FrancophonIA/ELRC3.0 huggingface dataset:
English: Developed proven or probable IFI while on study drug * Primary endpoint of the study ** Difference in proportions, 95% CI and p-valuesobtained after adjustment for randomization
Croatian: Nastala dokazana ili vjerojatna invazivna gljivična infekcija tijekom uzimanja ispitivanog lijeka * Primarni ishod ispitivanja ** Razlika u udjelima, 95%-tni CI i p-vrijednosti dobivene nakon prilagodbe za randomizaciju
English: Critical Instructions for safe and effective use of infusion kit Aseptic procedures will be followed during kit preparation Bag must be inverted when the reconstituted Voriconazole is added
Croatian: Tijekom pripreme kompleta moraju se primjenjivati aseptičke tehnike Vrećica se mora preokrenuti kada se u nju doda rekonstituirani vorikonazol
English: In the case of treatment-related adverse events, discontinuation of voriconazole and use of alternative antifungal agents must be considered (see section 4.4 and 4.8)
Croatian: U slučaju štetnih događaja povezanih s liječenjem, treba razmisliti o prekidu uzimanja vorikonazola i primjeni zamjenskih antimikotika (vidjeti dijelove 4.4 i
English: Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole) [CYP2C9 substrate]
Croatian: Varfarin (jedna doza od 30 mg, primijenjena istodobno s vorikonazolom u dozi od 300 mg BID) [supstrat CYP2C9]
English: 9 mg/kg twice a day (a maximum dose of 350 mg twice daily)
Croatian: 9 mg/kg dvaput na dan (maksimalna doza je 350 mg dvaput na dan)
English: Phenytoin [CYP2C9 substrate and potent CYP450 inducer]
Croatian: Fenitoin [supstrat CYP2C9 i snažan induktor CYP450]
English: • VFEND powder for solution for infusion in single use glass vial.
Croatian: • VFEND prašak za otopinu za infuziju u staklenoj bočici za jednokratnu uporabu
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended.
Croatian: Preporučuju se česte kontrole zbog mogućih nuspojava i toksičnosti vezanih uz metadon, uključujući produljenje QTintervala.
English: St. John's Wort [CYP450 inducer; Pgp inducer] 300 mg TID (coadministered with voriconazole 400 mg single dose)
Croatian: Gospina trava [induktor CYP450; induktor P-glikoproteina] 300 mg TID (primijenjeno istodobno s jednom dozom vorikonazola od 400 mg)
English: Infuse at a maximum rate of 3 mg/kg per hour.
Croatian: Infundirati brzinom od najviše 3 mg/kg na sat.
English: Blood products and short-term infusion of concentrated solutions of electrolytes: Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be corrected prior to initiation of voriconazole therapy (see sections 4.2 and 4.4).
Croatian: Krvni pripravci i kratkotrajna infuzija koncentriranih otopina elektrolita: Poremećaje elektrolita poput hipokalijemije, hipomagnezijemije i hipokalcijemije treba nadzirati i po potrebi korigirati prije započinjanja i tijekom liječenja vorikonazolom (vidjeti dijelove 4.2 i 4.4).
English: Sulfonylureas (e.g., tolbutamide, glipizide, glyburide) [CYP2C9 substrates]
Croatian: Sulfonilureja (npr. tolbutamid, glipizid, gliburid) [supstrati CYP2C9]
English: 2 film-coated tablets 30 film-coated tablets 100 film-coated tablets
Croatian: 2 filmom obložene tablete 30 filmom obloženih tableta 100 filmom obloženih tableta
English: Oral Contraceptives [CYP3A4 substrate; CYP2C19 inhibitor]
Croatian: Oralni kontraceptivi [supstrat CYP3A4; inhibitor CYP2C19]
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.
Croatian: 1 staklenu bočicu od 30 ml (prozirno staklo tipa I) za jednokratnu uporabu s gumenim čepom i aluminijskim zatvaračem s plastičnim zaštitnim zatvaračem koja sadrži VFEND 200 mg, prašak za otopinu.
