FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used in adults (older than 18 years of age) to treat eosinophilic oesophagitis, which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food.
Slovenian: Uporabljamo ga pri odraslih (starejših od 18 let) za zdravljenje eozinofilnega ezofagitisa, ki je vnetna bolezen požiralnika, ki povzroča težave pri požiranju hrane.
English: Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity.
Slovenian: Zaviranje vnetnega odziva in delovanja imunskega sistema poveča tako bolnikovo dovzetnost za okužbe kot resnost okužb.
English: Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg Germany
Slovenian: Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg
English: Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effect, the maximal concentration of budesonide in plasma has to be expected to be higher in the treatment with Jorveza compared to inhaled budesonide.
Slovenian: Čeprav podatki o uporabi inhalacijskega budezonida pri velikem številu izpostavljenih nosečnosti niso pokazali neželenih učinkov, lahko pri zdravljenju z zdravilom Jorveza pričakujemo višjo najvišjo plazemsko koncentracijo budezonida kot pri inhalacijskem budezonidu.
English: Alu / Alu-blister.
Slovenian: Alu/alu pretisni omot.
English: When ketoconazole was administered approximately 12 hours after budesonide, the plasma concentration of budesonide increased approximately 3-fold.
Slovenian: Ob dajanju ketokonazola približno 12 ur za budezonidom se je plazemska koncentracija budezonida povečala za približno 3-krat.
English: Reduced liver function may affect the elimination of budesonide, causing higher systemic exposure.
Slovenian: Zmanjšano delovanje jeter lahko vpliva na izločanje budezonida, kar povzroča večjo sistemsko izpostavljenost.
English: The orodispersible tablet should not be taken with liquid or food.
Slovenian: Orodisperzibilne tablete se ne sme vzeti s tekočino ali hrano.
English: If you stop taking Jorveza
Slovenian: Če ste prenehali jemati zdravilo Jorveza
English: Therefore, concomitant use should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.
Slovenian: Zato se je treba sočasni uporabi izogibati, razen kadar koristi odtehtajo povečano tveganje za sistemske neželene učinke kortikosteroidov.
English: − inflammation of the pancreas, which causes severe pain in the belly and back
Slovenian: − vnetje trebušne slinavke, ki povzroča hude bolečine v trebuhu in hrbtu;
English: Pseudotumor cerebri including papilloedema in adolescents
Slovenian: Bolezni živčevja cerebralni psevdotumor, vključno z edemom papile pri mladostnikih
English: The safety and efficacy of Jorveza in children and adolescents under the age of 18 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Jorveza pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: Symptoms of infections can be atypical or masked.
Slovenian: Simptomi okužb so lahko atipični ali prikriti.
English: In the treatment of EoE with Jorveza, budesonide inhibits antigen-stimulated secretion of many pro-inflammatory signal molecules such as thymic stromal lymphopoeitin, interleukin-13 and eotaxin-3 in the esophageal epithelium, which results in a significant reduction of the esophageal eosinophilic inflammatory infiltrate.
Slovenian: Pri zdravljenju EoE z zdravilom Jorveza budezonid zavira antigensko stimulirano izločanje številnih provnetnih signalnih molekul, kot so timusni stromalni limfopoetin, interlevkin 13 in eotaksin 3 v ezofagealnem epiteliju, kar povzroči znatno zmanjšanje ezinofilnih vnetnih infiltratov v požiralniku.
English: − diabetes, or if somebody in your family has diabetes
Slovenian: (katarakta) ali če ima kdo v družini glavkom,
English: - The other ingredients are disodium hydrogen citrate, docusate sodium, macrogol 6000, magnesium stearate, mannitol, anhydrous monosodium citrate, povidone K25, sodium hydrogen carbonate and sucralose (see also section 2, ”Jorveza contains sodium”).
