FrancophonIA/ELRC3.0 huggingface dataset:
English: Beclometasone dipropionate demonstrated to be non-genotoxic.
Croatian: Pokazalo se da beklometazondipropionat nije genotoksičan.
English: For instruction on preparation and dilution of the medicinal product, see section 6.6.
Croatian: Za upute o pripremi i razrjeđivanju lijeka vidjeti dio 6.6.
English: If used concomitantly with systemic or intranasal steroids the suppressive effect on adrenal function will be additive.
Croatian: Ako se primjenjuje istodobno sa sistemskim ili intranazalnim steroidima, supresivni učinak na adrenalnu funkciju bit će aditivan.
English: The remaining quantity has to be used within 12 hours after first opening.
Croatian: Preostala količina mora se upotrijebiti unutar 12 sati nakon prvog otvaranja
English: This should be treated immediately with a fast-acting inhaled bronchodilator.
Croatian: To stanje odmah treba liječiti brzodjelujućim inhalacijskim bronhodilatatorom.
English: Replacement of systemic steroid treatment with inhaled therapy sometimes also unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic medicinal product.
Croatian: Zamjena sistemskog steroidnog liječenja inhalacijskom terapijom ponekad također otkrije alergije kao što su alergijski rinitis ili ekcem koji su ranije bili kontrolirani sistemskim lijekom.
English: During this time your doctor will monitor the level of corticosteroids in your body regularly.
Croatian: Vaš liječnik će Vam redovito kontrolirati razine kortikosteroida u tijelu.
English: Talk to you doctor or pharmacist before using {INVENTED NAME} if any of the following applies to you:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite {NOVOIZUMLJENO IME} ako se bilo što od sljedećeg odnosi na Vas:
English: In healthy males a single dose of 1600 µg beclometasone dipropionate by nebulisation had no effect on 24-h urinary cortisol excretion, while a single dose of 3200 µg produced a urinary cortisol excretion reduction of about 10% without any significant differences between the two dosage treatments.
Croatian: U zdravih muškaraca jednokratna doza od 1600 µg beklometazondipropionata primijenjena atomizatorom nije imala učinka na 24-satno izlučivanje kortizola urinom, dok je jednokratna doza od 3200 µg dovela do smanjenja izlučivanje kortizola urinom od oko 10 %, bez značajnih razlika u liječenju tim dvjema dozama.
English: At high doses over a long period of time, {INVENTED NAME} may affect the normal production of corticosteroids in the body.
Croatian: Pri visokim dozama tijekom dugog vremenskog razdoblja, {NOVOIZUMLJENO IME} može utjecati na normalno stvaranje kortikosteroida u tijelu.
English: After improvement of control of asthma or wheezing, the total daily dose should be reduced to the lowest effective dose and a once daily dosing can be applied.
Croatian: Nakon poboljšanja kontrole astme ili zviždanja u plućima, ukupna dnevna doza treba se smanjiti na najnižu učinkovitu dozu i može se primjeni doziranje jedanput dnevno.
English: If you have used more {INVENTED NAME} than you should, tell your doctor as soon as possible.
Croatian: Ako ste primijenili više lijeka {NOVOIZUMLJENO IME} nego što ste trebali, obratite se svom liječniku što je prije moguće.
English: If it is almost time for your next dose, do not use the missed dose, just use the next dose when it is due.
Croatian: Ako je uskoro vrijeme za sljedeću dozu, nemojte primijeniti propuštenu dozu, samo primijenite sljedeću dozu u predviđeno vrijeme.
English: A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely.
Croatian: Ozbiljna reakcija preosjetljivosti uključujući edem oka, lica, usana i grla (angioedem) prijavljena je rijetko.
English: Your doctor will decide if you need a course of corticosteroid tablets or possibly a corticosteroid injection and will also advise you as to how long you need to take the course of corticosteroid tablets and how you should reduce these as you get better.
