natgillin/translations-raw huggingface dataset:
Mucosal candidiasis (Oropharyngeal and oesophageal) in children
Mukozna kandidiaza (orofaringealna in ezofagealna) pri otrocih
Antifungal agents are being used in many prophylactic settings, but only a few studies have adequately evaluated their efficacy.
Antimikotiki se uporabljajo za več namenov preprečevanja, njihova učinkovitost pa je bila ustrezno ocenjena le v majhnem številu študij.
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.
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.
In all studies fluconazole was as or more effective than placebo in preventing clinical relapse.
V vseh študijah je bil flukonazol enako ali bolj učinkovit kot placebo pri preprečevanju kliničnih ponovitev.
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.
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.
The use of broad-spectrum antibiotics, corticosteroids, cytotoxic drugs, and radiation therapy are also predisposing factors.
Uporaba antibiotikov širokega spektra, kortikosteroidov, citotoksičnih zdravil in radioterapije so prav tako predispozijcijski dejavniki.
Thus the outcome of this referral procedure does not include any evaluation of the gel formulation.
Tako izid tega napotitvenega postopka na vključuje ocene formulacije gela.
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.
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.
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.
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.
Fluconazole is used to treat paediatric patients with cryptococcal disease.
Flukonazol se uporablja za zdravljenje pediatričnih bolnikov s kriptokokno boleznijo.
Furthermore, fluconazole was also available for topical use in the 0.5% gel formulation.
Flukonazol je bil na voljo tudi za lokalno uporabo v obliki gela 0,5 %.
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.
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.
• Cryptococcal meningitis (see section 4.4).
• kriptokoknega meningitisa (glejte poglavje 4.4);
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.
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.
Fluconazole therapy is efficacious for several deep mycoses and this is supported by clinical trial data and recommended by clinical guidelines.
Zdravljenje s flukonazolom je učinkovito pri več globokih mikozah, kar potrjujejo tudi podatki iz kliničnih preskušanj in priporočajo klinične smernice.
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.
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).
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.
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.
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.
Večina bolnikov je začela s protiglivično profilakso pred obdobji nevtropenije zaradi kemoterapije ali radioterapije za maligne bolezni ali presaditve kostnega mozga.
The CHMP concluded that the fluconazole, at 400 mg to 800 mg daily is a safe and effective primary treatment for coccidioidomycosis.
CHMP je sklenil, da je zdravljenje s flukonazolom, z odmerkom od 400 mg do 800 mg na dan, varno in učinkovito primarno zdravljenje kokcidioidomikoze.
Fluconazole has proven to be safe and efficacious for invasive candidiasis.
Flukozanol je dokazano varen in učinkovit pri invazivni kandidiazi.
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.
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.
Candidal infection of male and female genital areas is relatively common and responds well to an oral administration of fluconazole.
Okužbe moških in ženskih spolnih organov s kandido so relativno pogoste in se dobro odzivajo na peroralno uporabo flukozanola.
Cryptococcal meningitis is caused by the fungus Cryptococcus neoformans.
Kriptokokni meningitis povzroča gliva Cryptococcus neoformans.
Diflucan is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:
Zdravilo Diflucan je pri novorojenčkih, dojenčkih, malčkih, otrocih in mladostnikih, starih od 0 do 17 let, indicirano za:
The prophylactic use of Diflucan, as distinct from the treatment indications was also discussed and justified.
Razpravljali in utemeljevali so tudi profilaktično uporabo zdravila Diflucan, kakor se razlikuje od indikacij za zdravljenje.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, ki jih je predstavila Evropska agencija za zdravila
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.
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).
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.
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.
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.
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.
Moreover halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4.
Poleg tega je bilo za halofantrin dokazano, da priporočeni terapevtski odmerek podaljšuje interval QTc in je substrat CYP3A4.
Fluconazole displays antifungal activity against most clinically common Candida species.
Flukonazol deluje antimikotično proti večini klinično običajnih vrst Candida.
Regarding cryptococcosis the evidence for efficacy of fluconazole in the treatment of cryptococcosis of other sites (e.g. pulmonary and cutaneous cryptococcosis) is limited.