Slovenian: - Druge sestavine zdravila so dinatrijev hidrogencitrat, natrijev dokusat, makrogol 6000, magnezijev stearat, manitol, brezvodni mononatrijev citrat, povidon K25, natrijev hidrogenkarbonat in sukraloza (glejte tudi konec poglavja 2 »Zdravilo Jorveza vsebuje natrij«).
English: INFORMATION IN BRAILLE Jorveza 1mg
Slovenian: PODATKI V BRAILLOVI PISAVI Jorveza 1 mg
English: During treatment of patients with hepatic impairment with other budesonide containing products, budesonide levels were increased.
Slovenian: Okvara jeter Med zdravljenjem bolnikov z okvaro jeter z drugimi zdravili, ki vsebujejo budezonid, so bile ravni budezonida povečane.
English: Because budesonide is not excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with the same doses as patients without renal impairment.
Slovenian: Ker se budezonid ne izloča skozi ledvice, je pri bolnikih z blago do zmerno okvaro morda potrebna previdnost pri zdravljenju z enakimi odmerki kot pri bolnikih brez okvare ledvic.
English: Adverse reactions observed in clinical studies with Jorveza are listed in the table below, by MedDRA system organ class and frequency.
Slovenian: Neželeni učinki, opaženi v kliničnih študijah z zdravilom Jorveza so navedeni v spodnji preglednici, po organskem sistemu MedDRA in pogostnosti.
English: − general feeling of being ill.
Slovenian: - splošno slabo počutje.
English: − if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Jorveza: - če ste alergični na budezonid ali katero koli sestavino zdravila (navedeno v poglavju 6).
English: The orodispersible tablet should be taken after a meal.
Slovenian: Orodisperzibilno tableto je treba vzeti po obroku.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medicalprescription .
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom.
English: If you have any problem with your kidney or liver, talk to your doctor.
Slovenian: Če imate težave z ledvicami ali jetri, se posvetujte z zdravnikom.
English: You should not drink grapefruit juice whilst you are taking this medicine as this can worsen its side effects.
Slovenian: Med zdravljenjem z zdravilom Jorveza ne smete piti soka grenivke, ker to lahko poslabša neželene učinke zdravila.
English: Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)
Slovenian: Žilne bolezni povečano tveganje za trombozo, vaskulitis (odtegnitveni sindrom po dolgotrajnem zdravljenju)
English: Jorveza is not recommended for use in patients with severe renal impairment.
Slovenian: Uporaba zdravila Jorveza se ne priporoča pri bolnikih s hudo okvaro ledvic.
English: Do not take this medicine if you are breast-feeding unless you have checked with your doctor.
Slovenian: Tega zdravila ne uporabljajte, če dojite, razen če ste se posvetovali z zdravnikom.
English: − weakening of the bones (osteoporosis), bone damage due to poor circulation of blood
Slovenian: − tanjšanje kosti (osteoporoza), poškodba kostnega tkiva zaradi slabega pretoka krvi (osteonekroza);
English: If you have any liver disease, you should not take Jorveza.
Slovenian: Če imate kakršno koli bolezen jeter, ne smete uporabljati zdravila Jorveza.
English: If indicated, symptomatic candidiasis of the mouth and throat can be treated with topical or systemic anti-fungal therapy whilst still continuing treatment with Jorveza.
Slovenian: Če je indicirano, se simptomatska kandidiaza ust in žrela lahko zdravi z lokalno ali sistemsko antimikotično terapijo, medtem ko se zdravljenje z zdravilom Jorveza nadaljuje.
English: Budesonide is a non-halogenated glucocorticosteroid, which acts primarily anti-inflammatory via binding to the glucocorticoid receptor.
Slovenian: Budezonid je nehalogenirani glukokortikosteroid, ki deluje primarno protivnetno, tako da se veže na glukokortikoidni receptor.
English: Openlabel extension of the treatment with 1 mg budesonide orodispersible tablet twice daily for further 6 weeks in patients without remission in the double-blind phase increased the rate of patients with clinico-pathologic remission to 84.7%.
