FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of voriconazole use for longer than 180 days has not been adequately studied in clinical trials.
Slovenian: Varnosti in učinkovitosti uporabe vorikonazola, daljše od 180 dni, v kliničnih preskušanjih niso ustrezno raziskali.
English: The excretion of voriconazole into breast milk has not been investigated.
Slovenian: Izločanje vorikonazola v materino mleko ni raziskano.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: As GPMT (guinea pig maximisation test) result was positive, prescribers should be aware of the hypersensitivity potential of the intravenous formulation.
Slovenian: Ker je bil test GPMT (maksimizacijski test pri morskih prašičkih) pozitiven, se mora predpisovalec zavedati preobčutljivostnega potenciala intravenskega pripravka.
English: Success rates and other secondary endpoints are presented in the table below:
Slovenian: Stopnje uspešnosti in drugi sekundarni opazovani dogodki so prikazani v spodnji preglednici:
English: Greater than proportional increase in exposure is observed with increasing dose.
Slovenian: Povečevanje odmerka povzroči več kot sorazmeren porast izpostavljenosti.
English: On the basis of the high oral bioavailability (96 %; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Slovenian: Glede na veliko peroralno biološko uporabnost (96 %, glejte poglavje 5.2) je menjava med intravensko in peroralno uporabo primerna, če je klinično indicirana.
English: This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.
Slovenian: To zdravilo je samo za enkratno uporabo; neuporabljeno raztopino je treba zavreči, uporabite pa lahko samo bistro raztopino brez delcev.
English: It is recommended to initiate the therapy with intravenous regimen, and oral regimen should be considered only after there is a significant clinical improvement.
Slovenian: Priporočljivo je, da zdravljenje začnemo z intravensko obliko, o peroralni uporabi pa razmislimo le po pomembnem kliničnem izboljšanju.
English: The safety profile of voriconazole in adults is based on an integrated safety database of more than 2,000 subjects (including 1,603 adult patients in therapeutic trials) and an additional 270 adults in prophylaxis trials).
Slovenian: Varnostni profil vorikonazola pri odraslih temelji na integrirani varnostni podatkovni bazi več kot 2.000 preskušancev (vključno s 1.603 odraslimi bolniki v terapevtskih preskušanjih in dodatnih 270 odraslih v študijah profilakse).
English: Close monitoring of prothrombin time or other suitable anticoagulation tests is recommended, and the dose of anticoagulants should be adjusted accordingly.
Slovenian: Priporočljivo je pozorno nadziranje protrombinskega časa ali drugih primernih koagulacijskih testov in ustrezno prilagoditi odmerjanje antikoagulantov.
English: ≤S (Susceptible)
Slovenian: ≤S (občutljivi)
English: Amphotericin B → fluconazole (N=122)
Slovenian: amfotericin B → flukonazol (N=122)
English: Once reconstituted further dilution is required before administration.
Slovenian: Ko je raztopina rekonstituirana, je pred uporabo potrebna nadaljnja redčitev.
English: From a microbiological point of view, once reconstituted, the product must be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji.
English: Children and adolescents Voriconazole Hikma should not be given to children younger than 2 years of age.
Slovenian: Otroci in mladostniki Zdravila Vorikonazol Hikma ne smejo dobiti otroci, mlajši od 2 let.
English: The median duration of study drug prophylaxis was 95.5 days in the MITT group.
Slovenian: V skupini MITT je bila mediana trajanja profilakse s preiskovanim zdravilom 95,5 dneva.
English: • You are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
Slovenian: • imate kardiomiopatijo, nereden srčni utrip, upočasnjeno bitje srca ali nepravilnost v elektrokardiogramu (EKG), imenovano »sindrom dolgega intervala QTc«.
English: Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença 2705-906 Terrugem SNT Portugal
Slovenian: Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença 2705-906 Terrugem SNT Portugalska
English: Therefore, no dosage adjustment based on gender is necessary.
Slovenian: Zato prilagoditev odmerka glede na spol ni potrebna.
English: If antifungal susceptibility testing is available, the MIC results may be interpreted using breakpoint criteria established by European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Slovenian: V primeru, da je na voljo preverjanje občutljivosti na protiglivična zdravila, je rezultate, ki se nanašajo na minimalno inhibitorno koncentracijo (MIK), mogoče interpretirati z uporabo kriterija mejne vrednosti, ki jo je ugotovil Evropski odbor za preverjanje občutljivosti na protimikrobna zdravila /European Committee on Antimicrobial Susceptibility Testing/ (EUCAST).
