FrancophonIA/ELRC3.0 huggingface dataset:
English: Fablyn has been shown to reduce fractures in the spine and elsewhere in the body, but not in the hip.
Maltese: Fablyn ġie muri li jnaqqas ksur fix-xewka tad-dahar u f'partijiet oħra tal-ġisem, iżda mhux tal-ġenbejn.
English: The company that makes Fablyn will make sure that an educational programme is available in all Member States for all healthcare workers who will prescribe Fablyn or order pelvic ultrasound scans for women taking the medicine.
Maltese: L-effetti ta' Fablyn għall-ewwel ġew ittestjati f'mudelli esperimentali qabel ma' ġew studjati filbniedem.
English: Fablyn is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women (women who have been through the menopause).
Maltese: Fablyn jintuża fil-kura u l-prevenzjoni tal-osteoporożi (marda li tagħmel l-għadam fraġli) f'nisa li għaddew mill-menopawża (meta n-nisa kienu fil-menopawża).
English: What is the risk associated with Fablyn?
Maltese: Għal xiex jintuża Fablyn?
English: For the full list of all side effects reported with Fablyn, see the package leaflet.
Maltese: Għal lista sħiħa tal-effetti sekondarji rappuratati tal-Fablyn, ara l-fuljett ta' tagħrif.
English: The programme will include information about the risk of venous thromboembolism, changes in the womb that may occur when taking the medicine, and the need to investigate unexplained bleeding from the womb.
Maltese: Il-programm ser jinkludi informazzjoni dwar ir-riskju ta' tromboemboliżmu fil-vini, tibdil fil-ġuf li jista' jiġri meta tittieħed il-mediċina u l-ħtieġa li jiġu investigati tnixxijiet ta' demm mill-ġuf bla spjegazzjoni.
English: Lasofoxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Maltese: Illasofoksifina taġixxi bħala 'agonista' tar-riċettur tal-estroġenu (sustanza li tistimula r-riċettur għal estroġenu) f'xi tessuti fil-ġisem.
English: The most common side effect with Fablyn (seen in more than 1 patient in 10) is muscle cramps.
Maltese: L-iktar effett sekondarju komuni b'Fablyn (li deher f'iktar minn pazjent 1 minn kull 10) huwa lbugħawwieġ.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Maltese: Losteoporożi hija aktar komuni fin-nisa li għaddew mill-menopawża, meta l-livelli tal-ormoni tan-nisa, lestroġeni, jonqsu: l-estroġenu jnaqqas ir-ritmu li bih jitkisser l-għadam u jagħmel l-għadam inqas suxxettibbli għall-ksur.
English: When deciding whether to prescribe Fablyn or other treatments, doctors should consider whether the patient has any symptoms of the menopause, and the possible effects of treatment on the womb, the breast, and the heart and blood vessels.
Maltese: Meta jiddeċiedu dwar jekk jippreskrivux Fablyn jew trattamenti oħrajn, it-tobba għandhom jikkunsidraw jekk il-pazjenta għandhiex sintomi tal-menopawża, u l-effetti possibbli tat-trattament fuq il-ġuf, is-sider u l-qalb u l-vini u l-arterji.
English: What measures are being taken to ensure the safe use of Fablyn?
Maltese: X'miżuri qegħdin jitteħdu biex jassiguraw l-użu sigur ta' Fablyn?
