FrancophonIA/ELRC3.0 huggingface dataset:
English: The following constituents of Poulvac FluFend H5N3 RG are included in Table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Slovenian: Naslednje sestavine zdravila Poulvac FluFenf H5N3 RG so vključene v tabeli 1 priloge Uredbe Komisije (EU) št. 37/2010:
English: Manufacturer for the batch release: Pfizer Global Manufacturing Weesp CJ van Houtenlaan 36
Slovenian: Izdelovalec, odgovoren za sproščanje serije: Pfizer Global Manufacturing Weesp CJ van Houtenlaan 36
English: Polyoxyethylen e sorbitan monooleate and trioleate
Slovenian: Polioksietilen sorbitan monooleat in trioleatkrmni
English: One dose of 0.5 ml contains:
Slovenian: 1 odmerek (0,5 ml) vsebuje:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
English: For disposal read the package leaflet.
Slovenian: Za navodilo o pravilnem odstranjevanju preberite navodilo za uporabo.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES One dose of 0.5 ml contains:
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI 1 odmerek (0,5 ml) vsebuje:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Poulvac FluFend H5N3 RG
English: Sorbitan sesquioleate
Slovenian: Sorbitan seskvioleat
English: White oil is a mineral hydrocarbon, Arlacel 83V is sorbitan sesquioleate, Tween 80 is polyoxyethylene sorbitan monooleate, sodium phosphate dibasic (E339) and potassium phosphate monobasic (E340) are substances with E numbers.
Slovenian: Belo olje je hidrokarbon, mineralni, Arlacel 83V je sorbitan seskvioleat, Tween 80 je polioksietilen sorbitan monooleat, dvobazni natrijev fosfat (E339) in enobazni kalijev fosfat sta snovi s številko E. Navedene sestavine zdravila Poulvac FluFend H5N3 RG so vključene v tabelo 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
English: MARKETING AUTHORISATION NUMBER EU/2/06/060/001-002
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/06/060/001-002
English: MANUFACTURER'S BATCH NUMBER Lot (Number)
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija> <lot><številka serije>{številka}
English: No Entry
Slovenian: Ni vnosa
English: PACKAGE SIZE 1 x 500 ml 10 x 500 ml
Slovenian: VELIKOST PAKIRANJA 1 x 500 ml
English: THE WORDS ‘FOR ANIMAL TREATMENT ONLY' AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
English: At one day old: 0.2 ml subcutaneously in the neck.
Slovenian: Pri starosti enega dne: 0,2 ml podkožno v vrat.
English: Sorbitan sesquioleate Polysorbate 80
Slovenian: Sorbitan seskvioleat Polisorbat 80
English: For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
Slovenian: Aktivna imunizacija piščancev in rac proti virusu aviarne influence tipa A, podtipa H5.
English: No information is available on the safety of this vaccine for birds in lay.
Slovenian: O varnosti tega cepiva za ptice v obdobju nesnosti ni podatkov.
English: Only substances approved as additives in foodstuffs for human
Slovenian: Ni vnosa Ni vnosa številko odobreni kot dodatki za živila v prehrani ljudi proizvodnj o živil
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Poulvac FluFend H5N3 RG emulzija za injiciranje za piščance in race
English: To induce serological response against N3 neuraminidase which can act as a marker to Differentiate Infected from Vaccinated Animals (DIVA strategy).
Slovenian: Cepivo je namenjeno spodbujanju aktivne imunosti pri piščancih in racah proti virusu aviarne influence podtipa H5 in sproženju serološkega odziva proti N3 neuraminidazi, ki lahko služi kot marker za razlikovanje med okuženimi in cepljenimi živalmi (t.i. strategija DIVA)
English: Duration of immunity in ducks: 14 weeks after the second injection.
Slovenian: Čas trajanja imunske zaščite pri racah: 14 tednov od druge injekcije
English: No information is available on the interference of maternally derived antibodies on vaccination for both target species.
