FrancophonIA/ELRC3.0 huggingface dataset:
English: Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a blue push button and the strength “500 mcg/0.5 mL” highlighted in blue on the label.
Maltese: Il-pinna mimlija għal-lest hi magħmula minn polypropylene abjad, b'buttuna tal-injezzjoni blu u l qawwa “500 mcg/0.
English: Titration phase
Maltese: Fażi ta' titrazzjoni
English: Ropeginterferon alfa-2b may inhibit the activity of CYP1A2 and CYP2D6 and thus may increase the blood concentrations of these medicinal products.
Maltese: Għalhekk, ropeginterferon alfa-2b jista' jimpedixxi l-attività ta' CYP1A2 u CYP2D6 u jżid il-konċentrazzjonijiet tad-demm f'dawn il-prodotti mediċinali.
English: Do not use Besremi if you are taking telbivudine (for treating hepatitis B) since the combination of these medicines increases the risk of peripheral neuropathy (numbness, tingling, or burning sensations in the arms and legs).
Maltese: M'għandekx tuża Besremi jekk qed tieħu telbivudine (għal trattament ta' epatite B) peress li l-kombinazzjoni ta' dawn il-mediċini żżid ir-riskju ta' newropatija periferali (tmewwit, tnemnim, jew sensazzjoni ta' ħruq fid-dirgħajn u r-riġlejn).
English: • If you have used your Besremi 500 microgram pre-filled pen once before, continue directly with step 7.
Maltese: • Jekk qatt użajt l-pinna mimlija għal-lest ta' Besremi 500 mikrogramma darba oħra, kompli direttament minn stadju 7.
English: The metabolism of ropeginterferon alfa-2b is not fully characterised.
Maltese: Il-metaboliżmu ta' ropeginterferon alfa-2b mhux ikkaraterizzat b'mod sħiħ.
English: Patient characteristics at screening in the PROUD-PV Study.
Maltese: Disturbi fil-fwied u fil-marrara:
English: It is not known if Besremi is present in breast milk.
Maltese: Aqrahom qabel ma tibda tuża Besremi.
English: Patients with pre-existing or a history of cardiovascular disorders should be closely monitored during ropeginterferon alfa-2b therapy.
Maltese: Pazjenti bi storja eżistenti minn qabel ta' disturbi kardjovaskulari għandhom jiġu monitorati mill-qrib wara terapija b'ropeginterferon alfa 2b.
English: Patients who develop this condition during treatment and cannot be controlled by medicinal products should discontinue ropeginterferon alfa-2b therapy.
Maltese: Pazjenti li jiżvillupaw din il-kundizzjoni waqt it-trattament u ma jistgħux jiġu kkontrollati bi prodotti mediċinali għandhom iwaqqfu t-terapija b'ropeginterferon alfa-2b.
English: Further information on Simponi can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/simponi.
Maltese: ema.europa.eu/en/medicines/human/EPAR/simponi.
English: This overview was last updated in 02-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'02-2019.
English: Simponi received a marketing authorisation valid throughout the EU on 1 October 2009.
Maltese: Simponi ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha flt-1 ta' Ottubru 2009.
English: Simponi is an anti-inflammatory medicine.
Maltese: Simponi huwa mediċina antiinfjammatorja.
English: Simponi contains the active substance golimumab.
Maltese: Simponi fih is-sustanza attiva golimumab.
English: The active substance in Simponi, golimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Simponi, il-golimumab, hija antikorp monoklonali.
English: The most serious side effects include serious infections, such as sepsis (blood infection), pneumonia (lung infection), tuberculosis and infections due to fungi or yeasts, demyelinating disorders (disorders suggesting damage to the protective sheath around nerves, such as changes to vision and weak arms or legs), re-activation of hepatitis B (a disease of the liver due to infection with the hepatitis B virus), congestive heart failure (a heart disease), lupus-like syndrome, blood reactions, severe allergic reactions, vasculitis (inflammation of the blood vessels), and lymphoma and leukaemia (types of cancer of the white blood cells).
