FrancophonIA/ELRC3.0 huggingface dataset:
English: • VFEND solvent for solution for infusion in an overwrapped, sterile, single use, polypropylene infusion bag.
Slovenian: • VFEND vehikel za raztopino za infundiranje v s folijo oviti, sterilni polipropilenski infuzijski vrečki za enkratno uporabo.
English: The predicted total exposures in children following IV maintenance doses of 4 and 8 mg/kg twice daily were comparable to those in adults following 3 and 4 mg/kg IV twice daily, respectively.
Slovenian: Pričakovane celokupne izpostavljenosti pri otrocih po uporabi intravenskih vzdrževalnih odmerkov, 4 mg/kg oziroma 8 mg/kg dvakrat na dan, so bile primerljive s tistimi pri odraslih po uporabi 3 mg/kg oziroma 4 mg/kg intravensko dvakrat na dan.
English: Other HIV Protease Inhibitors (e.g., saquinavir, amprenavir and nelfinavir) [CYP3A4 substrates and inhibitors]
Slovenian: Drugi zaviralci proteaze HIV (kot so sakvinavir, amprenavir in nelfinavir) [substrati in inhibitorji CYP3A4]
English: Studies conducted in Caucasian and Japanese healthy subjects have shown that poor metabolisers have, on average, 4-fold higher voriconazole exposure (AUCτ) than their homozygous extensive metaboliser counterparts.
Slovenian: Študije pri zdravih preskušancih bele rase in preskušancih z Japonske so pokazale, da je izpostavljenost vorikonazolu (AUCτ) pri osebah z zmanjšano presnovo v povprečju 4-krat večja kot pri primerljivih homozigotnih osebah z izrazito presnovo.
English: Silica Colloidal Anhydrous Titanium Dioxide (E171) Xanthan Gum Sodium Citrate Citric Acid Anhydrous Sodium Benzoate (E211) Natural Orange Flavour
Slovenian: 6.1 Seznam pomožnih snovi saharoza brezvodni koloidni silicijev dioksid titanov dioksid (E171) ksantanski gumi natrijev citrat brezvodna citronska kislina natrijev benzoat (E211) naravna pomarančna aroma
English: Phenytoin [CYP2C9 substrate and potent CYP450 inducer]
Slovenian: Fenitoin [substrat CYP2C9 in močan induktor CYP450]
English: Everolimus [CYP3A4 substrate, P-gp substrate]
Slovenian: Everolimus [substrat CYP3A4, substrat P-gp]
English: Bioequivalence was established between the 200 mg tablet and the 40 mg/ml oral suspension when administered as a 200 mg dose.
Slovenian: Bioekvivalenco so dokazali med 200 mg tabletami in 40 mg/ml peroralno suspenzijo, dano kot 200 mg odmerek.
English: 6b Keeping the infusion bag inverted, connect the infusion line.
Slovenian: 6b Držite infuzijsko vrečko obrnjeno s spodnjim koncem navzgor in jo spojite z infuzijskim sistemom.
English: Do not pass it on to others.
Slovenian: Ne uporabljajte z drugimi zdravili.
English: * Primary endpoint of study ** Using a margin of 5%, non inferiority is demonstrated ***Difference in proportions, 95% CI obtained after adjustment for randomization
Slovenian: * Primarni opazovani dogodek v študiji ** Pri 5 % meji so pokazali neinferiornost *** Razlike v deležih in 95 % IZ, pridobljeni po prilagoditvi za randomizacijo
English: It is likely that these subjects may metabolize voriconazole more similarly to children than to adults.
Slovenian: Mogoče je, da je presnova vorikonazola pri teh preskušancih bolj podobna presnovi pri otrocih kakor tisti pri odraslih.
English: Alfentanil (20 μg/kg single dose, with concomitant naloxone)
Slovenian: alfentanil (enkratni 20 μg/kg odmerek s sočasno danim naloksonom)
English: Phenytoin (CYP2C9 substrate and potent CYP450 inducer) Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole.
