FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit/risk balance and the dosages were assessed during the Marketing Application of the originator and as the originator has been approved for children with the adult dose, the benefit/risk of this dose is positive, including in paediatric populations.
Slovenian: Razmerje med koristmi in tveganji ter odmerjanje sta bila ovrednotena pri obravnavi vloge za dovoljenje za promet z originatorskim zdravilom in ker je bilo originatorsko zdravilo odobreno za otroke z odmerkom za odrasle, je razmerje med koristmi in tveganji pozitivno tudi pri pediatrični populaciji.
English: - the ascorbic acid contained in the product is not expected to impact the systemic exposure of budesonide,
Slovenian: - ne pričakuje se, da bi askorbinska kislina, ki je v zdravilu, vplivala na sistemsko izpostavljenost budezonidu;
English: Finally, therapeutic equivalence is proven for this hybrid application, therefore the efficacy and safety are considered equivalent for adults and can be extrapolated to children.
Slovenian: Nazadnje je za to hibridno vlogo dokazana terapevtska enakovrednost, zato se učinkovitost in varnost štejeta za enakovredni pri odraslih in ju lahko prenesemo na otroke.
English: As it is not known to which extent budesonide is excreted into breast milk, use in lactation requires that the therapeutic benefit to the mother be weighed against any potential risk to the neonate.
Slovenian: Ker ni znano, v kolikšni meri se budezonid izloča v materino mleko, je ob uporabi v obdobju dojenja nujno pretehtati terapevtski učinek na mater v primerjavi s potencialnim tveganjem za novorojenca.
English: A clinical study conducted by the Applicant, demonstrated therapeutic equivalence to the originator, indicated similar local availability of budesonide and identified no safety concerns that could be attributed to an increased systemic availability.
Slovenian: V klinični študiji, ki jo je opravil predlagatelj, so dokazali terapevtsko enakovrednost originatorskemu zdravilu, nakazali podobno lokalno razpoložljivost budezonida in ugotovili odsotnost varnostnih zadržkov, ki bi jih pripisali povečani sistemski razpoložljivosti.
English: • Remove the plastic nozzle with a clean tissue and wash in warm - not hot - water.
Slovenian: • Odstranite plastični nastavek s pomočjo čistega robčka in ga umijte v topli, a ne vroči vodi.
English: The recommended dose for the treatment of nasal polyps is 256 micrograms.
Slovenian: Priporočeni odmerek za zdravljenje nosnih polipov je 256 mikrogramov.
English: The Applicant is of the opinion that Budesonide Sandoz and the originator show comparable local tolerability and systemic safety in children and are fully interchangeable.
Slovenian: Predlagatelj meni, da imata zdravilo Budesonide Sandoz in originatorsko zdravilo primerljiv profil lokalne tolerance in sistemske varnosti pri otrocih ter da sta popolnoma izmenljiva.
English: • for the treatment of symptoms of nasal polyps (small growths on the lining of the nose).
Slovenian: • zdravljenje simptomov nosnih polipov (majhni izrastki v notranjosti nosu).
English: The results obtained suggest that budesonide is not systemically available, that the pharmacokinetic profile does not differ significantly between the two formulations, that no systemic effects are to be expected and that the products are comparable with regards to the biopharmaceutic properties.
Slovenian: Dobljeni rezultati nakazujejo, da budezonid ni sistemsko razpoložljiv, da se farmakokinetični profil med formulacijama bistveno ne razlikuje, da sistemskih učinkov ne pričakujemo in da sta zdravili primerljivi glede na biofarmacevtske lastnosti.
English: During the procedure it was concluded that therapeutic equivalence to the reference product was demonstrated in adults, the safety in adults was therefore considered proven and no PK data was required.
Slovenian: Med postopkom je bilo ugotovljeno, da je terapevtska enakovrednost z referenčnim zdravilom dokazana pri odraslih, zato se varnost pri odraslih šteje za dokazano in niso potrebni farmakokinetični podatki.
English: The systemic availability of budesonide is 33% of the delivered intranasal amount of budesonide.
