FrancophonIA/ELRC3.0 huggingface dataset:
English: The most serious undesirable effects are rare reports of hypersensitivity reactions, including anaphylaxis (less than 1 case per 1000 patients).
Croatian: Najozbiljnije nuspojave su rijetko prijavljene reakcije preosjetljivosti, uključujući anafilaksiju (manje od 1 slučaja na 1000 bolesnika).
English: There was no effect on serum cortisol in subjects with severe hepatic impairment (fluticasone furoate/vilanterol 100/12.5 micrograms).
Croatian: Nije bilo učinka na serumski kortizol u ispitanika s teškim oštećenjem jetre (flutikazonfuroat/vilanterol 100/12,5 mikrograma).
English: • before you use it for the first time • if you have left the cap off for 5 days or the intranasal device has not been used for 30 days or more.
Croatian: • ako ga niste držali zatvorenog 5 dana ili ukoliko intranazalni uređaj nije bio korišten 30 dana ili više.
English: Contents of the pack and other information Step-by-step guide to using the nasal spray
Croatian: Sadržaj pakiranja i druge informacije Korak po korak vodič za uporabu spreja za nos
English: The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright.
Croatian: Naprava se priprema za primjenu pritiskom na tipku za ispuštanje maglice s najmanje šest potisaka spreja (dok nije vidljiva fina maglica), držeći napravu u uspravnom položaju.
English: • Always keep the cap on the nasal spray when you are not using it.
Croatian: • Uvijek držite zatvarač na spreju za nos dok ga ne koristite.
English: Urinary excretion accounted for approximately 1 % and 2 % of the orally and intravenously administered dose, respectively.
Croatian: Urinarna ekskrecija odgovorna je za oko 1% oralno i 2% intravenski primijenjene doze.
English: Children (6 to 11 years of age)
Croatian: Djeca (6 do 11 godina)
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Croatian: Smetnje vida mogu biti prijavljene kod sistemske i topikalne primjene kortikosteroida.
English: Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Croatian: Avamys je indiciran u liječenju simptoma alergijskog rinitisa.
English: Avamys has no or negligible influence on the ability to drive and use machines.
Croatian: Avamys ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate (see section 4.5).
Croatian: Ne preporučuje se istovremena primjena s ritonavirom zbog rizika od povećane sistemske izloženosti flutikazonfuroatu (vidjeti dio 4.5).
English: Avamys nasal spray should be used within 2 months after first opening.
Croatian: Nakon prvog otvaranja, Avamys sprej za nos se mora upotrijebiti u roku od 2 mjeseca.
English: Therefore, no clinical studies have been conducted to investigate interactions of fluticasone furoate on other drugs.
Croatian: Stoga, nisu provedena klinička ispitivanja s ciljem istraživanja interakcija flutikazonfuroata s drugim lijekovima.
English: • Blurred vision or temporary changes to vision with long term use.
Croatian: Zamagljen vid ili prolazne promjene vida tijekom dugotrajne primjene.
English: Very common side effects (may affect more than 1 in 10 people) • Nosebleeds (generally minor), particularly if you use Avamys for more than 6 weeks continuously.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) Krvarenje iz nosa (uglavnom blago), osobito ako neprestano primjenjujete Avamys više od 6 tjedana.
English: Therefore, children should be maintained on the lowest possible efficacious dose which delivers adequate symptom control (see section 4.2).
Croatian: Stoga djeca moraju primati najmanju učinkovitu dozu koja održava odgovarajuću kontrolu simptoma (vidjeti dio 4.2).
English: Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very high affinity for the glucocorticoid receptor and has a potent anti-inflammatory action.
Croatian: Flutikazonfuroat je sintetički trifluorirani kortikosteroid koji posjeduje vrlo visok afinitet za glukokortikoidne receptore te ima snažno protuupalno djelovanje.
English: Adults and adolescents (12 years and over)
Croatian: Odrasli i adolescenti (12 i više godina)
English: The device should be cleaned after each use and the cap replaced.
Croatian: Nakon svake uporabe potrebno je očistiti napravu i vratiti zatvarač.
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Croatian: Ukoliko bolesnik ima simptome kao što su zamagljen vid ili druge smetnje vida, potrebno je razmotriti upućivanje bolesnika na pregled oftalmologu na procjenu mogućih uzroka koji mogu uključivati kataraktu, glaukom ili rijetke bolesti poput centralne serozne korioretinopatije (CSCR) koje su prijavljene nakon primjene sistemskih i topikalnih kortikoteroida.
