FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Da oralt og intravenøst administreret fluconazol har de samme farmakokinetiske egenskaber, og fluconazol har god biotilgængelighed, er resultater indhentet med oral dosering også relevante for den intravenøse formulering.
English: Fluconazole also exhibits activity in vitro against Cryptococcus species.
Danish: Fluconazol er også aktiv in vitro mod Cryptococcus-arter.
English: The same situation appeared for cryptococcosis/prevention of cryptococcal infections, for invasive candidiasis or vaginal candidiasis.
Danish: Det samme gjorde sig gældende for kryptokokkose/forebyggelse af kryptokokinfektioner, for invasiv candidiasis eller vaginal candidiasis.
English: In all studies fluconazole was as or more effective than placebo in preventing clinical relapse.
Danish: I alle undersøgelserne var fluconazol lige så effektivt eller mere effektivt end placebo til at forebygge klinisk recidiv.
English: Fluconazole has proven to be safe and efficacious for invasive candidiasis.
Danish: Fluconazol har vist sig at være sikker og effektiv til behandling af invasiv candidiasis.
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.
Danish: Dissemineret candidiasis ses sjældent hos hiv-inficerede børn, men Candida kan sprede sig fra øsofagus, særligt ved samtidig infektion med herpes simplex-virus (HSV) eller cytomegalovirus (CMV).
English: Fluconazole is also used as maintenance therapy (prophylaxis) for prevention of the recurrence of vaginal candidiasis.
Danish: Fluconazol anvendes også som vedligeholdelsesbehandling (profylakse) til forebyggelse af recidiverende vaginal candidiasis.
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.
Danish: Der blev tilføjet underoverskrifter som Virkningsmåde, Forholdet mellem farmakokinetik og farmakodynamik, Resistensmekanisme(r) og Breakpoints (i henhold til European Committee of Antimicrobial Succeptibility TestingEUCAST).
English: All the above changes were accepted by the CHMP and apply to all formulations.
Danish: Alle ovenstående ændringer blev godkendt af CHMP og gælder alle formuleringer.
English: Fluconazole displays antifungal activity against most clinically common Candida species.
Danish: Fluconazol udviser antimykotisk aktivitet over for de fleste klinisk almindelige Candida-arter.
English: So these indications are no longer referred to in section 4.1 of the SPC and a warning has been added in the corresponding section.
Danish: 4.1 i produktresuméet, og der er tilføjet en advarsel i det tilsvarende punkt.
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.
Danish: Disse undersøgelser viste, at oral fluconazol er et effektivt og veltolereret antimykotisk middel mod Tinea corporis, Tinea cruris, Tinea pedis, Tinea versicolor og onychomykose.
English: Invasive candidiasis in children
Danish: Invasiv candidiasis hos børn
English: Fluconazole is effective as a treatment against fungal infections in adults across the dose range recommended in national SPCs (50-400 mg daily).
Danish: Fluconazol er effektivt som behandling mod svampeinfektioner hos voksne i det dosisområde, som er anbefalet i de nationale produktresuméer (50-400 mg dagligt).
English: Fluconazole specifically inhibits the fungal ergosterol synthesis and the mycotic cytochrome P-450 mediated enzymes.
Danish: Fluconazol hæmmer specifikt svampes ergosterolsyntese og de mykotiske cytokrom P-450-medierede enzymer.
English: Oral or IV fluconazole solutions, administered for 14-21 days, are highly effective for treatment of Candida oesophagitis.
Danish: fluconazol-opløsninger givet i 14-21 dage er meget effektive til behandling af Candida øsofagitis.
English: In Member States there were differences in the posology of various infections, e.g. for individual mucosal candida infections.
Danish: Medlemsstaterne havde forskellige doseringer ved forskellige infektionstyper, f.eks. for individuelle candidainfektioner i slimhinder.
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.
Danish: I tilfælde af dybe endemiske mykoser var dokumentation for fluconazols effekt ved behandling af andre former for endemiske mykoser som paracoccidioidomycosis, lymphocutaneous sporotrichosis og histoplasmosis begrænset, og de nævnes ikke længere i pkt.
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)).
