FrancophonIA/ELRC3.0 huggingface dataset:
English: Avonex Pen - after injection (prepared for disposal)
Maltese: Avonex Pen - wara l-injezzjoni (ippreparata għar-rimi)
English: Injecting yourself
Maltese: Tagħti l-injezzjoni
English: If you have severe depression or thoughts about suicide, you must not use Avonex.
Maltese: Jekk għandek depressjoni serja jew ħsibijiet ta´ suwiċidju, m'għandekx tuża Avonex.
English: Immune system disorders not known anaphylactic reaction, anaphylactic shock, hypersensitivity reactions (angioedema, dyspnoea, urticaria, rash, pruritic rash)
Maltese: Disturbi fis-sistema immuni mhux magħrufa reazzjoni anafilattika, xokk anafilattiku, ipersensittività (anġoedema, qtugħ ta' nifs, urtikarja, raxx, raxx bil-ħakk),
English: • Avonex is injected into a muscle, for example, the upper thigh muscle.
Maltese: • Avonex jiġi injettat ġo muskolu.
English: This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers.
Maltese: Din ir-rabta tagħti bidu għal ringiela komplessa ta' reazzjonijiet INTRAċELLILARI li jwasslu għall-produzzjoni ta' ħafna prodotti ġenetiċi indotti mill-interferon u indikaturi.
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 4.8, 5.1 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: Tell your doctor as they may be signs of a possible kidney problem.
Maltese: Sejjaħ tabib minnufiħ għax dawn jistgħu jkunu sinjali ta' problema possibli tal-fwied.
English: 4 Confirm injection delivery • Check the circular display window.
Maltese: • Ħares minn ġod-display window ovali.
English: • Do not re-use the Avonex Pen.
Maltese: • Terġax tuża l-Avonex Pen.
English: AVONEX can be stored at room temperature (between 15°C and 30°C) for up to one week.
Maltese: Avonex jista' jinħażen f'temperatura ta' l-ambjent (bejn 15°C u 30°C) sa ġimgħa.
English: 3 Extend the injector shield
Maltese: 3 Estendi l-protezzjoni tal-injettur
English: How to store AVONEX
Maltese: X'inhu AVONEX
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Maltese: Huwa rraportat li l-interferoni jnaqqsu l-attivita' ta' enżimi epatiċi li jiddependu fuq iċ-ċitokromju P450 kemm fil-bniedem kif ukoll fl-annimali.
English: You may get a needle injury.
Maltese: Tużahiex jekk tkun skadiet.
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Maltese: Ir-riskju ta' abort spontanju f'nisa tqal li huma esposti għal interferon beta ma jistax jiġi evalwat b'mod xieraq abbażi tad-dejta attwalment disponibbli, iżda d-dejta ma tissuġġerixxix riskju miżjud s'issa.
English: Experience with exposure during the second and third trimester is very limited.
Maltese: L-esperjenza b'esponiment waqt it-tieni u t-tielet trimestru hija limitata ħafna.
English: Once the pen is sealed there is no risk of injury.
Maltese: Ġaladarba l-pinna tkun issiġillata, m'hemm l ebda riskju ta' korriment.
English: Check the blister tray contains one pre-filled syringe and one injection needle (see picture “Contents of the plastic tray”).
Maltese: Iċċekkja li t-trej tal-plastik fiħ siringa waħda mimlija lesta u labra waħda għall-injezzjoni (ara l-istampa “Kontenut fit-trej tal-plastik”).
English: Disability progression was measured as an increase in the Expanded Disability Status Scale (EDSS) of 1.0 point, sustained for at least six months.
Maltese: Kienet ikkunsidrata bħala deterjorazzjoni fid-diżabilita' żieda ta' punt fl-EDSS (Expanded Disabilty Status Scale) li baqgħet għal ta' l-inqas sitt xhur.
English: Remove the syringe cap
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni
English: Liver problems
Maltese: Twissijiet u prekawzjonijiet
English: The small rectangular window area will disappear.
Maltese: Il-window rettangolari żgħira ser tisparixxi.
English: 5 Check the liquid
Maltese: Iċċekkja l-likwidu
English: Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended.
