natgillin/translations-raw huggingface dataset:
There was no effect on serum cortisol in subjects with severe hepatic impairment (fluticasone furoate/vilanterol 100/12.5 micrograms).
Pri preiskovancih s hudo okvaro jeter ni bilo vpliva na kortizol v serumu (flutikazonfuroat/vilanterol 100/12,5 mikrograma).
These findings are not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure.
Malo je verjetno, da bi bile te ugotovitve pomembne za uporabo priporočenih nazalnih odmerkov pri človeku, pri katerih je dosežena minimalna sistemska izpostavljenost.
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods (see section 4.4).
Pojavijo se lahko sistemski učinki nazalnih kortikosteroidov, še posebej pri uporabi visokih odmerkov daljši čas (glejte poglavje 4.4).
Seasonal and perennial allergic rhinitis in children (under 6 years):
Sezonski in celoletni alergijski rinitis pri otrocih (mlajših od 6 let):
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).
Povprečna hitrost rasti je bila v 52-tedenskem obdobju manjša med prejemniki flutikazonfuroata (5,19 cm/leto) kot med prejemniki placeba (5,46 cm/leto).
Musculoskeletal and connective tissue disorders (Children) Not known
Bolezni mišično-skeletnega sistema in vezivnega tkiva (otroci)
The paediatric posology is based on assessment of the efficacy data across the allergic rhinitis population in children.
Odmerjanje pri otrocih temelji na oceni podatkov o učinkovitosti pri skupini otrok z alergijskim rinitisom.
In a two-year study designed to assess the ocular safety of fluticasone furoate (110 micrograms once daily intranasal spray), adults and adolescents with perennial allergic rhinitis received either fluticasone furoate (n=367) or placebo (n=181).
V dveletni študiji za oceno očesne varnosti flutikazonfuroata (110 mikrogramov enkrat na dan v pršilu za nos) so odrasli in mladostniki s celoletnim alergijskim rinitisom prejemali flutikazonfuroat (n = 367) ali placebo (n = 181).
A randomised, double-blind, parallel-group, multicenter, one-year placebo-controlled clinical growth study evaluated the effect of fluticasone furoate nasal spray 110 micrograms daily on growth velocity in 474 prepubescent children (5 to 7.5 years of age for girls and 5 to 8.5 years of age for boys) with stadiometry.
V randomizirani, dvojno slepi, multicentrični, enoletni, s placebom kontrolirani klinični študiji rasti z vzporednima skupinama so s stadiometrijo ocenili učinek 110 mikrogramov flutikazonfuroata na dan v nosnem pršilu na hitrost rasti pri 474 otrocih pred puberteto (deklice v starosti od 5 do 7,5 let in dečki v starosti od 5 do 8,5 let).
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.
Simptomi alergije se lahko pojavijo v določenem letnem času kot posledica preobčutljivosti za cvetni prah trav ali dreves (seneni nahod), ali pa se pojavljajo skozi vse leto kot posledica preobčutljivosti za živali, hišne pršice ali plesni, če omenimo nekatere najpogostejše.
Efficacy was maintained over the full 24-hours dosing period with once daily administration.
Pri odmerjanju enkrat na dan se je učinkovitost ohranila celotno 24-urno odmerno obdobje.
The principal route of metabolism was hydrolysis of the Sfluoromethyl carbothioate function to form the 17β-carboxylic acid metabolite.
Glavna pot presnove je hidroliza S-fluorometil karbotioata do presnovka 17karboksilne kisline.
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.
V primeru dokaza, da je bolnik uporabljal odmerke, višje od priporočenih, je treba v obdobju stresa ali načrtovanega kirurškega posega razmisliti o dodatni uporabi sistemskih kortikosteroidov.
The cap keeps the dust out, seals in the pressure and stops the nozzle from blocking up.
Pokrovček ščiti pred prahom, ohranja tlak in preprečuje zamašitev nastavka.
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.
Če se rast upočasni, je treba zdravljenje ponovno ovrednotiti in odmerek nazalnega kortikosteroida po možnosti zmanjšati na najmanjši odmerek, ki še zagotavlja učinkovito nadzorovanost simptomov.
Growth retardation **In a one-year clinical study assessing growth in pre-pubescent children receiving 110 micrograms of fluticasone furoate once daily, an average treatment difference of -0.27 cm per year in growth velocity was observed compared to placebo (see Clinical efficacy and safety).
