FrancophonIA/ELRC3.0 huggingface dataset:
English: In repeat dose toxicology studies in rats, adverse effects (e.g. thickening of epiphyseal plates, lesions of the incisors) were mostly related to the mechanism of action (i.e. VEGFR-2 inhibition) of nintedanib.
Maltese: Fi studji tossikoloġiċi dwar doża ripetuta fil-firien, l-effetti avversi (eż. tħaxxin tal-epiphyseal plates, leżjonijiet tal-incisors) kienu fil-biċċa l-kbira tagħhom relatati mal-mekkaniżmu ta' azzjoni (i.e. inibizzjoni ta' VEGFR-2) ta' nintedanib.
English: Stable brain metastasis
Maltese: Metastasi stabbli tal-moħħ
English: The frequency of arterial thromboembolic events was comparable between the two treatment arms in the phase 3 trial 1199.13 (LUME-Lung 1).
Maltese: Il-frekwenza ta' avvenimenti tromboemboliċi arterjali kienet komparabbli bejn iż-żewġ partijiet tal-istudju dwar il-kura fil-prova ta' fażi 3, 1199.
English: Teratogenic effects on the aortic arches in combination with the heart and the urogenital system were noted at an exposure 4 times higher than at the MRHD and on the embryofoetal development of the axial skeleton at an exposure 3 times higher than at the MRHD.
Maltese: Effetti teratoġeniċi fuq l-arkati aortiċi flimkien mal -qalb u s-sistema uroġenitali ġew osservati f'esponiment 4 darbiet ogħla milli fl-MRHD u fuq l-iżvilupp embrijofetali tal-iskeletru assjali f'esponiment 3 darbiet ogħla milli fl- MRHD.
English: The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee (IRC) based on the intent-to-treat (ITT) population and tested by histology.
Maltese: Il-punt aħħari primarju kienet sopravivenza mingħajr progressjoni (PFS) kif evalwat minn kumitat ta' reviżjoni indipendenti (IRC) ibbażat fuq il-popolazzjoni b'intenzjoni li tiġi kkurata (ITT) u ttestjat skont l-istoloġija.
English: As shown in Table 4, the addition of nintedanib to docetaxel led to a statistically significant reduction in the risk of progression or death by 23 % for the adenocarcinoma population (HR 0.77; 95 % CI: 0.62 - 0.96).
Maltese: Kif muri f'Tabella 4, i ż-żieda ta' nintedanib ma' docetaxel wassal għal tnaqqis statistikament sinifikanti fir-riskju ta' progressjoni jew mewt bi 23 % għall-popolazzjoni b'adenokarċinoma (HR 0.77;
English: In this trial single oral doses of 200 mg nintedanib as well as multiple oral doses of 200 mg nintedanib administered
Maltese: F'din il-prova, dożi orali waħidhom ta' 200 mg nintedanib kif ukoll dożi orali multipli ta' 200 mg nintedanib mogħtija darbtejn kuljum għal 15-il jum, ma tawlux l-intervall tal-QTcF.
English: Collected blood samples from the LUME-Lung 1 and LUME-Lung 2 studies will be assessed for germline genetic variability in angiogenic factors, including VEGF or its downstream receptors.
Maltese: Kampjuni tad-demm miġbura mill-istudji LUME-Lung 1 u LUME-Lung 2 se jiġu vvalutati għal varjabilità ġenetika fil-linja ġerminali fil-fatturi anġjoġeniċi, inkluż VEGF jew ir-riċetturi downstream tiegħu.
English: No increased frequency of impaired wound healing was observed in the LUME-Lung 1 trial.
Maltese: Ma ġiet osservata l-ebda frekwenza miżjuda ta' indeboliment fil-fejqan tal-feriti fil-prova LUME-Lung 1 .
English: Women who can become pregnant must use an effective combination of birth control methods, including barrier methods as a second form of contraception, while they are taking Vargatef and for at least 3 months after stopping treatment.
Maltese: Nisa li jistgħu joħorġu tqal iridu jużaw metodi effettivi ta' kombinazzjoni effettiva ta' kontraċezzjoni, li jinkludu metodi barriera bħala t-tieni forma ta' kontraċezzjoni, meta jkunu qed jieħdu Vargatef u għal mill-inqas 3 xhur wara li jwaqqfu l-kura.
