FrancophonIA/ELRC3.0 huggingface dataset:
English: Gluscan 500 can be used: - in cancer medicine to help detect the location of tumours, as cancer cells use a lot of energy and will absorb more fluodeoxyglucose than non-cancerous cells; - in cardiac medicine to help locate areas of the heart that are not taking up as much glucose as expected because of ischaemia (reduced blood supply); - in neurology to detect specific areas within the brain of epileptic patients before surgery; - and to locate areas of the body where there are abnormally high numbers of white blood cells (such as the sites of deep-seated infections or inflammation).
Maltese: Gluscan 500 jista' jintuża: - fl-onkoloġija biex jgħin fil-kxif tal-post fejn qiegħed it-tumur, minħabba li ċ-ċelloli tal-kanċer jużaw ħafna enerġija u jassorbu aktar fluwodeossiglukożju miċ-ċelloli b'saħħithom; - fil-kardjoloġija biex jgħin biex jinstabu iż-żoni tal-qalb li mhumiex qegħdin jieħdu biżżejjed glukożju daqs kemm hu mistenni minħabba l-iskemija (provvista tad-demm imnaqqsa); - fin-newroloġija għal-lokalizzazzjoni ta' żoni speċifiċi fil-moħħ ta' pazjenti bl-epilessija qabel intervent kirurġiku; - u biex jinstabu ż-żoni tal-ġisem fejn hemm għadd abnormi kbir ta' ċelloli bojod tad-demm (bħas-siti ta' infezzjonijiet ħafna jew infjammazzjoni fil-fond).
English: Why was Gluscan 500 reviewed?
Maltese: Għaliex ġie rivedut Gluscan 500?
English: The grounds for the referral were concerns from the Spanish medicines regulatory agency that, while the use of fluodeoxyglucose (18F) with PET in the areas of cancer, cardiac and neurology medicine were well established, its use in the diagnosis of infectious and inflammatory conditions had not been shown to be sufficiently established in the European Union, and therefore the use of Gluscan 500 as a diagnostic radiopharmaceutical in the diagnosis of these conditions should not be authorised.
Maltese: Ir-raġunijiet għar-referenza kienu tħassib mill-aġenzija ta' regolamentazzjoni tal-mediċini Spanjola li, filwaqt li l-użu ta' fluwodeossiglukożju (18F) bil-PET fl-oqsma tal-onkoloġija, tal-kardjoloġija u tan newroloġija kienu stabbiliti sew, l-użu tiegħu fid-dijanjożi ta' kundizzjonijiet ta' infezzjoni u infjammazzjoni ma ntweriex li kien stabbilit biżżejjed fl-Unjoni Ewropea, u għalhekk l-użu ta' Gluscan 500 bħala radjufarmaċewtiku dijanjostiku fid-dijanjożi ta' dawn il-kundizzjonijiet ma għandux jiġi awtorizzat.
English: This is a procedure when one Member State (the ‘reference Member State', in this instance France) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance are Germany, Poland, Portugal and Spain)2.
Maltese: Din il-proċedura tiġi applikata meta Stat Membru (l-‘Istat Membru ta' referenza', f'dan il-każ Franza) jevalwa mediċina bil-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l‘Istati Membri kkonċernati', f'dan il-każ huma l-Ġermanja, il-Polonja, il-Portugall u Spanja)2.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Gluscan 500.
Maltese: L-Aġenzija Ewropea dwar il-Mediċini (EMEA) lestiet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea fir-rigward tal-awtorizzazzjoni tal-mediċina Gluscan 500.
English: London, 2 June 2009
Maltese: Londra, 2 ta' Ġunju 2009 Dok ta' ref.
English: Once in the cell, the radioactivity remains trapped, and can be seen on scans such as those obtained using a ‘PET' (positron emission tomography) scanner.
Maltese: Ladarba tkun fiċ-ċellola, ir-radjuattività tinqabad ġewwa, u tkun tidher fuq skans bħal dawk miksuba bl-użu ta' skanner ‘PET' (tomografija bl-emissjoni tal-positroni - positron emission tomography).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Gluscan 500 outweigh its risks, and the marketing authorisation can be granted in France and in the following Member States of the European Union Germany, Poland, Portugal and Spain.
Maltese: IlKumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li lbenefiċċji ta' Gluscan 500 huma akbar mir-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fi Franza u fl-Istati Membri tal-Unjoni Ewropea li ġejjin: il-Ġermanja, il-Polonja, ilPortugall u Spanja.
