FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently encountered serious adverse events were comas (75 cases).
Maltese: L-aktar avvenimenti avversi serji innotati b'mod komuni kienu koma (75 każ).
English: Overall benefit-risk assessment
Maltese: Evalwazzjoni ġenerali tal-benefiċċju-riskju
English: The most frequently encountered serious adverse events were comas (11 cases), consciousness disorders (16 cases), confusion states (15 cases) and intoxications (33 cases, including deliberate, accidental or nonspecified).
Maltese: L-aktar avvenimenti avversi serji innotati b'mod komuni kienu koma (11-il każ), disturbi fl-għarfien (16-il każ), stati ta' konfużjoni (15-il każ) u intossikazzjonijiet (33 każ, inkluż intenzjonati, aċċidentali jew mhux speċifikati).
English: The study period was defined as covering the period July 2009 to March 2011 and the resulting data was compared to data from the May 2006 to July 2009 period.
Maltese: Il-perjodu tal-istudju kien definit bħala li jkopri l-perjodu ta' bejn Lulju 2009 sa Marzu 2011 u d-dejta li rriżultat tqabblet mad-dejta mill-perjodu Mejju 2006 sa Lulju 2009.
English: The CHMP noted that despite the 10% decrease in the proportion of elderly patient during the current study period, elderly patients remained the main affected age group (40% of patients over 65 years of age and 32% of patients over 75 years of age).
Maltese: Is-CHMP innota li minkejja t-tnaqqis ta' 10% fil-proporzjon ta' pazjenti anzjani matul il-perjodu attwali ta' studju, ilpazjenti anzjani baqgħu l-aktar grupp prinċipali ta' età milqut (40% tal-pazjenti kellhom aktar minn 65 sena u 32% tal-pazjenti kellhom aktar minn 75 sena).
English: Regarding the meprobamate/aceprometazine combination products, the second Lille CPRV analysis identified 365 medically confirmed cases during the study period, of which 277 (76%) were recorded as serious (corresponding to 894 adverse events) while 88 were recorded as non-serious (corresponding to 153 adverse events).
Maltese: Fir-rigward tal-prodotti li kien fihom kombinazzjoni ta' meprobamat u aceprometazine, it-tieni analiżi ta' Lille CPRV identifikat 365 każ medikament ikkonfermat matul il-perjodu tal-istudju, li minnhom 277 (76%) kienu reġistrati bħala serji (li jikkorrispondu għal 894 episodju avvers) filwaqt li 88 kienu reġistrati bħala mhux serji ( li jikkorrispondu għal 153 avveniment avvers).
English: During the study period, the main adverse events occurred generally in the SOCs nervous system disorders (34%), procedure-related lesions/intoxications and complications (8%) and general disorders (8%).
Maltese: Matul il-perjodu tal-istudju, l-avvenimenti avversi ewlenin ġeneralment seħħew fid-disturbi fis-sistema nervuża (34%), leżjonijiet/intossikazzjonijiet u komplikazzjonijiet relatati ma' proċedura (8%) u disturbi ġenerali (8%) tas-SOC.
English: The CHMP also reviewed spontaneous case reports submitted to the Eudravigilance database and identified 18 cases of accidental overdoses, of which 17 were fatal.
Maltese: Is-CHMP irreveda wkoll rapporti ta' każijiet spontanji sottomessi lid-database ta' Eudravigilance u identifika 18-il każ ta' dożi eċċessivi aċċidentali, li 17 minnhom kienu fatali.
English: Other frequent SOCs were psychiatric disorders, skin and subcutaneous tissue disorders, and haematologic and lymphatic disorders (6-9% each).
Maltese: SOCs frekwenti oħra kienu disturbi psikjatriċi, disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda, u disturbi ematoloġiċi u limfatiċi (6-9% kull wieħed).
English: This is comparable to the 15 fatalities (including 7 due to overdoses) recorded during the May 2006 to July 2009 period.
Maltese: Dan huwa komparabbli mal-15-il fatalità (inkluż 7 minħabba dożi eċċessivi) irreġistrati matul il-perjodu ta' bejn Mejju 2006 u Lulju 2009.
English: Meprobamate is considered to have a relatively narrow therapeutic index, with a steep dose-response curve, resulting in an increased risk of unintentional overdoses with serious and potentially fatal adverse events, including coma, profound hypotension, hypothermia, respiratory arrest and cardiogenic shock.
