FrancophonIA/ELRC3.0 huggingface dataset:
English: • invasive aspergillosis
Slovenian: • invazivno aspergilozo
English: Clinical efficacy has been demonstrated for the following Aspergillus species: Aspergillus fumigatus, A. flavus, A. niger, and A. terreus(see further below).
Slovenian: Klinična učinkovitost je bila dokazana za naslednje vrste gliv Aspergillus: Aspergillus fumigatus, A. flavus, A. niger, and A. terreus (glejte v nadaljevanju spodaj).
English: 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.
Slovenian: 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.
English: In rats, a dose-related increase in the incidence of zygomatic arch fusion was also noted in offspring (see section 4.6).
Slovenian: Pri podganah je bila opažena tudi od odmerka odvisna povečana pojavnost fuzije zigomatičnega loka pri potomcih (glejte poglavje 4.6).
English: Ketoconazole is contraindicated (see section 4.3).
Slovenian: Ketokonazol je kontraindiciran (glejte poglavje 4.3).
English: Therefore, caution is advised when CYP2B6 substrates, especially medicinal products with a narrow therapeutic index such as cyclophosphamide, are co-administered with CRESEMBA.
Slovenian: Zato je potrebna previdnost ob sočasni uporabi substratov CYP2B6, zlasti zdravil z ozkim terapevtskim indeksom, kot je ciklofosfamid, sočasno z zdravilom CRESEMBA.
English: Systemic exposure to medicinal products metabolised by CYP2B6 may be decreased when co-administered with CRESEMBA.
Slovenian: Sistemska izpostavljenost zdravilom, ki se presnavljajo s CYP2B6, se lahko pri sočasni uporabi z zdravilom CRESEMBA zmanjša.
English: Marked elevations of liver transaminases > 10 × ULN developed in 1.2% of patients on isavuconazole.
Slovenian: Do izrazitejšega povečanja jetrnih transaminaz na več kot 10-kratnik ULN je prišlo pri 1,2 % bolnikov, ki so prejemali izavukonazol.
English: The infusion solution contains approximately 1.5 mg/mL isavuconazonium sulfate (corresponding to approximately 0.8 mg isavuconazole per mL).
Slovenian: Infuzijska raztopina vsebuje približno 1,5 mg/ml izavukonazonijevega sulfata (kar ustreza približno 0,8 mg izavukonazola na ml).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of isavuconazole/metabolites in milk (see section 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje izavukonazola/presnovkov v mleko (glejte poglavje 5.3).
English: Uridine diphosphate-glucuronosyltransferases (UGT) substrates
Slovenian: Substrati uridin difosfat glukuroniltransferaze (UGT)
English: Skin problems Tell your doctor straight away if you get severe blistering of the skin, mouth, eyes or genitals.
Slovenian: Kožne težave Povejte svojemu zdravniku, če se vam pojavijo hudi mehurji na koži, ustih, očeh ali spolovilih.
English: Co-administration with high-dose ritonavir (>200 mg every 12 hours) (see section 4.5).
Slovenian: Sočasna uporaba z visokim odmerkom ritonavirja ( > 200 mg vsakih 12 ur) (glejte poglavje 4.5).
English: Cresemba 200 mg powder for concentrate for solution for infusion must be reconstituted and diluted prior to infusion.
Slovenian: Cresemba 200 mg prašek za koncentrat za raztopino za infundiranje je treba pred infundiranjem rekonstituirati in razredčiti.
English: (OCT2 inhibition)
Slovenian: (inhibicija OCT2)
English: The myITT population comprised 123 patients receiving isavuconazole and 108 patients receiving voriconazole.
Slovenian: Populacija myITT je obsegala 123 bolnikov, ki so prejemali izavukonazol in 108 bolnikov, ki so prejemali vorikonazol.
English: Isavuconazole is the active moiety formed after oral or intravenous administration of isavuconazonium sulfate (see section 5.2).
Slovenian: Izavukonazol je aktivna spojina, ki nastane po peroralni ali intravenski uporabi izavukonazonijevega sulfata (glejte poglavje 5.2).
