FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP was concerned that the main study was not sufficient to establish the benefit of Evoltra in the treatment of AML in elderly patients who were unsuitable for intensive chemotherapy, and that the results of a study comparing Evoltra with standard treatment would be necessary to determine the medicine's effectiveness.
Maltese: Is-CHMP kellu tħassib dwar il-fatt li l-istudju ewlieni ma kienx suffiċjenti għall-istabbiliment talbenefiċċju ta' Evoltra fit-trattament ta' AML f'pazjenti anzjani li ma kinux idonei għall-kimoterapija intensiva, u li r-riżultati ta' studju li qabbel Evoltra ma' trattament standard kienu ikun meħtieġa biex tiġi determinata l-effikaċja tal-mediċina.
English: The active substance in Evoltra, clofarabine, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells).
Maltese: Is-sustanza attiva f'Evoltra, klofarabina, hija ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qed jimmultiplikaw, bħaċ-ċelloli tal-kanċer).
English: The study did not compare Evoltra with any other treatment.
Maltese: L-istudju ma qabbilx Evoltra ma' trattament ieħor.
English: It was to be used in patients who are not suitable for intensive chemotherapy, because they have certain genetic abnormalities in their myeloid cells, ‘secondary' AML (AML following a previous blood disorder) or another disease in addition to AML, or because they are 70 years of age or older.
Maltese: Kellu jintuża f'pazjenti li mhumiex adatti għall-kimoterapija, minħabba li jkollhom ċerti anomaliji ġenetiċi fiċ-ċelloli mjelojdi tagħhom, AML ‘sekondarja' (AML wara problemi preċedenti fid-demm) jew marda oħra minbarra AML, jew minħabba li l-età tal-pazjent tkun 70 sena jew aktar.
English: In the new indication, Evoltra was also expected to be used to treat patients aged over 65 years who have acute myeloid leukaemia (AML, cancer of the myeloid cells, a type of immature white blood cell).
Maltese: Fl-indikazzjoni l-ġdida, Evoltra kien mistenni wkoll li jintuża fit-trattament ta' pazjenti ta' ‘l fuq minn 65 sena li jkollhom lewċemija mjelojde akuta (AML, kanċer fiċ-ċelloli mjelojdi, tip ta' ċellola bajda tad-demm li tkun immatura).
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 some concerns and was of the provisional opinion that Evoltra could not have been approved for the treatment of the treatment of AML in elderly patients.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Evoltra ma setax jiġi approvat għattrattament ta' AML f'pazjenti anzjani.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Evoltra had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Maltese: Ma hemm l-ebda konsegwenza fuq l-użu ta' Evoltra fl-indikazzjoni awtorizzata, fejn il-bilanċ bejn ilbenefiċċju u r-riskju jibqa' invarjat.
English: The change concerned an extension of indication to add the treatment of acute myeloid leukaemia in elderly patients.
Maltese: Kien hemm xi tħassib ukoll dwar l-effetti sekondarji tal-mediċina, li kienu jaffettwaw il-kliewi.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF A CHANGE TO THE MARKETING AUTHORISATION for EVOLTRA
Maltese: MISTOQSIJA U TWEĠIBA DWAR L-IRTIRAR TA' MODIFIKA FL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ għal EVOLTRA
English: This 5 years retrospective (new users) study will also compare the relative risk between dexamfetamine and other stimulants in the patient population.
Maltese: Dan l-istudju retrospettiv ta' 5 snin (utenti ġodda) sejjer iqabbel ukoll ir-riskju relattiv bejn dexamfetamine u stimulanti oħra fil-popolazzjoni tal-pazjenti.
English: As part of this study the MAH shall actively obtain reports of abuse, misuse, diversion and dependence in children with ADHD from poison centres, drug monitoring centres, other databases, publicly available information in the literature and online.
Maltese: Bħala parti minn dan l-istudju, l-MAH għandu jikseb b'mod attiv rapporti ta' abbuż, użu ħażin, devjazzjoni u dipendenza fi tfal b'ADHD minn ċentri tal-veleni, ċentri ta' sorveljanza talmediċina, databases oħrajn, informazzjoni disponibbli pubblikament fid-dokumentazzjoni u online.
English: The applicant shall submit an updated RMP taking into consideration the following recommendations: 1. section VI.2.5 Documentation for public summary should include a summary of risk minimisation measures by safety concern.
