FrancophonIA/ELRC3.0 huggingface dataset:
English: Ergot alkaloids (e.g., ergotamine and dihydroergotamine) [CYP3A4 substrates]
Slovenian: Alkaloidi ergot (kot sta ergotamin in dihidroergotamin) [substrati CYP3A4]
English: squamous cell carcinoma*
Slovenian: ploščatocelič ni karcinom*
English: 6 mg/kg every 12 hours
Slovenian: 6 mg/kg vsakih 12 ur
English: Each bottle contains 3 g of voriconazole.
Slovenian: Ena plastenka vsebuje 3 g vorikonazola.
English: Slowly pull back the plunger of the oral syringe to the graduation mark that marks the dose for you.
Slovenian: Počasi vlecite bat brizge do oznake vašega odmerka.
English: VFEND 50 mg film-coated tablets and 200 mg film-coated tablets are available as packs of 2, 10, 14, 20, 28, 30, 50, 56 and 100.
Slovenian: VFEND 50 mg filmsko obložene tablete in 200 mg filmsko obložene tablete so na voljo v pakiranjih po 2, 10, 14, 20, 28, 30, 50, 56 in 100 tablet.
English: Tablets Patients 40 kg and above Patients less than 40 kg
Slovenian: tablete bolniki s telesno maso 40 kg in več bolniki s telesno maso manj kot 40 kg odmerek v prvih 24 urah
English: Visual impairment (change in vision including blurred vision, visual color alterations, abnormal intolerance to visual perception of light, colour blindness, eye disorder, halo vision, night blindness, swinging vision, seeing sparks, visual aura, visual acuity reduced, visual brightness, loss of part of the usual field of vision, spots before the eyes)
Slovenian: - okvare vida (spremembe vida, vključno z zamegljenim vidom, spremembami zaznavanja barv, nenormalno občutljivostjo pri vidnem zaznavanju svetlobe, barvno slepoto, okvaro vida, videnjem svetlobnih krogov (halo), nočno slepoto, nihajočim vidom, videnjem iskrenja, avro z vidnimi pojavi, zmanjšano ostrino vida, občutkom svetlosti pri gledanju, izpadom običajnega vidnega polja, pikami v vidnem polju) - vročina - izpuščaj - siljenje na bruhanje, bruhanje, driska
English: Omeprazole (40 mg QD) [CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate]
Slovenian: Omeprazol (40 mg QD) [inhibitor CYP2C19; substrat CYP2C19 in CYP3A4]
English: Once the powder in the vial has been reconstituted, VFEND should be used immediately, but if necessary may be stored for up to 24 hours at 2°C - 8°C (in a refrigerator) with the infusion bag.
Slovenian: Ko je prašek v viali rekonstituiran, je zdravilo VFEND treba uporabiti takoj, če pa je treba, se ga lahko skupaj z infuzijsko vrečko shrani pri temperaturi med 2 °C in 8 °C (v hladilniku) za največ 24 ur.
English: VFEND 40 mg/ml powder for oral suspension voriconazole
Slovenian: VFEND 40 mg/ml prašek za peroralno suspenzijo vorikonazol
English: 400 mg (10 ml) every 12 hours
Slovenian: 400 mg (10 ml) vsakih 12 ur
English: Blister foil for 200 mg film-coated tablets (all blister packs)
Slovenian: Folija za 200 mg filmsko obložene tablete (vsa pakiranja)
English: Solvent for solution for infusion: Sodium chloride 0.9% in Water for Injections
Slovenian: Vehikel za raztopino za infundiranje: 0,9 % natrijev klorid v vodi za injekcije
English: Other proton pump inhibitors that are CYP2C19 substrates may also be inhibited by voriconazole and may result in increased plasma concentrations of these medicinal products.
Slovenian: Vorikonazol lahko zavre tudi presnovo drugih zaviralcev protonske črpalke, ki so substrati CYP2C19, zaradi česar se zviša njihova koncentracija v plazmi.
English: 1 sterile, single use syringe.
Slovenian: 1 sterilno brizgo za enkratno uporabo.