Slovenian: Fenitoin (substrat CYP2C9 in močan induktor CYP450) Med sočasno uporabo fenitoina in vorikonazola je priporočljivo natančno nadziranje koncentracije fenitoina.
English: VFEND 40 mg/ml powder for oral suspension
Slovenian: VFEND 40 mg/ml prašek za peroralno suspenzijo
English: Benzodiazepines (e.g., midazolam, triazolam, alprazolam) [CYP3A4 substrates]
Slovenian: Benzodiazepini (kot so midazolam, triazolam, alprazolam) [substrati CYP3A4]
English: Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported with the use of voriconazole.
Slovenian: Pri uporabi vorikonazola so poročali o hudih kožnih neželenih učinkih (SCAR - Severe Cutaneous Adverse Reactions), kot so na primer Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) ter reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms), ki so lahko življenjsko nevarni ali smrtni.
English: Reconstitution and Dilution information
Slovenian: Informacije o pripravi in redčenju
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking VFEND if:
Slovenian: Pred začetkom uporabe zdravila VFEND se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
English: VFEND solvent for solution for infusion is a sterile, single use polypropylene infusion bag.
Slovenian: VFEND vehikel za raztopino za infundiranje je sterilen vehikel za enkratno uporabo v polipropilenski infuzijski vrečki.
English: The bag should be checked to ensure that the infusion is complete.
Slovenian: Vrečko je treba pregledati, da se zagotovi, da ni poškodovana.
English: Coadministration with rifampicin, carbamazepine and phenobarbital since these medicinal products are likely to decrease plasma voriconazole concentrations significantly (see section 4.5).
Slovenian: Sočasna uporaba z rifampicinom, karbamazepinom in fenobarbitalom, ker lahko ta zdravila pomembno zmanjšajo koncentracije vorikonazola v plazmi (glejte poglavje 4.5).
English: Mycophenolic acid (1 g single dose) [UDP-glucuronyl transferase substrate]
Slovenian: Mikofenolna kislina (enkratni 1 g odmerek) [substrat UDP-glukuroniltransferaze]
English: In an independent published study, Oxycodone Cmax  1.7-fold Oxycodone AUC0-  3.6-fold
Slovenian: v neodvisni objavljeni študiji, oksikodon Cmax  1,7-krat oksikodon AUC0-  3,6-krat
English: Indinavir Cmax ↔ Indinavir AUC ↔ Voriconazole Cmax ↔ Voriconazole AUC ↔
Slovenian: indinavir Cmax ↔ indinavir AUC ↔ vorikonazol Cmax ↔ vorikonazol AUC ↔
English: Oral Suspension Patients 40 kg and above*
Slovenian: intravensko peroralna suspenzija bolniki s telesno maso 40 kg in več*
English: It is recommended that VFEND is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.
Slovenian: Zdravilo VFEND je treba aplicirati s hitrostjo največ 3 mg/kg na uro v obdobju 1 do 3 ur.
English: Efavirenz may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 400 mg every 12 hours and the efavirenz dose is reduced by 50%, i.e. to 300 mg once daily.
Slovenian: Efavirenz se lahko uporablja sočasno z vorikonazolom, če se vzdrževalni odmerek vorikonazola poveča na 400 mg vsakih 12 ur, odmerek efavirenza pa zmanjša za 50 %, tj. na 300 mg enkrat na dan.
English: The medicines in the following list must not be taken during your VFEND treatment:
Slovenian: Med zdravljenjem z zdravilom VFEND ne smete jemati zdravil, ki so na spodnjem seznamu:
English: The powder is reconstituted with either 19 ml of water for injections or 19 ml of 9 mg/ml (0.9%) Sodium Chloride for Infusion to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ml of voriconazole.
