FrancophonIA/ELRC3.0 huggingface dataset:
English: The issue here is clearly not a problem of interchangeability between Sandimmune and its optimized formulation of Neoral, but a lack of proof of bioequivalence, since this is a generic procedure.
Maltese: Huwa ċar li l-kwistjoni hawnhekk mhijiex problema ta' interkambjabbiltà bejn Sandimmune u l-formulazzjoni ottimizzata tiegħu ta' Neoral, iżda nuqqas ta' prova ta' bijoekwivalenza, minħabba li din hija proċedura ġenerika.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR REFUSAL
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: - the 90% CI relates to the population effects, whereas in clinical practice the substantial intraindividual variability is critical for the variable ciclosporin blood levels and this is the reason why it is monitored by frequent plasma through concentration even with the brand leader and these determinations which are routinely performed will allow to correct immediately deviation of the 10% or 20%.
Maltese: Il-proċedura inkludiet spjegazzjoni orali, li fiha l-MAH ippreżentaw il-fehmiet tagħhom li: - il-klassifikazzjoni klinika bbażata fuq l-evidenza ta' Ciclosporin bħala mediċina NTI kienet għadha nieqsa, diffiċli li tiġi kkalkulata, u bbażata biss fuq l-avvenimenti avversi li għalihom diġà ingħatat spjegazzjoni, - l-IF ta' 90% huwa relatat mal-effetti tal-popolazzjoni, filwaqt li fil-prattika klinika l-varjabbiltà sostanzjali intra-individwali hija kritika għal-livelli varjabbli fid-demm ta' ciclosporin u din hija rraġuni għaliex hija mmonitorjata bi plażma frekwenti permezz tal-konċentrazzjoni anke mal-marka ewlenija u dawn id-determinazzjonijiet li jitwettqu normalment jippermettu li tiġi kkorreġuta immedjatament id-devjazzjoni tal-10% jew 20%.
English: The CHMP noted that MAH stressed the need for routine TDM and from experienced physicians to prescribe ciclosporin, but these arguments could not counterbalance any failed bioequivalence for any compound being proposed as generic of the reference product.
Maltese: Is-CHMP innota li l-MAH enfasizza l-ħtieġa għal TDM ta' rutina u minn tobba b'esperjenza biex jippreskrivu ciclosporin, iżda dawn l-argumenti ma setgħux ipattu għal kwalunkwe nuqqas ta' bijoekwivalenza għal kwalunkwe kompost li qiegħed jiġi propost bħala ġeneriku tal-prodott ta' referenza.
English: Ciclosporina IDL 25 mg 25 mg capsule
Maltese: FRANZA Ciclosporina IDL 25 mg 25 mg kapsula
English: Ciklosporin IDL 100 mg 100 mg capsule
Maltese: FRANZA Ciklosporin IDL 100 mg100 mg kapsula
English: Ciclosporina IDL 50 mg 50 mg capsule
Maltese: FRANZA Ciclosporina IDL 50 mg 50 mg kapsula
English: Ciclosporin IDL 25 mg 25 mg capsule
Maltese: FRANZA Ciclosporin IDL 25 mg 25 mg kapsula
English: Ciklosporin IDL 25 mg 25 mg capsule
Maltese: FRANZA Ciklosporin IDL 25 mg 25 mg kapsula
English: Ciclosporin IDL 50 mg 50 mg capsule
Maltese: FRANZA Ciclosporin IDL 50 mg 50 mg kapsula
English: The CHMP did not agree upon the lack of safety concerns in fasting conditions and did not endorse the use of asymmetric CIs.
Maltese: Is-CHMP ma qabilx man-nuqqas ta' tħassib ta' sigurtà fil-kundizzjonijiet ta' sawm u ma approvax lużu ta' IF asimmetriċi.
English: The other study in fed conditions showed that Ciclosporin IDL was less affected by food than Novartis Neoral reference product.
Maltese: L-istudju l-ieħor taħt kundizzjonijiet ta' tmigħ wera li Ciclosporin IDL kien inqas affettwat mill-ikel mill-prodott ta' referenza Novartis Neoral.
English: Ciklosporin IDL 50 mg 50 mg capsule
Maltese: FRANZA Ciklosporin IDL 50 mg 50 mg kapsula
English: Differences in Cmax were considered less important, because a peak level is maintained for only a short period of time, whereas AUC represents the total exposure to the drug, but it was felt that the conventional range should be used.
