FrancophonIA/ELRC3.0 huggingface dataset:
English: Caelyx is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride.
Maltese: Caelyx huwa formulazzjoni liposomali pegilata li ddum tiċċirkola ta' doxorubicin hydrochloride.
English: A phase III randomised, parallel-group, open-label, multicentre study comparing the safety and efficacy of Caelyx plus bortezomib combination therapy with bortezomib monotherapy in patients with multiple myeloma who have received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy, was conducted in 646 patients.
Maltese: III li qabbel is-sigurtà u leffikaċja tat-terapija kombinata b'Caelyx u bortezomib ma' monoterapija b'bortezomib f'pazjenti b'majeloma multipla li rċevew mill-anqas terapija 1 minn qabel u li ma avvanzawx filwaqt li kienu qed jirċievu terapija bbażata fuq anthracycline, sar f'646 pazjenti.
English: Grade 2 (painful erythema, oedema, or ulcers, but can eat)
Maltese: Grad 2 (ħmura tal-ġilda bluġigħ, edima, jew ulċeri, iżda tista' tiekol)
English: The survival rates at 1, 2 and 3 years were 56.3%, 34.7% and 20.2% respectively on Caelyx, compared to 54.0%, 23.6% and 13.2% on topotecan.
Maltese: Ir-rati ta' sopravivenza f'etajiet ta' sena, 2 u 3 snin kienu 56.3 %, 34.7 % u 20.2 % rispettivament fuq Caelyx, imqabbla ma' 54.0 %, 23.6 % u 13.2 % fuq topotecan.
English: Growth factor support or transfusion support was necessary in 5.1% and 5.5% of patients, respectively (see section 4.2).
Maltese: Appoġġ tal-fattur tal-iżviluppr jew appoġġ ta' trasfużjoni kien meħtieġ f'5.1 % u 5.5 % tal-pazjenti rispettivament (ara sezzjoni 4.2).
English: Leukopaenia, anaemia, thrombocytopaenia
Maltese: Lewkopenija, anemija, tromboċitopenija
English: Prior to Caelyx administration, evaluate hepatic function using conventional clinical laboratory tests such as ALT/AST, alkaline phosphatase, and bilirubin.
Maltese: Qabel jingħata Caelyx, irid jitqies il-funzjoni tal-fwied billi jintużaw it-testijiet kliniċi konvenzjonali tal-laboratorju bħalma huma ALT/AST, alkaline phosphotase u bilirubin.
English: Headache, peripheral sensory neuropathy, paraesthesia, dizziness
Maltese: Uġigħ ta' ras, newropatija sensorjali periferali, parasteżija, sturdament
English: A phase III comparative study of Caelyx versus topotecan in patients with epithelial ovarian cancer following the failure of first-line, platinum-based chemotherapy was completed in 474 patients.
Maltese: III ta' Caelyx versus topotecan f'pazjenti b'kanċer tal-ovarji epitiljali wara li falliet il-kura preferita, kemoterapija bażata fuq il-platinum kienet tlestiet f'474 pazjent.
English: Manufacturer Janssen Pharmaceutica NV
Maltese: Janssen Pharmaceutica NV Turnhoutseweg 30
English: The incidence of life threatening (grade 4) haematologic effects was < 1.0% and sepsis was reported in 1% of patients.
Maltese: L-inċidenza ta' effetti ematoloġiċi li huma ta' theddida għal ħajja (grad 4) kienet ta' < 1.0 % u sepsis ġie rrappurtat f'1 % tal-pazjenti.
English: At equivalent doses, the plasma concentration and AUC values of Caelyx which represent mostly pegylated liposomal doxorubicin hydrochloride (containing 90% to 95% of the measured doxorubicin) are significantly higher than those achieved with standard doxorubicin hydrochloride preparations.
Maltese: F'dożi ekwivalenti, il-konċentrazzjoni fil- plażma u valuri AUC ta' Caelyx li jirrappreżentaw prinċipalment doxorubicin hydrochloride liposomali pegilat (fihom 90 % sa 95 % ta' doxorubicin imkejjel) huma ogħla b'mod sinifikanti minn dawk li jintlaħqu bil-preparazzjonijiet doxorubicin hydrochloride standard.
