FrancophonIA/ELRC3.0 huggingface dataset:
English: During the 4 week single-blind withdrawal period in Study 2 (IBS-3002), no evidence of rebound diarrhoea or abdominal pain was demonstrated.
Maltese: Waqt il-perjodu ta' tneħħija single-blind ta' 4 ġimgħat fi Studju 2 (IBS-3002), ma ntweritx evidenza ta' dijarea jew uġigħ addominali rebound.
English: Sphincter of Oddi spasm3
Maltese: Xi effetti sekondarji jistgħu jkunu serji
English: The apparent clearance of eluxadoline is markedly reduced and half-life increases in hepatic-impaired patients (see sections 4.3 and 4.4).
Maltese: It-tneħħija apparenti ta' eluxadoline hija mnaqqsa b'mod sinifikanti u l-half-life tiżdied f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.3 u 4.4).
English: The main symptoms of IBS-D include: - stomach ache; - stomach discomfort; - diarrhoea; - urgent bowel movements.
Maltese: Is-sintomi ewlenin tal-IBS-D jinkludu: - uġigħ fl-istonku; - skumdità fl-istonku; - dijarea;
English: Eluxadoline may cause constipation.
Maltese: Eluxadoline jista' jikkawża stitikezza.
English: • A history of pancreatitis; or known or suspected structural diseases of the pancreas, including pancreatic duct obstruction.
Maltese: • Storja ta' pankreatite; jew mard strutturali tal-frixa magħruf jew suspettat, inkluż il-imblukkar talkanal tal-frixa.
English: These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm (see section 4.4).
Maltese: Pankreatite Hemm żieda fir-riskju ta' pankreatite bi jew mingħajr spażmu tal-isfinteru ta' Oddi (ara sezzjoni 4.3)
English: Avoid taking Truberzi with any other medicines that may cause constipation (see Section 2: Other medicines and Truberzi).
Maltese: Evita li tieħu Truberzi ma' kwalunkwe mediċina oħra li tista' tikkawża stitikezza (ara Sezzjoni 2: Mediċini oħra u Truberzi).
English: Patients should be instructed to stop the medicinal product and seek medical attention if they develop severe constipation (see section 4.4).
Maltese: Il-pazjenti għandhom jingħataw istruzzjonijiet sabiex iwaqqfu l-prodott mediċinali u jfittxu l-assistenza medika jekk jiżviluppaw stitikezza severa (ara sezzjoni 4.4).
English: Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg eluxadoline and there were no serious complications of constipation related to eluxadoline use in pivotal studies.
Maltese: Ir-rati ta' stitikezza severa kienu inqas minn 1% fil-pazjenti li rċevew 75 mg u 100 mg eluxadoline u ma kienx hemm komplikazzjonijiet serji ta' stitikezza fir-rigward ta' eluxadoline użat fi studji pivotali.
English: Efficacy of eluxadoline was assessed using an overall responder analyses as defined by the simultaneous improvement in the daily WAP score by ≥30% as compared to the baseline weekly average AND a reduction in the BSS to <5 on at least 50% of the days within a time interval.
Maltese: L-effikaċja ta' eluxadoline ġiet ivvalutata bl-użu ta' analiżi ta' dawk li jirrispondu b'mod ġenerali kif definit mit-titjib simultanju fil-punteġġ tal-WAP ta' kuljum bi ≤30% kif imqabbel mal-medja ta' kull ġimgħa tal-linja bażi U tnaqqis fil-BSS għal <5 f'mill-anqas 50% tal-jiem f'intervall tal-ħin.
English: Truberzi 100 mg film-coated tablets.
Maltese: Truberzi 100 mg pilloli miksijin b'rita.
English: Bile acid malabsorption
Maltese: GĦAMLA KWALITATTIVA
English: Additional cases of pancreatitis not associated with sphincter of Oddi spasm were reported in clinical studies.
Maltese: Każijiet addizzjonali ta' pankreatite mhux assoċjati ma' spażmu tal-isfinkter ta' Oddi ġew irrapportati fi studji kliniċi.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of eluxadoline in milk (for details see section 5.3).
Maltese: Data farmakodinamika/tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' eluxadoline fil-ħalib tas-sider (gћad-dettalji ara 5.3). Ir-riskju gћat-trabi tat-twelid mhux eskluż.
English: Assessment of drug interactions
Maltese: pjacir mid-droga.
English: An overdose of eluxadoline may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product.
