FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Fil-popolazzjoni pedjatrika, fluconazole tintuża għall-kura ta' kandidjażi mukosali (orofarinġali, fl-esofagu), kandidjażi sistemika u infezzjonijiet kriptokokkali u l-prevenzjoni ta' infezzjoni fungali fi tfal immunokompromessi f'riskju wara kemjoterapija ċitotossika jew radjoterapija.
English: The MAH submitted a proposal for harmonisation of the Quality module.
Maltese: Il-MAH issottometta proposta għall-armonizzazzjoni tal-modulu tal-Kwalità.
English: • Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
Maltese: • Kandidjażi mukosali, inkluż kandidjażi orofarinġeali, kandidjażi esofaġeali, kandidurja u kandidjażi mukokutanja kronika.
English: Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated.
Maltese: Il-koamministrazzjoni ta' prodotti mediċinali oħra magħrufa għall-prolungament tal-intervall QT u li huma metabolizzati permezz taċ-ċitokromju P450 (CYP) 3A4 huma kontroindikati.
English: The CHMP concluded that the fluconazole, at 400 mg to 800 mg daily is a safe and effective primary treatment for coccidioidomycosis.
Maltese: Is-CHMP ikkonkluda li fluconazole, f'dożi minn 400 mg sa 800 mg kuljum, hija kura primarja sikura u effettiva għallkokkidjojdomikożi.
English: Oral or IV fluconazole solutions, administered for 14-21 days, are highly effective for treatment of Candida oesophagitis.
Maltese: Soluzzjonijiet orali jew IV ta' fluconazole, amministrati għal 14-21 ġurnata, huma ferm effettivi għallkura tal-Candida fl-esofagu.
English: Recently, the Infectious Diseases Society of America (IDSA: Pappas et al 2009) published updated guidance for use of antifungal agents including the prevention indication where fluconazole is recommended for prevention.
Maltese: Pappas et al 2009) ippubblikat gwida aġġornata għall-użu ta' aġenti antifungali inkluż l-indikazzjoni ta' prevenzjoni fejn fluconazole hija rrakkomandata għall-prevenzjoni.
English: Furthermore, fluconazole was also available for topical use in the 0.5% gel formulation.
Maltese: Barra minn hekk, fluconazole kienet disponibbli wkoll għal użu topikali fil-formulazzjoni ta' ġel ta' 0.5%.
English: The incidence of oesophageal candidiasis is around 0.08 per 100 child-years after introduction of HAART in around 2001.
Maltese: L-inċidenza ta' kandidjażi fl-esofagu hi ta' madwar 0.08 għal kull 100 tfal-snin wara l-introduzzjoni tal-HAART madwar is-sena 2001.
English: Diflucan is indicated in adults for the prophylaxis of:
Maltese: Diflucan huwa indikat fl-adulti għall-profilassi ta':
English: Diflucan is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:
Maltese: Diflucan huwa indikat fi trabi tat-twelid li twieldu fi żmienhom, trabi, tfal żgħar, tfal, u adoloxxenti ta' bejn 0 u 17-il sena:
English: The use of fluconazole for the above indications is also supported by the Infectious Diseases Society of America (IDSA) guidelines.
Maltese: Dan l-aħħar, l-Infectious Diseases Society of America (IDSA:
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.
Maltese: Is-CHMP ikkonkluda li terapija kontinwa b'fluconazole b'100 mg/kuljum u terapija kontinwa u intermittenti b'200 mg/kuljum huma effettivi fil-prevenzjoni ta' rikaduta ta' kandidjażi orofarinġali jew fl-esofagu f'pazjenti immunokompromessi u huma tollerati tajjeb.
English: Fluconazole is a substance belonging to the chemical class of triazole derivatives.
Maltese: Fluconazole hi sustanza li tagħmel parti mill-klassi kimika tad-derivattivi tat-triazole.
English: • To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).
Maltese: • Għat-tnaqqis tal-inċidenza ta' rikorrenza tal-kandidjażi vaġinali (4 episodji jew aktar fissena).
English: The CHMP noted the MAH proposal and adopted a harmonised text for this section, applicable to all Diflucan formulations.
