natgillin/translations-raw huggingface dataset:
Adults and adolescents (12 years of age and over): one dose of Aerius 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 Aerius 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).
Aerius oral lyophilisate disperses instantly and water or other liquid is not needed.
Aerius peroralni liofilizat se v ustih dispergira v trenutku in ni potrebno pitje vode ali drugih tekočin.
The dose can be taken regardless of mealtime.
Odmerke lahko bolnik jemlje ne glede na obroke.
Immediately before use, the blister must be carefully peeled open and the dose of oral lyophilisate removed without crushing it.
Pri tem naj pazi, da ne zdrobi zdravila.
The dose of oral lyophilisate is placed in the mouth where it will disperse immediately.
Odmerek peroralnega liofilizata naj položi v usta, kjer bo takoj razpadel.
The dose must be taken as soon as the blister has been opened.
Odmerek lahko zaužije takoj po odpiranju pretisnega omota.
In the case of severe renal insufficiency, Aerius should be used with caution.
V primeru hude ledvične insuficience morate zdravilo Aerius uporabljati previdno.
15 This product contains aspartame 1.75 mg per dose.
15 To zdravilo vsebuje 1, 75 mg aspartama na odmerek.
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, v katerih so bolniki sočasno s tabletami Aerius jemali tudi eritromicin ali ketokonazol, niso opažali 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).
V klinični farmakološki raziskavi pri sočasnem jemanju tablet Aerius 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 Aerius 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 Aerius poročali pri 3% bolnikov več kot pri tistih, ki so bili zdravljeni 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.
Cardiac disorders Gastrointestinal disorders
Halucinacije Psihiatrične motnje
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)
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.
16 Na podlagi izsledkov kliničnega preskušanja večkratnega odmerjanja zdravila, v kateri so bolniki dobili do 45 mg desloratadina (9- kratni klinični odmerek), niso opažali nobenih klinično pomembnih učinkov zdravila.
16 Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
Desloratadina iz telesa ni mogoče odstraniti s hemodializo in ni znano, ali se lahko odstrani s peritonealno dializo.
R06A X27
Farmakoterapevtska skupina: antihistaminiki za sistemsko zdravljenje – antagonist H1 receptorjev, Oznaka ATC:
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity.
R06A X27 Desloratadin je nesedativen, dolgodelujoč histaminski antagonist s selektivnim antagonističnim delovanjem na periferne histaminske receptorje H1.
In two single-dose trials, Aerius 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 Aerius peroralni liofilizat, kar je razvidno iz kliničnih laboratorijskih izvidov, pregleda telesa, vitalnih znakov in podatkov o EKG intervalih.
At the recommended dose, Aerius oral lyophilisate was found to be bioequivalent to the conventional tablet formulation of desloratadine.
Ugotovili so, da je zdravilo Aerius peroralni liofilizat v priporočenem odmerku bioekvivalenten običajni formulaciji desloratadina v obliki tablet.
Therefore, the efficacy of Aerius oral lyophilisate is expected to be the same as with the Aerius tablet formulation.
Zato je pričakovana učinkovitost zdravila Aerius peroralni liofilizat enaka učinkovitosti tablet Aerius.
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 klinični 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, v katerem so bolniki jemali desloratadin v odmerku 45 mg na dan (9- kratni klinični odmerek) 10 dni, niso opažali podaljšanja QTc intervala.
Aerius tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
V kliničnih preskušanjih tablete Aerius 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 Aerius z alkoholom ni okrepila šlodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
Aerius tablets effectively controlled symptoms for 24 hours.
17 Tablete Aerius učinkovito obvladujejo te simptome za čas 24 ur.
17 Aerius was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Aerius je učinkovito ublažil težave, povezane s sezonskim alergijskim rinitisom, kar so pokazali skupni rezultati vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom.
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, kar so ugotavljali na podlagi meritev s štiritočkovno lestvico za oceno teh spremenljivk.
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.
In single-dose crossover studies of Aerius oral lyophilisate with Aerius tablets, the formulations were bioequivalent.
