FrancophonIA/ELRC3.0 huggingface dataset:
English: Coccidioidomycosis is a disease with protean manifestations.
Slovenian: Kokcidioidomikoza je bolezen z različnimi manifestacijami.
English: Invasive candidiasis in children
Slovenian: Invazivna kandidiaza pri otrocih
English: Diflucan (fluconazole) is indicated in the following fungal infections (see section 5.1).
Slovenian: Zdravilo Diflucan (flukonazol) je indicirano za naslednje glivične okužbe (glejte poglavje 5.1).
English: The CHMP accepted that the data presented by the MAH was satisfactory for these indications.
Slovenian: CHMP je potrdil, da so podatki, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, za te indikacije zadovoljivi.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Slovenian: • obseg napotitve je bil uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
English: • Coccidioidomycosis (see section 4.4).
Slovenian: • kokcidioidomikoze (glejte poglavje 4.4);
English: It is most often associated with severe immunological impairment due to diabetes mellitus, leukaemia, lymphoma, malignancy, neutropenia and HIV infection where it presents as a predictor of clinical progression to AIDS.
Slovenian: Najpogosteje je povezana s hudimi imunskimi okvarami zaradi sladkorne bolezni, levkemije, limfoma, rakavih obolenj, nevtropenije in okužb z virusom HIV, pri čemer predstavlja napovednik za klinično napredovanje bolezni v AIDS.
English: More extensive information has been added in section 4.5 of the SPC.
Slovenian: Obsežnejše informacije so bile vključene v poglavje 4.5 povzetka glavnih značilnosti zdravila.
English: The CHMP concluded that continuous therapy with fluconazole at 100 mg/day and continuous or intermittent therapy at 200 mg/day are effective in preventing relapse of oropharyngeal or oesophageal candidiasis in immunocompromised patients and are well tolerated.
Slovenian: CHMP je ugotovil, da sta neprekinjeno zdravljenje z flukonazolom z odmerkom 100 mg/dan in neprekinjeno ali občasno zdravljenje z odmerkom 200 mg/dan učinkovita pri preprečevanju ponovitve orofaringealne ali ezofagealne kandidiaze pri imunsko oslabljenih bolnikih, ki so zdravljenje tudi dobro prenašali.
English: Fluconazole has been used to treat invasive candida infections in children.
Slovenian: Flukonazol se je uporabljal za zdravljenje invazivnih okužb s kandido pri otrocih.
English: The CHMP agreed that fluconazole should be indicated for the treatment of chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
Slovenian: CHMP se je strinjal z indikacijo flukonazola za zdravljenje kronične oralne atrofične kandidiaze (razjede v ustih), kadar zobna higiena ali topično zdravljenje ne zadostujeta.
English: Fluconazole has demonstrated in vitro and in vivo efficacy against Cryptococcus neoformans and providing clinicians with a treatment option that is less toxic than amphotericin B. Fluconazole has been established as a safe and effective antifungal therapy in healthy and immunocompromised patients with cryptococcal meningitis and there are clinical data supporting fluconazole as treatment in children and adults.
Slovenian: Pri flucozanolu je bila dokazana in vitro in in vivo učinkovitost proti Cryptococcus neoformans, kar zdravnikom ponuja možnost zdravljenja z zdravilom, ki je manj toksično kot amfotericin B. Flukonazol je dokazano varno in učinkovito protiglivično zdravilo pri zdravljenju zdravih in imunsko oslabljenih bolnikov s kriptokoknim meningitisom, obstajajo pa tudi klinični podatki, ki podpirajo uporabo flukonazola za zdravljenje otrok in odraslih.
English: 50 mg, 100 mg, 150 mg and 200 mg capsule, 5 mg/mL syrup, 50 mg/5mL or 200 mg/5 mL powder for oral suspension, 2 mg/mL solution for infusion.
Slovenian: Kapsule 50 mg, 100 mg, 150 mg in 200 mg, sirup 5 mg/ml, prašek za peroralno suspenzijo 50 mg/5ml ali 200 mg/5 ml, raztopina za infundiranje 2 mg/ml.
English: The CHMP agreed that the data available are sufficient for the safe and efficacious use of fluconazole for the treatment and prevention of the mycosal (oropharyngeal and oesophageal) candidiasis in children.
Slovenian: CHMP je potrdil, da razpoložljivi podatki ustrezno potrjujejo varno in učinkovito uporabo flukonazola pri zdravljenju in preprečevanju mikozne (orofaringealne in ezofagealne) kandidiaze pri otrocih.
English: However as the first line treatment of this candidiasis is the topical application, the one 150 mg capsule presentation is specifically indicated for the above genital candidiasis indications in adults when local therapy is not appropriate.