Maltese: 1. sezzjoni VI.2.5 Dokumentazzjoni għal sommarju pubbliku għandha tinkludi sommarju tal-miżuri ta' minimizzazzjoni tar-riskju minn tħassib fuq is-sigurtà.
English: The applicant shall conduct a PASS to evaluate the long-term safety profile of dexamfetamine in children with ADHD, specifically targeting key issues such as cardiovascular events, growth and psychiatric related adverse events.
Maltese: L-applikant għandu jwettaq PASS biex jiġi vvalutat il-profil ta' sigurtà fit-tul ta' dexamfetamine fi tfal b'ADHD, li jimmira b'mod speċifiku kwistjonijiet ewlenin bħal avvenimenti kardjovaskulari, tkabbir u avvenimenti avversi psikjatriċi.
English: 2. annex 2 should include the proposed text of the package leaflet in addition to the proposed SmPC.
Maltese: 2. anness 2 għandu jinkludi t-test propost tal-fuljett ta' tagħir flimkien mal-SmPC propost.
English: 4. part III, pharmacovigilance plan: category 1 should be added for the PASS and the DUS.
Maltese: III, pjan ta' farmakoviġilanza: kategorija 1 għandhom jiġu miżjuda għall-PASS u d-DUS.
English: The applicant shall undertake a DUS to follow the use of prescribed dexamfetamine in the European Union using multiple data sources.
Maltese: L-applikant għandu jwettaq DUS biex jiġi segwit l-użu ta' dexamfetamine preskritt fl-Unjoni Ewropea permezz ta' sorsi ta' dejta multipli.
English: 3. annex 7: should include the text of a proposed follow up form to be used for specific adverse event follow-up.
Maltese: 3. anness 7: għandu jinkludu t-test ta' formula ta' segwitu proposta li għandha tintuża għal segwitu għal avveniment avvers speċifiku.
English: Conditions to the marketing authorisations
Maltese: Kundizzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq
English: The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Maltese: L-applikant għandu jissottometti RMP aġġornat li jieħu inkonsiderazzjoni r-rakkomandazzjonijiet li ġejjin:
English: The mean age was 70.2 and 71.6 years, respectively.
Maltese: L-età medja kienet ta' 70.2 u ta' 71.6 sena, rispettivament.
English: Safety of the injectable formulations of buflomedil
Maltese: Sigurtà tal-formulazzjoni injettabbli tal-buflomedil
English: These reported 188 and 26 patients respectively who experienced AEs.
Maltese: Dawn irrapportaw 188 u 26 pazjent rispettivament li esperjenzaw AEs.
English: The CHMP also noted the two French pharmacovigilance enquiries covering the period 1998 to 2004 and 2006 to 2009.
Maltese: Is-CHMP innota wkoll iż-żewġ inkjesti Franċiżi ta' farmakoviġilanza li kienu jkopru l-perjodu 1998 sa 2004 u 2006 sa 2009.
English: The CHMP noted that the MAH did not propose to withdraw the 300 mg tablets formulation.
Maltese: Is-CHMP innota li l-MAH ma pproponiex l-irtirar talformulazzjoni tal-pilloli ta' 300 mg.
English: The EudraVigilance review identified 74 cases of adverse events associated with buflomedil, with a total of 35 cases recording cardiac adverse and 39 cases recording neurological adverse events.
Maltese: Ir-reviżjoni ta' EudraVigilance identifikat 74 każ ta' avvenimenti avversi assoċjati mal-buflomedil, b'total ta' 35 każ li rreġistraw avvenimenti avversi kardijaċi u 39 każ li rreġistraw avvenimenti avversi newroloġiċi.
English: Buflomedil is currently approved in France in the treatment of ”symptomatic peripheral arterial occlusive disease (PAOD Stage II) symptoms”.
Maltese: Il-buflomedil hija attwalment approvat fi Franza fil-kura ta' “sintomi ta' mard sintomatiku okklussiv arterjali periferali (PAOD fi Stadju II)”.
English: As a result, a procedure under Article 107 of Directive 2001/83/EC, as amended was automatically initiated.
Maltese: B'riżultat ta' dan, awtomatikament inbdiet proċedura skont lArtikolu 107 tad-Direttiva 2001/83/KE, kif emendata.