English: F) is already authorised via national procedures in the Czech Republic, Ireland and the
Maltese: F) huwa diġà awtorizzat permezz ta' proċeduri nazzjonali fir-Repubblika Ċeka, fl
English: However, the Member States were not able to reach an agreement and the French medicines regulatory agency referred the matter to the CHMP for arbitration on 30 January 2009.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal ftehim u l-aġenzija ta' regolamentazzjoni talmediċini Franċiża rreferiet il-kwistjoni lill-CHMP għall-arbitraġġ fit-30 ta' Jannar 2009.
English: MA (EU) Number
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: EU/1/08/502/001 Mepact
Maltese: EU/1/08/502/001
English: 1 vial + 1 filter
Maltese: 1 kunjett + 1 filtru
English: 4 mg Powder for concentrate for dispersion for infusion
Maltese: 4 mg Trab għal konċentrat għal dispersjoni għall-infużjoni.
English: Intravenous use vial (glass)
Maltese: Użu għal ġolvini kunjett (ħġieġ)
English: Pack size
Maltese: Mepact
English: EMA Procedure Number
Maltese: Numru tal-proċedura ta' l-EMA
English: Strength Pharmaceutical Form Route of administration
Maltese: Numru tal-MA Isem Qawwa Għamla farmaċewtika
English: Immediate Packaging
Maltese: Il-pakkett li jmiss mal-prodott Daqs talpakkett
English: Intravenous use, Subcutaneous use vial (glass)
Maltese: Użu għal ġol-vini, Użu għal taħt il-ġilda kunjett (ħġieġ)
English: Powder for solution for injection
Maltese: Trab għal soluzzjoni għall-injezzjoni
English: MA (EU) Numbers (Invented) name Strength
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 20 July 2011
Maltese: 20 ta' Lulju 2011
English: The active substance in Kytril, granisetron, is a ‘5HT3 antagonist'.
Maltese: Is-sustanza attiva fi Kytril, il-granisetron, hija ‘antagonist ta' 5HT3 ‘.
English: Kytril was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Kien identifikat li Kytril jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproki u Deċentralizzati - Umani (CMD(h)).
English: Kytril is an anti-emetic (a medicine that prevents nausea and vomiting).
Maltese: Kytril huwa antiemetiku (mediċina li tipprevjeni n-nawżja u d-dardir).
English: Questions and answers on Kytril and associated names (granisetron, 1 and 2 mg tablets, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml solution for injection) EMA/585560/2011
Maltese: Mistoqsijiet u tweġibiet dwar Kytril u l-ismijiet assoċjati (granisetron, pilloli ta' 1 u 2 mg, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml soluzzjoni għall-injezzjoni) EMA/660572/2011
English: Kytril solution for injection is given into a vein at a dose of 1-3 mg (10-40 g/kg) for the prevention and treatment of nausea and vomiting in adults.
Maltese: Is-soluzzjoni għall-injezzjoni ta' Kytril tingħata ġo vina f'doża ta' 1-3 mg (10-40 g/kg) għallprevenzjoni u l-kura tan-nawżja u tar-rimettar fl-adulti.
English: Questions and answers on Kytril and associated names (granisetron, 1 and 2 mg tablets, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml solution for injection)
Maltese: Mistoqsijiet u tweġibiet dwar Kytril u l-ismijiet assoċjati (granisetron, pilloli ta' 1 u 2 mg, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml soluzzjoni għall-injezzjoni)
English: What is Kytril?
Maltese: X'inhu Kytril?
English: Kytril is also available in the EU under the trade name Kevatril.
Maltese: Kytril huwa wkoll disponibbli fl-UE bl-isem kummerċjali Kevatril.
English: The European Medicines Agency has completed a review of Kytril.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Kytril.
English: Kytril is authorised in the EU via national procedures.
Maltese: Kytril huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Other sections harmonised by the CHMP include sections on special warnings, side effects and the medicines pharmacological properties.
Maltese: Sezzjonijiet oħra armonizzati mis-CHMP jinkludu s-sezzjonijiet dwar twissijiet speċjali, effetti sekondarji u l-karatteristiċi farmakoloġiċi tal-mediċina.
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Maltese: Meta 5HT jeħel ma' dawn ir-riċetturi, normalment jikkawża nawżja u rrimettar.