Maltese: Huwa importanti li jiġu rrappurtati effetti avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: The film-coated tablets are modified capsule-shaped, pink-orange to peach and debossed with ‘FX100' on one side.
Maltese: Il-pilloli miksijin b'rita huma f'għamla ta' kapsula modifikata, roża-oranġjo għal kulur il-ħawħ, u għandhom “FX100” imnaqqxa fuq naħa waħda.
English: Pharmacodynamic effects
Maltese: GĦAMLA FARMAĊEWTIKA
English: Truberzi 75 mg n=381
Maltese: 75 mg n=381 Plaċebo n=382
English: Composite Response
Maltese: Rispons kompost
English: • Known or suspected biliary tree and/or pancreatic duct obstruction (e.g. gallstones, tumour, periampullary duodenal diverticulum) or sphincter of Oddi disease or dysfunction.
Maltese: • Ostruzzjoni magħrufa jew suspettata tas-siġra tal-bili u/jew tal-passaġġ tal-frixa (eż. ġebel fil marrara, tumur, diverticulum duwodenali periampullari) jew disfunzjoni tal-isfinkter ta' Oddi Dawn ilpazjenti huma f'riskju ogħla ta' spażmu tal-isfinkter ta' Oddi (ara sezzjoni 4.4).
English: Sphincter of Oddi Spasm
Maltese: - Is-sustanzi l-oħra huma:
English: (called ‘IBS with constipation' [IBS-C]); - if you have, or may have, a blockage in your intestine/bowels; - If you take medicines that may increase the level of the concentration of eluxadoline in the blood (so-called OATP1B1 inhibitor, e.g. ciclosporin).
Maltese: (imsejħa ‘IBS bi stitikezza' [IBS-C]); - jekk għandek, jew kellek, imblokk fl-intestini/imsarnek; - jekk tieħu mediċini li jistgħu jżidu l-livell tal-konċentrazzjoni ta' eluxadoline fid-demm (hekk imsejjaħ inibitur OATP1B1, eż. ciclosporin).
English: Although exposure of eluxadoline was significantly increased in ESRD participants not yet on dialysis compared with matched, healthy participants with normal renal function, such an increase is unlikely to be of clinical significance because the geometric mean Cmax and AUC0-t in the participants with ESRD was in the same range as observed in several larger studies in healthy volunteers.
Maltese: Għalkemm l-esponiment għal eluxadoline żdied b'mod sinifikanti f'parteċipanti b'ESRD li kienu għadhom ma tpoġġewx fuq iddijalisi meta mqabbel ma' parteċipanti f'saħħithom b'funzjoni tal-kliewi normali, żieda bħal din mhux probabbli li tkun klinikament sinifikanti peress li l-medja ġeometrika ta' Cmax u l-AUC0-t filparteċipanti b'ESRD kienet fl-istess firxa kif osservat f'diversi studji akbar li saru fuq voluntiera f'saħħithom.
English: • pain may begin soon after you start Truberzi.
Maltese: • l-uġigħ jista' jibda malajr wara li tibda tieħu Truberzi.
English: - if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6); - if you have, or have had, pancreatitis (inflammation of the pancreas); - if you don't have a gallbladder by birth or your gallbladder has been surgically removed; - if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink alcohol; - if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum); - if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine);
Maltese: - jekk għandek jew kellek, pankreatite (infjammazzjoni tal-frixa); - jekk ma għandekx marrara mit-twelid jew jekk il-marrara tiegħek tneħħiet b'mod kirurġiku; - jekk għandek jew kellek, problemi b'abbuż tal-alkoħol, vizzju tal-alkoħol, jew jekk tixrob l alkoħol; - jekk għandek jew kellek, kwalunkwe imblokk fil-marrara, fil-kanal biljari, jew fil-frixa (bħal ġebel fil-marrara, tumur, divertikulum duwodenali);
English: Pregnancy
Maltese: Truberzi
English: A relevant proportion of patients diagnosed with IBS-D may be affected by bile-acid malabsorption as a potential reason for IBS-D symptoms.
Maltese: Proporzjon relevanti ta' pazjenti dijanjostikati b'IBS-D jistgħu jkunu affettwati b'assorbiment ħażin tal-aċidu biljari bħala raġuni potenzjali għal sintomi ta' IBS-D.
English: Patients should be instructed to stop the medicinal product and seek medical attention if these symptoms develop while taking eluxadoline (see section 4.8).
