FrancophonIA/ELRC3.0 huggingface dataset:
English: C] isavuconazonium sulfate in humans, in addition to the active moiety (isavuconazole) and the inactive cleavage product, a number of minor metabolites were identified.
Slovenian: C] izavukonazonijevega sulfata pri ljudeh, je razen aktivne spojine (izavukonazola) in neaktivnega produkta cepitve prepoznanih več manj pomembnih metabolitov.
English: In a QT study in healthy human subjects, isavuconazole shortened the QTc interval in a concentration-related manner.
Slovenian: V študiji intervala QT pri zdravih ljudeh je izavukonazol od koncentracije odvisno skrajšal interval QTc.
English: Cresemba can sometimes affect your liver function.
Slovenian: Zdravilo Cresemba lahko včasih vpliva na delovanje jeter.
English: Each capsule pocket is connected to a pocket that contains ‘desiccant' to protect the capsule from moisture.
Slovenian: Vsak žepek s kapsulo je povezan z žepkom, ki vsebuje sušilno sredstvo za zaščito kapsul pred vlago.
English: For intravenous use after reconstitution and dilution Use an in-line filter for infusion.
Slovenian: za intravensko uporabo po rekonstituciji in redčenju Uporabite linijski filter za infuzijo.
English: Reconstituted concentrate should be clear and free of visible particulate.
Slovenian: Pripravljeni koncentrat mora biti prozoren in brez vidnih delcev.
English: Isavuconazole may increase the exposure of medicinal products that are P-gp substrates.
Slovenian: Izavukonazol lahko poveča izpostavljenost zdravilom, ki so substrati P-gp.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with CRESEMBA in one or more subsets of the paediatric population in the treatment of invasive aspergillosis and the treatment of mucormycosis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom CRESEMBA pri eni ali več podskupin pediatrične populacije za zdravljenje invazivne aspergiloze in zigomikoze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Following oral administration of radio-labelled isavuconazonium sulfate to healthy subjects, a mean of 46.1% of the radioactive dose was recovered in faeces, and 45.5% was recovered in urine.
Slovenian: Po peroralni uporabi radioaktivno označenega izavukonazonijevega sulfata pri zdravih osebah je bilo v blatu najdenega v povprečju 46,1 % radioaktivnega odmerka, v urinu pa 45,5 %.
English: Limitations of the clinical data
Slovenian: Omejeni klinični podatki
English: Interactions between isavuconazole and co-administered medicinal products are listed in Table 1 (increase is indicated as “↑”, decrease as “↓”), ordered by therapeutic class.
Slovenian: Interakcije med izavukonazolom in sočasno uporabljenimi zdravili so navedene v Preglednici 1 (povečanje je označeno s „↑“, zmanjšanje pa s „↓“) in razvrščene po terapevtskih skupinah.
English: Metformin: dose reduction may be required.
Slovenian: Metformin: morda bo potrebno zmanjšanje odmerka.
English: How Cresemba works Isavuconazole works by killing or stopping the growth of the fungus, which causes the infection.
Slovenian: Kako deluje zdravilo Cresemba Izavukonazol uničuje ali zaustavlja rast gliv, ki povzročajo okužbo.
English: Potential of medicinal products to affect the pharmacokinetics of isavuconazole
Slovenian: Potencial zdravil za vplivanje na farmakokinetiko izavukonazola
English: One 10 mL Type I glass vial with rubber stopper and an aluminum cap with plastic seal.
Slovenian: Ena 10 ml steklena viala tipa I z gumijastim zamaškom in aluminijasto zaporko s plastičnim pečatom.
English: Protease inhibitor concentrations may decrease (as observed with lopinavir/ritonavir) or increase.
Slovenian: Koncentracije inhibitorjev proteaz se lahko zmanjšajo (podobno kot pri lopinavirju/ritonavirju) ali povečajo.
English: Repaglinide:
Slovenian: Repaglinid:
English: Medicinal products transported by BCRP
Slovenian: Zdravila, ki jih prenaša BCRP
English: It is important to keep taking this medicine as long as your doctor tells you.
Slovenian: Pomembno je, da to zdravilo jemljete tako dolgo, kot vam naroči zdravnik.
English: Median treatment duration was 84 days for the overall mucormycosis patient population, and 102 days for the 21 patients not previously treated for mucormycosis.