Maltese: Għalhekk jekk il-karatteristiċi kliniċi ta 'TMA huma osservati, aktar ittestjar tal-livelli tal-plejtlits fid-demm, LDH serum, films tad-demm u funzjoni renali hu rakkomandat.
English: These are the side effects that people reported when Avonex was being tested.
Maltese: Dawn huma l-effetti sekondarji li n-nies irrappurtaw meta Avonex kien qed jiġi studjat.
English: The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX PEN).
Maltese: L-istruzzjonijiet dwar kif tinjetta lilek innifsek jinsabu fl-aħħar ta' dan il-fuljett (ara sezzjoni 7, Kif tinjetta bl-Avonex Pen tiegħek).
English: Caution should be exercised when AVONEX is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. some classes of antiepileptics and antidepressants.
Maltese: Jinħtieġ kawtela meta AVONEX jingħata flimkien ma' prodotti mediċinali oħra li għandhom indiċi terapewtiku dejjaq u li jiddependu fil-parti l-kbira fuq is-sistema epatika taċ-ċitokromju P450 sabiex jitneħħew mill-ġisem, per eżempju ċerti klassijiet ta' anti-epilettiċi u anti-depressivi.
English: Very common side effects (may affect more than 1 in 10 people) - Flu-like symptoms - headache, muscle aches, chills or a fever: see Flu-like symptoms - Headache.
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw iktar minn pazjent f'kull 10 pazjenti) sintomi jixbħu lill-influwenza - uġigħ ta' ras, uġigħ fil-muskoli, tkexkix ta´ bard jew deni: ara Sintomi jixbħu lill-influwenza, taħt uġigħ ta' ras.
English: A large amount of data (more than 1000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy.
Maltese: Ammont kbir ta' dejta (iktar minn 1000 riżultat ta' tqala) minn reġistri u esperjenza ta' wara t-tqegħid fis-suq ma jindika l-ebda riskju miżjud ta' anomaliji konġenitali maġġuri wara esponiment qabel ilkonċepiment għal interferon beta jew tali esponiment fl-ewwel trimestru tat-tqala.
English: Impairment of Fertility: Fertility and developmental studies in rhesus monkeys have been carried out with a related form of interferon beta-1a.
Maltese: Avvenimenti ġew irrapportati f'diversi punti ta' żmien, anki sa diversi snin wara l-bidu tal-kura b'interferon beta.
English: Tablet 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets
Maltese: Pillola 14-il pillola 28 pillola 30 pillola 50 pillola 56 pillola 84 pillola 90 pillola 98 pillola 112 pillola 196 pillola
English: Date of first authorisation: 21-March-2012 Date of latest renewal: 05 December 2016
Maltese: Data tal-aħħar tiġdid: Diċembru 5, 2016
English: Accord Healthcare Limited Sage House,
Maltese: Accord Healthcare Limited
English: Pioglitazone Accord is available in Aluminium/Aluminium blister packs containing 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Maltese: Pioglitazone Accord jiġi f'pakketti ta' strixxi tal-Aluminju/Aluminju li fihom 14, 28, 30, 50, 56, 84, 90, 98, 112 u 196 pillola.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Accord (Logo)
Maltese: FIS-SUQ Accord(Logo)
English: • The active substance in Pioglitazone Accord is pioglitazone.
Maltese: • Is-sustanza attiva ta' Pioglitazone Accord hija pioglitazone.
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Aluminju/Folja tal-aluminju, pakketti ta' 14, 28, 30, 50, 56, 84, 90, 98, 112 u 196 pillola.
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Maltese: Ir-rapporti ta' edima ġeneralment kienu ħfief għal moderati u normalment ma kienux jinħtieġu ttwaqqif tal-kura.
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Maltese: Tibdiliet simili dehru fi provi kkontrollati komparattivi b'pioglitazone f'pazjenti kkurati b'metformin (tnaqqis relattiv flemoglobina 3 - 4% u fl-ematokrita 3.6 - 4.1%) u fi kwantità inqas b'sulphonylurea u bl-insulina (tnaqqis relattiv fl-emoglobina 1 - 2 % u fl-ematokrita 1 - 3.2%).
