FrancophonIA/ELRC3.0 huggingface dataset:
English: Isavuconazole was negative in a bacterial reverse mutation assay, was weakly clastogenic at cytotoxic concentrations in the L5178Y tk+/- mouse lymphoma chromosome aberration assay, and showed no biologically relevant or statistically significant increase in the frequency of micronuclei in an in vivo rat micronucleus test.
Maltese: Isavuconazole kien negattiv f'assaġġ batteriku ta' mutazzjoni inversa, kien klastoġeniku b'mod dgħajjef f'konċentrazzjonijiet ċitotossiċi tal-assaġġ ta' aberazzjoni kromosomali ta' limfoma tal-ġurdien L5178Y th+/-, u ma wera l-ebda żieda bijoloġikament rilevanti jew statistikament sinjifikanti ta' mikronuklei f'test ta' mikronukleju tal-far in vivo.
English: Ciclosporin, sirolimus, tacrolimus: monitoring of plasma levels and appropriate dose adjustment if required.
Maltese: Ciclosporin, sirolimus, tacrolimus: monitoraġġ tal-livelli ta' plażma u aġġustamenti xierqa fid-doża jekk meħtieġ.
English: CRESEMBA is also available as powder for concentrate for solution for infusion containing 200 mg isavuconazole, equivalent to 372 mg isavuconazonium sulfate.
Maltese: CRESEMBA jiġi wkoll bħala trab għal konċentrat għal soluzzjoni għall-infużjoni li fih 200 mg isavuconazole, ekwivalenti għal 372 mg isavuconazonium sulfate.
English: Isavuconazole is a mild inhibitor of P-glycoprotein (P-gp); co-administration with CRESEMBA may result in increased plasma concentrations of P-gp substrates.
Maltese: Isavuconazole huwa impeditur ħafif ta' P-glycoprotein (P-gp); l-għoti flimkien ma' CRESEMBA jista' jirriżulta f'żieda fil-konċentrazzjonijiet ta' sottostrati ta' P-gp fil-plażma.
English: In the intent-to-treat (ITT) population, 258 patients received isavuconazole and 258 patients received voriconazole.
Maltese: Fil-popolazzjoni maħsuba għal trattament (intent-to-treat, ITT) 258 pazjent irċevew isavuconazole u 258 pazjent irċevew voriconazole.
English: For other strong CYP3A4/5 inhibitors, a less pronounced effect can be expected.
Maltese: Għal impedituri qawwijin oħrajn ta' CYP3A4/5, huwa mistenni effett inqas notevoli.
English: 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.
Maltese: Isavuconazole huwa impeditur moderat ta' CYP3A4/5; l-għoti ta' CRESEMBA flimkien ma' prodotti mediċinali li huma sottostrati ta' CYP3A4/5 jista' jirriżulta f'konċentrazzjonijiet ogħla ta' dawn ilprodotti mediċinali fil-plażma.
English: CRESEMBA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: CRESEMBA ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh KLassi Ċ).
English: Medicinal products transported by P-gp in the intestine
Maltese: Prodotti mediċinali trasportati b'P-gp fl-imsaren
English: AUCinf = area under the plasma concentration-time profiles extrapolated to infinity; AUCtau = area under the plasma concentration-time profiles during the 24 h interval at steady state; Cmax = peak plasma concentration; Cmin,ss = trough levels at steady state.
Maltese: AUCinf = żona taħt il-profili ta' konċentrazzjoni fil-plażma mal-ħin estrapolati għal infinità; AUCtau = żona taħt il-profili ta' konċentrazzjoni fil-plażma mal-ħin matul l-intervall ta' 24 siegħa fi stat fiss; Cmax = l-aktar konċentrazzjoni għolja fil-plażma; Cmin,ss = livelli l-aktar baxxi fi stat fiss.
English: Isavuconazole: AUCtau: ↑ 8% Cmax: ↑ 5%
Maltese: AUCtau: ↑ 8% Cmax: ↑ 5%
English: In 5 patients with mucormycosis due to Rhizomucor spp., no favourable responses were observed.
Maltese: F'5 pazjenti b'mukormikosi minħabba Rhizomucor spp., ma ġie osservat l-ebda rispons favorevoli.
English: CYP2B6 substrates
Maltese: Sottostrati ta' CYP2B6
English: Interactions between isavuconazole and co-administered medicinal products are listed in Table 1 (increase is indicated as “↑”, decrease as “↓”), ordered by therapeutic class.