Slovenian: Za obe ciljni vrsti ni podatkov o vplivih materinih protiteles na cepljenje.
English: SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Slovenian: POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: TARGET SPECIES Chickens and ducks
Slovenian: CILJNE ŽIVALSKE VRSTE Piščanci in race
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2° to 8°C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte pri temperaturi (2 C - 8 C).
English: MRLs Target tissues
Slovenian: MRL Ciljna tkiva
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega za sproščanje serije
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Slovenian: C. POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET Z ZDRAVILOM GLEDE VARNE IN UČINKOVITE UPORABE
English: Chickens: Reduction of mortality and virus excretion after challenge.
Slovenian: Piščanci: Zmanjšanje smrtnosti in izločanja virusa po izpostavljenost.
English: 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.
Slovenian: 500 ml cepiva v plastenkah iz polietilena visoke gostote, z nitrilnim gumijastim zamaškom in aluminijasto zaporko
English: For animal treatment only
Slovenian: Samo za živali.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Slovenian: A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: EXPIRY DATE EXP (month/year) Once broached, use within 2 hours.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
English: Incompatibilities
Slovenian: 6.2 Inkompatibilnosti
English: Store and transport refrigerated (2ºC - 8ºC).
Slovenian: Shranjujte in prevažajte v hladilniku (2 C - 8 C).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
English: Reduction of mortality and virus excretion after challenge.
Slovenian: Zmanjšanje smrtnosti in izločanje virusa po izpostavljenost.
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
English: Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04)
Slovenian: Neaktiviran rekombinantni virus aviarne influence podtipa H5N3 (sev rg-A/ck/VN/C58/04)
English: Reduction of clinical signs and virus excretion after challenge.
Slovenian: Zmanjšanje pojava kliničnih znakov in izločanja virusa po izpostavljenost.
English: 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.
Slovenian: Po vnosu dvojnega odmerka pri piščancih in racah niso zasledili drugačnih neželenih učinkov, kot so opisani v poglavju 6.
English: Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI units per dose
Slovenian: Inaktivirani rekombinantni virus aviarne influence podtipa H5N3 (sev rg-A/ck/VN/C58/04) > 1:40 HI Enot v odmerku
English: Ducks: Reduction of clinical signs and virus excretion after challenge.
Slovenian: Race: Zmanjšanje pojava kliničnih znakov in izločanja virusa po izpostavljenost.
English: Store and transport refrigerated (2° to 8°C).
Slovenian: Shranjujte in prevažajte pri temperaturi (2 C - 8 C).
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: THE WORDS ‘FOR ANIMAL TREATMENT ONLY' AND CONDITIONS OF
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Slovenian: B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: 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.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
English: Phosphate Buffer Saline
Slovenian: Fosfatni pufer s soljo
English: Food additives (substances with a valid E number approved as additives in
Slovenian: Samo snovi odobrene kot dodatki za živila za prehrano ljudi z izjemo prezervati vov navedenih v dodatku III
English: 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.
Slovenian: Ponovno cepljenje po treh tednih: 0,5 ml subkutano v vrat.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Slovenian: Ni nujno, da so v prometu vsa navedena pakiranja
English: Chickens
Slovenian: Piščanci
English: Excipients:
Slovenian: Race:
English: MRLs Target
Slovenian: Ramsgate Road
English: STATEMENT OF THE MRLs
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA ( MRL)
English: Animal
Slovenian: Race
English: In general the Core Safety Profile, dated 2 April 2009 was considered.
Slovenian: Na splošno je bil upoštevan Glavni varnostni profil z dne 2. aprila 2009.
English: In addition minor typographic errors were corrected.
Slovenian: Poleg tega so bile popravljene tudi manjše tipografske napake.
English: QUALITY - MODULE 3
Slovenian: KAKOVOST - MODUL 3
English: There are differences between all Member States concerning the individual paragraphs in this section.
