FrancophonIA/ELRC3.0 huggingface dataset:
English: Stimulants (analeptics) must not be used.
Croatian: Ne smiju se koristiti stimulansi (analeptici).
English: Patients should be carefully monitored.
Croatian: Bolesnike je potrebno pažljivo pratiti.
English: Not known: frequency cannot be estimated from the available data • abnormal behaviour
Croatian: Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka • neuobičajeno ponašanje
English: Swallow the tablet whole with water.
Croatian: Tabletu progutajte cijelu s vodom.
English: • increased sugar in blood
Croatian: • povišena razina šećera u krvi
English: Other medicines and Aerinaze
Croatian: Drugi lijekovi i Aerinaze
English: Do not take this medicine for more than 10 days continuously unless your doctor tells you to do so.
Croatian: Nemojte uzimati ovaj lijek više od 10 dana bez prekida osim ako Vam tako nije rekao liječnik.
English: Risks of abuse
Croatian: Rizici od zlouporabe
English: The recommended dosage and the duration of treatment should not be exceeded.
Croatian: Preporučena doza i trajanje liječenja ne smiju se prekoračiti.
English: Increased doses may ultimately produce toxicity.
Croatian: Povećane doze naposljetku mogu izazvati toksičnost.
English: Older adults may be more sensitive to the effects of this medicine - if you have diabetes
Croatian: Starije osobe mogu biti osjetljivije na djelovanje ovog lijeka - ako imate šećernu bolest
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalosti pojavljivanja definirane su kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared.
Croatian: Liječenje treba trajati što kraće i ne smije se nastaviti nakon povlačenja simptoma.
English: Aerinaze with alcohol
Croatian: Aerinaze s alkoholom
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 dozu lijeka na vrijeme, uzmite je čim prije, a zatim lijek nastavite uzimati po uobičajenom rasporedu.
English: Distribution Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Croatian: Desloratadin se umjereno veže (83%-87%) za proteine u plazmi.
English: Adults and adolescents 12 years of age and over The recommended dose is one tablet twice daily with a glass of water, with or without food.
Croatian: Odrasli i adolescenti u dobi od 12 ili više godina Preporučena doza je jedna tableta dvaput na dan s čašom vode, s hranom ili bez nje.
English: Do not take tablets more often than recommended.
Croatian: Nemojte uzimati tablete češće nego što je preporučeno.
English: • digitalis (see section 4.4)
Croatian: • digitalisom (vidjeti dio 4.4)
English: What Aerinaze looks like and contents of the pack
Croatian: Kako Aerinaze izgleda i sadržaj pakiranja
English: What Aerinaze is and what it is used for
Croatian: Što je Aerinaze i za što se koristi
English: What Aerinaze is and what it is used for What you need to know before you take Aerinaze How to take Aerinaze
Croatian: Što je Aerinaze i za što se koristi Što morate znati prije nego počnete uzimati Aerinaze Kako uzimati Aerinaze
English: Interference with serological testing
Croatian: Interferencija sa serološkim testiranjima
English: The half-life for desloratadine is 27.4 hours.
Croatian: Poluvijek desloratadina iznosi 27,4 sata.
English: Do not crush, break or chew.
Croatian: Nemojte drobiti, lomiti niti žvakati.
English: What you need to know before you take Aerinaze
Croatian: Što morate znati prije nego počnete uzimati Aerinaze
English: • tricyclic antidepressants and other antihistamines.
Croatian: • tricikličke antidepresive i druge antihistaminike.
English: Therefore Aerinaze should be used with caution in patients above 60 years of age.
Croatian: Stoga Aerinaze treba primjenjivati uz oprez u bolesnika starijih od 60 godina.
English: In clinical trials involving 414 adults the most frequent of adverse reactions reported were insomnia (8.9 %), dry mouth (7.2 %) and headache (3.1 %).
Croatian: U kliničkim ispitivanjima kojima je obuhvaćeno 414 odraslih osoba najčešće prijavljene nuspojave bile su nesanica (8,9%), suha usta (7,2%) i glavobolja (3,1%).
English: Date of first authorisation: 30 July 2007 Date of latest renewal: 30 July 2012
Croatian: Datum prvog odobrenja: 30. srpnja 2007.
