FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.4).
Maltese: Il-farmakokinetika ta' efavirenz għadha ma ġietx studjata f'pazjenti b'insuffiċjenza tal-kliewi; madankollu, anqas minn 1 % tad-doża ta' efavirenz titneħħa mhux mibdula fl-awrina, għalhekk l impatt ta' indeboliment tal-kliewi fuq l-eliminazzjoni ta' efavirenz għandu jkun mill-inqas (ara sezzjoni 4.4).
English: Mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Maltese: Ġie rraportat raxx minn ħafif sa moderat fi studju kliniċi b'efavirenz, u s-soltu jgħaddi mattkomplija tat-terapija.
English: (hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts, catatonia (condition in which the patient is rendered motionless and speechless for a period) - whistling, ringing or other persistent noise in the ears - tremor (shaking) - flushing
Maltese: (alluċinazzjonijiet), manija (kundizzjoni mentali kkaratterizzata minn episodji ta' attività eċċessiva, ferħ kbir jew irritabbiltà), paranoja, ħsibijiet ta' suwiċidju, katatonja (kundizzjoni li fiha l-pazjent jispiċċa ma jistax jiċċaqlaq u ma jistax jitkellem għal perjodu ta' żmien) - tisfir, żarżir jew xi ħoss persistenti ieħor fil-widnejn - tregħid
English: Antimycobacterials Rifabutin/efavirenz (300 mg once daily/600 mg once daily)
Maltese: Rifabutin/Efavirenz (300 mg darba kuljum/600 mg darba kuljum)
English: In clinical controlled trials, frequently reported adverse reactions included, but were not limited to dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming.
Maltese: Fi provi kliniċi kkontrollati, ir-reazzjonijiet avversi li ġew irrappurtati b'mod frekwenti, kienu jinkludu, imma ma kinux limitati għal: sturdament, nuqqas ta' rqad, ngħas, nuqqas ta' konċentrazzjoni u ħolm mhux normali.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS EFAVIRENZ TEVA 600 mg FILM-COATED TABLET: BLISTER FOIL LABEL
Maltese: efavirenz rriżulta f'livelli aktar baxxi ta' methadone filplażma u sinjali ta'
English: CCR5 antagonist Maraviroc/efavirenz (100 mg twice daily/600 mg once daily)
Maltese: Maraviroc/Efavirenz (100 mg darbtejn kuljum/ 600 mg darba kuljum)
English: Study PACTG 1021 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of efavirenz in combination with didanosine and emtricitabine in paediatric patients who were antiretroviral therapy naive.
Maltese: Studju PACTG 1021 kien studju open-label biex jevalwa l-farmakokinetika, is-sigurtà, it-tollerabbiltà,
English: Responder rates (NC = Fa) Plasma HIV-RNA
Maltese: Rati tar-rispons (NC = Fa)
English: Since decreased concentrations of artemether, dihydroartemisinin, or lumefantrine may result in a decrease of antimalarial efficacy, caution is recommended when efavirenz and artemether/lumefantrine tablets are coadministered.
Maltese: Minħabba li konċentrazzjonijiet imnaqqsa ta' artemether, dihydroartemisinin, jew lumefantrine jistgħu jirriżultaw fi tnaqqis fl-effiċjenza ta' sustanzi kontra l-malarja, huwa rrakkomandat li tingħata kawtela meta efavirenz u pilloli ta' artemether/lumefantrine jingħataw flimkien.
English: Atazanavir/ritonavir/efavirenz (400 mg once daily/200 mg once daily/600 mg once daily, all administered with food)
Maltese: Atazanavir/ritonavir/Efavirenz (400 mg darba kuljum/200 mg darba kuljum/600 mg darba kuljum, kollha mogħtija mal-ikel)
English: When efavirenz is co-administered with a calcium channel blocker that is a substrate of the CYP3A4 enzyme, there is a potential for reduction in the plasma concentrations of the calcium channel blocker.