Slovenian: Kljub temu pa je zdravilo prvega izbora te kandidiaze topična uporaba zdravila in ena kapsula 150 mg flukonazola je posebej indicirana za prej navedene indikacije genitalne kandidiaze pri odraslih, kadar lokalno zdravljenje ni primerno.
English: The CHMP noted the MAH proposal and adopted a harmonised text for this section, applicable to all Diflucan formulations.
Slovenian: CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo za to poglavje, ki velja za vse formulacije zdravila Diflucan.
English: The final Package Leaflet wording was adopted by the CHMP.
Slovenian: Končno besedilo navodila za uporabo je sprejel CHMP.
English: Fluconazole is effective as a treatment against fungal infections in adults across the dose range recommended in national SPCs (50-400 mg daily).
Slovenian: Flukonazol je učinkovit pri zdravljenju glivičnih okužb pri odraslih z različnimi odmerki, priporočenimi v nacionalnih povzetkih glavnih značilnosti zdravila (50-400 mg).
English: The solubility characteristic allows oral as well as intravenous administration.
Slovenian: Njegova topnost omogoča tako peroralno kot intravensko uporabo.
English: Fluconazole also exhibits activity in vitro against Cryptococcus species.
Slovenian: Flukonazol deluje tudi in vitro proti vrstam Cryptococcus.
English: • Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.
Slovenian: • vaginalne kandidiaze, akutne ali ponavljajoče se, kadar lokalno zdravljenje ni primerno;
English: Overall, the use of fluconazole as a prophylaxis agent to prevent breakthrough fungal infections in neutropenic patients was established in the original application.
Slovenian: Na splošno je bila uporaba flukonazola kot profilaktičnega zdravila za preprečevanje izbruhov glivičnih okužb pri nevtropeničnih bolnikih dokazana pri prvotni vlogi.
English: Fluconazole is approved to treat acute or recurrent vulvovaginal candidiasis in women and candidal balanitis in men.
Slovenian: Flukozanol je odobren za zdravljenje akutne ali ponavljajoče se vulvovaginalne kandidiaze pri ženskah in kandidnega balanitisa pri moških.
English: The MAH was asked to evaluate all other sections of the nationally approved SPCs and suggest appropriate changes in the text where divergences exist.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj oceni vsa ostala poglavja nacionalno odobrenih povzetkov glavnih značilnosti zdravila in v primerih razlik med besedili predlaga potrebne spremembe.
English: The CHMP considered that the treatment of invasive candidiasis in children is sufficiently demonstrated.
Slovenian: CHMP je menil, da je zdravljenje invazivne kandidiaze pri otrocih ustrezno dokazano.
English: It was also agreed by the CHMP that the MAH provided sufficient data on the efficacy and safety of fluconazole in invasive fungal infections (cryptococcosis, invasive candidiasis) as compared to other therapeutic options and demonstrated a favourable benefit/risk ratio.
Slovenian: CHMP se je strinjal, da je imetnik dovoljenja za promet z zdravilom predložil zadostne podatke o učinkovitosti in varnosti flukonazola pri zdravljenju invazivnih glivičnih okužb (kriptokokoza, invazivna kandidiaza) v primerjavi z drugimi možnostmi zdravljenja ter dokazal pozitivno razmerje med koristmi in tveganjem.
English: The CHMP concluded that fluconazole with its activity against Candida species and its pharmacokinetics offers a safe, effective, and convenient alternative to topical therapy in a single-dose regimen for both candidal vaginitis and candidal balanitis in adults as well as for the prevention of the recurrence of vaginal candidiasis.
Slovenian: CHMP je ugotovil, da delovanje flukonazola proti vrstam Candida in njegov farmakokinetični profil zagotavljata varno, učinkovito in primerno nadomestno možnost zdravljenja namesto topičnega zdravljenja, in sicer z enojnim odmerkom tako za kandidni vaginitis in kandidni balanitis pri odraslih kot za preprečevanje ponovitev vaginalne kandidiaze.
English: The CHMP noted the MAH proposal and adopted a harmonised text for this section.
Slovenian: CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo za to poglavje.
English: In conclusion, based on the assessment of the MAH proposal and responses and following the discussions of the committee, the CHMP adopted harmonised sets of Product Information documents for the various presentations of Diflucan and associated names, taking into account the pharmaceutical forms.
Slovenian: CHMP je na osnovi ocene predlogov in odgovorov imetnika dovoljenja za promet z zdravilom ter po razpravi znotraj Odbora ob upoštevanju farmacevtskih oblik sprejel usklajene sklope dokumentacije informacij o zdravilu za različne oblike zdravila Diflucan in povezanih imen.
