natgillin/translations-raw huggingface dataset:
Isavuconazole is a mild inhibitor of the organic cation transporter 2 (OCT2).
Izavukonazol je blag inhibitor prenašalcev organskih kationov 2 (OCT2 - organic cation transporter 2).
• mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1)
• zigomikozo pri bolnikih, za katere amfotericin B ni primeren (glejte poglavji 4.4. in 5.1).
Patients with familial short QT syndrome (see section 4.4).
Bolniki z družinskim sindromom kratkega intervala QT (glejte poglavje 4.4).
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.
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.
The vial will be given as a drip into a vein by your doctor or nurse.
Vialo boste prejeli kot infuzijo v veno od zdravnika ali medicinske sestre.
CRESEMBA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Zdravila CRESEMBA niso preučevali pri bolnikih s hudo jetrno okvaro (Child-Pugh razred C).
Table 2 Summary of adverse reactions by MedDRA System Organ Class and frequency
Preglednica 2: povzetek neželenih učinkov, razvrščenih po organskem sistemu MedDRA in po pogostnosti
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.
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.
NNRTI concentrations may decrease (CYP2B6 induction by isavuconazole) or increase.
Koncentracije NNRTI se lahko zmanjšajo (indukcija CYP2B6 z izavukonazolom) ali povečajo.
For other strong CYP3A4 inhibitors, such as clarithromycin, indinavir and saquinavir, a less pronounced effect can be expected, based on their relative potency.
Pri drugih močnih inhibitorjih CYP3A4, kot so klaritromicin, indinavir in sakvinavir, je mogoče pričakovati manj izražen učinek, glede na njihovo relativno potentnost.
The reconstituted solution should be inspected visually for particulate matter and discoloration.
Pripravljeno raztopino je treba vizualno pregledati glede delcev in obarvanja.
Your doctor should monitor you for possible side effects
Zdravnik vas mora nadzirati zaradi možnih neželenih učinkov
In the intent-to-treat (ITT) population, 258 patients received isavuconazole and 258 patients received voriconazole.
Pri populaciji z namenom zdravljenja (ITT - intent-to treat) je 258 bolnikov prejelo izavukonazol, 258 bolnikov pa je prejelo vorikonazol.
Based on these findings, intravenous and oral dosing can be used interchangeably.
Na osnovi teh ugotovitev je mogoče prehajati med intravenskim in peroralnim odmerjanjem.
Isavuconazonium sulfate is a water-soluble prodrug that can be administered as an intravenous infusion or orally as hard capsules.
Izavukonazonijev sulfat je vodotopno predzdravilo, ki ga je mogoče uporabljati v obliki intravenske infuzije ali peroralno v obliki trdih kapsul.
Table 2 presents adverse reactions with isavuconazole in the treatment of invasive fungal infections, by System Organ Class and frequency.
Preglednica 2 prikazuje neželene učinke z izavukonazolom pri zdravljenju invazivnih glivičnih okužb, po organskem sistemu in pogostnosti.
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.
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.
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.
Obstoječo intravensko linijo je treba sprati z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali 50 mg/ml (5 %) raztopino dekstroze.
The adjusted treatment difference (voriconazole−isavuconazole) was 4.0% (95% confidence interval: −7.9; 15.9).
Prilagojena razlika zaradi zdravljenja (vorikonazol-izavukonazol) je bila 4,0 % (95 % interval zaupanja: -7,9; 15,9).
Swedish Orange (reddish-brown) capsule body marked with ”100” in black ink and a white cap marked with "C" in black ink.
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“.
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.
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.
Oral administration of CRESEMBA equivalent to 400 mg isavuconazole with a high-fat meal reduced isavuconazole Cmax by 9% and increased AUC by 9%.
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 %.
Medicinal products transported by P-gp in the intestine
Zdravila, ki jih prenaša P-gp v črevesju
Ritonavir (at doses >200 mg every 12 hours) (strong CYP3A4/5 inducer)
Ritonavir (pri odmerkih > 200 mg vsakih 12 ur) (močan induktor CYP3A4/5)
Saquinavir concentrations may decrease (as observed with lopinavir/ritonavir) or increase (CYP3A4 inhibition).
