FrancophonIA/ELRC3.0 huggingface dataset:
English: Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of Savene solvent.
Maltese: Kull ml fih 20 mg ta' dexrazoxane wara rikonstituzzjoni b'25 ml solvent ta' Savene.
English: BATCH NUMBER Batch
Maltese: KUNJETT TAT-TRAB
English: In studies, dexrazoxane did not affect the pharmacokinetics of doxorubicin.
Maltese: Fl-istudji, dexrazoxane ma affettwax ilfarmakokinetika ta' doxorubicin.
English: Treatment with Savene had to be started within 6 hours from the incident and was repeated after 24 and 48 hours.
Maltese: It-trattament b'Savene kellu jinbeda fi żmien 6 sigħat mill-inċident u ġie ripetut wara 24 u 48 siegħa.
English: 3.1.3 Remove the syringe and needle and mix manually by repeated inversions until the powder is fully dissolved.
Maltese: 3.1.3 Neħħi s-siringa u l-labra u ħallat manwalment permezz ta' qlib ripetut sakemm it-trab idub għal kollox.
English: Contains cytotoxics.
Maltese: Tħawwadx.
English: Savene contains potassium and sodium
Maltese: Il-kontenut tal-potassju u tas-sodju
English: Nausea
Maltese: FIS-SUQ
English: Tissue distribution is rapid, with the highest levels of unchanged parent compound and hydrolysed product appearing in liver and kidneys.
Maltese: Id-distribuzzjoni fit-tessut hija rapida, bl-ogħla livelli ta' sustanza prinċipali mhux mibdula u prodott idrolizzat jidhru fil-fwied u l-kliewi.
English: • Women of childbearing potential not using contraceptive measures (see section 4.6).
Maltese: • Nisa b'potenzjal li jwelldu li ma jużawx miżuri ta' kontraċezzjoni (ara sezzjoni 4.6).
English: There are limited fertility data from animal studies available, but testicular changes were observed in rats and rabbits following repeat dosing.
Maltese: Hemm dejta dwar il-fertilità limitata minn studji f'annimali disponibbli, iżda ġie osservat tibdil testikolari fil-firien u l-fniek wara dożaġġ ripetut.
English: - The other ingredient(s) are: The solvent which contains sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide and water for injections.
Maltese: Is-solvent li fih sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide u ilma għall-injezzjonijiet.
English: Myalgia
Maltese: Remettar
English: • Vaginal bleeding
Maltese: • Ħalq xott
English: Myelosuppression is thus common.
Maltese: Il-mjelosuppressjoni hija għalhekk komuni.
English: Thus, dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation.
Maltese: Għalhekk, dimethylsulfoxide (DMSO) m'għandux jintuża f'pazjenti li qed jingħataw dexrazoxane sabiex tiġi trattata ekstravażjoni minn anthracycline.
English: Concomitant use not recommended:
Maltese: Savene huwa pprovdut bħala:
English: The mean AUC0-24 values for day 1 and day 2 were comparable with each other, and the AUC0-last at day 3 was approximately half that of the first two days, suggesting that the pharmacokinetics of dexrazoxane are dose-dependent.
Maltese: Il-valuri medji tal-AUC0-24 għal jum 1 u jum 2 kienu kumparabbli ma' xulxin, u l-AUC0-last f'jum 3 kienet madwar nofs ta' dik talewwel jumejn, li tissuġġerixxi li l-farmakokinetika ta' dexrazoxane tiddependi fuq id-doża.
English: Dizziness, tiredness and sudden fainting have been reported in a few patients treated with Savene.
Maltese: Jekk għandek problemi fil-kliewi, it-tabib tiegħek jista' jnaqqas id-doża tiegħek.
English: It can reduce the amount of tissue damage caused by anthracycline extravasation.
Maltese: Savene jintuża biex jikkura adulti b'ekstravażjoni dovuta għall-anthracycline.
English: Bibliographical data demonstrate that serum kinetics of dexrazoxane after intravenous administration follow an open two-compartment model independent of schedule and dose.
Maltese: Tagħrif biblijografiku juri li l-kinetika fis-serum ta' dexrazoxane wara għoti ġol-vini issegwi mudell miftuħ ta' żewġ kompartimenti indipendenti mill-iskeda u d-doża.