English: Currently there are insufficient data to allow dosing recommendations in this situation (see section 4.5).
Slovenian: Trenutno ni na voljo zadosti podatkov, ki bi omogočili priporočila o odmerjanu v tem primeru (glejte poglavje 4.5).
English: The ERG changes did not progress over 29 days of treatment and were fully reversible on withdrawal of voriconazole.
Slovenian: Spremembe ERG med 29-dnevnim zdravljenjem niso napredovale in so bile po opustitvi vorikonazola povsem reverzibilne.
English: Your doctor may stop the infusion if this occurs.
Slovenian: Če se to zgodi, lahko zdravnik ustavi infuzijo.
English: From all patients 58% were subject to myeloablative conditions regimens.
Slovenian: Pri 58 % od vseh bolnikov so izvedli mieloablativni režim.
English: Prophylaxis should be as short as possible depending on the risk for developing invasive fungal infection (IFI) as defined by neutropenia or immunosuppression.
Slovenian: Profilaksa mora biti čim krajša, trajanje pa naj bo odvisno od tveganja za pojav invazivne glivične okužbe (IGO), ki se kaže kot nevtropenija ali imunosupresija.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1004/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/15/1004/001
English: In rats, mice and dogs, voriconazole also induced minimal adrenal changes.
Slovenian: Pri podganah, miših in psih je vorikonazol povzročil tudi minimalne spremembe nadledvičnih žlez.
English: It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF), as an increased sensitivity of skin to the sun's UV rays can occur.
Slovenian: Pomembno je, da pokrijete izpostavljene predele kože in uporabljate kremo za zaščito pred soncem z visokim zaščitnim faktorjem, ker se lahko pojavi povečana občutljivost kože na sončne UV žarke.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale toksičen vpliv na razmnoževanje (glejte poglavje 5.3).
English: The doctor may decide to decrease the dose if you have mild to moderate cirrhosis.
Slovenian: Zdravnik se bo morda odločil za zmanjšanje odmerka, če imate blago do zmerno cirozo.
English: : Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial responses) of 7 patients with S. prolificans infection.
Slovenian: : Uspešen odziv na zdravljenje z vorikonazolom so ugotovili pri 16 (6 popolnih, 10 delnih odzivov) od 28 bolnikov, okuženih s S. apiospermum, in pri 2 (oba delna odziva) od 7 bolnikov, okuženih s S. prolificans.
English: The safety profile and plasma concentrations observed in male and female patients were similar.
Slovenian: Varnostni profil in ugotovljene koncentracije v plazmi so bili pri bolnikih in bolnicah podobni.
English: 10 Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
Slovenian: 10 Vključuje z zdravili povzročene poškodbe jeter, toksični hepatitis, hepatocelularne poškodbe in hepatotoksičnost.
English: • Allergic reaction or exaggerated immune response
Slovenian: • alergijske reakcije ali pretiran imunski odziv
English: • Very fast heart rate or skipped heartbeats, sometimes with erratic electrical impulses
Slovenian: • zelo hiter srčni utrip ali preskakovanje posameznih utripov, včasih z nerednimi električnimi impulzi
English: Careful monitoring of blood glucose is recommended.
Slovenian: Priporočljiv je natančen nadzor glukoze v krvi.
English: Standard genotoxicity and reproduction studies with the excipient SBECD reveal no special hazard for humans.
Slovenian: Standardne študije genotoksičnosti in reprodukcijske študije s pomožno snovjo SBECD ne kažejo posebnega tveganja za človeka.
English: Your doctor will determine your dose depending on your weight and the type of infection you have.
Slovenian: Odmerek, ki ga potrebujete, bo zdravnik določil glede na vašo telesno maso in vrsto okužbe.
English: 1 Strains with MIC values above the Susceptible (S) breakpoint are rare, or not yet reported.
Slovenian: 1 Sevi z vrednostmi MIK nad mejno vrednostjo Občutljivo (S) so redki, oziroma o njih še niso poročali.
English: It works by killing or stopping the growth of the fungi that cause infections.
Slovenian: Deluje tako, da ubije glivice, ki povzročajo okužbe, ali ustavi njihovo rast.
English: The second study enrolled 22 patients with invasive candidiasis including candidaemia (ICC), and esophageal candidiasis (EC) requiring either primary or salvage therapy, of whom 17 were included in the MITT efficacy analyses.
