FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the abovementioned products (and its associated names), the European Commission notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the European Union.
Slovenian: Zaradi različnih nacionalnih odločitev držav članic o odobritvi dovoljenj za promet z zgoraj navedenim zdravilom (in povezanih imen) je Evropska komisija obvestila sekretariat CHMP/ EMA o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, z namenom razrešitve nesoglasij med nacionalnimi povzetki glavnih značilnosti zdravila in s tem uskladitve različnih povzetkov glavnih značilnosti zdravila v EU.
English: It was also generally well tolerated and there were no changes of clinical significance at doses of up to and including 400 mg/day.
Slovenian: Na splošno se je zdravilo dobro prenašalo in ni bilo nobene klinično pomembne razlike pri odmerkih do (in vključno s) 400 mg/dan.
English: Diflucan can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4).
Slovenian: Zdravilo Diflucan se lahko uporablja kot vzdrževalno zdravljenje za preprečevanje ponovitev kriptokoknega meningitisa pri otrocih z visokim tveganjem za ponovitve (glejte poglavje 4.4).
English: Several different dosing regimens were employed, 100 mg/day, 200 mg/day and 200 mg three times/week.
Slovenian: Uporabljenih je bilo več različnih načinov odmerjanja, in sicer 100 mg/dan, 200 mg/dan in 200 mg trikrat/teden.
English: Candidemia occurs in up to 12% of HIV-infected children with chronically indwelling central venous catheters for total parental nutrition or intravenous antibiotics.
Slovenian: Kandidemija se pojavlja pri do 12 % otrok, okuženih z virusom HIV, s stalno vstavljenim centralnim venskim katetrom za celovito prehranjevanje ali intravensko dajanje antibiotikov.
English: The general text of frequencies classification, and the adverse reaction obtained from post-marketing experience were clarified, and the frequency of a number of events was revised.
Slovenian: Splošno besedilo o razvrstitvi pogostnosti in opis neželene reakcije, pridobljen iz obdobja trženja zdravila, sta bila preoblikovana v jasnejšo obliko in popravljene so bile pogostnosti več reakcij.
English: Consideration should be given to official guidance on the appropriate use of antifungals.
Slovenian: Upoštevajte tudi uradne smernice za ustrezno uporabo antimikotikov .
English: The CHMP assessed the Product Information of the product taking into account the current national ones and the existing scientific knowledge and discussed the indications for each individual medical condition.
Slovenian: CHMP je ocenil informacije o zdravilu, pri čemer je upošteval veljavne nacionalne informacije o zdravilu in obstoječe strokovno znanje ter preučil indikacije za vsako posamezno zdravstveno stanje.
English: • Relapse of cryptococcal meningitis in patients with high risk of recurrence.
Slovenian: • ponovitve kriptokoknega meningitisa pri bolnikih z visokim tveganjem za ponovitve;
English: Based on the above, the CHMP considers the benefit/risk ratio of Diflucan and associated names to be favourable and the harmonised Product Information documents to be approvable.
Slovenian: Na osnovi navedenega je CHMP menil, da je razmerje med koristmi in tveganji za zdravilo Diflucan in povezana imena ugodno ter da se dokumentacija usklajenih informacij o zdravilu lahko odobri.
English: Section 4.4 - Special warnings and precaution for use
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi
English: • Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation (see section 5.1)).
Slovenian: • kandidnih okužb pri bolnikih z dolgotrajno nevtropenijo (kot so bolniki s hematološkimi malignimi boleznimi, ki prejemajo kemoterapijo, ali pri prejemnikih transplantata krvotvornih matičnih celic (glejte poglavje 5.1)).
English: Furthermore the CHMP is of the opinion, that the safety and efficacy for indication of genital candidiasis has not been established in the paediatric population as all available data in children and adolescents are from studies in other indications rather than genital candidiasis.
