FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients (n) PASI 75, n (%) 120 (88.2 %) 114 (68.7 %) PASI 90, n (%) PASI 100, n (%) 49 (36.0 %) * Ixekizumab 160 mg was given as a loading dose followed by 80 mg at week 2,4,6,8,10 and 12, and 80 mg Q4W thereafter ** Weight based dosing: Patients treated with ustekinumab received 45 mg or 90 mg at Weeks 0 and 4, then every 12 weeks until Week 52 (dosed by weight as per approved posology) §p < 0.001 versus ustekinumab (p value only provided for primary endpoint)
Maltese: Ġie muri mir-radjografija li fl-24 Ġimgħa l-progressjoni tal-ħsara fil-ġogi ġiet imwaqfa minn Taltz (Tabella 9) u mill-għażla b'mod arbitrarju sal-24 Ġimgħa, il-persentaġġ ta' pazjenti li mir-radjografija ma dehret ebda progressjoni ta' ħsara fil-ġogi (imfissra bħala bidla mil-linja bażi fl-mTSS ta' ≤0.5) kien ta' 94.8% għal Taltz Q2W (p<0.001), 89.0% għal Taltz Q4W (p=0.026), 95.8% għal adalimumab (p<0.
English: You must look out for signs of these conditions while you are using Taltz.
Maltese: tilqim waqt li tkun qed/a tuża Taltz.
English: 1 GET READY 1a Take the syringe from the refrigerator.
Maltese: 1a Ħu s-siringa mill-friġġ.
English: 80 mg Q4W (induction) / Placebo (maintenance) (N = 191)
Maltese: 80 mg Q4W (fil-bidu) / 80 mg Q4W (manteniment) (N = 195)
English: 1 pre-filled pen of 1 ml solution 2 pre-filled pens of 1 ml solution 3 pre-filled pens of 1 ml solution
Maltese: Pinna 1 mimlija għal-lest b'1 ml ta' soluzzjoni 2 pinen mimlijin għal-lest b'1 ml ta' soluzzjoni 3 pinen mimlijin għal-lest b'1 ml ta' soluzzjoni
English: - hives.
Maltese: BISS.
English: Radiographic joint damage progression was inhibited by Taltz (Table 9) at Week 24, and the percentage of patients with no radiographic joint damage progression (defined as a change from baseline in mTSS of ≤0.5) from randomisation to Week 24 was 94.8% for Taltz Q2W(p<0.001),
Maltese: Ġie muri mir-radjografija li fl-24 Ġimgħa l-progressjoni tal-ħsara fil-ġogi ġiet imwaqfa minn Taltz (Tabella 9) u mill-għażla b'mod arbitrarju sal-24 Ġimgħa, il-persentaġġ ta' pazjenti li mir-radjografija ma dehret ebda progressjoni ta' ħsara fil-ġogi (imfissra bħala bidla mil-linja bażi fl-mTSS ta' ≤0.5) kien ta' 94.8% għal Taltz Q2W (p<0.001),, 89.0% għal Taltz Q4W (p=0.026), 95.8% għal adalimumab (p<0.
English: Placebo (N = 193)
Maltese: (manteniment) (N = 191)
English: Expiration date
Maltese: Skopijiet finali
English: Each pre-filled pen contains 80 mg ixekizumab in 1 ml.
Maltese: Kull pinna mimlija għal-lest fiha 80 mg ixekizumab f'1 ml.
English: MA(EU) Number
Maltese: Numru tal-proċedura ta' l-EMA
English: The full EPAR for Repso 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: The European Commission granted a marketing authorisation valid throughout the European Union for Repso to TEVA Pharma B.V. on 14 March 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Respo lil TEVA Pharma B.V. fl-14 ta' Marzu 2011.
English: The active substance in Repso, leflunomide, is an immunosuppressant.
Maltese: Is-sustanza attiva f'Repso, leflunomide, hija mediċina immunosuppressiva.
English: It is available as tablets (white and round: 10 mg; dark beige and triangular: 20 mg).
Maltese: Huwa disponibbli bħala pilloli (bojod u tondi: 10 mg; beġ skur u trijangolari 20 mg).
English: This is a summary of the European public assessment report (EPAR) for Repso.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Repso.