English: Solvent for solution for infusion: Sodium chloride 0.9% in Water for Injections
Croatian: Otapalo za otopinu za infuziju: Natrijev klorid 0,9% u vodi za injekcije
English: • VFEND solvent for solution for infusion in an overwrapped, sterile, single use, polypropylene infusion bag.
Croatian: • VFEND otapalo za otopinu za infuziju u omotanoj, sterilnoj polipropilenskoj infuzijskoj vrećici za jednokratnu uporabu
English: Reactions during the infusion have occurred uncommonly with VFEND (including flushing, fever, sweating, increased heart rate and shortness of breath).
Croatian: Kod primjene lijeka VFEND su se manje često javile reakcije tijekom infuzije (uključujući crvenilo praćeno osjećajem užarenosti, vrućicu, znojenje, ubrzani puls i nedostatak zraka).
English: Reconstituted VFEND needs to be diluted with a compatible infusion solution first before it is infused.
Croatian: Pripremljeni VFEND mora se prije infuzije razrijediti s kompatibilnom infuzijskom otopinom. (Dodatne informacije navedene su na kraju ove upute o lijeku).
English: Wash the oral syringe as instructed below.
Croatian: Operite štrcaljku za usta prema uputama u nastavku.
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
Croatian: Poremećaji živčanog sustava glavobolja konvulzije, sinkopa, tremor, hipertonija parestezija, somnolencija, omaglica edem mozga, encefalopatija ekstrapiramidni poremećaj periferna neuropatija, ataksija, hipoestezija, disgeuzija jetrena encefalopatija, GuillainBarréov sindrom, nistagmus
English: Coadministration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations (see section 4.4).
Croatian: Istodobna primjena vorikonazola i everolimusa se ne preporučuje jer se očekuje da bi vorikonazol značajno povisio koncentracije everolimusa (vidjeti dio 4.4).
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
Croatian: EU/1/02/212/022 2 filmom obložene tablete EU/1/02/212/023 30 filmom obloženih tableta EU/1/02/212/024 100 filmom obloženih tableta
English: • The active substance is voriconazole.
Croatian: • Djelatna tvar je vorikonazol.
English: Coadministration with St. John's Wort (see section 4.5).
Croatian: Istodobna primjena s gospinom travom (vidjeti dio 4.5).
English: Bottle outer pack and bottle label for 200 mg film-coated tablets - Pack of 2, 30, 100
Croatian: Kutija za bocu i naljepnica na boci za 200 mg filmom obložene tablete - pakiranje od 2, 30, 100
English: Frequent monitoring for opiateassociated adverse reactions may be necessary.
Croatian: Možda će biti potrebne česte kontrole zbog mogućih nuspojava povezanih s opijatima.
English: How to store VFEND
Croatian: Kako čuvati VFEND
English: Fluconazole (200 mg QD) [CYP2C9, CYP2C19 and CYP3A4 inhibitor]
Croatian: Flukonazol (200 mg QD) [inhibitor CYP2C9, CYP2C19 i CYP3A4]
English: VFEND 50 mg film-coated tablets EU/1/02/212/001-012
Croatian: VFEND 50 mg filmom obložene tablete EU/1/02/212/001-012
English: If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking VFEND.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja lijeka VFEND.
English: Omeprazole Cmax  116% Omeprazole AUC  280% Voriconazole Cmax  15% Voriconazole AUC  41%
Croatian: Omeprazol Cmax  116% Omeprazol AUC  280% Vorikonazol Cmax  15% Vorikonazol AUC  41%
English: Other HIV Protease Inhibitors (e.g., saquinavir, amprenavir and nelfinavir) [CYP3A4 substrates and inhibitors]
Croatian: Drugi inhibitori HIV proteaze (npr. sakvinavir, amprenavir i nelfinavir)* [supstrati i inhibitori CYP3A4]
English: For intravenous use
Croatian: Za intravensku primjenu.
