natgillin/translations-raw huggingface dataset:
VFEND 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.
Zdravila VFEND 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.
Treatment of serious fungal infections caused by Scedosporium spp.
- zdravljenje hudih glivičnih okužb, ki jih povzročajo Scedosporium spp.
The suspension should not be further diluted with water or any other liquids.
Pripravljene suspenzije ne redčite več z vodo ali katerokoli drugo tekočino.
Keep it in a clean safe place with the medicine.
Hranite jo na suhem in varnem mestu skupaj z zdravilom.
Keep the container tighly closed.
Vsebnik shranjujte tesno zaprt.
Add 46 ml of water and shake vigorously for about 1 minute.
Dodajte 46 ml vode in močno stresajte približno 1 minuto.
Medicinal product [Mechanism of interaction]
Zdravilo [mehanizem interakcije]
• For storage information, please refer to Section 5 ‘How to store VFEND'.
• Glede informacij za shranjevanje glejte poglavje 5 "Shranjevanje zdravila VFEND".
Altered taste perception
Spremenjeno zaznavanje okusa
The compatibility of VFEND with diluents other than listed above (or listed below under ‘Incompatibilities') is unknown.
Združljivost zdravila VFEND z drugimi tekočinami razen zgoraj naštetih (ali omenjenih spodaj pod "Inkompatibilnosti") ni znana.
The infusion bag should be checked to ensure that the entire contents of the bag have been infused, especially if the same intravenous line is to be used for sequential infusion of other drugs.
Infuzijsko vrečko je treba pregledati, da zagotovimo, da je bila infundirana vsa vsebina vrečke, še posebej, če bomo isti infuzijski sistem uporabili za zaporedno infundiranje drugih zdravil.
Bioequivalence between the powder for oral suspension and tablets has not been investigated in a paediatric population.
Bioekvivalentnost praška za peroralno suspenzijo in tablet v pediatrični populaciji ni raziskana.
In vitro activity against the following pathogens has been shown, but the clinical significance is unknown: Curvularia spp.
In vitro je bilo dokazano delovanje proti naslednjim patogenom, vendar klinični pomen tega ni znan: Curvularia spp.
It is recommended that your pharmacist constitutes VFEND suspension before giving it to you.
Priporočljivo je, da vam vaš farmacevt pripravi zdravilo VFEND peroralna suspenzija, preden vam ga izroči.
The connected syringe and vial are then gently swirled to ensure that the VFEND powder has completely dissolved and no particulates are visible (do not shake).
Spojeno brizgo in vialo nato nežno sučite, da zagotovite, da se je ves VFEND prašek popolnoma raztopil in ni prisotnih vidnih delcev (ne stresajte).
Hang the infusion bag.
Obesite infuzijsko vrečko.
Pull the plunger out of the syringe and wash both parts in warm soapy water.
Izvlecite bat iz brizge in operite oba dela z milnico v topli vodi.
This will force the medicine back into the bottle.
Tako boste zdravilo potisnili nazaj v plastenko.
It is used for the treatment of patients (adults and children over the age of 2) with:
Uporablja se za zdravljenje bolnikov (odraslih in otrok, starih 2 leti ali več):
Pregnancy There are no adequate data on the use of VFEND in pregnant women available.
Nosečnost O uporabi zdravila VFEND pri nosečnicah ni na voljo dovolj podatkov.
On the basis of the high oral bioavailability (96%; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Glede na veliko peroralno biološko uporabnost (96 %, glejte poglavje 5.2) je menjava med intravensko in peroralno uporabo primerna, če je klinično indicirana.
If particles are seen, swirl again and re-inspect.
Če so vidni delci, jo ponovno sučite in preglejte.
7b Once the infusion delivery to the patient starts, do not manually squeeze the bag compartment as this may interfere with the dose delivery to the patient and may cause air ingress into the IV line.
7b Ko se dostava infuzije bolniku prične, ne smete stiskati predelka vrečke, saj to lahko moti dostavo odmerka bolniku in lahko povzroči, da v i.v.
• Remove the bag of VFEND solvent for solution for infusion from the foil overwrap (do not use scissors or any other sharp tool).