English: Over the dose range of 10 mg/m 2-60 mg/m 2 Caelyx displayed non-linear pharmacokinetics.
Maltese: F'dożi iżjed baxxi (10 mg/m 20 mg/m2) Caelyx wera farmakokinetika linejari.
English: The incidence of grade 3 and 4 thrombocytopaenia was higher in the combination therapy group than in the monotherapy group (22% vs. 14%).
Maltese: L-inċidenza ta' tromboċitopenija ta' grad 3 u 4 kienet ogħla fil-grupp b'terapija kombinata milli fil-grupp b'monoterapija (22 % vs. 14 %).
English: At cumulative doses greater than 450 mg/m2 there were no cardiac events with Caelyx.
Maltese: F'dożi kumulattivi ogħla minn 450 mg/m ma seħħewx każijiet kardijaċi b'Caelyx.
English: 10 vials 50 mg/25 ml
Maltese: 10 kunjetti 50 mg/25 ml
English: Neutropaenia, thrombocytopaenia
Maltese: Newtropenija, tromboċitopenija
English: Neutropaenia, thrombocytopaenia, and anaemia were the most frequently reported haematologic events reported with both combination therapy of Caelyx plus bortezomib and bortezomib monotherapy.
Maltese: Newtropenija, tromboċitopenija, u anemija kienu l-każijiet ematoloġiċi rrapurtati bl-aktar mod frekwenti kemm b'terapija kombinata b'Caelyx ma' bortezomib kif ukoll b'monoterapija b'bortezomib.
English: 3 and/or the platelet count is < 50,000/mm
Maltese: 3 u/jew l-għadd tal-plejtlets ikun < 50,000/mm
English: Uncommon  1/1,000 and < 1/100 Rare
Maltese:  1/1,000 u < 1/100
English: A similar incidence of infusion reactions (12.4%) and treatment discontinuation (1.5%) was observed in the breast cancer program.
Maltese: Inċidenza simili ta' reazzjonijiet għall-infużjoni (12.4 %) u waqfien tat-trattament (1.5 %) kienu nnotati fil-programm ta' kanċer tas-sider.
English: The plasma pharmacokinetics of Caelyx were evaluated in 23 patients with KS who received single doses of 20 mg/m2 administered by a 30-minute infusion.
Maltese: Il-farmakokinetiċi tal-plażma ta'Caelyx ġew evalwati fi 23 pazjent bi KS li ngħataw dożi ta' darba ta' 20 mg/m2 mogħtija b'infużjoni ta' 30 minuta.
English: Respiratory, thoracic and mediastinal disorders common dyspnoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni
English: Grade 3 (blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing)
Maltese: Grad 3 (infafet, ulċerazzjoni, jew nefha li tfixkel il-mixi jew l-attivitajiet normali ta' kuljum; ma tistax tilbes il-ħwejjeġ tas-soltu)
English: Other less frequently (< 5%) observed undesirable effects included hypersensitivity reactions including anaphylactic reactions.
Maltese: Effetti mhux mixtieqa oħrajn li kienu innutati b'mod anqas frekwenti (< 5 %) kienu jinkludu reazzjonijiet ta' sensittività eċċessiva inklużi reazzjonijiet anafilattiċi.
English: Vaginitis
Maltese: Vażodilatazzjoni
English: Palmar-Plantar erythrodysesthesia Week after prior Caelyx dose
Maltese: Palmar - Plantar eritrodisestesija Ġimgħa wara d-doża ta' Caelyx ta' qabel
English: 10 vials 20 mg/10 ml
Maltese: 10 kunjetti 20 mg/10 ml
English: Common adverse events which led to treatment discontinuation of bortezomib and Caelyx included PPE, neuralgia, peripheral neuropathy, peripheral sensory neuropathy, thrombocytopaenia, decreased ejection fraction, and fatigue.