Maltese: Meprobamat huwa kkunsidrat li għandu indiċi terapewtiku relattivament dejjaq, b'kurva wieqfa tad-doża rispons, li jwassal għal żieda fir-riskju ta' dożi eċċessivi mhux intenzjonati b'avvenimenti avversi serji u potenzjalment fatali, inkluż koma, pressjoni baxxa profonda, ipotermja, arrest respiratorju u xokk kardjoġeniku.
English: System Organ Classes (SOCs) nervous system disorders (29%) and procedure-related lesions/intoxications and complications (12%).
Maltese: Matul il-perjodu tal-istudju, l-avvenimenti avversiewlenin irrapportati ġeneralment seħħew fis-Sistema tal-Klassifika tal-Organi (SOCs) bħala disturbi fissistema nervuża (29%) u leżjonijiet/intossikazzjonijiet u komplikazzjonijiet relatati ma' proċedura (12%).
English: 6 cases of inhalation pneumopathy and 3 cases of addiction/withdrawal were reported.
Maltese: Ġew irrapportati 6 każijiet ta' pnewmopatija wara inalazzjoni u 3 każijiet ta' dipendenza/astinenza.
English: The CHMP considered that the data identified a risk of pharmacodependence, based on utilization data issued from a claims database showing prolonged use of meprobamate.
Maltese: Is-CHMP ikkunsidra li d-dejta identifikat riskju ta' farmakodipendenza, abbażi ta' dejta ta' utilizzazzjoni maħruġa minn database ta' indikazzjonijiet li turi l-użu fit-tul ta' meprobamat.
English: Two recent pharmacovigilance analyses of data from spontaneous reports, conducted by the Lille CRPV (Centre régional de pharmacovigilance) and finalised in 2011, did not identify any significant impact of the implemented risk minimisation measures and noted the lack of clinical data on the benefit of these products.
Maltese: Żewġ analiżi riċenti talfarmakoviġilanza ta' dejta minn rapporti spontanji, li saru mill-Lille CRPV (Centre régional de farmakoviġilanza) u ffinalizzati fl-2011, ma identifikaw l-ebda impatt sinifikanti tal-miżuri għallminimizzazzjoni tar-riskju li ġew implimentati u nnotaw in-nuqqas ta' dejta klinika dwar il-benefiċċju ta' dawn il-prodotti.
English: There were also reports of consciousness disorders (36 cases), falls (30 cases), hypotension (26 cases) and confusion and disorientation (20 cases).
Maltese: Kien hemm ukoll rapporti ta' disturbi fl-għarfien (36 każ), waqgħat (30 każ), pressjoni baxxa (26 każ) u konfużjoni u diżorjentament (20 każ).
English: As a result, a procedure under article 107 of Directive 2011/83/EC was automatically initiated at European level for meprobamate-containing medicinal products for oral use.
Maltese: B'riżultat ta' dan, skont l-Artikolu 107 tad-Direttiva 2011/83/KE inbdiet proċedura awtomatika fuq livell Ewropew għal prodotti mediċinali għall-użu orali li fihom meprobamat.
English: Meprobamate can cause physical and psychological dependence and a potentially life-threatening abstinence syndrome with delirium on abrupt withdrawal, in particular after prolonged use, with pharmacological effects similar to those of alcohol and barbiturates, including within the normal dosage and treatment duration, due to the nature of the product.
Maltese: Meprobamat jista' jikkawża dipendenza fiżika u psikoloġika u sindromu ta' astinenza potenzjalment fatali b'delirju meta jitwaqqaf f'daqqa, b'mod partikolari wara l-użu fit-tul, b'effetti farmakoloġiċi simili għal dawk talalkoħol u tal-barbiturati, inkluż f'dożaġġ normali u waqt tul tal-kura normali, minħabba n-natura talprodott.
English: In conclusion, taking into account the serious neurological and psychiatric adverse events associated with the use of meprobamate, including under normal conditions of use, the risk of accidental overdoses and of pharmacodependence associated with withdrawal symptoms, the very limited clinical evidence of meprobamate and the lack of effectiveness of the implemented and proposed risk minimisation measures, the CHMP was of the opinion that the risk-benefit balance of meprobamatecontaining medicinal products for oral use is not positive under normal conditions of use.