English: The tablet may be taken with a full glass of water but must be swallowed entirely (without crushing, breaking or chewing it).
Croatian: Tablete se mogu uzeti s punom čašom vode, ali se moraju progutati cijele (bez drobljenja, lomljenja ili žvakanja).
English: After emergency treatment, medical monitoring of the patient should be continued.
Croatian: Nakon hitnog liječenja treba nastaviti nadzirati bolesnika.
English: In the event of overdose, symptomatic and supportive treatment immediately should be started and maintained it for as long as necessary.
Croatian: U slučaju predoziranja odmah se mora uvesti simptomatsko i potporno liječenje i nastaviti koliko god je potrebno.
English: The prevalence of this poor metabolizer 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 ispitanika crne rase nego u odraslih bijelaca (18% naspram 2%), međutim, sigurnosni profil u tih se ispitanika nije razlikovao od opće populacije.
English: Patients should be informed that most people do not experience drowsiness.
Croatian: Bolesnicima treba napomenuti da se u većine ljudi neće javiti pospanost.
English: Keep the blisters in the outer carton in order to protect from light.
Croatian: Blistere čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Gastrointestinal and genitourinary effects
Croatian: Gastrointestinalni i genitourinarni učinci
English: Some patients may present a toxic psychosis with delusions and hallucinations.
Croatian: U nekih bolesnika može nastupiti toksična psihoza s deluzijama i halucinacijama.
English: The following combinations are not recommended:
Croatian: Ne preporučuju se kombinacije sa sljedećim lijekovima:
English: The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded.
Croatian: Još nije utvrđen enzim odgovoran za metabolizam desloratadina stoga se ne mogu u potpunosti isključiti neke interakcije s drugim lijekovima.
English: If you are scheduled to have surgery, your doctor may advise you to stop taking Aerinaze 24 hours beforehand.
Croatian: Ako planirate kirurški zahvat, liječnik će Vam možda savjetovati da 24 sata prije toga prestanete uzimati lijek Aerinaze.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego uzmete ovaj lijek.
English: These effects may be more likely to occur in adolescents from 12 years old, elderly patients, or in cases of overdose (see section 4.9).
Croatian: Pojava ovih učinaka je vjerojatnija u adolescenata nakon 12. godine života, starijih bolesnika te u slučajevima predoziranja (vidjeti dio 4.9).
English: Swallow the tablet whole; do not crush, break or chew the tablet before swallowing.
Croatian: Tabletu progutajte cijelu; nemojte je drobiti, lomiti niti žvakati prije gutanja.
English: Athletes taking Aerinaze may have positive doping-tests.
Croatian: Sportaši koji uzimaju Aerinaze mogu imati pozitivan rezultat doping testa.
English: However, non-clinical data with desloratadine 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: Međutim, neklinički podaci o desloratadinu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: • weight increased, increased appetite
Croatian: • povećana tjelesna težina, povećan apetit
English: Desloratadine does not readily penetrate the central nervous system.
Croatian: Desloratadin ne prodire lako u središnji živčani sustav.
English: 2220 Heist-op-den-Berg Belgium
Croatian: 2220 Heist-op-den-Berg Belgija
English: Taking Aerinaze is not recommended if you are pregnant.
Croatian: Ne preporučuje se uzimati Aerinaze ako ste trudni.
English: There were no significant differences in the efficacy of Aerinaze tablets across subgroups of patients defined by gender, age, or race.
Croatian: Nije bilo značajnih razlika u djelotvornosti Aerinaze tableta između podskupina bolesnika određenih temeljem spola, dobi ili rase.
English: The safety and efficacy of Aerinaze in children below the age of 12 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Aerinaze u djece mlađe od 12 godina nisu ustanovljene.
English: • anorexogenics or amphetamine-type psychostimulants
Croatian: • anorektike ili psihostimulanse amfetaminske skupine
English: Caution should be exercised in the following patient groups:
Croatian: Potreban je oprez kod primjene lijeka u sljedećim skupinama bolesnika:
English: Very rarely: the following other side effects reported during the marketing of desloratadine, may affect up to 1 in 10,000 people
Croatian: Vrlo rijetko: sljedeće nuspojave prijavljene su nakon stavljanja desloratadina u promet i mogu se javiti u do 1 na 10 000 osoba
English: If you forget to take Aerinaze
Croatian: Ako ste zaboravili uzeti Aerinaze
English: If you suddenly stop treatment, depression may occur.
