FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no impact on the SmPC at the moment since it has not been demonstrated that any of the settings of this indication significantly benefit from PET/CT fusion as compared to PET alone.
Maltese: Ġie rrappurtat impatt totali għoli fuq l-immaniġġjar tal-pazjenti għall-indikazzjoni ġenerali u għal kull marda speċifika.
English: In conclusion the CHMP considers that the benefit-risk profile is favourable for Gluscan (FDG) in the indication ‘infectious or inflammatory diseases' addressed above.
Maltese: Bħala konklużjoni għal dan, is-CHMP jikkunsidra li l-profil benefiċċju-riskju għal Gluscan (FDG) bħala wieħed favorevoli fl-indikazzjoni ‘mard infettiv jew infjammatorju' indirizzata hawn fuq.
English: 27 June 2013
Maltese: 27 ta' Ġunju 2013
English: Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 31 of Directive 2001/83/EC
Maltese: Eżitu tal-proċeduri skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 u l-Artikolu 31 tad-Direttiva 2001/83/KE
English: (This does not apply to Zostavax, which has different strength and indications.)
Maltese: (Dan ma japplikax għal Zostavax, li għandu qawwa u indikazzjonijiet differenti.)
English: EMEA/H/C/000604/A20/45 EMEA/H/C/000622/A20/60 EMEA/H/C/000674/A20/52
Maltese: EMEA/H/C/000674/A20/52
English: • In children with HIV infection, vaccination is contraindicated in those with age-specific CD4+ percentages of less than 25% below 12 months, less than 20% between 12 and 35 months, or less 15% between 36 and 59 months.
Maltese: • Fit-tfal infettati bl-HIV, it-tilqim huwa kontraindikat f'dawk b'persentaġġi ta' CD4+ speċifiċi għalletà ta' inqas minn 25% taħt it-12-il xahar, inqas minn 20% bejn it-12 u l-35 xahar, jew inqas minn 15% bejn is-36 u d-59 xahar.
English: The European Commission issued a decision for M-M-RVAXPRO Article 20 on 20 February 2013.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni għal M-M-RVAXPRO Artikolu 20 fl-20 ta' Frar 2013.
English: What are MMRV?
Maltese: X'inhuma l-MMRV?
English: Other monovalent and multivalent vaccines against measles, mumps, rubella, and varicella have been available for many years and are authorised by national procedures in the EU Member States, under different trade names including Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R.
Maltese: Vaċċini oħrajn monovalenti u multivalenti kontra l-ħożba, il-gattone, ir-rubella, u l-variċella ilhom disponibbli għal bosta snin u huma awtorizzati permezz ta' proċeduri nazzjonali fl-Istati Membri tal-UE, taħt ismijiet kummerċjali differenti inklużi Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R. Vax, Rouvax, Trivivac, Varilrix, Varivax, u ismijiet assoċjati.
English: The current European public assessment report for ProQuad 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: The current European public assessment report for M-M-RVAXPRO can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Maltese: Ir-rapport attwali pubbliku Ewropew ta' valutazzjoni għal M-M-RVAXPRO jista' jinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
English: • Vaccination with MMRV remains contraindicated in pregnancy and in patients with severe humoral or cellular immunodeficiency (such as severe combined immunodeficiency, agammaglobulinaemia, or AIDS).
Maltese: • It-tilqim bl-MMRV jibqa' kontraindikat fit-tqala u f'pazjenti b'immunodefiċjenza umorali jew ċellolari severa (bħal immunodefiċjenza kkombinata severa, agammaglobulinemija, jew AIDS).
English: The multivalent vaccines M-M-RVAXPRO and ProQuad, and the monovalent zoster (shingles) vaccine Zostavax, are centrally authorised for use throughout the European Union (EU).
Maltese: Il-vaċċini multivalenti M-M-RVAXPRO u ProQuad, u l-vaċċin monovalenti taż-żoster (ħruq ta' Sant'Antnin) Zostavax, huma ċentralment awtorizzati għall-użu fl-Unjoni Ewropea kollha (UE).