English: Onset of action has been observed as early as 8 hours after initial administration.
Croatian: Nastup djelovanja primijećen je već 8 sati nakon početka primjene.
English: There was no evidence for a higher incidence of patients with quantifiable fluticasone furoate concentrations in the elderly, when compared with the younger patients.
Croatian: Nije bilo dokaza za višu stopu incidencije bolesnika s mjerljivim koncentracijama flutikazonfuroata kod starijih osoba u usporedbi s mlađim bolesnicima.
English: 30 sprays 60 sprays 120 sprays
Croatian: 30 potisaka 60 potisaka 120 potisaka
English: If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Croatian: Ako postoji dokaz o primjeni viših doza od preporučenih, potrebno je razmotriti dodatnu zaštitu sistemskim kortikosteroidima tijekom stresnih razdoblja ili elektivnih kirurških zahvata.
English: Tell your doctor or pharmacist if you feel discomfort when using the spray.
Croatian: Obavijestite liječnika ili ljekarnika ako osjećate neugodu prilikom primjene spreja.
English: Avamys should not be used at the same time with other nasal sprays containing steroids.
Croatian: Avamys se ne bi trebamo primjenjivati zajedno s drugim nazalnim sprejevima koji sadrže steroide.
English: If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained.
Croatian: Ako je rast usporen, terapiju je potrebno revidirati s ciljem smanjenja doze nazalnog kortikosteroida ako je to moguće, na najmanju dozu kojom je moguće održavati učinkovitu kontrolu simptoma.
English: Fluticasone furoate is rapidly cleared (total plasma clearance of 58.7 l/h) from systemic circulation principally by hepatic metabolism to an inactive 17β-carboxylic metabolite (GW694301X), by the cytochrome P450 enzyme CYP3A4.
Croatian: Flutikazonfuroat se rapidno uklanja (ukupni klirens u plazmi od 58,7 l/h) iz sistemske cirkulacije, prvenstveno pomoću jetrenog metabolizma u neaktivni 17β-karboksilni metabolit (GW694301X) putem citokroma P450 enzima CYP3A4.
English: Allergy symptoms can occur at specific times of the year and be caused by allergy to pollen from grass or trees (hayfever), or they can occur all year round and be caused by allergy to animals, house-dust mites or moulds to name some of the most common.
Croatian: Alergijski simptomi se mogu pojaviti u određeno vrijeme godine te ih može izazvati pelud trave ili drveća (peludna groznica) ili se mogu pojavljivati tijekom cijele godine te biti izazvani alergijom na životinje, kućne grinje i prašinu, kao neke od najčešćih.
English: Seasonal Allergic Rhinitis in adults and adolescents
Croatian: Sezonski alergijski rinitis kod odraslih i adolescenata
English: At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular opacity values within ± 0.1 of baseline values for each eye and, at week 104, ≤1% of subjects in both treatment groups had 0.3 increase from baseline in posterior subcapsular opacity.
Croatian: U tjednima 52 i 104, 95% ispitanika iz obje skupine imalo je vrijednosti stražnjeg subkapsularnog zamućenja unutar ±0,1 od početne vrijednosti za svako oko, a u 104. tjednu ≤1% ispitanika iz obje skupine imalo je povećanje stražnjeg subkapsularnog zamućenja ≥0,3 od početne vrijednosti.
English: Administration of fluticasone furoate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Croatian: Primjena flutikazonfuroata kod dojilja dolazi u obzir samo ako je očekivana korist za majku veća od bilo kojeg mogućeg rizika za dijete.
English: The medicinal product is available in three pack sizes: 1 bottle of 30, 60 or 120 sprays.
Croatian: Lijek je dostupan u tri veličine pakiranja: 1 bočica s 30, 60 ili 120 potisnih doza.
English: The enzyme induction and inhibition data suggest that there is no theoretical basis for anticipating metabolic interactions between fluticasone furoate and the cytochrome P450 mediated metabolism of other compounds at clinically relevant intranasal doses.
Croatian: Podaci o indukciji i inhibiciji enzima ukazuju da nema teorijske osnove za očekivanje metaboličkih interakcija između flutikazonfuroata i drugih lijekova čiji je metabolizam posredovan citokromom P450, primijenjenog u klinički značajnim intranazalnim dozama.
English: As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently.
