natgillin/translations-raw huggingface dataset:
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours.
Razpolovni čas v terminalni fazi je je približno 27 ur.
In a pharmacokinetic trial in which patient demographics were comparable to those of the general seasonal allergic rhinitis population, 4% of the subjects achieved a higher concentration of desloratadine.
V preskušanjih farmakokinetike zdravila, v kateri so bile demografske značilnosti bolnikov podobne tistim za splošno populacijo s sezonskim alergijskim rinitisom, so pri 4% preiskovancev dosegli višje koncentracije desloratadina.
Maximum desloratadine concentration was about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.
Največje koncentracije desloratadina so bile približno 3- krat višje po približno 7 urah, pri razpolovnem času v terminalni fazi približno 89 ur.
Desloratadine is moderately bound (83% - 87%) to plasma proteins.
Desloratadin se zmerno (83- 87%) veže na plazemske beljakovine.
Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Desloratadin ne zavira encima CYP3A4 in vivo, in vitro študije pa so pokazale, da zdravilo tudi ne inhibira encima CYP2D6 in da ni ne substrat ne inhibitor P- glikoproteina.
In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high caloric breakfast) on the disposition of desloratadine.
V študiji uporabe enkratnega 7, 5 mg odmerka desloratadina niso ugotavljali nobenega vpliva hrane (zajtrk z veliko vsebnostjo maščob in z veliko kalorijami) na porazdelitev desloratadina v telesu.
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.
6.1 List of excipients
5 6. 1 Seznam pomožnih snovi
Tablet coating: film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.
Obloga tablete: filmska obloga (vsebuje monohidrat laktoze, hipromelozo, titanov dioksid, makrogol 400, indigo karmin (E132)), prozorna obloga (vsebuje hipromelozo in makrogol 400), vosek karnauba in beli vosek.
Aerius is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
Aerius je na voljo v laminatnih pretisnih omotih za enojni odmerek, ki ga sestavljata film pretisnega, omota in folija, ki ga prekriva.
The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/ Polyvinyl Chloride (PVC) film (product contact surface) with an aluminium foil lidding coated with a vinyl heat seal coat (product contact surface) which is heat sealed.
Material pretisnega omota je sestavljen iz poliklorotrifluoroetilenskega (PCTFE) / polivinil kloridnega (PVC) filma (stična površina z zdravilom), prekritega z aluminjasto folijo, prevlečeno s toplotno zavarjeno vinilno prevleko (stična površina z zdravilom), za toplotno varjenje.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 tablets.
Škatle po 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 ali 100 tablet.
SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium
SP Europe Rue de Stalle 73 B- 1180 Bruxelles Belgija
Date of first authorisation:
Datum pridobitve dovoljenja:
15 January 2001 Date of last renewal:
15. januar 2001 Datum zadnjega podaljšanja dovoljenja:
15 January 2006
15. januar 2006
DATE OF REVISION OF THE TEXT 6 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
Each ml of syrup contains 0.5 mg desloratadine.
Vsak ml sirupa vsebuje 0, 5 mg desloratadina.
Aerius 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 Aerius 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 Aerius.
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 Aerius.
Children 1 through 5 years of age:
Otroci v starosti od 1 do 5 let:
2.5 ml (1.25 mg) Aerius syrup once a day.
2, 5 ml (1, 25 mg) sirupa Aerius enkrat na dan.
Children 6 through 11 years of age:
Otroci v starosti od 6 do 11 let:
5 ml (2.5 mg) Aerius syrup once a day.
5 ml (2, 5 mg) sirupa Aerius enkrat na dan.
In adults and adolescents (12 years of age and over):
Odrasli in mladostniki (12 let ali več):
10 ml (5 mg) Aerius syrup once a day.
10 ml (5 mg) sirupa Aerius enkrat na dan.
Efficacy and safety of Aerius syrup in children under 1 year of age have not been established.
Pri otrocih, mlajših od 1 leta, še niso ugotovili učinkovitosti in varnosti Aerius sirupa.
8 In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis.
8 Pri otrocih, mlajših od 2 let, je diagnozo alergijski rinitis še posebej težko razlikovati od drugih oblik rinitisa.
Approximately 6% of adults and children 2- to 11-year old are phenotypic poor metabolisers of desloratadine and exhibit a higher exposure (see section 5.2).