Croatian: Vaš će liječnik odlučiti trebate li primiti tablete kortikosteroida ili možda injekciju kortikosteroida te će Vas također savjetovati koliko dugo trebate uzimati tablete kortikosteroida i kako ćete smanjivati dozu kako Vam bude sve bolje.
English: Your doctor may prescribe a course of antibiotics.
Croatian: Vaš liječnik će Vam možda propisati antibiotike.
English: No formal pharmacokinetic drug-drug interaction studies have been conducted.
Croatian: Nisu provedena formalna farmakokinetička ispitivanja interakcija.
English: • Your doctor may need to increase the dose of {INVENTED NAME} or give you a course of corticosteroid tablets, or change your treatment altogether.
Croatian: • Vaš će liječnik možda trebati povećati dozu lijeka {NOVOIZUMLJENO IME} ili uvesti tablete kortikosteroida, ili promijeniti Vaše cjelokupno liječenje.
English: After first opening the pouch, write the date in the box provided on the pouch.
Croatian: Nakon prvog otvaranja vrećice zapišite datum otvaranja u kućicu na vrećici koja je predviđena za to.
English: What {INVENTED NAME} looks like and contents of the pack {INVENTED NAME} is a white or almost white nebuliser suspension.
Croatian: Kako {NOVOIZUMLJENO IME} izgleda i sadržaj pakiranja CLENIL je bijela ili gotovo bijela suspenzija za atomizator.
English: Consideration can be given to referring the patient to paediatric pulmonologist.
Croatian: Može se razmotriti i upućivanje bolesnika pedijatru pulmologu.
English: Since glucocorticoids are excreted in breast-milk, it is reasonable to assume that beclometasone dipropionate and its metabolites are also excreted into breast milk.
Croatian: Budući da se glukokortikoidi izlučuju u majčino mlijeko, razumno je pretpostaviti da se beklometazondipropionat i njegovi metaboliti također izlučuju u majčino mlijeko.
English: After inhalation, any unused suspension remaining in the nebuliser chamber must be discarded.
Croatian: Nakon inhalacije se sva neiskorištena suspenzija preostala u komori atomizatora mora baciti.
English: Adverse reactions observed in clinical trials with inhaled beclometasone in the treatment of asthma and wheezing are listed in the table below according the MedDRA system organ class and frequencies: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave opažene u kliničkim ispitivanjima s inhalacijskim beklometazonom u liječenju astme i zviždanja u plućima navedene su u tablici u nastavku sukladno MedDRA klasifikaciji organskih sustava i učestalosti: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1 000 i <1/100); rijetko (≥1/10 000 i <1/1 000); vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka)..
English: WHAT YOU NEED TO KNOW BEFORE YOU USE {INVENTED NAME}
Croatian: Što morate znati prije nego počnete primjenjivati {NOVOIZUMLJENO IME}
English: Your doctor is likely to assess your asthma or wheezing and if necessary may start you on another course of treatment.
Croatian: Vaš će liječnik vjerojatno ocijeniti Vašu astmu ili zviždanje u plućima i, ako je potrebno, započeti s drugim načinom liječenja.
English: The starting dose should be prescribed by your doctor according to the frequency and severity of your disease.
Croatian: Početnu dozu treba propisati Vaš liječnik u skladu s učestalosti i težinom bolesti.
English: If patients find that short-acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.
Croatian: Ako bolesnici primijete da primjena kratkodjelujućih bronhodilatatora za trenutno ublažavanje simptoma postaje manje djelotvorna ili da trebaju više inhalacija nego uobičajeno, moraju potražiti liječničku pomoć.
English: If your child is below 5 years of age and is receiving prolonged treatment of recurrent wheezing with {INVENTED NAME}, your doctor will regularly monitor his/her height to evaluate if growth impairment occurs and whether to stop the treatment.
