FrancophonIA/ELRC3.0 huggingface dataset:
English: However, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
Croatian: Međutim, češće su prijavljeni umor, suha usta i glavobolja nego kod primjene tablete placeba.
English: 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.
Croatian: Intermitentni alergijski rinitis (simptomi su prisutni manje od 4 dana u tjednu ili kraće od 4 tjedna) potrebno je liječiti u skladu s procjenom povijesti bolesti bolesnika, a liječenje se može prekinuti nakon nestanka simptoma te ponovno započeti pri ponovnoj pojavi simptoma.
English: 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.
Croatian: U dva placebom kontrolirana ispitivanja u trajanju od šest tjedana u bolesnika s kroničnom idiopatskom urtikarijom, Aerius je učinkovito ublažavao pruritus i smanjivao veličinu i broj koprivnjača do kraja prvog intervala doziranja.
English: In a clinical pharmacology trial, Aerius tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Croatian: U kliničkom farmakološkom ispitivanju, uzimanje Aerius tableta istodobno s alkoholom nije pojačalo štetne učinke alkohola na ponašanje (vidjeti dio 5.1).
English: 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.
Croatian: Budući da su tijek alergijskog rinitisa odnosno kronične idiopatske urtikarije te profil desloratadina slični u odraslih i pedijatrijskih bolesnika, podaci o djelotvornosti desloratadina u odraslih mogu se ekstrapolirati na pedijatrijsku populaciju.
English: 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.
Croatian: U kliničkom ispitivanju pojedinačne doze desloratadina u dozi od 7,5 mg, nije bilo utjecaja hrane (visokokalorični doručak, s visokim udjelom masti) na raspoloživost desloratadina.
English: 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.
Croatian: U farmakokinetičkom ispitivanju u kojem su demografski podaci ispitanika bili usporedivi s podacima opće populacije koja je imala sezonski alergijski rinitis, 4% ispitanika imalo je višu koncentraciju desloratadina.
English: 1 film-coated tablet 2 film-coated tablets 3 film-coated tablets 5 film-coated tablets 7 film-coated tablets 10 film-coated tablets 14 film-coated tablets 15 film-coated tablets 20 film-coated tablets 21 film-coated tablets 30 film-coated tablets 50 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Croatian: 1 filmom obložena tableta 2 filmom obložene tablete 3 filmom obložene tablete 5 filmom obloženih tableta 7 filmom obloženih tableta 10 filmom obloženih tableta 14 filmom obloženih tableta 15 filmom obloženih tableta 20 filmom obloženih tableta 21 filmom obložena tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 90 filmom obloženih tableta 100 filmom obloženih tableta
English: If you forget to take Aerius
Croatian: Ako ste zaboravili uzeti Aerius
English: No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
Croatian: Klinički značajne interakcije nisu opažene u kliničkim ispitivanjima istodobne primjene desloratadin tableta s eritromicinom ili ketokonazolom (vidjeti dio 5.1).
English: If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.
Croatian: Ako je Vaš alergijski rinitis intermitentni (simptomi su prisutni manje od 4 dana u tjednu ili manje od 4 tjedna), liječnik će Vam preporučiti raspored liječenja koji će ovisiti o procjeni Vaše povijesti bolesti.
English: Aerius contains lactose
Croatian: Aerius sadrži laktozu
English: BOTTLE OF 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML
Croatian: BOCA SA 30 ml, 50 ml, 60 ml, 100 ml, 120 ml, 150 ml, 225 ml, 300 ml
English: 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.
Croatian: Aerius 2,5 mg tablete nisu ispitivane u pedijatrijskih bolesnika; međutim, farmakokinetički podaci o Aerius raspadljivim tabletama za usta zajedno s podacima iz pedijatrijskih ispitivanja utvrđivanja doze podupiru primjenu doze od 2,5 mg u pedijatrijskih bolesnika u dobi od 6 do 11 godina.
English: 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.
Croatian: Uz uvriježenu klasifikaciju na sezonski i cjelogodišnji, alergijski rinitis može se dodatno klasificirati na intermitentni i perzistentni alergijski rinitis, ovisno o dužini trajanja simptoma.
