natgillin/translations-raw huggingface dataset:
The effectiveness of Aerius was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
Učinkovitost zdravila Aerius so merili s spremembo simptomov (nabiranje sluzi v nosu, srbenje, kihanje in zamašenost nosu), ki so jih opazovali pred zdravljenjem in dva do štiri tedne po zaključku zdravljenja.
Aerius has also been studied in 416 patients with urticaria.
Zdravilo Aerius so raziskali tudi pri 416 bolnikih z urtikarijo.
In all studies, the effectiveness of Aerius was compared with that of placebo (a dummy treatment).
V vseh študijah so učinkovitost zdravila Aerius primerjali s placebom (zdravilo brez zdravilne učinkovine).
Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.
Predstavljene so bile dodatne študije, s katerimi je dokazano, da sirup, peroralno raztopino in orodisperzibilne tablete telo prenaša enako kot tablete ter da se lahko varno uporabljajo pri otrocih.
In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Aerius led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Dva tedna dolgo zdravljenje z zdravilom Aerius v odmerku 5 mg je pri alergijskem rinitisu v vseh študijah skupaj privedlo do povprečnega zmanjšanja števila simptomov za 25 do 32%, v primerjavi z 12 - do 26- odstotnim zmanjšanjem pri bolnikih, ki so prejemali placebo.
In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Aerius was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
V dveh študijah pri bolnikih z urtikarijo se je število simptomov po šestih tednih zdravljenja z zdravilom Aerius zmanjšalo za 58 in 67% v primerjavi s 40 in 33% pri bolnikih, ki so prejemali placebo.
In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
Najpogostejši neželeni učinki pri odraslih in mladostnikih so utrujenost (1, 2%), suha usta (0, 8%) in glavobol (0, 6%).
The side effects seen in children are similar.
Neželeni učinki pri otrocih so podobni.
In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%).
2, 3%).
For the full list of all side effects reported with Aerius, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aerius, glejte navodilo za uporabo.
Aerius should not be used in people who may be hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Zdravila Aerius ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) desloratadin, loratadin ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aerius’ s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria.
Odbor za uporabo zdravil v humani medicini (CHMP) je zaključil, da so koristi zdravila Aerius pri lajšanju simptomov alergijskega rinitisa ali urtikarije večje od z njim povezanih tveganj.
The Committee recommended that Aerius be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Aerius odobri dovoljenje za promet.
Other information about Aerius:
Druge informacije o zdravilu Aerius:
The European Commission granted a marketing authorisation valid throughout the European Union for Aerius to SP Europe on 15 January 2001.
Evropska komisija je dovoljenje za promet z zdravilom Aerius, veljavno po vsej Evropski uniji, odobrila družbi SP Europe dne 15. januarja 2001.
The marketing authorisation was renewed on 15 January 2006.
Dovoljenje za promet je bilo podaljšano 15. januarja 2006.
The full EPAR for Aerius is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aerius je na voljo tukaj.
This summary was last updated in 04-2008.
Povzetek je bil nazadnje posodobljen 04- 2008.
