FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition to oral medicines and suppositories, this review also covered injectable flupirtine medicines which were being given as a single injection for pain following surgery.
Maltese: Minbarra l-mediċini orali u s-suppożitorji, din ir-reviżjoni tkopri wkoll mediċini injettabbli ta' flupirtine li kienu qed jingħataw bħala injezzjoni waħda għall-uġigħ wara intervent kirurġiku.
English: The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority new recommendations to restrict the use of oral flupirtine medicines and suppositories.
Maltese: Fis-26 ta' Ġunju 2013, il-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u lProċedura Deċentralizzata - mediċina għall-użu mill-bniedem (CMDh) approva b'maġġoranza, rakkomandazzjonijiet ġodda biex jillimita l-użu tal-mediċini orali u s-suppożitorji ta' flupirtine.
English: The PRAC also reviewed the available data on the benefits of flupirtine and concluded that, while there were data from studies in the treatment of acute pain, there were insufficient data to support its use in the treatment of long-term pain.
Maltese: Il-PRAC irreveda wkoll id-dejta disponibbli dwar il-benefiċċji ta' flupirtine u kkonkluda li, filwaqt li kien hemm dejta mill-istudji fil-kura ta' uġigħ akut, ma kienx hemm dejta suffiċjenti biex jiġi appoġġjat l-użu tiegħu fil-kura ta' uġigħ għal żmien twil.
English: • You should not take flupiritine as a long-term treatment for chronic pain.
Maltese: • Ma għandekx tieħu flupirtine bħala kura għal żmien twil għal uġigħ kroniku.
English: • Treatment must be stopped in any patient with abnormal liver function tests results or symptoms of liver disease.
Maltese: • Il-kura għandha titwaqqaf fi kwalunkwe pazjent b'riżultati tat-testijiet tal-funzjoni tal-fwied mhux normali jew b'sintomi ta' mard fil-fwied.
English: 1 tablet bottle (glass) + syringe (plastic)
Maltese: flixkun (ħġieġ) + siringa (plastik)
English: 31 October 2013
Maltese: 31 ta' Ottubru 2013
English: Both medicines contain the active substance ciclosporin.
Maltese: Iż-żewġ mediċini fihom is-sustanza attiva ciclosporin.
English: Sandimmun and Sandimmun Neoral are available as capsules (10, 25, 50 and 100 mg) and oral solution (100 mg/ml).
Maltese: Sandimmun u Sandimmun Neoral huma disponibbli bħala kapsuli (10, 25, 50 u 100 mg) u soluzzjoni orali (100 mg/ml).
English: EMA/391239/2013 Rev. 1 EMEA/H/A-30/1300
Maltese: EMA/391239/2013 Rev.
English: On 27 June 2013, the European Medicines Agency completed a review of Sandimmun and Sandimmun Neoral.
Maltese: Fis-27 ta' Ġunju 2013, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Sandimmun u Sandimmun Neoral.
English: Both medicines are available in the EU under other trade names: Immunosporin, Neoral, Neoral - Sandimmun, Sandimmun Optoral and Sandimmune.
Maltese: Immunosporin, Neoral, Neoral - Sandimmun, Sandimmun Optoral u Sandimmune.
English: The Committee also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.5 (interactions with other medicines) and 4.6 (use in pregnancy and breast feeding).
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħra tal-SmPC, inkluż sezzjonijiet 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu), 4.5 (Interazzjoni ma' mediċini oħra) u 4.6 (użu waqt tqala u treddigħ).
English: • Nephrotic syndrome (a kidney disease);
Maltese: • Sindromu nefrotiku (mard tal-kliewi);
English: • Solid organ transplantation (for the prevention and treatment of graft rejection);
Maltese: • Trapjant ta' organu solidu (għall-prevenzjoni u l-kura ta' rifjut tal-graft);
English: Sandimmun and Sandimmun Neoral are immunosuppressive medicines (medicines that reduce the activity of the immune system, the body's natural defences).
