FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati li juru effett(i) mhux mixtieq(a) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: During laboratory and clinical field testing, no interactions between Bravecto spot-on solution for cats and routinely used veterinary medicinal products were observed.
Maltese: Waqt studji kliniċi ma kienu osservati l-ebda interazzjonijiet bejn Bravecto soluzzjoni spot-on għal qtates u prodotti mediċinali veterinarji użati b'mod regolari.
English: Pharmacotherapeutic group: Ectoparasiticides for systemic use ATCvet code: QP53B E02
Maltese: Agħfas il-pipetta bil-mod u applika l-kontenut kollu direttament mal-ġilda tal-qattus.
English: Bravecto chewable tablets
Maltese: Bravecto pilloli li jintmagħdu
English: The veterinary medicinal product was well tolerated in collies with a deficient multidrug-resistanceprotein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose.
Maltese: Il-prodott mediċinali veterinarju kien ittollerat sew f'Collies b'multidrug-resistance-protein 1 (MDR1/-) defiċjenti wara doża waħda amministrata mill-ħalq f'doża 3 darbiet aktar mid-doża rakkomandata.
English: It is efficacious against ticks (Ixodes spp.)
Maltese: Huwa effikaċi kontra l-qurdien (Ixodes spp.) u l-briegħed
English: Pharmacotherapeutic group: Ectoparasiticides for systemic use.
Maltese: Ektoparassitiċidi għal użu sistemiku.
English: During laboratory and clinical field testing, no interactions between Bravecto spot-on solution for dogs and routinely used veterinary medicinal products were observed.
Maltese: Waqt studji kliniċi ma kienu osservati l-ebda interazzjonijiet bejn Bravecto soluzzjoni spoton għal klieb u prodotti mediċinali veterinarji użati b'mod regolari.
English: No adverse reactions were observed following topical administration to kitten aged 11-13 weeks and weighing 1.2-1.5 kg treated with overdoses of up to 5 times the maximum recommended dose (93 mg, 279 mg and 465 mg fluralaner/kg body weight) on three occasions at shorter intervals than recommended (8-week intervals).
Maltese: Ma deher l-ebda effett mhux mixtieq wara amministrazzjoni topikali lil frieħ tal-qtates ta' 11-13-il ġimgħa u li jiżnu 1.2-1.5 kg ittrattati b'dożi eċċessivi sa 5 darbiet aktar mid-doża massima rakkomandata (93 mg, 279 mg u 465 mg fluralaner/kg piż) fi tliett okkażjonijiet f'intervalli iqsar minn dawk rakkomandati (intervalli ta' 8 ġimgħat).
English: Bravecto should be administered in accordance with the following table (corresponding to a dose of 25-56 mg fluralaner/kg body weight):
Maltese: Bravecto għandu jiġi amministrat skont it-tabella li ġejja (li tikkorrispondi għal doża ta' 25-56 mg fluralaner/kg piż korporju):
English: No adverse reactions were observed following topical administration to puppies aged 8-9 weeks and weighing 2.0-3.7 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg fluralaner/kg bodyweight) on three occasions at shorter intervals than recommended (8-week intervals).
Maltese: Ma deher l-ebda effett mhux mixtieq wara amministrazzjoni topikali lil ġriewi ta' 8-9 ġimgħat u li jiżnu 2.0-3.7 kg ittrattati b'dożi eċċessivi sa 5 darbiet aktar mid-doża massima rakkomandata (56 mg, 168 mg u 280 mg fluralaner/kg piż) fi tliet okkażjonijiet f'intervalli iqsar minn dawk rakkomandati (intervalli ta' 8 ġimgħat).