English: Efficacy of Aerius syrup has not been investigated in paediatric trials in children less than 12 years of age.
Croatian: Djelotvornost Aerius sirupa nije ispitivana u pedijatrijskim kliničkim ispitivanjima u djece mlađe od 12 godina.
English: There is no evidence of clinically relevant active substance accumulation following once daily adult and adolescent dosing of desloratadine (5 mg to 20 mg) for 14 days.
Croatian: Ne postoji dokaz o klinički značajnoj akumulaciji djelatne tvari nakon primjene desloratadina u odraslih i adolescenata jedanput na dan (5 mg do 20 mg) tijekom 14 dana.
English: Very rare: the following may affect up to 1 in 10,000 people
Croatian: Vrlo rijetke: sljedeće nuspojave mogu se javiti u do 1 na 10 000 osoba
English: Aerius tablets contain lactose.
Croatian: Aerius tablete sadrže laktozu.
English: However, cases of alcohol intolerance and intoxication have been reported during post-marketing use.
Croatian: Međutim, nakon stavljanja lijeka u promet prijavljeni su slučajevi intolerancije alkohola i intoksikacije.
English: ● upset stomach
Croatian: ● bol u želucu
English: Hallucinations Abnormal behaviour, aggression
Croatian: Psihijatrijski poremećaji vrlo rijetko nepoznato halucinacije neuobičajeno ponašanje, agresija
English: In another study, grapefruit juice had no effect on the disposition of desloratadine.
Croatian: U drugoj studiji, sok od grejpa nije utjecao na raspoloživost desloratadina.
English: There is no evidence of clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days.
Croatian: Ne postoji dokaz o klinički značajnoj akumulaciji lijeka nakon primjene desloratadina jedanput na dan (5 mg do 20 mg) tijekom 14 dana.
English: 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.
Croatian: Prevalencija tog fenotipa sporih metabolizatora bila je usporediva u odraslih (6%) i pedijatrijskih ispitanika u dobi od 2 do 11 godina (6%), ali je u obje populacije bila veća u crnaca (18% odrasli, 16% pedijatrijski ispitanici) nego u bijelaca (2% odrasli, 3% pedijatrijski ispitanici).
English: The safety profile of these subjects was not different from that of the general population.
Croatian: Sigurnosni profil u ovih ispitanika se nije razlikovao od onog u općoj populaciji.
English: Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours.
Croatian: Desloratadin se dobro apsorbira te dostiže maksimalnu koncentraciju nakon približno 3 sata; poluvijek u terminalnoj fazi približno iznosi 27 sati.
English: In clinical trials, desloratadine in the syrup formulation was administered to a paediatric population.
Croatian: U kliničkim ispitivanjima, desloratadin se u obliku sirupa primjenjivao u pedijatrijskoj populaciji.
English: Phenylalanine may be harmful for people with phenylketonuria.
Croatian: Fenilalanin može naškoditi osobama koje boluju od fenilketonurije.
English: 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.
Croatian: U ispitivanju učinka jednokratnih doza desloratadina od 5 mg u odraslih, nije bilo utjecaja na standardna mjerila uspješnosti upravljanja letjelicama, uključujući i egzacerbaciju subjektivne pospanosti ili zadataka vezanih uz upravljanje letjelicama.
English: 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.
Croatian: Aerius je bio učinkovit u ublažavanju simptoma sezonskog alergijskog rinitisa, što se vidi iz ukupnog rezultata upitnika o kvaliteti života ispitanika s rinokonjuktivitisom.
English: As with other antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non-responsive to antihistamines was excluded.
Croatian: Kao i kod drugih ispitivanja antihistaminika kod kronične idiopatske urtikarije, manji broj pacijenata, kod kojih je utvrđeno da ne reagiraju na antihistaminike, bio je isključen iz ispitivanja.