Maltese: Il pazjenti għandhom jingħataw istruzzjonijiet sabiex iwaqqfu l-prodott mediċinali u jfittxu attenzjoni medika jekk dawn is-sintomi jiżviluppaw waqt it-teħid ta' eluxadoline (ara sezzjoni 4.8).
English: Sphincter of Oddi spasm
Maltese: TWISSIJA(IET) SPEĊJALI
English: However, given the potential for increased sensitivity to experience undesirable effects, it may be considered to initiate eluxadoline treatment in a dosage of 150 mg daily (one 75 mg tablet twice daily).
Maltese: jista' jkun ikkunsidrat li l-kura b'eluxadoline tinbeda b'150 mg kuljum (pillola waħda ta' 75 mg darbtejn kuljum).
English: Patients receiving eluxadoline also reported significant reductions in bowel movement frequency and abdominal bloating compared to placebo as demonstrated by changes from baseline in daily bowel movements and bloating score at Weeks 12 and 26.
Maltese: Il-pazjenti li rċevew eluxadoline irrapportaw ukoll tnaqqis b'mod sinifikanti fil-frekwenza tal-moviment tal-musrana u nefħa addominali meta mqabbel mal-plaċebo kif muri minn bidliet mil-linja bażi fil-movimenti tal-musrana ta' kuljum u punteġġ tan-nefħa fil-Ġimgħat 12 u 26.
English: MRP2 inhibitors
Maltese: Uġigħ fl-addome2
English: Co-administration of eluxadoline with rosuvastatin (an OATP1B1 substrate) resulted in an up to 1.4-fold increase in exposure of rosuvastatin and the major active metabolite, n-desmethyl rosuvastatin compared to administration of rosuvastatin alone.
Maltese: L-effett fuq statini oħrajn li huma sottostrati ta' OATP1B1 iktar sensittivi (eż simvastatin u atorvastatin) madankollu jista' jkun iktar pronunzjat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 100 mg
Maltese: KARTUNA - 100 mg
English: The efficacy results for ≥50% of responder days (primary composite endpoint) over 6 months are shown in Table 2.
Maltese: Ir-riżultati tal-effikaċja għal ≤50% tal-jiem ta' dawk li rrispondew (punt aħħari kompost primarju) fuq
English: OATP1B1 poor function haplotypes
Maltese: Effett tal-varjabilità tal-funzjoni tat-trasportatur OATP1B1 fuq il-livelli fil-plażma
English: CYP3A substrates
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Of the 5 cases reported, 3 were associated with excessive alcohol intake, 1 was associated with biliary sludge, and in one case the patient discontinued eluxadoline 2 weeks prior to the onset of symptoms.
Maltese: Mill-5 każijiet irrapportati, 3 kienu assoċjati ma' teħid eċċessiv tal-alkoħol, 1 kien assoċjat mal-ħama biljari, u f'każ wieħed, il-pazjent waqqaf eluxadoline ġimagħtejn qabel il-bidu tas sintomi.
English: Co-administration of eluxadoline with probenecid (MRP2 inhibitor) resulted in approximately 1.4-fold increase in exposure to eluxadoline.
Maltese: Eluxadoline m'għandux jingħata b'mod konkomitanti ma' dawn il prodotti mediċinali (ara sezzjoni 4.3).
English: Packaging
Maltese: Kontenut
English: 0.5 ml (10 µ/ml) 1 vial
Maltese: 0.5 ml (10 µ/ml)
English: separate needle
Maltese: Mnejn jingħata
English: 0.5 ml (10 µg/ml) 1 vial + 1 syringe + 1 needle
Maltese: 1 kunjett + 1 siringa + 1 labra
English: 10 pre-filled syringes with 1 separate needle
Maltese: 10 siringi mimlijin għal-lest b'labra 1 separata
English: It is available as pink, round tablets (75 mg).
Maltese: Jiġi bħala pilloli tondi roża (75mg).
English: can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Clopidogrel Krka d.d. jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Previously known as Zopya.
Maltese: 1 Preċedentement magħruf bħala Zopya.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zopya on 21 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zopya fil-21 ta' Settembru 2009.
English: The active substance in Clopidogrel Krka d.d., clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel Krka d.d., il-klopidogrel, hi inibitur tal-aggregazzjoni tal-pjastrini (platelets).
English: • patients with peripheral arterial disease (problems with blood flow in the arteries).
Maltese: • pazjenti b'mard fl-arterji periferiċi (problemi bil-fluss tad-demm fl-arterji).
