natgillin/translations-raw huggingface dataset:
However in very rare cases treatment in adolescents is imperative (i.e. no other (especially local) treatment option is appropriate) and these cases should not be totally excluded from treatment. 
Vendar pa je v zelo redkih primerih zdravljenje pri mladostnikih nujno (npr. na voljno ni druge primerne možnosti (še posebej lokalnega) zdravljenja) in v teh primerih zdravljenje ne sme biti popolnoma izključeno.
• To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year). 
• zmanjševanja pojavnosti ponavljajoče se vaginalne kandidiaze (4 ali več epizod na leto);
Endemic mycoses remain a major public health problem in several countries and they are becoming increasingly frequent with the spread of HIV infection. 
Endemične mikoze ostajajo velika težava za javno zdravje v več državah in so s širjenjem okužb s HIV vedno pogostejše.
Neutropenic patients are at especially high risk for candidemia. 
Nevtropenični bolniki so še posebej ogroženi s kandidemijo.
Overall summary of the scientific evaluation of Diflucan and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Diflucan in povezanih imen (glejte Dodatek I)
• Invasive candidiasis. 
• invazivne kandidiaze;
The concomitant use of fluconazole and halofantrine is therefore not recommended. 
Sočasna uporaba flukonazola in halofantrina se zato ne priporoča.
A warning on tinea capitis and the fact that should not be used in children has been added. 
Dodano je bilo opozorilo za tinea capitis in dejstvo, da se ne sme uporabljati pri otrocih.
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. 
Zdravljenje se lahko začne, preden so znani izvidi kultur in drugih laboratorijskih študij; ko so ti izvidi na voljo, je treba antiinfektivno zdravljenje ustrezno prilagoditi .
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. 
Zdravilo Diflucan je bilo vključeno na seznam zdravil za uskladitev povzetkov glavnih značilnosti zdravila (SPC) v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena.
Based on the review of data the CHMP adopted a harmonised Module 3. 
Na podlagi pregleda podatkov je CHMP sprejel usklajen Modul 3.
An EU work sharing project-Assessment of Paediatric data took place in 2005-2006. 
Med letoma 2005-2006 je potekal skupni delovni projekt EU - Ocena pediatričnih podatkov.
The incidences in the endemic areas of these fungal infections are increasing and the population travelling toward its specific endemic regions in the United States and Southern America is growing. 
Pojavnost na območjih, ogroženih s temi glivičnimi okužbami, je naraščajoča in vedno več je ljudi, ki potujejo v te endemične regije v Združenih državah Amerike in v Južni Ameriki.
This indication does not make any more reference to individual forms of invasive candidal infections. 
Ta indikacija se ne nanaša na posamezne oblike invazivnih kandidnih okužb.
The use of fluconazole for the above indications is also supported by the Infectious Diseases Society of America (IDSA) guidelines. 
Uporabo flukonazola pri zgoraj navedenih indikacijah podpirajo tudi smernice Ameriškega združenja za infekcijske bolezni (IDSA).
During the time of the evaluation of the procedure the Marketing Authorisation Holder (MAH) voluntarily withdrew the gel formulation from the European Market. 
Med postopkom ocenjevanja je imetnik dovoljenja za promet z zdravilom prostovoljno umaknil formulacijo gela z evropskega tržišča.
Section 4.1 - Therapeutic Indications 
Poglavje 4.1 - Terapevtske indikacije
The warning on the effect on the cardiovascular system and the association with prolongation of the QT interval on the electrocardiogram has been reinforced. 
Opozorilo o učinku na srčno-žilni sistem in povezava s podaljšanjem intervala QT na elektrokardiogramu je bilo ponovno poudarjeno.
All these changes were accepted by the CHMP. 
Vse te spremembe je CHMP potrdil.
Cryptococcal infections in children 
Kriptokokne okužbe pri otrocih
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. 
Ocenjevali so farmakokinetične podatke za 113 pediatričnih bolnikov iz 5 študij, dveh študij z enojnim odmerkom, 2 z različnimi odmerki in študijo pri nedonošenih novorojenčkih.
Cryptococcosis is a defining opportunistic infection for AIDS. 
Kriptokokoza je tipična oportunistična okužba za AIDS.
