FrancophonIA/ELRC3.0 huggingface dataset:
English: The most recent study (Vellas 1998 - Not published) that became available after the granting of the initial marketing autohrisation, uses a standardised definition of diagnosis (patients had to present a moderate memory deficit, with a Mini-Mental Sate Examination MMSE > 25 and a score total > 38 and < 70 on the Mac Nair and Kahn auto-questionnaire assessing the difficulties in daily activities) and defines the primary efficacy criterion a priori (the Mac Nair and Kahn auto-questionnaire and the Gröber and Buschke test).
Maltese: Laktar studju riċenti (Vellas 1998 - Mhux ippubblikat) li sar disponibbli wara l-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq inizjali, tuża definizzjoni standardizzata tad-dijanjosi (il-pazjenti riedu jippreżentaw defiċit moderat ta' memorja, b'Mini-Mental Sate Examination MMSE ta' > 25 u punteġġ totali ta' > 38 u < 70 fuq l-awtokwestjonarju ta' Mac Nair u Kahn li jivvaluta d-diffikultajiet flattivitajiet ta' kuljum) u jiddefinixxi l-kriterju prinċipali tal-effikaċja minn qabel (l-awtokwestjonarju ta' Mac Nair u Kahn u t-test ta' Gröber u Buschke).
English: • Symptomatic treatment of veno-lymphatic insufficiency
Maltese: • Kura sintomatika ta' insuffiċjenza venolimfatika
English: The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocristine.
Maltese: Is-CHMP ikkunsidra t-totalità tad-dejta disponibbli dwar is-sigurtà u l-effikaċja ta' dihydroergocristine.
English: Results are heterogeneous and inconsistent.
Maltese: Ir-riżultati huma mħallta u inkonsistenti.
English: Dihydroergocristine is a partial agonist of α-adrenoreceptors that decreases the activity of sympathetic centres and is responsible for a peripheral adrenolytic effect with an increased venous wall tone.
Maltese: Dihydroergocristine huwa agonist parzjali tal-adrenoriċetturi-α li jnaqqas l-attività taċ-ċentri simpatetiċi u huwa responsabbli għal effett adrenolitiku periferali b'żieda fit-ton tal-ħitan tal-vini.
English: In six of the evaluable studies with population under 100 patients there were similar findings.
Maltese: F'sitta mill-istudji evalwabbli b'popolazzjoni ta' anqas minn 100 pazjent, kien hemm sejbiet simili.
English: The relationship between fibrosis and serotininergic receptor activation, particularly 5-HT2B receptors by ergot derivatives is extensively described in the literature.
Maltese: Ir-relazzjoni bejn il-fibrożi u l-attivazzjoni tar-riċetturi serotoninerġiċi, b'mod partikolari r-riċetturi 5-HT2B permezz tad-derivati tal-ergotina hija deskritta b'mod estensiv fil-letteratura.
English: The Committee concluded that the benefit-risk balance of dihydroergocristine containing products is not favourable pursuant to Article 116 of Directive 2001/83/EC for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia), for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin and for acute retinopathies of vascular origin.
Maltese: Il-Kumitat ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali li fihom dihydroergocristine mhuwiex wieħed favorevoli skont l-Artikolu 116 tad-Direttiva 2001/83/KE għallkura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (esklużi lmarda ta' Alzheimer u tipi oħra ta' dimenzja), għall-kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-kamp viżiv presumibbilment ta' oriġini vaskulari u għal retinopatiji akuti ta' oriġini vaskulari.
English: Of the 6 randomised, double blind, placebo-controlled studies, 5 studies were not considered relevant by the CHMP because the definition of the diagnosis was not standardised, no primary efficacy criterion was selected among the multi-dimensional assessment, the number of patients per group was small (from 47 to 65), and the treatment duration was short (2 and 3 months).
Maltese: Mis-6 studji double-blind, aleatorji, ikkontrollati bi plaċebo, 5 studji ma tqisux rilevanti mis-CHMP minħabba li d-definizzjoni tad-dijanjosi ma kinitx standardizzata, ma ntgħażel l-ebda kriterju primarju tal-effikaċja fost il-valutazzjoni multidimensjonali, in-numru ta' pazjenti f'kull grupp kien żgħir (minn 47 sa 67), u t-tul tal-kura kien qasir (2 u 3 xhur).
English: The MAHs also submitted their own overviews and critical summaries of all spontaneous reports of fibrotic reactions (cardiac with or without pulmonary arterial hypertension, pulmonary, pleural, peritoneal, retroperitoneal, etc) and ergotism with their ergot derivatives-containing medicinal products.
