FrancophonIA/ELRC3.0 huggingface dataset:
English: The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Danish: Metoden og den statistiske fremgangsmåde samt de indsendte data blev gennemgået, og CHMP anså den anslåede hyppighed for at være passende.
English: Furthermore, fluconazole was also available for topical use in the 0.5% gel formulation.
Danish: Desuden kunne fluconazol også fås til topikal anvendelse i en formulering som 0,5 % gel.
English: There were also differences in the wording on the dosage recommendation for adolescents and children regarding all indications.
Danish: Der var også forskelle i ordlyden i doseringsanbefalingen for unge og børn ved alle indikationer.
English: For patients with renal impairment a warning has been added with a cross reference to the posology section of 4.2 in this patient population.
Danish: For patienter med nedsat nyrefunktion er der tilføjet en advarsel med en krydsreference til punktet med dosering 4.2 for denne patientpopulation.
English: Pharmacokinetic data were assessed for 113 paediatric patients from 5 studies; 2 single-doses studies, 2 multiple-dose studies, and a study in premature neonates.
Danish: Farmakokinetiske data blev bedømt for 113 pædiatriske patienter fra 5 undersøgelser: 2 enkeltdosisundersøgelser, 2 flerdosisundersøgelser og en undersøgelse hos for tidligt fødte.
English: In particular, the indications and their associated posology recommendations were harmonised.
Danish: Særligt blev indikationerne og deres tilhørende doseringsanbefalinger harmoniseret.
English: The solubility characteristic allows oral as well as intravenous administration.
Danish: Opløseligheden giver mulighed for såvel oral som intravenøs administration.
English: The prophylactic use of Diflucan, as distinct from the treatment indications was also discussed and justified.
Danish: Profylaktisk anvendelse af Diflucan separat fra behandlingsindikationerne blev også drøftet og begrundet.
English: More extensive information has been added in section 4.5 of the SPC.
Danish: Der er tilføjet mere omfattende information i punkt 4.5 i produktresuméet.
English: The use of fluconazole for the treatment of fungal skin infections was examined in several comparative and non-comparative studies.
Danish: Brug af fluconazol til behandling af svampeinfektioner i huden er undersøgt i flere sammenlignende og ikke-sammenlignende undersøgelser.
English: Following questions raised by the CHMP the MAH provided a posology for this specific age group based on the “Guideline on the role of pharmacokinetics in the development of medicinal product in the paediatric population, 2006.”
Danish: Efter at CHMP havde taget spørgsmålet op, fremlagde indehaveren af markedsføringstilladelsen en dosering for denne specifikke aldersgruppe baseret på "Guideline on the role of pharmacokinetics in the development of medicinal product in the paediatric population, 2006".
English: The pharmacokinetic profile of fluconazole in children has a well understood relationship to that in adults when volume of distribution and clearance are taken into account.
Danish: Fluconazols farmakokinetiske profil hos børn har et velkendt forhold til profilen hos voksne, når der tages højde for distributionsvolumen og clearance.
English: Section 4.1 - Therapeutic Indications
Danish: Punkt 4.1 - Terapeutiske indikationer
English: This indication does not make any more reference to individual forms of invasive candidal infections.
Danish: Denne indikation indeholder ikke referencer til individuelle former for invasive candidainfektioner.
English: Section 4.4 - Special warnings and precaution for use
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen
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.
Danish: CHMP vurderede lægemidlets produktinformation under hensyntagen til de eksisterende nationale produktresuméer og den eksisterende faglig viden og drøftede indikationerne for hver enkelt medicinsk tilstand.
English: The original applications for the prevention of fungal infections indication included seven comparative clinical studies in which 755 patients received oral fluconazole, 383 patients placebo and 374 patients oral comparative agents.
Danish: De oprindelige ansøgninger til indikationen forebyggelse af svampeinfektioner indeholdt syv kliniske sammenlignende undersøgelser, hvor 755 patienter fik oral fluconazol, 383 patienter placebo og 374 patienter orale sammenlignende midler.
English: Although C. neoformans typically infects immunocompromised persons, patients with no apparent immune system problems also develop cryptococcosis.
Danish: Selvom C. neoformans typisk inficerer immunkompromitterede personer, udvikler patienter uden åbenlyse problemer med immunsystemet også kryptokokkose.
English: Oropharyngeal candidiasis (OPC) continues to be one of the most frequent opportunistic infections in HIV-infected children during the Highly Active Anti-Retroviral Therapy (HAART) era (28% of children), with an incidence rate of 0.93 per 100 child-years.