Croatian: Ako naglo prestanete uzimati lijek, može se javiti depresija.
English: The safety and efficacy of Aerinaze have not been established in this population, and there are insufficient data to give adequate dose recommendations.
Croatian: Nisu ustanovljene sigurnost i djelotvornost lijeka Aerinaze u ovoj populaciji i nema dovoljno podataka da bi se mogle dati odgovarajuće preporuke za doziranje.
English: Treatment of the pseudoephedrine sulphate overdose is symptomatic and supportive.
Croatian: Liječenje predoziranja pseudoefedrinsulfatom je simptomatsko i potporno.
English: The active substance and its metabolite are excreted in urine; 55-75 % of the administered dose is excreted unchanged.
Croatian: Djelatna tvar i njezini metaboliti izlučuju se mokraćom, a 55-75% primijenjene doze izluči se u neizmijenjenom obliku.
English: • painful or difficult urination
Croatian: • bolno ili otežano mokrenje
English: Posology The recommended dose of Aerinaze is one tablet twice a day.
Croatian: Doziranje Preporučena doza lijeka Aerinaze je jedna tableta dvaput na dan.
English: Stop taking Aerinaze at least 48 hours before you have any skin tests since antihistamines may influence the result of the skin test.
Croatian: Prestanite uzimati Aerinaze najmanje 48 sati prije kožnog testa na alergene jer antihistaminici mogu utjecati na rezultat kožnog testa.
English: The clinical efficacy and safety of Aerinaze tablets was evaluated in two, 2-week multicentre, randomized parallel group clinical trials involving 1,248 patients 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received Aerinaze tablets.
Croatian: Klinička djelotvornost i sigurnost Aerinaze tableta ocijenjena je u dva dvotjedna multicentrična, randomizirana klinička ispitivanja s paralelnim skupinama, u koja je uključeno 1248 bolesnika sa sezonskim alergijskim rinitisom u dobi od 12 do 78 godina, od kojih je 414 uzimalo Aerinaze tablete.
English: If signs and symptoms such as pyrexia, erythema or many small pustules are observed, administration of Aerinaze should be discontinued and appropriate measures taken if needed.
Croatian: Ako se opaze znakovi i simptomi poput pireksije, eritema ili mnogobrojnih malih pustula, primjenu lijeka Aerinaze potrebno je prekinuti i, po potrebi, poduzeti odgovarajuće mjere.
English: As a precautionary measure, it is preferable to avoid the use of Aerinaze during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Aerinaze tijekom trudnoće.
English: Desloratadine has demonstrated antiallergic properties from in vitro studies.
Croatian: Desloratadin je pokazao antialergijska svojstva u ispitivanjima in vitro.
English: Therefore, if surgery is scheduled, it is preferable to discontinue treatment 24 hours before anaesthesia.
Croatian: Stoga je, kada se planira kirurški zahvat, uputno prekinuti liječenje 24 sata prije anestezije.
English: Aerinaze has no or negligible influence on the ability to drive and use machines.
Croatian: Aerinaze ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Speak with your doctor, pharmacist or nurse regarding whether you can drink alcohol while taking Aerinaze.
Croatian: Porazgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom o tome smijete li piti alkohol dok uzimate Aerinaze.
English: Aerinaze is also contraindicated in patients with:
Croatian: Aerinaze je kontraindiciran i u bolesnika koji imaju:
English: What Aerinaze is
Croatian: Što je Aerinaze
English: Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or hypothermia blanket.
Croatian: Hiperpireksiju će, osobito u djece, možda trebati liječiti kupkama mlakom vodom i spužvom ili hipotermijskom dekom.
English: • hyperthyroidism,
Croatian: • hipertireozu,
English: Continuous use can lead to tolerance resulting in an increased risk of overdosing.
Croatian: Produljenom primjenom može se razviti tolerancija s posljedičnim povećanim rizikom od predoziranja.
English: • changes in the way the heart beats
Croatian: • promjene u načinu otkucaja srca
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to adrenergic medicinal products or to loratadine.