English: The CHMP decided that Fablyn's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: A. Goštauto g. 40A, LT-01112 Vilnius, LITHUANIA
Maltese: Goštauto g. 40A, LT-01112 Vilnius, LITHUANIA
English: Stonemasons Way, Rathfarnham, Dublin 16
Maltese: Stonemasons Way, Rathfarnham, Dublin 16 IRELAND
English: A-1140 Wien AUSTRIA
Maltese: A-1140
English: GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 80339 München GERMANY
Maltese: KG, Theresienhöhe 11 80339 München GERMANY
English: Granules for Suspension
Maltese: Granijiet għal Suspensjoni
English: GlaxoSmithKline S.p.A.Via A. Fleming, 237135 Verona ITALY
Maltese: Fleming, 237135 Verona ITALY
English: SI-1000 Ljubljana SLOVENIA
Maltese: Ljubljana SLOVENIA
English: Austria
Maltese: Wien AUSTRIA
English: Granules
Maltese: Cefuroxima
English: 125mg Film-coated Tablet
Maltese: Zinnat 125 mg 125mg Film-coated Tablet
English: Zinnat 250 mg
Maltese: Oraxim 250 mg
English: Cefuroxima Allen 250 mg comprimidos recubiertos con película EFG
Maltese: Allen 250 mg comprimidos recubiertos con película EFG
English: Cefuroxima Allen 500 mg comprimidos recubiertos con película EFG
Maltese: Allen 500 mg comprimidos recubiertos con película EFG
English: Zinnat 250 mg apvalkotās tabletes 250mg Film-coated Tablets
Maltese: Zinnat 250 mg apvalkotās tabletes
English: Sweden
Maltese: SPAIN
English: Oraxim
Maltese: Granijiet
English: Zinnat 500 mg
Maltese: 500mg
English: Zinnat 500 mg apvalkotās tabletes 500mg Film-coated Tablets
Maltese: Zinnat 500 mg apvalkotās tabletes
English: 1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Maltese: 1 L-Artikolu 31 tad-Direttiva 2001/83/KE kif emendata, referenza skont interess tal-Komunità.
English: Ref. EMA/562492/2010 Rev. EMEA/H/A-31/968
Maltese: EMEA/H/A-31/968
English: London, 14 June 2010 Doc.
Maltese: Londra, 14 ta' Ġunju 2010
English: Medicines containing dextropropoxyphene on its own are authorised in 10 Member States (Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden) and medicines containing dextropropoxyphene combined with paracetamol (sometimes with caffeine) are authorised in six Member States (Belgium, Cyprus, France, Luxembourg, Malta and Portugal) as well as Norway.
Maltese: Mediċini li fihom dextropropoxyphene waħdu huma awtorizzati f'10 Stati Membri (il-Belġju, idDanimarka, il-Finlandja, Franza, il-Greċja, l-Italja, il-Lussemburgu, l-Olanda, Spanja u l-Isvezja) u mediċini li fihom dextropropoxyphene flimkien ma' paracetamol (kultant mal-kafeina) huma awtorizzati f'sitt Stati Membri (il-Belġju, Ċipru, Franza, il-Lussemburgu, Malta u l-Portugall) kif ukoll fin-Norveġja.
English: What is dextropropoxyphene?
Maltese: X'inhu dextropropoxyphene?
English: The review was carried out under an ‘Article 31' referral1.
Maltese: Ir-reviżjoni saret taħt referenza skont ‘l-Artikolu 31'1.
English: In light of differences between Member States in terms of the number of fatal overdoses reported, the Committee also sought data from other sources available in Member States, including case reports of fatal overdose, data from poison centres, data from coroners' services, hospital statistics, national mortality statistics, and toxicology data from forensic services, from both published and unpublished research.
Maltese: Fid-dawl ta' differenzi bejn Stati Membri fit-termini ta' dożi eċċessivi fatali rrapportati, il-Kumitat fittex ukol dejta minn sorsi oħrajn disponibbli fl-Istati Membri, inklużi rapporti ta' każijiet ta' doża eċċessiva fatali, dejta minn ċentri tal-valeni, dejta minn servizzi ta' coroners, statistiċi minn spartijiet, statistiċi nazzjonali ta' mortalità, u dejta tossikoloġika minn servizzi forensiċi, kemm minn riċensjoni ppubblikata kif ukoll mhux ippubblikata.
English: It has been available as a prescription-only medicine for about 40 years, both on its own and in combination, as tablets, capsules, suppositories and solutions for injection.
Maltese: Ilu disponibbli bħala mediċina li tingħata b'riċetta biss għal madwar 40 sena, kemm waħdu kif ukoll f'kombinazzjoni, bħala pilloli, kapsuli, suppożitorji u soluzzjonijiet għal injezzjoni.