English: The CHMP recommended that Kytril tablets and solution for injection can be used in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy, and also for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Maltese: Is-CHMP irrakkomanda li l-pilloli u s-soluzzjoni għall-injezzjoni ta' Kytril jistgħu jintużaw fl-adulti għallprevenzjoni u l-kura tan-nawżja u tar-rimettar akuti assoċjati mal-kimoterapija u mar-radjuterapija, kif wkoll għall-prevenzjoni tan-nawżja u tar-rimettar ittardjati assoċjati mal-kimoterapija u marradjuterapija.
English: Why was Kytril reviewed?
Maltese: Għaliex ġie rivedut Kytril?
English: When used for treatment, further doses of the solution may be given at least 10 minutes apart, up to a maximum of 9 mg per 24 hours.
Maltese: Meta użat għall-kura, jistgħu jingħataw dożi ulterjuri tas-soluzzjoni mill-inqas 10 minuti ħin minn xulxin, sa massimu ta' 9 mg kull 24 siegħa. 4.3 Kontra-indikazzjonijiet
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the in the brain and the gut.
Maltese: Dan ifisser li twaqqaf lil kimika filġisem li tissejjaħ 5-hydroxytryptamine (5HT, magħrufa wkoll bħala serotonin) milli teħel ma' riċetturi ta' 5HT3 fil-moħħ u fl-imsaren.
English: On 3 June 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Kytril in the EU.
Maltese: Fit-3 ta' Ġunju 2010 l-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP biex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Kytril fl-UE.
English: It is used to prevent nausea and vomiting following treatments for cancer such as chemotherapy and radiotherapy.
Maltese: Jintuża għall-prevenzjoni ta' nawżja u rimettar wara l-għoti ta' trattamenti għall-kanċer bħall-kimoterapija u r-radjuterapija.
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 Kytril in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jeħtieġ li l-informazzjoni dwar il-preskrizzjoni għal Kytril tiġi armonizzata fl-Unjoni Ewropea (UE).
English: 25 (5 x 5) cartridges (multipack)
Maltese: 25 (5 x 5) skartoċċ (pakkett multiplu)
English: 5 (5 x 1) vials (multipack)
Maltese: 5 (5 x 1) kunjetti (pakkett multiplu)
English: 10 (2 x 5) prefilled pens (multipack)
Maltese: 10 (2 x 5) pinen mimlijin għal-lest (pakkett multiplu)
English: • Signs and symptoms of infection and sepsis
Maltese: • Sinjali u sintomi ta' infezzjoni u sepsis
English: • Enrolment in the PNH and aHUS registries
Maltese: • Reġistrazzjoni fir-reġistri PNH u aHUS
English: Drug distribution will only be possible after written confirmation that the patient has effectively received meningococcal vaccination and/or antibiotic prophylaxis.
Maltese: Id-distribuzzjoni tal-mediċina se tkun possibbli biss wara konferma bil-miktub li l-pazjent effettivament irċieva tilqima meningokokkali u/jew profilassi antibijotika.
English: • No clinical data on exposed pregnancies is available.
Maltese: • M'hemm l-ebda dejta klinika disponibbli dwar tqaliet esposti.
English: • The risk of developing antibodies to eculizumab
Maltese: • Ir-riskju li jiżviluppaw antikorpi għal eculizumab
English: The educational material should be agreed with the National Competent Authority and should contain the following:
Maltese: Il-materjal edukattiv għandu jiġi maqbul mal-Awtorità Kompetenti Nazzjonali u għandu jkun fih dawn li ġejjin:
English: • The importance of meningococcal vaccination prior to treatment and/or to receive antibiotic prophylaxis
Maltese: • L-importanza ta' tilqima meningokokkali qabel il-kura u/jew biex jirċievu profilassi antibijotika
English: • All patients must be monitored for signs of meningitidis
Maltese: • Il-pazjenti kollha għandhom jiġu mmonitorjati għal sinjali ta' meningitidis.
