FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in children (a paediatrician or paediatric neurologist).
Slovenian: Zdravljenje z zdravilom Diacomit mora potekati pod nadzorom zdravnika, specializiranega za diagnosticiranje in obravnavo epilepsije pri otrocih (pediatra ali pediatričnega nevrologa).
English: What is the risk associated with Diacomit?
Slovenian: Kakšna tveganja so povezana z zdravilom Diacomit?
English: Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).
Slovenian: Podobni rezultati so bili ugotovljeni tudi v drugi študiji, kjer se je na zdravljenje odzvalo 67 % bolnikov (8 bolnikov od 12), ki so prejeli zdravilo Diacomit , in 9 % bolnikov (1 bolnik od 9), ki so prejemali placebo.
English: The CHMP concluded that Diacomit had shown its effectiveness in SMEI, albeit studies were limited and did not last as long as the Committee expected.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je zdravilo Diacomit pokazalo učinkovitost proti hudi mioklonični epilepsiji v otroštvu, četudi samo v študijah, ki so bile omejene in niso trajale tako dolgo, kot je Odbor pričakoval.
English: Because the number of patients with SMEI is low, the disease is considered ‘rare', and Diacomit was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
Slovenian: Ker je bolnikov s hudo mioklonično epilepsijo v otroštvu malo, velja ta bolezen za redko, zato je bilo zdravilo Diacomit 5. decembra 2001 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Diacomit is used in children with a very rare type of epilepsy called ‘severe myoclonic epilepsy in infancy' (SMEI), also known as Dravet's syndrome.
Slovenian: Zdravilo Diacomit se uporablja pri otrocih z zelo redko vrsto epilepsije, imenovano huda mioklonična epilepsija v otroštvu (SMEI), znana tudi kot Dravetov sindrom.
English: Decisions regarding the use of Diacomit in younger children should be made on a patient-by-patient basis: it can only be given to younger children if the diagnosis of SMEI has been confirmed.
Slovenian: Odločitev o uporabi zdravila Diacomit pri mlajših otrocih je treba sprejeti za vsak primer posebej: mlajšim otrokom se lahko daje le, če je bila diagnoza hude mioklonične epilepsije v otroštvu potrjena.
English: Diacomit must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations).
Slovenian: Zdravilo Diacomit se prav tako ne sme uporabljati pri bolnikih z anamnezo psihoz (hudih duševnih stanj z motenim dojemanjem stvarnosti) z napadi delirija (duševnim stanjem zmedenosti, razburjenosti, nemirnosti in halucinacij).
English: Care must be taken when Diacomit is used at the same time as other medicines.
Slovenian: Pri sočasnem jemanju zdravila Diacomit z drugimi zdravili je potrebna previdnost.
English: Diacomit is used as an add-on to clobazam and valproate (other anti-epileptic medicines) to treat generalised tonic-clonic seizures (major fits, including loss of consciousness) when these are not adequately controlled with clobazam and valproate.
Slovenian: Zdravilo Diacomit se uporablja kot dodatek klobazamu in valproatu (drugima zdraviloma za epilepsijo) pri zdravljenju generaliziranih tonično-kloničnih epileptičnih napadov (hudih napadov, ki vključujejo izgubo zavesti), če teh ni mogoče zadostno nadzorovati s klobazamom in valproatom.
English: For the full list of all side effects reported with Diacomit, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Diacomit, glejte navodilo za uporabo.
English: Why has Diacomit been approved?
Slovenian: Zakaj je bilo zdravilo Diacomit odobreno?
English: The studies compared Diacomit capsules or sachets with placebo (a dummy treatment), when they were added to the children's existing treatment with clobazam and valproate.
Slovenian: V študijah so učinkovitost kapsul ali vrečk zdravila Diacomit primerjali z učinkovitostjo placeba (zdravila brez zdravilne učinkovine), ki so jih dodajali otrokovemu obstoječemu zdravljenju s klobazamom in valproatom.
English: How has Diacomit been studied?
Slovenian: Kako je bilo zdravilo Diacomit raziskano?
English: How does Diacomit work?
Slovenian: Kako zdravilo Diacomit deluje?
English: What is Diacomit used for?
Slovenian: Za kaj se zdravilo Diacomit uporablja?
English: How is Diacomit used?
Slovenian: Kako se zdravilo Diacomit uporablja?
English: What is Diacomit?
Slovenian: Kaj je zdravilo Diacomit?
English: In particular:
Slovenian: Še posebno:
English: This will usually take about two minutes.
Slovenian: To običajno traja približno dve minuti.