Maltese: L-effetti sekondarji l-aktar serji jinkludu infezzjonijiet serji, bħas-sepsis (infezzjoni fid-demm), pulmonite (infezzjoni fil-pulmun), tuberkolożi u infezzjonijiet minħabba fungi jew ħmira, disturbi demjelinizzanti (disturbi li juru ħsara filkisja protettiva tan-nervituri, bħal bidliet fil-viżjoni u dirgħajn jew saqajn għajjenin), riattivazzjoni talepatite B (marda tal-fwiedminħabba infezzjoni bil-virus tal-epatite B), indeboliment konġestiv tal-qalb (mard tal-qalb), sindromu qisu lupus, reazzjonijiet tad-demm, reazzjonijiet allerġiċi gravi, vaskulite (infjammazzjoni tal-vini), u linfoma u lewkimja (tipi ta' kanċer taċ-ċelloli tad-demm bojod ).
English: Other information about Simponi
Maltese: Aktar informazzjoni dwar Simponi
English: Ankylosing spondylitis
Maltese: Spondilite ankilosanti
English: What are the risks associated with Simponi?
Maltese: X'inhuma r-riskji assoċjati ma' Simponi?
English: The second study, involving 1,228 patients, compared Simponi 50 or 100 mg with placebo as maintenance treatment.
Maltese: It-tieni studju, li fih ħadu sehem 1,228 pazjent, qabbel Simponi ta' 50 jew 100 mg mal-plaċebo bħala kura ta' manutenzjoni.
English: • axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including: - adults with severe active ankylosing spondylitis who have not responded adequately to other treatments; - adults with severe non-radiographic axial spondyloarthritis (when there are objective signs of inflammation but no abnormalities seen on x-ray) who have not responded adequately or are intolerant to anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs);
Maltese: - adulti bi spondiloartrite aksjali mhux radjografika gravi (meta jkun hemm sinjali oġġettivi ta' infjammazzjoni iżda l-ebda anormalità ma tidher fuq ir-raġġi x) li ma rrispondewx b'mod adegwat jew li huma intolleranti għall-mediċini antiinfjammatorji msejħa mediċini antiinfjammatorji nonsterojdali (NSAIDs);
English: Axial spondyloarthritis
Maltese: Spondiloartrite aksjali
English: In the second study, around 50% of patients receiving maintenance treatment with Simponi 100 mg and around 47% of those given Simponi 50 mg responded to treatment after 54 weeks, compared with around 31% of patients given placebo.
Maltese: Fit-tieni studju, madwar 50% tal-pazjenti li ngħataw il-kura ta' manutenzjoni b'Simponi ta' 100 mg u madwar 47% ta' dawk li ngħataw Simponi ta' 50 mg irrispondew għall-kura wara 54 ġimgħa, meta mqabbla ma' madwar 31% tal-pazjenti li ngħataw plaċebo.
English: Of these patients, 87% of (151 out of 173) had 30% reduction in the number and severity of symptoms after 16 weeks.
Maltese: Minn dawn il-pazjenti, 87% (151 minn 173) kellhom tnaqqis ta' 30% fin-numru u lgravità tas-sintomi wara 16-il ġimgħa.
English: In the third study, in patients who had not been previously treated with either methotrexate or another anti-TNF-α, after 24 weeks, 40% of patients (64 out of 159) who received Simponi with methotrexate achieved 50% reductions compared with 29% of patients (47 out of 160) who received placebo and methotrexate.
Maltese: TNF-, wara 24 ġimgħa, 40% tal-pazjenti (64 minn 159) li ngħataw Simponi bil-metotressat kellhom tnaqqis ta' 50% meta mqabbla mad-29% tal-pazjenti (47 minn 160) li ngħataw plaċebo u l-metotressat.
English: Of the patients who received Simponi, 59% (82 out of 138) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 22% of patients who were given placebo (17 out of 78).
Maltese: Mill-pazjenti li ngħataw Simponi, 59% (82 minn 138) kellhom tnaqqis ta' 20% fl-għadd u l-gravità tas-sintomi wara 14-il ġimgħa, meta mqabbla ma' 22% tal-pazjenti li ngħataw plaċebo (17 minn 78).