English: The CHMP reviewed the available safety data on MMRV in pregnancy from post-marketing use and the published literature, focusing on the risk of spontaneous abortion, stillbirth, malformations, immaturity and low birth weight.
Maltese: Is-CHMP irreveda d-dejta disponibbli dwar is-sigurtà tal-MMRV fit-tqala mill-użu wara t-tqegħid fis-suq u mil-letteratura ppubblikata, waqt li iffoka fuq ir-riskju ta' abort spontanju, twelid ta' trabi mejta, malformazzjonijiet, nuqqas ta' maturità u piż baxx mat-twelid.
English: This included reports on over 3,500 women inadvertently given a rubellacontaining vaccine in early pregnancy, and over 1,800 who were given a varicella-containing vaccine during pregnancy.
Maltese: Dan kien jinkludi rapporti dwar aktar minn 3,500 mara li aċċidentalment tlaqqmu b'vaċċin li kien fih ir-rubella kmieni fit-tqala, u aktar minn 1,800 li waqt it-tqala ngħataw vaċċin li kien fih il-variċella.
English: On 13 December 2012, the European Medicines Agency completed a review of the use of monovalent and multivalent measles, mumps, rubella and/or varicella vaccines (MMRV) during pregnancy and in patients with immune deficiencies (weakened immune systems).
Maltese: Fit-13 ta' Diċembru 2012, l-Aġenzija Ewropea għall-Mediċini lestiet reviżjoni tal-użu ta' vaċċini monovalenti u multivalenti tal-ħożba, gattone, rubella u/jew tal-variċella (MMRV) waqt it-tqala u f'pazjenti b'defiċjenzi immunitarji (sistema immunitarji dgħajfa).
English: Why were MMRV reviewed?
Maltese: Għalxiex ġew riveduti l-MMRV?
English: • Women should not be given monovalent or multivalent MMRV during pregnancy.
Maltese: • In-nisa m'għandhomx jingħataw MMRV monovalenti jew multivalenti waqt it-tqala.
English: Patients with severe immune deficiencies were at risk of serious adverse effects if given live virus vaccines, but in patients with minor immune deficiencies, including those with HIV infection but adequate blood counts of CD4 cells (a type of white blood cell important in fighting infection), the evidence suggested that MMRV could be given safely and might provide benefit.
Maltese: Il-pazjenti b'defiċjenzi immunitarji severi kienu f'riskju ta' effetti ħżiena serji jekk jingħataw vaċċini talvirus ħaj, iżda f'pazjenti b'defiċjenzi immunitarji żgħar, inklużi dawk infettati bl-HIV iżda b'għadd adegwat ta' ċelloli tad-demm CD4 (tip ta' ċellola bajda tad-demm importanti sabiex tiġġieled linfezzjoni), l-evidenza indikat li l-MMRV jista' jingħata mingħajr periklu u jista' jkun ta' benefiċċju.
English: Although a risk cannot be completely excluded, no cases of congenital rubella syndrome or congenital varicella syndrome have been reported among over 5,300 reports in women who were inadvertently given MMRV during pregnancy.
Maltese: Għalkemm ir-riskju ma jistax ikun eskluż għal kollox, ma ġie rrapportat l-ebda każ ta' sindromu tarrubella konġenitali jew ta' sindromu tal-variċella konġenitali fost aktar minn 5,300 rapport f'nisa li aċċidentalment ingħataw l-MMRV waqt it-tqala.
English: • Vaccination may be considered in patients with certain immune deficiencies where the benefits outweigh the risks of vaccination (e.g. asymptomatic HIV-infected patients, patients with selective IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease and complement deficiency diseases).