English: Ciclosporin, sirolimus, tacrolimus: monitoring of plasma levels and appropriate dose adjustment if required.
Slovenian: Ciklosporin, sirolimus, takrolimus: spremljanje ravni v plazmi in ustrezna prilagoditev odmerka, če je to potrebno.
English: Studies in animals did not show impairment of fertility in male or female rats (see section 5.3).
Slovenian: Študije na živalih niso pokazale zmanjšane plodnosti pri podganjih samcih ali samicah (glejte poglavje 5.3).
English: Mannitol Sulfuric acid (for pH-adjustment)
Slovenian: Manitol Žveplova kislina (za uravnavanje pH)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Isavuconazole is not removed by haemodialysis.
Slovenian: Izavukonazol se s hemodializo ne odstrani.
English: You will be given this dose until your doctor tells you otherwise.
Slovenian: Ta odmerek boste prejemali, dokler vam vaš zdravnik ne predpiše drugače.
English: 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.
Slovenian: 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.
English: Hypersensitivity to isavuconazole may result in adverse reactions that include: hypotension, respiratory failure, dyspnoea, drug eruption, pruritus, and rash.
Slovenian: Preobčutljivost na izavukonazol lahko povzroči neželene učinke, ki vključujejo: hipotenzijo, respiratorno odpoved, dispnejo, izpuščaj zaradi zdravil, srbenje in kožni izpuščaj.
English: 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.
Slovenian: 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.
English: 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%).
Slovenian: 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 %).
English: 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.
Slovenian: 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.
English: Natural products Caffeine (CYP1A2 substrate)
Slovenian: Naravna sredstva Kofein (substrat CYP1A2)
English: Short-acting opiates (alfentanyl, fentanyl): careful monitoring for any occurrence of drug toxicity, and dose reduction if required.
Slovenian: Kratkodelujoči opiati (alfentanil, fentanil): skrbno spremljati vsakršen pojav toksičnih učinkov zdravila in po potrebi zmanjšati odmerek.
English: 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.
Slovenian: 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).
English: Isavuconazole is a substrate of CYP3A4 and CYP3A5 (see section 5.2).
Slovenian: Izavukonazol je substrat za CYP3A4 in CYP3A5 (glejte poglavje 5.2).
English: 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).
Slovenian: 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).
English: For detailed instructions on the reconstitution and dilution of CRESEMBA before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije in redčenja zdravila CRESEMBA pred dajanjem glejte poglavje 6.6.
English: Do not stop taking Cresemba unless you doctor has told you to do so.
Slovenian: Ne prenehajte jemati zdravila Cresemba, razen če vam je tako naročil vaš zdravnik.
English: Excipients: mannitol (E421) and sulfuric acid
Slovenian: Pomožne snovi: manitol (E421) in žveplova kislina
English: CRESEMBA is also available as powder for concentrate for solution for infusion containing 200 mg isavuconazole, equivalent to 372 mg isavuconazonium sulfate.
Slovenian: 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.
English: 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%).
Slovenian: 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
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Starting dose for the first two days (48 hours) The recommended dose is two capsules three times a day (every 8 hours).
Slovenian: Začetni odmerek v prvih dveh dneh (48 urah) Priporočeni odmerek sta dve kapsuli trikrat na dan (vsakih 8 ur).
English: The solution for infusion must be administered via an infusion set with an in-line filter (pore size 0.2 μm to 1.2 μm) made of polyether sulfone (PES).
Slovenian: Raztopino za infundiranje je treba dajati preko infuzijskega kompleta z linijskim filtrom (velikost por 0,2 μm do 1,2 μm), izdelanim iz polietersulfona (PES).
English: Metformin (OCT1, OCT2 and MATE1 substrate)
Slovenian: Metformin (substrat OCT1, OCT2 in MATE1)
English: Administration of isavuconazonium sulfate to rats at a dose of 90 mg/kg/day (2.3-fold the human maintenance dose [200 mg] based on mg/m2/day) during pregnancy through the weaning period showed an increased perinatal mortality of the pups.
