FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have medical or familial history of seizures.
Croatian: - ako imate napadaje u osobnoj ili obiteljskoj povijesti bolesti.
English: Water or other liquid is not needed to swallow the dose.
Croatian: Nije potrebna voda ili druga tekućina da bi se doza progutala.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aerius therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Aerius uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Croatian: Ako ste zaboravili uzeti svoju dozu lijeka na vrijeme, uzmite je što je prije moguće, a zatim nastavite lijek uzimati prema uobičajenom rasporedu.
English: ● abnormal behaviour
Croatian: ● neuobičajeno ponašanje
English: Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
Croatian: Proizvođač: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgija.
English: Pharmacotherapeutic group: antihistamines - H1 antagonist, ATC code: R06A X27
Croatian: Farmakoterapijska skupina: antihistaminici - antagonist H1-receptora, ATK oznaka: R06A X27
English: Treatment with Aerius also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Croatian: Liječenje lijekom Aerius također je značajno smanjilo utjecaj na spavanje i dnevne aktivnosti, što se mjerilo skalom od četiri stupnja za procjenu tih varijabli.
English: There are no known interactions of Aerius with other medicines.
Croatian: Nema poznatih interakcija između lijeka Aerius i drugih lijekova.
English: Aerius effectively controlled symptoms for 24 hours.
Croatian: Aerius je učinkovito kontrolirao simptome tijekom 24 sata.
English: Swallow the tablet whole with water.
Croatian: Tabletu progutati cijelu s vodom.
English: Common in children less than 2 years of age: the following may affect up to 1 in 10 children
Croatian: Česte u djece mlađe od 2 godine starosti: sljedeće nuspojave mogu se javiti u do 1 na 10 djece
English: Contains mannitol and aspartame.
Croatian: Sadrži manitol i aspartam.
English: As a precautionary measure, it is preferable to avoid the use of Aerius during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Aerius tijekom trudnoće.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude temeljem konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.
Croatian: Najveće poboljšanje uočeno je na području praktičnih problema i dnevnih aktivnosti koje su inače ograničene zbog simptoma alergije.
English: The effect of desloratadine on newborns/infants is unknown.
Croatian: Učinak desloratadina na novorođenčad/dojenčad nije poznat.
English: Not known: frequency cannot be estimated from the available data ● unusual weakness
Croatian: Nepoznata učestalost: ne može se procijeniti iz dostupnih podataka ● neuobičajena slabost
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/ neonatal toxicity of desloratadine.
Croatian: Velika količina podataka o trudnicama (više od 1000 ishoda trudnoće) nije ukazala na malformativne niti feto/neonatalne toksične učinke desloratadina.
English: In both studies, changes in exposure (AUC and Cmax) of desloratadine and 3-hydroxydesloratadine were not clinically relevant.
Croatian: U oba ispitivanja promjene u izloženosti (AUC i Cmax) desloratadinu i 3hidroksidesloratadinu nisu bile klinički značajne.
English: 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.
Croatian: Desloratadin ne inhibira CYP3A4 in vivo, a in vitro studije su pokazale da lijek ne inhibira CYP2D6 i da nije supstrat niti inhibitor P-glikoproteina.
English: Excipient(s) with known effect: This medicine contains mannitol and aspartame (E951).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: Ovaj lijek sadrži manitol i aspartam (E951).
English: In the case of severe renal insufficiency, Aerius should be used with caution (see section 5.2).
Croatian: U slučaju teške insuficijencije bubrega, Aerius treba oprezno primjenjivati (vidjeti dio 5.2).
English: Desloratadine has been identified in breastfed newborns/infants of treated women.
Croatian: Desloratadin je nađen u dojenoj novorođenčadi/dojenčadi liječenih žena.
English: Talk to your doctor, pharmacist or nurse before taking Aerius: - if you have poor kidney function.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Aerius - ako imate oslabljenu funkciju bubrega.
English: Very rare: the following may affect up to 1 in 10,000 people ● severe allergic reactions
Croatian: Vrlo rijetke: sljedeće nuspojave mogu se javiti u do 1 na 10 000 osoba ● teške alergijske reakcije ● osip
English: In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis.
Croatian: U djece mlađe od dvije godine osobito je teško razlikovati dijagnozu alergijskog rinitisa od drugih oblika rinitisa.
English: Use caution when taking Aerius with alcohol.
Croatian: Potreban je oprez kada se Aerius uzima s alkoholom.
English: The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.
Croatian: Profil štetnih događaja povezanih s predoziranjem, primijećenih nakon stavljanja lijeka u promet, bio je sličan onom primijećenom pri primjeni terapijskih doza, ali opseg učinaka može biti veći.
English: Non-clinical studies conducted with desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine.
