FrancophonIA/ELRC3.0 huggingface dataset:
English: Such transfer may also unmask pre-existing allergic conditions, such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
Croatian: U slučaju takvog prijelaza mogu doći do izražaja i postojeća alergijska stanja kao što su alergijski konjunktivitis i ekcem, koji su prethodno bili suprimirani tijekom sistemske kortikosteroidne terapije.
English: If you use steroids for a long time or in large amounts they may, rarely, affect some of your hormones.
Croatian: Dugotrajna ili uporaba velikih količina steroida rijetko može utjecati na neke od hormona.
English: There is no known information on the effect of Nasonex on the ability to drive or use machinery.
Croatian: Nema informacija o utjecaju lijeka Nasonex na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Prior to administration of the first dose, shake container well and actuate the pump 10 times (until a uniform spray is obtained).
Croatian: Prije primjene prve doze, spremnik treba dobro protresti i aktivirati pumpicu 10 puta (sve dok se ne postigne jednoliki mlaz).
English: “not known (cannot be estimated from the available data)”.
Croatian: Učestalost štetnih događaja nakon stavljanja u promet se smatra „nepoznatom (ne može se procijeniti iz dostupnih podataka)“.
English: There were also reductions in maternal body weight gains, effects on foetal growth (lower foetal body weight and/or delayed ossification) in rats, rabbits and mice, and reduced offspring survival in mice.
Croatian: Opažena su također smanjena dobivanja na tjelesnoj težini majki, učinci na fetalni rast (smanjena fetalna tjelesna težina i/ili odgođena osifikacija) u štakora, kunića i miševa te smanjeno preživljavanje potomstva miševa.
English: The European Medicines Agency has waived the obligation to submit the results of studies with NASONEX Nasal Spray and associated names in all subsets of the paediatric population in seasonal and perennial allergic rhinitis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja NASONEX spreja za nos i s njime povezanih naziva u svim podskupinama pedijatrijske populacije u sezonskom i cjelogodišnjem alergijskom rinitisu (vidjeti dio 4.2 za informacije o primjeni u pedijatrijskoj populaciji).
English: Nevertheless, patients using NASONEX Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa.
Croatian: Ipak, bolesnike koji koriste NASONEX sprej za nos tijekom nekoliko mjeseci ili dulje potrebno je periodički pregledati zbog mogućih promjena na sluznici nosa.
English: Use in adults over 18 years old
Croatian: Nosni polipi Primjena u odraslih starijih od 18 godina
English: Start to breathe in gently or slowly through your nose and whilst you are breathing in squirt a spray of fine mist into your nose by pressing down ONCE with your fingers.
Croatian: Počnite udisati kroz nos blago ili sporo, te dok udišete štrcnite jednolik mlaz u nos pritiskom prstima JEDNOM prema dolje.
English: If you do not start to feel any better, you should see your doctor and he or she may tell you to increase the dose; the maximum daily dose is four sprays into each nostril once a day.
Croatian: • Ukoliko se ne počnete bolje osjećati, posjetite svog liječnika, koji Vam može savjetovati da povećate dozu; maksimalna dnevna doza je 4 uštrcaja u svaku nosnicu jedanput na dan.
English: Mometasone furoate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in plasma, using a sensitive assay with a lower quantitation limit of 0.25 pg/ml.
Croatian: Mometazonfuroat, primijenjen kao vodeni sprej za nos, ima sistemsku bioraspoloživost od < 1% u plazmi, koristeći osjetljive testove s donjom kvantifikacijskom granicom od 0,25 pg/ml.
English: After initial priming of the NASONEX Nasal Spray pump, each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate.
Croatian: Nakon početnog aktiviranja pumpice NASONEX spreja za nos, svakim se uštrcajem oslobađa približno 100 mg suspenzije mometazonfuroata koja sadrži mometazonfuroat hidrat u količini koja odgovara 50 mikrograma mometazonfuroata.
English: You may also seem to develop other allergies, such as itchy, watering eyes or patches of red and itchy skin.
Croatian: Također se mogu javiti druge alergije kao što su svrbež očiju, suzenje očiju ili crvene mrlje i svrbež kože.
English: Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Croatian: Zbog inhibitornog učinka kortikosteroida na zacjeljivanje rana, bolesnici koji su nedavno imali operaciju ili ozljedu nosa ne smiju upotrebljavati nazalne kortikosteroide dok rana ne zacijeli.
English: When used at high doses for long periods of time, corticosteroid nasal sprays may cause certain sideeffects, such as slowed growth rate in children.