Maltese: L-MAHs ippreżentaw ukoll il-ħarsiet ġenerali u ssommarji kritiċi tagħhom tar-rapporti spontanji kollha ta' reazzjonijiet fibrotiċi (kardijaċi bi jew mingħajr pressjoni għolja tal-arterji pulmonari, pulmonari, plewrali, peritoneali, retroperitoneali, eċċ) u ergotiżmu bil-prodotti mediċinali tagħhom li fihom derivati tal-ergotina.
English: In Europe, dihydroergocristine is also available in combination with etofyllinum.
Maltese: Fl-Ewropa, dihydroergocristine huwa disponibbli wkoll f'kombinazzjoni ma' etofyllinum.
English: The MAHs submitted 27 literature references to support the efficacy of dihydroergocristine on the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”.
Maltese: L-MAHs ippreżentaw 27 referenza mil-letteratura biex jappoġġaw l-effikaċja ta' dihydroergocristine flindikazzjoni “kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (eskluża l-marda ta' Alzheimer u tipi oħra ta' dimenzja)”.
English: Additionally one case of retroperitoneal fibrosis was reported in the literature (concerning fibrotic plaque), and a scan performed one year after the discontinuation of dihydroergocristine revealed a marked reduction of the fibrotic plaque which was considered by the CHMP in favour of a causal relationship between the retroperitoneal fibrosis observed and dihydroergocristine.
Maltese: Barra minn hekk kien irrappurtat każ wieħed ta' fibrożi retroperitoneali fil-letteratura (li jirrigwarda lplakka fibrotika), u skansjoni mwettqa sena wara t-twaqqif ta' dihydroergocristine żvelat tnaqqis evidenti tal-plakka fibrotika li tqies mis-CHMP favur relazzjoni kawżali bejn il-fibrożi retroperitoneali osservata u dihydroergocristine.
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Maltese: • Kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-kamp viżiv presumibbilment ta' oriġini vaskulari
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li fihom derivati tal-ergotina fl-indikazzjonijiet ikkonċernati.
English: • Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease
Maltese: • Kura anċillari ta' klawdikazzjoni intermittenti f'mard okklużiv tal-arterji periferali (PAOD Stadju II)
English: Among these 3 studies, the publications by Lazzaroni et al and Aranda et al indicated superiority over placebo, while the study by Vellas et al demonstrated similar efficacy to placebo.
Maltese: Fost dawn ittliet studji, il-pubblikazzjonijiet ta' Lazzaroni et al u Aranda et al indikaw superjorità fuq il-plaċebo, filwaqt li l-istudju ta' Vellas et al wera effikaċja simili għall-plaċebo.
English: For the indications “ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin” and “acute retinopathies of vascular origin”, the few preclinical findings submitted reporting the effects of topical doses of dihydroergocristine were considered by the CHMP insufficient to support the use of dihydroergocristine as intraocular pressure (IOP) lowering agent in human or for other ocular conditions presumably of vascular origin.
Maltese: Għall-indikazzjonijiet “kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-kamp viżiv, presumibbilment ta' oriġini vaskulari” u “retinopatiji akuti ta' oriġini vaskulari”, il-ftit sejbiet ta' qabel lużu kliniku li ġew ippreżentati biex jirrappurtaw l-effetti ta' dożi topiċi ta' dihydroergocristine kienu kkunsidrati mis-CHMP bħala insuffiċjenti biex jappoġġaw l-użu ta' dihydroergocristine bħala sustanza li tbaxxi l-pressjoni ġol-għajn (IOP) fil-bniedem jew għal kundizzjonijiet oħra tal-għajn presumibbilment ta' oriġini vaskulari.
English: Scientific conclusions
Maltese: sintomatiku
English: In addition it has a pharmacological action on the serotoninergic and dopaminergic receptors leading to interesting effects on cerebral metabolism.
Maltese: Barra minn hekk huwa għandu azzjoni farmakoloġika fuq ir-riċetturi serotoninerġiċi u dopaminerġiċi li twassal għal effetti interessanti fuq il-metaboliżmu ċerebrali.
English: Overall summary of the scientific evaluation of dihydroergocristine containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika tal-prodotti mediċinali li fihom dihydroergocristine (ara Anness I)
English: However, in this study with adequate methodological quality standard, non-significant difference between dihydroergocristine + raubasine and placebo groups was observed.
Maltese: Madankollu, f'dan l-istudju bi standard ta' kwalità metodoloġika adegwata, kienet osservata differenza mhux sinifikanti bejn il-gruppi li ħadu dihydroergocristine + raubasine u l-gruppi li ħadu l-plaċebo.