Maltese: Sandimmun u Sandimmun Neoral huma mediċini immunosoppressivi (mediċini li jnaqqsu l-attività tassistema immunitarja, id-difiżi naturali tal-ġisem).
English: However, while Sandimmun is an oil-based formulation of ciclosporin, Sandimmun Neoral is a microemulsified formulation, which allows for a more uniform absorption of ciclosporin by the body.
Maltese: Madankollu, filwaqt li Sandimmun huwa formulazzjoni ta' ciclosporin b'bażi ta' żejt, Sandimmun Neoral huwa formulazzjoni mikroemulsifikata, li tippermetti aktar assorbiment uniformi ta' ciclosporin millġisem.
English: mg/ml).
Maltese: Tibdil ieħor
English: Sandimmun and Sandimmun Neoral are authorised in the EU via national procedures.
Maltese: Sandimmun u Sandimmun Neoral huma awtorizzati fl-UE permezz ta' proċeduri nazzjonali.
English: • Endogenous uveitis (inflammation of the uvea, the middle layer of the eye);
Maltese: • Uveite endoġena (infjammazzjoni tal-uvea, is-saff tan-nofs tal-għajn);
English: The active substance in Sandimmun and Sandimmun Neoral, ciclosporin, acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in autoimmune diseases, normal tissue.
Maltese: Is-sustanza attiva f'Sandimmun u Sandimmun Neoral, ciclosporin, taġixxi fuq xi ċelloli speċjali fissistema immunitarja msejħa ċelloli-T li huma responsabbli biex jattakkaw organi trapjantati jew, f'mard awto-immuni, it-tessut normali.
English: Sandimmun and Sandimmun Neoral were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Sandimmun u Sandimmun Neoral kienu identifikati li jeħtieġu armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri ta' Rikonoxximent Reċiproċku u Deċentralizzata - Umani (CMDh).
English: • Severe atopic dermatitis (eczema, an itchy red rash of the skin).
Maltese: • Dermatite atopika severa (ekżema, raxx aħmar bil-ħakk tal-ġilda).
English: They should also not be given in combination with a herbal medicine called St John's wort (used to treat depression) nor with medicines whose blood levels may be increased by ciclosporin and lead to serious side effects, such as dabigatran etexilate (used to prevent the formation of blood clots after surgery) or bosentan and aliskiren (used to treat high blood pressure).
Maltese: M'għandhomx jingħataw ukoll f'kombinazzjoni ma' mediċina erbali msejħa St John's wort (li tintuża fil-kura tad-dipressjoni) u lanqas ma' mediċini li llivelli fid-demm tagħhom jistgħu jiżdiedu b'ciclosporin u jwasslu għal effetti sekondarji serji, bħal dabigatran etexilate (li jintuża għall-prevenzjoni tal-formazzjoni ta' emboli tad-demm wara kirurġija) jew bosentan u aliskiren (li jintużaw għall-kura ta' pressjoni tad-demm għolja).
English: Sandimmun and Sandimmun Neoral are used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ) and to treat or prevent graftversus-host disease (when the immune system of the transplanted organ attacks the patient's tissues).
Maltese: Sandimmun u Sandimmun Neoral jintużaw fuq pazjenti li sarilhom trapjant, biex jiġi evitat ir-rifjut (meta s-sistema immunitarja tattakka l-organu trapjantat) u għall-kura jew il-prevenzjoni ta' mard talgraft kontra l-ospitu (meta s-sistema immunitarja tal-organu trapjantat tattakka t-tessuti tal-pazjent).
English: • Bone marrow transplantation (for the prevention of graft rejection and prevention or treatment of graft-versus-host disease).
Maltese: • Trapjant tal-mudullun (għall-prevenzjoni ta' rifjut tal-graft u l-prevenzjoni jew il-kura tal-marda tal-graft kontra l-ospitu).
