FrancophonIA/ELRC3.0 huggingface dataset:
English: Coadministration with CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine since increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes (see section 4.5).
Slovenian: Sočasna uporaba s substrati CYP3A4, terfenadinom, astemizolom, cisapridom, pimozidom in kinidinom, ker lahko povečana koncentracija teh zdravil v plazmi povzroči podaljšanje QTc in v redkih primerih nastanek torsades de pointes (glejte poglavje 4.5).
English: In vitro, voriconazole displays broad-spectrum antifungal activity with antifungal potency against Candida species (including fluconazole -resistant C. krusei and resistant strains of C. glabrata and C. albicans) and fungicidal activity against all Aspergillus species tested.
Slovenian: Vorikonazol ima in vitro širok spekter antimikotičnega delovanja z antimikotičnim učinkom proti vrsti Candida (vključno s C. krusei, odporno na flukonazol, in odpornimi sevi C. glabrata in C. albicans) ter fungiciden učinek proti vsem testiranim vrstam Aspergillus.
English: • Methadone (used to treat heroin addiction)
Slovenian: • metadon (uporablja se za zdravljenje heroinske odvisnosti)
English: • Astemizole (used for allergy)
Slovenian: • astemizol (uporablja se proti alergiji)
English: Patients have developed severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) (uncommon), toxic epidermal necrolysis (TEN) (rare), drug reaction with eosinophilia and systemic symptoms (DRESS) (rare) and erythema multiforme (rare) during treatment with VFEND (see section 4.4).
Slovenian: Pri bolnikih so se med zdravljenjem z zdravilom VFEND pojavili hudi kožni neželeni učinki (SCAR), vključno s Stevens-Johnsonovim sindromom (SJS) (občasno), toksično epidermalno nekrolizo (TEN) (redko), reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) (redko) in multiformnim eritemom (redko) (glejte poglavje 4.4).
English: Developed proven or probable
Slovenian: Razvoj dokazane ali verjetne IGO do
English: Diclofenac Cmax  114% Diclofenac AUC0-  78%
Slovenian: diklofenak Cmax  114 % diklofenak AUC0-  78 %
English: Therefore, from a microbiological point of view, the reconstituted solution must be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji.
English: • The required volume of the reconstituted concentrate is then added to a recommended compatible infusion solution listed below to obtain a final VFEND solution containing 0.5 to 5 mg/ml of voriconazole.
Slovenian: • Potrebni volumen pripravljenega koncentrata se nato doda eni od priporočenih združljivih infuzijskih raztopin, naštetih spodaj, da nastane končna raztopina zdravila VFEND, ki vsebuje od 0,5 do 5 mg/ml vorikonazola.
English: Intravenous use only Not for bolus injection
Slovenian: samo za intravensko uporabo Ni primerno za bolusno injekcijo.
English: Depending on your response to treatment, your doctor may increase the daily dose to 300 mg twice a day.
Slovenian: Odvisno od vašega odziva na zdravljenje bo vaš zdravnik morda povečal odmerek na 300 mg dvakrat na dan.
English: In an oral single-dose (200 mg) study in subjects with normal renal function and mild (creatinine clearance 41-60 ml/min) to severe (creatinine clearance <20 ml/min) renal impairment, the pharmacokinetics of voriconazole were not significantly affected by renal impairment.
Slovenian: V raziskavi posamičnega peroralnega odmerka (200 mg) pri preskušancih z normalnim delovanjem ledvic ter blago (očistek kreatinina 41-60 ml/min) do hudo (očistek kreatinina < 20 ml/min) ledvično okvaro takšna okvara ni pomembno vplivala na farmakokinetiko vorikonazola.
English: Powder for solution for infusion: Sulfobutylether beta cyclodextrin sodium (SBECD)
Slovenian: Prašek za raztopino za infundiranje: sulfobutileter betaciklodekstrin natrij (SBECD)
English: It may only be continued up to 180 days after transplantation in case of continuing immunosuppression or graft versus host disease (GvHD) (see section 5.1).
Slovenian: Pri neprekinjeni imunosupresiji ali bolezni presadka proti prejemniku (GVHD - Graft Versus Host Disease) lahko traja največ 180 dni po transplantaciji (glejte poglavje 5.1).