English: Inflammation of the sinuses, inflammation of the gums, chills, weakness Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help the blood to clot Low blood sugar, low blood potassium, low sodium in the blood Anxiety, depression, confusion, agitation, inability to sleep, hallucinations Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness Bleeding in the eye
Slovenian: - vnetje sinusov, vnetje dlesni, mrzlica, slabotnost - nizko število, vključno s hudim znižanjem števila nekaterih vrst rdečih (včasih povezano z imunskim sistemom) in/ali belih krvnih celic (včasih z vročino), nizko število krvnih ploščic, ki pomagajo pri strjevanju krvi - nizka raven sladkorja v krvi, nizka raven kalija v krvi, nizka raven natrija v krvi - tesnobnost, depresija, zmedenost, agitacija, nespečnost, halucinacije - epileptični napadi, tresavica ali nenadzorovani mišični gibi, mravljinčenje ali nenormalen občutek na koži, povečan tonus mišic, zaspanost, omotica - krvavitve v očesu - težave s srčnim ritmom, vključno s prehitrim utripom in prepočasnim utripom, omedlevica - nizek krvni tlak, vnetje žile (ki je lahko povezano z nastankom krvnega strdka) - akutne težave z dihanjem, bolečine v prsnem košu, otekanje obraza (ust, ustnic in okoli oči),
English: VFEND requires reconstitution and dilution (see section 6.6) prior to administration as an intravenous infusion.
Slovenian: Zdravilo VFEND je treba pred aplikacijo v obliki intravenske infuzije rekonstituirati in redčiti (glejte poglavje 6. 6).
English: Coadministration with sirolimus since voriconazole is likely to increase plasma concentrations of sirolimus significantly (see section 4.5).
Slovenian: Sočasna uporaba s sirolimusom, ker lahko vorikonazol pomembno poveča koncentracijo sirolimusa v plazmi (glejte poglavje 4.5).
English: Although not studied clinically, voriconazole is likely to increase the plasma concentrations of benzodiazepines that are metabolised by CYP3A4 and lead to a prolonged sedative effect.
Slovenian: Čeprav ni klinično raziskano, lahko vorikonazol poveča plazemsko koncentracijo benzodiazepinov, ki se presnavljajo preko CYP3A4, in se tako podaljša sedativni učinek.
English: Step 7
Slovenian: Korak 7
English: Dose reduction of alfentanil, fentanyl and other short-acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered.
Slovenian: V poštev pride zmanjšanje odmerka alfentanila, fentanila in drugih kratkodelujočih opiatov, ki so po zgradbi podobni alfentanilu in se presnavljajo preko CYP3A4 (kot je sufentanil).
English: Prevention of fungal infections in high risk bone marrow transplant recipients.
Slovenian: Preprečevanje glivičnih okužb pri prejemnikih presadka kostnega mozga, pri katerih obstaja veliko tveganje.
English: C.
Slovenian: KT
English: 1 ml of the constituted suspension contains 40 mg voriconazole.
Slovenian: 1 ml pripravljene suspenzije vsebuje 40 mg vorikonazola.
English: 1 vial of VFEND powder for solution for infusion (single use vial) 1 overwrap
Slovenian: 1 vialo VFEND praška za raztopino za infundiranje (viala za enkratno uporabo) 1 infuzijsko vrečko v ovoju
English: One 100 ml high-density polyethylene (HDPE) bottle (with a polypropylene child resistant closure) contains
Slovenian: Ena 100 ml plastenka (HDPE) iz polietilena visoke gostote (s polipropilensko za otroke varno zaporko) vsebuje 45 g praška za peroralno suspenzijo.
English: Step 4
Slovenian: Korak 4
English: For administration, the twist-off port at the bottom of the infusion bag should be opened and the infusion line connected and primed.
Slovenian: Za aplikacijo odprite zaporko na dnu infuzijske vrečke, spojite infuzijsko vrečko z infuzijskim sistemom in infuzijski sistem napolnite.
English: PVC / Aluminium blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets.
Slovenian: PVC/aluminijski pretisni omot v škatlah z 2, 10, 14, 20, 28, 30, 50, 56 ali 100 filmsko obloženimi tabletami.
English: Breakthrough IFI - Day 180 1 (1.0%)
Slovenian: Izbruh IGO - 180. dan
English: For the constituted suspension:
Slovenian: Pripravljena suspenzija:
English: 300 mg QD (coadministered with voriconazole 350 mg BID)
Slovenian: 300 mg QD (sočasno uporabljan s 350 mg vorikonazola BID)
English: Prednisolone (60 mg single dose) [CYP3A4 substrate]
Slovenian: Prednizolon (enkratni 60 mg odmerek) [substrat CYP3A4]
English: Infuse at a maximum rate of 3 mg/kg per hour.