Slovenian: Mediana trajanja zdravljenja je bila 84 dni pri celokupni populaciji bolnikov z zigomikozo in 102 dni za 21 bolnikov, ki se predhodno niso zdravili za zigomikozo.
English: NNRTI, non-nucleoside reverse-transcriptase inhibitor; P-gp, P-glycoprotein.
Slovenian: NNRTI, nenukleozidni inhibitor reverzne transkriptaze; P-gp, P-glikoprotein.
English: Renal excretion of intact isavuconazole was less than 1% of the dose administered.
Slovenian: Ledvično izločanje nespremenjenega izavukonazola je bilo manjše od 1 % uporabljenega odmerka.
English: AUCinf = area under the plasma concentration-time profiles extrapolated to infinity; AUCtau = area under the plasma concentration-time profiles during the 24 h interval at steady state; Cmax = peak plasma concentration; Cmin,ss = trough levels at steady state.
Slovenian: AUCinf = površina pod profili koncentracije v plazmi in časa, ekstrapoliranimi do neskončnosti; AUCtau = površina pod profili koncentracije v plazmi in časa v 24-urnem intervalu v stabilnem stanju; Cmax = najvišja koncentracija v plazmi; Cmin,ss = najnižja koncentracija v stanju dinamičnega ravnovesja.
English: See sections 4.2 and 4.4.
Slovenian: Glejte poglavji 4.2 in 4.4.
English: CRESEMBA is indicated in adults for the treatment of
Slovenian: Zdravilo CRESEMBA je indicirano za zdravljenje odraslih bolnikov z
English: No clear correlation between in vitro MIC and clinical response for the different species (Aspergillus and Mucorales) could be established.
Slovenian: Jasne povezave med in vitro MIK in kliničnim odzivom za različne vrste (Aspergillus in Mucorales) niso uspeli dokazati.
English: Mycophenolic acid (MPA, active metabolite) :
Slovenian: Mikofenolna kislina (MPA, aktivni metabolit):
English: Caffeine:
Slovenian: Kofein:
English: Isavuconazole 200 mg (n = 37)
Slovenian: Izavukonazol 200 mg (n = 37)
English: Capsules can be taken with or without food.
Slovenian: Kapsule se lahko uporabljajo skupaj s hrano ali brez nje.
English: CRESEMBA must be reconstituted and then further diluted to a concentration corresponding to approximately 0.8 mg/mL isavuconazole prior to administration by intravenous infusion over a minimum of 1 hour to reduce the risk of infusion-related reactions.
Slovenian: Zdravilo CRESEMBA je treba pred uporabo rekonstituirati in nato nadalje razredčiti do koncentracije, ki ustreza približno 0,8 mg/ml izavukonazola; raztopino se da v obliki intravenske infuzije, ki traja najmanj 1 uro, da se zmanjša tveganje infuzijske reakcije.
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če opazite katerega od naslednjih neželenih učinkov:
English: Ethinyl oestradiol and norethindrone: no dose adjustment required.
Slovenian: Etinilestradiol in noretisteron: prilagoditev odmerka ni potrebna.
English: Potential for CRESEMBA to affect exposures of other medicines
Slovenian: Potencial zdravila CRESEMBA za vpliv na izpostavljenost drugim zdravilom
English: Following oral administration of CRESEMBA in healthy subjects, the active moiety isavuconazole is absorbed and reaches maximum plasma concentrations (Cmax) approximately 2-3 hours after single and multiple dosing (see Table 3).
Slovenian: Po peroralni uporabi zdravila CRESEMBA pri zdravih preiskovancih se aktivna spojina izavukonazol absorbira in doseže največje koncentracije v plazmi (Cmax) približno 2-3 ure po enkratnem in večkratnem odmerjanju (glejte Preglednico 3).
English: corresponding to 200 mg isavuconazole.
Slovenian: kar ustreza 200 mg izavukonazola.
English: See sections 4.2, 4.8 and 5.2.
Slovenian: Glejte poglavja 4.2, 4.8 in 5.2.
English: Co-administration should be avoided unless the potential benefit is considered to outweigh the risk.
Slovenian: Sočasni uporabi se je treba izogibati, razen če potencialne koristi odtehtajo tveganja.