English: What Aerius is and what it is used for What you need to know before you take Aerius How to take Aerius
Croatian: Što je Aerius i za što se koristi Što morate znati prije nego počnete uzimati Aerius Kako uzimati Aerius
English: Efficacy of Aerius oral solution has not been investigated in separate paediatric trials.
Croatian: Djelotvornost Aerius oralne otopine nije ispitivana u posebnim pedijatrijskim kliničkim ispitivanjima.
English: 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.
Croatian: Slični farmakokinetički parametri opaženi su i u farmakokinetičkom ispitivanju primjene višestrukih doza desloratadina provedenom s desloratadin sirupom u pedijatrijskih ispitanika u dobi od 2 do 11 godina koji sporo metaboliziraju desloratadin, a kojima je dijagnosticiran alergijski rinitis.
English: Aerius with food, drink and alcohol Aerius may be taken with or without a meal.
Croatian: Aerius s hranom, pićem i alkoholom Aerius se može uzeti uz ili bez obroka.
English: Aerius orodispersible tablet with food, drink and alcohol Aerius orodispersible tablet does not need to be taken with water or liquid.
Croatian: Aerius raspadljive tablete za usta s hranom, pićem i alkoholom Aerius raspadljive tablete za usta ne trebaju se uzimati s vodom ili drugom tekućinom.
English: 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.
Croatian: Izloženost desloratadinu (AUC) bila je šest puta viša, a vršna koncentracija (Cmax) tri do četiri puta viša nakon tri do šest sati, dok je poluvrijeme života u terminalnoj fazi iznosilo oko 120 sati.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i na blisteru iza oznake "EXP".
English: Common: the following may affect up to 1 in 10 people
Croatian: Česte: sljedeće nuspojave mogu se javiti u do 1 na 10 osoba
English: The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table.
Croatian: Učestalost nuspojava prijavljenih u kliničkom ispitivanju češće u odnosu na placebo i drugih nuspojava prijavljenih nakon stavljanja lijeka u promet navedena je u sljedećoj tablici.
English: In clinical studies in most children and adults, side effects with Aerius were about the same as with a dummy solution or tablet.
Croatian: U kliničkim ispitivanjima u većine djece i odraslih su nuspojave kod primjene lijeka Aerius bile približno iste kao kod uzimanja otopine ili tableta placeba.
English: 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.
Croatian: U zasebnim ispitivanjima primjene jednokratne doze pri preporučenim su dozama vrijednosti AUC i Cmax desloratadina u pedijatrijskih bolesnika bile usporedive s vrijednostima u odraslih koji su primili dozu od 5 mg desloratadin sirupa.
English: In clinical studies with Aerius, the following side effects were reported as:
Croatian: U kliničkim ispitivanjima s lijekom Aerius, sljedeće nuspojave bile su prijavljene kao:
English: How Aerius works
Croatian: Kako djeluje Aerius
English: Do not use this medicine if you notice any change in the appearance of the tablets.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakvu promjenu izgleda tableta.
English: What you need to know before you take Aerius
Croatian: Što morate znati prije nego počnete uzimati Aerius
English: Since histamine release is a causal factor in all urticarial diseases, desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
Croatian: Budući da je uzročni faktor svih urtikarijskih bolesti otpuštanje histamina, prema navodima kliničkih smjernica očekuje se da će desloratadin biti učinkovit u ublažavanju simptoma ne samo kronične idiopatske urtikarije nego i drugih urtikarijskih stanja.
English: Clinical efficacy and safety In a multiple dose trial, Aerius orodispersible tablets were well tolerated.
Croatian: Klinička djelotvornost i sigurnost U ispitivanju primjene višestrukih doza ispitanici su dobro podnosili Aerius raspadljive tablete za usta.
English: 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.
Croatian: Aerius tablete su bile učinkovite u ublažavanju simptoma sezonskog alergijskog rinitisa, što se vidi iz ukupnog rezultata upitnika o kvaliteti života ispitanika s rinokonjuktivitisom.
English: Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and for more than 4 weeks.
Croatian: Perzistentni alergijski rinitis definira se kao prisutnost simptoma 4 ili više dana u tjednu te duže od 4 tjedna.