Slovenian: Infundirajte s hitrostjo največ 3 mg/kg na uro.
English: Rifabutin [potent CYP450 inducer]
Slovenian: Rifabutin [močan induktor CYP450]
English: VFEND is also available as 200 mg powder for solution for infusion, 200 mg powder and solvent for solution for infusion and 40 mg/ml powder for oral suspension.
Slovenian: Zdravilo VFEND je na voljo tudi v obliki 200 mg praška za raztopino za infundiranje, 200 mg praška in vehikla za raztopino za infundiranje ter 40 mg/ml praška za peroralno suspenzijo.
English: VFEND 50 mg film-coated tablets
Slovenian: VFEND 50 mg filmsko obložene tablete
English: Shake the closed bottle of constituted suspension for approximately 10 seconds before use.
Slovenian: Pred uporabo stresajte plastenko s pripravljeno suspenzijo približno 10 sekund.
English: Expiry date of the constituted suspension:
Slovenian: Rok uporabnosti pripravljene suspenzije:
English: 7a Attach the IV line to the patient injection site.
Slovenian: linijo na bolnikovo mesto injiciranja.
English: However, if the combination is strictly needed, the maintenance dose of voriconazole may be increased from 200 mg to 350 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Slovenian: Če je sočasna uporaba nujno potrebna, pa se vzdrževalni odmerek vorikonazola lahko poveča z 200 mg na 350 mg peroralno dvakrat na dan (s 100 mg na 200 mg peroralno dvakrat na dan pri bolnikih, ki tehtajo manj kot 40 kg); glejte poglavji 4.4 in 4.5.
English: Nervous system disorders headache convulsion, syncope, tremor, hypertonia paraesthesia, somnolence, dizziness brain oedema, encephalopathy extrapyramidal disorder neuropathy peripheral, ataxia, hypoaesthesia, dysgeusia hepatic encephalopathy, Guillain-Barre syndrome, nystagmus
Slovenian: Bolezni živčevja glavobol konvulzije, sinkopa, tremor, hipertonija parestezija, somnolenca, omotica možganski edem, encefalopatija ekstrapiramidne motnje periferna nevropatija, ataksija, hipestezija, disgevzija hepatična encefalopatíja, GuillainBarrejev sindrom, nistagmus
English: How to use VFEND
Slovenian: Kako uporabljati zdravilo VFEND
English: 200 mg twice a day 100 mg twice a day
Slovenian: 200 mg dvakrat na dan 100 mg dvakrat na dan
English: Step 6
Slovenian: Korak 6
English: Prednisolone Cmax  11% Prednisolone AUC0-  34%
Slovenian: prednizolon Cmax  11 % prednizolon AUC0-  34 %
English: Excipient: sulfobutylether beta cyclodextrin sodium.
Slovenian: Pomožna snov: sulfobutileter betaciklodekstrin natrij.
English: EXP Shelf life after reconstitution: 24 hours when stored at 2°C - 8°C.
Slovenian: Rok uporabnosti po rekonstituciji: 24 h, če je raztopina hranjena pri temperaturi med 2 ºC in 8 ºC.
English: Lactose monohydrate Pregelatinised starch Croscarmellose sodium Povidone
Slovenian: Jedro tablete laktoza monohidrat predgelirani škrob premreženi natrijev karmelozat povidon magnezijev stearat
English: Statins (e.g., lovastatin) [CYP3A4 substrates]
Slovenian: Statini (kot je lovastatin) [substrati CYP3A4]
English: VFEND 200 mg film-coated tablets
Slovenian: VFEND 200 mg filmsko obložene tablete
English: Blood and lymphatic system disorders agranulocytosis pancytopenia, thrombocytopenia leukopenia, anaemia bone marrow failure, lymphadenopathy, eosinophilia disseminated intravascular coagulation
Slovenian: Bolezni krvi in limfatičnega sistema agranulocitoza pancitopenija, trombocitopenija levkopenija, anemija odpoved kostnega mozga, limfadenopatija, eozinofilija diseminirana intravaskularna koagulacija
English: Once reconstituted, VFEND should be used immediately, but if necessary may be stored for up to 24 hours at 2°C - 8°C (in a refrigerator).