Maltese: Is-CHMP ikkunsidra l-proposta tal-MAH u adotta test armonizzat għal din is-sezzjoni, applikabbli għall-formulazzjonijiet kollha ta' Diflucan.
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.
Maltese: Dawn l-istudji wrew li fluconazole orali hija sustanza antimikotika effettiva u ttollerata tajjeb għal kontra t-Tinea corporis, it-Tinea cruris, it-Tinea pedis, it-Tinea versicolor u l-onikomikożi.
English: In Member States there were differences in the posology of various infections, e.g. for individual mucosal candida infections.
Maltese: Fl-Istati Membri kien hemm differenzi fil-pożoloġija ta' diversi infezzjonijiet, eż. għal infezzjonijiet ta' candida mukosali individwali.
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.
Maltese: Finalment u bħala konklużjoni, is-CHMP adotta s-settijiet ta' indikazzjonijiet li ġejjin għal Diflucan u l-ismijiet assoċjati għal kapsuli (50 mg, 100 mg, 150 mg, 200 mg), soluzzjoni għall-infużjoni (IV), xiropp, trab għal sospensjoni orali.
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)).
Maltese: • Profilassi ta' infezzjonijiet kandidali f'pazjenti b'newtropenja mtawwla (bħal pazjenti b'malinni ematoloġiċi li jkunu qegħdin jirċievu l-kemoterapija jew pazjenti li jkunu qed jirċievu Trapjant ta' Ċelloli Staminali Ematopojtiċi (ara s-sezzjoni 5.1)).
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.
Maltese: Diflucan jintuża għall-kura tal-kandidjażi mukosali (orofarinġeali jew esofaġeali), kandidjażi invażiva, meninġite kriptokokkali u l-profilassi ta' infezzjonijiet kandidali f'pazjenti immunokompromessi.
English: • Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.
Maltese: • Kandidjażi vaġinali, akuta jew rikorrenti; meta t-terapija lokali mhijiex xierqa.
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.
Maltese: Fluconazole amministrata lil tfal f'dożi ta' 12 mg/Kg/kuljum tipprovdi espożizzjoni simili għal dożaġġ standard ta' 400 mg kuljum fl-adulti u dożi aktar għoljin mhumiex rakkomandati għat-tfal.
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.
Maltese: Id-dejta li tappoġġa l-indikazzjoni għall-prevenzjoni ta' fluconazole ta' infezzjoni fungali f'pazjenti immunokompromessi fid-Dossier ta' Reġistrazzjoni Internazzjonali (1993) pedjatriku ġiet minn tliet studji fit-tfal; studju minnhom iddetermina l-effikaċja ta' fluconazole meta mqabbel ma kura b'nystatin waħidha, studju minnhom kontra l-polieni orali (nystatin jew amphotericin B) u t-tielet studju kontra ketoconazole. Fluconazole, amministrata f'dożi ta' 1 mg/Kg/kuljum u 3 mg/Kg/kuljum kienet aktar effettiva mill-kumparatur attiv fil-prevenzjoni ta' infezzjonijiet fungali.
English: • Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
Maltese: • Kandidjażi atrofika orali kronika (uġigħ fil-ħalq minħabba d-dentatura) jekk l-iġjene dentali jew it-trattament topikali mhumiex biżżejjed.
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.
Maltese: L-inklużjoni ta' sustanzi li għalihom huma magħrufa l-involviment ta' CYP 3A4 u l-effetti negattivi ta' addittivi fuq ilprolungament tal-intervall QT (bħal halofantrine, midazolam u triazolam) hija ġġustifikata.
English: The CHMP agreed that fluconazole is indicated in the prophylaxis of candidal infections in immunocompromised children.
Maltese: Is-CHMP qabel li fluconazole hi indikata fil-profilassi ta' infezzjonijiet kandidali fi tfal immunokompromessi.
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.
Maltese: It-test ġenerali tal-klassifikazzjoni tal-frekwenzi, u r-reazzjoni avversa miksuba minn esperjenza ta' wara t-tqegħid fis-suq ġew iċċarati, u l-frekwenza tan-numru ta' avvenimenti ġiet riveduta.
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.
Maltese: 2 studji ta' doża waħda, 2 studji ta' dożi multipli, u studju fin-neonati prematuri.
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.