English: Limited safety data available from 9 patients with moderate hepatic impairment (Child Pugh B) are insufficient to characterize this population.
Maltese: Data limitata dwar is-sigurtà disponibbli minn 9 pazjenti b'indeboliment tal-fwied moderat (Child Pugh B) mhijiex biżżejjed biex tikkaratterizza din il-popolazzjoni.
English: One box containing 120 capsules (12 aluminium blisters of 10 capsules each).
Maltese: - Kaxxa waħda fiha 120 kapsula (12-il folja tal-aluminju li fihom 10 kapsuli kull waħda).
English: As initial measure for the management of adverse reactions (see Tables 1 and 2) treatment with nintedanib should be temporarily interrupted until the specific adverse reaction has resolved to levels that allow continuation of therapy (to grade 1 or baseline).
Maltese: Bħala miżura inizjali għall-immaniġġjar tar-reazzjonijiet avversi (ara Tabelli 1 u 2) il-kura b'nintedanib għandha titwaqqaf temporanjament sakemm ir-reazzjoni avversa speċifika tkun fieqet għal livelli li jippermettu l-kontinwazzjoni tat-terapija (għal grad 1 jew il-linja bażi).
English: Brown-coloured, opaque, oblong soft-gelatin capsule imprinted on one side in black with the Boehringer Ingelheim company symbol and “150”.
Maltese: Kapsuli ta' kulur kannella, opaki, oblongi, magħmulin minn ġelatina ratba, stampati bl-iswed fuq naħa waħda bis-simbolu tal-logo tal-kumpanija Boehringer Ingelheim u “150”.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (100 mg - 60 capsules for multipack - without Blue Box)
Maltese: KAPSULA GĦALL-PAKKETT MULTIPLU - MINGĦAJR KAXXA BLU)
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued
Maltese: Ħlief jekk ikun hemm kawża alternattiva stabbilita, Vargatef għandu jitwaqqaf b'mod permanenti
English: Peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “100”.
Maltese: Kapsuli ta' kulur il-ħawħ, opaki, oblongi, magħmulin minn ġelatina ratba, stampati bl-iswed fuq naħa waħda bis-simbolu tal-logo tal-kumpanija Boehringer Ingelheim u “100”.
English: Black ink:
Maltese: ULN:
English: th percentile) relative to a patient with the median age of 62 years.
Maltese: th percentile) fir-rigward ta' pazjent bl-età medjana ta' 62 sena.
English: Nausea ≥ grade 3 despite anti-emetic treatment Other non-haematological or haematological adverse reaction of ≥ grade 3
Maltese: Nawseja ≥ grad 3 minkejja l-kura kontra r-rimettar Reazzjoni avversa oħra mhux ematoloġika jew ematoloġika ta' ≥ grad 3
English: Each soft capsule contains150mg nintedanib (as esilate).
Maltese: Kull kapsula ratba fiha 150 mg ta' nintedanib (bħala esilate).
English: In order to investigate suitable bio-/tumour markers (including VEGF) to allow identification and selection of a more targeted population of patients most likely to benefit from the treatment of nintedanib, the Applicant will conduct and submit results from a Biomarkers research programme including: 1.
Maltese: Sabiex jiġu investigati bijomarkaturi/markaturi tat-tumur xierqa (inkluż VEGF) sabiex tkun tista' ssir identifikazzjoni u għażla ta' popolazzjoni aktar immirata ta' pazjenti li l-aktar li jistgħu jibbenefikaw mill-kura b'nintedanib, l-Applikant se jwettaq u jippreżenta riżultati mill-programm ta' riċerka ta' Bijomarkaturi inkluż: 1.
English: Drug-induced liver injury
Maltese: Kumplikazzjoni fil-fejqan tal-feriti
English: Recommended dose adjustments for Vargatef (nintedanib) in case of AST and/or ALT and bilirubin elevations
Maltese: Tabella 2: Aġġustamenti fid-doża rakkomandata għal Vargatef (nintedanib) fil-każ ta' żidiet ta' AST u/jew ALT u bilirubina
English: Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
Maltese: Vargatef huwa indikat flimkien ma' docetaxel għall-kura ta' pazjenti adulti b'kanċer tal-pulmun ta' ċelluli mhux żgħar (NSCLC) lokalment avvanzat, metastatiku jew lokalment rikorrenti ta' istoloġija ta' tumur adenokarċinoma wara kimoterapija primarja.