Maltese: Każijiet avversi komuni li wasslu għat-twaqqif tal-kura b'bortezomib u Caelyx kienu jinkludu PPE, nevralġja, newropatija periferali, newropatija sensorjali periferali, tromboċitopenija, tnaqqis filfrazzjoni tal-ħruġ, u għeja.
English: Mouth ulceration, esophagitis, nausea and vomiting, gastritis, dysphagia, dry mouth, flatulence, gingivitis, taste perversion
Maltese: Ulċeri fil-ħalq, esofagite, dardir u rimettar, gastrite, disfaġja, ħalq xott, gass fl-istonku, ġenġivite, perverżjoni tat-togħma
English: Very rare side effects (may affect up to 1 in 10,000 people) - serious skin reactions such as widespread peeling skin, blisters as well as mucous membrane erosion (Stevens-Johnson syndrome/toxic epidermal necrolysis); - oral cancer may occur when Caelyx is taken for a long time (more than one year).
Maltese: Effetti sekondarji rari ħafna (li jistgħu jaffettwaw sa persuna 1 f'10,000) - reazzjonijiet serji tal-ġilda bħal ġilda li qed titqaxxar madwar il-ġisem, infafet kif ukoll tqaxxir tar-rita mukuża (sindromu ta' Stevens-Johnson.nekrolisi epidermali tossika); - kanċer orali li jista' jseħħ meta Caelyx jittieħed għal żmien twil (għal aktar minn sena).
English: Folliculitis, fungal infection, cold sores (non-herpetic), upper respiratory tract infection
Maltese: Follikulite, infezzjoni tal-moffa, qsim taxxofftejn (mhux bl-erpe), infezzjoni tas-sistema respiratorja tal-parti ta' fuq
English: Caelyx can be administered to patients with liver metastases with concurrent elevation of bilirubin and liver enzymes up to 4 x the upper limit of the normal range.
Maltese: Caelyx jista' jingħata lil pazjenti b'metastasi fil-fwied u li għandhom żieda ta' bilirubin u enzimi tal-fwied 4 darbiet l-ogħla limitu tal-medda normali.
English: GRADE
Maltese: LOTT
English: Peripheral sensory neuropathy, neuralgia, headache
Maltese: Newropatija sensorjali periferali, nevralġja, uġigħ ta' ras
English: The mean intrinsic clearance was 0.016 l/h/m2 (range 0.008-0.027 l/h/m2), the mean central volume of distribution was 1.46 l/m 2 (range 1.10-1.64 l/m 2).
Maltese: distribuzzjoni kien ta' 1.46 l/m 2 (medda 1.10 - 1.64 l/m 2).
English: Caelyx must not be used to treat AIDS-KS that may be treated effectively with local therapy or systemic alfa-interferon.
Maltese: Caelyx m'għandux jintuża għat-trattament ta' AIDS-KS li jista' jiġi ttrattat b'mod effettiv b'terapija lokali jew sistematika ta' alfa-interferon.
English: Infusion reactions rarely recur after the first treatment cycle with Caelyx (see section 4.2).
Maltese: Ir-reazzjonijiet għall-infużjoni rari li jseħħu wara l-ewwel ċiklu ta' trattament b'Caelyx (ara sezzjoni 4.2).
English: Pneumonia, nasopharyngitis, upper respiratory tract infection, oral candidiasis
Maltese: Pulmonite, nażofarinġite, infezzjoni fil-passaġġ respiratorju ta' fuq, kandidijażi orali
English: Caelyx concentrate for solution for infusion: vials which provide 10 ml (20 mg) or 25 ml (50 mg).
Maltese: Kunjetti li jipprovdu 10 ml (20 mg) jew 25 ml (50 mg).
English: The incidence of grade 3 and 4 neutropaenia was higher in the combination therapy group than in the monotherapy group (28% vs. 14%).
Maltese: L-inċidenza ta' newtropenija ta' grad 3 u 4 kienet ogħla fil-grupp b'terapija kombinata milli fil-grupp b'monoterapija (28 % vs. 14 %).
