FrancophonIA/ELRC3.0 huggingface dataset:
English: Caelyx 2 mg/ml concentrate for solution for infusion Pegylated liposomal doxorubicin hydrochloride
Maltese: Caelyx 2 mg/ml konċentrat għal soluzzjoni għall-infużjoni Doxorubicin hydrochlorinated liposomali pegilat
English: Secondary oral neoplasms
Maltese: Neoplażmi orali sekondarji
English: The pharmacokinetic parameters of Caelyx (primarily representing pegylated liposomal doxorubicin hydrochloride and low levels of unencapsulated doxorubicin hydrochloride) observed after the 20 mg/m2 doses are presented in
Maltese: Il-parametri farmakokinetiċi ta' Caelyx (primarjament jirrappreżentaw doxorubicin hydrochlorinated liposomali pegilat u livelli baxxi ta' doxorubicin hydrochlorinated mhux enkapsulati) li ġew innotati wara l-użu ta' dożi ta' 20 mg/m2 qed jiġu ppreżentati f'Tabella 10.
English: 512 patients with ovarian cancer (a subset of 876 solid tumour patients) were treated with Caelyx at a dose of 50 mg/m2 in clinical trials.
Maltese: 512-il pazjenta b'kanċer tal-ovarji (sottosett ta' 876 pazjenta b'tumuri solidi) ġew ittrattati b'Caelyx b'doża ta' 50 mg/m2 fi provi kliniċi.
English: 100 out of 929 patients (10.8%) with solid tumours were described as having an infusion-associated reaction during treatment with Caelyx as defined by the following Costart terms: allergic reaction, anaphylactoid reaction, asthma, face oedema, hypotension, vasodilatation, urticaria, back pain, chest pain, chills, fever, hypertension, tachycardia, dyspepsia, nausea, dizziness, dyspnoea, pharyngitis, rash, pruritus, sweating, injection site reaction and medicinal product interaction.
Maltese: 100 mid-929 pazjent (10.8 %) b'tumuri solidi ġew deskritti bħala li kellhom reazzjonijiet assoċjati ma' l-infużjoni waqt it-trattament b'Caelyx skond it-terminoloġija Costart li ġejja: reazzjoni allerġika, reazzjoni anafilattojda, ażma, edima fil-wiċċ, pressjoni baxxa, vażodilatazzjoni, urtikarja, uġigħ fid-dahar, uġigħ fis-sider, dehxiet, deni, pressjoni għolja, takikardja, dispepsja, tqallih, sturdament, qtugħ ta' nifs, farinġite, raxx, ħakk, għaraq, reazzjoni fil-post mnejn tingħata l-injezzjoni u interazzjoni ma' prodotti mediċinali.
English: Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100) Infections and infestations common oral moniliasis
Maltese: Mhux komuni (≥ 1/1,000, < 1/100) Infezzjonijiet u infestazzjonijiet komuni monilijażi orali
English: Treatment related undesirable effects reported in multiple myeloma clinical trial (Caelyx 30 mg/m2 in combination with bortezomib every 3 weeks) by severity, MedDRA system organ class and preferred term Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100)
Maltese: Effetti mhux mixtieqa relatati mal-kura rrappurtati fil-prova klinika b'majeloma multipla (Caelyx 30 mg/m2 f'kombinazzjoni ma' bortezomib kull 3 ġimgħat) skont is-severità, klassi tas-sistema tal-organi MedDRA u terminu preferut Komuni ħafna (≥ 1/10); Komuni (≥ 1/100, < 1/10);
English: Vascular disorders uncommon venous thromboembolism, including thrombophlebitis, venous thrombosis and pulmonary embolism
Maltese: Disturbi vaskulari mhux komuni tromboemoliżmu venuż, li jinkludi tromboplebite, trombosi venuża u emboliżmu pulmonari
English: In the pivotal phase III trial versus doxorubicin, 58/509 (11.4%) randomised subjects (10 treated with Caelyx at a dose of 50 mg/m2/every 4 weeks versus 48 treated with doxorubicin at a dose of
Maltese: III versus doxorubicin, 58/509 (11.4 %) individwi magħżula b'mod każwali (10 ttrattati b'Caelyx b'doża ta' 50 mg/m2/kull 4 ġimgħat versus 48 ittrattati b'doxorubicin b'doża ta'
English: Based on the review of the safety data of pegylated liposomal doxorubicin hydrochloride (Caelyx), a signal of lichenoid keratosis was detected with a total of 10 cases reported.