English: What VFEND is and what it is used for What you need to know before you take VFEND How to use VFEND
Slovenian: Kaj je zdravilo VFEND in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo VFEND Kako uporabljati zdravilo VFEND Možni neželeni učinki
English: Frequent monitoring for adverse reactions and toxicity related to NSAIDs is recommended.
Slovenian: Priporočljiv je pogost nadzor neželenih učinkov in toksičnosti NSAID.
English: This product should only be taken under the supervision of a doctor.
Slovenian: To zdravilo se sme jemati samo pod zdravniškim nadzorom.
English: Voriconazole N=224
Slovenian: Vorikonazol n = 224
English: Unscrew the syringe and discard the vial adaptor and vial.
Slovenian: Odvijte brizgo in zavrzite nastavek za vialo in vialo.
English: EU/1/02/212/013 2 film-coated tablets EU/1/02/212/014 10 film-coated tablets EU/1/02/212/015 14 film-coated tablets EU/1/02/212/016 20 film-coated tablets EU/1/02/212/017 28 film-coated tablets EU/1/02/212/018 30 film-coated tablets EU/1/02/212/019 50 film-coated tablets EU/1/02/212/020 56 film-coated tablets EU/1/02/212/021 100 film-coated tablets EU/1/02/212/037 2 film-coated tablets EU/1/02/212/038 10 film-coated tablets EU/1/02/212/039 14 film-coated tablets EU/1/02/212/040 20 film-coated tablets EU/1/02/212/041 28 film-coated tablets EU/1/02/212/042 30 film-coated tablets EU/1/02/212/043 50 film-coated tablets EU/1/02/212/044 56 film-coated tablets EU/1/02/212/045 100 film-coated tablets
Slovenian: EU/1/02/212/013 2 filmsko obloženi tableti EU/1/02/212/014 10 filmsko obloženih tablet EU/1/02/212/015 14 filmsko obloženih tablet EU/1/02/212/016 20 filmsko obloženih tablet EU/1/02/212/017 28 filmsko obloženih tablet EU/1/02/212/018 30 filmsko obloženih tablet EU/1/02/212/019 50 filmsko obloženih tablet EU/1/02/212/020 56 filmsko obloženih tablet EU/1/02/212/021 100 filmsko obloženih tablet EU/1/02/212/037 2 filmsko obloženi tableti EU/1/02/212/038 10 filmsko obloženih tablet EU/1/02/212/039 14 filmsko obloženih tablet EU/1/02/212/040 20 filmsko obloženih tablet EU/1/02/212/041 28 filmsko obloženih tablet EU/1/02/212/042 30 filmsko obloženih tablet EU/1/02/212/043 50 filmsko obloženih tablet EU/1/02/212/044 56 filmsko obloženih tablet EU/1/02/212/045 100 filmsko obloženih tablet
English: • Discard the VFEND vial if the vacuum does not pull the diluent into the vial.
Slovenian: • Zavrzite vialo zdravila VFEND, če vakuum ne vsrka raztopine v vialo.
English: In an open-label, comparative, multicenter study comparing voriconazole and itraconazole as primary prophylaxis in adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI, permanent discontinuation of voriconazole due to AEs was reported in 39.3% of subjects versus 39.6% of subjects in the itraconazole arm. Treatment-emergent hepatic AEs resulted in permanent discontinuation of study medication for 50 subjects (21.4%) treated with voriconazole and for 18 subjects (7.1%) treated with itraconazole.
Slovenian: V odprti primerjalni multicentrični študiji, v kateri so primerjali vorikonazol in itrakonazol kot primarno profilakso pri odraslih in mladostnikih, ki so bili prejemniki homolognih HSCT brez predhodno dokazane ali verjetne IGO, so o trajni prekinitvi zdravljenja z vorikonazolom zaradi neželenih učinkov poročali pri 39,3 % preskušancev v primerjavi z 39,6 % preskušancev v skupini, ki je prejemala itrakonazol.
English: The syringe, vial and vial adapter can then be discarded.
Slovenian: Brizgo, vialo in nastavek za vialo lahko nato zavržete.
English: For administration, the required volume of the reconstituted concentrate is added to a recommended compatible infusion solution (detailed in the table below) to obtain a final voriconazole solution containing 0.5-5 mg/ml.