Maltese: Id-doża ta' fluconazole rakkomandata għall-prevenzjoni ta' infezzjonijiet fungali fl-adulti hi 50-400 mg u l-użu tal-algorittmu ta' hawn fuq jirriżulta f'doża rakkomandata ta' 3-12 mg/Kg għat-tfal.
English: Oral single-dose therapy with fluconazole in vaginal candidiasis and candidal balanitis has been a treatment option for around 30 years.
Maltese: Terapija orali b'doża waħda b'fluconazole f'kandidjażi vaġinali u f'balanite kandidali ilha għażla ta' kura għal madwar 30 sena.
English: Systemic therapy is essential for oesophageal disease and should be initiated empirically among HIV-infected children who have OPC and oesophageal symptoms.
Maltese: Terapija sistemika hi essenzjali għal marda fl-esofagu u għandha tkun mibdija empirikament fost tfal infettati bl-HIV li għandhom l-OPC u sintomi esofaġeali.
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).
Maltese: Diflucan jista' jintuża bħala terapija ta' manteniment biex jipprevjeni rrikaduta tal-meninġite kriptokokkali fi tfal b'riskju għoli ta' rikorrenza (ara sezzjoni 4.4).
English: Fluconazole and amphotericin B were associated with similar clinical response rates and survival in the treatment of candidemia; however, drug-related adverse events were more frequent with amphotericin B. The CHMP concluded that fluconazole is a safe and effective medicinal product in prophylaxis or treatment for invasive candidiasis compared to other therapies.
Maltese: Fluconazole u amphotericin B ġew assoċjati ma' rati ta' rispons kliniku u sopravivenza simili fil-kura tal-kandidemja; madanakollu, episodji avversi relatati mat-trattament kienu aktar frekwenti bl-amphotericin B.
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.
Maltese: Ġew implimentati subintestaturi bħall-Mekkaniżmu ta' azzjoni, Ir-relazzjoni PK/PD, Il-Mekkaniżmu(i) tar-reżistenza u l-Breakpoints (skont il-Kumitat Ewropew dwar l-Ittestjar tas-Suxxettibilità Antimikrobika - EUCAST).
English: Moreover halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4.
Maltese: Barra minn hekk, ingħatat prova li halofantrine jtawwal l-intervall QTc fid-doża terapewtika rakkomandata u huwa substrat ta' CYP3A4.
English: The CHMP noted the MAH proposal and adopted a harmonised text for this section.
Maltese: Is-CHMP ikkunsidra l-proposta tal-MAH u adotta test armonizzat għal din is-sezzjoni.
English: • Relapse of cryptococcal meningitis in patients with high risk of recurrence.
Maltese: • Rikaduta ta' meninġite kriptokokkali f'pazjenti b'riskju għoli ta' rikorrenza.
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.
Maltese: Ġiet emendata l-inklużjoni tal-formolazzjoni tal-kliem fuq l-interazzjoni ta' itraconazole (triazole ieħor) fil-PI ta' saquinavir u tqiesu l-bidliet reċenti fit-tikketta għal saquinavir (kontraindikazzjoni għall-amministrazzjoni konkomittanti ma' mediċini oħrajn li jtawwlu l-intervall QTc).
English: Other conditions which pose an increased risk include certain lymphomas (e.g. Hodgkin's lymphoma), sarcoidosis, and patients on long-term corticosteroid therapy.
Maltese: Kundizzjonijiet oħra li huma ta' riskju akbar jinkludu ċerti linfomi (eż. il-linfoma ta' Hodgkin), sarkojdożi, u pazjenti fuq terapija ta' kortikosterojdi għal perjodu twil.
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.
Maltese: B'hekk, il-verżjoni finali tal-formulazzjoni fis-sezzjoni 4.2 tal-SPC dwar din lindikazzjoni, tirrefletti d-diskussjoni tas-CHMP fil-formulazzjonijiet kollha, inkluż il-preżentazzjoni ta' kapsula waħda ta' 150 mg.
English: An EU work sharing project-Assessment of Paediatric data took place in 2005-2006.
Maltese: Fl-2005-2006, saret valutazzjoni ta' proġett tal-UE dwar il-kondiviżjoni tax-xogħol ta' dejta Pedjatrika.
