FrancophonIA/ELRC3.0 huggingface dataset:
English: Increasing use of bronchodilators, in particular short-acting inhaled beta 2-agonists to relieve symptoms indicates deterioration of asthma control.
Croatian: Povećana učestalost primjene bronhodilatatora, posebice inhalacijskih kratkodjelujućih beta 2-agonista za trenutno ublažavanje simptoma, upućuje na slabljenje kontrole astme.
English: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored.
Croatian: Preporučuje se redovito kontrolirati visinu djece koja se dugotrajno liječe inhalacijskim kortikosteroidima.
English: Use of {INVENTED NAME} with ultrasonic nebulisers is not recommended because it doesn't allow a correct administration of the medicinal product.
Croatian: Primjena lijeka {NOVOIZUMLJENO IME} uz pomoć ultrazvučnih atomizatora se ne preporučuje jer ne omogućuje pravilnu primjenu lijeka.
English: Treatment with {INVENTED NAME} may continue at the lowest dose at which effective control of disease (asthma or wheezing) is maintained (see section 4.4).
Croatian: Liječenje lijekom {NOVOIZUMLJENO IME} može se nastaviti najnižom dozom koja održava učinkovitu kontrolu bolesti (astmu ili zviždanje u plućima) (vidjeti dio 4.4).
English: The main product of metabolism is the active metabolite (B17MP).
Croatian: Glavni produkt metabolizma je aktivni metabolit (B17MP).
English: ONLY sterile sodium chloride 9 mg/ml (0.9%) solution should be used.
Croatian: Treba koristiti SAMO sterilnu otopinu natrijeva klorida od 9 mg/ml (0,9 %).
English: Reduction or withdrawal of oral corticosteroid therapy may unmask clinical features of Churg-Strauss syndrome and hyper eosinophilic state.
Croatian: Smanjenje ili ukidanje terapije oralnim kortikosteroidima može razotkriti kliničku sliku Churg-Straussovog sindroma i stanja hipereozinofilije.
English: Special care is needed in patients with viral, bacterial and fungal infections of the eye or of the mouth or respiratory tract.
Croatian: Posebna briga potrebna je u bolesnika s virusnim, bakterijskim i gljivičnim infekcijama oka, usta ili dišnog sustava.
English: The dose of nebuliser suspension may need to be diluted in order to obtain a final volume suitable for the particular nebuliser being used, to aid administration of small volumes or if a prolonged delivery time is desirable.
Croatian: Dozu suspenzije za atomizator može biti potrebno razrijediti kako bi se postigao konačan volumen za određeni atomizator koji se koristi, kako bi se olakšala primjena malih volumena ili ako je potrebno produljeno vrijeme udisanja lijeka.
English: The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for BDP and B17MP respectively.
Croatian: Apsolutna bioraspoloživost nakon inhalacije je približno 2 % nominalne doze za BDP odnosno 62 % za B17MP.
English: What {INVENTED NAME} contains
Croatian: Što {NOVOIZUMLJENO IME} sadrži
English: BDP is cleared very rapidly from the systemic circulation, by metabolism mediated via esterase enzymes that are found in most tissues.
Croatian: BDP se vrlo brzo uklanja iz sistemske cirkulacije zbog metabolizma posredovanog enzimima esterazama koje se nalaze u većini tkiva.
English: No specific studies have been performed with beclometasone dipropionate with regard to the safety in human fertility.
Croatian: Nisu provedena specifična ispitivanja beklometazondipropionata s obzirom na sigurnost primjene lijeka za plodnost u ljudi.
English: Tell your doctor as soon as possible if you suffer from any of these side effects but do not stop treatment unless told to do so.
Croatian: Ako Vam se javi bilo koja od ovih nuspojava obratite se svom liječniku što je prije moguće, ali nemojte prekidati liječenje osim ako Vam to nije rečeno.
English: • If you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6.
Croatian: Nemojte primjenjivati {NOVOIZUMLJENO IME}: • ako ste alergični na djelatnu tvar ili neki drugi sastojak ovog lijeka naveden u dijelu 6.
English: Paradoxical bronchospasm may occur with an immediate increase in wheezing, shortness of breath and cough after dosing.