Maltese: Meta efavirenz jingħata fl-istess ħin ma' imblokkatur tal-kanali talkalċju li jkun substrat tal-enzima CYP3A4,
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Maltese: Għalkemm l-etjoloġija titqies li għandha għadd ta' fatturi (inklużi użu ta' kortikosterojdi, konsum talalkoħol, immunosoppressjoni qawwija, indiċi ogħla tal-massa tal-ġisem), ġew irrappurtati każijiet ta' ostjonekrożi speċjalment f'pazjenti b'mard avvanzat tal-HIV u/jew esponiment fit-tul għat-terapija antiretrovirali kombinata (CART).
English: If
Maltese: OPOIDI
English: Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.
Maltese: L-esponiment għal efavirenz jista' jiżdied meta jingħata ma' prodotti mediċinali (per eżempju,
English: Risk to the infant cannot be excluded.
Maltese: Ma jistax jiġi eskluż riskju għat-tarbija.
English: The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions (see sections 4.4 and 5.2).
Maltese: Il-konċentrazzjonijiet ogħla ta' efavirenz li ġew osservati wara l-għoti ta' efavirenz mal-ikel jistgħu jwasslu għal żieda fil-frekwenza ta' reazzjonijiet avversi (ara sezzjonijiet 4.4 u 5.2).
English: Lopinavir/ritonavir tablets/ efavirenz
Maltese: Pilloli rotob jew soluzzjoni orali ta' Lopinavir/ritonavir/efavirenz
English: Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz.
Maltese: Ġie rrapurtat raxx qawwi marbut ma' nfafet, tqaxxir umdu tal-ġilda u ulċeri f'inqas minn 1% mill-pazjenti kkurati b'efavirenz.
English: - severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
Maltese: - ideat suwiċidali - attentati mhux fatali ta' suwiċidju 0.4 % - mġieba aggressiva
English: - Methadone (a medicine used to treat opiate addiction): your doctor may recommend an alternative treatment.
Maltese: - Methadone (mediċina użata biex tikkura l-vizzju ta' opjati): it-tabib tiegħek jista'jirrakkomanda kura alternattiva.
English: Photoallergic dermatitis†
Maltese: Mediċini li Jtawlu l-QT
English: Malformations were observed in 3 of 20 foetuses/newborns from efavirenz-treated cynomolgus monkeys given doses resulting in plasma efavirenz concentrations similar to those seen in humans.
Maltese: 3 minn 20 fetu / mwieled frisk minn xadini cynomolgus ikkurati b'efavirenz li ngħataw dożi li rriżultaw f'konċentrazzjonijiet ta' efavirenz fil-plażma li kienu simili għal dawk li ġew osservati filbnedmin.
English: Efavirenz in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Maltese: darunavir/ritonavir 800/100 mg darba kuljum jista' jwassal għal
English: ATC code: J05AG03
Maltese: J05AG03 Mekkaniżmu ta' azzjoni
English: The median increase from baseline in CD4+ count at 48 weeks of therapy was 238 cells/mm3 and the median increase in CD4+ percentage was 13%.
Maltese: Iż-żieda medjana mil-linja bażi fl-għadd ta' CD4+ wara 48 ġimgħa ta' terapija kienet ta' 238 ċellula/mm3 u ż-żieda medjana fil-perċentwali ta' CD4+ kienet ta' 13%.
English: Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc.
Maltese: Karatteristiċi tal-Prodott għallprodott mediċinali li fih maraviroc.
English: Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
Maltese: Efavirenz huwa indikat għall-kura kombinata antiretrovirali tal-adulti, l-adoloxxenti u t-tfal ta' tliet snin jew ikbar li huma nfettati bil-virus tal-immunodefiċjenza umana-1 (HIV-1).
English: Theoretically, efavirenz may therefore initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index (see section 4.3).
Maltese: CYP3A4 b'indiċi terapewtiku dejjaq (ara sezzjoni 4.3).
English: Efavirenz must be given in combination with other antiretroviral medicines (see section 4.5).
Maltese: Efavirenz irid jingħata flimkien ma' mediċini oħra antiretrovirali (ara sezzjoni 4.5).
English: Medicinal product subject to medical prescription.
Maltese: dawn il-prodotti mediċinali.
English: In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ml at the missing time points.
