FrancophonIA/ELRC3.0 huggingface dataset:
English: New information has become available on three key issues: risk estimates; the diagnosis of PML before the development of clinical symptoms; and anti-JC virus antibodies.
Maltese: Saret disponibbli informazzjoni ġdida dwar tliet kwistjonijiet ewlenin: l-istimi tar-riskju; id-dijanjożi ta' PML qabel l-iżvilupp tas-sintomi kliniċi; u l-antikorpi kontra l-virus ta' JC.
English: Biomarkers for PML development
Maltese: Bijomarkaturi tal-iżvilupp tal-PML
English: • The PRAC concluded that PML which is clinically asymptomatic at diagnosis represents more frequently localised disease in MRI, with a higher survival rate and better clinical outcome as compared to symptomatic PML.
Maltese: • Il-PRAC ikkonkluda li PML li hija klinikament asintomatika fid-dijanjożi tirrappreżenta mard lokalizzat aktar frekwenti fl-MRI, b'rata ogħla ta' sopravivenza u eżitu kliniku aħjar meta mqabbel ma' PML sintomatika.
English: Therefore a number of risk minimisation measures in relation to PML are in place for Tysabri.
Maltese: Għaldaqstant huwa fis-seħħ għadd ta' miżuri għall-minimizzazzjoni tar-riskju firrigward tal-PML għal Tysabri.
English: For natalizumab-treated patients with MS, who are at high risk of PML, brain MRI screening using a protocol that includes FLAIR (fluidattenuated inversion recovery), T2-weighted and diffusion -weighted imaging is recommended.
Maltese: Għal pazjenti b'MS ikkurati b'natalizumab, li huma f'riskju għoli ta' PML, huma rakkomandati eżamijiet tal-MRI tal-moħħ permezz ta' protokoll li jinkludi immaġnijiet FLAIR (irkupru tal-inverżjoni attenwat mill-fluwidu), ippeżat b'T2 u ppeżat b'diffużjoni.
English: In spite of limitations of the currently available evidence such as small numbers, lack of information about MRI frequency in PML patients, false positive and false negative rate of MRI screenings, patients with a high risk for PML development may in particular benefit from more frequent MRIs because periodic brain MRI are likely to provide earlier detection of PML, even before symptoms develop, and subsequently better outcomes.
Maltese: L-MRI hija meqjusa bħala metodu sensittiv sabiex jiġu identifikati anke leżjonijiet żgħar u asintomatiċi ta' PML. Meta wieħed iqis id-dijanjożi severa ta' PML, livell għoli ta' viġilanza u limitu baxx anke għal miżuri u interventi dijanjostiċi invażivi bħall-MRI huma ġġustifikati għall-ġestjoni ta' pazjenti b'riskju għoli li jiżviluppaw PML. Minkejja l-limitazzjonijiet tal-evidenza attwalment disponibbli bħal numri żgħar, nuqqas ta' informazzjoni dwar il-frekwenza tal-MRI f'pazjenti b'PML, rata pożittiva falza u negattiva falza tal-eżamijiet tal-MRI, il-pazjenti b'riskju għoli li jiżviluppaw PML jistgħu b'mod partikolari jibbenefikaw minn MRIs aktar frekwenti minħabba li MRI perjodiċi tal-moħħ x'aktarx li jipprovdu detezzjoni aktar bikrija ta' PML, anke qabel ma jiżviluppaw is-sintomi, u sussegwentement riżultati aħjar.
English: Considering real world data from UNILABS from four EU countries showing that the upper annual serostatus change rate can be as high as 16%, the annual (negative to positive) serostatus change rate in the Physician Information and Management Guidelines needs to be updated.