Maltese: Bħala konklużjoni, b'kunsiderazzjoni tal-avvenimenti avversi serji newroloġiċi u psikjatriċi assoċjati mal-użu ta' meprobamat, inkluż taħt kondizzjonijiet normali ta' użu, ir-riskju ta' dożi eċċessivi aċċidentali u ta' farmakodipendenza assoċjati ma' sintomi ta' astinenza, l-evidenza klinika limitata ħafna ta' meprobamat u n-nuqqas ta' effikaċja tal-miżuri implimentati u proposti għall-minimizzazzjoni tar-riskju, is-CHMP kien tal-opinjoni li l-bilanċ tal-benefiċċju-riskju ta' prodotti mediċinali għall-użu orali li fihom meprobamat ma kienx pożittiv taħt kundizzjonijiet normali ta' użu.
English: By comparison, 308 serious and non-serious reports were recorded during the 2001 to 2006 period.
Maltese: B'paragun, ġew reġistrati 308 rapporti serji u mhux serji matul il-perjodu ta' bejn l-2001 u l-2006.
English: The CHMP was concerned by the identified risk of pharmacodependence, including in cases under normal conditions of use, as suggested by the 17 reported cases of pharmacodependence and withdrawal symptoms (13 serious and 4 non-serious).
Maltese: Is-CHMP kien imħasseb minħabba r-riskju identifikat ta' farmakodipendenza, inkluż f'każijiet taħt kondizzjonijiet normali ta' użu, kif issuġġerit mis-17-il każ ta' farmakodipendenza rrapportati u sintomi ta' astinenza (13 serji u 4 mhux serji).
English: The risks of serious withdrawal symptoms were also acknowledged by the MAH during the oral explanation.
Maltese: Ir-riskji ta' sintomi serji ta' astinenza kienu rikonoxxuti wkoll mill-MAH waqt lispjegazzjoni orali.
English: With regards to safety, the CHMP considered that a number of serious neurological (coma, loss of consciousness) and psychiatric (pharmacodependence and withdrawal symptoms) adverse events, which can be serious and potentially fatal, have been reported with the use of meprobamate, including under normal conditions of use.
Maltese: Fir-rigward ta' sigurtà, is-CHMP ikkunsidra li ġew irrapportati għadd ta' avvenimenti avversi serji newroloġiċi (koma, telf mis-sensi) u psikjatriċi (farmakodipendenza u sintomi ta' astinenza), li jistgħu jkunu serji u potenzjalment fatali, bl-użu ta meprobamat, inkluż taħt kondizzjonijiet normali ta' użu.
English: Grounds for the suspension of the Marketing Authorisations
Maltese: Raġunijiet għas-sospensjoni tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq
English: 7 fatalities associated with meprobamate were reported during the study period (including 2 due to overdoses).
Maltese: Matul il-perjodu tal-istudju ġew irrapportati 7 imwiet assoċjati ma' meprobamat (inkluż 2 minħabba dożi eċċessivi).
English: The overall reports involved patients over the age of 65 in 22% of cases and patients aged 75 and over in 13% of cases.
Maltese: Ir-rapporti globali kienu jinvolvu pazjenti li kellhom aktar minn 65 sena fi 22% talkażijiet u pazjenti li kellhom aktar minn 75 sena fi 13% tal-każijiet.
English: Annex II Scientific conclusions and grounds for the suspension of the marketing authorisations presented by the EMA
Maltese: Anness II Konklużjonijiet xjentifiċi u r-raġunijiet għas-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq ippreżentati mill-EMA
English: • The CHMP considered that the available data showed only very limited clinical efficacy of meprobamate in its approved indications.
Maltese: • Is-CHMP ikkunsidra li d-dejta disponibbli uriet biss effikaċja klinika limitata ħafna ta' meprobamat fl-indikazzjonijiet approvati tiegħu.
English: The CHMP was of the opinion that the identified risks persist, despite the implemented risk minimisation measures, particularly in patients over the age of 65, who are at high risk of falls and confusion.
Maltese: Is-CHMP kien tal-opinjoni li minkejja l-miżuri implimentati għallminimizzazzjoni tar-riskju, ir-riskji identifikati jippersistu, speċjalment f'pazjenti ta' aktar minn 65 sena, li qegħdin f'riskju għoli ta' waqgħat u ta' konfużjoni.