Slovenian: CHMP je menil tudi, da varnost in učinkovitost za indikacijo genitalna kandidiaza pri pediatrični populaciji nista bili dokazani, saj vsi razpoložljivi podatki za otroke in mladostnike izhajajo iz študij o drugih indikacijah, in ne za genitalno kandidiazo.
English: In addition, the pharmacokinetic profile of fluconazole enables its use as a single agent due to its prolonged elimination half-life of approximately 36 hours and its distribution into vaginal tissues and secretions, with concentrations above the minimum inhibitory concentration for C. albicans persisting for at least 72 hours.
Slovenian: Poleg tega pa farmakokinetični profil flukonazola omogoča njegovo samostojno uporabo zaradi podaljšanega razpolovnega časa izločanja, ki traja okoli 36 ur, in njegove porazdelitve v vaginalna tkiva in izločke, pri čemer ostajajo koncentracije nad minimalno inhibitorno koncentracijo za C.albicans vsaj 72 ur.
English: Other conditions which pose an increased risk include certain lymphomas (e.g. Hodgkin's lymphoma), sarcoidosis, and patients on long-term corticosteroid therapy.
Slovenian: Druga stanja, ki predstavljajo povečano tveganje, so nekateri limfomi (npr. Hodgkinov limfom) in sarkoidoza ter bolniki z dolgotrajnim zdravljenjem s kortikosteroidi.
English: In particular, the indications and their associated posology recommendations were harmonised.
Slovenian: Še posebej so bile usklajene indikacije in z njimi povezana priporočila za odmerjanje.
English: For the indications of paracoccidioidomycosis, histoplasmosis, lymphocutaneous sporotrichosis, where other agents have failed or are not tolerated, it was deemed by the CHMP that the submitted data on efficacy was not adequate.
Slovenian: Za indikacije parakokcidioidomikoza, histoplazmoza, limfokutana sporotrihoza, pri katerih so druga zdravila neuspešna ali jih bolniki niso prenašali, je CHMP ocenil, da predloženi podatki o učinkovitosti niso zadostni.
English: Based on the submitted data the CHMP agreed on the dosing recommendations for each indication.
Slovenian: Na podlagi predloženih podatkov je CHMP potrdil priporočila za odmerjanje za vsako indikacijo.
English: Risk factors for oesophageal candidiasis in children with HIV infection include low CD4 count (<100 cells/mm3), high viral load, and neutropenia (<500 cells/mm3).
Slovenian: Dejavniki tveganja za ezofagealno kandidiazo pri otrocih z okužbo HIV so nizko število CD4 (<100 celic/mm3), visoko virusno breme in nevtropenijo (<500 celic/mm3).
English: Treatment of invasive candidiasis requires higher doses of fluconazole than are used for mucocutaneous disease.
Slovenian: Zdravljenje invazivne kandidiaze zahteva večje odmerke flukonazola, kot se uporabljajo pri mukokutani bolezni.
English: The MAH submitted a proposal for harmonisation of the Quality module.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil predlog za uskladitev modula za kakovost.
English: Mucosal candidiasis (Oropharyngeal and oesophageal) in children
Slovenian: Mukozna kandidiaza (orofaringealna in ezofagealna) pri otrocih
English: Antifungal agents are being used in many prophylactic settings, but only a few studies have adequately evaluated their efficacy.
Slovenian: Antimikotiki se uporabljajo za več namenov preprečevanja, njihova učinkovitost pa je bila ustrezno ocenjena le v majhnem številu študij.
English: So, the final wording in section 4.2 of the SPC regarding this indication reflects the CHMP discussion in all formulations including the 150 mg, one capsule presentation.
Slovenian: Tako končno besedilo v poglavju 4.2 povzetka glavnih značilnosti zdravila glede te indikacije odraža razpravo v CHMP o vseh formulacijah, vključno z obliko ene 150-miligramske kapsule.
English: In all studies fluconazole was as or more effective than placebo in preventing clinical relapse.
Slovenian: V vseh študijah je bil flukonazol enako ali bolj učinkovit kot placebo pri preprečevanju kliničnih ponovitev.
