FrancophonIA/ELRC3.0 huggingface dataset:
English: For treatment of depression, doses of up to 200 mg daily and, occasionally, up to 300 mg daily have been used in severely depressed patients in hospital.
Maltese: Għal trattament ta' depressjoni, dożi sa 200 mg kuljum u, kultant, sa 300 mg kuljum intużaw f'pazjenti depressi b'mod sever fi sptar biss.
English: • thyroid disease
Maltese: • mard tat-tirojde
English: It is important that you read this card carefully.
Maltese: Huwa importanti li taqra din il-karta b'attenzjoni.
English: Index 0.9 to
Maltese: Indiċi 0.9 sa
English: Index more than 1.5
Maltese: Indiżi iżjed minn 1.5
English: Tysabri was authorised in the European Union in June 2006.
Maltese: Tysabri kien awtorizzat fl-Unjoni Ewropea f'Ġunju 2006.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific part of a protein called ‘α4β1 integrin'.
Maltese: Is-sustanza attiva f'Tysabri, natalizumab, hija antikorp monoklonali (tip ta' proteina) li ġiet imfassla biex tagħraf u teħel ma' parti speċifika ta' proteina msejħa "α4β1 integrin".
English: 1 PRAC recommendations issued on 11 February 2016
Maltese: 1 Ir-rakkomandazzjonijiet ta' PRAC maħruġin fil-11 ta' Frar 2016
English: 2 PML risk estimates were derived using the life table method based on the pooled cohort of 21,696 patients who participated in the STRATIFY-2, TOP, TYGRIS, and STRATA clinical studies.
Maltese: L-istimi tar-riskju għall-PML ġew derivati bl-użu ta' metodu tat-tabella tal-ħajja bbażat fuq il-koorti miġbura ta' 21,696 pazjent li pparteċipaw fl-istudji kliniċi STRATIFY-2, TOP, TYGRIS, u STRATA.
English: • Progressive multifocal leukoencephalopathy (PML, a serious brain infection) is known to be an uncommon risk with the multiple sclerosis medicine Tysabri.
Maltese: • Il-lewkoenċefalopatija multifokali progressiva (PML, infezzjoni serja fil-moħħ) hija magħrufa li hija riskju mhux komuni bil-mediċina Tysabri ta' sklerożi multipla.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali li torbot legalment applikabbli fl-Istati Membri tal-UE kollha fi 25/04/2016.
English: Prior use of immunosuppressants
Maltese: L-ebda użu preċedenti ta' immunosupperessanti
English: On 25 February 2016, EMA completed its review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab), and confirmed initial recommendations1 aimed at minimising this risk.
Maltese: Fil-25 ta' Frar 2016, l-EMA lestiet ir-reviżjoni tagħha tar-riskju magħruf ta' lewkoenċefalopatija multifokali progressiva (PML, progressive multifocal leukoencephalopathy) bil-mediċina tal-isklerożi multipla Tysabri (natalizumab), u kkonfermat ir-rakkomandazzjonijiet inizjali1 immirati sabiex inaqqsu r-riskju.
English: The review of Tysabri was initiated on 7 May 2015 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni ta' Tysabri nbdiet fis-7 ta' Mejju 2015 fuq talba mill-Kummissjoni Ewropea, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: Table 1: PML risk estimates per 1,000 patients in anti-JC virus antibody positive patients* Duration of Tysabri use
Maltese: Tabella 1: Stimi ta' riskju ta' PML għal kull 1,000 pazjent f'pazjenti b'antikopri kontra l-virsu JC*
English: In patients who tested negative for JC virus antibodies, the PML risk estimate remains unchanged at 0.1 per 1,000 patients.
Maltese: F'pazjenti li ġew ittestjati negattivi għall-antikorpi tal-virus JC, l-istima tar-riskju ta' PML tibqa' mhux mibdula fil-livell ta' 0.1 kull 1,000 pazjent.