Slovenian: V drugo študijo so vključili 22 bolnikov z invazivno kandidozo, vključno s kandidemijo (ICC - Invasive candidiasis including candidaemia), in kandidozo požiralnika (EC - Esophageal candidiasis), ki zahteva primarno ali rešilno zdravljenje, od katerih so 17 bolnikov vključili v analize učinkovitosti MITT.
English: Prophylaxis with study drug was started immediately after HSCT: 224 received voriconazole and 241 received itraconazole.
Slovenian: S profilakso s preiskovanim zdravilom so pričeli takoj po HSCT: 224 preskušancev je prejemalo vorikonazol, 241 pa itrakonazol.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Slovenian: Od zdravstvenihdelavcev se zahteva, da poročajo o kateremkoli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V*.
English: The pharmacokinetics of voriconazole have been characterised in healthy subjects, special populations and patients.
Slovenian: Farmakokinetika vorikonazola je bila opredeljena pri zdravih preskušancih, posebnih populacijah in bolnikih.
English: However, the in vitro activity of voriconazole against Candida species is not uniform.
Slovenian: Vendar pa in vitro delovanje vorikonazola proti vrstam Candida ni poenoteno.
English: Clinical management should include laboratory evaluation of hepatic function (specifically AST and ALT) at the initiation of treatment with voriconazole and at least weekly for the first month of treatment.
Slovenian: Klinična obravnava mora obsegati laboratorijsko oceno delovanja jeter (zlasti AST in ALT) na začetku zdravljenja z vorikonazolom in vsaj enkrat tedensko v prvem mesecu zdravljenja.
English: In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medicinal product was defined as resolution/improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites at 12 weeks after the end of therapy (EOT).
Slovenian: V primarni analizi je bil uspešen odziv (kot ga je ocenil Odbor za pregled podatkov [OPP], slepljen za proučevano zdravilo) opredeljen kot izginotje/izboljšanje vseh kliničnih znakov in simptomov okužbe ter odstranitev Candide iz krvi in okuženih mest v globokih tkivih 12 tednov po koncu terapije (KT).
English: Pregnancy There are no adequate data on the use of voriconazole in pregnant women available.
Slovenian: Nosečnost O uporabi vorikonazola pri nosečnicah ni na voljo dovolj podatkov.
English: The overall rate of response (ICC and EC combined) was 88.9% (8/9) for 2 to <12 years old and 62.5% (5/8) for 12 to <18 years old.
Slovenian: Celokupna stopnja odziva (ICC in EC skupaj) je bila 88,9 % (8/9) za skupino, staro od 2 do < 12 let, in 62,5 % (5/8) za skupino, staro od 12 do < 18 let.
English: Indinavir Cmax ↔ Indinavir AUCτ ↔ Voriconazole Cmax ↔ Voriconazole AUCτ ↔
Slovenian: indinavir Cmax ↔ indinavir AUCτ ↔ vorikonazol Cmax ↔ vorikonazol AUCτ ↔
English: Pharmacotherapeutic group: Antimycotics for systemic use, - triazole derivatives ATC code: J02AC03
Slovenian: Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, derivati triazola oznaka ATC: J02AC03
English: It is recommended that all patients, including children, avoid exposure to direct sunlight during VORICONAZOLE HIKMA treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Slovenian: Priporočljivo je, da se vsi bolniki, vključno z otroci, med zdravljenjem z zdravilom VORIKONAZOL HIKMA izogibajo izpostavljenosti neposredni sončni svetlobi in sledijo ukrepom, kot so zaščitna oblačila in krema za zaščito pred soncem z visokim zaščitnim faktorjem.
English: Ciclosporin (in stable renal transplant recipients receiving chronic ciclosporin therapy)
Slovenian: ciklosporin (pri stabilnih prejemnikih presajene ledvice, ki prejemajo kronično terapijo s ciklosporinom)
English: Patients must avoid potentially hazardous tasks, such as driving or operating machinery while experiencing these symptoms.
Slovenian: Bolniki se morajo med doživljanjem teh simptomov izogibati opravljanju potencialno nevarnih opravil kot na primer vožnja ali upravljanje s stroji.
English: The breakthrough IFI rate to Day 180 and the primary endpoint of the study, which is Success at Day 180, for patients with AML and myeloablative conditioning regimens respectively, is presented in the table below:
Slovenian: Delež izbruha IGO do 180. dneva in primarni opazovani dogodek v študiji, ki je uspešnost na 180. dan, sta za bolnike z AML in mieloablativnim režimom prikazana v spodnjih preglednicah:
English: Carcinogenicity studies were not performed with SBECD.
