FrancophonIA/ELRC3.0 huggingface dataset:
English: Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Maltese: Dan it-tagħrif jissuġġerixxi li l interazzjoni bejn levtiracetam u l-proteina talbużżieqa tas-sinapsi 2A donnhom jikkontribwixxu għall-mekkaniżmu t'azzjoni kontra l-epilessija tal-prodott mediċinali.
English: The NOAEL was ≥ 1,800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
Maltese: In- NOAEL kien ta' ≥ 1,800 mg/kg/ġurnat għal firien feminili F0, u għassopravivenza, kobor u l-iżvillup taż-żrameġ F1 sa kemm jibdew jieklu weħedhom ( x6 il-MRHD fuq bażi ta' mg/m2).
English: Convulsion, balance
Maltese: Aċċessjoni, mard tal-bilanċ,
English: A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
Maltese: Studju retrospettiv ta' interazzjoni farmakokinetika fit-tfal u l-addoloxxenti b'epilessija (4 sa 17- il sena) ikkonferma li terapija miżjuda b' levetitacetam li jittieħed mill-ħalq ma kellux effett fuq konċentrazzjonijiet tas-serum fi stat fiss ta' carbamazepine u valproate li jingħataw fl-istess ħin.
English: 35 mg (0.35 ml) twice daily 105 mg (1.05 ml) twice daily
Maltese: 105 mg (1.05 ml) darbtejn kuljum
English: 72 x serum creatinine (mg/dl)
Maltese: Rata ta' tneħħija tal krejatinina (ml/min/1.73 m2)
English: • sudden decrease in kidney function;
Maltese: • malfunzjoni f'daqqa tal-kliewi;
English: 233 of these patients were treated with levetiracetam in placebo-controlled studies.
Maltese: Sittin minn dawn il pazjenti ġew trattati b'levetiracetam fi studji kkontrollati bil-plaċebo.
English: 49 mg (0.5 ml) twice daily 147 mg (1.5 ml) twice daily
Maltese: 147 mg (1.5 ml) darbtejn kuljum
English: Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function:
Maltese: Regolar tad-doża f'pazjenti adulti u addoloxxenti li jiżnu iżjed minn 50 kg b' indeboliment fil kliewi: Grupp
English: Maltitol liquid
Maltese: Indeboliment tal-fwied
English: In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N-type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
Maltese: Studji in vitro juru li levetiracetam jaffetwa livelli ta' Ca2+ intranewronali billi jinibixxi parzjalment il-kurrenti ta' Ca2+ tat-tip N u billi jnaqqas kemm jintreħa Ca2+ mill-ħażniet intranewronali.
English: Breast-feeding is not recommended during treatment.
Maltese: Mhux irrikkmandat t-treddigħ waqt it-trattament.
English: • a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme);
Maltese: • raxx tal-ġilda li jista' jifforma infafet u dehra ta' miri żgħar (tikek skuri ċentrali mdawra minn żona iktar ċara, b'ċirku skur madwar it-tarf) (erythema multiforme);
English: (2) A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: 5 mg/kg (0.105 ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: The patients were randomized to carbamazepine CR 400 - 1,200 mg/day or levetiracetam 1,000 - 3,000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Maltese: Il-pazjenti kienu maqsuma mingħajr ma ġew magħżula biex jieħdu jew carbamazepine CR 400-1,200 mg/ġurnata jew levetiracetam 1,000-3,000 mg/ġurnata, b'trattament li dam sa 121 ġimgħa skond kemm kien ir-rispons.
English: What Levetiracetam Actavis Group is and what it is used for What you need to know before you take Levetiracetam Actavis Group How to take Levetiracetam Actavis Group Possible side effects
Maltese: Jekk it-tabib tiegħek jiddeċiedi li jwaqqaf it-trattament tiegħek b'Levetiracetam Actavis Group, hu/hi se jagħtik struzzjonijiet dwar l-irtirar gradwali ta' Levetiracetam Actavis Group.
English: Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes.
