FrancophonIA/ELRC3.0 huggingface dataset:
English: - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
Maltese: Actos jista jintuża waħdu f'pazjenti li ma jistgħux jieħdu metformin, u fejn trattament ma' dieta u eżercizzju naqas milli jikkontrolla z-zokkor fid-demm jew jista' jittieħed flimkien ma'terapiji oħra (bħal metformin, sulphonylurea jew insulina) li naqsu milli jipprovdu kontroll biżżejjed taz-zokkor fid-demm.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Maltese: Fi studju ta' sentejn b'terapija kombinata li qabbel pioglitazone ma' gliclazide meta miżjuda ma' metformin, il-kontroll gliċemiku mkejjel bħala it-tibdil medju mill-linja bażika ta' HbA1c kien simili bejn il-gruppi ta' kura wara l-ewwel sena.
English: 4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Maltese: Twettqet analiżi ta' tagħrif miġbur ta' rapporti ta' effetti mhux mixtieqa ta' fratturi fl-għadam minn provi kliniċi randomised, ikkontrollati b'paragun, u double blind b'aktar minn 8100 pazjent fil-gruppi kkurati b'pioglitazone u 7400 pazjent fil-gruppi kkurrati bi prodott paragun li damu sa 3.5 snin.
English: A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Maltese: Prova klinika ta' pioglitazone vs. gliclazide bħala monterapija ġiet estiża għal sentejn sabiex jiġi studjat il-ħin sal-falliment tal-kura (definit bħala d-dehra ta' HbA1c ≥ 8.0% wara l-ewwel sitt xhur ta' terapija).
English: The safety and efficacy of Actos in children and adolescents under 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Actos fit-tfal u adolexxenti taħt l-eta' ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Hepatic impairment Pioglitazone should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Maltese: Indeboliment epatiku Pioglitazone m'għandux jintuża f'pazjenti b'indeboliment epatiku (ara sezzjoni 4.3 u 4.4).
English: HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Maltese: HOMA juri li pioglitazone itejjeb il-funzjoni taċ-ċellola beta kif ukoll iżid is-sensittività għall-insulina.
English: EU/1/00/150/011 14 tablets EU/1/00/150/012 28 tablets EU/1/00/150/022 30 tablets EU/1/00/150/013 50 tablets EU/1/00/150/014 56 tablets EU/1/00/150/023 84 tablets EU/1/00/150/024 90 tablets EU/1/00/150/015 98 tablets EU/1/00/150/029 112 tablets EU/1/00/150/030 196 tablets
Maltese: EU/1/00/150/011 14-il pillola EU/1/00/150/012 28 pillola EU/1/00/150/022 30 pillola EU/1/00/150/013 50 pillola EU/1/00/150/014 56 pillola EU/1/00/150/023 84 pillola EU/1/00/150/024 90 pillola EU/1/00/150/015 98 pillola EU/1/00/150/029 112 pillola EU/1/00/150/030 196 pillola
English: Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Maltese: Terapija b'pioglitazone m'għandiex tinbeda f'pazjenti b'livelli miżjuda ta' l-enżimi tal-fwied fil-linja bażika (ALT > 2.5 x l-għola limitu tan-normal) jew b'xi evidenza oħra ta' mard tal-fwied.
English: EU/1/00/150/001 EU/1/00/150/002 EU/1/00/150/003 EU/1/00/150/004 EU/1/00/150/005 EU/1/00/150/006 EU/1/00/150/007 EU/1/00/150/008 EU/1/00/150/009 EU/1/00/150/010 EU/1/00/150/011 EU/1/00/150/012 EU/1/00/150/013 EU/1/00/150/014
Maltese: EU/1/00/150/001 EU/1/00/150/002 EU/1/00/150/003 EU/1/00/150/004
English: EU/1/00/150/008 14 tablets EU/1/00/150/004 28 tablets EU/1/00/150/019 30 tablets EU/1/00/150/005 50 tablets EU/1/00/150/010 56 tablets EU/1/00/150/020 84 tablets EU/1/00/150/021 90 tablets EU/1/00/150/006 98 tablets EU/1/00/150/027 112 tablets EU/1/00/150/028 196 tablets
Maltese: EU/1/00/150/008 14-il pillola EU/1/00/150/004 28 pillola EU/1/00/150/019 30 pillola EU/1/00/150/005 50 pillola EU/1/00/150/010 56 pillola EU/1/00/150/020 84 pillola EU/1/00/150/021 90 pillola EU/1/00/150/006 98 pillola EU/1/00/150/027 112 pillola EU/1/00/150/028 196 pillola
English: Actos 45 mg tablets pioglitazone
Maltese: IL-PRODOTT MEDIĊINALI Actos 45 mg pilloli pioglitazone
English: In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Maltese: Fi PROactive, studju dwar l-effett kardjovaskulari, 5238 pazjent b'dijabete mellitus tat-tip 2 u b'mard makrovaskulari maġġur li kien hemm minn qabel kienu randomised għal pioglitazone jew plaċebo li kienu miżjuda ma' terapija anti-dijabetika u kardjovaskulari eżistenti, sa 3.5 snin.