English: Proposed activities to reduce this risk, such as including further warnings or restrictions, or limiting the size of packs, were not considered to be adequate to protect public health.
Maltese: Attivitajiet proposti għat-tnaqqis tar-riskju, bħażżieda ta' aktar twissijiet jew restrizzjonijiet, jew l-illimitar tad-daqs tal-pakketti, ma kinux ikkunsidrati adegwati għall-protezzjoni tas-saħħa pubblika.
English: On 21 October 2009, the Committee confirmed its original recommendation that the marketing authorisations for the non-parenteral (tablets, capsules and suppositories) forms of dextropropoxyphene-containing medicines should be withdrawn.
Maltese: Fil-21 ta' Ottubru 2009, il-Kumitat ikkonferma r-rakkomandazzjoni tiegħu li l-awtorizzazzjonijiet għat-tqegħid fis-suq għall-forom mhux parentali (pilloli, kapsuli u suppożitorji) ta' mediċini li fihom dextropropoxyphene għandhom ikunu irtirati.
English: The available evidence suggests that the combination of dextropropoxyphene and paracetamol is no more effective than paracetamol on its own, or ibuprofen, for short-term pain.
Maltese: L-evidenza disponibbli tissuġġerixxi li l-kombinazzjoni ta' dextropropoxyphene u paracetamol mhijiex aktar effettiva minn paracetamol waħdu, jew ibuprofen, għal uġigħ għal żmien qasir.
English: The CHMP also concluded that data from several Member States, specifically those from forensic centres and national mortality statistics, showed a significant number of deaths associated with overdose in patients taking dextropropoxyphene.
Maltese: Is-CHMP ikkonkluda wkoll li dejta minn diversi Stati Membri, speċifikament dawk minn ċentri forensiċi u statistika nazzjonali tal-mortalità, urew numru sinifikanti ta' mwiet assoċjati ma' doża eċċessiva f'pazjenti li jieħdu dextropropoxyphene.
English: On 25 June 2009, the European Medicines Agency completed a review of the safety and effectiveness of dextropropoxyphene-containing medicines.
Maltese: Fil-25 ta' Ġunju 2009, l-Aġenzija Ewropea għall-Mediċini lestiet reviżjoni tas-sigurtà u l-effikaċja ta' mediċini li fihom dextropropoxyphene.
English: What were the conclusions of CHMP after the initial review?
Maltese: X'kienu l-konklużjonijiet tas-CHMP wara r-reviżjoni inizjali?
English: In November 2007, the European Commission asked the CHMP to carry out a full assessment of the benefit-risk balance of combination products containing dextropropoxyphene and paracetamol and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Maltese: F'Novembru 2007, il-Kummissjoni Ewropea tablet lis-CHMP sabiex iwettaq valutazzjoni sħiħa talbilanċ benefiċċju-riskju għall-prodotti ta' kombinazzjoni li fihom dextropropoxyphene u paracetamol u sabiex joħroġ opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għal dawn il-mediċini għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati madwar l-UE.
English: Because of this, a number of Member States have carried out safety reviews of this combination, but these have led to different conclusions.
Maltese: Minħabba dan, numru ta' Stati Membri wettqu reviżjonijiet tas-sigurtà ta' din il-kombinazzjoni, imma dawn wasslu għal konklużjonijiet differenti.
English: For long-term pain, the Committee noted that there is no evidence that dextropropoxyphene and paracetamol is more effective than alternative painkillers.
Maltese: Għal uġigħ għal tul ta' żmien twil, il-Kumitat innota li ma hemmx evidenza li dextropropoxyphene u paracetamol huma aktar effettivi minn mediċini alternattivi kontra l-uġigħ.
English: Which data has the CHMP reviewed?
Maltese: Liema dejta rreveda s-CHMP?
English: The full extent of the risks of dextropropoxyphene-containing medicine only became apparent when looking at complete forensic data and national mortality statistics, including toxicology data.
Maltese: Il-firxa sħiħa tar-riskji tal-mediċini li fihom dextropropoxyphene saru jidhru biss meta ngħatat ħarsa lejn data forensika sħiħa u l-istatistika nazzjoniali tal-mortalità, inkluża dejta tattossikoloġija.