Maltese: Fl-analiżi tar-rati tar-rispons (lanaliżi li fiha n-nuqqas ta' tkomplija titqies bħala falliment [NC = F]), pazjenti li temmew l-istudju kmieni kienet x'kienet ir-raġuni, jew li kellhom kejl ta' HIV-RNA nieqes li qablu jew warajh sar kejl li kien ogħla mil-livell ta' kwantifikazzjoni tal-assay kienu kkonsidrati li kellhom HIV-RNA ‘il fuq minn 50 jew ‘il fuq minn 400 kopja/ml fil-punti ta' żmien neqsin.
English: (CYP3A induction - effect on boceprevir) *0-8 hours
Maltese: (induzzjoni ta' CYP3A - effett fuq boceprevir)
English: Patients taking drugs that are known to prolong the QTc interval (proarrythmic).
Maltese: Karatteristiċi tal-Prodott fil-Qosor korrispondenti.
English: Tests may show: - increased cholesterol in the blood
Maltese: Testijiet jistgħu juru: - żieda ta' kolesterol fid-demm
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Maltese: F'każ ta' terapija antiretrovirali li qed tingħata fl-istess ħin għall-epatite B u C, jekk jogħġbok irreferi wkoll għall-informazzjoni relevanti dwar il-prodott għal dawn il-prodotti mediċinali.
English: Core
Maltese: Jekk
English: Concomitant administration of sofosbuvir/velpatasvir with efavirenz resulted in a reduction (approximately 50%) in the systemic exposure of velpatasvir.
Maltese: (ta' madwar 50%) flesponiment sistemiku għal velpatasvir.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti li jkollhom infezzjoni avvanzata tal-HIV (AIDS) u storja ta' infezzjoni opportunistika, jista' jkun li ftit wara li tibda l-kura kontra l-HIV, iseħħu sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet li ġew qabel.
English: If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with efavirenz needs to be weighed against the potential risks of significant liver toxicity.
Maltese: Jekk hemm xhieda ta' mard tal-fwied li jeħżien jew ta' livelli persistentement għolja ta' serum transaminases għal iktar minn 5 darbiet il-livell ta' fuq tal-medda normali, il-benefiċċju tat-tkomplija tat-terapija b'efavirenz għandu jitkejjel kontra r-riskji potenzjali ta' tossiċita` sinifikanti tal-fwied.
English: Nervous system symptoms may occur more frequently when efavirenz is taken concomitantly with meals possibly due to increased efavirenz plasma levels (see section 5.2).
Maltese: Għandu jiġi kkunsidrat ir-rispons individwali tat-tollerabilità u viroloġiku meta wieħed jagħmel l-aġġustament fiddoża (ara sezzjoni 5.2).
English: - nervousness, forgetfulness, confusion, fitting (seizures), abnormal thoughts - blurred vision - a feeling of spinning or tilting (vertigo) - pain in the abdomen (stomach) caused by inflammation of the pancreas - allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme,
Maltese: Mhux komuni (jaffettwaw utent wieħed sa 10 minn kull 1,000) - nervożiżmu, tinsa l-affarijiet, konfużjoni, attakki (aċċessjonijiet), ħsibijiet mhux normali - viżta mċajpra - sensazzjoni ta' tidwir jew għelib (vertiġni) - uġigħ fl-istonku ikkawżat minn infjammazzjoni tal-frixa - reazzjoni allerġika (sensittività eċċessiva) li tista' tikkawża reazzjonijiet severi tal-ġilda (ertema multiforme, is-sindromu ta' Stevens-Johnson)
English: letter
Maltese: Communication')
English: In Europe, nimesulide is nationally authorised in 16 Member States (Austria, Belgium, Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Portugal, Romania, Slovakia and Slovenia).
Maltese: Ġewwa l-Ewropa, nimesulide huwa awtorizzat b'mod nazzjonali f'17 -il Stat Membru (l-Awstrija, ilBelġju, il-Bulgarija, ir-Repubblika Ċeka, Ċipru, Franza, il-Greċja, l-Ungerija, l-Italja, il-Latvja, ilLitwanja, Malta, Il-Polonja, il-Portugall, ir-Rumanija, l-Islovakkja u s-Slovenja).
