FrancophonIA/ELRC3.0 huggingface dataset:
English: However, a trend towards a higher frequency of liver enzyme elevations, reported as adverse events in clinical trials was observed in paediatric patients as compared to adults (14.2% transaminases increased in paediatrics compared to 5.3% in adults).
Slovenian: Na splošno je bil varnostni profil vorikonazola pri pediatrični populaciji podoben kot pri odraslih, vendar pa so v kliničnih preskušanjih pri pediatričnih bolnikih v primerjavi z odraslimi poročali o večji pogostnosti zvišanja ravni jetrnih encimov kot neželenem učinku (pogostnost zvišanja ravni transaminaz 14,2 % v pediatrični populaciji v primerjavi s 5,3 % pri odraslih).
English: Co-administration of voriconazole and low dose ritonavir (100 mg BID) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Slovenian: Sočasni uporabi vorikonazola in manjših odmerkov ritonavirja (100 mg BID) se je treba izogniti, razen če ocena koristi in tveganja za bolnika opraviči uporabo vorikonazola.
English: Rifampicin (600 mg QD) [potent CYP450 inducer]
Slovenian: rifampicin (600 mg QD) [močan induktor CYP450]
English: Co-administration 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: Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medicinal products and have concurrent conditions that may result in decreased renal function (see section 4.8).
Slovenian: Z vorikonazolom zdravljeni bolniki pogosto hkrati dobivajo nefrotoksična zdravila in imajo sočasne bolezni, ki lahko poslabšajo delovanje ledvic (glejte poglavje 4.8).
English: Other treated fungal infections (often with 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, Paecilomyces lilacinus, Penicillium spp., vključno s P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis ter Trichosporon spp., vključno z okužbami s T. beigelii.
English: Skin rashes which may lead to severe blistering and peeling of the skin characterized by a flat, red area on the skin that is covered with small confluent bumps, redness of the skin
Slovenian: • kožni izpuščaji, ki lahko povzročijo hude mehurje in luščenje kože, za katere je značilna ravna rdeča površina kože, prekrita z majhnimi zlivajočimi izboklinami, , pordelost kože
English: Tacrolimus Cmax ↑ 117% Tacrolimus AUCt ↑ 221%
Slovenian: takrolimus Cmax ↑ 117% takrolimus AUCt ↑ 221%
English: In an independent published study, Fentanyl AUC∞ ↑ 1.34-fold
Slovenian: V neodvisni objavljeni študiji, fentanil AUC∞ ↑ 1.34-krat
English: Dose adjustments in prophylaxis studies have not been explored.
Slovenian: V študijah profilakse prilagajanja odmerka niso raziskovali.
English: Not for administration as a bolus injection.
Slovenian: Zdravilo se ne sme aplicirati kot bolusna injekcija.
English: Voriconazole Hikma has a moderate influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Vorikonazol Hikma ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
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
English: What Voriconazole Hikma looks like and contents of the pack Voriconazole Hikma is a white to off-white lyophilised cake.
Slovenian: Izgled zdravila Vorikonazol Hikma in vsebina pakiranja Vorikonazol Hikma je bela do umazano bela liofilizirana pogača.
English: The placeboadjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg. No subject in any group had an increase in QTc of ≥60 msec from baseline.
Slovenian: Placebu prirejeno povprečno največje podaljšanje QTc, glede na izhodišče po 800, 1200 in 1600 mg vorikonazola, je bilo 5,1; 4,8 in 8,2 milisekunde ter 7,0 milisekund po 800 mg ketokonazola.
English: Each vial of Voriconazole Hikma contains 217.6 mg of sodium per vial.
Slovenian: Ena viala zdravila Vorikonazol Hikma vsebuje 217,6 mg natrija.
English: There have been post-marketing reports of prolonged visual adverse events (see section 4.4).
Slovenian: V obdobju trženja so poročali o dolgotrajnih neželenih učinkih na vid (glejte poglavje 4.4).
English: Ethinylestradiol Cmax ↑ 36% Ethinylestradiol AUCτ ↑ 61% Norethisterone Cmax ↑ 15% Norethisterone AUCτ ↑ 53% Voriconazole Cmax ↑ 14% Voriconazole AUCτ ↑ 46%
Slovenian: etinilestradiolCmax ↑ 36% etinilestradiolAUCτ ↑ 61% noretisteron Cmax ↑ 15% noretisteron AUCτ ↑ 53% vorikonazol Cmax ↑ 14% vorikonazol AUCτ ↑ 46%
English: • Ritonavir (used for treating HIV) in doses of 100 mg twice daily
Slovenian: • ritonavir (uporablja se za zdravljenje okužbe s HIV) v odmerkih 100 mg dvakrat na dan
English: • Rifabutin (used for treating tuberculosis).
Slovenian: • rifabutin (uporablja se za zdravljenje tuberkuloze).