Slovenian: Sistemska biološka uporabnost budezonida je 33% intranazalno aplicirane količine budezonida.
English: When patients are transferred from systemic corticosteroid (oral or parenteral) to Budesonide nasal spray suspension, adverse reactions outside the nasal area which were previously under control by systemic therapy e.g. allergic conjunctivitis or dermatitis, may become unmasked.
Slovenian: Ko bolniki preidejo s sistemskih kortikosteroidov (peroralnih ali parenteralnih) na Budezonid pršilo za nos, suspenzijo, se lahko izrazijo neželene reakcije zunaj nosnega območja, ki so bile pred tem nadzorovane s sistemskim zdravljenjem, npr. alergijski konjunktivitis ali dermatitis.
English: The results of a study in children and adolescents with perennial rhinitis were in line with the observations for adults, and no consistent differences in 24-hour urinary cortisol measurements were observed, therefore no systemic effects are expected in the paediatric population, irrespective of plasma budesonide concentrations.
Slovenian: Rezultati študije pri otrocih in mladostnikih s celoletnim rinitisom so se ujemali z opažanji pri odraslih, ugotovljenih pa ni bilo nobenih doslednih razlik v 24-urnih meritvah kortizola v urinu, zato se pri pediatrični populaciji sistemski učinki, ne glede na koncentracije budezonida v plazmi, ne pričakujejo.
English: You should not use Budesonide nasal spray if you are pregnant unless you have discussed this with your doctor.
Slovenian: Zdravila Budezonid pršilo za nos ne smete uporabljati, če ste noseči, razen, če ste se o uporabi posvetovali s svojim zdravnikom.
English: Very rare side effects (fewer than 1 patient in every 10.000 patients treated), or where the frequency is not known (cannot be estimated from the available data):
Slovenian: Zelo redki neželeni učinki (manj kot 1 bolnik na 10.000 zdravljenih bolnikov) ali kjer je pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov):
English: This medicine generally only treats symptoms affecting the nose (eg congestion or a “runny nose”).
Slovenian: To zdravilo v splošnem zdravi le simptome, ki prizadenejo nos (npr. zamašenost nosu ali izcedek iz nosu).
English: The CHMP noted that several published studies indicate that INCs taken at the recommended dosages do not affect the hypothalamic-pituitaryadrenal axis in children and that the long-term treatment for 1 to 2 years with intranasal budesonide daily in children with perennial allergic rhinitis reveals no negative effects on growth or endogenous cortisol production.
Slovenian: CHMP je navedel, da več objavljenih študij kaže, da intranazalni kortikosteroidi v priporočenih odmerkih ne vplivajo na os hipotalamus-hipofiza-nadledvična žleza pri otrocih ter da dolgotrajno dnevno zdravljenje z intranazalnim budezonidom od 1 do 2 let pri otrocih s celoletnim alergijskim rinitisom ne kaže negativnih učinkov na rast ali endogeno nastajanje kortizola.
English: 6.6 Special precautions for disposal <and other handling> No special requirements
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
English: • if you are hypersensitive (allergic) to budesonide, or any of the other ingredients of Budesonide Nasal Spray suspension (see section 6.
Slovenian: • če ste alergični (preobčutljivi) na budezonid ali katerokoli sestavino zdravila Budezonid pršilo za nos, suspenzija (glejte poglavje 6.
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Slovenian: Odmerek moramo titrirati do najnižjega odmerka, s katerim dosežemo učinkovit nadzor simptomov.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV V DRŽAVAH ČLANICAH
English: Based on the review of the data on quality, safety and efficacy, the CHMP considers that the overall benefit/risk ratio of Budesonide Sandoz in children is positive and that the application for Budesonide Sandoz, in the treatment of seasonal and perennial allergic rhino-conjunctivitis (SAR, PAR) as well as nasal polyps, is approvable.
