FrancophonIA/ELRC3.0 huggingface dataset:
English: Capsule contents magnesium citrate (anhydrous) microcrystalline cellulose talc silica, colloidal anhydrous stearic acid
Maltese: Kontenut tal-kapsula magnesium citrate (anidru) microcrystalline cellulose talc silica, anidru, kollojdali stearic acid
English: CRESEMBA 100 mg hard capsules Isavuconazole
Maltese: CRESEMBA 100 mg kapsuli ibsin Isavuconazole
English: Other medicines and Cresemba
Maltese: Mediċini oħra u Cresemba
English: Medicinal products transported by BCRP
Maltese: Prodotti mediċinali trasportati b'BRCP
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.
Maltese: Suxxettibilità mnaqqsa għal sustanzi antifungali bi triazole ġiet assoċjata ma' mutazzjonijiet fil-ġeni fungali cyp51A u cyp51B kodifikanti għall-proteina fil-mira lanosterol 14-alpha demethylase involuta fil-bijosintesi ta' ergosterol.
English: Treatment of invasive aspergillosis
Maltese: Trattament għal asperġillosi invażiva
English: Monitoring of adverse reactions typical of statins is advised.
Maltese: Monitoraġġ hu rakkomandat għal reazzjonijiet avversi tipiċi ta' statins.
English: Mannitol Sulfuric acid (for pH-adjustment)
Maltese: Mannitol Sulfuric acid (għal aġġustament ta' pH)
English: In vitro / in vivo studies indicate that CYP3A4, CYP3A5, and subsequently uridine diphosphateglucuronosyltransferases (UGT), are involved in the metabolism of isavuconazole.
Maltese: Studji in vitro / in vivo jindikaw li CYP3A4, CYP3A5, u sussegwentement uridine diphosphateglucuronosyltransferases (UGT) huma involuti fil-metaboliżmu ta' isavuconazole.
English: Warfarin (CYP2C9 substrate)
Maltese: Warfarin (Sottostrat ta' CYP2C9)
English: The protocol-defined maximum treatment duration was 84 days.
Maltese: Iż-żmien massimu ta' trattament imfisser bil-protokoll kien ta' 84 jum.
English: Isavuconazole is a substrate of CYP3A4 and CYP3A5 (see section 5.2).
Maltese: Isavuconazole huwa sottostrat ta' CYP3A4 u CYP3A5 (ara sezzjoni 5.2).
English: The overall response in this population was n = 43 (35%) for isavuconazole and n = 42 (38.9%) for voriconazole.
Maltese: Ir-rispons globali f'din il-popolazzjoni kien n = 43 (35%) għal isavuconazole u n = 42 (38,9%) għal voriconazole.
English: Systemic exposure to medicinal products metabolised by CYP2B6 may be decreased when co-administered with CRESEMBA.
Maltese: L-esponiment sistemiku ta' prodotti mediċinali metabolizzati b'CYP2B6 jista' jitnaqqas meta jingħata flimkien ma' CRESEMBA.
English: In 9 patients with mucormycosis due to Rhizopus spp., 4 patients showed a favourable response to isavuconazole.
Maltese: F'9 pazjenti b'mukormikosi dovuti għal Rhizopus spp., 4 pazjenti wrew rispons favorevoli għal isavuconazole.
English: Oral midazolam: AUCinf: ↑ 103% Cmax: ↑ 72%
Maltese: Midazolam orali: AUCinf: ↑ 103% Cmax: ↑ 72%
English: Antiretroviral agents Lopinavir 400 mg / Ritonavir 100 mg (CYP3A4/5 strong inhibitors and substrates)
Maltese: Sustanzi antiretrovirali Lopinavir 400 mg / Ritonavir 100 mg (Impedituri qawwija u sottostrati ta' CYP3A4/5)
English: % decrease of the mean trough level values b)
Maltese: tnaqqis % tal-valuri tal-livelli medji l-aktar baxxi b)
English: Clinical efficacy has been demonstrated for the following Aspergillus species: Aspergillus fumigatus, A. flavus, A. niger, and A. terreus(see further below).
Maltese: Aspergillus fumigatus, A. flavus, A. niger, u A. terreus (ara aktar ‘l isfel).