English: Of these, 18 concerned placebocontrolled trials, 2 concerned actively-controlled trials and 7 concerned open label studies.
Maltese: Minn dawn, 18 kienu jirrigwardaw provi kkontrollati bi plaċebo, 2 kienu jirrigwardaw provi kkontrollati bis-sustanza attiva u 7 kienu jirrigwardaw studji open label.
English: Therefore, even if it is highly pharmacologically plausible that ergot derivatives acting as 5HT2B receptor agonists may induce "serotonergic" valve disease similar to that induced by carcinoid tumours or fibrotic lesions of other tissues, it must be remembered that some ergot derivatives are not 5-HT2B receptor agonists.
Maltese: Għalhekk, anki jekk huwa farmakoloġikament plawsibbli ħafna li d-derivati tal-ergotina li jaġixxu bħala agonisti tar-riċetturi 5-HT2B jistgħu jikkawżaw mard "serotonerġiku" fil-valvi simili għal dak ikkawżat minn tumuri karċinojdi jew leżjonijiet fibrotiċi ta' tessuti oħra, wieħed irid jiftakar li xi derivati tal-ergotina mhumiex agonisti tar-riċetturi 5-HT2B.
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Maltese: − Kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-kamp viżiv presumibbilment ta' oriġini vaskulari.
English: − Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Maltese: • Kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (esklużi l-marda ta' Alzheimer u tipi oħra ta' dimenzja)
English: Overall, the varying affinity for serotoninergic receptors with the different ergot derivatives and the therapeutic doses used may explain the differences observed for notification rates for the fibrotic reactions.
Maltese: B'mod ġenerali, l-affinità li tvarja għar-riċetturi serotoninerġiċi bid-derivati tal-ergotina differenti u d-dożi terapewtiċi użati jistgħu jispjegaw id-differenzi osservati firrati ta' notifika għar-reazzjonijiet fibrotiċi.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Maltese: Ġiet issottolinjata s-serjetà ta' dawn l-effetti avversi u l-eżitu fatali possibbli tagħhom.
English: The data from the reported cases of fibrosis (n=12) are indicative of the capacity of dihydroergocristine to induce fibrotic reactions, mostly localised in the pulmonary area considering also the improvement of some patients following discontinuation of the product.
Maltese: Id-dejta mill-każijiet irrappurtati ta' fibrożi (n=12) hija indikattiva tal-kapaċità ta' dihydroergocristine li jikkawża reazzjonijiet fibrotiċi, lokalizzati l-aktar fiż-żona pulmonari meta jitqies ukoll it-titjib ta' xi pazjenti wara t-twaqqif tal-prodott.
English: • The Committee considered that the benefit-risk balance of dihydroergocristine containing products:
Maltese: • Il-Kumitat ħass li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti li fihom dihydroergocristine:
English: − Is not favourable for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Maltese: − Mhuwiex favorevoli għall-kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-kamp viżiv presumibbilment ta' oriġini vaskulari.
English: • The Committee considered the overall submitted data provided by the MAHs and the outcome of the scientific advisory group.
Maltese: • Il-Kumitat ikkunsidra d-dejta globali ppreżentata li ġiet ipprovduta mill-MAHs u l-eżitu tal-grupp ta' konsulenza xjentifiku.
English: Therefore, other mechanisms inducing fibrosis cannot be excluded, which suggests a causal link between fibrosis and agonism of 5-HT2A and 5-HT1B receptors and also plausible effect on serotonin transporter.
Maltese: Għalhekk, ma jistgħux jiġu esklużi mekkaniżmi oħra li jikkawżaw il-fibrożi, li jissuġġerixxi rabta kawżali bejn il-fibrożi u l-agoniżmu tar-riċetturi 5-HT2A u 5-HT1B kif ukoll effett plawsibbli fuq it-trasportatur tas-serotonin.
English: − Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Maltese: − Mhuwiex favorevoli għall-kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (eskluża l-marda ta' Alzheimer u tipi oħra ta' dimenzja).
English: Following a national pharmacovigilance review held in 2011 new spontaneous notifications reported with some of those products identified serious cases of fibrosis and ergotism and France considered that this safety concern is not outweighed by the limited evidence of efficacy.
Maltese: Wara reviżjoni ta' farmakoviġilanza nazzjonali li saret fl-2011, notifiki spontanji ġodda rrappurtati b'xi wħud minn dawn il-prodotti identifikaw każijiet serji ta' fibrożi u ergotiżmu u Franza qieset li dan it-tħassib dwar issigurtà mhuwiex megħlub mill-evidenza limitata dwar l-effikaċja.