English: Nimesulide is a non-steroidal anti-inflammatory drug (NSAID), available only on prescription and authorised in Europe since 1985.
Maltese: Nimesulide huwa mediċina anti-infjammatorja mhux sterojdi (NSAID), li huwa disponibbli biss fuq preskrizzjoni u huwa awtorizzat fl-Ewropa mill-1985.
English: - The maximum duration of a treatment course with nimesulide is 15 days.
Maltese: - Id-dewmien massimu tal-kors tat-trattament b'nimesulide huwa ta' 15 -il jum.
English: During its plenary meeting in May 2007, the CHMP considered the emerging safety data from Ireland on the risk of fulminant hepatic failure associated with nimesulide, as well as data available from published literature, and concluded that hepatotoxicity data on nimesulide should be reviewed in accordance with Article 107(2) of Directive 2001/83/EC, as amended.
Maltese: Matul il-laqgħa plenarja tiegħu f'Mejju tal-2007, is-CHMP ikkunsidra d-dejta l-ġdida li ħarġet millIrlanda dwar ir-riskju ta' insuffiċjenza epatika fulminanti assoċjata ma' nimesulide, kif ukoll id-dejta li kienet disponibbli mid-dokumentazzjoni ppubblikata u kkonkluda li d-dejta tal-epatotossiċċità b'nimesulide għandha tiġi riveduta skont l-Artikolu 107(2) tad-Direttiva 2001/83/KE, kif emendata.
English: - The CHMP considered the gastrointestinal toxicity profile of nimesulide and the possible consequences of switching to other NSAIDs.
Maltese: - Is-CHMP jikkundisra l-profil ta' tossiċità gastrointestinali ta' nimesulide u l-konsegwenzi possibli meta wieħed jaqleb għal NSAIDs oħra.
English: On 15th May 2007, following new safety information regarding cases of fulminant hepatic failure associated with nimesulide, the Irish Medicines Board suspended the national marketing authorisations for all systemic medicinal products containing nimesulide available in Ireland.
Maltese: Fil-15 ta' Mejju 2007, wara informazzjoni ġdida dwar is-sigurezza fir-rigward ta' każijiet ta' insuffiċjenza epatika fulminanti b'nimesulide, il-Bord Irlandiż għall-Prodotti Mediċinali issospenda lawtorizzazzjonijiet nazzjonali għat-tqegħid fis-suq għall-prodotti mediċinali sistemiċi kollha li kien fihom nimesulide u li kienu jinsabu disponibbli ġewwa l-Irlanda.
English: The CHMP reviewed the data presented, including answers provided by the Marketing Authorisations Holders (MAHs), pharmacovigilance data provided by the Member States, data provided by the EMEA and literature review.
Maltese: Is-CHMP irreveda d-dejta ppreżentata, inklużi t-tweġbiet ipprovduti mid-Detenturi talAwtorizzazzjonijiet għat-Tqegħid fis-Suq (MAHs), id-dejta tal-farmakoviġilanza pprovduta mill-Istati Membri, id-dejta pprovduta mill-EMEA u r-reviżjoni tad-dokumentazzjoni ppublikata.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NIMESULIDE CONTAINING MEDICINAL PRODUCTS (SYSTEMIC FORMULATIONS) (see Annex I)
Maltese: TAL-EVALWAZZJONI XJENTIFIKA FUQ PRODOTTI MEDIĊINALI LI FIHOM NIMESULIDE (FORMULAZZJONIJIET SISTEMIĊI) (ara Anness I)
English: Finally, according to the data submitted by the Marketing Authorisation Holder the majority of hepatic disorders (56%), occurred after two weeks of treatment, therefore a treatment period of not longer than 15 days may limit the risk of acute liver injury.
Maltese: Finalment, skont dejta sottomessa mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, il-biċċa lkbira tal-problemi epatiċi (56%) dehru wara ġimgħatejn ta' trattament, għalhekk perjodu ta' trattament li ma jkunx iktar minn 15 -il jum jista' jillimita r-riskju ta' problemi serji fil-fwied.