English: Antiarrhythmics Digoxin (P-gp substrate)
Maltese: Antiarritmiċi Digoxin (Sottostrat ta' P-gp)
English: Cyclophosphamide (CYP2B6 substrate)
Maltese: Cyclophosphamide (sottostrat ta' CYP2B6)
English: Lipid-lowering agents Atorvastatin and other statins (CYP3A4 substrates e.g., simvastatin, lovastatin, rosuvastatin) (CYP3A4/5 and/or BCRP substrates))
Maltese: Sustanzi li jbaxxu l-lipidi Atorvastatin u statins oħra (sottostrati ta' CYP3A4 eż., simvastatin, lovastatin, rosuvastatin) (Sottostrati ta' CYP3A4/5 u/jew BRCP)
English: Table 2 presents adverse reactions with isavuconazole in the treatment of invasive fungal infections, by System Organ Class and frequency.
Maltese: Tabella 2 tirrapreżenta reazzjonijiet avversi b'isovuconazole fit-trattament ta' infezzjonijiet fungali invażivi, skont is-Sistema tal-Klassifika tal-Organi u l-frekwenza.
English: In animal models of disseminated and pulmonary aspergillosis, the pharmacodynamic (PD) index important in efficacy is exposure divided by minimum inhibitory concentration (MIC) (AUC/MIC).
Maltese: F'mudelli fuq annimali ta' asperġillosi mxerrda u pulmonari, l-indiċi farmakodinamika (pharmacodynamic, PD) importanti fl-effikaċja hu diviż skont l-espożizzjoni b'konċentrazzjoni impeditorja minima (minimum inhibitory concentration, MIC) (AUC/MIC).
English: What Cresemba is Cresemba is an anti-fungal medicine that contains the active substance isavuconazole.
Maltese: X'inhu Cresemba Cresema huwa mediċina antifungali li fiha s-sustanza attiva isavuconazole.
English: Delirium includes reactions of confusional state.
Maltese: Delirju jinkludi reazzjonijiet ta' stat konfużjonali.
English: Lopinavir/ritonavir: no dose adjustment for lopinavir 400 mg / ritonavir 100 mg every 12 hours required, but careful monitoring for any occurrence of lack of anti-viral efficacy.
Maltese: Lopinavir/ritonavir: mhu meħtieġ ebda aġġustament fid-doża għal lopinavir 400 mg/ritonavir 100 mg kull 12-il siegħa, iżda monitoraġġ attent għal kull każ ta' nuqqas ta' effikaċja antivirali.
English: Benzodiazepines Midazolam (CYP3A4/5 substrate)
Maltese: Benzodiazepines Midazolam (sottostrat ta' CYP3A4/5)
English: Germany
Maltese: Deutschland
English: AUC (h•ng/mL) Mean
Maltese: AUC (h•ng/mL) Medja
English: This is started 12 to 24 hours after your last starting dose.
Maltese: Din tinbeda 12 sa 24 siegħa wara l-aħħar doża tal-bidu tiegħek.
English: What Cresemba contains - The active substance is isavuconazole.
Maltese: X'fih Cresemba - Is-sustanza attiva hi isavuconazole.
English: - Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Maltese: - Linka tal-istampar: propylene glycol, potassium hydroxide, blaxk iron oxide (E172).
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.
Maltese: C] isavuconazonium sulfate filbniedem, minbarra l-porzjon attiv (isavuconazole) u l-prodott inattiv mill-ksur, ġew identifikati għadd ta' metaboliti minuri.
English: Chemical and physical in-use stability after reconstitution and dilution has been demonstrated for 24 hours at 2 °C to 8 °C, or 6 hours at room temperature.
Maltese: L-istabilità kimika u fiżika waqt l-użu wara r-rikostituzzjoni u d-dilwazzjoni ġew murija għal 24 siegħa f'temperaturi ta' 2 °C sa 8 °C, jew 6 sigħat f'temperatura tal-kamra.
English: Each carton contains 2 aluminium blisters pack, with 7 capsules each.
Maltese: Kull kartuna fiha 2 pakketti ta' folji tal-alumiju, b'7 kapsuli kull waħda.
English: The all-cause mortality at Day 42 in this population was 18.7% for isavuconazole and 22.2% for voriconazole.