EU Number
Številka EU EU/ 1/ 00/ 160/ 001
Invented name
EU/ 1/ 00/ 160/ 002
Strength
2 tableti
Pharmaceutical Form
EU/ 1/ 00/ 160/ 003
Route of Administration
Filmsko obložena tableta
Packaging
3 tablete
Content
5 tablet
Package size
EU/ 1/ 00/ 160/ 005
EU/ 1/ 00/ 160/ 001 EU/ 1/ 00/ 160/ 002 EU/ 1/ 00/ 160/ 003 EU/ 1/ 00/ 160/ 004 EU/ 1/ 00/ 160/ 005 EU/ 1/ 00/ 160/ 006 EU/ 1/ 00/ 160/ 007 EU/ 1/ 00/ 160/ 008 EU/ 1/ 00/ 160/ 009 EU/ 1/ 00/ 160/ 010 EU/ 1/ 00/ 160/ 011 EU/ 1/ 00/ 160/ 012 EU/ 1/ 00/ 160/ 013
EU/ 1/ 00/ 160/ 006
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
pretisni omot (Aclar/ PVC, alu)
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
pretisni omot (Aclar/ PVC, alu)
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Peroralna uporaba
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
pretisni omot (Aclar/ PVC, alu)
blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu)
pretisni omot (Aclar/ PVC, alu)
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
5 mg
EU/ 1/ 00/ 160/ 014 EU/ 1/ 00/ 160/ 015 EU/ 1/ 00/ 160/ 016 EU/ 1/ 00/ 160/ 017 EU/ 1/ 00/ 160/ 018 EU/ 1/ 00/ 160/ 019 EU/ 1/ 00/ 160/ 020 EU/ 1/ 00/ 160/ 021 EU/ 1/ 00/ 160/ 022 EU/ 1/ 00/ 160/ 023 EU/ 1/ 00/ 160/ 024 EU/ 1/ 00/ 160/ 025 EU/ 1/ 00/ 160/ 026 EU/ 1/ 00/ 160/ 027 EU/ 1/ 00/ 160/ 028 EU/ 1/ 00/ 160/ 029 EU/ 1/ 00/ 160/ 030 EU/ 1/ 00/ 160/ 031 EU/ 1/ 00/ 160/ 032
Filmsko obložena tableta
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
Peroralna uporaba
0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
pretisni omot (Aclar/ PVC, alu)
Syrup Syrup Syrup Syrup Syrup Syrup Syrup Syrup Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate
Filmsko obložena tableta
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
Peroralna uporaba
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)
pretisni omot (Aclar/ PVC, alu)
30 ml 50 ml 60 ml 100 ml 120 ml 150 ml 225 ml 300 ml
30 tablet
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
50 table
Oral lyophilisate Oral lyophilisate
pretisni omot (Aclar/ PVC, alu)
Oral use Oral use
EU/ 1/ 00/ 160/ 014
blister (PVC/ Alu) blister (PVC/ Alu)
sleklenička (steklo)
bottle (glass)
sleklenička (steklo
1 bottle with 1 oral syringe
1 steklenička z 1 odmerno žličko
EU/ 1/ 00/ 160/ 036 EU/ 1/ 00/ 160/ 037 EU/ 1/ 00/ 160/ 038 EU/ 1/ 00/ 160/ 039 EU/ 1/ 00/ 160/ 040 EU/ 1/ 00/ 160/ 041 EU/ 1/ 00/ 160/ 042 EU/ 1/ 00/ 160/ 043 EU/ 1/ 00/ 160/ 044 EU/ 1/ 00/ 160/ 045 EU/ 1/ 00/ 160/ 046 EU/ 1/ 00/ 160/ 047 EU/ 1/ 00/ 160/ 048 EU/ 1/ 00/ 160/ 049 EU/ 1/ 00/ 160/ 050 EU/ 1/ 00/ 160/ 051 EU/ 1/ 00/ 160/ 052 EU/ 1/ 00/ 160/ 053 EU/ 1/ 00/ 160/ 054 EU/ 1/ 00/ 160/ 055 EU/ 1/ 00/ 160/ 056 EU/ 1/ 00/ 160/ 057 EU/ 1/ 00/ 160/ 058 EU/ 1/ 00/ 160/ 059 EU/ 1/ 00/ 160/ 060
EU/ 1/ 00/ 160/ 022 EU/ 1/ 00/ 160/ 023 EU/ 1/ 00/ 160/ 024 EU/ 1/ 00/ 160/ 025 EU/ 1/ 00/ 160/ 026 EU/ 1/ 00/ 160/ 027 EU/ 1/ 00/ 160/ 028 EU/ 1/ 00/ 160/ 029 EU/ 1/ 00/ 160/ 030 EU/ 1/ 00/ 160/ 031 EU/ 1/ 00/ 160/ 032 EU/ 1/ 00/ 160/ 033 EU/ 1/ 00/ 160/ 034
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
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
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
Film-coated 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 Orodispersible tablet
Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat
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
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
blister (Aclar/ 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)
90 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 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
EU/ 1/ 00/ 160/ 061
EU/ 1/ 00/ 160/ 035
Oral solution
EU/ 1/ 00/ 160/ 037
Oral use
5 tablet
bottle (glass) + spoon (plastic)
pretisni omot (PVC/ OPA/ alu)
30 ml
30 tablet
Oral solution
Orodisperzibilna tableta
50 ml
50 tablet
1 bottle
6 tablet
EU/ 1/ 00/ 160/ 063
EU/ 1/ 00/ 160/ 055
0.5 mg/ ml
30 tablet