Croatian: Kao kod svih intranazalnih kortikosteroida, prilikom svakog propisivanja istovremene primjene ostalih oblika kortikosteroidnog liječenja mora se razmotriti ukupno sistemsko opterećenje kortikosteroidima.
English: 5 Press the button firmly all the way in, while you breathe in through your nose - see picture h.
Croatian: 5 Pritisnite čvrsto tipku do kraja, dok udišete kroz nos - pogledajte sliku h.
English: *Epistaxis
Croatian: *epistaksa
English: Headache.
Croatian: Glavobolja.
English: Mean growth velocity over the 52-week treatment period was lower in the patients receiving fluticasone furoate (5.19 cm/year) compared to placebo (5.46 cm/year).
Croatian: Srednja vrijednost brzine rasta nakon 52-tjednog liječenja bila je niža u bolesnika koji su primali flutikazonfuroat (5,19 cm/godišnje) u usporedbi s placebom (5,46 cm/godišnje).
English: Coadministration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.
Croatian: Kombinaciju treba izbjegavati, osim kada korist nadmašuje povećani rizik od sistemskih nuspojava kortikosteroida, a u tom slučaju je bolesnike potrebno pratiti radi otkrivanja sistemskih nuspojava kortikosteroida.
English: Quantifiable levels were observed in 15.1 % of paediatric patients following intranasal dosing of 110 micrograms once daily and only 6.8 % of paediatric patients following 55 micrograms once daily.
Croatian: Mjerljive razine bile su primijećene kod 15,1% pedijatrijskih bolesnika nakon intranazalne doze od 110 mikrograma jednom na dan i samo kod 6,8% pedijatrijskih bolesnika nakon doze od 55 mikrograma jednom na dan.
English: Very rare side effects (may affect up to 1 in 10,000 people) • Small holes (perforations) in the ridge inside the nose that separates the nostrils.
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba) • Male rupice (perforacije) u nosnom grebenu koji razdvaja nosnice.
English: In animal studies glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine growth retardation.
Croatian: U ispitivanjima na životinjama pokazalo se da glukokortikoidi izazivaju malformacije, uključujući rascjep nepca i zaostajanje u intrauterinom rastu ploda.
English: Avamys nasal spray is for administration by the intranasal route only.
Croatian: Avamys sprej za nos primjenjuje se isključivo intranazalnim putem.
English: Transient ocular changes (see Clinical experience), vision blurred (see also section 4.4) Respiratory, thoracic and mediastinal disorders Very common
Croatian: Poremećaji oka Nepoznato prolazne očne promjene (vidjeti Kliničko iskustvo), zamagljen vid (vidjeti također dio 4.4) Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često
English: For full therapeutic benefit regular, scheduled usage is recommended.
Croatian: Za postizanje potpunog terapijskog učinka preporučuje se redovita primjena prema preporučenom režimu.
English: • If symptoms are very bad your doctor may increase the dose to 2 sprays in each nostril once every day until the symptoms are under control.
Croatian: Ako su simptomi jako izraženi, liječnik može povećati dozu na 2 potiska u svaku nosnicu jednom na dan dok simptomi ne dođu pod kontrolu.
English: These events were transient in nature for six subjects in the fluticasone furoate group and one placebo subject.
Croatian: Ovi događaji bili su prolazne naravi za 6 ispitanika iz skupine liječene flutikazonfuroatom i za jednog ispitanika iz placebo skupine.
English: Always keep the cap on.
Croatian: Uvijek držite zatvarač na spreju.
English: Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.
Croatian: Liječenje višim dozama nazalno primijenjenih kortikosteroida od preporučenih može imati za posljedicu klinički značajnu adrenalnu supresiju.
English: Fluticasone furoate should be used in pregnancy only if the benefits to the mother outweigh the potential risks to the foetus or child.
Croatian: Primjena flutikazonfuroata u trudnoći dozvoljena je samo ako pozitivni učinci za majku nadilaze moguće rizike za fetus ili dijete.
English: The most commonly reported adverse reactions during treatment with fluticasone furoate are epistaxis, nasal ulceration and headache.
Croatian: Najčešće prijavljene nuspojave tijekom liječenja flutikazonfuroatom su epistaksa, ulceracija u nosu i glavobolja.
English: Taking Avamys:
Croatian: Uzimanje Avamysa:
English: • The mist-release button must be pressed firmly all the way in, to release the mist through the nozzle - see picture c.