English: Laboratory effects
Slovenian: Učinki na laboratorijske parametre
English: The clinical data for isavuconazole in the treatment of mucormycosis are limitedto one prospective non-controlled clinical study in 37 patients with proven or probable mucormycosis who received isavuconazole for primary treatment, or because other antifungal treatments (predominantly amphotericin B) were inappropriate.
Slovenian: Klinični podatki za izavukonazol pri zdravljenju zigomikoze so omejeni na eno prospektivno nenadzorovano klinično študijo pri 37 bolnikih z dokazano ali verjetno zigomikozo, ki so prejeli izavukonazol v primarnem zdravljenju ali pa zato, ker drugi antimikotiki (predvsem amfotericin B), niso bili primerni.
English: For patients with probable or proven mucormycosis as defined by the independent Data Review Committee (DRC), all-cause mortality at Day 84 was 43.2% (16/37) for the overall patient population, 42.9% (9/21) for mucormycosis patients receiving isavuconazole as primary treatment, and 43.8% (7/16) for mucormycosis patients receiving isavuconazole who were refractory to, or intolerant of, prior antifungal therapy (mainly amphotericin B-based treatments).
Slovenian: Pri bolnikih z verjetno ali dokazano zigomikozo, kot jo je opredelil neodvisni odbor za pregled podatkov (DRC - Data Review Committee), je bila umrljivost iz vseh vzrokov po 84. dnevu 43,2 % (16/37) za celotno populacijo bolnikov, 42,9 % (9/21) za bolnike z zigomikozo, ki so kot primarno zdravljenje prejemali izavukonazol, in 43,8 % (7/16) za bolnike z zigomikozo, ki so bili odporni ali intolerantni na predhodno antimikotično terapijo (predvsem na zdravljenje na osnovi amfotericina B).
English: Isavuconazole is a mild inhibitor of the organic cation transporter 2 (OCT2).
Slovenian: Izavukonazol je blag inhibitor prenašalcev organskih kationov 2 (OCT2 - organic cation transporter 2).
English: • mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1)
Slovenian: • zigomikozo pri bolnikih, za katere amfotericin B ni primeren (glejte poglavji 4.4. in 5.1).
English: Isavuconazole 600 mg (n = 32)
Slovenian: Izavukonazol 600 mg (n = 32)
English: Patients with familial short QT syndrome (see section 4.4).
Slovenian: Bolniki z družinskim sindromom kratkega intervala QT (glejte poglavje 4.4).
English: Isavuconazole is extensively distributed, with a mean steady state volume of distribution (Vss) of approximately 450 L. Isavuconazole is highly bound (> 99%) to human plasma proteins, predominantly to albumin.
Slovenian: Izavukonazol se v veliki meri porazdeli, pri tem pa je povprečje porazdelitve v stanju dinamičnega ravnovesja (Vss) približno 450 l. Izavukonazol se močno veže (> 99 %) na človeške plazemske beljakovine, predvsem na albumin.
English: The vial will be given as a drip into a vein by your doctor or nurse.
Slovenian: Vialo boste prejeli kot infuzijo v veno od zdravnika ali medicinske sestre.
English: CRESEMBA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Slovenian: Zdravila CRESEMBA niso preučevali pri bolnikih s hudo jetrno okvaro (Child-Pugh razred C).
English: Table 2 Summary of adverse reactions by MedDRA System Organ Class and frequency
Slovenian: Preglednica 2: povzetek neželenih učinkov, razvrščenih po organskem sistemu MedDRA in po pogostnosti
English: After reconstitution, the entire content of the reconstituted concentrate should be removed from the vial and added to an infusion bag containing at least 250 mL of either sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) dextrose solution.
Slovenian: Po rekonstituciji je treba celotno vsebino pripravljenega koncentrata odvzeti iz viale in jo dodati v infuzijsko vrečko, ki vsebuje najmanj 250 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali 50 mg/ml (5 % ) raztopine dekstroze.
English: NNRTI concentrations may decrease (CYP2B6 induction by isavuconazole) or increase.
Slovenian: Koncentracije NNRTI se lahko zmanjšajo (indukcija CYP2B6 z izavukonazolom) ali povečajo.
English: For other strong CYP3A4 inhibitors, such as clarithromycin, indinavir and saquinavir, a less pronounced effect can be expected, based on their relative potency.
