FrancophonIA/ELRC3.0 huggingface dataset:
English: Because the number of patients with the various forms of lipodystrophy is low, the diseases are considered ‘rare', and Myalepta was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 July 2012.
Maltese: Minħabba li l-għadd ta' pazjenti bid-diversi forom ta' distrofija huwa baxx, il-mard huwa kkunsidrat ‘rari', u Myalepta ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis17 ta' Lulju 2012.
English: Since Myalepta has been authorised under exceptional circumstances, the company that markets Myalepta will set-up a registry of patients treated the medicine, and conduct studies to further investigate the benefits and risks of treatment including the possibility for Myalepta to trigger the production of antibodies.
Maltese: Minħabba li Myalepta ġiet awtorizzata taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed Myalepta fis-suq se tistabbilixxi reġistru ta' pazjenti kkurati bil-mediċina, u se twettaq studji sabiex jiġu investigati aktar il-benefiċċji u r-riskji tal-kura inkluż il-possibbiltà li Myalepta tiskatta l-produzzjoni ta' antikorpi.
English: As for all medicines, data on the use of Myalepta are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Myalepta hija ssorveljata kontinwament.
English: The medicine is used in:
Maltese: Il-mediċina tintuża fi:
English: For the full list of side effects and restrictions with Myalepta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Myalepta, ara l-fuljett ta' tagħrif.
English: The company that markets Myalepta will provide educational materials to patients and doctors with detailed information on how to use the medicine and what to do in case of side effects, including allergic reactions, hypoglycaemia and serious infections.
Maltese: Il-kumpanija li tqiegħed Myalepta fis-suq ser tipprovdi materjal edukattiv lill-pazjenti u lit-tobba b'informazzjoni dettaljata dwar kif tintuża l-mediċina u dwar x'għandu jsir f'każ ta' effetti sekondarji, inkluż reazzjonijiet allerġiċi, ipogliċemija u infezzjonijiet serji.
English: Myalepta has been shown to correct some abnormalities caused by leptin deficiency in patients with lipodystrophy, a rare condition for which few treatments are available.
Maltese: Myalepta ntwera li jsewwi xi anormalitajiet ikkawżati minn defiċjenza ta' leptin f'pazjenti b'lipodistrofija, kondizzjoni rari li ftit hemm kuri disponibbli għaliha.
English: How does Myalepta work?
Maltese: Kif jintuża Myalepta?
English: Myalepta is a medicine used in addition to diet to treat lipodystrophy, where patients have loss of fatty tissue under the skin and build-up of fat elsewhere in the body such as in the liver and muscles.
Maltese: Myalepta huwa mediċina li tintuża b'mod addizzjonali għad-dieta biex tikkura lipodistrofija, fejn ilpazjenti jitilfu tessut tax-xaħam taħt il-ġilda u jakkumulaw ix-xaħam x'imkien ieħor fil-ġisem bħal filfwied u l-muskoli.
English: Further information on the orphan designations can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (Bernardinelli-Seip syndrome: 17/07/12; Lawrence syndrome: 17/07/12; familial partial lipodystrophy: 17/07/12; Barraquer-Simons syndrome: 17/07/12).
Maltese: Dan jirriżulta wkoll f'reżistenza għall-insulina (meta l-ġisem ma jkunx jista' jagħraf linsulina, ormon li jgħin biex jirregola l-livelli ta' zokkor fid-demm).
English: It replaces leptin and increases fat breakdown in the blood, muscles and liver, thereby correcting some abnormalities in patients with lipodystrophy, including insulin resistance.
Maltese: Din tissostitwixxi leptin u żżid ittkissir tax-xaħam fid-demm, fil-muskoli u fil-fwied, b'hekk issewwi xi anormalitajiet f'pazjenti b'lipodistrofija, inkluż reżistenza għall-insulina.
English: It is available as capsules (1.5 mg, 3 mg, 4.5 mg and 6 mg) and as an oral solution (2 mg/ml).
Maltese: Jiġi f' kapsuli (1.5 mg, 3 mg, 4.5 mg u 6 mg) u f'soluzzjoni orali (2 mg/ml).
English: The full EPAR for Rivastigmine 1 A Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Rivastigmine 1 A Pharma jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The active substance in Rivastigmine 1 A Pharma, rivastigmine, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Rivastigmine 1 A Pharma, ir-rivastigmina, hija mediċina kontra d-dimenzja.
English: Rivastigmine 1 A Pharma has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's disease.
Maltese: Rivastigmine 1 A Pharma ġie studjat fi tliet studji ewlenin li involvew 2,126 pazjent bil-marda ta' Alzheimer minn moderata għal gravi.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine 1 A Pharma.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Rivastigmine 1 A Pharma.