English: Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 173
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Boehringer Ingelheim International GmbH Binger Strasse 173
English: Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal nintedanib, għall-karawett jew sojja, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: This medicine is used in combination with another cancer medicine (docetaxel) to treat a cancer of the lung called non-small cell lung cancer (NSCLC).
Maltese: Din il-mediċina tintuża flimkien ma' mediċina oħra kontra l-kanċer (docetaxel) biex tikkura kanċer tal-pulmun ta' ċelluli mhux żgħar (NSCLC).
English: Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways with CYP 3A4 being the predominant enzyme involved.
Maltese: Parti żgħira biss tal-bijotrasformazzjoni ta' nintedanib kienet tikkonsisti minn passaġġi ta' CYP, b'CYP 3A4 li tkun l-enzima predominanti involuta.
English: The frequency of gastrointestinal perforation was comparable between the treatment arms in the clinical trial.
Maltese: Il-frekwenza ta' perforazzjoni gastrointestinali kienet komparabbli bejn il-partijiet tal-istudju dwar il-kura fil-prova klinika.
English: 100 kg patient (95
Maltese: FOLJA (150 MG)
English: Fertility The effect of this medicine on human fertility has not been investigated.
Maltese: Fertilità L-effett ta' din il-mediċina fuq il-fertilità fil-bniedem ma ġiex investigat.
English: Patients with active brain metastasis were excluded from clinical trials and are not recommended for treatment with Vargatef.
Maltese: Pazjenti b'metastasi attiva tal-moħħ ġew esklużi mill-provi kliniċi u mhumiex rakkomandati għall-kura b'Vargatef.
English: QT/QTc measurements were recorded and analysed from a dedicated trial comparing nintedanib monotherapy against sunitinib monotherapy in patients with renal cell carcinoma.
Maltese: Il-kejl tal-QT/QTc ġie rreġistrat u analizzat minn prova ddedikata li qabblet monoterapija b'nintedanib kontra monoterapija b'sunitinib f'pazjenti b'karċinoma taċ-ċelluli tal-kliewi.
English: The majority of these events were reported for patients in the IPF indication.
Maltese: Il-maġġoranza ta' dawn l-avvenimenti kienu rrappurtati għall-pazjenti fl-indikazzjoni ta' IPF.
English: In case of further persistence of the adverse reaction(s), i.e. if a patient does not tolerate 100 mg twice daily, treatment with Vargatef should be permanently discontinued.
Maltese: F'każ ta' persistenza addizzjonali tar-reazzjoni(jiet) avversa, i.e. jekk pazjent ma jittollerax 100 mg darbtejn kuljum, il-kura b'Vargatef għandha titwaqqaf b'mod permanenti.
English: Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A; see sections 4.2 and 5.2).
Maltese: Fuq il-bażi taż-żieda fl-esponiment, ir-riskju ta' avvenimenti avversi jista' jiżdied f'pazjenti b'indeboliment tal-fwied ħafif (Child Pugh A; ara sezzjonijiet 4.2 u 5.2).
English: Transaminase, ALKP and bilirubin levels should be investigated before initiation of the combination treatment with Vargatef plus docetaxel.
Maltese: Il-livelli ta' transaminase, ALKP u bilirubina għandhom jiġu investigati qabel ma tinbeda l-kura kombinata ta' Vargatef flimkien ma' docetaxel.
English: However, the frequency of patients with gastrointestinal perforation was low.
Maltese: Madankollu, il-frekwenza ta' pazjenti b'perforazzjoni gastrointestinali kienet baxxa.
English: There was no evidence of liver enzyme increases in rats, dogs, and Cynomolgus monkeys.
Maltese: Ma kien hemm l-ebda evidenza ta' żidiet fl-enzimi tal-fwied fil-firien, fil-klieb u fix-xadini Cynomolgus.
English: LIST OF EXCIPIENTS Contains soya.
Maltese: Il-kapsuli fihom soya lecithin.
English: Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka
Maltese: Boehringer Ingelheim RCV GmbH & Co
English: PK-efficacy analyses were not performed for clinical endpoints.