English: Clopidogrel Krka d.d.F EMA/971273/2011
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'12-2011.
English: What are the benefits and risks of Clopidogrel Krka d.d.
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Clopidogrel Krka d.d.?
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Maltese: Dan iwaqqaf lill-pjastrini milli jsiru ‘jwaħħlu', inaqqas ir-riskju li jiżviluppaw emboli tad-demm u jgħin fil-prevenzjoni ta' attakki tal-qalb jew ta' puplesiji oħrajn.
English: is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel Krka d.d. huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: The name of the medicine was changed to Clopidogrel Krka d.d.
Maltese: Għaliex ġie approvat Clopidogrel Krka d.d.?
English: ○C and ANC < 1,000/mm
Maltese: ○C u ANC < 1,000/mm
English:  1/100 and < 1/10
Maltese:  1/100 u < 1/10
English: UAB "JOHNSON & JOHNSON"filiāle Latvijā Mūkusalas iela 101
Maltese: JOHNSON"filiāle Latvijā Mūkusalas iela 101
English: Grades 3/4** n=318
Maltese: Gradi 3/4** N=318
English: PPE*, rash
Maltese: PPE*, raxx
English: The overall incidence of PPE reported was 44.0%-46.1%.
Maltese: L-inċidenza globali ta' PPE rrappurtata kienet ta' 44.0 % - 46.1 %.
English: Caelyx is a unique formulation.
Maltese: Caelyx hija formulazzjoni unika.
English: 1 half-life (hours)
Maltese: 1 half-life (sigħat)
English: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Maltese: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Il-Belġju
English: Multiple myeloma program
Maltese: Programm ta' majeloma multipla
English: 2 half-life (hours)
Maltese: 2 half-life(sigħat)
English: Date of first authorisation: 21 June 1996 Date of lastest renewal: 19 May 2006
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Ġunju 1996 Data tal-aħħar tiġdid: 19 ta' Mejju 2006
English: 3 in subsequent cycles.
Maltese: 3 fiċ-ċikli sussegwenti.
English: Caelyx is administered as an intravenous infusion.
Maltese: Caelyx jiġi amministrat bħala infużjoni intravenuża.
English: Maximum plasma concentration* (µg/ml) Plasma clearance (l/h/m Volume of distribution (l/m AUC (µg/mlh)
Maltese: Konċentrament ta' plażma massimu* (µg/ml) Tneħħija mill-plażma (l/h/m Volum ta' distribuzzjoni (l/m AUC (µg/mlh)
English: Fever ≥ 38
Maltese: Deni ≥ 38
English: 4 weeks) was palmar-plantar erythrodysesthesia (PPE).
Maltese: 4 ġimgħat) kien palmar-plantar erythrodysesthesia (PPE).
English: Sepsis related to leukopaenia was rarely (< 1%) observed.
Maltese: Sepsis relatata mal-lewkopenija ġiet innutata rarament (< 1 %).
English: Reproductive toxicity
Maltese: Tossiċità tas-sistema riproduttiva
English: UAB "JOHNSON & JOHNSON"Eesti filiaal Lõõtsa 2
Maltese: JOHNSON"Eesti filiaal Lõõtsa
English: This interim analysis showed a TTP risk reduction of 45% (95% CI: 29-57%), p < 0.0001.
Maltese: Din l-analiżi interim uriet tnaqqis fir-riskju TTP ta' 45 % (95 % CI: 29-57 %), p < 0.0001.
English: Ovarian cancer n=512
Maltese: Kanċer ovarju n=512
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fil-friġġ (2°C sa 8°C).
English: Pegylated liposomes contain surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol (MPEG).
Maltese: Illiposomi pegilati fihom segmenti mlaqqma fil-wiċċ tal-hydrophilic polymer methoxypolyethylene glycol (MPEG).
English: Renal Impairment
Maltese: Indeboliment Renali
English: * Measured at the end of a 30-minute infusion
Maltese: *Imkejjel fl-aħħar ta' infużjoni ta' 30 minuta
English: The most frequently observed OI's in clinical studies were candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumonia, and mycobacterium avium complex.
Maltese: L-iżjed OI's frekwenti fl-istudji kliniċi kienu; kandidijażi, ċitomegalovirus, Herpes simplex, pulmonite b'Pneumocystis carinii u mycobacterium avium complex.
English: The range of Billingham cardiotoxicity scores was grades 0-1.5.
