natgillin/translations-raw huggingface dataset:
Punkt 4.8 - Bivirkninger 
Section 4.8 - Undesirable effects
Sikkerhedsprofilen blev taget i betragtning ved harmonisering af de angivne bivirkninger mellem de nationale produktresuméer for Diflucan. 
The Core Safety Profile was considered when harmonising the listed adverse reactions between national SPCs of Diflucan.
Diflucan er hos voksne indiceret til behandling af: 
Diflucan is indicated in adults for the treatment of:
Medtagelse af ordlyden om interaktion af itraconazol (et andet triazol) i indlægssedlen for saquinavir under hensyntagen til de nye ændringer i etiketteringen for saquinavir (kontraindikation for samtidig administration med andre lægemidler, som forlænger QTc-intervallet), blev ændret. 
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.
Candidæmi forekommer hos op til 12 % af hiv-smittede børn med kroniske indre centralvenekatetre til parenteral ernæring eller intravenøse antibiotika. 
Candidemia occurs in up to 12% of HIV-infected children with chronically indwelling central venous catheters for total parental nutrition or intravenous antibiotics.
I alle undersøgelser af mykotisk candidiasis var fluconazol effektivt og ækvivalent med eller bedre end standardstofferne hos både voksne og pædiatriske patienter. 
In all the mycosal candidiasis studies fluconazole was efficacious and equivalent or superior to the standard agents in both adults and paediatric patients.
Som ved andre azoler er der tilføjet en advarsel om overfølsomhedsreaktioner. 
A warning on hypersensitivity reactions has been added as per other azoles.
På grundlag af de indsendte data godkendte CHMP dosisanbefalingerne for hver indikation. 
Based on the submitted data the CHMP agreed on the dosing recommendations for each indication.
Hos cancerpatienter var det bedre end placebo til forebyggelse af mykologisk recidiv. 
In cancer patients it was superior to placebo in preventing mycological relapse.
• Tilbagevendende kryptokok-meningitis hos patienter med høj risiko for recidiv. 
• Relapse of cryptococcal meningitis in patients with high risk of recurrence.
Oral enkeltdosisbehandling med fluconazol ved vaginal candidiasis og candida balanitis har i ca. 30 år været en behandlingsmulighed. 
Oral single-dose therapy with fluconazole in vaginal candidiasis and candidal balanitis has been a treatment option for around 30 years.
CHMP godkendte den endelige ordlyd for indikationen. 
The CHMP is in agreement on the final wording of the indication.
Den endelige ordlyd af indlægssedlen blev vedtaget af CHMP. 
The final Package Leaflet wording was adopted by the CHMP.
Diflucan kan anvendes som vedligeholdelsesterapi for at forhindre recidiv af kryptokok-meningitis hos børn med høj risiko for tilbagefald (se pkt. 
Diflucan can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4).
Størstedelen af patienterne påbegyndte profylakse mod svampeinfektion, før de skulle gennemgå en periode med induceret neutropeni på grund af kemoterapi eller strålebehandling for malign sygdom eller knoglemarvstransplantation. 
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.
Det er hyppigst forbundet med svær immunologisk hæmning på grund af diabetes mellitus, leukæmi, lymfom, malignitet, neutropeni og hiv-infektion, hvor den forekommer som indikator for klinisk progression til aids. 
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.
CHMP vurderede, at behandlingen af invasiv candidiasis hos børn er tilstrækkeligt påvist. 
The CHMP considered that the treatment of invasive candidiasis in children is sufficiently demonstrated.
CHMP accepterede, at underbyggende data kun var for indikationen kryptokok-meningitis, som var medtaget i produktresuméet, og ikke den generelle kryptokok-indikation. 
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.
Doser på 3 mg/kg hos børn har vist sig at have effekt på svampeinfektioner hos immunkompromitterede børn og også til behandling af pædiatriske patienter med alvorlige svampeinfektioner som kryptokok-meningitis. 
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.
4.2 i produktresuméet vedrørende denne indikation CHMP's drøftelse i alle formuleringer, herunder formuleringen med en kapsel, 150 mg. 
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.
Indehaveren af markedsføringstilladelsen blev bedt om at evaluere alle andre punkter i de nationalt godkendte produktresuméer og foreslå passende ændringer i teksten ved divergenser. 
The MAH was asked to evaluate all other sections of the nationally approved SPCs and suggest appropriate changes in the text where divergences exist.