English: The CHMP agreed that Sandimmun and Sandimmun Neoral should be used in the following indications, which were already approved in several but not all EU Member States:
Maltese: Is-CHMP qabel li Sandimmun u Sandimmun Neoral għandhom jintużaw fl-indikazzjonijiet li ġejjin, li diġà kienu approvati f'diversi Stati Membri tal-UE iżda mhux f'kollha:
English: What are Sandimmun and Sandimmun Neoral?
Maltese: X'inhuma Sandimmun u Sandimmun Neoral?
English: • Severe rheumatoid arthritis (a disease causing damage and inflammation in the joints);
Maltese: • Artrite rewmatika severa (marda li tikkawża ħsara u infjammazzjoni fil-ġogi);
English: On 15 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Sandimmun and Sandimmun Neoral in the EU.
Maltese: Fil-15 ta' Diċembru 2011, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Sandimmun u Sandimmun Neoral fl-UE.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Sandimmun and Sandimmun Neoral in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jeħtieġ li l-informazzjoni dwar il-preskrizzjoni ta' Sandimmun u Sandimmun Neoral tiġi armonizzata fl-Unjoni Ewropea (EU).
English: Sandimmun is also available as a concentrate for solution for infusion (50
Maltese: Sandimmun huwa wkoll disponibbli bħala konċentrat għal soluzzjoni għall infużjoni (50 mg/ml).
English: Why were Sandimmun and Sandimmun Neoral reviewed?
Maltese: Għaliex ġew riveduti Sandimmun u Sandimmun Neoral?
English: 18 March 2018 EMA/286850/2018
Maltese: EMA/286850/2018
English: Zinbryta is a medicine that was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Maltese: Zinbryta huwa mediċina li ġiet awtorizzata fl-2016 għall-kura ta' forom rikaduti ta' sklerożi multipla.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.
Maltese: Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-EMA kkonferma li l-mediċina tal-isklerożi multipla Zinbryta (daclizumab beta) toħloq riskju ta' reazzjonijiet tal-immunità serji u potenzjalment fatali li jaffettwaw il-moħħ, il-fwied u organi oħra.
English: On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine.
Maltese: Fis-27 ta' Marzu 2018, l-awtorizzazzjoni għat-tqegħid fis-suq ġiet irtirata fuq talba ta' Biogen Idec Ltd, il-kumpanija li qiegħdet il-mediċina fis-suq.
English: The PRAC has now concluded its review of the available evidence on Zinbryta.
Maltese: Il-PRAC issa kkonkluda r-reviżjoni tiegħu tal-evidenza disponibbli dwar Zinbryta.
English: Healthcare professionals should continue monitoring patients who have been treated with Zinbryta in line with recommendations issued in March 2018.
Maltese: Il-professjonisti tal-kura tas-saħħa għandhom jibqgħu jimmonitorjaw il-pazjenti li ġew ikkurati b'Zinbryta f'konformità mar-rakkomandazzjonijiet li ħarġu f'Marzu 2018.
English: On 6 March 2018, while the review was ongoing, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended suspension of the marketing authorisation of Zinbryta and a recall of the
Maltese: Fis-6 ta' Marzu 2018, waqt li r-reviżjoni kienet għadha għaddejja, il-Kumitat dwar il-Valutazzjoni tarRiskji tal-Farmakoviġilanza (PRAC) tal-EMA rrakkomanda s-sospensjoni tal-awtorizzazzjoni għat
English: Zinbryta is no longer available in hospitals and pharmacies in the EU.
Maltese: Zinbryta m'għadux disponibbli fl-isptarijiet u fl-ispiżeriji fl-UE.
English: The European Commission issued a legally binding decision to suspend the marketing authorisation on 8 March 2018.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti biex tiġi sospiża l-awtorizzazzjoni għat-tqegħid fis-suq fit-8 ta' Marzu 2018.