In Member States there were differences in the posology of various infections, e.g. for individual mucosal candida infections. 
Med državami članicami so obstajale razlike v odmerjanju pri različnih okužbah, na primer za posamezne mukozne kandidne okužbe.
There were also differences in the wording on the dosage recommendation for adolescents and children regarding all indications. 
Razlike so se pojavljale tudi v besedilih priporočil za odmerjanje pri mladostnikih in otrocih, in sicer pri vseh indikacijah.
The use of fluconazole for the treatment of fungal skin infections was examined in several comparative and non-comparative studies. 
Uporabo flukonazola pri zdravljenju glivičnih okužb kože so preučevali v več primerjalnih in neprimerjalnih študijah.
Fluconazole is a substance belonging to the chemical class of triazole derivatives. 
Flukonazol je snov, ki spada v kemijsko skupino derivatov triazola.
Candida oesophagitis continues to be seen in children who are not responding to antiretroviral therapy. 
Candida oesophagitis je še vedno prisotna pori otrocih, ki se ne odzivajo na protivirusno zdravljenje.
This formulation was only approved in Italy and was indicated for the treatment of dermatomycoses due to dermatophytes, yeasts and moulds. 
Ta formulacija je bila odobrena samo v Italiji in je bila indicirana za zdravljenje dermatomikoze zaradi dermatofitov, kvasovk in plesni.
Oral or IV fluconazole solutions, administered for 14-21 days, are highly effective for treatment of Candida oesophagitis. 
Peroralne ali intravensko raztopine flukonazola, ki se uporabljajo 14-21 dni, so zelo učinkovite za zdravljenje Candida oesophagitis.
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. 
Orofaringealna kandidiaza (OPC) je še vedno ena najpogostejših oportunističnih okužb pri otrocih, okuženih z virusom HIV, v času prejemanja močno aktivne protivirusne terapije (Highly Active Anti-Retroviral Therapy (HAART)) (28 % otrok), s stopnjo pojavnosti 0,93 na 100 otrok/leto.
The incidence of oesophageal candidiasis is around 0.08 per 100 child-years after introduction of HAART in around 2001. 
Pojavnost ezofagealne kandidiaze je okoli 0,08 na 100 otrok/leto po začetku zdravljenja po režimu HAART okoli leta 2001.
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.” 
Po zastavljenih vprašanjih CHMP je imetnik dovoljenja za promet z zdravilom predložil način odmerjanja za to starostno skupino, ki ga je oblikoval na podlagi „Smernice o vlogi farmakokinetike pri razvoju zdravila pri pediatrični populaciji, 2006“.
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). 
V končnem odobrenem besedilu v poglavju 4.2 povzetka glavnih značilnosti zdravila so bili odmerki za pediatrično populacijo ločeni glede na starostno skupino dojenčkov, malčkov in otrok (28 dni do 11 let), mladostnikov (12 let do 17 let) in novorojenčkov (0 do 27 dni).
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. 
Rezultati izvedenega testa kažejo zadovoljivo doslednost in enotnost pomembnih značilnosti kakovosti zdravila, zato se sklepa, da ima zdravilo lahko zadovoljiv in enoten kliničen učinek.
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. 
Nedavno je Ameriško združenje za infekcijske bolezni (ISDA: Pappas et al 2009) objavilo posodobljeno smernico za uporabo antimikotikov, vključno z indikacijo za preprečevanje, pri čemer je flukozanol priporočen za preprečevanje.
All the above changes were accepted by the CHMP and apply to all formulations. 
Vse navedene spremembe je CHMP potrdil in veljajo za vse formulacije.
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. 
Izvirnim vlogam za indikacijo za preprečevanje glivičnih okužb je bilo priloženih sedem primerjalnih kliničnih študij, v katerih je sodelovalo 755 bolnikov, ki so prejemali peroralni flukonazol, 383 bolnikov je prejemalo placebo in 374 bolnikov primerjalna peroralna zdravila.
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. 
Za bolnike z okvarjenim delovanjem ledvic je bilo dodano opozorilo s sklicem na poglavje o odmerjanju 4.2 za to skupino bolnikov.
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. 