English: Further stratification of PML risk by anti-JC virus antibody index interval for patients with no prior use of immunosuppressants were derived from combining the overall yearly risk with the antibody index distribution.
Maltese: Aktar stratifikazzjoni tar-riskju ta' PML minn intervall tal-indiċi tal-antikorpi ta' kontra l-virus JC għal pazjenti bl-ebda użu preċedenti ta' immunosuppressanti ġiet derivata mill-kombinazzjoni tar-riskju annwali kumplessiv mad-distribuzzjoni tal-indiċi tal-antikorpi.
English: Tysabri is a medicine used to treat adults with highly active multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Maltese: Tysabri huwa mediċina li tintuża biex tikkura adulti bi sklerożi multipla (SM) attiva ħafna, marda tannervituri fejn l-infjamazzjoni teqred is-saff protettiv madwar iċ-ċelloli tan-nervituri.
English: • Anti-JC virus antibody testing should be done every 6 months in antibody-negative patients.
Maltese: • L-ittestjar tal-antikopri kontra l-virus JC għandu jsir kull 6 xhur f'pazjenti b'antikorpi negattivi.
English: • either have used an immunosuppressant before starting Tysabri, or have not used immunosuppressants and have a high JC virus antibody index.
Maltese: • jew ikunu użaw immunisuppressant qabel bdew Tysabri, jew ma jkunux użaw immunosuppressanti u għandhom indiċi tal-antikorpi tal-virus JC għoli.
English: • have tested positive for JC virus, and
Maltese: • ikunu ġew ittestjati b'riżultati pożittivi għall-virus JC, u
English: Tysabri is used in the type of MS known as ‘relapsing-remitting' MS, when the patient has attacks (relapses) in between periods with no symptoms (remissions).
Maltese: Tysabri jintuża f'tip ta' SM magħruf bħala SM "reċidiv-remittenti", meta l-pazjent ikollu attakki (reċidivi) bejn perjodi mingħajr sintomi (remittenti).
English: It is used when the disease has failed to respond to treatment with a beta-interferon or glatiramer acetate (other types of medicines used in MS), or is severe and getting worse rapidly.
Maltese: Jintuża meta l-marda ma tkunx irrispondiet għall-kura b'beta -interferon jew glatiramer aċetat (tipi oħrajn ta' mediċini użati għal SM), jew hija gravi u tkun qed taqleb għallagħar b'mod rapidu.
English: • Before starting treatment, a baseline MRI should be available (usually within 3 months) as a reference, and a baseline anti-JCV antibody test should be performed to support PML risk stratification.
Maltese: • Qabel ma tinbeda l-kura, MRI tal-linja bażi għandha tkun disponibbli (normalment fi żmien 3 xhur) bħala referenza, u test tal-linja bażi tal-antikopri ta' kontra l-JCV għandu jitwettaq biex jappoġġa listratifikazzjoni tar-riskju tal-PML.
English: More detailed information on the risk stratification, diagnosis and treatment of PML will be included in the updated Physician Information and Management Guidelines for Tysabri.
Maltese: Aktar informazzjoni dettaljata fuq l-istratifikazzjoni tar-riskju, id-dijanjosi u l-kura tal-PML se tkun inkluża fl-Informazzjoni għat-Tabib u Linji Gwida għall-Immaniġġjar għal Tysabri.
English: months *from Tysabri Physician Information and Management Guidelines
Maltese: Aktar dwar il-mediċina
English: More about the procedure
Maltese: Tul ta'
English: • Your risk of PML depends on several factors, such as whether you have antibodies against JC virus in your blood (a sign that you have been exposed to the virus that causes PML) and what their level is, how long you have been treated with Tysabri, and whether or not you were treated with medicines that suppress your immune system before starting Tysabri.