English: 509 patients with advanced breast cancer who had not received prior chemotherapy for metastatic disease were treated with Caelyx (n=254) at a dose of 50 mg/m2 every 4 weeks, or doxorubicin
Maltese: 509 pazjent b'kanċer tas-sider avvanzat li ma kinux ingħataw kemoterapija preċedenti għall-mard metastatiku, ngħataw trattament b'Caelyx (n=254) b'doża ta' 50 mg/m2 kull 4 ġimgħat, jew doxorubicin (n=255) b'doża ta' 60 mg/m2 kull 3 ġimgħat, fi prova klinika ta' fażi
English: Grade 3 or 4 non-haematologic medicine related toxicity
Maltese: Tossiċità mhux ematoloġika mhux relatata mal-mediċina ta' Grad 3 jew 4
English: Respiratory undesirable effects commonly occurred in clinical studies of Caelyx and may be related to opportunistic infections (OI's) in the AIDS population.
Maltese: Fl-istudji kliniċi dwar Caelyx, effetti respiratorji mhux mixtieqa seħħew b'mod komuni u jistgħu jkunu relatati ma' infezzjonijiet opportunistiċi (opportunistic infections, OI's) fil-popolazzjoni ta' pazjenti bl-AIDS.
English: Treatment of acute overdose of the severely myelosuppressed patient consists of hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
Maltese: It-trattament ta' doża eċċessiva akuta ta' pazjent gravement majelosoppress tikkonsisti fit-teħid l-isptar, antibijotiċi, trasfużjonijiet ta' plejtlets u granuloċiti u trattament sintomatiku tal-mukożite.
English: Dosage adjustments for Caelyx + bortezomib combination therapy - patients with multiple myeloma
Maltese: Aġġustamenti tad-dożaġġi għal terapija kombinata b'Caelyx + Bortezomib pazjenti b'majeloma multipla
English: Grade 3 (painful erythema, edema, or ulcers, but cannot eat)
Maltese: Grad 3 (ħmura tal-ġilda bluġigħ, edima, jew ulċeri, u ma tistax tiekol)
English: These grading scores are consistent with no or mild cardiac toxicity.
Maltese: Dawn il-punteġġi fil-gradazzjoni huma konsistenti ma' nuqqas ta' tossiċità kardijaka jew tossiċità kardijaka ħafifa.
English: < 1/10,000 including isolated reports
Maltese: < 1/10,000 li jinkludu rapport iżolati
English: If the bilirubin is > 3.0 mg/dl, the first dose is reduced by 50%.
Maltese: Jekk il-bilirubin ikun > 3.0 mg/dl, l-ewwel doża titnaqqas b'50 %.
English: An increased incidence of congestive heart failure is associated with doxorubicin therapy at cumulative lifetime doses > 450 mg/m2 or at lower doses for patients with cardiac risk factors.
Maltese: Inċidenza ogħla ta' insuffiċjenza tal-qalb konġestiva hi marbuta mat-terapija b'doxorubicin f' dożi kumulattivi tul il-ħajja ta' > 450 mg/m2 jew f'dożi aktar baxxi f'pazjenti b'fatturi ta' riskju kardijaku.
English: Haematological toxicity (ANC or platelets) - Management of patients with breast or ovarian cancer
Maltese: Tabella 3. Tossiċità ematoloġika (ANC jew plejtlets) - Immaniġjar ta' pazjenti b'kanċer tas-sider jew tal-ovarji
English: Caelyx 2 mg/ml concentrate for solution for infusion
Maltese: Caelyx 2 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: Caelyx may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
Maltese: Caelyx jista' jintuża bħala l-kura kimoterapewtika preferita, jew bħala kemoterapija tal-kura tat-tieni preferenza f'pazjenti b'AIDS-KS b'mard li baqa' jinfirex, jew f'pazjenti intolleranti għal, kimoterapija sistemika kkombinata li ngħatat qabel li fiha mill-inqas tnejn mis-sustanzi li ġejjin: alkaloid vinka, bleomycin, u doxorubicin standard (jew anthracycline ieħor).