English: • Risk of severe thrombotic microangiopathic complications following eculizumab discontinuation and postponement of administration, its signs, symptoms, monitoring and management (aHUS only)
Maltese: • Riskju ta' kumplikazzjonijiet mikroanġjopatiċi trombotiċi severi wara t-twaqqif ta' eculizumab u d-differiment tal-għoti, is-sinjali u s-sintomi tiegħu, monitoraġġ u mmaniġġjar (aHUS biss)
English: • The requirement to vaccinate children against pneumococcus and haemophilus before eculizumab treatment
Maltese: • Il-ħtieġa li t-tfal jiġu mlaqqma kontra pneumococcus u haemophilus qabel il-kura b'eculizumab
English: • Risk of severe thrombotic microangiopathic complications (in aHUS) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
Maltese: • Riskju ta' kumplikazzjonijiet mikroanġjopatiċi trombotiċi severi (f'aHUS) wara t-twaqqif/differiment tal-għoti ta' eculizumab, is-sinjali u s-sintomi tagħhom u r-rakkomandazzjoni biex jikkonsultaw lil min jagħti r-riċetta qabel it-twaqqif/differiment tal-għoti ta' eculizumab
English: The MAH shall send annually to prescribers and pharmacists who prescribe/dispense eculizumab, a reminder about the need for (re)-vaccination against Neisseria meningitidis for patients on eculizumab.
Maltese: Il-professjonisti kollha liċenzjati fil-qasam tal-kura tas-saħħa li jistgħu jagħtu riċetta għal eculizumab jirċievu l-materjal edukattiv adattat.
English: • The need to explain to and ensure understanding of by patients/carers: o the risks of treatment with eculizumab o the signs and symptoms of sepsis/severe infection and what action to take o the patient's/carer's guides and their contents o the need to carry the patient safety card and to tell any healthcare practitioner that he/she is receiving treatment with eculizumab o the requirement for pre-treatment vaccinations/antibiotic prophylaxis o the enrolment in the registries
Maltese: • Il-ħtieġa li tispjega lil pazjenti/dawk li jieħdu ħsiebhom u li taċċerta ruħek li jkunu qed jifhmu dak li qed tispjagalhom: o ir-riskji tal-kura b'eculizumab o il-sinjali u sintomi ta' sepsis/infezzjoni severa u liema azzjoni għandha tittieħed o il-ħtieġa tal-gwidi għall-pazjent/persuna li tieħu ħsieb il-pazjent u l-kontenut tagħhom o il-ħtieġa li jżommu fuqhom il-kard tas-sigurtà tal-pazjent u biex jgħidu lil kwalunkwe professjonist fil-qasam tal-kura tas-saħħa li hu/hi qed jirċievu l-kura b'eculizumab o il-ħtieġa għal tilqim/profilassi antibijotika qabel il-kura o ir-reġistrazzjoni fir-reġistri
English: The MAH shall agree the details of a controlled drug distribution system and educational material including a patient safety card with each National CompetentAuthority and must implement such programmes nationally to ensure that:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jaqbel dwar id-dettalji ta' sistema ta' distribuzzjoni u materjal edukattiv ta' mediċina kkontrollata li tinkludi kard tas-sigurtà tal-pazjent ma' kull Awtorità Kompetenti Nazzjonali u jrid jimplimenta programmi bħal dawn b'mod nazzjonali biex jiżgura li:
English: • Treatment with eculizumab increases the risk of severe infection and sepsis, especially of Neisseria meningitidis
Maltese: • Il-kura b'eculizumab iżżid ir-riskju ta' infezzjoni severa u sepsis, b'mod speċjali ta' Neisseria meningitidis
English: • Signs and symptoms of severe infection and the need to obtain urgent medical care
Maltese: • Sinjali u sintomi ta' infezzjoni severa u l-ħtieġa li tikseb kura medika urġenti
English: • Risk of severe haemolysis (in PNH) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
Maltese: • Riskju ta' emolisi severa (f'PNH) wara t-twaqqif/differiment tal-għoti ta' eculizumab, is-sinjali u s-sintomi tagħhom u r-rakkomandazzjoni biex jikkonsultaw lil min jagħti r-riċetta qabel it-twaqqif/differiment tal-għoti ta' eculizumab
English: • The risk of infusion reactions with eculizumab, including anaphylaxis, and the need for clinical monitoring post-infusion
Maltese: • Ir-riskju ta' reazzjonijiet minħabba l-infużjoni b'eculizumab, li jinkludu anafilassi, u l-ħtieġa għal monitoraġġ kliniku wara l-infużjoni
English: • Patient's/carer's information brochures
Maltese: • Kard tas-sigurtà tal-pazjent
English: • Risk of serious haemolysis following eculizumab discontinuation and postponement of administration, its criteria, the required post-treatment monitoring and its proposed management (PNH only)
Maltese: • Riskju ta' emolisi serja wara t-twaqqif ta' eculizumab u d-differiment tal-għoti, il-kriterji tiegħu, il-monitoraġġ meħtieġ wara l-kura u l-immaniġġjar propost tiegħu (PNH biss)
English: • The need for patients to be vaccinated against Neisseria meningitidis two weeks prior to receiving eculizumab and/or to receive antibiotic prophylaxis
Maltese: • Il-ħtieġa li l-pazjenti jiġu mlaqqma kontra Neisseria meningitidis ġimagħtejn qabel ma jirċievu eculizumab u/jew biex jirċievu profilassi antibijotika
English: • Treatment with eculizumab increases the risk of severe infection, especially Neisseria meningitidis
Maltese: • Il-kura b'eculizumab iżżid ir-riskju ta' infezzjoni severa, b'mod speċjali ta' Neisseria meningitidis
English: It was to be available as tablets (15, 30 and 45 mg).