Danish: • Profylakse af candidainfektioner hos patienter med langvarig neutropeni (såsom patienter med hæmatologiske maligniteter, som får kemoterapi, eller patienter, som får hæmatopoietisk stamcelletransplantation (se pkt.
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.
Danish: CHMP konkluderede, at fluconazol med sin aktivitet mod Candida-arter og sin farmakokinetik er et sikkert, effektivt og bekvemt alternativ til topikal behandling i et enkeltdosisregime til såvel candida vaginitis og candida balanitis hos voksne samt til profylakse af recidiverende vaginal candidiasis.
English: Moreover fluconazole has become established as a standard treatment for the prevention of breakthrough infections in neutropenic patients.
Danish: Desuden er fluconazol fastlagt som standardbehandling til forebyggelse af udbrud af infektioner hos neutropene patienter.
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.
Danish: Indikationen genital candidiasis og mere specifikt vulvovaginal candidiasis hos voksne kvinder og candida balanitis hos voksne mænd var godkendt i nogle medlemsstater til formuleringen en kapsel med 150 mg på grund af den bekvemme behandling med én dosis.
English: Diflucan (fluconazole) is indicated in the following fungal infections (see section 5.1).
Danish: Diflucan (fluconazol) er indiceret ved følgende svampeinfektioner (se pkt.5.1).
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.
Danish: CHMP konkluderede, at kontinuerlig behandling med fluconazol med 100 mg dagligt og kontinuerlig eller periodisk behandling med 200 mg dagligt er effektiv til forebyggelse af recidiv af orofaryngeal eller øsofageal candidiasis hos immunkompromitterede patienter og er veltolereret.
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.
Danish: Generelt er en enkelt 150 mg dosis fluconazol derfor en sikker og effektiv behandling af vulvovaginal candidiasis hos voksne kvinder eller candida balanitis hos voksne mænd.
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.
Danish: CHMP vedtog således, baseret på bedømmelsen af forslag og svar fra indehaveren af markedsføringstilladelsen og efter drøftelser i udvalget, den harmoniserede produktinformation for de forskellige formuleringer af Diflucan og relaterede navne, under hensyntagen til lægemiddelformerne.
English: Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated.
Danish: Samtidig administration af andre lægemidler, som man ved forlænger QT-intervallet, og som metaboliseres via cytocrom P450 3A4, er kontraindiceret.
English: Invasive Candida infections have become common and life threatening complications in patients with leukaemia, cancer, hematologic malignancies and patients with bone marrow transplantation.
Danish: Invasive candidainfektioner er blevet almindelige og livstruende komplikationer hos patienter med leukæmi, cancer, hæmatologiske maligniteter og patienter, som har fået knoglemarvstransplantation.
English: Coccidioidomycosis is a disease with protean manifestations.
Danish: Coccidioidomykose er en sygdom med forskellige manifestationer.
English: Fluconazole is approved to treat acute or recurrent vulvovaginal candidiasis in women and candidal balanitis in men.
Danish: Fluconazol er godkendt til behandling af akut eller recidiverende vulvovaginal candidiasis hos kvinder og candida balanitis hos mænd.
English: Fluconazole is used to treat paediatric patients with cryptococcal disease.
Danish: Fluconazol anvendes til behandling af pædiatriske patienter med kryptokokinfektioner.
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.
Danish: Data, som understøtter indikationen for fluconazol som forebyggelse af svampeinfektioner hos immunkompromitterede patienter i det pædiatriske International Registration Dossier (1993), er udledt fra tre undersøgelser med børn: en undersøgelse fastlagde effekten af fluconazol versus behandling med nystatin alene, en undersøgelse versus orale polyener (nystatin eller amphotericin B) og den tredje undersøgelse versus ketoconazol.
English: Overall, the use of fluconazole as a prophylaxis agent to prevent breakthrough fungal infections in neutropenic patients was established in the original application.
Danish: Generelt blev anvendelse af fluconazol som profylaktisk middel for at forhindre udbrud af svampeinfektioner hos neutropene patienter fastlagt i den oprindelige ansøgning.
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.
Danish: CHMP var af den opfattelse, at de tilgængelige data er tilstrækkelige til sikker og effektiv anvendelse af fluconazol til behandling og forebyggelse af candidiasis i slimhinderne (orofaryngeal og øsofageal) hos børn.
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.