English: Each Actos 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola Actos 45 mg fiha 45 mg ta' pioglitazone (bħala hydrochloride).
English: Actos 30 mg tablets pioglitazone
Maltese: IL-PRODOTT MEDIĊINALI Actos 30 mg pilloli pioglitazone
English: EU/1/00/150/007 14 tablets EU/1/00/150/001 28 tablets EU/1/00/150/016 30 tablets EU/1/00/150/002 50 tablets EU/1/00/150/009 56 tablets EU/1/00/150/017 84 tablets EU/1/00/150/018 90 tablets EU/1/00/150/003 98 tablets EU/1/00/150/025 112 tablets EU/1/00/150/026 196 tablets
Maltese: EU/1/00/150/007 14-il pillola EU/1/00/150/001 28 pillola EU/1/00/150/016 30 pillola EU/1/00/150/002 50 pillola EU/1/00/150/009 56 pillola EU/1/00/150/017 84 pillola EU/1/00/150/018 90 pillola EU/1/00/150/003 98 pillola EU/1/00/150/025 112 pillola EU/1/00/150/026 196 pillola
English: − Actos 30 mg tablets are white to off-white, round, flat tablets marked ‘30' on one face and
Maltese: - Actos 30 mg huma pilloli bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b'‘30' fuq naħa waħda u b'‘ACTOS' fuq in-naħa l-oħra.
English: Each Actos 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola Actos 30 mg fiha 30 mg ta' pioglitazone (bħala hydrochloride).
English: Musculoskeletal and connective tissue disorders fracture bone4
Maltese: Disturbi muskoluskeletrali u tattessuti konnettivi ksur ta' għadam4
English: Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily.
Maltese: Trattament ta' Pioglitazone jista' jinbeda b'15 mg jew 30 mg darba kuljum.
English: In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Maltese: Fil-biċċa l-kbira tal-provi kliniċi, kienu osservati tnaqqis fit-triġliċeridi totali fil-plażma u fil-fatty acids ħielsa, u żieda fil-livelli ta' HDL-kolesterol meta mqabbel mal-plaċebo, b'żiediet żgħar, iżda klinikament rilevanti fil-livelli ta' LDL-kolesterol.
English: common common common common common arthralgia common common common back pain common
Maltese: komuni komuni komuni komuni komuni artralġja komuni komuni komuni uġigħ fid-dar komuni
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Maltese: Rapporti ta' wara t-tqegħid fis-suq ta' żvilupp jew irkadar ta' edima makulari dijabetika bi tnaqqis fl-akutezza viżiva ġew irrappurtati b' thiazolidinediones, inkluż pioglitazone.
English: You can usually continue to take other medicines whilst you are being treated with Actos.
Maltese: Kellem lit-tabib tiegħek qabel ma twaqqaf dan it-trattament.
English: Actos 15 mg tablets pioglitazone
Maltese: IL-PRODOTT MEDIĊINALI Actos 15 mg pilloli pioglitazone
English: In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Maltese: Fid-dawl ta' riskji potenzjali marbuta ma' terapija fit-tul, it-tobba għandhom jikkonfermaw f'evalwazzjonijiet ta' rutina sussegwenti li l-benefiċċju ta' pioglitazone hu mmantenut (ara sezzjoni 4.4).