Croatian: Neklinička ispitivanja provedena s desloratadinom i loratadinom pokazala su da ne postoje kvalitativne niti kvantitativne razlike u profilu toksičnosti desloratadina i loratadina pri usporedivim razinama izloženosti desloratadinu.
English: The presence of food prolongs Tmax for desloratadine from 2.5 to 4 hours and Tmax for 3-OHdesloratadine from 4 to 6 hours.
Croatian: Prisutnost hrane produljuje Tmax desloratadina sa 2,5 na 4 sata, a Tmax 3-OH-desloratadina sa 4 na 6 sati.
English: Nevertheless, as there is individual variation in response to all medicinal products, it is recommended that patients are advised not to engage in activities requiring mental alertness, such as driving a car or using machines, until they have established their own response to the medicinal product.
Croatian: Ipak, s obzirom da postoje individualne razlike u odgovoru na sve lijekove, preporučuje se savjetovati bolesnicima da ne poduzimaju aktivnosti koje zahtijevaju mentalnu pozornost, poput vožnje automobila ili rukovanja strojevima, dok ne utvrde kakva je njihova reakcija na ovaj lijek.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Desloratadine has demonstrated antiallergic properties from in vitro studies.
Croatian: Desloratadin je pokazao antialergijska svojstva u in vitro ispitivanjima.
English: Aerius tablets effectively controlled symptoms for 24 hours.
Croatian: Aerius tablete su učinkovito kontrolirale simptome tijekom 24 sata.
English: The absence of upper respiratory tract infection or structural abnormalities, as well as patient history, physical examinations, and appropriate laboratory and skin tests should be considered.
Croatian: Potrebno je uzeti u obzir izostanak infekcije gornjih dišnih puteva ili strukturalnih anomalija kao i povijest bolesti, fizikalni pregled te odgovarajuće laboratorijske i kožne testove.
English: Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
Croatian: Desloratadin se ne uklanja hemodijalizom; nije poznato može li se ukloniti peritonealnom dijalizom.
English: The dose of orodispersible tablet is placed in the mouth where it will disperse immediately.
Croatian: Raspadljiva tableta stavlja se u usta, gdje će se odmah otopiti.
English: In case an oral measuring syringe is provided with the bottle of oral solution, you can alternatively use it to take the appropriate amount of oral solution.
Croatian: U slučaju da je uz bocu oralne otopine priložena odmjerna štrcaljka za usta, možete je koristiti umjesto žličice kako biste uzeli odgovarajuću količinu oralne otopine.
English: For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.
Croatian: Trajanje liječenja urtikarije razlikuje se od bolesnika do bolesnika, stoga trebate slijediti upute svojeg liječnika.
English: 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.
Croatian: Ova svojstva uključuju inhibiciju otpuštanja proinflamatornih citokina poput IL-4, IL-6, IL-8 i IL-13 iz ljudskih mastocita/bazofila, kao i inhibiciju ekspresije adhezijske molekule P-selektina na endotelnim stanicama.
English: Excipient(s) with known effect: This medicine contains lactose.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: Ovaj lijek sadrži laktozu.
English: ● pounding or irregular heartbeat
Croatian: ● lupanje ili nepravilni otkucaji srca
English: In clinical trials in a paediatric population, the desloratadine syrup formulation was administered to a total of 246 children aged 6 months through 11 years.
Croatian: U kliničkim ispitivanjima u pedijatrijskoj populaciji desloratadin se u obliku sirupa primjenjivao u ukupno 246 djece u dobi od 6 mjeseci do 11 godina.
English: However, the safety of desloratadine syrup formulation, which contains the same concentration of desloratadine as Aerius oral solution, was demonstrated in three paediatric trials.
Croatian: Međutim, sigurnost primjene desloratadina u obliku sirupa, koji sadrži istu koncentraciju desloratadina kao i Aerius oralna otopina, dokazana je u tri pedijatrijska ispitivanja.
English: When given at the recommended doses, the plasma concentrations of desloratadine (see section 5.2) were comparable in the paediatric and adult populations.
Croatian: Kada su se davale preporučene doze, koncentracije desloratadina u plazmi (vidjeti dio 5.2) u pedijatrijskoj populaciji mogle su se usporediti s onima u odraslih.
English: Not known: frequency cannot be estimated from the available data
Croatian: Nepoznata učestalost: ne može se procijeniti iz dostupnih podataka
English: 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.
Croatian: U kliničkom ispitivanju s 578 ispitanika adolescenata, u dobi od 12 do 17 godina, najčešći štetni događaj bila je glavobolja koja se javljala u 5,9% bolesnika liječenih desloratadinom i u 6,9% bolesnika koji su primali placebo.
English: At the recommended dose, this medicine is not expected to affect your ability to drive or use machines.
Croatian: Ako se uzme u preporučenoj dozi, ovaj lijek ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili rada na strojevima.