• Odstranite vrečko VFEND vehikla za raztopino za infundiranje iz ovoja (ne uporabite škarij ali kateregakoli drugega ostrega orodja).
Total parenteral nutrition: Total parenteral nutrition (TPN) need not be discontinued when prescribed with VFEND, but does need to be infused through a separate line.
Popolna parenteralna prehrana: Pri predpisanem zdravilu VFEND ni potrebno prekiniti dajanja popolne parenteralne prehrane (TPN - total parenteral nutrition), vendar mora biti le-ta infundirana skozi ločeno linijo.
5b Empty the contents of the syringe into the bag.
5b Izpraznite vsebino brizge v vrečko.
Candida species
Vrsta Candida
Clinical management should include laboratory evaluation of hepatic function (specifically AST and ALT) at the initiation of treatment with VFEND and at least weekly for the first month of treatment.
Klinična obravnava mora obsegati laboratorijsko oceno delovanja jeter (zlasti AST in ALT) na začetku zdravljenja z zdravilom VFEND in vsaj enkrat tedensko v prvem mesecu zdravljenja.
Other additives should not be introduced into the infusion bag.
V infuzijsko vrečko ne smemo dodajati drugih aditivov.
Amphotericin B → fluconazole (N=122)
amfotericin B → flukonazol (n = 122)
Scedosporium and Fusarium infections
Okužbe s Scedosporium in Fusarium
The safety and efficacy of VFEND in children below 2 years has not been established.
Varnost in učinkovitost zdravila VFEND pri otrocih, mlajših od 2 let, nista bili dokazani.
VFEND has moderate influence on the ability to drive and use machines.
Zdravilo VFEND ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Completed at least 100 days of study drug prophylaxis
Zaključenih vsaj 100 dni profilakse s preiskovanim zdravilom
Considering the assumed limited gastroenteric transit time in paediatric patients, the absorption of tablets may be different in paediatric compared to adult patients.
Upoštevaje domnevno omejeni gastro-enterični čas prehoda pri pediatričnih bolnikih je mogoče, da je absorpcija iz tablet pri pediatričnih bolnikih drugačna kot pri odraslih.
Infusion of total parenteral nutrition can occur simultaneously with VFEND but not in the same line or cannula.
Sočasna infuzija popolne parenteralne prehrane z vorikonazolom je možna, vendar ne v isto linijo ali kanilo.
Infusions of blood products must not occur simultaneously with VFEND.
Infuzije krvnih pripravkov se ne sme dajati hkrati z zdravilom VFEND.
Do not administer to the patient as a bolus injection.
Ne dajajte bolnikom kot bolusno injekcijo.
Therefore, from a microbiological point of view, once solvent has been removed from the bag to reconstitute the VFEND powder for solution for infusion and then reintroduced into the bag, the product must be used immediately.
Zato je z mikrobiološkega vidika po odvzetju vehikla iz vrečke, rekonstituiranju VFEND praška za raztopino za infundiranje in ponovni uvedbi zdravila v vrečko, zdravilo treba uporabiti takoj.
VFEND must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g., Aminofusin 10% Plus).
Zdravila VFEND se ne sme infundirati v isto linijo ali kanilo sočasno z infundiranjem drugih zdravil, vključno s parenteralno prehrano (npr. Aminofusin 10 % Plus).
Following constitution, the total volume of the suspension must be 75 ml.
Skupni volumen suspenzije po pripravi mora biti 75 ml.
When the VFEND infusion is complete, the line may be used for administration of other intravenous products.
Ko je infuzija zdravila VFEND končana, se lahko linija uporabi za dajanje drugih intravenskih pripravkov.
It is recommended that all patients, including children, avoid exposure to direct sunlight during VFEND treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Priporočljivo je, da se vsi bolniki, vključno z otroci, med zdravljenjem z zdravilom VFEND izogibajo izpostavljenosti neposredni sončni svetlobi in sledijo ukrepom, kot so zaščitna oblačila in krema za zaščito pred soncem z visokim zaščitnim faktorjem.
If VFEND is continued, however, dermatologic evaluation should be performed on a systematic and regular basis, to allow early detection and management of premalignant lesions.