Maltese: Meta wieħed iqis id-data mid-dinja reali minn UNILABS minn erba' pajjiżi tal-UE li turi li l-ogħla bidla annwali fir-rata tas-serostatus tista' tilħaq is-16 %, il-bidla fir-rata tas-serostatus (negattiva sa pożittiva) fl-Informazzjoni għat-Tabib u Linji Gwida għall-Immaniġġjar teħtieġ li tiġi aġġornata.
English: • The PRAC reviewed all data presented by the MAH on the risk of PML in association with Tysabri, as well as other data made available during the procedure and the views expressed by the neurology scientific advisory group.
Maltese: • Il-PRAC irreveda d-data kollha ppreżentata mill-MAH dwar ir-riskju ta' PML b'rabta ma' Tysabri, kif ukoll data oħra li ssir disponibbli waqt il-proċedura u l-opinjonijiet espresssi mill-grupp ta' konsulenza xjentifika newroloġika.
English: In view of the above, on 29 April 2015 the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004, and asked the Agency to assess the above elements and their potential impact on the benefit-risk balance of Tysabri.
Maltese: Fid-dawl ta' dak li ntqal hawn fuq, fid-29 ta' April 2015 il-Kummissjoni Ewropea bdiet proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004, u talbet lill-Aġenzija sabiex tivvaluta lelementi ta' hawn fuq u l-impatt potenzjali tagħhom fuq il-bilanċ bejn il-benefiċċju u r-riskju ta' Tysabri.
English: The wording of a Direct Healthcare Professional Communication has been adopted, together with a communication plan.
Maltese: Il-kliem ta' Komunikazzjoni Diretta tal-Professjonisti fil-Qasam tas-Saħħa ġie adottat, flimkien ma' pjan ta' komunikazzjoni.
English: Currently available evidence suggests that the risk of PML is low at an index equal to or below 0.9 (and lower than previously estimated) and increases substantially above 1.5 for patients who have been on treatment with Tysabri for longer than 2 years.
Maltese: L-evidenza attwalment disponibbli tissuġġerixxi li r-riskju ta' PML huwa baxx f'indiċi daqs jew taħt 0.9 (u aktar baxxa milli stmat qabel) u jiżdied b'mod sostanzjali 'l fuq minn 1.5 għal pazjenti li kienu fuq kura b'Tysabri għal aktar minn sentejn.
English: However, it is unclear whether a single index cut-point can be identified within the range of index thresholds assessed that will provide optimal clinical utility in terms of treatment decisions.
Maltese: Madankollu, mhuwiex ċar jekk punt tal-qtugħ tal-indiċi wieħed jistax jiġi identifikat fi ħdan il-firxa ta' limiti tal-indiċi vvalutati li se jipprovdu utilità klinika ottimali f'termini ta' deċiżjonijiet dwar il-kura.
English: In sixty-two PML patients (10.9%) asymptomatic onset PML has been reported.
Maltese: 9 %) ġiet irrapportata PML b'bidu asintomatiku.
English: • The PRAC recommended that patients with low anti-JCV antibody index who have not received prior immunosuppressant therapy should be retested every six months once they reach the 2-year treatment point.
Maltese: • Il-PRAC irrakkomanda li l-pazjenti b'indiċi tal-antikorp kontra l-JCV baxx li ma rċevewx terapija immunosuppressanti minn qabel għandhom jerġgħu jiġu ttestjati kull sitt xhur meta jilħqu l-punt tal-kura ta' sentejn.
English: Thus, adequate guidance needs to be provided in the educational materials, and other tools may also be explored (e.g. web-based) for sharing MRIs and consultation of additional expertise.
Maltese: Għaldaqstant, hemm il-ħtieġa li tiġi pprovduta gwida adegwata fil-materjal edukattiv u jistgħu jiġu esplorati wkoll għodod oħrajn (eż. ibbażati fuq linternet) għall-qsim tal-MRIs u konsultazzjoni ta' għarfien tekniku addizzjonali.
English: Patients who survive often have serious morbidity associated with serious and permanent disability.