Croatian: Kad se primjenjuje u visokim dozama tijekom dugih razdoblja, kortikosteroidni sprejevi za nos mogu uzrokovati određene nuspojave, kao što je usporen rast u djece.
English: This medicinal product is authorised in the Member States of the EEA under the following names: [See Annex I - To be completed nationally]
Croatian: Ovaj lijek je odobren u državama članicama Europskog ekonomskog prostora (EEA) pod sljedećim nazivima: [Vidjeti Dodatak I - Ispunjava država članica]
English: The safety and efficacy of NASONEX Nasal Spray in children and adolescents under 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost NASONEX spreja za nos u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Treatment related adverse reactions (≥1%) reported in clinical trials in patients with allergic rhinitis or nasal polyposis and post-marketing regardless of indication are presented in Table 1.
Croatian: Nuspojave povezane s liječenjem (≥1%) prijavljene u kliničkim ispitivanjima u bolesnika s alergijskim rinitisom ili nosnom polipozom i nakon stavljanja u promet, bez obzira na indikaciju, prikazane su u Tablici
English: Although NASONEX Nasal Spray will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms.
Croatian: Iako će se NASONEX sprejem postići kontrola nazalnih simptoma u većine bolesnika, konkomitantna primjena odgovarajućeg dodatnog liječenja može pružiti dodatno ublažavanje drugih simptoma,
English: Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.
Croatian: Inhalacija ili peroralna primjena prekomjernih doza kortikosteroida može dovesti do supresije HHA osi.
English: However, some people, after using Nasonex or other corticosteroid nasal sprays, may find that they suffer from:
Croatian: Međutim, neki ljudi nakon primjene Nasonex spreja za nos ili drugih sprejeva za nos s kortikosteroidima mogu imati sljedeće:
English: In 28% of the patients with seasonal allergic rhinitis, NASONEX Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose.
Croatian: U 28% bolesnika sa sezonskim alergijskim rinitisom NASONEX sprej za nos pokazao je klinički značajan nastup djelovanja unutar 12 sati nakon prve doze.
English: Nasonex reduces the inflammation in the nose, causing the polyps to gradually shrink, thereby relieving a blocked feeling in the nose which may affect breathing through the nose.
Croatian: Nasonex smanjuje upalu u nosu te time uzrokuje postupno smanjenje polipa ublažavajući tako osjećaj začepljenosti nosa, koji može utjecati na disanje kroz nos.
English: Nasal polyps are small growths on the lining of the nose and usually affect both nostrils.
Croatian: Nosni polipi su male izrasline u sluznici nosa koje obično zahvaćaju obje nosnice.
English: Once symptoms are controlled, dose reduction to one actuation in each nostril (total dose 100 micrograms) may be effective for maintenance.
Croatian: Kada se simptomi stave pod kontrolu, smanjenje doze na jedan uštrcaj u svaku nosnicu (ukupna doza 100 mikrograma) može biti učinkovito u terapiji održavanja.
English: Elimination Absorbed mometasone furoate is extensively metabolized and the metabolites are excretedin urine and bile.
Croatian: Apsorbirani momtazonfuroat opsežno se metabolizira, a metaboliti se izlučuju mokraćom i u žuči.
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: Mogući sistemski učinci mogu uključivati Cushingov sindrom, Cushingoidna obilježja, supresiju nadbubrežne žlijezde, zastoj u rastu u djece i adolescenata, kataraktu, glaukom i rjeđe, niz psiholoških učinaka ili učinaka na ponašanje uključujući psihomotornu hiperaktivnost, poremećaje spavanja,
English: Remove the nozzle from this nostril and breathe out through the mouth.
Croatian: Izvadite mlaznicu iz nosnice te izdahnite kroz usta.
English: If you or your child suffer badly from hayfever, your doctor may tell you to start using Nasonex before the start of the pollen season, as this will help to prevent your hayfever symptoms from occurring.
Croatian: Ako Vi ili Vaše dijete imate težak oblik peludne groznice liječnik Vam može propisati primjenu lijeka Nasonex prije početka sezone cvjetanja jer će se time spriječiti javljanje simptoma peludne groznice.
English: There are limited data available on the safety and efficacy of NASONEX Nasal Spray in the paediatric population aged 3 to 5 years, and an appropriate dosage range cannot be established.