Slovenian: CHMP na podlagi pregleda podatkov o kakovosti, varnosti in učinkovitosti meni, da je skupno razmerje med koristmi in tveganji za zdravilo Budesonide Sandoz pri otrocih pozitivno ter da je vlogo za zdravilo Budesonide Sandoz za zdravljenje sezonskega in letnega alergijskega rinokonjuktivitisa nosnih polipov mogoče odobriti.
English: • itraconasole, a medicine to treat fungal infections
Slovenian: • itrakonazol, zdravilo za zdravljenje glivičnih okužb
English: To support the application, the Applicant submitted one clinical study in adults.
Slovenian: Predlagatelj je v podporo vloge predložil eno klinično študijo pri odraslih.
English: Important: Pump may need to be primed before use (see enclosed instructions) EXPIRY DATE
Slovenian: Pomembno: Pred uporabo morate pripraviti črpalko (glejte priložena navodila).
English: It may cause irritation of the skin or mucous membranes (e.g. contact dermatitis).
Slovenian: Lahko povzroči draženje kože ali membran sluznic (npr. kontaktni dermatitis).
English: 6.4 Special precautions for storage Do not store above 30°C
Slovenian: 6.4 Posebna navodila za shranjevanje Shranjujte pri temperaturi do 30 °C.
English: Potassium sorbate, an ingredient of this medicine, might cause irritation of the skin or mucous membranes, such as the inside if your nose.
Slovenian: Kalijev sorbat, pomožna snov v tem zdravilu, lahko povzroči razdraženje kože ali membran sluznic, na primer v notranjosti nosu.
English: • Rinse the nozzle thoroughly, dry it and then replace onto the top of the bottle.
Slovenian: • Nastavek temeljito splaknite, osušite in namestite na vrh stekleničke.
English: If after priming the nozzle again the pump is still not working, clean the nozzle by using the following instructions:
Slovenian: Če po ponovni napolnitvi nastavka črpalka še vedno ne deluje, nastavek očistite skladno z naslednjimi navodili:
English: Budesonide has a high systemic clearance (appr. 1.2 L/min) and the half-life in plasma following an intravenous dose is on average appr. 4 hours.
Slovenian: Budezonid ima velik sistemski očistek (približno 1,2 l/min), plazemski razpolovni čas po intravenskem odmerku pa je v povprečju približno 4 ure.
English: 1,28 mg/ml
Slovenian: Nazalna uporaba 1,28 mg/ml
English: Afterwards, the lowest dose should be chosen that keeps the patient just without symptoms.
Slovenian: Nato moramo izbrati najnižji odmerek, ki še vzdržuje bolnikovo stanje brez simptomov.
English: The Applicant stated that available studies show that budesonide has no effect on growth as measured by knemometry in doses below 400 µg/d and that it can be virtually excluded that locally applied corticosteroids cause relevant permanent growth retardation, clinically relevant growth suppression or reduced adult height.
Slovenian: Predlagatelj je navedel, da razpoložljive študije kažejo, da budezonid pri odmerkih pod 400 µg/dan ne vpliva na rast, izmerjeno knemometrično, ter da lahko skoraj izključimo možnost, da bi lokalno uporabljeni kortikosteroidi povzročili trajen zastoj rasti, klinično pomembno zaviranje rasti ali nižjo višino pri odraslih.
English: Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.
Slovenian: Zdravljenje z višjimi odmerki nosnih kortikosteroidov, kot so priporočeni, ima lahko za posledico klinično značilno supresijo nadledvične žleze.
English: The Applicant discussed the available knowledge regarding the systemic exposure of intranasally applied budesonide including its high topical potency and low systemic bioactivity, primarily due to absorption through the nasal mucosa and the metabolism steps involved.
Slovenian: Predlagatelj je razpravljal o razpoložljivem znanju o sistemski izpostavljenosti intranazalno uporabljenemu budezonidu ter njegovi veliki topični aktivnosti in nizki sistemski bioaktivnosti, zlasti zaradi absorpcije skozi nosno sluznico ter stopenj presnove, ki sledijo.