English: The frequency of these events is currently not known:
Slovenian: Pogostnost teh neželenih učinkov trenutno ni znana:
English: There is no specific antidote.
Slovenian: Specifičnega protistrupa ni.
English: Do not take a smaller amount.
Slovenian: Ne smete vzeti manjšega.
English: This will ensure that your medicine works properly.
Slovenian: Tako boste zagotovili, da vaše zdravilo deluje pravilno.
English: Subsequent treatment should be symptomatic and supportive.
Slovenian: Naknadno zdravljenje mora biti simptomatsko in podporno.
English: Plasma protein binding is on average 85-90%.
Slovenian: Njegova vezava na plazemske beljakovine je v povprečju od 85 do 90 %.
English: The effects of these illnesses can be much more severe during treatment with this medicine.
Slovenian: Učinki teh bolezni so lahko med zdravljenjem s tem zdravilom veliko resnejši.
English: Press it gently against the roof of your mouth with your tongue until it has dissolved completely (this usually takes about two minutes).
Slovenian: Z jezikom jo nežno pritisnite ob ustno nebo, dokler se popolnoma ne raztopi (to običajno traja približno dve minuti).
English: Please also report your vaccination status to your doctor.
Slovenian: Zdravnika obvestite tudi o svojem statusu cepljenja.
English: The use of this medicine in children younger than 18 years of age has not yet been studied.
Slovenian: Uporaba tega zdravila pri otrocih, mlajših od 18 let, še ni raziskana.
English: In case of short-term overdose no emergency medical treatment is required.
Slovenian: V primeru kratkotrajnega prevelikega odmerka ni potrebno nujno zdravljenje.
English: However, no systematic data are available.
Slovenian: Vendar pa sistematični podatki niso na voljo.
English: In patients who have not had these diseases, the vaccination status should be checked, and particular care should be taken to avoid exposure.
Slovenian: Pri bolnikih, ki teh bolezni še niso imeli, je treba preveriti stanje cepljenosti in posvetiti posebno pozornost, da ne pride do izpostavljenosti.
English: Your doctor will decide on the appropriate measures and if it is still all right for you to take this medicine.
Slovenian: Zdravnik se bo odločil o primernih ukrepih in ali je še vedno prav, da jemljete to zdravilo.
English: If you have any of the conditions mentioned above you may be at increased risk of side effects.
Slovenian: Če imate katero od zgoraj navedenih bolezni, je morda pri vas povečano tveganje za neželene učinke.
English: The symptoms of some infections can be unusual or less noticeable.
Slovenian: Simptomi določenih okužb so lahko neobičajni ali manj opazni.
English: In case your symptoms do not get better in the first 6 weeks of treatment, you may need to take this medicine for up to 6 more weeks.
Slovenian: Če se vaši simptomi ne izboljšajo v prvih 6 tednih zdravljenja, boste to zdravilo morda morali jemati še do 6 tednov.
English: For patients who are not appropriately responding during 6 weeks the treatment can be extended to up to 12 weeks.
Slovenian: Za bolnike, ki se v teh 6 tednih ne odzivajo ustrezno, se zdravljenje lahko podaljša do največ 12 tednov.
English: Your treatment should last about 6 to 12 weeks.
Slovenian: Zdravljenje bo trajalo približno 6 do 12 tednov.
English: The antibody response to other vaccines may be diminished.
Slovenian: Odziv protiteles na druga cepiva je morda zmanjšan.
English: Some of these medicines may increase the effects of Jorveza and your doctor may wish to monitor you carefully if you are taking these medicines.
Slovenian: Nekatera od teh zdravil lahko povečajo učinek zdravila Jorveza in zdravnik vas bo morda želel skrbno spremljati, če jemljete ta zdravila.
English: Place the orodispersible tablet on the tip of your tongue and close your mouth.
Slovenian: Orodisperzibilno tableto položite na konico jezika in zaprite usta.
English: White, round, biplane orodispersible tablet, with diameter of 7.1 mm and height of 2.2 mm.
Slovenian: Bela, okrogla, ploščata orodisperzibilna tableta s premerom 7,1 mm in višino 2,2 mm.
English: Take one orodispersible tablet in the morning and one orodispersible tablet in the evening.
Slovenian: Eno orodisperzibilno tableto vzemite zjutraj in eno orodisperzibilno tableto zvečer.
English: The total number of infections (including those diagnosed by endoscopy and histology without symptoms) was 33, occurring in 27 out of 87 patients (31%).
Slovenian: Skupno število okužb (vključno z diagnosticiranimi z endoskopijo in histologijo brez simptomov) je bilo 33, pojavile pa so se pri 27 od 87 bolnikov (31%).