Maltese: Id-differenzi fil-Cmax tqiesu inqas importanti, minħabba li livell ogħla jinżamm biss għal perjodu qasir ta' żmien, filwaqt li AUC jirrappreżenta l-espożizzjoni totali għallmediċina, iżda kien maħsub li għandha tintuża l-firxa konvenzjonali.
English: The MAH noted that the SPCs of Sandimune and Neoral state that these two products are not bioequivalent, but a switch between these products is allowed with an appropriate therapeutic drug monitoring (TDM), indicating that this is well established common practice blood concentration guided dosing of ciclosporin.
Maltese: Id-dejta uriet li l-varjabbiltà ma' kull formulazzjoni bejn tmigħ kontra sawm hija ferm aktar baxxa għall-mediċina ta' prova milli għal dik ta' referenza, għalkemm lerja taħt il-kurva mhijiex wisq differenti.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CICLOSPORIN IDL Ciclosporin is a calcineurin inhibitor and as such an immunosuppressive drug.
Maltese: Fil-prattika klinika ta' rutina, il-monitoraġġ tal-mediċina terapewtika isir sabiex tiġi kkontrollata u mmonitorjata s-sigurtà.
English: The CHMP acknowledged that a therapeutic index (TI) calculation has not been reported for ciclosporin but disagreed with the statement from MAH that it is based on the adverse events profile.
Maltese: Is-CHMP irrikonoxxa li kalkolu tal-indiċi terapewtiku (IT) ma ġiex irrapportat għal ciclosporin iżda ma qabilx mad-dikjarazzjoni tal-MAH li huwa bbażat fuq il-profil tal-avvenimenti avversi.
English: The MAH answered that the reduced effect of food on generic ciclosporin pharmacokinetics as compared to the innovator formulation could be seen as an advantage over the reference product and a compelling argument for the acceptance of the former.
Maltese: Il-MAH wieġeb li l-effett imnaqqas tal-ikel fuq il-farmakokinetiċi ta' ciclosporin ġeneriku meta mqabbel mal-formulazzjoni innovattiva jista' jitqies bħala ta' vantaġġ fuq il-prodott ta' referenza u argument konvinċenti għall-aċċettazzjoni tal-ewwel wieħed.
English: The MAH stated that this issue needs to be addressed by the Regulatory Authorities and should be taken into consideration when evaluating IDL test product formulation, because this could play a definite role for safety issues, knowing that efficacy was preserved in any case as shown by the AUCs results.
Maltese: Il-MAH iddikjara li din il-kwistjoni teħtieġ li tiġi indirizzata mill-Awtoritajiet Regolatorji u għandha titqies meta tiġi evalwata lformulazzjoni tal-prodott ta' prova IDL, minħabba li jista' jkun li din ikollha rwol definit għallkwistjonijiet ta' sigurtà, bl-għarfien li l-effikaċja kienet miżmuma fi kwalunkwe każ kif jidher mirriżultati tal-AUCs.
English: CHMP concluded that the bioequivalence data observed were inadequate to establish efficacy and safety.
Maltese: Is-CHMP ikkonkluda li d-dejta tal-bijoekwivalenza osservati ma kienux xierqa biex jiġu stabbiliti l-effikaċja u s-sigurtà.
English: The CHMP in principle agreed that a decreased sensitivity of the ciclosporin absorption to food intake could be seen as an advantage, however a generic product should be bioequivalent and possible to be used interchangeably with an originator product based on bioequivalence and this has not been demonstrated.
Maltese: Is-CHMP fil-prinċipju qabel li sensittività mnaqqsa tal-assorbiment ciclosporin għall-konsum tal-ikel jista' jitqies bħala vantaġġ, madankollu prodott ġeneriku għandu jkun bijoekwivalenti u għandu jkun possibbli li jintuża minflok prodott oriġinatur fuq il-bażi tal-bijoekwivalenza u dan ma ntweriex.
English: In particular the upper confidence limit for the comparison of Cmax was outside even the standard acceptance range.
Maltese: B'mod partikolari l-limitu ta' fiduċja ta' fuq għat-tqabbil ta' Cmax kien 'il hinn anke mill-firxa ta' aċċettazzjoni standard.
English: For generic applications no other data than bioequivalence is assessed and therefore approval should be based with confidence that such risk is reduced at maximum by narrowing the CI.