Maltese: Abbażi ta' reviżjoni tad-data ta' sigurtà ta' doxorubicin hydrochloride liposomali pegilat (Caelyx), ġie nnutat sinjal ta' keratożi likenuża b'total ta' 10 każijiet irrappurtati.
English: The treatments were similar in the sub-group of patients with platinum-refractory disease: HR of 1.069 (95% CI: 0.823; 1.387), p=0.618.
Maltese: HR ta' 1.069 (95 % CI; 0.823; 1.387), p=0.618.
English: Of 646 patients with multiple myeloma who have received at least 1 prior therapy, 318 patients were treated with combination therapy of Caelyx 30 mg/m2 as a one hour intravenous infusion administered on day 4 following bortezomib which is administered at 1.3 mg/m² on days 1, 4, 8, and 11, every three weeks or with bortezomib monotherapy in a phase III clinical trial.
Maltese: Mis-646 pazjent b'majeloma multipla li rċevew mill-anqas terapija waħda minn qabel, 318-il pazjent kienu ikkurati b'terapija kombinata b'Caelyx 30 mg/m2 bħala infużjoni ġol-vina ta' siegħa mogħtija f'jum 4 wara bortezomib li jingħata b'1.3 mg/m2 f'jiem 1, 4, 8, u 11, kull tlett ġimgħat jew b'monoterapija b'bortezomib fi prova klinika ta' fażi
English: The mean intrinsic clearance of Caelyx was 0.030 l/h/m (range 0.008 to 0.152 l/h/m2) and the mean central volume of distribution was 1.93 l/m
Maltese: It-tneħħija medja intrinsika ta'Caelyx kienet ta' 0.030 l/h/m 2 (medda 0.008 sa 0.152 l/h/m 2) u l-volum ta' distribuzzjoni ċentrali medju kien ta'
English: There was a significant improvement in the primary endpoint of time to progression (TTP) for patients treated with combination therapy of Caelyx plus bortezomib compared to patients treated with bortezomib monotherapy as indicated by a risk reduction (RR) of 35% (95% CI: 21-47%), p < 0.0001, based on 407 TTP events.
Maltese: Kien hemm titjib sinifikanti fil-punt aħħari primarju għaż-żmien biex avvanza (time to progression, TTP) għall-pazjenti kkurati bitterapija kombinata b'Caelyx u bortezomib meta mqabbla ma' pazjenti kkurati b'monoterapija b'bortezomib hekk kif indikat b'riskju mnaqqas (risk reduction, RR) ta' 35 % (95 % CI: 21-47 %), p < 0.0001, ibbażat fuq 407 każ ta' TTP.
English: Nervous system disorders common dizziness uncommon paresthesia
Maltese: Disturbi fis-sistema nervuża komuni sturdament mhux komuni paresteżija
English: Very rarely, convulsions also have been observed in relation to infusion reactions (see section 4.8).
Maltese: Rari ħafna, konvulsjonijiet kienu relatati ma' reazzjonijiet tal-infużjoni (ara sezzjoni 4.8).
English: Breast cancer Grades 3/4 n=254
Maltese: Kanċer tas-sider Gradi 3/4 n=254
English: * Palmar-plantar erythrodysesthesia (Hand-foot syndrome).
Maltese: * palmar-plantar eritrodisestesija (Sindrome tal-id u tas-sieq).
English: 0.96-3.85 l/m2) approximating the plasma volume.
Maltese: 1.93 l/m 2 (medda 0.96 - 3.85 l/m 2) li tqarrab il-volum tal-plażma.
English: Acute overdosing with doxorubicin hydrochloride worsens the toxic effects of mucositis, leukopaenia and thrombocytopaenia.
Maltese: Doża eċċessiva akuta b'doxorubicin hydrochloride żżid l-effetti tossiċi ta' mukożite, lewkopenija u tromboċitopenija.