Slovenian: Za aplikacijo se potrebni volumen rekonstituiranega koncentrata doda priporočeni združljivi raztopini za infundiranje (navedene so v preglednici spodaj), da nastane končna raztopina zdravila VFEND, ki vsebuje 0,5-5 mg/ml.
English: Sirolimus (2 mg single dose)
Slovenian: sirolimus (enkratni 2 mg odmerek)
English: After an oral single-dose (200 mg), AUC was 233% higher in subjects with mild to moderate hepatic cirrhosis (Child-Pugh A and B) compared with subjects with normal hepatic function.
Slovenian: Po enkratnem peroralnem odmerku (200 mg) je bila AUC pri preskušancih z blago do zmerno cirozo jeter (Child-Pugh A in B) 233 % večja kot pri tistih z normalnim delovanjem jeter.
English: Excipient with known effect Each bag contains 177.02 mg sodium.
Slovenian: Pomožna snov z znanim učinkom Ena vrečka vsebuje 177,02 mg natrija.
English: Other treated fungal infections (often with either partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp.
Slovenian: Med drugimi zdravljenimi glivičnimi okužbami (pogosto z delnim ali popolnim odzivom) so bili posamezni primeri Alternarie spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis,
English: Coadministration with ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, since increased plasma concentrations of these medicinal products can lead to ergotism (see section 4.5).
Slovenian: Sočasna uporaba z alkaloidi ergot (ergotamin, dihidroergotamin), ki so substrati CYP3A4, ker lahko povečana koncentracija teh zdravil v plazmi povzroči ergotizem (glejte poglavje 4.5).
English: EU/1/02/212/001 2 film-coated tablets EU/1/02/212/002 10 film-coated tablets EU/1/02/212/003 14 film-coated tablets EU/1/02/212/004 20 film-coated tablets EU/1/02/212/005 28 film-coated tablets EU/1/02/212/006 30 film-coated tablets EU/1/02/212/007 50 film-coated tablets EU/1/02/212/008 56 film-coated tablets EU/1/02/212/009 100 film-coated tablets EU/1/02/212/028 2 film-coated tablets EU/1/02/212/029 10 film-coated tablets EU/1/02/212/030 14 film-coated tablets EU/1/02/212/031 20 film-coated tablets EU/1/02/212/032 28 film-coated tablets EU/1/02/212/033 30 film-coated tablets EU/1/02/212/034 50 film-coated tablets EU/1/02/212/035 56 film-coated tablets EU/1/02/212/036 100 film-coated tablets
Slovenian: EU/1/02/212/001 2 filmsko obloženi tableti EU/1/02/212/002 10 filmsko obloženih tablet EU/1/02/212/003 14 filmsko obloženih tablet EU/1/02/212/004 20 filmsko obloženih tablet EU/1/02/212/005 28 filmsko obloženih tablet EU/1/02/212/006 30 filmsko obloženih tablet EU/1/02/212/007 50 filmsko obloženih tablet EU/1/02/212/008 56 filmsko obloženih tablet EU/1/02/212/009 100 filmsko obloženih tablet EU/1/02/212/028 2 filmsko obloženi tableti EU/1/02/212/029 10 filmsko obloženih tablet EU/1/02/212/030 14 filmsko obloženih tablet EU/1/02/212/031 20 filmsko obloženih tablet EU/1/02/212/032 28 filmsko obloženih tablet EU/1/02/212/033 30 filmsko obloženih tablet EU/1/02/212/034 50 filmsko obloženih tablet EU/1/02/212/035 56 filmsko obloženih tablet EU/1/02/212/036 100 filmsko obloženih tablet
English: VFEND 200 mg powder and solvent for solution for infusion Each 50 ml polypropylene bag contains sodium chloride 0.9% in Water for Injections.
Slovenian: VFEND 200 mg prašek in vehikel za raztopino za infundiranje Ena 50 ml polipropilenska vrečka vsebuje 0,9 % natrijev klorid v vodi za injekcije.
English: Discard the VFEND vial if vacuum does not pull the diluent into the vial.
Slovenian: Zavrzite vialo zdravila VFEND, če vakuum ne vsrka raztopine v vialo.