Slovenian: Ko je zdravilo VFEND pripravljeno (rekonstituirano), ga je treba uporabiti takoj, če pa je treba, se ga lahko shrani pri temperaturi med 2 °C in 8 °C (v hladilniku) za največ 24 ur.
English: Oral suspension Patients 40 kg and above Patients less than 40 kg
Slovenian: peroralna suspenzija bolniki s telesno maso 40 kg in več bolniki s telesno maso manj kot 40 kg odmerek v prvih 24 urah
English: The potential to block the venting action exists if large amounts of air or drug are injected when the vial is inverted.
Slovenian: Če medtem, ko je viala obrnjena s spodnjim koncem navzgor, pride do injiciranja velikih količin zraka ali zdravila, lahko pride do zavrtja sproščanja tlaka.
English: Turn the bottle back upright with the oral syringe still in place.
Slovenian: Obrnite plastenko s pritrjeno peroralno brizgo ponovno v pokončni položaj.
English: VFEND 200 mg powder for solution for infusion Powder for solution for infusion:White lyophilised powder.
Slovenian: VFEND 200 mg prašek za raztopino za infundiranje prašek za raztopino za infundiranje: bel liofiliziran prašek
English: the first 24 hours the first 24 hours
Slovenian: v prvih 24 urah odmerek po prvih 24 urah
English: Vinca Alkaloids (e.g., vincristine and vinblastine) [CYP3A4 substrates]
Slovenian: Alkaloidi rožnatega zimzelena (kot sta vinkristin in vinblastin) [substrati CYP3A4]
English: Single use vial Infuse at a maximum rate of 3 mg/kg per hour.
Slovenian: viala za enkratno uporabo Infundirajte s hitrostjo največ 3 mg/kg na uro.
English: VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets Voriconazole
Slovenian: VFEND 50 mg filmsko obložene tablete VFEND 200 mg filmsko obložene tablete vorikonazol
English: In vitro studies showed that voriconazole is metabolised by the hepatic cytochrome P450 isoenzymes CYP2C19, CYP2C9 and CYP3A4.
Slovenian: Študije in vitro so pokazale, da se vorikonazol presnavlja preko izoencimov CYP2C19, CYP2C9 in CYP3A4 jetrnega citokroma P450.
English: Coadministration of voriconazole and high doses of ritonavir (400 mg and above BID) is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba vorikonazola in večjih odmerkov ritonavirja (400 mg in več BID) je kontraindicirana (glejte poglavje 4.3).
English: Voriconazole Cmax  93% Voriconazole AUC  96%
Slovenian: vorikonazol Cmax  93 % vorikonazol AUC  96 %
English: 100 mg (2.5 ml) twice a day
Slovenian: 100 mg (2,5 ml) dvakrat na dan
English: Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID
Slovenian: Efavirenz 400 mg QD, sočasno uporabljan z 200 mg vorikonazola BID
English: EXP Any remaining suspension should be discarded 14 days after constitution.
Slovenian: Uporabno do Morebitno preostalo suspenzijo zavrzite 14 dni po pripravi.
English: • A sterile, single use vial adapter.
Slovenian: • sterilen nastavek za vialo za enkratno uporabo.
English: 200 mg every 12 hours
Slovenian: 200 mg vsakih 12 ur
English: In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., and Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2 µg/ml.
Slovenian: In vitro so opažali delovanje proti kliničnim izolatom Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp.
English: Vial contains 200 mg of voriconazole.
Slovenian: Viala vsebuje 200 mg vorikonazola.
English: • Health Care Professional (HCP) Question and Answer Brochure for Phototoxicity, SCC and Hepatic toxicity; - Advises HCPs on the risks of phototoxicity, skin SCC and liver toxicity associated with voriconazole use.
Slovenian: • Brošura za zdravstvene delavce z vprašanji in odgovori o fotoksičnosti, ploščatoceličnem karcinomu in hepatotoksičnosti; - svetuje zdravstvenim delavcem o tveganjih fototoksičnosti, ploščatoceličnega karcinoma kože in hepatotoksičnosti, povezanih z uporabo vorikonazola; - obvešča zdravstvene delavce o trenutnih priporočilih za spremljanje in obvladovanje teh tveganj; - opominja zdravstvene delavce, naj uporabijo Kontrolni seznam za zdravstvene delavce in Opozorilno kartico za bolnika, ter jih obvešča, kako pridobiti dodatne izvode.