Maltese: Pazjenti li jibqgħu ħajjin sikwit ikollhom morbidità serja assoċjata ma' diżabilità serja u permanenti.
English: Patients who have all three risk factors for PML have a significantly higher risk of PML.
Maltese: Pazjenti li għandhom it-tliet fatturi kollha tar-riskju ta' PML għandhom riskju kunsiderevolment ogħla ta' PML.
English: In patients with MRI lesions suggestive for PML, the MRI protocol should be extended to include contrast-enhanced T1-weighted imaging to detect inflammatory features and the possible coincidence of PML and PML-IRIS (Immune Reconstitution Inflammatory Syndrome), particularly during follow up.
Maltese: L-isforzi riċenti sabiex jiġu identifikati l-bijomarkaturi potenzjali huma promettenti iżda s'issa għadhom ma rriżultawx fl-identifikazzjoni ta' markaturi ġodda li jistgħu jintużaw fil-prattika klinika sabiex tittejjeb l-istratifikazzjoni tar-riskju ta' PML eżistenti.
English: Supplemental presentations of PML risk using different methodologies may be complementary to the information within the current algorithm and will provide additional information to physicians as they engage in benefit/risk discussions with their patients.
Maltese: Preżentazzjonijiet supplimentali tar-riskju ta' PML permezz ta' metodoloġiji differenti jistgħu jkunu kumplimentarji għall-informazzjoni fi ħdan l-algoritmu attwali u se jipprovdu informazzjonali addizzjonali lit-tobba hekk kif jidħlu għal diskussjonijiet dwar il-benefiċċju/riskju mal-pazjenti tagħhom.
English: Most importantly, in terms of outcomes, asymptomatic patients appeared to have less accrual of disability over time and higher survival rates compared with symptomatic patients (95% vs. 74%).
Maltese: Fuq kollox, f'termini ta' eżiti, il-pazjenti asintomatiċi ġew osservat li kellhom anqas akkumulazzjoni ta' diżabilità maż-żmien u rati ta' sopravivenza ogħla meta mqabbla ma' pazjenti asintomatiċi (95 % vs. 74 %).
English: Diffusion -weighted imaging is highly sensitive for depicting acute demyelinisation and can also aid differentiation of acute PML lesions from chronic and subacute demyelinating PML lesions.
Maltese: Għal pazjenti b'kura immunosuppressanti minn qabel, ma kinitx osservata differenza sinifikanti fl-indiċi medjan bejn pazjenti b'PML u mingħajr PML.
English: The onset of PML in MS has serious prognostic implications, as it leads to death in about 20% of patients or to serious disability in 40% of survivors.
Maltese: Il-bidu ta' PML fl-MS għandu implikazzjonijiet pronjostiċi serji, minħabba li jwassal għal mewt f'bejn wieħed u ieħor 20 % tal-pazjenti jew għal diżabilità serja f'40 % ta' dawk li jibqgħu ħajjin.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Tysabri 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' Tysabri jibqa' favorevoli soġġett għall-emendi fl-informazzjoni tal-prodott deskritti hawn fuq.
English: Available data to date suggest that anti-JCV antibody index is correlated with the risk of PML in anti-JCV antibody positive patients with no prior immunosuppressant use.
Maltese: Id-data disponibbli sal-lum tissuġġerixxi li l-indiċi tal-antikorp kontra l-JCV huwa korrelat marriskju ta' PML f'pazjenti pożittivi għall-antikorp kontra l-JCV mingħajr użu immunosuppressanti minn qabel.
English: Scientific evidence on progressive multifocal leukoencephalopathy (PML) in patients treated with Tysabri is rapidly growing.
Maltese: L-evidenza xjentifika dwar il-lewkoenċefalopatija multifokali progressiva (PML) f'pazjenti kkurati b'Tysabri qed tiżdied b'rata mgħaġġla.
