FrancophonIA/ELRC3.0 huggingface dataset:
English: However, disagreement between the member states involved in the procedure regarding the inclusion of children and adolescents remained, and the procedure was referred to the CHMP.
Slovenian: Vendar je ostalo nesoglasje med državami članicami, ki sodelujejo v postopku, glede vključitve otrok in mladostnikov, zato je bil postopek napoten na Odbor za zdravila za uporabo v humani medicini (CHMP).
English: The Applicant stated that growth is divided into 3 distinct age-related phases and that conclusions from studies in one age group cannot be generalised to other age groups.
Slovenian: Predlagatelj je navedel, da se rast razdeli v 3 ločene, od starosti odvisne faze ter da zaključkov iz študij v eni starostni skupini ni mogoče posplošiti na druge starostne skupine.
English: Note, it is not necessary to breathe in at the same time as you spray.
Slovenian: Ni nujno, da sočasno, ko popršite, vdihnete.
English: • if you are a child and are taking high doses of this medicine for a long time, your doctor will check your height regularly
Slovenian: • če ste otrok in jemljete visoke odmerke tega zdravila daljše časovno obdobje, bo vaš zdravnik redno preverjal vašo višino;
English: You should also tell your doctor if you are takng any other medicines such as:
Slovenian: Svojemu zdravniku tudi povejte, če jemljete katerakoli druga zdravila, kot so:
English: For a full therapeutic benefit regular use is essential.
Slovenian: Za popoln terapevtski učinek je nujna redna uporaba zdravila.
English: • irritation of the skin
Slovenian: • razdraženje kože
English: If you notice these symptoms you should contact your doctor immediately.
Slovenian: Če opazite omenjene simptome, se nemudoma posvetujte s svojim zdravnikom.
English: • swollen face, tongue and/or pharynx and/or difficulty to swallow or hives together with difficulties to breathe (angioedema): if this happens you should contact your doctor immediately
Slovenian: • zatekel obraz, jezik in/ali žrelo in/ali težave pri požiranju ali koprivnica skupaj s težavami pri dihanju (angioedem): če se to zgodi, nemudoma obvestite svojega zdravnika.
English: Shake the bottle (figure 1).
Slovenian: Stekleničko pretresite (slika 1).
English: The main metabolites 6-beta-hydroxybudesonide and 16-alpha-hydroxyprednisolon are almost ineffective.
Slovenian: Glavna presnovka 6-beta-hidroksibudezonid in 16-alfa-hidroksiprednizolon sta skoraj neučinkovita.
English: Rare: osteoporosis (with longterm treatment)
Slovenian: Redki: osteoporoza (pri dolgotrajnem zdravljenju)
English: If you were previously treated with steroid tablets or injections but your doctor has now prescribed this medicine instead, you might experience a worsening of some of your other symptoms (eg red and itchy eyes).
Slovenian: Če ste bili predhodno zdravljeni s steroidnimi tabletami ali injekcijami in vam je namesto njih zdravnik zdaj predpisal to zdravilo, boste morda občutili poslabšanje nekaterih drugih simptomov (npr. rdeče in srbeče oči).
English: Budesonide Sandoz has no influence on the ability to drive or use machines.
Slovenian: Budezonid Sandoz nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Maintenance dose It takes 7 to 14 days for this medicine to work.
Slovenian: Da to zdravilo začne delovati, traja 7 do 14 dni.
English: This may cause symptoms such as anorexia, abdominal pain, weight loss, nausea, headache, vomiting, decreased level of consciousness, low blood sugar,levels and seizures.
Slovenian: To lahko povzroči simptome, kot so: anoreksija, bolečine v trebuhu, izguba telesne mase, slabost, glavobol, bruhanje, zmanjšana stopnja zavesti, nizek krvni sladkor in krči.