English: Cryptococcal infections are more likely to occur in association with HIV disease, however, cryptococcal infections occur much less frequently among HIV-infected children than among adults.
Slovenian: Kriptokokne okužbe se pogosteje pojavljajo v povezavi z boleznijo HIV, vendar pa se kriptokokne okužbe pojavljajo redkeje pri otrocih, okuženih s HIV, kot pri odraslih.
English: The use of broad-spectrum antibiotics, corticosteroids, cytotoxic drugs, and radiation therapy are also predisposing factors.
Slovenian: Uporaba antibiotikov širokega spektra, kortikosteroidov, citotoksičnih zdravil in radioterapije so prav tako predispozijcijski dejavniki.
English: Thus the outcome of this referral procedure does not include any evaluation of the gel formulation.
Slovenian: Tako izid tega napotitvenega postopka na vključuje ocene formulacije gela.
English: As per the adult indication the CHMP agreed that there is sufficient evidence for the indication of treatment as well of prevention of relapse of cryptococcal meningitis in children.
Slovenian: Kot pri indikaciji za odrasle se je CHMP strinjal, da obstajajo zadostni dokazi za indikacijo za zdravljenje in tudi za preprečevanje ponovitev kriptokoknega meningitisa pri otrocih.
English: Since oral absorption is rapid and almost complete, the doses of fluconazole recommended for the treatment and/or the prophylaxis of the different indications are the same for oral (capsules, oral suspension and syrup) and IV administration.
Slovenian: Ker je peroralna absorpcija hitra in skoraj popolna, so odmerki flukonazola, priporočeni za zdravljenje in/ali preprečevanje različnih indikacij, enaki za peroralne oblike (kapsule, peroralna suspenzija in sirup) in za intravensko uporabo.
English: Fluconazole is used to treat paediatric patients with cryptococcal disease.
Slovenian: Flukonazol se uporablja za zdravljenje pediatričnih bolnikov s kriptokokno boleznijo.
English: Furthermore, fluconazole was also available for topical use in the 0.5% gel formulation.
Slovenian: Flukonazol je bil na voljo tudi za lokalno uporabo v obliki gela 0,5 %.
English: The inclusion of substances for which an involvement of CYP 3A4 and additive negative effects on QT interval prolongation is known (such as halofantrine, midazolam and triazolam) is justified.
Slovenian: Vključitev snovi, za katere je znano, da nanje vpliva CYP3A4 ter da negativno učinkujejo na podaljšanje intervala QT (kot so halofantrin, midazolam in triazolam) je utemeljena.
English: • Cryptococcal meningitis (see section 4.4).
Slovenian: • kriptokoknega meningitisa (glejte poglavje 4.4);
English: As fluconazole is a potent CYP2C9 inhibitor and a moderate CYP3A4 inhibitor and fluconazole is also an inhibitor of CYP2C19, treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C9, CYP2C19 and CYP3A4, should be monitored.
Slovenian: Ker je flukonazol močan zaviralec CYP2C9, zmerni zaviralec CYP3A4 in tudi zaviralec CYP2C19, je treba posebej nadzorovati bolnike, ki se sočasno zdravijo z zdravili z ozkim terapevtskim oknom, ki se presnavljajo z CYP2C9, CYP2C19 in CYP3A4.
English: Fluconazole therapy is efficacious for several deep mycoses and this is supported by clinical trial data and recommended by clinical guidelines.
Slovenian: Zdravljenje s flukonazolom je učinkovito pri več globokih mikozah, kar potrjujejo tudi podatki iz kliničnih preskušanj in priporočajo klinične smernice.
English: Disseminated candidiasis is infrequent among HIV-infected children, but Candida can disseminate from the oesophagus particularly when co-infection with herpes simplex virus (HSV) or cytomegalovirus (CMV) is present.