Maltese: • It-tilqim jista' jiġi kkunsidrat f'pazjenti b'ċerti defiċjenzi immunitarji fejn il-benefiċċji huma akbar mir-riskji tat-tilqim (eż. pazjenti infettati bl-HIV asintomatiċi, pazjenti b'defiċjenzi selettivi tassottoklassi
English: The European Commission issued a correcting decision for MMRV Art 31 on 27 June 2013.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni għall-MMRV Artikolu 31 fis-27 ta' Ġunju 2013.
English: In particular, rubella can cause malformations and problems particularly with the ears, eyes and heart (known as ‘congenital rubella syndrome') and varicella can cause malformations affecting the limbs (known as ‘congenital varicella syndrome') in babies whose mothers become infected in early pregnancy.
Maltese: fl-għajnejn u fil-qalb (magħrufa bħala ‘sindromu tar-rubella konġenitali') u l-variċella tista' tikkawża malformazzjonijiet li jaffettwaw lir-riġlejn (magħrufa bħala ‘sindromu tal-variċella konġenitali') fi trabi ta' ommijiet li jkunu ġew infettati kmieni fit-tqala.
English: The European Commission issued a decision for ProQuad Article 20 on 18 February 2013
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni għal ProQuad Artikolu 20 fit-18 ta' Frar 2013
English: The European Commission issued a decision for MMRV Article 31 on 28 February 2013.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni għall-MMRV Artikolu 31 fit-28 ta' Frar 2013.
English: MMRV may be available as individual vaccines for each infection (monovalent) or as combination vaccines (multivalent).
Maltese: L-MMRV jistgħu jkunu disponibbli bħala vaċċini individwali għal kull infezzjoni (monovalenti) jew bħala vaċċini kkombinati (multivalenti).
English: MMRV are vaccines that help protect against the viral infections measles, mumps, rubella, and varicella (which may cause chickenpox or shingles [zoster]).
Maltese: Mistoqsijiet u tweġibiet dwar ir-reviżjoni ta' vaċċini monovalenti u multivalenti tal-ħożba, gattone, rubella u/jew tal-variċella
English: In addition MMRV should continue to be avoided in patients with the most severely weakened immune systems, but their use could be considered in less severe immune deficiency.
Maltese: Barra minn hekk l-MMRV għandhom jibqgħu jkunu evitati f'pazjenti bl-aktar sistemi immunitarji severament dgħajfa, iżda l-użu tagħhom jista' jkun ikkunsidrat f'defiċjenza immunitarja inqas severa.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that these vaccines should continue to be avoided during pregnancy, but that inadvertent vaccination of pregnant women with measles-, mumps- and/or rubella-containing vaccines should not be a reason for termination of pregnancy.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li dawn ilvaċċini għandhom jibqgħu jkunu evitati waqt it-tqala, iżda li t-tilqim aċċidentali ta' nisa tqal bil-vaċċini li jkun fihom il-ħożba, il-gattone, ir-rubella u/jew il-variċella m'għandux ikun raġuni biex titwaqqaf ittqala.
English: • Immunocompromised patients who are vaccinated may not develop adequate immunity and should be monitored for subsequent development of measles, parotitis, rubella or varicella after contact with these diseases.
Maltese: • Il-pazjenti b'immunità kompromessa li jitlaqqmu jistgħu ma jiżviluppawx immunità adegwata u għandhom ikunu ssorveljati għal żvilupp sussegwenti ta' ħożba, parotite, rubella jew variċella wara l-kuntatt ma' dan il-mard.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of MMRV do not outweigh their risks in pregnancy or in severe immune deficiencies, and recommended that vaccination should continue to be contraindicated in these groups.
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCHMP ikkonkluda li l-benefiċċji tal-MMRV mhumiex akbar mir-riskji tagħhom fit-tqala jew f'defiċjenzi immunitarji severi, u rrakkomanda li t-tilqim għandu jibqa' jkun kontraindikat f'dawn il-gruppi.
English: The European Commission issued a decision for Zostavax Article 20 on 13 February 2013.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni għal Zostavax Artikolu 20 fit-13 ta' Frar 2013.