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Maltese: Fi studji tossikoloġiċi, l-espansjoni tal-volum tal-plażma permeżz ta' emodiluzzjoni, anemija u ipertrofija kardijaka eċċentrika riversibbli kienet apparenti b'mod konsistenti wara dożaġġ ripetut fil-ġrieden, firien, klieb u xadini.
English: Each Actos 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola Actos 15 mg fiha 15 mg ta' pioglitazone (bħala hydrochloride).
English: − Actos 45 mg tablets are white to off-white, round, flat tablets marked ‘45' on one face and
Maltese: - Actos 45 mg huma pilloli bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b'‘45' fuq naħa waħda u b'‘ACTOS' fuq in-naħa l-oħra.
English: Eli Lilly Nederland B.V. Tel: +31 (0) 30 60 25 800
Maltese: Tel: + 31 (0) 30 60 25 800
English: These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Maltese: Dawn is-sejbiet kienu osservati fi speċi differenti b'konċentrazzjonijiet fil-plażma  4 darbiet l-espożizzjoni klinika.
English: It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately.
Maltese: Huwa mediċina anti-dijabetika wżata biex tikkura dijabete mellitus tat-tip 2 (mhux dipendenti mill-insulina) fl-adulti, meta metformin ma jkunx xieraq jew ikun naqas li jaħdem b'mod adegwat.
English: − The active substance in Actos is pioglitazone.
Maltese: X'fih Actos - Is-sustanza attiva ta' Actos hi pioglitazone.
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Takeda Belgium Tél/Tel:
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Maltese: Għalkemm l-istudju falla fil-mira primarja tiegħu, li kienet magħmula mill-kawżi kollha ta' mortalità, infart mijokariku mhux fatali, puplesija, sindromu koronarju akut, amputazzjoni maġġura tas-sieq, rivaskularizzazzjoni koronarja u rivaskularizzazzjoni tas-sieq, ir-riżultati ssuġġerixxu li m'hemmx periklu kardjovaskulari dwar l-użu ta' pioglitazone fit-tul.
English: Others
Maltese: Tqala
English: Τηλ: +45 46 77 11 11
Maltese: Takeda Pharma A/S Τηλ: +45 46 77 11 11
English: Environmental Risk Assessment (ERA): No environmental impact is anticipated from the clinical use of pioglitazone.
Maltese: L-ebda impatt ambjentali ma huwa antiċipat mill-użu kliniku ta' pioglitazone.
English: Gastrointestinal disorders flatulence uncommon common
Maltese: Disturbi gastrointestinali
English: Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Maltese: Pioglitazone huwa indikat ukoll għall-użu flimkien ma' insulina f'pazjenti adulti b'dijabete mellitus tat-tip 2 b'kontroll gliċemiku insuffiċjenti bl-insulina u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza (ara sezzjoni 4.4).
English: Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni filpassaġġ respiratorju ta' fuq komuni komuni komuni komuni komuni bronkite komuni sinusite mhux komuni mhux komuni mhux komuni mhux komuni mhux komuni
English: In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included insulin.
Maltese: Fi studju dwar ir-riżultat f'pazjenti b'mard makrovaskulari maġġuri minn qabel, l-inċidenza ta' insuffiċjenza serja tal-qalb kienet 1.6% għola b'pioglitazone milli bil-plaċebo, meta miżjud ma' terapija li tinkludi insulina.
English: Your doctor will check whether Actos is working 3 to 6 months after you start taking it.
Maltese: It-tabib tiegħek ser jiċċekkja jekk Actos qed jaħdem 3 sa 6 xhur wara li tibda tieħdu.
English: In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥ 65 years compared with those less than 65 years (9.7% compared to 4.0%).
Maltese: F'dan l-istudju f'pazjenti li qed jirċievu pioglitazone u l-insulina, kien osservat persentaġġ ogħla ta' pazjenti b'insuffiċjenza tal-qalb f'pazjenti li għandhom ≥ 65 sena meta mqabbla ma'dawk iżgħar minn 65 sena (9.7% meta mqabbla ma'4.0%).