Maltese: Il-medda ta' livelli ta' kardjotossiċità Billingham kienu ta' gradi 0 - 1.5.
English: Breast cancer n=404
Maltese: Kanċer tas-sider n=404
English: PPE*, alopecia, rash PPE*
Maltese: PPE*, alopeċja, raxx
English: See the SPC for bortezomib.
Maltese: Ara l-SKP għal bortezomib.
English: The incidence of anaemia was similar in both treatment groups (7% vs. 5%).
Maltese: L-inċidenza ta' anemija kienet simili fiż-żewġ gruppi ta' kura (7 % vs. 5 %).
English: Metabolism and nutrition disorders common anorexia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni anoreksja
English: Store in a refrigerator (2C - 8C).
Maltese: Aħżen fi friġġ (2 C - 8 C ).
English: Undesirable effects observed in patients with AIDS-related KS according to CIOMS III frequency categories
Maltese: Effetti mhux mixtieqa osservati f'pazjenti b'SK relatat ma' AIDS skont kategoriji ta' frekwenza ta' CIOMS III
English: Grade 3 PPE was reported in 5% of patients.
Maltese: PPE ta' Grad 3 kienet irrappurtata f'5 % tal-pazjenti.
English: Platelet count < 25,000/mm Haemoglobin < 8 g/dl ANC < 500/mm
Maltese: Emoglobina < 8 g/dl ANC < 500/mm
English: Ovarian cancer Grades 3/4 n=512
Maltese: Kanċer ovarju Gradi 3/4 n=512
English: The most frequently reported (medicine-related treatment-emergent) adverse events in combination therapy (Caelyx + bortezomib) were nausea (40%), diarrhoea (35%), neutropaenia (33%), thrombocytopaenia (29%), vomiting (28%), fatigue (27%), and constipation (22%).
Maltese: L-aktar każijiet avversi frekwenti li kienu rrappurtati (relatati mal-mediċina u ħarġu malkura) bit-terapija kombinata (Caelyx + bortezomib) kienu dardir (40 %), dijarea (35 %), newtropenija (33 %), tromboċitopenija (29 %), remettar (28 %), għeja (27 %), u stitikezza (22 %).
English: - For treatment of AIDS-related Kaposi's sarcoma (KS) in patients with low CD4counts (< 200 CD4 lymphocytes/mm
Maltese: - Trattament ta' sarkoma ta' Kaposi (Kaposi's sarcoma, KS) relatata mal-AIDS f'pazjenti b'għadd ta' CD4 baxx (< 200
English: EU/1/96/011/003 (1 vial) EU/1/96/011/004 (10 vials)
Maltese: EU/1/96/011/003 (kunjett 1) EU/1/96/011/004 (10 kinjetti)
English: Infection, oral moniliasis, herpes zoster, urinary tract infection
Maltese: Infezzjoni, monilijażi orali, herpes zoster, infezzjoni fis-sistema tal-awrina
English: Secondary haematological malignancies
Maltese: Malinni ematoloġiċi sekondarji
English: The following common adverse events were reported more often with doxorubicin than with Caelyx: nausea (53% vs. 37%; grade 3/4 5% vs. 3%), vomiting (31% vs. 19%; grade 3/4 4% vs. less than 1%), any alopecia (66% vs. 20%), pronounced alopecia (54% vs.7%), and neutropaenia (10% vs. 4%; grade 3/4 8% vs.
Maltese: L-effetti mhux mixtieqa komuni li ġejjin ġew irrappurtati iżjed spiss b'doxorubicin milli b'Caelyx: dardir (53 % vs 37 %; grad 3/4 5 % vs 3 %), rimettar (31 % vs 19 %; grad 3/4 4 % vs anqas minn 1 %), alopeċja (66 % vs 20 %), alopeċja b'mod evidenti (54 % vs 7 %) u newtropenja (10 % vs 4 % grad 3/4 8 % vs 2 %).
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskoluskeletriċi u tat-tessut konnettiv
English: Depending on the dose and indication, this may take from 30 minutes to more than one hour (i.e., 90 minutes).
Maltese: Skont id-doża u l-indikazzjoni, dan jista' jieħu sa 30 minuta għal aktar minn siegħa (i.e. 90 minuta)
English: Skin and subcutaneous tissue disorders rare lichenoid keratosis very rare erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda rari keratożi likenuża rari ħafna eritema multiforme, sindromu ta' Stevens Johnson u nekrolisi epidermali tossika
English: Grade 1 1,500 - 1,900
Maltese: TIBDIL Grad 1 1,500 - 1,900 75,000 - 150,000
English: The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the Caelyx plus bortezomib combination therapy patients.