Maltese: Il--mortalità dovuta minn kwalunkwe kawża f'Jum 42 f'din il-popolazzjoni kienet ta' 18.7% għal isavuconazole u 22.2% għal voriconazole.
English: Date of first authorisation: 15 October 2015.
Maltese: Data tal-ewwel awtorizzazzjoni: 15 Ottubru 2015
English: This medicinal product may pose a risk to the environment (see section 5.3).
Maltese: Dan il-prodott mediċinali jista' jkun ta' riskju għall-ambjent (ara sezjoni 5.3).
English: The concomitant administration of CRESEMBA and St John's wort is contraindicated.
Maltese: L-għoti fl-istess waqt ta' CRESEMBA u St John's Wort hu kontraindikat.
English: Herbal medicines St John's wort (strong CYP3A4/5 inducer)
Maltese: Mediċini ta' ħxejjex St John's wort (induttur qawwi ta' CYP3A4/5)
English: Ketoconazole is contraindicated (see section 4.3).
Maltese: Ketoconazole huwa kontraindikat (ara sezzjoni 4.3).
English: (BCRP inhibition)
Maltese: (impediment ta' BCRP)
English: - The other ingredients ingredients are: - Capsule content: magnesium citrate (anhydrous), microcrystalline cellulose, talc, anhydrous colloidal silica, stearic acid.
Maltese: - Kontenut tal-kapsula: magnesium citrate (anidru), microcrystalline cellulose, talc, silica, anidru kollojdali, stearic acid.
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%.
Maltese: L-għoti orali ta' CRESEMBA ekwivalenti għal 400 mg isavuconazole b'ikla b'ħafna grass naqqas isavuconazole Cmax b'9% u żied l-AUC b'9%.
English: Patients with familial short QT syndrome (see section 4.4).
Maltese: Pazjenti b'sindromu familjali ta' QT qasir (ara sezzjoni 4.4).
English: Your doctor should monitor you for possible side effects,
Maltese: It-tabib tiegħek ser jissorveljak għal effetti sekondarji possibbli,
English: Carbamazepine, phenobarbital and phenytoin (strong CYP3A4/5 inducers)
Maltese: Carbamazepine, phenobarbital u phenytoin (indutturi qawwija ta' CYP3A4/5)
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02AC05
Maltese: Antimijotiċi għal użu sistemiku, derivati ta' triazole, Kodiċi ATC:
English: How to store Cresemba 6.
Maltese: Kif taħżen Cresemba 6.
English: - The other ingredients (excipients) are mannitol (E421) and sulfuric acid.
Maltese: - Is-sustanzi l-oħra (eċċipjenti) huma mannitol (E421) u sulfuric acid.
English: A stable response was observed in an additional 10/35 patients (28.6%).
Maltese: Ġie osservat rispons stabbli f'10/35 pazjent addizzjonali (28,6%).
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].
Maltese: Irriżultat żieda fid-doża għal 600 mg f'differenza ta' LSM mill-plaċebo ta' 24.6 ms sagħtejn wara li ttieħdet id-doża [90% Cl: 28.7, 20.4 ms].
English: 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].
Maltese: Għal programm ta' kura b'doża ta' 200 mg, id-differenza fl-inqas medja kwadra (least squares mean, LSM), mill-plaċebo kienet ta' 13.1 ms wara sagħtejn li ttieħdet iddoża [90% CI: 17.1, 9.1 ms].
English: Marked elevations of liver transaminases > 10 × ULN developed in 1.2% of patients on isavuconazole.
Maltese: Livelli ferm ogħla ta' transaminases tal-fwied > 10 x ULN żviluppaw f'1.2% ta' pazjenti fuq isavuconazole.
English: Antigout agent Colchicine (P-gp substrate)
Maltese: Sustanza antigotta Colchicine (Sottostrat ta' P-gp)
English: Other anticancer agents (daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan) (BCRP substrates)
Maltese: Sustanzi oħra ta' kontra lkanċer (daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan) (Sottostrati ta' BCRP)
English: Hepatitis has been reported with azole antifungal agents including CRESEMBA.
Maltese: Ġiet irrappurtata epatite b'sustanzi antifungali li jkun fihom azole inkluż CRESEMBA.