Slovenian: Prašek se rekonstituira ali z 19 ml vode za injekcije ali pa z 19 ml 9 mg/ml (0,9 %) natrijevega klorida za infundiranje, tako da nastane 20 ml ekstraktibilnega volumna bistrega koncentrata, ki vsebuje 10 mg/ml vorikonazola.
English: If patient is unable to tolerate treatment, reduce the intravenous dose by 1 mg/kg steps.
Slovenian: Če bolnik zdravljenja ne prenaša, intravenski odmerek zmanjšujemo v korakih po 1 mg/kg.
English: Use of standard doses of voriconazole with efavirenz doses of 400 mg QD or higher is contraindicated (see section 4.3).
Slovenian: Uporaba standardnih odmerkov vorikonazola z odmerki efavirenza v velikosti 400 mg QD ali več je kontraindicirana (glejte poglavje 4.3).
English: If patient is unable to tolerate treatment, reduce the dose by 1 mg/kg steps (or by 50 mg steps if the maximum oral dose of 350 mg was used initially).
Slovenian: Če bolnik zdravljenja ne prenaša, odmerek zmanjšujemo v korakih po 1 mg/kg (ali v korakih po 50 mg, če je bil na začetku uporabljen največji peroralni odmerek 350 mg).
English: VFEND 200 mg powder for solution for infusion Each vial contains 200 mg of voriconazole.
Slovenian: VFEND 200 mg prašek za raztopino za infundiranje Ena viala vsebuje 200 mg vorikonazola.
English: • The VFEND powder is reconstituted by using the specially marked syringe provided to remove 19 ml of VFEND solvent for solution for infusion (Sodium Chloride (0.9%) from the blue port of the infusion bag.
Slovenian: • VFEND prašek rekonstituirajte z uporabo priložene, posebej označene brizge, s katero odvzemite 19 ml VFEND vehikla za raztopino za infundiranje (0,9 % natrijev klorid) iz modrega priključka na infuzijski vrečki.
English: It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact amount (19.0 ml) of water for injections or (9 mg/ml [0.9%]) Sodium Chloride for Infusion is dispensed.
Slovenian: Priporočljiva je uporaba standardne 20-ml (neavtomatične) brizge, da se zagotovi aplikacija natančne količine (19,0 ml) vode za injekcije ali (9 mg/ml [0,9 %]) natrijevega klorida za infundiranje.
English: While the bottle is upright, on a flat surface, insert the tip of the oral syringe into the adaptor.
Slovenian: Medtem ko je plastenka v pokončnem položaju na ravni površini, vstavite vrh peroralne brizge v nastavek za plastenko.
English: EU/1/02/212/022 2 film-coated tablets EU/1/02/212/023 30 film-coated tablets EU/1/02/212/024 100 film-coated tablets
Slovenian: EU/1/02/212/022 2 filmsko obloženi tableti EU/1/02/212/023 30 filmsko obloženih tablet EU/1/02/212/024 100 filmsko obloženih tablet
English: Fluconazole (200 mg QD) [CYP2C9, CYP2C19 and CYP3A4 inhibitor]
Slovenian: Flukonazol (200 mg QD) [inhibitor CYP2C9, CYP2C19 in CYP3A4]
English: In vitro studies show that voriconazole may inhibit the metabolism of HIV protease inhibitors and the metabolism of voriconazole may also be inhibited by HIV protease inhibitors.
Slovenian: Študije in vitro nakazujejo, da lahko vorikonazol zavre presnovo zaviralcev proteaze HIV, lahko pa tudi zaviralci proteaze HIV zavrejo presnovo vorikonazola.
English: EU/1/02/212/010 2 film-coated tablets EU/1/02/212/011 30 film-coated tablets EU/1/02/212/012 100 film-coated tablets
Slovenian: EU/1/02/212/010 2 filmsko obloženi tableti EU/1/02/212/011 30 filmsko obloženih tablet EU/1/02/212/012 100 filmsko obloženih tablet
English: The spike in the vial adapter will penetrate the vial seal.