English: EMA/483217/2018 EMEA/H/C/000670
Maltese: EMA/549578/2018 EMA/H/C/000670
English: Further information on Exjade 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: Other information about Exjade
Maltese: Informazzjoni oħra dwar Exjade
English: Exjade contains the active substance deferasirox.
Maltese: Exjade fih is-sustanza attiva deferasirox.
English: Other common side effects (in up to 1 patient in 10) include nausea (feeling sick), vomiting, diarrhoea, indigestion, abdominal (belly) pain, constipation, headache, rash, itching, blood tests showing raised transaminases (which may suggest liver damage) and protein in urine.
Maltese: Effetti sekondarji oħra (minn pazjent 1 minn kull 10) jinkludu nawsja (tħossok ma tiflaħx), remettar, dijarea, indiġestjoni, uġigħ addominali (ta' żaqq), stitikezza, uġigħ ta' ras, raxx, ħakk, testijiet tad-demm li juru żieda fit-transaminases (li tista' tissuġġerixxi ħsara fil-fwied) u proteina fl-awrina.
English: The active substance in Exjade, deferasirox, is an ‘iron chelator'.
Maltese: Is-sustanza attiva f'Exjade, id-deferasirox, hija ‘kelatur tal-ħadid'.
English: Exjade received a marketing authorisation valid throughout the EU on 28 August 2006.
Maltese: Exjade ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-28 ta' Awwissu 2006.
English: What are the risks associated with Exjade?
Maltese: X'inhuma r-riskji assoċjati ma' Exjade?
English: As for all medicines, data on the use of Exjade are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Exjade hija ssorveljata kontinwament.
English: In patients treated with Exjade, liver iron levels decreased on average by 3.8 mg per gram of liver compared with an average increase of 0.4 mg per gram of liver in patients treated with placebo.
Maltese: F'pazjenti kkurati b'Exjade, il-livelli ta' ħadid filfwied naqsu b'medja ta' 3.8 mg għal kull gramma ta' fwied meta mqabbel ma' żieda medja ta' 0.4 mg għal kull gramma ta' fwied fil-pazjenti kkurati bil-plaċebo.
English: The iron level was reduced satisfactorily in 53% of the patients receiving Exjade, compared with 66% of the patients receiving deferoxamine.
Maltese: Il-livell ta' ħadid tnaqqas b'mod sodisfaċenti fi 53 % tal-pazjenti li kienu qed jirċievu Exjade, meta mqabbel ma' 66 % tal-pazjenti li kienu qed jirċievu deferoxamine.
English: Another study involved 184 patients who could not be treated with deferoxamine, including patients with beta thalassaemia major and with other types of anaemia.
Maltese: Studju ieħor involva 184 pazjent li ma setgħux jiġu kkurati b'deferoxamine, inkluż pazjenti b'beta talassemija maġġuri u b'tipi ta' anemija oħrajn.
English: In a further main study involving 166 patients from 10 years of age (including 21 patients aged 10 to 18 years) with non-transfusion-dependent thalassaemia syndromes and iron overload, Exjade was more effective than placebo (a dummy treatment).
Maltese: Fi studju ewlieni ieħor li involva 166 pazjent minn 10 snin 'il fuq (inkluż 21 pazjent li kellhom 10 snin sa 18-il sena) b'sindromi ta' talassemija li mhijiex dipendenti mit-trasfużjonijiet u b'akkumulu eċċessiv ta' ħadid, Exjade kien aktar effettiv mill-plaċebo (kura finta).
English: How is Exjade used?
Maltese: Kif jaħdem Exjade?
English: Exjade must not be used in people whose creatinine clearance is less than 60 ml per minute.
Maltese: Exjade ma għandux jintuża f'persuni li t-tneħħija tal-kreatina tagħhom tkun inqas minn 60 ml kull minuta.
English: Exjade was not as effective overall as the comparator medicine.
Maltese: Exjade ma kienx effettiv globalment daqs il-mediċina komparatur.