Približno 6% odraslih in otrok, starih od 2 do 11 let, ima fenotip slabega presnavljanja desloratadina in je pri njih izpostavljenost zdravilu večja (glejte poglavje 5. 2).
The safety of Aerius syrup in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.
Varnost zdravila Aerius sirup pri otrocih, starih od 2 do 11 let, ki slabo presnavljajo zdravilo, je enaka kot pri tistih otrocih, ki zdravilo presnavljajo normalno.
The effects of Aerius syrup in poor metabolisers < 2 years of age have not been studied.
Učinkov zdravila Aerius sirup pri otrocih, mlajših od 2 let, ki slabo presnavljajo zdravilo, niso raziskovali.
This medicinal product contains sucrose and sorbitol; thus, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
To zdravilo vsebuje saharozo in sorbitol, zato ga ne smejo jemati bolniki z redkimi dednimi boleznimi, ki imajo prirojeno intoleranco fruktoze, pri glukoza- galaktoza malabsorpcijskem sindromu ali pomanjkanju saharozne- izomaltaze.
This medicinal product contains the colouring agent E110 which may cause allergic reactions.
To zdravilo vsebuje barvilo E110, ki lahko povzroči alergijske reakcije.
No clinically relevant interactions were observed in clinical trials with Aerius tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
V kliničnih preskušanjih tablet Aerius, 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, Aerius tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
(glejte poglavje 5. 1).
Desloratadine was not teratogenic in animal studies.
V študijah na živalih desloratadin ni bil teratogen.
Desloratadine is excreted into breast milk, therefore the use of Aerius is not recommended in breastfeeding women.
Desloratadin se izloča v materino mleko, zato ne priporočamo uporabe zdravila Aerius pri doječih materah.
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 v zelo redkih primerih nekateri ljudje postanejo zaspani, kar lahko vpliva na njihovo sposobnost vožnje ali upravljanja s stroji.
In clinical trials in a paediatric population, Aerius syrup was administered to a total of 246 children aged 6 months through 11 years.
V kliničnih preskušanjih pri pediatrični populaciji so zdravilo Aerius 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 Aerius syrup and the placebo groups.
Skupna incidenca neželenih učinkov pri otrocih, starih od 2 do 11 let, ki so prejemali zdravilo Aerius, je bila podobna skupni incidenci pri skupini, ki je prejemala placebo.
In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhoea (3.7%), fever (2.3%) and insomnia (2.3%).
Pri dojenčkih in majhnih otrocih, starih od 6 do 23 mesecev, so bili najpogostejši neželeni učinki, o katerih so poročali z večjo pogostnostjo kot pri placebu, driska (3, 7%), zvišana telesna temperatura (2, 3%) in nespečnost (2, 3%).
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 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 na dan o neželenih učinkih zdravila Aerius poročali pri 3% bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.
Drugi zelo redki neželeni učinki, o katerih so poročali v okviru postmarketinških izkušenj, so navedeni v spodnji preglednici.
9
9 Halucinacije Psihiatrične motnje
Tachycardia, palpitations Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Omotica, zaspanost, nespečnost, psihomotorična Bolezni živčevja hiperaktivnost, epileptični napadi
Elevations of liver enzymes, increased bilirubin, hepatitis
Tahikardija, palpitacije Srčne bolezni
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Trebušne bolečine, navzeja, bruhanje, dispepsija, Bolezni prebavil 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)
In the event of overdose, consider standard measures to remove unabsorbed active substance.
V primeru prevelikega odmerjanja zdravila lahko upoštevajte standardne ukrepe za odstranjevanje neabsorbirane učinkovine iz telesa.
Based on a multiple dose clinical trial in adults and adolescents, 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 večkratnega odmerjanja zdravila pri odraslih in mladostnikih, v kateri so bolniki dobili do 45 mg desloratadina (9- kratni klinični odmerek), niso opažali nobenih klinično pomembnih učinkov zdravila.
Efficacy of Aerius syrup has not been investigated in separate paediatric trials.
Učinkovitosti zdravila Aerius sirup niso raziskovali v ločenih pediatričnih preskušanjih.
Safety of Aerius syrup was demonstrated in three paediatric trials.