Slovenian: Med državami članicami obstajajo razlike med posameznimi odstavki v tem poglavju.
English: So a warning has been added in this section.
Slovenian: Zato je bilo v to poglavje dodano opozorilo.
English: This section was partly restructured according to guidelines.
Slovenian: To poglavje je bilo v skladu s smernicami deloma spremenjeno.
English: A harmonised Module 3 was also adopted.
Slovenian: Sprejet je bil tudi usklajen modul 3.
English: Additional data were available from a compassionate use study (EU, 2006).
Slovenian: Na voljo so bili tudi dodatni podatki iz študije sočutne uporabe (EU, 2006).
English: Section 4.8 - Undesirable effects
Slovenian: Poglavje 4.8 - Neželeni učinki
English: In most patients, symptoms should resolve within days after the start of effective therapy.
Slovenian: Pri večini bolnikov naj bi simptomi izginili v nekaj dneh po začetku učinkovitega zdravljenja.
English: Acute oral candidiasis may occur in up to 5% of newborn infants.
Slovenian: Akutna oralna kandidiaza se lahko pojavi pri do 5 % novorojenčkov.
English: In addition the paediatric indications have been clarified.
Slovenian: Poleg tega so pojasnili tudi pediatrične indikacije.
English: The proposed text for the pharmokinetics in children is the wording that was agreed during the EU work sharing project.
Slovenian: Predlagano besedilo za farmakokinetiko pri otrocih je besedilo, ki je bilo dogovorjeno v skupnem delovnem projektu EU.
English: 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.
Slovenian: 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.
English: • To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).
Slovenian: • zmanjševanja pojavnosti ponavljajoče se vaginalne kandidiaze (4 ali več epizod na leto);
English: Endemic mycoses remain a major public health problem in several countries and they are becoming increasingly frequent with the spread of HIV infection.
Slovenian: Endemične mikoze ostajajo velika težava za javno zdravje v več državah in so s širjenjem okužb s HIV vedno pogostejše.
English: Neutropenic patients are at especially high risk for candidemia.
Slovenian: Nevtropenični bolniki so še posebej ogroženi s kandidemijo.
English: Overall summary of the scientific evaluation of Diflucan and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Diflucan in povezanih imen (glejte Dodatek I)
English: • Invasive candidiasis.
Slovenian: • invazivne kandidiaze;
English: The concomitant use of fluconazole and halofantrine is therefore not recommended.
Slovenian: Sočasna uporaba flukonazola in halofantrina se zato ne priporoča.
English: A warning on tinea capitis and the fact that should not be used in children has been added.
Slovenian: Dodano je bilo opozorilo za tinea capitis in dejstvo, da se ne sme uporabljati pri otrocih.
English: 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.
Slovenian: 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 .
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.
Slovenian: 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.
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Slovenian: Na podlagi pregleda podatkov je CHMP sprejel usklajen Modul 3.
English: An EU work sharing project-Assessment of Paediatric data took place in 2005-2006.
Slovenian: Med letoma 2005-2006 je potekal skupni delovni projekt EU - Ocena pediatričnih podatkov.
English: 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.
Slovenian: 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.
English: This indication does not make any more reference to individual forms of invasive candidal infections.
Slovenian: Ta indikacija se ne nanaša na posamezne oblike invazivnih kandidnih okužb.
English: The use of fluconazole for the above indications is also supported by the Infectious Diseases Society of America (IDSA) guidelines.
Slovenian: Uporabo flukonazola pri zgoraj navedenih indikacijah podpirajo tudi smernice Ameriškega združenja za infekcijske bolezni (IDSA).
English: During the time of the evaluation of the procedure the Marketing Authorisation Holder (MAH) voluntarily withdrew the gel formulation from the European Market.
Slovenian: Med postopkom ocenjevanja je imetnik dovoljenja za promet z zdravilom prostovoljno umaknil formulacijo gela z evropskega tržišča.