Danish: Orofaryngeal candidiasis (OPC) er fortsat en af de hyppigst forekommende opportunistiske infektioner hos hiv-inficerede børn under HAART (Highly Active Anti-Retroviral Therapy)-perioden (28 % af børnene) med en forekomst på 0,93 per 100 børneår.
English: This formulation was only approved in Italy and was indicated for the treatment of dermatomycoses due to dermatophytes, yeasts and moulds.
Danish: Denne formulering var kun godkendt i Italien og var indiceret til behandling af dermatomykose, som skyldes dermatofytter, gær og skimmelsvampe.
English: Candida oesophagitis continues to be seen in children who are not responding to antiretroviral therapy.
Danish: Candida øsofagitis ses stadig hos børn, som ikke responderer på antiretroviral behandling.
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.
Danish: Kryptokokinfektioner forekommer med større sandsynlighed i forbindelse med hiv-sygdom, men kryptokokinfektioner forekommer langt mindre hyppigt blandt hiv-inficerede børn end blandt voksne.
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Danish: På baggrund af gennemgang af data vedtog CHMP et harmoniseret afsnit 3.
English: Treatment of invasive candidiasis requires higher doses of fluconazole than are used for mucocutaneous disease.
Danish: Behandling af invasiv candidiasis kræver højere doser fluconazol, end der anvendes til mukokutan sygdom.
English: All these changes were accepted by the CHMP.
Danish: Alle disse ændringer blev godkendt af CHMP.
English: The warning on the effect on the cardiovascular system and the association with prolongation of the QT interval on the electrocardiogram has been reinforced.
Danish: Advarslen om virkningen på hjerte-kar-systemet og forbindelsen til et forlænget QT-interval på elektrokardiogrammet er understreget.
English: Information on development, manufacture and control of capsules, powder for oral suspension, syrup and solution for infusion has been presented in a satisfactory manner.
Danish: Information om udvikling, fremstilling og kontrol af kapsler, pulver til oral suspension, syrup og infusionsvæske, opløsning er fremlagt på en tilfredsstillende måde.
English: The indication of relapse prevention in immunocompromised (HIV and cancer) patients was investigated.
Danish: Indikationen recidivforebyggelse hos immunkompromitterede (hiv- og cancer-) patienter blev undersøgt.
English: Oesophageal candidiasis is primarily associated with HIV infection or other forms of immunosuppression in children.
Danish: Øsofageal candidiasis er primært forbundet med hiv-infektion eller andre former for immunsuppression hos børn.
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.
Danish: For at harmonisere doseringen foreslog indehaveren af markedsføringstilladelsen at medtage en tabel i punktet om dosering med de anbefalede doser for hver indikation og at skelne mellem behandling og forebyggelse.
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.
Danish: Desuden er CHMP af den opfattelse, at sikkerhed og virkning for indikationen genital candidiasis ikke er fastlagt hos den pædiatriske population, da alle tilgængelige data om børn og unge stammer fra undersøgelser med andre indikationer end genital candidiasis.
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.
Danish: Da oral absorption sker hurtigt og næsten komplet, er doserne af fluconazol, som anbefales til behandling og/eller profylakse ved de forskellige indikationer, de samme for oral (kapsler, oral suspension og syrup) og i.v.-administration.
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.
Danish: På grund af de divergerende nationale beslutninger i medlemsstaterne vedrørende godkendelse af ovenfor nævnte lægemidler (og relaterede navne) indgav Europa-Kommissionen meddelelse til CHMP/EMA-sekretariatet om en officiel indbringelse i henhold til artikel 30, stk. 2 , i direktiv 2001/83/EF med senere ændringer for at løse divergenser mellem de nationalt godkendte produktresuméer og dermed harmonisere de divergerende produktresuméer i EU.
English: Alternatively, an initial course of amphotericin B therapy can be administered and then carefully followed by completion of a course of fluconazole therapy.
Danish: Alternativt kan der gives et indledende behandlingsforløb med amphotericin B, som derefter omhyggeligt følges af en fuld behandling med fluconazol.
English: Other conditions which pose an increased risk include certain lymphomas (e.g. Hodgkin's lymphoma), sarcoidosis, and patients on long-term corticosteroid therapy.
Danish: Andre tilstande, som udgør en øget risiko, omfatter visse lymfomer (f.eks. Hodgkins lymfom), sarcoidose og patienter på langvarig kortikosteroid behandling.
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.
Danish: På baggrund af ovenstående anser CHMP benefit/risk-forholdet for Diflucan og relaterede navne for positivt og den harmoniserede produktinformation som egnet til godkendelse.
English: Moreover halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4.
Danish: Desuden har halofantrin vist sig at forlænge QTc-intervallet ved den anbefalede terapeutiske dosis og er et substrat af CYP3A4.