English: Injection site induration Injection site swelling Peripheral oedema Somnolence
Maltese: Ir-reazzjonijiet avversi rapportati huma elenkati skont il-frekwenza li ġejja:
English: NAME OF THE MEDICINAL PRODUCT Savene 20 mg/ml powder and solvent for concentrate for solution for infusion.
Maltese: Savene 20 mg/ml trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni.
English: - Phenytoin (a treatment against seizures) (Savene may reduce the effectiveness of this medicine).
Maltese: - Antikoagulanti (li jraqqu d-demm) (id-demm tiegħek jaf ikollu bżonn jiġi ssorveljat aktar spiss).
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara r-rikostituzzjoni u d-dilwazzjoni tal-prodott mediċinali, ara sezzjoni 6.3
English: Powder vial none
Maltese: Solvent għal Savene
English: The concentrate should then be diluted further in the remaining Savene solvent.
Maltese: Ilkonċentrat għandu mbagħad jiġi dilwit iżjed fil-kumplamanet tas-solvent ta' Savene.
English: Dexrazoxane may cause foetal harm when administered to pregnant women.
Maltese: Dexrazoxane jippreżenta kinetika ta' tneħħija b'żewġ fażijiet.
English: EU (MA) number Invented name Strength Pharmaceutical form Target species Route of administration Packaging Content Package size Withdrawal period
Maltese: Numru tal-UE Isem kummerċjali Qawwa Għamla Farmaċewtika Speċi li fuqhom għandu jintuża l-prodott Mod ta' Amministra-zzjoni Ippakkjar Kontenut Daqs tal-pakkett Perjodu ta' Tiżmim
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu http://www.who.int/prequal
Maltese: 3660 8427 Indirizz tal-email: press@ema.europa.eu http://www.who.int/prequal
English: More about Semler
Maltese: Aktar dwar Semler
English: The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from Semler's bioanalytical site (Semler Research Center Private Ltd, 75A, 15th Cross, 1st Phase, JP Nagar, Bangalore 560 078, Karnataka, India) and from Semler's clinical site (PA Arcade, #21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, India).
Maltese: Ir-rieżami kopra mediċini awtorizzati permezz ta' proċeduri nazzjonali fi Stati Membri tal-UE individwali, li l-applikazzjonijiet għall-awtorizzazzjoni tas-suq tagħhom kienu jinkludu data mis-sit bijoanalitiku ta' Semler (Semler Research Center Private Ltd, 75A, 15th Cross, 1st Phase, JP Nagar, Bangalore 560 078, Karnataka, l-Indja) u mis-sit kliniku ta' Semler (PA Arcade, #21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, l-Indja).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 September 2016 EMA/633693/2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 ta' Settembru 2016
English: Semler is a contract research organisation (CRO) with an analytical and a clinical site located in Bangalore, India.
Maltese: Semler hija organizzazzjoni ta' riċerka b'kuntratt (CRO) b'sit analitiku u kliniku f'Bangalore, l-Indja.
English: EMA's review followed an FDA inspection1 that identified several issues at Semler's bioanalytical site, including the substitution and manipulation of subjects' clinical samples.
Maltese: Ir-rieżami tal-EMA segwa spezzjoni tal-FDA1 li identifikat diversi kwistjonijiet fis-sit bijoanalitiku ta' Semler, inkluż is-sostituzzjoni u l-manipulazzjoni tal-kampjuni kliniċi tal-individwi.
English: The review of Semler was initiated on 28 April 2016 at the request of Denmark, Germany, the Netherlands, Spain and the United Kingdom under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' Semler inbeda fit-28 ta' April 2016 fuq talba tad-Danimarka, il-Ġermanja, in-Netherlands, Spanja u r-Renju Unit skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: The studies, called ‘bioequivalence' studies, are usually the basis for approving generic medicines.
Maltese: L-istudji, imsejħa studji ta' "bijoekwivalenza", normalment huma l-bażi għall-approvazzjoni ta' mediċini ġeneriċi.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 22 September 2016.
Maltese: Lopinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti applikabbli fl-Istati Membri tal-UE kollha fit-22 ta' Settembru 2016.
English: On 21 July 2016, the European Medicines Agency (EMA) recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India.