Maltese: • Ir-riskju tiegħek ta' PML jiddependi fuq diversi fatturi, bħal jekk għandekx antikorpi kontra l-virus JC fid-demm tiegħek (sinjal li tkun ġejt espost/a għall-virus li jikkawża l-PML) u x'inhu l-livell tagħhom, kemm ilek tiġi kkurat/a b'Tysabri, u jekk ġejtx jew jekk ma ġejtx ikkurat/a b'mediċini li jrażżnu s-sistema immunitarja tiegħek qabel ma bdejt Tysabri.
English: If lesions suggestive of PML are discovered, the MRI protocol should be extended to include ‘contrast-enhanced T1-weighted MRI', and testing the spinal fluid for the presence of JC virus should be considered.
Maltese: Jekk jiġu skoperti leżjonijiet li jindikaw PML, il-protokoll tal-MRI għandu jiġi estiż biex jinkludi "MRI ppeżat b'T1 b'kuntrast imtejjeb", u għandu jitqies l-ittestjar tal-fluwidu spinali għall-preżenza tal-virus JC.
English: • During treatment with Tysabri, patients should be monitored at regular intervals for signs and symptoms of new neurological dysfunction, and a full brain MRI should be performed at least once a year for the duration of treatment.
Maltese: • Waqt il-kura b'Tysabri, il-pazjenti għandhom jiġu mmonitorjati f'intervalli regolari għal sinjali u sintomi ta' disfunzjoni newroloġika ġdida, u MRI tal-moħħ sħiħa għandha titwettaq mill-inqas darba f'sena għal kemm iddum il-kura.
English: Your doctor will also check for signs and symptoms suggestive of PML.
Maltese: It-tabib tiegħek se jiċċekkja wkoll għal sinjali u sintomi li jindikaw PML.
English: The updated risk estimates above show that the risk of developing PML is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with Tysabri for longer than 2 years.
Maltese: L-istimi tar-riskju aġġornati t'hawn fuqu juru li r-riskju tal-iżvilupp ta' PML huwa żgħir, u iktar baxx minn kemm kien stmat qabel, fil-valuri tal-indiċi tal-antikorpi ta' 0.9 jew anqas, u jiżdied b'mod sostanzjali f'pazjenti b'valuri tal-indiċi 'l fuq minn 1.5 li ġew ikkurati b'Tysabri għal iktar minn sentejn.
English: • If PML is suspected, the MRI protocol should be extended to include contrast-enhanced T1weighted imaging and testing of CSF for the presence of JC virus DNA using ultrasensitive PCR should be considered.
Maltese: • Jekk il-PML hija ssuspettata, il-protokoll tal-MRI għandu jiġi estiż biex jinkludi immaġini ppeżata b'T1 b'kuntrast imtejjeb, u għandu jitqies l-ittestjar tas-CSF għall-preżenza tad-DNA tal-virus JC blużu ta' PCR ultra sensittiva.
English: New data from large clinical studies also suggest that, in patients who have not been treated with immunosuppressants (medicines that reduce the activity of the immune system) before starting Tysabri, the blood level of antibodies against JC virus (‘antibody index') relates to the level of risk for PML.
Maltese: Dejta ġdida minn studji kliniċi kbar tissuġġerixxi wkoll li, f'pazjenti li ma ġewx ikkurati b'immunosuppressanti (mediċini li jnaqqsu l-attività tas-sistema immunitarja) qabel ma bdew Tysabri, il-livell tad-demm tal-antikorpi kontra l-virus JC ("l-indiċi tal-antikort") jirrelata għal-livell ta' riskju għall-PML. Fid-dawl tal-evidenza l-ġdida, il-pazjenti huma meqjusin f'riskju ogħla li jiżviluppaw il-PML jekk:
English: EMA confirms recommendations to minimise risk of brain infection PML with Tysabri
Maltese: L-EMA tikkonferma r-rakkomandazzjoniojiet biex jonqos ir-riskju ta' infezzjoni PML fil-moħħ b'Tysabri
English: Known risk factors for the development of PML in patients treated with Tysabri are the presence of antibodies against JC virus, treatment with Tysabri for more than two years, and previous use of immunosuppressants.
