FrancophonIA/ELRC3.0 huggingface dataset:
English: The data assessed during the Art.31 referral procedure in 2011 regarded the carcinogenic potential of dexrazoxane due its cytotoxic activity and on the occurrence of second malignant neoplasms in the paediatric population; such data justified the introduction of a contraindication of the product in children aged 0 to 18 years.
Maltese: Id-data vvalutata matul il-proċedura ta' referenza tal-Artikolu 31 fl-2011 kienet tirrigwarda l-potenzjal karċinoġeniku ta' dexrazoxane minħabba l-attività ċitotossika tiegħu u l-okkorrenza ta' neoplażmi malinni oħra fil-popolazzjoni pedjatrika; tali data ġġustifikat l-introduzzjoni ta' kontraindikazzjoni talprodott għal tfal ta' bejn 0 sa 18-il sena.
English: In view of the potential serious risk to public health raised by UK, the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 13(1) of Regulation (EC) No 1234/2008 by France on 04/11/2016.
Maltese: Fid-dawl tar-riskju serju potenzjali għas-saħħa pubblika mqajjem mir-Renju Unit, il-proċedura ġiet riferuta lill-Grupp ta' Koordinazzjoni għal Proċedura tarRikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), skont l-Artikolu 13(1) tarRegolament (KE) Nru 1234/2008 minn Franza fl-04/11/2016.
English: • The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008.
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 13 tar-Regolament (KE) Nru 1234/2008.
English: • The Committee noted the reassuring safety data on the occurrence of secondary primary malignancies in particular acute myelogenous leukaemia and myelodysplastic syndrome in children and adolescents aged 0 to 18 years, the high risk for long term occurrence of severe cardiomyopathy when using high cumulated dose of anthracycline in children and adolescents and the medical need of high anthracycline dosing regimen for pathology such as sarcoma or acute myelogenous leukaemia relapses in children and adolescents
Maltese: • Il-Kumitat innota d-data dwar is-sikurezza ta' riassigurazzjoni li tirrigwarda l-okkorrenza ta' malinni primarji sekondarji b'mod partikolari l-lewkimja mijeloġenuża u s-sindrome mijelodisplastiku fi tfal u adolexxenti ta' bejn 0 sa 18-il sena, ir-riskju għoli għall-okkorenza fit-tul ta' kardjomijopatija severa meta tintuża doża kumulattiva għolja ta' anthracycline fit-tfal u fl-adolexxenti u l-ħtieġa medika ta' reġim ta' dożaġġ għoli ta' anthracycline għal patoloġija bħal sarkoma jew rikaduti tallewkimja mijoleġenuża akuta fit-tfal u fl-adolexxenti.
English: A type II grouping of variations application was submitted under the mutual recognition procedure for Cardioxane 500 mg powder for solution for infusion.
Maltese: L-applikazzjoni għall-gruppi tal-varjazzjonijiet tat-tip II ġiet sottomessa skont il-proċedura ta' rikonoxximent reċiproku għal Cardioxane 500 mg trab għal soluzzjoni għal infużjoni.
English: • widening of the indication from “advanced and/or metastatic adult breast cancer patients” to “cancer patients”.
Maltese: • it-twessigħ tal-indikazzjoni minn “pazjenti adulti b'kanċer fis-sider avvanzat u/jew metastatiku” għal “pazjenti bil-kanċer”.
English: With higher cumulative doses of anthracyclines, studies (including several RCTS and non-randomised studies) have showed that DRZ could improve the surrogate cardiac markers and therefore reduce subclinical acute cardiotoxicity.
Maltese: B'dożi kumulattivi ogħla ta' anthracyclines, studji (inklużi bosta RCTs u studji mhux randomizzati) urew li d-DRZ jista' jtejjeb il-markaturi kardijaċi surrogati u għalhekk inaqqas il-kardjotossiċità akuta subklinika.
English: It is acknowledged that DRZ may increase the risk of myelosuppression and infections; however these risks can be minimised by appropriate measures currently in place in standard paediatric treatment protocols.
Maltese: Huwa rikonoxxut li d-DRZ jista' jżid ir-riskju ta' majelosoppressjoni u infezzjonijiet; madankollu, dawn ir-riskji jistgħu jiġu minimizzati b'miżuri xierqa li huma attwalment fis-seħħ fil-protokolli ta' kura pedjatrika standard.