English: Psychiatric disorders uncommon confusion
Maltese: Disturbi psikjatriċi mhux komuni konfużjoni
English: After dilution: - Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Maltese: Wara li jiġi dilwit: - L-istabilità kimika u fiżika waqt l-użu ġiet ippruvata għal 24 siegħa f'temperatura ta' bejn 2°C sa 8°C.
English: Pharmacokinetic parameters in Caelyx-treated AIDS-KS patients Mean + standard error
Maltese: Parametri farmakokinetiċi f'pazjenti bl-AIDS-KS ttrattati b'Caelyx Medja + errur standard
English: However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Maltese: Madankollu tnaqqis tal-QRS complex jitqies li hu iżjed indikattiv ta' tossiċità kardijaka.
English: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)--methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE) fully hydrogenated soy phosphatidylcholine (HSPC) cholesterol ammonium sulphate sucrose histidine water for injections hydrochloric acid (for pH-adjustment) sodium hydroxide (for pH-adjustment)
Maltese: -(2-[1,2-distearoyl -sn-glycero (3)phosphooxy]ethylcarbamoyl)--methoxypoly (oxyethylen)40 sodium salt (MPEG-DSPE) soy phosphatidylcholine (HSPC) kompletament idroġenat kolesterolammonium sulphate sucrose histidine ilma għall-injezzjonijiet hydrochloric acid (għall-aġġustament tal-pH) sodium hydroxide (għall-aġġustament tal-pH)
English: Dehydration, cachexia
Maltese: Disidratazzjoni, kakeksja
English: Standard doxorubicin hydrochloride displays extensive tissue distribution (volume of distribution: 700 to 1,100 l/m 2) and a rapid elimination clearance (24 to
Maltese: Doxorubicin hydrochloride standard wera distribuzzjoni estensiva fit-tessut (volum ta' distribuzzjoni: 700 sa 1,000 l/m 2) u tneħħija ta' eliminazzjoni mgħaġġla mill-ġisem (24 sa 73 l/h/m2).
English: One ml of Caelyx contains 2 mg pegylated liposomal doxorubicin hydrochloride.
Maltese: 1 ml ta' Caelyx fih 2 mg doxorubicin hydrochlorinated liposomali pegilat.
English: All Severities n=318
Maltese: Is-severitajiet kollha n=318
English: The survival rates at 1, 2 and 3 years were 74.1%, 51.2% and 28.4% respectively on Caelyx, compared to 66.2%, 31.0% and 17.5% on topotecan.
Maltese: Ir-rati ta' sopravivenza f'etajiet ta' sena, 2 u 3 snin kienu 74.1 %, 51.2 % u 28.4 % rispettivament fuq Caelyx, imqabbla ma' 66.2 %, 31.0 % u 17.5 % fuq topotecan.
English: Caelyx contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells.
Maltese: Caelyx fih mediċina li kapaċi tinteraġixxi maċ-ċelluli b'mod illi toqtol iċ-ċelluli tal-kanċer selettivament.
English: There was a benefit in overall survival (OS) for Caelyx-treated patients over topotecan-treated patients as indicated by a hazard ratio (HR) of 1.216 (95% CI: 1.000; 1.478), p=0.050.
Maltese: Kien hemm benefiċċju fis-sopravivenza ġenerali (OS) għall-pazjenti trattati b'Caelyx fuq dawk b'topotecan kif jidher mill-proporzjon ta' periklu (HR) ta' 1.216 (95 % CI; 1.000; 1.478), p=0.050.
English: Decrease dose by 25%; return to 4 week interval
Maltese: Naqqas id-doża b'25 %; erġa' lura għal intervalli ta' 4 ġimgħat.
English: Dehydration, hypokalaemia, hyperkalaemia, hypomagnesaemia, hyponatraemia, hypocalcaemia
Maltese: Deidrazzjoni, ipokalimja, iperkalimja, ipomagneżimja, iponatrimja, ipokalċemija
English: Population pharmacokinetic data (in the range of creatinine clearance tested of 30-156 ml/min) demonstrate that Caelyx clearance is not influenced by renal function.
