natgillin/translations-raw huggingface dataset:
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2° to 8°C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte pri temperaturi (2 C - 8 C).
MRLs Target tissues
MRL Ciljna tkiva
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega za sproščanje serije
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
C. POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET Z ZDRAVILOM GLEDE VARNE IN UČINKOVITE UPORABE
Chickens: Reduction of mortality and virus excretion after challenge.
Piščanci: Zmanjšanje smrtnosti in izločanja virusa po izpostavljenost.
6.5 Nature and composition of immediate packaging 500 ml of vaccine in high-density polyethylene bottles, closed with a nitrile rubber stopper and aluminium cap.
500 ml cepiva v plastenkah iz polietilena visoke gostote, z nitrilnim gumijastim zamaškom in aluminijasto zaporko
For animal treatment only
Samo za živali.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
EXPIRY DATE EXP (month/year) Once broached, use within 2 hours.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
Store and transport refrigerated (2ºC - 8ºC).
Shranjujte in prevažajte v hladilniku (2 C - 8 C).
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
Reduction of mortality and virus excretion after challenge.
Zmanjšanje smrtnosti in izločanje virusa po izpostavljenost.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04)
Neaktiviran rekombinantni virus aviarne influence podtipa H5N3 (sev rg-A/ck/VN/C58/04)
Reduction of clinical signs and virus excretion after challenge.
Zmanjšanje pojava kliničnih znakov in izločanja virusa po izpostavljenost.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 6 have been observed.
Po vnosu dvojnega odmerka pri piščancih in racah niso zasledili drugačnih neželenih učinkov, kot so opisani v poglavju 6.
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI units per dose
Inaktivirani rekombinantni virus aviarne influence podtipa H5N3 (sev rg-A/ck/VN/C58/04) > 1:40 HI Enot v odmerku
Ducks: Reduction of clinical signs and virus excretion after challenge.
Race: Zmanjšanje pojava kliničnih znakov in izločanja virusa po izpostavljenost.
Store and transport refrigerated (2° to 8°C).
Shranjujte in prevažajte pri temperaturi (2 C - 8 C).
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
THE WORDS ‘FOR ANIMAL TREATMENT ONLY' AND CONDITIONS OF
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 4.6 have been observed.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
Phosphate Buffer Saline
Fosfatni pufer s soljo
Food additives (substances with a valid E number approved as additives in
Samo snovi odobrene kot dodatki za živila za prehrano ljudi z izjemo prezervati vov navedenih v dodatku III
Revaccinate after 3 weeks: 0.5 ml subcutaneously in the neck The vaccination schedule should be completed at least 4 weeks before the start of laying.
Ponovno cepljenje po treh tednih: 0,5 ml subkutano v vrat.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Ni nujno, da so v prometu vsa navedena pakiranja
Excipients:
Race:
STATEMENT OF THE MRLs
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA ( MRL)
Animal
Race
In general the Core Safety Profile, dated 2 April 2009 was considered.
Na splošno je bil upoštevan Glavni varnostni profil z dne 2. aprila 2009.
In addition minor typographic errors were corrected.
Poleg tega so bile popravljene tudi manjše tipografske napake.
QUALITY - MODULE 3
KAKOVOST - MODUL 3
There are differences between all Member States concerning the individual paragraphs in this section.
Med državami članicami obstajajo razlike med posameznimi odstavki v tem poglavju.
So a warning has been added in this section.
Zato je bilo v to poglavje dodano opozorilo.
This section was partly restructured according to guidelines.
To poglavje je bilo v skladu s smernicami deloma spremenjeno.
A harmonised Module 3 was also adopted.
Sprejet je bil tudi usklajen modul 3.
Additional data were available from a compassionate use study (EU, 2006).
Na voljo so bili tudi dodatni podatki iz študije sočutne uporabe (EU, 2006).
Section 4.8 - Undesirable effects
Poglavje 4.8 - Neželeni učinki
In most patients, symptoms should resolve within days after the start of effective therapy.
Pri večini bolnikov naj bi simptomi izginili v nekaj dneh po začetku učinkovitega zdravljenja.
Acute oral candidiasis may occur in up to 5% of newborn infants.
Akutna oralna kandidiaza se lahko pojavi pri do 5 % novorojenčkov.
In addition the paediatric indications have been clarified.
Poleg tega so pojasnili tudi pediatrične indikacije.
The proposed text for the pharmokinetics in children is the wording that was agreed during the EU work sharing project.
Predlagano besedilo za farmakokinetiko pri otrocih je besedilo, ki je bilo dogovorjeno v skupnem delovnem projektu EU.
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.