Maltese: L-effiċjenza ta' levetiracetam kien muri f' studju double-blind ikkontrollati minn plaċebo f i studju li dam 16 -il ġimgħa, f'pazjenti ta' 12 -il sena jew iżjed li jbagħtu minn epilessija ġeneralizzata idjopatika b'aċċessjonijiet mijokloniċi b'sindromi differenti.
English: However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
Maltese: mhumiex magħrufa l-effetti fit-tul fuq it-tagħlim, l-intelliġenza, il-kobor, il-funzjoni endokrinali, il puberta' u l-potenzjal li wieħed ikollu t-tfal.
English: Clear, faint yellowish-brown solution.
Maltese: - Żomm dan il-fuljett.
English: The 300 ml glass bottle of Levetiracetam Actavis Group (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.
Maltese: Il- flixkun tal-ħġieg ta' 300 ml ta' Levetiracetam Actavis Group (għal trabi u tfal żgħar ta' bejn isżgħar sitt xhur sa mhux iżjed minn sentejn ) huwa ppakkjat f'kaxxa tal-kartun li fiha siringa orali ta' 3 ml (b'marka tal-kejl kull 0.1 ml) u adattur għas-siringa.
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women)
Maltese: CLcr (ml/min) = ----------------------------------------- (x 0.85 għan-nisa) 72 x livell ta' krejatinina fis-serum (mg/dl)
English: Levetiracetam Actavis Group oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Maltese: Levetiracetam Actavis Group soluzzjoni orali fih parahydroxybenzoate (E218) u propylparahydroxybenzoate (E216) li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jista' jkun jieħdu iż żmien biex jidhru). Levetiracetam Actavis Group soluzzjoni orali fiha wkoll maltitol.
English: The initial therapeutic dose is 10 mg/kg twice daily.
Maltese: Id-doża terapewtika tal-bidu hija 10 mg/kg darbtejn kuljum.
English: Hepatitis B virus reactivation
Maltese: Riattivazzjoni tal-virus tal-epatite B
English: Hepatocellular carcinoma
Maltese: Karċinoma epatoċellulari
English: The protocol of this study shall be submitted to the PRAC by 15 June 2017 and the final study results by Q4 2019.
Maltese: Il-protokoll ta' dan l-istudju għandu jiġi ppreżentat lill-PRAC sal-15 ta' Ġunju 2017 u r-riżultati finali tal-istudju sa Q4 2019.
English: Other published data from larger cohorts did not support the findings (Pol et al, 2016).
Maltese: (2016) Data oħra ppubblikata minn koorti ikbar ma tappoġġjax issejbiet (Pol et al, 2016).
English: Literature cases (Balagopal et al., 2015; Collins et al., 2015; Ende et al., 2015) described HBV viral load increase after a rapid decline of HCV viral load in patients treated with direct acting antivirals (DAA) in interferon-free regimens, and further cases have been identified in EudraVigilance.
Maltese: Ende et al., 2015) iddeskrivew iż-żieda fit-tagħbija virali tal-HBV wara tnaqqis rapidu fit-tagħbija virali tal-HCV f'pazjenti kkurati b'antivirali li jaġixxu b'mod dirett (DAA) f'korsijiet mingħajr interferon, u ġew identifikati każijiet oħra f'EudraVigilance.
English: A joint study is encouraged.
Maltese: Huwa mħeġġeġ studju konġunt.
English: In addition, interim results should be submitted for PRAC assessment by Q4 2019.
Maltese: Barra minn hekk, ir-riżultati interim għandhom jiġu ppreżentati għal valutazzjoni mill-PRAC sa Q4 2019.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax remains favourable subject to the amendments to the product information and to the conditions described above.
Maltese: Konsegwentement, is-CHMP, jikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax jibqa' favorevoli soġġett għall-emendi fl-informazzjoni dwar ilprodott u fil-kundizzjonijiet deskritti hawn fuq.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for direct-acting antiviral agents (DAAs) indicated in the treatment chronic hepatitis C.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat tad-data ta' farmakoviġilanza għall-aġenti antivirali li jaħdmu b'mod dirett (DAAs) indikati fil-kura tal-epatite Ċ kronika.