English: In chronic iron overload due to blood transfusions, one main study compared Exjade with deferoxamine in 591 patients with beta thalassaemia major.
Maltese: Fil-każ ta' akkumulu eċċessiv kroniku ta' ħadid minħabba trasfużjonijiet tad-demm, studju ewlieni wieħed qabbel Exjade ma' deferoxamine f'591 pazjent b'beta talassemija maġġuri.
English: • patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin in the blood) and who receive frequent blood transfusions;
Maltese: • f'pazjenti minn sitt snin 'il fuq li jbatu mill-beta talassemija maġġuri (diżordni ereditarja fid-demm fejn il-pazjenti ma jkollhomx emoglobina normali biżżejjed fid-demm) u li jingħataw trasfużjonijiet tad-demm b'mod frekwenti;
English: However, in the 381 patients who had particularly high levels of iron at the beginning of the study and who received comparable amounts of Exjade and deferoxamine, the two medicines were as effective as each other.
Maltese: Madankollu, fit381 pazjent li kellhom livelli partikolarment għoljin ta' ħadid fil-bidu tal-istudju u li rċivew ammonti komparabbli ta' Exjade u ta' deferoxamine, iż-żewġ mediċini kienu effettivi daqs xulxin.
English: Exjade is a medicine used to treat chronic iron overload (an excess of iron in the body) in:
Maltese: Exjade hija mediċina li tintuża biex tikkura l-akkumulu eċċessiv kroniku ta' ħadid (eċċess ta' ħadid filġisem):
English: Side effects reported with Exjade are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Exjade huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Kidney and liver tests should be done before starting treatment and at regular intervals during treatment with Exjade.
Maltese: Għandhom isiru testijiet talkliewi u tal-fwied qabel tinbeda l-kura u f'intervalli regolari matul il-kura b'Exjade.
English: For the full list of side effects of Exjade, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Exjade, ara l-fuljett ta' tagħrif.
English: The most common side effect with Exjade (which may affect more than 1 in 10 people) is increased blood creatinine (a marker of kidney problems).
Maltese: L-effett sekondarju l-aktar komuni b'Exjade (li jista' jaffettwa aktar minn pazjent 1 minn kull 10) huwa żieda fil-kreatinina fid-demm (indikatur ta' problemi fil-kliewi).
English: This pack aims to inform them about the treatment recommendations with Exjade, including choosing the right dose, that the doses are different for dispersible tablets compared to film-coated tablets or granules, and the need to monitor the patient's health, especially kidney function.
Maltese: Dan jgħin filkontroll tal-akkumulu eċċessiv ta' ħadid u jipprevjeni ħsara lill-organi bħall-qalb jew il-fwied minħabba ħadid eċċessiv.
English: What is Novantrone?
Maltese: X'inhu Novantrone?
English: Novantrone is marketed in the following EU member states: Cyprus, Finland, France, Germany, Greece, Italy, Romania, Slovenia, Spain and Sweden, as well as Iceland and Norway.
Maltese: Ċipru, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Italja, ir-Rumanija, is-Slovenja, Spanja u l-Iżvezja, kif ukoll l-Iżlanda u n-Norveġja.
English: The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), 4.8 (side effects) and 5.1 (pharmacodynamic properties).
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħra tal-SmPC inklużi sezzjonijiet 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu), 4.5 (interazzjonijiet), 4.6 (fertilità, tqala u treddigħ), 4.7 (effetti fuq il-ħila biex issuq u tħaddem magni), 4.8 (effetti sekondarji) u 5.1 (proprjetajiet farmakodinamiċi).
English: • Non-Hodgkin's lymphoma;
Maltese: • Limfoma mhux ta' Hodgkin;
English: On 28 April 2016, the European Medicines Agency completed a review of Novantrone.
Maltese: Fit-28 ta' April 2016, l-Aġenzija Ewropea għall-Mediċini temmet rieżami ta' Novantrone.