Oral solution
EU/ 1/ 00/ 160/ 057
Oral use
50 tablet
60 ml
60 tablet
Oral solution
Peroralna raztopina
bottle (glass) + spoon (plastic)
steklenička (steklo) + žlička (plastika)
bottle (glass) + syringe (plastic)
steklenička (steklo) + brizgo (plastika)
Aerius is indicated for the relief of symptoms associated with:
Aerius je indiciran za lajšanje simptomov:
- allergic rhinitis (see section 5.1)
- alergijskega rinitisa (glejte poglavje 5. 1)
- urticaria (see section 5.1)
- urtikarije (glejte poglavje 5. 1)
Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal 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): ena tableta enkrat na dan 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).
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Izkušenj iz kliničnih preskušanj glede učinkovitosti uporabe desloratadina pri mladostnikih, starih od 12 do 17 let, je malo (glejte poglavji 4. 8 in 5. 1).
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’ s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
Zdravljenje lahko prekinete po umiritvi simptomov in ga ponovno uvedete, če se ti spet pojavijo.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov ali loratadin.
Efficacy and safety of Aerius tablets in children under 12 years of age have not been established.
Pri otrocih, mlajših od 12 let, še niso ugotovili učinkovitosti in varnosti Aerius tablet.
In the case of severe renal insufficiency, Aerius should be used with caution (see section 5.2).
V primeru hude ledvične insuficience morate zdravilo Aerius uporabljati previdno (glejte poglavje 5. 2).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Bolniki z redko dedno motnjo neprenašanja galaktoze, Lappovega pomanjkanja laktaze ali malabsorpcije glukoze in galaktoze ne smejo jemati tega zdravila.
2 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
2 V kliničnih preskušanjih, v katerih so bolniki sočasno s tabletami desloratadina jemali tudi eritromicin ali ketokonazol, niso opažali klinično pomembnih interakcij med zdravili (glejte poglavje 5. 1).
In a clinical pharmacology trial Aerius taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
(glejte poglavje 5. 1).
The safe use of the medicinal product during pregnancy has not been established.
V študijah na živalih niso ugotavljali nobenih teratogenih učinkov desloratadina.
The use of Aerius during pregnancy is therefore not recommended.
Varnost zdravila Aerius 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 Aerius is not recommended in breast- feeding women.
Desloratadin se izloča v materino mleko, zato ne priporočamo uporabe zdravila Aerius pri doječih materah.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving desloratadine.
V kliničnih preskušanjih za oceno sposobnosti vožnje pri bolnikih, ki so prejemali desloratadin, ni prišlo do nikakšnega poslabšanja te sposobnosti.
However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Bolnikom pa morate povedati, da zelo redko nekateri ljudje postanejo zaspani, kar lahko vpliva na njihovo sposobnost vožnje ali upravljanja s stroji.
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 Aerius 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 Aerius poročali pri 3% bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
The most frequent of adverse events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).
Najpogostejši neželeni učinki, katerih pogostnost je bila večja kot pri placebu, so bili utrujenost (1, 2%), suha usta (0, 8%) in glavobol (0, 6%).
In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9% of patients treated with desloratadine and 6.9% of patients receiving placebo.
V kliničnem preskušanju s 578 mladostniki, starimi od 12 do 17, je bil najpogostejši neželeni učinek glavobol.
Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.
Ta se je pojavil pri 5, 9% bolnikov, zdravljenih z desloratadinom, in pri 6, 9% bolnikov, zdravljenih s placebom.