Maltese: Għallapplikazzjonijiet ġeneriċi l-ebda dejta ħlief il-bijoekwivalenza ma ġiet ivvalutata u għalhekk lapprovazzjoni għandha tiġi bbażata b'fiduċja li tali riskju huwa mnaqqas għall-massimu billi titnaqqas l-IF.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem ivvintat Qawwa Għamla farmaċewtika
English: • rifampicin (an antibiotic).
Maltese: • rifampicin (antibijotiku).
English: • dexamethasone (a steroid)
Maltese: • dexamethasone (sterojd)
English: Xellia Pharmaceuticals ApS Dalslandsgade 11, København S, 2300, Denmark
Maltese: Xellia Pharmaceuticals ApS Dalslandsgade 11, København S, 2300, Id-Danimarka
English: DOSE*
Maltese: DOŻA*
English: Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], and Aspergillus candidus [N = 3]).
Maltese: Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], u Aspergillus candidus [N = 3]).
English: • The active substance is caspofungin.
Maltese: • Is-sustanza attiva hija caspofungin.
English: Toxic epidermal necrolysis and StevensJohnson syndrome (see section 4.4)
Maltese: Nekrolożi epidermali tossika u syndrome ta' StevensJohnson syndrome (ara sezzjoni 4.4)
English: Date of first authorization: 11 February 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 11 Frar 2016
English: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom
Maltese: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Ir-Renju Unit
English: • if you have ever had any other medical problem.
Maltese: • inti qatt kellek xi problema medika oħra.
English: not responding to ≥96 hours of parenteral antibacterial therapy.
Maltese: ≥96 siegħa ta' terapija antibatterika parenterali.
English: Pharmacodynamic effects Caspofungin has in vitro activity against Aspergillus species (Aspergillus fumigatus [N = 75],
Maltese: Effetti farmakodinamiċi Caspofungin għandu attività in vitro kontra l-ispeċijiet Aspergillus (Aspergillus fumigatus [N = 75],
English: For reconstitution directions see section 6.6.
Maltese: Għall-istruzzjonijiet dwar ir-rikostituzzjoni ara sezzjoni 6.6.
English: Caspofungin undergoes spontaneous degradation to an open ring compound.
Maltese: Caspofungin jgħaddi minn degradazzjoni spontanja għal kompost open ring.
English: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
Maltese: BSA (m2) X 50 mg/m2 = Doża ta' Manteniment ta' Kuljum
English: A similar effect could be expected for other medicinal products that induce metabolic enzymes.
Maltese: Jista' jkun mistenni effett simili għal prodotti mediċinali oħra li jinduċu l-enzimi metaboliċi.
English: Sodium hydroxide (to adjust the pH)
Maltese: Sodium hydroxide (biex jaġġusta l-pH)
English: Beta (1,3)-D-glucan is not present in mammalian cells.
Maltese: Beta (1,3)-D-glucan mhuwiex preżenti fiċ-ċelloli mammiferi.
English: In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6 or 3A4.
Maltese: Studji in vitro juru li caspofungin mhuwiex inibitur tal-enzimi taċ-ċitokromu P450 1A2, 2A6, 2C9, 2C19, 2D6 jew 3A4.
English: Excipients: sucrose, mannitol, succinic acid and sodium hydroxide.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: sucrose, mannitol, succinic acid u sodium hydroxide.
English: There is limited treatment experience in patients 65 years of age and older (see section 5.2).
Maltese: Hemm esperjenza limitata ta' trattament f'pazjenti ta' 65 sena u aktar (ara sezzjoni 5.2).
English: 70 mg (from two 50 mg vials)**
Maltese: 70 mg (minn żewġ kunjetti ta' 50 mg)**
English: Unopened vials: store in a refrigerator 2°C - 8°C).
Maltese: Kunjetti mhux miftuħin: aħżen fi friġġ (2°C - 8°C).
English: The mechanism of resistance identified is FKS1 and/or FKS2 (for C. glabrata) gene mutations.
Maltese: Ilmekkaniżmu ta' reżistenza identifikat huwa mutazzjoni fil-ġene FKS1 u/jew FKS2 (għal C. glabrata).