English: - hypersensitivity to the active substance or to any of the excipients listed in 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Maltese: - sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 - insuffiċjenza kardijaka jew passat ta' insuffiċjenza kardijaka (NYHA stadju I sa IV) - indeboliment epatiku - ketoaċidożi dijabetika - kanċer tal-bużżieqa attwali jew storja ta' kanċer tal-bużżieqa - ematurja makroskopika mhux mistħarrġa
English: Pioglitazone Accord contains pioglitazone.
Maltese: Pioglitazone Accord fih pioglitazone.
English: Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets
Maltese: Pioglitazone Accord 15 mg pilloli Pioglitazone Accord 30 mg pilloli Pioglitazone Accord 45 mg pilloli
English: • The other ingredients are lactose monohydrate, carmellose calcium, hydroxypropyl cellulose (E
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, carmellose calcium, hydroxypropyl cellulose (E 465), magnesium stearate (E 572).
English: Each tablet contains 74.46 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha 74.46 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: Pioglitazone Accord tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
Maltese: Il-pilloli Pioglitazone Accord fihom lactose monohydrate u għalhekk m'għandhomx jingħataw lillpazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta' glucose-galactose.
English: Each tablet contains 37.24 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha 37.24 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Maltese: Studji fil-bniedem jissuġġerixxu li m'hemm l-ebda induzzjoni taċċitokromju prinċipali induċibbli P450, 1A, 2C8/9 u 3A4.
English: common common common common common blood creatine phosphokinase increased common increased lactic dehydrogenase uncommon alanine aminotransferase increased 7
Maltese: komuni komuni komuni komuni komuni żieda fil-creatine phosphokinase fiddemm komuni żieda ta' lactic dehydrogenase mhux komuni żieda f'alanine aminotransferase7
English: Other medicines and Pioglitazone Accord
Maltese: Mediċini oħra u Pioglitazone Accord
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03.
Maltese: Mediċini li jittieħdu fid-dijabete, mediċini li jbaxxu l-glucose fiddemm, minbarra l-insulini; Kodiċi ATC:
English: 319 Pinner Road, North Harrow,
Maltese: Sage House, 319 Pinner road, North Harrow, HA1 4HF, Middlesex Ir-Renju Unit
English: In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥65 years compared to 4.0% in patients less than 65 years.
Maltese: F'pazjenti fuq l-insulina mingħajr pioglitazone l-inċidenża ta'insuffiċjenza tal-qalb kienet 8.2% f'dawk ≥ 65 sena meta mqabbla ma' 4.0% f'pazjenti li għandhom inqas minn 65 sena.
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness
Maltese: - qtugħ ta' nifs - tnaqqis żgħir fl-għadd taċ-ċelloli ħomor tad-demm - gass mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) - zokkor fl-awrina, proteina fl-awrina - żieda fl-enżimi - vertigo - tgħoroq - għejja - żieda fl-aptit
English: The safety and efficacy of Pioglitazone Accord in children and adolescents under 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Pioglitazone Accord fi tfal u adolexxenti taħt l-eta' ta' 18-il sena, ma ġewx determinati s'issa.
English: 5 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Maltese: 5Edima kienet irrappurtata f'6 - 9% tal-pazjenti kkurati b'pioglitazone fuq medda ta' sena fi provi kliniċi kkontrollati.
English: 4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Maltese: 4Twettqet 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: • Pioglitazone Accord 15 mg tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side.
Maltese: • Pioglitazone Accord 15 mg huma pilloli bojod għal abjad jagħti fil-griż, tondi, bikonvessi, mhux miksija, imnaqqxin b'‘P' fuq naħa u b'‘15' fuq in-naħa l-oħra.
English: Pioglitazone Accord 30 mg tablets
Maltese: Pioglitazone Accord 30 mg pilloli
English: Pioglitazone Accord 45 mg tablets
Maltese: Pioglitazone Accord 45 mg pilloli
English: Pioglitazone Accord 15 mg tablets
Maltese: Pioglitazone Accord 15 mg pilloli
English: Pioglitazone Accord 30 mg tablets Pioglitazone
Maltese: Pioglitazone Accord 30 mg pilloli Pioglitazone
English: It is an anti-diabetic medicine used to treat type 2 (noninsulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately.