English: • Concerning HBV reactivation, the PRAC concluded that available data provide evidence of a risk of HBV reactivation in patients co-infected with HBV/HCV treated for chronic hepatitis C with DAAs.
Maltese: • Dwar ir-riattivazzjoni tal-HBV, il-PRAC ikkonkluda li d-data disponibbli tipprovdi evidenza ta' riskju għar-riattivazzjoni tal-HBV f'pazjenti koinfettati bl-HBV/HCV ikkurati għall-epatite Ċ kronika b'DAAs.
English: ANNEX IV SCIENTIFIC CONCLUSIONS
Maltese: ANNESS IV
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
Maltese: Għalhekk is-CHMP jirrakkomanda l-varjazzjoni għat-termini tal-awtorizzazzjoni għat-tqegħid fis-suq għal Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
English: The virological and immunological aspects of HBV/HCV co-infection are not fully comprehended.
Maltese: L-aspetti viroloġiċi u immunoloġiċi tal-koinfezzjoni HBV/HCV mhumiex mifhuma għal kollox.
English: A study from Reig et al. (2016) showed a signal of HCC recurrence in patients treated with DAAs; similar results were obtained by Conti et al. (2016).
Maltese: (2016) wera sinjal ta' rikorrenza tal-HCC f'pazjenti kkurati b'DAAs, riżultati simili nkisbu wkoll minn Conti et al.
English: Direct-acting antiviral agents (DAAs) target specific non-structural proteins of the hepatitis C virus and result in disruption of viral replication and infection.
Maltese: L-aġenti antivirali li jaħdmu b'mod dirett (DAAs - Direct-acting antiviral agents) għandhom fil-mira tagħhom proteini mhux strutturali speċifiċi tal-virus tal-epatite Ċ u jirriżultaw fit-tkissir tar-replikazzjoni u l-infezzjoni virali.
English: Overall, the PRAC was of the view that evidence exists of a risk of HBV reactivation in HBV/HCV coinfected patients treated with DAAs and therefore HBV reactivation in co-infected patients should be considered as an important identified risk which should be closely monitored through routine risk minimisation activities.
Maltese: B'mod ġenerali, il-PRAC kien tal-fehma li l-evidenza turi riskju ta' riattivazzjoni tal-HBV f'pazjenti koinfettati bl-HBV/HCV ikkurati b'DAAs u għalhekk ir-riattivazzjoni tal-HBV f'pazjenti koinfettati għandha tiġi kkunsidrata bħala riskju identifikat importanti li jeħtieġ li jiġi mmonitorjat aktar mill-qrib permezz ta' attivitajiet ta' rutina ta' minimizzazzjoni tar-riskju.
English: With regards to the risk of hepatitis B reactivation, since chronic hepatitis B infection (HbsAg+) was generally considered an exclusion criterion and the collection of data regarding HBV serology and DNA was not mandatory in the development programme of DAAs agents, there is limited information on hepatitis B reactivation obtainable from the completed clinical trials.
Maltese: Fir-rigward tar-riskju tar-riattivazzjoni tal-epatite B, peress li l-infezzjoni tal-epatite B kronika (HbsAg+) kienet ġeneralment ikkunsidrata bħala kriterju ta' esklużjoni u l-ġbir tad-data rigward isseroloġija tal-HBV u d-DNA ma kienx obbligatorju fil-programm ta' żvilupp tal-aġenti DAAs, hemm informazzjoni limitata dwar ir-riattivazzjoni tal-epatite B li nkisbet minn provi kliniċi mitmuma.
English: The PRAC, as a consequence, recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
Maltese: Konsegwentement, il-PRAC jirrakkomanda l-varjazzjoni għat-termini tal-awtorizzazzjoni għat-tqegħid fis-suq għal Daklinza, Exviera, Harvoni, Olysio, Sovaldi u Viekirax.
English: Still, it was considered that the impact of DAAs therapies on the incidence and type of de novo HCC should be further investigated by the MAHs through a prospective cohort study to be conducted in HCV infected patients with compensated cirrhosis (CPT-A) without history of HCC and treated with DAAs.