English: The approved maximum daily dose in patients with normal renal function is 600 mg and 300 mg in patients with renal impairment.
Maltese: Id-doża massima approvata ta' kuljum f'pazjenti b'funzjonament renali normali hija ta' 600 mg u ta' 300 mg f'pazjenti b'indeboliment renali.
English: This opinion supersedes the opinion on temporary measures adopted on 4 July 2011.
Maltese: Din l-opinjoni tieħu post l-opinjoni dwar miżuri temporanji adottata fl-4 ta' Lulju 2011.
English: France previously conducted two pharmacovigilance and toxicovigilance investigations following reports of nervous system and cardiac serious adverse events (SAEs) associated with the use of buflomedil.
Maltese: Preċedentement, Franza wettqet żewġ investigazzjonijiet ta' farmakoviġilanza u ta' tossikoviġilanza, wara rapporti ta' avveniment avversi serji (SAEs) kardijaċi u tas-sistema nervuża assoċjati mal-użu tal-buflomedil.
English: Various indications previously registered across the EU were deleted and the indication was restricted to the Symptomatic treatment of chronic peripheral vascular disease (stage 2) (intermittent claudication), bringing it in line with the French SmPC.
Maltese: Bosta indikazzjonijiet preċedentement irreġistrati madwar l-UE tneħħew u l-indikazzjoni ġiet ristretta għall-Kura sintomatika ta' mard periferali vaskulari kroniku (stadju 2) (claudication intermittenti), li jġibha konformi mal-SmPC Franċiż.
English: The CHMP noted the efficacy data submitted by the MAH, including the relatively recent large placebocontrolled LIMB (Limbs International Medicinal Buflomedil) study.
Maltese: Is-CHMP innota d-dejta dwar l-effikaċja sottomessa mill-MAH, inkluż l-istudju relattivament riċenti, kbir, ikkontrollat bi plaċebo LIMB (Limbs Internazzjonali Buflomedil Mediċinali).
English: The CHMP noted that according to the French experience (including the results of the Thalès study and the publication by Bruhat et al.), cases of non-compliance with the recommended dose, nonadjustment of dose in patients with renal impairment and lack of monitoring of renal function persist, resulting in cases of serious adverse events, which is unacceptable for a product for which the only benefit is a limited level of efficacy in the lower limb peripheral vascular disease indication.
Maltese: Is-CHMP innota li skont l-esperjenza Franċiża (inklużi r-riżultati tal-istudju Thalès u l-pubblikazzjoni minn Bruhat et al.), każi ta' non-konformità mad-doża rakkomandata, in-nuqqas ta' aġġustament taddoża f'pazjenti b'indeboliment renali u n-nuqqas ta' monitoraġġ tal-funzjoni renali jippersistu, li jirriżultaw f'każi ta' avvenimenti avversi serji, li mhuwiex aċċettabbli għal prodott li l-uniku benefiċċju tiegħu huwa livell limitat ta' effikaċja fl-indikazzjoni ta' mard vaskulari periferali tarriġlejn.
English: The CHMP noted a review of French Eudravigilance data analysing spontaneous reports associated with treatment with buflomedil, to identify cases where cardiac and neurological reactions occurred under normal therapeutic doses (i.e. maximum of 600 mg daily for the oral tablet formulation).
Maltese: Is-CHMP innota reviżjoni tad-dejta Franċiża ta' Eudravigilance li analizzat rapporti spontanji assoċjati ma' kura bil-buflomedil, biex jidentifika każi fejn seħħew reazzjonijiet kardijaċi u newroloġiċi taħt dożi terapewtiċi normali (jiġifieri massimu ta' 600 mg kuljum għall-formulazzjoni tal-pillola orali).
English: Regarding the LIMB study, the results indicated a trend of a decrease in symptoms (symptomatic deterioration of PAOD, amputations) although there was an increase in cardiovascular events (MI, stroke, CV deaths).
Maltese: Fir-rigward tal istudju LIMB, ir-riżultati indikaw tendenza ta' tnaqqis fis-sintomi (deterjorazzjoni sintomatika ta'PAOD, amputazzjonijiet) għalkemm kien hemm żieda f'avvenimenti kardjovaskulari (MI, puplesija, mwiet kardjovaskulari (CV)).