English: EU/1/00/150/015 EU/1/00/150/016 EU/1/00/150/017 EU/1/00/150/018 EU/1/00/150/019 EU/1/00/150/020 EU/1/00/150/021 EU/1/00/150/022 EU/1/00/150/023 EU/1/00/150/024 EU/1/00/150/025 EU/1/00/150/026 EU/1/00/150/027 EU/1/00/150/028 EU/1/00/150/029 EU/1/00/150/030
Maltese: EU/1/00/150/016 EU/1/00/150/017 EU/1/00/150/018 EU/1/00/150/019 EU/1/00/150/020
English: Adverse reaction Frequency of adverse reactions of pioglitazone by treatment regimen
Maltese: Frekwenza ta' effetti mhux mixtieqa ta' pioglitazone b'regimen ta' trattament
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8)
Maltese: Sorveljanza mill-viċin tal-kontroll gliċemiku għandha tiġi kkunsidrata (ara sezzjoni 4.4).
English: When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Maltese: Meta l-attività, konċetrazzjonijiet u twaħħil mal-proteini jittieħdu f'konsiderazzjoni, pioglitazone u l-metabolita
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Maltese: Disturbi fissistema nervuża ipoesteżija komuni komuni komuni komuni komuni uġigħ ta' ras komuni mhux komuni sturdament komuni insonnja mhux komuni mhux komuni mhux komuni mhux komuni mhux komuni
English: As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.
Maltese: Bħala konsegwenza ta' żieda fis-sensittività għall-insulina, pazjenti li qed jirċievu pioglitazone f'terapija mill-ħalq doppja jew trippla ma' mediċina tat-tip sulphonylurea jew f'terapija doppja mal-insulina jistgħu jkunu f'riskju ta' ipogliċemija relatat mad-doża, u tista' tkun neċessarja tnaqqis fid-doża tal-mediċina tat-tip sulphonylurea jew tal-insulina.
English: When Actos is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Maltese: Meta Actos jittieħdu flimkien ma' mediċini oħra wżati għall-kura tad-dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it-tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal-mediċini tiegħek.
English: Foetal growth restriction was apparent in animal studies with pioglitazone.
Maltese: Restrizzjoni fit-tkabbir tal-fetu kienet apparenti fi studji fl-annimali b'pioglitazone.
English: After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Maltese: Wara l-esklużjoni ta' pazjenti fejn l-espożizzjoni għall-mediċina tal-istudju kien ta' inqas minn sena fiż-żmien id-dijanjosi tal-kanċer tal-bużżieqa tal-awrina, kien hemm 7 każijiet (0.06%) fuq pioglitazone u 2 każijiet (0.02%) fil-gruppi ikkontrollati.
English: As a consequence, the conditions or restrictions with regards to the safe and effective use of the medicinal product should be updated to remove the additional risk minimisation measures.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Maltese: komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - infezzjoni respiratorja - vista mhux normali - żieda fil-piż - tirżiħ mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) - sinusite - insonnja mhux maghrufa (frekwenza ma tistax tiġi stmata mid-dejta disponibbli) - żieda fl-enżimi tal-fwied - reazzjonijiet allerġiċi
English: The RMP has been updated in accordance.
Maltese: L-RMP ġie aġġornat f'konformità ma' dan.
English: The tablets are white to off-white, round, convex and marked ‘15' on one face and ‘ACTOS' on the other face.
Maltese: Il-pilloli huma bojod għal abjad maħmuġ, tondi, bbużżati miż-żewġ naħat u mmarkati b'‘15' fuq naħa waħda u b'‘ACTOS' fuq in-naħa l-oħra.
English: Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment (risks include age, smoking history, exposure to some occupational or chemotherapy agents e.g. cyclophosphamide or prior radiation treatment in the pelvic region).
Maltese: Fatturi ta' riskju għal kanċer tal-bużżieqa għandha tiġi evalwata qabel ma tinbeda kura b'pioglitazone (ir-riskji jinkludu l-età, l-istorja tat-tipjip, l-espożizzjoni għal xi aġenti okkupazzjonali jew kimoterapija eż. cyclophosphamide jew qabel it-trattament tar-radjazzjoni fir-reġjun pelviku).
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Maltese: It-tabib tiegħek jista' jżid id-doża sa massimu ta' 45 mg darba kuljum.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali, mod ta' amministrazzjoni u applikanti fl-Istati Membri
English: Dexamed 5 mg comprimidos 5 mg
Maltese: Dexamed 5 mg comprimidos
English: Capsule
Maltese: Kapsula
English: S C Biofarm S A
Maltese: Biofarm S A
English: Hungaro-Gal Gyógyszergyártó Kft
Maltese: Hungaro-Gal Gyógyszergyártó
English: Capsule, Hard
Maltese: Kapsula, Iebsa
English: Tablets
Maltese: Tablet
English: S.C. Zentiva S.A.