Croatian: S obzirom na to da su dostupni podaci o sigurnosti i djelotvornosti primjene NASONEX spreja za nos u pedijatrijskoj populaciji od 3 do 5 godina starosti ograničeni, nije moguće utvrditi odgovarajući raspon doziranja.
English: Efficacy and Safety studies of NASONEX Nasal Spray for the treatment of nasal polyposis were four months in duration.
Croatian: Ispitivanja djelotvornosti i sigurnosti NASONEX spreja za nos u liječenju nosne polipoze trajale su četiri mjeseca.
English: Like other glucocorticoids, mometasone furoate showed a clastogenic potential in-vitro at high concentrations.
Croatian: Poput ostalih glukokortikosteroida, mometazonfuroat je pokazao klastogeni učinak in vitro u visokim koncentracijama.
English: As with other nasal corticosteroid preparations, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from NASONEX Nasal Spray therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Kao i s drugim nazalnim kortikosteroidnim pripravcima, mora se odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja NASONEX sprejem za nos uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: (Figure 2) Tilt your head forward slightly, keeping the bottle upright.
Croatian: Malo nagnite glavu naprijed držeći bocu uspravno.
English: What Nasonex is and what it is used for
Croatian: Što je lijek Nasonex i za što se koristi
English: Typical glucocorticoid-related effects, including several non-neoplastic lesions, were observed.
Croatian: Zabilježeni su tipični učinci vezani za glukokortikosteroide, uključujući nekoliko neneoplastičnih lezija.
English: Biotransformation The small amount that may be swallowed and absorbed undergoes extensive first-pass hepatic metabolism.
Croatian: Mala količina koja se može progutati i apsorbirati podliježe opsežnom metabolizmu prvog prolaska kroz jetru.
English: The safety and efficacy of NASONEX Nasal Spray has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities.
Croatian: Sigurnost i djelotvornost NASONEX spreja za nos nije ispitivana u liječenju unilateralnih polipa, polipa povezanih s cističnom fibrozom ili polipa koji potpuno zatvaraju nosne šupljine.
English: If you forget to use your nasal spray at the right time, use it as soon as you remember, then carry on as before.
Croatian: Ako ste zaboravili primijeniti Nasonex Ako ste zaboravili primijeniti sprej za nos u propisano vrijeme, uzmite dozu čim se sjetite, zatim nastavite s liječenjem kao i obično.
English: Tell your doctor if you accidentally use more than you were told.
Croatian: Obavijestite liječnika ukoliko ste slučajno primijenili više lijeka od propisanog.
English: NASONEX Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, or systemic viral infections.
Croatian: NASONEX sprej za nos se mora oprezno primjenjivati, ili uopće ne primjenjivati, u bolesnika s aktivnom ili latentnom tuberkuloznom infekcijom respiratornog trakta te u slučaju neliječenih gljivičnih, bakterijskih ili sistemskih virusnih infekcija.
English: Close one nostril and put the nozzle into the other nostril as shown.
Croatian: Zatvorite jednu nosnicu te stavite mlaznicu u drugu nosnicu kao što je prikazano (Slika 2).
English: Treatment with NASONEX Nasal Spray may need to be initiated some days before the expected start of the pollen season in patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis.
Croatian: Liječenje s NASONEX sprejem za nos možda će trebati započeti nekoliko dana prije očekivanog početka peludne sezone u bolesnika koji u anamnezi imaju umjerene do jake simptome sezonskog alergijskog rinitisa.
English: What Nasonex looks like and contents of the pack Nasonex is a nasal spray suspension.
Croatian: Kako Nasonex izgleda i sadržaj pakiranja Nasonex je sprej za nos u obliku suspenzije.
English: It is recommended that the height of children receiving long-term treatment with nasal corticosteroids is regularly monitored and if any changes are noted, their doctor should be notified.
Croatian: Preporučuje se redovito mjeriti tjelesnu visinu djece koja se dugotrajno liječe kortikosteroidima s primjenom u nos i obavijestiti liječnika ako se opaze ikakve promjene.
English: Point the nozzle away from you and then press down with your fingers to pump the spray 10 times until a fine mist is produced.
Croatian: Mlaznicu usmjerite od sebe i zatim prstima pritisnite prema dolje kako bi sprej štrcnuo 10 puta sve dok se ne postigne jednolik mlaz.
English: What you need to know before you use Nasonex
Croatian: Što morate znati prije nego počnete primjenjivati lijek Nasonex
English: This has been demonstrated by decreases (vs placebo) in histamine and eosinophil activity and reductions (vs baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins.