Maltese: Interazzjonijiet bejn isavuconazole u prodotti mediċinali mogħtija fl-istess waqt huma elenkati f'tabella 1 (żieda hi indikata b'“↑”, tnaqqis b'“↓”), mqiegħda skont il-klassi terapewtika.
English: 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).
Maltese: CRESEMBA ġie mogħti ġol-vina (ekwivalenti għal 200 mg isavuconazole) kull 8 sigħat għall-ewwel 48 siegħa, segwit minn trattament ġol-vina jew orali (ekwivalenti għal 200 mg isavuconazole) darba kuljum.
English: 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.
Maltese: Testijiet kimiċi tal-fwied elevati jinkludu każijiet ta' żieda f'alanine aminotransferase, żieda f'aspartate aminotransferase, żieda f'alkaline phosphatase fid-demm, żieda tal-bilirudina fid-demm, żieda fil-lactate dehydrogenase fid-demm, żieda fil-gamma-glutamyltransferase, żieda fl-enzima epatika, funzjoni abnormali epatika, iperbilirubinemija, test tal-funzjoni tal-fwied abnormali u żieda fi transaminases.
English: On the basis of the high oral bioavailability (98%, see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Maltese: Abbażi tal-bijodisponibilità orali għolja (98%, ara sezzjoni 5.2), il-qlib bejn it-teħid ġol-vini u t-teħid orali ikun xieraq meta klinikament indikat.
English: Daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone or topotecan: careful monitoring for any occurrence of drug toxicity, and dose reduction if required.
Maltese: Daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone jew topotecan: monitoraġġ mill-qrib għal kull każ ta' tossiċità tal-mediċina, u tnaqqis fid-doża jekk meħtieġ.
English: Each capsule contains 100 mg isavuconazole (as 186.3 mg isavuconazonium sulfate).
Maltese: Kull kapsula fiha 100 mg isavuconazole (bħala 186.3 mg isavucanazonium sulfate).
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).
Maltese: L-ebda aġġustament mhu meħtieġ f'pazjenti b'indeboliment ħafif jew moderat (Child-Pugh A u B) (ara sezzjonijiet 4.4 u 5.2).
English: Following oral administration of radio-labelled isavuconazonium sulfate to healthy subjects, a mean of 46.1% of the radioactive dose was recovered in faeces, and 45.5% was recovered in urine.
Maltese: Wara l-għoti orali ta' isavuconazonium sulfate radjutikkettat lil individwi b'saħħithom, medja ta' 46.1% tad-doża radjutikkettata kienet irkuprata fl-ippurgar, u 45.5% kienet irkuprata fl-awrina.
English: 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.
Maltese: Id-doża ta' manteniment rakkomandata hi ta' żewġ kapsuli (ekwivalenti għal 200 mg ta' isavuconazole) darba kuljum, li jibdew 12 sa 24 siegħa wara l-aħħar doża inizjali.
English: - cyclophosphamide, used for cancer, - digoxin, used to treat heart failure or an uneven heart beat, - colchicine, used for gout attack, - dabigatran etexilate, used to stop blood clots after hip or knee replacement surgery, - clarithromycin, used for bacterial infections, - saquinavir, amprenavir, nelfinavir, indinavir, delavirdine, nevirapine, lopinavir/ritonavir combination, used for HIV, - alfentanil, fentanyl, used against strong pain, - vincristine, vinblastine, used for cancer, - mycophenolate mofetil (MMF), used in transplant patients, - midazolam, used for severe insomnia and stress, - bupropion, used for depression, - metformin, used for diabetes, - daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan, used for different sorts of cancer.
Maltese: - saquinavir, amprenavir, nelfinavir, indinavir, delavirdine, nevirapine, lopinavir/ritonavir combination, użati għal HIV, - alfentanil, fentanyl, użati kontra uġigħ qawwi, - vincristine, vinblastine, użat għal kanċer, - mycophenolate mofetil (MMF), użat f'pazjenti bi trapjant, - midazolam: użat f'każ sever ta' nuqqas ta' rqadt u stress, - bupropion, użat għal depressjoni, - metformin, użat għad-dijabete, - daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan użati għal tipi differenti ta' kanċer.
English: The myITT population comprised 123 patients receiving isavuconazole and 108 patients receiving voriconazole.