English: • moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut).
Maltese: • kolite ulċerattiva attiva minn moderata sa gravi (marda li tikkawża infjammazzjoni u ulċeri fir-rita tal-imsaren).
English: As for all medicines, data on the use of Simponi is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Simponi hija ssorveljata kontinwament.
English: Golimumab has been designed to attach to and block a substance in the body called tumour necrosis factor alpha (TNF-α).
Maltese: Il-golimumab tfasslet biex teħel ma' u biex timblokka sustanza fil-ġisem magħrufa bħala fattur alfa tan-nekrożi minn tumur (TNF-).
English: Of the patients who received Simponi, 71% (69 out of 97) had 20% reductions in the number and severity of symptoms after 16 weeks, compared with 40% of patients who were given placebo (40 out of 100).
Maltese: Mill-pazjenti li ngħataw Simponi, 71% (69 minn 97) kellhom tnaqqis ta' 20% flgħadd u l-gravità tas-sintomi wara 16-il ġimgħa, meta mqabbla ma' 40% tal-pazjenti li ngħataw plaċebo (40 minn 100).
English: • active rheumatoid arthritis (a disease causing inflammation of the joints).
Maltese: • artrite rewmatojde attiva (marda li tikkawża infjammazzjoni tal-ġogi).
English: In the second study, after 14 weeks, 35% of patients who received Simponi alone (54 out of 153) achieved 20% reductions in the number and severity of symptoms compared with 18% of patients who received placebo (28 out of 155).
Maltese: Fit-tieni studju, wara 14-il ġimgħa, 35% tal-pazjenti li ngħataw Simponi waħdu (54 minn 153) kellhom tnaqqis ta' 20% fl-għadd u l-gravità tas-sintomi meta mqabbla mat-18% tal-pazjenti li ngħataw il-plaċebo (28 minn 155).
English: For rheumatoid arthritis, Simponi was compared with placebo (a dummy treatment) in three studies involving 1,542 patients with moderate to severe rheumatoid arthritis, including patients who had not received or responded adequately to other treatments.
Maltese: Għall-artrite rewmatojde, Simponi tqabbel ma' plaċebo (kura finta) fi tliet studji li fihom ħadu sehem 1,542 pazjent b'artrite rewmatojde moderata sa gravi, inklużi pazjenti li ma ngħatawx jew ma kinux irrispondew b'mod adegwat għal kuri oħrajn.
English: The first study, involving 1,065 patients, compared different doses of Simponi with placebo as induction treatment.
Maltese: L-ewwel studju, li fih ħadu sehem 1,065 pazjent, qabbel dożi differenti ta' Simponi ma' plaċebo bħala kura ta' induzzjoni.
English: Why is Simponi authorised in the EU?
Maltese: Għaliex Simponi huwa awtorizzat fl-UE?
English: • active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Maltese: • artrite psorjatika attiva u progressiva (marda li tikkawża rqajja' ħomor, bil-qxur fuq il-ġilda u infjammazzjoni tal-ġogi).
English: Of the patients who received Simponi, 51% (74 out of 146) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 9% of patients who were given placebo (10 out of 113).
Maltese: Mill-pazjenti li ngħataw Simponi, 51% (74 minn 146) kellhom tnaqqis ta' 20% fl-għadd u l-gravità tas-sintomi wara 14-il ġimgħa, meta mqabbla ma' 9% tal-pazjenti li ngħataw plaċebo (10 minn 113).
English: In the first study, around 51% of patients receiving induction treatment with Simponi (starting at 200 mg) responded to treatment after 6 weeks, compared with around 30% of patients given placebo.
Maltese: Fl-ewwel studju, madwar 51% tal-pazjenti li ngħataw kura ta' induzzjoni b'Simponi (li bdiet b'200 mg) irrispondew għall-kura wara 6 ġimgħat, meta mqabbla ma' madwar 30% tal-pazjenti li ngħataw plaċebo.
English: • polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints).