English: • Jaundice, inflammation of the liver and liver injury
Slovenian: • zlatenica, vnetje jeter in poškodbe jeter
English: Larger inter-subject variability was observed in paediatric patients compared to adults.
Slovenian: Pri pediatričnih preskušancih so v primerjavi z odraslimi opazili večjo variabilnost med posamezniki.
English: Side effects with frequency not known: • Freckles and pigmented spots
Slovenian: Neželeni učinki z neznano pogostnostjo: pege in pigmentne lise
English: IFI while on study drug * Primary endpoint of the study ** Difference in proportions, 95% CI and p-values obtained after adjustment for randomization
Slovenian: * Primarni opazovani dogodek v študiji ** Razlike v deležih, 95 % IZ in vrednosti p, pridobljeni po prilagoditvi za randomizacijo
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for infusion
Slovenian: PHARMACEUTICAL FORM AND CONTENTS prašek za raztopino za infundiranje 1 viala
English: Sodium Chloride 9 mg/ml (0.9%) Solution for Injection Compound Sodium Lactate Intravenous Infusion 5% Glucose and Lactated Ringer's Intravenous Infusion 5% Glucose and 0.45% Sodium Chloride Intravenous Infusion 5% Glucose Intravenous Infusion 5% Glucose in 20 mEq Potassium Chloride Intravenous Infusion 0.45% Sodium Chloride Intravenous Infusion 5% Glucose and 0.9% Sodium Chloride Intravenous Infusion
Slovenian: Natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje Hartmannovo raztopino za intravensko infundiranje 5 % glukozo in Ringerjevim laktatom za intravensko infundiranje 5 % glukozo in 0,45 % natrijevim kloridom za intravensko infundiranje 5 % glukozo za intravensko infundiranje 5 % glukozo v 20 mEq raztopini kalijevega klorida za intravensko infundiranje 0,45 % natrijevim kloridom za intravensko infundiranje 5 % glukozo in natrijevim kloridom 9 mg/ml (0,9 %) za intravensko infundiranje
English: Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to initiation of voriconazole therapy (see sections 4.2 and 4.4).
Slovenian: Motnje elektrolitov, kot so hipokaliemija, hipomagneziemija in hipokalciemija, morajo biti korigirane pred začetkom zdravljenja z vorikonazolom (glejte poglavji 4.2 in 4.4).
English: Increased tacrolimus levels have been associated with nephrotoxicity.
Slovenian: Zvišane koncentracije takrolimusa so bile povezane z nefrotoksičnostjo.
English: Voriconazole N=224
Slovenian: Vorikonazol n=224
English: Immune system disorders hypersensitivity anaphylactoid reaction
Slovenian: Bolezni imunskega sistema preobčutljivost anafilaktoidna reakcija
English: • Efavirenz (used for treating HIV) in doses of 400 mg and above once daily
Slovenian: • efavirenz (uporablja se za zdravljenje okužbe s HIV) v odmerkih 400 mg in več, enkrat na dan
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 % preskušanci v skupini, ki je prejemala itrakonazol.
English: Hikma Italia S.p.A. Tél/Tel: + 39 0382 1751801
Slovenian: Tél/Tel: + 39 0382 1751801
English: Voriconazole has been shown to be more selective for fungal cytochrome P-450 enzymes than for various mammalian cytochrome P-450 enzyme systems.
Slovenian: Ugotovili so, da je vorikonazol bolj selektiven za glivični citokrom P450 kot pa za različne sesalske encimske sisteme citokroma P450.
English: Diclofenac (50 mg single dose)
Slovenian: diklofenak (enkratni 50 mg odmerek)
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: • Terfenadine (used for allergy)
Slovenian: • terfenadin (uporablja se proti alergiji)
English: Patients with severe hepatic impairment must be carefully monitored for drug toxicity (see section 4.8).
Slovenian: Bolnike s hudo jetrno okvaro je treba natančno nadzirati glede toksičnih učinkov zdravila (glejte poglavje
English: Co-administration 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: Dosage adjustment
Slovenian: Prilagajanje odmerka
English: and Sporothrix spp.
Slovenian: in Sporothrix spp.
English: Your doctor should monitor the function of your liver and kidneys by doing blood tests.
Slovenian: Vaš zdravnik mora s krvnimi preiskavami nadzirati delovanje vaših jeter in ledvic.
English: What you need to know before you take Voriconazole Hikma 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vorikonazol Hikma 3.