Slovenian: Konica nastavka za vialo bo prebodla zaporko na viali.
English: Low dose (100 mg BID)
Slovenian: majhni odmerki (100 mg BID)
English: 4 Gently invert the vial.
Slovenian: 4 Nežno obrnite vialo s spodnjim koncem navzgor.
English: Omeprazole Cmax  116% Omeprazole AUC  280% Voriconazole Cmax  15% Voriconazole AUC  41%
Slovenian: omeprazol Cmax  116 % omeprazol AUC  280 % vorikonazol Cmax  15 % vorikonazol AUC  41 %
English: Solvent for VFEND powder for solution for infusion Sodium Chloride 0.9% in Water for Injections Intravenous use
Slovenian: Vehikel za VFEND prašek za raztopino za infundiranje 0,9 % natrijev klorid v vodi za injekcije za intravensko uporabo
English: Step 5
Slovenian: Korak 5
English: • VFEND powder for solution for infusion in single use glass vial.
Slovenian: • VFEND prašek za raztopino za infundiranje v stekleni viali za enkratno uporabo.
English: 3b Screw the syringe onto the vial adapter.
Slovenian: 3b Privijte brizgo na nastavek za vialo.
English: Ritonavir Cmax  25% Ritonavir AUC 13% Voriconazole Cmax  24% Voriconazole AUC  39%
Slovenian: ritonavir Cmax  25 % ritonavir AUC 13 % vorikonazol Cmax  24 % vorikonazol AUC  39 %
English: • Fluconazole (used for fungal infections)
Slovenian: • flukonazol (uporablja se za zdravljenje glivičnih okužb)
English: Excipient with known effect Each vial contains 217.6 mg sodium.
Slovenian: Pomožna snov z znanim učinkom Ena viala vsebuje 217,6 mg natrija.
English: Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole) [CYP2C9 substrate]
Slovenian: Antikoagulanti varfarin (enkratni 30 mg odmerek, sočasno uporabljan s 300 mg vorikonazola BID) [substrat CYP2C9]
English: hours for the first 24 hours hours for the first 24 hours
Slovenian: v prvih 24 urah v prvih 24 urah odmerek po prvih 24 urah
English: Use only items provided in the box with VFEND powder and solvent for solution for infusion in the preparation of the infusion.
Slovenian: Za pripravo infuzije se sme uporabiti samo pripomočke, ki so priloženi v škatli zdravila VFEND prašek in vehikel za raztopino za infundiranje.
English: Oxycodone (10 mg single dose)
Slovenian: oksikodon (enkratni 10 mg odmerek)
English: 9 mg/kg twice a day (a maximum dose of 350 mg twice daily)
Slovenian: 9 mg/kg dvakrat na dan (največji odmerek 350 mg dvakrat na dan)
English: From a microbiological point of view, once reconstituted, the product must be used immediately.
Slovenian: Z mikrobiološkega stališča je zato treba zdravilo uporabiti takoj po pripravi.
English: Snap open the blue port of the infusion bag.
Slovenian: Odlomite (odprite) modri priključek na infuzijski vrečki.
English: Bottle outer pack and bottle label for 200 mg film-coated tablets - Pack of 2, 30, 100
Slovenian: Zunanja ovojnina plastenke in nalepka na plastenki za 200 mg filmsko obložene tablete - pakiranje z 2, 30, 100 tabletami
English: Each vial of VFEND contains 217.6 mg of sodium.
Slovenian: Ena viala zdravila VFEND vsebuje 217,6 mg natrija.
English: PVC / Aluminium/PVC/PVDC blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets.
Slovenian: PVC/aluminijski/PVC/PVDC pretisni omot v škatlah z 2, 10, 14, 20, 28, 30, 50, 56 ali 100 filmsko obloženimi tabletami.