English: The CHMP noted that safety was less of a concern for the parenteral form, because these medicines are only given in a hospital setting where there is a lower risk of overdose.
Maltese: Is-CHMP innota li s-sigurtà kienet ta' inqas tħassib fil-forma parentali, minħabba li l-mediċini jingħataw biss fl-ambjnet ta' sptarijiet fejn hemm riskju iżgħar ta' doża eċċessiva.
English: The Committee acknowledged that it is important that patients continue to receive adequate pain relief, and that it is necessary to allow for those who currently take dextropropoxyphene-containing medicines to be transferred to alternative treatments.
Maltese: Il-Kumitat irrikonoxxa li kien importanti li l-pazjenti jkomplu jirċievu serħan mill-uġigħ xieraq, u li huwa meħtieġ li jkun permess li min bħalissa qed jieħu mediċini li fihom dextropropoxyphene jiġi ttrasferit għal trattamenti alternattivi.
English: The Committee also reviewed data from published literature including analyses comparing the results of different studies (meta-analyses) in short-term pain relief.
Maltese: IlKumitat irreveda wkoll dejta minn riċensjoni ppubblikata inklużi analiżi li jqabblu r-riżultati ta' studji differenti (meta-analiżi) fi tnaqqis tal-uġigħ fuq żmien qasir.
English: • Prescribers should be aware that the availability of dextropropoxyphene-containing medicines will decrease as the withdrawal takes place according to national timeframes.
Maltese: • Min jippreskrivi għandu jkun konxju li d-disponibbilità tal-mediċini li fihom dextropropoxyphene sejra tonqos meta jseħħ l-irtirar skont il-qafas ta' żmien nazzjonali.
English: The CHMP therefore recommended that the marketing authorisations for the parenteral form of dextropropoxyphene-containing medicines be suspended until further data are available to show that the benefits outweigh the risks.
Maltese: Is-CHMP għalhekk irrikmanda li lawtorizzazzjonijiet għat-tqegħid fis-suq għall-forma parentali tal-mediċini li fihom dextropropoxyphene ikunu sospiżi sakemm tkun disponibbli aktar data sabiex turi li l-benefiċċji huma akbar mir-riskji.
English: The CHMP concluded that the available data showed that dextropropoxyphene-containing medicines were weak painkillers, and only have limited effectiveness in the treatment of pain.
Maltese: Is-CHMP ikkonkluda li d-dejta disponibbli uriet li l-mediċini li fihom dextropropoxyphene kienu mediċini ħfief kontra l-uġigħ, u kellhom effikaċja limitata biss fil-kura tal-uġigħ.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of dextropropoxyphene do not outweigh its risks, and recommended that all marketing authorisations for dextropropoxyphene-containing medicines should be withdrawn throughout the European Union (EU).
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-benefiċċji ta' dextropropoxyphene mhumiex akbar mir-riskji, u rrakkomanda li l-awtorizzazzjonijiet għat-tqegħid fis-suq kollha għall-mediċini li fihom dextropropoxyphene għandhom jiġu rtirati minn madwar l-Unjoni Ewropea (UE).
English: In the United Kingdom and Sweden, the marketing authorisations for these medicines were withdrawn from 2005.
Maltese: Fir-Renju Unit u fl-Isvezja, l-awtorizzazzjonijiet għat-tqegħid fis-suq għal dawn il-mediċini ġew irtirati mill-2005.
English: It is a weak opioid (opioids are medicines related to morphine) that relieves pain by acting on receptors in the brain and spinal cord.
Maltese: Huwa opjojde ħafif (l-opjojdi huma mediċini relatati malmorfina) li jnaqqas l-uġigħ billi jaħdem fuq riċetturi fil-moħħ u fil-korda spinali.
English: Dextropropoxyphene is a painkiller that is used to treat short- and long-term (chronic) pain.
Maltese: Dextropropoxyphene huwa prodott mediċinali kontra l-uġigħ li jintuża għall-kura ta' uġigħ għal żmien qasir u għal tul ta' żmien twil (kroniku).