English: Do not use this medicine if you notice any change in the appearance of Aerius orodispersible tablet.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakvu promjenu izgleda Aerius raspadljivih tableta za usta.
English: What Aerius looks like and contents of the pack
Croatian: Kako Aerius izgleda i sadržaj pakiranja
English: How to take Aerius
Croatian: Kako uzimati Aerius
English: Fertility There are no data available on male and female fertility.
Croatian: Plodnost Nisu dostupni podaci o plodnosti u muškaraca i žena.
English: 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.
Croatian: Materijali od kojih se sastoji blister su poliklorotrifluoroetilenski (PCTFE)/polivinilkloridni (PVC) film (strana u dodiru s lijekom) prekriven aluminijskom folijom presvučenom toplinski zalijepljenim vinilom (strana u dodiru s lijekom), koja je toplinski zalijepljena.
English: The cold form blister film is composed of polyvinyl chloride (PVC) film adhesively laminated to an oriented polyamide (OPA) film, adhesively laminated to aluminum foil, adhesively laminated to polyvinyl chloride (PVC) film.
Croatian: Hladno oblikovani blister film sastoji se od polivinilkloridnog (PVC) filma slijepljenog i laminiranog na usmjereni poliamidni (OPA) film, koji je slijepljen i laminiran na aluminijsku foliju, koja je slijepljena i laminirana na polivinilkloridni (PVC) film.
English: Aerius oral solution contains sorbitol
Croatian: Aerius oralna otopina sadrži sorbitol
English: Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and aggression.
Croatian: Ostale nuspojave nepoznate učestalosti prijavljene u pedijatrijskih bolesnika nakon stavljanja u promet uključivale su produljenje QT intervala, aritmiju, bradikardiju, neuobičajeno ponašanje i agresiju.
English: In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Croatian: Kod perzistentnog alergijskog rinitisa (simptomi su prisutni 4 ili više dana u tjednu i duže od 4 tjedna), bolesnicima se može preporučiti kontinuirano liječenje tijekom razdoblja izloženosti alergenu.
English: How to store Aerius oral solution Contents of the pack and other information
Croatian: Kako čuvati Aerius oralnu otopinu Sadržaj pakiranja i druge informacije
English: All packages except the 150 ml package are supplied with a measuring spoon marked for doses of 2.5 ml and 5 ml.
Croatian: U svim pakiranjima osim pakiranja od 150 ml priložena je odmjerna žličica s oznakama za doze od 2,5 ml i 5 ml.
English: The pharmacokinetics of desloratadine in patients with chronic renal insufficiency (CRI) was compared with that of healthy subjects in one single-dose study and one multiple dose study.
Croatian: Farmakokinetika desloratadina u bolesnika s kroničnom insuficijencijom bubrega bila je uspoređivana s onom u zdravih ispitanika u jednom ispitivanju jednokratnih doza te u ispitivanju višekratnih doza.
English: How to store Aerius orodispersible tablet Contents of the pack and other information
Croatian: Kako čuvati Aerius raspadljive tablete za usta Sadržaj pakiranja i druge informacije
English: If you take more Aerius orodispersible tablet than you should Take Aerius orodispersible tablet only as prescribed for you.
Croatian: Ako uzmete više Aerius raspadljivih tableta za usta nego što ste trebali Uzimajte Aerius raspadljive tablete za usta samo na način kako Vam je propisano.
English: 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.
Croatian: U farmakokinetičkom ispitivanju primjene višestrukih doza provedenom s tabletama u zdravih odraslih ispitanika, pronađena su četiri ispitanika sa sporim metaboliziranjem desloratadina.