English: • Tinea unguinium (onychomycosis) when other agents are not considered appropriate.
Maltese: • Tinea unguinium (onikomikożi) meta sustanzi oħra mhumiex ikkunsidrati bħala xierqa.
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.
Maltese: Barra minn hekk, il-profil farmakokinetiku ta' fluconazole jippermetti l-użu tagħha bħala sustanza unika minħabba l-half-life ta' eliminazzjoni mtawla tagħha ta' bejn wieħed u ieħor 36 siegħa u d-distribuzzjoni tagħha fit-tessuti u ttnixxijat vaġinali, b'konċentrazzjonijiet ogħla mill-konċentrazzjoni inibitorja minima għal C. albicans persistenti għal tal-inqas 72 siegħa.
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.
Maltese: Kandidjażi disseminata mhijiex frekwenti fost it-tfal infettati bl-HIV, iżda l-Candida tista' tinxtered mill-esofagu partikolarment meta l-koinfezzjoni bil-vajrus tal-herpes simplex (HSV) jew iċċitomegalovajrus (CMV) tkun preżenti.
English: The concomitant use of fluconazole and halofantrine is therefore not recommended.
Maltese: Għaldaqstant, l-użu konkomittanti ta' fluconazole u halofantrine mhuwiex rakkomandat.
English: For Tinea unguinium
Maltese: Konklużjonijiet xjentifiċi
English: Fluconazole is also used as maintenance therapy (prophylaxis) for prevention of the recurrence of vaginal candidiasis.
Maltese: Fluconazole hija użata wkoll bħala terapija ta' manteniment (profilassi) għall-prevenzjoni tar-rikorrenza ta' kandidjażi vaġinali.
English: More extensive information has been added in section 4.5 of the SPC.
Maltese: Informazzjoni aktar estensiva żdiedet fissezzjoni 4.5 tal-SPC.
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.
Maltese: Is-CHMP ikkonkluda li fluconazole bl-attività tagħha kontra l-ispeċji Candida u l-farmakokinetiċi toffri alternattiva sikura, effettiva, u konvenjenti għal terapija topikali f'doża waħda kemm għall-vaġinite kandidali kif ukoll għall-balanite kandidali fl-adulti kif ukoll għallprevenzjoni ta' rikorrenza ta' kandidjażi vaġinali.
English: The use of broad-spectrum antibiotics, corticosteroids, cytotoxic drugs, and radiation therapy are also predisposing factors.
Maltese: L-użu ta' antibiotiċi b'firxa wiesgħa, kortikosterojdi, trattamenti ċikotossiċi, u kura bir-radjazzjoni huma fatturi predispożittivi wkoll.
English: The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Maltese: Il-metodu u l-approċċ statistiku flimkien mad-dejta pprovduta ġew riveduti u s-CHMP qies il-frekwenza stmata bħala waħda xierqa.
English: The CHMP noted that adolescent posology had been omitted; none of the national SPCs described the posology for this age group.
Maltese: Is-CHMP innota li l-pożoloġija tal-adoloxxenti tneħħiet; l-ebda SPC nazzjonali ma ddeskriva lpożoloġija għal dan il-grupp ta' età.
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.
Maltese: L-indikazzjoni tal-kandidjażi ġenitali u aktar speċifikament il-kandidjażi vulvovaġinali fin-nisa adulti u l-balanite kandidali fl-irġiel adulti ġiet awtorizzata f'xi SM għad-doża ta' 150 mg, fi preżentazzjoni ta' kapsula waħda minħabba l-konvenjenza tal-kura b'doża waħda.
English: For the one 150 mg capsule presentation the section 4.1 of the SPC is agreed by the CHMP as follows:
Maltese: Għall-preżentazzjoni ta' kapsula waħda ta' 150 mg, kien hemm qbil mis-CHMP dwar is-sezzjoni 4.1 tal-SPC kif ġej:
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.”
Maltese: Wara kwistjonijiet imqajma mis-CHMP, il-MAH ipprovda pożoloġija għal dan il-grupp ta' età speċifiku ibbażata fuq il-“Linja gwida dwar ir-rwol ta' farmakokinetiċi fl-iżvilupp ta' prodott mediċinali fil-popolazzjoni pedjatrika, 2006.
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.