Maltese: Informazzjoni farmakokinetika tal-popolazzjoni (fil-medda ta' tneħħija ta' kreatinina ittestjata ta' 30-156 ml/min) turi li t-tneħħija ta'Caelyx mhix affettwata mit-tħaddim tal-kliewi.
English: The survival rates at 1, 2 and 3 years were 41.5%, 21.1% and 13.8% respectively on Caelyx, compared to 43.2%, 17.2% and 9.5% on topotecan.
Maltese: 41.5 %, 21.1 % u 13.8 % rispettivament b'Caelyx, imqabbla ma' 43.2 %, 17.2 % u 9.5 % fuq topotecan.
English: Grade 2 1,000 - < 1,500 50,000 - < 75,000 Wait until ANC  1,500 and platelets
Maltese: Grad 2 1,000 - < 1,500 50,000 - < 75,000
English: The frequency of lichenoid keratosis was determined as “rare” based on clinical trials.
Maltese: Il-frekwenza ta' keratożi likenuża ġiet determinata bħala “rari” abbażi ta' provi kliniċi.
English: For the sub-group of patients with platinum-sensitive disease the difference was greater: HR of 1.432 (95% CI: 1.066; 1.923), p=0.017.
Maltese: Għas-sottogrupp ta' pazjenti li kellhom marda sensittiva għall-platinum, id-differenza kienet akbar: HR ta' 1.432 (95 % CI; 1.066; 1.923), p=0.017.
English: CAELYX CARTON 50 mg/25 ml - 1 vial CAELYX CARTON 50 mg/25 ml - 10 vials
Maltese: KARTUNA CAELYX 50 mg/25 ml - kunjett 1 KARTUNA CAELYX 50 mg/25 ml - 10 kunjett
English: Furthermore, only 1 patient (cumulative anthracycline dose of 944 mg/m2), discontinued study treatment because of clinical symptoms of congestive heart failure.
Maltese: Barra minn dan pazjent 1 biss (doża kumulattiva ta' anthracycline ta' 944 mg/m2), waqqaf it-trattament minħabba sintomi kliniċi ta' insuffiċjenza tal-qalb konġestiva.
English: The pharmacokinetics of Caelyx over the dose range of 10 mg/m2 to 60 mg/m2 was best described by a two compartment non-linear model with zero order input and Michaelis-Menten elimination.
Maltese: - 60 mg/m 2 ġiet deskritta l-aħjar permezz ta' mudell mhux linejari ta' żewġ kumpartimenti b'input ta' ordni zero u eliminazzjoni Michaelis-Menten.
English: Stomatitis/mucositis and nausea were also commonly reported in breast/ovarian cancer patient populations, whereas the AIDS-KS Program (20 mg/m2 every 2 weeks), myelosuppression (mostly leukopaenia) was the most common side effect (see AIDS-KS).
Maltese: Stomatite/mukożite u dardir ġew rappurtati komunement minn popolazzjonijiet ta' pazjenti b'kanċer tas-sider/ovarji waqt li fil-Programm AIDS-KS (20 mg/m2 kull ħmistax) l-effett mhux mixtieq l-iżjed komuni kien il-majelosoppressjoni (prinċipalment lewkopenija) (ara AIDS-KS).
English: Caelyx contains soya oil and sodium
Maltese: Caelyx fih iż-żejt tas-soja u sodium
English: Myelosuppression associated with anaemia, thrombocytopaenia, leukopaenia, and rarely febrile neutropaenia, has been reported in Caelyx-treated patients.
Maltese: Majelosoppressjoni assoċjata ma' anemija, tromboċitopenija, lewkopenija, u rarament, newtropenija bid-deni, kienu rappurtati f'pazjenti trattati b'Caelyx.
English: A similar, but less severe response was also noted in dogs treated with Caelyx and standard doxorubicin.
Maltese: Rispons simili iżda anqas gravi ġiet innutata wkoll fi klieb ittrattati b'Caelyx u doxorubicin standard.
English: See Table 7 for adverse effects reported in ≥ 5% patients treated with combination therapy of Caelyx plus bortezomib.