English: • if you have been taking higher than recommended doses of this medicine: your doctor may prescribe steroid tablets during periods of stress (such if you have an infection) or before an operation
Slovenian: • če jemljete višje odmerke tega zdravila od priporočenih: zdravnik vam bo med stresnim obdobjem (npr. če imate vnetje) ali pred operacijo morda predpisal steroidne tablete;
English: For example, if you have hay fever, start using this medicine about 2 weeks before your hay fever symptoms usually begin to be a problem and stop using this medicine after the end of season of allergen exposure.
Slovenian: Na primer, če imate seneni nahod, začnite zdravilo uporabljati približno 2 tedna preden simptomi senenega nahoda za vas običajno začnejo predstavljati težavo in ga prenehajte uporabljati po koncu sezone izpostavljenosti alergenom.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BUDESONIDE SANDOZ AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA BUDESONIDE SANDOZ IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: Spray into the other nostril in the same way.
Slovenian: Na enak način popršite v drugo nosnico.
English: However, the intravenous pharmacokinetic of budesonide in healthy volunteers and patients with liver cirrhosis is approximately the same.
Slovenian: Farmakokinetika intravenskega budezonida pri zdravih prostovoljcih in bolnikih s cirozo jeter pa je približno enaka.
English: Similar effects are considered unlikely to occur in humans at therapeutic doses.
Slovenian: Ni verjetno, da bi se pri terapevtskih odmerkih pojavili podobni učinki pri ljudeh.
English: Budesonide is eliminated through metabolism, mainly by the enzyme CYP3A4.
Slovenian: Budezonid se izloča s presnavljanjem, v glavnem z encimom CYP3A4.
English: Your doctor might need to check your liver, and as a result, may need to reduce your dose
Slovenian: Zdravnik vam bo preverjal jetra in posledično mogoče znižal odmerek;
English: In the therapeutic equivalence study, systemic exposure was determined indirectly by measurement of 12-h free cortisol in the urine, correcting for creatinine excretion.
Slovenian: V študiji terapevtske enakovrednosti so sistemsko izpostavljenost določali posredno z merjenjem 12-urnega prostega kortizola v urinu s korekcijo glede na izločanje kreatinina.
English: The pharmacokinetics and pharmacodynamics properties of intranasal applied budesonide in children were shown to be comparable to those in adults from all aspects.
Slovenian: Dokazano je bilo, da so farmakokinetične in farmakodinamične lastnosti intranazalno uporabljenega budezonida pri otrocih z vseh vidikov primerljive s tistimi pri odraslih.
English: White homogeneous suspension
Slovenian: Bela, homogena suspenzija.
English: The combination should be avoided as there are no dose recommendations for the combination, but if not possible the time interval between the administrations of the two drugs should be as long as possible.
Slovenian: Ker ni priporočil o odmerkih, se moramo tej kombinaciji izogniti, če pa to ni mogoče, naj bo časovni razmik med aplikacijama teh dveh zdravil čim daljši.
English: Situations which may potentially trigger acute adrenal crisis include trauma, infection, surgery or any rapid reduction in dosage.
Slovenian: Razmere, ki lahko izzovejo akutno adrenalno krizo, so poškodbe, okužbe, operacija ali hitro zmanjšanje odmerka.
English: • The active substance(s) is (are)…
Slovenian: • Zdravilna(e) učinkovina(e) je (so) …
English: In this leaflet:
Slovenian: Ob upoštevanju naslednjega:
English: Because the recommended maximum daily dose of the originator is considerably larger than for Budesonide Sandoz, it must be assumed that the safety of these doses has been assessed in this spopulation.
Slovenian: Ker je največji priporočeni dnevni odmerek originatorskega zdravila precej večji od odmerka zdravila Budesonide Sandoz, je treba predpostaviti, da je bila varnost teh odmerkov v tej populaciji ovrednotena.
English: Make sure you tell your doctor if you are taking ketoconasole tablets, a medicine used to treat fungal infections, such as thrush.
Slovenian: Svojemu zdravniku zagotovo povejte, če jemjete: tablete ketokonazola, zdravila, ki se uporablja za zdravljenje glivičnih okužb, kot je ustni oprh.