English: • Oral contraceptives (if you take VFEND whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Slovenian: • peroralne kontraceptive (če med jemanjem peroralnih kontraceptivov jemljete zdravilo VFEND,
English: 400 mg every 12 hours
Slovenian: 400 mg vsakih 12 ur
English: A measuring cup (graduated to indicate 23 ml), 5 ml oral syringe and a press-in bottle adaptor
Slovenian: 1 plastenka s 45 g merica (z oznako za 23 ml), 5 ml peroralna brizga in potisni nastavek za plastenko
English: Volume of VFEND Concentrate (10 mg/ml) required for: 3 mg/kg dose (number of vials)
Slovenian: Volumen VFEND koncentrata (10 mg/ml), potreben za:
English: Voriconazole Cmax  18% Voriconazole AUC  23%
Slovenian: vorikonazol Cmax  18 % vorikonazol AUC  23 %
English: It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving voriconazole (see section 5.2).
Slovenian: Pri bolnikih z blago do zmerno cirozo jeter (Child-Pugh A in B), ki dobivajo vorikonazol, je priporočljivo uporabiti standardno polnilno odmerjanje, vzdrževalni odmerek pa prepoloviti (glejte poglavje 5.2).
English: Includes dyspnoea and dyspnoea exertional.
Slovenian: Vključuje dispnejo in dispnejo med naporom.
English: Each tablet contains 50 mg voriconazole.
Slovenian: Ena tableta vsebuje 50 mg vorikonazola.
English: VFEND powder and solvent for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse.
Slovenian: Prašek in vehikel za raztopino za infundiranje VFEND bo pripravil in redčil na pravo koncentracijo bolnišnični farmacevt ali medicinska sestra (dodatne informacije najdete na koncu tega navodila).
English: Therefore unless your doctor instructs you to stop treatment, it is important to keep taking VFEND correctly, as described above.
Slovenian: Zato je pomembno, da zdravilo VFEND jemljete pravilno, kot je opisano zgoraj, razen če vam zdravnik ne naroči, da zdravljenje končajte.
English: 1 sterile, single use vial adapter.
Slovenian: 1 sterilen nastavek za vialo za enkratno uporabo.
English: Efavirenz (a non-nucleoside reverse transcriptase inhibitor) [CYP450 inducer; CYP3A4 inhibitor and substrate]
Slovenian: Efavirenz (nenukleozidni zaviralec reverzne transkriptaze) [induktor CYP450; zaviralec in substrat CYP3A4]
English: The predicted total exposure in children following an oral maintenance dose of 9 mg/kg (maximum of 350 mg) twice daily was comparable to that in adults following 200 mg oral twice daily.
Slovenian: Pričakovana celokupna izpostavljenost pri otrocih po uporabi peroralnega vzdrževalnega odmerka, 9 mg/kg (največ 350 mg) dvakrat na dan, je bila primerljiva s tisto pri odraslih po uporabi 200 mg peroralno dvakrat na dan. Intravenski odmerek 8 mg/kg povzroči približno 2-krat večjo izpostavljenost vorikonazolu kot peroralni odmerek 9 mg/kg.
English: Rifabutin Cmax  195% Rifabutin AUC  331% Compared to voriconazole 200 mg BID,
Slovenian: rifabutin Cmax  195 % rifabutin AUC  331 % v primerjavi z 200 mg vorikonazola BID, vorikonazol Cmax  104 % vorikonazol AUC  87 %
English: Therefore, no adjustment is necessary for oral dosing for patients with mild to severe renal impairment (see section 5.2).
Slovenian: Zato pri bolnikih z blago do hudo ledvično okvaro peroralnega odmerjanja ni treba prilagajati (glejte poglavje
English: Store in the original container
Slovenian: Shranjujte v originalni embalaži.
English: VFEND contains sodium
Slovenian: Zdravilo VFEND vsebuje saharozo
English: 4 mg/kg twice daily 200 mg (5 ml) twice daily
Slovenian: 4 mg/kg dvakrat na dan 200 mg (5 ml) dvakrat na dan
English: Solvent for solution for infusion:
Slovenian: Vehikel za raztopino za infundiranje:
English: How to take VFEND
Slovenian: Kako jemati zdravilo VFEND
English: Maintenance Dose (after first 24 hours)
Slovenian: polnilni odmerek (prvih 24 ur)
English: Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term VFEND treatment.