English: The assessment of these consequences were supported by a simulation of the possible impact of nimesulide withdrawal in Italy.
Maltese: L-evalwazzjoni ta' dawn il-konsegwenzi saret permezz ta' simulazzjoni tal-impatt possibbli tal-irtirar ta' nimesulide ġewwa l-Italja.
English: The additional Product Information restrictions together with a limitation of duration of treatment and withdrawal of the pack sizes above 30 units aim at further minimising such risk, together with the conditions (see Annex IV) and the effort of national competent authorities in education and information activities on both prescribers and patients.
Maltese: Ir-restrizzjonijiet addizzjonali tal-Informazzjoni tal-Prodott flimkien mal-limitazzjoni fid-dewmien tat-trattament u l-irtirar tad-daqsijiet tal-pakkett li jkun ‘il fuq minn 30 unità għandhom l-għan li jkomplu jiminimizzaw ir-riskju, u dan flimkien mal-kondizzjonijiet (ara Anness IV) u l-isforzi tal-awtoritajiet kompetenti nazzjonali fil-qasam tal-edukazzjoni u lattivitajiet ta' informazzjoni għal dawk li jippreskrivu kuf ukoll għall-pazjenti.
English: This referral concluded, with divergent positions submitted by Finland, Spain and Ireland, that the benefit/risk profile of nimesulide for systemic use remained positive, subject to revision of the product information, including a restriction of the maximum oral dose to 100 mg twice daily.
Maltese: Fl-2002, wara li kienet saret sospensjoni tal-liċenzja tiegħu ġewwa l-Finlandja u sussegwentament ġewwa Spanja minħabba tħassib fir-rigward l-epatotossiċità, nimesulide kien suġġett għal riferiment lis-CHMP skont l-Artikolu 31. Dan ir-riferiment ikkonkluda, b'pożizzjonijiet divergenti sottomessi mill-Finlandja, Spanja u l-Irlanda, li l-profil bejn il-benefiċċju u r-riskju ta' nimesulide għall-użu sistemiku jibqa' wieħed pożittiv ladarba ssirlu reviżjoni tal-informazzjoni tal-prodott, inkluża rrestrizzjoni tad-doża orali massima għal 100 mg darbtejn kuljum.
English: This decision was endorsed by the European Commission in April 2004 and the product information was subsequently amended to contraindicate its use in patients with hepatic impairment, and to include warnings about the risk of hepatitis, fulminant hepatitis (including fatal cases), jaundice and cholestasis.
Maltese: Id-deċiżjoni ġiet adottata millKummissjoni Ewropea f'April tal-2004 u l-informazzjoni dwar il-prodott ġiet sussegwentament emendata fejn ikkontra-indikat l-użu tiegħu f'pazjenti b'indebboliment epatiku, u sabiex tinkludi twissijiet dwar ir-riskju ta' epatite, epatite fulminanti (inklużi każijiet fatali) suffejra u cholestasis. Linformazzjoni armonizzata dwar il-prodott ġiet implimentata fl-Istati Membri lrjn l-aħħar tal-2004 u lbidu tal-2005.
English: - Nimesulide showed a higher frequency of severe adverse hepatic reactions but the overall safety profile of nimesulide is not modified.
Maltese: - Nimesulide wera frekwenza iktar għolja ta' reazzjonijiet epatiċi ħżiena u severi iżda l-profil ġenerali ta' sigurtà ta' nimesulide m'huwiex modifikat.
English: Having considered all of the available evidence, the CHMP concluded that the data did not support a suspension of all marketing authorisations in Europe.
Maltese: Wara li kkunsidra l-evidenza kollha disponibbli, is-CHMP ikkonkluda li d-dejta ma kienetx issostni sospensjoni tal-awtorizzazzjonijiet kollha għat-tqegħid fis-suq fl-Ewropa.
English: However, with the exception of the signal of serious hepatic adverse reactions raised by Ireland, the review of the overall data submitted do not modify the safety profile of nimesulide as established after the previous CHMP opinion.