English: - updated safety data leading to reassurance as regard to the occurrence of SPMs, particularly AML and MDS,
Maltese: - tad-data dwar is-sikurezza aġġornata li twassal għal riassigurazzjoni fir-rigward tal-okkorrenza tal-SPMs, b'mod partikolari AML u MDS,
English: Day 60 of the CMDh procedure was on 30/01/2017 and as no agreement could be reached, the procedure and the objections raised by the UK to the lifting of the contraindication for a subset of anthracycline treated paediatric population were referred to the CHMP on 31/01/2017 by the RMS.
Maltese: Is-60 jum tal-proċedura tas-CMDh kien fit-30/01/2017 u peress li ma seta' jintlaħaq ebda ftehim, ilproċedura u l-oġġezzjonijiet imqajma mir-Renju Unit għat-tneħħija tal-kontraindikazzjoni għal subsett tal-popolazzjoni pedjatrika kkurata b'anthracycline ġew riferuti lis-CHMP fil-31/01/2017 mill-RMS.
English: Delayed effects usually manifest as congestive heart failure which can occur up to 20 years post treatment.
Maltese: Normalment l-effetti mdewma jirriżultaw bħala insuffiċjenza konġestiva tal-qalb li tista' sseħħ sa 20 sena wara l-kura.
English: The CHMP considers that the presented data support the removal of the contraindication for Cardioxane for the subset of paediatric population receiving high cumulative anthracycline doses (above 300mg/m2 of doxorubicin or equivalent).
Maltese: Is-CHMP iqis li d-data ppreżentata tappoġġja t-tneħħija tal-kontraindikazzjoni għal Cardioxane għassubsett tal-popolazzjoni pedjatrika li tirċievi dożi kumulattivi għoljin ta' anthracycline ('il fuq minn 300 mg/m2 ta' doxorubicin jew ekwivalenti).
English: However, the RMS considered acceptable to alleviate the contra-indication in children and proposed limiting it to children receiving low cumulative anthracycline doses (less than 300mg/m2 of doxorubicin or equivalent).
Maltese: Madankollu, l-RMS qies bħala aċċettabbli li tittaffa l-kontraindikazzjoni fit-tfal u ppropona li din tiġi limitata għal tfal li jieħdu dożi kumulattivi baxxi ta' anthracycline (inqas minn 300 mg/m2 ta' doxorubicin jew ekwivalenti).
English: The evaluation of the data submitted as part of this procedure have allowed a better characterisation of the risk of the short term effects on SPM, myelosuppression and infections, following treatment with DRZ in children undergoing chemotherapy with anthracycline based regimens.
Maltese: L-evalwazzjoni tad-data sottomessa bħala parti minn din il-proċedura ppermettiet karatterizzazzjoni aħjar tar-riskju tal-effetti fuq żmien qasir fuq SPM, majelosoppressjoni u infezzjonijiet, wara l-kura bidDRZ fi tfal li qed jirċievu kimoterapija b'reġimi abbażi ta' anthracycline.
English: The assessment of this risk is confounded by concomitant chemotherapy treatments, small numbers of patients and the overall rarity of SPM events.
Maltese: Ilvalutazzjoni ta' dan ir-riskju hija mxekkla minn kura konkomittanti tal-kimoterapija, għadd żgħir ta' pazjenti u r-rarità globali tal-avvenimenti SPM.
English: The CHMP was informed that the MAH will conduct a prospective safety study in children using existing cancer disease registries to collect data on dexrazoxane use in the paediatric population, the incidence of adverse events (e.g. secondary malignancies, myelosuppression and infections) and the long-term (>12 years) cardiac effects (including cardiac failure, left ventricular failure).
Maltese: Is-CHMP ġie infurmat li l-MAH ser iwettaq studju prospettiv dwar is-sikurezza fit-tfal bl-użu tar-reġistri eżistenti tal-marda tal-kanċer għall-ġbir ta' data dwar l-użu ta' dexrazoxane fil-popolazzjoni pedjatrika, l-inċidenza ta' avvenimenti avversi (eż. malinni sekondarji, majelosoppressjoni u infezzjonijiet) u leffetti kardijaċi fit-tul (>12-il sena) (inklużi insuffiċjenza kardijaka, insuffiċjenza ventrikulari taxxellug).