English: Ranitidine (150 mg BID) [increases gastric pH]
Slovenian: Ranitidin (150 mg BID) [zvišuje pH v želodcu]
English: When there is also a potential for voriconazole to increase the plasma concentrations of substances metabolised by CYP3A4 isoenzymes (certain antihistamines, quinidine, cisapride, pimozide), coadministration is contraindicated (see below and section 4.3).
Slovenian: Kadar obstaja možnost, da bi vorikonazol zvišal plazemsko koncentracijo snovi, ki se presnavljajo preko izoencima CYP3A4 (določeni antihistaminiki, kinidin, cisaprid, pimozid), je sočasno dajanje vorikonazola kontraindicirano (glejte spodnje besedilo in poglavje 4.3).
English: If patient response to treatment is inadequate, the dose may be increased by 1 mg/kg steps (or by 50 mg steps if the maximum oral dose of 350 mg was used initially).
Slovenian: Če je bolnikov odziv na zdravljenje nezadosten, se odmerek lahko povečuje v korakih po 1 mg/kg (ali v korakih po 50 mg, če je bil na začetku uporabljen največji peroralni odmerek 350 mg).
English: Without the loading dose, accumulation occurs during twice daily multiple dosing with steady-state plasma voriconazole concentrations being achieved by Day 6 in the majority of subjects.
Slovenian: Brez polnilnega odmerka se med večkratnim odmerjanjem dvakrat na dan pojavi kopičenje; pri večini preskušancev je koncentracija vorikonazola v stanju dinamičnega ravnovesja dosežena do 6. dne.
English: Ritonavir Cmax and AUC ↔ Voriconazole Cmax  66% Voriconazole AUC  82%
Slovenian: ritonavir Cmax and AUC ↔ vorikonazol Cmax  66 % vorikonazol AUC  82 %
English: including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp.
Slovenian: Paecilomyces lilacinus, Penicillium spp., vključno s P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis ter Trichosporon spp., vključno z okužbami s T. beigelii.
English: Wash the oral syringe as instructed below.
Slovenian: Peroralno brizgo operite po spodnjih navodilih.
English: Write the date of expiry of the constituted suspension on the bottle label (the shelf-life of the constituted suspension is 14 days).
Slovenian: Na nalepko plastenke napišite rok uporabnosti pripravljene suspenzije (rok uporabnosti pripravljene suspenzije je 14 dni).
English: Efavirenz (CYP450 inducer; CYP3A4 inhibitor and substrate) When voriconazole is coadministered with efavirenz the dose of voriconazole should be increased to 400 mg every 12 hours and the dose of efavirenz should be decreased to 300 mg every 24 hours (see sections 4.2, 4.3 and 4.5).
Slovenian: Efavirenz (induktor CYP450; zaviralec in substrat CYP3A4) Med sočasno uporabo vorikonazola in efavirenza je potrebno odmerek vorikonazola povečati na 400 mg vsakih 12 ur, odmerek efavirenza pa zmanjšati na 300 mg vsakih 24 ur (glejte poglavja 4.2, 4.3 in 4.5).
English: For storage conditions after constitution, see section 6.3.
Slovenian: Za pogoje shranjevanja pripravljene suspenzije glejte poglavje 6.3.
English: Treatment of candidaemia in non-neutropenic patients.
Slovenian: - zdravljenje kandidemije pri nenevtropeničnih bolnikih
English: VFEND tablets contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Slovenian: Tablete VFEND vsebujejo laktozo, zato jih ne smejo jemati bolniki z redkimi dednimi težavami, kot so galaktozna intoleranca, laponska oblika zmanjšane aktivnosti laktaze ali malabsorpcija glukoze in galaktoze.
English: Tell your doctor if you experience this.
Slovenian: Če doživite te učinke, to povejte zdravniku.
English: Coadministration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations (see section 4.4).
Slovenian: Sočasna uporaba vorikonazola in everolimusa ni priporočena, saj se pričakuje, da vorikonazol pomembno zviša koncentracijo everolimusa (glejte poglavje 4.4).
English: In an oral multiple-dose study Cmax and AUCτ in healthy elderly males (≥65 years) were 61% and 86% higher, respectively, than in healthy young males (18-45 years).
