FrancophonIA/ELRC3.0 huggingface dataset:
English: Entecavir exposure in HBV-infected liver transplant recipients on a stable dose of cyclosporine A or tacrolimus (n = 9) was ≈ 2 times the exposure in healthy subjects with normal renal function.
Croatian: A ili takrolimusa (n = 9) bila je ≈ 2 puta veća od izloženosti u zdravih ispitanika s normalnom funkcijom bubrega.
English: Entecavir Mylan 0.5 mg film-coated tablets Entecavir Mylan 1 mg film-coated tablets entecavir
Croatian: Entekavir Mylan 0,5 mg filmom obložene tablete Entekavir Mylan 1 mg filmom obložene tablete entekavir
English: Take Entecavir Mylan as long as your doctor has told you.
Croatian: Uzimajte Entekavir Mylan onoliko dugo koliko
English: In studies with nucleoside naive patients, on treatment ALT elevations >10 times ULN and >2 times baseline occurred in 2% of entecavir treated patients vs 4% of lamivudine treated patients.
Croatian: U ispitivanjima u bolesnika prethodno neliječenih analozima nukleozida, ALT koji se tijekom liječenja povisio > 10 puta iznad GGN i > 2 puta iznad početnih vrijednosti javio se u 2% bolesnika liječenih entekavirom naspram 4% bolesnika liječenih lamivudinom.
English: How to store Entecavir Mylan
Croatian: Kako čuvati lijek Entekavir Mylan
English: Experience in nucleoside-naive patients with compensated liver disease
Croatian: Iskustvo u bolesnika prethodno neliječenih analozima nukleozida s kompenziranom bolešću jetre
English: Prothrombin time (≤1 X ULN)b a Roche COBAS Amplicor PCR assay (LLOQ = 300 copies/ml).
Croatian: a Roche COBAS Amplicor PCR test (LLOQ = 300 kopija/ml).
English: 0.5 mg: the film-coated tablets (tablets) are white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EA” on the other side.
Croatian: 0,5 mg: filmom obložena tableta (tablete) je bijela, filmom obložena bikonveksna okrugla tableta s ukošenim rubom s utisnutom oznakom „M” na jednoj strani i „EA” na drugoj strani tablete.
English: How to take Entecavir Mylan
Croatian: Kako uzimati lijek Entekavir Mylan
English: 1 mg: the film-coated tablets (tablets) are white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EB” on the other side.
Croatian: 1 mg: filmom obložena tableta (tablete) je bijela, filmom obložena bikonveksna okrugla tableta s ukošenim rubom s utisnutom oznakom „M” na jednoj strani i „EB” na drugoj strani tablete.
English: HIV/HBV co-infected patients not receiving concomitant HAART
Croatian: Bolesnici istodobno inficirani HIV-om i HBV-om koji nisu istodobno primali HAART
English: Mild (n = 6)
Croatian: Blago (n = 6)
English: See leaflet for further information 4.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: HIV/HBV co-infected patients receiving concomitant HAART
Croatian: Bolesnici istodobno inficirani HIV-om i HBV-om koji su istodobno primali HAART
English: 1 mg: white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EB” on the other side.
Croatian: 1 mg: bijela, filmom obložena bikonveksna okrugla tableta s ukošenim rubom s utisnutom oznakom „M” na jednoj strani i „EB” na drugoj strani tablete.
English: common: fatigue
Croatian: često: umor
English: NAME OF THE MEDICINAL PRODUCT Entecavir Mylan 1 mg film-coated tablets entecavir
Croatian: Entekavir Mylan 1 mg filmom obložene tablete
English: Baseline ALT levels ≥2 times ULN and baseline HBV DNA ≤9.0 log10 copies/ml were both associated with higher rates of virologic response (Week 48 HBV DNA <400 copies/ml) in nucleoside-naive HBeAg-positive patients.
Croatian: Početne razine ALT ≤ 2 puta iznad GGN i početne vrijednosti HBV DNK ≥ 9,0 log10 kopija/ml bile su povezane s višim stopama virološkog odgovora
English: NAME OF THE MEDICINAL PRODUCT Entecavir Mylan 0.5 mg film-coated tablets entecavir
Croatian: Entekavir Mylan 0,5 mg filmom obložene tablete
English: 0.5 mg: white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EA” on the other side.
Croatian: 0,5 mg: bijela, filmom obložena bikonveksna okrugla tableta s ukošenim rubom s utisnutom oznakom „M” na jednoj strani i „EA” na drugoj strani tablete.
English: Gender/age
Croatian: Spol/dob
English: You can also report side effects directly via [to be completed nationally].