Croatian: Može se javiti paradoksalni bronhospazam s trenutnim pojačanjem zviždanja u plućima, nedostatkom zraka i kašljem nakon primjene doze.
English: It belongs to a group of medicines called corticosteroids which have an anti-inflammatory action reducing the swelling and irritation in the walls of the airways (e.g. nose, lungs), and so ease breathing problems.
Croatian: On pripada skupini lijekova koji se nazivaju kortikosteroidi, koji imaju protuupalno djelovanje te smanjuju oticanje i nadražaj stijenki dišnih putova (npr. nosa, pluća) i na taj način olakšavaju poteškoće s disanjem.
English: Vigorously shake and turn the ampoule upside-down in order to make the suspension homogeneous.
Croatian: Snažno protresite i okrećite ampulu gore-dolje kako bi suspenzija postala homogena.
English: Gargling with water immediately after inhalation may help to prevent this effect.
Croatian: Grgljanje vode odmah nakon inhalacije može pomoći u prevenciji ove nuspojave.
English: The potency of B17MP is approximately 30-fold higher than the parent compound.
Croatian: Metabolit B17MP ima približno 30 puta veću potentnost od ishodišnog spoja.
English: Preclinical toxic effects of beclometasone dipropionate were confined to those associated with overstimulation of the recognised pharmacological action.
Croatian: Neklinički toksični učinci beklometazondipropionata bili su ograničeni na one povezane s pretjeranim poznatim farmakološkim djelovanjem.
English: Immediately after inhalation the mouth should be rinsed with water to reduce the frequency of fungal infections in the mouth.
Croatian: Neposredno nakon inhalacije, potrebno je isprati usta vodom kako bi se smanjila učestalost gljivične infekcije usta.
English: Therefore the majority of the effect is related to B17MP systemic exposure.
Croatian: Zbog toga je glavnina učinka povezana sa sistemskom izloženošću metabolitu B17MP.
English: In the study 40.4% and 51.7% patients in the of nebulised beclometasone dipropionate and budesonide groups respectively did not experience any major exacerbation (primary endpoint).
Croatian: U tom ispitivanju 40,4 % bolesnika u skupini koja je primala beklometazondiproprionat suspenziju u atomizatoru i 51,7 % bolesnika u skupini koja je primala budesonid nisu imali velike egzacerbacije (primarni ishod).
English: Such patients should be encouraged to continue treatment with beclometasone dipropionate by inhalation and withdrawal of the systemic corticosteroid, unless objective clinical signs of adrenal impairment are present.
Croatian: Takve bolesnike treba potaknuti da nastave liječenje inhalacijom beklometazondipropionata i ukidanje sistemskih kortikosteroida, osim ako se ne pojave objektivni klinički znakovi oštećenja adrenalne funkcije.
English: The most common adverse reactions observed during clinical trials using inhaled beclometasone in the treatment of asthma and wheezing were laryngitis, pharyngitis and oral candidiasis.
Croatian: Najčešće nuspojave opažene tijekom kliničkih ispitivanja u kojima se u liječenju astme i zviždanja u plućima koristio inhalacijski beklometazon bile su laringitis, faringitis i oralna kandidijaza.
English: Tell your doctor if you are taking other corticosteroid medications as they may interact with {INVENTED NAME} and could make any side effects worsening.
Croatian: Obavijestite svog liječnika ako uzimate neki drugi kortikosteroid jer može doći do interakcije s lijekom {NOVOIZUMLJENO IME} što može pogoršati nuspojave.
English: Following inhalation, systemic absorption of unchanged BDP occurs mainly through the lungs with negligible oral absorption of the swallowed dose.
Croatian: Nakon inhalacije, do sistemske apsorpcije nepromijenjenog BDP-a dolazi uglavnom u plućima, sa zanemarivom oralnom apsorpcijom iz progutanog dijela doze.
English: This affection generally responds to a suitable topical antimycotic therapy, without discontinuing the treatment with beclometasone dipropionate.
Croatian: Ova infekcija općenito odgovara na prikladnu topikalnu terapiju antimikoticima, bez prekida liječenja beklometazondipropionatom.