English: On 27 March 2018, the European Commission withdrew the marketing authorisation of the medicine at the request of the marketing authorisation holder Biogen Idec Ltd.
Maltese: Fis-27 ta' Marzu 2018, il-Kummissjoni Ewropea rtirat l-awtorizzazzjoni għat-tqegħid fis-suq talmediċina fuq talba tad-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq Biogen Idec Ltd.
English: The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.
Maltese: Għalhekk il-PRAC ikkonferma lkonklużjonijiet preċedenti tiegħu li r-riskji ta' Zinbryta huma akbar mill-benefiċċji għal pazjenti bi sklerożi multipla.
English: There are no immediate consequences of the PRAC's review as Zinbryta is no longer authorised in the EU.
Maltese: Ma kien hemm l-ebda konsegwenza immedjata tar-reviżjoni tal-PRAC peress li Zinbryta m'għadux awtorizzat fl-UE.
English: To date over 10,000 patients have been treated with Zinbryta worldwide.
Maltese: S'issa, ‘il fuq minn 10,000 pazjent ġew ikkurati b'Zinbryta madwar id-dinja.
English: Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies
Maltese: Mediċina tal-isklerożi multipla li m'għadhiex awtorizzata u ġiet irtirata millisptarijiet u mill-ispiżeriji
English: EMA review of Zinbryta confirms medicine's risks outweigh its benefits
Maltese: Reviżjoni tal-EMA ta' Zinbryta tikkonferma li r-riskji tal-mediċina huma akbar mill benefiċċji tagħha
English: 0.5 mL (0.5 mg/mL) 1 pre-filled syringe
Maltese: 0.5 mL (0.5 mg/mL) siringa 1 mimlija għal-lest
English: 0.5 mL (0.5 mg/mL) 5 pre-filled syringes
Maltese: 0.5 mL (0.5 mg/mL) 5 siringi mimlija għal-lest
English: The full EPAR for Valtropin 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 03-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2011.
English: EPAR summary for the public somatropin
Maltese: Sommarju tal-EPAR għall-pubbliku somatropin
English: Valtropin contains the active substance somatropin.
Maltese: Valtropin fih issustanza attiva somatropin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Valtropin to BioPartners GmbH on 24 April 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Valtropin lil BioPartners GmbH fl-24 ta' April 2006.
English: After 12 months, treatment with Valtropin and Humatrope brought about similar increases in height and speed of growth (speed of +11.4 and +10.5 cm per year, respectively).
Maltese: Wara 12-il xahar, il-kura b' Valtropin u b'Humatrope ġabet żidiet simili fit-tul u l-veloċità ta' tkabbir (veloċità ta' +11.4 u +10.5 cm kull sena, rispettivament).
English: Other information about Valtropin
Maltese: Informazzjoni oħra dwar Valtropin
English: This is a summary of the European public assessment report (EPAR) for Valtropin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Valtropin.
English: The most common side effects with Valtropin are reactions at the site of injection and hormonal changes, and, in adults, headache, paraesthesia (unusual sensation like pins and needles), arthralgia (joint pain) and joint disorders.
Maltese: L-effetti sekondarji l-aktar komuni b' Valtropin huma reazzjonijiet fis-sit tal-injezzjoni u tibdil ormonali, u, fl-adulti, uġigħ ta' ras, paraesteżija (sensazzjoni anormali bħal tniggiż), artralġija (uġigħ fil-ġogi) u mard tal-ġogi.
English: Valtropin was studied to show that it is comparable to the reference medicine, Humatrope.
Maltese: Valtropin kien studjat biex jintwera li huwa komparabbli mal-mediċina ta' referenza, Humatrope.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a yeast that has received a gene (DNA) that makes it able to produce somatropin.
Maltese: Hija tiġi prodotta permezz ta' metodu magħruf bħala ‘teknoloġija rikombinant tad-DNA ': l-ormon huwa magħmul minn ħmira li tkun irċeviet ġene (DNA) li jagħmilha kapaċi li tipproduċi somatropin.