V treh preskušanjih pri pediatričnih bolnikih so dokazali varnost zdravila Aerius sirup.
Children, 1-11 years of age, who were candidates for antihistamine therapy received a daily desloratadine dose of 1.25 mg (1 through 5 years of age) or 2.5 mg (6 through 11 years of age).
Otroci v starosti od 1 do 11 let, ki so bili kandidati za antihistaminsko terapijo, so prejemali dnevni odmerek desloratadina po 1, 25 mg (starost od 1 do 5 let) ali 2, 5 mg (starost od 6 do 11 let).
When given at the recommended doses, the plasma concentrations of desloratadine (see section 5.2) were comparable in the paediatric and adult populations.
Pri uporabi v priporočenih odmerkih so bile plazemske koncentracije desloratadina (glejte poglavje 5. 2) pri otrocih podobne kot pri odraslih.
Thus, since the course of allergic rhinitis/ chronic idiopathic urticaria and the profile of desloratadine are similar in adults and paediatric patients, desloratadine efficacy data in adults can be extrapolated to the paediatric population.
Ker sta potek alergijskega rinitisa oz. kronične idiopatske urtikarije ter profil desloratadina pri otrocih in mladostnikih ter odraslih podobna, lahko torej podatke o učinkovitosti desloratadina za odrasle ekstrapoliramo na otroke in mladostnike.
In a multiple dose clinical trial, in adults and adolescents, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
10 V kliničnih preskušanjih večkratnega odmerjanja zdravila pri odraslih in mladostnikih, 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 adults and adolescents, in which desloratadine was administered to adults at a dose of 45 mg daily (nine times the clinical dose) for ten days, no prolongation of QTc interval was seen.
V drugem kliničnem farmakološkem preskušanju, v katerem so odrasli jemali desloratadin v odmerku 45 mg na dan (9 - kratni klinični odmerek) 10 dni, niso opažali podaljšanja QTc intervala.
In controlled clinical trials, at the recommended dose of 5 mg daily for adults and adolescents, there was no excess incidence of
V kontroliranih kliničnih preskušanjih s priporočenim odmerkom 5 mg na dan pri odraslih in mladostnikih niso opažali povečane incidence zaspanosti v primerjavi s placebom.
Aerius 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 Aerius pri enkratnem dnevnem odmerku 7, 5 mg pri odraslih in mladostnikih ni vplivalo na psihofizične 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 z poslabšanjem subjektivnega občutka zaspanosti in opravili pri pilotiranju.
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 Aerius z alkoholom ni okrepila škodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
Efficacy of Aerius syrup has not been investigated in paediatric trials in children less than 12 years of age.
Učinkovitosti zdravila Aerius sirup niso proučili v pediatričnih preskušanjih pri otrocih, mlajših od 12 let.
Aerius 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.
Aerius 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, 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.
As with other antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non- responsive to antihistamines was excluded.
Kot pri drugih preskušanjih uporabe antihistaminikov pri kronični idiopatski urtikariji so iz raziskave izločili manjše število bolnikov, za katere je bilo ugotovljeno, da se ne odzivajo na antihistaminike.
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.
Zdravljenje z
Treatment with Aerius also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
11 zdravilom Aerius je tudi bistveno zmanjšalo motnje spanja in dnevnih dejavnosti, kar so ugotavljali na podlagi meritev s štiritočkovno lestvico za oceno teh spremenljivk.
Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine administration in adults and adolescents.
Pri odraslih in mladostnikih plazemsko koncentracijo desloratadina lahko zaznamo že v 30 minut po uporabi zdravila.
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours.
Razpolovni čas v terminalni fazi je približno 27 ur.
The prevalence of this poor metaboliser phenotype was comparable for adult (6%) and
V vrsti farmakokinetičnih in kliničnih preskušanj je 6% preiskovancev doseglo večje koncentracije desloratadina.
11 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.
Prevalenca tega fenotipa slabega presnavljanja je bila podobna pri odraslih (6%) in pri pediatričnih bolnikih, starih od 2 do 11 let (6%), in večja pri bolnikih črne rase (18% odrasli, 16% pediatrični bolniki) kot pri belcih (2% odrasli, 3% pediatrični bolniki) v obeh populacijah.
In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult subjects, four subjects were found to be poor metabolisers of desloratadine.