English: 48 months
Maltese: 48 xahar
English: Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, have been reported during treatment with azole antifungal agents.
Maltese: Reazzjonijiet avversi severi tal-ġilda, bħas-Sindrome ta' Stevens-Johnson, ġew irrapportati waqt ittrattament b'sustanzi antifungali li fihom azole.
English: Antiemetics
Maltese: Antiemetiċi
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.
Maltese: Wara li doża waħda ta' 100 mg isavuconazole ġiet amministrata lil 32 pazjent b'insuffiċjenza talfwied ħafifa (Child-Pugh Klassi A) u 32 pazjent b'insuffiċjenza tal-fwied moderata (Child Pugh Klassi B), (16-il pazjent minn ġol-vina u 16-il pazjent b'mod orali għal kull klassi ta' Child-Pugh), lesponiment sistemiku għal medja tal-inqas kwadru (AUC) żdidiet b'64% fil-grupp ta' Child-Pugh Klassi A, u 84% fil-grupp ta' Child-Pugh Klassi B, meta mqabbla ma' 32 individwu magħżula skont leta u l-piż b'funzjoni fwied normali.
English: Efavirenz (CYP3A4/5 moderate inducer and CYP2B6 substrate)
Maltese: Efavirenz (induttur moderat ta' CYP3A4/5 u sottostrat ta' CYP2B6)
English: CRESEMBA is indicated in adults for the treatment of
Maltese: CRESEMBA hu indikat f'adulti għat-trattament ta'
English: - phenytoin, used for epilepsy, - St John's wort, a herbal medicine used for depression, - efavirenz, etravirine, used for HIV, - nafcillin, used for bacterial infections.
Maltese: - St John's wort, mediċina minn ħxejjex użata għal depressjoni, - efavirenz, etravirine, użati f'HIV, - nafcillin, użat għal infezzjoni batterika.
English: Prednisone (CYP3A4 substrate)
Maltese: Prednisone (sottostrati ta' CYP3A4)
English: (P-gp inhibition).
Maltese: (impediment ta' P-gp).
English: Nafcillin (moderate CY3A4/5 inducer)
Maltese: Nafcillin (induttur moderat ta' CY3A4/5)
English: CRESEMBA is contraindicated in patients with familial short QT syndrome (see section 4.3).
Maltese: CRESEMBA huwa kontraindikat f'pazjenti b'sindromu familjali ta' QT qasir (ara sezzjoni 4.3).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of isavuconazole/metabolites in milk (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fl-annimali wriet li kien hemm eliminazzjoni ta' isavuconazole/metaboliti fil-ħalib (ara sezzjoni 5.3).
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).
Maltese: Għal pazjenti b'mukormikosi probabbli jew provata kif imfisser mill-Kumitat ta' Reviżjoni tad-Dejta indipendenti (Data Review Committee, DRC), il-mortalità minħabba kwalunkwe kawża f'Jum 84 kien ta' 43.2% (16/37) għallpopolazzjoni globali ta' pazjenti, 42.9% (9/21) għal pazjenti b'mukormikosi li rċevew isavuconazole bħala trattament prinċipali, u 43.8% (7/16) għal pazjenti b'mukormikosi li rċevew isavuconazole u li kienu refrattorji għal, jew intolleranti għal, terapija antifungali li ngħatat qabel, (prinċipalment trattamenti b-ażati fuq amphotericin).
English: The infusion solution contains approximately 1.5 mg/mL isavuconazonium sulfate (corresponding to approximately 0.8 mg isavuconazole per mL).
Maltese: Is-soluzzjoni ta' infużjoni fiha madwar 1.5 mg/mL isavuconazonium sulfate (li jikkorispondi għal madwar 0.8 mg isavuconazole kull mL).
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.
Maltese: Isavuconazole juri effett fungiċidali billi jimblokka s-sintesi ta' ergosterol, komponent ewlieni fir-rita taċ-ċellula fungali, permezz tal-impediment tal-enzima lanosterol 14-alpha-demethylase dipendenti fuq cytochrome P-450 responsabbli għall-konverżjoni ta' lanosterol għal ergosterol.
English: Elevated liver transaminases have been reported in clinical studies (see section 4.8).