Croatian: To je dokazano smanjenjem (naspram placeba) aktivnosti histamina i eozinofila te smanjenjem (naspram početnih vrijednosti) broja eozinofila, neutrofila i proteina za adheziju epitelnih stanica.
English: If localised fungal infection of the nose or pharynx develops, discontinuance of NASONEX Nasal Spray therapy or appropriate treatment may be required.
Croatian: Ukoliko se razvije lokalna gljivična infekcija nosa ili ždrijela, može biti potrebno prekinuti primjenu NASONEX spreja za nos ili provesti odgovarajuće liječenje.
English: Distribution Not applicable as mometasone is poorly absorbed via the nasal route.
Croatian: Nije primjenjivo jer se mometazon slabo apsorbira nazalnim putem.
English: In studies of reproductive function, subcutaneous mometasone furoate, at 15 micrograms/kg prolonged gestation and prolonged and difficult labour occurred with a reduction in offspring survival and body weight or body weight gain.
Croatian: ispitivanjima reproduktivne funkcije, mometazonfuroat primijenjen supkutano, u dozi od 15 mikrograma/kg dovodi do produženja gestacije te produženog i otežanog porođaja, smanjenog preživljenja potomstva te smanjene porođajne težine i smanjenog dobivanja na težini.
English: When mometasone furoate is sprayed into the nose, it can help to relieve inflammation (swelling and irritation of the nose), sneezing, itching and a blocked up or runny nose.
Croatian: Kada se mometazonfuroat uštrca u nos, može pomoći u ublažavanju upale (otoka i nadraženosti nosa), kihanja, svrbeža te začepljenosti ili curenja nosa.
English: If you are using the spray for the first time you need to ‘prime' the bottle by pumping the spray 10 times until a fine mist is produced:
Croatian: Ukoliko po prvi put koristite sprej trebate prvo "pripremiti" bocu za primjenu tako da štrcnete 10 puta u zrak sve dok se ne postigne jednolik mlaz:
English: In patients treated for nasal polyposis, the overall incidence of adverse events was similar to that observed for patients with allergic rhinitis.
Croatian: U bolesnika liječenih zbog nosne polipoze, ukupna incidencija štetnih događaja bila je slična onoj zapaženoj u bolesnika s alergijskim rinitisom.
English: Like other glucocorticoids, mometasone furoate is a teratogen in rodents and rabbits.
Croatian: Poput ostalih glukokortikosterida, mometazonfuroat je teratogen u glodavaca i kunića.
English: Other medicines and Nasonex Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Seasonal Allergic or Perennial Rhinitis
Croatian: Sezonski alergijski ili cjelogodišnji rinitis
English: Nasonex Nasal Spray contains mometasone furoate, one of a group of medicines called corticosteroids.
Croatian: Nasonex sprej za nos sadrži mometazonfuroat koji pripada skupini lijekova koji se nazivaju kortikosteroidi.
English: How to use your nasal spray
Croatian: Kako koristiti sprej za nos
English: Your Nasonex Nasal Spray has a dust cap which protects the nozzle and keeps it clean.
Croatian: Nasonex sprej za nos sadrži zatvarač koji štiti mlaznicu i održava je čistom.
English: Common side effects (may affect up to 1 in 10 people): headache sneezing nose bleeds [occurred very commonly (may affect more than1 in 10 people) in people with nasal polyps receiving Nasonex two sprays in each nostril twice a day] sore nose or throat ulcers in the nose respiratory tract infection
Croatian: • krvarenje iz nosa [javlja se vrlo često (može se javiti u više od 1 na 10 osoba) u ljudi s nosnim polipima koji primaju Nasonex u dozi od dva uštrcaja u svaku nosnicu dvaput na dan]
English: No toxicological effects unique to mometasone furoate exposure were demonstrated.
Croatian: Nisu pokazani jedinstveni toksikološki učinci mometazonfuroata.
English: You should not use the nasal spray until your nose has healed.
Croatian: Ne smijete započeti s primjenom spreja za nos sve dok rana ne zacijeli.
English: Wash the nozzle and dust cap in warm water and then rinse under a running tap.
Croatian: • Operite mlaznicu i zatvarač u toploj vodi te zatim isperite u mlazu vode.
English: Seasonal Allergic Rhinitis and Perennial Rhinitis The safety and efficacy of NASONEX Nasal Spray in children under 3 years of age have not been established.
Croatian: Sezonski alergijski rinitis i cjelogodišnji rinitis Sigurnost i djelotvornost NASONEX spreja za nos u djece mlađe od 3 godine nisu ustanovljene.