Koncentracije sakvinavirja se lahko zmanjšajo (podobno kot pri lopinavirju/ritonavirju) ali povečajo (inhibicija CYP3A4).
The adjusted treatment difference (isavuconazole−voriconazole) was −2.7% (95 % confidence interval: −12.9; 7.5).
Prilagojena razlika zaradi zdravljenja (izavukonazol-vorikonazol) je bila -2,7 (95 % interval zaupanja: -12,9; 7,5).
For other strong CYP3A4/5 inhibitors, a less pronounced effect can be expected.
Pri drugih močnih inhibitorjih CYP3A4/5 je mogoče pričakovati manj izrazit učinek.
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.
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.
Elevated liver transaminases have been reported in clinical studies (see section 4.8).
V kliničnih študijah so poročali o povišanih vrednostih jetrnih transaminaz (glejte poglavje 4.8).
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.
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.
During intravenous administration of isavuconazole, infusion-related reactions including hypotension, dyspnoea, dizziness, paraesthesia, nausea, and headache were reported (see section 4.8).
Pri intravenskem dajanju izavukonazola so poročali o reakcijah zaradi infuzije, vključno s hipotenzijo, dispnejo, omotico, parestezijo, navzeo in glavobolom (glejte poglavje 4.8).
Short-acting opiate concentrations may increase.
Koncentracije kratkodelujočih opiatov se lahko povečajo.
Do not swallow or use the desiccant.
Ne pogoltnite ali uporabite sušilnega sredstva.
Generally, concentrations of isavuconazole required to inhibit Mucorales are higher than those required to inhibit the majority of Aspergillus species.
Na splošno so koncentracije izavukonazola potrebne za inhibicijo Mucorales višje od tistih potrebnih za inhibicijo večine vrste gliv Aspergillus.
CRESEMBA is contraindicated in patients with familial short QT syndrome (see section 4.3).
Zdravilo CRESEMBA je kontraindicirano pri bolnikih z družinskim sindromom kratkega intervala QT (glejte poglavje 4.3).
The concomitant administration of CRESEMBA and carbamazepine, phenytoin and long-acting barbiturates such as phenobarbital is contraindicated.
Sočasna uporaba zdravila CRESEMBA in karbamazepina, fenitoina in dolgodelujočih barbituratov, kot je fenobarbital, je kontraindicirana.
Based on results with atorvastatin, no statin dose adjustment required.
Na podlagi rezultatov z atorvastatinom prilagajanje odmerka statina ni potrebno.
- The other ingredients (excipients) are mannitol (E421) and sulfuric acid.
- Druge sestavine zdravila (pomožne snovi) so manitol (E421) in žveplova kislina.
Appropriate therapeutic drug monitoring and dose adjustment may be necessary during co-administration (see section 4.5).
V primeru sočasne uporabe bosta morda potrebna ustrezno terapevtsko spremljanje in prilagoditev odmerka (glejte poglavje 4.5).
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.
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.
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.
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.
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.
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“.
In utero exposure to the active moiety isavuconazole had no effect on the fertility of the surviving pups.
Izpostavljenost aktivni spojini izavukonazolu in utero ni vplivala na plodnost preživelih mladičev.
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.
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.
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.
Eno vialo praška za koncentrat za raztopino za infundiranje je treba pripraviti z dodajanjem 5 ml vode za injekcije v vialo.
Concomitant use of CRESEMBA with CYP3A4 substrates such as the immunosuppressants tacrolimus, sirolimus or ciclosporin may increase the systemic exposure to these medicinal products.
Sočasna uporaba zdravila CRESEMBA s substrati CYP3A4, kot so imunosupresivi takrolimus, sirolimus ali ciklosporin, lahko poveča sistemsko izpostavljenost tem zdravilom.
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.
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.
Midazolam: careful monitoring of clinical signs and symptoms recommended, and dose reduction if required.
Midazolam: priporočljivo je skrbno spremljanje kliničnih znakov in simptomov ter zmanjšanje odmerka, če je to potrebno.