English: • Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.
Slovenian: • dermatomikoze, vključno s tinea pedis, tinea corporis, tinea cruris, tinea versicolor in kožne kandidne okužbe, kadar je potrebno sistematsko zdravljenje;
English: The CHMP accepted that the supporting data were only for the indication of cryptococcal meningitis which was implemented in the SPC and not the general cryptococcosis indication.
Slovenian: CHMP je potrdil, da podatki podpirajo samo indikacijo kriptokokni meningitis, kar je tudi navedeno v povzetku glavnih značilnosti zdravila, ne pa tudi splošne indikacije kriptokokoze.
English: Diflucan is indicated in adults for the treatment of:
Slovenian: Zdravilo Diflucan je indicirano pri odraslih za preprečevanje:
English: Finally and summarising here the CHMP adopted the following sets of indications for Diflucan and associated names for capsules (50mg, 100mg, 150mg, 200mg), solution for infusion (IV), syrup, powder for oral suspension.
Slovenian: CHMP je tako sprejel naslednje sklope indikacij za zdravilo Diflucan in povezana imena za kapsule (50 mg, 100 mg, 150 mg, 200 mg), raztopino za infundiranje (i.v.
English: Powder for Suspension
Slovenian: ), sirup, prašek za peroralno suspenzijo.
English: In the paediatric population fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), systemic candidiasis and cryptococcal infections and the prevention of fungal infection in at-risk immunocompromised children following cytotoxic chemotherapy or radiotherapy.
Slovenian: Pri pediatrični populaciji se flukonazol uporablja za zdravljenje mukozne kandidiaze (orofaringealna, ezofagealna), sistemske kandidiaze in kriptokoknih okužb ter za preprečevanje glivičnih okužb pri ogroženih, imunsko oslabljenih otrocih po citotoksični kemoterapiji ali radioterapiji.
English: Diflucan (fluconazole) is indicated in the following fungal infections in adults (see section 5.1):
Slovenian: Zdravilo Diflucan (flukonazol) je indicirano za naslednje glivične okužbe (glejte poglavje 5.1):
English: • Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
Slovenian: • kronične oralne atrofične kandidiaze (razjede v ustih), kadar zobna higiena ali topično zdravljenje ne zadostujeta;
English: Doses of 3 mg/Kg in children have proved effective against fungal infections in immunocompromised children and also for the treatment of paediatric patients with serious fungal infections, such as cryptococcal meningitis.
Slovenian: Zaradi tega je režim odmerjanja pri otrocih enak kakor pri odraslih Odmerek 3 mg/kg se je pokazal učinkovit pri zdravljenju glivičnih okužb pri imunsko oslabljenih otrocih in pri zdravljenju pediatričnih bolnikov s hudimi glivičnimi okužbami, kot je na primer kriptokokni meningitis.
English: Following all the changes in the SPC there are several corresponding changes to the Package Leaflet After the corrections were implemented a Readability Testing was performed which was submitted and assessed during the referral procedure.
Slovenian: Po vnosu popravkov je bil izveden tudi test berljivosti, ki je bil nato predložen in ocenjen v napotitvenem postopku.
English: Dermatomycoses include Tinea pedis, Tinea corporis, Tinea cruris, Tinea versicolor, Tinea unguinium (onychomycosis) and dermal Candida infections.
Slovenian: Dermatomikoze vključujejo tinea pedis, tinea cruris, tinea versicolor, tinea unguinium (onikomikoza) in kožne okužbe s Candido.
English: The indication of relapse prevention in immunocompromised (HIV and cancer) patients was investigated.
Slovenian: Preučevali so tudi indikacijo za preprečevanje ponovitev pri imunsko oslabelih (HIV in rakavih) bolnikih.
English: As the treatment of genital candidiasis requires a single 150 mg dose of fluconazole, a convenient presentation containing a single 150 mg fluconazole capsule is available in some Member States (MSs) only for the indication of genital candidiasis, more specifically for the treatment of acute vaginal candidiasis and candidal balanitis.
Slovenian: Zdravljenje genitalne kandidiaze poteka z enojnim 150-miligramskim odmerkom flukonazola in v nekaterih državah članicah je na voljo priročna oblika kapsule, ki vsebuje 150-miligramski odmerek, samo za indikacijo genitalne kandidiaze, natančneje za zdravljenje akutne vaginalne kandidiaze in kandidnega balanitisa.
English: The CHMP noted that adolescent posology had been omitted; none of the national SPCs described the posology for this age group.