Slovenian: Pri drugih močnih inhibitorjih CYP3A4, kot so klaritromicin, indinavir in sakvinavir, je mogoče pričakovati manj izražen učinek, glede na njihovo relativno potentnost.
English: The reconstituted solution should be inspected visually for particulate matter and discoloration.
Slovenian: Pripravljeno raztopino je treba vizualno pregledati glede delcev in obarvanja.
English: Your doctor should monitor you for possible side effects
Slovenian: Zdravnik vas mora nadzirati zaradi možnih neželenih učinkov
English: In the intent-to-treat (ITT) population, 258 patients received isavuconazole and 258 patients received voriconazole.
Slovenian: Pri populaciji z namenom zdravljenja (ITT - intent-to treat) je 258 bolnikov prejelo izavukonazol, 258 bolnikov pa je prejelo vorikonazol.
English: Based on these findings, intravenous and oral dosing can be used interchangeably.
Slovenian: Na osnovi teh ugotovitev je mogoče prehajati med intravenskim in peroralnim odmerjanjem.
English: Isavuconazonium sulfate is a water-soluble prodrug that can be administered as an intravenous infusion or orally as hard capsules.
Slovenian: Izavukonazonijev sulfat je vodotopno predzdravilo, ki ga je mogoče uporabljati v obliki intravenske infuzije ali peroralno v obliki trdih kapsul.
English: Table 2 presents adverse reactions with isavuconazole in the treatment of invasive fungal infections, by System Organ Class and frequency.
Slovenian: Preglednica 2 prikazuje neželene učinke z izavukonazolom pri zdravljenju invazivnih glivičnih okužb, po organskem sistemu in pogostnosti.
English: In rats and rabbits, isavuconazole at systemic exposures below the therapeutic level were associated with dose-related increases in the incidence of skeletal anomalies (rudimentary supernumerary ribs) in offspring.
Slovenian: Pri podganah in kuncih je bila sistemska izpostavljenost izavukonazolu, nižja od terapevtske stopnje, povezana z od odmerka odvisnim povečanjem pojavnosti anomalij okostja (nerazvita nadštevilna rebra) pri potomcih.
English: An existing intravenous line should be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) dextrose solution.
Slovenian: Obstoječo intravensko linijo je treba sprati z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali 50 mg/ml (5 %) raztopino dekstroze.
English: The adjusted treatment difference (voriconazole−isavuconazole) was 4.0% (95% confidence interval: −7.9; 15.9).
Slovenian: Prilagojena razlika zaradi zdravljenja (vorikonazol-izavukonazol) je bila 4,0 % (95 % interval zaupanja: -7,9; 15,9).
English: Swedish Orange (reddish-brown) capsule body marked with ”100” in black ink and a white cap marked with "C" in black ink.
Slovenian: Kapsula s telesom barve Swedish Orange (rdečkasto-rjave), na katerem je s črnim črnilom odtisnjena oznaka „100“, ter belim pokrovčkom s črno odtisnjeno oznako „C“.
English: Cresemba is used in adults to treat the following fungal infections: - invasive aspergillosis, caused by a fungus in the ‘Aspergillus' group; - mucormycosis, caused by a fungus beloning to the ‘Mucorales' group in patients for whom a treatment with amphotericin B is not appropriate.
Slovenian: Zdravilo Cresemba se uporablja pri odraslih za zdravljenje naslednjih glivičnih okužb: - invazivne aspergiloze, ki jo povzroča gliva iz skupine „Aspergillus“; - zigomikoze, ki jo povzroča gliva iz skupine „Mucorales“ pri bolnikih, pri katerih zdravljenje z amfotericinom B ni primerno.
English: Oral administration of CRESEMBA equivalent to 400 mg isavuconazole with a high-fat meal reduced isavuconazole Cmax by 9% and increased AUC by 9%.
Slovenian: Pri peroralni uporabi zdravila CRESEMBA, enakovredni 400 mg izavukonazola, z obrokom z visoko vsebnostjo maščob se je vrednost Cmax izavukonazola zmanjšala za 9 %, vrednost AUC pa povečala za 9 %.