Maltese: Huwa mediċina anti-dijabetika użata 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 MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: Id-detentur tal-awtorizazzjoni għat-tqegħid fis-suq għandu jwettaq l-attivitajiet ta' farmakoviġilanza dettaljati fil-Pjan ta' Farmakoviġilanza, kif miftiehem fil-Pjan ta' Ġestjoni tar-Riskju ppreżentat f'Modulu 1.8.2 ta' l-Awtorizzazzjoni tal-Kummerċ u kull aġġornament sussegwenti tal-RMP miftiehem mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) .
English: • Each Pioglitazone Accord 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Maltese: • Kull pillola ta' Pioglitazone Accord 45 mg fiha 45 mg ta' pioglitazone (bħala hydrochloride).
English: Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
Maltese: Kull ematurja makroskopika għandha tiġi investigata qabel ma tinbeda terapija b'pioglitazone.
English: Pioglitazone Accord 45 mg tablets Pioglitazone
Maltese: Pioglitazone Accord 45 mg pilloli Pioglitazone
English: Eye disorders visual disturbance2
Maltese: Disturbi flgħajnejn disturbi viżwali2
English: EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 pilloli alu/alu folja) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 pilloli alu/alu folja) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 pilloli alu/alu folja)
English: Pioglitazone Accord 15 mg tablets Pioglitazone
Maltese: Pioglitazone Accord 15 mg pilloli Pioglitazone
English: Carmellose calcium Hydroxypropyl cellulose Lactose monohydrate Magnesium stearate
Maltese: Fiha wkoll lactose monohydrate.
English: • Each Pioglitazone Accord 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Maltese: • Kull pillola ta' Pioglitazone Accord 30 mg fiha 30 mg ta' pioglitazone (bħala hydrochloride).
English: Prior to distribution of the prescriber guide in each Member State, the MAH agreed the content and format of the educational material, together with a communication plan, with the national competent authority.
Maltese: Qabel id-distribuzzjoni tal-gwida riċetta f'kull Stat Membru, id-detentur tal-awtorizazzjoni għat-tqegħid fis-suq għandu jaqbel dwar ilkontenut u format tal-materjal edukattiv, flimkien ma' pjan ta' komunikazzjoni, l-awtorità kompetenti nazzjonali.
English: Marketing Authorisation Holder: Accord Healthcare S.L.U.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Accord Healthcare S.L.U.
English: Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 30 mg pioglitazone (bħala hydrochloride).
English: EU/1/11/722/021 14 tablets EU/1/11/722/022 28 tablets EU/1/11/722/023 30 tablets EU/1/11/722/024 50 tablets EU/1/11/722/025 56 tablets EU/1/11/722/026 84 tablets EU/1/11/722/027 90 tablets EU/1/11/722/028 98 tablets EU/1/11/722/029 112 tablets EU/1/11/722/030 196 tablets
Maltese: EU/1/11/722/021 14 pilloli EU/1/11/722/022 28 pilloli EU/1/11/722/023 30 pilloli EU/1/11/722/024 50 pilloli EU/1/11/722/025 56 pilloli EU/1/11/722/026 84 pilloli EU/1/11/722/027 90 pilloli EU/1/11/722/028 98 pilloli EU/1/11/722/029 112 pilloli EU/1/11/722/030 196 pilloli
English: Pioglitazone should not be used in patients with hepatic impairment (see section 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: Pioglitazone Accord 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Maltese: Pilloli Pioglitazone Accord 15 mg Kull pillola fiha 15 mg ta' pioglitazone (bħala hydrochloride).