Slovenian: V študiji večkratnih peroralnih odmerkov je bila Cmax pri zdravih starejših moških (≥ 65 let) 61 % višja, AUCτ pa 86 % višja kot pri zdravih mladih moških (18-45 let).
English: Required Volumes of 10 mg/ml VFEND Concentrate
Slovenian: Volumni, potrebni za 10 mg/ml VFEND koncentrata telesna masa (kg)
English: • Sulfonylureas (e.g., tolbutamide, glipizide, and glyburide) (used for diabetes)
Slovenian: • sulfonilsečnine (npr. tolbutamid, glipizid in gliburid) (uporabljajo se za zdravljenje sladkorne bolezni)
English: Method of administration VFEND oral suspension is to be taken at least one hour before, or two hours following, a meal.
Slovenian: Način uporabe VFEND peroralno suspenzijo je treba vzeti vsaj eno uro pred jedjo ali dve uri po jedi.
English: 2b Push the syringe plunger down fully.
Slovenian: 2b Bat brizge potisnite popolnoma noter.
English: Methadone (32-100 mg QD) [CYP3A4 substrate]
Slovenian: Metadon (32-100 mg QD) [substrat CYP3A4]
English: VFEND suspension contains 0.54g sucrose per ml of suspension.
Slovenian: VFEND peroralna suspenzija vsebuje 0,54 g saharoze v 1 ml suspenzije.
English: Excipient with known effect Each ml of suspension contains 0.54 g sucrose.
Slovenian: Pomožna snov z znanim učinkom: 1 mililiter suspenzije vsebuje 0,54 g saharoze.
English: Hold the vial adapter over the vial and press down firmly, until the vial locks into place.
Slovenian: Nastavek za vialo držite nad vialo in ga čvrsto pritisnite navzdol, da se viala zaskoči.
English: High dose (400 mg BID)
Slovenian: veliki odmerki (400 mg BID)
English: Kit Operating Instructions for Use: VFEND Powder and Solvent for Solution for Infusion
Slovenian: Delovna navodila za uporabo kompleta: VFEND prašek in vehikel za raztopino za infundiranje
English: 1 vial adaptor
Slovenian: 1 nastavek za vialo
English: If a patient develops a rash he should be monitored closely and VFEND discontinued if lesions progress.
Slovenian: Če se bolniku pojavi izpuščaj, ga je treba skrbno spremljati in jemanje zdravila VFEND prekiniti, če lezije napredujejo.
English: VFEND oral suspension contains sucrose and should not be given to patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption.
Slovenian: VFEND peroralna suspenzija vsebuje saharozo, zato je ne smejo jemati bolniki z redkimi dednimi težavami, kot so fruktozna intoleranca, pomanjkanje saharoze-izomaltaze ali malabsorpcija glukoze in galaktoze.
English: Take your tablet at least one hour before, or one hour after a meal.
Slovenian: Tableto vzemite vsaj eno uro pred jedjo ali najmanj eno uro po jedi.
English: It is therefore recommended to use the oral suspension formulation in children aged 2 to <12.
Slovenian: Zato je pri otrocih, starih od 2 do < 12 let, priporočljiva uporaba peroralne suspenzije.
English: Instructions for use: Shake the closed bottle of constituted suspension for approximately 10 seconds before each use.
Slovenian: Pred vsako uporabo tresite zaprto plastenko s pripravljeno suspenzijo približno 10 sekund.
English: If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for VFEND.
Slovenian: Pri infuziji skozi multi-lumni kateter je treba pri dajanju TPN uporabiti drugo odprtino kot za zdravilo VFEND.
English: Other Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine) [CYP3A4 substrates, inhibitors or CYP450 inducers]
Slovenian: Drugi nenukleozidni zaviralci reverzne transkriptaze (NNRTIs) (kot sta delavirdin, nevirapin) [substrati CYP3A4, inhibitorji ali induktorji CYP450]
English: What VFEND is and what it is used for What you need to know before you take VFEND How to take VFEND
Slovenian: Kaj je zdravilo VFEND in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo VFEND Kako jemati zdravilo VFEND Možni neželeni učinki
English: • This medicinal product is for single use only and any unused solution should be discarded.