Maltese: III. Ara Tabella 7 għall-effetti avversi rrappurtati f'≥ 5 % tal-pazjenti kkurati b'terapija kombinata b'Caelyx ma' bortezomib.
English: Hypochromic anaemia
Maltese: Anemija ipokromika
English: Pharmacotherapeutic group: Cytotoxic agents (anthracyclines and related substances), ATC code: L01DB01.
Maltese: Sustanzi ċitotossiċi (anthracyclines u sustanzi relatati) Kodiċi ATC:
English: After dilution:
Maltese: Wara li jiġi dilwit:
English: CAELYX CARTON 20 mg/10 ml - 1 vial CAELYX CARTON 20 mg/10 ml - 10 vials
Maltese: CAELYX KARTUNA 20 mg/10 ml - kunjett 1 CAELYX KARTUNA 20 mg/10 ml - 10 kunjetti
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Maltese: L-istabilità kimika u fiżika waqt l-użu ġiet ippruvata għal 24 siegħa f'temperatura ta' bejn 2°C sa 8°C.
English: Population based analysis demonstrates that age across the range tested (21-75 years) does not significantly alter the pharmacokinetics of Caelyx.
Maltese: Analiżi bbażata fuq popolazzjoni turi li fil-medda ttestjata (21-75 sena) l-età ma tibdilx il-farmakokinetiċi ta' Caelyx.
English: This can be infused over 60 or 90 minutes as detailed in 4.2.
Maltese: Dan jista' jiġi infuż fuq medda ta' 60 jew 90 minuta kif spjegat f' 4.2.
English: No grade 4 stomatitis was reported.
Maltese: L-ebda stomatite ta' grad 4 ma kienet irrappurtata.
English: Contains fully hydrogenated soy phosphatidylcholine (from soyabean) - see section 4.3 Contains less than 1 mmol sodium (23 mg) per dose, and is essentially ‘sodium-free'.
Maltese: Fih soy phosphatidylcholine (mill-fażola soja) kompletament idroġenat - ara sezzjoni 4.3 Fih inqas minn 1 mmol sodium (23 mg) f'kull doża, u huwa essenzjalment ‘ħieles mis-sodium'.
English: In patients with solid tumours, including a subset of patients with breast and ovarian cancers, treated at a dose of 50 mg/m2/cycle with lifetime cumulative anthracycline doses up to 1,532 mg/m2, the incidence of clinically significant cardiac dysfunction was low.
Maltese: F'pazjenti b'tumuri solidi, fosthom sottogrupp ta' pazjenti b'kanċer tas-sider jew tal-ovarji, ittrattati b'doża ta' 50 mg/m2/ċiklu b'dożi ta' anthracycline kumulattivi għall-ħajjithom sa 1,532 mg/m2, linċidenza ta' disfunzjoni kardijaka klinikament sinifikanti kienet baxxa.
English: Caelyx, a liposome formulation, is doxorubicin hydrochloride encapsulated in liposomes with surface-bound methoxypolyethylene glycol (MPEG).
Maltese: Caelyx, formulazzjoni ta' liposoma, huwa doxorubicin hydrochloride enkapsulat f'liposomi li għandhom methoxypolyethylene glycol marbut fil-wiċċ tagħhom (methoxypolyethylene glycol, MPEG).
English: In a subset of 410 patients with ovarian cancer, clinically significant laboratory abnormalities occurring in clinical trials with Caelyx included increases in total bilirubin (usually in patients with liver metastases) (5%) and serum creatinine levels (5%).
Maltese: F'sottosett ta' 410 pazjenta b'kanċer tal-ovarji, l-abnormalitajiet tal-laboratorju klinikament sinifikanti li seħħu fi provi kliniċi b'Caelyx kienu jinkludu żieda ta' bilirubin totali (ġeneralment f'pazjenti b'metastasi fil-fwied) (5 %) u żjieda fil-livelli ta' kreatinina fis-serum (5 %).
English: PPE infrequently resulted in permanent treatment discontinuation (3.7%-7.0%).
Maltese: B'mod mhux frekwenti l-PPE wasslet għall-waqfien permanenti tat-trattament (3.7 % - 7.0 %).