Croatian: Ako je Vaše dijete mlađe od 5 godina i dugotrajno se liječi lijekom {NOVOIZUMLJENO IME} radi opetovanog zviždanja u plućima, liječnik će redovito kontrolirati njegovu/njezinu visinu kako bi ocijenio da li se pojavio poremećaj rasta i treba li prekinuti liječenje.
English: Store the ampoules in the upright position in the original package (carton box) in order to protect from light.
Croatian: Čuvati ampule u uspravnom položaju u originalnom pakiranju (kartonska kutija) radi zaštite od svjetlosti.
English: • an allergic reaction (swelling of the eyes, face, lips and throat leading to severe difficulty in breathing, skin rashes, hives, itching or redness)
Croatian: • alergijska reakcija (oticanje očiju, lica, usana i grla što dovodi do ozbiljnih poteškoća s disanjem, kožni osip, koprivnjača, svrbež ili crvenilo kože)
English: Damage to the infant is not reported to date.
Croatian: Do danas nisu prijavljena štetna djelovanja na dojenčad.
English: In any case, beclometasone dipropionate should be administered without discontinuing the systemic treatment; after approximately one week, the latter should be gradually reduced (the size of the reduction should correspond to the maintenance dose of the systemic steroid), patient should be checked at regular intervals (in particular, adrenocortical function tests should be carried out) and dose of inhaled beclometsone dipropionate should be adjusted according to the results obtained.
Croatian: U svakom slučaju, beklometazondipropionat treba primjenjivati bez prekidanja sistemskog liječenja; nakon otprilike tjedan dana sistemsko liječenje treba postupno smanjivati (veličina smanjenja treba odgovarati dozi održavanja sistemskih steroida), bolesnika treba kontrolirati u pravilnim vremenskim razmacima (posebice treba provoditi testove adrenokortikalne funkcije) te prilagođavati dozu inhalacijskog beklometazondipropionata u skladu s dobivenim nalazima.
English: WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR
Croatian: Što je {NOVOIZUMLJENO IME} i za što se koristi
English: Nebuliser suspension 10 ampoules
Croatian: Suspenzija za atomizator 10 ampula
English: Beclometasone was teratogenic and embryolethal in animals after, subcutaneous and oral administration.
Croatian: Beklometazon je bio teratogen i embrioletalan u životinja nakon subkutane i oralne primjene.
English: Besides evidence coming from long lasting use of inhaled beclometasone in the treatment of asthma and wheezing, the following data are a collection of the main supportive published data.
Croatian: Osim dokaza dobivenih dugotrajnom primjenom inhalacijskog beklometazona u liječenju astme i zviždanja u plućima, slijedeći podaci su skup glavnih podupirućih objavljenih podataka.
English: Measures to minimize the occurrence of candidiasis, hoarseness and paradoxical bronchospasm are described in section 4.4.
Croatian: Mjere koje će smanjiti pojavu kandidijaze, promuklosti i paradoksalnog bronhospazma, opisane su u dijelu 4.4.
English: If this occurs do not take another dose of {INVENTED NAME}.
Croatian: Ako dođe do toga, nemojte uzeti drugu dozu lijeka {NOVOIZUMLJENO IME}.
English: It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of disease is maintained.
Croatian: Stoga je važno redovito kontrolirati bolesnika te dozu inhalacijskih kortikosteroida smanjiti na najnižu dozu kojom se održava učinkovita kontrola bolesti.
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses administered for long periods of time.
Croatian: Sistemski učinci mogu se pojaviti uz svaki inhalacijski kortikosteroid, posebice uz visoke doze primijenjene tijekom dugih razdoblja.
English: • You have an infection in your chest.
Croatian: • Imate infekciju prsišta.
English: As BDP or its metabolites were not traced in urine, an increase in systemic exposure is not envisaged in patients with renal impairment.
Croatian: Budući da BDP ili njegovi metaboliti nisu nađeni u urinu, ne predviđa se povećanje sistemske izloženosti u bolesnika s oštećenjem funkcije bubrega.