English: What are the benefits and risks of Repso?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Repso?
English: Repso is a medicine that contains the active substance leflunomide.
Maltese: Repso huwa mediċina li fiha s-sustanza attiva leflunomide.
English: Repso is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Maltese: Repso jintuża għat-trattament ta' adulti bl-artrite rewmatika attiva (marda tas-sistema immunitarja li tikkawża infjammazzjoni tal-ġogi) jew bl-artrite psorjatika attiva (marda li tikkawża dbabar ħomor bilqoxra fil-ġilda u infjammazzjoni tal-ġogi).
English: The CHMP concluded that, in accordance with EU requirements, Repso has been shown to have comparable quality and to be bioequivalent to Arava.
Maltese: Is-CHMP kkonkluda li, konformi mar-rekwiżiti tal-UE, Repso wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Arava.
English: Why has Repso been approved?
Maltese: Għaliex ġie approvat Repso?
English: Because Repso is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Maltese: Billi Repso huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw ilbijoekwivalenza tiegħu mal-mediċini ta' referenza, Arava.
English: Because Repso is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Repso huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għall-aktar informazzjoni dwar il-mediċini ġeneriċi, ara ddokument mistoqsijiet-u-tweġibiet hawnhekk.
English: This means that Repso is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Maltese: Repso huwa ‘mediċina ġenerika' Dan ifisser li Repso jixbah lil ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li tssejjaħ Arava.
English: Repso treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Maltese: Il-kura b'Repso tibda b' ‘doża inizjali' ta' 100 mg darba kuljum għal tlett ijiem, segwiti b'doża ta' manteniment.
English: How is Repso used?
Maltese: X'inhu Repso?
English: How has Repso been studied?
Maltese: Kif ġie studjat Repso?
English: What is Repso?
Maltese: Għal xiex jintuża Repso?
English: Repso is a ‘generic medicine'.
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta ta' tabib.
English: Repso treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Maltese: Il-kura b'Repso għandha tinbeda u tiġi segwita minn speċjalista li jkollu esperjenza fil-kura tal-artrite rewmatika u l-artrite psorjatika.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Repso, and regularly during treatment.
Maltese: Inqas ma jkun hemm limfoċiti inqas ikun hemm infjammazzjoni, u dan jgħin biex jiġu kkontrollati s-sintomi tal-artrite.
English: 1.1 Mania
Maltese: 1.1 Manija
English: Adverse Events
Maltese: Avvenimenti Avversi
English: In adults:
Maltese: Fl-adulti:
English: Ratiopharm Nederland B.V. Florapark 4
Maltese: L-Olanda ratiopharm Nederland bv Florapark 4
English: Rua Quinta do PinheiroEdifício Tejo 6° Piso Carnaxide
Maltese: Rua Quinta do PinheiroEdifício
English: Manic episodes in bipolar disorder:
Maltese: Episodji manijaċi f'disturbi bipolari:
English: 89070 Ulm Germany
Maltese: 89079 Ulm
English: Antiepileptic therapy is always a long-term therapy.
Maltese: It-terapija anti-epilettika hi dejjem terapija fit-tul.
English: 1.3 Chemical forms and formulations of valproate
Maltese: 1.3 Għamliet u formulazzjonijiet kimiċi ta' valproate
English: The mean daily dose usually ranges between 1000 and 2000 mg <valproate>.
Maltese: Id-doża medja ta' kuljum normalment tvarja bejn 1000 u 2000 mg <valproate>.
English: Concerning recurrence prevention of mood episodes, evidence of efficacy of valproate is mainly based on two double-blind studies with a maintenance period of 52 weeks and 20 months duration, respectively (Bowden et al., 2000 and Calabrese et al., 2005).
Maltese: Rigward il-prevenzjoni tar-rikorrenza tal-episodji tal-burdata, l-evidenza tal-effikaċja hija bbażata laktar fuq żewġ studji double blind b'perijodu ta' manteniment ta' 52 ġimgħa u li damu għaddejjin 20 xahar, rispettivament (Bowden et al., 2000 u Calabrese et al., 2005).
English: In most of the EU Member States valproate is also approved (as valproic acid, sodium valproate, valproate semisodium) for the treatment of patients with bipolar disorder (approved in 25 European countries, in 21 countries with a first-line indication).