English: 5 x 1 dose 10 x 1 dose
Maltese: 5 x doża 1 10 x doża 1
English: Onset of immunity:
Maltese: Bidu ta' immunità:
English: Intervet International B.V. Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 NL-5831 AN Boxmeer Olanda
English: Phosphate buffer
Maltese: Buffer tal-fosfat
English: Influenza Onset of immunity:
Maltese: Influwenza Bidu ta' immunita:
English: A/equine-2/South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50 AU).
Maltese: Kull doża ta' 1 ml: A/equine-2/South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 08 July 2005 / 08 July 2010
Maltese: 8 ta' Lulju 2005 / 08 ta' Lulju 2010
English: 1 ml.
Maltese: 1 ml intramuskolari.
English: Equine influenza virus strains:
Maltese: Strejns tal-virus tal-influwenza taż-żwiemel:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza [a clear pictogram of a horse]
Maltese: VETERINARJU Equilis Prequenza [stamap ċara ta' żiemel]
English: PACKAGE SIZE 1 dose
Maltese: DAQS TAL-PAKKETT Doża 1
English: METHODS AND ROUTE OF ADMINISTRATION i.m.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: Is-sustanzi mhux attivi (inklus l-adġuvanti) msemmija f'sezzjoni 6.1 tal- KPQ huma, jew sustanzi permessi li tabella 1 tal-anness tar-Regola tal-Kummissjoni (EU) No 37/2010 tindika li l-ebda MRLs mhuma meħtieġa jew kunsidrati li ma jaqawx fl-iskop tar-Regolament (EC) No 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/056/001-004
Maltese: EU/2/05/056/001-004
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Maltese: Intervet International B.V.
English: Antigenic units Adjuvant Purified saponin
Maltese: Sustanzi mhux attivi Saponin purifikat
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later).
Maltese: F'każ ta' riskju akbar ta' infezzjoni jew te] id insuffiċenti ta' kolostrum, tilqima addizjonali tista ting] ata fir-4 xahar segwita bil-programm komplut ta' va``inazzjoni (l-ewwel kors ta' tiqim f'l-età ta' 6 xhur u doża oħra 4 ġimgħat wara).
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U L-MANIFATTUR RESPONSABBLI
English: IMMUNOLOGICAL PROPERTIES To stimulate active immunity against Equine influenza ATC-vet code: QI05AA01
Maltese: Biex tistimula immunita attiva kontra l-influwenza taż-żwiemel.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: T] allat ma' ebda prodott mediċinali veterinarju ieħor
English: None
Maltese: ż
English: Store at 2-8°C, protected from light.
Maltese: Aħżen fil-friġġ (2°C - 8°C ), ipproteġi mid-dawl.
English: SPECIAL STORAGE CONDITIONS Store at 2-8 °C, protected from light.
Maltese: } alli t-temperatura tal-va``in tilħaq t-temperatura tal-kamra.
English: Cardboard box with 10 glass vials of 1 ml.
Maltese: Kaxxa tal-kartun b'10 kunjetti tal-] [ ie[ ta' 1 ml.
English: 62.5 micrograms For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: SPECIAL WARNINGS Read the package leaflet before use
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: PHARMACEUTICAL FORM Clear opalescent suspension for injection
Maltese: Suspensjoni g] all-injezzjoni
English: The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
Maltese: Kull 12 -il xahar huwa rakkomandat li ting] ata tilqima addattata kontra l-influwenza taż-żwiemel, li jkollha l-istrejns A/equi 1/Prague 56, A/equi 2/Newmarket-1/93 u A/equi 2/Newmarket-2/93, sabiex jinżamm il-livell ta' immunita.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose of vaccine, no side-effects other than those described under 4.6 have been observed except for some depression at the day of vaccination 4.11 Withdrawal period(s)
Maltese: Wara injezzjoni doppja ta' va``in, l-ebda effett mhux mixtieq , apparti dawk deskritti f'sezzjoni 4.6 ma ġieosservat apparti ftit sintomi ta' dipressjoni fil-jum tal-va``inazzjoni.