Mycophenolate mofetil (MMF) (UGT substrate)
Mofetilmikofenolat (MMF) (substrat UGT)
• invasive aspergillosis
• invazivno aspergilozo
Clinical efficacy has been demonstrated for the following Aspergillus species: Aspergillus fumigatus, A. flavus, A. niger, and A. terreus(see further below).
Klinična učinkovitost je bila dokazana za naslednje vrste gliv Aspergillus: Aspergillus fumigatus, A. flavus, A. niger, and A. terreus (glejte v nadaljevanju spodaj).
In an open-label non-controlled study, 37 patients with proven or probable mucormycosis received isavuconazole at the same dose regimen as that used to treat invasive aspergillosis.
V nekontrolirani študiji odprtega tipa je 37 bolnikov z dokazano ali verjetno zigomikozo prejemalo izavukonazol z istim režimom odmerjanja, kot se uporablja za zdravljenje invazivne aspergiloze.
In rats, a dose-related increase in the incidence of zygomatic arch fusion was also noted in offspring (see section 4.6).
Pri podganah je bila opažena tudi od odmerka odvisna povečana pojavnost fuzije zigomatičnega loka pri potomcih (glejte poglavje 4.6).
Ketoconazole is contraindicated (see section 4.3).
Ketokonazol je kontraindiciran (glejte poglavje 4.3).
Therefore, caution is advised when CYP2B6 substrates, especially medicinal products with a narrow therapeutic index such as cyclophosphamide, are co-administered with CRESEMBA.
Zato je potrebna previdnost ob sočasni uporabi substratov CYP2B6, zlasti zdravil z ozkim terapevtskim indeksom, kot je ciklofosfamid, sočasno z zdravilom CRESEMBA.
Systemic exposure to medicinal products metabolised by CYP2B6 may be decreased when co-administered with CRESEMBA.
Sistemska izpostavljenost zdravilom, ki se presnavljajo s CYP2B6, se lahko pri sočasni uporabi z zdravilom CRESEMBA zmanjša.
Marked elevations of liver transaminases > 10 × ULN developed in 1.2% of patients on isavuconazole.
Do izrazitejšega povečanja jetrnih transaminaz na več kot 10-kratnik ULN je prišlo pri 1,2 % bolnikov, ki so prejemali izavukonazol.
The infusion solution contains approximately 1.5 mg/mL isavuconazonium sulfate (corresponding to approximately 0.8 mg isavuconazole per mL).
Infuzijska raztopina vsebuje približno 1,5 mg/ml izavukonazonijevega sulfata (kar ustreza približno 0,8 mg izavukonazola na ml).
Available pharmacodynamic/toxicological data in animals have shown excretion of isavuconazole/metabolites in milk (see section 5.3).
Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje izavukonazola/presnovkov v mleko (glejte poglavje 5.3).
Uridine diphosphate-glucuronosyltransferases (UGT) substrates
Substrati uridin difosfat glukuroniltransferaze (UGT)
Skin problems Tell your doctor straight away if you get severe blistering of the skin, mouth, eyes or genitals.
Kožne težave Povejte svojemu zdravniku, če se vam pojavijo hudi mehurji na koži, ustih, očeh ali spolovilih.
Co-administration with high-dose ritonavir (>200 mg every 12 hours) (see section 4.5).
Sočasna uporaba z visokim odmerkom ritonavirja ( > 200 mg vsakih 12 ur) (glejte poglavje 4.5).
Cresemba 200 mg powder for concentrate for solution for infusion must be reconstituted and diluted prior to infusion.
Cresemba 200 mg prašek za koncentrat za raztopino za infundiranje je treba pred infundiranjem rekonstituirati in razredčiti.
(OCT2 inhibition)
(inhibicija OCT2)
The myITT population comprised 123 patients receiving isavuconazole and 108 patients receiving voriconazole.
Populacija myITT je obsegala 123 bolnikov, ki so prejemali izavukonazol in 108 bolnikov, ki so prejemali vorikonazol.
Isavuconazole is the active moiety formed after oral or intravenous administration of isavuconazonium sulfate (see section 5.2).