Slovenian: Odprto podaljšanje zdravljenja z 1 mg budezonida v obliki orodisperzibilne tablete dvakrat dnevno za dodatnih 6 tednov pri bolnikih brez remisije v dvojno slepi fazi je povečalo delež bolnikov s klinično-patološko remisijo na
English: What you need to know before you take Jorveza
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Jorveza
English: The median elimination half-life is 2 - 3 hours in healthy subjects (receiving 1 mg budesonide) and 4 - 5 hours in EoE patients (receiving 4 mg budesonide).
Slovenian: Mediani razpolovni čas izločanja pri zdravih osebah (ki so prejele 1 mg budezonida) je 2 do 3 ure, pri bolnikih z EoE (ki so prejeli 4 mg budenozida) pa 4 do 5 ur.
English: The mean peak plasma concentration (± standard deviation) was 0.44 ± 0.31 ng/mL, the area under the plasma-concentration-time curve (AUC0-12) was 1.44 ± 0.31 hr*ng/mL.
Slovenian: Srednja največja plazemska koncentracija (± standardni odklon) je bila 0,44 ± 0,31 ng/ml, površina pod krivuljo plazemske koncentracije v času (AUC0-12) je bila 1,44 ± 0,31 ure*ng/ml.
English: reduced potassium level in the blood (hypokalaemia), irregular periods in women, unwanted body hair in women, impotence, stretch marks on the skin, acne.
Slovenian: zmanjšana količina kalija v krvi (hipokaliemija), neredne menstruacije pri ženskah, neželena poraščenost pri ženskah, impotenca, strije na koži, akne; - upočasnjena rast pri otrocih;
English: Each orodispersible tablet contains 26 mg sodium.
Slovenian: Ena orodisperzibilna tableta vsebuje 26 mg natrija.
English: Budesonide undergoes extensive biotransformation by CYP3A4 in the mucosa of the small intestine and in the liver to metabolites of low glucocorticosteroid activity.
Slovenian: Budezonid je podvržen obsežni biotransformaciji s CYP3A4 v sluznici tankega črevesja in v jetrih, pri čemer nastanejo presnovki s šibkim glukokortikosteroidnim delovanjem.
English: Co-treatment with potent CYP3A inhibitors such as ketoconazole, ritonavir, itraconazole, clarithromycin, cobicistat and grapefruit juice may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions.
Slovenian: Zaviralci CYP3A4 Sočasno zdravljenje z močnimi zaviralci CYP3A, kot so ketokonazol, ritonavir, itrakonazol, klaritromicin kobicistat in sok grenivke, lahko povzročijo izrazito povečanje koncentracije budezonida v plazmi in pričakuje se povečano tveganje za sistemske neželene učinke.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew or swallow.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Ne žvečite ali pogoltnite.
English: Kidney and liver problems
Slovenian: Težave z ledvicami in jetri
English: This medicinal product contains 52 mg of sodium per daily dose equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 52 mg natrija na dnevni odmerek, kar je enako 2,6 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: There are no data on the effect of budesonide on human fertility.
Slovenian: Ni podatkov o vplivu budezonida na plodnost pri človeku.
English: Your doctor will help you decide whether you should continue treatment and not breast-feed or if you should stop treatment over the period your baby is being breast-fed.
Slovenian: Zdravnik vam bo pomagal pri odločitvi, ali naj nadaljujete z zdravljenjem in prekinete dojenje ali pa prekinete zdravljenje v času, ko otroka dojite.
English: Single dose pharmacokinetic data in fasted patients with EoE are available with 4 mg budesonide: Median lag-time was 0.00 hours (range 0.00 - 0.17), median time to peak plasma concentration was 1.00 hour (range 0.67 - 2.00 hours); peak plasma concentration was 2.56 ± 1.36 ng/mL, and AUC0-12 was 8.96 ± 4.21 hr*ng/mL.