English: Aspartate aminotransferase increased, ejection fraction decreased, blood creatinine increased, alanine aminotransferase increased
Maltese: Żieda ta' aspartate aminotransferase, tnaqqis fil-frazzjoni tal-ħruġ, żieda tal-kreatinina fid-demm, żieda tal-alanine aminotransferase
English: Arthralgia, myalgia, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal chest pain
Maltese: Artralġja, mijalġja, spasmi fil-muskoli, dgħjufija filmuskoli, uġigħ muskoluskeletriku, uġigħ muskoluskeletriku fissider
English: In patients with AIDS, exacerbation of cyclophosphamide-induced haemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with standard doxorubicin hydrochloride.
Maltese: F'pazjenti b'AIDS ġie rrappurtat li kien hemm tħarrix ta' ċistite emorraġika indotta minn cyclophosphamide u żjieda fl-epatotossiċità ta' 6-mercatopurine meta jintuża doxorubicin hydrochloride standard.
English: Decreased testicular weights and hypospermia were present in rats after repeat doses 0.25mg/kg/day and diffuse degeneration of the seminiferous tubules and a marked decrease in spermatogenesis were observed in dogs after repeat doses of 1 mg/kg/day (see section 4.6).
Maltese: Tnaqqis ta' piż testikolari u tnaqqis fil-produzzjoni ta' sperma seħħew fil-firien wara dożi ripetuti ta' ≥ 0.25 mg/kg/jum u deġenerazzjoni tat-tubi li jġorri l-isperma u tnaqqis sostanzjali filproduzzjoni ta' sperma ġew innutati fil-klieb wara dożi ripetuti ta' 1 mg/kg/jum (ara sezzjoni 4.6).
English: Temporarily suspend Caelyx treatment in patients when the ANC count is < 1,000/mm
Maltese: Waqqaf it-trattament b'Caelyx temporanjament f'pazjenti meta l-għadd ta' ANC < 1,000/mm
English: The toxicity grading in these tables is based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
Maltese: Il-gradazzjoni ta' tossiċità f'dawn it-tabelli hija bbażata fuq il-Kriterja tat-Tossiċità tal-Istitut Nazzjonali tal-Kanċer (National Cancer Institute Common Toxicity Criteria, NCI-CTC).
English: Excipients: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.
Maltese: Eċċipjenti: -(2-[1,2-distearoyl -sn-glycero(3) phosphoxy] ethylcarbamoyl)- -methoxypoly (oxyethylen)-40 sodium salt, soy phosphatidylcholine kompletament idroġenat, kolesterol, ammonium sulphate, sucrose, histidine, ilma għall-injezzjonijiet, hydrochloric acid u sodium hydroxide.
English: Caelyx pharmacokinetics determined in a small number of patients with elevated total bilirubin levels do not differ from patients with normal total bilirubin; however, until further experience is gained, the Caelyx dosage in patients with impaired hepatic function should be reduced based on the experience from the breast and ovarian clinical trial programs as follows: at initiation of therapy, if the bilirubin is between 1.2-3.0 mg/dl, the first dose is reduced by 25%.
Maltese: Il-farmakokinetika ta' Caelyx ippruvata f'numru żgħir ta' pazjenti b'livelli ta' bilirubin totali għolja ma kinitx differenti minn dik f'pazjenti b'bilirubin totali normali; madankollu sakemm ma tinkisibx aktar esperjenza, id-dożaġġ f'pazjenti li jbatu minn funzjoni epatika indebolita għandu jitnaqqas skont l-esperjenza miksuba mill-programmi ta' provi kliniċi tas-sider jew tal-ovarji kif ġej: fil-bidu tat-terapija, jekk il-bilirubin ikun bejn 1.2 - 3.0 mg/dl, l-ewwel doża titnaqqas b'25 %.
English: The primary analysis of cardiac toxicity showed the risk of developing a cardiac event as a function of cumulative anthracycline dose was significantly lower with Caelyx than with doxorubicin (HR=3.16, p < 0.001).
Maltese: L-analiżi primarja ta' kardjotossiċità wriet li r-riskju li jiiżviluppa każ kardijaku bħala funzjoni ta' doża kumulattiva ta' anthracycline kien iżjed baxx b'mod sinifikanti meta jintuża Caelyx milli doxorubicin (PR=3.16, p < 0.001).