Slovenian: Diseminirana kandidiaza med otroci, okuženimi s HIV, ni pogosta, vendar se Candida lahko razširja iz požiralnika, še zlasti pri sočasni okužbi z virusom herpes simpleks (HSV) ali citomegalovirusom (CMV).
English: In order to harmonise the posology the MAH was requested to include in the posology section a table with the recommended doses regarding each indication and to distinguish between treatment and prevention.
Slovenian: Za uskladitev odmerjanja je bil imetnik dovoljenja za promet z zdravilom pozvan, naj v poglavje o odmerjanju doda razpredelnico s priporočenimi odmerki za vsako indikacijo ter naj loči med odmerjanjem za zdravljenje in za preprečevanje.
English: The majority of patients began antifungal prophylaxis prior to undergoing a period of induced neutropenia through chemo- or radiotherapy for malignant disease or bone marrow transplantation.
Slovenian: Večina bolnikov je začela s protiglivično profilakso pred obdobji nevtropenije zaradi kemoterapije ali radioterapije za maligne bolezni ali presaditve kostnega mozga.
English: The CHMP concluded that the fluconazole, at 400 mg to 800 mg daily is a safe and effective primary treatment for coccidioidomycosis.
Slovenian: CHMP je sklenil, da je zdravljenje s flukonazolom, z odmerkom od 400 mg do 800 mg na dan, varno in učinkovito primarno zdravljenje kokcidioidomikoze.
English: Fluconazole has proven to be safe and efficacious for invasive candidiasis.
Slovenian: Flukozanol je dokazano varen in učinkovit pri invazivni kandidiazi.
English: Since the pharmacokinetic properties of orally and intravenously administered fluconazole are similar and fluconazole has good bioavailability, results obtained with oral dosing are also applicable to the intravenous formulation.
Slovenian: Ker so farmakokinetične lastnosti peroralne in intravenske uporabe flukozanola podobne in ker je flukozanol dobro biološko uporaben, se lahko rezultati, pridobljeni pri peroralnem odmerjanju, uporabljajo tudi za intravensko formulacijo.
English: Candidal infection of male and female genital areas is relatively common and responds well to an oral administration of fluconazole.
Slovenian: Okužbe moških in ženskih spolnih organov s kandido so relativno pogoste in se dobro odzivajo na peroralno uporabo flukozanola.
English: Cryptococcal meningitis is caused by the fungus Cryptococcus neoformans.
Slovenian: Kriptokokni meningitis povzroča gliva Cryptococcus neoformans.
English: Diflucan is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:
Slovenian: Zdravilo Diflucan je pri novorojenčkih, dojenčkih, malčkih, otrocih in mladostnikih, starih od 0 do 17 let, indicirano za:
English: The prophylactic use of Diflucan, as distinct from the treatment indications was also discussed and justified.
Slovenian: Razpravljali in utemeljevali so tudi profilaktično uporabo zdravila Diflucan, kakor se razlikuje od indikacij za zdravljenje.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, ki jih je predstavila Evropska agencija za zdravila
English: Subheadings like Mode of action, PK/PD relationship, Mechanism(s) of resistance and Breakpoints (according to European Committee of Antimicrobial Succeptibility Testing - EUCAST) were implemented.
Slovenian: Dodana so bila podpoglavja, kot so način delovanja, odnos med farmakokinetiko/farmakodinamiko, mehanizem(-mi) odpornosti in mejne vrednosti (v skladu z Evropskim odborom za testiranje protimikrobne občutljivosti - EUCAST).
English: Fluconazole administered to children at 12 mg/Kg/day provides exposure similar to standard 400 mg daily dosing in adults and higher doses are not recommended in children.
Slovenian: Uporaba flukonazola pri otrocih z odmerkom 12 mg/kg/dan zagotavlja izpostavljenost, ki je podobna odmerku 400 mg na dan pri odraslih, večji odmerki pa se pri otrocih ne priporočajo.
English: In the case of deep endemic mycoses the evidence for efficacy of fluconazole in the treatment of other forms of endemic mycoses such as paracoccidioidomycosis, lymphocutaneous sporotrichosis and histoplasmosis was limited and they are no longer mentioned in the section 4.1 of the PI.