V navzkrižnih študijah primerjave enkratnega odmerka zdravil Aerius peroralni liofilizat in Aerius tablet sta se ti dve formulaciji izkazali za bioekvivalentni.
The presence of food has no relevant influence on AUC and Cmax of Aerius 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 Aerius peroralni liofilizat, podaljša pa Tmax desloratadina z 2, 5 na 4 ure in Tmax 3- OH- desloratadina s 4 na 6 ur.
18 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
No significant local irritant effect was observed when the rapidly-dissolving form was tested in a hamster cheek pouch mucous membrane irritation assay.
Niso opažali bistvenega lokalnega učinka draženja pri testiranju hitro topne oblike s testom draženja sluznice lične vreče pri hrčku.
gelatin mannitol aspartame (E951) polacrilin potassium Dye Opatint Red (containing red iron oxide (E172) and hypromellose (E464)) flavour Tutti-Frutti citric acid anhydrous
želatina manitol aspartam (E951) kalijev polakrilin barvilo Opatint Red (vsebuje rdeči železov oksid (E172) in hipromelozo (E464)) aroma (Tutti- Frutti) brezvodna citronska kislina
Aerius oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Aerius peroralni liofilizat 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 polyvinyl chloride (PVC) film (product contact surface) with an incorporated aluminium foil lidding coated with a vinyl heat seal coat (product contact surface) which is heat sealed.
Material pretisnega omota je sestavljen iz polivinilkloridnega (PVC) filma (stična površina z zdravilom), prekritega z aluminijasto 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, 100 doses of oral lyophilisate.
Pakiranja po 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 odmerkov peroralnega liofilizata.
Aerius 2.5 mg orodispersible tablets
Aerius 2, 5 mg orodisperzibilne tablete
Each dose of Aerius orodispersible tablet contains 2.5 mg desloratadine.
Vsaka orodisperzibilna tableta vsebuje 2, 5 mg desloratadina.
Orodispersible Tablet
Orodisperzibilna tableta
Light-red, flat-faced, round, speckled tablets, one side branded with “ K”
Svetlo rdeče, ploske in okrogle pikčaste tablete z oznako ″ K ″ na eni strani.
Children 6 to 11 years of age: one 2.5 mg Aerius 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 Aerius 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 Aerius 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 Aerius 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).
The dose can be taken regardless of mealtime.
Bolnik lahko jemlje zdravilo ne glede na obroke.
Immediately before use, the blister must be carefully peeled open and the dose of orodispersible tablet removed without crushing it.
Pri tem naj pazi, da ne zdrobi zdravila.
21 4.4 Special warnings and precautions for use
21 4. 4 Posebna opozorila in previdnostni ukrepi
Efficacy and safety of Aerius 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 Aerius 2, 5 mg orodisperzibilnih tablet.
This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Aerius orodispersible tablet.
Aerius orodisperzibilne tablete vsebujejo 1, 4 mg fenilalanina na 2, 5 mg odmerek zdravila.
The overall incidence of adverse events was similar between the desloratadine syrup and the placebo groups and did not differ significantly than the safety profile seen in adult patients.
Skupna incidenca neželenih učinkov pri sirupu z desloratadinom je bila podobna kot v skupini, ki je prejemala placebo, in se ni bistveno razlikovala od profila varnosti tega zdravila pri odraslih bolnikih.
Hepatobiliary disorders
Srčne bolezni
Elevations of liver enzymes, increased bilirubin, hepatitis
Tahikardija, palpitacije
Musculoskeletal and connective tissue disorders General disorders
Trebušne bolečine, navzeja, bruhanje, dispepsija, driska
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
22 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 večkratnega odmerjanja zdravila, v kateri so bolniki dobili do 45 mg desloratadina (9- kratni klinični odmerek), niso opažali nobenih klinično pomembnih učinkov zdravila.
In addition, Aerius orodispersible tablets were well tolerated in a multiple dose trial.
Poleg tega so bolniki dobro prenašali zdravilo Aerius orodisperzibilne tablete tudi v preskušanju z uporabo večkratnih odmerkov zdravila.
At the recommended dose, Aerius 5 mg orodispersible tablet was found to be bioequivalent to the Aerius 5 mg conventional tablet and the Aerius 5 mg oral lyophilisate formulations of desloratadine.