Maltese: Ma twettqux analiżijiet PK dwar l-effikaċja għal punti aħħarin kliniċi.
English: By blocking the activity of these proteins, nintedanib can help stop the growth and spread of the cancer.
Maltese: Billi jimblokka l-attività ta' dawn il-proteini, nintedanib jista' jgħin iwaqqaf it-tkabbir u t-tixrid tal-kanċer.
English: Treatment with Vargatef is not recommended in patients with moderate or severe hepatic impairment (see section 4.2).
Maltese: Il-kura b'Vargatef mhijiex rakkomandata f'pazjenti b'indeboliment moderat jew sever tal-fwied (ara sezzjoni 4.2).
English: The potential for interactions of nintedanib with hormonal contraceptives was not explored.
Maltese: Il-potenzjal għal interazzjonijiet ta' nintedanib ma' kontraċettivi ormonali ma ġiex esplorat.
English: Do not use this medicine after the expiry date which is stated on the carton, wrapper and blisters.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna, wrapper u folji.
English: In preclinical disease models nintedanib, as single agent, effectively interfered with the formation and maintenance of the tumour vascular system resulting in tumour growth inhibition and tumour stasis.
Maltese: F'mudelli ta' mard qabel l-użu kliniku, nintedanib, bħala sustanza unika, interferixxa b'mod effettiv mal-formazzjoni u l-manutenzjoni tas-sistema vaskulari tat-tumur, u dan rriżulta f'inibizzjoni għat-tkabbir tat-tumur u stasis tat-tumur.
English: `Locally recurrent´ was defined as local re-occurrence of the tumour without metastases at trial entry.
Maltese: `Lokalment rikorrenti´ ġie definit bħala okkorrenza lokali mill-ġdid tat-tumur mingħajr metastasijiet meta l-individwu daħal fil-prova.
English: If necessary, your doctor may further reduce your daily dose to 200 mg per day (two capsules of 100 mg).
Maltese: Jekk ikun meħtieġ, it -tabib tiegħek jista' jnaqqas b'mod addizzjonali d-doża tiegħek ta' kuljum għal 200 mg kuljum (żewġ kapsuli ta' 100 mg).
English: Data from black individuals was very limited but in the same range as for Caucasians.
Maltese: Dejta minn individwi suwed kienet limitata ħafna, iżda fl-istess medda bħal dik għal Kawkasi.
English: In rats, embryofoetal lethality and teratogenic effects were observed at exposure levels below human exposure, at the maximum recommended human dose (MRHD) of 200 mg b.i.d.
Maltese: Fil-firien, ġew osservati letalità embrijofetali u effetti teratoġeniċi f' livelli ta' esponiment taħt l-esponiment uman, fid-doża massima rakkomandata fil-bniedem (MRHD) ta' 200 mg b.i.d. Effetti fuq l-iżvilupp tal-iskeletru assjali u fuq l-iżvilupp tal-arterji l-kbar ġie osservat ukoll f'livelli ta' esponiment subterapewtiku.
English: Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with Vargatef (see section 4.2).
Maltese: L-immaniġġjar tar-reazzjonijiet avversi jista' jkun jeħtieġ l-interruzzjoni, it-tnaqqis fid-doża, jew it-twaqqif tat-terapija b'Vargatef (ara sezzjoni 4.2).
English: Package leaflet: Information for the patient Vargatef 150 mg soft capsules nintedanib
Maltese: Informazzjoni għall-pazjent Vargatef 150 mg kapsuli rotob nintedanib
English: If you cannot tolerate the recommended dose of 400 mg per day because of side effects (see section 4), your doctor may reduce the daily dose of Vargatef.
Maltese: Jekk ma tistax tittollera d-doża rakkomandata ta' 400 mg kuljum minħabba l-effetti sekondarji (ara sezzjoni 4), it-tabib tiegħek jista' jnaqqas id-doża ta' kuljum ta' Vargatef.
English: performance status was 0 (28.6 %) or 1 (71.3 %); one patient had a baseline ECOG performance status of 2.
Maltese: Il-maġġoranza tal-pazjenti ma kinux Asjatiċi (81.6 %), l-età medjana kienet ta' 60.0 sena, l-istat ta' prestazzjoni ECOG fil-linja bażi kien ta' 0 (28.6 %) jew 1 (71.3 %); pazjent wieħed kellu stat ta' prestazzjoni ECOG fil-linja bażi ta' 2.