Maltese: Fil-21 ta' Lulju 2016, l-Aġenzija Ewropea għall-Mediċini (EMA) irrakkomandat is-sospensjoni ta' numru ta' mediċini approvati fuq livell nazzjonali li għalihom saru studji ta' bijoekwivalenza f'Semler Research Centre Private Ltd, Bangalore, l-Indja.
English: Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in a given EU Member State.
Maltese: Xi wħud mill-mediċini li ġew irrakkomandati għas-sospensjoni jistgħu jkunu ta' importanza kritika (eż. minħabba n-nuqqas ta' alternattivi disponibbli) fi Stat Membru tal-UE partikolari.
English: • Generic medicines containing abacavir/lamivudine (used to treat HIV), which were approved on the basis of studies conducted at Semler, can remain on the market in the EU.
Maltese: • Mediċini ġeneriċi li fihom abacavir/lamivudine (użati biex jikkuraw l-HIV), li ġew approvati fuq ilbażi ta' studji mwettqa f'Semler, jistgħu jibqgħu fis-suq tal-UE.
English: Bioequivalence studies usually form the basis for approval of generic medicines.
Maltese: L-istudji ta' bijoekwivalenza normalment jifformaw il-bażi għall-approvazzjoni tal-mediċini ġeneriċi.
English: • Medicines still under evaluation cannot be granted authorisation in the EU on the basis of studies conducted at Semler; further data would have to be provided to support authorisation.
Maltese: • Il-mediċini li għadhom taħt evalwazzjoni ma jistgħux jingħataw l-awtorizzazzjoni fl-UE fuq il-bażi tal-istudji mwettqa f'Semler; aktar data jkollha tiġi pprovduta biex tappoġġja l-awtorizzazzjoni.
English: The World Health Organization (WHO) also raised serious concerns2 regarding data integrity and manipulation of study samples following its own inspections of Semler's bioanalytical and clinical sites.
Maltese: L-Organizzazzjoni Dinjija tas-Saħħa (WHO) qajmet ukoll tħassib serju2 rigward l-integrità tad-data u l-manipulazzjoni talkampjuni tal-istudju wara l-ispezzjonijiet tagħha stess tas-siti bijoanalitiċi u kliniċi ta' Semler.
English: The Semler site also performs bioequivalence studies for some medicines authorised in the US and medicines included in the WHO prequalification programme3.
Maltese: Is-sit ta' Semler iwettaq ukoll studji ta' bijoekwivalenza għal xi mediċini awtorizzati fl-Istati Uniti u mediċini inklużi filprogramm ta' kwalifikazzjoni minn qabel tad-WHO3.
English: Bioequivalence studies performed at the site cannot be used to support medicines approval in the EU
Maltese: L-istudji ta' bijoekwivalenza mwettqa fuq is-sit ma jistgħux jintużaw biex jappoġġjaw l-approvazzjoni tal-mediċini fl-UE
English: Information for patients and healthcare professionals
Maltese: Informazzjoni għall-pazjenti u l-professjonisti fil-kura tas-saħħa
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla Farmaċewtika
English: Date of latest renewal: 07 September 2011.
Maltese: Data tal-aħħar tiġdid: 07 ta' Settembru 2011.
English: Caspofungin has in vitro activity against Aspergillus species (Aspergillus fumigatus [N = 75], Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], and Aspergillus candidus [N = 3]).
Maltese: Caspofungin għandu attività in vitro kontra l-ispeċijiet Aspergillus (Aspergillus fumigatus [N = 75], Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], u Aspergillus candidus [N = 3]).
English: CANCIDAS contains no preservatives.
Maltese: CANCIDAS ma fihx preservattivi.
English: Laboratories Merck Sharp & Dohme- Chibret, Route de Marsat-RIOM, 63963 Clermont-Ferrand Cedex 9, France
Maltese: Laboratories Merck Sharp & Dohme- Chibret, Route de Marsat-RIOM, 63963 Clermont-Ferrand Cedex 9, Franza
English: Cancidas contains sucrose (a type of sugar).
Maltese: Cancidas fih sucrose (tip ta' zokkor).
English: Store in a refrigerator (2C to 8C).
Maltese: Aħżen fi friġġ (2°C sa 8°C).