English: • the treatment and prevention of the symptoms of year-round nasal allergy caused for example by house dust (chronic rhinitis)
Slovenian: • zdravljenje in preprečevanje celoletnih nosnih alergij, ki jih npr. povzroča hišni prah (kronični rinitis)
English: 0,64 mg/ml 1,28 mg/ml
Slovenian: Nazalna uporaba 0,64 mg/ml 1,28 mg/ml
English: Corticosteroids are a group of medicines which help fight inflammation.
Slovenian: Kortikosteroidi so skupina zdravil, ki nam pomagajo zdravljenju vnetja[E5].
English: Finally, the CHMP agreed that no local safety related issues are expected for Budesonide Sandoz nasal spray and that there is no evidence that the safety of Budesonide Sandoz in children is different from that of the originator.
Slovenian: CHMP se je nazadnje strinjal, da se za pršilo za nos Budesonide Sandoz ne pričakujejo lokalni varnostni zadržki in da ni dokazov, da je varnost zdravila Budesonide Sandoz pri otrocih drugačna kot pri originatorskem zdravilu.
English: - the therapeutic equivalence of Budesonide Sandoz to the originator in adults has been established and
Slovenian: - dokazana je terapevtska enakovrednost zdravila Budesonide Sandoz z originatorskim zdravilom pri odraslih;
English: The CHMP therefore agrees with the argumentation concerning the dosage in children, and furthermore considered that in the context of a hybrid application, if therapeutic equivalence to the originator is proven, the new hybrid product should adopt the dosing recommendations of the originator.
Slovenian: CHMP se zato strinja z argumenti glede odmerjanja pri otrocih, poleg tega pa je upošteval, da mora novo hibridno zdravilo v okviru hibridne vloge privzeti priporočila za odmerjanje originatorskega zdravila, če se dokaže terapevtska enakovrednost z originatorskim zdravilom.
English: - the pharmacology of budesonide is well established for the originator, with respect to the administration, dosage and adverse events in children,
Slovenian: - farmakologija budezonida je dobro poznana pri originatorskem zdravilu, kar zadeva dajanje, odmerjanje in neželene učinke pri otrocih;
English: In conclusion, the Applicant considered that the pharmacology of budesonide in the paediatric population has been well investigated and characterised and that it is reasonable to assume that Budesonide Sandoz will be therapeutically equivalent to the originator in the paediatric population as equivalence has been convincingly demonstrated in the adult population.
Slovenian: Predlagatelj je v zaključku upošteval, da je farmakologija budezonida pri pediatrični populaciji dobro raziskana in opisana ter da lahko utemeljeno sklepamo o terapevtski enakovrednosti zdravila Budesonide Sandoz in originatorskega zdravila pri pediatrični populaciji, saj je bila enakovrednost prepričljivo dokazana pri odrasli populaciji.
English: Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods.
Slovenian: Lahko se pojavijo sistemski učinki inhalacijskih kortikosteroidov, zlasti pri visokih odmerkih, predpisanih skozi daljše časovno obdobje.
English: The CHMP agreed with the rationale for including ascorbic acid as an anti-oxidant and that the amount of ascorbic acid contained in Budesonide Sandoz will not affect the pharmacokinetics/pharmacodynamics of the product.
Slovenian: CHMP se je strinjal z razlogom za vključitev askorbinske kisline kot antioksidanta in mnenjem, da količina askorbinske kisline v zdravilu Budesonide Sandoz ne bo vplivala na farmakokinetiko/farmakodinamiko zdravila.
English: The dose may be administered once daily in the morning or divided into two administrations, in the morning and in the evening.
Slovenian: Odmerek lahko apliciramo enkrat na dan zjutraj ali razdeljenega na dva odmerka, zjutraj in zvečer.
English: The use of budesonide nasal spray is not recommended in patients with infections of the airways.
Slovenian: Uporaba Budezonid pršila za nos ni priporočljiva pri bolnikih z okužbami dihalnih poti.
English: Glucocorticosteroids including budesonide have produced teratogenic effects in animals, including cleft palate and skeletal abnormalities.