English: • Ritonavir (used for treating HIV) in doses of 400 mg and more twice daily
Slovenian: • ritonavir (uporablja se za zdravljenje okužbe s HIV) v odmerkih 400 mg in več, dvakrat na dan
English: Immunosuppressants [CYP3A4 substrates] Sirolimus (2 mg single dose)
Slovenian: Imunosupresivi [substrati CYP3A4] sirolimus (enkratni 2 mg odmerek)
English: Volume of Voriconazole Hikma Concentrate (10 mg/ml) required for:
Slovenian: Volumen koncentrata (10 mg/ml) zdravila Vorikonazol Hikma, potrebnega za:
English: As an evolution towards SCC has been reported, stringent measures for the photoprotection are warranted in this population of patients.
Slovenian: Poročali so o razvoju v smeri ploščatoceličnega karcinoma, zato je pri tej populaciji treba uporabiti strožje ukrepe za zaščito pred svetlobo.
English: EU/1/15/1004/001 1 Pack EU/1/15/1004/002 5 Pack
Slovenian: ŠTEVILKE DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/15/1004/001 pakiranje z 1 vialo EU/1/15/1004/002 pakiranje s 5 vialami
English: • Vinca alkaloids (e.g., vincristine and vinblastine) (used in treating cancer)
Slovenian: • alkaloide rožnatega zimzelena (npr. vinkristin in vinblastin) (uporabljajo se za zdravljenje raka)
English: Candidaemia in non-neutropenic patients
Slovenian: Kandidemija pri nenevtropeničnih bolnikih
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), co-administration 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: Use of voriconazole in prophylaxis for greater than 180 days (6 months) requires careful assessment of the benefit-risk balance (see sections 4.4 and 5.1).
Slovenian: Uporaba vorikonazola pri profilaksi, daljši od 180 dni (6 mesecev), zahteva natančno oceno razmerja med koristmi in tveganji (glejte poglavji 4.4 in 5.1).
English: Three hundred and seventy non-neutropenic patients (above 12 years of age) with documented candidaemia were included in the study, of whom 248 were treated with voriconazole.
Slovenian: Študija je zajela 370 nenevtropeničnih bolnikov (starejših od 12 let) s potrjeno kandidemijo; 248 teh bolnikov je dobivalo terapijo z vorikonazolom.
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 atrioventrikularni blok, kračni blok, nodalni ritem
English: If patient response to treatment is inadequate, the maintenance dose may be increased to 300 mg twice daily for oral administration.
Slovenian: Če bolnikov odziv na zdravljenje ni zadosten, se lahko vzdrževalni odmerek pri peroralnem dajanju poveča na 300 mg dvakrat na dan.
English: • Fluconazole (used for treating fungal infections)
Slovenian: • flukonazol (uporablja se za zdravljenje glivičnih okužb)
English: Frequent monitoring for opiate-associated adverse reactions may be necessary.
Slovenian: Priporočljiv je pogost nadzor glede pojavljanja z opiati povezanih neželenih učinkov.
English: Although not studied, carbamazepine and long-acting barbiturates are likely to significantly decrease plasma voriconazole concentrations.
Slovenian: Čeprav ni raziskano, je verjetno, da karbamazepin in dolgodelujoči barbiturati pomembno zmanjšajo koncentracijo vorikonazola v plazmi.
English: Voriconazole Cmax and AUCτ ↔
Slovenian: vorikonazol Cmax in AUCτ ↔
English: When initiating voriconazole in patients already receiving omeprazole doses of 40 mg or above, it is recommended that the omeprazole dose be halved.
Slovenian: Kadar se pri bolnikih, ki že dobivajo omeprazol v odmerku 40 mg ali več, vpelje vorikonazol, je odmerek omeprazola priporočljivo prepoloviti.
English: When initiating voriconazole in patients already on tacrolimus, it is recommended that the tacrolimus dose be reduced to a third of the original dose and tacrolimus level carefully monitored.
Slovenian: Kadar se pri bolnikih, ki že dobivajo takrolimus, vpelje vorikonazol, je odmerek takrolimusa priporočljivo zmanjšati na tretjino izvornega odmerka, koncentracijo takrolimusa pa skrbno nadzirati.
English: Carbamazepine and long-acting barbiturates (e.g., phenobarbital, mephobarbital) [potent CYP450 inducers]
Slovenian: kontraindicirano (glejte poglavje karbamazepin in dolgodelujoči barbiturati (kot so fenobarbital, mefobarbital) [močni induktorji CYP450]
English: • Rifampicin (used for treating tuberculosis)
Slovenian: • rifampicin (uporablja se za zdravljenje tuberkuloze)
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: Benzodiazepines (e.g., midazolam, triazolam, alprazolam) [CYP3A4 substrates]
Slovenian: benzodiazepini (kot so midazolam, triazolam, alprazolam) [substrati CYP3A4]
English: When initiating voriconazole in patients already on ciclosporin it is recommended that the ciclosporin dose be halved and ciclosporin level carefully monitored.
Slovenian: Kadar se pri bolnikih, ki že dobivajo ciklosporin, vpelje vorikonazol, je odmerek ciklosporina priporočljivo prepoloviti in koncentracijo ciklosporina skrbno nadzirati.