English: The CHMP noted that the MAH will reflect the ongoing observational study (Effects of Dexrazoxane Hydrochloride on Biomarkers Associated with Cardiomyopathy and Heart Failure after Cancer Treatment, NCT01790152.)
Maltese: Is-CHMP innota li l-MAH ser jirrifletti l-istudju ta' osservazzjoni li għaddej (Effetti ta' Dexrazoxane Hydrochloride fuq il-Bijomarkaturi Assoċjati mal-Kardjomijopatija u l-Insuffiċjenza tal-Qalb wara l-Kura għall-Kanċer, NCT01790152.) fil-Pjan tiegħu tal-Ġestjoni tar-Riskji skont kif xieraq.
English: High cumulative doses of anthracycline are rarely used in the paediatric population; however, they are requested for the treatment of some pathologies such as sarcomas and relapsed acute myeloid leukaemia.
Maltese: Dożi kumulattivi għolja ta' anthracycline rari jintużaw fil-popolazzjoni pedjatrika; madankollu, huma mitluba għall-kura ta' ċerti patoloġiji bħal sarkomi u lewkimja mijelojde akuta rikaduta.
English: - the medical need of high anthracycline dosing regimen for pathology such as sarcoma or AML relapses in children and adolescents
Maltese: - tal-ħtieġa medika ta' reġim ta' dożaġġ għoli ta' anthracycline għal patoloġija bħal sarkoma jew rikaduti tal-AML fi tfal u adolexxenti
English: There is therefore no robust long term efficacy data that demonstrate that the use of DRZ prevents the chronic or long term cardiotoxic effects of anthracyclines in the paediatric population.
Maltese: Għaldaqstant, m'hemm l-ebda data robusta dwar l-effikaċja u fuq terminu twil li turi li l-użu tad-DRZ jipprevjeni l-effetti kardjotossiċi kroniċi jew fit-tul ta' anthracyclines fil-popolazzjoni pedjatrika.
English: • The Committee concluded that, in view of the above, it is justified to limit the contraindication for Cardioxane in children aged 0 to 18 years receiving low cumulative anthracycline doses (less than 300 mg/m2 of doxorubicin or equivalent)
Maltese: • Il-Kumitat ikkonkluda li, fid-dawl ta' dan ta' hawn fuq, huwa ġustifikat li l-kontraindikazzjoni għal Cardioxane tiġi limitata fi tfal ta bejn 0 sa 18-il sena li jirċievu dożi kumulattivi baxxi ta' anthracycline (inqas minn 300 mg/m2 ta' doxorubicin jew ekwivalenti)
English: Data are reassuring as regard to occurrence of SPMs in children after being exposed to DRZ, up to 12 years post treatment.
Maltese: Id-data hija inkoraġġanti fir-rigward tal-okkorrenza tal-SPMs fit-tfal wara li jkunu ġew esposti għadDRZ, sa 12-il sena wara l-kura.
English: DRZ efficacy as a cardioprotectant has not been demonstrated in children for cumulative anthracycline doses of less than 300 mg/m2.
Maltese: L-effikaċja tad-DRZ bħala sustanza li tipproteġi l-qalb ma ntwerietx fit-tfal għal dożi kumulattivi ta' anthracycline ta' anqas minn 300 mg/m2.
English: Anthracycline related cardiac damage can be acute, manifesting as acute heart failure, reduction in the shortening fraction or changes to the ventricular wall thickening.
Maltese: Il-ħsara kardijaka relatata ma' anthracycline tista' tkun akuta, manifestata bħala insuffiċjenza akuta tal-qalb, tnaqqis fil-frazzjoni ta' tqassir jew bidliet fil-ħxuna tal-ħajt ventrikolari.
English: The full EPAR for Zavicefta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment usually lasts between 5 and 14 days, depending on the type of infection.
Maltese: Ġeneralment il-kura ddum bejn 5 ijiem u 14-il jum, skont it-tip ta' infezzjoni.
English: This is a summary of the European public assessment report (EPAR) for Zavicefta.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zavicefta.