Maltese: Ilpopolazzjoni myITT kienet tikkonsisti minn 123 pazjent li rċevew isavuconazole u 108 pazjent li rċevew voriconazole.
English: Each vial contains 200 mg isavuconazole (as 372.6 mg isavuconazonium sulfate).
Maltese: Kull kunjett fih 200 mg isavuconazole (bħala 372.6 mg isavucanazonium sulfate).
English: Hypersensitivity to isavuconazole may result in adverse reactions that include: hypotension, respiratory failure, dyspnoea, drug eruption, pruritus, and rash.
Maltese: Sensittività eċċessiva għal isavuconazole tista' tirriżulta f'reazzjonijiet avversi li jinkludu: pressjoni baxxa, falliment respiratorju, dispnea, eruzzjoni tal-mediċina, ħakk u raxx.
English: Isavuconazole: AUCtau: ↑ 422% Cmax: ↑ 9%
Maltese: AUCtau: ↓ 422% Cmax: ↑ 9%
English: What you need to know before you take Cresemba 3.
Maltese: X'għandek tkun taf qabel ma tieħu Cresemba 3.
English: Isavuconazole is the active moiety formed after oral or intravenous administration of isavuconazonium sulfate (see section 5.2).
Maltese: Isavuconazole huwa l-porzjon attiv iffurmat wara l-għoti orali jew ġol-vina ta' isavuconazonium sulfate (ara sezzjoni 5.2).
English: Table 3Steady state pharmacokinetic parameters of isavuconazole following oral administration of CRESEMBA Parameter Statistic
Maltese: Tabella 3 Parametri farmakokinetiċi fl-istat fiss ta' isavuconazole wara l-għoti orali ta' CRESEMBA
English: Potential of medicinal products to affect the pharmacokinetics of isavuconazole
Maltese: Prodotti mediċinali potenzjali li jistgħu jaffettwaw il-farmakokinetiċi ta' isavuconazole
English: Daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan concentrations may increase.
Maltese: Il-konċentrazzjonijiet ta' daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan jistgħu jiżdiedu.
English: Each vial contains 200 mg isavuconazole (as 372.6 mg isavuconazonium sulfate)
Maltese: Kull kunjett fih 200 mg isavuconazole (bħala 372.6 mg isavucanazonium sulfate)
English: Short-acting opiates (alfentanyl, fentanyl) (CYP3A4/5 substrate)
Maltese: Opjati li jaġixxu għal żmien qasir (alfentanyl, fentanyl) (sottostrat ta' CYP3A4/5)
English: Pioglitazone (mild CYP3A4/5 inducer)
Maltese: Pioglitazone (induttur ħafif ta' CYP3A4/5)
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).
Maltese: L-użu tas-sottostrat CYP2B6 efavirenz ma' CRESEMBA hu kontraindikat peress li efavirenz huwa induttur moderat ta' CYP3A4/5 (ara sezzjoni 4.3).
English: Each hard capsule contains 100 mg isavuconazole (as 186.3 mg isavuconazonium sulfate)
Maltese: Kull kapsula iebsa fiha 100 mg isavuconazole (bħala 186.3 mg isavucanazonium sulfate)
English: Ethinyl oestradiol and norethindrone: no dose adjustment required.
Maltese: Ethinyl oestradiol u norenthindrone: mhu meħtieġ ebda aġġustament fiddoża.
English: Carton for 100 mg hard capsules
Maltese: Kartuna ta' 100 mg kapsuli ibsin
English: CYP3A4/5 substrates including immunosuppressants
Maltese: Sottostrati ta' CYP3A4/5 li jinkludu immunosoppressanti
English: 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).
Maltese: Id-doża rakkomandata tal-bidu hija ta' kunjett wieħed wara r-rikostituzzjoni u dilwazzjoni (ekwivalenti għal 200 mg isavuconazole) kull 8 sigħat għal tal-inqas 48 siegħa (6 għotjiet b'kollox).
English: Anticonvulsants
Maltese: Antikonvulżanti
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.
Maltese: Mill-403 pazjent li rċevew CRESEMBA fl-istudji ta' Fażi 3, 79 (20%) tal-pazjenti kienu stmati li kellhom rata ta' filtrazzjoni glomerulari (glomerular filtration rate, GFR) inqas minn 60 mL/min/1.73m2.
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).