English: After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system.
Croatian: Nakon peroralne primjene, desloratadin selektivno blokira periferne histaminske H1-receptore budući da ne prodire u središnji živčani sustav.
English: Excipient(s) with known effect: This medicinal product contains 150 mg/ml of sorbitol
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: Ovaj lijek sadrži 150 mg/ml sorbitola.
English: What Aerius is Aerius contains desloratadine which is an antihistamine.
Croatian: Što je Aerius Aerius sadrži desloratadin, koji je antihistaminik.
English: No significant differences were found in the psychomotor test results between desloratadine and placebo groups, whether administered alone or with alcohol.
Croatian: Nisu ustanovljene značajne razlike u rezultatima testova psihomotorike između skupine koja je primala desloratadin i one na placebu, bez obzira jesu li uzimani sami ili s alkoholom.
English: These symptoms include itching and hives.
Croatian: Ovi simptomi uključuju svrbež i koprivnjaču.
English: 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.
Croatian: Liječnik koji propisuje lijek treba znati da je većina slučajeva rinitisa u djece mlađe od dvije godine infektivnog podrijetla (vidjeti dio 4.4) te da ne postoje podaci koji podupiru liječenje infektivnog rinitisa lijekom Aerius.
English: What Aerius contains
Croatian: Što Aerius sadrži
English: The safety of desloratadine in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.
Croatian: Sigurnost primjene desloratadina u djece u dobi od 2 do 11 godina starosti koja sporo metaboliziraju desloratadin ista je kao i u djece koja ga normalno metaboliziraju.
English: ● changes in the way the heart beats
Croatian: ● promjene u načinu otkucaja srca
English: Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1receptor antagonist activity.
Croatian: Desloratadin je dugodjelujući antagonist histamina bez sedativnog učinka, sa selektivnim antagonističkim djelovanjem na periferne H1-receptore.
English: 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).
Croatian: Djeca u dobi od 1 do 11 godina koja su bila kandidati za liječenje antihistaminicima primala su dnevnu dozu desloratadina od 1,25 mg (1 do 5 godina starosti) odnosno 2,5 mg (6 do 11 godina starosti).
English: Take the dose immediately after removal from the blister.
Croatian: Uzmite dozu odmah nakon što ste je izvadili iz blistera.
English: Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.
Croatian: Iako se u većine ljudi ne javlja omamljenost, preporučuje se da ne poduzimate aktivnosti koje zahtijevaju mentalnu pozornost, poput vožnje automobila ili rukovanja strojevima sve dok ne ustanovite kako ovaj lijek utječe na Vas.
English: The dose can be taken with or without food.
Croatian: Doza se može uzeti s hranom ili bez nje.
English: 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.
Croatian: Zabilježeno je smanjenje pruritusa za više od 50% kod 55% bolesnika liječenih desloratadinom, u usporedbi s 19% bolesnika koji su primali placebo.
English: During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Croatian: Nakon stavljanja u promet lijeka Aerius, slučajevi teških alergijskih reakcija (otežano disanje, zviždanje pri disanju, svrbež, koprivnjača i oticanje) bili su prijavljeni vrlo rijetko.
English: The bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
Croatian: Bioraspoloživost desloratadina bila je proporcionalna dozi u rasponu od 5 mg do 20 mg.
English: What Aerius is and what it is used for
Croatian: Što je Aerius i za što se koristi
English: Contains propylene glycol and sorbitol.
Croatian: Sadrži propilenglikol i sorbitol.
English: The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency.
Croatian: Stupanj nakupljanja desloratadina bio je u skladu s njegovim poluvijekom (približno 27 sati) i s učestalosti doziranja jedanput na dan.
English: Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine administration in adults and adolescents.
Croatian: Koncentracije desloratadina u plazmi mogu se izmjeriti unutar 30 minuta od primjene lijeka u odraslih i adolescenata.
English: In adolescents, headache was the most commonly reported side effect.
Croatian: U adolescenata, najčešće prijavljena nuspojava bila je glavobolja.
English: The overall incidence of adverse reactions was similar between the desloratadine syrup and the placebo groups and did not differ significantly than the safety profile seen in adult patients.
Croatian: Ukupna incidencija nuspojava bila je slična u skupinama koje su uzimale desloratadin sirup i onima koje su uzimale placebo i nije se značajnije razlikovala od sigurnosnog profila viđenog u odraslih bolesnika.
English: In infants and toddlers aged 6 to 23 months, the most frequent adverse reactions reported in excess of placebo were diarrhoea (3.7 %), fever (2.3 %) and insomnia (2.3 %).
Croatian: Kod dojenčadi i male djece u dobi od 6 do 23 mjeseca, najčešće nuspojave prijavljene češće nego kod primjene placeba bile su proljev (3,7%), vrućica (2,3%) i nesanica (2,3%).