Maltese: Għaldaqstant, ġeneralment, doża waħda ta' 150 mg ta' fluconazole tipprovdi trattament sikur u effettiv għall-kandidjażi vulvovaġinali f'nisa adulti jew għall-balanite kandidali f'irġiel adulti.
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.
Maltese: Fil-każ ta' mikożi endemika fonda, il-provi għall-effikaċja ta' fluconazole fil-kura ta' forom oħra ta' mikożi endemika bħall-parakokkidjojdomikożi, is-sporotrikożi limfokutanea u l-istoplasmożi kienu limitati u ma għadhomx imsemmija fis-sezzjoni 4.1 tal-PI.
English: Diflucan is indicated in adults for the treatment of:
Maltese: Diflucan huwa indikat fl-adulti għall-kura ta':
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.
Maltese: Għalkemm li C. neoformans normalment jinfetta l-persuni immunokompromessi, pazjenti mingħajr problemi ċari fissistema immuni jiżviluppaw il-kriptokokkożi wkoll. Fluconazole uriet effikaċja in vitro u in vivo kontra l-Cryptococcus neoformans u tipprovdi lit-tobba b'għażla għal kura li hija inqas tossika minn amphotericin B. Fluconazole ġiet stabbilita bħala terapija antifungali sikura u effettiva f'pazjenti b'saħħithom u immunokompromessi b'meninġite kriptokokkali u hemm dejta klinika li tappoġġa lil fluconazole bħala kura għat-tfal u l-adulti.
English: Invasive candidiasis in children
Maltese: Kandidjażi invażiva fit-tfal
English: Fluconazole therapy is efficacious for several deep mycoses and this is supported by clinical trial data and recommended by clinical guidelines.
Maltese: Il-kura bi Fluconazole hija effikaċi għal diversi mikożi profondi u dan huwa sostnut mid-dejta tal-provi kliniċi u rrakkomandat mil-linji gwida kliniċi.
English: Paediatric population
Maltese: Il-popolazzjoni pedjatrika
English: Other Sections of the SPC
Maltese: Sezzjonijiet oħra tal-SPC
English: • Candidal balanitis when local therapy is not appropriate.
Maltese: • Balanite kandidali meta t-terapija lokali mhijiex xierqa.
English: The results are supportive of fluconazole as an appropriate treatment for mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
Maltese: Ir-riżultati jappoġġaw lil fluconazole bħala kura xierqa għal kandidjażi mukożali, inkluż il-kandidjażi orofarinġeali, esofagzli, il-kandidurja u l-kandidjażi mukokutanja kronika.
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.
Maltese: Minħabba li l-kura ta' kandidjażi ġenitali teħtieġ doża waħda ta' 150 mg ta' fluconazole, preżentazzjoni konvenjenti li fiha kapsula waħda ta' 150 mg ta' fluconazole hija disponibbli f'xi Stati Membri (SMi) għall-indikazzjoni ta' kandidjażi ġenitali biss, b'mod aktar speċifika għall-kura ta' kandidjażi vaġinali akuta u balanite kandidali.
English: The evidence is based on a clinical trial programme of three studies in vulvovaginal candidiasis and one in candidal balanitis.
Maltese: Il-provi huma bbażati fuq programm ta' provi kliniċi ta' tliet studji dwar il-kandidjażi vulvovaġinali u wieħed dwar il-balanite kandidali.
English: • Acute vaginal candidiasis when local therapy is not appropriate.
Maltese: • Kandidjażi vaġinali akuta meta t-terapija lokali ma tkunx xierqa.
English: This indication does not make any more reference to individual forms of invasive candidal infections.
Maltese: Din l-indikazzjoni ma tagħmilx aktar referenza għall-forom individwali ta' infezzjonijiet kandidali invażivi.
English: Concomitant use of fluconazole with saquinavir was contraindicated accordingly with a cross reference to section 4.3 of the PI. Concomitant use of fluconazole with saquinavir was contraindicated accordingly with a cross reference to section 4.3 of the PI. All the above changes were accepted by the CHMP and apply to all formulations.
Maltese: B'hekk, l-użu konkomittanti ta' fluconazole ma' saquinavir ġie kontroindikat bi kross-referenza għas-sezzjoni 4.3 tal-PI.