English: • complicated (difficult to treat) infections of the tissues and organs within the belly (intra-abdominal infections);
Maltese: • infezzjonijiet ikkumplikati (diffiċli biex jiġu kkurati) tat-tessuti u tal-organi fiż-żaqq (infezzjonijiet intra-addominali);
English: Zavicefta alone (for urinary tract infection) or in combination with metronidazole (for intra-abdominal infection) provided similar results to a number of alternative antibiotics in curing the infection: 91% of patients (140 out of 154) were cured after treatment with Zavicefta compared with 91% (135 out of 148) after treatment with the best alternative antibiotic.
Maltese: Zavicefta waħdu (għal infezzjoni fl-apparat tal-awrina) jew f'kombinazzjoni ma' metronidazole (għal infezzjoni intra-addominali) wera riżultati simili għal għadd ta' antibijotiċi alternattivi fil-kura tal-infezzjoni: 91% tal-pazjenti (140 minn 154) fiequ wara kura b'Zavicefta meta mqabbla ma' 91% (135 minn 148) wara kura bl-aħjar antibijotiku alternattiv.
English: Why is Zavicefta approved?
Maltese: Għaliex ġie approvat Zavicefta?
English: • complicated (difficult to treat) infections of the urinary tract (structures that carry urine), including pyelonephritis (kidney infection);
Maltese: • infezzjonijiet ikkumplikati (diffiċli biex jiġu trattati) tal-apparat tal-awrina (strutturi li jġorru lawrina), li jinkludu pyelonephritis (infezzjoni tal-kliewi);
English: What are the risks associated with Zavicefta?
Maltese: X'inhuma r-riskji assoċjati ma' Zavicefta?
English: Other information about Zavicefta
Maltese: Informazzjoni oħra dwar Zavicefta
English: Avibactam blocks the action of bacterial enzymes called beta-lactamases.
Maltese: Avibactam jimblokka l-azzjoni ta' enzimi batteriċi li jissejħu beta-lactamases.
English: Zavicefta was at least as effective as doripenem: 77% of patients (304 out of 393) treated with Zavicefta showed a response compared with 71% of patients (296 out of 417) treated with doripenem.
Maltese: Zavicefta kien tal-inqas effettiv daqs doripenem: 77% tal-pazjenti (304 minn 393) li ngħataw kura b'Zavicefta wrew rispons meta mqabbla ma' 71% tal-pazjenti (296 minn 417) li ngħataw kura b'doripenem.
English: A third study looked at 332 patients with complicated intra-abdominal or urinary tract infections caused by Gram-negative bacteria that were resistant to ceftazidime (could not be killed by ceftazidime).
Maltese: 332 pazjent b'infezzjonijiet ikkumplikati intra-addominali jew fl-apparat talawrina kkawżati minn batterji Gram-negattivi li kienu reżistenti għal ceftazidime (ma setgħux jinqatlu minn ceftazidime).
English: The active substances in Zavicefta are ceftazidime and avibactam.
Maltese: Is-sustanzi attivi f'Zavicefta huma ceftazidime u avibactam.
English: Ceftazidime is an antibiotic called a cephalosporin, which belongs to the wider group ‘beta-lactams'.
Maltese: Ceftazidime huwa antibijotiku li jissejjaħ cephalosporin, li jagħmel parti mill-grupp usa' ta' ‘beta-lactams'.
English: In the second study, 94% of patients (166 out of 177) treated with Zavicefta and metronidazole were cured, compared with 94% (173 out of 184) of patients treated with meropenem.
Maltese: Fit-tieni studju, 94% tal-pazjenti (166 minn 177) li ngħataw kura b'Zavicefta u metronidazole fiequ, meta mqabbla ma' 94% (173 minn 184) tal-pazjenti li ngħataw kura b'meropenem.
English: In the first study, one of the patient groups studied showed 92% of patients (376 out of 410) treated with Zavicefta and metronidazole were cured, compared with 93% (385 out of 416) of patients treated with meropenem.
Maltese: Flewwel studju, wieħed mill-gruppi ta' pazjenti studjati wera li 92% tal-pazjenti (376 minn 410) li ngħataw kura b'Zavicefta u metronidazole fiequ, meta mqabbla ma' 93% (385 minn 416) tal-pazjenti li ngħataw kura b'meropenem.