English: • The Committee raised concerns regarding the rapid deterioration of renal function in patients with peripheral vascular disease, requiring regular and frequent monitoring.
Maltese: • Il-Kumitat qajjem tħassib dwar id-deterjorazzjoni rapida tal-funzjoni renali f'pazjenti b'mard vaskulari periferali, li jeħtieġu monitoraġġ regolari u frekwenti.
English: According to the approved indication, the injection formulation of buflomedil is used to initiate PAOD therapy, to be followed by a switch to oral therapy.
Maltese: Skont l-indikazzjoni approvata, ilformulazzjoni tal-injezzjoni tal-buflomedil tintuża biex tinbeda terapija PAOD, li għandha tiġi segwita minn qalba għal terapija orali.
English: The CHMP also examined a review of all available individual case safety data related to buflomedil, conducted by the MAH, based on post-marketing safety data from Abbott Laboratories' global safety database and Amdipharm's safety database, published medical literature (worldwide) and from a number of other sources, including Toxicology/Poison Control Centres and Regulatory Authorities.
Maltese: Is-CHMP eżamina wkoll reviżjoni tad-dejta kollha disponibbli dwar każi individwali ta' sigurtà relatati mal-buflomedil, imwettqa mill-MAH, abbażi tad-dejta dwar is-sigurtà wara t-tqegħid fis-suq mid-database ta' Abbott Laboratories dwar is-sigurtà globali u mid-database ta' Amdipharm dwar is-sigurtà, mill letteratura medika ppubblikata (madwar id-dinja) u minn għadd ta' sorsi oħra, inkluż minn Ċentri għall-Kontroll tal-Velenu/Tossikoloġiku u minn Awtoritajiet Regolatorji.
English: • The Committee considered that buflomedil-containing medicinal products showed only limited clinical efficacy in the symptomatic treatment of chronic peripheral vascular disease.
Maltese: • Il-Kumitat ikkunsidra li prodotti mediċinali li fihom il-buflomedil urew biss effikaċja klinika limitata fil-kura sintomatika ta' mard vaskulari periferali kroniku.
English: There were 6 cases of cardiovascular and 6 cases of neurological serious adverse events.
Maltese: Kien hemm 6 każi ta' avvenimenti avversi serji kardjovaskulari u 6 każi newroloġiċi.
English: Thalès observational drug utilisation study
Maltese: Thalès dwar l-użu tal-mediċina
English: Overall summary on safety and on risk minimisation measures
Maltese: Miżuri għall-minimizzazzjoni tar-riskju
English: Buflomedil is an α1-, α2-adrenolytic agent with vasoactive and haemorheologic properties, improving the blood flow in the microcirculation as well as tissue oxygenation.
Maltese: Is-sustanza buflomedil hija aġent adrenolittiku tat-tip α1 u α2 b'karatteristiċi vażoattivi u emoreoloġiċi, li żżid il-fluss tad-demm fil-mikroċirkolazzjoni kif ukoll l-ossiġenazzjoni tat-tessuti.
English: The CHMP also noted the pharmacovigilance and toxicovigilance data which show no improvement of the safety profile of buflomedil despite the implementation of the RMP in France in 2006; instead, a two fold increase of misuse compared to the previous period was observed.
Maltese: Is-CHMP innota wkoll li dejta ta' farmakoviġilanza u ta' tossikoviġilanza ma turi l-ebda titjib fil-profil ta' sigurtà tal-buflomedil minkejja l-implimentazzjoni tal-RMP fi Franza fl-2006; minflok, ġiet osservata żieda ta' darbtejn flużu ħażin meta mqabbla mal-perjodu preċedenti.
English: Serious cardiovascular and neurological adverse events under normal conditions of use
Maltese: Avvenimenti avversi serji kardjovaskulari u newroloġiċi taħt kundizzjonijiet normali ta' użu
English: In these enquires, the reported nervous system SAEs consisted mainly of convulsions, myoclonia and status epilepticus while the cardiac SAEs consisted mainly of tachycardia, hypotension, ventricular rhythm disorders and cardiac arrest.
Maltese: F'dawn l-inkjesti, l-SAEs irrapportati tas-sistema nervuża kienu jikkonsistu prinċipalment minn konvulżjonijiet, majoklonja u status epilepticus filwaqt li l-SAEs kardijaċi kienu jikkonsistu prinċipalment minn takikardja, pressjoni baxxa, disturbi fir-rittmi ventrikulari u arrest kardijaku.