English: Medicinal products transported by P-gp in the intestine
Slovenian: Zdravila, ki jih prenaša P-gp v črevesju
English: Ritonavir (at doses >200 mg every 12 hours) (strong CYP3A4/5 inducer)
Slovenian: Ritonavir (pri odmerkih > 200 mg vsakih 12 ur) (močan induktor CYP3A4/5)
English: Saquinavir concentrations may decrease (as observed with lopinavir/ritonavir) or increase (CYP3A4 inhibition).
Slovenian: Koncentracije sakvinavirja se lahko zmanjšajo (podobno kot pri lopinavirju/ritonavirju) ali povečajo (inhibicija CYP3A4).
English: The adjusted treatment difference (isavuconazole−voriconazole) was −2.7% (95 % confidence interval: −12.9; 7.5).
Slovenian: Prilagojena razlika zaradi zdravljenja (izavukonazol-vorikonazol) je bila -2,7 (95 % interval zaupanja: -12,9; 7,5).
English: For other strong CYP3A4/5 inhibitors, a less pronounced effect can be expected.
Slovenian: Pri drugih močnih inhibitorjih CYP3A4/5 je mogoče pričakovati manj izrazit učinek.
English: No clinically relevant changes were observed in the total Cmax and AUC of isavuconazole in subjects with mild, moderate or severe renal impairment compared to subjects with normal renal function.
Slovenian: V celokupnih vrednostih Cmax in AUC izavukonazola niso opazili nobenih klinično pomembnih sprememb pri osebah z blago, zmerno ali hudo okvaro ledvic v primerjavi z osebami z normalnim delovanjem ledvic.
English: Elevated liver transaminases have been reported in clinical studies (see section 4.8).
Slovenian: V kliničnih študijah so poročali o povišanih vrednostih jetrnih transaminaz (glejte poglavje 4.8).
English: Following administration, isavuconazonium sulfate is rapidly hydrolysed by plasma esterases to the active moiety isavuconazole; plasma concentrations of the prodrug are very low, and detectable only for a short time after intravenous dosing.
Slovenian: Po dajanju zdravila esteraze v plazmi izavukonazonijev sulfat hitro hidrolizirajo v aktivno spojino izavukonazol; koncentracije predzdravila v plazmi so zelo nizke in zaznavne le kratek čas po intravenskem odmerjanju.
English: During intravenous administration of isavuconazole, infusion-related reactions including hypotension, dyspnoea, dizziness, paraesthesia, nausea, and headache were reported (see section 4.8).
Slovenian: Pri intravenskem dajanju izavukonazola so poročali o reakcijah zaradi infuzije, vključno s hipotenzijo, dispnejo, omotico, parestezijo, navzeo in glavobolom (glejte poglavje 4.8).
English: Short-acting opiate concentrations may increase.
Slovenian: Koncentracije kratkodelujočih opiatov se lahko povečajo.
English: Do not swallow or use the desiccant.
Slovenian: Ne pogoltnite ali uporabite sušilnega sredstva.
English: Generally, concentrations of isavuconazole required to inhibit Mucorales are higher than those required to inhibit the majority of Aspergillus species.
Slovenian: Na splošno so koncentracije izavukonazola potrebne za inhibicijo Mucorales višje od tistih potrebnih za inhibicijo večine vrste gliv Aspergillus.
English: CRESEMBA is contraindicated in patients with familial short QT syndrome (see section 4.3).
Slovenian: Zdravilo CRESEMBA je kontraindicirano pri bolnikih z družinskim sindromom kratkega intervala QT (glejte poglavje 4.3).
English: The concomitant administration of CRESEMBA and carbamazepine, phenytoin and long-acting barbiturates such as phenobarbital is contraindicated.
Slovenian: Sočasna uporaba zdravila CRESEMBA in karbamazepina, fenitoina in dolgodelujočih barbituratov, kot je fenobarbital, je kontraindicirana.
English: Based on results with atorvastatin, no statin dose adjustment required.
Slovenian: Na podlagi rezultatov z atorvastatinom prilagajanje odmerka statina ni potrebno.
English: - The other ingredients (excipients) are mannitol (E421) and sulfuric acid.
Slovenian: - Druge sestavine zdravila (pomožne snovi) so manitol (E421) in žveplova kislina.
English: Appropriate therapeutic drug monitoring and dose adjustment may be necessary during co-administration (see section 4.5).