English: Laboratories Merck Sharp & Dohme- Chibret Route de Marsat-RIOM 63963 Clermont-Ferrand Cedex 9 France
Maltese: Laboratories Merck Sharp & Dohme- Chibret Route de Marsat-RIOM 63963 Clermont-Ferrand Cedex 9 Franza
English: Cancidas contains a medicine called caspofungin.
Maltese: Cancidas fih mediċina msejħa caspofungin.
English: Cancidas contains sucrose
Maltese: Cancidas fih sucrose
English: Other medicines and Cancidas
Maltese: Mediċini oħra u Cancidas
English: Each vial contains: 70 mg caspofungin.
Maltese: Kull kunjett fih: 70 mg caspofungin.
English: You will be given Cancidas:
Maltese: Inti se tingħata Cancidas:
English: Pharmacotherapeutic group: antimycotics for systemic use, ATC Code: J02AX04
Maltese: Kategorija farmakoterapewtika: antimikotiċi għall-użu sistemiku, Kodiċi ATC:
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], amphotericin B liposomali 85.5 % [461/539]), u (5) tluq tad-deni matul il-perjodu ta' newtropenija (caspofungin 41.2 % [229/556], amphotericin B liposomali 41.4 % [223/539]).
English: Each vial contains: 50 mg caspofungin.
Maltese: Kull kunjett fih: 50 mg caspofungin.
English: Unopened vials: store in a refrigerator (2°C - 8°C).
Maltese: Kunjetti mhux miftuħin: aħżen fi friġġ (2°C - 8°C).
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: MSD Α.Φ.Β.Ε.Ε Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com
Maltese: Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com
English: In clinical studies, 1,865 adult individuals received single or multiple doses of caspofungin: 564 febrile neutropaenic patients (empirical therapy study), 382 patients with invasive candidiasis, 228 patients with invasive aspergillosis, 297 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies.
Maltese: Fi studji kliniċi, 1,865 individwu adult ingħataw dożi waħdiena jew multipli ta' caspofungin: 564 pazjent newtropeniku bid-deni (studju ta' terapija empirika), 382 pazjent b'kandidjasi invażiva, 228 pazjent b'asperġillożi invażiva, 297 pazjent b'infezzjonijiet Candida lokalizzati, u 394 individwu rreġistrati fi studji ta' Fażi I.
English: Sucrose, mannitol, glacial acetic acid, and sodium hydroxide.
Maltese: TA' EĊĊIPJENTI Sucrose, mannitol, glacial acetic acid, u sodium hydroxide.
English: Hepatobiliary disorders elevated liver values (alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase, bilirubin conjugated, blood bilirubin)
Maltese: Disturbi fil-fwied u fil-marrara valuri tal-fwied għoljin (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase fiddemm, bilirubin konjugat, bilirubin taddemm)
English: The mechanism of resistance identified is FKS1 and/or FKS2 (for C. glabrata) gene mutations.
Maltese: Ilmekkaniżmu ta' reżistenza identifikat huwa mutazzjonijiet fil-ġene FKS1 u/jew FKS2 (għal C. glabrata).
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: Caspofungin also has in vitro activity against 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: Sucrose, mannitol, glacial acetic acid and sodium hydroxide.
Maltese: TA' EĊĊIPJENTI Sucrose, mannitol, glacial acetic acid u sodium hydroxide.
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: Aseptically add 10.5 ml of water for injection.
Maltese: B'mod asettiku żid 10.5 ml ta' ilma għall-injezzjoni.
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: Iżolati ta' 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' tekniki ta' ttestjar standardizzati tal-MIC approvati minn CLSI).
English: • Cancidas has not been studied in pregnant women.
Maltese: • Cancidas ma ġiex studjat f'nisa tqal.
English: The distribution into tissues peaked at 1.5 to 2 days after dosing when 92 % of the dose was distributed into tissues.
Maltese: Id-distribuzzjoni fit-tessuti laħqet l-ogħla livell ma' 1.5 sa 2 ġranet wara l-għoti tad-doża meta 92% tad-doża kien distribwit fit tessuti.
English: In a double-blind, randomized (2:1) comparator-controlled study safety, tolerability and efficacy of caspofungin (2 mg/kg/d intravenously, infused over 2 hours) vs amphotericin B deoxycholate (1 mg/kg/d) was evaluated in neonates and infants less than 3 months of age with (culture-confirmed) invasive candidiasis.