English: These allergies should be symptomatically treated with antihistamines and/or topical medicinal product, including steroids for local use.
Croatian: Takve alergije treba simptomatski liječiti antihistaminicima i/ili topikalnim lijekovima, uključujući steroide za lokalnu primjenu.
English: Both treatments were associated with a marked reduction in night-time wheezing and in the number of days of steroid use.
Croatian: Oba su liječenja bila povezana sa značajnim smanjenjem zviždanja u plućima tijekom noći te smanjenjem broja dana uporabe steroida.
English: If you have been taking corticosteroid tablets at high doses or for a long time, your dose may be gradually reduced, approximately one week after you started treatment with {INVENTED NAME}.
Croatian: Ako ste tablete kortikosteroida uzimali u visokim dozama ili dugo vremena, doza će Vam se možda postupno smanjivati, približno tjedan dana nakon početka liječenja lijekom {NOVOIZUMLJENO
English: • cold sores (herpes simplex) painful blisterlike vesicles on your lips and in your mouth
Croatian: • groznica (herpes simplex), bolni, prozirni mjehurići na usnicama i u ustima
English: If treatment during pregnancy is necessary, the lowest effective dose of beclometasone dipropionate should be used.
Croatian: Ako je liječenje nužno tijekom trudnoće, treba primijeniti najnižu učinkovitu dozu beklometazondipropionata.
English: Special care is necessary in patients with active or quiescent pulmonary tuberculosis and other infections.
Croatian: Posebna briga potrebna je u bolesnika s aktivnom ili latentnom tuberkulozom pluća ili drugim infekcijama.
English: Carefully separate a new ampoule from the strip, firstly from the top, then in the middle (Figure B), leaving the rest in the pouch.
Croatian: Pažljivo odvojite novu ampulu od stripa, najprije od vrha, zatim u sredini (slika B), ostavljajući ostale u vrećici.
English: There are strips 5 ampoules in each sealed pouch, in pack sizes of 10 ampoules (2 pouches), 20 ampoules (4 pouches) or 40 ampoules (8 pouches).
Croatian: U svakoj zatvorenoj vrećici nalazi se strip s 5 ampula, u veličinama pakiranja od 10 ampula (2 vrećice), 20 ampula (4 vrećice) ili 40 ampula (8 vrećica).
English: Rinsing your mouth or gargling with water immediately after inhalation may help to prevent these effects.
Croatian: Ispiranje usta vodom ili grgljanje vode odmah nakon inhalacije može pomoći u prevenciji ovih nuspojava.
English: In case of bacterial infection of the respiratory tract an adequate antibiotic co-medication may be required.
Croatian: U slučaju bakterijske infekcije dišnog sustava može biti potrebna istodobna primjena odgovarajuće antibiotske terapije.
English: Adults and adolescents (from 12 years of age) :
Croatian: Odrasli i adolescenti (od 12 godina starosti):
English: The ampoule should be opened immediately before administration.
Croatian: Ampulu treba otvoriti neposredno prije primjene.
English: However, at therapeutic doses of beclometasone dipropionate no effect on the breastfed newborns/infants are anticipated.
Croatian: Međutim, pri terapijskim dozama beklometazondipropionata ne očekuju se učinci na dojenu novorođenčad/dojenčad.
English: There is insufficient data available regarding the possible growth-inhibiting effect of inhaled corticosteroids in infants and toddlers less than 2 years.
Croatian: Nije dostupno dovoljno podataka o mogućem učinku inhalacijskih kortikosteroida na usporavanje rasta u dojenčadi i male djece mlađe od 2 godine.
English: {INVENTED NAME} should be discontinued immediately, the patient assessed and, if necessary, alternative therapy instituted.
Croatian: Liječenje lijekom {NOVOIZUMLJENO IME} treba odmah obustaviti, procijeniti stanje bolesnika te, ako je potrebno, uvesti alternativnu terapiju.