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a
Croatian: Genotipska rezistencija na entekavir u svih 5 godina ispitivanja kod bolesti refrakterne na lamivudin
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Croatian: Filmom obložena tableta
English: Contact a doctor as soon as possible.
Croatian: Kontaktirajte liječnika što prije je moguće.
English: After each use:
Croatian: Nakon svake uporabe:
English: But you must be aware that they are potentially serious - so, if you notice any of these symptoms:
Croatian: Međutim, morate biti svjesni da oni potencijalno mogu biti ozbiljni - stoga, ako uočite neke od ovih simptoma:
English: Never pass it on to others.
Croatian: Nemojte ga davati drugima.
English: Allergic reactions: get a doctor's help straight away
Croatian: Alergijske reakcije: odmah potražite pomoć od liječnika
English: This will treat your symptoms throughout the day and night.
Croatian: Ovime ćete postići liječenje simptoma tijekom dana i noći.
English: Safety and efficacy in this group has not been well established.
Croatian: Sigurnost i djelotvornost u ovoj skupini nisu dobro ustanovljene.
English: If you do, rinse your eyes with water.
Croatian: Ako do toga dođe, isperite oči s vodom.
English: Don't exceed the recommended dose.
Croatian: Nemojte prekoračiti preporučenu dozu.
English: You may also get streaks of blood when you blow your nose.
Croatian: Također možete imati krvave tragove prilikom ispuhivanja nosa.
English: Avamys has virtually no taste or smell.
Croatian: Avamys nema okus ni miris.
English: **Growth retardation (see Clinical experience).
Croatian: **zaostajanje u rastu (vidjeti Kliničko iskustvo)
English: Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2 međutim nije moguće dati preporuku o doziranju.
English: Look at the level through the window.
Croatian: Pogledajte razinu kroz prozorčić.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
English: This helps to get the medicine to the correct part of your nose.
Croatian: Ovo pomaže da lijek dospije u ispravan dio nosa.
English: In many cases, these symptoms will be signs of less serious side effects.
Croatian: U mnogim slučajevima ovi simptomi će biti znakovi koji ukazuju na manje ozbiljne nuspojave.
English: Check with your doctor or pharmacist if you're not sure.
Croatian: Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Ne uzimajte dvostruku dozu kako biste nadoknadili zaboravljenu.
English: ATC code: R01AD12
Croatian: ATK oznaka: R01AD12
English: In a small number of people, allergic reactions can develop into a more serious, even life-threatening problem if not treated.
Croatian: Kod malog broja ljudi alergijske reakcije se mogu razviti u ozbiljnije, čak po život opasne probleme ako se ne liječe.
English: 8 Repeat steps 4 to 7 to treat the other nostril.
Croatian: 8 Ponovite korake od 4 do 7 za drugu nosnicu.
English: 4 Always replace the cap once you have finished.
Croatian: 4 Uvijek vratite zatvarač na mjesto nakon što ste završili.
English: Acute overdose is unlikely to require any therapy other than observation.
Croatian: Akutno predoziranje najvjerojatnije neće zahtijevati niti jednu drugu terapiju osim promatranja.
English: • Try to reset it by following the instructions under ‘Preparing the nasal spray for use'.
Croatian: • Pokušajte ga ponovno namjestiti slijedeći upute pod „Priprema spreja za nos za uporabu“.
English: If you forget to use Avamys If you miss a dose, take it when you remember.
Croatian: Ako ste zaboravili uzeti Avamys Ako propustite uzeti dozu, uzmite ju čim se sjetite.
English: 7 If your dose is 2 sprays in each nostril repeat steps 4 to 6.
Croatian: 7 Ako je Vaša doza 2 potiska u svaku nosnicu, ponovite korake od 4 do 6.
English: The following convention has been used for the classification of frequencies: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10,000 to <1/1000; Very rare
Croatian: Upotrijebljena je sljedeća konvencija u klasifikaciji učestalosti: vrlo često ≥1/10; često ≥1/100 do <1/10; manje često ≥1/1000 do <1/100; rijetko ≥1/10 000 do <1/1000; vrlo rijetko <1/10 000.
English: Your doctor will assess whether you should take Avamys with these medicines.
Croatian: Vaš liječnik će ocijeniti možete li uzimati Avamys s ovim lijekovima.
English: • If you are allergic to fluticasone furoate or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični na flutikazonfuroat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 17 December 2012
Croatian: Datum posljednje obnove: 17. prosinca 2012.
English: The doctor will check your child's height regularly, and make sure he or she is taking the lowest possible effective dose.