English: Why was dextropropoxyphene reviewed?
Maltese: Għalxiex ġie rivedut dextropropoxyphene?
English: • Prescribers should carefully consider the best alternative treatments for patients currently taking dextropropoxyphene-containing medicines in line with national recommendations.
Maltese: • Min jippreskrivi l-mediċini għandu jikkunsidra bir-reqqa l-aħjar kura alternattiva għall-pazjenti li bħalissa qed jieħdu mediċini li fihom dextropropoxyphene skont ir-rakkomandazzjonijiet nazzjonali.
English: However, for the parenteral form (solution for injection), the CHMP recommended that the marketing authorisations be suspended until further data are available.
Maltese: Madankollu, għall-forma parentali (soluzzjoni għal injezzjoni), is-CHMP irrakkomanda li l-awtorizzazzjonijiet għat-tqegħid fis-suq għandhom jiġu sospiżi sakemm tkun disponibbli aktar data.
English: The CHMP noted that data from case reports of fatal overdose and from national poison centres underestimate the number of deaths from overdose with dextropropoxyphene-containing medicines.
Maltese: Is-CHMP għall-ewwel irreveda dejta ppreżentata mill-kumpaniji li jqiegħdu fis-suq mediċini li fihom dextropropoxyphene, li pprovdiet informazzjoni dwar l-effikaċja u s-sigurtà tal-mediċini tagħhom.
English: During the re-examination, the CHMP looked again at the data it had previously received, taking into consideration the different forms of dextropropoxyphene-containing medicines.
Maltese: Waqt l-eżaminazzjoni mill-ġdid, is-CHMP ħares mill-ġdid lejn id-dejta li kien irċieva qabel, u kkunsidra l-forom differenti tal-mediċini li fihom dextropropoxyphene.
English: EMA/283978/2014 EMEA/H/C/306
Maltese: EMA/283978/2014
English: The full EPAR for Metalyse 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 contains the active substance tenecteplase.
Maltese: Fih is-sustanza attiva tenecteplase.
English: Other information about Metalyse:
Maltese: Informazzjoni oħra dwar Metalyse:
English: This summary was last updated in 05-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 05-2014.
English: This document is a summary of the European Public Assessment Report (EPAR) for Metalyse.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Metalyse.
English: The most common bleedings (seen in between 1 and 10 patients in 100) are epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), ecchymosis (bleeding beneath the skin), urogenital haemorrhage (bleeding from the structures that carry urine or from the genital area), bleeding at the injection site, and bleeding at puncture site.
Maltese: L-emorraġiji l-aktar komuni (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma epistassi (fġir), emorraġija gastrointestinali (fsada flistonku jew il-musrana), ekkimożi (fsada taħt il-ġilda), emorraġija uroġenitali (fsada mill-istrutturi li jġorru l-awrina jew miż-żona ġenitali), fsada fis-sit tal-injezzjoni, u fsada fis-sit tat-titqib.
English: Around 94% of patients who received either medicine were alive 30 days after treatment.
Maltese: Madwar 94% tal-pazjenti li ngħataw waħda mill-mediċini baqgħu ħajjin 30 jum wara l-kura.
English: Tenecteplase is made by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Maltese: Tenecteplase huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': isir minn ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċih.
English: Metalyse was compared with alteplase (another medicine used to treat heart attacks) in one main study involving about 17,000 adults who were having a heart attack.
Maltese: Metalyse tqabbel ma' alteplase (mediċina oħra użata biex tikkura l-attakki tal-qalb) fi studju ewlieni wieħed li involva madwar 17,000 adult li kellhom attakk tal-qalb.
English: It works by converting a protein in the clots called plasminogen into its active form, plasmin, which breaks down the fibrous protein holding the clot together.
Maltese: Jaħdem billi jikkonverti proteina fl-emboli msejħa plasiminogen fil-forma attiva tagħha, plasmin, li tkisser il-proteina fibruża li żżomm l-embolu magħqud.