Če pa se zdravljenje z zdravilom VFEND nadaljuje, je treba bolnike redno in sistematično dermatološko ocenjevati, da se omogoči zgodnje odkrivanje in obravnavanje predrakavih lezij.
• Cardiomyopathy, in particular when heart failure is present.
• kardiomiopatija, posebej ob prisotnem popuščanju srca,
VFEND suspension should not be mixed with any other medicine.
VFEND peroralne suspenzije ne smete mešati z nobenim drugim zdravilom.
• The syringe may then be removed and the contents of the infusion bag mixed gently by inverting the bag several times.
• Brizgo lahko nato odstranite, vsebino infuzijske vrečke pa nežno premešajte tako, da vrečko večkrat zasučete.
• candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count),
• s kandidemijo (druga vrsta glivične okužbe, ki jo povzročajo vrste Candida) pri nenevtropeničnih bolnikih (bolniki, ki nimajo nenormalno zmanjšanega števila belih krvnih celic),
Children and adolescents VFEND should not be given to children younger than 2 years of age.
Zdravila VFEND ne smejo dobiti otroci, mlajši od 2 let.
Women of child-bearing potential Women of child-bearing potential must always use effective contraception during treatment.
Ženske v rodni dobi Ženske v rodni dobi morajo med zdravljenjem vedno uporabljati učinkovito kontracepcijo.
• Serious dermatological adverse reactions (including SCC) The frequency of phototoxicity reactions is higher in the paediatric population.
• Resni dermatološki neželeni učinki (vključno s ploščatoceličnim karcinomom) Pri pediatrični populaciji je pogostnost fototoksičnih reakcij večja.
Manufacturer Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Francija
VFEND may cause blurring of vision or uncomfortable sensitivity to light.
Zdravilo VFEND lahko povzroči zamegljen vid ali neprijetno občutljivost na svetlobo.
Your pharmacist should advise you how to measure the medicine using the multi-dosing oral syringe provided in the pack.
Vaš farmacevt vam bo svetoval, kako odmeriti zdravilo s pomočjo večodmerne peroralne brizge, ki je priložena v škatli.
Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation [HSCT]), should be monitored closely during VFEND treatment.
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 zdravilom VFEND skrbno nadzorovati.
The bag should be carefully inspected to ensure that there are no particulates.
Vrečko je treba pozorno pregledati, da zagotovimo, da ni prisotnih vidnih delcev.
If you have liver disease, your doctor may prescribe a lower dose of VFEND.
Če imate bolezen jeter, vam bo vaš zdravnik morda predpisal manjši odmerek zdravila VFEND.
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 12 weeks after the end of therapy (EOT).
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).
The effect of voriconazole on either erythromycin or azithromycin is unknown.
Učinek vorikonazola na eritromicin ali azitromicin ni znan.
• you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
• imate kardiomiopatijo, nereden srčni utrip, upočasnjeno bitje srca ali nepravilnost v elektrokardiogramu (EKG), imenovano »sindrom dolgega intervala QTc«.
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 ˚C - 8 ˚C).
AUC, 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.
AUC, 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.
Powder for oral suspension 45 g
prašek za peroralno suspenzijo 45 g
For Caucasians and Blacks the prevalence of poor metabolisers is 3-5%.
Med belci in črnci je prevalenca oseb z zmanjšano presnovo 3-5 %.
If any particles are seen, discard the infusion bag.
Če so vidni delci, infuzijsko vrečko zavrzite.
To measure the dose accurately, the top edge of the black ring should be lined up with the graduated mark on the oral syringe.
Da boste odmerili točen odmerek, mora biti zgornji rob črnega prstana poravnan z oznako vašega odmerka na peroralni brizgi.
The majority of rashes were of mild to moderate severity.
Večina izpuščajev je bila blagih do zmerno izrazitih.
(Maintenance Dose)
(vzdrževalni odmerek)
If you take more suspension than prescribed (or if someone else takes your suspension) you must seek medical advice or go to the nearest hospital casualty department immediately.
Če vzamete več suspenzije, kot je predpisano (ali če kdo drug vzame vašo suspenzijo), morate takoj poiskati zdravniški nasvet ali se takoj zglasiti v ambulanti za nujno pomoč najbližje bolnišnice.