English: Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischaemia.
Maltese: L-interruzzjoni tal-kura għandha tiġi kkunsidrata f'pazjenti li jiżviluppaw sinjali jew sintomi ta' iskemija mijokardijaka akuta.
English: Events of pancreatitis have been reported in patients taking nintedanib for the treatment of IPF and NSCLC.
Maltese: Ġiet osservata korrelazzjoni inversa bejn il-piż tal-ġisem u l-esponiment għal nintedanib.
English: Stratified Log-Rank Test p-value*
Maltese: NUMRU TAL-LOTT Lot
English: In the event of dehydration, administration of electrolytes and fluids is required.
Maltese: Fil-każ ta' deidrazzjoni, l-għoti ta' elettroliti u fluwidi hu meħtieġ.
English: Breast-feeding should be discontinued during treatment with Vargatef.
Maltese: It-treddigħ għandu jieqaf waqt it-trattament b'Vargatef.
English: Velcade bortezomib
Maltese: Velcade borteżomib
English: The full EPAR for Velcade 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: This summary was last updated in 01-2015.
Maltese: Is-sommarju ġie aġġornat l-aħħar f'01-2015.
English: Other information about Velcade:
Maltese: Informazzjoni oħra dwar Velcade:
English: In multiple myeloma, Velcade has been evaluated in 10 main studies involving over 4,339 adults, which evaluated the benefits of Velcade alone or in combination with other treatments.
Maltese: F'majeloma multipla, Velcade ġie evalwat f'10 studji ewlenin li involvew aktar minn 4,339 adult, li evalwaw il-benefiċċji ta' Velcade waħdu jew f'kombinazzjoni ma' kuri oħrajn.
English: This document is a summary of the European public assessment report (EPAR) for Velcade.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Velcade.
English: The most commonly reported side effects during treatment with Velcade are nausea (feeling sick), diarrhoea, constipation, vomiting, fatigue (tiredness), pyrexia (fever), thrombocytopenia (low blood platelets count), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), peripheral neuropathy (nerve damage in the hands and feet), headache, paraesthesia (unusual sensations like pins and needles), decreased appetite, dyspnoea (difficulty breathing), rash, herpes zoster (shingles) and myalgia (muscle pain).
Maltese: L-effetti sekondarji l-aktar komuni rrappurtati waqt il-kura b'Velcade huma nawżja (tħossok ma tiflaħx), dijarrea, stitikezza, remettar, għeja, piressija (deni), tromboċitopenija (għadd baxx ta' pjastrini fid-demm), anemija (għadd baxx ta' ċelloli ħomor fid-demm), newtropenija (livelli baxxi ta' newtrofili, tip ta' ċelloli bojod li jiġġieldu l-infezzjoni), newtropatija periferali (ħsara fin-nervituri fl-idejn u s-saqajn), uġigħ ta' ras, paraestesija (sensazzjonijiet mhux normali bħal xewk u labar), nuqqas flaptit, dispnea (diffikultà fin-nifs), raxx, il-ħruq ta' Sant Antnin u mijalġja (uġigħ fil-muskoli).
English: The active substance in Velcade, bortezomib, is a proteasome inhibitor.
Maltese: Is-sustanza attiva f'Velcade, il-borteżomib, hija inibitur tal-proteażom.
English: The most serious adverse reactions include heart failure, tumour lysis syndrome (complications due to breakdown of cancer cells), pulmonary hypertension (high blood pressure in the arteries of the lungs), posterior reversible encephalopathy syndrome (a reversible brain disorder), acute diffuse infiltrative pulmonary disease (a severe lung problem), and autonomic neuropathy (damage to nerves controlling organs such as the bladder, eyes, gut, heart and blood vessels).
Maltese: L-effetti sekondarji l-aktar serji inkludew insuffiċjenza kardijaka, is-sindromu tat-tumur ta' lise (komplikazzjoni dovuta għat-tkissir taċ-ċelloli tal-kanċer), ipertensjoni pulmonarja (pressjoni għolja flarterji tal-pulmun), is-sindromu ta' enċefalopatija posterjuri riversibbli (disturb riversibbli fil-moħħ), marda infiltrattiva pulmonarja diffuża akuta (problema gravi fil-pulmun), u newropatija awtonomika (ħsara lin-nervituri li jikkontrollaw l-organi bħall-bużżieqa tal-awrina, l-għajnejn, l-imsaren, il-qalb u larterji).