Maltese: Fatturi tar-riskju magħrufa għall-iżvilupp ta' PML f'pazjenti kkurati b'Tysabri huma l-preżenza talantikopri kontra l-virus JC, il-kura b'Tysabri għal iktar minn sentejn, u l-użu preċedenti ta' immunosuppressanti.
English: • If PML is suspected, your doctor will stop treatment with Tysabri until PML can be ruled out.
Maltese: • Jekk il-PML tkun suspettata, it-tabib tiegħek se jwaqqaf il-kura b'Tysabri sakemm il-PML tkun tista' tiġi eskluża.
English: • Symptoms of PML may be similar to those of a multiple sclerosis attack, and include progressive weakness, speech and communication difficulties, vision problems, and sometimes changes in mood or behaviour.
Maltese: • Is-sintomi ta' PML jistgħu jkunu simili għal dawk ta' attakk ta' sklerożi multipla u jinkludu dgħufija progressiva, diffikultajiet fid-diskors u fil-komunikazzjoni, tibdil fil-vista, u xi kultant bidliet filburdata jew fl-imġiba.
English: These tests may be done more often if you are considered at higher risk for PML.
Maltese: Dawn it-testijiet jistgħu jsiru aktar spiss jekk inti titqies f'riskju ogħla għal PML.
English: The most common symptoms of PML are progressive weakness, speech and communication difficulties, vision changes, and sometimes changes in mood or behaviour.
Maltese: L-iktar sintomi komuni ta' PML huma dgħufija progressiva, diffikultajiet fid-diskors u fil-komunikazzjoni, tibdil fil-vista, u xi kultant bidliet fil-burdata jew fl-imġiba.
English: • After 2 years of treatment, patients should be informed again about the risk of PML with Tysabri.
Maltese: • Wara sentejn ta' kura, il-pazjenti għandhom jerġgħu jiġu infurmati dwar ir-riskju ta' PML b'Tysabri.
English: The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lillKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għall-mistoqsijiet dwar il-mediċini għall-użu mill-bniedem, li adotta l-opinjoni finali tal-Aġenzija.
English: • More information about the risk of PML with Tysabri is included in the Patient Alert Card you have been given by your doctor.
Maltese: • Aktar informazzjoni dwar ir-riskju ta' PML b'Tysabri hija inkluża fil-Karta tat-Twissija tal-Pazjent li tkun ingħatajt mit-tabib tiegħek.
English: • Before starting treatment with Tysabri, and then regularly during treatment, your doctor will do blood tests to measure the level of antibodies for JC virus and MRI scans to monitor your condition.
Maltese: • Qabel ma tibda l-kura b'Tysabri, u wara b'mod regolari waqt il-kura, it-tabib tiegħek se jagħmel testijiet tad-demm biex ikejjel il-livell tal-antikorpi għall-virus JC u għall-iskans tal-MRI biex jimmonitorja l-kondizzjoni tiegħek.
English: All patients taking Tysabri should undergo full MRI scans at least once a year, but on the basis of the new data EMA recommended that for patients at higher risk of PML more frequent MRI scans (e.g. every 3 to 6 months) performed using simplified protocols should be considered.
Maltese: Każijiet asintomatiċi ta' PML jistgħu jiġu identifikati fi skans tal-MRI, u l-esperti fil-qasam tal-MRI u tal-isklerożi multipla jaqblu li lprotokolli tal-MRI ssimplifikati (li jippermettu proċeduri iqsar, iżda wkoll jillimitaw il-piż għal pazjenti li qed jagħmlu l-iskans) jippermettu l-identifikazzjoni tal-leżjonijiet tal-PML. Il-pazjenti kollha li jieħdu Tysabri għandhom jagħmlu skans tal-MRI kompluti mill-inqas darba f'sena, iżda fuq il-bażi tad-dejta lġdida, l-EMA irrakkomandat li għal pazjenti b'riskju ogħla ta' PML għandhom jiġu kkunsidrati skans talMRI iktar frekwenti (eż. kull 3 sa 6 xhur) li jitwettqu bl-użu ta' protokolli ssimplifikati.