Ugotovili so, da je zdravilo Aerius orodisperzibilna tableta v priporočenem odmerku 5 mg bioekvivalenten običajni formulaciji desloratadina v obliki zdravila Aerius 5 mg tablete in Aerius 5 mg peroralni liofilizat.
23 Desloratadine does not readily penetrate the central nervous system.
23 primerjavi s placebom.
Aerius tablets effectively controlled symptoms for 24 hours.
Tablete Aerius učinkovito obvladujejo te simptome za čas 24 ur.
Aerius was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Aerius je učinkovito ublažil težave, povezane s sezonskim alergijskim rinitisom, kar so pokazali skupni rezultati vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom.
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 bila pri 6% preiskovancev koncentracija desloratadina zvišana.
The prevalence of this poor metaboliser phenotype was comparable for adult (6%) and paediatric subjects 2- to 11-year old (6%), and greater among Blacks (18% adult, 16% paediatric) than Caucasians (2% adult, 3% paediatric) in both populations however the safety profile of these subjects was not different from that of the general population.
Prevalenca tega fenotipa slabih metabolizatorjev je bila pri odraslih preiskovancih (6%) podobna kot pri pediatričnih preiskovancih v starosti od 2 do 11 let (6%), medtem ko je bila pri črncih (18% pri odraslih in 16% pri pediatričnih preiskovancih) večja kot pri
24 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 z uporabo večkratnih odmerkov zdravila, ki so jo opravili pri zdravih preiskovancih z uporabo te formulacije tablet, so pri štirih preiskovancih ugotovili, da so slabi metabolizatorji desloratadina.
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 po približno 7 urah okoli 3- krat večjo koncentracijo Cmax, razpolovna doba končne faze pa je znašala približno 89 ur.
In single-dose crossover studies of Aerius 5 mg orodispersible tablets with Aerius 5 mg conventional tablets or Aerius 5 mg oral lyophilisate, the formulations were bioequivalent.
V navzkrižnih študijah primerjave enkratnega odmerka zdravil Aerius 5 mg orodisperzibilne tablete z zdravili Aerius 5 mg tablete in Aerius 5 mg peroralni liofilizat sta se ti dve formulaciji izkazali za bioekvivalentni.
Aerius 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 Aerius orodispersible tablets supports the use of the 2.5 mg dose in paediatric patients 6 to 11 years of age.
Uporabe zdravila Aerius 2, 5 mg tablete niso ovrednotili pri pediatričnih bolnikih, vendar pa skupaj s študijami za ugotavljanje pediatričnega odmerka tudi farmakokinetični podatki za zdravilo Aerius 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 Aerius 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 Aerius peroralni liofilizat, podaljša pa Tmax desloratadina z 2, 5 na 4 ure in Tmax 3- OH- desloratadina s 4 na 6 ur.
Water had no affect on the bioavailability of Aerius orodispersible tablets.
Voda ni vplivala na biološko uporabnost zdravila Aerius orodisperzibilne tablete.
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
mikrokristalna celuloza predgeliran škrob natrijev karboksimetil škrob magnezijev stearat butilmetakrilatni kopolimer krospovidon natrijev hidrogen karbonat citronska kislina koloidni silicijev dioksid železov oksid manitol
6.2 Incompatibilities 25 Not applicable.
25 aspartam (E951) aroma Tutti- Frutti
Each dose of Aerius orodispersible tablet contains 5 mg desloratadine.
Vsaka orodisperzibilna tableta vsebuje 5 mg desloratadina.
Light-red, flat-faced, round, speckled tablets, one side branded with “ A”
Svetlo rdeče, ploske in okrogle pikčaste tablete z oznako ″ A ″ na eni strani.
Adults and adolescents (12 years of age and over): one 5 mg Aerius 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).
Odrasli in mladostniki (stari 12 let ali več): eno 5 mg orodisperzibilno tableto Aerius 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).
27 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
Efficacy and safety of Aerius orodispersible tablets in children under 12 years of age have not been established.