Izavukonazol je aktivna spojina, ki nastane po peroralni ali intravenski uporabi izavukonazonijevega sulfata (glejte poglavje 5.2).
Ciclosporin, sirolimus, tacrolimus: monitoring of plasma levels and appropriate dose adjustment if required.
Ciklosporin, sirolimus, takrolimus: spremljanje ravni v plazmi in ustrezna prilagoditev odmerka, če je to potrebno.
Studies in animals did not show impairment of fertility in male or female rats (see section 5.3).
Študije na živalih niso pokazale zmanjšane plodnosti pri podganjih samcih ali samicah (glejte poglavje 5.3).
Mannitol Sulfuric acid (for pH-adjustment)
Manitol Žveplova kislina (za uravnavanje pH)
The infusion must be administered via an infusion set with an in-line filter with a microporous membrane made of polyethersulfone (PES) and with a pore size of 0.2 μm to 1.2 μm.
Infuzijo je treba dajati z infuzijskim kompletom z linijskim filtrom z mikroporozno membrano, izdelano iz polietersulfona (PES) in z velikostjo por od 0,2 μm do 1,2 μm.
After a single 100 mg dose of isavuconazole was administered to 32 patients with mild (Child-Pugh Class A) hepatic insufficiency and 32 patients with moderate (Child-Pugh Class B) hepatic insufficiency (16 intravenous and 16 oral patients per Child-Pugh class), the least square mean systemic exposure (AUC) increased 64% in the Child-Pugh Class A group, and 84% in the Child-Pugh Class B group, relative to 32 age- and weight-matched healthy subjects with normal hepatic function.
Po tem, ko je 32 bolnikov z blago (Child-Pugh razred A) in 32 bolnikov z zmerno jetrno insuficienco (Child-Pugh razred B) prejelo enkratni 100 mg odmerek izavukonazola (16 intravensko in 16 peroralno pri vsakem razredu Child-Pugh) se je najnižja povprečna vrednost (po metodi najmanjših kvadratov) sistemske izpostavljenosti (AUC) povečala za 64 % v skupini razreda Child-Pugh A in za 84 % v skupini razreda Child-Pugh B v primerjavi z 32 zdravimi preiskovanci enake starosti in telesne mase z normalnim delovanjem jeter.
Isavuconazole is not removed by haemodialysis.
Izavukonazol se s hemodializo ne odstrani.
You will be given this dose until your doctor tells you otherwise.
Ta odmerek boste prejemali, dokler vam vaš zdravnik ne predpiše drugače.
Reduced susceptibility to triazole antifungal agents has been associated with mutations in the fungal cyp51A and cyp51B genes coding for the target protein lanosterol 14-alpha-demethylase involved in ergosterol biosynthesis.
Zmanjšana občutljivost za triazolske antimikotike je bila povezana z mutacijami v kodiranju glivinih genov cyp51A in cyp51B za ciljno beljakovino lanosterol 14-alfa-demetilazo, ki je vključena v biosintezo ergosterola.
Hypersensitivity to isavuconazole may result in adverse reactions that include: hypotension, respiratory failure, dyspnoea, drug eruption, pruritus, and rash.
Preobčutljivost na izavukonazol lahko povzroči neželene učinke, ki vključujejo: hipotenzijo, respiratorno odpoved, dispnejo, izpuščaj zaradi zdravil, srbenje in kožni izpuščaj.
Of the 403 patients who received CRESEMBA in the Phase 3 studies, 79 (20%) of patients had an estimated glomerular filtration rate (GFR) less than 60 mL/min/1.73 m2. No dose adjustment is required in patients with renal impairment, including those patients with end-stage renal disease.
Od 403 bolnikov, ki so prejemali zdravilo CRESEMBA v študiji 3. faze, je imelo 79 (20 %) bolnikov ocenjeno hitrost glomerulne filtracije (GFR) nižjo od 60 ml/min/1,73 m2.
The most common treatment-related adverse reactions were elevated liver chemistry tests (7.9%), nausea (7.4%), vomiting (5.5%), dyspnoea (3.2%), abdominal pain (2.7%), diarrhoea (2.7%), injection site reaction (2.2%), headache (2.0%), hypokalaemia (1.7%) and rash (1.7%).