English: • Prophylaxis of migraine headache
Maltese: • Profilassi ta' wġigħ ta' ras emigraniku
English: The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) ippreżentaw id-dejta kollha disponibbli dwar l-effikaċja minn provi kliniċi u studji ta' osservazzjoni, inkluża dejta li saret disponibbli wara lgħoti tal-awtorizzazzjoni għat-tqegħid fis-suq inizjali.
English: These included limiting treatment duration in certain conditions, contraindicating the product in patients with pre-existing fibrosis or in association with other drugs, the issuing of a DHPC highlighting the risk, a checklist for prescribers, and a pharmacological in vitro study for 5-HT subclass receptors affinity to the product.
Maltese: Dawn kienu jinkludu llimitazzjoni tat-tul tal-kura f'ċerti kundizzjonijiet, il-kontraindikazzjoni tal-prodott f'pazjenti b'fibrożi diġà eżistenti jew flimkien ma' mediċini oħra, il-ħruġ ta' DHPC li tissottolinja r-riskju, lista ta' kontroll għal min jordna l-mediċina, u studju farmakoloġiku in vitro għall-affinità tar-riċetturi tassottokategorija 5-HT għall-prodott.
English: Agonism to 5-HT2B receptors induces a proliferative response and mitogenicity of the cells expressing this receptor leading to fibrogenesis.
Maltese: Id-derivati tal-ergotina huma rikonoxxuti bħala li jistgħu jinduċi l-fibrożi, b'mod partikolari fibrożi filvalvi tal-qalb.
English: While it is agreed that the medical terminology used nowdays and in the past differs and that the data needs to be assessed bearing this aspect in mind, the clinical symptom of dementia is a result of various pathophysiological processes which makes pooling and comparison of the data difficult, especially when the individual studies used slightly different inclusion criteria.
Maltese: Filwaqt li jeżisti qbil li hemm differenzi bejn it-terminoloġija medika użata illum u fl-imgħoddi u li ddejta trid tiġi valutata b'konsiderazzjoni ta' dan l-aspett, is-sintomu kliniku tad-dimenzja huwa rriżultat ta' diversi proċessi patofiżjoloġiċi li jagħmlu l-ġbir flimkien u t-tqabbil tad-dejta wieħed diffiċli, speċjalment meta l-istudji individwali użaw kriterji ta' inklużjoni daqsxejn differenti.
English: • The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergocristine cannot be excluded.
Maltese: • Il-Kumitat ħass li ma tistax tiġi eskluża relazzjoni kawżali potenzjali bejn ir-reazzjonijiet fibrotiċi jew l-ergotiżmu u dihydroergocristine.
English: The full EPAR for Glivec 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: It is available as capsules (50 and 100 mg) and tablets (100 and 400 mg).
Maltese: Jiġi bħala kapsuli (50 u 100 mg) u pilloli (100 u 400 mg).
English: The most common side effects with Glivec (seen in more than 1 in 10 patients) are weight increase, neutropenia (low levels of the white blood cells that fight infection), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), abdominal (tummy) pain, periorbital oedema (swelling around the eyes), rash, muscle spasm and cramps, muscle, bone and joint pain, fluid retention and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni bi Glivec (li dehru f'aktar minn pazjent wieħed minn kull 10) huma żieda fil-piż, newtropenja (għadd baxx ta' ċelloli bojod fid-demm li jiġġieldu l-infezzjonijiet), tromboċitopenja (għadd baxx ta' pjastrini tad-demm), anemija (għadd baxx ta' ċelloli ħomor fiddemm), uġigħ ta' ras, nawżea (dardir), rimettar, dijarea, dispepsja (indiġestjoni), uġigħ fl-addome (fiżżaqq), edema perjorbitali (nefħa fl-għajnejn), raxx, spażmi tal-muskoli u krampi, uġigħ fil-muskoli u fil-ġogi, ritenzjoni tal-fluwidi u għeja kbira.
English: The active substance in Glivec, imatinib, is a protein-tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Glivec, l-imatinib, hija inibitur tal-proteina tiroxina kinażi.
English: Glivec is a medicine that contains the active substance imatinib.
Maltese: Glivec huwa mediċina li fiha s-sustanza attiva imatinib.
English: These included a study involving 1,106 adults that compared Glivec with the combination of interferon alpha plus cytarabine (other anticancer medicines).
Maltese: Dawn inkludew studju li involva 1,106 adulti li qabbel Glivec mal-kombinazzjoni ta' interferon alfa u u sitarabin (mediċini oħrajn għal kontra l-kanċer).