English: Orally ingested budesonide is in the first passage rapidly and extensively biotransformed by the liver (90%) to metabolites with lower glucocorticosteroid activity.
Slovenian: Peroralno vzet budezonid se v prvem prehodu hitro in obsežno biotransformira v jetrih (90%) do presnovkov z nižjo glukokortikosteroidno aktivnostjo.
English: Administration of doses higher than recommended (see section 4.2) for a longer period (over months) may result in suppression of hypothalamic-pituitaryadrenal axis.
Slovenian: Aplikacija odmerkov, ki so večji od priporočenih (glejte poglavje 4.2), skozi daljše časovno obdobje (preko več mesecev) ima lahko za posledico supresijo osi hipotalamus-hipofiza-nadledvična žleza.
English: • if you have been taking this medicine continuously for a long time, your doctor will want to examine the inside of your nose at least every six months
Slovenian: • če to zdravilo jemljete neprekinjeno in daljše časovno obdobje, bo zdravnik preveril notranjost vašega nosu najmanj vsakih šest mesecev;
English: When results from growth studies are evaluated, it is important to realise that an effect on growth found in short- or intermediate-term studies is not necessarily equivalent to an effect on final adult height and that height measurements made over a period of less than one year are liable to error and misinterpretation.
Slovenian: Pri vrednotenju rezultatov študij rasti je pomembno upoštevati, da učinek na rast, ugotovljen v kratkoročnih in srednjeročnih študijah, ni nujno enakovreden učinku na končno višino pri odraslih ter da so meritve višine v obdobju, krajšem od enega leta, nagnjene k napakam in napačnemu razlaganju.
English: Pump the nozzle up and down several times (5-10 times), spraying into the air until an even mist is seen.
Slovenian: Nastavek nekajkrat (5-10-krat) potisnite gor in dol, popršite v zrak, da se pokaže enakomerna meglica.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Shake the bottle
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Stekleničko pretresite.
English: Insert the tip of the nozzle into your nostril as shown in figure 3.
Slovenian: Vstavite konico nastavka v nosnico, kot je prikazano na sliki 3.
English: If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained.
Slovenian: Če je rast upočasnjena, je potrebno zdravljenje ponovno pretehtati, in sicer z namenom znižati odmerek nosnega kortikosteroida, če je to mogoče, na najnižji odmerek, pri katerem vzdržujemo učinkovit nadzor simptomov.
English: The Applicant stated that a number of key studies in the paediatric population have indicated that intranasal corticosteroids are effective and well-tolerated and discussed single studies from the literature.
Slovenian: Predlagatelj je navedel, da so številne ključne študije pri pediatrični populaciji nakazale, da so intranazalni kortikosteroidi učinkoviti in se dobro prenašajo, ter razpravljal o posameznih študijah iz literature.
English: Additionally, any dose-related, short-term effects of inhaled corticosteroids on growth velocity identified suggest that compensatory mechanisms are involved.
Slovenian: Poleg tega vsi ugotovljeni od odmerka odvisni, kratkoročni učinki vdihanih kortikosteroidov na hitrost rasti kažejo, da so vpleteni kompenzacijski mehanizmi.
English: Comparable systemic exposure of the test and reference product has not unequivocally been shown in the adult population.
Slovenian: Primerljiva sistemska izpostavljenost testnemu in referenčnemu zdravilu ni bila jasno dokazana pri odrasli populaciji.
English: If you don't experience an immediate relief, you should continue using your medicine regularly as it may take a few days to start working.
Slovenian: Četudi ne boste občutili takojšnjega izboljšanja, nadaljujte z rednim jemanjem tega zdravila, ker lahko traja nekaj dni, preden zdravilo začne delovati.
English: But because therapeutic equivalence has been demonstrated in adults, similarity including safety can be inferred for children, provided that no differences between adults and children are expected.