Slovenian: • To zdravilo je samo za enkratno uporabo; neuporabljeno raztopino je treba zavreči.
English: Powder for oral suspension: store at 2°C - 8°C (in a refrigerator) before constitution.
Slovenian: Prašek za peroralno suspenzijo: pred pripravo shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku).
English: Each vial contains 200 mg voriconazole, equivalent to a 10 mg/ml solution when reconstituted as directed by your hospital pharmacist or nurse (see the information at the end of this leaflet).
Slovenian: • Druge sestavine zdravila: sulfobutileter betaciklodekstrin natrij Ena viala vsebuje 200 mg vorikonazola, kar ustreza raztopini 10 mg/ml, če jo bolnišnični farmacevt ali medicinska sestra pripravita po navodilu (glejte informacije na koncu navodila).
English: Voriconazole Cmax  57% Voriconazole AUC  79% Fluconazole Cmax ND Fluconazole AUC ND
Slovenian: vorikonazol Cmax  57 % vorikonazol AUC  79 % flukonazol Cmax ND flukonazol AUC ND
English: • Ritonavir (used for treating HIV) in doses of 400mg and more twice daily
Slovenian: • ritonavir (uporablja se za zdravljenje okužbe s HIV) v odmerkih 400 mg in več, dvakrat na dan
English: including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans; Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis; and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans; and Fusarium spp.
Slovenian: Klinična učinkovitost, opredeljena kot delni ali popolni odziv, je bila dokazana za Aspergillus spp., vključno z A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, za Candida spp., vključno s C. albicans, C. glabrata, C. krusei, C. parapsilosis in C. tropicalis in omejenim številom C. dubliniensis, C. inconspicua, in C. guilliermondii, za Scedosporium spp., vključno s S. apiospermum in S. prolificans ter za Fusarium spp.
English: • Congenital or acquired QTc-prolongation.
Slovenian: • prirojeno ali pridobljeno podaljšanje intervala QTc,
English: A measuring cup (graduated to indicate 23 ml), 5 ml oral syringe and a press-in bottle adaptor are also provided.
Slovenian: Priložena je tudi merica (označena, da kaže 23 ml), 5 ml peroralna brizga in potisni nastavek za plastenko.
English: If a patient develops a rash they should be monitored closely and VFEND discontinued if lesions progress.
Slovenian: Če se bolniku pojavi izpuščaj, ga je treba skrbno spremljati in uporabo zdravila VFEND prekiniti, če lezije napredujejo.
English: Please refer to Patient Information Leaflet for detailed instructions.
Slovenian: Za podrobnejša navodila glejte navodila za bolnika.
English: Frequent monitoring for opiateassociated adverse reactions may be necessary.
Slovenian: Priporočljiv je pogost nadzor glede pojavljanja z opiati povezanih neželenih učinkov.
English: An impurity present in SBECD has been shown to be an alkylating mutagenic agent with evidence for carcinogenicity in rodents.
Slovenian: Dokazano je, da je nečistoča v SBECD alkilirajoča mutagena snov, karcinogena pri glodalcih.
English: 2 film-coated tablets 30 film-coated tablets 100 film-coated tablets
Slovenian: 2 filmsko obloženi tableti 30 filmsko obloženih tablet 100 filmsko obloženih tablet
English: In an oral multiple-dose study, Cmax and AUCτ for healthy young females were 83% and 113% higher, respectively, than in healthy young males (18-45 years).
Slovenian: V študiji večkratnih peroralnih odmerkov je bila pri zdravih mladih ženskah Cmax 83 % višja, AUCτ pa 113 % višja kot pri zdravih mladih moških (18-45 let).
English: - The other ingredients are sucrose; silica colloidal; titanium dioxide; xanthan gum; sodium citrate; sodium benzoate; citric acid; natural orange flavour.
Slovenian: • Druge sestavine zdravila so: saharoza, koloidni silicijev dioksid, titanov dioksid, ksantanski gumi, natrijev citrat, natrijev benzoat, citronska kislina in naravna aroma pomaranče.
English: VFEND 50 mg film-coated tablets EU/1/02/212/001-012
Slovenian: VFEND 50 mg filmsko obložene tablete EU/1/02/212/001-012