English: The reference medicine for Valtropin is Humatrope.
Maltese: Il-mediċina ta' referenza għal Valtropin hija Humatrope.
English: The active substance in Valtropin, somatropin, is identical to human growth hormone.
Maltese: Is-sustanza attiva f'Valtropin, somatropin, hija identika għall-ormon tat-tkabbir uman.
English: Valtropin is a ‘biosimilar' medicine.
Maltese: Valtropin huwa mediċina ‘bijosimili'.
English: The CHMP decided that, in accordance with EU requirements, Valtropin has been shown to have a comparable quality, safety and efficacy profile to Humatrope.
Maltese: Is-CHMP iddeċieda li, skont il-ħtiġijiet tal-UE, Valtropin intwera li għandu profil ta' kwalità, sigurtà u effikaċja komparabbli għal Humatrope.
English: Why has Valtropin been approved?
Maltese: Għalxiex ġie approvat Valtropin?
English: This means that Valtropin is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Valtropin and the reference medicine contain the same active substance.
Maltese: Dan ifisser li Valtropin huwa simili għal mediċina bijoloġika (il‘mediċina ta' referenza') li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li Valtropin u l-mediċina ta' referenza fihom l-istess sustanza attiva.
English: • children who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Maltese: • tfal li huma qosra minħabba s-sindromu ta' Turner (marda ġenetika rari li taffettwa lill-bniet), ikkonfermat permezz ta' analiżi tal-kromożomi (testijiet tad-DNA);
English: • children from two years of age and adolescents who fail to grow because they lack growth hormone (replacement therapy);
Maltese: • tfal minn sentejn u adoloxxenti li ma jikbrux minħabba n-nuqqas ta' ormon ta' tkabbir (terapija ta' sostituzzjoni);
English: Valtropin replaces the natural hormone.
Maltese: Valtropin jieħu post l-ormon naturali.
English: Valtropin is also used to treat adults with pronounced growth hormone deficiency, which has started in adulthood or childhood and needs to be confirmed by testing before treatment (replacement therapy).
Maltese: Valtropin jintuża wkoll fil-kura ta' adulti li għandhom defiċjenza evidenti tal-ormon tat-tkabbir, li bdiet f'età adulta jew waqt it-tfulija u li trid tiġi kkonfermata permezz ta' testijiet qabel il-kura (terapija ta' sostituzzjoni).
English: • children before puberty, who fail to grow because of longstanding kidney disease (chronic renal insufficiency).
Maltese: • tfal qabel il-pubertà, li ma jikbrux minħabba marda fit-tul tal-kliewi (insuffiċjenza renali kronika).
English: What is Valtropin?
Maltese: X'inhu Valtropin?
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar mediċini bijosimili, ara d-dokument ta' mistoqsija-u-tweġiba li jinsab hawn.
English: Therefore, the CHMP's view was that, as for Humatrope, the benefit outweighs the identified risks.
Maltese: Għalhekk, il-fehma tas-CHMP kienet li, bħal Humatrope, ilbenefiċċji kienu akbar mir-riskji identifikati.
English: Valtropin should not be used in people who may be hypersensitive (allergic) to somatropin or any of the other ingredients (the solvent for Valtropin contains metacresol).
Maltese: Valtropin ma għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal somatropin jew għal xi wieħed mis-sustanzi l-oħra (is-solvent għal Valtropin fih metacresol).
English: What is the risk associated with Valtropin?
Maltese: X'inhu r-riskju assoċjat ma' Valtropin?
English: How has Valtropin been studied?
Maltese: Kif ġie studjat Valtropin?
English: EU/1/14/965 /001 Ketoconazole HRA 200 mg Tablet
Maltese: EU/1/14/965 /001 Ketoconazole HRA 200 mg Pillola
English: Oral use blister (PVC/alu)
Maltese: Użu orali folja (PVC/alu)
English: 11 October 2013 EMA/584237/2013
Maltese: 11 ta' Ottubru 2013 EMA/584237/2013
English: References.