Slovenian: Pri dajanju 90 mg/kg/dan izavukonazonijevega sulfata (2,3-kratnik vzdrževalnega odmerka pri človeku [200 mg] na podlagi mg/m2/dan) med brejostjo do časa odstavitve mladiča od dojenja se je pokazala povečana perinatalna umrljivost mladičev.
English: Concentrations of isavuconazole required to inhibit Aspergillus species and genera/species of the order Mucorales in vitro have been very variable.
Slovenian: Koncentracije izavukonazola potrebnega za inhibicijo vrste Aspergillus in rodu/vrste reda Mucorales in vitro so zelo spremenljive.
English: Tell your doctor straight away if you notice any of the following side effects: - severe blistering of the skin, mouth, eyes or genitals.
Slovenian: Takoj obvestite zdravnika, če opazite katerega od naslednjih neželenih učinkov: - hude mehurje na koži, ustih, očeh ali spolovilih.
English: Dabigatran etexilate has a narrow therapeutic index and should be monitored, and dose reduction if required.
Slovenian: Dabigatran eteksilat ima ozek terapevtski indeks in ga je treba spremljati in zmanjšati odmerek, če je to potrebno.
English: For the strong CYP3A4 inhibitor lopinavir/ritonavir, a two-fold increase in isavuconazole exposure was observed.
Slovenian: Pri močnih inhibitorjih CYP3A4, kot sta lopinavir/ritonavir, so opazili dvakratno zvečanje izpostavljenosti izavukonazolu.
English: What Cresemba is and what it is used for
Slovenian: Kaj je zdravilo Cresemba in za kaj ga uporabljamo
English: Methotrexate (BCRP, OAT1, OAT3
Slovenian: Metotreksat (substrat BCRP, OAT1, OAT3)
English: The safety and efficacy of isavuconazole for the treatment of patients with invasive aspergillosis was evaluated in a double-blind, active-controlled clinical study in 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi.
Slovenian: Varnost in učinkovitost izavukonazola za zdravljenje bolnikov z invazivno aspergilozo so ocenili v dvojno slepi, z zdravilno učinkovino nadzorovani klinični študiji pri 516 bolnikih z invazivno glivično boleznijo zaradi gliv rodu Aspergillus ali drugih nitastih gliv.
English: Isavuconazole did not affect the fertility of male or female rats treated with oral doses up to 90 mg/kg/day (2.3-fold the clinical maintenance dose based on mg/m2/day comparisons).
Slovenian: Izavukonazol ni vplival na plodnost podganjih samcev ali samic, ki so jim dajali peroralne odmerke do 90 mg/kg/dan (2,3-kratnik kliničnega vzdrževalnega odmerka na podlagi mg/m2/dan).
English: These data indicate that concentrations of isavuconazole required for inhibition in vitro are very variable between genera/species within the order of Mucorales, and generally higher than concentrations required to inhibit Aspergillus species.
Slovenian: Ti podatki kažejo na to, da so koncentracije izavukonazola, potrebne za inhibicijo in vitro, zelo spremenljive med rodovi/vrstami znotraj reda Mucorales in na splošno višje od koncentracij, potrebnih za vrste gliv Aspergillus.
English: Increasing the dose to 600 mg resulted in an LSM difference from placebo of 24.6 ms at 2 hours post dose [90% CI: 28.7, 20.4 ms].
Slovenian: Povečanje odmerka na 600 mg je povzročilo razliko v LSM v primerjavi s placebom v trajanju 24,6 ms 2 uri po odmerjanju [90 % CI: 28,7; 20,4 ms].
English: What Cresemba is Cresemba is an anti-fungal medicine that contains the active substance isavuconazole.
Slovenian: Kaj je zdravilo Cresemba Zdravilo Cresemba je antimikotik, ki vsebuje zdravilno učinkovino izavukonazol.
English: How to store Cresemba 6.
Slovenian: Shranjevanje zdravila Cresemba 6.