Slovenian: Glukokortikosteroidi, vključno z budezonidom, so pri živalih povročili teratogene učinke, vključno z razpokami neba v ustih in anomalijami skeleta.
English: Figure 3.
Slovenian: Slika 3.
English: If you forget to use your medicine on time, use it as soon as possible, then go back to your regular dosing schedule.
Slovenian: Če ste pozabili uporabiti zdravilo Budezonid pršilo za nos Če ste pozabili pravočasno uporabiti zdravilo, ga uporabite takoj, ko se spomnite, in nato nadaljujte po ustaljenem urniku odmerjanja.
English: Concomitant therapy may sometimes be necessary to treat the symptoms affecting the eye caused by the allergy.
Slovenian: Za zdravljenje zaradi alergije povzročenih simptomov, ki prizadenejo oči, je včasih potrebno spremljajoče zdravljenje.
English: If a longer period of time passes before the next dose is taken, the nozzle must be primed (filled with medicine) again.
Slovenian: Če do uporabe naslednjega odmerka preteče daljše časovno obdobje, morate nastavek ponovno pripraviti (napolniti z zdravilom).
English: The Applicant also stated that nasally applied budesonide did not significantly alter hypothalamic-pituitary-adrenal (HPA) axis function in the originator's clinical studies.
Slovenian: Predlagatelj je navedel tudi, da budezonid, nanesen v nos, ni bistveno spremenil funkcije osi hipotalamus-hipofiza-nadledvična žleza v kliničnih študijah originatorskega zdravila.
English: Common: local symptoms like nasal mucosa irritation, slight haemorrhagic secretion, epistaxis (immediately after application)
Slovenian: Pogosti: lokalni simptomi kot je razdraženost nosne sluznice, rahla hemoragična sekrecija, krvavitve iz nosu (takoj po aplikaciji)
English: • if your have infectious blisters on your lips (a cold sore), in the nose or aroud your eyes
Slovenian: • če imate vnetne mehurčke na ustnicah (herpes), v nosu ali okrog oči;
English: − Rinse the nozzle thoroughly, dry it and then replace onto the top of the bottle.
Slovenian: ￚ Nastavek temeljito splaknite, osušite in namestite na vrh stekleničke.
English: In case of infections of the nose caused by bacteria or fungi, Budesonide nasal spray suspension should be used only if concomitant antibacterial or antifungal treatment is carried out.
Slovenian: V primeru okužb nosu, povzročenih z bakterijami ali glivami, lahko Budezonid pršilo za nos, suspenzijo uporabimo le v primeru sočasnega protibakterijskega ali protiglivičnega zdravljenja.
English: If there is evidence of higher than recommended doses being used then additional systemic corticosteroid cover should be considered during period of stress or elective surgery.
Slovenian: Če se kažejo znaki uporabe višjih odmerkov od priporočenih, je treba v obdobju stresa ali določenih operacij razmisliti o dodatni zaščiti s sistemskim kortikosteroidom.
English: It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored.
Slovenian: Priporočljivo je redno nadziranje telesne višine otrok, ki so dolgotrajno zdravljeni z nosnimi kortikosteroidi.
English: c.) No paediatric data has been presented so far in this application.
Slovenian: c.) Za to vlogo še niso bili predstavljeni podatki o otrocih.
English: After the desired clinical effect has appeared, the lowest dose should be chosen that keeps the patient without symptoms.
Slovenian: Ko dosežemo želen klinični učinek, moramo izbrati najnižji odmerek, ki vzdržuje bolnikovo stanje brez simptomov.
English: − Never try to unblock the nozzle by using a pin or other sharp object.
Slovenian: ￚ Nikoli ne poskušajte nastavka odstraniti z uporabo igle ali drugega ostrega predmeta.
English: - the safety profile for children of Budesonide Sandoz is not expected to differ from that of the originator,
Slovenian: - ne pričakuje se, da bi bil varnostni profil zdravila Budesonide Sandoz pri otrocih drugačen kot pri originatorskem zdravilu;
English: There is no information about this interaction following nasal administration of budesonide, but increased plasma concentrations are expected.