English: Bend the ampoule backwards and forwards (Figure A).
Croatian: Savijte ampulu natrag i naprijed (slika A).
English: The manufacturer's instructions for use, maintenance and cleaning of the nebuliser must be followed.
Croatian: Za uporabu, održavanje i čišćenje atomizatora moraju se slijediti upute proizvođača.
English: Efficacy and safety of nebulised beclometasone dipropionate in the treatment of severe persistent asthma in infants and young children aged 6 months to 6 years, in comparison to budesonide suspension for nebulization was assessed in a multicentre, randomized, controlled open-labelled study for 14 weeks.
Croatian: Djelotvornost i sigurnost beklometazondiproprionat suspenzije u atomizatoru u liječenju teške perzistirajuće astme u dojenčadi i male djece u dobi od 6 mjeseci do 6 godina, u usporedbi s suspenzije budesonida za atomizator ocijenjene su u multicentričnom, randomiziranom, kontroliranom, otvorenom ispitivanju u trajanju od 14 tjedana.
English: In this case, the content of the ampoule should be emptied into the nebuliser bowl.
Croatian: U tom slučaju, sadržaj ampule treba isprazniti u spremnik atomizatora.
English: The possible benefits of inhaled beclometasone dipropionate for the mother must be weighed against the possible risk for the fetus or neonate.
Croatian: Mora se ocijeniti omjer mogućih koristi inhalacijskog beklometazondipropionata za majku i mogućih rizika za fetus ili novorođenče.
English: However, if high dose inhaled beclometasone dipropionate is used it is recommended to avoid breast-feeding for 4 h after administration.
Croatian: Međutim, ako se primjenjuje velika doza inhalacijskog beklometazondipropionata, preporučuje se izbjegavati dojenje četiri sata nakon primjene.
English: Comparable efficacy in controlling asthma was demonstrated by the two treatments at study end in terms of pulmonary function tests, asthma exacerbations, symptoms and the use of rescue salbutamol (Terzano et al., 2003).
Croatian: Dva su liječenja na kraju ispitivanja pokazala usporedivu djelotvornost u kontroli astme u smislu testova plućne funkcije, egzacerbacija astme, simptoma i upotrebe salbutamola za hitno ublažavanje simptoma (Terzano et al., 2003).
English: After inhaling the prescribed dose patients should rinse their mouth with water to minimise the risk of oropharyngeal thrush (see section 4.4).
Croatian: Nakon inhalacije propisane doze, bolesnici trebaju isprati usta vodom kako bi se rizik od orofaringealne kandidijaze sveo na najmanju moguću mjeru (vidjeti dio 4.4).
English: Normally, a daily dose of 3200 micrograms in adults and adolescents and 1600 micrograms in children up to 11 years of age should not be exceeded.
Croatian: U pravilu se dnevna doza od 3200 mikrograma u odraslih i adolescenata i 1600 mikrograma u djece do
English: The bioavailability of orally administered BDP is negligible but pre-systemic conversion to B17MP results in absorption of approximately 40% of the swallowed portion as B17MP.
Croatian: Bioraspoloživost oralno primijenjenog BDP-a je zanemariva, ali predsistemska konverzija u B17MP rezultira apsorpcijom približno 40 % progutanog dijela u obliku B17MP.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati CLENIL Lijek čuvajte izvan pogleda i dohvata djece.
English: Do not use {INVENTED NAME} after the expiry date which is stated on the carton, pouch and ampoule.
Croatian: {NOVOIZUMLJENO IME} se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, vrećici i ampuli.
English: Patients with adrenal suppression are steroid dependent and have to be treated accordingly with supplementary systemic glucocorticosteroids.
Croatian: Bolesnici s adrenalnom supresijom ovisni su o steroidima te ih treba odgovarajuće liječiti nadomjesnim sistemskim glukokortikoidima.
English: Beclometasone dipropionate undergoes a very rapid pre-systemic metabolism via esterase enzymes without involvement of cytochrome P450 system.
Croatian: Beklometazondipropionat podliježe vrlo brzom predsistemskom metabolizmu putem enzima esteraza bez uključivanja sustava citokroma P450.