English: • It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact amount (19.0 ml) of Water for Injections or of 9 mg/ml (0.9%) Sodium Chloride for Infusion is dispensed.
Slovenian: • Priporočljiva je uporaba standardne 20-ml (neavtomatične) brizge, da se zagotovi aplikacija natančne količine (19,0 ml) vode za injekcije ali 9 mg/ml (0,9 %) natrijevega klorida za infundiranje.
English: When voriconazole treatment is stopped, the initial dose of efavirenz should be restored (see section 4.2 and 4.4).
Slovenian: Ko se zdravljenje z vorikonazolom konča, je treba obnoviti prejšnje odmerjanje efavirenza (glejte poglavji 4.2 in 4.4).
English: Ethinylestradiol Cmax  36% Ethinylestradiol AUC  61% Norethisterone Cmax  15% Norethisterone AUC  53% Voriconazole Cmax  14% Voriconazole AUC  46%
Slovenian: etinilestradiol Cmax  36 % etinilestradiol AUC  61 % noretisteron Cmax  15 % noretisteron AUC  53 % vorikonazol Cmax  14 % vorikonazol AUC  46 %
English: Erythromycin (1 g BID) [CYP3A4 inhibitor]
Slovenian: Makrolidni antibiotiki eritromicin (1 g BID) [inhibitor CYP3A4]
English: If phototoxic reactions occur multidisciplinary advice should be sought, VFEND discontinuation and use of alternative antifungal agents should be considered and the patient should be referred to a dermatologist.
Slovenian: Razmisliti je treba o prekinitvi zdravljenja z zdravilom VFEND in uporabi drugih antimikotikov ter bolnika napotiti k dermatologu.
English: There have been reports of skin cancer in patients treated with VFEND for long periods of time.
Slovenian: Pri bolnikih, ki so se z zdravilom VFEND zdravili dlje časa, so poročali o pojavu raka kože.
English: VFEND 200 mg film-coated tablets EU/1/02/212/013-024
Slovenian: VFEND 200 mg filmsko obložene tablete EU/1/02/212/013-024
English: Powder for oral suspension White to off-white powder
Slovenian: prašek za peroralno suspenzijo bel do belkast prašek
English: 3a Remove the adaptor casing from the vial adaptor and discard.
Slovenian: 3a Odstranite ohišje z nastavka za vialo in ga zavrzite.
English: This medicinal product is for single use only and any unused solution should be discarded.
Slovenian: Zdravilo je namenjeno samo za enkratno uporabo; morebitno neuporabljeno raztopino je treba zavreči.
English: For oral use after constitution
Slovenian: za peroralno uporabo po pripravi
English: Voriconazole Cmax and AUC ↔ No dose adjustment
Slovenian: vorikonazol Cmax and AUC ↔ Prilagajanje odmerka ni potrebno.
English: • VFEND powder for solution for infusion needs to first be reconstituted with either 19 ml of Water for Injections or 19 ml of 9 mg/ml (0.9%) Sodium Chloride for Infusion to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ml voriconazole.
Slovenian: • Prašek za raztopino za infundiranje VFEND je treba najprej pripraviti (rekonstituirati) ali z 19 ml vode za injekcije ali pa z 19 ml 9 mg/ml (0,9 %) natrijevega klorida za infundiranje, tako da nastane 20 ml ekstraktibilnega volumna bistrega koncentrata, ki vsebuje 10 mg/ml vorikonazola.
English: 200 mg (5 ml) every 12 hours
Slovenian: 200 mg (5 ml) vsakih 12 ur
English: Includes periorbital oedema, lip oedema, and oedema mouth.
Slovenian: Vključuje periorbitalni edem, edem ustnic in edem ust.
English: Ensure the internal spike of the vial adaptor is placed at the centre of the vial septum and push the adaptor firmly onto the vial until it snaps into place.