English: Overall summary of the scientific evaluation of meprobamate-containing medicinal products for oral use (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali għall-użu orali li fihom meprobamat (ara Anness I)
English: This was confirmed by the analysis, which identified 9 cases of addiction/withdrawal during the study period (3 serious cases and 6 non-serious cases).
Maltese: Dan kien ikkonfermat mill-analiżi, li identifikat 9 każijiet ta' dipendenza/astinenza matul il-perjodu tal-istudju (3 każijiet serji u 6 każijiet mhux serji).
English: Following a number of French national safety and efficacy reviews and pharmacovigilance analyses of meprobamate, the French National Competent Authority (Afssaps) implemented risk minimisation measures to reduce the identified risks of meprobamate and initiated national pharmacovigilance analyses to assess the impact of these measures.
Maltese: Wara għadd ta' reviżjonijiet nazzjonali Franċiżi tas-sigurtà u l-effikaċja u analiżi tal-farmakoviġilanza ta' meprobamat, l-Awtorità Kompetenti Nazzjonali Franċiża (Afssaps) implimentat miżuri għallminimizzazzjoni tar-riskju biex jitnaqqas ir-riskji identifikati ta' meprobamat u tat bidu għal analiżi nazzjonali ta' farmakoviġilanza biex tevalwa l-impatt ta' dawn il-miżuri.
English: In summary, the CHMP noted the 52 fatal cases identified (including 30 cases of overdoses) in the two French pharmacovigilance analyses, for which an association with meprobamate was considered possible.
Maltese: Fil-qosor, is-CHMP innota li t-52 każ fatali identifikati (inkluż 30 każ ta' dożi eċċessivi) fiż-żewġ analiżi Franċiżi ta' farmakoviġilanza, li r-rabta tagħhom ma' meprobamat kienet ikkunsidrata possibbli.
English: • The CHMP considered that meprobamate has a potential for pharmacodependence under normal conditions of use and that as a consequence, meprobamate is also associated with a risk of serious withdrawal symptoms.
Maltese: • Is-CHMP ikkunsidra li meprobamat għandu l-potenzjal għal farmakodipendenza taħt kondizzjonijiet normali ta' użu u li bħala konsegwenza, meprobamat huwa assoċjat ukoll ma' riskju ta' sintomi serji ta' astinenza.
English: The measures were also inadequate to address the risk of pharmacodependence and of serious withdrawal symptoms.
Maltese: Ilmiżuri kienu wkoll inadegwati biex jindirizzaw ir-riskju ta' farmakodipendenza u ta' sintomi serji ta' astinenza.
English: With regard to risk minimisation measures, the CHMP reviewed the pharmacovigilance analyses of the impact of the risk minimisation measures for meprobamate and meprobamate/aceprometazine implemented in France and the limited additional risk minimisation measures proposed by the MAHs.
Maltese: Fir-rigward tal-miżuri għall-minimizzazzjoni tar-riskju, is-CHMP irreveda l-analiżi ta' farmakoviġilanza tal-impatt tal-miżuri għall-minimizzazzjoni tar-riskju għal meprobamat u meprobamat/aceprometazine implimentati fi Franza u l-miżuri limitati addizzjonali għall-minimizzazzjoni tar-riskju proposti mill-MAHs.
English: Afssaps therefore considered the benefit-risk of meprobamate-containing products to be unfavourable and notified the European Medicines Agency (EMA) and the Committee for Medicinal Products for Human Use (CHMP) on 25 July 2011 of its intention to suspend the French marketing authorisations of oral medicines containing meprobamate, effective as of January 2012.
Maltese: Għalhekk l-Afssaps ikkunsidrat li l-benefiċċju-riskju tal-prodotti li fihom meprobamat kien sfavorevoli u fil-25 ta' Lulju 2011 innotifikat lill-Aġenzija Ewropea tal-Mediċini (EMA) u lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tissospendi lawtorizzazzjonijiet Franċiżi għat-tqegħid ta' mediċini orali li fihom meprobamat, b'effett minn Jannar 2012.
English: A number of indications are approved across Europe, including aid for alcohol withdrawal, treatment of anxiety states, treatment of muscle tension, cramps or spastic state of voluntary muscles, symptomatic treatment of digestive functional disorders, treatment of migraine attacks and treatment of occasional insomnia.