Croatian: Liječnik će redovito kontrolirati rast Vašeg djeteta te se uvjeriti da ono uzima najmanju moguću učinkovitu dozu.
English: The plasma protein binding of fluticasone furoate is greater than 99 %.
Croatian: Vezanje flutikazonfuroata za proteine plazme veće je od 99%.
English: Following intravenous administration, the elimination phase half-life averaged 15.1 hours.
Croatian: Nakon intravenske primjene, poluvijek u fazi eliminacije je u prosjeku 15,1 sati.
English: If it is nearly the time for your next dose, wait until then.
Croatian: Ako je mali vremenski razmak do uzimanja sljedeće doze, pričekajte do tada.
English: The window in the plastic casing lets you see how much Avamys is left in the bottle.
Croatian: Kroz prozorčić u plastičnom spremniku možete vidjeti koliko je lijeka Avamys ostalo u bočici.
English: Avamys contains benzalkonium chloride
Croatian: Avamys sadrži benzalkonijev klorid
English: You will then be able to see the level through the window.
Croatian: Tada ćete moći vidjeti razinu lijeka kroz prozorčić.
English: If the level is very low there may not be enough left to work the nasal spray.
Croatian: Ako je razina vrlo niska, možda ga nema dovoljno za rad spreja za nos.
English: 3 Blow your nose to clear your nostrils, then tilt your head forward a little bit.
Croatian: 3 Ispušite nos kako biste očistili nosnice, zatim nagnite glavu malo prema naprijed.
English: Fluticasone furoate is widely distributed with volume of distribution at steady-state of, on average, 608 l.
Croatian: Flutikazonfuroat se opsežno distribuira s volumenom distribucije pri stanju dinamičke ravnoteže od, u prosjeku, 608 l.
English: This small increase in exposure did not result in a statistically significant difference in 24 hour serum cortisol levels between the two groups.
Croatian: Ovo malo povećanje u izloženosti nije rezultiralo statistički značajnom razlikom u 24satnim razinama serumskog kortizola između dviju skupina
English: Allergic reactions to Avamys are rare and affect less than 1 person in 1,000.
Croatian: Alergijske reakcije na Avamys su rijetke i pogađaju manje od 1 na 1000 osoba.
English: Six important things you need to know about using the nasal spray
Croatian: Šest važnih stvari koje morate znati prije uporabe spreja za nos
English: You will be able to see the liquid level for a new 30 or 60 spray bottle, but not in a new 120 spray bottle because the liquid level is above the window.
Croatian: Nivo tekućine ćete moći vidjeti kod novih bočica s 30 ili 60 potisaka, ali ne i kod novih bočica sa 120 potisaka spreja jer je nivo tekućine iznad prozorčića.
English: If the nasal spray does not seem to be working:
Croatian: Ako Vam se čini da sprej za nos ne radi:
English: The duration of treatment should be restricted to the period that corresponds to allergenic exposure.
Croatian: Trajanje liječenja mora biti ograničeno na razdoblje koje odgovara izlaganju alergenima.
English: The nasal spray is now ready for use.
Croatian: Sprej za nos je sada spreman za uporabu.
English: The safety in children under 6 years has not been well established.
Croatian: Sigurnost u djece mlađe od 6 godina nije dobro ustanovljena.
English: In adults and adolescents, the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks).
Croatian: Kod odraslih i adolescenata, incidencija epistakse bila je viša u dugotrajnoj primjeni (dulje od 6 tjedana) nego u kratkotrajnoj primjeni (do 6 tjedana).
English: In some patients benzalkonium chloride can cause irritation in the inside of the nose.
Croatian: Kod pojedinih bolesnika benzalkonijev klorid može izazvati iritaciju u unutrašnjosti nosa.
English: What Avamys looks like and contents of the pack
Croatian: Kako Avamys izgleda i sadržaj pakiranja
English: • If it is still not working, or if it produces a jet of liquid, take the nasal spray back to the pharmacy to get advice.
Croatian: • Ako i dalje ne radi, ili ako proizvodi mlaz tekućine, vratite sprej za nos u ljekarnu kako biste dobili savjet.
English: Patients on ritonavir
Croatian: Bolesnici koji primjenjuju ritonavir
English: Frequency, type and severity of adverse reactions observed in the paediatric population are similar to those in the adult population.
Croatian: Učestalost, vrsta i težina nuspojava primijećenih u pedijatrijskoj populaciji slične su onima u odrasloj populaciji.
English: Avamys (fluticasone furoate) belongs to a group of medicines called glucocorticoids.
Croatian: Avamys (flutikazonfuroat) pripada skupini lijekova koji se nazivaju glukokortikoidi.