English: The active substance in Metalyse, tenecteplase, is a modified copy of the human enzyme ‘tissue plasminogen activator', which the body uses to break down clots.
Maltese: Is-sustanza attiva f'Metalyse, tenecteplase, hija kopja modifikata tal-enzima tal-bniedem ‘attivatur talplasminogen tal-bniedem', li l-ġisem juża biex ikisser l-emboli tad-demm.
English: What is Metalyse?
Maltese: X'inhu Metalyse?
English: Metalyse is given once as a single injection into a vein over around 10 seconds.
Maltese: Metalyse jingħata darba bħala injezzjoni unika ġo vina fuq madwar 10 sekondi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Metalyse on 23 February 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal Metalyse fit-23 ta' Frar 2001.
English: Metalyse is used to treat adults suspected of having an acute myocardial infarction (heart attack) within six hours of the first symptoms appearing.
Maltese: Metalyse jintuża biex jikkura l-adulti li huma suspettati li għandhom infart mijokardijaku akut (attakk tal-qalb) fi żmien sitt sigħat mid-dehra tal-ewwel sintomi.
English: Metalyse is a powder and a solvent that are made up into a solution for injection.
Maltese: Metalyse huwa trab u solvent li huma prodotti f'soluzzjoni għall-injezzjoni.
English: Metalyse should not be used in people who have had an anaphylactic reaction (a severe, lifethreatening allergic reaction) to tenecteplase, gentamicin (an ingredient found in the medicine) or any of the other ingredients.
Maltese: Metalyse ma għandux jintuża f'nies li kellhom reazzjoni anafilattika (reazzjoni allerġika severa ta' periklu għall-ħajja) għal tenecteplase, gentamicin (sustanza li tinstab fil-mediċina) jew għal xi sustanzi oħra.
English: For the full list of all side effects reported with Metalyse, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Metalyse, ara l-fuljett ta' tagħrif.
English: The most common side effect with Metalyse was haemorrhage (bleeding).
Maltese: L-effett sekondarju l-aktar komuni b'Metalyse kienet emorraġija (fsada).
English: What is the risk associated with Metalyse?
Maltese: Għal xiex jintuża Metalyse?
English: Based on this and all other available data, the Committee decided that Metalyse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Abbażi ta' dan u d-dejta l-oħra kollha disponibbli, il-Kumitat iddeċieda li Metalyse għandu iktar benefiċċji milli riskji u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Metalyse should not be used in patients who have or have had recent bleeding problems or major surgery, or have a disease which may cause bleeding (such as a past stroke or severe high blood pressure).
Maltese: Metalyse ma għandux jintuża f'pazjenti li għandhom jew li kellhom problemi ta' fsada jew kirurġija ewlenija, jew għandhom marda li tista' tikkawża fsada (bħal puplesija fil-passat jew pressjoni tad-demm għolja severa).
English: What benefit has Metalyse shown during the studies?
Maltese: Liema benefiċċju wera Metalyse waqt l-istudji li twettqu?
English: The Marketing Authorisation Holder (MAH) shall ensure, prior to the distribution of the product to a particular Healthcare Establishment, that all surgeons and other healthcare professionals involved in the handling and administration of ChondroCelect or its components, as well as those involved in follow-up of patients treated with ChondroCelect in the Healthcare Establishment, receive training as per the educational programme described in the Risk Management Plan.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jassigura, qabel ma jqassam ilprodott fi stabbiliment tal-kura tas-saħħa partikolari, li l-kirurgi kollha u l-professjonisti oħra talqasam tas-saħħa involuti fil-ġestjoni u l-amministrazzjoni ta' ChondroCelect jew il-komponenti tiegħu, kif ukoll dawk involuti fis-segwitu tal-pazjenti li jkunu ġew ikkurati b'ChondroCelect flistabbiliment tal-kura tas-saħħa, jirċievu taħriġ skont il-programm edukattiv imsemmi fil-Pjan ta' Ġestjoni tar-Riskji.
English: • The implantation procedure by knee-joint arthrotomy
Maltese: • Il-proċedura tal-impjant permezz tal-artrotomija tal-ġogi tal-irkoppa