Maltese: Is-soluzzjoni għall-infużjoni għandha tiġi mogħtija permezz ta' sett tal-infużjoni b'filter ġol-pajp (daqs tat-toqba 0.2 μm sa 1.2 μm) magħmul minn polyether sulfone (PES).
English: Look out for side effects
Maltese: Oqgħod attent għal effetti sekondarji
English: Oral contraceptives Ethinyl oestradiol and norethindrone
Maltese: Kontraċettivi orali Ethinyl oestradiol u norenthindrone (sottostrati ta' CYP3A4/5)
English: CRESEMBA is also available as hard capsules containing 100 mg isavuconazole, equivalent to 186 mg isavuconazonium sulfate.
Maltese: CRESEMBA jiġi wkoll f'kapsuli ibsin li fihom 100 mg isavuconazole, ekwivalenti għal 186 mg isavuconazonium sulfate.
English: Median treatment duration was 84 days for the overall mucormycosis patient population, and 102 days for the 21 patients not previously treated for mucormycosis.
Maltese: Iżżmien ta' trattament medjan kien ta' 84 jum għall-popolazzjoni globali ta' pazjenti b'mukormikosi, u 102 jiem għall-21 pazjent li ma ġewx ikkurati qabel għal mukormikosi.
English: Co-administration with strong CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, longacting barbiturates (e.g. phenobarbital), phenytoin and St. John's wort or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine (see section 4.5).
Maltese: L-għoti fl-istess waqt b'indutturi qawwija ta' CYP3A4/5 bħal rifampicin, rifabutin, carbamazepine, barbiturati li jaġixxu fit-tul (eż. phenobarbital),phenytoinu St.
English: Midazolam: careful monitoring of clinical signs and symptoms recommended, and dose reduction if required.
Maltese: Midazolam: monitoraġġ attent ta' sinjali u sintomi kliniċi rakkomandat, u tnaqqis fid-doża jekk meħtieġ.
English: Co-administration of CRESEMBA with medicinal products which are substrates of OCT2 may result in increased plasma concentrations of these medicinal products.
Maltese: L-għoti ta' CRESEMBA flimkien ma' prodotti mediċinali li huma sottostrati ta' OCT2 jista' jirriżulta f'konċentrazzjonijiet ogħla ta' dawn il-prodotti mediċinali fil-plażma.
English: One 10 mL Type I glass vial with rubber stopper and an aluminum cap with plastic seal.
Maltese: Kunjett ta' 10 mL, ta' ħġieġ Tip I b'tapp tal-lastku u għatu tal-aluminju b'siġill tal-plastik.
English: Antifungals
Maltese: Antokoagulanti
English: The overall response at end-of-treatment (EOT) in the myITT population (patients with proven and probable invasive aspergillosis based on cytology, histology, culture or galactomannan testing) was assessed by an independent blinded Data Review Committee.
Maltese: Ir-rispons globali fi tmiem it-trattament (end of treatment, EOT) fil-popolazzjoni myITT (pazjenti b'asperġillosi invażiva provata u probabbli bażata fuq testijiet ċitoloġiċi, istoloġiċi, kultura jew galactomannan) kien assessjat minn Kumitat ta' Reviżjoni tad-Dejta indipendenti u mogħmi.
English: Anticoagulants Dabigatran etexilate (P-gp substrate)
Maltese: Dabigatran etexilate (Sottostrat ta' P-gp)
English: Co-administration of CRESEMBA with potent CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long-acting barbiturates (e.g., phenobarbital), phenytoin and St. John's wort, or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine, is contraindicated, since these medicinal products can significantly decrease plasma concentrations of isavuconazole (see section 4.3).
Maltese: John's wort jew b'indutturi moderati ta CYP3A4/5 bħal efavirenz, nafcilin u etravirine hu kontraindikat peress li dawn il-prodotti mediċinali jistgħu jnaqqsu b'mod sinifikanti l-konċentrazzjonijiet ta' isavuconazole filplażma (ara sezzjoni 4.3).
English: Vinca alkaloids: careful monitoring for any occurrence of drug toxicity, and dose reduction if required.
Maltese: Alkalojdi vinca: monitoraġġ attent għal kull każ ta' tossiċità tal-mediċina, u tnaqqis fid-doża jekk meħtieġ.
English: Co-administration with high-dose ritonavir (>200 mg every 12 hours) (see section 4.5).