English: Velcade is a cancer medicine that contains the active substance bortezomib.
Maltese: Velcade huwa mediċina kontra l-kanċer li fiha s-sustanza attiva borteżomib.
English: Why has Velcade been approved?
Maltese: Għaliex ġie approvat Velcade?
English: • Around 34% of the patients responded partially or completely to treatment with Velcade (in a study in which Velcade was not compared with any other medicine)
Maltese: • Madwar 34% tal-pazjenti irrispondew parzjalment jew kompletament għall-kura b'Velcade (fi studju li fih Velcade ma tqabbilx ma' xi mediċina oħra).
English: • Around 15% of patients who were candidates for high-dose chemotherapy and a blood stem-cell transplant responded to treatment with Velcade plus dexamethasone, compared with 6% of those given standard combinations.
Maltese: • Madwar 15% tal-pazjenti li kienu kandidati għal kimoterapija ta' doża għolja u għal trapjant taċċelloli staminali tad-demm wieġbu għall-kura b'Velcade u deksametażon, meta mqabbla ma' 6% ta' dawk li ngħataw kombinazzjonijiet standard.
English: Velcade was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Maltese: Oriġinarjament Velcade kien awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni', għaliex, għal raġunijiet xjentifiċi, kien hemm disponibbli informazzjoni limitata fi żmien l-approvazzjoni.
English: It is available in vials (1 and 3.5 mg) as a powder to be made up into a solution for injection.
Maltese: Jiġi fi vjali (1 u 3.5 mg) u bħala trab biex isir soluzzjoni għall-injezzjoni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Velcade on 26 April 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Velcade valida fl-Unjoni Ewropea kollha fis-26 ta' April 2004.
English: In addition, 49% of these patients responded to Velcade plus thalidomide and dexamethasone, compared with about 26% who responded to treatment containing Velcade plus other anticancer drugs, and 17% who responded to thalidomide and dexamethasone alone.
Maltese: Barra minn hekk, 49% ta' dawn il-pazjenti wieġbu għal Velcade flimkien ma' talidomid u deksametażon, meta mqabbla ma' 26% li wieġbu għall-kura li kien fiha Velcade u mediċini oħra kontra l-kanċer, u 17% ta' dawk li wieġbu għal talidomid u deksametażon waħdu.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 19 March 2012.
Maltese: Billi l-kumpanija pprovdiet it-tagħrif addizzjonali mitlub, iċ-‘ċirkostanzi ta' eċċezzjonali' ntemmu fid-19 ta' Marzu 2012.
English: At least 72 hours must pass between two consecutive doses of Velcade.
Maltese: Iridu jkunu għaddew mill-inqas 72 siegħa bejn żewġ dożi konsekuttivi ta' Velcade.
English: For mantle cell lymphoma, Velcade is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Maltese: Għal limfoma taċ-ċelloli tal“mantle”, Velcade jintuża f'kombinazzjoni ma' rituksimab, ċiklofosfamid, doksorubiċina u predniżon.
English: In mantle cell lymphoma, Velcade was evaluated in a main study involving 487 previously untreated adults who were not considered suitable for blood stem-cell transplantation.
Maltese: Fil-limfoma taċ-ċelloli tal-“mantle”, Velcade ġie evalwat fi studju prinċipali li involva 487 adult li ma ġewx ikkurati qabel li ma kinux meqjusin xierqa għal trapjant taċ-ċelloli staminali tad-demm.
English: Studies in multiple myeloma showed Velcade and combinations containing Velcade to be beneficial in several patient groups.
Maltese: Studji f'majeloma multipla urew li Velcade u kombinazzjonijiet li fihom Velcade huma ta' benefiċċju f'bosta gruppi ta' pazjenti.
English: The recommended starting dose is 1.3 mg per square metre body surface area (calculated using the patient's height and weight).
Maltese: Id-doża inizjali rakkomandata hi 1.3 mg għall-kull metru kwadru tal-erja tas-superfiċje tal-ġisem (ikkalkulata skont it-tul u l-piż tal-pazjent).