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.
Danish: Den generelle tekst om klassificering af hyppighed og de bivirkninger, der er blevet indberettet efter markedsføring, blev klarlagt, og hyppigheden af en række bivirkninger blev revideret.
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.
Danish: Til indikationerne paracoccidioidomykose, histoplasmose, lymphokutan sporotrichose, hvor andre stoffer har været virkningsløse eller ikke er tolereret, mente CHMP, at de fremlagte data om effekt ikke var tilstrækkelige.
English: Candidal infection of male and female genital areas is relatively common and responds well to an oral administration of fluconazole.
Danish: Candidainfektioner er relativt almindelige i genitalområdet hos mænd og kvinder og responderer godt på oral administration af fluconazol.
English: The use of broad-spectrum antibiotics, corticosteroids, cytotoxic drugs, and radiation therapy are also predisposing factors.
Danish: Brugen af bredspektret antibiotika, kortikosteroider, cytotoksiske lægemidler og strålebehandling er også disponerende faktorer.
English: QUALITY - MODULE 3
Danish: KVALITET - AFSNIT 3
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).
Danish: Risikofaktorer for øsofageal candidiasis hos børn med hiv-infektioner omfatter et lavt CD4-tal (<100 celler/mm3), høj virusmængde og neutropeni (<500 celler/mm3).
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.
Danish: Desuden gør den farmakokinetiske profil det muligt at anvende fluconazol som enkeltstof på grund af den lange halveringstid på cirka 36 timer og distributionen i vaginas væv og sekreter med koncentrationer over den minimale hæmmende koncentration for C. albicans, som varede ved i mindst 72 timer.
English: • Tinea unguinium (onychomycosis) when other agents are not considered appropriate.
Danish: • Tinea unguinium (onychomykose,) når andre midler ikke betragtes som velegnede.
English: Systemic therapy is essential for oesophageal disease and should be initiated empirically among HIV-infected children who have OPC and oesophageal symptoms.
Danish: Systemisk behandling er essentiel for øsofageal sygdom og skal indledes empirisk hos hiv-inficerede børn med OPC og øsofageale symptomer.
English: Diflucan is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:
Danish: Diflucan er indiceret til fuldbårne nyfødte, spædbørn, småbørn, børn og unge i alderen fra 0-17 år.
English: Cryptococcal meningitis is caused by the fungus Cryptococcus neoformans.
Danish: Kryptokok-meningitis forårsages af svampen Cryptococcus neoformans.
English: In the final approved text of the section 4.2 of the SPC the doses in the paediatric population have been divided in age groups of Infant, toddler and children (28 days to 11 years old), adolescents (12 years to 17 years old) and term newborn infants (0 to 27 days old).
Danish: 4.2 i produktresuméet er doserne til den pædiatriske population opdelt efter aldersgrupper med spædbørn, små børn og børn (28 dage til 11 år), unge (12 -17 år) og fuldbårne nyfødte (0-27 dage).
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.
Danish: Medtagelse af stoffer, for hvilke der er en kendt involvering af CYP 3A4 og yderligere negative påvirkninger af forlængelsen af QT-intervallet (som halofantrin, midazolam og triazolam), er berettiget.
English: Fluconazole is a substance belonging to the chemical class of triazole derivatives.
Danish: Fluconazol er et stof, som tilhører den kemiske klasse triazolderivater.
English: Diflucan has been included in the list of products for Summary of Product Characteristics (SPC) harmonisation in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Danish: Diflucan stod på den liste over lægemidler, for hvilke produktresuméerne skulle harmoniseres i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF med senere ændringer.
English: The CHMP concluded that the fluconazole, at 400 mg to 800 mg daily is a safe and effective primary treatment for coccidioidomycosis.
Danish: CHMP konkluderede, at fluconazol ved 400 mg til 800 mg dagligt er en sikker og effektiv førstevalgsbehandling af coccidioidomykose.
English: Several different dosing regimens were employed, 100 mg/day, 200 mg/day and 200 mg three times/week.
Danish: Der blev anvendt flere dosisregimer, 100 mg dagligt, 200 mg dagligt og 200 mg tre gange ugentligt.
English: The evidence is based on a clinical trial programme of three studies in vulvovaginal candidiasis and one in candidal balanitis.
Danish: Evidensen er baseret på et klinisk undersøgelsesprogram med tre studier af vulvovaginal candidiasis og et af candida balanitis.
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.
Danish: Fluconazol, et tredjegenerations azol, er karakteriseret ved høj oral biotilgængelighed, omfattende distribution i legemsvæsker og væv, forudsigelig renal clearance og administration en gang dagligt.
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.