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
Croatian: EU/1/02/212/010 2 filmom obložene tablete EU/1/02/212/011 30 filmom obloženih tableta EU/1/02/212/012 100 filmom obloženih tableta
English: Ritonavir Cmax  25% Ritonavir AUC 13% Voriconazole Cmax  24% Voriconazole AUC  39%
Croatian: Ritonavir Cmax  25% Ritonavir AUC 13% Vorikonazol Cmax  24% Vorikonazol AUC  39%
English: Voriconazole Cmax and AUC ↔ No dose adjustment
Croatian: Vorikonazol Cmax i AUC ↔ Nije potrebna prilagodba doze.
English: Step 5
Croatian: Korak 5
English: Remove the oral syringe from the bottle.
Croatian: Skinite štrcaljku za usta s boce.
English: Solvent for VFEND powder for solution for infusion Sodium Chloride 0.9% in Water for Injections Intravenous use
Croatian: Otapalo za VFEND prašak za otopinu za infuziju natrijev klorid 0,9% u vodi za injekcije Intravenska primjena
English: Required Volumes of 10 mg/ml VFEND Concentrate
Croatian: Potreban volumen koncentrata lijeka VFEND od 10 mg/ml
English: Treatment of serious fungal infections caused by Scedosporium spp.
Croatian: liječenje ozbiljnih gljivičnih infekcija uzrokovanih vrstama iz rodova Scedosporium i Fusarium.
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).
Croatian: Bolesnici su tijekom primjene lijeka VFEND razvijali teške kožne nuspojave (SCARs), uključujući Stevens-Johnsonov sindrom (SJS) (manje često), toksičnu epidermalnu nekrolizu (TEN) (rijetko), reakciju na lijek s eozinofilijom i sistemskim simptomima (DRESS) (rijetko) i multiformni eritem (rijetko) (vidjeti dio 4.4).
English: -The other ingredient is sulfobutylether beta cyclodextrin sodium.
Croatian: - Drugi sastojak je natrijev sulfobutileter beta-ciklodekstrin.
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.
Croatian: • VFEND prašak za otopinu za infuziju se najprije mora rekonstituirati ili s 19 ml vode za injekcije ili s 19 ml otopine natrijevog klorida 0,9% (9 mg/ml) za infuziju kako bi se dobio iskoristivi volumen od 20 ml bistrog koncentrata koji sadrži 10 mg/ml vorikonazola.
English: (Loading Dose)
Croatian: (udarna doza)
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.
Croatian: Efavirenz se smije istodobno primijeniti s vorikonazolom ako se doza održavanja vorikonazola poveća na 400 mg svakih 12 sati, a doza efavirenza smanji za 50%, tj. na 300 mg jedanput na dan.
English: Oral Suspension Patients 40 kg and above*
Croatian: Oralna suspenzija Bolesnici tjelesne težine 40 kg i više*
English: Ethinylestradiol Cmax  36% Ethinylestradiol AUC  61% Norethisterone Cmax  15% Norethisterone AUC  53% Voriconazole Cmax  14% Voriconazole AUC  46%
Croatian: Etinilestradiol Cmax  36% Etinilestradiol AUC  61% Noretisteron Cmax  15% Noretisteron AUC  53% Vorikonazol Cmax  14% Vorikonazol AUC  46%
English: Dose after the first 24 hours
Croatian: Doza nakon prva 24 sata
English: Oxycodone (10 mg single dose)
Croatian: Oksikodon (jedna doza od 10 mg)
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).
Croatian: Ako bolesnik ne podnosi liječenje, treba smanjivati dozu u koracima od 1 mg/kg (ili u koracima od 50 mg ako je liječenje započelo maksimalnom peroralnom dozom od 350 mg).
English: EUCAST has not determined non-species related breakpoints for voriconazole.
Croatian: EUCAST za vorikonazol nije utvrdio granične vrijednosti nevezane za vrstu.
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.