English: The CHMP noted that of the 24 reported cases (about 5% of all adverse drug reactions recorded in the MAH database), a majority (13 out of 24) were cases of accidental overdose.
Maltese: Is-CHMP innota li mill-24 każ irrapportati (madwar 5% tar-reazzjonijiet avversi kollha tal-mediċina rreġistrati fiddatabase tal-MAH), il-maġġoranza (13 minn 24) kienu każi ta' doża eċċessiva aċċidentali.
English: The CHMP acknowledged that variations to implement the European harmonisation of the SmPC are still ongoing in some countries but noted that the RMP proposed by Amdipharm in May 2010 was largely equivalent to the RMPs already implemented in France.
Maltese: Is-CHMP irrikonoxxa li l-varjazzjonijiet biex jimplimentaw l-armonizzazzjoni Ewropea tal-SmPC għadhom għaddejjin f'xi pajjiżi imma nnota li l-RMP propost minn Amdipharm f'Mejju 2010 kien bażikament ekwivalenti għall-RMPs diġà implimentati fi Franza.
English: Overall benefit-risk assessment
Maltese: Valutazzjoni ġenerali tal-benefiċċju-riskju
English: The CHMP noted the proposed additional revisions to the SmPC, restricting the population by further narrowing the PAOD indication and revising the wording of the contraindication in severe renal impairment in order to improve compliance to prescribing in the event of renal insufficiency.
Maltese: IsCHMP innota li r-reviżjonijiet addizzjonali proposti lill-SmPC, ir-restrizzjoni tal-popolazzjoni billi lindikazzjoni PAOD tkompli titnaqqas u r-reviżjoni tat-test tal-kontraindikazzjoni f'indeboliment renali sever sabiex titjieb il-konformità għall-preskrizzjoni fil-każ ta' insuffiċjenza renali.
English: The study showed that about 30% of patients with renal failure still receive an excessive dose, although it was noted that this had decreased from 75% prior to the DHPC.
Maltese: L-istudju wera li madwar 30% tal-pazjent b'insuffiċjenza renali għadhom jirċievu doża eċċessiva, għalkemm ġie nnotat li din kienet naqset minn 75% qabel idDHPC.
English: As the Risk Management Plan (RMP) proposed in the scope of this Article 107 procedure is equivalent to the French RMP implemented in 2006, the CHMP was therefore of the opinion that it is possible to conclude on the effectiveness of the proposed RMMs, despite the lack of implementation in all member states.
Maltese: Peress li Pjan għall-Ġestjoni tar-Riskju (RMP) propost fil-kamp ta' applikazzjoni talproċedura ta' dan l-Artikolu 107 huwa ekwivalenti għall-RMP Franċiż implimentat fl-2006, is-CHMP kien għalhekk tal-opinjoni li huwa possibbli li jiġi konkluż dwar l-effikaċja tal-RMMs proposti, minkejja n-nuqqas ta' implimentazzjoni fl-istati membri kollha.
English: Discussion on safety
Maltese: Diskussjoni dwar is-sigurtà
English: Grounds for the suspension of the Marketing Authorisations
Maltese: Ewropea s-sospensjoni tal
English: Annex II Scientific conclusions and grounds for the suspension of the marketing and use of the products presented by the EMA
Maltese: Anness II Konklużjonijiet xjentifiċi u r-raġunijiet għas-sospensjoni tat-tqegħid fissuq u l-użu tal-prodotti ppreżentati mill-EMA
English: The study compared a reference period of 6 months before the 2006 French evaluation with two 6-months evaluation periods following the implementation of the resulting RMMs and the circulation of a DHPC.
Maltese: Franċiża tal-2006 ma' żewġ perjodi ta' valutazzjoni ta' 6 xhur wara l-implimentazzjoni tal-RMMs li rriżultaw u ċ-ċirkolazzjoni ta' DHPC.
English: In addition, the CHMP observed with concern that an initial assessment of renal function was only carried out in 20% of patients and that measurements of creatinine clearance were only performed in 17% of patients, despite the SmPC recommendations.