Danish: Fluconazol har udvist effekt in vitro og in vivo over for Cryptococcus neoformans og giver læger en behandlingsmulighed, som er mindre toksisk end amphotericin B. Det er fastlagt, at fluconazol er en sikker og effektiv behandling mod svampeinfektioner hos raske og immunkompromitterede patienter med kryptokok-meningitis, og der foreligger kliniske data, som understøtter fluconazol som behandling til børn og voksne.
English: • Coccidioidomycosis (see section 4.4).
Danish: • Coccidioidomycose (se pkt.
English: (onychomycosis) it was concluded that fluconazole is indicated only when other agents are not considered appropriate.
Danish: Ved Tinea unguinium (onychomykose) blev det konkluderet, at fluconazol kun er indiceret, når andre stoffer ikke betragtes som velegnede.
English: Fluconazole has been used to treat invasive candida infections in children.
Danish: Fluconazol er anvendt til behandling af invasive candidainfektioner hos børn.
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.
Danish: Endelig og sammenfattende vedtog CHMP følgende sæt af indikationer for Diflucan og relaterede navne for kapsler (50 mg, 100 mg, 150 mg, 200 mg), infusionsvæske, opløsning (i.v.
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
Danish: Videnskabelige konklusioner og begrundelser for ændring af produktresumé, etikettering og indlægsseddel fremlagt af EMA
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.
Danish: Da behandlingen af genital candidiasis kræver en enkelt dosis fluconazol a 150 mg, fås en bekvem formulering med en enkelt 150 mg fluconazol-kapsel i nogle medlemsstater udelukkende til indikationen genital candidiasis, mere specifikt til behandling af akut vaginal candidiasis og candida balanitis.
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.
Danish: Dosen af fluconazol, som anbefales til forebyggelse af svampeinfektioner hos voksne, er 50-400 mg og giver ved anvendelse af ovenstående algoritme en dosisanbefaling hos børn på 3-12 mg/kg.
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.
Danish: 50 mg, 100 mg, 150 mg og 200 mg kapsler, 5 mg/ml syrup, 50 mg/5 ml eller 200 mg/5 ml pulver til oral suspension og 2 mg/ml infusionsvæske, opløsning.
English: For the 150 mg, one capsule presentation
Danish: For formuleringen en kapsel, 150 mg
English: Mucosal candidiasis (Oropharyngeal and oesophageal) in children
Danish: Candidiasis i slimhinder (orofaryngeal og øsofageal) hos børn
English: Diflucan (fluconazole) is indicated in the following fungal infections in adults (see section 5.1):
Danish: Diflucan (fluconazol) er indiceret ved følgende svampeinfektioner hos voksne (se pkt.5.1).
English: Other Sections of the SPC
Danish: Andre punkter i produktresuméet
English: The CHMP noted the MAH proposal and adopted a harmonised text for this section, applicable to all Diflucan formulations.
Danish: CHMP noterede sig forslaget fra indehaveren af markedsføringstilladelsen og vedtog en harmoniseret tekst for dette punkt, der gælder for alle Diflucan-formuleringer.
English: The CHMP accepted that the data presented by the MAH was satisfactory for these indications.
Danish: CHMP vedtog, at data fremlagt af indehaveren af markedsføringstilladelsen var tilfredsstillende til disse indikationer.
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.
Danish: Efter implementering af ændringer blev der foretaget en læsbarhedstest, som blev fremlagt og bedømt under indbringelsesproceduren.
English: • Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse.
Danish: • Recidiv af orofaryngeal eller øsofageal candidiasis hos patienter med hiv-infektion, som har stor risiko for recidiv.
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.
Danish: Vedrørende kryptokokkose foreligger der begrænset dokumentationen for fluconazols virkning ved behandling af kryptokokkose andre steder (f.eks. lunger og kutan kryptokokkose).
English: The CHMP agreed that fluconazole is indicated in the prophylaxis of candidal infections in immunocompromised children.
Danish: CHMP var af den opfattelse, at fluconazol er indiceret ved profylakse af candidainfektioner hos immunkompromitterede børn.
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.
Danish: CHMP vedtog, at fluconazol skal indiceres til behandling af kronisk oral atrofisk candidiasis (protesestomatit), hvis mundhygiejne eller topikal behandling er utilstrækkeligt.