Maltese: Referenzi
English: Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease CHMP/EWP/1343/01 Rev. 1, Apr 2010.
Maltese: Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease (Linji gwida dwar l-evalwazzjoni klinika ta' aġenti antifungali għall-kura u lprofilassi ta' mard fungali invażiv) CHMP/EWP/1343/01 Rev. 1, Apr 2010.
English: The review of oral ketoconazole was initiated in July 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' ketoconazole orali nbdiet f'Lulju 2011 fuq talba ta' Franza, skont l-Artikolu 31 tadDirettiva 2001/83/KE.
English: Garcia Rodriguez et al. A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs.
Maltese: Garcia Rodriguez et al. A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs (Studju ta' koorti fuq ir-riskju ta' ħsara fil-fwied akut fost min juża ketoconazole u mediċini antifungali oħrajn).
English: Ketoconazole taken orally (by mouth) has been authorised in the EU since 1980, and later topical (on the skin) formulations, such as creams, ointments and shampoos, have become available.
Maltese: Ketoconazole li jittieħed oralment (mill-ħalq) ilu awtorizzat fl-UE sa mill-1980, u mbagħad saru disponibbli formulazzjonijiet topiċi (fuq il-ġilda), bħal kremi, ingwenti u shampoos.
English: The review of oral ketoconazole was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the EMA's final opinion.
Maltese: Ir-reviżjoni ta' ketoconazole orali twettqet mill-Kumitat għall-Prodotti Mediċina għall-Użu mill-Bniedem (CHMP) tal-EMA, responsabbli għall-mistoqsijiet kollha dwar il-mediċini għall-użu mill-bniedem, li adotta l-opinjoni finali tal-EMA.
English: Ketoconazole is an antifungal medicine used to treat infections caused by dermatophytes and yeasts.
Maltese: Ketoconazole hija mediċina antifungali biex jiġu kkurati l-infezzjonijiet ikkawżati mid-dermatofiti u lħmira.
English: The EU-wide review of oral ketoconazole was triggered by the suspension of the medicine in France.
Maltese: Ir-reviżjoni madwar l-UE ta' ketoconazole orali nbdiet mas-sospensjoni tal-mediċina fi Franza.
English: • If you are currently taking oral ketoconazole for fungal infections, you should speak to your doctor at a routine appointment to discuss suitable alternative treatments.
Maltese: • Jekk bħalissa qed tieħu ketoconazole orali għal infezzjonijiet orali, għandek tkellem lit-tabib tiegħek f'appuntament ta' rutina biex tiddiskuti kuri alternattivi xierqa.
English: Oral formulations of ketoconazole have been authorised in the EU via national procedures, and are currently available in several EU Member States under various trade names, including Nizoral and Fungoral.
Maltese: Stati Membri tal-UE taħt diversi ismijiet kummerċjali, inkluż Nizoral u Fungoral.
English: • The risk minimisation measures proposed, such as limiting the treatment duration or restricting the use to patients refractory or intolerant to alternative treatments and to physicians experienced in treating rare fungal infections, were not considered sufficient to reduce the risk of hepatotoxicity to an acceptable level.
Maltese: • Il-miżuri ta' minimizzazzjoni tar-riskju proposti, bħal-limitazzjoni tal-perjodu ta' kura jew irrestrizzjoni tal-użu għall-pazjenti refrattarji jew intolleranti għal kuri alternattivi u għat-tobba b'esperjenza fil-kura ta' infezzjonijiet fungali rari, ma kinux ikkunsidrati suffiċjenti biex jitnaqqas irriskju ta' epatotossiċità sa livell aċċettabbli.
English: The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 11 October 2013.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li approvatha u adottat deċiżjoni finali li torbot legalment madwar l-UE kollha fi 11 ta' Ottubru 2013.