English: Hayfever, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds and also moulds and fungal spores.
Croatian: Peludna groznica je alergijska reakcija koja se javlja u određeno doba godine te je uzrokovana udisanjem peludi drveća, trava, korova i također pljesni ili spora gljivica.
English: It is not known if mometasone furoate is found in breast milk.
Croatian: Nije poznato izlučuje li se mometazonfuroat u majčino mlijeko.
English: In some patients Nasonex should begin to relieve symptoms 12 hours after the first dose; however full benefit of treatment may not be seen for up to two days.
Croatian: Nasonex je pokazao da do ublažavanja simptoma dolazi već unutar 12 sati nakon prve doze; međutim, potpuno djelovanje lijeka možda će se postići tek za dva dana.
English: • 4.2 Posology and method of administration
Croatian: 4.2 Doziranje i način primjene
English: Adults (including older patients) and children 12 years of age and older: The usual recommended dose is two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms).
Croatian: Odrasli (uključujući starije bolesnike) i djeca u dobi od 12 godina i starija: uobičajena preporučena doza je dva uštrcaja (50 mikrograma/uštrcaj) u svaku nosnicu jedanput na dan (ukupna doza 200 mikrograma).
English: If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, the patient should be re-evaluated and treatment strategy reconsidered.
Croatian: Ukoliko nakon 5 do 6 tjedana primjene od dvaput na dan ne dođe do poboljšanja simptoma, bolesnika treba ponovno pregledati i ponovno razmotriti plan liječenja.
English: If you stop using Nasonex
Croatian: Ako prestanete primjenjivati Nasonex
English: Persistence of nasopharyngeal irritation may be an indication for discontinuing NASONEX Nasal Spray.
Croatian: Trajna iritacija nosa i ždrijela može biti indikacija za prestanak primjene NASONEX spreja za nos.
English: NASONEX Nasal Spray is indicated for use in adults and children 3 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.
Croatian: NASONEX sprej za nos je indiciran za primjenu u odraslih i djece u dobi od 3 godine i starijih za liječenje simptoma sezonskog alergijskog rinitisa ili cjelogodišnjeg rinitisa.
English: If you develop any of these effects, you should contact your doctor.
Croatian: Ako se javi bilo koja od ovih nuspojava, obratite se svom liječniku.
English: Once symptoms are under control, your doctor may advise you to decrease your dose.
Croatian: Kada se simptomi ublaže, liječnik Vam može savjetovati da smanjite dozu.
English: Use of Nasonex during an untreated infection in your nose, such as herpes, can worsen the infection.
Croatian: Vašem nosu, kao što je herpes, može pogoršati infekciju.
English: There is little or no information on the use of Nasonex in pregnant women.
Croatian: Nema podataka ili ima malo podataka o primjeni lijeka Nasonex u trudnica.
English: While you are using Nasonex, talk to your doctor if your immune system is not functioning well (if you have difficulty in fighting infection) and you come into contact with anyone with measles or chickenpox.
Croatian: • Ako Vam imunološki sustav ne funkcionira dobro (ako se otežano borite protiv infekcije), a bili ste u kontaktu s osobom koja ima ospice ili vodene kozice.
English: A few people may find that once they discontinue oral or injected corticosteroids they suffer from some undesirable effects, such as joint or muscular pain, weakness and depression.
Croatian: Mali broj ljudi može imati neke nuspojave nakon što su prekinuli uzimanje kortikosteroida na usta ili injekcijom, kao što su bol u zglobovima ili mišićima, slabost i depresija.
English: Allow the dust cap and nozzle to dry in a warm place.
Croatian: • Ostavite zatvarač i mlaznicu na toplom mjestu da se osuše.
English: Shake the bottle gently and remove the dust cap. (Figure 1) Gently blow your nose.
Croatian: Nježno protresite bocu i uklonite zatvarač (Slika 1).
English: Remember to take this off before using the spray and to replace it after use.
Croatian: Uvijek se sjetite skinuti zatvarač prije primjene te ga vratiti nakon primjene.
English: In studies utilising nasal antigen challenge, NASONEX Nasal Spray has shown anti-inflammatory activity in both the early- and late- phase allergic responses.
Croatian: U ispitivanjima u kojima su primjenjivani nazalni antigeni, NASONEX sprej za nos pokazao je protuupalnu aktivnost i kod ranog i kod kasnog odgovora na alergiju.