English: Your doctor will decide how long you are to continue the treatment, depending on your condition and your response to the treatment.
Slovenian: Vaš zdravnik bo presodil, kako dolgo morate nadaljevati zdravljenje, kar je odvisno od vaše bolezni in vašega odziva na zdravljenje.
English: However, no systematic study investigating different levels of hepatic impairment is available.
Slovenian: Vendar pa sistematične študije za preučitev različnih ravni okvare jeter niso na voljo.
English: Patients with hepatic impairment should not be treated (see sections 4.4 and 5.2).
Slovenian: Bolnikov z okvaro jeter se ne sme zdraviti (glejte poglavji 4.4 in 5.2).
English: − Tell your doctor if you have not yet had measles and/or if and when you have received your last vaccination for this disease.
Slovenian: - Povejte zdravniku, če še niste preboleli ošpic in/ali kdaj ste prejeli zadnje cepljenje za to bolezen.
English: The treatment with this medicinal product should be initiated by a physician experienced in the diagnosis and treatment of eosinophilic esophagitis.
Slovenian: Zdravljenje s tem zdravilom mora začeti zdravnik z izkušnjami v diagnosticiranju in zdravljenju eozinofilnega ezofagitisa.
English: Take the following precautions during treatment with Jorveza because your immune system may be weakened:
Slovenian: Med zdravljenjem z zdravilom Jorveza upoštevajte naslednje previdnostne ukrepe, ker je vaš imunski sistem lahko oslabljen:
English: It is important that you do not stop taking your medicine without talking to your doctor.
Slovenian: Pomembno je, da zdravila ne prenehate jemati, ne da bi se posvetovali z zdravnikom.
English: Budesonide passes in small amounts into the breast milk.
Slovenian: Budezonid v majhnih količinah prehaja v materino mleko.
English: − Keep away from people who have chickenpox or herpes zoster (shingles) if you have not had these infections.
Slovenian: - Izogibajte se osebam, ki imajo norice ali herpes zoster (pasovec), če sami še niste imeli teh okužb.
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 2,6 % največjega priporočenega dnevnega vnosa natrija za odraslo osebo.
English: − mood changes, such as depression, irritability or euphoria
Slovenian: - spremembe razpoloženja, kot so depresija, razdražljivost ali evforija;
English: Budesonide had no effect on fertility in rats.
Slovenian: Budezonid ni vplival na plodnost pri podganah.
English: Jorveza with food and drink
Slovenian: Zdravilo Jorveza skupaj s hrano in pijačo
English: − Tell your doctor if you get fungal infections in the mouth, throat and gullet or if you think you have any infection during treatment with this medicine.
Slovenian: - Zdravniku povejte, če se pojavi glivična okužba v ustih, žrelu in požiralniku, ali če menite, da imate med zdravljenjem s tem zdravilom kakšno okužbo.
English: Use as directed by the physician.
Slovenian: Uporabljajte v skladu z navodili zdravnika.
English: Systemic effects of glucocorticosteroids
Slovenian: Sistemski učinki glukokortikosteroidov
English: Do not take this medicine during pregnancy without checking with your doctor first.
Slovenian: Tega zdravila ne uporabljajte med nosečnostjo, ne da bi se najprej posvetovali z zdravnikom.
English: There should be at least 30 minutes before eating or drinking or performing oral hygiene.
Slovenian: Vzeti jo je treba najmanj 30 minut pred obrokom ali pijačo oziroma opravljanjem ustne higiene.
English: Patients showed a 35% increase in peak plasma concentrations and a 60% increase in AUC0-12 compared to healthy subjects.
Slovenian: Pri bolnikih se je pokazalo 35-% povečanje največje plazemske koncentracije in 60-% povečanje vrednosti AUC0-12 v primerjavi z zdravimi osebami.
English: EU/1/17/1254/003 EU/1/17/1254/004 EU/1/17/1254/005
Slovenian: EU/1/17/1254/001 EU/1/17/1254/002 EU/1/17/1254/003 EU/1/17/1254/004 EU/1/17/1254/005
English: The co-administration of live vaccines and glucocorticosteroids should be avoided as this is likely to reduce the immune response to vaccines.
Slovenian: Izogibati se je treba sočasni uporabi živih cepiv in glukokortikosteroidov, saj je verjetno, da se bo imunski odziv na cepiva zmanjšal.
English: Jorveza could affect the results of adrenal function tests (ACTH stimulation test) ordered by your doctor or in hospital.