Glede kriptokokoze pa so dokazi o učinkovitosti flukonazola pri zdravljenju kriptokokoze na drugih mestih (npr. pljučna in kožna kriptokokoza) omejeni.
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.
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.
The same situation appeared for cryptococcosis/prevention of cryptococcal infections, for invasive candidiasis or vaginal candidiasis.
Enako je bilo za kriptokokozo/preprečevanje kriptokoknih okužb, za invazivno kandidiazo ali vaginalno kandidiazo.
In all the mycosal candidiasis studies fluconazole was efficacious and equivalent or superior to the standard agents in both adults and paediatric patients.
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.
Oesophageal candidiasis is primarily associated with HIV infection or other forms of immunosuppression in children.
Ezofagealna kandidiaza se primarno povezuje z okužbami s HIV ali drugimi oblikami imunske oslabljenosti pri otrocih.
• Tinea unguinium (onychomycosis) when other agents are not considered appropriate.
• tinea unguinium (onikomikoza), kadar zdravljenje z drugimi zdravili ni primerno.
Whereas
Ob upoštevanju naslednjega,
Although C. neoformans typically infects immunocompromised persons, patients with no apparent immune system problems also develop cryptococcosis.
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.
Fluconazole is also used as maintenance therapy (prophylaxis) for prevention of the recurrence of vaginal candidiasis.
Flukonazol se uporablja tudi kot vzdrževalno zdravljenje (profilaksa) za preprečevanje ponovitve vaginalne kandidiaze.
The evidence is based on a clinical trial programme of three studies in vulvovaginal candidiasis and one in candidal balanitis.
Dokazi temeljijo na programu kliničnih preskušanj treh študij, v katerih so preučevali vulvovaginalno kandidiazo, in ene študije kandidnega balanitisa.
The CHMP agreed with the submitted data and accepted that fluconazole is efficient for the prophylaxis of candidal infections in patients with prolonged neutropenia.
CHMP se je strinjal s predloženimi podatki in potrdil, da je flukonazol učinkovit pri preprečevanju kandidnih okužb pri bolnikih z dolgotrajno nevtropenijo.
Systemic therapy is essential for oesophageal disease and should be initiated empirically among HIV-infected children who have OPC and oesophageal symptoms.
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.
A warning on hypersensitivity reactions has been added as per other azoles.
Podobno kot pri drugih azolih je bilo vključeno opozorilo glede preobčutljivostnih reakcij.
The CHMP is in agreement on the final wording of the indication.
CHMP je potrdil končno besedilo za indikacijo.
In cancer patients it was superior to placebo in preventing mycological relapse.
Pri bolnikih z rakom je bil boljši kot placebo pri preprečevanju ponovitve glivične okužbe.
Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated.
Sočasna uporaba drugih zdravil, za katera je znano, da podaljšujejo interval QT in ki jih presnavlja citokrom P450 (CYP) 3A4 je kontraindicirana.
Oral single-dose therapy with fluconazole in vaginal candidiasis and candidal balanitis has been a treatment option for around 30 years.
Peroralno zdravljenje z enojnim odmerkom flukonazola pri vaginalni kandidiazi in kandidnem balanitisu je kot možnost zdravljenja na voljo že okoli 30 let.
Fluconazole specifically inhibits the fungal ergosterol synthesis and the mycotic cytochrome P-450 mediated enzymes.
Flukonazol specifično zavira sintezo glivičnega ergosterola in encimov, ki presnavljajo mikotični citokrom P-450.
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.
Tako enojni odmerek 150 mg flukonazola zagotavlja varno in učinkovito zdravljenje vulvovaginalne kandidiaze pri odraslih ženskah ali kandidnega balanitisa pri odraslih moških.
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.
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.
Alternatively, an initial course of amphotericin B therapy can be administered and then carefully followed by completion of a course of fluconazole therapy.
Zdravljenje se lahko prične tudi z amfotericinom B, potek zdravljenja pa se nato previdno nadaljuje s flukonazolom.
• Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse.
• ponovitve orofaringealne ali ezofagealne kandidiaze pri bolnikih, ki so okuženih z HIV in pri katerih obstaja visoko tveganje za ponovitev;
Invasive Candida infections have become common and life threatening complications in patients with leukaemia, cancer, hematologic malignancies and patients with bone marrow transplantation.