English: Uncommon side effects (may affect up to 1 in 100 people) - confusion; - inflammation of the veins and formation of blood clots in the veins which could lead to blockage of blood flow to your lungs causing difficulty breathing, chest pain and palpitations; - abnormal heart rhythm, heart beat feels fast or uneven (palpitations), heart failure, which makes you short of breath and may lead to swollen legs, cardiac arrest.
Maltese: Effetti sekondarji mhux komuni (li jistgħu jaffettwaw sa persuna 1 f'100) - konfużjoni - infjammazzjoni tal-vini u l-formazzjoni ta' emboli tad-demm li jistgħu jwasslu għal xkiel fl-influss tad-demm fil-pulmun tiegħek li jagħmilha diffiċli biex tieħu n-nifs, uġigħ is-sider u palpitazzjonijiet; - ritmu mhux normali tal-qalb, it-taħbit tal-qalb jinħass mgħaġġel jew mhux regolari (palpitatazzjonijiet), insuffiċjenza tal-qalb, li ġġegħlek taqta' nifsek u tista' twassal għal riġlejn minfuħin, waqfien tal-qalb.
English: CAELYX LABEL 50 mg/25 ml
Maltese: TIKKETTA CAELYX 50 mg/25 ml
English: Summary of the safety profile The most common undesirable effect reported in breast/ovarian clinical trials (50 mg/m every
Maltese: Sommarju tal-profil tas-sigurtà L-effett mhux mixtieq l-iżjed komuni li ġie rrappurtat fil-provi kliniċi tas-sider/ovarji (50 mg/m2 kull
English: Caelyx is an antitumour agent.
Maltese: Caelyx huwa sustanza kontra t-tumur.
English: The median TTP was 6.9 months for the bortezomib monotherapy patients compared with 8.9 months for the Caelyx plus bortezomib combination therapy patients.
Maltese: It-TTP medjan kien 6.9 xhur għall-pazjenti fuq monoterapija b'bortezomib meta mqabbel ma' 8.9 xhur għall-pazjenti fuq terapija kombinata b'Caelyx u bortezomib.
English: Paresthesia
Maltese: Parasteżija
English: The reported incidence of life-threatening (grade 4) cases was < 1%.
Maltese: L-inċidenza rappurtata ta' każijiet li jheddu l-ħajja (grad 4) kien < 1 %.
English: Abdominal pain, dyspepsia
Maltese: Newtropenija bid-deni, limfopenija
English: One ml of Caelyx contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal formulation.
Maltese: 1 ml ta' Caelyx fih 2 mg doxorubicin hydrochloride b'formulazzjoni ta' liposoma pegilata.
English: Anaemia, neutropaenia, thrombocytopaenia
Maltese: Anemija, newtropenija, tromboċitopenija
English: The protocol-specified objective of demonstrating non-inferiority between Caelyx and doxorubicin was met, the hazard ratio (HR) for progression-free survival (PFS) was 1.00 (95% CI for HR=0.82-1.22).
Maltese: Il-mira stabbilita skont il-protokoll biex jintwera li Caelyx mhux inferjuri għal doxorubicin ntlaħqet, il-proporzjon ta' riskju (Hazard ratio, HR) għal sopravivenza minn progressjoni tal-marda (progression free survival, PFS) kien 1.00 (95 % CI għal HR=0.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: Type I glass vials, each with a siliconised grey bromobutyl stopper, and an aluminium seal, with a deliverable volume of 10 ml (20 mg) or 25 ml (50 mg).
Maltese: Kunjetti tal-ħġieġ Tip I, kull wieħed b'tapp tal-bromobutyl griż silikonizzat, u siġill tal-aluminju, b'volum li jista' jintuża ta' 10 ml (20 mg) jew 25 ml (50 mg).