Danish: Da fluconazol er en potent hæmmer af CYP2C9 og en moderat hæmmer af CYP3A4, og fluconazol også er hæmmer af CYP2C19, bør behandlede patienter, som samtidig får behandling med lægemidler med et smalt terapeutisk vindue, der metaboliseres via CYP2C9, CYP2C19 og CYP3A4, overvåges.
English: Section 4.8 - Undesirable effects
Danish: Punkt 4.8 - Bivirkninger
English: The Core Safety Profile was considered when harmonising the listed adverse reactions between national SPCs of Diflucan.
Danish: Sikkerhedsprofilen blev taget i betragtning ved harmonisering af de angivne bivirkninger mellem de nationale produktresuméer for Diflucan.
English: Diflucan is indicated in adults for the treatment of:
Danish: Diflucan er hos voksne indiceret til behandling af:
English: The inclusion of the wording on the interaction of itraconazole (another triazole) in the PI of saquinavir and taking into account the recent labelling changes for saquinavir (contraindication for concomitant administration with other QTc interval prolonging drugs) was amended.
Danish: 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.
English: Candidemia occurs in up to 12% of HIV-infected children with chronically indwelling central venous catheters for total parental nutrition or intravenous antibiotics.
Danish: Candidæmi forekommer hos op til 12 % af hiv-smittede børn med kroniske indre centralvenekatetre til parenteral ernæring eller intravenøse antibiotika.
English: In all the mycosal candidiasis studies fluconazole was efficacious and equivalent or superior to the standard agents in both adults and paediatric patients.
Danish: I alle undersøgelser af mykotisk candidiasis var fluconazol effektivt og ækvivalent med eller bedre end standardstofferne hos både voksne og pædiatriske patienter.
English: A warning on hypersensitivity reactions has been added as per other azoles.
Danish: Som ved andre azoler er der tilføjet en advarsel om overfølsomhedsreaktioner.
English: Based on the submitted data the CHMP agreed on the dosing recommendations for each indication.
Danish: På grundlag af de indsendte data godkendte CHMP dosisanbefalingerne for hver indikation.
English: In cancer patients it was superior to placebo in preventing mycological relapse.
Danish: Hos cancerpatienter var det bedre end placebo til forebyggelse af mykologisk recidiv.
English: • Relapse of cryptococcal meningitis in patients with high risk of recurrence.
Danish: • Tilbagevendende kryptokok-meningitis hos patienter med høj risiko for recidiv.
English: Oral single-dose therapy with fluconazole in vaginal candidiasis and candidal balanitis has been a treatment option for around 30 years.
Danish: Oral enkeltdosisbehandling med fluconazol ved vaginal candidiasis og candida balanitis har i ca. 30 år været en behandlingsmulighed.
English: The CHMP is in agreement on the final wording of the indication.
Danish: CHMP godkendte den endelige ordlyd for indikationen.
English: The final Package Leaflet wording was adopted by the CHMP.
Danish: Den endelige ordlyd af indlægssedlen blev vedtaget af CHMP.
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).
Danish: Diflucan kan anvendes som vedligeholdelsesterapi for at forhindre recidiv af kryptokok-meningitis hos børn med høj risiko for tilbagefald (se pkt.
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.
Danish: 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.
English: It is most often associated with severe immunological impairment due to diabetes mellitus, leukaemia, lymphoma, malignancy, neutropenia and HIV infection where it presents as a predictor of clinical progression to AIDS.
Danish: 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.
English: The CHMP considered that the treatment of invasive candidiasis in children is sufficiently demonstrated.
Danish: CHMP vurderede, at behandlingen af invasiv candidiasis hos børn er tilstrækkeligt påvist.
English: The CHMP accepted that the supporting data were only for the indication of cryptococcal meningitis which was implemented in the SPC and not the general cryptococcosis indication.
Danish: CHMP accepterede, at underbyggende data kun var for indikationen kryptokok-meningitis, som var medtaget i produktresuméet, og ikke den generelle kryptokok-indikation.
English: Doses of 3 mg/Kg in children have proved effective against fungal infections in immunocompromised children and also for the treatment of paediatric patients with serious fungal infections, such as cryptococcal meningitis.
Danish: 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.
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.
Danish: 4.2 i produktresuméet vedrørende denne indikation CHMP's drøftelse i alle formuleringer, herunder formuleringen med en kapsel, 150 mg.
English: The MAH was asked to evaluate all other sections of the nationally approved SPCs and suggest appropriate changes in the text where divergences exist.
Danish: Indehaveren af markedsføringstilladelsen blev bedt om at evaluere alle andre punkter i de nationalt godkendte produktresuméer og foreslå passende ændringer i teksten ved divergenser.