Maltese: Hemm għadd ta' indikazzjonijiet approvati madwar l-Ewropa, inkluż għajnuna għallastinenza mill-alkoħol, il-kura ta' stati ta' ansjetà, il-kura ta' tensjoni fil-muskoli, bugħawwieġ jew stat spastiku tal-muskoli volontarji, il-kura sintomatika ta' disturbi diġestivi funzjonali, il-kura ta' attakki tal-emigranja u l-kura ta' insomnija okkażjonali.
English: Discussion on efficacy
Maltese: III tal-Opinjoni).
English: • The CHMP considered, based on the assessment of the impact of the risk minimisation measures implemented in France and of the limited additional risk minimisation measures proposed by the MAHs, that no risk minimisations measures could be identified that would adequately reduce the identified risks associated with the use of meprobamate to a clinically acceptable level.
Maltese: • Is-CHMP ikkunsidra, abbażi tal-evalwazzjoni tal-impatt tal-miżuri għall-minimizzazzjoni tar-riskju implimentati fi Franza u tal-miżuri limitati addizzjonali għall-minimizzazzjoni tar-riskju proposti mill-MAHs, li ma setgħu jiġu identifikati l-ebda miżuri għall-minimizzazzjoni tar-riskju li b'mod adegwat jistgħu jnaqqsu r-riskji identifikati assoċjati mal-użu ta' meprobamat għal livell klinikament aċċettabbli.
English: This analysis assessed the impact of the implementation of the 2009 risk minimisation measures (restriction of the indications, reduction of pack size and circulation of a DHPC) on their risk profile.
Maltese: Din l-analiżi evalwat l-impatt tal-implimentazzjoni tal-miżuri għall-minimizzazzjoni tar-riskju tal-2009 (restrizzjoni tal-indikazzjonijiet, tnaqqis fid-daqs tal-pakkett u ċirkolazzjoni ta' DHPC) fuq ilprofil tar-riskju tagħhom.
English: The CHMP reviewed the available data submitted by the MAHs but considered that this limited data was insufficient to conclude on the safety of meprobamate and the predictability of any associated risks.
Maltese: Is-CHMP irreveda d-dejta disponibbli sottomessa mill-MAHs iżda kkunsidra li din id-dejta limitata ma kinitx biżżejjed biex jikkonkludi dwar is-sigurtà ta' meprobamat u l-prevedibbiltà ta' xi riskji assoċjati.
English: Oral formulations of meprobamate have been authorised in the EU as prescription-only products.
Maltese: Il-formulazzjonijiet orali ta' meprobamat ġew awtorizzati fl-UE bħala prodotti li jistgħu jinkisbu biss bi preskrizzjoni medika.
English: Based on the same Eudravigilance dataset, the CHMP also noted 11 cases of withdrawal symptoms, of which one was fatal.
Maltese: Abbażi tal-istess sett ta' dejta ta' Eudravigilance, is-CHMP innota wkoll 11-il każ ta' sintomi ta' astinenza, li wieħed minnhom kien fatali.
English: However, the CHMP was of the opinion that this may have increased the risks of adverse events with meprobamate due to interactions and therefore it cannot be excluded that meprobamate may have had a contributory role.
Maltese: Madankollu, isCHMP kien tal-opinjoni li dan seta' żied ir-riskji ta' avvenimenti avversi bi meprobamat minħabba interazzjonijiet u għalhekk ma jistax jiġi eskluż li meprobamat seta' kellu rwol kontributorju.
English: The second analysis reviewed a combination product containing meprobamate together with aceprometazine, indicated in the treatment of occasional insomnia, with a treatment duration of 2 to 5 days.
Maltese: It-tieni analiżi irrivediet prodott li kien fih kombinazzjoni ta' meprobamat flimkien ma' aceprometazine, indikat għall-kura ta' insomnija okkażjonali, b'tul ta' kura ta' 2 sa 5 ijiem.
English: This analysis assessed the impact of the implementation of risk minimisation measures (restriction of the indication and the posology as well as a reduction of the pack size) on its risk profile.
Maltese: Din l-analiżi evalwat l-impatt talimplimentazzjoni tal-miżuri għall-minimizzazzjoni tar-riskju (restrizzjoni tal-indikazzjoni u talpożoloġija, kif ukoll tnaqqis fid-daqs tal-pakkett) fuq il-profil tar-riskju tiegħu.
English: The CHMP also noted the pharmacovigilance analyses of the impact of the risk minimisation measures for meprobamate and meprobamate/aceprometazine implemented in France, which did not result in a significant nor sufficient reduction of the incidence of adverse reactions associated with meprobamate, including in cases of normal conditions of use.