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. 
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.
Fluconazol er også aktiv in vitro mod Cryptococcus-arter. 
Fluconazole also exhibits activity in vitro against Cryptococcus species.
Det samme gjorde sig gældende for kryptokokkose/forebyggelse af kryptokokinfektioner, for invasiv candidiasis eller vaginal candidiasis. 
The same situation appeared for cryptococcosis/prevention of cryptococcal infections, for invasive candidiasis or vaginal candidiasis.
I alle undersøgelserne var fluconazol lige så effektivt eller mere effektivt end placebo til at forebygge klinisk recidiv. 
In all studies fluconazole was as or more effective than placebo in preventing clinical relapse.
Fluconazol har vist sig at være sikker og effektiv til behandling af invasiv candidiasis. 
Fluconazole has proven to be safe and efficacious for invasive candidiasis.
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). 
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.
Fluconazol anvendes også som vedligeholdelsesbehandling (profylakse) til forebyggelse af recidiverende vaginal candidiasis. 
Fluconazole is also used as maintenance therapy (prophylaxis) for prevention of the recurrence of vaginal candidiasis.
Der blev tilføjet underoverskrifter som Virkningsmåde, Forholdet mellem farmakokinetik og farmakodynamik, Resistensmekanisme(r) og Breakpoints (i henhold til European Committee of Antimicrobial Succeptibility TestingEUCAST). 
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.
Alle ovenstående ændringer blev godkendt af CHMP og gælder alle formuleringer. 
All the above changes were accepted by the CHMP and apply to all formulations.
Fluconazol udviser antimykotisk aktivitet over for de fleste klinisk almindelige Candida-arter. 
Fluconazole displays antifungal activity against most clinically common Candida species.
4.1 i produktresuméet, og der er tilføjet en advarsel i det tilsvarende punkt. 
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.
Disse undersøgelser viste, at oral fluconazol er et effektivt og veltolereret antimykotisk middel mod Tinea corporis, Tinea cruris, Tinea pedis, Tinea versicolor og onychomykose. 
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.
Invasiv candidiasis hos børn 
Invasive candidiasis in children
Fluconazol er effektivt som behandling mod svampeinfektioner hos voksne i det dosisområde, som er anbefalet i de nationale produktresuméer (50-400 mg dagligt). 
Fluconazole is effective as a treatment against fungal infections in adults across the dose range recommended in national SPCs (50-400 mg daily).
Fluconazol hæmmer specifikt svampes ergosterolsyntese og de mykotiske cytokrom P-450-medierede enzymer. 
Fluconazole specifically inhibits the fungal ergosterol synthesis and the mycotic cytochrome P-450 mediated enzymes.
fluconazol-opløsninger givet i 14-21 dage er meget effektive til behandling af Candida øsofagitis. 
Oral or IV fluconazole solutions, administered for 14-21 days, are highly effective for treatment of Candida oesophagitis.
Medlemsstaterne havde forskellige doseringer ved forskellige infektionstyper, f.eks. for individuelle candidainfektioner i slimhinder. 
In Member States there were differences in the posology of various infections, e.g. for individual mucosal candida infections.
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. 
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.
• Profylakse af candidainfektioner hos patienter med langvarig neutropeni (såsom patienter med hæmatologiske maligniteter, som får kemoterapi, eller patienter, som får hæmatopoietisk stamcelletransplantation (se pkt. 
• 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)).
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. 
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.
Desuden er fluconazol fastlagt som standardbehandling til forebyggelse af udbrud af infektioner hos neutropene patienter. 
Moreover fluconazole has become established as a standard treatment for the prevention of breakthrough infections in neutropenic patients.
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. 
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.
Diflucan (fluconazol) er indiceret ved følgende svampeinfektioner (se pkt.5.1). 
Diflucan (fluconazole) is indicated in the following fungal infections (see section 5.1).
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. 
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.
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. 
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.
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. 
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.
Samtidig administration af andre lægemidler, som man ved forlænger QT-intervallet, og som metaboliseres via cytocrom P450 3A4, er kontraindiceret. 
Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated.
Invasive candidainfektioner er blevet almindelige og livstruende komplikationer hos patienter med leukæmi, cancer, hæmatologiske maligniteter og patienter, som har fået knoglemarvstransplantation. 
Invasive Candida infections have become common and life threatening complications in patients with leukaemia, cancer, hematologic malignancies and patients with bone marrow transplantation.