Maltese: Barra minn hekk, is-CHMP osserva bi tħassib li valutazzjoni inizjali talfunzjoni renali saret biss f'20% tal-pazjenti u li l-kejl għat-tneħħija ta' creatinine sar biss fi 17% tal-pazjenti, minkejja r-rakkomandazzjonijiet tas-SmPC.
English: With regards to safety, the CHMP concluded that the use of buflomedil is associated with a number of serious cardiological (mainly tachycardia, hypotension, ventricular rhythm disorders and cardiac arrest) and neurological (mainly convulsions, myoclonia and status epilepticus) adverse events, which occur under normal conditions of use, particularly in elderly patients, who are predominantly the patient population relevant to the approved indication.
Maltese: Fir-rigward tas-sigurtà, is-CHMP ikkonkluda li l-użu tal-buflomedil huwa assoċjat ma' numru ta' avvenimenti avversi serji kardjoloġiċi (prinċipalment takikardja , pressjoni baxxa, disturbi fir-ritmu ventrikulari u arrest kardijaku) u newroloġiċi (prinċipalment konvulżjonijiet, majoklonja u status epilepticus), li jseħħu taħt kundizzjonijiet normali ta' użu, partikularment f'pazjenti anzjani, li predominantement huma l-popolazzjoni ta' pazjenti rilevanti għall-indikazzjoni approvata.
English: In December 2010, a further French benefit-risk evaluation of buflomedil was carried out, following which the French National Competent Authority suspended all French Marketing Authorisations for buflomedil-containing products.
Maltese: F'Diċembru 2010, twettqet valutazzjoni ulterjuri Franċiża tal-benefiċċju-riskju tal-buflomedil, u wara dan l-Awtorità Nazzjonali Kompetenti Franċiża ssospendiet l-Awtorizzazzjonijiet għat-Tqegħid fis-Suq Franċiżi kollha għal prodotti li fihom il-buflomedil.
English: Buflomedil-containing medicines are authorised and marketed in 12 EU countries by national procedures and were first authorised in France in 1974.
Maltese: Mediċini li fihom il-buflomedil huma awtorizzati u mqiegħda fis-suq fi 12-il pajjiż tal-UE permezz ta' proċeduri nazzjonali u fl-UE kienu ġew awtorizzati l-ewwel fl-1974, fi Franza.
English: In addition, 32 cardiological adverse events were retrieved; the most frequent reactions were tachycardia, hypertension, flushing and hypotension.
Maltese: Barra minn hekk, inġabru 32 avveniment avvers kardjoloġiku; l-aktar reazzjonijiet frekwenti kienu takikardja, pressjoni għolja, fwawar u pressjoni baxxa.
English: The CHMP also considered a review of the individual case safety reports (ICSR) database conducted by the MAH, to identify cases of cardiological or neurological adverse events under normal conditions of use, i.e. cases where the dose did not exceed the maximum daily dose of 600mg, cases with accidental overdoses or cases including patients with known renal impairment requiring dose adjustment.
Maltese: Is-CHMP ikkunsidra wkoll reviżjoni tad-database ta' rapporti dwar każi individwali ta' sigurtà (ICSR) mwettqa mill-MAH, biex jidentifika każi ta' avvenimenti avversi kardjoloġiċi jew newroloġiċi taħt kundizzjonijiet normali ta' użu, jiġifieri każi fejn id-doża ma kinitx taqbeż id-doża massima ta' kuljum ta' 600 mg, każi ta' dożi eċċessivi aċċidentali jew każi li jinkludu pazjenti b'indeboliment renali magħruf li kienu jeħtieġu aġġustament tad-doża.
English: The CHMP also noted the results of the Thalès observational drug utilisation study, including 300 000 patients and conducted to assess the impact of the RMMs implemented in France on prescription patterns.
Maltese: Thalès dwar l-użu tal-mediċina, li fih ħadu sehem 300 000 pazjent u li sar biex jevalwa l-impatt tal-RMMs implimentati fi Franza fuq mudelli ta' preskrizzjoni.
English: Overall summary of the scientific evaluation of buflomedil-containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti mediċinali li fihom il-buflomedil (ara l-Anness I)
English: The reported ADRs were mainly related to serious neurological and cardiovascular ADRs.
Maltese: L-ADRs irrapportati kienu prinċipalment relatati ma' ADRs serji newroloġiċi u kardjovaskulari.