English: In two studies, the effects of the combination of Zavicefta and metronidazole (another antibiotic) were compared with those of the antibiotic meropenem in 1490 patients with complicated intra-abdominal infection.
Maltese: F'żewġ studji, l-effetti tal-kombinazzjoni ta' Zavicefta u metronidazole (antibijotiku ieħor) tqabblu ma' dawk tal-antibijotiku meropenem f'1490 pazjent b'infezzjoni intra-addominali kkumplikata.
English: These enzymes enable bacteria to break down beta-lactam antibiotics such as ceftazidime, making them resistant to the antibiotic's action.
Maltese: Dawn l-enzimi jippermettu lill-batterji jkissru l-antibijotiċi beta-lactam bħal ceftazidime, u jagħmluhom aktar reżistenti għall-azzjoni tal-antibijotiku.
English: Zavicefta is an antibiotic used in adults to treat the following infections:
Maltese: Zavicefta huwa antibijotiku li jintuża fl-adulti għall-kura tal-infezzjonijiet li ġejjin:
English: In addition, disease-causing bacteria were eliminated in 82% (126 out of 154) of patients after treatment with Zavicefta compared with 63% (94 out of 148) after treatment with the best alternative antibiotic.
Maltese: Barra minn hekk, fi 82% (126 minn 154) tal-pazjenti, il-batterji li jikkawżaw il-mard ġew eliminati wara kura b'Zavicefta meta mqabbla ma' 63% (94 minn 148) wara kura bl-aħjar antibijotiku alternattiv.
English: The most common side effects with Zavicefta (which affected more than 5 in 100 people) are nausea (feeling sick), diarrhoea and a positive result in a Coombs test (a sign of the development of antibodies that attack red blood cells).
Maltese: L-effetti sekondarji l-aktar komuni b'Zavicefta (li affettwaw aktar minn 5 persuni minn kull 100) huma nawseja (dardir), dijarea u riżultat pożittiv f'test ta' Coombs (sinjal tal-iżvilupp ta' antikorpi li jattakkaw iċ-ċelloli ħomor tad-demm).
English: Zavicefta must not be used in patients who are hypersensitive (allergic) to the active substances in Zavicefta or any of the other ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Maltese: Zavicefta ma għandux jintuża f'persuni li huma ipersensittivi (allerġiċi) għas-sustanzi attivi f'Zavicefta jew għal xi sustanza oħra tal-mediċina, jew f'dawk li huma ipersensittivi għal antibijotiċi cephalosporin oħrajn jew li qatt kellhom reazzjoni allerġika severa għal antibijotiku beta-lactam ieħor.
English: The CHMP considered that the studies on Zavicefta show that is effective at treating complicated intra-abdominal and urinary tract infections.
Maltese: Is-CHMP qies li l-istudji dwar Zavicefta juru li huwa effettiv fil-kura ta' infezzjonijiet ikkumplikati intraaddominali u fl-apparat tal-awrina.
English: However, the CHMP considered that the data already available supported Zavicefta's activity in hospital-acquired pneumonia and for the treatment of infections due to aerobic Gram-negative organisms in adult patients when other treatments might not work.
Maltese: Madankollu, is-CHMP qies li d-data diġà disponibbli tappoġġa l-attività ta' Zavicefta f'pulmonite li tittieħed mill-isptar u għall-kura ta' infezzjonijiet minħabba organiżmi aerobiċi Gramnegattivi f'pazjenti adulti meta kura oħra tista' ma taħdimx.
English: For the full list of all side effects with Zavicefta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Zavicefta, ara l-fuljett ta' tagħrif.
English: In a fourth study, 1,020 patients with complicated urinary tract infections (including pyelonephritis) caused by Gram-negative bacteria were treated with Zavicefta or the antibiotic doripenem.
Maltese: Fir-raba' studju, 1,020 pazjent b'infezzjonijiet ikkumplikati fl-apparat tal-awrina (li jinkludu pyelonephritis) ikkawżati minn batterji Gram-negattivi ngħataw kura b'Zavicefta jew bl-antibijotiku doripenem.
English: How is Zavicefta used?
Maltese: Kif jintuża Zavicefta?
English: Regarding Zavicefta's safety profile, side effects were those that can be expected for ceftazidime and a betalactamase inhibitor.