Invazivne okužba s Candido so postale običajne in življenjsko ogrožajoče za bolnike z levkemijo, rakom, hematološkimi oblikami raka in bolnike s presajenim kostnim mozgom.
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.
Flukonazol z odmerkom 1 mg/kg/dan in 3 mg/kg/dan je bil pri preprečevanju glivičnih okužb bolj učinkovit kot primerjalno zdravilo.
Coccidioidomycosis is a disease with protean manifestations.
Kokcidioidomikoza je bolezen z različnimi manifestacijami.
Invasive candidiasis in children
Invazivna kandidiaza pri otrocih
Diflucan (fluconazole) is indicated in the following fungal infections (see section 5.1).
Zdravilo Diflucan (flukonazol) je indicirano za naslednje glivične okužbe (glejte poglavje 5.1).
The CHMP accepted that the data presented by the MAH was satisfactory for these indications.
CHMP je potrdil, da so podatki, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, za te indikacije zadovoljivi.
• the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
• obseg napotitve je bil uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
• Coccidioidomycosis (see section 4.4).
• kokcidioidomikoze (glejte poglavje 4.4);
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.
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.
More extensive information has been added in section 4.5 of the SPC.
Obsežnejše informacije so bile vključene v poglavje 4.5 povzetka glavnih značilnosti zdravila.
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.
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.
Fluconazole has been used to treat invasive candida infections in children.
Flukonazol se je uporabljal za zdravljenje invazivnih okužb s kandido pri otrocih.
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.
CHMP se je strinjal z indikacijo flukonazola za zdravljenje kronične oralne atrofične kandidiaze (razjede v ustih), kadar zobna higiena ali topično zdravljenje ne zadostujeta.
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.
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.
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.
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.
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.
CHMP je potrdil, da razpoložljivi podatki ustrezno potrjujejo varno in učinkovito uporabo flukonazola pri zdravljenju in preprečevanju mikozne (orofaringealne in ezofagealne) kandidiaze pri otrocih.
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.
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.
The CHMP noted the MAH proposal and adopted a harmonised text for this section, applicable to all Diflucan formulations.
CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo za to poglavje, ki velja za vse formulacije zdravila Diflucan.
The final Package Leaflet wording was adopted by the CHMP.
Končno besedilo navodila za uporabo je sprejel CHMP.
Fluconazole is effective as a treatment against fungal infections in adults across the dose range recommended in national SPCs (50-400 mg daily).
Flukonazol je učinkovit pri zdravljenju glivičnih okužb pri odraslih z različnimi odmerki, priporočenimi v nacionalnih povzetkih glavnih značilnosti zdravila (50-400 mg).
The solubility characteristic allows oral as well as intravenous administration.
Njegova topnost omogoča tako peroralno kot intravensko uporabo.
Fluconazole also exhibits activity in vitro against Cryptococcus species.
Flukonazol deluje tudi in vitro proti vrstam Cryptococcus.
• Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.
• vaginalne kandidiaze, akutne ali ponavljajoče se, kadar lokalno zdravljenje ni primerno;
Overall, the use of fluconazole as a prophylaxis agent to prevent breakthrough fungal infections in neutropenic patients was established in the original application.
Na splošno je bila uporaba flukonazola kot profilaktičnega zdravila za preprečevanje izbruhov glivičnih okužb pri nevtropeničnih bolnikih dokazana pri prvotni vlogi.
Fluconazole is approved to treat acute or recurrent vulvovaginal candidiasis in women and candidal balanitis in men.
Flukozanol je odobren za zdravljenje akutne ali ponavljajoče se vulvovaginalne kandidiaze pri ženskah in kandidnega balanitisa pri moških.
The MAH was asked to evaluate all other sections of the nationally approved SPCs and suggest appropriate changes in the text where divergences exist.
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.
The CHMP considered that the treatment of invasive candidiasis in children is sufficiently demonstrated.
CHMP je menil, da je zdravljenje invazivne kandidiaze pri otrocih ustrezno dokazano.
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.
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.
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.
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.
The CHMP noted the MAH proposal and adopted a harmonised text for this section.
CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo za to poglavje.