Maltese: Livelli ogħla ta' transaminases tal-fwied ġew irrapportati fi studji kliniċi (ara sezzjoni 4.8).
English: (CYP3A4 induction).
Maltese: (induzzjoni ta' CYP3A4).
English: Digoxin: serum digoxin concentrations should be monitored and used for titration of the digoxin dose.
Maltese: Digoxin: il-konċentrazzjonijiet ta' digoxin fis-serum għandhom jiġu mmonitorjati u użati għal titrazzjoni tad-doża ta' digoxin.
English: Indinavir was only studied after a single dose of 400 mg isavuconazole.
Maltese: Indinavir ġie studjat biss wara doża waħda ta' 400 mg isavuconazole.
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
Maltese: Sintomi rapportati bi frekwenza akbar f'dożi supraterapewtiċi ta' CRESEMBA (ekwivalenti għal isavuconazole 600 mg/jum) evalwati fi studju ta' QT milli fi grupp b'doża terapewtika (ekwivalenti għal doża ta' isavuconazole 200 mg/jum) kineu jinkludu: uġigħ ta' ras, sturdament, paraestesja, ħedla, disturb fl-attenzjoni, disgewsja, ħalq xott, dijarea, ipoestesija orali, remettar, fwawar sħan, ansjeta, irrikwitezza, palpitazzjonijiet, takikardja, fotofobija u artralġja
English: Isavuconazole is not readily dialysable (see section 4.2).
Maltese: Isavuconazole ma jiġix dijalizzat faċilment (ara sezzjoni 4.2).
English: Effects on drug concentrations / Geometric Mean Change (%) in AUC, Cmax (Mode of action)
Maltese: Bidla Ġeometrika Medja(%) f'AUC, Cmax (Mod ta' azzjoni)
English: The frequency of adverse reactions shown in Table 2 is based on data from 403 patients with invasive fungal infections treated with CRESEMBA in phase 3 studies.
Maltese: Il-frekwenza ta' reazzjonijiet avversi murija f'Tabella 2 hi bażata fuq dejta minn 403 pazjenti b'infezzjonijiet fungali invażivi trattati b'CRESEMBA fi studji ta' fażi 3.
English: The pharmacokinetics in paediatric patients (< 18 years) have not yet been evaluated.
Maltese: Il-farmakokinetiċi f'pazjenti pedjatriċi (<18-il sena) għadhom ma ġewx evalwati.
English: 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).
Maltese: Isavuconazole impedixxa l-kanal tal-potassju hERG u l-kanal tal-kalċju ta' tip L b'IC 50 ta' 5.82 µM u 6.57 µM rispettivament (34 u 38 darba is-Cmax tar-rabta mhux ma' proteina fid-doża massima rakkomandata fil-bniedem (maximum recommended human dose, [MRHD], rispettivament).
English: Switch to oral isavuconazole
Maltese: Meta taqleb għal isavuconazole orali
English: MMF: monitoring for MPArelated toxicities is advised.
Maltese: MMF: monitiraġġ għal tossiċitajiet marbuta ma' MPA rakkomandat.
English: Ritonavir (at doses >200 mg every 12 hours) (strong CYP3A4/5 inducer)
Maltese: Ritonavir (f'dożi ta' >200 mg kull 12-il siegħa) (induttur qawwi ta' CYP3A4/5)
English: Unimedic Pharma AB Tlf: +45 691 26521
Maltese: Tlf: +45 691 26521
English: Etravirine (moderate CYP3A4/5 inducer)
Maltese: Etravirine (induttur moderat ta' CYP3A4/5)
English: AUCtau: ↓ 31% Cmax: ↓ 33%
Maltese: ↓ 31% Cmax: ↓ 33%
English: Ethinyl oestradiol AUCinf: ↑ 8% Cmax: ↑ 14%
Maltese: Ethinyl oestradiol AUCinf: ↑ 8% Cmax: ↑ 14% Norenthindrone AUCinf: ↑ 16% Cmax: ↑ 6%
English: Omeprazole (CYP2C19 substrate and gastric pH )
Maltese: Omeprazole (Sottostrat ta' CYP2C19 u pH tal-istonku )
English: Unimedic Pharma AB Tlf: +47 85 29 50 42
Maltese: Tlf: +47 85 29 50
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.