Croatian: • Preporučuje se uporaba standardne (neautomatizirane) štrcaljke od 20 ml, kako bi se osiguralo odmjeravanje točne količine (19,0 ml) vode za injekcije ili otopine natrijevog klorida 9 mg/ml (0,9%) za infuziju.
English: Only clear solutions without particles should be used.
Croatian: Smije se upotrijebiti samo bistra otopina koja ne sadrži čestice.
English: 1 ml of the constituted suspension contains 40 mg voriconazole.
Croatian: 1 ml pripremljene suspenzije sadrži 40 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.
Croatian: • Brošura za zdravstvenog radnika s pitanjima i odgovorima o fototoksičnosti, SCC-u te o toksičnosti za jetru; - Upozorava zdravstvene radnike na rizik od fototoksičnosti, karcinoma skvamoznih stanica kože (SCC) te toksičnosti za jetru povezanih uz primjenu vorikonazola.
English: Bottle outer pack and bottle label for 50 mg film-coated tablets - Pack of 2, 30, 100
Croatian: Kutija za bocu i naljepnica na boci za 50 mg filmom obložene tablete - pakiranje od 2, 30, 100
English: PVC / Aluminium/PVC/PVDC blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets.
Croatian: PVC / aluminij/PVC/PVDC blisteri u kutijama sa 2, 10, 14, 20, 28, 30, 50, 56 ili 100 filmom obloženih tableta.
English: 1 sterile, single use syringe.
Croatian: 1 sterilnu štrcaljku za jednokratnu uporabu.
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C03
Croatian: Farmakoterapijska skupina: Antimikotici za sistemsku primjenu, derivati triazola.
English: • To prepare the VFEND vial for reconstitution, remove the plastic cap from the vial and wipe the top with an antiseptic swab.
Croatian: • Kako biste VFEND bočicu pripremili za rekonstituciju, skinite plastični zatvarač i prebrišite vrh bočice vatom sa sredstvom za dezinfekciju.
English: EXP Shelf life after reconstitution: 24 hours when stored at 2°C - 8°C.
Croatian: Rok valjanosti Rok valjanosti nakon rekonstitucije: 24 sata ako se čuva na temperaturi od 2°C do 8°C.
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).
Croatian: Istodobna je primjena kontraindicirana kada postoji mogućnost da će vorikonazol povećati plazmatske koncentracije lijekova koji se metaboliziraju pomoću izoenzima CYP3A4 (određeni antihistaminici, kinidin, cisaprid, pimozid) (vidjeti u nastavku i dio 4.3).
English: VFEND 200 mg powder for solution for infusion EU/1/02/212/025
Croatian: VFEND 200 mg prašak za otopinu za infuziju EU/1/02/212/025
English: Each tablet contains 50 or 200 mg voriconazole.
Croatian: Jedna tableta sadrži 50 ili 200 mg vorikonazola.
English: Jaundice; Changes in blood tests of liver function Pancreatitis
Croatian: - osip - žutica; promjene u krvnim pretragama jetrene funkcije - pankreatitis (upala gušterače).
English: Rifabutin (Potent CYP450 inducer)
Croatian: Rifabutin (snažan induktor CYP450)
English: 6c Prime the IV line according to the manufacturer's guidelines.
Croatian: 6c Pripremite intravensku infuzijsku liniju (izbacite zrak) sukladno uputama proizvođača.
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.
Croatian: Vorikonazol može inhibirati i metabolizam drugih inhibitora protonske pumpe koji su supstrati CYP2C19, što može dovesti do povećanja koncentracije tih lijekova u plazmi.
English: Each vial of VFEND contains 217.6 mg of sodium.
Croatian: Jedna bočica lijeka VFEND sadrži 217,6 mg natrija.
English: 2b Push the syringe plunger down fully.
Croatian: 2b Pritisnite klip štrcaljke do kraja.
English: In an independent published study, Fentanyl AUC0-  1.34-fold
Croatian: Fentanil AUC0-∞  1,34 puta
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.