Croatian: Preosjetljivost na djelatne tvari, neku od pomoćnih tvari navedenih u dijelu 6.1 ili na adrenergičke lijekove ili na loratadin.
English: Continuous use may lead to taking more Aerinaze than the recommended dose to get the desired effect, resulting in an increased risk of overdosing.
Croatian: Produljena primjena može dovesti do povećanog uzimanja tableta Aerinaze nego što je preporučeno kako biste postigli željeni učinak, čime se povećava rizik od predoziranja.
English: The apparent half-life of pseudoephedrine sulphate is 7.9 hours.
Croatian: Prividni poluvijek pseudoefedrinsulfata je 7,9 sati.
English: Athletes should be informed that treatment with pseudoephedrine sulphate could lead to positive doping tests.
Croatian: Sportaše treba upozoriti da liječenje pseudoefedrinsulfatom može dovesti do pozitivnih rezultata doping testova.
English: EU/1/07/399/001 2 modified-release tablets EU/1/07/399/002 4 modified-release tablets EU/1/07/399/003 7 modified-release tablets EU/1/07/399/004 10 modified-release tablets EU/1/07/399/005 14 modified-release tablets EU/1/07/399/006 20 modified-release tablets
Croatian: EU/1/07/399/001 2 tablete s prilagođenim oslobađanjem EU/1/07/399/002 4 tablete s prilagođenim oslobađanjem EU/1/07/399/003 7 tableta s prilagođenim oslobađanjem EU/1/07/399/004 10 tableta s prilagođenim oslobađanjem EU/1/07/399/005 14 tableta s prilagođenim oslobađanjem EU/1/07/399/006 20 tableta s prilagođenim oslobađanjem
English: It has an indirect sympathomimetic effect due primarily to the release of adrenergic mediators from the post-ganglionic nerve endings.
Croatian: Njegov je neizravni simpatomimetički učinak prvenstveno posljedica otpuštanja adrenergičkih medijatora iz postganglijskih živčanih završetaka.
English: • cardiovascular diseases such as ischaemic heart disease, tachyarrhythmia and severe hypertension,
Croatian: • kardiovaskularne bolesti poput ishemijske bolesti srca, tahiaritmije i tešku hipertenziju,
English: As Aerinaze contains pseudoephedrine sulphate, it is also contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment.
Croatian: Budući da Aerinaze sadrži pseudoefedrinsulfat, također je kontraindiciran u bolesnika koji se liječe inhibitorima monoamino-oksidaze (MAO) odnosno tijekom 2 tjedna od prestanka primjene tih lijekova.
English: Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced by the body.
Croatian: Antihistaminici pomažu ublažiti simptome alergije sprječavanjem djelovanja tvari koja se zove histamin, a koja se stvara u tijelu.
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 ispitivanja in vitro pokazala su da ovaj lijek ne inhibira CYP2D6 te da nije ni supstrat ni inhibitor P-glikoproteina.
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 većina ljudi neće osjetiti pospanost, preporučuje se da ne poduzimate aktivnosti koje zahtijevaju mentalnu pozornost, poput vožnje automobila ili rukovanja strojem dok ne ustanovite kako reagirate na ovaj lijek.
English: Talk to your doctor, pharmacist or nurse before taking Aerinaze: - if you are 60 years of age or older.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Aerinaze: - ako imate 60 ili više godina.
English: Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.
Croatian: Zdravstveni djelatnici mogu razmotriti prekid primjene desloratadina u bolesnika u kojih se za vrijeme liječenja pojave napadaji.
English: • restlessness with increased body movement
Croatian: • nemir uz pojačane pokrete tijela
English: Patients should be informed that the treatment should be discontinued in case of hypertension, tachycardia, palpitations or cardiac arrhythmias, nausea or any other neurological sign (such as headache or increased headache).
Croatian: Bolesnicima treba napomenuti da se liječenje mora prekinuti u slučaju hipertenzije, tahikardije, palpitacija ili srčanih aritmija, mučnine ili nekog drugog neurološkog simptoma (poput glavobolje ili pojačanja glavobolje).
English: B-2220 Heist-op-den-Berg Belgium.