Maltese: L-għoti fl-istess waqt ma' doża qawwija ta' -ritonavir (>200 mg kull 12-il siegħa) (ara sezzjoni 4.5).
English: During intravenous administration of isavuconazole, infusion-related reactions including hypotension, dyspnoea, dizziness, paraesthesia, nausea, and headache were reported (see section 4.8).
Maltese: Waqt l-għoti ta' isavuconazole ġol-vina, ġew irrapportati reazzjonijiet relatati mal-infużjoni li jinkludu pressjoni baxxa, dispnea, sturdament, paraestesija, dardir u uġigħ ta' ras (ara sezzjoni 4.8).
English: Saquinavir (strong CYP3A4 inhibitor)
Maltese: Saquinavir (impeditur qawwi ta' CYP3A4)
English: Methotrexate: AUCinf: ↓ 3% Cmax: ↓ 11%
Maltese: AUCinf: ↓ 3% Cmax: ↓ 11%
English: Rifabutin (strong CYP3A4/5 inducer)
Maltese: Rifabutin (induttur qawwi ta' CYP3A4/5)
English: 40% reduction in terminal half-life R-methadone (active opiate isomer).
Maltese: R-methadone (isomeru ta' opiate attiv).
English: After reconstitution, the entire content of the reconstituted concentrate should be removed from the vial and added to an infusion bag containing at least 250 mL of either sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) dextrose solution.
Maltese: Wara r-rikostituzzjoni, il-kontenut kollu tal-konċentrat rikostitwit għandu jitneħħa mill-kunjett u jiġi miżjud ġo borża tal-infużjoni li jkun fiha tal-anqas 250 mL ta' jew soluzzjoni għal injezzjoni ta' 9 mg/mL (0.9%) sodium chloride jew 50 mg/mL (5 %) soluzzjoni ta' dextrose.
English: Cresemba 200 mg powder for concentrate for solution for infusion Isavuconazole
Maltese: CRESEMBA 200 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Isavuconazole
English: Other protease inhibitors (e.g., amprenavir, nelfinavir) (CYP3A4/5 strong or moderate inhibitors and substrates)
Maltese: Impedituri qawwija oħrajn (eż. amprenavir, nelfinavir) (Impedituri qawwija jew moderati u sottostrati ta' CYP3A4/5)
English: The clinical data for isavuconazole in the treatment of mucormycosis are limitedto one prospective non-controlled clinical study in 37 patients with proven or probable mucormycosis who received isavuconazole for primary treatment, or because other antifungal treatments (predominantly amphotericin B) were inappropriate.
Maltese: It-tagħrif kliniku dwar isavuconazole fit-trattament ta' mukormikosi huwa limitat għal studju kliniku prospettiv wieħed mingħajr kontrolli fuq 37 pazjent b'mukormikosi kkonfermata jew probabbli li rċevew isavuconazole għal trattament primarju, jew minħabba li trattamenti antifungali oħrajn (prinċipalment amphotericin B) ma kinux adattati.
English: Common Renal failure
Maltese: GĦAMLA KWALITATTIVA
English: CRESEMBA.
Maltese: Pożoloġija
English: • mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1)
Maltese: • mukormikosi f'pazjenti li għalihom amphotericin B mhuwiex adattat (ara sezzjonijiet 4.4 u 5
English: Studies in healthy subjects have demonstrated that the pharmacokinetics of isavuconazole are proportional up to 600 mg per day.
Maltese: Studji minn individwi b'saħħithom urew li l-farmakokinetiċi ta' isavuconazole huma proporzjonali sa 600 mg kuljum.
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.
Maltese: L-għoti ta' isavuconazonium sulfate fil-firien f'doża ta' 90 mg/kg/jum (2.3 darbiet id-doża ta' manteniment fil-bniedem [200 mg] bażata fuq mg/m2/jum) waqt it-tqala sal-perjodu tal-ftim wera mortalità ogħla waqt il-perjodu tal-ħlas tal-frieħ.
English: The population pharmacokinetic evaluation of isavuconazole in healthy subjects and patients with mild or moderate hepatic dysfunction demonstrated that the mild and moderate hepatic impairment populations had 40% and 48% lower isavuconazole clearance (CL) values, respectively, than the healthy population.