Slovenian: Ker pa je terapevtska enakovrednost dokazana pri odraslih, lahko o podobnosti, vključno z varnostjo, sklepamo tudi za otroke, če razlike med odraslimi in otroci niso pričakovane.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: • occasional sneezing, dry nose or stinging in your nose
Slovenian: • občasno kihanje, suh nos ali napetost v nosu
English: The Applicant discussed a number of knemometry studies (which measure the length of the lower-leg), concluding that knemometry and short-term growth studies have limitations and do not correlate to long-term growth.
Slovenian: Predlagatelj je razpravljal o številnih knemometričnih študijah (pri katerih so merili dolžino goleni) ter zaključil, da imajo knemometrične študije in študije kratkoročne rasti omejitve in se ne skladajo z dolgoročno rastjo.
English: Question 1a
Slovenian: Vprašanje 1a
English: • troleandomycin, a medicine to treat bacterial infections
Slovenian: • troleandomicin, zdravilo za zdravljenje bakterijskih okužb
English: Uncommon: immediate or delayed hypersensitivity reaction (urticaria, rash, itching, dermatitis, angioedema)
Slovenian: Občasni: takojšnje ali zakasnjene preobčutljivostne reakcije (urtikarija, izpuščaj, srbenje, dermatitis, angioedem)
English: Question 1c
Slovenian: Vprašanje 1c
English: The Applicant stated that the only difference with the originator product is an additional 0.01% of ascorbic acid, a well-characterised chemical substance and a well-established excipient in locally applied products, with no reported adverse effects.
Slovenian: Predlagatelj je navedel, da je edina razlika glede na originatorsko zdravilo dodatek 0,01 % askorbinske kisline, ki je dobro poznana kemikalija ter zelo uveljavljena pomožna snov v lokalno nanesenih zdravilih, zanjo pa ni poročil o neželenih učinkih.
English: The recommended initial dose of 256 micrograms may be administered once daily in the morning or divided into two administrations, in the morning and in the evening.
Slovenian: Priporočen začetni odmerek 256 mikrogramov lahko apliciramo enkrat na dan zjutraj ali razdeljenega na dva odmerka, zjutraj in zvečer.
English: It is possible that these medicines could also increase the concentration of budesonide in your body.
Slovenian: Mogoče je, da tudi ta zdravila zvišajo koncentracijo budezonida v vašem telesu.
English: The most sensitive and accurate methods of detection of systemic corticosteroid bioactivity available (measurement of endogenous cortisol secretion from the adrenal cortex) found measurable effects but only at doses above 400 µg/d.
Slovenian: Z najbolj občutljivimi in natančnimi razpoložljivimi metodami ugotavljanja sistemske bioaktivnosti kortikosteroidov (merjenje endogenega izločanja kortizola iz adrenalnega korteksa) so določili merljive učinke šele pri odmerkih nad 400 µg/dan.
English: The duration of the therapy with Budesonide nasal spray should be restricted to the period of allergen exposure and depends on the nature and the characteristics of the allergen.
Slovenian: Trajanje zdravljenja z zdravilom Budezonid pršilo za nos moramo omejiti na obdobje izpostavljenosti alergenom in je odvisno od narave in lastnosti alergena.
English: Impaired liver function influences the pharmacokinetics of corticosteroids.
Slovenian: Okvarjeno delovanje jeter vpliva na farmakokinetiko kortikosteroidov.
English: Since for nasal application no differences are expected between adults and children with respect to the systemic exposure, no additional measurements of adverse events such as growth retardation are necessary.
Slovenian: Ker za uporabo v nosu med odraslimi in otroci ne pričakujemo razlik v smislu sistemske izpostavljenosti, niso potrebne dodatne meritve neželenih učinkov, kot je zastoj rasti.
English: The CHMP noted the clinical equivalence study and agreed that therapeutic equivalence has been demonstrated in adults, although no formal bioequivalence studies on systemic exposure were performed, neither in adults nor in children.