Maltese: • artrite idjopatika ġuvenili poliartikulari (marda rari li tfeġġ fit-tfulija li tikkawża infjammazzjoni ta' ħafna ġogi).
English: Patients treated with Simponi must be given a reminder card that summarises the safety information about the medicine and when to seek medical advice.
Maltese: Il-pazjenti kkurati b'Simponi għandhom jingħataw karta ta' tfakkira li tiġbor fil-qosor l-informazzjoni dwar is-sikurezza tal-mediċina u meta għandhom ifittxu parir mediku.
English: What measures are being taken to ensure the safe and effective use of Simponi?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Simponi?
English: In the first study, in which patients were also given methotrexate, after 14 weeks, 55% patients who received Simponi (49 out of 89) achieved 20% reductions compared with 33% (44 out of 133) of patients who received placebo.
Maltese: Fl-ewwel studju, li fih il-pazjenti ngħataw ukoll il-metotressat, wara 14-il ġimgħa, 55% tal-pazjenti li ngħataw Simponi (49 minn 89) kellhom tnaqqis ta' 20% meta mqabbla ma' 33% (44 minn 133) talpazjenti li ngħataw il-plaċebo.
English: For polyarticular juvenile idiopathic arthritis, 173 patients between 2 and 18 years old who had not responded adequately to treatment with methotrexate were treated for 12 weeks with Simponi and methotrexate.
Maltese: Għall-artrite idjopatika ġuvenili poliartikulari, 173 pazjent bejn is-sentejn u t-18-il sena li ma kinux irrispondew b'mod adegwat għall-kura b'metotressat ġew ikkurati għal 12-il ġimgħa b'Simponi u metotressat.
English: Simponi is used in combination with methotrexate.
Maltese: Simponi jintuża flimkien mal-metotressat.
English: For non-radiographic axial spondyloarthritis, Simponi was compared with placebo over 16 weeks in one main study involving 198 patients who had the disease without evidence of ankylosing spondylitis but with signs of inflammation and who had not responded adequately to treatment with NSAIDs.
Maltese: Għall-ispondiloartrite aksjali mhux radjografika, Simponi tqabbel ma' plaċebo fuq medda ta' 16-il ġimgħa fi studju ewlieni minnhom li fih ħadu sehem 198 pazjent li kellhom il-marda mingħajr evidenza tal-ispondilite ankilosanti iżda bis-sinjali ta' infjammazzjoni u li ma kinux irrispondew b'mod adegwat għall-kura bl-NSAIDs.
English: For psoriatic arthritis, Simponi was compared with placebo over 24 weeks in one main study involving 405 patients who had not responded adequately to other treatments.
Maltese: Għall-artrite psorjatika, Simponi tqabbel ma' plaċebo fuq medda ta' 24 ġimgħa fi studju ewlieni li fih ħadu sehem 405 pazjenti li ma kinux irrispondew b'mod adegwat għal kuri oħrajn.
English: Polyarticular juvenile idiopathic arthritis
Maltese: Artrite idjopatika ġuvenili poliartikulata
English: Side effects reported with Simponi are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Simponi huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' struttura speċifika (imsejħa antiġen) li tinsab fil-ġisem.
English: For ankylosing spondylitis, Simponi was compared with placebo over 24 weeks in one main study involving 356 patients who had not responded adequately to other treatments.
Maltese: Għall-ispondilite ankilosanti, Simponi tqabbel ma' plaċebo fuq medda ta' 24 ġimgħa fi studju ewlieni li fih ħadu sehem 356 pazjent li ma kinux irrispondew b'mod adegwat għal kuri oħrajn.
English: This was assessed after 6 weeks in the first study and after 54 weeks in the second study.
Maltese: Dan ġie vvalutat wara 6 ġimgħat fl-ewwel studju u wara 54 ġimgħa fit-tieni studju.
English: It is available as a prolongedrelease suspension for injection in pre-filled syringes (25, 50, 75, 100 and 150 mg).
Maltese: Jiġi bħala sospensjoni ta' rilaxx fit-tul għat-tilqima f'siringi mimlijin minn qabel (25, 50, 75, 100 and 150 mg).