Slovenian: CHMP je menil, da odmerjanje pri mladostnikih manjka, saj v nobenem nacionalnem povzetku glavnih značilnosti zdravila ni bilo opisano odmerjanje za to starostno skupino.
English: Moreover fluconazole has become established as a standard treatment for the prevention of breakthrough infections in neutropenic patients.
Slovenian: Flukonazol je tako postal uveljavljen kot običajno zdravilo za preprečevanje izbruhov okužb pri nevtropeničnih bolnikih.
English: The pharmacokinetic profile of fluconazole in children has a well understood relationship to that in adults when volume of distribution and clearance are taken into account.
Slovenian: Farmakokinetični profil flukozanola je glede volumna porazdelitve in očistka pri otrocih razumljen podobno kot pri odraslih.
English: The indication of the genital candidiasis and more specifically the vulvovaginal candidiasis in adult women and the candidal balanitis in adult men was authorised in some MS for the 150 mg, one capsule presentation due to the convenience of one dose treatment.
Slovenian: V nekaterih državah članicah je za indikacijo genitalne kandidiaze, in sicer natančneje vulvovaginalne kandidiaze pri odraslih ženskah in kandidnega balanitisa pri odraslih moških, odobreno zdravljenje s 150-miligramsko kapsulo zaradi prikladnosti zdravljenja z enim odmerkom.
English: For the 150 mg, one capsule presentation
Slovenian: Ena kapsula, 150 mg
English: These studies demonstrated that oral fluconazole is an effective and well-tolerated antimycotic agent against Tinea corporis, Tinea cruris, Tinea pedis, Tinea versicolor and onychomycosis.
Slovenian: Te študije so pokazale, da je peroralna uporaba flukonazola učinkovita in da se flukonazol kot antimikotik pri inea corporis, tinea cruris, tinea pedis,
English: The results are supportive of fluconazole as an appropriate treatment for mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
Slovenian: Rezultati podpirajo flukonazol kot primerno zdravljenje za kandidiazo sluznic, vključno z orofaringealno in ezofagealno kandidiazo, kandidurijo in kronično mukokutano kandidiazo.
English: For the one 150 mg capsule presentation the section 4.1 of the SPC is agreed by the CHMP as follows:
Slovenian: Za obliko 150-miligramskih kapsul je CHMP potrdil naslednje besedilo v poglavju 4.1 povzetka glavnih značilnosti zdravila:
English: N/A
Slovenian: DODATEK II
English: The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Slovenian: Pregledani so bili metoda, statistični pristop in predloženi podatki.
English: Diflucan is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients.
Slovenian: Zdravilo Diflucan se uporablja za zdravljenje mukozne kandidiaze (orofaringealne, ezofagealne), invazivne kandidiaze, kriptokoknega meningitisa in za preprečevanje kandidnih okužb pri imunsko oslabljenih bolnikih.
English: The CHMP agreed that fluconazole is indicated in the prophylaxis of candidal infections in immunocompromised children.
Slovenian: CHMP je potrdil, da se flukonazol indicira za preprečevanje kandidnih okužb pri imunsko oslabljenih otrocih.
English: Oral use
Slovenian: Navodilo za uporabo
English: Fluconazole is available for oral use in the 50 mg, 100 mg, 150 mg and 200 mg capsule formulation, in the 5 mg/mL syrup formulation, and in the 50 mg or 200 mg/5 mL powder for oral suspension on reconstitution with water formulation.
Slovenian: Flukozanol je na voljo za peroralno uporabo v obliki 50-, 100-, 150- in 200-miligramskih kapsul, v obliki sirupa 5 mg/ml ter v obliki praška za peroralno suspenzijo, ki se pripravi z rekonstitucijo z vodo.
English: • Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
Slovenian: • mukozne kandidiaze, vključno z orofaringealno in ezofagealno kandidiazo, kandidurijo ter kronično mukokutano kandidiazo;
English: The CHMP is in agreement in separating the treatment from the prophylaxis of the relapse on Oropharyngeal Candidiasis and presenting the posology accordingly.
Slovenian: CHMP se je strinjal z ločitvijo zdravljenja in profilakso ponovitev pri orofaringealni kandidiazi ter v skladu s tem tudi z navedbo odmerjanja.
English: The inclusion of the wording on the interaction of itraconazole (another triazole) in the PI of saquinavir and taking into account the recent labelling changes for saquinavir (contraindication for concomitant administration with other QTc interval prolonging drugs) was amended.
Slovenian: Ob upoštevanju nedavnih sprememb označevanja za sakvinavir (kontraindicirana sočasna uporaba z drugimi zdravili, ki podaljšujejo interval QTc) je bila v informacije o zdravilni učinkovini sakvinavir dopolnjena vključitev besedila o medsebojnem delovanju z itrakonazolom (drugi triazol).