Maltese: Is-CHMP innota wkoll l-analiżi ta' farmakoviġilanza tal-impatt tal-miżuri għall-minimizzazzjoni tar-riskju għal meprobamat u għal meprobamat/aceprometazine implimentati fi Franza, li la rriżultaw fi tnaqqis sinifikanti u lanqas suffiċjenti fl-inċidenza ta' reazzjonijiet avversi assoċjati ma' meprobamat, inkluż f'każijiet ta' kondizzjonijiet normali ta' użu.
English: Giving due consideration to the serious risk of withdrawal symptoms, the CHMP recommended that the withdrawal of meprobamate from the market should be implemented over a 15 month period, in order to ensure the safe termination of treatment or switching of patients already being treated with meprobamate.
Maltese: B'kunsiderazzjoni xierqa għar-riskju serju ta' sintomi ta' astinenza, is-CHMP irrakkomanda li l-irtirar ta' meprobamat mis-suq għandu jiġi implimentati fuq perjodu ta' 15-il xahar, sabiex tiġi żgurata t-terminazzjoni sigura tal-kura jew il-qalba ta' pazjenti li diġà qegħdin jirċievu kura bi meprobamat.
English: This is of particular concern in the elderly population.
Maltese: Dan huwa ta' tħassib partikolari fil-popolazzjoni anzjana.
English: Therefore, in order to assess the safety profile of meprobamate, mainly neurological and psychiatric adverse events, including pharmacodependence and serious withdrawal symptoms under normal conditions of use, particularly in the elderly, the CHMP reviewed the data from the two pharmacovigilance analyses of safety data on meprobamate conducted by the Lille CRPV, which were the basis of the Afssaps decision to suspend the marketing authorisations for the products concerned.
Maltese: Għalhekk, sabiex jevalwa l-profil ta' sigurtà ta' meprobamat, prinċipalment avvenimenti avversi newroloġiċi u psikjatriċi, inkluż farmakodipendenza u sintomi serji ta' astinenza taħt kondizzjonijiet normali ta' użu, partikularment fl-anzjani, is-CHMP irreveda d-dejta miż-żewġ analiżi ta' farmakoviġilanza tad-dejta dwar is-sigurtà ta' meprobamat li saru minn Lille CRPV, li kienu l-bażi taddeċiżjoni tal-AFSSAPS li tissospendi l-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti kkonċernati.
English: • The Committee considered that a number of neurological and psychiatric adverse events, which can be serious and potentially fatal, have been reported with the use of meprobamate, including under normal conditions of use.
Maltese: • Il-Kumitat ikkunsidra li ġew irrapportati għadd ta' avvenimenti avversi newroloġiċi u psikjatriċi, li jistgħu jkunu serji u potenzjalment fatali, bl-użu ta' meprobamat, inkluż taħt kondizzjonijiet normali ta' użu.
English: • The CHMP therefore concluded that the risk-benefit balance of meprobamate-containing medicinal products for oral use is not positive under normal conditions of use.
Maltese: • Is-CHMP għalhekk ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' prodotti mediċinali għall-użu orali li fihom meprobamat mhuwiex pożittiv taħt kundizzjonijiet normali ta' użu.
English: The CHMP also noted that the available medical practice guidelines for anxiety disorder, alcohol withdrawal and migraine do not recommend meprobamate.
Maltese: Is-CHMP innota wkoll li l-linji gwida ta' prattika medika disponibbli għal disturb ta' ansjetà, astinenza mill-alkoħol u emigranja ma jirrakkomandawx meprobamat.
English: The CHMP noted that meprobamate has a relatively narrow therapeutic index, with a steep dose-response curve, as supported by the available data which identified a number of accidental overdoses which were often serious, including fatalities.
Maltese: Is-CHMP innota li meprobamat għandu indiċi terapewtiku relattivament dejjaq, b'kurva wieqfa tad-doża rispons, kif appoġġat mid-dejta disponibbli li identifikat numru ta' dożi eċċessivi aċċidentali li ħafna drabi kienu serji, inkluż imwiet.
English: It is available as a single product or as fixed combinations with other substances.
Maltese: Huwa disponibbli bħala prodott waħdu jew bħala kombinazzjonijiet fissi ma' sustanzi oħra.