Maltese: L-evalwazzjoni farmakokinetika tal-popolazzjoni ta' isavuconazole f'individwi b'saħħithom u pazjenti b'disfunzjoni tal-fwied ħafifa jew moderata wriet li l-popolazzjonijiet b'indeboliment ħafif u moderat kellhom valuri ta' tneħħija (clearence, CL) ta' 40% u 48% rispettivament aktar baxxa ta' isavuconazole millpopolazzjoni b'saħħitha.
English: Cyclophosphamide: careful monitoring for any occurrence of lack of efficacy, and dose increase if required..
Maltese: Cyclophosphamide: monitoraġġ attent għal kull każ ta' nuqqas ta' effikaċja, u żieda fid-doża jekk meħtieġ.
English: QT shortening
Maltese: TA' KIF JINGĦATA
English: Medicinal products that induce CYP3A4/5
Maltese: Indutturi ta' CYP3A4/5
English: Potential for CRESEMBA to affect exposures of other medicines
Maltese: Effetti fuq konċentrazzjonijiet tal-mediċina /
English: Clarithromycin (strong CYP3A4/5 inhibitor)
Maltese: Clarithromycin (Impeditur qawwi ta' CYP3A4/5)
English: Blister for 100 mg hard capsules
Maltese: Folji għal 100 mg kapsuli ibsin
English: Blood and lymphatic system disorders Uncommon Neutropenia; Thrombocytopenia^; Pancytopenia; Leukopenia^; Anaemia^ Immune system disorders Uncommon Hypersensitivity^ Metabolism and nutrition disorders Common Hypokalaemia; Decreased appetite Uncommon Hypomagnesaemia; Hypoglycaemia; Hypoalbuminaemia; Malnutrition^ Psychiatric disorders Common Delirium^ Uncommon Depression; Insomnia^ Nervous system disorders Common Headache; Somnolence Uncommon Convulsion^; Syncope; Dizziness ; Paraesthesia^; Encephalopathy; Presyncope; Neuropathy peripheral; Dysgeusia; Ear and labyrinth disorders Uncommon Vertigo Cardiac disorders Uncommon Atrial fibrillation; Tachycardia; Bradycardia^; Palpitations Atrial flutter; Electrocardiogram QT shortened; Supraventricular tachycardia; Ventricular extrasystoles ; Supraventricular extrasystoles Vascular disorders Common Thrombophlebitis^ Uncommon Circulatory collapse; Hypotension Respiratory, thoracic and mediastinal disorders Common Dyspnoea;^ Acute respiratory failure^ Uncommon Bronchospasm; Tachypnoea; Haemoptysis; Epistaxis Gastrointestinal disorders Common Vomiting; Diarrhoea; Nausea; Abdominal pain^ Uncommon Dyspepsia; Constipation; Abdominal distension Hepatobiliary disorders Common Elevated liver chemistry tests^ Uncommon Hepatomegaly; Hepatitis
Maltese: - livelli ta' zokkor baxx fid-demm, - livelli baxxi ta' manjezju fid-demm, - livelli baxxi fid-demm ta' proteina li tissejjaħ ‘albumina', - li ma tiħix l-benefiċċji xierqa mid-dieta tiegħek (malnutrizzjoni), - depressjoni, diffikultà biex torqod, - attakk pupletiku, tħossok ħażin jew tistordi, stordament, - sensazzjoni ta' tnemnin, tgħarix jew qris tal-ġilda (paraestesija), - stat mentali mibdul (enċefalopatija), - bidla fit-togħma (disgewsja), - tħossok qed ‘iddur' jew sturdut (vertiġni), - problemi bit-taħbit tal-qalb - jista' jkun mgħaġġel wisq jew irregolari, jew ikun hemm taħbit żejjed - dan jista' jidher fl-intraċċar tal-qalb (elettrokardjogramma jew ECG), - problemi biċ-ċirkolazzjoni tad-demm, - pressjoni tad-demm baxxa, - tħarħir, tieħu nifs malajr wisq, tisgħol id-demm jew riq bid-demm, tinfaraġ, - indiġestjoni, - stitikezza, - tħossok minfuħ (distensjoni addominali), - fwied mkabbar, - infjammazzjoni tal-fwied, - problemi bil-ġilda, dbabar ħomor jew vjola fuq il-ġilda (petechiae), ġilda infjammata
English: Elevated liver transaminases or hepatitis
Maltese: Transaminases tal-fwied elevati jew epatite