Slovenian: Prepričajte se, da se konica nastavka za vialo nahaja nad središčem zamaška viale, in čvrsto pritisnite nastavek na vialo, da se zaskoči.
English: Each tablet contains 50 or 200 mg voriconazole.
Slovenian: Ena tableta vsebuje 50 ali 200 mg vorikonazola.
English: Other oral coumarins (e.g., phenprocoumon, acenocoumarol) [CYP2C9 and CYP3A4 substrates]
Slovenian: drugi peroralni kumarini (kot sta fenprokumon in acenokumarol) [substrati CYP2C9 in CYP3A4]
English: Ritonavir (protease inhibitor) [potent CYP450 inducer; CYP3A4 inhibitor and substrate]
Slovenian: Ritonavir (zaviralec proteaze) [močan induktor CYP450; zaviralec in substrat CYP3A4]
English: Tap the bottle to release the powder.
Slovenian: Rahlo udarite po plastenki, da zrahljate prašek.
English: Coadministration with St. John's Wort (see section 4.5).
Slovenian: Sočasna uporaba s šentjanževko (glejte poglavje 4.5).
English: Each bag contains 50 ml of sodium chloride 0.9% in Water for Injections.
Slovenian: Ena vrečka vsebuje 50 ml 0,9 % natrijevega klorida v vodi za injekcije.
English: VFEND is also available as 50 mg and 200 mg film-coated tablets and 40 mg/ml powder for oral suspension.
Slovenian: Zdravilo VFEND je na voljo tudi v obliki 50 mg in 200 mg filmsko obloženih tablet in 40 mg/ml praška za peroralno suspenzijo.
English: 1 single use 30 ml clear Type I glass vial with rubber stopper and aluminium cap with plastic seal of VFEND 200 mg, powder for solution.
Slovenian: 1 30-ml vialo za enkratno uporabo, izdelano iz stekla tipa I, z gumijastim zamaškom in aluminijasto zaporko s plastičnim pečatom, ki vsebuje VFEND 200 mg prašek za raztopino.
English: Bottle outer pack and bottle label for 50 mg film-coated tablets - Pack of 2, 30, 100
Slovenian: Zunanja ovojnina plastenke in nalepka na plastenki za 50 mg filmsko obložene tablete - pakiranje z 2, 30 ali 100 tabletami
English: 200 mg twice a day
Slovenian: 200 mg dvakrat na dan
English: If you stop taking VFEND
Slovenian: Če ste prenehali jemati zdravilo VFEND
English: VFEND 200 mg powder for solution for infusion EU/1/02/212/025
Slovenian: VFEND 200 mg prašek za raztopino za infundiranje: EU/1/02/212/025
English: Jaundice; Changes in blood tests of liver function Pancreatitis
Slovenian: - izpuščaj - zlatenica; spremembe izvidov krvnih preiskav za spremljanje delovanja jeter - vnetje trebušne slinavke
English: Cardiac disorders arrhythmia supraventricular, tachycardia, bradycardia ventricular fibrillation, ventricular extrasystoles, ventricular tachycardia, electrocardiogram QT prolonged, supraventricular tachycardia torsades de pointes, atrioventricular block complete, bundle branch block, nodal rhythm
Slovenian: Srčne bolezni supraventrikularna aritmija, tahikardija, bradikardija ventrikularna fibrilacija, ventrikularne ekstrasistole, ventrikularna tahikardija, podaljšanje intervala QT, supraventrikularna tahikardija torsades de pointes, popolni atrioventrikula rni blok, kračni blok, nodalni ritem
English: 8 mg/kg twice a day 4 mg/kg twice a day
Slovenian: 8 mg/kg dvakrat na dan 4 mg/kg dvakrat na dan
English: In an independent published study, Fentanyl AUC0-  1.34-fold
Slovenian: v neodvisni objavljeni študiji, alfentanil AUC0-  6-krat v neodvisni objavljeni študiji, fentanil AUC0-  1,34-krat
English: Your doctor should also monitor your liver function while you are being treated with VFEND by doing blood tests.