Maltese: Xorta, ġie kkunsidrat li l-impatt tat-terapiji b'DAAs fuq l-inċidenza u t-tip ta' HCC de novo għandu jiġi investigat aktar mill-MAHs permezz ta' studju ta' koorti prospettiv li għandu jsir f'pazjenti infettati bl-HCV b'ċirrożi kkumpensata (CPT-A) li ma kellhomx l-HCC fil-passat u li huma kkurati b'DAAs.
English: In addition, ‘patients with previous HCC' should be considered as missing information, since this population was excluded from available clinical trials.
Maltese: Barra minn hekk, il-”pazjenti li kellhom l-HCC fil-passat” għandhom jitqiesu bħala informazzjoni nieqsa, peress li din il-popolazzjoni kienet eskluża mill-provi kliniċi disponibbli.
English: In accordance with the PRAC recommendation, in order to evaluate the recurrence of hepatocellular carcinoma associated with direct-acting antivirals, the MAHs shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and method for screening.
Maltese: F'konformità mar-rakkomandazzjoni tal-PRAC, sabiex tiġi evalwata r-rikorrenza tal-karċinoma epatoċellulari assoċjata ma' antivirali li jaħdmu b'mod dirett, il-MAHs għandhom iwettqu u jippreżentaw ir-riżultati ta' studju prospettiv dwar is-sigurtà li juża data derivata minn koorti ta' grupp ta' pazjenti definit tajjeb, ibbażat fuq protokoll miftiehem li jistabbilixxi kriterji għad-dħul u s-segwitu ta' pazjenti f'termini ta' żmien u metodu tal-iskrinjar.
English: The available data provide evidence that the reactivation of HBV replication may occur in the context of the treatment of chronic HCV active infection with any form of effective treatment in patients coinfected with HBV and HCV.
Maltese: Id-data disponibbli tipprovdi evidenza li r-riattivazzjoni tar-replikazzjoni tal-HBV tista' ssir fil-kuntest tal-kura tal-infezzjoni attiva HCV kronika bi kwalunkwe forma ta' kura effettiva f'pazjenti koinfettati blHBV u bl-HCV.
English: After further consideration of the timelines proposed for the submission of the final study report and taking into account that the protocol is due to be submitted by 15 June 2017, the CHMP was of the opinion that the date for the submission of the final study report should be postponed to Q2 2021 in order to allow sufficient time for agreement on a joint protocol and for collection of sufficient data to adequately respond to the scientific question.
Maltese: Wara aktar konsiderazzjoni tal-iskedi ta' żmien proposti għas-sottomissjoni tar-rapport finali ta' studju u wara li tqies il-protokoll għandu jiġi ppreżentat sal-15 ta Ġunju 2017, is-CHMP kien tal-fehma li ddata għas-sottomisjoni tar-rapport finali ta' studju għandha tiġi posposta għal Q2 2021 sabiex tagħti lok għal ħin suffiċjenti għal ftehim dwar protokoll konġunt u għall-ġbir ta' data suffiċjenti sabiex iwieġeb b'mod adegwat għall-kwistjoni xjentifika.
English: CHMP opinion and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Maltese: L-opinjoni tas-CHMP u spjegazzjoni dettaljata tar-raġunijiet xjentifiċi għad-differenzi mirrakkomandazzjoni tal-PRAC
English: Clinical trial data on incidence of new on-set HCC show higher point estimates for HCC after reaching SVR with IFN-free regimens compared to IFN-containing regimens, also when stratifying by presence of cirrhosis.
Maltese: Data tal-provi kliniċi dwar l-inċidenza ta' HCC attwali ġdida turi stimi puntwali ogħla għall-HCC wara li nkisbet SVR b'korsijiet mingħajr IFN meta mqabbla ma' korsijiet li fihom IFN, anki fi stratifikazzjoni bil-preżenza taċ-ċirrożi.
English: Hepatitis В virus (HBV) and hepatitis C virus (HCV) co-infection is not uncommon due to overlapping transmission modes.