English: Section 4.1 - Therapeutic Indications
Slovenian: Poglavje 4.1 - Terapevtske indikacije
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.
Slovenian: Opozorilo o učinku na srčno-žilni sistem in povezava s podaljšanjem intervala QT na elektrokardiogramu je bilo ponovno poudarjeno.
English: All these changes were accepted by the CHMP.
Slovenian: Vse te spremembe je CHMP potrdil.
English: Cryptococcal infections in children
Slovenian: Kriptokokne okužbe pri otrocih
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.
Slovenian: 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.
English: Cryptococcosis is a defining opportunistic infection for AIDS.
Slovenian: Kriptokokoza je tipična oportunistična okužba za AIDS.
English: In Member States there were differences in the posology of various infections, e.g. for individual mucosal candida infections.
Slovenian: Med državami članicami so obstajale razlike v odmerjanju pri različnih okužbah, na primer za posamezne mukozne kandidne okužbe.
English: There were also differences in the wording on the dosage recommendation for adolescents and children regarding all indications.
Slovenian: Razlike so se pojavljale tudi v besedilih priporočil za odmerjanje pri mladostnikih in otrocih, in sicer pri vseh indikacijah.
English: The use of fluconazole for the treatment of fungal skin infections was examined in several comparative and non-comparative studies.
Slovenian: Uporabo flukonazola pri zdravljenju glivičnih okužb kože so preučevali v več primerjalnih in neprimerjalnih študijah.
English: Fluconazole is a substance belonging to the chemical class of triazole derivatives.
Slovenian: Flukonazol je snov, ki spada v kemijsko skupino derivatov triazola.
English: Candida oesophagitis continues to be seen in children who are not responding to antiretroviral therapy.
Slovenian: Candida oesophagitis je še vedno prisotna pori otrocih, ki se ne odzivajo na protivirusno zdravljenje.
English: This formulation was only approved in Italy and was indicated for the treatment of dermatomycoses due to dermatophytes, yeasts and moulds.
Slovenian: Ta formulacija je bila odobrena samo v Italiji in je bila indicirana za zdravljenje dermatomikoze zaradi dermatofitov, kvasovk in plesni.
English: Oral or IV fluconazole solutions, administered for 14-21 days, are highly effective for treatment of Candida oesophagitis.
Slovenian: Peroralne ali intravensko raztopine flukonazola, ki se uporabljajo 14-21 dni, so zelo učinkovite za zdravljenje Candida oesophagitis.
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.
Slovenian: 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.
English: The incidence of oesophageal candidiasis is around 0.08 per 100 child-years after introduction of HAART in around 2001.
Slovenian: Pojavnost ezofagealne kandidiaze je okoli 0,08 na 100 otrok/leto po začetku zdravljenja po režimu HAART okoli leta 2001.
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.”
Slovenian: 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“.
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).
Slovenian: 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).
English: 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.
Slovenian: Rezultati izvedenega testa kažejo zadovoljivo doslednost in enotnost pomembnih značilnosti kakovosti zdravila, zato se sklepa, da ima zdravilo lahko zadovoljiv in enoten kliničen učinek.
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.
Slovenian: 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.
English: All the above changes were accepted by the CHMP and apply to all formulations.
Slovenian: Vse navedene spremembe je CHMP potrdil in veljajo za vse formulacije.
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.
Slovenian: 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.
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.
Slovenian: Za bolnike z okvarjenim delovanjem ledvic je bilo dodano opozorilo s sklicem na poglavje o odmerjanju 4.2 za to skupino bolnikov.
English: 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.
Slovenian: Zato te indikacije niso več navedene v poglavju 4.1 povzetka glavnih značilnosti zdravila, v ustrezna poglavja pa so bila dodana opozorila.
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.
Slovenian: Informacije o razvoju, izdelovanju in kontroli kapsul, praška za peroralno suspenzijo, sirupa in raztopine za infundiranje so bile predstavljene na zadovoljiv način.