English: • Before starting treatment with Tysabri, patients and carers should be advised about the risk of PML.
Maltese: • Qabel tinbeda l-kura b'Tysabri, il-pazjenti u l-persuni li jindukraw għandhom jiġu avżati bir-riskju ta' PML.
English: More about the medicine
Maltese: żmien talużu ta'
English: London, 19 March 2008 Doc.
Maltese: Londra, 19 ta' Marzu 2006 Dok. Ref.
English: Ref. EMEA/136938/2008
Maltese: EMEA/180142/2008
English: International non-proprietary name (INN): eprodisate sodium
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): eprodisat tas-sodju
English: What is Kiacta?
Maltese: X'inhu Kiacta?
English: It was to be available as capsules.
Maltese: Hija disponibbli f'kapsuli.
English: Kiacta is a medicine containing the active substance eprodisate disodium.
Maltese: Kiacta hija mediċina li fiha s-sustanza attiva eprodisat tad-disodju.
English: On 13 March 2008, Neurochem Luxco II SARL officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kiacta for the treatment of amyloid A amyloidosis.
Maltese: Fit-13 ta' Marzu 2008, ISTA Neurochem Luxco II SARL għarrfet uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni għallawtorizzazzjoni għat-tqegħid fis-suq għal Kiacta, għat-trattament ta' l-amilojdożi AA (amyloid A amyloidosis).
English: Kiacta was designated an orphan medicinal product on 31 July 2001.
Maltese: Kiacta ġie kklassifikat bħala prodott mediċinali orfni fil-31 ta' Lulju 2001.
English: The effectiveness of Kiacta was studied in one main study involving 183 patients with AA amyloidosis, in which Kiacta was compared with placebo (a dummy treatment).
Maltese: L-effikaċja ta' Kiacta ġiet studjata fi studju prinċipali wieħed li involva 183 pazjenti li jbatu minn amilojdożi AA, li fihom Kiacta tqabbel mal-plaċebo (trattament finta).
English: This is a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.
Maltese: Din hija marda rari u potenzjalment fatali li sseħħ f'pazjenti li jkollhom infjammazzjoni għat-tul, normalment dovuta għal artrite rewmatojde.
English: AA is produced in the body from a protein called ‘serum amyloid A', which is released by liver cells in response to inflammation.
Maltese: AA hija prodotta fil-ġisem minn proteina msejħa 'serum amilojde A', li huwa rilaxxat miċ-ċelluli tal-fwied bħala reazzjoni għall-infjammazzjoni.
English: The active substance in Kiacta, eprodisate disodium, is expected to work by interfering with the formation of fibrils of AA, preventing the deposits from building up in the organs.
Maltese: Is-sustanza attiva f'Kiacta, eprodisat tad-disodju, hija mistennija li taħdem billi tindaħal filformazzjoni tal-fibrilli ta' AA, tipprevjeni d-depożiti milli jakkumulaw fl-organi.
English: The company informed the CHMP that the ongoing clinical trial with Kiacta is being stopped, so that it can carry out a second study to compare Kiacta with placebo.
Maltese: Il-kumpanija għarrfet lis-CHMP li l-prova klinika li għaddejja bl-użu ta' Kiacta twaqqfet, bil-għan li tkun tista' twettaq studju ieħor biex tqabbel Kiacta mal-plaċebo.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Kiacta for the treatment of AA amyloidosis.