English: Dose adjustment of medicinal products that are P-gp substrates, especially medicinal products with a narrow therapeutic index such as digoxin, colchicine and dabigatran etexilate, may be needed when concomitantly administered with CRESEMBA (see section 4.5).
Slovenian: Pri sočasni uporabi substratov P-gp, zlasti zdravil z ozkim terapevtskim indeksom, kot so digoksin, kolhicin in dabigatran eteksilat, z zdravilom CRESEMBA, bo morda potrebna prilagoditev odmerka (glejte poglavje 4.5).
English: It should be noted that there was no dose-finding study in mucormycosis, and patients were administered the same dose of isavuconazole as was used for the treatment of invasive aspergillosis.
Slovenian: Vedeti je treba, da ni bilo študij za ugotovitev odmerka pri zigomikozi in bolniki so prejeli enak odmerek izavukonazola kot so ga uporabili za zdravljenje invazivne aspergiloze.
English: Powder for concentrate for solution for infusion White to yellow powder
Slovenian: Prašek za koncentrat za raztopino za infundiranje Bel do rumen prašek
English: Infusion-related reactions
Slovenian: Reakcije zaradi infuzije
English: Cresemba may make you feel confused, tired or sleepy.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila Cresemba se lahko počutite zmedeni, utrujeni ali zaspani.
English: Starting dose for the first two days (48 hours) The recommended dose is one vial three times a day (every 8 hours).
Slovenian: Začetni odmerek v prvih dveh dneh (48 urah) Priporočeni odmerek je ena viala trikrat na dan (vsakih 8 ur).
English: Antiretroviral agents Lopinavir 400 mg / Ritonavir 100 mg (CYP3A4/5 strong inhibitors and substrates)
Slovenian: Protiretrovirusna zdravila Lopinavir 400 mg / Ritonavir 100 mg (močna inhibitorja in substrata CYP3A4/5)
English: The elevations in liver transaminases rarely required discontinuation of CRESEMBA.
Slovenian: Pri povišanih vrednostih jetrnih transaminaz je v redkih primerih treba prekiniti zdravljenje z zdravilom CRESEMBA.
English: Symptoms reported more frequently at supratherapeutic doses of CRESEMBA (equivalent to isavuconazole 600 mg/day) evaluated in a QT study than in the therapeutic dose group (equivalent to isavuconazole 200 mg/day dose) included: headache, dizziness, paraesthesia, somnolence, disturbance in attention, dysgeusia, dry mouth, diarrhoea, oral hypoaesthesia, vomiting, hot flush, anxiety, restlessness, palpitations, tachycardia, photophobia and arthralgia
Slovenian: Simptomi, o katerih so pogosteje poročali pri supraterapevtskih odmerkih zdravila CRESEMBA (enakovredno 600 mg izavukonazola na dan), proučevanih v študiji intervala QT, kot v skupini terapevtskih odmerkov (enakovredno 200 mg izavukonazola na dan), so vključevali: glavobol, omotico, parestezije, zaspanost, motnje pozornosti, motnje okušanja, suha usta, drisko, hipestezijo, bruhanje, vročinske oblive, anksioznost, nemir, palpitacije, tahikardijo, fotofobijo in artralgijo
English: Colchicine has a narrow therapeutic index and should be monitored, dose reduction if required.
Slovenian: Kolhicin ima ozek terapevtski indeks in ga je treba spremljati in zmanjšati odmerek, če je to potrebno.
English: No dose adjustment is warranted for moderate to mild CYP3A4/5 inhibitors.
Slovenian: Prilagajanje odmerka ni potrebno za zmerne do blage inhibitorje CYP3A4/5.
English: Table 3Steady state pharmacokinetic parameters of isavuconazole following oral administration of CRESEMBA Parameter Statistic
Slovenian: Preglednica 3 Farmakokinetični parametri v stanju ravnotežja za izavukonazol po peroralni uporabi zdravila CRESEMBA
English: Breast-feeding should be discontinued during treatment with CRESEMBA.
Slovenian: Med zdravljenjem z zdravilom CRESEMBA je treba dojenje prekiniti.
English: Isavuconazole is an inhibitor in vitro of BCRP, and plasma concentrations of substrates of BCRP may therefore be increased.
Slovenian: Izavukonazol je in vitro inhibitor BCRP, zato se lahko koncentracije substratov BCRP v plazmi povečajo.
English: Repaglinide (CYP2C8 and OATP1B1 substrate)
Slovenian: Repaglinid (substrat CYP2C8 in OATP1B1)
English: Antiemetics
Slovenian: Antiemetiki
English: The use of the CYP2B6 substrate efavirenz with CRESEMBA is contraindicated because efavirenz is a moderate inducer of CYP3A4/5 (see section 4.3).
Slovenian: Uporaba substrata CYP2B6 efavirenza skupaj z zdravilom CRESEMBA je kontraindicirana, saj je efavirenz zmeren induktor CYP3A4/5 (glejte poglavje 4.3).
English: Isavuconazole is an inducer of CYP2B6.
Slovenian: Izavukonazol je induktor CYP2B6.
English: Isavuconazole:
Slovenian: Izavukonazol:
English: Methadone (CYP3A4/5, 2B6 and 2C9 substrate)
Slovenian: Metadon (substrat CYP3A4/5, 2B6 in 2C9)
English: No CRESEMBA dose adjustment necessary; caution is advised as adverse drug reactions may increase.
Slovenian: Prilagajanje odmerkov zdravila CRESEMBA ni potrebno; potrebna je previdnost, saj se lahko neželeni učinki zdravila povečajo.
English: Co-administered medicinal product by therapeutic area
Slovenian: Sočasno uporabljeno zdravilo po terapevtskih področjih
English: After the reconstituted concentrate is further diluted, the diluted solution may show fine white-to-translucent particulates of isavuconazole that do not sediment (but will be removed by in-line filtration).
Slovenian: Po razredčenju rekonstituiranega koncentrata so v razredčeni raztopini lahko vidni drobni beli do prosojni delci izavukonazola, ki ne tvorijo usedline (se pa odstranijo z linijsko filtracijo).
English: - Capsule shell: hypromellose, water, red iron oxide (E172) (capsule body only), titanium dioxide (E171), gellan gum, potassium acetate, disodium edetate, sodium laurilsulfate.
Slovenian: - ovojnica kapsule: hipromeloza, voda, rdeči železov oksid (E172) (le v telesu kapsule), titanov dioksid (E171), gelanski gumi, kalijev acetat, dinatrijev edetat, natrijev lavrilsulfat.
English: Statins concentrations may increase.
Slovenian: Koncentracije statinov se lahko povečajo.
English: CRESEMBA capsules can be taken with or without food.
Slovenian: Kapsule CRESEMBA se lahko uporabljajo skupaj s hrano ali brez nje.
English: Severe cutaneous adverse reactions
Slovenian: Hude kožne neželene reakcije
English: Co-administration of CRESEMBA with medicinal products which are substrates of OCT2 may result in increased plasma concentrations of these medicinal products.
Slovenian: Sočasna uporaba zdravila CRESEMBA z zdravili, ki so substrati OCT2, lahko povzroči povečanje koncentracije teh zdravil v plazmi.
English: (UGT inhibition)
Slovenian: (inhibicija UGT)
English: Pharmacokinetics in special populations
Slovenian: Farmakokinetika pri posebnih skupinah bolnikov Pediatrični bolniki
English: CYP3A4/5 substrates including immunosuppressants
Slovenian: Substrati CYP3A4/5, vključno z imunosupresivi
English: Co-administration with ketoconazole (see section 4.5).
Slovenian: Sočasna uporaba s ketokonazolom (glejte poglavje 4.5).
English: Do not take this medicine after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete jemati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Isavuconazole concentrations may decrease (CYP3A induction by carbamazepine, phenytoin and long-acting barbiturates such as phenobarbital).
Slovenian: Koncentracije izavukonazola se lahko zmanjšajo (inhibicija CYP3A s karbamazepinom, fenitoinom in dolgodelujočimi barbiturati kot je fenobarbital).