Slovenian: Zdravilo Jorveza lahko vpliva na rezultate preiskav delovanja nadledvične žleze (stimulacijski test z ACTH), ki jih naroči vaš zdravnik ali jih opravijo v bolnišnici.
English: If you have taken too many orodispersible tablets on one occasion, take your next dose as prescribed.
Slovenian: Če ste enkrat vzeli preveč orodisperzibilnih tablet, naslednjič vzemite predpisani odmerek.
English: Patients with hepatic impairment should therefore not be treated.
Slovenian: Bolnikov z okvaro jeter se zato ne sme zdraviti.
English: Frequencies are defined as 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) or not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki
English: These side effects depend on the duration of treatment, concomitant and previous glucocorticosteroid treatment and the individual sensitivity.
Slovenian: Ti neželeni učinki so odvisni od trajanja zdravljenja, sočasnega in predhodnega zdravljenja z glukokortikosteroidi in občutljivosti posameznika.
English: There are currently no data available for patients with renal impairment.
Slovenian: Trenutno ni na voljo podatkov za bolnike z okvaro ledvic.
English: Do not take this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Slovenian: Tega zdravila ne smete jemati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu, poleg oznake »EXP«.
English: EU/1/17/1254/001 (20 orodispersible tablets) EU/1/17/1254/002 (30 orodispersible tablets) EU/1/17/1254/003 (60 orodispersible tablets) EU/1/17/1254/004 (90 orodispersible tablets) EU/1/17/1254/005 (100 orodispersible tablets)
Slovenian: EU/1/17/1254/001 (20 orodisperzibilnih tablet) EU/1/17/1254/002 (30 orodisperzibilnih tablet) EU/1/17/1254/003 (60 orodisperzibilnih tablet) EU/1/17/1254/004 (90 orodisperzibilnih tablet) EU/1/17/1254/005 (100 orodisperzibilnih tablet)
English: The risk of adverse reactions (systemic glucocorticosteroid effects) will be increased.
Slovenian: Tveganje za neželene učinke (sistemski učinki glukokortikosteroidov) bo večje.
English: The usual duration of treatment is 6 weeks.
Slovenian: Zdravljenje običajno traja 6 tednov.
English: It should be placed on the tip of the tongue and gently pressed against the top of the mouth, where it will dissolve.
Slovenian: Treba jo je položiti na konico jezika in jo nežno pritisniti ob ustno nebo, kjer se raztopi.
English: 20 orodispersible tablets 30 orodispersible tablets 60 orodispersible tablets 90 orodispersible tablets 100 orodispersible tablets
Slovenian: 20 orodisperzibilnih tablet 30 orodisperzibilnih tablet 60 orodisperzibilnih tablet 90 orodisperzibilnih tablet 100 orodisperzibilnih tablet
English: Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Slovenian: Zdravilo Jorveza je indicirano za zdravljenje eozinofilnega ezofagitisa (EoE) pri odraslih (starejših od 18 let).
English: Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).
Slovenian: Ker zdravljenje z budezonidom lahko zavira delovanje nadledvične žleze, lahko stimulacijski test z ACTH za diagnostiko insuficience hipofize pokaže napačne rezultate (nizke vrednosti).
English: CYP3A5 does not contribute significantly to the metabolism of budesonide.
Slovenian: CYP3A5 ne prispeva bistveno k presnovi budezonida.
English: Jorveza may cause typical side effects of corticosteroid medicines and may affect all parts of the body, particularly when you take this medicine at high doses and over a long time (see section 4).
Slovenian: Zdravilo Jorveza lahko povzroči značilne neželene učinke kortikosteroidnih zdravil, ki lahko vplivajo na vse dele telesa, še posebej pri uporabi velikih odmerkov tega zdravila dalj časa (glejte poglavje 4).
English: Further precautions during treatment with Jorveza − Contact your doctor if you get blurred vision or have other problems with your vision.
Slovenian: Dodatni previdnostni ukrepi med zdravljenjem z zdravilom Jorveza - Obvestite zdravnika, če se vam pojavi zamegljen vid ali druge težave z vidom.
English: Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see section 4.5).
Slovenian: Izogibajte se sočasnemu zdravljenju s ketokonazolom ali drugimi zaviralci CYP3A4 (glejte poglavje 4.5)
English: When patients are subject to surgery or other stresses, supplementary systemic glucocorticosteroid treatment is therefore recommended.