Croatian: • Tipka za ispuštanje maglice mora se čvrsto pritisnuti skroz do kraja kako bi otpustila maglicu kroz raspršivač - pogledajte sliku c.
English: There are no adequate data from the use of fluticasone furoate in pregnant women.
Croatian: Nema dostupnih podataka o primjeni flutikazonfuroata u trudnica.
English: In the majority of patients fluticasone furoate is not quantifiable (< 10 pg/ml) following intranasal dosing of 110 micrograms once daily.
Croatian: Kod većine bolesnika flutikazonfuroat nije mjerljiv (<10 pg/ml) nakon intranazalnog doziranja od 110 mikrograma jednom na dan.
English: Do not use Avamys if you are pregnant, or planning to become pregnant, unless your doctor or pharmacist tells you to.
Croatian: Ne primjenjujte Avamys ako ste trudni ili planirate trudnoću, osim na preporuku liječnika ili ljekarnika.
English: The absolute bioavailability for intranasal fluticasone furoate is 0.50 %, such that less than 1 microgram of fluticasone furoate would be systemically available after administration of 110 micrograms (see section 4.9).
Croatian: Apsolutna bioraspoloživost za intranazalni flutikazonfuroat je 0,50%, tako da će nakon primjene 110 mikrograma biti sistemski raspoloživo manje od 1 mikrograma flutikazonfuroata (vidjeti dio 4.9).
English: Fluticasone furoate undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut resulting in negligible systemic exposure.
Croatian: Flutikazonfuroat prolazi nepotpunu apsorpciju i ekstenzivni metabolizam prvog prolaza u jetri i crijevima što rezultira zanemarivom sistemskom izloženosti.
English: Preparing the nasal spray helps to make sure you always get the full dose of medicine.
Croatian: Priprema spreja za nos je važna kako bi uvijek dobili punu dozu lijeka.
English: 3 years In-use shelf life: 2 months
Croatian: 3 godine Rok valjanosti nakon otvaranja: 2 mjeseca.
English: • Never use a pin or anything sharp to clear the nozzle.
Croatian: • Nikad ne koristite iglu niti išta oštro da očistite raspršivač.
English: Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Croatian: Potencijalni sistemski učinci mogu uključivati Cushingov sindrom, Cushingoidna obilježja, adrenalnu supresiju, zaostajanje u rastu djece i adolescenata, kataraktu, glaukom i rjeđe niz psiholoških i bihevioralnih učinaka uključujući psihomotornu hiperaktivnost, poremećaje spavanja, anksioznost, depresiju ili agresivnost (osobito u djece).
English: Glaxo Operations UK, Ltd,(trading as Glaxo Wellcome Operations) Harmire Road
Croatian: Glaxo Operations UK, Ltd, (posluje kao Glaxo Wellcome Operations) Harmire Road
English: Based on these findings the average predicted exposure of 110 micrograms of intranasal fluticasone furoate in this patient population would not be expected to result in suppression of cortisol.
Croatian: Na temelju tih nalaza, ne očekuje se da će u toj populaciji bolesnika, prosječna predviđena izloženost intranazalnom flutikazonfuroatu od 110 mikrograma rezultirati supresijom kortizola.
English: Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, coadministration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.
Croatian: Na osnovi podataka o drugom glukokortikoidu (flutikazonpropionat), koji se metabolizira putem CYP3A4, ne preporučuje se istovremena primjena s ritonavirom zbog povećanog rizika od sistemske izloženosti flutikazonfuroatu.
English: However, it is usually effective within 8 to 24 hours of use.
Croatian: Međutim, početak djelovanja obično se primjećuje već unutar 8 do 24 sata nakon početka primjene.
English: • Check you still have medicine left.
Croatian: • Provjerite ima li još lijeka u bočici.
English: These findings are not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure.
Croatian: Ova otkrića se ne drže relevantnima kod ljudi pri preporučenim nazalnim dozama koje rezultiraju minimalnom sistemskom izloženošću.
English: Efficacy was maintained over the full 24-hours dosing period with once daily administration.
Croatian: Djelotvornost je održavana tijekom čitavih 24-satnih intervala s jednokratnim dnevnim doziranjima.
English: Data are available following inhaled administration of fluticasone furoate (as fluticasone furoate or fluticasone furoate/vilanterol) to subjects with hepatic impairment that are also applicable for intranasal dosing.