Maltese: Fil-maġġoranza tal-Istati Membri tal-UE, valproate huwa approvat ukoll (bħalma huma valproic acid, sodium valproate, valproate semisodium) għattrattament ta' pazjenti b'disturb bipolari (approvat f'25 pajjiż Ewropew, f'21 pajjiż b'indikazzjoni talewwel).
English: Following the literature presented as well the post-marketing experience the adverse events of “nausea”, “sedation” and “extrapyrimidal disorders” are proposed to be added to the Section 4.8 “Undesirable effects” of the SPC.
Maltese: Skont id-dokumentazzjoni ppreżentata kif ukoll l-esperjenza ta' wara t-tqegħid fis-suq, l-avvenimenti avversi ta' “nawżea”, “sedazzjoni” u “disturbi ekstrapiramidali” huma proposti li jiżdiedu fisSezzjoni 4.8 “Effetti mhux mixtieqa” tal-SPC.
English: POSSIBLE SIDE EFFECTS Nausea, sedation, extrapyramidal disorders.
Maltese: SEKONDARJI LI JISTA' JKOLLU Nawseja, sedazzjoni, disturbi ekstrapiramidali.
English: Seizures:
Maltese: Accessjonijiet:
English: After 12 months of treatment following a manic index episode, 41% of patients treated with valproate were still in remission compared to 24% of patients in the lithium group and 13% of patients in the placebo group.
Maltese: Wara 12-il xahar ta' trattament wara episodju ta' manija ta' indiċi, 41% tal-pazjenti li ġew trattati b'valproate kienu għadhom f'remissjoni meta mqabbla ma' 24% tal-pazjenti fil-grupp ta' litju u 13% tal-pazjenti fil-grupp ta' plaċebo.
English: Efficacy
Maltese: EFFETTI
English: A teratogenic risk associated with the use of valproate in pregnant women, including the potential for delayed intellectual development has been identified following in utero exposure to valproate.
Maltese: Riskju teratoġeniku assoċjat mal-użu ta' valproate fin-nisa tqal, inkluża l-possibbiltà ta' dewmien fliżvilupp intelletwali ġie identifikat wara l-espożizzjoni in utero għal valproate.
English: Valprotek CR 500 mg (prolonged release) tablets 500 mg
Maltese: Valprotek CR 500 mg (prolonged release) tablets
English: 199,8 mg + 87 mg Prolonged-release tablet Oral use
Maltese: 199,8 mg + 87 mg
English: 4.1 Therapeutic indications
Maltese: 4.1 INDIKAZZJONIJIET TERAPEWTICI
English: Valprotek CR 300 mg (prolonged release) tablets 300 mg
Maltese: Valprotek CR 300 mg (prolonged release) tablets
English: In the two-arm study performed by Calabrese and co-workers (2005) patients in the valproate group performed better in several efficacy parameters compared to the lithium group (in a statistically nonsignificant way), however significantly more patients in the lithium group experienced various adverse effects (tremor, polyuria, polydipsia) compared to the valproate group.
Maltese: Fl-istudju b'żewġ fergħat imwettaq minn Calabrese u ko-ħaddiema (2005), il-pazjenti fil-grupp ta' valproate kellhom prestazzjoni aħjar f'bosta parametri tal-effikaċja meta mqabbla mal-grupp ta' litju (b'mod li huwa statistikament mhux sinifikanti), madankollu ħafna aktar pazjenti fil-grupp ta' litju kellhom effetti avversi varji (rogħda, polyuria, polydipsia) meta mqabbla mal-grupp ta' valproate.
English: Acido valproico E sodio Valproato Ratiopharm 300 mg
Maltese: Acido valproico E sodio Valproato Ratiopharm
English: Children and adolescents under 18 years of age: […] should not be used in children and adolescents under 18 years of age for the treatment of mania.
Maltese: Tfal u adolexxenti ta' taħt it-18-il sena: […] m'għandux jintuża fi tfal u adolexxenti taħt l-età ta' 18-il sena għal kura ta' manija.