Zato te indikacije niso več navedene v poglavju 4.1 povzetka glavnih značilnosti zdravila, v ustrezna poglavja pa so bila dodana opozorila.
Information on development, manufacture and control of capsules, powder for oral suspension, syrup and solution for infusion has been presented in a satisfactory manner. 
Informacije o razvoju, izdelovanju in kontroli kapsul, praška za peroralno suspenzijo, sirupa in raztopine za infundiranje so bile predstavljene na zadovoljiv način.
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. 
Zaradi različnih nacionalnih odločitev držav članic o odobritvi dovoljenj za promet z zgoraj navedenim zdravilom (in povezanih imen) je Evropska komisija obvestila sekretariat CHMP/ EMA o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, z namenom razrešitve nesoglasij med nacionalnimi povzetki glavnih značilnosti zdravila in s tem uskladitve različnih povzetkov glavnih značilnosti zdravila v EU.
It was also generally well tolerated and there were no changes of clinical significance at doses of up to and including 400 mg/day. 
Na splošno se je zdravilo dobro prenašalo in ni bilo nobene klinično pomembne razlike pri odmerkih do (in vključno s) 400 mg/dan.
Diflucan can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4). 
Zdravilo Diflucan se lahko uporablja kot vzdrževalno zdravljenje za preprečevanje ponovitev kriptokoknega meningitisa pri otrocih z visokim tveganjem za ponovitve (glejte poglavje 4.4).
Several different dosing regimens were employed, 100 mg/day, 200 mg/day and 200 mg three times/week. 
Uporabljenih je bilo več različnih načinov odmerjanja, in sicer 100 mg/dan, 200 mg/dan in 200 mg trikrat/teden.
Candidemia occurs in up to 12% of HIV-infected children with chronically indwelling central venous catheters for total parental nutrition or intravenous antibiotics. 
Kandidemija se pojavlja pri do 12 % otrok, okuženih z virusom HIV, s stalno vstavljenim centralnim venskim katetrom za celovito prehranjevanje ali intravensko dajanje antibiotikov.
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. 
Splošno besedilo o razvrstitvi pogostnosti in opis neželene reakcije, pridobljen iz obdobja trženja zdravila, sta bila preoblikovana v jasnejšo obliko in popravljene so bile pogostnosti več reakcij.
Consideration should be given to official guidance on the appropriate use of antifungals. 
Upoštevajte tudi uradne smernice za ustrezno uporabo antimikotikov .
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. 
CHMP je ocenil informacije o zdravilu, pri čemer je upošteval veljavne nacionalne informacije o zdravilu in obstoječe strokovno znanje ter preučil indikacije za vsako posamezno zdravstveno stanje.
• Relapse of cryptococcal meningitis in patients with high risk of recurrence. 
• ponovitve kriptokoknega meningitisa pri bolnikih z visokim tveganjem za ponovitve;
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. 
Na osnovi navedenega je CHMP menil, da je razmerje med koristmi in tveganji za zdravilo Diflucan in povezana imena ugodno ter da se dokumentacija usklajenih informacij o zdravilu lahko odobri.
Section 4.4 - Special warnings and precaution for use 
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi
• 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)). 
• kandidnih okužb pri bolnikih z dolgotrajno nevtropenijo (kot so bolniki s hematološkimi malignimi boleznimi, ki prejemajo kemoterapijo, ali pri prejemnikih transplantata krvotvornih matičnih celic (glejte poglavje 5.1)).
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. 
CHMP je menil tudi, da varnost in učinkovitost za indikacijo genitalna kandidiaza pri pediatrični populaciji nista bili dokazani, saj vsi razpoložljivi podatki za otroke in mladostnike izhajajo iz študij o drugih indikacijah, in ne za genitalno kandidiazo.
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. 
Poleg tega pa farmakokinetični profil flukonazola omogoča njegovo samostojno uporabo zaradi podaljšanega razpolovnega časa izločanja, ki traja okoli 36 ur, in njegove porazdelitve v vaginalna tkiva in izločke, pri čemer ostajajo koncentracije nad minimalno inhibitorno koncentracijo za C.albicans vsaj 72 ur.