Coccidioidomykose er en sygdom med forskellige manifestationer. 
Coccidioidomycosis is a disease with protean manifestations.
Fluconazol er godkendt til behandling af akut eller recidiverende vulvovaginal candidiasis hos kvinder og candida balanitis hos mænd. 
Fluconazole is approved to treat acute or recurrent vulvovaginal candidiasis in women and candidal balanitis in men.
Fluconazol anvendes til behandling af pædiatriske patienter med kryptokokinfektioner. 
Fluconazole is used to treat paediatric patients with cryptococcal disease.
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. 
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.
Generelt blev anvendelse af fluconazol som profylaktisk middel for at forhindre udbrud af svampeinfektioner hos neutropene patienter fastlagt i den oprindelige ansøgning. 
Overall, the use of fluconazole as a prophylaxis agent to prevent breakthrough fungal infections in neutropenic patients was established in the original application.
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. 
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.
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. 
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.
• Coccidioidomycose (se pkt. 
• Coccidioidomycosis (see section 4.4).
Ved Tinea unguinium (onychomykose) blev det konkluderet, at fluconazol kun er indiceret, når andre stoffer ikke betragtes som velegnede. 
(onychomycosis) it was concluded that fluconazole is indicated only when other agents are not considered appropriate.
Fluconazol er anvendt til behandling af invasive candidainfektioner hos børn. 
Fluconazole has been used to treat invasive candida infections in children.
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. 
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.
Videnskabelige konklusioner og begrundelser for ændring af produktresumé, etikettering og indlægsseddel fremlagt af EMA 
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
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. 
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.
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. 
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.
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. 
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.
For formuleringen en kapsel, 150 mg 
For the 150 mg, one capsule presentation
Candidiasis i slimhinder (orofaryngeal og øsofageal) hos børn 
Mucosal candidiasis (Oropharyngeal and oesophageal) in children
Diflucan (fluconazol) er indiceret ved følgende svampeinfektioner hos voksne (se pkt.5.1). 
Diflucan (fluconazole) is indicated in the following fungal infections in adults (see section 5.1):
Andre punkter i produktresuméet 
Other Sections of the SPC
CHMP noterede sig forslaget fra indehaveren af markedsføringstilladelsen og vedtog en harmoniseret tekst for dette punkt, der gælder for alle Diflucan-formuleringer. 
The CHMP noted the MAH proposal and adopted a harmonised text for this section, applicable to all Diflucan formulations.
CHMP vedtog, at data fremlagt af indehaveren af markedsføringstilladelsen var tilfredsstillende til disse indikationer. 
The CHMP accepted that the data presented by the MAH was satisfactory for these indications.
Efter implementering af ændringer blev der foretaget en læsbarhedstest, som blev fremlagt og bedømt under indbringelsesproceduren. 
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.
• Recidiv af orofaryngeal eller øsofageal candidiasis hos patienter med hiv-infektion, som har stor risiko for recidiv. 
• Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse.
Vedrørende kryptokokkose foreligger der begrænset dokumentationen for fluconazols virkning ved behandling af kryptokokkose andre steder (f.eks. lunger og kutan kryptokokkose). 
Regarding cryptococcosis the evidence for efficacy of fluconazole in the treatment of cryptococcosis of other sites (e.g. pulmonary and cutaneous cryptococcosis) is limited.
CHMP var af den opfattelse, at fluconazol er indiceret ved profylakse af candidainfektioner hos immunkompromitterede børn. 
The CHMP agreed that fluconazole is indicated in the prophylaxis of candidal infections in immunocompromised children.
CHMP vedtog, at fluconazol skal indiceres til behandling af kronisk oral atrofisk candidiasis (protesestomatit), hvis mundhygiejne eller topikal behandling er utilstrækkeligt. 
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.
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. 
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.
• Dermatomycose, herunder tinea pedis, tinea corporis, tinea cruris, tinea versicolor og candida-infektioner i huden, når systemisk behandling er indiceret. 
• Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.
Diflucan er hos voksne indiceret til profylakse af: 
Diflucan is indicated in adults for the prophylaxis of:
CHMP er enigt i at adskille behandling fra recidivprofylakse ved orofaryngeal candidiasis og fremlægge doseringen tilsvarende. 
The CHMP is in agreement in separating the treatment from the prophylaxis of the relapse on Oropharyngeal Candidiasis and presenting the posology accordingly.
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. 
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.