English: Ratiopharm GmbH Graf Arco Strasse 3
Maltese: Il-Lussemburgu ratiopharm GmbH Graf-Arco-Strasse 3
English: <Valproinsäure-ratiopharm chrono 500 Retardtabletten> The recommended daily doses usually range between 1000 mg and 2000 mg (2 and 4 tablets).
Maltese: <[TRADENAME] 500 PILLOLI LI JERĦU L-MEDIĊINA BIL-MOD >Id-dożi rakkomandati ta' kuljum normalment ivarjaw bejn 1000 mg u 2000 mg (2 u 4 pilloli).
English: It was highlighted that although the indication exists in many Member States, sustained efficacy both in acute mania as well as in the prevention of recurrence of mood episodes has not been clearly demonstrated in well designed clinical trials which comply with the requirements of the CPMP Note for Guidance on Clinical Investigation of Medicinal products for the Treatment and Prevention of Bipolar Disorder (CPMP/EWP/567/98).
Maltese: Ġie enfasizzat li għalkemm l-indikazzjoni teżisti f'bosta Stati Membri, l-effikaċja sostnuta kemm filmanija akuta kif ukoll fil-prevenzjoni tar-rikorrenza ta' episodji tal-burdata ma ntweritx b'mod ċar fi provi kliniċi mfasslin tajjeb li jikkonformaw mar-rekwiżiti tan-Nota ta' Gwida tas-CHMP dwar lInvestigazzjoni Klinika tal-prodotti Mediċinali għat-Trattament u l-Prevenzjoni tad-Disturb Bipolari (CPMP/EWP/567/98).
English: <Valproinsäure-ratiopharm chrono 300 Retardtabletten> The recommended daily doses usually range between 1000 mg and 2000 mg (3 ½ and 6 ½ tablets).
Maltese: <[TRADENAME] 300 PILLOLI LI JERĦU L-MEDIĊINA BIL-MOD > Id-dożi rakkomandati ta' kuljum normalment ivarjaw bejn 1000 mg u 2000 mg (3½ u 6½ pilloli).
English: Strength
Maltese: Tqala
English: Whereas, in the original analysis time to recurrence of any mood episode or depressive episode, respectively was not significantly different in the three treatment groups, post-hoc analyses showed that valproate treated patients dropped out significantly less frequent than placebo treated patients because of a mood episode and due to a depressive episode, respectively, whereas the respective difference was not statistically significant compared to lithium treated patients.
Maltese: Filwaqt li, fl-analiżi oriġinali, il-ħin għar-rikorrenza ta' kwalunkwe episodju tal-burdata jew episodju depressiv, rispettivament ma kienx differenti b'mod sinifikanti fit-tliet gruppi ta' trattament, l-analiżi post-hoc urew li l-pazjenti trattati b'valproate ħarġu mill-istudju b'mod ferm inqas frekwenti mill-pazjenti trattati b'plaċebo minħabba episodju tal-burdata u minħabba episodju depressiv, rispettivament, filwaqt li d-differenza rispettiva ma kinitx statistikament sinifikanti meta mqabbla mal-pazjenti li ġew ittrattati b'litju.
English: “Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Maltese: “Trattament ta' episodju ta' manija f'disturb bipolari meta litju huwa kontra-indikat jew mhuwiex ittollerat.
English: Bipolar disorder is a severe mental disorder characterized by recurrent episodes of mania and depression, which as a recurrent affective illness produces significant distress and dysfunction, ranking among the top 30 causes of worldwide disability.
Maltese: Id-disturb bipolari huwa disturb mentali sever li huwa kkaratterizzat minn episodji rikorrenti ta' manija u depressjoni, li bħala marda affettiva rikorrenti tipproduċi dieqa u disfunzjoni sinifikanti, u hija kklassifikata fost l-ewwel 30 kawża ta' diżabbiltà dinjija.
English: Suicidality
Maltese: Suwiċidjalità
English: Therefore the CHMP recommended that valproate in the indication treatment of acute episodes is restricted to modified-release (solid oral) formulations.
Maltese: Għaldaqstant, is-CHMP irrakkomanda li valproate fl-indikazzjoni ta' trattament ta' episodji akuti jiġi ristrett għall-formulazzjonijiet b'rilaxx modifikat (solidi orali).