Slovenian: CHMP je upošteval klinično študijo enakovrednosti in se strinjal, da je terapevtska enakovrednost dokazana pri odraslih, čeprav formalne študije biološke enakovrednosti o sistemski izpostavljenosti niso bile opravljene niti pri odraslih niti pri otrocih.
English: Concomitant administration of other potent inhibitors of CYP3A4 (e.g.: ketoconazol, ciclosporin, ethinylestradiol und troleandomycin) is likely to result in a marked increase of budesonide plasma concentrations.
Slovenian: Sočasna aplikacija drugih močnih zaviralcev CYP3A4 (npr. ketokonazola, ciklosporina, etinilestradiola in troleandomicina) bo verjetno imela za posledico izražene povečane plazemske koncentracije budezonida.
English: • a hole in the cartilage dividing your nostrils
Slovenian: • luknja v hrustancu, ki razmejuje nosnici
English: In continuous long-term treatment, the nasal mucosa should be inspected regularly e.g. every 6 months.
Slovenian: Pri neprekinjenem dolgotrajnem zdravljenju moramo redno, npr. vsakih 6 mesecev, pregledovati nosno sluznico.
English: • if you have problems with your liver because the amount of budesonide could build up in your body.
Slovenian: • če imate težave z jetri, ker se lahko budezonid kopiči v vašem telesu.
English: Question 1b
Slovenian: Vprašanje 1b
English: This medicine does not affect your ability to drive and use machines at the recommended dose (see section 3.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo pri priporočenih odmerkih ne vpliva na vašo sposobnost upravljanja vozil in strojev (glejte poglavje 3.
English: If this happens, first check if the nozzle is primed with medicine (see earlier).
Slovenian: Če se to zgodi, preverite, če je nastavek napolnjen z zdravilom (glejte zgoraj).
English: b.) Children will receive the same dose as adults, most likely exposing this more vulnerable population to higher systemic budesonide concentrations.
Slovenian: b.) Otroci bodo prejeli enak odmerek kot odrasli, kar verjetno pomeni izpostavitev te ranljivejše populacije višjim sistemskim koncentracijam budezonida.
English: Do not stop treatment even if you feel better unless told to by your doctor.
Slovenian: Čeprav se boste počutili bolje, ne prekinjajte zdravljenja, razen, če vam je to naročil zdravnik.
English: Store the bottle in an upright position.
Slovenian: Stekleničko hranite v pokončnem položaju.
English: Budesonide Sandoz and the originator product have the same pharmaceutical form, contain the same amount of active substance and have identical delivery devices.
Slovenian: Zdravilo Budesonide Sandoz in originatorsko zdravilo imata enako farmacevtsko obliko, vsebujeta enako količino zdravilne učinkovine in imata identični pripomoček za odmerjanje.
English: In adults the maximal plasma concentration after administration of 256 micrograms of budesonide is 0,64 nmol/L and is reached within 0,7 hours.
Slovenian: Pri odraslih je največja plazemska koncentracija po aplikaciji 256 mikrogramov budezonida 0,64 nmol/l in je dosežena v 0,7 ure.
English: Therefore, no new or additional aspects concerning the safety for Budesonide Sandoz in the paediatric population can be expected from additional studies.
Slovenian: Zato od dodatnih študij ne moremo pričakovati nobenih novih ali dodatnih vidikov varnosti zdravila Budesonide Sandoz pri pediatrični populaciji.
English: • Never try to unblock the nozzle by using a pin or other sharp object.
Slovenian: • Nikoli ne poskušajte nastavka odstraniti z uporabo igle ali drugega ostrega predmeta.
English: Following intranasal application budesonide is absorbed through nasal and to some extent through gastrointestinal mucosa.
Slovenian: Po intranazalni aplikaciji se budezonid absorbira skozi nosno in do določene mere skozi gastrointestinalno sluznico.
English: Children will receive the same dose as adults, most likely exposing this more vulnerable population to higher systemic budesonide concentrations.