Maltese: Il-koinfezzjoni bil-virus tal-epatite B (HBV) u l-virus tal-epatite Ċ mhijiex xi ħaġa mhux komuni minħabba modalitajiet ta' trażmissjoni li jissovrapponu lil xulxin.
English: With regards to the review of HCC with DAAs, MAHs were requested to perform a comprehensive review of all available data from clinical trials, observational studies, spontaneous reports and published literature on HCC in patients with chronic hepatitis C after treatment with DAAs.
Maltese: Fir-rigward tar-rieżami tal-HCC b'DAAs, il-MAHs ġew mitluba jwettqu rieżami komprensiv tad-data kollha disponibbli mill-provi kliniċi, studji ta' osservazzjoni, rapporti spontanji u riċensjoni ppubblikata dwar l-HCC f'pazjenti bl-epatite Ċ kronika wara l-kura b'DAAs.
English: Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested unexpected early HCC recurrence.
Maltese: Għalhekk, f'April 2016, il-Kummissjoni Ewropea estendiet ilkamp ta' applikazzjoni tal-proċedura sabiex tippermetti konsiderazzjoni ta' data oħra biex jiġi evalwat ir-riskju tal-karċinoma epatoċellulari u l-impatt tagħha fuq il-bilanċ bejn il-benefiċċju u r-riskju għadDAAs kollha fil-kura tal-epatite Ċ kronika.
English: The impact of chronic HCV infection characteristics, such as HCV genotype, viral load and histopathologic staging, on the risk of occurrence of HBV reactivation could not be clarified from the available data.
Maltese: L-impatt tal-karatteristiċi tal-infezzjoni HCV kronika, bħal ġenotip tal-HCV, ittagħbija virali u l-waqfien istopatoloġiku, fuq ir-riskju tal-okkorrenza tar-riattivazzjoni tal-HBV ma setax jiġi ċċarat mid-data disponibbli.
English: • The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral diseases.
Maltese: • Il-PRAC irrieżamina t-totalità tad-data ppreżentata bil-miktub u waqt l-ispjegazzjonijiet bilfomm mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fir-rigward tar-riskju tarriattivazzjoni tal-epatite B u t-tħassib li tqajjem wara r-rapporti tal-karċinoma epatoċellulari f'pazjenti bl-użu ta' DAAs, kif ukoll ir-riżultat tal-laqgħa tal-grupp konsultattiv xjentifiku dwar lHIV/il-Mard virali.
English: • The PRAC was also of the opinion that the impact of DAAs treatment on the incidence and type of de novo hepatocellular carcinoma should be further investigated though a prospective cohort study in HCV infected patients with cirrhosis.
Maltese: • Il-PRAC kien ukoll tal-opinjoni li l-impatt tal-kura b'DAAs fuq l-inċidenza u t-tip tal-karċinoma epatoċellulari de novo għandu jiġi investigat aktar permezz ta' studju ta' koorti prospettiv f'pazjenti infettati bl-HCV li għandhom iċ-ċirrożi.
English: The RMP should be updated accordingly within 3 months of this CHMP opinion.
Maltese: L-RMP għandu jiġi aġġornat kif xieraq fi żmien 3 xhur minn din l-opinjoni tas-CHMP.
English: The RMP of the relevant medicinal products will be updated accordingly.
Maltese: L-RMP tal-prodotti mediċinali rilevanti se jiġi aġġornat kif xieraq.
English: Patients with HBV/HCV co-infection should be monitored during and after treatment according to current clinical guidelines.
Maltese: HBV/HCV għandhom jiġu ssorveljati matul u wara l-kura skont il-linji gwida kliniċi attwali.
English: Overall, the PRAC considered that further studies were warranted to further characterise the risk of HCC recurrence associated with DAAs, in order to address remaining uncertainties about this potential risk and conclude on the need for any additional advice on clinical management.