English: Each pipette delivers:
Maltese: Kull pillola li tintmagħad fiha:
English: EU/2/13/158/018 (112.5 mg, 1 pipette) EU/2/13/158/019 (112.5 mg, 2 pipettes) EU/2/13/158/022 (250 mg, 1 pipette) EU/2/13/158/023 (250 mg, 2 pipettes) EU/2/13/158/026 (500 mg, 1 pipette) EU/2/13/158/027 (500 mg, 2 pipettes)
Maltese: EU/2/13/158/018 (112.5 mg, pipetta 1) EU/2/13/158/019 (112.5 mg, 2 pipetti)
English: 112.5 mg fluralaner 250 mg fluralaner 500 mg fluralaner
Maltese: 250 mg fluralaner
English: EXP: (MM/YYYY)
Maltese: DATA TA' SKADENZA EXP: (XX/SSSS)
English: EU/2/13/158/001 EU/2/13/158/002 EU/2/13/158/003 EU/2/13/158/004 EU/2/13/158/005 EU/2/13/158/006 EU/2/13/158/007 EU/2/13/158/008 EU/2/13/158/009 EU/2/13/158/010 EU/2/13/158/011 EU/2/13/158/012 EU/2/13/158/013
Maltese: EU/2/13/158/005 EU/2/13/158/006 EU/2/13/158/007 EU/2/13/158/008 EU/2/13/158/009
English: During clinical field testing, no interactions between Bravecto chewable tablets for dogs and routinely used veterinary medicinal products were observed.
Maltese: Waqt studji kliniċi ma kienu osservati l-ebda interazzjonijiet bejn Bravecto pilloli li jintmagħdu għal klieb u prodotti mediċinali veterinarji użati b'mod regolari.
English: This veterinary medicinal product is a systemic insecticide and acaricide that provides immediate and persistent flea (Ctenocephalides felis) and tick (Ixodes ricinus) killing activity for 12 weeks.
Maltese: Dan il-prodott mediċinali veterinarju huwa insettiċida u akaraċida sistemiku li jipprovdi azzjoni immedjata u persistenti li toqtol il-bergħud (Ctenocephalides felis) u l-qurdien (Ixodes ricinus) għal
English: Maize starch
Maltese: L-AWSTRIJA
English: This veterinary medicinal product is a systemic insecticide and acaricide that provides: - immediate and persistent flea (Ctenocephalides felis and C. canis) killing activity for 12 weeks, - immediate and persistent tick (Ixodes ricinus, Rhipicephalus sanguineus and Dermacentor reticulatus) killing activity for 12 weeks.
Maltese: - azzjoni immedjata u persistenti li toqtol il-bergħud (Ctenocephalides felis u Ctenocephalides canis) għal 12-il ġimgħa, u - azzjoni immedjata u persistenti li toqtol il-qurdien (Ixodes ricinus, Rhipicephalus sanguineus u Dermacentor reticulatus) għal 12-il ġimgħa.
English: Veterinary medicinal product subject to prescription.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni spot-on.
English: EU/2/13/158/018-019 112.5 mg EU/2/13/158/022-023 250 mg EU/2/13/158/026-027 500 mg
Maltese: EU/2/13/158/022-023 250 mg
English: Incubation of fluralaner in the presence of carprofen or warfarin in dog plasma at maximum expected plasma concentrations did not reduce the protein binding of fluralaner, carprofen or warfarin.
Maltese: L-inkubazzjoni tal-fluralaner fil-presenza ta' carprofen jew worfarina fil-livelli massimi mistennija fil-plażma tal-klieb, ma naqqsux l-abbinar mal-proteini tal-flualaner, carprofen jew worfarina.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati li juru effett(i) mhux mixtieq(a) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat)
English: Strength and number of pipettes to be administered
Maltese: Saħħa u numru ta' pipetti li għandhom jiġu amministrati
English: Fluralaner is highly bound to plasma proteins and might compete with other highly bound active substances such as non-steroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative warfarin.
Maltese: Fluralaner jabbina b'mod qawwi mal-proteini tal-plażma u jista' jikkompeti ma' sustanzi attivi oħra li jabbinaw b'mod qawwi bħal non-steroidal anti-inflammatory drugs (NSAIDs) u d-derivat tal-kumarin, il-worfarina.
English: No adverse reactions were observed following oral administration to puppies aged 8-9 weeks and weighing 2.0-3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg fluralaner/kg bodyweight) on three occasions at shorter intervals than recommended (8-week intervals).
Maltese: Ma deher l-ebda effett mhux mixtieq wara amministrazzjoni mill-ħalq lil ġriewi ta' 8-9 ġimgħat u jiżnu 2.0-3.6 kg ittrattati b'dożi eċċessivi sa 5 darbiet aktar mid-doża massima rakkomandata (56 mg, 168 mg u 280 mg fluralaner/kg piż) fi tliett okkażjonijiet f'intervalli iqsar minn dawk rakkomandati (intervalli ta' 8 ġimgħat).
English: Mild and transient skin reactions at the application site, such as erythema and pruritus or alopecia were commonly observed in clinical trials (2.2% of treated cats).
Maltese: Reazzjonijiet tal-ġilda, ħfief u li jgħaddu bħal eritema jew alopexja fis-sit tal-applikazzjoni ġew osservati b'mod komuni fi studji kliniċi (2.2% tal-qtates ittrattati).
English: Bravecto chewable tablets should be administered in accordance with the following table (corresponding to a dose of 25-56 mg fluralaner/kg bodyweight within one weight band):
Maltese: Bravecto għandu jiġi amministrat skont it-tabella li ġejja (li tikkorrispondi għal doża ta' 25-56 mg fluralaner/kg piż f'faxxa waħda ta' piż):
English: In molecular on-target studies on insect GABA receptors of flea and fly, fluralaner is not affected by dieldrin resistance.
Maltese: Fi studji molekulari on-target fuq riċetturi tal-GABA fl-insetti tal-briegħed u tad-dubbien, fluralaner mhuwiex affettwat b'reżistenza għad-dieldrin.
English: The product should not be used by persons with a hypersensitivity to the active substance or to any of the excipients (see contraindications, section 4.3).
Maltese: Il-prodott m'għandux jintuża minn nies ipersensittivi għas-sustanza attiva jew għal kwalunkwe sustanza oħra (ara kontra indikazzjonijiet, sezzjoni 4.3).
English: Bravecto 112.5 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats (>2.8 - 6.25 kg) Bravecto 500 mg spot-on solution for large cats (>6.25 - 12.5 kg) fluralaner
Maltese: Bravecto 112.5 mg soluzzjoni spot-on għal qtates żgħar (1.2 - 2.8 kg) Bravecto 250 mg soluzzjoni spot-on għal qtates ta'daqs medju (>2.8 - 6.25 kg) Bravecto 500 mg soluzzjoni spot-on għal qtates kbar (>6.25 - 12.5 kg) fluralaner
English: Unit dose pipette made of laminated aluminium/polypropylene foil closed with an HDPE cap and packed in a laminated aluminium foil sachet.
Maltese: Żomm il-prodott fil-pakkett oriġinali sakemm tużah biex tevita li tfal ikollhom aċċess dirett għal prodott.
English: For spot-on use
Maltese: NUMRU TAL-LOTT
English: for very small dogs 2 - 4.5 kg for small dogs >4.5 - 10 kg for medium-sized dogs >10 - 20 kg for large dogs >20 - 40 kg for very large dogs >40 - 56 kg
Maltese: għal klieb żgħar ħafna 2 - 4.5 kg għal klieb żgħar >4.5 - 10 kg għal klieb ta'daqs medju >10 - 20 kg għal klieb kbar >20 - 40 kg għal klieb kbar ħafna >40 - 56 kg
English: Fluralaner is readily absorbed from the topical administration site into the hair, skin and subjacent tissues, from where it is slowly absorbed into the vascular system.
Maltese: Fluralaner jiġi assorbit sew mis-sit tal-applikazzjoni topikali għal ġox-xahar, ġilda u tessuti tal-inħawi minn fejn jiġi assorbit bil-mod għal ġos-sistema vaskolari.
English: Bravecto 112.5 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats (>2.8 - 6.25 kg) Bravecto 500 mg spot-on solution for large cats (>6.25 - 12.5 kg)
Maltese: VETERINARJU Bravecto 112.5 mg soluzzjoni spot-on għal qtates żgħar (1.2 - 2.8 kg) Bravecto 250 mg soluzzjoni spot-on għal qtates ta'daqs medju (>2.8 - 6.25 kg) Bravecto 500 mg soluzzjoni spot-on għal qtates kbar (>6.25 - 12.5 kg)
English: METHOD AND ROUTE OF ADMINISTRATION
Maltese: B'MOD KORRETT Metodu tal-amministrazzjoni
English: Following oral administration, fluralaner is readily absorbed reaching maximum plasma concentrations within 1 day.
Maltese: Wara amministrazzjoni mill-ħalq, fluralaner jiġi assorbit sew u jilħaq konċentrazzjonijiet massimi filplażma fi żmien ġurnata.
English: Bravecto 112.5 mg spot-on solution for very small dogs (2 - 4.5 kg) Bravecto 250 mg spot-on solution for small dogs (>4.5 - 10 kg) Bravecto 500 mg spot-on solution for medium-sized dogs (>10 - 20 kg) Bravecto 1,000 mg spot-on solution for large dogs (>20 - 40 kg) Bravecto 1,400 mg spot-on solution for very large dogs (>40 - 56 kg) fluralaner
Maltese: Bravecto 112.5 mg soluzzjoni spot-on għal klieb żgħar ħafna (2 - 4.5 kg) Bravecto 250 mg soluzzjoni spot-on għal klieb żgħar (>4.5 - 10 kg) Bravecto 500 mg soluzzjoni spot-on għal klieb ta'daqs medju (>10 - 20 kg) Bravecto 1,000 mg soluzzjoni spot-on għal klieb kbar (>20 - 40 kg) Bravecto 1,400 mg soluzzjoni spot-on għal klieb kbar ħafna (>40 - 56 kg) fluralaner
English: Mild and transient skin reactions such as erythema or alopecia at the application site were commonly observed in clinical trials (1.2% of treated dogs).
Maltese: Reazzjonijiet tal-ġilda, ħfief u li jgħaddu bħal eritema jew alopexja fis-sit tal-applikazzjoni ġew osservati b'mod komuni fi studji kliniċi (1.2% tal-klieb ittrattati).
English: This veterinary medicinal product is a systemic insecticide and acaricide that provides: - immediate and persistent flea (Ctenocephalides felis and Ctenocephalides canis) killing activity for 12 weeks, and - immediate and persistent tick (Ixodes ricinus, Rhipicephalus sanguineus and Dermacentor reticulatus) killing activity for 12 weeks.
Maltese: Dan il-prodott mediċinali veterinarju huwa insettiċida u akaraċida sistemiku li jipprovdi - azzjoni immedjata u persistenti li toqtol il-bergħud (Ctenocephalides felis) għal 12-il ġimgħa, - azzjoni immedjata u persistenti li toqtol il-qurdien (Ixodes ricinus, Dermacentor reticulatus u
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zinbryta (daclizumab).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat tad-data ta' farmakoviġilanza għal Zinbryta (daclizumab).
English: Zinbryta (daclizumab) is a centrally authorised medicinal product indicated at the start of this review in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Maltese: Zinbryta (daclizumab) huwa prodott mediċinali awtorizzat b'mod ċentrali indikat fil-bidu ta' dan irrieżami f'pazjenti adulti għall-kura ta' forom rikaduti ta' sklerożi multipla (RMS).
English: These clinical effects were supported by robust and substantial treatment effects in reducing all key brain magnetic resonance imaging (MRI) parameters of acute and chronic inflammatory and destructive central nervous system disease activity.
Maltese: Dawn l-effetti kliniċi kienu sostnuti minn effetti ta' kura robusti u sostanzjali fit-tnaqqis tal-parametri ewlenin kollha tal-immaġni tar-reżonanza manjetika (MRI) tal-moħħ ta' attività infjammatorja u distruttiva akuta u kronika tal-marda tassistema nervuża ċentrali.
English: Patients with hepatitis C virus (HCV) or hepatitis B virus (HBV) were excluded from clinical trials and no correlation has been established between pre-existing infections with these viruses and daclizumab-induced serious liver injury at present.
Maltese: Il-pazjenti bil-virus tal-epatite C (HCV) jew bil-virus tal-epatite B (HBV) kienu esklużi mill-provi kliniċi u ma ġiet stabbilita l-ebda korrelazzjoni bejn l-infezzjonijiet diġà eżistenti b'dawn il-virusis u l-ħsara serja fil-fwied ikkawżata b'daclizumab fil-preżent.
English: On 9 June 2017 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Zinbryta (daclizumab) and to issue a recommendation on whether the marketing authorisation should be maintained, varied, suspended or revoked.
Maltese: Għalhekk fid-9 ta' Ġunju 2017, il-KE tat bidu għal proċedura skont l-Artikolu 20 tarRegolament (KE) Nru 726/2004 bħala riżultat ta' data dwar il-farmakoviġilanza, u talbet lill-PRAC jevalwa l-impatt tat-tħassib imsemmi hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' Zinbryta (daclizumab) u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjoni għat-tqegħid fis-suq għandhiex tinżamm, tiġi varjata, sospiża jew revokata.
English: • As a consequence, the PRAC recommended restriction of the indication of daclizumab to the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with another DMT is contraindicated or otherwise unsuitable.
Maltese: • B'konsegwenza, il-PRAC irrakkomanda r-restrizzjoni tal-indikazzjoni ta' daclizumab għallkura ta' pazjenti adulti b'forom rikaduti ta' sklerożi multipla (RMS) li kellhom rispons mhux adegwat għal tal-inqas żewġ terapiji li jimmodifikaw il-marda (DMTs) u li għalihom il-kura b'DMT oħra hija kontraindikata jew inkella mhux adattata.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Zinbryta (daclizumab) remains favourable subject to the amendments to the product information described above.
Maltese: Konsegwentement, is-CHMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' Zinbryta (daclizumab) jibqa' favorevoli soġġett għall-emendi fl-informazzjoni tal-prodott deskritti hawn fuq.
English: The PRAC also considered the views expressed by experts consulted during the course of the procedure (scientific advisory group (SAG) on neurology).
Maltese: Il-PRAC ikkunsidra wkoll l-opinjonijiet espressi mill-esperti kkonsultati tul il-kors tal-proċedura (grupp konsultattiv xjentifiku (SAG) dwar in-newroloġija).
English: The educational material in place should also be updated.
Maltese: Il-materjal edukattiv eżistenti għandu jiġi aġġornat.
English: The PRAC considered all the data provided by the MAH on cases of liver injury that occurred since the marketing authorisation, including a recent fatal case of fulminant liver failure, as well as safety and efficacy data from clinical trials with daclizumab, in relation to the overall risk of liver injury with daclizumab.
Maltese: Il-PRAC ikkunsidra d-data kollha pprovduta mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq dwar każijiet ta' ħsara fil-fwied li seħħew mill-awtorizzazzjoni għat-tqegħid fis-suq, inkluż każ fatali reċenti ta' insuffiċjenza fulminanti tal-fwied kif ukoll data dwar is-sigurtà u l-effikaċja minn provi kliniċi b'daclizumab fir-rigward tar-riskju globali ta' ħsara fil-fwied b'daclizumab.
English: The CHMP discussed the recommended wording of the indication, in particular that restricting daclizumab treatment to patients for whom another disease modifying therapy is contraindicated or otherwise unsuitable, and considered that for clarity it should be stated that this relates to any other disease modifying therapy.
Maltese: Is-CHMP iddiskuta l-formulazzjoni rakkomandata tal-indikazzjoni, b'mod partikolari li r-restrizzjoni tal-kura b'daclizumab għal pazjenti li għalihom terapija oħra li timmodifika l-marda hija kontraindikata jew inkella mhux adattata, u kkunsidra li għal ċarezza jrid jiġi ddikjarat li din tirrigwarda kwalunkwe terapija oħra li timmodifika l-marda.
English: The PRAC concluded that the benefit-risk balance remained positive, provided that Zinbryta is only used in the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with another DMT is contraindicated or otherwise unsuitable and that changes are implemented in the product information to minimise the risk of serious liver injury.
Maltese: Il-PRAC ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju baqa' pożittiv, sakemm Zinbryta jintuża biss fil-kura ta' pazjenti adulti b'forom rikaduti ta' sklerożi multipla (RMS) li kellhom rispons adegwat għal tal-inqas żewġ terapiji li jimmodifikaw il-marda (DMTs) u li għalihom il-kura b'DMT oħra hija kontraindikata jew inkella mhux adattata u li l-bidliet huma implimentati fl-informazzjoni dwar il-prodott biex jitnaqqas ir-riskju ta' ħsara severa fil-fwied.
English: Transaminases elevations and serious hepatic injury are known risks associated to treatment with Zinbryta (daclizumab) and several risk minimisation measures (RMMs) were implemented in this regard at the time of the initial marketing authorisation, including monthly liver function monitoring.
Maltese: Żidiet fit-transaminażi u ħsara serja fil-fwied huma riskji magħrufa assoċjati mal-kura b'Zinbryta (daclizumab) u f'dan ir-rigward, fil-ħin tal-awtorizzazzjoni għat-tqegħid fis-suq inizjali ġew implimentati diversi miżuri ta' minimizzazzjoni tar-riskju (RMMs), inkluż monitoraġġ kull xahar talfunzjoni tal-fwied.
English: The PRAC also considered the views expressed by the scientific advisory group on neurology.
Maltese: Il-PRAC ikkunsidra wkoll l-opinjonijiet espressi mill-grupp konsultattiv xjentifiku dwar in-newroloġija.
English: The PRAC concluded that daclizumab is associated with a potentially fatal risk of immune-mediated liver injury.
Maltese: Il-PRAC ikkonkluda li daclizumab huwa assoċjat ma' riskju potenzjalment fatali ta' ħsara li tinvolvi s-sistema immuni fil-fwied.
English: • The PRAC reviewed the totality of the data provided by the marketing authorisation holder on cases of serious liver injury reported since the initial marketing authorisation and safety and efficacy data from clinical trials, in relation to the overall risk of liver injury with daclizumab.
Maltese: • Il-PRAC irrieżamina d-data kollha pprovduta mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq dwar każijiet ta' ħsara serja fil-fwied irrappurtati sa mill-awtorizzazzjoni għattqegħid fis-suq inizjali u d-data dwar is-sigurtà u l-effikaċja mill-provi kliniċi, fir-rigward tar-riskju globali ta' ħsara fil-fwied b'daclizumab.
English: • The PRAC concluded that daclizumab is associated, during the treatment and for several months after the end of treatment, with an unpredictable and potentially fatal risk of immune-mediated liver injury.
Maltese: • Il-PRAC ikkonkluda li daclizumab huwa assoċjat, matul il-kura u għal diversi xhur wara ttmiem tal-kura, ma' riskju mhux prevedibbli u potenzjalment fatali ta' ħsara li tinvolvi ssistema immuni fil-fwied.
English: Results from both studies demonstrated clinically meaningful and statistically significant reductions in relapse rate, the primary efficacy endpoint in each study.
Maltese: Riżultati miż-żewġ studji wrew tnaqqis klinikament sostanzjali u statistikament sinifikanti fir-rata ta' rikaduta, l-end-point primarju tal-effikaċja f'kull studju.
English: The efficacy of daclizumab was demonstrated in two pivotal studies in subjects with relapsing remitting multiple sclerosis (RRMS) that led to the indication in relapsing multiple sclerosis.
Maltese: L-effikaċja ta' daclizumab intweriet f'żewġ studji pivotali f'individwi bi sklerożi multipla remittenti rikaduta (RRMS), li wasslet għall-indikazzjoni fi sklerożi multipla rikaduta.