Slovenian: Študij karcinogenosti SBECD ni bilo.
English: Serious refractory Candida infections
Slovenian: Hude refraktarne okužbe s Candido
English: A positive association between mean, maximum or minimum plasma voriconazole concentration and efficacy in therapeutic studies was not found and this relationship has not been explored in prophylaxis studies.
Slovenian: Pozitivne povezave med povprečno, največjo ali najmanjšo koncentracijo vorikonazola v plazmi ter učinkovitostjo v terapevtskih študijah niso ugotovili, v študijah profilakse pa te povezave niso raziskovali.
English: The safety and efficacy of voriconazole in children below 2 years has not been established.
Slovenian: Varnost in učinkovitost vorikonazola pri otrocih, mlajših od 2 let, nista bili dokazani.
English: 2 Includes immune thrombocytopenic purpura.
Slovenian: 2 Vključuje imunsko trombocitopenično purpuro.
English: 5 Includes akathisia and parkinsonism.
Slovenian: 5 Vključuje akatizije in parkinsonizem.
English: Not recommended
Slovenian: Ni priporočljivo.
English: The MITT group included 40 patients with prior IFI, including 31 with aspergillosis, 5 with candidiasis, and 4 with other IFI.
Slovenian: V skupini MITT je bilo 40 bolnikov s predhodno IGO, vključno z 31 bolniki z aspergilozo, 5 bolniki s kandidozo in 4 bolniki z drugimi IGO.
English: If any of these side effects persist or are troublesome, please tell your doctor.
Slovenian: Če je katerikoli od teh neželenih učinkov trdovraten ali moteč, povejte zdravniku.
English: Compatible Infusion Solutions: The reconstituted solution can be diluted with:
Slovenian: Združljive raztopine za infundiranje: Pripravljeno (rekonstituirano) raztopino je mogoče redčiti z:
English: The safety profile of voriconazole in young and elderly patients was similar and, therefore, no dosage adjustment is necessary for the elderly (see section 4.2).
Slovenian: Varnostni profil vorikonazola je bil pri mladih in starejših bolnikih podoben, zato pri starejših odmerka ni treba prilagajati (glejte poglavje 4.2).
English: It is estimated that, on average, increasing the oral dose from 200 mg twice daily to 300 mg twice daily leads to a 2.5-fold increase in exposure (AUCτ).
Slovenian: Ocenjujejo, da povečanje peroralnega odmerka z 200 mg dvakrat na dan na 300 mg dvakrat na dan povzroči v povprečju 2,5-kratno povečanje izpostavljenosti (AUCτ).
English: The modified intent-to-treat (MITT) group included 465 allogeneic HSCT recipients with 45% of patients having AML.
Slovenian: Spremenjena skupina bolnikov, ki so jih nameravali zdraviti (modified intent-to-treat - MITT), je vključevala 465 prejemnikov homolognih HSCT, od katerih jih je 45 % imelo akutno mieloično levkemijo (AML).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani evropske Agencije za zdravila http://www.ema.europa.eu.
English: All occurred in paediatric patients, who received up to five times the recommended intravenous dose of voriconazole.
Slovenian: Do vseh je prišlo pri pediatričnih bolnikih, ki so dobili do petkratni priporočeni intravenski odmerek vorikonazola.
English: • candidaemia (another type of fungal infection due to Candida sp.) in non-neutropenic patients (patients without abnormally low white blood cell count),
Slovenian: • s kandidemijo (druga vrsta glivične okužbe, ki jo povzročajo vrste Candida) pri nenevtropeničnih bolnikih (bolniki, ki nimajo nenormalno zmanjšanega števila belih krvnih celic),
English: The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to <18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Slovenian: Varnost vorikonazola so raziskali pri 288 pediatričnih bolnikih, starih od 2 do < 12 let (169) in od 12 do < 18 let (119),, ki so vorikonazol v kliničnih preskušanjih dobivali za profilakso (183) in terapijo (105).
English: Oral dosage forms of voriconazole are available from other manufacturers.
Slovenian: Peroralne oblike vorikonazola so na voljo s strani drugih proizvajalcev.
English: 3 Includes nuchal rigidity and tetany.
Slovenian: 3 Vključuje rigidnost tilnika in tetanijo.
English: If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis.
Slovenian: Če se vam pojavijo zgoraj opisane težave s kožo, vas bo vaš zdravnik morda napotil k dermatologu, ki se po posvetu lahko odloči, da je za vas pomembno, da ga redno obiskujete.