Slovenian: V povezavi z dolgotrajnim zdravljenjem z zdravilom VFEND so poročali o ploščatoceličnem karcinomu kože.
English: Blister pack for 50 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
Slovenian: Pretisni omot za 50 mg filmsko obložene tablete - pakiranje z 2, 10, 14, 20, 28, 30, 50, 56, 100 tabletami
English: For prophylaxis use, dose adjustments are not recommended in the case of lack of efficacy or treatmentrelated adverse events.
Slovenian: Če profilaksa ni učinkovita ali se pojavijo z zdravljenjem povezani neželeni učinki, odmerka ni priporočljivo prilagajati.
English: Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Slovenian: Fenitoin se lahko uporablja sočasno z vorikonazolom, če se vzdrževalni odmerek vorikonazola poveča z 200 mg na 400 mg peroralno dvakrat na dan (s 100 mg na 200 mg peroralno dvakrat na dan pri bolnikih, ki tehtajo manj kot 40 kg); glejte poglavji 4.4 in 4.5.
English: Allergic reaction or exaggerated immune response
Slovenian: ekcem - reakcije na mestu infundiranja - alergijske reakcije ali pretiran imunski odziv
English: Voriconazole Cmax  49% Voriconazole AUC  69%
Slovenian: vorikonazol Cmax  49 % vorikonazol AUC  69 %
English: Immunosuppressants [CYP3A4 substrates]
Slovenian: Imunosupresivi [substrati CYP3A4]
English: MIC breakpoint (mg/L) ≤S (Susceptible) >R (Resistant)
Slovenian: Mejna vrednost MIK (mg/L) ≤S (Občutljivi)
English: In an overdose, haemodialysis may assist in the removal of voriconazole from the body.
Slovenian: V primeru prevelikega odmerjanja se lahko presežki vorikonazola iz telesa odstranijo s hemodializo.
English: VFEND powder for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse.
Slovenian: Prašek za raztopino za infundiranje VFEND bo pripravil in redčil na pravo koncentracijo bolnišnični farmacevt ali medicinska sestra (dodatne informacije najdete na koncu tega navodila).
English: Voriconazole Cmax  69% Voriconazole AUC  78%
Slovenian: vorikonazol Cmax  69 % vorikonazol AUC  78 %
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: • Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: VFEND 50 mg film-coated tablets White to off-white, round tablet, debossed “Pfizer” on one side and “VOR50”on the reverse.
Slovenian: VFEND 50 mg filmsko obložene tablete bele do skoraj bele, okrogle tablete z reliefno oznako "Pfizer" na eni strani in "VOR50" na drugi
English: Reconstituted VFEND needs to be diluted with a compatible infusion solution first before it is infused.
Slovenian: Tako pripravljeno zdravilo VFEND je treba pred infundiranjem redčiti z združljivo infuzijsko raztopino (dodatne informacije najdete na koncu tega navodila).
English: Monitoring for voriconazoleassociated adverse reactions is recommended if voriconazole is used sequentially after fluconazole (see section 4.5).
Slovenian: Če se vorikonazol uporablja zaporedno za flukonazolom, je priporočljiv nadzor glede neželenih učinkov, povezanih z vorikonazolom (glejte poglavje 4.5).
English: Voriconazole (N=125)
Slovenian: Opazovani dogodki v študiji Vorikonazol (n = 125)
English: VFEND 200 mg powder for solution for infusion:
Slovenian: VFEND 200 mg prašek za raztopino za infundiranje:
English: 300 mg QD (coadministered with voriconazole 400 mg BID)
Slovenian: 300 mg QD (sočasno uporabljan s 400 mg vorikonazola BID)
English: Hepatobiliary disorders liver function test abnormal jaundice, jaundice cholestatic, hepatitis hepatic failure, hepatomegaly, cholecystitis, cholelithiasis
Slovenian: Bolezni jeter, žolčnika in žolčevodov nenormalni izvidi testov jetrne funkcije ikterus, holestatski ikterus, hepatitis jetrna odpoved, hepatomegalija, holecistitis, holelitiaza
English: Breast-feeding must be stopped on initiation of treatment with VFEND.
Slovenian: Ko se začne zdravljenje z zdravilom VFEND, mora ženska prenehati z dojenjem.