Slovenian: Otroci bodo prejeli enak odmerek kot odrasli, kar verjetno pomeni izpostavitev te ranljivejše populacije višjim sistemskim koncentracijam budezonida.
English: Furthermore, the safety profile of Budesonide Sandoz in the therapeutic equivalence trial was similar to that of both the originator product and the placebo and it is therefore reasonable and justified to assume comparable safety in all target populations, including children ≥ 6 years of age and adolescents.
Slovenian: Poleg tega je bil varnostni profil zdravila Budesonide Sandoz v preskušanju terapevtske enakovrednosti podoben originatorskemu zdravilu in tudi placebu ter je zato razumno in utemeljeno sklepati o primerljivi varnosti v vseh ciljnih populacijah, vključno z otroci, starimi ≥6 let, ter mladostniki.
English: • slightly bloody discharge from your nose
Slovenian: • rahlo krvav izloček iz nosu
English: Spray once (or more if your doctor has told you to).
Slovenian: Enkrat (ali večkrat, če vam je tako naročil zdravnik) popršite.
English: The area under the curve (AUC) after administration of 256 micrograms of Budesonide nasal spray suspension is 2.7 nmol*h/L in adults and 5.5 nmol*h/L in children, indicating a higher systemic exposure in children.
Slovenian: Površina pod krivuljo (AUC) po aplikaciji 256 mikrogramov suspenzije zdravila Budezonid pršilo za nos je 2,7 nmol*h/l pri odraslih in 5,5 nmol*h/l pri otrocih, kar nakazuje na večjo sistemsko izpostavljenost pri otrocih.
English: No better efficacy is to be expected with a dose greater than 256 micrograms.
Slovenian: Pri odmerku, večjem od 256 mikrogramov, ni pričakovati boljše učinkovitosti.
English: This medicinal product contains potassium sorbate and may cause skin reactions (e.g. contact dermatitis).
Slovenian: To zdravilo vsebuje kalijev sorbat in lahko povzroči reakcije na koži (npr. kontaktni dermatitis).
English: An excessive level of systemic glucocorticoids would reduce the endogenous production of cortisol, which can be detected by evaluating basal HPA activity, therefore measurements of HPA function, such as area-under-the curve cortisol concentrations and urinary free cortisol excretion, are considered the most sensitive indicators of INC systemic bioavailability, while stimulation tests of HPA-axis function are not as sensitive in identifying the systemic bioavailability of the INCs, but predict the likelihood of adverse events more accurately.
Slovenian: Čezmerna raven sistemskih glukokortikoidov bi zmanjšala endogeno nastajanje kortizola, kar je mogoče zaznati z vrednotenjem bazalne aktivnosti osi hipotalamushipofiza-nadledvična žleza, zato se meritve funkcije osi hipotalamus-hipofiza-nadledvična žleza, kot sta ploščina pod krivuljo koncentracij kortizola in izločanje prostega kortizola v urinu, štejejo za najobčutljivejše kazalnike sistemske biološke razpoložljivosti intranazalnih kortikosteroidov, medtem ko stimulacijski preskusi funkcije osi hipotalamus-hipofiza-nadledvična žleza niso tako občutljivi za odkrivanje sistemske biološke razpoložljivosti intranazalnih kortikosteroidov, vendar pa lahko natančneje napovejo verjetnost neželenih učinkov.
English: The maximal daily dose of Budesonide Sandoz was determined as being 256 µg/d.
Slovenian: Največji določeni dnevni odmerek zdravila Budesonide Sandoz je 256 µg/dan.
English: How can comparable safety in the paediatric population be concluded based on the facts that: a.) Comparable systemic exposure of the test and reference product has not unequivocally been shown in the adult population.
Slovenian: Kako lahko glede na naslednja dejstva sklepamo o primerljivi varnosti pri pediatrični populaciji: a.) Primerljiva sistemska izpostavljenost testnemu in referenčnemu zdravilu ni bila jasno dokazana pri odrasli populaciji.
English: • increased pressure in the eyes
Slovenian: • povečan očesni tlak