English: The study comprised 55 patients with serious refractory systemic Candida infections (including candidaemia, disseminated and other invasive candidiasis) where prior antifungal treatment, particularly with fluconazole, had been ineffective.
Slovenian: Študija je zajela 55 bolnikov s hudimi refraktarnimi sistemskimi okužbami s Candido (vključno s kandidemijo, diseminirano kandidiazo in drugimi invazivnimi oblikami kandidiaze), pri katerih prejšnje antimikotično zdravljenje, zlasti s flukonazolom, ni bilo učinkovito.
English: MIC breakpoint (mg/L)
Slovenian: Majna vrednost MIK (mg/L)
English: Voriconazole Hikma must not be administered simultaneously with any blood product or any short-term infusion of concentrated solutions of electrolytes, even if the two infusions are running in separate lines.
Slovenian: Zdravila Vorikonazol Hikma se ne sme dajati sočasno s katerimkoli krvnim pripravkom ali s katerokoli kratkotrajno infuzijo koncentriranih raztopin elektrolitov, tudi če infuziji potekata po dveh ločenih linijah.
English: Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UK
Slovenian: Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW Velika Britanija
English: A satisfactory global response (complete or partial resolution of all attributable symptoms signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53 % of voriconazole-treated patients compared to 31 % of patients treated with comparator.
Slovenian: Zadovoljiv globalni odziv (popolno ali delno izginotje vseh izhodiščno prisotnih pripisljivih simptomov, znakov, rentgenoloških/bronhoskopskih nenormalnosti) so ugotovili pri 53 % bolnikov, zdravljenih z vorikonazolom, in pri 31 % bolnikov, zdravljenih s primerjalnim zdravilom.
English: Chemical and physical stability of the of the diluted solutions for infusion has been demonstrated for 36 hours at 2°C to 8°C followed by 3 hours at room temperature.
Slovenian: Kemična in fizikalna stabilnost razredčene raztopine za infundiranje med uporabo sta bili dokazani za 36 ur pri temperaturi med 2 °C in 8 °C, čemur so sledile 3 ure pri sobni temperaturi.
English: Extended and frequent monitoring for respiratory depression and other opiateassociated adverse reactions is recommended.
Slovenian: Priporočljiv je povečan in pogost nadzor glede pojavljanja depresije dihanja in drugih z opiati povezanih neželenih učinkov.
English: It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines.
Slovenian: Zelo pomembno je, da obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, ali zdravilo rastlinskega izvora.
English: Dose reduction of methadone may be needed (see section 4.5).
Slovenian: Morda bo treba zmanjšati odmerek metadona (glejte poglavje 4.5).
English: AUCτ, AUCt and AUC0-∞ represent area under the curve over a dosing interval, from time zero to the time with detectable measurement and from time zero to infinity, respectively.
Slovenian: AUCτ, AUCt in AUC0-∞ predstavljajo površino pod krivuljo preko odmernega intervala, površino pod krivuljo od časa nič do časa detekcije in površino pod krivuljo od časa nič do neskončnosti.
English: • Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
Slovenian: • zdravljenje hudih, invazivnih, proti flukonazolu odpornih okužb s Candido (vključno s C. krusei)
English: Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation (HSCT)), should be monitored closely during voriconazole treatment.
Slovenian: Bolnike, še posebej otroke, z dejavniki tveganja za akutni pankreatitis (npr. nedavna kemoterapija, presaditev matičnih krvotvornih celic [HSCT - Haematopoietic Stem Cell Transplantation]) je treba med zdravljenjem z vorikonazolom skrbno nadzorovati.
English: In clinical trials there were 3 cases of accidental overdose.
Slovenian: V kliničnih preskušanjih so zabeležili 3 primere nenamernega prevelikega odmerjanja.
English: Patients receiving voriconazole must be carefully monitored for hepatic toxicity.
Slovenian: Bolnike, ki dobivajo vorikonazol, je treba skrbno nadzorovati glede hepatotoksičnosti.
English: The terminal half-life of voriconazole depends on dose and is approximately 6 hours at 200 mg (orally).
Slovenian: Končni razpolovni čas vorikonazola je odvisen od odmerka in znaša pri 200 mg (peroralno) približno 6 ur.
English: Use in paediatric patients aged 2 to <12 years with hepatic or renal insufficiency has not been studied (see sections 4.8 and 5.2).
Slovenian: Uporaba pri pediatričnih bolnikih, starih od 2 do < 12 let, z insuficienco jeter ali ledvic ni raziskana (glejte poglavji 4.8 in 5.2).