English: Rivastigmine 1 A Pharma is a medicine containing the active substance rivastigmine.
Maltese: Rivastigmine 1 A Pharma huwa mediċina li fiha s-sustanza attiva rivastigmina.
English: For the global score, patients taking Rivastigmine 1 A Pharma had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Maltese: Għall-punteġġ globali, il-pazjenti ttrattati b'Rivastigmine 1 A Pharma kellhom żieda fis-sintomi ta' 4.1 punti apparagun ma' 4.4 punti rreġistrati fil-pazjenti ttrattati bi plaċebo.
English: An additional study in 27 patients was used to show that Rivastigmine 1 A Pharma capsules and oral solution produced similar levels of the active substance in the blood.
Maltese: Sar studju addizzjonali ieħor fuq 27 pazjent biex juri li l-kapsuli u s-soluzzjoni orali ta' Rivastigmine 1 A Pharma ipproduċew livelli simili tas-sustanza attiva fid-demm.
English: In the three studies of Rivastigmine 1 A Pharma in patients with Alzheimer's dementia, patients taking doses of Rivastigmine 1 A Pharma between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Maltese: Fit-tliet studji li saru dwar Rivastigmine 1 A Pharma fuq pazjenti bid-dimenzja ta' Alzheimer, il-pazjenti li ħadu dożi ta' Rivastigmine 1 A Pharma ta' bejn 6 u 9 mg kuljum kellhom żieda medja fis-sintomi konjittivi ta' 0.2 punti, mill-valur inizjali ta' 22.9 punti fil-bidu tal-istudju.
English: Rivastigmine 1 A Pharma was more effective than placebo at controlling symptoms.
Maltese: Rivastigmine 1 A Pharma kien aktar effikaċi mill-plaċebo fil-kontroll tas-sintomi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 1 A Pharma on 11 December 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rivastigmine 1 A Pharma fil-11 ta' Diċembru 2009.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Maltese: Filpazjenti b'dimenzja tat-tip Alzheimer jew b'dimenzja kkaġunata mill-marda ta' Parkinson ċerti ċelluli nervużi tal-moħħ imutu, u dan jikkawża livelli baxxi tan-newrotrażmettitur aċetilkolina (sustanza kimika li tippermetti ċ-ċelluli nervużi jikkomunikaw ma' xulxin).
English: The patients with dementia due to Parkinson's disease taking Rivastigmine 1 A Pharma capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Maltese: Il-pazjenti b'dimenzja kkaġunata mill-marda ta' Parkinson li ġew ittrattati bil-kapsuli ta' Rivastigmine 1 A Pharma wrew titjib fis-sintomi konjittivi ta' 2.1 punti apparagun ma' tnaqqis ta' 0.7 punti rreġistrat fil-pazjenti li ngħataw il-plaċebo, minn valur inizjali ta' madwar 24 punt.
English: Rivastigmine 1 A Pharma was also studied in 541 patients with dementia due to Parkinson's disease.
Maltese: Rivastigmine 1 A Pharma ġie studjat ukoll f'541 pazjent b'dimenzja kkaġunata mill-marda ta' Parkinson.
English: This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Maltese: Dan tqabbel ma' żieda ta' 2.6 punti rreġistrati fil-pazjenti ttrattati bi plaċebo mill-valur inizjali ta' 22.5.
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Rivastigmine 1 A Pharma's benefits did not outweigh its risks.
Maltese: Għall-ewwel il-Kumitat kien ikkonkluda li fit-trattament tad-dimenzja kkaġunata mill-marda ta' Parkinson, il-benefiċċji ta' Rivastigmine 1 A Pharma ma kinux ogħla mir-riskji tiegħu.
English: What is Rivastigmine 1 A Pharma?
Maltese: X'inhu Rivastigmine 1 A Pharma?
English: Rivastigmine 1 A Pharma is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Maltese: Rivastigmine 1 A Pharma jintuża wkoll għat-trattament tad-dimenzja minn ħafifa għal moderatament gravi f'pazjenti bil-Parkinson.
English: Rivastigmine 1 A Pharma is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Rivastigmine 1 A Pharma jintuża fil-kura ta' pazjenti bid-dimenzja ta' Alzheimer minn ħafifa għal moderatament gravi, diżordni progressiva tal-moħħ li bil-mod il-mod taffettwa l-memorja, l-abbiltà intellettwali u l-imġiba.
English: This authorisation was based on the authorisation granted to Exelon in 1998 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq lawtorizzazzjoni mogħtija lil Exelon fl-1998 (‘kunsens infurmat').