English: In repeat-dose toxicity studies, administration of beclometasone dipropionate by nebulisation to rats (for 180 days) and dogs (for 90 days) had no effect on body weight and blood cells or on trophism of the airways mucosa.
Croatian: U ispitivanjima toksičnosti ponovljenih doza, primjena beklometazondipropionata atomizatorom u štakora (tijekom 180 dana) i pasa (tijekom 90 dana) nije imala učinka na tjelesnu težinu, krvne stanice ili na tropizam mukoze dišnih puteva.
English: Severe exacerbations of asthma must be treated in the normal way, e.g. by increasing the dose of inhaled beclometasone dipropionate and, if necessary, by giving a systemic steroid, and/or an antibiotic if appropriate, and by use of beta 2-agonist therapy.
Croatian: Teške egzacerbacije astme moraju se liječiti na uobičajen način, npr. povećanjem doze inhalacijskog beklometazondipropionata i, po potrebi, davanjem sistemskih steroida i/ili antibiotika ako je prikladno, te primjenom terapije beta 2-agonistom.
English: Your doctor may decide that your dose should be diluted.
Croatian: Vaš liječnik može odlučiti da trebate razrijeđenu dozu.
English: {INVENTED NAME} is indicated to treat asthma in adults and children up to 18 years of age when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate.
Croatian: {NOVOIZUMLJENO IME} je indiciran za liječenje astme u odraslih i djece u dobi do 18 godina kada primjena stlačenog inhalata ili praška inhalata nije zadovoljavajuća ili nije primjerena.
English: Animal studies indicate that administration of glucocorticoids during pregnancy may increase the risk for intrauterine growth retardation, adult cardiovascular and/or metabolic disease and/or neurobehavioral development.
Croatian: Ispitivanja na životinjama ukazuju da primjena glukokortikoida tijekom trudnoće može povećati rizik od intrauterinog usporavanja rasta, srčanožilne i/ili metaboličke bolesti u odraslih i/ili neurobihevioralnog poremećaja.
English: Do not inject into a vein or use orally.
Croatian: Nemojte injicirati u venu ili primijeniti kroz usta.
English: {INVENTED NAME} is also indicated to treat recurrent wheezing in children up to 5 years of age.
Croatian: {NOVOIZUMLJENO IME} je također indiciran za liječenje opetovanog zviždanja u plućima u djece u dobi do 5 godina.
English: In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroids or a course of oral corticosteroids).
Croatian: U takvim slučajevima stanje bolesnika treba ponovno procijeniti i razmotriti potrebu pojačane protuupalne terapije (npr. veće doze inhalacijskih kortikosteroida ili uvođenje oralnih kortikosteroida).
English: The terminal elimination half-lives are 0.5 h and 2.7 h for BDP and B17MP respectively.
Croatian: Terminalni poluvijek eliminacije je 0,5 h za BDP odnosno 2,7 h za B17MP.
English: If you have been treated for a long time with high doses of inhaled corticosteroid, you may require an extra corticosteroid treatment in times of stress.
Croatian: Ako ste se dugo vremena liječili visokim dozama inhalacijskih kortikosteroida, možda ćete trebati dodatno liječenje kortikosteroidima u razdoblju povećanog stresa.
English: However if you experience side effects such as dizziness and/or trembling, your ability to drive or operate machines may be affected.
Croatian: Ipak, ako imate nuspojave kao što su omaglica i/ili drhtanje, to može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Other medicines and {INVENTED NAME} Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Corticosteroids pass into breast milk at low amounts.
Croatian: Kortikosteroidi u malim količinama prelaze u majčino mlijeko.
English: If growth impairment occurs, the treatment should be assessed with the aim of reducing the dose of inhaled corticosteroid.
Croatian: Ako dođe do usporavanja rasta, liječenje treba ocijeniti s ciljem smanjenja doze inhalacijskog kortikosteroida.