Slovenian: Vaš zdravnik bo v času zdravljenja z zdravilom VFEND s pomočjo krvnih preiskav prav tako nadziral delovanje vaših jeter.
English: Dosage adjustments in case of co-administration Rifabutin or phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg intravenously twice daily, see sections 4.4 and 4.5.
Slovenian: Rifabutin ali fenitoin se lahko uporabita sočasno z vorikonazolom, če se vzdrževalni odmerek vorikonazola poveča na 5 mg/kg intravensko dvakrat na dan; glejte poglavji 4.4 in 4.5.
English: Your doctor should monitor the function of your liver and kidney by doing blood tests.
Slovenian: Vaš zdravnik mora s krvnimi preiskavami nadzirati delovanje vaših jeter in ledvic.
English: St. John's Wort [CYP450 inducer; Pgp inducer] 300 mg TID (coadministered with voriconazole 400 mg single dose)
Slovenian: Šentjanževka [inductor CYP450; induktor P-gp] 300 mg TID (sočasno uporabljana z enkratnim 400 mg odmerkom vorikonazola)
English: Concomitant use of voriconazole and phenytoin should be avoided unless the benefit outweighs the risk (see section 4.5).
Slovenian: Vorikonazola in fenitoina se ne sme uporabljati sočasno, razen če korist odtehta tveganje (glejte poglavje 4.5).
English: Voriconazole (N=248)
Slovenian: časovna točka vorikonazol (n = 248)
English: Efavirenz Cmax  38% Efavirenz AUC  44% Voriconazole Cmax  61% Voriconazole AUC  77%
Slovenian: efavirenz Cmax  38 % efavirenz AUC  44 % vorikonazol Cmax  61 % vorikonazol AUC  77 %
English: • The active substance is voriconazole.
Slovenian: • Zdravilna učinkovina je vorikonazol.
English: Indinavir (800 mg TID) [CYP3A4 inhibitor and substrate]
Slovenian: Indinavir (800 mg TID) [inhibitor in substrat CYP3A4]
English: VFEND is also available as 50 mg and 200 mg film-coated tablets, 200 mg powder for solution for injection and 200 mg powder and solvent for solution for infusion.
Slovenian: Zdravilo VFEND je na voljo tudi v obliki 50 mg in 200 mg filmsko obloženih tablet, 200 mg praška za raztopino za infundiranje in 200 mg praška in vehikla za raztopino za infundiranje.
English: Replace the cap and shake the bottle vigorously for about 1 minute.
Slovenian: Namestite zaporko in plastenko močno stresajte približno 1 minuto.
English: The most commonly reported adverse reactions were visual impairment, pyrexia, rash, vomiting, nausea, diarrhoea, headache, peripheral oedema, liver function test abnormal, respiratory distress and abdominal pain.
Slovenian: Najpogosteje opisani neželeni učinki so bili okvare vida, pireksija, izpuščaj, bruhanje, navzea, diareja, glavobol, periferni edemi, nenormalni izvidi testov jetrne funkcije, dihalna stiska in bolečine v trebuhu.
English: • Not for administration as a bolus injection.
Slovenian: • Zdravilo se ne sme aplicirati kot bolusna injekcija.
English: Blister foil for 50 mg film-coated tablets (all blister packs)
Slovenian: Folija za 50 mg filmsko obložene tablete (vsa pakiranja)
English: VFEND 200 mg powder for solution for infusion and VFEND 200 mg powder and solvent for solution for infusion:
Slovenian: VFEND 200 mg prašek za raztopino za infundiranje in VFEND 200 mg prašek in vehikel za raztopino za infundiranje:
English: Rare: may affect up to 1 in 1000 people
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: Set the infusion rate accurately.
Slovenian: Natančno nastavite hitrost infundiranja.