English: ● severe allergic reactions
Croatian: ● teške alergijske reakcije ● osip
English: Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
Croatian: Aspartam je izvor fenilalanina koji može naškoditi osobama koje boluju od fenilketonurije.
English: Intermittent allergic rhinitis is defined as the presence of symptoms for less than 4 days per week or for less than 4 weeks.
Croatian: Intermitentni alergijski rinitis definira se kao prisutnost simptoma manje od 4 dana u tjednu ili kraće od 4 tjedna.
English: The overall incidence of adverse events in children 2 through 11 years of age was similar for the desloratadine and the placebo groups.
Croatian: Ukupna incidencija nuspojava u djece u dobi od 2 do 11 godina bila je slična u skupinama koje su uzimale desloratadin i onima koje su primale placebo.
English: As Aerius oral solution contains the same concentration of desloratadine, no bioequivalence study was required and it is expected to be equivalent to the syrup and tablet.
Croatian: Budući da Aerius oralna otopina sadrži jednaku koncentraciju desloratadina, nije bilo potrebno provesti ispitivanje bioekvivalencije sa sirupom i tabletama i očekuje se da su te formulacije ekvivalentne.
English: The prevalence of this poor metaboliser phenotype was greater among Black adults than Caucasian adults (18 % vs. 2 %) however the safety profile of these subjects was not different from that of the general population.
Croatian: Prevalencija tog fenotipa sporih metabolizatora bila je veća u odraslih crnaca nego u odraslih bijelaca (18% naspram 2%), međutim, sigurnosni profil u tih se ispitanika nije razlikovao od opće populacije.
English: Water had no effect on the bioavailability of Aerius orodispersible tablets.
Croatian: Voda nije utjecala na bioraspoloživost Aerius raspadljivih tableta za usta.
English: Adverse reactions seen with Aerius
Croatian: Nuspojave opažene uz Aerius
English: ● liver inflammation ● abnormal liver function tests body movement
Croatian: ● odstupanja od normalnih rezultata pokretima tijela testova jetrene funkcije
English: Therefore, the efficacy of Aerius orodispersible tablet is expected to be the same as with the Aerius tablet formulation.
Croatian: Stoga se očekuje da će djelotvornost Aerius raspadljivih tableta za usta biti jednaka kao kod primjene Aerius tableta.
English: 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.
Croatian: Kronična idiopatska urtikarija proučavana je kao klinički model ispitivanja urtikarijskih stanja zbog slične osnovne patofiziologije, bez obzira na etiologiju i zbog toga što je kronične bolesnike lakše prospektivno uključivati u ispitivanja.
English: ● hallucinations
Croatian: ● halucinacije
English: Desloratadine plasma concentrations can be detected within 30 minutes of administration.
Croatian: Koncentracije desloratadina u plazmi mogu se izmjeriti unutar 30 minuta od primjene.
English: 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).
Croatian: Približno 6% odraslih i djece u dobi od 2 do 11 godina fenotipski sporo metaboliziraju desloratadin pa je u njih izloženost lijeku veća (vidjeti dio 5.2).
English: The collective analysis of preclinical and clinical irritation studies for the orodispersible tablet indicate that this formulation is unlikely to pose risk for local irritation with clinical use.
Croatian: Skupna analiza nekliničkih i kliničkih ispitivanja iritacije kod primjene raspadljivih tableta za usta pokazuje da nije vjerojatno da bi ova formulacija izazvala lokalnu iritaciju u kliničkoj primjeni.
English: Do not use this medicine after the expiry date which is stated on the bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci iza oznake "EXP".
English: The efficacy of Aerius tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Croatian: Djelotvornost Aerius tableta još nije jasno dokazana u ispitivanjima na adolescentnim bolesnicima u dobi od 12 do 17 godina.
English: ● aggression
Croatian: ● agresija
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine.
Croatian: Preosjetljivost na djelatnu tvar, neku od pomoćnih tvari navedenih u dijelu 6.1 ili na loratadin.
English: The most frequent of adverse reactions reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Croatian: Najčešće prijavljene nuspojave kod primjene lijeka, a koje su češće u odnosu na placebo, bile su umor (1,2%), suha usta (0,8%) i glavobolja (0,6%).
English: No serious problems are expected with accidental overdose.
Croatian: Kod slučajnog predoziranja ne biste trebali imati ozbiljnijih problema.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili glukoza-galaktoza malapsorpcijom ne smiju uzimati ovaj lijek.
English: However, common side effects in children less than 2 years of age were diarrhoea, fever and insomnia while in adults, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
Croatian: Međutim, česte nuspojave u djece mlađe od 2 godine bile su proljev, vrućica i nesanica, a u odraslih su umor, suha usta i glavobolja prijavljene češće nego kod primjene tableta placeba.