English: The switch to {INVENTED NAME} of patients who have been treated with systemic steroids for long periods of time, or at a high dose, needs special care, since recovery from any adrenocortical suppression sustained may take a considerable time.
Croatian: Prelazak na {NOVOIZUMLJENO IME} u bolesnika koji su bili liječeni sistemskim steroidima tijekom dugog vremenskog razdoblja, ili u visokim dozama, zahtijeva posebnu brigu budući da oporavak od produljene adrenokortikalne supresije može trajati dosta dugo.
English: With high doses for a very short period of time, suppression of HPA-axis may occur.
Croatian: Kod primjene visokih doza u vrlo kratkom vremenskom razdoblju, može doći do supresije HPA osovine.
English: 20 ampoules
Croatian: 20 ampula
English: The incidence of candidiasis seems to be related to the administered dose and treatment duration.
Croatian: Čini se da je incidencija kandidijaze povezana s primijenjenom dozom i trajanjem liječenja.
English: Perhaps you are more wheezy and short of breath than usual, or your nebuliser seems to be less effective.
Croatian: Možda primjećujete više zviždanja u plućima i nedostatka zraka nego uobičajeno, ili Vam se čini da atomizator slabije djeluje.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [to be completed nationally]
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: Repeat this operation, until the whole content is fully dispersed and mixed (Figure C).
Croatian: Ponavljajte te radnje dok se sav sadržaj ne rasprši i pomiješa (slika C).
English: 40 ampoules
Croatian: 40 ampula
English: If your child suffers from recurrent wheezing, the duration of treatment should not exceed 3 months, unless otherwise prescribed by the paediatrician.
Croatian: Ako Vaše dijete boluje od opetovanog zviždanja u plućima, liječenja ne smije trajati duže od 3 mjeseca, osim ako pedijatar nije propisao drugačije.
English: In this case, empty the contents of the ampoule into the nebuliser bowl then add the quantity of sterile sodium chloride 9 mg/ml (0.9%) solution that your doctor has told you to use.
Croatian: U tom slučaju, ispraznite sadržaj ampule u spremnik atomizatora i zatim dodajte onoliku količinu sterilne otopine natrijevog klorida 9 mg/ml (0,9 %) koliku Vam je liječnik rekao da dodate.
English: No significant effect on morning serum cortisol levels was reported in asthmatic patients after a 3-week treatment period of 1600 and 3200 µg per day b.i.d.
Croatian: Nisu zabilježeni značajni učinci na jutarnje razine kortizola u serumu bolesnika s astmom nakon razdoblja liječenja od 3 tjedna dozom od 1600 i 3200 µg na dan podijeljenom u dvije doze,
English: If no treatment benefit is observed within 2-3 months or if a diagnosis of asthma is not likely, {INVENTED NAME} should be discontinued to avoid unnecessary long-term exposure to inhaled corticosteroids and associated risks in children including growth retardation (see section 4.8).
Croatian: Ako se u roku od 2-3 mjeseca ne primijeti korist od liječenja, ili dijagnoza astme nije vjerojatna, liječenje lijekom {NOVOIZUMLJENO IME} treba prekinuti, kako bi se izbjeglo nepotrebno dugotrajna izloženost inhalacijskim kortikosteroidima u djece, te rizicima koji su s time povezani, uključujući usporavanje rasta (vidjeti dio 4.8).
English: Growth retardation and behavioural disorders may be more prevalent in children than in adults, particularly at high doses administered for prolonged periods of time.
Croatian: Usporavanje rasta i bihevioralni poremećaji mogu biti rašireniji u djece nego u odraslih, posebice pri većim dozama primijenjenim kroz dulje vremensko razdoblje.
English: Infants and neonates born to mothers receiving substantial doses of beclometasone dipropionate during pregnancy should be observed for adrenal suppression.
Croatian: Dojenčad i novorođenčad rođenu od majki koje su primale značajne doze beklometazondipropionata tijekom trudnoće treba nadzirati zbog moguće adrenalne supresije.