English: The most frequently reported side effects are insomnia (difficulty sleeping), headache, anxiety, upper respiratory tract infection (colds), reactions at the site of injection, parkinsonism (neurological symptoms including tremor and impaired muscular control), increased weight, akathisia (restlessness), agitation, somnolence (sleepiness), nausea, constipation, dizziness, muscle and bone pain, tachycardia (rapid heartbeat), tremor (shaking), abdominal pain (stomach ache), vomiting diarrhoea, fatigue (tiredness) and dystonia (involuntary muscle contractions).
Maltese: L-effetti sekondarji rrapurtati l-aktar ta' spiss huma insonnja (diffikultà fl-irqad), uġigħ ta' ras, ansjetà, infezzjoni fil-passaġġ respiratorju fin-naħa ta' fuq (irjiħat), reazzjonijiet fis-sit tal-injezzjoni, parkinsoniżmu (sintomi newroloġiċi inklużi rogħda u indeboliment tal-kontroll muskolari), żieda fil-piż, akathisia (nuqqas ta' sabar), aġitazzjoni, ħedla, nawżja, stitikezza, sturdament, uġigħ fil-muskoli u flgħadam, takikardja (taħdbit il-qalb mgħaġġel), rogħda, uġigħ addominali (uġigħ fl-istonku), remettar dijarrea, għeja and dystonia (ġbid involontarju tal-muskoli).
English: The full EPAR for Xeplion can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Xeplion jista' jinstab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The monthly maintenance dose is 75 mg.
Maltese: Id-doża ta' manutenzjoni kull xahar hija 75 mg.
English: The active substance in Xeplion, paliperidone, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Xeplion, il-paliperidone, hija mediċina antipsikotika.
English: This is a summary of the European public assessment report (EPAR) for Xeplion.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Xeplion.
English: Four of the studies, involving 1,774 adults with schizophrenia, compared Xeplion with placebo (a dummy treatment).
Maltese: Erba' mill-istudji, li jinvolvu 1,774 adult bl-iskizofrenija, qabblu Xeplion bi plaċebo (tratatment finta).
English: One of the studies, involving 410 adults, compared Xeplion with placebo.
Maltese: Wieħed mill-istudji, li jinvolvi 410 adulti, qabbel Xeplion mal-plaċebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xeplion on 4 March 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Xeplion valida fl-Unjoni Ewropea kollha fl-4 ta' Marzu 2007.
English: What is the risk associated with Xeplion?
Maltese: X'inhu r-riskju assoċjat ma' Xeplion?
English: Why has Xeplion been approved?
Maltese: Għaliex ġie approvat Xeplion?
English: Xeplion is a medicine that contains the active substance paliperidone.
Maltese: Xeplion huwa mediċina li fiha s-sustanza attiva paliperidone.
English: What is Xeplion?
Maltese: X'inhu Xeplion?
English: (day 1) followed by 100 mg on day 8.
Maltese: Iż-żewġ injezzjonijiet inizjali huma 150 mg fl-ewwel ġurnata segwita minn 100 mg fit-8 ġurnata.
English: Paliperidone acts mainly by blocking receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia.
Maltese: Il-paliperidone jaġixxi prinċipalment billi jimblokka lir-riċetturi għannewrotrażmettituri dopamina u 5-hydroxytryptamine (imsejjaħ ukoll serotonin), li huma involuti fliskizofrenija.
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Maltese: Il-paliperidone huwa prodott tat-tkissir (metabolit) attiv tar-risperidone, mediċina antipsikotika oħra li ilha tintuża fit-trattament tal-iskizofrenija mis-snin disgħin.
English: The second study, involving 749 adults, compared Xeplion with risperidone long-acting injection (taken with oral risperidone supplements) and looked at the change in the patients' symptoms.
Maltese: It-tieni studju, li jinvolvi 749 adult, qabbel Xeplion mal-injezzjoni li taħdem fit-tul tar-risperidone (meħuda ma' supplimenti tar-risperidone tal-ħalq) u ħares lejn il-bidla fis-sintomi tal-pazjenti.