V farmakokinetični študiji uporabe večih odmerkov, opravljeni s formulacijo tablet pri zdravih odraslih preiskovancih, so pri štirih ugotovili, da slabo presnavljajo desloratadin.
These subjects had a Cmax concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.
Ti preiskovanci so imeli koncentracijo Cmax približno 3- krat večjo po približno 7 urah, razpolovna doba končne faze pa je bila približno 89 ur.
Similar pharmacokinetic parameters were observed in a multiple-dose pharmacokinetic study conducted with the syrup formulation in paediatric poor metaboliser subjects 2- to 11-year old diagnosed with allergic rhinitis.
Podobne farmakokinetične parametre so opažali tudi v farmakokinetični študiji uporabe večih odmerkov, opravljeni s formulacijo sirupa pri pediatričnih bolnikih z diagnozo alergijskega rinitisa, starih od 2 do 11 let, ki slabo presnavljajo zdravilo.
The exposure (AUC) to desloratadine was about 6-fold higher and the Cmax was about 3 to 4 fold higher at 3-6 hours with a terminal half-life of approximately 120 hours.
Izpostavljenost (AUC) desloratadinu je bila približno 6- krat večja, vrednost Cmax pa je bila približno 3 do 4- krat večja po 3 do 6 urah, pri čemer je bila razpolovna doba končne faze približno 120 ur.
The effects of Aerius syrup in poor metabolizers < 2 years of age have not been studied.
Učinkov zdravila Aerius sirup pri bolnikih, mlajših od 2 let, ki slabo presnavljajo zdravilo, niso raziskovali.
In separate single dose studies, at the recommended doses, paediatric patients had comparable AUC and Cmax values of desloratadine to those in adults who received a 5 mg dose of desloratadine syrup.
V ločenih študijah uporabe enkratnega odmerka desloratadina v priporočenih odmerkih so bile vrednosti AUC in Cmax desloratadina pri mladostnikih in otrocih podobne tistim pri odraslih, ki so prejeli 5 mg odmerek sirupa z desloratadinom.
Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Desloratadin ne inhibira encima CYP3A4 in vivo, in vitro študije pa so pokazale, da zdravilo tudi ne inhibira encima CYP2D6 in da ni ne substrat ne inhibitor P- glikoproteina.
In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high caloric breakfast) on the disposition of desloratadine.
V raziskavi uporabe enkratnega 7, 5 mg odmerka desloratadina niso ugotavljali nobenega vpliva hrane (zajtrk z veliko vsebnostjo maščob in z veliko kalorijami) na porazdelitev desloratadina v telesu.
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.
12 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.
Propylene glycol, sorbitol, citric acid anhydrous, sodium citrate, sodium benzoate, disodium edetate,
Propilenglikol, sorbitol, brezvodna citronska kislina, natrijev citrat, natrijev benzoat, dinatrijev edetat, prečiščena voda, saharoza, naravna in umetna aroma (za žvečilne gumije), oranžno barvilo E110
Aerius 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.
Aerius 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.
The caps have a liner made of Low Density Polyethylene (LDPE), polyethylene foam, ethylenevinylacetate (EVA), and polyvinylidene chloride (PvDC).
Zaporke imajo oblogo, izdelano iz polietilena majhne gostote (LDPE), polietilenske pene, etilenvinilacetata (EVA) in polivinilidenklorida (PvDC).
LDPE is the product contact surface.
Kontaktna površina z zdravilom je iz LDPE.
Supplied with a rigid, transparent, polystyrene measuring spoon, calibrated at 2.5 ml and 5 ml, or with a plastic oral measuring syringe with graduations of 2.5 ml and 5 ml (for the 150 ml bottle only).
Zdravilu je priložena trdna, prosojna polistirenska odmerna žlička, umerjena na 2, 5 ml in 5 ml ali plastična odmerna brizga za peroralno dajanje umerjena na 2, 5 ali 5ml (samo za 150 ml stekleničko).
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
Aerius 5 mg oral lyophilisate
Aerius 5 mg peroralni liofilizat
Each dose of Aerius oral lyophilisate contains 5 mg desloratadine.
Vsak odmerek zdravila Aerius peroralni liofilizat vsebuje 5 mg desloratadina.
Oral lyophilisate
Peroralni liofilizat