Slovenian: V primeru sočasne uporabe bosta morda potrebna ustrezno terapevtsko spremljanje in prilagoditev odmerka (glejte poglavje 4.5).
English: The population pharmacokinetic evaluation of isavuconazole in healthy subjects and patients with mild or moderate hepatic dysfunction demonstrated that the mild and moderate hepatic impairment populations had 40% and 48% lower isavuconazole clearance (CL) values, respectively, than the healthy population.
Slovenian: Vrednotenje populacijske farmakokinetike izavukonazola pri zdravih osebah in bolnikih z blago ali zmerno jetrno okvaro je pokazala, da je imela populacija z blago jetrno okvaro 40 %, z zmerno jetrno okvaro pa 48 % nižje vrednosti očistka (CL) kot zdrava populacija.
English: Isavuconazole demonstrates a fungicidal effect by blocking the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450-dependent enzyme lanosterol 14-alpha-demethylase, responsible for the conversion of lanosterol to ergosterol.
Slovenian: Izavukonazol ima dokazan fungicidni učinek z zaviranjem sinteze ergosterola, ključnega sestavnega dela celične membrane gliv, z inhibicijo od citokroma P-450 odvisnega encima lanosterola 14-alfademetilaze, ki je odgovoren za pretvorbo lanosterola v ergosterol.
English: What Cresemba looks like and contents of the pack Cresemba 100 mg hard capsules are capsules with a reddish-brown body marked with “100” in black ink and a white cap marked with “C” in black ink.
Slovenian: Izgled zdravila Cresemba in vsebina pakiranja Cresemba 100 mg so kapsule z rdečkasto-rjavim telesom, na katerem je s črnim črnilom odtisnjena oznaka „100“, ter belim pokrovčkom s črno odtisnjeno oznako „C“.
English: In utero exposure to the active moiety isavuconazole had no effect on the fertility of the surviving pups.
Slovenian: Izpostavljenost aktivni spojini izavukonazolu in utero ni vplivala na plodnost preživelih mladičev.
English: Isavuconazole was negative in a bacterial reverse mutation assay, was weakly clastogenic at cytotoxic concentrations in the L5178Y tk+/- mouse lymphoma chromosome aberration assay, and showed no biologically relevant or statistically significant increase in the frequency of micronuclei in an in vivo rat micronucleus test.
Slovenian: Rezultati za izavukonazol so bili negativni pri bakterijskem preskusu reverzne mutacije, pokazala se je šibka klastogenost pri citotoksičnih koncentracijah v preskusu kromosomskih aberacij limfoma L5178Y tk+/- pri miših, pri in vivo mikronukleusnem preskusu na podganah pa se ni pokazalo biološko pomembno ali statistično značilno povečanje pogostnosti mikronukleusa.
English: One vial of the powder for concentrate for solution for infusion should be reconstituted by addition of 5 mL water for injections to the vial.
Slovenian: Eno vialo praška za koncentrat za raztopino za infundiranje je treba pripraviti z dodajanjem 5 ml vode za injekcije v vialo.
English: Concomitant use of CRESEMBA with CYP3A4 substrates such as the immunosuppressants tacrolimus, sirolimus or ciclosporin may increase the systemic exposure to these medicinal products.
Slovenian: Sočasna uporaba zdravila CRESEMBA s substrati CYP3A4, kot so imunosupresivi takrolimus, sirolimus ali ciklosporin, lahko poveča sistemsko izpostavljenost tem zdravilom.
English: Fungal strains with reduced in vitro susceptibility to isavuconazole have been reported, and cross-resistance with voriconazole and other triazole antifungal agents cannot be excluded.
Slovenian: Poročali so o zmanjšani in vitro dovzetnosti glivnih sevov za izavukonazol, prav tako pa ni mogoče izključiti navzkrižne odpornosti z vorikonazolom in drugimi triazolskimi antimikotiki.
English: Midazolam: careful monitoring of clinical signs and symptoms recommended, and dose reduction if required.
Slovenian: Midazolam: priporočljivo je skrbno spremljanje kliničnih znakov in simptomov ter zmanjšanje odmerka, če je to potrebno.
English: Mycophenolate mofetil (MMF) (UGT substrate)
Slovenian: Mofetilmikofenolat (MMF) (substrat UGT)