Croatian: Dostupni su podaci nakon inhalacijske primjene flutikazonfuroata (u obliku flutikazonfuroata ili kombinacije flutikazofuroat/vilanterola) u ispitanika s oštećenjem jetre, koji su također primjenjivi za intranazalno doziranje.
English: The paediatric posology is based on assessment of the efficacy data across the allergic rhinitis population in children.
Croatian: Doziranje u pedijatriji zasniva se na ocjeni podataka o djelotvornosti u dječjoj populaciji s alergijskim rinitisom.
English: Only a small number of elderly patients (≥ 65 years, n=23/872; 2.6 %) provided pharmacokinetic data.
Croatian: Farmakokinetički podaci dobiveni su samo od malog broja starijih bolesnika (≥65 godina, n=23/872; 2,6%).
English: Symptoms include: - becoming very wheezy, coughing or having difficulty with breathing - suddenly feeling weak or light-headed (which may lead to collapse or loss of consciousness) - swelling around the face - skin rashes or redness.
Croatian: Simptomi uključuju: - jako piskanje, kašalj ili poteškoće u disanju - iznenadni osjećaj slabosti ili ošamućenosti (što može dovesti do kolapsa ili gubitka svijesti) - oticanje lica - kožni osip ili crvenilo.
English: Nasal corticosteroids can affect the normal production of hormones in your body, particularly if you use high doses for a long time.
Croatian: Kortikosteroidi koji se uzimaju kroz nos mogu utjecati na stvaranje hormona u Vašem tijelu, pogotovo ako se uzima veća doza tijekom dužeg vremenskog razdoblja.
English: Some people will not feel the full effects until several days after first using Avamys.
Croatian: Kako dugo je potrebno za početak djelovanja lijeka Avamys Pojedine osobe neće osjetiti potpuni učinak do nekoliko dana nakon prve primjene lijeka Avamys.
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake 'EXP'.
English: Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods (see section 4.4).
Croatian: Mogu se pojaviti sistemski učinci nazalnih kortikosteroida, pogotovo ako su propisane više doze lijeka tijekom dužih vremenskih razdoblja (vidjeti dio 4.4).
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Avamys.
Croatian: Ako uzimate takve lijekove Vaš liječnik će Vas možda htjeti pažljivo pratiti jer neki lijekovi mogu povećati nuspojave lijeka Avamys.
English: Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.
Croatian: Flutikazonfuroat se brzo uklanja ekstenzivnim metabolizmom prvog prolaza putem citokroma P450 3A4.
English: In vivo studies have revealed no evidence of cleavage of the furoate moiety to form fluticasone.
Croatian: In vivo ispitivanja nisu otkrila dokaz cijepanja furoatne skupine u svrhu stvaranja flutikazona.
English: Follow these steps: 1 Shake the nasal spray vigorously with the cap on for about 10 seconds.
Croatian: Slijedite sljedeće korake: 1 Dobro protresite sprej za nos sa zatvaračem oko 10 sekundi.
English: The cap keeps the dust out, seals in the pressure and stops the nozzle from blocking up.
Croatian: Zatvarač sprječava ulaz prašini, čuva tlak i sprječava da se raspršivač blokira.
English: There is a step-by-step guide to using the nasal spray after Section 6 of this leaflet.
Croatian: Priložen je korak po korak vodič za korištenje spreja za nos na kraju dijela 6 ove upute.
English: Increases in IOP (7 mmHg from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms: 7 (2%) for fluticasone furoate 110 micrograms once daily and 1 (<1%) for placebo.
Croatian: Povećanje IOT (≥ 7 mmHg od početne vrijednosti) bilo je češće u ispitanika liječenih flutikazonfuroatom 110 mikrograma: 7 (2%) za flutikazonfuroat 110 mikrograma jednom na dan i 1 (<1%) za placebo.
English: Adults and children 12 years and over
Croatian: Odrasli i djeca od 12 i više godina starosti
English: There are no data with intranasal fluticasone furoate in patients with hepatic impairment.
Croatian: Nema podataka o intranazalnom flutikazonfuroatu kod bolesnika s oštećenjem jetre.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Harmire Road
Croatian: Glaxo Operations UK Ltd. (posluje pod nazivom Glaxo Wellcome Operations) Harmire Road
English: 1 Wipe the nozzle and inside of the cap with a clean, dry tissue - see pictures i and j.
Croatian: 1 Obrišite raspršivač i unutrašnjost zatvarača sa čistim, suhim rupčićem - pogledajte slike i i j.