27 Pri otrocih, mlajših od 12 let, še niso ugotovili učinkovitosti in varnosti Aerius orodisperzibilnih tablet.
This product contains 2.9 mg of phenylalanine per 5 mg dose of Aerius orodispersible tablet.
Aerius orodisperzibilne tablete vsebujejo 2, 9 mg fenilalanina na 5 mg odmerek zdravila.
28 4.9 Overdose
28 4. 9 Preveliko odmerjanje
In addition, Aerius orodispersible tablets were well tolerated in a multiple-dose trial.
Poleg tega so bolniki dobro prenašali zdravilo Aerius orodisperzibilne tablete tudi v preskušanju z uporabo večkratnih odmerkov zdravila.
Therefore, the efficacy of Aerius orodispersible tablet is expected to be the same as with the Aerius tablet formulation.
Zato je pričakovana učinkovitost zdravila Aerius peroralni liofilizat enaka učinkovitosti tablet Aerius.
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 klinični 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 clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced impairment in performance or increase in sleepiness.
29 V kliničnih farmakoloških preskušanjih sočasna uporaba zdravila Aerius z alkoholom ni okrepila šlodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
29 In patients with allergic rhinitis, Aerius 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.
Pri bolnikih z alergijskim rinitisom tablete Aerius učinkovito lajšajo simptome, kakor so kihanje, iztok iz nosa in srbenje, pa tudi srbenje oči, solzenje in vnetje očesne veznice ter srbenje ustnega neba.
2%) however the safety profile of these subjects was not different from that of the general population.
Prevalenca tega fenotipa slabih metabolizatorjev je bila sicer večja pri odraslih črncih kot pri odraslih belcih (18% v primerjavi z 2%), vendar se profil varnosti zdravila pri teh preiskovancih ni razlikoval od profila varnosti pri splošni populaciji.
Desloratadine is moderately bound (83% - 87%) to plasma proteins.
30 Desloratadin se zmerno (83- 87%) veže na plazemske beljakovine.
30 In single-dose crossover studies of Aerius 5 mg orodispersible tablets with Aerius 5 mg conventional tablets or Aerius 5 mg oral lyophilisate, the formulations were bioequivalent.
V navzkrižnih študijah primerjave enkratnega odmerka zdravil Aerius 5 mg orodisperzibilne tablete z zdravili Aerius 5 mg tablete in Aerius 5 mg peroralni liofilizat sta se ti dve formulaciji izkazali za bioekvivalentni.
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
mikrokristalna celuloza predgeliran škrob natrijev karboksimetil škrob magnezijev stearat butilmetakrilatni kopolimer krospovidon natrijev hidrogen karbonat citronska kislina koloidni silicijev dioksid železov oksid manitol aspartam (E951) aroma Tutti- Frutti
6.4 Special precautions for storage
31 6. 4 Posebna navodila za shranjevanje
31 The blister materials consist of a four layer aluminum foil laminate cold form blister film and a paper backed laminated aluminum foil lidding film.
Material pretisnega omota je sestavljen iz štiriplastnega laminata aluminijeve folije, hladno stiskane folije pretisnega omota in prekrivne laminirane aluminijeve folije s podlogo iz papirja.
Aerius 0.5 mg/ ml oral solution
Aerius 0, 5 mg/ ml peroralna raztopina
Each ml of oral solution contains 0.5 mg desloratadine.
Vsak ml peroralne raztopine vsebuje 0, 5 mg desloratadina.
This medicinal product contains 150 mg/ ml of sorbitol
To zdravilo vsebuje 150 mg/ ml sorbitola.
2.5 ml (1.25 mg) Aerius oral solution once a day.
2, 5 ml (1, 25 mg) peroralne raztopine Aerius enkrat na dan.
5 ml (2.5 mg) Aerius oral solution once a day.
5 ml (2, 5 mg) peroralne raztopine Aerius enkrat na dan.
10 ml (5 mg) Aerius oral solution once a day.
10 ml (5 mg) peroralne raztopine Aerius enkrat na dan.
33 4.4 Special warnings and precautions for use
33 4. 4 Posebna opozorila in previdnostni ukrepi