyr orodisperzibilne tablete vsebujejo 1, 4 mg fenilalanina na 2, 5 mg odmerek zdravila.
In addition, Azomyr orodispersible tablets were well tolerated in a multiple dose trial.
Poleg tega so bolniki dobro prenašali zdravilo Azomyr orodisperzibilne tablete tudi v preskušanju z uporabo večkratnih odmerkov zdravila.
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.
Ugotovili so, da je zdravilo Azomyr orodisperzibilna tableta v priporočenem odmerku 5 mg bioekvivalenten običajni formulaciji desloratadina v obliki zdravila Azomyr 5 mg tablete in Azomyr 5 mg peroralni liofilizat.
In clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
V kliničnih preskušanjih tablete Azomyr pri enkratnem dnevnem odmerku 7, 5 mg niso vplivale na psihofizične sposobnosti bolnikov.
Azomyr tablets effectively controlled symptoms for 24 hours.
Tablete Azomyr učinkovito obvladujejo te simptome za čas 24 ur.
The efficacy of Azomyr tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Azomyr
Azomyr was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Azomyr je učinkovito ublažil težave, povezane s sezonskim alergijskim rinitisom, kar so pokazali skupni rezultati vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom.
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.
V navzkrižnih študijah primerjave enkratnega odmerka zdravil Azomyr 5 mg orodisperzibilne tablete z zdravili Azomyr 5 mg tablete in Azomyr 5 mg peroralni liofilizat sta se ti dve formulaciji izkazali za bioekvivalentni.
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.
Uporabe zdravila Azomyr 2, 5 mg tablete niso ovrednotili pri pediatričnih bolnikih, vendar pa skupaj s študijami za ugotavljanje pediatričnega odmerka tudi farmakokinetični podatki za zdravilo Azomyr orodisperzibilne tablete govorijo v prid uporabi 2, 5 mg odmerka pri pediatričnih bolnikih starih 6 do 11 let.
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.
Prisotnost hrane nima pomembnejšega vpliva na vrednost AUC in Cmax za zdravilo Azomyr peroralni liofilizat, podaljša pa Tmax desloratadina z 2, 5 na 4 ure in Tmax 3- OH- desloratadina s 4 na 6 ur.