Maltese: Skond l-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fiżżmien l-irtirar, is-CHMP kien ta opinjoni negattiva u ma rrakkomandax li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq għal Kiacta għat-trattament ta' l-amilojdożi AA.
English: What are the consequences of the withdrawal for patients in clinical trials with Kiacta?
Maltese: Għal xiex kien mistenni li jintuża Kiacta?
English: Amyloid A amyloidosis is caused by the build-up of insoluble ‘fibrils' (fine threads) of a protein called ‘amyloid A' (AA) in the organs of the body.
Maltese: L-amilojdożi AA hija kkawżata mill-akkumulu ta' 'fibrilli' (slejtiet) ta' proteina msejħa 'amilojde A' (AA) fl-organi tal-ġisem.
English: The CHMP was concerned that the effectiveness of Kiacta in treating AA amyloidosis had not been demonstrated sufficiently in the single main study.
Maltese: L-effetti ta' Kiacta ġew għall-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Kiacta was expected to be used to treat amyloid A amyloidosis.
Maltese: Kiacta kien mistenni li jintuża għat-trattament ta' l-amilojdożi AA.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANTI / DETENTURI TALAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Pharmaceutical Co. Ltd.
Maltese: Pharmaceutical Co.
English: EMA/634874/2015 EMEA/H/C/004021
Maltese: EMA/H/C/004021
English: The full EPAR and risk management plan summary for Aripiprazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: They may also have episodes of depression.
Maltese: Il-pazjenti jista' jkollhom ukoll episodji ta' depressjoni.
English: Aripiprazole Accord is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Maltese: Aripiprazole Accord jiġi bħala pilloli (5, 10, 15 u 30 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Aripiprazole Accord contains the active substance aripiprazole and is a ‘generic medicine'.
Maltese: Aripiprazole Accord fih is-sustanza attiva aripiprazole u huwa ‘mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Accord.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Aripiprazole Accord.
English: Other information about Aripiprazole Accord
Maltese: Informazzjoni oħra dwar Aripiprazole Accord
English: The active substance in Aripiprazole Accord, aripiprazole, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Aripiprazole Accord, aripiprazole, hija mediċina antipsikotika.
English: • bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Maltese: • disturb bipolari tat-tip I, marda mentali li biha l-pazjenti jesperjenzaw episodji manijaċi (perjodi anormali ta' burdata tajba), alternati ma' perjodi ta' burdata normali.
English: Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Maltese: Peress li d-dopamina u l-5-hydroxytryptamine huma involuti fi skiżofrenja u disturb bipolari, aripiprazole jgħin biex iġib lura għan-normal l-attività tal-moħħ, billi jnaqqas is-sintomi psikotiċi jew sintomi manijaċi u jipprevjenihom milli jirritornaw.
English: Aripiprazole Accord is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Maltese: Aripiprazole Accord jintuża f'adulti għall-kura ta' episodji manijaċi minn moderati sa severi u għall-prevenzjoni ta' episodji manijaċi ġodda f'adulti li rrispondew għallmediċina fl-imgħoddi.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsijiet-utweġibiet hawnhekk.
English: Because Aripiprazole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Maltese: Minħabba li Aripiprazole Accord huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet biex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Abilify.
English: For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Maltese: Għall-kura ta' episodji manijaċi f'pazjenti li għandhom bejn 13 u 17-il sena, id-doża inizjali hija ta' 2 mg kuljum (permezz ta' prodott li fih aripiprazole f'għamla likwida), li gradwalment tiżdied għad-doża rakkomandata ta' 10 mg darba kuljum.
English: This means that Aripiprazole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Maltese: Dan ifisser li Aripiprazole Accord huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Abilify.
English: For schizophrenia, the recommended starting dose is 10 or 15 mg per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Maltese: Għall-iskiżofrenja, id-doża inizjali rakkomandata hija ta' 10 jew 15 mg kuljum għall-adulti, segwita minn doża ta' ‘manteniment' ta' 15 mg darba kuljum.