In the combined data from three bioequivalence studies using the powder for oral suspension formulation, treatment-related taste perversion was recorded in 12 (14%) of subjects.
V kombiniranih podatkih iz treh bioekvivalenčnih študij, kjer so uporabljali prašek za peroralno suspenzijo, so pri 12 osebah (14%) zabeležili spremenjeno zaznavanje okusa, povezano z zdravljenjem.
These oral dose recommendations for children are based on studies in which voriconazole was administered as the powder for oral suspension.
Ta priporočila o peroralnem odmerjanju pri otrocih temeljijo na študijah, v katerih so vorikonazol uporabljali v obliki praška za peroralno suspenzijo.
The compatibility of voriconazole with diluents other than described above or in section 6.2 is unknown.
Združljivost vorikonazola z drugimi redčili razen tistih, navedenih zgoraj oz. v poglavju 6.2, ni znana.
• you are suffering from, or have ever suffered from liver disease.
• imate ali ste v preteklosti imeli bolezen jeter.
Voriconazole has been associated with QTc interval prolongation.
Vorikonazol je bil povezan s podaljšanjem intervala QTc.
Safety and effectiveness in paediatric subjects below the age of two years has not been established (see sections 4.8 and 5.1).
Varnost in učinkovitost pri pediatričnih preskušancih, mlajših od dveh let, nista bili dokazani (glejte poglavji 4.8 in 5.1).
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.
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).
Voriconazole should be administered with caution to patients with potentially proarrhythmic conditions, such as:
Vorikonazol je treba pazljivo predpisati bolnikom s potencialno proaritmičnimi stanji, kot so:
Slowly draw off the required volume of the solution.
Počasi odvzemite zahtevani volumen raztopine.
Includes akathisia and parkinsonism.
Vključuje akatizije in parkinsonizem.
In light of these data the duration of treatment with the intravenous formulation should be no longer than 6 months.
Na osnovi teh podatkov zdravljenje z intravenskim pripravkom ne sme trajati več kot 6 mesecev.
In addition VFEND has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Poleg tega je bilo zdravilo VFEND povezano s fototoksičnostjo, vključno z reakcijami, kot so efelide, lentigo, aktinična keratoza in psevdoporfirija.
Treatment of invasive aspergillosis
- zdravljenje invazivne aspergiloze
The absolute bioavailability of voriconazole after oral administration is estimated to be 96%.
Ocenjena absolutna biološka uporabnost vorikonazola po peroralni uporabi je 96 %.
Label on the vial
Nalepka na viali
Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
Vključuje z zdravili povzročene poškodbe jeter, toksični hepatitis, hepatocelularne poškodbe in hepatotoksičnost.
If you take more tablets than prescribed (or if someone else takes your tablets) you must seek medical advice or go to the nearest hospital casualty department immediately.
Če vzamete več tablet, kot je predpisano (ali če kdo drug vzame vaše tablete), morate takoj poiskati zdravniški nasvet ali se takoj zglasiti v ambulanti za nujno pomoč najbližje bolnišnice.
Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or VFEND are still having the desired effect:
Zdravniku povejte, če jemljete katerokoli od naslednjih zdravil, ker bo morda potrebna prilagoditev odmerka ali nadziranje, da preveri, ali imajo le-ta oziroma zdravilo VFEND še vedno želeni učinek:
Azithromycin (500 mg QD)
azitromicin (500 mg QD)
Use in children and adolescents The recommended dose for children and teenagers is as follows:
Priporočeni odmerek za otroke in najstnike je:
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C03
Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, derivati triazola oznaka ATC: J02AC03
Depending on your response to treatment, your doctor may increase or decrease the daily dose.
Odvisno od vašega odziva na zdravljenje bo vaš zdravnik povečal ali zmanjšal vaš dnevni odmerek.
• Everolimus (used for treating advanced kidney cancer and in transplant patients)
• everolimus (uporablja se za zdravljenje napredovalega raka ledvic in pri bolnikih po presaditvi)
This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
VFEND treatment will continue for as long as your doctor advises, however duration of treatment with VFEND powder for solution for infusion should be no more than 6 months.