English: AE by body system Breast cancer All severities n=254
Maltese: Kanċer tas-sider Severitajiet kollha n=254
English: Leukopaenia, anaemia, neutropaenia, thrombocytopaenia
Maltese: Lewkopenija, anemija, newtropenija, tromboċitopenija
English: Nausea and vomiting were reported more frequently in the combination therapy group (40% and 28%) than in the monotherapy group (32% and 15%) and were mostly grade 1 and 2 in severity.
Maltese: Dardir u rimettar kienu rrappurtati b'mod aktar frekwenti fil-grupp b'terapija kombinata (40 % u 28 %) milli fil-grupp b'monoterapija (32 % u 15 %) u kienu l-aktar ta' grad 1 u 2 fis-severità tagħhom.
English: Although no studies have been conducted with Caelyx, doxorubicin hydrochloride, the pharmacologically active ingredient of Caelyx, is mutagenic and carcinogenic.
Maltese: Għalkemm ma sarux studji b'Caelyx, doxorubicin hydrochloride, is-sustanza farmakoloġikament attiva f'Caelyx, hi mutaġenika u karċinoġenika.
English: 6.2 Incompatibilities
Maltese: .2 Inkompatabbiltajiet
English: Peripheral oedema, chills, influenza-like illness, malaise, hyperthermia
Maltese: Edema periferali, dehxiet, mard bħal influwenza, tħossok ma tiflaħx, ipertermija
English: Caelyx resulted in mild to moderate ovarian and testicular atrophy in mice after a single dose of 36 mg/kg.
Maltese: Caelyx wassal għal atrofija ħafifa jew moderata tal-ovarji u tat-testikoli fil-ġrieden wara doża waħda ta' 36 mg/kg.
English: Dry skin
Maltese: Tnaqqis tal-piż
English: The cardiac safety profile for the dosing schedule recommended for both breast and ovarian cancer (50 mg/m 2) is similar to the 20 mg/m 2 profile in patients with AIDS-KS (see section 4.8).
Maltese: Il-profil ta' sigurtà kardijaka għall-iskeda ta' dożaġġ irrakkomandata kemm għall-kanċer tas-sider kemm għal dak tal-ovarji (50 mg/m 2) hu simili għall-profil ta' 20 mg/m 2 f'pazjenti bl-AIDS-KS (ara sezzjoni 4.8)
English: CAELYX LABEL 20 mg/10 ml
Maltese: TIKKETTA CAELYX 20 mg/10 ml
English: Gastrointestinal disorders very common nausea common diarrhoea, stomatitis, vomiting, mouth ulceration, abdominal pain, glossitis, constipation, nausea and vomiting
Maltese: Disturbi gastrointestinali komuni ħafna dardir komuni dijarea, stomatite, rimettar, ulċeri fil-ħalq, uġigħ addominali, glossite, stitikezza, tqallih u rimettar
English: The exact mechanism of the antitumour activity of doxorubicin is not known.
Maltese: Il-mekkaniżmu preċiż tal-attività antitumurali ta' doxorubicin mhux magħruf.
English: Caelyx, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies.
Maltese: Bħal preparazzjonijiet b'doxorubicin hydrochloride oħra, Caelyx jista' jippotenzja t-tossiċità ta' terapiji kontra l-kanċer oħrajn.
English: ** Grade 3/4 adverse events are based on the adverse event terms of all severities with an overall incidence ≥ 5% (see adverse events listed in first column).
Maltese: * Palmar-plantar eritrodisestesija (Sindrome tal-Id-Sieq). ** Każijiet avversi ta' Grad 3/4 huma bbażati fuq it-termini tal-każijiet avversi tas-severitajiet kollha b'inċidenza globali ta' > 5 % (ara l-każijiet avversi elenkati fl-ewwel kolonna).
English: In a pooled analysis of 4,231 patients receiving Caelyx for breast cancer, ovarian cancer, multiple myeloma, or AIDS-related KS, ventricular arrythmia, palpitations, cardiac failure, cardiac arrest, bundle branch block right, and ejection fraction decreased were reported uncommonly, and atrioventricular block, cyanosis, and conduction disorder were reported rarely.