Maltese: Zentiva S.A.
English: S.F.
Maltese: S.C.
English: Suppository
Maltese: Suppożitorju
English: Noraminophenazoni Fono Vii.
Maltese: Noraminophenazoni Fono Vii. Naturland
English: Meditop Pharmaceutical Co. Ltd.
Maltese: Meditop Pharmaceutical Co.
English: Aramis Pharma Kft
Maltese: Aramis Pharma
English: Oral
Maltese: Orali
English: Pharma Gmbh Metagelan
Maltese: G.L. Pharma Gmbh Metagelan
English: G.L.
Maltese: Ltd.
English: Abc Farmaceutici S.P.A. Metamizolo Sodico Abc Metamizole Sodium 500mg/ml
Maltese: Metamizolo Sodico Abc Metamizole Sodium 500mg/ml
English: Pharma Gmbh Metamilan
Maltese: G.L. Pharma Gmbh Metamilan
English: Melting Tablets
Maltese: Pillola Miksija
English: Aristo Pharma Iberia, S.L.
Maltese: Iberia, S.L.
English: Sanofi-Aventis Zrt
Maltese: Sanofi-Aventis
English: Powder For Oral Solution In Sachet
Maltese: Trab Għal Soluzzjoni Orali
English: Laboratorio Stada, S.L.
Maltese: Laboratorio Stada, S.L. Metamizol Stada
English: 8 March 2018 EMA/155367/2018
Maltese: EMA/134289/2018
English: Evidence indicates risk of serious inflammatory brain disorders
Maltese: L-evidenza tindika riskju ta' disturbi tal-moħħ infjammatorji serji
English: Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Maltese: Zinbryta ġie awtorizzat fl-2016 għall-kura ta' forom rikaduti ta' sklerożi multipla.
English: To date EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis.
Maltese: S'issa, il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-EMA irreveda 12-il każ ta' disturbi infjammatorji medjati mill-immunità, inkluż enċefalite.
English: These could be signs of a reaction to Zinbryta.
Maltese: Dawn jistgħu jkunu sinjali ta' reazzjoni għal Zinbryta.
English: The review of Zinbryta was initiated following a request from the European Commission on 26 February 2018, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni ta' Zinbryta nbdiet fuq talba mill-Kummissjoni Ewropea fis-26 ta' Frar 2018, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: On 6 March 2018, the European Medicines Agency (EMA) recommended the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMA) rrakkomandat is-sospensjoni immedjata u l-ġbir lura talmediċina tal-isklerożi multipla Zinbryta (daclizumab beta) wara 12-il rapport ta' disturbi tal-moħħ infjammatorji serji, inkluż enċefalite u meningoenċefalite.
English: • Patients stopping treatment should be monitored at least monthly and more frequently as clinically indicated for up to 6 months after the last dose of Zinbryta.
Maltese: • Il-pazjenti li jwaqqfu l-kura għandhom jiġu mmonitorjati tal-inqas kull xahar u b'mod aktar frekwenti kif indikat klinikament sa 6 xhur wara l-aħħar doża ta' Zinbryta.
English: Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis.
Maltese: Evidenza disponibbli tindika wkoll li Zinbryta jista' jkun marbut ma' disturbi oħrajn medjati millimmunità, bħal diskrażiji tad-demm, tirojdite jew glomerulonefrite.
English: A previous PRAC review in 2017 found that unpredictable and potentially fatal immune-mediated liver injury can occur with Zinbryta for up to 6 months after stopping treatment and concluded that patients stopping treatment should be followed up.
Maltese: Reviżjoni preċedenti tal-PRAC fl-2017 sabet li tista' sseħħ ħsara fil-fwied medjata mill-immunità mhux prevista u potenzjalment fatali b'Zinbryta sa 6 xhur wara li titwaqqaf il-kura u kkonkludiet li l-pazjenti li jwaqqfu l-kura għandhom jiġu segwiti.
English: • Do not take another injection of Zinbryta.
Maltese: • Tibdiex xi pazjent ġdid fuq Zinbryta.