English: The CHMP concluded that Rivastigmine 1 A Pharma has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Maltese: Is-CHMP ikkonkluda li Rivastigmine 1 A Pharma għandu effikaċja moderata fit-trattament tas-sintomi tad-dimenzja ta' Alzheimer, għad illi dan tassew jirrappreżenta benefiċċju importanti għal uħud millpazjenti.
English: It must also not be used in patients who are suspected to have had in the past an allergic reaction called ‘allergic contact dermatitis' to Exelon patch.
Maltese: Ma għandux jintuża minn pazjenti li dwarhom ikun hemm suspett li fl-imgħoddi seta' kellhom reazzjonijiet allerġiċi msejħa ‘dermatite allerġika tal-kuntatt' għall-istikk Exelon.
English: Other information about Rivastigmine 1 A Pharma
Maltese: Aktar tagħrif dwar Rivastigmine 1 A Pharma
English: In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Maltese: F'pazjenti li jittolleraw din id-doża, din tista' tiżdied b'1.5 mg kull darba, iżda bejn żieda u oħra għandu jitħalla intervalli ta' mhux iqsar minn ħmistax, sakemm tintlaħaq doża regolari ta' 3 sa 6 mg darbtejn kuljum.
English: The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Maltese: Il-kejl ewlieni tal-effikaċja kien ilbidla fis-sintomi f'żewġ oqsma prinċipali: konjittiv (il-ħila tal-ħsieb, tat-tagħlim u tal-ftakir) u globali (taħlita ta' bosta oqsma fosthom il-funzjonament ġenerali, is-sintomi konjittivi, l-imġiba u l-kapaċità li jsiru l-attivitajiet ta' kuljum).
English: What is the risk associated with Rivastigmine 1 A Pharma?
Maltese: X'inhu r-riskju assoċjat ma' Rivastigmine 1 A Pharma?
English: For the full list of all side effects reported with Rivastigmine 1 A Pharma, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bl-użu ta' Rivastigmine 1 A Pharma, ara l-fuljett ta' tagħrif.
English: By blocking these enzymes, Rivastigmine 1 A Pharma allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Maltese: Billi jimblokka dawn lenzimi, Rivastigmine 1 A Pharma jippermetti żieda fil-livelli tal-aċetilkolina fil-moħħ, u b'hekk jgħin fittnaqqis tas-sintomi tad-dimenzja tat-tip Alzheimer u tad-dimenzja kkaġunata mill-marda ta' Parkinson.
English: Overall, the most common side effects include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine 1 A Pharma is being increased.
Maltese: Kollox ma' kollox, l-effetti sekondarji l-aktar komuni jinkludu nawżja (dardir,li dehru fi 38 pazjent minn 100) u remettar (li dehru fi 23 pazjent minn 100),
English: The global symptom score also improved more in the patients taking Rivastigmine 1 A Pharma.
Maltese: Il-punteġġ globali tas-sintomi wkoll tjieb iktar fil-pazjenti ttrattati b'Rivastigmine 1 A Pharma.
English: EMA/238133/2010 rev. EMEA/H/A-30/1151
Maltese: EMEA/H/A-30/1151
English: János Borvendég (Hungary)
Maltese: János Borvendég (L-Ungerija)
English: 22 April 2010
Maltese: 22 ta' April 2010
English: The usual dose is 2.5 to 5 mg per day.
Maltese: Id-doża normali hija ta' 2.5 sa 5 mg kuljum.
English: The company that markets these medicines is F. Hoffmann - La Roche Ltd.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija F. Hoffmann - La Roche Ltd.
English: Vascace is also available in the EU under other trade names: Dynorm, Inhibace, Inibace, Justor and Vascase.
Maltese: Vascace huwa disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħrajn: Dynorm, Inhibace, Inibace, Justor u Vascase.
English: Vascace is a medicine that contains the active substance cilazapril.
Maltese: Vascace huwa prodott mediċinali li fih is-sustanza attiva cilazapril.
English: What is Vascace?
Maltese: X'inhu Vascace?
English: Some of the areas harmonised include:
Maltese: Xi oqsma armonizzati jinkludu:
English: The active substance in Vascace, cilazapril, is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Maltese: Is-sustanza attiva f'Vascace, cilazapril, hija ‘inibitur tal-enżima li tikkonverti l-anġjotensin (ACE)'.
English: A lower starting dose of 0.5 mg is recommended for hypertension in patients with a highly activated ‘renin-angiotensin-aldosterone system' as they may experience an excessive drop in blood pressure.