English: 60 mg/m2/every 3 weeks) met the protocol-defined criteria for cardiac toxicity during treatment and/or follow-up.
Maltese: 60 mg/m2/kull 3 ġimgħat) laħqu l-kriterji skond il-protokoll għall-kardjotossiċità waqt it-trattament u/jew wara t-trattament.
English: Wait until ANC  1,500 and platelets  75,000; decrease dose by 25% or continue full dose with growth factor support.
Maltese: Stenna sakemm ANC  1,500 u plejtlets  75,000; erġa' ddoża mingħajr tnaqqis tad-doża.
English: The dose of Caelyx is diluted in 250 ml 5% (50 mg/ml) glucose solution for infusion and administered by intravenous infusion over 30 minutes.
Maltese: Id-doża ta'Caelyx titħallat f'250 ml 5 % (50 mg/ml) soluzzjoni tal-glucose għall-infużjoni u tingħata bħala infużjoni fil-vina fuq medda ta' 30 minuta.
English: Pruritus, papular rash, allergic dermatitis, erythema, skin hyperpigmentation, petechiae, alopecia, medicine eruption
Maltese: Ħakk, raxx papulari, dermatite allerġika, ħmura, iperpigmentazzjoni talġilda, ponot ħomor, alopeċja, eruzzjoni talmediċina
English: Ventricular arrhythmia
Maltese: Reazzjoni allerġika
English: Grade 4 (requires parenteral or enteral support)
Maltese: Grad 4 (teħtieġ appoġġ parenterali jew enterali)
English: Pyridoxine at a dose of 50-150 mg per day and corticosteroids have been used for the prophylaxis and treatment of PPE, however, these therapies have not been evaluated in phase III trials.
Maltese: Għall-profilassi u t-trattament tal-PPE jintużaw pyridoxine b'doża ta 50 - 150 mg kuljum u kortikosterojdi, madankollu dawn it-terapiji ma ġewx evalwati fi provi ta' fażi
English: For doses < 90 mg: dilute Caelyx in 250 ml 5% (50 mg/ml) glucose solution for infusion.
Maltese: Għal dożi < 90 mg: ħallat Caelyx ma' 250 ml 5 % (50 mg/ml) soluzzjoni tal-glucose għall-infużjoni.
English: Grade 3 stomatitis was reported in 2% of patients in the combination therapy group.
Maltese: Stomatite ta' grad 3 kienet irrappurtata f'2 % tal-pazjenti fil-grupp b'terapija kombinata.
English: Caelyx contains less than 1 mmol sodium (23 mg) per dose, that is to say ‘essentially sodium-free'.
Maltese: Caelyx fih inqas minn 1 mmol sodium (23 mg) f'kull doża, li huwa ‘essenzjalment ħieles missodium'.
English: The mean intrinsic clearance was 0.021 l/h/m2 (range 0.009-0.041 l/h/m2), the mean central volume of distribution was 1.95 l/m 2 (range 1.67-2.40 l/m 2).
Maltese: distribuzzjoni kien ta' 1.95 l/m 2 (medda 1.67 - 2.40 l/m 2).
English: Chills, chest pain, malaise, peripheral oedema
Maltese: Dehxiet, uġigħ tassider, ħass ħażin, edima periferali
English: Blood and lymphatic system disorders very common neutropaenia, anaemia, leukopaenia common thrombocytopaenia
Maltese: Disturbi tad-demm u tas-sistema limfatika komuni ħafna newtropenija, anemija, lewkopenija komuni tromboċitopenija
English: The apparent half-life ranged from 24-231 hours, with a mean of 73.9 hours.
Maltese: Il-half-life apparenti kien ta' bejn 24 - 231 siegħa, b'medja ta' 73.9 siegħa.
English: For doses  90 mg: dilute Caelyx in 500 ml 5% (50 mg/ml) glucose solution for infusion.
Maltese: Għal dożi  90 mg: ħallat Caelyx ma' 500 ml 5 % (50 mg/ml) soluzzjoni tal-glucose għall-infużjoni.