English: 2 mg/ml
Slovenian: v obliki 2 mg/ml solne raztopine.
English: The Core Safety Profile was considered when harmonising the listed adverse reactions between national SPCs of Diflucan.
Slovenian: Pri usklajevanju navedenih neželenih učinkov med nacionalnimi povzetki glavnih značilnosti zdravila Diflucan se je upošteval Glavni varnostni profil.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Diflucan and associated names (see Annex I).
Slovenian: • povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet, so bili ocenjeni na osnovi predložene dokumentacije in znanstvene razprave v Odboru;
English: • Candidal balanitis when local therapy is not appropriate.
Slovenian: • kandidnega balanitisa, kadar lokalno zdravljenje ni primerno;
English: Fluconazole and amphotericin B were associated with similar clinical response rates and survival in the treatment of candidemia; however, drug-related adverse events were more frequent with amphotericin B. The CHMP concluded that fluconazole is a safe and effective medicinal product in prophylaxis or treatment for invasive candidiasis compared to other therapies.
Slovenian: Vendar pa so bili neželeni učinki, povezani z uporabo zdravila, pogostejši pri amfotericinu B. CHMP je sklenil, da je flukonazol varno in učinkovito zdravilo za preprečevanje ali zdravljenje invazivne kandidiaze v primerjavi z drugimi zdravili.
English: (onychomycosis) it was concluded that fluconazole is indicated only when other agents are not considered appropriate.
Slovenian: Dogovorjeno je bilo, da se pri tinea unguinium (onikomikoza) flukozanol uporablja samo, kadar druga zdravila niso primerna.
English: Fluconazole is available also for intravenous (IV) use in the 2 mg/mL saline solution formulation.
Slovenian: Flukonazol je na voljo tudi za intravensko uporabo (i.v.)
English: Prophylaxis of candidal infections in immunocompromised children Data supporting the indication for fluconazole prevention of fungal infection in immunocompromised patients in the paediatric International Registration Dossier (1993) were derived from three studies in children; one study determined the efficacy of fluconazole versus nystatin therapy alone, one study versus oral polyenes (nystatin or amphotericin B) and the third study versus ketoconazole.
Slovenian: Podatki v podporo flukonazolu pri indikaciji za preprečevanje glivičnih okužb pri imunsko oslabljenih bolnikih v pediatrični Dokumentaciji za registracijo zdravil (1993) so bili pridobljeni iz treh študij z otroki.
English: • Acute vaginal candidiasis when local therapy is not appropriate.
Slovenian: • akutna vaginalna kandidiaza, kadar lokalno zdravljenje ni primerno; • kandidni balanitis, kadar lokalno zdravljenje ni primerno.
English: Concomitant use of fluconazole with saquinavir was contraindicated accordingly with a cross reference to section 4.3 of the PI. Concomitant use of fluconazole with saquinavir was contraindicated accordingly with a cross reference to section 4.3 of the PI. All the above changes were accepted by the CHMP and apply to all formulations.
Slovenian: Sočasna uporaba flukonazola s sakvinavirjem je bila kontraindicirana v skladu s sklicem na poglavje 4.3
English: Pharmaceutical form
Slovenian: informacij o zdravilu.
English: Date of first authorisation: 12 September 2008 Date of latest renewal: 9 April 2013
Slovenian: Datum prve odobritve: 12. september 2008 Datum zadnjega podaljšanja: 9. april 2013
English: Safety features will be implemented until 9/2/2019.
Slovenian: Zaščitni elementi bodo uvedeni do 9. 2. 2019
English: Out of these 87 patients, 82.8% did not change their dose, 13.8% increased and 3.4% decreased their dose.
Slovenian: Od teh 87 bolnikov jih 82,8 % ni spremenilo odmerka, 13,8 % ga je povečalo, 3,4 % pa zmanjšalo.
English: In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Slovenian: V odprtih nadaljevalnih preskušanjih, ki so trajala več kot tri leta, ni bilo znakov upadanja učinkovitosti.
English: The absolute bioavailability is greater than 90%.
Slovenian: Absolutna biološka uporabnost je več kot 90 %.
English: Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol.
Slovenian: Bodite previdni, če jemljete kakršnakoli zdravila, ki vas pomirijo (imajo sedativni učinek), ali če pijete alkohol.
English: In this case, you will have to take the tablets only once or twice a day.
Slovenian: V tem primeru boste tablete jemali samo 1-krat ali 2-krat na dan.
English: Please note:
Slovenian: Opomba: