FrancophonIA/ELRC3.0 huggingface dataset:
English: The main objective of a method validation is to demonstrate the reliability of a particular method for the determination of an analyte concentration in a specific bioanalytical matrix and should appropriately be performed before analysis of study/subject samples.
Maltese: L-objettiv ewlieni tal-validazzjoni tal-metodu huwa li juri l-affidabilità ta' metodu partikolari biex tiġi ddeterminata l-konċentrazzjoni ta' analit f'matriċi bijoanalitika speċifika u għandu jsir b'mod xieraq qabel l-analiżi tal-kampjuni tal-istudju/suġġett.
English: These inconsistencies led to a Good Clinical Practice (GCP) inspection of the contract laboratory by the German authority (BfArM).
Maltese: Dawn l-inkonsistenzi wasslu għal spezzjoni dwar Prattika Klinika Tajba (GCP) tal-laboratorju taħt kuntratt mill-awtorità Ġermaniża (BfArM).
English: • The Committee agreed that the bioanalytical studies submitted by the MAHs were not conducted in accordance with GCP as required by Annex I of Directive 2001/83/EC as amended and the nature of the findings is such that the conduct of the studies and their results cannot be relied on to maintain the marketing authorisation.
Maltese: • Il-Kumitat qabel li l-istudji bijoanalitiċi sottomessi mill-MAH ma sarux skont il-GCP kif meħtieġ minn Anness I tad-Direttiva 2001/83/KE kif emendata u n-natura tas-sejbiet hija tali li t-twettiq tal-istudji u r-riżultati tagħhom ma jistgħux jiġu invokati biex tinżamm l-awtorizzazzjoni għattqegħid fis-suq.
English: The results of these studies were submitted in a number of marketing authorisation applications of goserelin-containing generic medicinal products to demonstrate therapeutic equivalence with the reference product Zoladex in the course of a MAA under Article.
Maltese: Ir-riżultati ta' dawn listudji ġew sottomessi f'numru ta' applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq ta' prodotti mediċinali ġeneriċi li fihom goserelin biex juru ekwivalenza terapewtika mal-prodott ta' referenza Zoladex fil-proċess ta' MAA taħt l-Artikolu. 10(3), jiġifieri applikazzjoni ibrida.
English: The MAH agreed with the authorities that GCP violations have happened at the bioanalytical testing facility of the contract laboratory and has taken extensive measures to correct these facts for future clinical trials.
Maltese: Il-MAH qabel mal-awtoritajiet li kien seħħ ksur tal-GCP fil-faċilità tal-ittestjar bijoanalitiku tallaboratorju taħt kuntratt u ħa miżuri estensivi biex jikkoreġi dawn il-fatti għal provi kliniċi futuri.
English: Data generated and reported in connection with these two studies had to be classified as not credible.
Maltese: Id-dejta ġġenerata u rrapportata f'konnessjoni ma' dawn iż-żewġ studji kellha tiġi kklassifikata bħala mhux kredibbli.
English: The MAH believes that the impact of these analytical findings on the conclusions of the clinical studies is limited, because clinical efficacy in both studies is based on a comparison of testosterone levels attained during treatment for the MAH's product and the comparator drug.
Maltese: Il-MAH jemmen li l-impatt ta' dawn is-sejbiet analitiċi dwar il-konklużjonijiet tal-istudji kliniċi huma limitati, minħabba li fiż-żewġ studji, l-effikaċja klinika hija bbażata fuq paragun bejn il-livelli ta' testosteron miksuba waqt kura bil-prodott tal-MAH u l-mediċina komparatur.
English: It needs to be emphasized that the unique small (n=40) pharmacodynamic study performed by the sponsor is meant to substitute for a full clinical development.
Maltese: Għandu jiġi enfasizzat li l-uniku studju farmakodinamiku żgħir (n=40) li sar mill-isponsor huwa maħsub li jissostitwixxi żvilupp kliniku sħiħ.
English: Pack size
Maltese: 14-il pillola
English: 3 pre-filled syringes
Maltese: 3 siringi mimlija għal-lest
English: 3 pre-filled pens
Maltese: 3 pinen mimlija għal-lest
English: The protection against the virus lasts at least 6 months.
Maltese: Il-protezzjoni kontra l-virus iddum mill-inqas 6 xhur.
English: The full EPAR for Rabitec can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Rabitec rabies virus vaccine (live)
Maltese: Rabitec vaċċin għall-virus tar-rabja (ħaj)
English: This is a summary of the European public assessment report (EPAR) for Rabitec.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rabitec.
English: This summary was last updated in October 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Ottubru 2017.
English: Rabitec is a vaccine.
Maltese: Rabitec huwa vaċċin.
English: Laboratory studies showed that around 90% of foxes and raccoon dogs produce antibodies against the rabies virus within 15 days of eating the bait.
Maltese: L-istudji laboratorji wrew li madwar 90 % tal-volpijiet u tal-klieb rakkuni jipproduċu antikorpi kontra l-virus tar-rabja fi żmien 15-il jum wara li jieklu l-għalf.
English: Rabitec is a veterinary vaccine used to protect wild foxes and raccoon dogs against rabies.
Maltese: Rabitec huwa vaċċin veterinarju li jintuża biex jipproteġi lill-volpijiet selvaġġi u l-klieb rakkuni kontra r-rabja.
English: Why is Rabitec approved?
Maltese: Għaliex ġie approvat Rabitec?
English: Other information about Rabitec?
Maltese: Kif jintuża Rabitec?
English: What are the risks associated with Rabitec?
Maltese: -riskji asso ċjati ma' Rabitec?
English: Rabitec is available as a liquid (suspension) contained in a bait pellet scented with fish meal to be chewed.
Maltese: Rabitec huwa disponibbli bħala likwidu (sospensjoni) li jinsab f'għalf fil-forma ta' pillolla f'boċċa żgħira bl-aroma ta' platt tal-ħut li għandu jintmagħad.
English: When a fox or raccoon dog chews a bait and the vaccine is released in the animal's mouth, the immune system recognises the virus as ‘foreign' and makes defences against it.
Maltese: Kemm-il darba fil-ġejjieni l-annimali jkunu esposti għall-virus tar-rabja, is-sistema immunitarja tkun kapaċi tirreaġixxi aktar malajr, u dan se jgħin biex jipproteġi kontra l-marda.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Rabitec, including the appropriate precautions to be followed by healthcare professionals and people who handle the product or come into contact with it.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif għal Rabitec ġiet inkluża informazzjoni rigward is-sigurtà, inklużi l-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti tal-kura tas-saħħa u mill-persuni li jimmaniġġjaw il-prodott jew jiġu f'kuntatt miegħu.
English: It presents a risk for people since it can be transmitted by bites or saliva from an infected animal.
Maltese: Din tippreżenta riskju għan-nies peress li tista' tiġi trażmessa permezz ta' gdim jew bżieq minn annimal infettat.
English: There are no known side effects.
Maltese: M'hemm l-ebda effett sekondarju magħruf.
English: Rabitec contains a modified live rabies virus which has been weakened so that it does not cause disease.
Maltese: Rabitec fih virus tar-rabja ħaj modifikat, li ddgħajjef sabiex ma jikkawżax mard.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Rabitec's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Rabitec huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Avda Osa Mayor nº 4 28023 - Aravaca, Madrid
Maltese: Osa Mayor nº 4 28023 - Aravaca, Madrid
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants / marketing authorisation holders in the Member States
Maltese: Lista ta' ismijiet, forma farmaċewtika, dożar ta' prodotti mediċinali, rottot ta' administrazjoni, applikanti/detenturi ta' l- awtorizzazzjoni għat-tqegħid fis-suq f'stati membri
English: Iceland
Maltese: Islanda
English: Matoride XL 18 mg Prolonged-release Tablets
Maltese: Matoride XL 18 mg Pillola Prolongedreleases
English: Matoride XL 54 mg Prolonged-release Tablets
Maltese: Matoride XL 54 mg Pillola Prolongedreleases
English: Matoride XL 36 mg Prolonged-release Tablets
Maltese: Matoride XL 36 mg Pillola Prolongedreleases
English: Atazanavir Mylan is available as capsules (150 mg, 200 mg and 300 mg).
Maltese: Atazanavir Mylan jiġi f'kapsuli (150 mg, 200 mg u 300 mg).
English: The full EPAR for Atazanavir Mylan 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: Atazanavir Mylan is a ‘generic medicine'.
Maltese: Atazanavir Mylan huwa ‘mediċina ġenerika'.
English: A small dose of another medicine, ritonavir, is normally given at the same time as a ‘booster'.
Maltese: Doża żgħira ta' mediċina oħra, ritonavir, normalment tingħata fl-istess ħin bħala 'booster'.
English: Atazanavir Mylan is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Maltese: Atazanavir Mylan huwa mediċina għall-HIV użat biex jikkura pazjenti infettati bil-virus talimmunodefiċjenza tal-bniedem tat-tip 1 (HIV-1), virus li jikkawża s-sindrome mill-immunodefiċjenza akkwiżita (AIDS).
English: This summary was last updated in 08-2016.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi: XX-2016.
English: For adults, the recommended dose is 300 mg once a day.
Maltese: Għall-adulti, id-doża rakkomandata hija ta' 300 mg darba kuljum.
English: The active substance in Atazanavir Mylan, atazanavir, is a protease inhibitor.
Maltese: Is-sustanza attiva f'Atazanavir Mylan, atazanavir, hija inibitur tal-proteażi.
English: This is a summary of the European public assessment report (EPAR) for Atazanavir Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Atazanavir Mylan.
English: Atazanavir Mylan atazanavir
Maltese: Kif jintuża Atazanavir Mylan?
English: Why is Atazanavir Mylan approved?
Maltese: Għaliex ġie approvat Atazanavir Mylan?
English: This means that Atazanavir Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Reyataz.
Maltese: Dan ifisser li Atazanavir Mylan huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Reyataz.
English: Because Atazanavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Reyataz.
Maltese: Minħabba li Atazanavir Mylan huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet biex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Reyataz.
English: Because Atazanavir Mylan 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 Atazanavir Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Atazanavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Atazanavir Mylan, meta jittieħed flimkien ma' mediċini antivirali oħra, inaqqas l-ammont tal-HIV fid-demm u jżommu f'livell baxx.
English: The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Mylan (protease inhibitors) do not work.
Maltese: Mhuwiex mistenni li l-mediċina taħdem fuq pazjenti li fuqhom ma jkunux jaħdmu ħafna mediċini flistess klassi ta' Atazanavir Mylan (inibituri tal-proteażi).
English: This allows a lower dose of atazanavir to be used for the same antiviral effect.
Maltese: Dan jippermetti li atazanavir jintuża f'doża iżgħar għall-istess effett antivirali.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Atazanavir Mylan has been shown to have comparable quality and to be bioequivalent to Reyataz.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Atazanavir Mylan wera li għandu kwalità komparabbli u huwa bijoekwivlenti għal Reyataz.
English: Atazanavir Mylan is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Maltese: Atazanavir Mylan normalment jingħata ma' ritonavir biex tissaħħaħ l-azzjoni tiegħu iżda f'sitwazzjonijiet speċifiċi, it-tobba jistgħu jikkunsidraw li jwaqqfu ritonavir fl-adulti.
English: Other information about Atazanavir Mylan
Maltese: Informazzjoni oħra dwar Atazanavir Mylan
English: Atazanavir Mylan does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Atazanavir Mylan ma jfejjaqx linfezzjoni tal-HIV jew tal-AIDS, iżda jista' jittardja l-ħsara li ssir lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: The Committee recommended that Atazanavir Mylan be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Atazanavir Mylan ikun approvat għall-użu fl-UE.
English: Therefore, the CHMP's view was that, as for Reyataz, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, fil-każ ta' Reyataz, il-benefiċċji huma akbar mir-riskji identifikati.
English: CHMP conclusions
Maltese: Konklużjonijiet tas-CHMP
English: The application was submitted to the reference Member State (RMS): Austria and the concerned Member States (CMS): Denmark, Spain, Finland, France, Germany, Ireland, The Netherlands, Poland, Portugal, Sweden and the United Kingdom.
Maltese: L-applikazzjoni ġiet ippreżentata lill-Istat Membru ta' referenza (RMS): l-Awstrija u l-Istati Membri kkonċernati (CMS): id-Danimarka, Spanja, il-Finlandja, Franza, il-Ġermanja, l-Irlanda, in-Netherlands, il-Polonja, il-Portugall, l-Iżvezja u r-Renju Unit.
English: Like GABA, it exerts an overall inhibiting effect on the central nervous system (CNS).
Maltese: Bħal GABA, dan jipproduċi effett ta' inibizzjoni globali fuq is-sistema nervuża ċentrali (CNS).
English: Alcover granules in sachet contains the active substance sodium oxybate, which is the sodium salt of Gamma-hydroxybutyric acid (GHB), a derivative of gamma-aminobutyric acid (GABA).
Maltese: Alcover granuli f'qartas fih is-sustanza attiva sodium oxybate, li hija l-melħ tas-sodju tal-aċidu Gamma-hydroxybutyric (GHB), derivattiv tal-aċidu gamma-aminobutirriku (GABA).
English: The CHMP consulted an ad-hoc expert meeting on some of the aspects that formed part of the detailed grounds submitted by Debrégeas & Associés (D&A).
Maltese: Is-CHMP ikkonsulta laqgħa tal-esperti ad hoc dwar xi aspetti li jiffurmaw parti mir-raġunijiet dettaljati ppreżentati minn Debrégeas & Associés (D&A).
English: The applicant Debrégeas & Associés (D&A) submitted an application for marketing authorisation (MAA) for Alcover 750 mg, 1250 mg and 1750 mg through the Decentralised Procedure (DCP) under the legal basis of Article 8(3) of Directive 2001/83/EC, as a full-mixed application for the treatment of long-term maintenance of alcohol abstinence and alcohol withdrawal syndrome in alcohol-dependent adult patients.
Maltese: L-applikant Debrégeas & Associés (D&A) ippreżenta applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq (MAA) għal Alcover 750 mg, 1250 mg u 1750 mg mill-Proċedura Deċentralizzata (DCP) skont il-bażi legali tal-Artikolu 8(3) tad-Direttiva 2001/83/KE, bħala applikazzjoni sħiħa mħallta għall-kura ta' manteniment fit-tul ta' astinenza mill-alkoħol u sindrome ta' twaqqif tal-alkoħol f'pazjenti adulti dipendenti fuq l-alkoħol.
English: • The Committee considered the notification of the referral initiated by Austria under Article 29(4) of Directive 2001/83/EC, where Denmark, Spain, Finland, France, Ireland, the Netherlands, Portugal, Sweden and the United Kingdom raised objections to the marketing authorisation application for Alcover and associated names, 750 mg, 1250 mg, 1750 mg granules in sachets, which were considered to be a potential serious risk to public health;
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-riferiment li bdiet l-Awstrija skont l-Artikolu 29(4) tadDirettiva 2001/83/KE, fejn id-Danimarka, Spanja, il-Finlandja, Franza, l-Irlanda, inNetherlands, il-Portugall, l-Iżvezja u r-Renju Unit qajmu oġġezzjonijiet għall-applikazzjoni talawtorizzazzjoni għat-tqegħid fis-suq għal Alcover u l-ismijiet assoċjati, 750 mg, 1250 mg, 1750 mg granuli fi qratas, li ġew ikkunsidrati bħala riskju serju potenzjali għas-saħħa pubblika;
English: Following the adoption of the CHMP Opinion during the June 2017 CHMP meeting, the applicant Debrégeas & Associés (D&A) requested a re-examination of the Opinion.
Maltese: Wara l-adozzjoni tal-Opinjoni tas-CHMP waqt il-laqgħa tas-CHMP ta' Ġunju 2017, l-applikant Debrégeas & Associés (D&A) talab eżaminazzjoni mill-ġdid tal-Opinjoni.
English: The meta-analysis that included GATE 2, SMO032/10/03, Gallimberti 1992 and Di Bello 1995 have several methodological flaws and quality concerns such as GATE 2 did not evaluate the population of interest; SMO032/10/03 trial included only a subset of High/Very High DRL patients and failed to meet its primary endpoint; Gallimberti trial did not report primary endpoint or follow-up time; Di Bello had a very small sample size (total n=17) and failed to specify the primary endpoint.
Maltese: Il-metaanaliżi li inkludiet GATE 2, SMO032/10/03, Gallimberti 1992 u Di Bello 1995 kellha diversi nuqqasijiet metodoloġiċi u tħassib dwar is-sigurtà bħal GATE 2 ma evalwatx il-popolazzjoni ta' interess; il-prova SMO032/10/03 inkludiet biss subsett ta' pazjenti b'DRL Għoli/Għoli Ħafna u ma rnexxilhiex tissodisfa l-end-point primarju tagħha; il-prova Gallimberti ma rrappurtatx l-end-point primarju jew iż-żmien ta' segwitu; Di Bello kellu daqs ta' kampjunar żgħir ħafna (total n=17) u ma rnexxilux jispeċifika l-end-point primarju.
English: Therefore, the Committee recommends the refusal of the marketing authorisation for Alcover and associated names, 750 mg, 1250 mg, 1750 mg granules in sachets.
Maltese: Għalhekk, il-Kumitat jirrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għal Alcover u l-ismijiet assoċjati, 750 mg, 1250 mg, 1750 mg granuli fi qratas.
English: The application in Germany was withdrawn during the DCP.
Maltese: L-applikazzjoni fil-Ġermanja ġiet irtirata waqt id-DCP.
English: The trials submitted with active arm comparators (Gate 1, Nava 2007, Addolorato 1999 and Nimmerrichter 2002) had several methodological flaws such as open label, small sample size, heterogeneity in the studies' population, lack of protocol or defined primary endpoints, assessment of large number of outcomes, and long enrolment period, which lead to conclusions based on post-hoc analysis that do not provide sufficient evidence to establish the efficacy for the use of sodium oxybate granules in the treatment of AWS.
Maltese: Il-provi li ġew ippreżentati b'komparaturi tal-fergħa attivi (Gate 1, Nava 2007, Addolorato 1999 u Nimmerrichter 2002) kellhom diversi nuqqasijiet metodoloġiċi bħal tikketta miftuħa, daqs ta' kampjunar żgħir, eteroġenità fil-popolazzjoni tal-istudji, nuqqas ta' protokoll jew end-points primarji definiti, valutazzjoni ta' numru kbir ta' riżultati, u perjodu ta' reġistrazzjoni twil, li wassal għal konklużjonijiet ibbażati fuq analiżi post-hoc li ma jipprovdux biżżejjed evidenza sabiex tiġi stabbilita l-effikaċja għall-użu tal-granuli ta' sodium oxybate fil-kura ta' AWS.
English: As an additional point, the experts commented on the potential place of this medicine as substitution treatment or reduction of craving and prolongation of abstinence.
Maltese: Bħala punt addizzjonali, l-esperti kkummentaw dwar il-post potenzjali ta' din il-mediċina bħala kura ta' sostituzzjoni jew tnaqqis ta' xenqa u titwil talastinenza.
English: Referring to the results in abstinence rate from study SMO032/10/03, Gallimberti 1992, GATE 2 and Di Bello 1995, apart from different study designs, post-hoc chosen patient groups, different study duration, it cannot be concluded whether continuous abstinence was measured, and whether responders (a posteriori defined as completers with a DRL<high or who did not relapse to heavy drinking) are actually the group of people aimed at with full abstinence in mind.
Maltese: B'referenza għar-riżultati fir-rata ta' astinenza mill-istudju SMO032/10/03, Gallimberti 1992, GATE 2 u Di Bello 1995, minbarra tfassil ta' studju differenti, gruppi tal-pazjent magħżula post-hoc, durata ta' studju differenti, ma jistax jiġi konkluż jekk tkejlitx astinenza kontinwa, u jekk ir-rispondenti (a posteriori definiti bħala li temmew b'DRL<għoli jew li ma rikadewx għal ħafna xorb) humiex attwalment il-grupp ta' nies immirati b'kunsiderazzjoni ta' astinenza sħiħa.
English: Furthermore, it was noted by the CHMP that, despite the limited sample size in the clinical trials, this patient population cannot be considered as a ‘small population' as defined by the EMA Guideline on Clinical Trials in Small Populations (CHMP/EWP/83561/2005).
Maltese: Barra minn hekk, ġie nnutat mis-CHMP li, minkejja d-daqs ta' kampjunar limitat fil-provi kliniċi, din il-popolazzjoni tal-pazjenti ma tistax tiġi kkunsidrata bħala “popolazzjoni żgħira” kif definita milLinja Gwida tal-EMA dwar il-Provi Kliniċi f'Popolazzjonijiet Żgħar (CHMP/EWP/83561/2005).
English: The Gallimberti 1989 trial was the only placebo-controlled RCT to evaluate sodium oxybate in the treatment of AWS, which had a small sample (n=11 oxybate vs n= 12 placebo), that evaluated the first 7 hours of treatment, showing favourable results for the active arm.
Maltese: Il-prova Gallimberti 1989 kienet lunika RCT ikkontrollata bil-plaċebo li evalwat sodium oxybate fil-kura ta' AWS, li kellha kampjunar żgħir (n=11 oxybate vs n=12 plaċebo), li evalwat l-ewwel 7 sigħat ta' kura, biex uriet riżultati favorevoli għall-fergħa attiva.
English: The CHMP thoroughly assessed the detailed grounds for re-examination submitted by the applicant for the use of Alcover granules in the long-term maintenance of alcohol abstinence in AD patients with a very high Drinking Risk Level (VH-DRL) and the treatment of acute alcohol withdrawal syndrome (AWS) and took into consideration the outcome of the consultation of an ad-hoc expert group on 4 October 2017.
Maltese: Is-CHMP ivvaluta sew ir-raġunijiet dettaljati għal eżaminazzjoni mill-ġdid ippreżentati millapplikant għall-użu ta' Alcover granuli fil-manteniment fit-tul tal-astinenza mill-alkoħol f'pazjenti AD b'Livell ta' Riskju ta' Xorb għoli ħafna (VH-DRL) u l-kura ta' sindrome ta' twaqqif tal-alkoħol (AWS) akuta u kkunsidra grupp ta' esperti ad-hoc fl-4 ta' Ottubru 2017.
English: In order to further mitigate these risks in the clinical practice, the applicant has proposed additional risk minimization measures in addition to the warnings/guidance in the product information; dose reduction at the end of treatment to prevent risk of withdrawal; inpatient setting in the treatment of AWS; warnings and guidance in case of concomitant alcohol consumption, and implementation of a restricted prescribing, controlled distribution system and a packaging containing only 4 days treatment.
Maltese: Sabiex ikomplu jiġu mmitigati dawn ir-riskji fil-prassi klinika, l-applikant ippropona miżuri talimminimizzar tar-riskju addizzjonali flimkien mat-twissijiet/mal-gwida fl-informazzjoni dwar ilprodott; tnaqqis fid-doża fl-aħħar tal-kura għall-prevenzjoni tar-riskju tat-twaqqif; ambjent talpazjent fil-kura ta' AWS; twissijiet u gwida fil-każ ta' konsum tal-alkoħol konkomitanti, u implimentazzjoni ta' preskrizzjoni ristretta, sistema ta' distribuzzjoni kkontrollata u imballaġġ li fih biss kura għal 4 ijiem.