Upočasnitev rasti **V enoletni klinični študiji, ki je ocenjevala rast otrok pred puberteto, zdravljenih s 110 mikrogrami flutikazonfuroata enkrat na dan, so pri teh otrocih ugotovili povprečno razliko v hitrosti rasti -0,27 cm na leto v primerjavi s prejemniki placeba (glejte Klinična učinkovitost in varnost).
When the cap is in place the mistrelease button cannot be pressed accidentally.
Če je pokrovček nameščen, ni mogoče pomotoma pritisniti gumba za sprostitev meglice.
3 years In-use shelf life: 2 months
3 leta Rok uporabnosti po prvem odprtju: 2 meseca.
• ketoconazole, used to treat fungal infections
• ketokonazol, ki ga uporabljamo pri zdravljenju glivičnih bolezni.
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.
Podatki o encimski indukciji in inhibiciji kažejo, da teoretična osnova za pričakovane presnovne reakcije med flutikazonfuroatom in drugimi učinkovinami, ki se presnavljajo s citokromom P450, pri klinično pomembnih nazalnih odmerkih ne obstaja.
• Use once a day
• Zdravilo uporabljajte enkrat na dan.
If you have any further questions on the use of this medicine, or if you have any discomfort using the nasal spray ask your doctor or pharmacist or nurse.
Če imate dodatna vprašanja o uporabi tega zdravila ali če vam uporaba pršila za nos povzroča kakšno nelagodje, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
What Avamys looks like and contents of the pack
Izgled zdravila Avamys in vsebina pakiranja
At weeks 52 and 104, the majority of subjects (>95%) had IOP values of within ± 5mmHg of the baseline value.
Po 52 in 104 tednih je imela večina preiskovancev (> 95 %) očesni tlak znotraj ± 5 mm Hg v primerjavi z izhodiščem.
• may when taken for a long time cause children to grow more slowly.
• lahko pri dolgotrajni uporabi upočasni rast pri otrocih.
There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis.
V študijah varnosti in učinkovitosti je bilo več kot 2700 bolnikov zdravljenih s flutikazonfuroatom zaradi sezonskega in celoletnega alergijskega rinitisa.
Fluticasone furoate undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut resulting in negligible systemic exposure.
Absorpcija flutikazonfuroata je nepopolna, presnova prvega prehoda v jetrih in črevesu pa obsežna, zato je sistemska izpostavljenost malenkostna.
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.
Na voljo so podatki po inhalacijski uporabi flutikazonfuroata (v obliki flutikazonforuata ali kombinacije flutikazonfuroat/vilanterol) pri preiskovancih z okvaro jeter; ti podatki veljajo tudi za intranazalno uporabo.
A 6-week study that assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily on adrenal function in children aged 2 to 11 years showed that there was no significant effect on 24-hour serum cortisol profiles, compared with placebo.
6-tedenska študija, ki je vrednotila učinek flutikazonfuroata v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan na delovanje nadledvičnih žlez pri otrocih, starih od 2 do 11 let, je pokazala, da v primerjavi s placebom ne prihaja do pomembnejšega učinka na vrednosti 24-urnega kortizola v serumu.
In a drug interaction study of intranasal fluticasone furoate with the potent CYP3A4 inhibitor ketoconazole there were more subjects with measurable fluticasone furoate concentrations in the ketoconazole group (6 of the 20 subjects) compared to placebo (1 out of 20 subjects).
V študiji medsebojnega delovanja med nazalnim flutikazonfuroatom in ketokonazolom, močnim zaviralcem CYP3A4, so o večjem številu oseb z merljivimi koncentracijami flutikazonfuroata poročali v skupini, ki je prejemala ketokonazol (6 od 20 oseb), kot v skupini, ki je prejemala placebo (1 od 20 oseb).
• If you think the nozzle may be blocked, don't use a pin or anything sharp to clear it.
• Če mislite, da je nastavek zamašen, za njegovo čiščenje ne uporabite igle ali česa drugega ostrega.
This is not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure (see section 5.2).
Malo je verjetno, da bi bili ti izsledki pomembni za uporabo priporočenih nazalnih odmerkov pri človeku, pri katerih je dosežena minimalna sistemska izpostavljenost (glejte poglavje 5.2).
• Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril,
• Ko bodo simptomi pod nadzorom, boste odmerek morda lahko zmanjšali na 1 vpih v vsako nosnico enkrat na dan.
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.
Zvišanje očesnega tlaka ( 7 mmHg od izhodišča) je bilo pogostejše pri preiskovancih, zdravljenih s 110 mikrogrami flutikazonfuroata: 7 (2 %) s 110 mikrogrami flutikazonfuroata enkrat na dan in 1 (< 1 %) s placebom.
Also contains: Glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.
Vsebuje tudi: brezvodno glukozo, disperzibilno celulozo, polisorbat 80, benzalkonijev klorid, dinatrijev edetat in prečiščeno vodo.
• ritonavir or cobicistat, used to treat HIV
• ritonavir ali kobicistat, ki ju uporabljamo pri zdravljenju okužbe z virusom HIV,
Increases in posterior subcapsular opacity or IOP were not accompanied by any adverse events of cataracts or glaucoma.
Povečanja posteriorne subkapsularne motnosti ali zvišanja očesnega tlaka nista spremljala neželena učinka katarakta ali glavkom.
The increase in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (fluticasone furoate/vilanterol 200/25 micrograms) was associated with an average 34% reduction in serum cortisol compared with healthy subjects.
Povečanje sistemske izpostavljenosti flutikazonfuroatu je bilo pri preiskovancih z zmerno okvaro jeter (flutikazonfuroat/vilanterol 200/25 mikrogramov) povezano s povprečno 34 % znižanjem kortizola v serumu v primerjavi z zdravimi preiskovanci.
• The usual starting dose is 1 spray in each nostril once a day.
• Priporočeni začetni odmerek je 1 vpih v vsako nosnico enkrat na dan.
Increases in posterior subscapsular opacity (0.3 from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms [14 (4%)] versus placebo [4 (2%)] and were transient in nature for ten subjects in the fluticasone furoate group and two subjects in the placebo group.
Povečanje posteriorne subkapsularne motnosti ( 0,3 od izhodišča) je bilo pogostejše pri preiskovancih, zdravljenih s 110 mikrogrami flutikazonfuroata [14 (4 %)], kot pri prejemnikih placeba [4 (2 %)], ter je bilo prehodno pri desetih preiskovancih v skupini s flutikazonfuroatom in pri dveh preiskovancih v skupini s placebom.
Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate (see section 4.5).
Zaradi tveganja za večjo sistemsko izpostavljenost flutikazonfuroatu sočasne uporabe ritonavirja ne priporočamo (glejte poglavje 4.5).
• Avamys comes in an amber glass bottle.
• Zdravilo Avamys je na voljo v steklenički jantarne barve.
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.
Flutikazonfuroat se sme med dojenjem uporabljati le, če koristi za mater prevladajo nad kakršnimkoli tveganjem za dojenega otroka.
study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment (Child-Pugh B) resulted in increased Cmax (42 %) and AUC(0-∞) (172 %) and a modest (on average 23 %) decrease in cortisol levels in patients compared to healthy subjects.
V študiji z enim samim 400 mikrogramskim odmerkom peroralno inhaliranega flutikazonfuroata pri bolnikih z zmerno okvaro jeter (Child-Pugh B) sta se, v primerjavi z zdravimi osebami, pri bolnikih povečali vrednosti Cmax (42 %) in AUC(0-) (172 %), vrednosti kortizola pa zmerno zmanjšale (v povprečju za 23 %).
The values are similar to those seen in adults (12+) where median concentrations in those subjects with quantifiable levels were 15.4 pg/ml and 21.8 pg/ml at 55 micrograms and 110 micrograms, respectively.
Vrednosti so podobne vrednostim pri odraslih (12+), pri katerih je bila po uporabi 55 mikrogramskega odmerka mediana vrednost koncentracij 15,4 pg/ml, po uporabi 110 mikrogramskega odmerka pa 21,8 pg/ml.
A reduction in growth velocity has been observed in children treated with fluticasone furoate 110 micrograms daily for one year (see section 4.8 and section 5.1).
Pri otrocih, ki so eno leto prejemali 110 mikrogramov flutikazonfuroata na dan, so opažali upočasnitev rasti (glejte poglavji 4.8 in 5.1).
The other ingredients are glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water (see section 2).