Croatian: Preporučuje se uporaba standardne (neautomatizirane) štrcaljke od 20 ml, kako bi se osiguralo odmjeravanje točne količine (19,0 ml) vode za injekcije ili otopine natrijevog klorida za infuziju od 9 mg/ml (0,9%).
English: Efavirenz Cmax  38% Efavirenz AUC  44% Voriconazole Cmax  61% Voriconazole AUC  77%
Croatian: Efavirenz Cmax  38% Efavirenz AUC  44% Vorikonazol Cmax  61% Vorikonazol AUC  77%
English: • Health Care Professional (HCP) Checklist for Phototoxicity, SCC and Hepatic toxicity: - Reminds HCPs of the risks of phototoxicity, skin SCC and hepatotoxicity reported with voriconazole use.
Croatian: • Kontrolni popis za zdravstvenog radnika za fototoksičnost, SCC i toksičnost za jetru: - Podsjeća zdravstvene radnike na rizik od fototoksičnosti, SCC-a kože i toksičnosti za jetru povezanih uz primjenu vorikonazola.
English: Monitoring for voriconazoleassociated adverse reactions is recommended if voriconazole is used sequentially after fluconazole (see section 4.5).
Croatian: Preporučuje se nadzor kako bi se uočile nuspojave povezane s vorikonazolom ako se vorikonazol primjenjuje redom nakon liječenja flukonazolom (vidjeti dio 4.5).
English: Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4).
Croatian: Poremećaje elektrolita poput hipokalijemije, hipomagnezijemije i hipokalcijemije treba nadzirati i po potrebi korigirati prije započinjanja i tijekom liječenja vorikonazolom (vidjeti dio 4.4).
English: After reconstitution each ml contains 10 mg of voriconazole.
Croatian: Nakon rekonstitucije, jedan ml sadrži 10 mg vorikonazola.
English: Use only items provided in the box with VFEND powder and solvent for solution for infusion in the preparation of the infusion.
Croatian: Za pripremu infuzije koristite samo pribor koji se nalazi u kutiji sa VFEND praškom i otapalom za otopinu za infuziju.
English: Contact your doctor if you experience this.
Croatian: Javite se svom liječniku ako imate te nuspojave.
English: The findings of the effect of efavirenz on voriconazole suggest that the metabolism of voriconazole may be induced by an NNRTI.
Croatian: Nalazi o učinku efavirenza na vorikonazol upućuju na to NNRTI može inducirati metabolizam vorikonazola.
English: VFEND 200 mg powder for solution for infusion Each vial contains 200 mg of voriconazole.
Croatian: VFEND 200 mg prašak za otopinu za infuziju Jedna bočica sadrži 200 mg vorikonazola.
English: If patient response to treatment is inadequate, the intravenous dose may be increased by 1 mg/kg steps.
Croatian: Ako bolesnik ne postiže zadovoljavajući odgovor na liječenje, intravenska se doza može povećavati u koracima od 1 mg/kg.
English: Ritonavir (protease inhibitor) [potent CYP450 inducer; CYP3A4 inhibitor and substrate]
Croatian: Ritonavir (inhibitor proteaze) [snažan induktor CYP450; inhibitor i supstrat CYP3A4]
English: Silica Colloidal Anhydrous Titanium Dioxide (E171) Xanthan Gum Sodium Citrate Citric Acid Anhydrous Sodium Benzoate (E211) Natural Orange Flavour
Croatian: 6.1 Popis pomoćnih tvari saharoza silicijev dioksid, koloidni, bezvodni titanijev dioksid (E171) ksantanska guma natrijev citrat citratna kiselina, bezvodna natrijev benzoat (E211) prirodna aroma naranče
English: Coadministration with sirolimus since voriconazole is likely to increase plasma concentrations of sirolimus significantly (see section 4.5).
Croatian: Istodobna primjena sa sirolimusom, jer će vorikonazol vjerojatno dovesti do značajnog povećanja koncentracije sirolimusa u plazmi (vidjeti dio 4.5).
English: Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.2).