Zdravljenje z zdravilom VFEND se bo nadaljevalo, dokler bo zdravnik menil, da je potrebno, vendar pa zdravljenje s praškom za raztopino za infundiranje ne sme trajati več kot 6 mesecev.
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.
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.
Includes nuchal rigidity and tetany.
Vključuje rigidnost tilnika in tetanijo.
The instructions should be followed for reconstitution, dilution and administration of each kit.
Sledite navodilom za rekonstitucijo, redčenje in aplikacijo vsakega kompleta.
VFEND must not be infused into the same line or cannula concomitantly with other intravenous products.
Zdravila VFEND se ne sme infundirati v isto linijo ali kanilo sočasno z drugimi intravenskimi pripravki.
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.
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.
If you or your child are taking VFEND for prevention of fungal infections, your doctor may stop giving VFEND if you or your child develop treatment related side effects.
Če vi ali vaš otrok jemljete zdravilo VFEND za preprečevanje glivičnih okužb, vam bo zdravnik morda prenehal dajati zdravilo VFEND, če se pri vas ali vašemu otroku pojavijo neželeni učinki, povezani z zdravljenjem.
Voriconazole is rapidly and almost completely absorbed following oral administration, with maximum plasma concentrations (Cmax) achieved 1-2 hours after dosing.
Vorikonazol se po peroralni uporabi hitro in skoraj popolnoma absorbira in doseže največjo koncentracijo v plazmi (Cmax) 1 do 2 uri po zaužitju.
When cleared, proceed as directed.
Ko težavo odpravite, nadaljujte po navodilih.
If the medicine is to be given to a child, make sure the child is sitting, or is held, upright before giving the medicine.
Če zdravilo dajete otroku, se prepričajte, da otrok sedi ali ga držite v pokončnem položaju, preden mu date zdravilo.
If a dose of VFEND has been forgotten
Če je bil odmerek zdravila VFEND pozabljen
The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C. tropicalis, C. glabrata and C. krusei, all of which usually exhibit minimal inhibitory concentration (MICs) of less than 1 mg/L for voriconazole.
Vrste, ki so najpogosteje vpletene pri povzročanju okužb pri ljudeh, so C. albicans, C. parapsilosis, C. tropicalis, C. glabrata in C. krusei, pri čemer pri vseh naštetih minimalna inhibitorna koncentracija (MIK) za vorikonazol običajno znaša manj kot 1 mg/L.
Pfizer Europe MA EEIG (as MA Holder logo)
Pfizer Europe MA EEIG (kot logo imetnika dovoljenja za promet z zdravilom)
Powder: store at in a refrigerator before constitution.
Prašek: pred pripravo shranjujte v hladilniku.
If the liver function tests become markedly elevated, VFEND should be discontinued, unless the medical judgment of the risk-benefit of the treatment for the patient justifies continued use.
Če se vrednosti testov jetrne funkcije izrazito zvečajo, je treba zdravljenje z zdravilom VFEND prekiniti, razen če medicinska ocena koristi in tveganj zdravljenja za bolnika upravičuje nadaljnjo uporabo.
Instructions for Use - please be guided by the pictograms to understand how to use this product.
Navodila za uporabo - za navodila glede uporabe tega zdravila prosimo sledite slikovnim navodilom (piktogramom).
Do not take VFEND: If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
Če ste alergični na vorikonazol ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
In the same study, no significant differences in Cmax and AUCτ were observed between healthy elderly males and healthy elderly females (≥65 years).
V isti študiji niso ugotovili pomembnih razlik Cmax in AUCτ med zdravimi starejšimi moški in zdravimi starejšimi ženskami (≥ 65 let).
Pharmacokinetic/pharmacodynamic Relationship
Odnos med farmakokinetiko/farmakodinamiko
In fluconazole-resistant non-albicans species, a successful outcome was seen in 3/3 C. krusei (complete responses) and 6/8 C. glabrata (5 complete, 1 partial response) infections.
Pri ne-albicans vrstah, odpornih na flukonazol, so uspešen odziv ugotovili pri 3/3 okužbah s C. krusei (popolni odzivi) in 6/8 okužbah s C. glabrata (5 popolnih, 1 delni odziv).