Slovenian: Če so bolniki izpostavljeni kirurškemu posegu ali drugim stresnim dejavnikom, je zato priporočljivo dodatno sistemsko glukokortikosteroidno zdravljenje.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z budenozidom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, corticosteroids acting locally, ATC code: A07EA06
Slovenian: Farmakoterapevtska skupina: antidiaroiki, protivnetna in protimikrobna zdravila, kortikosteroidi z lokalnim delovanjem, oznaka ATC: A07EA06
English: Other medicines and Jorveza
Slovenian: Druga zdravila in zdravilo Jorveza
English: − ketoconazole or itraconazole (to treat fungal infections)
Slovenian: - ketokonazol ali itrakonazol (za zdravljenje glivičnih okužb),
English: The glucocorticosteroid activity of the major metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is less than 1% of that of budesonide.
Slovenian: Glukokortikosteroidna aktivnost njegovih poglavitnih presnovkov, 6β-hidroksibudezonida in 16α-hidroksiprednizolona, je manjša od 1 % aktivnosti budezonida.
English: If you have a kidney problem, your doctor will decide if Jorveza is suitable for you.
Slovenian: Če imate težave z ledvicami, se bo zdravnik odločil, ali je uporaba zdravila Jorveza za vas primerna.
English: Jorveza has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Jorveza nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Chickenpox, herpes zoster and measles can have a more serious course in patients treated with glucocorticosteroids.
Slovenian: Norice, herpes zoster in ošpice lahko imajo resnejši potek pri bolnikih, zdravljenih z glukokortikosteroidi.
English: Jorveza should not be used in children and adolescents under 18 years of age.
Slovenian: Zdravila Jorveza se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: Following administration of Jorveza, budesonide is rapidly absorbed.
Slovenian: Absorpcija Po dajanju zdravila Jorveza se budezonid hitro absorbira.
English: These measures ensure optimal exposure of the esophageal mucosa to the active substance.
Slovenian: Ti ukrepi zagotavljajo optimalno izpostavljenost ezofagealne sluznice učinkovini.
English: This medicine contains 52 mg sodium (main component of cooking/table salt) per daily dose.
Slovenian: To zdravilo vsebuje 52 mg natrija (glavna sestavina kuhinjske/namizne soli) na dnevni odmerek.
English: Pack sizes: 20, 30, 60, 90 or 100 orodispersible tablets.
Slovenian: Velikosti pakiranj 20, 30, 60, 90 ali 100 orodisperzibilnih tablet.
English: − decreased amount of the hormone cortisol in your blood.
Slovenian: - utrujenost; - zmanjšana količina hormona kortizola v krvi.
English: Oestrogens, oral contraceptives
Slovenian: Estrogeni, peroralni kontraceptivi
English: Symptoms of fungal infection can be white spots in the mouth and throat and difficulty in swallowing.
Slovenian: Simptomi glivične okužbe so lahko bele pike v ustih in žrelu ter težave pri požiranju.
English: The recommended daily dose is 2 mg budesonide as one 1-mg-tablet in the morning and one in the evening.
Slovenian: Priporočeni dnevni odmerek je 2 mg budezonida v obliki ene 1-mg tablete zjutraj in ene zvečer.
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Slovenian: Če se pri bolniku pojavijo simptomi, kot so zamegljen vid ali druge motnje vida, je potrebno razmisliti o napotitvi k oftalmologu zaradi ovrednotenja možnih vzrokov, ki lahko vključujejo katarakto, glavkom ali redke bolezni, kot je centralna serozna horioretinopatija, o katerih so poročali po sistemski in lokalniuporabi kortikosteroidov.
English: If you take more Jorveza than you should
Slovenian: Če ste vzeli večji odmerek zdravila Jorveza, kot bi smeli
English: − If you know that you are due to have an operation please tell your doctor that you are taking Jorveza.
Slovenian: - Če veste, da boste operirani, povejte zdravniku, da jemljete zdravilo Jorveza.
English: The recommended dose is two orodispersible tablets (2 mg budesonide) per day.
Slovenian: Priporočeni odmerek je dve orodisperzibilni tableti (2 mg budezonida) na dan.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca , odgovornega za sproščanje serij
English: Depression, irritability, euphoria, psychomotor hyperactivity, anxiety, aggression
Slovenian: Psihiatrične motnje depresija, razdražljivost, evforija, psihomotorična hiperaktivnost, anksioznost, agresija
English: − liver disease.
Slovenian: - bolezen jeter.
English: In clinical studies conducted with Jorveza oral, oropharyngeal and esophageal candida infections have been observed with a high frequency (see section 4.8).
Slovenian: V kliničnih študijah z zdravilom Jorveza so opazili oralne, orofaringealne in ezofagealne okužbe s kandido z veliko pogostnostjo (glejte poglavje 4.8).