English: - The Committee considered the referral made under article of Article 6 of Commission Regulation (EC) No 1084/2003, for Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) initiated by The Netherlands.
Maltese: - Il-Kumitat ikkunsidra r-referenza magħmula skont l-Artikolu 6 tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003, għal Valproate-ratiopharm chrono 300/500 mg Retardtabletten (u lismijiet assoċjati) li nbdiet mill-Olanda.
English: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Maltese: Il-Polonja ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: Taking into account that in different EU member States the authorised valproate products may have or not the indication for the bipolar disorder the CHMP has the following proposal:
Maltese: Wara li kkunsidra li fi Stati Membri diversi tal-UE, il-prodotti ta' valproate awtorizzati jista' jkollhom l-indikazzjoni għad-disturb bipolari jew le, is-CHMP għandu l-proposta li ġejja:
English: - acute mania and for the prevention of recurrence in patients with bipolar disorder - Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive.
Maltese: - manija akuta u għall-prevenzjoni ta' rikorrenza f'pazjenti b'disturb bipolari - Manija, fejn tista' tħossok eċċitat ħafna, ewforiku, aġitat, entużjast jew attiv iżżejjed.
English: 2.2 Risk Management Plan
Maltese: 2 Sikurezza
English: According to the CHMP recommendation for Valproate-ratiopharm chrono 300/500 mg Retardtabletten and associated names the indication should be adapted in the following due to the limitations and shortcomings of the data from clinical trials:
Maltese: Skont ir-rakkomandazzjoni tas-CHMP għal Valproate-ratiopharm chrono 300/500 mg Retardtabletten (u l-ismijiet assoċjati), l-indikazzjoni għandha tiġi addattata f'dan li ġej minħabba l-limitazzjonijiet u n-nuqqasijiet tad-dejta minn provi kliniċi:
English: Dedicated studies have shown that valproate can be used safely in combination with antipsychotic drugs.
Maltese: Studji ddedikati wrew li valproate jista' jintuża b'mod sikur flimkien ma' mediċini antipsikotiċi.
English: In 2008, in light of the results of the US FDA meta-analysis of clinical trial data for antiepileptics, and in light of the spontaneous and literature reports, the PhVWP concluded that any antiepileptic drug may be associated with a low risk of suicidal thoughts and behaviour.
Maltese: Fl-2008, fid-dawl tar-riżultati tal-meta-analiżi tal-US FDA tad-dejta tal-provi kliniċi għallantiepilettiċi, u fid-dawl tar-rapporti spontanji u dokumentati, il-PhVWP ikkonkluda li kwalunkwe mediċina antiepilettika tista' tiġi assoċjata ma' riskju baxx ta' ideat u mġiba ta' suwiċidju.
English: - The Committee concluded that Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) have a positive benefit-risk ratio in the proposed amended indication for the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated.
Maltese: - Il-Kumitat ikkonkluda li Valproate-ratiopharm chrono 300/500 mg Retardtabletten (u l-ismijiet assoċjati) għandu proporzjon pożittiv tal-benefiċċji/riskji fl-indikazzjoni emendata proposta għall-kura ta' manija f'disturb bipolari meta litju huwa kontra-indikat jew mhuwiex ittollerat.
English: Children and adolescents under 18 years of age: {Invented name} should not be used in children and adolescents under 18 years of age for the treatment of mania.
Maltese: Tfal u adolexxenti ta' taħt it-18-il sena: {Isem ivvintat} m'għandux jintuża fi tfal u adolexxenti taħt l-età ta' 18-il sena għal kura ta' manija.
English: In addition, valproate has been used as the reference comparator treatment in many Phase III studies of atypical antipsychotic drugs in the treatment and prevention of mania.
Maltese: Barra minn hekk, valproate ntuża bħala t-trattament ta' paragun ta' referenza f'bosta studji tal-Fażi III ta' mediċini antipsikotiċi atipiċi fit-trattament u l-prevenzjoni tal-manija.
English: 1.2 Prevention of Recurrence of mood episodes
Maltese: 1.2 Il-Prevenzjoni tar-Rikorrenza tal-episodji tal-burdata
English: Chemical forms and formulations of valproate
Maltese: Forom u formolazzjonijiet kimiċi ta' valproate
English: However, for theoretical reasons slow-release formulations could be advantageous for compliance reasons and also for avoiding high plasma peaks which may be accompanied by frequent adverse effects.