Maltese: Fi studju double-blind, randomizzat (2:1) ikkontrollat bil-komparatur, is-sigurtà, it-tollerabbiltà u leffikaċja ta' caspofungin (2 mg/kg/jum ġol-vini, infuż għal sagħtejn) kontra amphotericin B deoxycholate (1 mg/kg/jum) ġew evalwati fi trabi tat-twelid u trabi ta' età inqas minn 3 xhur b'kandidjażi invażiva (ikkonfermata bil-kultura).
English: Moderate (creatinine clearance 31 to 49 ml/min), advanced (creatinine clearance 5 to 30 ml/min), and end-stage (creatinine clearance <10 ml/min and dialysis dependent) renal impairment moderately increased caspofungin plasma concentrations after single-dose administration (range: 30 to 49 % for AUC).
Maltese: Indeboliment renali moderat (tneħħija tal-kreatinina ta' 31 sa 49 ml/min), avanzat (tneħħija tal-kreatinina ta' 5 sa 30 ml/min), u tal-aħħar stadju (tneħħija talkreatinina ta' <10 ml/min u dipendenti fuq id-dijalisi) żied moderatament il-konċentrazzjonijiet ta' caspofungin fil-plażma wara l-għoti ta' doża waħda (medda: 30 sa 49 % għall-AUC).
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 oesophageal candidiasis.
Maltese: MITT: 81 % (30/37) fil-kandidjasi invażiva, 50 % (5/10) fl-asperġillożi invażiva, u 100 % (1/1) fil-kandidjasi esofagali.
English: Standard preparation (reconstituted CANCIDAS added to 250 ml) final concentration
Maltese: (CANCIDAS rikostitwit miżjud ma' konċentrazzjoni finali ta' 250 ml)
English: • Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.
Maltese: • Terapija empirika għal infezzjonijiet fungali preżunti (bħal Candida jew Aspergillus) f'pazjenti newtropeniċi febbri adulti jew pedjatriċi.
English: Renal impairment: In a clinical study of single 70 mg doses, caspofungin pharmacokinetics were similar in adult volunteers with mild renal impairment (creatinine clearance 50 to 80 ml/min) and control subjects.
Maltese: Fi studju kliniku ta' dożi waħdiena ta' 70 mg, il-farmakokinetiċi ta' caspofungin kienu simili fil-voluntiera adulti b'indeboliment renali ħafif (tneħħija tal-kreatinina ta' 50 sa 80 ml/min) u s-suġġetti ta' kontroll.
English: The proportion of patients with fungal-free survival at 2 weeks post-therapy in the caspofungin treatment group (71.0 %) was similar to that seen in the amphotericin B deoxycholate treatment group (68.8 %).
Maltese: Il-proporzjon ta' pazjenti b'sopravivenza mingħajr każ fungali f'ġimagħtejn wara t-terapija fil-grupp ta' kura b'caspofungin (71.0 %) kien simili għal dak li deher fil-grupp ta' kura b'amphotericin B deoxycholate (68.8 %).
English: Excipients with known effect Each 70 mg vial contains 50.0 mg of sucrose.
Maltese: Kull kunjett ta' 70 mg fih 50.0 mg ta' sucrose.
English: Excipients with known effect: Each 50 mg vial contains 35.7 mg of sucrose.
Maltese: Kull kunjett ta' 50 mg fih 35.7 mg ta' sucrose.
English: Reconstitution of CANCIDAS
Maltese: Tużax Cancidas
English: The concentrations of the reconstituted vials will be 5.2 mg/ml.
Maltese: Il-konċentrazzjoni tal-kunjetti rikostitwiti se tkun 5.2 mg/ml.
English: Hepatic impairment
Maltese: Mhux Rakkomandata
English: Reduced volume infusion (reconstituted CANCIDAS added to 100 ml) final concentration
Maltese: Infużjoni ta' volum imnaqqas (CANCIDAS rikostitwit miżjud ma' konċentrazzjoni finali ta' 100 ml)
English: Equilibrate the refrigerated vial of CANCIDAS to room temperature.
Maltese: Ġib il-kunjett imkessaħ ta' CANCIDAS għat-temperatura tal-kamra.
English: 70 mg VIAL: PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
Maltese: KUNJETT TA' 70 mg: PREPARAZZJONI TAS-SOLUZZJONI GĦAL INFUŻJONI FL