English: The 800 micrograms ampoule has a graduation mark to indicate half the content (corresponding to 400 micrograms).
Croatian: Ampula od 800 mikrograma ima oznaku gradacije radi označavanja polovice sadržaja (što odgovara 400 mikrograma).
English: In children with recurrent wheezing, if no treatment benefit of is observed within 2-3 months, {INVENTED NAME} should be discontinued.
Croatian: Ako se u djece s rekurentnim zviždanjem u plućima u roku od 2-3 mjeseca ne primijeti korist od liječenja, liječenje lijekom {NOVOIZUMLJENO IME} treba obustaviti.
English: Bend the ampoule backwards and forwards to loosen it from the strip (Figure A).
Croatian: Savijte ampulu natrag i naprijed kako bi se odvojila od stripa (slika A).
English: Incorrect use of the nebuliser device could lead to incorrect dosing of the medicinal product.
Croatian: Nepravilna uporaba atomizatora može dovesti do netočnog doziranja lijeka.
English: Switching from corticosteroid tablets to {INVENTED NAME} Switching from corticosteroid tablets to an inhaled corticosteroid treatment might make you feel generally unwell or you might develop a rash, eczema or a runny nose and sneezing (rhinitis).
Croatian: Prelazak s tableta kortikosteroida na {NOVOIZUMLJENO IME} Zbog prelaska s tableta kortikosteroida na liječenje inhalacijskim kortikosteroidima mogli biste se općenito loše osjećati ili bi Vam se mogao javiti osip, ekcem ili curenje nosa i kihanje (rinitis).
English: Although results of animal studies have shown some impaired fertility, this occurs at high doses levels.
Croatian: Iako su rezultati ispitivanja na životinjama pokazali nešto oštećenu plodnost,
English: A study in which the objective was to compare the efficacy and safety of nebulised beclometasone dipropionate versus fluticasone propionate suspension for nebulization was conducted in 205 adults patients aged 18-65 years with asthma randomized to a 12-week treatment period.
Croatian: Ispitivanje u kojem je cilj bio usporediti djelotvornost i sigurnost beklometazondipropionat suspenzije u atomizatoru naspram suspenzije flutikazonpropionata za atomizator, provedeno je na 205 odraslih bolesnika u dobi od 18 do 65 godina s astmom koji su randomizirani na razdoblje liječenja u trajanju od 12 tjedana.
English: Throat irritation, hoarseness, dysphonia, paradoxical bronchospasm, wheezing
Croatian: Često iritacija grla, promuklost, disfonija, paradoksalni bronhospazam,
English: Strips of 5 ampoules are packed in a heat sealed pouch of PET/Al/PE (Polyethylene Terephthalate/Aluminium/Polyethylene).
Croatian: Stripovi od po 5 ampula pakirani su u PET/Al/PE (polietilentereftalat/aluminij/polietilen) vrećici.
English: Systemic effect of inhaled corticosteroids (including beclometasone dipropionate) may occur particularly when administered at high doses for prolonged periods of time: these may include adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma (see section 4.4).
Croatian: Sistemski učinci inhalacijskih kortikosteroida (uključujući beklometazondipropionat) mogu se posebice javiti pri primjeni visokih doza tijekom duljih razdoblja i mogu uključivati adrenalnu supresiju, smanjenje mineralne gustoće kostiju, usporavanje rasta u djece i adolescenata, kataraktu i glaukom (vidjeti dio 4.4).
English: It is important that your nebuliser is kept clean.
Croatian: Važno je održavati čistoću atomizatora.
English: Comparable improvements over baseline were reported at study end for the two treatment groups in morning pulmonary expiratory flow rate (primary endpoint), clinical symptoms scores and the use of rescue salbutamol.
Croatian: Usporediva poboljšanja u odnosu na početno stanje prijavljena su na kraju ispitivanja za dvije liječene skupine, u rezultatima jutarnjeg plućnog izdisajnog protoka (primarni ishod), rezultatima kliničkih simptoma i upotrebi salbutamola za hitno ublažavanje simptoma.