Croatian: Poremećaje elektrolita poput hipokalijemije, hipomagnezijemije i hipokalcijemije treba nadzirati i po potrebi korigirati prije početka i tijekom liječenja vorikonazolom (vidjeti dio 4.2).
English: Volume of VFEND Concentrate (10 mg/ml) required for: 3 mg/kg dose (number of vials)
Croatian: Volumen koncentrata lijeka VFEND (10 mg/ml) potreban za:
English: PVC / Aluminium blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets.
Croatian: PVC/aluminij blisteri u kutijama sa 2, 10, 14, 20, 28, 30, 50, 56 ili 100 filmom obloženih tableta.
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.
Croatian: Međutim, ako je kombinacija prijeko potrebna, doza održavanja vorikonazola smije se povećati s 200 mg na 350 mg peroralno, dvaput na dan (100 mg na 200 mg peroralno, dvaput na dan u bolesnika tjelesne težine manje od 40 kg), vidjeti dijelove 4.4 i 4.5.
English: Step 2
Croatian: Korak 2
English: • Discard the VFEND vial if the vacuum does not pull the diluent into the vial.
Croatian: • Odbacite bočicu lijeka VFEND ako vakuum ne povuče otapalo u bočicu.
English: Discard the VFEND vial if vacuum does not pull the diluent into the vial.
Croatian: Odbacite bočicu lijeka VFEND ako vakuum ne povuče otapalo u bočicu.
English: Respiratory, thoracic and mediastinal disorders respiratory distress acute respiratory distress syndrome, pulmonary oedema
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja respiratorni distres akutni respiratorni sindrom, edem pluća
English: • Congenital or acquired QTc-prolongation.
Croatian: • prirođeno ili stečeno produljenje QTc-intervala
English: In patients with moderate to severe renal dysfunction (creatinine clearance < 50 ml/min), accumulation of the intravenous vehicle, SBECD, occurs.
Croatian: U bolesnika s umjerenom do teškom disfunkcijom bubrega (klirens kreatinina < 50 ml/min) dolazi do kumulacije intravenskog vehikuluma (natrijevog sulfobutileter -ciklodekstrina (SBECD)).
English: Omeprazole (40 mg QD) [CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate]
Croatian: Omeprazol (40 mg QD) [inhibitor CYP2C19; supstrat CYP2C19 i CYP3A4]
English: Therefore, no adjustment is necessary for oral dosing for patients with mild to severe renal impairment (see section 5.2).
Croatian: Stoga nije potrebno prilagođavati dozu nakon peroralne primjene vorikonazola u bolesnika s blagim do teškim oštećenjem bubrega (vidjeti dio 5.2).
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.
Croatian: Nakon što se prašak u bočici otopi, VFEND se mora odmah primijeniti, no, ako je neophodno, može se čuvati najdulje 24 sata na temperaturi od 2°C do 8°C (u hladnjaku) zajedno s infuzijskom vrećicom.
English: VFEND 200 mg film-coated tablets EU/1/02/212/013-024
Croatian: VFEND 200 mg filmom obložene tablete EU/1/02/212/013-024
English: It is therefore recommended to use the oral suspension formulation in children aged 2 to <12.
Croatian: Stoga se u djece u dobi od 2 do < 12 godina preporučuje primjenjivati ovaj lijek u obliku oralne suspenzije.
English: If a patient develops a rash he should be monitored closely and VFEND discontinued if lesions progress.
Croatian: Ako se u bolesnika pojavi osip, treba ga pomno nadzirati te prekinuti primjenu lijeka VFEND u slučaju progresije lezija.
English: VFEND suspension contains 0.54g sucrose per ml of suspension.
Croatian: VFEND suspenzija sadrži 0,54 g saharoze u jednom mililitru.
English: Low dose (100 mg BID)
Croatian: Niska doza (100 mg BID)
English: Excipient with known effect Each vial contains 217.6 mg sodium.
Croatian: Pomoćna tvar s poznatim učinkom Jedna bočica sadrži 217,6 mg natrija.