Other conditions which pose an increased risk include certain lymphomas (e.g. Hodgkin's lymphoma), sarcoidosis, and patients on long-term corticosteroid therapy. 
Druga stanja, ki predstavljajo povečano tveganje, so nekateri limfomi (npr. Hodgkinov limfom) in sarkoidoza ter bolniki z dolgotrajnim zdravljenjem s kortikosteroidi.
In particular, the indications and their associated posology recommendations were harmonised. 
Še posebej so bile usklajene indikacije in z njimi povezana priporočila za odmerjanje.
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. 
Za indikacije parakokcidioidomikoza, histoplazmoza, limfokutana sporotrihoza, pri katerih so druga zdravila neuspešna ali jih bolniki niso prenašali, je CHMP ocenil, da predloženi podatki o učinkovitosti niso zadostni.
Based on the submitted data the CHMP agreed on the dosing recommendations for each indication. 
Na podlagi predloženih podatkov je CHMP potrdil priporočila za odmerjanje za vsako indikacijo.
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). 
Dejavniki tveganja za ezofagealno kandidiazo pri otrocih z okužbo HIV so nizko število CD4 (<100 celic/mm3), visoko virusno breme in nevtropenijo (<500 celic/mm3).
Treatment of invasive candidiasis requires higher doses of fluconazole than are used for mucocutaneous disease. 
Zdravljenje invazivne kandidiaze zahteva večje odmerke flukonazola, kot se uporabljajo pri mukokutani bolezni.
The MAH submitted a proposal for harmonisation of the Quality module. 
Imetnik dovoljenja za promet z zdravilom je predložil predlog za uskladitev modula za kakovost.
Mucosal candidiasis (Oropharyngeal and oesophageal) in children 
Mukozna kandidiaza (orofaringealna in ezofagealna) pri otrocih
Antifungal agents are being used in many prophylactic settings, but only a few studies have adequately evaluated their efficacy. 
Antimikotiki se uporabljajo za več namenov preprečevanja, njihova učinkovitost pa je bila ustrezno ocenjena le v majhnem številu študij.
So, the final wording in section 4.2 of the SPC regarding this indication reflects the CHMP discussion in all formulations including the 150 mg, one capsule presentation. 
Tako končno besedilo v poglavju 4.2 povzetka glavnih značilnosti zdravila glede te indikacije odraža razpravo v CHMP o vseh formulacijah, vključno z obliko ene 150-miligramske kapsule.
In all studies fluconazole was as or more effective than placebo in preventing clinical relapse. 
V vseh študijah je bil flukonazol enako ali bolj učinkovit kot placebo pri preprečevanju kliničnih ponovitev.
Cryptococcal infections are more likely to occur in association with HIV disease, however, cryptococcal infections occur much less frequently among HIV-infected children than among adults. 
Kriptokokne okužbe se pogosteje pojavljajo v povezavi z boleznijo HIV, vendar pa se kriptokokne okužbe pojavljajo redkeje pri otrocih, okuženih s HIV, kot pri odraslih.
The use of broad-spectrum antibiotics, corticosteroids, cytotoxic drugs, and radiation therapy are also predisposing factors. 
Uporaba antibiotikov širokega spektra, kortikosteroidov, citotoksičnih zdravil in radioterapije so prav tako predispozijcijski dejavniki.
Thus the outcome of this referral procedure does not include any evaluation of the gel formulation. 
Tako izid tega napotitvenega postopka na vključuje ocene formulacije gela.
As per the adult indication the CHMP agreed that there is sufficient evidence for the indication of treatment as well of prevention of relapse of cryptococcal meningitis in children. 
Kot pri indikaciji za odrasle se je CHMP strinjal, da obstajajo zadostni dokazi za indikacijo za zdravljenje in tudi za preprečevanje ponovitev kriptokoknega meningitisa pri otrocih.
Since oral absorption is rapid and almost complete, the doses of fluconazole recommended for the treatment and/or the prophylaxis of the different indications are the same for oral (capsules, oral suspension and syrup) and IV administration. 
Ker je peroralna absorpcija hitra in skoraj popolna, so odmerki flukonazola, priporočeni za zdravljenje in/ali preprečevanje različnih indikacij, enaki za peroralne oblike (kapsule, peroralna suspenzija in sirup) in za intravensko uporabo.