English: • some HIV medicines such as efavirenz or nevirapine
Maltese: • xi mediċini tal-HIV bħal efavirenz jew nevirapine
English: Pharmacotherapeutic group: antimycotics for systemic use, ATC code: J02AX04
Maltese: Kategorija farmakoterapewtika: antimikotiċi għall-użu sistemiku, kodiċi ATC:
English: The response rates among patients with pulmonary disease and extrapulmonary disease were 47 % (21/45) and 28 % (5/18), respectively.
Maltese: Ir-rati ta' rispons fost pazjenti b'mard pulmonari u mard ekstrapulmonari kienu 47% (21/45) u 28% (5/18), rispettivament.
English: The most frequent diagnoses were bloodstream infections (candidaemia) (77 %, n=186) and Candida peritonitis (8 %, n=19); patients with Candida endocarditis, osteomyelitis, or meningitis were excluded from this study.
Maltese: L-aktar sejbiet frekwenti kienu infezzjonijiet fin-nixxiegħa tad-demm (candidaemia) (77 %, n=186) u peritonite Candida (8 %, n=19); pazjenti b'endokardite, osteomjelite, jew meninġite Candida kienu esklużi minn dan l-istudju.
English: • Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole.
Maltese: • Trattament ta' asperġillożi invażiva f'pazjenti adulti jew pedjatriċi li huma refrattorji jew intolleranti għal amphotericin B, formulazzjonijiet lipidi ta' amphotericin B u/jew itraconazole.
English: The most common drug-related clinical adverse experiences reported in paediatric patients treated with caspofungin were pyrexia (11.7%), rash (4.7%) and headache (2.9%).
Maltese: Laktar esperjenzi kliniċi avversi komuni marbuta mal-mediċina rrappurtati f'pazjenti pedjatriċi kkurati b'caspofungin kienu deni (11.7%), raxx (4.7%) u uġigħ ta' ras (2.9%).
English: Hepatobiliary disorders elevated liver values (alanine aminotransferase, aspartate aminotranserase, blood alkaline phosphatase, bilirubin conjugated, blood bilirubin)
Maltese: Disturbi fil-fwied u filmarrara valuri tal-fwied għoljin (alanine aminotransferase, aspartate aminotranserase, alkaline phosphatase fiddemm, bilirubin konjugat, bilirubin taddemm)
English: Caspofungin is extensively bound to albumin.
Maltese: Caspofungin jeħel b'mod estensiv mal-albumina.
English: Caution is advised when treating this age group.
Maltese: Hija rakkomandata kawtela fittrattament ta' dan il-grupp ta' età.
English: The favourable response rates for patients who were either refractory to or intolerant of previous therapies were 36 % (19/53) and 70 % (7/10), respectively.
Maltese: Ir-rati ta' rispons favorevoli għallpazjenti li kienu jew refrattorji jew intolleranti għal terapiji preċedenti kienu 36 % (19/53) u 70 % (7/10), rispettivament.
English: Further metabolism involves peptide hydrolysis and N-acetylation.
Maltese: Metaboliżmu ulterjuri jinvolvi idrolisi tal-peptide u N-acetylation.
English: However, variability was seen in both C1 hr (Day 4 geometric mean 11.73 µg/mL, range 2.63 to 22.05 µg/mL) and C24 hr (Day 4 geometric mean 3.55 µg/mL, range 0.13 to 7.17 µg/mL).
Maltese: Madankollu, dehret varjabilità kemm fil-C1 hr (Jum 4 medja ġeometrika 11.73 µg/mL, medda 2.63 sa 22.05 µg/mL) kif ukoll fil-C24 hr (Jum 4 medja ġeometrika 3.55 µg/mL, medda 0.13 sa 7.17 µg/mL).
English: Candida species (Candida albicans [N = 1,032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis [N = 215], Candida rugosa [N = 1], and Candida tropicalis [N = 258]), including isolates with multiple resistance transport mutations and those with acquired or intrinsic resistance to fluconazole, amphotericin B, and 5-flucytosine.
Maltese: Caspofungin għandu wkoll attività in vitro kontra l ispeċijiet Candida (Candida albicans [N = 1032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis
English: Approximately 75 % of a radioactive dose was recovered during 27 days: 41 % in urine and 34 % in faeces.
Maltese: Madwar 75% ta' doża radjuattiva ġiet irkuprata tul 27 ġurnata: 41% fl-awrina u 34% fl-ippurgar.
English: Step 1 Reconstitution of conventional vials
Maltese: Pass 1 Rikostituzzjoni ta' kunjetti konvenzjonali
English: Favourable response rates in neutropaenic patients were 7/14 (50 %) in the caspofungin group and 4/10 (40 %) in the amphotericin B group.