Slovenian: O omenjenem medsebojnem delovanju po nazalni aplikaciji ni podatkov, vendar so pričakovane povečane plazemske koncentracije.
English: Use the lowest dose which still relieves your symptoms.
Slovenian: Uporabite najnižji odmerek, ki vam še olajša simptome.
English: • ciclosporin, immune suppression drug used e.g. in connection with transplants
Slovenian: • ciklosporin, imunosupresivno zdravilo, ki se npr. uporablja pri presaditvah organov
English: Budenoside nasal spray should be used during pregnancy only if clearly needed.
Slovenian: Zdravilo Budezonid pršilo za nos med nosečnostjo uporabljamo samo, če je uporaba zares nujna.
English: For nasal use only.
Slovenian: Le za nazalno uporabo.
English: At clinically relevant doses the kinetics of budesonide are dose proportional.
Slovenian: Pri klinično pomembnih odmerkih je kinetika budezonida sorazmerna z odmerkom.
English: Treatment of seasonal rhinitis should, if possible, start before exposure to the allergens.
Slovenian: Zdravljenje sezonskega rinitisa moramo, če je mogoče, začeti pred izpostavljenostjo alergenom.
English: Your doctor will tell how long your treatment with Budesonide nasal spray suspension will last.
Slovenian: Zdravnik vam bo povedal, kako dolgo bo trajalo zdravljenje z zdravilom Budezonid pršilo za nos, suspenzija.
English: Neither clinical data from the literature nor the clinical studies conducted by the originator indicate any adverse systemic effects for budesonide doses up to 400 µg daily and therefore, the Applicant considered that no “systemic adverse reactions” are expected and that no additional data are necessary.
Slovenian: Neželeni sistemski učinki odmerkov budezonida do 400 µg dnevno niso bili nakazani v kliničnih podatkih iz literature niti v kliničnih študijah z originatorskim zdravilom, zato je predlagatelj menil, da „sistemski neželeni učinki“ niso pričakovani in da dodatni podatki niso potrebni.
English: Be sure to tell your doctor immediately if you are breast-feeding.
Slovenian: Svojemu zdravniku zagotovo nemudoma povejte, če dojite.
English: • the treatment and prevention of the symptoms of allergies like hay fever (eg caused by grass pollen)
Slovenian: • zdravljenje in preprečevanje simptomov alergij, kot je seneni nahod (npr. povzročenih s pelodom trav)
English: Severe impairment of hepatic function influences the pharmacokinetics of orally administered budesonide resulting in increased systemic availability and reduced elimination capacity.
Slovenian: Huda okvara jetrnega delovanja vpliva na farmakokinetiko peroralno apliciranega budezonida, kar ima za posledico zvečano sistemsko biološko uporabnost in zmanjšano sposobnost izločanja.
English: Concomitant administration of oral ketoconazol 200 mg once daily and oral budesonide (3 mg single dose) increased the plasma concentrations of budesonide on average 6-fold.
Slovenian: Sočasna uporaba peroralnega ketokonazola 200 mg enkrat na dan in peroralnega budezonida (enkratni odmerek 3 mg) je v povprečju 6-kratno povečala plazemske koncentracije budezonida.
English: Rare: glaucoma, cataract (with long-term treatment)
Slovenian: Redki: glavkom, katarakta (pri dolgotrajnem zdravljenju)
English: If Budesonide Nasal Spray is used at shorter intervals it is sufficient to spray just once into the air.
Slovenian: Če Budezonid pršilo za nos uporabljate v krajših intervalih, je dovolj, če ga le enkrat popršite v zrak.
English: PHARMACEUTICAL FORM Nasal spray, suspension.
Slovenian: FARMACEVTSKA OBLIKA Pršilo za nos, suspenzija.
English: No paediatric data has been presented so far.
Slovenian: Podatki o otrocih še niso bili predstavljeni.
English: • ethinylestradiol, used for contraception.
Slovenian: • etinilestradiol, ki se uporablja za preprečevanje nosečnosti (kontracepcijo).