Pomožne snovi so brezvodna glukoza, disperzibilna celuloza, polisorbat 80, benzalkonijev klorid, dinatrijev edetat in prečiščena voda (glejte poglavje 2).
The intranasal dosing of 110 micrograms once daily does not typically result in measurable plasma concentrations (<10 pg/ml).
Pri nazalni uporabi odmerka 110 mikrogramov enkrat na dan plazemske koncentracije tipično niso merljive (< 10 pg/ml).
However the dose of intranasal fluticasone furoate should be reduced to the lowest dose at which effective control of the symptoms of rhinitis is maintained.
Odmerek nazalnega flutikazonfuroata pa je kljub temu treba zmanjšati na najmanjši odmerek, ki še zagotavlja učinkovito nadzorovanost simptomov rinitisa.
Fluticasone furoate is widely distributed with volume of distribution at steady-state of, on average, 608 l.
Volumen porazdelitve v stanju dinamičnega ravnovesja je v povprečju 608 litrov.
Urinary excretion accounted for approximately 1 % and 2 % of the orally and intravenously administered dose, respectively.
Pri peroralni uporabi se je z urinom izločilo približno 1 % prejetega odmerka, pri intravenski uporabi pa približno 2 % prejetega odmerka.
The bottle is in an off-white plastic casing with a light blue cap and side-actuated lever.
Steklenička je vložena v sivo plastično ohišje s svetlomodrim pokrovčkom in sprožilcem ob strani.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Odmerek je treba titrirati do najmanjšega odmerka, s katerim se lahko učinkovito obvladuje simptome.
4 Press the button firmly all the way in. Do this at least 6 times until it releases a fine mist of spray into the air - see picture f.
Naredite to vsaj 6-krat, dokler pršilo v zrak ne sprosti drobne meglice - glejte sliko f.
The most commonly reported adverse reactions during treatment with fluticasone furoate are epistaxis, nasal ulceration and headache.
Najpogosteje opisani neželeni učinki med zdravljenjem s flutikazonfuroatom so krvavitev iz nosu, razjede nosne sluznice in glavobol.
Children 6 to 11 years
Uporaba pri otrocih, starih od 6 do 11 let
Avamys has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Avamys nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
3 Never use a pin or anything sharp on the nozzle.
3 Na nastavku nikoli ne uporabite igle ali česa drugega ostrega.
In seasonal allergic rhinitis, fluticasone furoate nasal spray 110 micrograms once daily was effective but no significant differences were observed between fluticasone furoate nasal spray 55 micrograms once daily and placebo on any endpoint.
Pri sezonskem alergijskem rinitisu se je flutikazonfuroat v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan izkazal za učinkovitega, vendar pa pri nobenem opazovanem dogodku niso opazili pomembne razlike med flutikazonfuroatom v obliki pršila za nos v odmerku 55 mikrogramov enkrat na dan in placebom.
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.
Po 52 in 104 tednih je imelo 95 % preiskovancev v obeh terapevtskih skupinah na enem in drugem očesu posteriorno subkapsularno motnost znotraj ± 0,1 od izhodiščne vrednosti.
The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump.
Pršilo za nos je bela suspenzija v steklenički jantarne barve, zaprti s pršilnikom.
EXPIn-use shelf life: 2 months
EXP Rok uporabnosti po prvem odprtju: 2 meseca
Following repeat dosing of orally inhaled fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (on average two-fold as measured by AUC(0-24)) in subjects with moderate or severe hepatic impairment (Child-Pugh B or C) compared with healthy subjects.
Po ponavljajočem se odmerjanju peroralno inhalirane kombinacije flutikazonfuroat/vilanterol v obdobju 7 dni se je sistemska izpostavljenost flutikazonfuroata pri preiskovancih z zmerno ali hudo okvaro jeter (Child-Pugh B ali C) v primerjavi z zdravimi preiskovanci povečala ( v povprečju za dvakrat, merjeno z AUC(0-24)).
Preparing the nasal spray for use
Priprava pršila za nos za uporabo
Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.
Pri zdravljenju z nazalnimi kortikosteroidi v odmerkih, večjih od priporočenih, se lahko pojavi klinično pomembna zavora delovanja nadledvičnih žlez.
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.
• krvavitve iz nosu (običajno blažje), še posebej, če zdravilo Avamys uporabljate neprekinjeno dlje kot 6 tednov.
Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 110 micrograms).