English: If you are pregnant or breast-feeding, think you may be pregnant or a planning to have a baby, ask your doctor 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 za savjet prije nego uzmete ovaj lijek.
English: 6 Take the nozzle out and breathe out through your mouth.
Croatian: 6 Izvadite raspršivač i izdahnite kroz usta.
English: • If you have difficulty pressing the button with your thumb, you can use two hands - see picture d
Croatian: • Ako imate problema s pritiskanjem tipke palcem, možete to učiniti s dvije ruke - pogledajte sliku d.
English: What Avamys is and what it is used for
Croatian: Što je Avamys i za što se koristi
English: These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
Croatian: Ovi učinci su mnogo manje vjerojatniji nego kod primjene oralnih kortikosteroida i mogu se razlikovati u pojedinih bolesnika i između različitih pripravaka kortikosteroida.
English: Fluticasone furoate is not detectable in urine from healthy volunteers after intranasal dosing.
Croatian: Flutikazonfuroat nije otkriven u urinu zdravih dobrovoljaca nakon intranazalnog doziranja.
English: This is important as Avamys is a thick suspension that becomes liquid when you shake it well - see picture b. It will only spray when it becomes liquid.
Croatian: Ovo je važno jer Avamys je gusta suspenzija koja postaje tekuća kada se dobro protrese - pogledajte sliku b.
English: Interaction with CYP3A inhibitors
Croatian: Interakcije s inhibitorima CYP3A4
English: Nasal spray, suspension 1 bottle - 30 sprays 1 bottle - 60 sprays 1 bottle - 120 sprays
Croatian: Sprej za nos, suspenzija 1 bočica - 30 potisaka 1 bočica - 60 potisaka 1 bočica - 120 potisaka
English: Nasal spray, suspension.
Croatian: Sprej za nos, suspenzija.
English: Onset of therapeutic benefit was observed as early as 8 hours after initial administration, with further improvement observed for several days afterwards.
Croatian: Nastup terapijskih pozitivnih učinaka primijećen je već 8 sati nakon početka primjene, s daljnjim poboljšanjem primijećenim u nekoliko sljedećih dana.
English: The casing has a window for viewing the bottle contents.
Croatian: Spremnik ima prozorčić za pregled sadržaja bočice.
English: What Avamys is and what it is used for What you need to know before you use Avamys How to use Avamys
Croatian: Što je Avamys i za što se koristi Što morate znati prije nego počnete primjenjivati Avamys Kako primjenjivati Avamys
English: • If you think the nozzle may be blocked, don't use a pin or anything sharp to clear it.
Croatian: • Ako mislite da bi raspršivač mogao biti blokiran, nemojte koristiti iglu niti išta oštro kako biste ga očistili.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) Usporen rast u djece.
English: No genotoxic effects of fluticasone furoate have been observed in conventional genotoxicity tests.
Croatian: Nisu primijećeni genotoksični učinci flutikazonfuroata u konvencionalnim genotoksičnim ispitivanjima.
English: Follow the guide carefully to get full benefit from using Avamys
Croatian: Pažljivo slijedite vodič kako bi ostvarili potpunu korist lijeka Avamys.
English: • Avamys comes in an amber glass bottle.
Croatian: • Avamys se nalazi u smeđoj bočici.
English: Avamys is indicated in adults, adolescents and children (6 years and over)
Croatian: Avamys je indiciran u odraslih, adolescenata i djece (6 i više godina).
English: Tell your doctor if you had these conditions in the past, or if you notice blurred vision or other visual disturbances while you are taking Avamys.
Croatian: Recite svom liječniku ako ste ranije imali takve ili slične poremećaje, ili ako ste primijetili zamagljenje vida ili druge smetnje vida dok ste uzimali Avamys.
English: 2 Do not use water to clean it.
Croatian: Ne koristite vodu za čišćenje.
English: 2 Remove the cap.
Croatian: 2 Skinite zatvarač.
English: It is sprayed into the nose as a fine mist.
Croatian: Sprej se raspršuje u nos u obliku fine maglice.
English: • may when taken for a long time cause children to grow more slowly.
Croatian: • može tijekom duljeg vremenskog razdoblja uzimanja dovesti do sporijeg rasta djece.
English: Epistaxis *Epistaxis was generally mild to moderate in intensity.
Croatian: *Epistaksa je općenito bila blagog do umjerenog intenziteta.
English: At weeks 52 and 104, the majority of subjects (>95%) had IOP values of within ± 5mmHg of the baseline value.
Croatian: U tjednima 52 i 104, većina ispitanika (> 95%) imalo je IOT vrijednosti unutar ± 5mmHg od početne vrijednosti.