Slovenian: V primeru globoke endemične mikoze so dokazi o učinkovitosti flukonazola pri zdravljenju drugih oblik endemične mikoze, kot so na primer parakokcidioidomikoza, limfokutana sporotrihoza in histoplazmoza omejeni, in te indikacije niso več navedene v poglavju 4.1 informacij o zdravilu.
English: Moreover halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4.
Slovenian: Poleg tega je bilo za halofantrin dokazano, da priporočeni terapevtski odmerek podaljšuje interval QTc in je substrat CYP3A4.
English: Fluconazole displays antifungal activity against most clinically common Candida species.
Slovenian: Flukonazol deluje antimikotično proti večini klinično običajnih vrst Candida.
English: Regarding cryptococcosis the evidence for efficacy of fluconazole in the treatment of cryptococcosis of other sites (e.g. pulmonary and cutaneous cryptococcosis) is limited.
Slovenian: Glede kriptokokoze pa so dokazi o učinkovitosti flukonazola pri zdravljenju kriptokokoze na drugih mestih (npr. pljučna in kožna kriptokokoza) omejeni.
English: Fluconazole, a third generation azole, is characterised by high oral bioavailability, widespread distribution into body fluids and tissues, predictable renal clearance, and once-daily administration.
Slovenian: Flukonazol je tretja generacija azolov, zanj pa je značilna visoka peroralna biološka uporabnost, razširjena distribucija v telesne tekočine in tkiva, predvidljiv ledvični očistek in uporaba enkrat na dan.
English: The same situation appeared for cryptococcosis/prevention of cryptococcal infections, for invasive candidiasis or vaginal candidiasis.
Slovenian: Enako je bilo za kriptokokozo/preprečevanje kriptokoknih okužb, za invazivno kandidiazo ali vaginalno kandidiazo.
English: In all the mycosal candidiasis studies fluconazole was efficacious and equivalent or superior to the standard agents in both adults and paediatric patients.
Slovenian: V vseh študijah mikozne kandidiaze je bil flukonazol učinkovit in enakovreden ali boljši v primerjavi z drugimi običajnimi zdravili tako pri odraslih kot pri pediatričnih bolnikih.
English: Oesophageal candidiasis is primarily associated with HIV infection or other forms of immunosuppression in children.
Slovenian: Ezofagealna kandidiaza se primarno povezuje z okužbami s HIV ali drugimi oblikami imunske oslabljenosti pri otrocih.
English: • Tinea unguinium (onychomycosis) when other agents are not considered appropriate.
Slovenian: • tinea unguinium (onikomikoza), kadar zdravljenje z drugimi zdravili ni primerno.
English: Whereas
Slovenian: Ob upoštevanju naslednjega,
English: Although C. neoformans typically infects immunocompromised persons, patients with no apparent immune system problems also develop cryptococcosis.
Slovenian: Čeprav gliva C. neoformans običajno prizadene imunsko oslabele, pa se tudi pri bolnikih, pri katerih se ne kažejo težave z imunskim sistemom lahko razvije kriptokokoza.
English: Fluconazole is also used as maintenance therapy (prophylaxis) for prevention of the recurrence of vaginal candidiasis.
Slovenian: Flukonazol se uporablja tudi kot vzdrževalno zdravljenje (profilaksa) za preprečevanje ponovitve vaginalne kandidiaze.
English: The evidence is based on a clinical trial programme of three studies in vulvovaginal candidiasis and one in candidal balanitis.
Slovenian: Dokazi temeljijo na programu kliničnih preskušanj treh študij, v katerih so preučevali vulvovaginalno kandidiazo, in ene študije kandidnega balanitisa.
English: The CHMP agreed with the submitted data and accepted that fluconazole is efficient for the prophylaxis of candidal infections in patients with prolonged neutropenia.