Maltese: F'ġabra ta' analiżi ta' 4,231 pazjent li kienu qed jirċievu Caelyx għall-kanċer tas-sider, kanċer talovarji, majeloma multipla, jew KS marbuta mal-AIDS, arritmija tal-ventrikulu, palpitazzjonijiet, insuffiċjenza kardijaka, waqfien tal-qalb, imblokk f'fergħa ta' għadd ta' nervituri fin-naħa tal-lemin tas-sistema ta' konduzzjoni elettrika tal-qalb, u li l-porzjon ta' tfigħ 'il barra mill-qalb jonqos ġew irrappurtati b'mod mhux komuni, u imblokk atrioventrikulari, ċjanożi, u disturb fil-konduzzjoni ġew irrappurtati b'mod rari.
English: The treatment HR for PFS when adjusted for prognostic variables was consistent with PFS for the ITT population.
Maltese: It-trattament HR għall-PFS meta rranġat għall-varjanti mbassra kien konsistenti ma' PFS għall-popolazzjoni ITT.
English: Fertility The effect of doxorubicin hydrochloride on human fertility has not been evaluated (see section 5.3).
Maltese: Fertilità L-effett ta' doxorubicin hydrochloride fuq il-fertilità tal-bniedem ma ġiex evalwat (ara sezzjoni 5.3).
English: Cardiac toxicity was defined as a decrease of 20 points or greater from baseline if the resting LVEF remained in the normal range or a decrease of 10 points or greater if the LVEF became abnormal (less than the lower limit for normal).
Maltese: Il-kardjotossiċità ġiet deskritta bħala tnaqqis ta' 20 punt jew iżjed mill-linja bażika jekk l-LVEF baqa' fil-medda normali jew tnaqqas b' 10 punti jew aktar jekk l-LVEF sar anormali (anqas mill-limitu l-iżjed baxx tan-normali).
English: Grade 2 (erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter)
Maltese: Grad 2 (ħmura tal-ġilda, deskwamazzjoni, jew nefha li tfixkel, iżda li ma żżommx mill-attivitajiet normali; nfafet żgħar, ulċerazzjonijiet ta' anqas minn 2 ċm fid-dijametru)
English: These linear MPEG groups extend from the liposome surface creating a protective coating that reduces interactions between the lipid bilayer membrane and the plasma components.
Maltese: Dawn il-kategoriji ta' MPEG linejari joħorġu mill-wiċċ tal-liposoma biex joħolqu kisja protettiva li tnaqqas l-interazzjonijiet bejn il-membrana b'żewġ saffi ta' lipidi u l-komponenti talplażma.
English: The pegylated liposomes also have a low permeability lipid matrix and internal aqueous buffer system that combine to keep doxorubicin hydrochloride encapsulated during liposome residence time in circulation.
Maltese: Il-liposomi pegilati għandhom ukoll matriċi lipida ta' permeabilità baxxa u sistema interna ta' baffer akweju li jaħdmu flimkien biex iżommu doxorubicin hydrochloride enkapsulat fil-ħin ta' residenza tal-liposoma fiċċirkolazzjoni.
English: See Table 5 for complete listing of undesirable effects reported in Caelyx-treated patients.
Maltese: Ara Tabella 5 għall-lista sħiħa ta' effetti mhux mixtieqa rappurtati f'  5 % tal-pazjenti ttrattati b'Caelyx.
English: Neuropathy peripheral, neuropathy, paraesthesia, polyneuropathy, dizziness, dysgeusia
Maltese: Newropatija periferali, newropatija, parasteżija, polinewropatija, sturdament, tibdil fittogħma
English: Persistent severe myelosuppression, may result in superinfection or haemorrhage.
Maltese: Majelosoppressjoni gravi u persistenti, tista' twassal għal superinfezzjoni jew fsada.
English: Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.
Maltese: Caelyx m'għandux jinbidel bħala ekwivalenti ma' formulazzjonijiet oħra ta' doxorubicin hydrochloride.