English: This is a summary of the European public assessment report (EPAR) for Glivec.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Glivec.
English: For MD/MPD (31 patients), HES and CEL (176 patients), and DFSP (18 patients), Glivec was not compared with any other medicines.
Maltese: Għall-MD/MPD (31 pazjent), għall-HES u għas-CEL (176 pazjent), u għad-DFSP (18-il pazjent), Glivec ma tqabbilx ma' mediċini oħra.
English: Glivec is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Maltese: Glivec jintuża meta l-pazjenti jkunu ‘pożittivi għall-kromożoma ta' Filadelfja' (Ph+).
English: Why has Glivec been approved?
Maltese: Għaliex ġie approvat Glivec?
English: For CML, Glivec has been examined in four main studies involving 2,133 adults and one study of 54 children.
Maltese: Għas-CML, Glivec ġie eżaminat f'erba' studji ewlenin li involvew 2,133 adult u studju ieħor b'54 tifel u tifla.
English: It has also been examined in a fourth main study involving 160 children and young people aged 1 to 22 years.
Maltese: Ġie eżaminat ukoll fir-raba' studju li involva 160 tifel u tifla ta' bejn is1 u 22 sena.
English: In the non-comparative studies of CML, Ph+ ALL and GIST, between 26 and 96% of patients showed a response to Glivec.
Maltese: Fl-istudji mhux ta' tqabbil tas-CML, tal-Ph+ ALL u tal-GIST, bejn 26 u 96% tal-pazjenti wrew reazzjoni għal Glivec.
English: For Ph+ ALL, Glivec has been examined in three studies involving 456 adults, including one study comparing Glivec with standard chemotherapy (medicines used to kill cancer cells) in 55 newly diagnosed patients.
Maltese: Għall-Ph+ ALL, Glivec ġie eżaminat fi tliet studji li involvew 456 adult, fosthom studju li qabbel Glivec mal-kimoterapija standard (mediċini li jintużaw biex jeqirdu ċ-ċelloli tal-kanċer) f'55 pazjent li kienu għadhom kif ġew dijanjostikati.
English: Glivec is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Maltese: Glivec jintuża fil-kura tal-adulti bil-MD/MPD li kellhom arranġament mill-ġdid tal-ġene għar-riċettur tal-fattur tat-tkabbir derivat mill-pjastrini (PDGFR);
English: Glivec is an anticancer medicine.
Maltese: Glivec huwa mediċina għal kontra l-kanċer.
English: What is Glivec?
Maltese: X'inhu Glivec?
English: Glivec was also better than standard chemotherapy in patients with Ph+ ALL.
Maltese: Glivec kien ukoll aħjar mill-kimoterapija standard filpazjenti b'Ph+ ALL.
English: Glivec is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Maltese: Glivec jintuża għallkura tal-adulti bl-HES jew bis-CEL li għandhom arranġament mill-ġdid speċifiku ta' żewġ ġeni msejħa FIP1L1 u PDGFRα;
English: In patients with CML, the cancer had got worse in 16% of the patients taking Glivec after five years, compared with 28% of those taking interferon alpha plus cytarabine.
Maltese: Fil-pazjenti bis-CML, il-kanċer mar għall-agħar f'16% tal-pazjenti li kienu qegħdin jieħdu Glivec wara ħames snin, meta mqabbel ma' 28% għal dawk li kienu qegħdin jieħdu interferon alfa u sitarabin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Glivec on 7 November 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Glivec valida fl-Unjoni Ewropea kollha fis-7 ta' Novembru 2001.
English: Glivec is used in combination with other anticancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Maltese: Glivec jintuża flimkien ma' mediċini ta' kontra l-kanċer f'adulti u tfal li ġew dijanjostikati riċentement bil-Ph+ ALL.
English: Glivec is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Maltese: Glivec jingħata mill-ħalq ma' ikla u tazza ilma kbira biex jitnaqqas ir-riskju ta' irritazzjoni tal-istonku u tal-intestin.
English: • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Maltese: • dermatofibrosarkoma protuberans (DFSP), tip ta' kanċer (sarkoma) li fih, iċ-ċelloli fit-tessut ta' taħt il-ġilda jinqasmu b'mod inkontrollabbli.
English: For GIST, Glivec has been examined in two main studies.
Maltese: Għall-GIST, Glivec ġie eżaminat f'żewġ studji ewlenin.
English: What is the risk associated with Glivec?
Maltese: X'inhu r-riskju assoċjat ma' Glivec?
English: The CHMP decided that Glivec's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Glivec huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.