Slovenian: Farmakokinetični podatki o enkratnih odmerkih pri bolnikih z EoE na tešče so na voljo za 4 mg budezonida: mediana zakasnitve je bila 0,00 ure (razpon 0,00-0,17), mediana časa do največje plazemske koncentracije je bila 1,00 uro (razpon 0,67-2,00 uri); največja plazemska koncentracija je bila 2,56±1,36 ng/ml in AUC0-12 je bila 8,96 ± 4,21 ure*ng/ml.
English: Concommitant use of glucocorticoids may result in enhanced potassium excretion and aggravated hypokalaemia.
Slovenian: Sočasna uporaba z glukokortikoidi lahko povzroči povečano izločanje kalija in poslabša hipokaliemijo.
English: Fertility was unaffected following budesonide treatment in animal studies (see section 5.3).
Slovenian: V študijah na živalih zdravljenje z budezonidom ni vplivalo na plodnost (glejte poglavje 5.3).
English: − rash, red spots from bleeding in the skin, delayed wound healing, skin reactions such as contact dermatitis, bruising
Slovenian: - izpuščaj, rdeče lise zaradi kožnih krvavitev, upočasnjeno celjenje ran, kožne reakcije, kot je kontaktni dermatitis, podplutbe;
English: The following side effects have been reported and are typical with medicines similar to Jorveza (corticosteroids), and can therefore also occur with this medicine.
Slovenian: Za zdravila, ki so podobna zdravilu Jorveza (kortikosteroidi), so poročali o naslednjih neželenih učinkih, ki so značilna zanje, zato se lahko pojavijo tudi pri tem zdravilu.
English: − Cushing's syndrome, which is associated with too much corticosteroid and causes roundness of the face, weight gain, high blood sugar, build-up of fluid in the tissues (e.g. swollen legs),
Slovenian: - povečano tveganje za okužbe; - Cushingov sindrom, ki je povezan s preveč kortikosteroida in povzroča okrogel obraz, povečanje telesne mase, visoke vrednosti sladkorja v krvi, kopičenje tekočine v tkivih (npr. zatečene noge),
English: − oestrogens (used for hormone replacement therapy or contraception)
Slovenian: - estrogeni (za nadomeščanje hormonov ali preprečevanje nosečnosti).
English: Jorveza comes in blisters in packs with 20, 30, 60, 90 or 100 orodispersible tablets.
Slovenian: Zdravilo Jorveza je na voljo v pretisnih omotih po 20, 30, 60, 90 in 100 orodisperzibilnih tablet.
English: − tingling or numbness in your mouth
Slovenian: - mravljinčenje ali otrplost v ustih;
English: The orodispersible tablet should not be chewed or swallowed undissolved.
Slovenian: Orodisperzibilne tablete se ne sme žvečiti ali pogoltniti neraztopljene.
English: − If you need to be vaccinated please speak to your doctor first.
Slovenian: - Če se morate cepiti, se pred tem posvetujte z zdravnikom.
English: Increased risk of infection
Slovenian: Bolezni imunskega sistema povečano tveganje za okužbe
English: A relevant proportion of budesonide is metabolised in the liver by CYP3A4.
Slovenian: Pomemben delež budezonida se presnovi v jetrih s CYP3A4.
English: The action of glycoside can be potentiated by potassium deficiency which is a potential and known adverse reaction of glucocorticoids.
Slovenian: Srčni glikozidi Pomanjkanje kalija lahko poveča učinek glikozidov, kar je možen in znan neželeni učinek glukokortikoidov.
English: Budesonide had no mutagenic effects in a number of in vitro and in vivo tests.
Slovenian: Budezonid v številnih in vitro ter in vivo testih ni imel mutagenih učinkov.
English: In the clinical study BUL-1/EEA, a total of 10 out of 87 patients (11.5%) exposed to Jorveza (double-blind and open-label extension phase) experienced cases of suspected fungal infections associated with clinical symptoms, which were all of mild intensity, except in one patient for whom a moderate intensity was reported.