Maltese: Madanakollu, bl-eċċezzjoni tas-sinjalar ta' reazzjonijiet epatiċi ħżiena serji li tqajmu mill-Irlanda, ir-reviżjoni tad-dejta ġenerali sottomessa ma timmodifikax il-profil ta' sigurtà ta' nimesulide hekk kif kien ġie stabbilit fl-opinjoni tas-CHMP preċedenti.
English: The Irish Medicines Board informed the EMEA, other Member States and the Marketing Authorisation Holders in accordance with Article 107(2) of Directive 2001/83/EC, as amended.
Maltese: III tad-Deċiżjoni skont Artikolu 107(2) tad-Direttiva 2001/83/KE, u l-emendi suċċessivi tagħha.
English: Furthermore the maintenance of the Marketing Authorisations is linked to the conditions, below: - Submission of 6-monthly PSURs - Implementation of a retrospective study, followed by a prospective study in transplant centres - Update of Risk Management Plan - Information of healthcare professional via a ‘Direct Healthcare Professional Communication'
Maltese: Barra minn hekk iż-żamma tal-Awtorizzazzjonijet għat-Tqegħid fis-Suq hija marbuta malkondizzjonijiet hawn taħt imsemmija: - Sottomissjoni ta' Rapporti Perjodiċi ta' Aġġornament dwar is-Sigurtà (PSURs) - Implimentazzjoni ta' studju retrospettiv u wara ta' studju prospettiv fiċ-ċentri ta' trapjant.
English: The hepatotoxic signal seen in Ireland showed that nimesulide was associated with more cases of nonA non-B non-paracetamol-related fulminant hepatic failure requiring liver transplantation in Ireland than any other medicinal product.
Maltese: Is-sinjal epatotossiku li deher ġewwa l-Irlanda wera li nimesulide kien assoċjat ma' każijiet ta' insuffiċjenża epatika fulminanti mhux A, mhux B u mhux relatata mal-paracetamol li kienet teħtieġ trapjant tal-fwied.
English: - The limitation of treatment with nimesulide not longer than 15 days may limit the risk of acute liver injury.
Maltese: - Il-limitazzjoni tat-trattament b'nimesulide għal mhux iktar minn 15 -il jum jista' jillimita r-riskju ta' problemi serji fil-fwied.
English: The use of nimesulide in strict accordance with the Product Information recommendations has been shown to be equally effective in reducing hepatic toxicity.
Maltese: L-użu ta' nimesulide b'konformazzjoni stretta mar-rakkomandazzjonijiet tal-Informazzjoni tal-Prodott wera li kien daqstant effettiv fit-tnaqqis tat-tossiċità epatika.
English: The assessment of overall post-marketing spontaneous reporting data, clinical studies, and epidemiological data, show a higher frequency of severe adverse hepatic reactions with nimesulide compared with other NSAIDs.
Maltese: L-evalwazzjoni ġenerali ta' dejta ta' rappurtaġġ spontanju wara t-tqegħid fis-suq, l-istudji kliniċi u ddejta epidemjoloġika juru frekwenza ogħla ta' reazzjonijiet epatiċi ħżiena b'nimesulide meta pparagunati ma' NSAIDs oħra.
English: Overall, the benefit-risk profile of nimesulide-containing medicinal products for systemic use remains favourable and the Marketing Authorisations for products containing nimesulide for systemic use should be maintained with the following restrictions: - The decision to prescribe nimesulide should be based on an assessment of the individual patient's overall risks.
Maltese: B'mod ġenerali, il-profil bejn il-benefiċċju u r-riskju ta' prodotti mediċinali li jkun fihom nimesulide għal użu sistemiku jibqa' wieħed favorevoli u l-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għal prodotti li fihom nimesulide għal użu sistemiku għandhom jinżammu bir-restrizzjonijiet li ġejjin:
English: This review focused on the hepatic safety of nimesulide in light of the significant concern arising from the Irish data and within the defined scope of the Article 107.
Maltese: Din irreviżjoni iffukat fuq is-sigurtà epatica ta' nimesulide fid-dawl ta' tħassib sinnifikanti li ħareġ mid-dejta Irlandiża u fi ħdan l-iskop definit ta' Artikolu 107.