Najpogostejši neželeni učinki, povezani z zdravljenjem, so bili povišane vrednosti rezultatov preiskav kemije jeter (7,9 %), navzea (7,4 %), bruhanje (5,5 %), dispneja (3,2 %), bolečine v trebuhu (2,7 %), driska (2,7 % ), reakcija na mestu injiciranja (2,2 %), glavobol (2,0 %), hipokaliemija (1,7 %) in izpuščaj (1,7 %).
What Cresemba looks like and contents of the pack Cresemba 200 mg is presented in a single use glass vial as a powder for concentrate for solution for infusion.
Izgled zdravila Cresemba in vsebina pakiranja Zdravilo Cresemba 200 mg je pakirano v stekleni viali za enkratno uporabo v obliki praška za koncentrat za raztopino za infundiranje.
Natural products Caffeine (CYP1A2 substrate)
Naravna sredstva Kofein (substrat CYP1A2)
Short-acting opiates (alfentanyl, fentanyl): careful monitoring for any occurrence of drug toxicity, and dose reduction if required.
Kratkodelujoči opiati (alfentanil, fentanil): skrbno spremljati vsakršen pojav toksičnih učinkov zdravila in po potrebi zmanjšati odmerek.
In a double-blind, randomized, active-controlled clinical study of 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi, elevated liver transaminases (alanine aminotransferase or aspartate aminotransferase) > 3 × Upper Limit of Normal (ULN) were reported at the end of study treatment in 4.4% of patients who received CRESEMBA.
V dvojno slepi, randomizirani aktivno kontrolirani klinični študiji 516 bolnikov z invazivno glivično boleznijo z glivami rodu Aspergillus ali drugimi nitastimi glivami, so ob koncu zdravljenja pri 4,4 % bolnikov, ki so prejemali zdravilo CRESEMBA, poročali o povečani vrednosti jetrnih transaminaz (alanin-aminotransferaze ali aspartat aminotransferaze) na več kot 3-kratnik zgornje meje normalne vrednosti (ULN - Upper Limit of Normal).
Isavuconazole is a substrate of CYP3A4 and CYP3A5 (see section 5.2).
Izavukonazol je substrat za CYP3A4 in CYP3A5 (glejte poglavje 5.2).
No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B) (see sections 4.4 and 5.2).
Pri bolnikih z blago ali zmerno jetrno okvaro prilagoditev odmerka ni potrebna (Child-Pugh razred A in B) (glejte poglavji 4.4 in 5.2).
For detailed instructions on the reconstitution and dilution of CRESEMBA before administration, see section 6.6.
Za navodila glede rekonstitucije in redčenja zdravila CRESEMBA pred dajanjem glejte poglavje 6.6.
Do not stop taking Cresemba unless you doctor has told you to do so.
Ne prenehajte jemati zdravila Cresemba, razen če vam je tako naročil vaš zdravnik.
Excipients: mannitol (E421) and sulfuric acid
Pomožne snovi: manitol (E421) in žveplova kislina
CRESEMBA is also available as powder for concentrate for solution for infusion containing 200 mg isavuconazole, equivalent to 372 mg isavuconazonium sulfate.
Zdravilo CRESEMBA je na voljo tudi v obliki praška za koncentrat za raztopino za infundiranje, ki vsebuje 200 mg izavukonazola, kar ustreza 372 mg izavukonazonijevega sulfata.
The adverse reactions which most often led to permanent discontinuation of CRESEMBA treatment were confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnoea (0.5%), epilepsy (0.5%), respiratory failure (0.5%) and vomiting (0.5%).
Neželeni učinki, ki so najpogosteje privedli do trajne prekinitve zdravljenja z zdravilom CRESEMBA so bili stanje zmedenosti (0,7 %), akutna odpoved ledvic (0,7 %), zvišan bilirubin v krvi (0,5 %), konvulzije (0,5 %), dispneja (0,5 %), epilepsija (0,5 %), respiratorna odpoved (0,5 %) in bruhanje (0,5