Maltese: Madankollu, għal raġunijiet teoretiċi, ilformulazzjonijiet ta' rilaxx bil-mod jistgħu jkunu ta' vantaġġ għal raġunijiet ta' konformità u wkoll għall-evitar ta' livelli massimi ta' plażma li jistgħu jiġu akkumpanjati minn effetti avversi frekwenti.
English: Concerns were raised by the Netherlands regarding the efficacious and safe use of Valproateratiopharm chrono 300/500 mg Retardtabletten (and associated names) in the acute treatment of manic episodes and the prevention of recurrence of mood episodes in patients with bipolar disorder.
Maltese: Tqajjem tħassib mill-Olanda rigward l-użu effikaċi u sikur ta' Valproate-ratiopharm chrono 300/500 mg Retardtabletten (u l-ismijiet assoċjati) fit-trattament akut ta' episodji ta' manija u lprevenzjoni tar-rikorrenza ta' episodji tal-burdata f'pazjenti li għandhom disturb bipolari.
English: Natriumvalproaat ratiopharm chrono 300 mg 300 mg
Maltese: Natriumvalproaat ratiopharm chrono 300 mg
English: Natriumvalproaat ratiopharm chrono 500 mg 500 mg
Maltese: Natriumvalproaat ratiopharm chrono 500 mg
English: - The Committee concluded that the Product Information of all Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) should include information to the amended indication on the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated and therefore recommended the amendments to the relevant sections of the Summary of Product Characteristic and Package Leaflet accordingly.
Maltese: - Il-Kumitat ikkonkluda li l-Informazzjoni dwar il-Prodott ta' Valproate-ratiopharm chrono 300/500 mg Retardtabletten (u l-ismijiet assoċjati) kollha għandha tinkludi informazzjoni għallindikazzjoni emendata dwar it-trattament ta' manija f'disturb bipolari meta litju jkun kontraindikat jew ma jkunx tollerat u għalhekk irrakkomanda l-emendi għas-sezzjonijiet rilevanti tasSommarju tal-Karatteristiċi tal-Prodott u l-Fuljett ta' Tagħrif kif xieraq.
English: 333 mg + 145 mg Prolonged-release tablet Oral use
Maltese: 333 mg + 145 mg
English: Post-hoc analyses were done of the large Bowden study.
Maltese: Saru analiżi post-hoc tal-istudju kbir ta' Bowden.
English: BEFORE YOU TAKE {INVENTED NAME}
Maltese: ANNESS I LISTA TA`
English: Based on the submitted data it cannot be concluded, that efficacy of valproate in the claimed indication is dependent on chemical form or formulation.
Maltese: Fuq il-bażi tad-dejta sottomessa ma jistax jiġi konkluż, li l-effikaċja ta' valproate fl-indikazzjoni affermata tiddependi fuq l-għamla jew il-formulazzjoni kimika.
English: The continuation of treatment after manic episode could be considered in patients who have responded to the medicinal product for acute mania.
Maltese: Ilkontinwazzjoni tal-kura wara episodju ta' manija tista' tiġi kkunsidrata f'pazjenti li jkunu rrispondew għall-prodott mediċinali għal manija akuta.
English: As such, this represents one of the largest bodies of clinical trial data relating to the pharmacotherapy of bipolar disorder.
Maltese: B'hekk, dan jirrappreżenta waħda mill-akbar ġabriet ta' dejta ta' provi kliniċi relatati malfarmakoterapija tad-disturb bipolari.
English: However, it has recently been estimated that up to 40% of the patients with bipolar disorder do not or insufficiently respond to an adequate lithium therapy.
Maltese: Madankollu, reċentament ġie stmat li sa 40% tal-pazjenti b'disturb bipolari ma jirreaġġixxux jew ma jirreaġġixxux biżżejjed għal terapija adegwata bil-litju.
English: In addition the time to recurrence of manic and depression events has not shown differences.
Maltese: Barra minn hekk, il-ħin għarrikorrenza tal-avvenimenti manijaċi u ta' depressjoni ma weriex differenzi.