Maltese: Doża tal-bidu aktar baxxa ta' 0.5 mg hija rrakkomandata għall-pressjoni għolja f'pazjenti b''sistema ta' renin-anġjotensin-aldosteron' attivata sew minħabba li jista' jkollhom tnaqqis eċċessiv fil-pressjoni taddemm.
English: Vascace is authorised in the EU via national procedures.
Maltese: Vascace huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Vascace was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Vascace ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Konġunti u Diċentralizzati - tal-Bniedem (CMD(h)).
English: Company responses provided on: 28 December 2009, 22 March 2010 Opinion date:
Maltese: 28 ta' Diċembru 2009, 22 ta' Marzu 2010
English: Why was Vascace reviewed?
Maltese: Għalfejn ġie rivedut Vascace?
English: On 16 September 2009, European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace in the EU.
Maltese: Fis-16 ta' Settembru 2009, il-Kummissjoni Ewropea irreferiet il-kwistjoni lis-CHMP sabiex jiġu armonizzati l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Vascace fl-UE.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Vascace in the European Union (EU).
Maltese: Il-Kumitat għall-Mediċini għall-Użu millBniedem tal-Aġenzija (CHMP) ikkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni talpreskrizzjoni għal Vascace fl-Unjoni Ewropea (UE).
English: The European Medicines Agency has completed a review of Vascace.
Maltese: L-Aġenzija Ewropea għall-Mediċini lestiet reviżjoni ta' Vascace.
English: 24 September 2009
Maltese: 24 ta' Settembru 2010
English: If this dose is well tolerated by the patient, it can be increased to 1 or 2.5 mg once a day.
Maltese: Jekk din id-doża tkun ittollerata sew mill-pazjent, tista' tiżdied għal 1 jew 2.5 mg darba kuljum.
English: 7 July 2010
Maltese: 7 ta' Lulju 2010
English: Treatment with diuretics (medicines that help increase the amount of water removed from the body in the urine) should, where possible, be stopped two to three days before starting treatment with Vascace.
Maltese: Kura bid-dijuretiċi (mediċini li jgħinu biex iżidu l-ammont ta' ilma mneħħi mil-ġisem fl-urina) għandha, fejn possibbli, titwaqqaf jumejn jew tlett ijiem qabel tinbeda l-kura b'Vascace.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tad-dejta sottomessa u d-diskussjoni xjentifika fi ħdan il-Kumitat, kien tal-fehma li lSmPCs, tikketta u fuljetti ta' tagħrif għandhom jiġu armonizzati madwar l-UE.
English: It blocks the action of the enzyme ACE, which is responsible for the production of a hormone in the body called angiotensin II.
Maltese: Hija timblokka l-azzjoni tal-enżima ACE, li hija responsabbli għall-produzzjoni ta' ormon fil-ġisem li jismu anġjotensin II. Anġjotensin II huwa vażokostrittur qawwi (sustanza li traqqaq il-vini tad-demm).
English: For hypertension, the recommended starting dose is 1 mg per day, which can be adjusted depending on how the patient's blood pressure responds.
Maltese: Għall-pressjoni għolja, id-doża tal-bidu rrakkomandata hija ta' 1 mg kuljum, li tista' tiġi rranġata skont kif tirrispondi l-pressjoni tad-demm tal-pazjent.
English: It must not be used in patients with angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor or in patients with hereditary or idiopathic angioedema.
Maltese: Dan wassal għal diverġenzi madwar lIstati Membri fil-mod kif il-mediċina tista' tintuża, kif jidher fid-differenzi fis-sommarji tal-karatteristiċi tal-prodott (SmPCs), tikketta u fuljetti ta' tagħrif fil-pajjiżi li fihom jitqiegħdu fis-suq il-mediċini.
English: The CHMP agreed that Vascace should be used for the treatment of hypertension and chronic heart failure.
Maltese: Is-CHMP qabel li Vascace għandu jintuża għall-kura ta' pressjoni għolja u indeboliment kroniku talqalb.
English: The reduced blood pressure also helps patients with heart failure, because it is easier for the heart to pump out blood if the pressure in the blood vessels is not too high.
Maltese: Il-pressjoni tad-demm imnaqqsa tgħin ukoll lil pazjenti b'indeboliment tal-qalb, minħabba li huwa aktar faċli għall-qalb li tippompja d-demm jekk il-pressjoni fil-vini tad-demm ma tkunx għolja żżejjed.
English: Flexible PVC container holding 1.5, 2.0 or 2.5 litres.
Maltese: Reċipjent tal-PVC flessibbli li jżomm fih 1.5, 2.0 jew 2.5 litri.
English: • Do not store below 4°C.