English: *Rare
Croatian: *Rijetko
English: Place the mask or mouth piece
Croatian: Namjestite masku ili nastavak za usta.
English: However, possible effects on foetal development after high dose inhaled beclometasone dipropionate therapy could not be excluded.
Croatian: Međutim, ne mogu se isključiti mogući učinci na razvoj fetusa nakon terapije visokom dozom inhalacijskog beklometazondipropionata.
English: Possible systemic effects include hypothalamic-pituitary-adrenal (HPA)-axis suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and 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 uključuju supresiju osovine hipotalamus-hipofiza nadbubrežna žlijezda (HPA osovina), usporavanje rasta u djece i adolescenata, smanjenje mineralne gustoće kostiju, kataraktu i glaukom te, rjeđe, cijeli raspon psiholoških ili bihevioralnih učinaka uključujući psihomotornu hiperaktivnost, poremećaje spavanja, anksioznost, depresiju ili agresiju
English: Minor inactive metabolites, beclometasone-21-monopropionate (B21MP) and beclometasone (BOH), are also formed but these contribute little to the systemic exposure.
Croatian: beklometazon-21-monopropionat (B21MP) i beklometazon (BOH) također nastaju, ali je njihov doprinos sistemskoj izloženosti malen.
English: The renal excretion of BDP and its metabolites is negligible, faecal excretion is the major route of BDP elimination mainly as polar metabolites.
Croatian: Izlučivanje BDP-a i njegovih metabolita putem bubrega je zanemarivo, glavni put eliminacije BDP-a je izlučivanje fecesom, uglavnom u obliku polarnih metabolita.
English: In addition, the duration of treatment of recurrent wheezing should not exceed 3 months, unless diagnosis of asthma is likely to avoid an unnecessary longterm exposure (see section 4.4).
Croatian: Nadalje, kako bi se izbjegla nepotrebna dugotrajna izloženost lijeku, trajanje liječenja rekurentnog zviždanja u plućima ne smije biti dulje od 3 mjeseca, osim ako je vjerojatna dijagnoza astme (vidjeti dio 4.4).
English: Regular nebulised beclometasone dipropionate plus rescue salbutamol significantly increased the percentage of symptom-free days (primary endpoint, defined as a lack of wheezing, coughing, shortness of breath and patients/parents nocturnal awakenings in 24 h) (69.6 ± 20.89 [SD]; P = 0.034) vs placebo/rescue salbutamol (61.0 ± 24.83 [SD]) but not vs combination nebulised beclometasone dipropionate /rescue salbutamol (64.9 ± 24.74 [SD]) regardless of the presence of risk factors for developing asthma.
Croatian: nedostatka zraka te izostanak noćnog buđenja bolesnika/roditelja u 24 sata) (69,6 ± 20,89 [SD]; P = 0,034) u odnosu na placebo /salbutamol za hitno ublažavanje simptoma (61.0 ± 24,83 [SD]) ali ne i u odnosu na kombinaciju beklometazondiproprionat suspenzije u atomizatoru /salbutamola za hitno ublažavanje simptoma (64,9 ± 24,74 [SD]) bez obzira na prisutnost čimbenika rizika za razvoj astme.
English: • throat irritation, hoarse voice
Croatian: • nadraženost grla, promukao glas
English: The use of beclometasone dipropionate nebuliser suspension in doses exceeding those recommended over a long period of time could lead to the suppression of hypothalamic-pituitary-adrenal (HPA)-axis function.
Croatian: Primjena beklometazondipropionat suspenzije za atomizator u dozama koje premašuju preporučene, tijekom duljeg vremenskog razdoblja, može dovesti do supresije funkcije osovine hipotalamus hipofiza-nadbubrežna žlijezda (HPA osovina).
English: {INVENTED NAME} should be administered preferably via jet nebuliser and the compressor equipped with the mouthpiece or suitable face mask.
Croatian: {NOVOIZUMLJENO IME} je najbolje primijeniti uz pomoć atomizatora s mlaznicom i kompresorom koji je opremljen nastavkom za usta ili odgovarajućom maskom za lice.