Fluconazole is used to treat paediatric patients with cryptococcal disease. 
Flukonazol se uporablja za zdravljenje pediatričnih bolnikov s kriptokokno boleznijo.
Furthermore, fluconazole was also available for topical use in the 0.5% gel formulation. 
Flukonazol je bil na voljo tudi za lokalno uporabo v obliki gela 0,5 %.
The inclusion of substances for which an involvement of CYP 3A4 and additive negative effects on QT interval prolongation is known (such as halofantrine, midazolam and triazolam) is justified. 
Vključitev snovi, za katere je znano, da nanje vpliva CYP3A4 ter da negativno učinkujejo na podaljšanje intervala QT (kot so halofantrin, midazolam in triazolam) je utemeljena.
• Cryptococcal meningitis (see section 4.4). 
• kriptokoknega meningitisa (glejte poglavje 4.4);
As fluconazole is a potent CYP2C9 inhibitor and a moderate CYP3A4 inhibitor and fluconazole is also an inhibitor of CYP2C19, treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C9, CYP2C19 and CYP3A4, should be monitored. 
Ker je flukonazol močan zaviralec CYP2C9, zmerni zaviralec CYP3A4 in tudi zaviralec CYP2C19, je treba posebej nadzorovati bolnike, ki se sočasno zdravijo z zdravili z ozkim terapevtskim oknom, ki se presnavljajo z CYP2C9, CYP2C19 in CYP3A4.
Fluconazole therapy is efficacious for several deep mycoses and this is supported by clinical trial data and recommended by clinical guidelines. 
Zdravljenje s flukonazolom je učinkovito pri več globokih mikozah, kar potrjujejo tudi podatki iz kliničnih preskušanj in priporočajo klinične smernice.
Disseminated candidiasis is infrequent among HIV-infected children, but Candida can disseminate from the oesophagus particularly when co-infection with herpes simplex virus (HSV) or cytomegalovirus (CMV) is present. 
Diseminirana kandidiaza med otroci, okuženimi s HIV, ni pogosta, vendar se Candida lahko razširja iz požiralnika, še zlasti pri sočasni okužbi z virusom herpes simpleks (HSV) ali citomegalovirusom (CMV).
In order to harmonise the posology the MAH was requested to include in the posology section a table with the recommended doses regarding each indication and to distinguish between treatment and prevention. 
Za uskladitev odmerjanja je bil imetnik dovoljenja za promet z zdravilom pozvan, naj v poglavje o odmerjanju doda razpredelnico s priporočenimi odmerki za vsako indikacijo ter naj loči med odmerjanjem za zdravljenje in za preprečevanje.
The majority of patients began antifungal prophylaxis prior to undergoing a period of induced neutropenia through chemo- or radiotherapy for malignant disease or bone marrow transplantation. 
Večina bolnikov je začela s protiglivično profilakso pred obdobji nevtropenije zaradi kemoterapije ali radioterapije za maligne bolezni ali presaditve kostnega mozga.
The CHMP concluded that the fluconazole, at 400 mg to 800 mg daily is a safe and effective primary treatment for coccidioidomycosis. 
CHMP je sklenil, da je zdravljenje s flukonazolom, z odmerkom od 400 mg do 800 mg na dan, varno in učinkovito primarno zdravljenje kokcidioidomikoze.
Fluconazole has proven to be safe and efficacious for invasive candidiasis. 
Flukozanol je dokazano varen in učinkovit pri invazivni kandidiazi.
Since the pharmacokinetic properties of orally and intravenously administered fluconazole are similar and fluconazole has good bioavailability, results obtained with oral dosing are also applicable to the intravenous formulation. 
Ker so farmakokinetične lastnosti peroralne in intravenske uporabe flukozanola podobne in ker je flukozanol dobro biološko uporaben, se lahko rezultati, pridobljeni pri peroralnem odmerjanju, uporabljajo tudi za intravensko formulacijo.
Candidal infection of male and female genital areas is relatively common and responds well to an oral administration of fluconazole. 
Okužbe moških in ženskih spolnih organov s kandido so relativno pogoste in se dobro odzivajo na peroralno uporabo flukozanola.