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.
Danish: Ifølge indikationen til voksne var CHMP af den opfattelse, at der er tilstrækkelig dokumentation for indikationen behandling og forebyggelse af recidiv af kryptokokmengitis hos børn.
English: • Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.
Danish: • Dermatomycose, herunder tinea pedis, tinea corporis, tinea cruris, tinea versicolor og candida-infektioner i huden, når systemisk behandling er indiceret.
English: Diflucan is indicated in adults for the prophylaxis of:
Danish: Diflucan er hos voksne indiceret til profylakse af:
English: The CHMP is in agreement in separating the treatment from the prophylaxis of the relapse on Oropharyngeal Candidiasis and presenting the posology accordingly.
Danish: CHMP er enigt i at adskille behandling fra recidivprofylakse ved orofaryngeal candidiasis og fremlægge doseringen tilsvarende.
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.
Danish: Hos den pædiatriske population anvendes fluconazol til behandling af candidainfektion i slimhinder (orofaryngeal, øsofageal), systemisk candidiasis og kryptokokinfektioner samt forebyggelse af svampeinfektioner hos immunkompromitterede børn i risikogruppen efter cytotoksisk kemoterapi eller strålebehandling.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Danish: • formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen
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.
Danish: Fluconazol administreret til børn med 12 mg/kg/dag giver en eksponering, som svarer til en standarddosis på 400 mg dagligt hos voksne.
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.
Danish: CHMP var også af den opfattelse, at indehaveren af markedsføringstilladelsen havde fremlagt tilstrækkelige data om virkning og sikkerhed af fluconazol ved invasive svampeinfektioner (kryptokokkose, invasiv candidiasis) sammenlignet med andre behandlingsmuligheder, og at fluconazol udviste et positivt risk/benefitforhold.
English: Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Danish: Behandlingen kan indledes, før resultater af kulturer og andre laboratorieundersøgelser kendes.
English: The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that the products should have a satisfactory and uniform performance in the clinic.
Danish: Resultaterne af de udførte test viser en tilfredsstillende konsekvens og ensartethed af vigtige produktkvalitetsegenskaber.
English: The MAH submitted a proposal for harmonisation of the Quality module.
Danish: Indehaveren af markedsføringstilladelsen fremlagde en anmodning om harmonisering af afsnittet om kvalitet.
English: • Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
Danish: • Kronisk oral atrofisk candidiasis (protesestomatit), hvis mundhygiejne eller topikal behandling er utilstrækkeligt.
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.
Danish: Fluconazol findes til oral anvendelse som kapsler med 50 mg, 100 mg, 150 mg og 200 mg, som 5 mg/ml syrup og som 50 mg eller 200 mg/5 ml pulver til oral suspension i en formulering til rekonstitution med vand.
English: • Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.
Danish: • Vaginal candidiasis, akut eller recidiverende, når lokal behandling ikke er egnet.
English: • Cryptococcal meningitis (see section 4.4).
Danish: • Kryptokok-meningitis (se pkt.
English: • Candidal balanitis when local therapy is not appropriate.
Danish: • Candida balanitis, når lokal behandling ikke er velegnet.
English: Dermatomycoses include Tinea pedis, Tinea corporis, Tinea cruris, Tinea versicolor, Tinea unguinium (onychomycosis) and dermal Candida infections.
Danish: Dermatomykose inkluderer Tinea pedis, Tinea corporis, Tinea cruris, Tinea versicolor, Tinea unguinium (onychomykose) og candidainfektioner i huden.
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.
Danish: Diflucan anvendes til behandling af candidainfektion i slimhinder (orofaryngeal, øsofageal), invasiv candidiasis, kryptokok-meningitis og profylakse af candidainfektioner hos immunkompromitterede patienter.
English: The CHMP noted the MAH proposal and adopted a harmonised text for this section.
Danish: CHMP noterede sig forslaget fra indehaveren af markedsføringstilladelsen og vedtog en harmoniseret tekst til dette punkt.
English: Powder for Suspension
Danish: ), syrup, pulver til oral suspension.
English: • Acute vaginal candidiasis when local therapy is not appropriate.
Danish: • Akut vaginal candidiasis, når lokal behandling ikke er velegnet.