Maltese: Fir-rigward tal-profil tas-sigurtà ta' Zavicefta, l-effetti sekondarji kienu dawk li jistgħu jiġu mistennija għal ceftazidime u inibitur betalactamase.
English: • infections of the lungs that are caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe);
Maltese: • infezzjonijiet tal-pulmun li jittieħdu mill-isptar (pulmonite li ttieħdet mill-isptar), li jinkludu pulmonite assoċjata ma' ventilazzjoni mekkanika (pulmonite li tittieħed minn ventilazzjoni mekkanika, li hija magna li tgħin lil pazjent biex jieħu n-nifs);
English: • infections caused by Gram-negative bacteria (types of bacteria) when other treatments might not work.
Maltese: • Infezzjonijiet ikkawżati minn batterji Gram-negattivi (tipi ta' batterji) meta kura oħra tista' ma taħdimx.
English: How does Zavicefta work?
Maltese: Kif jaħdem Zavicefta?
English: By blocking the action of these enzymes, avibactam allows ceftazidime to act against bacteria that would otherwise be resistant.
Maltese: Billi jimblokka l-azzjoni ta' dawn l-enzimi, avibactam jippermetti lil ceftazidime jaġixxi kontra l-batterji li normalment ikunu reżistenti.
English: Zavicefta is available as a powder to be made up into a solution for infusion (drip) into a vein.
Maltese: Zavicefta jiġi bħala trab sabiex isir f'soluzzjoni għall-infużjoni (dripp) fil-vina.
English: It contains the active substance doxorubicin hydrochloride (2 mg/ml).
Maltese: Fih issustanza attiva doxorubicin hydrochloride (2 mg/ml).
English: The full EPAR for Caelyx can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Caelyx jinsab fil-websajt tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The marketing authorisation holder is Janssen-Cilag International NV.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Janssen-Cilag International NV.
English: Caelyx is used in combination with bortezomib (another anticancer medicine).
Maltese: Caelyx jintuża f'kombinazzjoni ma' bortezomib (mediċina oħra kontra l-kanċer).
English: Other very common side effects include palmar-plantar erythrodysaesthesia syndrome (redness and pain on the hands and feet), vomiting, stomatitis (inflammation of the lining of the mouth), rash, asthenia (weakness), low blood cell counts, loss of appetite, alopecia (hair loss), fatigue (tiredness), diarrhoea, constipation and mucositis (inflammation of the mouth and throat).
Maltese: Effetti sekondarji komuni ħafna oħrajn jinkludu sindromu ta' eritrodisestesija palmoplantari (ħmura u wġigħ fuq l-idejn u s-saqajn), rimettar, stomatite (infjammazzjoni tal-kisi tal-ħalq), raxx, astenija (dgħjufija), għadd baxx taċ-ċelloli tad-demm, anoressija (nuqqas ta' aptit), alopeċja (telf ta' xagħar), għeja kbira, dijarrea, stitikezza u mukożite (infjammazzjoni fil-ħalq u l-gerżuma).
English: Caelyx has been studied in a total of 2,512 patients in seven main studies.
Maltese: Caelyx ġie studjat f'total ta' 2,512-il pazjent f'seba' studji ewlenin.
English: Further studies compared Caelyx with the combination of doxorubicin, bleomycin and vincristine (other anticancer medicines) in 258 patients and with the combination of bleomycin and vincristine in 241 patients.
Maltese: Aktar studji qabblu Caelyx ma' kombinazzjoni ta' doxorubicin, bleomycin u vincristine (mediċini oħra kontra l-kanċer) f'258 pazjent u bil-kombinazzjoni ta' bleomycin u vincristine f'241 pazjent.
English: This is a summary of the European public assessment report (EPAR) for Caelyx.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Caelyx.
English: • Kaposi's sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS) who have very damaged immune systems and extensive sarcoma on the skin, the moist body surfaces or the internal organs;
Maltese: • Sarkoma ta' Kaposi (kanċer fil-vini u fl-arterji tad-demm) f'pazjenti bis-sindromu minn immunodefiċjenza akkwiżita (AIDS) li jkollhom ħsara kbira fis-sistema immunitarja u sarkoma estensiva fil-ġilda, fis-superfiċji umidi tal-ġisem jew fl-organi interni.