Slovenian: V klinični študiji BUL-1/EEA se je sum na primere glivičnih okužb, povezanih s kliničnimi simptomi, pojavil pri skupno 10 od 87 bolnikov (11,5 %), ki so bili izpostavljeni zdravilu Jorveza (dvojno slepa in odprta podaljšana faza), ki pa so bile vse blage jakosti, razen pri enemu bolniku,
English: The volume of distribution following administration of 1 mg budesonide to healthy subjects was 35.52 ± 14.94 L/kg and 42.46 ± 23.90 L/kg following administration of 4 mg budesonide to patients with EoE.
Slovenian: Porazdelitveni volumen po dajanju 1 mg budezonida zdravim osebam je bil 35,52 ±14,94 l/kg, po dajanju 4 mg budezonida bolnikom z EoE pa 42,46 ± 23,90 l/kg.
English: Clearance of budesonide is about 1315 L/hour/kg in healthy subjects and 6.54 ± 4.4 L/hour/kg in EoE patients.
Slovenian: Očistek budezonida pri zdravih osebah je približno 13-15 l/uro/kg, pri bolnikih z EoE pa 6,54 ± 4,4 l/uro/kg.
English: LIST OF EXCIPIENTS Contains sodium, see leaflet for further information.
Slovenian: Vsebuje natrij, za več informacij glejte navodilo.
English: Keep taking your medicine until your doctor tells you to stop, even if you feel better.
Slovenian: dokler vam zdravnik ne naroči, da prenehajte, čeprav se boste morda že prej počutili bolje.
English: Metabolism of budesonide is decreased in EoE patients compared to healthy subjects resulting in increased plasma concentrations of budesonide.
Slovenian: Presnova budezonida je pri bolnikih z EoE v primerjavi z zdravimi osebami zmanjšana, kar povzroči povečane plazemske koncentracije budezonida.
English: Glaucoma, cataract (including subcapsular cataract), blurred vision, central serous chorioretinopathy (CSCR) (see also section 4.4)
Slovenian: Očesne bolezni glavkom, katarakta (vključno s subkapsularno katarakto), zamegljen vid, centralna serozna horioretinopatija (glejte tudi poglavje 4.4)
English: If you do come into contact with chickenpox or shingles, see your doctor straight away.
Slovenian: Če pa ste kljub temu prišli v stik z osebo, ki ima norice ali herpes zoster, nemudoma obiščite zdravnika.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: Posodobljen RMP je treba predložiti: na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik
English: Take the carton and this leaflet with you if possible.
Slovenian: Če je mogoče, vzemite s seboj škatlico tega zdravila z navodili.
English: If you miss a dose, just take the next dose at the usual time.
Slovenian: Če ste pozabili vzeti zdravilo Jorveza Če ste pozabili vzeti odmerek, nadaljujte z naslednjim odmerkom ob običajnem času.
English: Preclinical data in acute, subchronic and chronic toxicological studies with budesonide showed atrophies of the thymus gland and adrenal cortex and a reduction especially of lymphocytes.
Slovenian: Predklinični podatki na osnovi študij akutne, subkronične in kronične toksičnosti budezonida so pokazali atrofijo priželjca in skorje nadledvične žleze, predvsem pa zmanjšano število limfocitov.
English: MedDRA system organ class Very common
Slovenian: Organski sistem MedDRA Zelo pogosti
English: Any oral solutions, sprays or chewable tablets should be used at least 30 minutes before or after administration of Jorveza.
Slovenian: Vse peroralne raztopine, pršila ali žvečljive tablete je treba uporabiti vsaj 30 minut pred uporabo zdravila
English: − pain in the upper part of your belly
Slovenian: - bolečina v zgornjem delu trebuha;
English: In a randomised, placebo-controlled, double-blind phase III clinical study including 88 adult patients with active EoE (randomisation rate: 2:1), 1 mg budesonide given twice daily as an orodispersible tablet for 6 weeks induced clinico-pathologic remission (defined as both peak of < 16 eosinophils/mm2 high power field in esophageal biopsies and no or only minimal symptoms of dysphagia or pain during swallowing) in 34 out of 59 patients (57.6%) versus 0/29 patients (0%) in the placebo-group.