Bolniki, ki se na zdravljenje z enim vpihom v vsako nosnico enkrat na dan (skupni dnevni odmerek 55 mikrogramov) ne odzovejo dovolj, lahko uporabljajo dva vpiha v vsako nosnico enkrat na dan (skupni dnevni odmerek 110 mikrogramov).
Follow these steps: 1 Shake the nasal spray vigorously with the cap on for about 10 seconds.
Sledite naslednjim korakom: Pršilo za nos z nameščenim pokrovčkom približno 10 sekund močno stresajte.
Compared with placebo, fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms (comprising rhinorrhoea, nasal congestion, sneezing and nasal itching) and ocular symptoms (comprising itching/burning, tearing/watering and redness of the eyes) in all 4 studies.
Sezonski alergijski rinitis pri odraslih in mladostnikih V primerjavi s placebom je flutikazonfuroat v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan v vseh 4 študijah pomembno izboljšal nosne simptome (ki so obsegali nosni izcedek, kongestijo nosne sluznice, kihanje in srbenje nosu) in očesne simptome (ki so obsegali srbenje/pekoč občutek v očeh, solzenje/izcedek iz oči in rdečino oči).
GlaxoSmithKline (Malta) Limited Tel: + 356 21 238131
GlaxoSmithKline (Malta) Linited Tel: + 356 21 238131
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.
Po nazalnem odmerku 110 mikrogramov enkrat na dan so bile merljive vrednosti opažene pri 15,1 % otrok, po odmerku 55 mikrogramov enkrat na dan pa le pri 6,8 % otrok.
Fluticasone furoate is not detectable in urine from healthy volunteers after intranasal dosing.
Po nazalni uporabi pri zdravih prostovoljcih flutikazonfuroata v urinu ni bilo mogoče dokazati.
Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods.
Pojavijo se lahko sistemski učinki nazalnih kortikosteroidov, še posebej pri uporabi visokih odmerkov daljši čas.
Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) is recommended.
Ko je dosežen zadosten nadzor simptomov, priporočamo zmanjšanje odmerka na en vpih v vsako nosnico enkrat na dan (skupni dnevni odmerek 55 mikrogramov).
Safety and efficacy studies were performed in a total of 271 patients from 2 to 5 years of age in both seasonal and perennial allergic rhinitis, of whom 176 were exposed to fluticasone furoate.
Študije varnosti in učinkovitosti so bile izvedene pri skupaj 271 bolnikih, starih od 2 do 5 let, tako pri sezonskem kot celoletnem alergijskem rinitisu.
4 Always replace the cap once you have finished.
4 Po koncu vedno namestite pokrovček nazaj.
Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.
Medsebojno delovanje z zaviralci CYP3A4 Flutikazonfuroat se hitro očisti z obsežno presnovo prvega prehoda s citokromom P450 3A4.
The device should be cleaned after each use and the cap replaced.
Po vsaki uporabi je treba pršilnik očistiti in ga pokriti s pokrovčkom.
3 Hold the nasal spray upright, then tilt and point the nozzle away from you.
Držite pršilo za nos pokonci, potem ga nagnite in usmerite nastavek proč od sebe.
GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com Lietuva
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
Seasonal and perennial allergic rhinitis in children:
Sezonski in celoletni alergijski rinitis pri otrocih:
Driving and using machines Avamys is unlikely to affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Verjetnost vpliva zdravila Avamys na sposobnost upravljanja vozil in strojev je majhna.
Children and adolescents Do not use in children under 6 years old.
Tega zdravila ne uporabljajte pri otrocih, mlajših od 6 let.
• Never use a pin or anything sharp to clear the nozzle.
• Za čiščenje nastavka nikoli ne uporabite igle ali česa drugega ostrega.
It is recommended that the growth of children receiving prolonged treatment with nasal corticosteroids is regularly monitored.
Otrokom, ki dolgo časa prejemajo nazalne kortikosteroide, je priporočljivo redno kontrolirati rast.
• steroid creams
• kortikosteroidne kreme,
No genotoxic effects of fluticasone furoate have been observed in conventional genotoxicity tests.
Pri običajnih preskušanjih genotoksičnosti genotoksičnega delovanja flutikazonfuroata niso ugotovili.
Elderly Patients No dose adjustment is required in this population (see section 5.2).
Starejši bolniki Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5.2).