Maltese: Jiġi f'għamla ta' pilloli (15, 30 u 45 mg).
English: What is Pioglitazone ratiopharm?
Maltese: X'inhu Pioglitazone ratiopharm?
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm had been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP kkonkluda li, b'konformità mar-rekwiżiti tal-UE, intwera li Pioglitazone ratiopharm għandu kwalità komparabbli u huwa bijoekwivalenti għal Actos.
English: Pioglitazone ratiopharm is a medicine that contains the active substance pioglitazone.
Maltese: Pioglitazone ratiopharm huwa mediċina li fiha s-sustanza attiva pijoglitażonu.
English: The active substance in Pioglitazone ratiopharm, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Pioglitazone ratiopharm, il-pijoglitażonu, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratiopharm, for the treatment of type 2 diabetes.
Maltese: Fit-3 ta' Frar 2012, ratiopharm GmbH uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Pioglitazone ratiopharm, għat-trattament tad-dijabete tat-tip 2.
English: Because Pioglitazone ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Pioglitazone ratiopharm hija mediċina ġenerika, l-istudji f'pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Actos.
English: Pioglitazone ratiopharm was also to be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Maltese: Pioglitazone ratiopharm kellu jintuża' wkoll flimkien kemm mal-metaformina kif ukoll mas-sulfonilurea f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti minkejja terapija doppja mill-ħalq (‘terapija tripla').
English: Pioglitazone ratiopharm was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Maltese: Pioglitazone ratiopharm kellu jintuża wkoll flimkien mal-metformina f'pazjenti li ma jkunux jistgħu jiġu kkontrollati b'mod sodisfaċjenti meta tintuża l-metformina waħidha, jew bis-sulfonilurea (tip ieħor ta' mediċina antidiabetika) meta ma tkunx tista' tintuża l-metformina ('terapija doppja').
English: This means that Pioglitazone ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Pioglitazone ratiopharm ġie żviluppat bħala ‘mediċina ġenerika' Dan ifisser li Pioglitazone ratiopharm huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: How is Pioglitazone ratiopharm expected to work?
Maltese: Għal xiex kien mistenni jintuża Pioglitazone ratiopharm?
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Maltese: Id-dijabete tat-tip 2 hija marda li fiha l-frixa ma tipproduċix biżżejjed insulina biex tikkontrolla l-livell ta' glukożju fid-demm jew meta l-ġisem ma jkunx jista' juża l-insulina b'mod effikaċi.
English: Pioglitazone ratiopharm was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Maltese: Pioglitazone ratiopharm kellu jintuża waħdu f'pazjenti li ma jkunux jistgħu jieħdu l-metformina (mediċina antidijabetika oħra).
English: Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratiopharm for the treatment of type 2 diabetes.
Maltese: Għaldaqstant, fiż-żmien meta l-mediċina ġiet irtirata, is-CHMP kellu opinjoni favorevoli, u rrakkomanda li tingħata awtorizzazzjoni għat-tqegħid fissuq għal Pioglitazone ratiopharm għall-kura tad-dijabete tat-tip 2.
English: This summary was last updated in 01-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'01-2014.
English: Myozyme is an enzyme replacement therapy.
Maltese: Myozyme hu terapija enzimatika sostituttiva.
English: It contains the active substance alglucosidase alfa.
Maltese: Fih is-sustanza attiva alglucosidase alfa.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Myozyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Myozyme huwa disponibbli fissit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/Rare disease designations .
English: The European Commission granted a marketing authorisation valid throughout the European Union for Myozyme to Genzyme Europe B.V. on 29 March 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Myozyme lil Genzyme Europe B.V. fid-29 ta' Marzu 2006.