Maltese: B'mod ġenerali, il-PRAC ikkunsidra li kienu meħtieġa aktar studji sabiex jiġi kkaratterizzat aktar irriskju tar-rikorrenza tal-HCC assoċjata mad-DAAs, sabiex jiġu indirizzati inċertezzi li għad fadal dwar dan ir-riskju potenzjali u jiġi konkluż il-bżonn għal kwalunkwe parir addizzjonali dwar l-immaniġġjar kliniku.
English: Generally, the reactivation occurred shortly after the initiation of treatment in a pattern that implies a correlation with the rapid decrease in HCV viral load which characterises the viral load dynamics with DAAs.
Maltese: Ġeneralment, ir-riattivazzjoni ssir ftit wara l-bidu tal-kura b'tendenza li timplika korrelazzjoni mat-tnaqqis rapidu fit-tagħbija virali tal-HCV li jikkaretterizza d-dinamiċi tat-tagħbija virali mad-DAAs.
English: The reactivation may occur mostly in subjects with detectable HBsAg and active HBV replication of any level, as evaluated by measurable levels of HBV-DNA, but may also occur in subjects without detectable HBsAg though with detectable anti-HBc antibody, of which a small percentage may also present with variable levels of active HBV replication.
Maltese: Ir-riattivazzjoni tista' ssir l-aktar f'individwi b'HBsAg li jista' jiġi individwat u b'replikazzjoni tal-HBV attiva ta' kwalunkwe livell, kif evalwat minn livelli li jistgħu jitkejlu tal-HBVDNA, iżda tista' ssir ukoll f'individwi mingħajr HBsAG individwata għalkemm b'antikorp anti-HBc individwat, li perċentwal żgħir minnu jista' jkun jiġi wkoll f'livelli li jvarjaw ta' replikazzjoni tal-HBV attiva.
English: HBV replication after starting treatment with DAAs for HCV infection is not currently described in the product information of currently authorised products and in view of the seriousness of the events described, the need for intervention on HBV replication and the biological plausibility of the replication it was considered that further investigation was warranted.
Maltese: Ir-replikazzjoni tal-HBV wara li tinbeda l-kura b'DAAs għall-infezzjoni HCV bħalissa mhijiex deskritta flinformazzjoni dwar il-prodott ta' prodotti awtorizzati attwali u fid-dawl tas-serjetà tal-avvenimenti deskritti, il-ħtieġa għal intervent dwar ir-replikazzjoni tal-HBV u l-plawsibilità bijoloġika tarreplikazzjoni, ġie kkunsidrat li kienet meħtieġa aktar investigazzjoni.
English: Given their increased potency against HCV and lack of anti-HBV activity, the risk of HBV reactivation may be greater with newer HCV treatment regimens than with the previously approved interferon-based HCV treatments.
Maltese: Minħabba l-potenza miżjuda tagħhom kontra l-HCV u n-nuqqas ta' attività kontra lHBV, ir-riskju tar-riattivazzjoni tal-HBV jista' jkun akbar b'korsijiet ta' kura tal-HCV ġodda milli bil-kuri tal-HCV ibbażati fuq interferon li ġew approvati qabel.
English: The PRAC was also of the view that ‘emergence of hepatocellular carcinoma' and ‘recurrence of hepatocellular carcinoma' should be considered as important potential risks.
Maltese: Il-PRAC kien ukoll tal-fehma li l-”feġġa tal-karċinoma epatoċellulari” u r-“rikorrenza tal-karċinoma epatoċellulari" għandhom jitqiesu bħala riskji potenzjali importanti.
English: 48 wounds
Maltese: 48 ferita
English: NN: {number} >
Maltese: {numru} NN: {numru} >
English: 60 wounds
Maltese: 60 ferita
English: (Number of wounds)
Maltese: (Numru ta' feriti)
English: An asterisk (*) indicates that additional information on the respective adverse reaction is provided below the list of adverse reactions.
Maltese: Asterisk (*) jindika li informazzjoni addizzjonali dwar ir-reazzjoni avversa rispettiva hi pprovduta taħt il-lista ta' reazzjonijiet avversi.
English: MediWound Ltd. 42 Hayarkon St. 81227 Yavne Israel
Maltese: 42 Hayarkon St. 81227 Yavne L-Iżrael