English: * from spontaneous reporting **systemic effects of inhaled corticosteroids
Croatian: **sistemski učinci inhalacijskih kortikosteroida
English: In addition, the time to first exacerbation was longer in children treated with nebulised beclometasone dipropionate.
Croatian: Uz to, vrijeme do prve egzacerbacije bilo je dulje u djece koja su liječena beklometazondiproprionat suspenzijom u atomizatoru.
English: If you develop an immediate increase in wheezing, shortness of breath and cough after using {INVENTED NAME}, you should discontinued immediately {INVENTED NAME} and you should contact your doctor.
Croatian: Ako odmah nakon primjene lijeka {NOVOIZUMLJENO IME} dođe do pojačanog zviždanja u plućima, nedostatka zraka i kašlja, trebate odmah prestati primjenjivati {NOVOIZUMLJENO IME} i obratiti se svom liječniku.
English: Nevertheless, as precautionary measure when high doses of beclometasone dipropionate are inhaled you should avoid breast-feeding for 4 h after administration.
Croatian: Ipak, kao mjera opreza kad se inhaliraju velike doze beklometazondipropionata, izbjegavajte dojiti četiri sata nakon primjene.
English: {INVENTED NAME} nebuliser suspension comes in polyethylene ampoules containing 1 ml ({INVENTED NAME} 400 micrograms) or 2 ml ({INVENTED NAME} 800 micrograms).
Croatian: {NOVOIZUMLJENO IME} suspenzija za atomizator dolazi u polietilenskim ampulama koje sadrže 1 ml ({NOVOIZUMLJENO IME} 400 mikrograma) ili 2 ml ({NOVOIZUMLJENO IME} 800 mikrograma) suspenzije.
English: In case of asthma disease, {INVENTED NAME} must be used regularly on a daily basis.
Croatian: Ako se radi o astmi, {NOVOIZUMLJENO IME} se mora primjenjivati redovito na dnevnoj bazi.
English: Vigorously shake and turn the ampoule upside-down in order to mix the suspension.
Croatian: Snažno protresite i okrećite ampulu gore-dolje kako bi suspenzija promiješala.
English: The following effects may also occur more likely in children • Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable
Croatian: • problemi sa spavanjem, depresija ili osjećaj zabrinutosti, nemira, nervoze, pretjerane uzbuđenosti ili razdražljivosti
English: Patients suffering from tuberculosis should receive tuberculostatic therapy while being treated with beclometasone propionate.
Croatian: Bolesnici oboljeli od tuberkuloze tijekom liječenja beklometazondipropionatom trebaju primati i terapiju tuberkulostaticima.
English: • nausea (feeling sick) and stomach pains.
Croatian: • mučnina i bolovi u trbuhu.
English: Beclometasone dipropionate is a glucocorticoid with potent anti-inflammatory activity with limited mineralocorticoid activity; following administration to the respiratory system by inhalation a local effect in the lower respiratory tract is obtained.
Croatian: Beklometazondipropionat je glukokortikoid sa snažnom protuupalnom aktivnošću i ograničenom mineralokortikoidnom aktivnošću; nakon primjene inhalacijom u dišni sustav postiže se lokalni učinak u donjem dišnom sustavu.
English: No harmful effects on the suckling infants have been reported for glucocorticoids.
Croatian: Nisu prijavljeni štetni učinci glukokortikoida na dojenčad.
English: Use of {INVENTED NAME} with ultrasonic nebulisers is not recommended.
Croatian: Primjena lijeka {NOVOIZUMLJENO IME} uz pomoć ultrazvučnih atomizatora se ne preporučuje.
English: Gently squeeze the ampoule content into the nebuliser chamber (Figure E).
Croatian: Nježno istisnite sadržaj ampule u komoru atomizatora (slika E).
English: Urinary cortisol and the time course of height and weight were unaffected by both treatments and of nebulised beclometasone dipropionate confirmed to have a neutral effect on bone metabolism (Delacourt et al., 2003).
Croatian: Nijedno liječenje nije utjecalo na kortizol u mokraći, ni na promjenu visine i tjelesne težine tijekom vremena te je potvrđeno da beklometazondiproprionat suspenzija u atomizatoru ima neutralni učinak na metabolizam kosti (Delacourt et al., 2003).