Maltese: • Taħżinx f'temperatura taħt 4°C.
English: Type of connector(s)
Maltese: Tip ta' konnettur(i)
English: • Store in the original package.
Maltese: • Żommu fil-pakkett oriġinali.
English: DIANEAL PD4 6.3 Shelf life
Maltese: DIANEAL PD4
English: 12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only).
Maltese: 12-il xahar (għal prodott mediċinali manifatturat minn Alliston, Canada u North Cove USA biss) Ġaladarba il-prodott jitneħħa mill-pawċ ta' fuq, għandu jintuża minnufih.
English: Product configuration
Maltese: Konfigurazzjoni tal-Prodott
English: The date is stated on the carton label and on the bag after the abbreviation Exp. and the symbol .
Maltese: Id-data hija dikjarata fuq it tikketta tal-kartuna u fuq il-borża wara l-abbrevjazzjoni Exp. I s-simbolu .
English: units per box
Maltese: kull kaxxa
English: The Lineo connector contains iodine.
Maltese: Il-konnettur Lineo fih il-jodju.
English: The shelf life of the product as packaged for sale is 24 months 12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only).
Maltese: Iż-żmien ta' kemm jibqa' tajjeb il-prodott kif ippakkettjat għall-bejgħ hu ta' 24 xahar (12-il xahar biss għal prodott mediċinali manifatturat minn Alliston, Canada u North Cove, USA biss).
English: • Do not use EXTRANEAL after the expiry date.
Maltese: • Tużax EXTRANEAL wara d-data ta' skadenza li tidher fuq il-kartuna.
English: How to store EXTRANEAL
Maltese: Kif taħżen EXTRANEAL
English: Volume
Maltese: Anness
English: EXTRANEAL 6.3 Shelf Life
Maltese: • Armi EXTRANEAL kif ġejt istruwit
English: Amendments to be included in the relevant sections of the summary of product characteristics and package leaflets for Dianeal PD4 and Extraneal, as applicable.
Maltese: Emendi biex jiġu inkluzi fis-sezzjonijiet rilevanti tas-sommarju tal-karatteristiħi tal-prodott u fuljetti ta taghrif kif applikabbli.
English: The lineo connector that may equip the Y transfer line of the twin bag, contains 10.5% of Povidone iodine ointment
Maltese: Il-konnettur lineo li jista' jitqabbad mal-pajp ta' trasferiment Y tal-borża doppja, fih 10.
English: Summary of Product Characteristics
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: Changes are shown as greyed boxed wording
Maltese: Il-bidliet jidhru bhala kliem fil-kaxxa griza
English: Polymyxins are a group of naturally occurring antibiotics produced by the bacterium Paenibacillus polymyxa.
Maltese: Polymyxins huma grupp ta' antibijotiċi naturali li huma prodotti mill-batterju Paenibacillus polymyxa.
English: Two forms of colistin are used clinically: colistin sulphate and its microbiologically inactive prodrug, colistimethate sodium (CMS).
Maltese: Żewġ għamliet ta' colistin jintużaw klinikament: colistin sulphate u l-promediċina mikrobijoloġikament inattiva tiegħu, colistimethate sodium (CMS).
English: Only polymyxin E (referred to as colistin) is approved for clinical use in the EU.
Maltese: Polymyxin E (imsejjaħ colistin) biss huwa approvat għall-użu kliniku fl-UE.
English: Overall summary of the scientific evaluation of polymyxin-based products (see Annex A and Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' prodotti li fihom polymyxin (ara Anness A u Anness I)
English: Polymyxins are currently listed among the critically important antimicrobials and in view of the importance of ensuring the availability of efficacious and safe antibiotics in order to efficiently respond to the threat posed by the spread of antimicrobial resistance, the European Commission initiated a procedure under Article 31 of Directive 2001/83/EC on 16 September 2013, requesting the CHMP to give its opinion on the benefit-risk of polymyxin-based products and on the need for regulatory measures.
Maltese: Polymyxins bħalissa huma mniżżlin fost l-antimikrobiċi ferm importanti u fid-dawl tal-importanza li tiġi żgurata d-disponibbiltà ta' antibijotiċi effikaċi u siguri sabiex ikun hemm rispons effiċjenti għattheddida maħluqa mit-tixrid ta' reżistenza għal antimikrobiċi, il-Kummissjoni Ewropea bdiet proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE fis-16 ta' Settembru 2013, li titlob lis-CHMP biex jagħti lopinjoni tiegħu dwar il-benefiċċji/riskji ta' prodotti bbażati fuq polymyxin u l-ħtieġa għal miżuri regolatorji.