Slovenian: 88 odraslih bolnikov z aktivnim EoE (randomizacija 2:1), je 6-tedensko dajanje 1 mg budezonida dvakrat dnevno v obliki orodisperzibilne tablete sprožilo klinično-patološko remisijo (opredeljena kot vrh < 16 eozinofilcev/mm2 v vidnem polju mikroskopa pri veliki povečavi pri ezofagealnih biopsijah ter kot stanje brez prisotnih simptomov ali le z minimalnimi simptomi disfagije ali bolečine med požiranjem) pri
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY}
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 08. januar 2018
English: How to take Jorveza
Slovenian: Kako jemati zdravilo Jorveza
English: Systemic effects of glucocorticosteroids (e.g., Cushing's syndrome, adrenal suppression, growth retardation, cataract, glaucoma, decreased bone mineral density and a wide range of psychiatric effects) may occur (see also section 4.8).
Slovenian: Lahko se pojavijo sistemski učinki glukokortikosteroidov (npr. Cushingov sindrom, adrenalna supresija, zastoj rasti, katarakta, glavkom, zmanjšana mineralna gostota kosti in širok razpon psihiatričnih učinkov)
English: Patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataract, family history of diabetes or family history of glaucoma may be at higher risk of experiencing systemic glucocorticosteroid adverse reactions (see below and section 4.8) and should therefore be monitored for the occurrence of such effects.
Slovenian: glavkomom, katarakto, sladkorno boleznijo v družinski anamnezi ali glavkomom v družinski anamnezi je morda tveganje za sistemske neželene učinke glukokortikosteroidov večje (glejte spodaj in poglavje 4.8), zato jih je treba spremljati glede morebitnega pojava teh učinkov.
English: In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause foetal death and abnormalities of foetal development (smaller litter size, intrauterine growth retardation of foetuses and skeletal abnormalities).
Slovenian: Raziskave so pokazale, da tako kot drugi glukokortikosteroidi tudi budezonid pri brejih živalih povzroča smrt ploda in motnje v razvoju ploda (manjše število mladičev, intrauterini zastoj rasti ploda in anomalije skeleta).
English: Each orodispersible tablet contains 1 mg of budesonide.
Slovenian: Ena orodisperzibilna tableta vsebuje 1 mg budezonida.
English: NAME OF THE MEDICINAL PRODUCT Jorveza 1 mg orodispersible tablets
Slovenian: IME ZDRAVILA Jorveza 1 mg orodisperzibilne tablete
English: Budesonide is eliminated only in marginal if any amounts by the kidney.
Slovenian: Skozi ledvice se budezonid izloča le v zelo majhnih količinah, če sploh.
English: Ketoconazole 200 mg once daily orally increased the plasma concentration of budesonide (3 mg single dose) approximately 6-fold during concomitant administration.
Slovenian: Med sočasno uporabo peroralnega ketokonazola 200 mg enkrat dnevno in budezonida (3 mg enkratni odmerek) se je plazemska koncentracija budezonida povečala za približno 6-krat.
English: No such effect has been observed with budesonide and concomitant intake of low-dose combination oral contraceptives.
Slovenian: Pri jemanju budezonida in sočasnem jemanju peroralnih nizkoodmernih kombiniranih kontraceptivov tega učinka niso opazili.
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Slovenian: Pri sistemski in lokalni uporabi kortikosteroidov lahko poročajo o motnjah vida.
English: No studies have been conducted with Jorveza in patients with impaired liver function.
Slovenian: Študij z zdravilom Jorveza pri bolnikih z okvaro delovanja jeter niso izvedli.