English: Investigations weight increased6
Maltese: Investigazzjonijie t żieda fil-piż6
English: EU/1/11/722/001 14 tablets EU/1/11/722/002 28 tablets EU/1/11/722/003 30 tablets EU/1/11/722/004 50 tablets EU/1/11/722/005 56 tablets EU/1/11/722/006 84 tablets EU/1/11/722/007 90 tablets EU/1/11/722/008 98 tablets EU/1/11/722/009 112 tablets EU/1/11/722/010 196 tablets
Maltese: EU/1/11/722/001 14 pillola EU/1/11/722/002 28 pillola EU/1/11/722/003 30 pillola EU/1/11/722/004 50 pillola EU/1/11/722/005 56 pillola EU/1/11/722/006 84 pillola EU/1/11/722/007 90 pillola EU/1/11/722/008 98 pillola EU/1/11/722/009 112 pillola EU/1/11/722/010 196 pillola
English: EU/1/11/722/011 14 tablets EU/1/11/722/012 28 tablets EU/1/11/722/013 30 tablets EU/1/11/722/014 50 tablets EU/1/11/722/015 56 tablets EU/1/11/722/016 84 tablets EU/1/11/722/017 90 tablets EU/1/11/722/018 98 tablets EU/1/11/722/019 112 tablets EU/1/11/722/020 196 tablets
Maltese: EU/1/11/722/011 14 pillola EU/1/11/722/012 28 pillola EU/1/11/722/013 30 pillola EU/1/11/722/014 50 pillola EU/1/11/722/015 56 pillola EU/1/11/722/016 84 pillola EU/1/11/722/017 90 pillola EU/1/11/722/018 98 pillola EU/1/11/722/019 112 pillola EU/1/11/722/020 196 pillola
English: Combination with with sulpho with with insulin therapy metformin nylurea metformin and sulphonylurea
Maltese: Madwar terz talpazjenti kienu qed jirċievu l-insulina flimkien ma' metformin u jew mediċina tat-tip sulphonylurea.
English: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is in appropriate 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
Maltese: bħala monoterapija - F'pazjenti adulti (speċjalment pażjenti b'piż żejjed) li mhumiex ikkontrollati sew minn dieta u eżerċizzju li għalihom metformin mhux adattat minħabba kontraindikazzjonijiet jew intolleranza.
English: The other side effects that have been experienced by some patients taking Pioglitazone Accord are:
Maltese: Effetti sekondarji oħra li ġew esperjenzati minn uħud mill-pazjenti li jieħdu Pioglitazone Accord huma:
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: Each tablet contains 111.70 mg of lactose monohydrate (see section 4.4).
Maltese: mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Pioglitazone Accord and have also been reported in male patients (frequency cannot be estimated from the available data) taking Pioglitazone Accord.
Maltese: Ksur tal-għadam kien irrappurtat b'mod komuni (jista' jaffettwa sa persuna waħda minn kull 10) f'pazjenti femminili li jieħdu Pioglitazone Accord u kien irrappurtat ukoll f'pazjenti maskili (ilfrekwenza ma tistax tiġi stamta mid-dejta disponibbli) li jieħdu Pioglitazone Accord.
English: • Pioglitazone Accord 45 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
Maltese: • Pioglitazone Accord 45 mg huma pilloli bojod għal abjad jagħti fil griż, ċatti, tondi, mhux miksijin bi truf iċċanfrati u mmarkati b'‘PIO' fuq naħa waħda u b'‘45' fuq in-naħa l-oħra.
English: How to take Pioglitazone Accord
Maltese: X'fih Pioglitazone Accord
English: • Each Pioglitazone Accord 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Maltese: • Kull pillola ta' Pioglitazone Accord 15 mg fiha 15 mg ta' pioglitazone (bħala hydrochloride).
English: • Pioglitazone Accord 30 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side.
Maltese: • Pioglitazone Accord 30 mg huma pilloli bojod għal abjad jagħti fil griż, ċatti, tondi, mhux miksijin bi truf iċċanfrati u mmarkati b'‘PIO' fuq naħa waħda u b'‘30' fuq in-naħa l-oħra.
English: The MAH shall submit within 1 month of the Commission decision an updated Risk Management Plan which shall include a risk minimisation plan which includes additional risk minimisation measures to address the identified risks of bladder cancer and heart failure, as detailed below.
Maltese: Id-detentur tal-awtorizazzjoni għat-tqegħid fis-suq għandu jissottometti fi żmien xahar 1 tad-deċiżjoni tal-Kummissjoni Ġestjoni tar-Riskji Pjan li għandu jinkludi pjan ta' minimizzazzjoni tar-riskju li jinkludi miżuri ta' minimizzazzjoni tar-riskju addizzjonali biex jiġu indirizzati r-riskji identifikati ta' kanċer tal-bużżieqa u insuffiċjenza tal-qalb, kif dettaljat hawn taħt.