English: 5 orodispersible tablets 6 orodispersible tablets 10 orodispersible tablets 12 orodispersible tablets 15 orodispersible tablets 18 orodispersible tablets 20 orodispersible tablets 30 orodispersible tablets 50 orodispersible tablets 60 orodispersible tablets 90 orodispersible tablets 100 orodispersible tablets
Croatian: 5 raspadljivih tableta za usta 6 raspadljivih tableta za usta 10 raspadljivih tableta za usta 12 raspadljivih tableta za usta 15 raspadljivih tableta za usta 18 raspadljivih tableta za usta 20 raspadljivih tableta za usta 30 raspadljivih tableta za usta 50 raspadljivih tableta za usta 60 raspadljivih tableta za usta 90 raspadljivih tableta za usta 100 raspadljivih tableta za usta
English: There is limited clinical trial efficacy experience with the use of desloratadine in children 6 through 11 years of age (see section 5.2).
Croatian: Postoji ograničeno iskustvo iz kliničkih ispitivanja djelotvornosti primjene desloratadina u djece u dobi od 6 do 11 godina (vidjeti dio 5.2).
English: The recommended dose is 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.
Croatian: Preporučena doza je 2,5 ml (pola žličice od 5 ml) oralne otopine jedanput na dan.
English: Aerius oral solution contains sorbitol.
Croatian: Aerius oralna otopina sadrži sorbitol.
English: Adults During the marketing of Aerius, the following side effects were reported as:
Croatian: Odrasli Nakon stavljanja u promet lijeka Aerius, sljedeće su nuspojave prijavljene kao:
English: The overall safety profile of these subjects was not different from that of the general population.
Croatian: Ukupan sigurnosni profil u ovih se ispitanika nije razlikovao od opće populacije.
English: Do not use this medicine if you notice any change in the appearance of the oral solution.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakvu promjenu izgleda oralne otopine.
English: There is limited clinical trial efficacy experience with the use of desloratadine in children 1 through 11 years of age and adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Croatian: Postoji ograničeno iskustvo iz kliničkih ispitivanja djelotvornosti primjene desloratadina u djece u dobi od 1 do 11 godina i adolescenata u dobi od 12 do 17 godina (vidjeti dijelove 4.8 i 5.1).
English: Children 1 through 5 years of age: 2.5 ml (1.25 mg) Aerius oral solution once a day.
Croatian: Djeca u dobi od 1 do 5 godina: 2,5 ml (1,25 mg) Aerius oralne otopine jedanput na dan.
English: The blister materials consist of a four layer aluminum foil laminate cold form blister film and a paper backed laminated aluminum foil lidding film.
Croatian: Materijali od kojih se sastoji blister su hladno oblikovani blister film od četveroslojnog laminata aluminijske folije i pokrovni film od laminirane aluminijske folije s papirnatom podlogom.
English: 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).
Croatian: Postoji ograničeno iskustvo iz kliničkih ispitivanja djelotvornosti primjene desloratadina u adolescenata u dobi od 12 do 17 godina (vidjeti dijelove 4.8 i 5.1).
English: Immediately before use, the blister must be carefully peeled open and the dose of orodispersible tablet removed without crushing it.
Croatian: Neposredno prije primjene blister se mora pažljivo odlijepiti te raspadljiva tableta za usta izvaditi pazeći da se ne zdrobi.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva nepoznato fotoosjetljivost
English: In single-dose crossover studies of Aerius 5 mg orodispersible tablets with Aerius 5 mg conventional tablets, the formulations were bioequivalent.
Croatian: U ispitivanjima naizmjenične primjene jedne doze Aerius 5 mg raspadljivih tableta za usta i konvencionalnih Aerius 5 mg tableta, te su formulacije bile bioekvivalentne.
English: No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose ketoconazole and erythromycin interaction trials.
Croatian: Nisu uočene klinički značajne promjene u koncentraciji desloratadina u plazmi tijekom ispitivanja interakcija višestrukih doza desloratadina s ketokonazolom i eritromicinom.
English: What Aerius orodispersible tablet is and what it is used for What you need to know before you take Aerius orodispersible tablet How to take Aerius orodispersible tablet Possible side effects
Croatian: Što je Aerius raspadljiva tableta za usta i za što se koristi Što morate znati prije nego počnete uzimati Aerius raspadljive tablete za usta Kako uzimati Aerius raspadljive tablete za usta Moguće nuspojave