English: The European Commission issued a decision on this opinion on 24/06/2016.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fl-24/06/2016.
English: Novantrone has been authorised in the EU via national procedures.
Maltese: Novantrone ġie awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: • Acute myeloid leukaemia (cancer of a type of white blood cell called myeloid cells);
Maltese: • Lewkimja majelojde akuta (kanċer ta' tip ta' ċelloli bojod tad-demm imsejħa ċelloli majelojdi);
English: It is also available in the EU under the trade names Elsep and Ralenova.
Maltese: Huwa disponibbli wkoll fl-UE taħt l-ismijiet kummerċjali ta' Elsep u Ralenova.
English: The educational materials will include a guide and checklist for healthcare professionals informing of the risks of cardiotoxicity (harm to the heart) and leukaemia with the medicine, and how patients should be monitored.
Maltese: Il-materjali edukattivi se jinkludu gwida u lista ta' kontroll għall-professjonisti fil-qasam tal-kura tas-saħħa li jinformaw dwar ir-riskji ta' kardjotossiċità (ħsara lill
English: Why was Novantrone reviewed?
Maltese: Għaliex ġie rieżaminat Novantrone?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Novantrone in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Novantrone fl-Unjoni Ewropea (UE).
English: Novantrone is a medicine that is used in the treatment of cancers including breast cancer, non-Hodgkin's lymphoma (a cancer of the lymphatic system, which is part of the immune system) and certain types of blood cancer, as well as pain caused by prostate cancer.
Maltese: Novantrone huwa mediċina li tintuża fil-kura tal-kanċers inkluż, il-kanċer tas-sider, il-limfoma mhux ta' Hodgkin (kanċer tas-sistema limfatika, li hija parti mis-sistema immunitarja) u ċerti tipi ta' kanċer fiddemm, kif ukoll uġigħ ikkawżat mill-kanċer fil-prostata.
English: The company that markets these medicines is MEDA.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija MEDA.
English: On 1 October 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Novantrone in the EU.
Maltese: Fil-1 ta' Ottubru 2014, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Novantrone fl-UE.
English: A risk management plan will be developed to ensure that Novantrone is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Novantrone jintuża bl-aktar mod sigur possibbli.
English: Novantrone was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Novantrone ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċeduri tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: Daily doses vary from 6 to 14 mg per square metre of body surface area (calculated using the patient's height and weight).
Maltese: Id-dożi ta' kuljum ivarjaw minn 6 sa 14 mg għal kull metru kwadru tal-erja tas-superfiċje tal-ġisem (ikkalkulata permezz tat-tul u l-piż tal-pazjent).
English: The CHMP also harmonised the recommendations on how to use Novantrone for the different indications.
Maltese: Is-CHMP armonizza wkoll ir-rakkomandazzjonijiet dwar kif Novantrone jintuża għal indikazzjonijiet differenti.
English: Mitoxantrone, the active substance in Novantrone, passes into breast milk and has been detected in breast milk for up to one month after the medicine was discontinued.
Maltese: Mitoxantrone, is-sustanza attiva f'Novantrone, tgħaddi fil-ħalib tas-sider u ġiet osservata fil-ħalib tassider sa xahar wara li l-mediċina twaqqfet.
English: Novantrone should only be given by infusion into a vein.
Maltese: Novantrone jenħtieġ li jingħata biss permezz ta' infużjoni ġol-vina.
English: • ‘Blast crisis' in chronic myeloid leukaemia (the final, rapidly progressive stage of another type of cancer of white blood cells);
Maltese: • "Kriżi blast" f'lewkimja majelojde kronika (l-aħħar stadju progressiv ħafna ta' tip ieħor ta' kanċer taċ-ċelloli bojod tad-demm);
English: Novantrone contains the active substance mitoxantrone and it is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Maltese: Novantrone fih is-sustanza attiva mitoxantrone u jiġi bħala konċentrat li jitħallat f'soluzzjoni għallinfużjoni (dripp) ġol-vina.