Maltese: Ir-rati ta' rispons favorevoli f'pazjenti newtropeniċi kienu 7/14 (50 %) fil-grupp ta' caspofungin u 4/10 (40 %) fil-grupp ta' amphotericin B.
English: Caspofungin has also been evaluated at 150 mg daily (for up to 51 days) in 100 adult patients (see section 5.1).
Maltese: Caspofungin ġie evalwat ukoll b'150 mg kuljum (għal mhux aktar minn 51 jum) f'100 pazjent adult (ara sezzjoni 5.1).
English: Cardiac disorders palpitations, tachycardia, arrhythmia, atrial fibrillation, cardiac failure congestive
Maltese: Disturbi fil-qalb palpitazzjonijiet, takikardija, arritmija, fibrillazzjoni atrijali, kollass kardijaku konġestiv
English: Hypersensitivity reactions (anaphylaxis and possibly histamine-mediated adverse reactions) have been reported (see section 4.4).
Maltese: Kienu rrappurtati reazzjonijiet ta' sensittività eċċessiva (anafilassi u reazzjonijiet avversi possibbilment medjati mill-istamina) (ara sezzjoni 4.4).
English: Caspofungin reduced the trough concentration of tacrolimus by 26 % in healthy adult volunteers.
Maltese: Caspofungin naqqas il-konċentrazzjoni ta' isfel ta' tacrolimus b'26% f'voluntiera adulti b'saħħithom.
English: • phenytoin or carbamazepine (used for the treatment of seizures)
Maltese: • phenytoin jew carbamazepine (jintużaw għall-kura ta' aċċessjonijiet)
English: Standard preparation (reconstituted Caspofungin Accord added to 250 mL) final concentration
Maltese: Preparazzjoni standard (Caspofungin Accord rikostitwit miżjud ma' konċentrazzjoni finali ta' 250 mL)
English: Patients in the caspofungin group experienced breakthrough infections due to the following uncommon yeasts and moulds: Trichosporon species (1), Fusarium species (1), Mucor species (1), and Rhizopus species (1).
Maltese: Pazjenti fil-grupp ta' caspofungin esperjenzaw infezzjonijiet ġodda minħabba dawn il-ħmejjer u mofof mhux komuni: speċi Trichosporon (1), speċi Fusarium (1), speċi Mucor (1), u speċi Rhizopus (1).
English: An overall favourable response required meeting each of 5 criteria: (1) successful treatment of any baseline fungal infection (caspofungin 51.9 % [14/27], liposomal amphotericin B 25.9 % [7/27]), (2) no breakthrough fungal infections during administration of study drug or within 7 days after completion of treatment (caspofungin 94.8 % [527/556], liposomal amphotericin B 95.5 % [515/539]), (3) survival for 7 days after completion of study therapy (caspofungin 92.6 % [515/556], liposomal amphotericin B 89.2 % [481/539]), (4) no discontinuation from the study drug because of drug-related toxicity or lack of efficacy (caspofungin 89.7 % [499/556], liposomal amphotericin B 85.5 % [461/539]), and (5) resolution of fever during the period of neutropaenia (caspofungin 41.2 % [229/556], liposomal amphotericin B 41.4 % [223/539]).
Maltese: 9 % [7/27]), (2) ebda infezzjonijiet fungali ġodda waqt l-għoti tal-mediċina tal-istudju jew sa 7 ijiem wara t-tlestija tattrattament (caspofungin 94.8 % [527/556], amphotericin B liposomali 95.5 % [515/539]), (3) sopravivenza għal 7 ijiem wara t-tlestija tat-terapija tal-istudju (caspofungin 92.6 % [515/556], amphotericin B liposomali 89.2 % [481/539]), (4) ebda twaqqif mill-mediċina tal-istudju minħabba effett tossiku relatat mal-mediċina jew nuqqas ta' effikaċja (caspofungin 89.7 % [499/556],
English: Isolates of Candida with reduced susceptibility to caspofungin have been identified in a small number of patients during treatment (MICs for caspofungin >2 mg/L (4- to 30-fold MIC increases) have been reported using standardized MIC testing techniques approved by the CLSI).