English: • Phenobarbital (used for severe insomnia and seizures)
Slovenian: • fenobarbital (uporablja se proti hudi nespečnosti in epilepsiji)
English: • Congenital or acquired QTc-prolongation
Slovenian: • prirojeno ali pridobljeno podaljšanje intervala QTc,
English: In that case, intravenous voriconazole administration is recommended.
Slovenian: V takšnem primeru je vorikonazol priporočljivo uporabiti intravensko.
English: You may be switched from the intravenous infusion to tablets once your condition improves.
Slovenian: Ko se bo stanje izboljšalo, boste morda z intravenske infuzije prešli na tablete.
English: When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5).
Slovenian: Ko se zdravljenje z vorikonazolom konča, je treba znova preiti na začetno odmerjanje efavirenza (glejte poglavji 4.4 in 4.5).
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: * 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: - If you get any side effects, talk to your doctor,pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Stevens-Johnson syndrome, phototoxicity, purpura, urticaria, dermatitis allergic, rash papular, rash macular, eczema toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, Actinic keratosis*, pseudoporphyria erythema multiforme, psoriasis, drug eruption cutaneous lupus erythemato sus* ephelides*, lentigo*
Slovenian: Stevens-Johnsonov sindrom, fototoksičnost, purpura, urtikarija, alergijski dermatitis, papulozni izpuščaj, makulozni izpuščaj, ekcem toksična epidermalna nekroliza, reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS), angioedem, aktinična keratoza*, psevdoporfirija, multiformni eritem, psoriaza, medikamentozni eksantem kožni eritematozni lupus*, efelide*, lentigo*
English: Ranitidine (150 mg BID) [increases gastric pH]
Slovenian: ranitidin (150 mg BID) [zvišuje pH v želodcu]
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)
Slovenian: Če se pojavijo z zdravljenjem povezani neželeni učinki, je treba razmisliti o prekinitvi zdravljenja z vorikonazolom in uporabi drugih antimikotikov (glejte poglavji 4.4 in 4.8).
English: Concomitant use of voriconazole and rifabutin should be avoided unless the benefit outweighs the risk (see section 4.5).
Slovenian: Vorikonazola in rifabutina se ne sme uporabljati sočasno, razen če korist odtehta tveganje (glejte poglavje 4.5).
English: Co-administration 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: Methadone (32-100 mg QD) [CYP3A4 substrate]
Slovenian: metadon (32-100 mg QD) [substrat CYP3A4 ]
English: 300 mg QD (co-administered with voriconazole 400 mg BID)*
Slovenian: 300 mg QD (co-administered with vorikonazol 400 mg BID)*
English: • Kidney failure, blood in the urine, changes in kidney function tests.
Slovenian: • odpoved ledvic, kri v urinu, spremembe izidov preiskav za spremljanje delovanja ledvic
English: Very common: may affect more than 1 in 10 people
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Infections and infestations sinusitis pseudomembranous colitis
Slovenian: Infekcijske in parazitske bolezni sinusitis psevdomembranski kolitis
English: Phenytoin [CYP2C9 substrate and potent CYP450 inducer] 300 mg QD
Slovenian: fenitoin [substrat CYP2C9 in močan induktor CYP450] 300 mg QD
English: Nervous system disorders headache convulsion, syncope, tremor, hypertonia3, paraesthesia, somnolence, dizziness brain oedema, encephalopathy4, extrapyramidal disorder5, neuropathy peripheral, ataxia, hypoaesthesia, dysgeusia hepatic encephalopathy, Guillain-Barre syndrome, nystagmus
Slovenian: Bolezni živčevja glavobol konvulzije, sinkopa, tremor, hipertonija3, parestezija, somnolenca, omotica možganski edem, encefalopatija4, ekstrapiramidne motnje5, periferna nevropatija, ataksija, hipestezija, disgevzija hepatična encefalopatíja, Guillain-Barrejev sindrom, nistagmus
English: Subjects who are heterozygous extensive metabolisers have on average 2-fold higher voriconazole exposure than their homozygous extensive metaboliser counterparts.
Slovenian: Pri heterozigotnih osebah z izrazito presnovo je izpostavljenost vorikonazolu v povprečju 2-krat večja kot pri homozigotnih osebah z izrazito presnovo.
English: If patients are 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: Repeated-dose toxicity studies with voriconazole indicated the liver to be the target organ.
Slovenian: Študije toksičnosti pri ponavljajočih se odmerkih vorikonazola so pokazale, da so tarčni organ jetra.
English: • Abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain,
Slovenian: • nenormalno delovanje možganov, simptomi, podobni Parkinsonovi bolezni, poškodba živca, ki povzroči otrplost, bolečino, mravljinčenje ali pekoč občutek v dlaneh ali stopalih