Hallucinations Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Drugi zelo redki neželeni učinki, o katerih so poročali v okviru postmarketinških izkušenj, so navedeni v spodnji preglednici:
Hepatobiliary disorders
Halucinacije Psihiatrične motnje
Elevations of liver enzymes, increased bilirubin, hepatitis
Omotica, zaspanost, nespečnost, psihomotorična Bolezni živčevja hiperaktivnost, epileptični napadi Tahikardija, palpitacije Srčne bolezni
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Trebušne bolečine, navzeja, bruhanje, dispepsija, Bolezni porebavil driska Povečane vrednosti jetrnih encimov in bilirubina, Bolezni jeter, žolčnika in žolčevodov hepatitis Mialgija Bolezni mišično- skeletnega sistema in vezivnega tkiva Preobčutljivostne reakcije (kot so. anafilaksija, Splošne težave angioedem, dispneja, pruritus, izpuščaj in urtikarija)
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.
Na podlagi izsledkov kliničnega preskušanja raziskave večkratnega odmerjanja zdravila, v kateri so bolniki dobili do 45 mg desloratadina (9- kratni klinični odmerek), niso opažali nobenih klinično pomembnih učinkov zdravila.
Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code:
Farmakoterapevtska skupina: antihistaminiki za sistemsko zdravljenje – antagonist H1 receptorjev, Oznaka ATC:
These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/ basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells.
IL- 4, IL- 6, IL- 8 in IL- 13 iz človeških mastocitov ali bazofilcev, pa tudi za inhibicijo ekspresije adhezijske molekule P- selektina na endotelijskih celicah.
In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
V kliničnih preskušanjih večkratnega odmerjanja zdravila, v kateri so preiskovanci prejemali do 20 mg desloratadina na dan v času 14 dni, niso opažali nobenih statistično značilnih ali klinično pomembnih učinkov tega zdravila na srce ali ožilje.
In a clinical pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the clinical dose) for ten days, no prolongation of QTc interval was seen.
V kliničnem farmakološkem preskušanju, pri katerem so bolniki jemali desloratadin v odmerku 45 mg na dan (9- kratni klinični odmerek) 10 dni, niso opažali podaljšanja QTc intervala.
Aerius given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
V kliničnih preskušanjih zdravilo Aerius v enem dnevnem odmerku 7, 5 mg ni vplivalo na psihomotorične sposobnosti bolnikov.
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.
V študiji enkratnega odmerka pri odraslih desloratadin v odmerku 5 mg ni vplival na standardna merila uspešnosti pilotiranja, vključno s subjektivnim poslabšanjem zaspanosti in opravili pri pilotiranju.
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 Aerius z alkoholom ni okrepila škodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
Aerius effectively controlled symptoms for 24 hours.
Aerius učinkovito obvladuje te simptome za čas 24 ur.
The efficacy of Aerius tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Učinkovitosti zdravila Aerius tablete niso jasno dokazali v preskušanjih pri mladostnikih, starih od 12 do 17 let.
Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and for more than 4 weeks.
Intermitentni alergijski rinitis je opredeljen kot prisotnost simptomov manj kot 4 dni na teden ali manj kot 4 tedne, perzistentni alergijski rinitis pa kot prisotnost simptomov 4 dni ali več na teden in dlje kot 4 tedne.
The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.
Aerius 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.
Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be more easily recruited prospectively.
Poleg tega je kronične bolnike lažje prospektivno vključevati v študije.
4 In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Aerius 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 Aerius učinkovito blažil srbenje in zmanjšal velikost in število izpuščajev koprivnice že do konca prvega intervala odmerjanja.
In each trial, the effects were sustained over the 24 hour dosing interval.
V vsakem preskušanju so učinki zdravila trajali ves čas 24 - urnega 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.
Pri 55% bolnikov, zdravljenih z desloratadinom, so ugotavljali več kot 50% izboljšanje srbenja, v primerjavi z 19% bolnikov, zdravljenih s placebom.
Treatment with Aerius also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Zdravljenje z zdravilom Aerius 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.