Maltese: Iżolatita' Candida b'suxxettibilità mnaqqsa għal caspofungin ġew identifikati f'numru żgħir ta' pazjenti waqt il-kura (MICs għal caspofungin >2 mg/L (żidiet ta' bejn 4 darbiet sa 30 darba l-MIC) kienu rrappurtati bl-użu ta' teknika ta' ittestjar standardizzat tal-MIC approvat minn CLSI).
English: For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), Caspofungin 35 mg daily is recommended based upon pharmacokinetic data.
Maltese: Fil-każ ta' pazjenti adulti b'indeboliment epatiku moderat (punteġġ Child-Pugh 7 sa 9), huwa rrakkomandat Caspofungin 35 mg kuljum skont informazzjoni farmakokinetika.
English: Patients had to be either refractory to (disease progression or failure to improve with other antifungal therapies given for at least 7 days) (84 % of the enrolled patients) or intolerant of (16 % of enrolled patients) other standard antifungal therapies.
Maltese: Il-pazjenti riedu jkunu jew refrattorji (progressjoni tal-marda jew nuqqas ta' titjib b'terapiji antifungali oħra mogħtija għal mill-anqas 7 ijiem) (84 % tal-pazjenti rreġistrati) jew intolleranti (16 % tal-pazjenti rreġistrati) għal terapiji antifungali oħra standard.
English: The second study was a prospective, open-label, non-comparative study estimating the safety and efficacy of caspofungin in paediatric patients (ages 6 months to 17 years) with invasive candidiasis, esophageal candidiasis, and invasive aspergillosis (as salvage therapy).
Maltese: It-tieni studju kien studju prospettiv, open-label, mhux komparattiv li kkalkula s-sigurtà u l-effikaċja ta' caspofungin f'pazjenti pedjatriċi (6 xhur sa 17-il sena) b'kandidjasi invażiva, kandidjasi esofagali, u asperġillożi invażiva (bħala terapija ta' salvataġġ).
English: Among patients with extrapulmonary disease, 2 of 8 patients who also had definite, probable, or possible CNS involvement had a favourable response.
Maltese: Fost il-pazjenti b'mard ekstrapulmonari, 2 minn 8 pazjenti li kellhom ukoll involviment definittiv, probabbli, jew possibbli tal-CNS kellhom rispons favorevoli.
English: Response rates to caspofungin and liposomal amphotericin B for baseline infections caused by Aspergillus species were, respectively, 41.7 % (5/12) and 8.3 % (1/12), and by Candida species were 66.7 % (8/12) and 41.7 % (5/12).
Maltese: Ir-rati ta' rispons għal caspofungin u amphotericin B liposomali għall-infezzjonijiet tal-linja bażi kkawżati mill-ispeċijiet Aspergillus kienu, rispettivament, 41.7 % (5/12) u 8.3 % (1/12), u mill-ispeċijiet Candida kienu 66.7 % (8/12) and 41.7 % (5/12).
English: The mechanism of interaction could possibly be due to an initial inhibition and subsequent induction of transport proteins.
Maltese: Il-mekkaniżmu tal-interazzjoni jista' jkun dovut għal inibizzjoni inizjali u induzzjoni suċċessiva ta' proteini tat-trasport.
English: The favourable response rate, by indication, at the end of caspofungin therapy was as follows in the MITT analysis: 81 % (30/37) in invasive candidiasis, 50 % (5/10) in invasive aspergillosis, and 100 % (1/1) in esophageal candidiasis.
Maltese: MITT: 81 % (30/37) fil-kandidjasi invażiva, 50 % (5/10) fl-asperġillożi invażiva, u 100 % (1/1) fil-kandidjasi esofagali.
English: Studies in vitro show that caspofungin is not an inhibitor of any enzyme in the cytochrome P450 (CYP) system.
Maltese: Studji in vitro juru li caspofungin ma huwa inibitur tal-ebda enzima fis-sistema taċ-ċitokromu P450 (CYP).
English: The overall success rates in the MITT analysis results, adjusted by risk strata, were as follows: 46.6 % (26/56) for caspofungin and 32.2 % (8/25) for liposomal amphotericin B.
Maltese: Ir-rati globali ta' suċċess fir-riżultati tal-analiżi MITT, aġġustati skont il-faxxa tar-riskju, kienu kif ġej: 46.6 % (26/56) għal caspofungin u 32.2 % (8/25) għal amphotericin B liposomali.
English: • Flushing, low blood pressure
Maltese: • Fwawar, pressjoni baxxa