Maltese: Kull pajp eżistenti li jwassal għal ġol-vina għandu jiġi flaxxjat b'soluzzjoni għall-injezzjoni ta' 9 mg/mL sodium chloride (0.9%) jew soluzzjoni ta' 50 mg/mL (5 %) ta' dextrose.
English: Pfizer ΕΛΛΑΣ A.E. Τηλ: +30 210 67 85 800
Maltese: Τηλ: +30 210 67 85 800
English: No clear correlation between in vitro MIC and clinical response for the different species (Aspergillus and Mucorales) could be established.
Maltese: Ma setgħet tiġi stabbilita ebda korrelazzjoni ċara bejn MIC in vitro u r-rispons kliniku għall-ispeċijiet differenti (Aspergillus u Mucorales).
English: (CYP3A4/5 or BCRP inhibition)
Maltese: (impedimenti ta' CYP3A4/5 jew BCRP)
English: Esomeprazole (CYP2C19 substrate and gastric pH )
Maltese: Esomeprazole (Sottostrat ta' CYP2C19 u pH tal-istonku )
English: (P-gp inhibition)
Maltese: (impediment ta' P-gp)
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.
Maltese: Fi studju kliniku, double-blind, każwali u kontrollat b'mod attiv b'516-il pazjent b'mard fungali invażiv ikkaġunat bl-ispeċi Aspergillus jew moffa filamentuża ieħor, ġew irrapportati transaminases tal-fwied għoljin (alanine aminotransferase jew aspartate aminotransferase) >3 x Limitu ta' Fuq tanNormal (Upper Limit of Normal, ULN) fi tmiem l-istudju ta' trattament f'4.4% ta' pazjenti li kienu rċevew CRESEMBA.
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.
Maltese: Isavuconazole jintrabat b'mod qawwi (> 99%) ma' proteini umani fil-plażma, prinċipalment ma' albumina.
English: CRESEMBA 100 mg hard capsules
Maltese: CRESEMBA 100 mg kapsuli ibsin
English: Each capsule contains 186.3 mg isavuconazonium sulfate, corresponding to 100 mg isavuconazole.
Maltese: Kull kapsula fiha 186.3 mg isavuconazole sulfate, li jikkorispondi għal 100 mg isavucanazole.
English: Common Thrombophlebitis^ Uncommon Circulatory collapse; Hypotension Respiratory, thoracic and mediastinal disorders Common Dyspnoea;^ Acute respiratory failure^ Uncommon Bronchospasm; Tachypnoea; Haemoptysis; Epistaxis Gastrointestinal disorders
Maltese: Falliment respiratorju akut^ Mhux komuni Bronkospażmu, Takipnea, Emoptisi; Epistassi Disturbi gastrointestinali Komuni
English: Except for the active moiety isavuconazole, no individual metabolite was observed with an AUC > 10% of total radio-labelled material.
Maltese: Għajr għall-porzjon attiv isavuconazole, l-ebda metabolit individwali ma ġie osservat b'AUC > 10% tal-materjal totali radjutikkettat.
English: Isavuconazole concentrations may decrease (CYP3A induction by carbamazepine, phenytoin and long-acting barbiturates such as phenobarbital).
Maltese: Il-konċentrazzjonijiet ta' isavuconazole jistgħu jonqsu (induzzjoni ta' CYP3A b'carbamazepine, phenytoin u barbiturati b'azzjoni fit-tul bħal phenobarbital).
English: Isavuconazole is a mild CYP2B6 inducer; co-administration of CRESEMBA may result in decreased plasma concentrations of CYP2B6 substrates.
Maltese: Isavuconazole huwa induttur ħafif ta' CYP2B6; l-għoti fl-istess waqt ta' CRESEMBA jista' jirriżulta fi tnaqqis tal-konċentrazzjonijiet tas-sottostrati ta' CYP2B6.
English: Medicinal products metabolised by CYP3A4/5
Maltese: Prodotti mediċinali metabolizzati b'CYP3A4/5
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).
Maltese: Isavuconium m'affettwax il-fertilità ta' firien irġiel jew nisa b'dożi orali sa 90 mg/kg/jum (2.3 darbiet id-doża ta' mateniment klinika bażata fuq tqabbil ta' mg/m2/jum).