Croatian: B-2220 Heist-op-den-Berg Belgija
English: In case of alkalinisation of the urine, a partial resorption takes place.
Croatian: U slučaju alkalizacije mokraće dolazi do djelomične resorpcije.
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 na individualne razlike u odgovoru na svaki lijek, preporučuje se savjetovati bolesnicima da ne poduzimaju aktivnosti koje zahtijevaju mentalnu pozornost, poput vožnje automobila ili rukovanja strojevima, dok ne ustanove kako reagiraju na ovaj lijek.
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: Ta svojstva obuhvaćaju inhibiciju otpuštanja proupalnih citokina poput IL-4, IL-6, IL-8 i IL-13 iz ljudskih mastocita/bazofila kao i inhibiciju ekspresije adhezijske molekule P-selektina na stanicama endotela.
English: During reproductive toxicity studies, the combination of loratadine/pseudoephedrine sulphate was not teratogenic when administered orally to rats at doses up to 150 mg/kg/day and rabbits at doses up to 120 mg/kg/day.
Croatian: U istraživanjima reproduktivne toksičnosti kombinacija loratadina i pseudoefedrinsulfata nije se pokazala teratogenom kada je peroralno primijenjena štakorima u dozama do 150 mg/kg na dan i kunićima u dozama do 120 mg/kg na dan.
English: • severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling)
Croatian: • teške alergijske reakcije (otežano disanje, piskanje pri disanju, svrbež, koprivnjača i oticanje)
English: Following oral administration of Aerinaze for 14 days in normal healthy volunteers, steady-state conditions were reached on day 10 for desloratadine, 3-hydroxydesloratadine and pseudoephedrine sulphate.
Croatian: Nakon peroralne primjene lijeka Aerinaze u zdravih dobrovoljaca tijekom 14 dana stanje dinamičke ravnoteže postignuto je 10. dana za desloratadin, 3-hidroksidesloratadin i pseudoefedrinsulfat.
English: Its elimination half-life in humans, at an approximate urinary pH of 6, ranges from 5 to 8 hours.
Croatian: Poluvrijeme eliminacije u ljudi pri pH vrijednosti mokraće od približno 6 u rasponu je od 5 do 8 sati.
English: • decreased sense of smell
Croatian: • smanjen osjet mirisa
English: Caution should be exercised in patients suffering from migraine who are currently being treated with ergot alkaloid vasoconstrictors (see section 4.5).
Croatian: Potreban je oprez kod primjene lijeka u bolesnika koji pate od migrene i trenutno se liječe vazokonstriktorima iz skupine ergot-alkaloida (vidjeti dio 4.5).
English: Drinking alcohol while taking Aerinaze is not recommended.
Croatian: Ne preporučuje se piti alkohol dok uzimate Aerinaze.
English: Apnoea is treated with respiratory assistance.
Croatian: Apneja se liječi asistiranom ventilacijom.
English: The combination of loratadine/pseudoephedrine sulphate used in acute and multiple-dose studies, exhibited a low order of toxicity.
Croatian: Kombinacija loratadina i pseudoefedrinsulfata korištena u istraživanjima akutnih i višestrukih doza pokazala je nisku toksičnost.
English: Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Croatian: Desloratadin primijenjen u jednoj dnevnoj dozi od 7,5 mg nije utjecao na psihomotoričke sposobnosti ispitanika u kliničkim ispitivanjima.
English: • pounding or irregular heart beat
Croatian: • lupanje ili nepravilno kucanje srca
English: It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudoephedrine sulphate may diminish.
Croatian: Preporučeno je ograničiti liječenje na približno 10 dana jer se djelovanje pseudoefedrinsulfata može umanjiti tijekom kronične primjene.
English: Central nervous system effects
Croatian: Učinci na središnji živčani sustav
English: Desloratadine is not removed by haemodialysis and it is not known if it is eliminated by peritoneal dialysis.
Croatian: Desloratadin se ne uklanja hemodijalizom i nije poznato može li se ukloniti peritonealnom dijalizom.
English: In controlled clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
Croatian: U kontroliranim kliničkim ispitivanjima pri preporučenoj dozi od 5 mg na dan incidencija somnolencije nije bila povećana u odnosu na placebo.