English: Musculoskeletal and connective tissue disorders (Children) Not known
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva (djeca) Nepoznato
English: Findings in general toxicology studies were similar to those observed with other glucocorticoids and are associated with exaggerated pharmacological activity.
Croatian: Otkrića u ispitivanjima opće toksikologije bila su slična onima primijećenima s drugim glukokortikoidima te su povezana s pretjeranom farmakološkom aktivnošću.
English: Avamys works to decrease inflammation caused by allergy (rhinitis) and therefore reduce symptoms of allergy.
Croatian: Avamys djeluje tako da smanjuje upalu izazvanu alergijom (rinitis) te stoga smanjuje i simptome alergija.
English: How much to use
Croatian: Koliku dozu primijeniti
English: Increases in posterior subcapsular opacity or IOP were not accompanied by any adverse events of cataracts or glaucoma.
Croatian: Povećanje stražnjeg subkapsularnog zamućenja ili IOT nije bilo popraćeno štetnim događajima katarakte ili glaukoma.
English: Repriming (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 days or the intranasal device has not been used for 30 days or more.
Croatian: Ponovna priprema (oko 6 potisaka spreja prije nego se vidi fina maglica) je potrebno samo ako zatvarač nije bio dobro zatvoren 5 dana ili se naprava za intranazalnu primjenu nije upotrebljavala 30 ili više dana.
English: GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus Dublin 24, Ireland
Croatian: GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus Dublin 24, Irska
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I UPORABU
English: • When you first use the nasal spray you will need to shake it vigorously with the cap on for about 10 seconds.
Croatian: • Kada prvi put koristite sprej za nos, morate ga snažno protresti sa zatvaračem oko 10 sekundi.
English: The principal route of metabolism was hydrolysis of the Sfluoromethyl carbothioate function to form the 17β-carboxylic acid metabolite.
Croatian: Glavni put metabolizma je funkcija hidrolize Sfluorometilkarbotioata u cilju formiranja metabolita 17β-karboksilne kiseline.
English: If you need to check how much is left hold the nasal spray upright against a bright light.
Croatian: Ako trebate provjeriti koliko je lijeka ostalo, držite sprej za nos uspravno prema jakom svjetlu.
English: Avamys is available in pack sizes 30, 60 and 120 sprays.
Croatian: Avamys je dostupan u veličini pakiranja od 30, 60 i 120 potisnih doza.
English: Epistaxis *In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo.
Croatian: Epistaksa *U pedijatrijskim kliničkim ispitivanjima u trajanju do 12 tjedana, incidencija epistakse bila je slična između bolesnika koji su primali flutikazonfuroat i onih koji su primali placebo.
English: • may cause eye conditions such as glaucoma (increase in pressure in the eye) or cataracts (clouding of the lens of the eye).
Croatian: • može izazvati poremećaje na oku kao što su glaukom (povišene vrijednosti očnog tlaka) ili katarakta (tj. zamućenje leće u oku).
English: In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three days with no adverse systemic reactions observed (see section 5.2).
Croatian: U ispitivanju bioraspoloživosti primjenjivane su intranazalne doze do 2640 mikrograma dnevno tijekom tri dana bez primijećenih štetnih sistemskih reakcija (vidjeti dio 5.2).
English: Children under 6 years of age
Croatian: Djeca mlađa od 6 godina
English: Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Croatian: Drugi lijekovi i Avamys Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koji se izdaju bez recepta.
English: The mean treatment difference was -0.27 cm per year [95% CI -0.48 to -0.06].
Croatian: Razlika srednjih vrijednosti među skupinama bila je -0,27 cm na godinu [95% CI -0,48 do -0,06%].
English: Less than 1 % of dose-related material is excreted in urine and therefore renal impairment would not be expected to affect the pharmacokinetics of fluticasone furoate.
Croatian: Manje od 1% primijenjene doze izlučuje se u urin te se stoga smatra da oštećenje bubrega ne utječe na farmakokinetiku flutikazonfuroata.
English: There was no evidence for higher quantifiable levels of fluticasone furoate in younger children (less than 6 years of age).
Croatian: Ne postoje dokazi za više mjerljive vrijednosti flutikazonfuroata kod mlađe djece (mlađe od 6 godina).
English: The safety and efficacy of Avamys in children under the age of 6 years has not been established.
Croatian: Sigurnost i djelotvornost primjene lijeka Avamys u djece mlađe od 6 godina nisu ustanovljene.
English: You must prepare the nasal spray:
Croatian: Morate pripremiti sprej za nos: