natgillin/translations-raw huggingface dataset:
Unless your doctor tells you otherwise, do not take this medicine and tell your doctor or pharmacist if you are taking any of the following medicines: - rufinamide or other medicines which decrease the QT interval on the heart tracing (ECG), - aprepitant, used to prevent nausea and vomiting by cancer treatment, - prednisone, used for rheumatoid arthritis, - pioglitazone, used for diabetes.
Osim ako Vam liječnik ne kaže drugačije, nemojte uzimati ovaj lijek i obavijestite svog liječnika ili ljekarnika ako uzimate neki od sljedećih lijekova: - rufinamid ili druge lijekove koji skraćuju QT interval na snimci rada srca (EKG), - aprepitant, za sprječavanje mučnine i povraćanja kod liječenja raka, - prednizon, za liječenje reumatoidnog artritisa, - pioglitazon, za liječenje dijabetesa.
Problems while having Cresemba as drip into a vein Tell your doctor straight away if you notice any of the following side effects: - low blood pressure, feel short of breath, nausea, dizziness, headache, tingling, - your doctor may decide to stop the infusion.
Problemi kod primanja lijeka Cresemba infuzijom u venu (drip) Odmah se obratite liječniku ako primijetite bilo koju od sljedećih nuspojava: - niski krvni tlak, nedostatak zraka, mučninu, omaglicu, glavobolju, trnce - liječnik može odlučiti prekinuti infuziju.
For the strong CYP3A4 inhibitor lopinavir/ritonavir, a two-fold increase in isavuconazole exposure was observed.
Kod snažnog inhibitora CYP3A4 lopinavira/ritonavira, uočeno je dvostruko povećanje izloženosti izavukonazolu.
In rats, a dose-related increase in the incidence of zygomatic arch fusion was also noted in offspring (see section 4.6).
Kod mladunčadi štakora je uočeno i povećanje incidencije spajanja zigomatičnog luka, povezano s dozom lijeka (vidjeti dio 4.6).
Isavuconazole may increase the exposure of medicinal products that are P-gp substrates.
Izavukonazol može povećati izloženost lijekovimaa koji su supstrati za P-gp.
- Capsule shell: hypromellose, water, red iron oxide (E172) (capsule body only), titanium dioxide (E171), gellan gum, potassium acetate, disodium edetate, sodium laurilsulfate.
- Ovojnica kapsule: hipromeloza, voda, željezov oksid crveni (E172) (samo tijelo kapsule), titanijev dioksid (E171), gelan guma, kalijev acetat, dinatrijev edetat, natrijev laurilsulfat.
Starting dose for the first two days (48 hours) The recommended dose is one vial three times a day (every 8 hours).
Početna doza tijekom prva dva dana (48 sati) Preporučena doza je jedna bočica tri puta na dan (svakih 8 sati).
It is important to keep taking this medicine as long as your doctor tells you.
Vrlo je važno da lijek uzimate onoliko dugo koliko Vam to odredi liječnik.
See sections 4.2 and 4.4.
Vidjeti dijelove 4.2 i 4.4
Use in these patients is not recommended unless the potential benefit is considered to outweigh the risks.
Primjena u ovih bolesnika se ne preporučuje osim ako postoji potencijalna korist koja bi nadmašila rizike.
The recommended maintenance dose is two capsules (equivalent to 200 mg of isavuconazole) once daily, starting 12 to 24 hours after the last loading dose.
Preporučena doza održavanja su dvije kapsule (što odgovara količini od 200 mg izavukonazola) jedanput na dan, počevši 12 do 24 sata nakon zadnje udarne doze.
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 bolesnika koji su primali lijek CRESEMBA u ispitivanjima faze 3, kod njih 79 (20%) procijenjena stopa glomerularne filtracije (GFR) bila je niža od 60 mL/min/1,73 m2.
(UGT inhibition)
(Inhibicija UGT)
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.
Treba primijetiti da nije bilo ispitivanja utvrđivanja doza za mukormikozu, te su bolesnici primali dozu izavukonazola koja je jednaka onoj kod liječenja invazivne aspergiloza.
Capsule shell hypromellose water red iron oxide (E172) (capsule body only) titanium dioxide (E171) gellan gum potassium acetate disodium edetate sodium laurilsulfate
Ovojnica kapsule hipromeloza voda željezov oksid, crveni (E172) (samo tijelo kapsule) titanijev dioksid (E171) gelan guma kalijev acetat dinatrijev edetat natrijev laurilsulfat
Co-administration with high-dose ritonavir (>200 mg twice daily) is contraindicated, as at high doses ritonavir may induce CYP3A4/5 and decrease isavuconazole plasma concentrations (see section 4.3).
Istodobna primjena s visokom dozom ritonavira (>200 mg dvaput na dan) je kontraindicirana jer visoke doze ritonavira mogu inducirati CYP3A4/5 i smanjiti koncentracije izavukonazola u plazmi (vidjeti dio 4.3).
Co-administration of CRESEMBA with medicinal products which are substrates of OCT2 may result in increased plasma concentrations of these medicinal products.
Istodobna primjena lijeka CRESEMBA s lijekovima koji su supstrati za OCT2 može rezultirati povećanim koncentracijama ovih lijekova u plazmi.
Daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone or topotecan: careful monitoring for any occurrence of drug toxicity, and dose reduction if required.
Daunorubicin, doksorubicin, imatinib, irinotekan, lapatinib, mitoksantron ili topotekan: pažljivo praćenje radi mogućeg razvoja toksičnosti lijeka i po potrebi smanjenje doze.
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
Simptomi koji su prijavljeni češće kod supraterapijskih doza lijeka CRESEMBA (što odgovara dozi izavukonazola od 600 mg/dan) ocjenjivanih u ispitivanju QT intervala nego u skupini koja je primala terapijsku dozu (što odgovara dozi izavukonazola od 200 mg/dan) uključuju: glavobolju, omaglicu, parestezije, somnolenciju, poremećaj pažnje, disgeuziju, suhoću usta, proljev, oralnu hipoesteziju, povraćanje, navale vrućine, tjeskobu, nemir, palpitacije, tahikardiju, fotofobiju i artralgiju.
Co-administration with high-dose ritonavir (>200 mg every 12 hours) (see section 4.5).
Istodobna primjena s visokim dozama ritonavira (>200 mg svakih 12 sati) (vidjeti dio 4.5).
Table 2 presents adverse reactions with isavuconazole in the treatment of invasive fungal infections, by System Organ Class and frequency.
Tablica 2 prikazuje nuspojave izavukonazola u liječenju invazivnih gljivičnih infekcija, navedene prema klasifikaciji organskih sustava i učestalosti.
S-warfarin AUCinf: ↑ 11% Cmax: ↓ 12% R-warfarin AUCinf: ↑ 20% Cmax: ↓ 7%
S-varfarin AUCinf: ↑ 11% Cmax: ↓ 12% R-varfarin AUCinf: ↑ 20% Cmax: ↓ 7%
Concentrations of isavuconazole required to inhibit Aspergillus species and genera/species of the order Mucorales in vitro have been very variable.
Koncentracije izavukonazola potrebne za in vitro inhibiciju vrsta Aspergillus i rodova/vrsta reda Mucorales vrlo su različite.
Ritonavir at high doses may significantly decrease isavuconazole concentrations.
Visoke doze ritonavira mogu značajno smanjiti koncentracije izavukonazola.
Statins concentrations may increase.
Koncentracije statina mogu se povećati.
Vinca alkaloids (vincristine, vinblastine) (P-gp substrates)
Lijekovi protiv raka Vinka alkaloidi (vinkristin, vinblastin) (Supstrati za P-gp)
Tell your doctor straight away if you notice any of the following side effects: - severe blistering of the skin, mouth, eyes or genitals.
Odmah se obratite liječniku ako primijetite neku od sljedećih nuspojava: - jako stvaranje mjehura po koži, u ustima, očima ili spolovilu.
Women of child-bearing potential
Žene u reproduktivnoj dobi
The reconstituted solution should be inspected visually for particulate matter and discoloration.
Rekonstituiranu otopinu potrebno je vizualno pregledati na prisutnost čestica i promjenu boje.
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.
Infuzija se mora primjenjivati uporabom kompleta za infuziju s ugrađenim filtrom s mikroporoznom membranom izrađenom od polietersulfona (PES) i porama veličine od 0,2 μm do 1,2 μm.
Ciclosporin:
Ciklosporin:
Medicinal products transported by P-gp in the intestine
Lijekovi koji se prenose putem P-glikoproteina (P-gp) u crijevu
Table 2 Summary of adverse reactions by MedDRA System Organ Class and frequency
Tablica 2 Sažetak nuspojava prema MedDRA klasifikaciji organskih sustava i učestalosti
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.
Nakon rekonstitucije cijeli sadržaj rekonstituiranog koncentrata treba izvaditi iz bočice i dodati u infuzijsku vrećicu koja sadrži najmanje 250 mL 0,9%-tne (9 mg/ml) otopine natrijevog klorida za injekciju ili 5%-tne (50 mg/ml) otopine glukoze.
Other anticancer agents (daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan) (BCRP substrates)
Drugi lijekovi protiv raka (daunorubicin, doksorubicin, imatinib, irinotekan, lapatinib, mitoksantron, topotekan) (Supstrati za BCRP)
Medicinal products metabolised by CYP2B6
Lijekovi koji se metaboliziraju putem CYP2B6
7-hydroxymetabolite: AUCinf: ↑ 29% Cmax: ↑ 15%
7-hidroksi metabolit: AUCinf: ↑ 29% Cmax: ↑ 15%
Vinca alkaloids: careful monitoring for any occurrence of drug toxicity, and dose reduction if required.
Vinka alkaloidi: pažljivo praćenje radi mogućeg razvoja toksičnosti lijeka i po potrebi smanjenje doze.
Antiemetics
Antiemetici
No dose adjustment is warranted for moderate to mild CYP3A4/5 inhibitors.
Nije potrebna prilagodba doze kod umjerenih do slabih inhibitora CYP3A4/5.
CRESEMBA was administered intravenously (equivalent to 200 mg isavuconazole) every 8 hours for the first 48 hours, followed by once-daily intravenous or oral treatment (equivalent to 200 mg isavuconazole).
Lijek CRESEMBA primjenjivan je intravenski (što odgovara količini od 200 mg izavukonazola) svakih 8 sati u prvih 48 sati i zatim jedanput na dan intravenski ili peroralno (što odgovara količini od 200 mg izavukonazola).
Co-administration of CRESEMBA with the strong CYP3A4/5 inhibitor ketoconazole is contraindicated, since this medicinal product can significantly increase plasma concentrations of isavuconazole (see sections 4.3 and 4.5).
Istodobna primjena lijeka CRESEMBA sa snažnim inhibitorom CYP3A4/5 ketokonazolom je kontraindicirana, jer taj lijek može značajno povećati koncentracije izavukonazola u plazmi (vidjeti dijelove 4.3 i 4.5).
Lipid-lowering agents Atorvastatin and other statins (CYP3A4 substrates e.g., simvastatin, lovastatin, rosuvastatin) (CYP3A4/5 and/or BCRP substrates))
Lijekovi za snižavanje razine lipida Atorvastatin i drugi statini (supstrati za CYP3A4 npr. simvastatin, lovastatin, rosuvastatin) (supstrati za CYP3A4/5 i/ili BCRP))
Warfarin (CYP2C9 substrate)
Varfarin (supstrat za CYP2C9)
Hypersensitivity to isavuconazole may result in adverse reactions that include: hypotension, respiratory failure, dyspnoea, drug eruption, pruritus, and rash.
Preosjetljivost na izavukonazol može rezultirati nuspojavama koje uključuju: hipotenziju, zatajenje disanja, dispneju, izbijanje kožnih promjena uzrokovano lijekom, pruritus i osip.
Prednisolone (active metabolite): AUCinf: ↑ 8%
Prednizolon (aktivni metabolit): AUCinf: ↑ 8%
Elevated liver chemistry tests includes events of alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, hepatic function abnormal, hyperbilirubinemia, liver function test abnormal, and transaminases increased.
Povišene vrijednosti laboratorijskih nalaza jetre uključuju slučajeve povišene alanin aminotransferaze, povišene aspartat aminotransferaze, povišene alkalne fosfataze u krvi, povišenog bilirubina u krvi, povišene laktat dehidrogenaze u krvi, povišene gama-glutamiltransferaze, povišene jetrene enzime, poremećenu funkciju jetre, hiperbilirubinemiju, poremećene vrijednosti nalaza jetrene funkcije i povišene transaminaze.
- The other ingredients ingredients are: - Capsule content: magnesium citrate (anhydrous), microcrystalline cellulose, talc, anhydrous colloidal silica, stearic acid.
- Drugi sastojci su: - Sadržaj kapsule: magnezijev citrat (bezvodni), mikrokristalična celuloza, talk, silicijev dioksid, koloidni, bezvodni, stearatna kiselina.
Colchicine concentrations may increase.
Koncentracije kolhicina mogu se povećati.
Anticoagulants Dabigatran etexilate (P-gp substrate)
Antikoagulansi Dabigatraneteksilat (supstrat za P-gp)
For the 200 mg dosing regimen, the least squares mean (LSM) difference from placebo was 13.1 ms at 2 hours post dose [90% CI: 17.1, 9.1 ms].
Za režim liječenja dozom od 200 mg, razlika srednje vrijednosti procijenjene metodom najmanjih kvadrata (engl. least square mean, LSM) u odnosu na placebo bila je 13,1 ms 2 sata nakon primjene doze [90% CI: 17,1; 9,1 ms].
Isavuconazole is an inhibitor in vitro of BCRP, and plasma concentrations of substrates of BCRP may therefore be increased.
Izavukonazol je in vitro inhibitor BCRP-a, pa zbog toga koncentracije supstrata za BCRP u plazmi mogu biti povećane.
Isavuconazole inhibited the hERG potassium channel and the L-type calcium channel with an IC50 of 5.82 µM and 6.57 µM respectively (34- and 38-fold the human non-protein bound Cmax at maximum recommended human dose [MRHD], respectively).The in vivo 39-week repeated-dose toxicology studies in monkeys did not show QTcF prolongation at doses up to 40 mg/kg/day (2.1-fold the recommended clinical maintenance dose, based on mg/m2/day comparisons).
Izavukonazol je inhibirao hERG kalijev kanal i L-tip kalcijevog kanala s IC50 od 5,82 µM odnosno 6,57 µM (34 odnosno 38 puta veća Cmax nevezane frakcije za proteine u ljudi pri maksimalnoj preporučenoj dozi za čovjeka (engl. maximum recommended human dose, MRHD).
Antiretroviral agents Lopinavir 400 mg / Ritonavir 100 mg (CYP3A4/5 strong inhibitors and substrates)
Antiretrovirusni lijekovi Lopinavir 400 mg / ritonavir 100 mg (snažni inhibitori i supstrati za CYP3A4/5)
Immunosuppresants Ciclosporin, sirolimus, tacrolimus (CYP3A4/5 substrates)
Imunosupresivi Ciklosporin, sirolimus, takrolimus (supstrati za CYP3A4/5)
Dextrorphan (active metabolite): AUCinf: ↑ 4%
Dekstrorfan (aktivni metabolit): AUCinf: ↑ 4%
The recommended maintenance dose is one vial after reconstitution and dilution (equivalent to 200 mg of isavuconazole) once daily, starting 12 to 24 hours after the last loading dose.
Preporučena doza održavanja je jedna bočica nakon rekonstitucije i razrjeđivanja (što odgovara količini od 200 mg izavukonazola) jedanput na dan, počevši 12 do 24 sata nakon zadnje udarne doze.
Co-administration of CRESEMBA with medicinal products which are substrates of UGT may result in mildly increased plasma concentrations of these medicinal products.
Istodobna primjena lijeka CRESEMBA s lijekovima koji su supstrati za UGT može rezultirati blagim povećanjem koncentracija ovih lijekova u plazmi.
Isavuconazole is a mild CYP2B6 inducer; co-administration of CRESEMBA may result in decreased plasma concentrations of CYP2B6 substrates.
Izavukonazol je slab induktor CYP2B6; istodobna primjena lijeka CRESEMBA može rezultirati smanjenim koncentracijama supstrata CYP2B6 u plazmi.
Capsule contents magnesium citrate (anhydrous) microcrystalline cellulose talc silica, colloidal anhydrous stearic acid
Sadržaj kapsule magnezijev citrat (bezvodni) celuloza, mikrokristalična talk silicijev dioksid, bezvodni koloidni stearatna kiselina
Oral midazolam: AUCinf: ↑ 103% Cmax: ↑ 72%
Oralni midazolam: AUCinf: ↑ 103% Cmax: ↑ 72%
Do not puncture the blister containing the desiccant.
Nemojte bušiti blister u kojem se nalazi sredstvo za sušenje.
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).
Otopina za infuziju mora se primijeniti pomoću kompleta za infuziju s ugrađenim filtrom (veličina pora 0,2 μm do 1,2 μm) izrađenim od polietersulfona (PES).
The recommended loading dose is two capsules (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total).
Preporučena udarna doza su dvije kapsule (što odgovara količini od 200 mg izavukonazola) svakih 8 sati u prvih 48 sati (ukupno 6 primjena).
Short-acting opiate concentrations may increase.
Koncentracije opijata s kratkotrajnim djelovanjem se mogu povećati.
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.
Postojeću intravensku liniju treba ispirati 0,9%-tnom (9 mg/mL) otopinom natrijevog klorida za injekciju ili 5%-tnom (50 mg/mL) otopinom glukoze.
Daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan concentrations may increase.
Koncentracije daunorubicina, doksorubicina, imatiniba, irinotekana, lapatiniba, mitoksantrona i topotekana se mogu povećati.
adjustment if required.
OD LIJEKA, AKO JE POTREBNO
Cyclophosphamide concentrations may decrease.
Koncentracije ciklofosfamida mogu se smanjiti.
Based on these findings, intravenous and oral dosing can be used interchangeably.
Na temelju ovih rezultata, moguć je prelazak s intravenskog na oralno doziranje, i obrnuto.
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 u velikoj mjeri veže (> 99%) na proteine ljudske plazme, prije svega na albumin.
Cyclophosphamide: careful monitoring for any occurrence of lack of efficacy, and dose increase if required..
Ciklofosfamid: pažljivo praćenje radi mogućeg izostanka djelotvornosti i po potrebi povećanje doze.
The use of the CYP2B6 substrate efavirenz with CRESEMBA is contraindicated because efavirenz is a moderate inducer of CYP3A4/5 (see section 4.3).
Primjena supstrata CYP2B6 efavirenza s lijekom CRESEMBA je kontraindicirana, jer je efavirenz umjereni induktor CYP3A4/5 (vidjeti dio
Isavuconazole : AUCtau : ↓ 90% Cmax : ↓ 75%
Izavukonazol: AUCtau: ↓ 90% Cmax: ↓ 75%
- Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
- Tinta za označavanje: šelak, propilenglikol, kalijev hidroksid, željezov oksid crni (E172).
(CYP2B6 induction)
(indukcija CYP2B6)
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.
Jednu bočicu praška za koncentrat za otopinu za infuziju potrebno je rekonstituirati dodavanjem 5 mL vode za injekcije u bočicu.
EUCAST MIC breakpoints are defined for the following species (susceptible S; resistant R):
Prema EUCAST-u (European Committee on Antimicrobial Susceptibility Testing) granične vrijednosti minimalnih inhibitornih koncentracija (MIK) utvrđene su za sljedeće vrste (S - osjetljiva; Rrezistentna):
Breast-feeding should be discontinued during treatment with CRESEMBA.
Tijekom terapije lijekom CRESEMBA dojenje treba prekinuti.
Short-acting opiates (alfentanyl, fentanyl) (CYP3A4/5 substrate)
Opijati s kratkotrajnim djelovanjem (alfentanil, fentanil) (supstrat za CYP3A4/5)
CRESEMBA is also available as hard capsules containing 100 mg isavuconazole, equivalent to 186 mg isavuconazonium sulfate.
CRESEMBA je dostupna i u obliku tvrdih kapsula koje sadrže 100 mg izavukonazola, što odgovara količini od 186 mg izavukonazonijevog sulfata.
CYP3A4/5 substrates including immunosuppressants
Supstrati CYP3A4/5 uključujući imunosupresive
Other protease inhibitors (e.g., amprenavir, nelfinavir) (CYP3A4/5 strong or moderate inhibitors and substrates)
Drugi inhibitori proteaze (npr. amprenavir, nelfinavir) (jaki ili umjereni inhibitori i supstrati za CYP3A4/5)
Other NNRTI (e.g., delavirdine, and nevirapine) (CYP3A4/5 and 2B6 inducers and substrates)
Drugi NNRTI (npr. delavirdin i nevirapin) (Induktori i supstrati za CYP3A4/5 i 2B6)
One vial of the powder for concentrate for solution for infusion should be reconstituted by addition of 5 mL water for injection to the vial.
Jednu bočicu praška za koncentrat za otopinu za infuziju potrebno je rekonstituirati dodavanjem 5 mL vode za injekciju u bočicu.
Benzodiazepines Midazolam (CYP3A4/5 substrate)
Benzodiazepini Midazolam (supstrat za CYP3A4/5)
The concomitant administration of CRESEMBA and ketoconazole is contraindicated.
Istodobna primjena lijeka CRESEMBA i ketokonazola je kontraindicirana.
The recommended loading dose is one vial after reconstitution and dilution (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total).
Preporučena udarna doza je jedna bočica nakon rekonstitucije i razrjeđivanja (što odgovara količini od 200 mg izavukonazola) svakih 8 sati u prvih 48 sati (ukupno 6 primjena).
Co-administration of medicinal products which are inducers of CYP3A4 and/or CYP3A5 may decrease the plasma concentrations of isavuconazole.
Istodobna primjena lijekova koji su induktori CYP3A4 i/ili CYP3A5 može sniziti koncentracije izavukonazola u plazmi.
Talk to your doctor, pharmacist or nurse before using Cresemba: - if you have had an allergic reaction to other ‘azole' anti-fungal treatments in the past, such as ketoconazole, fluconazole, itraconazole, voriconazole or posaconazole, - if you are suffering from severe liver disease.
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite lijek Cresemba: - ako ste ranije imali alergijsku reakciju na druge “azolne” lijekove protiv gljivica poput ketokonazola, flukonazola, itrakonazola, vorikonazola ili posakonazola, - ako bolujete od teške bolesti jetre.
Co-administered medicinal product by therapeutic area
Istodobno primijenjeni lijekovi prema terapijskom području
Antiarrhythmics Digoxin (P-gp substrate)
Antiaritmici Digoksin (Supstrat za P-gp)
Smoking cessation aids Bupropion (CYP2B6 substrate)
Lijekovi kao pomoć za prestanak pušenja Bupropion (supstrat za CYP2B6)
(P-gp inhibition).
(Inhibicija P-gp).
CRESEMBA 100 mg hard capsules
CRESEMBA 100 mg tvrde kapsule
Co-administration of medicinal products which are inhibitors of CYP3A4 and/or CYP3A5 may increase the plasma concentrations of isavuconazole.
Istodobna primjena lijekova koji su inhibitori CYP3A4 i/ili CYP3A5 može povećati koncentracije izavukonazola u plazmi.
Intravenous administration of
Intravenska primjena
Isavuconazole: AUCtau: ↑ 8% Cmax: ↑ 5%
Izavukonazol: AUCtau: ↑ 8% Cmax: ↑ 5%
Efavirenz concentrations may decrease.
Koncentracije efavirenza mogu se smanjiti.
Blister for 100 mg hard capsules
Blister za tvrde kapsule od 100 mg
Ethinyl oestradiol AUCinf: ↑ 8% Cmax: ↑ 14%
Etinilestradiol AUCinf: ↑ 8% Cmax: ↑ 14% Noretindron
Isavuconazole: AUCtau: ↑ 422% Cmax: ↑ 9%
Izavukonazol: AUCtau: ↑ 422% Cmax: ↑ 9%
Isavuconazole is a moderate inhibitor of CYP3A4/5; co-administration of CRESEMBA with medicinal products which are substrates of CYP3A4/5 may result in increased plasma concentrations of these medicinal products.
Izavukonazol je umjereni inhibitor CYP3A4/5; istodobna primjena lijeka CRESEMBA s lijekovima koji su supstrati za CYP3A4/5 može rezultirati povećanim koncentracijama tih lijekova u plazmi.
Each capsule contains 186.3 mg isavuconazonium sulfate, corresponding to 100 mg isavuconazole.
Jedna kapsula sadrži 186,3 mg izavukonazonijevog sulfata što odgovara količini od 100 mg izavukonazola.
Efavirenz (CYP3A4/5 moderate inducer and CYP2B6 substrate)
Efavirenz (umjereni induktor za CYP3A4/5 i supstrat za CYP2B6)