English: The injections on days 1 and 8 are into the upper part of the shoulder (deltoid muscle), while the maintenance doses can be given in the buttocks or the deltoid muscle.
Maltese: L-injezzjonijiet fl-1 u t-8 ġurnata jingħataw fil-parti ta' fuq tal-ispalla (ilmuskolu deltojdu), filwaqt li d-dożi ta' manutenzjoni jistgħu jingħataw fil-warrani jew il-muskolu deltojdu.
English: The CHMP noted that the studies comparing Xeplion with placebo and risperidone showed that the medicine is beneficial to patients with schizophrenia.
Maltese: Is-CHMP innota li l-istudji li jqabblu Xeplion mal-placebo u r-risperidone juru li l-mediċina hija ta benefiċċju għal pazjenti bl-iskizofrenija.
English: How has Xeplion been studied?
Maltese: Kif ġie studjat Xeplion?
English: Of these, akathisia and somnolence appear to be related to the dose.
Maltese: Minn dawn, akathisia u ħedla jidhru relatati mad-doża.
English: Two studies, involving 1,178 patients, compared Xeplion with risperidone long-acting injection (taken with oral risperidone supplements).
Maltese: Żewġ studji, li jinvolvu 1,178 pazjent, qabblu Xeplion blinjezzjoni li taħdem fit-tul tar-risperidone (meħuda b'supplimenti tar-risperidone tal-ħalq).
English: Because the medicine is a prolonged release suspension, it also has the advantage of being given at monthly intervals.
Maltese: Peress li l-mediċina hija sospensjoni ta' rilaxx fit-tul, għandha wkoll il-vantaġġ li tingħata f'intervalli ta' kull xahar.
English: Xeplion is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with paliperidone or risperidone.
Maltese: Xeplion jintuża għat-trattament ta' manutenzjoni tal-iskizofrenija fl-adulti li l-marda tagħhom diġà ġiet stabbli bi trattament bil-paliperidone jew ir-risperidone.
English: Implementation of the agreement by the Member States (submission of the variation type IB by the Marketing Authorisation Holder):
Maltese: Implimentazzjoni tal-ftehim mill-Istati Membri (sottomissjoni tal-varjazzjoni tat-tip IB midDetentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq):
English: 16 October 2015
Maltese: 16 ta' Ottubru 2015
English: May 2015 CMDh meeting
Maltese: Laqgħa tas-CMDh ta' Mejju 2015
English: Adoption of CMDh agreement:
Maltese: Adozzjoni tal-ftehim tas-CMDh:
English: 17 June 2015
Maltese: 17 ta' Ġunju 2015
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Maltese: Trażmissjoni lill-Awtoritajiet Nazzjonali Kompetenti tat-traduzzjonijiet tal-annessi għallftehim:
English: It is available as tablets (50 mg/850 mg and 50 mg/1,000 mg).
Maltese: Jiġi bħala pilloli (50 mg/850 mg u 50 mg/1,000 mg).
English: Vildagliptin / metformin hydrochloride
Maltese: Vildagliptin/metformina kloridrat
English: The full EPAR for Eucreas can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Eucreas jinsab fuq is-sit elettroniku tal-Aġenzija website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Doses of vildagliptin above 100 mg are not recommended.
Maltese: Mhumiex rakkomandati dożi ogħla minn 100 mg vildagliptin.
English: This is a summary of the European public assessment report (EPAR) for Eucreas.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Eucreas.
English: Patients adding vildagliptin had falls in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%.
Maltese: Il-pazjenti li żiedu l-vildagliptin kellhom tnaqqis fil-livelli ta' HbA1c ta' 0.88% punti perċentwali wara 24 ġimgħa minn livell tal-bidu li kien 8.38%.
English: Eucreas is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Maltese: Eucreas huwa mediċina li fiha s-sustanzi attivi vildagliptin u metformina kloridrat (metformin hydrochloride).
English: The European Commission granted a marketing authorisation valid throughout the EU for Eucreas on 14 November 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Eucreas fl-14 ta' Novembru 2007.