Slovenian: CHMP se je strinjal s predloženimi podatki in potrdil, da je flukonazol učinkovit pri preprečevanju kandidnih okužb pri bolnikih z dolgotrajno nevtropenijo.
English: Systemic therapy is essential for oesophageal disease and should be initiated empirically among HIV-infected children who have OPC and oesophageal symptoms.
Slovenian: Sistemska terapija je pri ezofagealni bolezni nujna in jo je treba empirično izvajati pri otrocih, ki so okuženi z virusom HIV ter imajo orofaringealno kandidiazo in ezofagealne simptome.
English: A warning on hypersensitivity reactions has been added as per other azoles.
Slovenian: Podobno kot pri drugih azolih je bilo vključeno opozorilo glede preobčutljivostnih reakcij.
English: The CHMP is in agreement on the final wording of the indication.
Slovenian: CHMP je potrdil končno besedilo za indikacijo.
English: In cancer patients it was superior to placebo in preventing mycological relapse.
Slovenian: Pri bolnikih z rakom je bil boljši kot placebo pri preprečevanju ponovitve glivične okužbe.
English: Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated.
Slovenian: Sočasna uporaba drugih zdravil, za katera je znano, da podaljšujejo interval QT in ki jih presnavlja citokrom P450 (CYP) 3A4 je kontraindicirana.
English: Oral single-dose therapy with fluconazole in vaginal candidiasis and candidal balanitis has been a treatment option for around 30 years.
Slovenian: Peroralno zdravljenje z enojnim odmerkom flukonazola pri vaginalni kandidiazi in kandidnem balanitisu je kot možnost zdravljenja na voljo že okoli 30 let.
English: Fluconazole specifically inhibits the fungal ergosterol synthesis and the mycotic cytochrome P-450 mediated enzymes.
Slovenian: Flukonazol specifično zavira sintezo glivičnega ergosterola in encimov, ki presnavljajo mikotični citokrom P-450.
English: Overall, therefore, a single 150 mg dose of fluconazole provides a safe and effective treatment for vulvovaginal candidiasis in adult women or candidal balanitis in adult men.
Slovenian: Tako enojni odmerek 150 mg flukonazola zagotavlja varno in učinkovito zdravljenje vulvovaginalne kandidiaze pri odraslih ženskah ali kandidnega balanitisa pri odraslih moških.
English: The dose of fluconazole recommended for prevention of fungal infections in adults is 50-400 mg and using the algorithm above results in a dose recommendation in children of 3-12 mg/Kg.
Slovenian: Priporočen odmerek flukonazola za preprečevanje glivičnih okužb pri odraslih je 50-400 mg in z uporabo zgornjega algoritma je bilo ugotovljeno, da je priporočen odmerek pri otrocih 3-12 mg/kg.
English: Alternatively, an initial course of amphotericin B therapy can be administered and then carefully followed by completion of a course of fluconazole therapy.
Slovenian: Zdravljenje se lahko prične tudi z amfotericinom B, potek zdravljenja pa se nato previdno nadaljuje s flukonazolom.
English: • Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse.
Slovenian: • ponovitve orofaringealne ali ezofagealne kandidiaze pri bolnikih, ki so okuženih z HIV in pri katerih obstaja visoko tveganje za ponovitev;
English: Invasive Candida infections have become common and life threatening complications in patients with leukaemia, cancer, hematologic malignancies and patients with bone marrow transplantation.
Slovenian: Invazivne okužba s Candido so postale običajne in življenjsko ogrožajoče za bolnike z levkemijo, rakom, hematološkimi oblikami raka in bolnike s presajenim kostnim mozgom.
English: Fluconazole, administered at doses of 1 mg/Kg/day and 3 mg/Kg/day was more effective than the active comparator at preventing fungal infections.
Slovenian: Flukonazol z odmerkom 1 mg/kg/dan in 3 mg/kg/dan je bil pri preprečevanju glivičnih okužb bolj učinkovit kot primerjalno zdravilo.