Maltese: L-OS medjan kien ta' 30.8 xhur (95% CI; 25.2-36.5 xhur) għal pazjenti li qegħdin fuq monoterapija ta' bortezomib u 33.0 xahar (95% CI; 28.9-37.1 xhur) għal pazjenti fuq terapija kkombinata ta' Caelyx flimkien ma' bortezomib.
English: Mucositis (23% vs. 13%; grade 3/4 4% vs. 2%), and stomatitis (22% vs. 15%; grade 3/4 5% vs. 2%) were reported more commonly with Caelyx than with doxorubicin.
Maltese: Il-mukożite (23 % vs 13 %; grad 3/4 4 % vs 2 %) u stomatite (22 % vs 15 %; grad 3/4 5 % vs 2 %) ġew irrappurtati iżjed spiss b'Caelyx milli b'doxorubicin.
English: EU/1/96/011/001 (1 vial) EU/1/96/011/002 (10 vials)
Maltese: EU/1/96/011/001 (kunjett 1) EU/1/96/011/002 (10 kunjetti)
English: Permanent treatment discontinuation was infrequently reported at 2%.
Maltese: Waqfien permanenti tat-trattament ġie rrappurtat b'mod rari b'rata ta' 2 %.
English: Caelyx contains soya oil.
Maltese: Caelyx fih iż-żejt tas-soja.
English: No grade 4 PPE was reported.
Maltese: L-ebda PPE ta' grad 4 ma kien irrappurtat.
English: Clinically significant laboratory abnormalities (grades 3 and 4) in this group was low with elevated total bilirubin, AST and ALT reported in 2.4%, 1.6% and < 1% of patients respectively.
Maltese: Anormalitajiet ta' laboratorju klinikament sinifikanti (gradi 3 u 4) f'dan il-grupp kienu baxxi, bil-bilirubin totali, AST u ALT għoljin rappurtati f'2.4 %, 1.6 % u < 1 % tal-pazjenti rispettivament.
English: In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/m2-1,680 mg/m2.
Maltese: Barra minn dan saru bijopsiji endomijokardijaċi fi 8 pazjenti b'tumuri solidi b'dożi kumulattivi ta' anthracycline ta' 509 mg/m2 - 1,680 mg/m2.
English: The active ingredient of Caelyx is doxorubicin hydrochloride, a cytotoxic anthracycline antibiotic obtained from Streptomyces peucetius var. caesius.
Maltese: Is-sustanza attiva ta'Caelyx hija doxorubicin hydrochloride, antibijotiku anthracycline ċitotossiku li jiġi minn Streptomyces peucetius var. caesius.
English: Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100)
Maltese: Komuni ħafna (≥ 1/10); Komuni (≥ 1/100, < 1/10);
English: The bortezomib regimen consists of 1.3 mg/m² on days 1, 4, 8, and 11 every 3 weeks.
Maltese: Il-programm ta' kura ta' bortezomib jikkonsisti f'1.3 mg/m2 f'jiem 1, 4, 8, u 11 kull 3 ġimgħat.
English: AIDS-related KS
Maltese: KS relatata mal-AIDS
English: Immune system disorders Common
Maltese: Disturbi fis-sistema immuni
English: Grade 3 500 - < 1,000 25,000 - < 50,000 Wait until ANC  1,500 and platelets
Maltese: Grad 3 500 - < 1,000 25,000 - < 50,000 Stenna sakemm ANC  1,500 u plejtlets  75,000; erġa' ddoża mingħajr tnaqqis tad-doża
English: The pharmacokinetics of Caelyx was evaluated in 120 patients from 10 different clinical trials using the population pharmacokinetic approach.
Maltese: Il-farmakokinetiċi ta'Caelyx ġew evalwati f'120 pazjent minn 10 provi kliniċi differenti bl-użu talapproċċ farmakokinetiku tal-popolazzjoni.
English: Lethargy, hypoaesthesia, syncope, dysaesthesia
Maltese: Letarġija, ipoesteżija, sinkope, disesteżija
English: PPE was reported in 16% of multiple myeloma patients treated with Caelyx plus bortezomib combination therapy.
Maltese: PPE kienet irrappurtata f'16 % tal-pazjenti b'majeloma multipla ikkurati b'terapija kombinata ta' Caelyx flimkien ma' bortezomib.