English: Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Maltese: Kaxxa(i) tal-kartun b' 1, 5 jew 10 siringi tal-] [ ie[ bil-labar, mimlija g] al-lest.
English: Name and address of the manufacturer of the biological active substance(s)
Maltese: Isem u indirizz tal-manufattur tas-sustanza(i) bioloġika(ċi) attiva(i)
English: INDICATION(S) Active immunisation of horses against equine influenza.
Maltese: Immunita attiva ta'ż zwiemel kontra l-influwenza ekwina.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza, suspension for injection, for horses
Maltese: Equilis Prequenza, suspensjoni g] all-injezzjoni, g] aż-żwiemel
English: THE WORDS ‘FOR ANIMAL TREATMENT ONLY'
Maltese: IL-KLIEM "GĦAL TRATTAMENT TA' L-ANNIMALI BISS"
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: 3 DIKJARAZZJONI TAS-SUSTANZA(I)
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years 6.4 Special precautions for storage
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ippakkjat għall-bejgħ :Sentejn 6.4
English: AUTHORISATION
Maltese: MANIFATTURI
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: 3 KONTENUT BĦALA
English: EXPIRY DATE EXP {number}
Maltese: FULJETT TA' TAGĦRIF
English: Type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Maltese: Siringa tal-] [ ie[ Tip I mimlija g] al-lest, li fiha planġer b'tarf tal-gomma halogenbutyl u mag] luq b' tapp tal-gomma halogenbutyl.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml:
Maltese: Doża kull 1 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza
Maltese: Equilis Prequenza
English: Vaccination schedule:
Maltese: Kodici ATC veterinarja:
English: The second revaccination is given 12 months after the first revaccination.
Maltese: It- tieni riva``inazzjoni ting] ata 12-il xahar wara l-ewwel rivaċċinazzjoni.
English: Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection.
Maltese: Immunizzazzjoni attiva [ ] al żwiemel mill-età ta' sitt xhur, kontra l-influwenza taż-żwiemel, biex tnaqqas is-sintomi klini`i u l-eskrezzjoni tal-virus, wara l-infezzjoni.
English: PHARMACEUTICAL FORM Suspension for injection
Maltese: GĦAMLA FARMAĊEWTIKA
English: For animal treatment only - to be supplied only on veterinary prescription.
Maltese: Jiġu mogħtija biss bi preskrizzjoni veterinarja.
English: The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Maltese: Iċ-ċiklu tar-rapport perjodiku aġġornat tas-sigurta` (PSUR) għandu jerġa jinbeda għall-sottomissjoni tar-rapporti ta' kull 6 xhur (li jkopru kull preżentazzjoni awtorizzata tal-prodott) għalsentejn, segwit b'rapporti annwali għas-sentejn sussegwenti u wara dan kull 3 snin.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Maltese: DIKJARAZZJONI TA' L-MRLs Peress li is-sustanza attiva hija fil-prinċipju ta' oriġni bijoloġika u maħsuba sabiex tipproduċi immunitàattiva m'hix fl-iskop tar-Regolazzjoni (EC)470/2009
English: Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Maltese: Kull prodott mediċinali veterinarju li ma ġiex użat jew skart derivat minn tali prodott mediċinali veterinarju għandhom jintremew skont kif titlob il-liġi tal-pajjiż.
English: Results were similar for genotypes 2 and 4-6.
Maltese: Ir-riżultati kienu simili għall-ġenotipi 2 u 4-6.
English: Further information on Maviret can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Maviret.
Maltese: ema.europa.eu/medicines/human/EPAR/Maviret.
English: Other information about Maviret
Maltese: Informazzjoni oħra dwar Maviret
English: • carbamazepine, phenobarbital, phenytoin, primidone (medicines for epilepsy);
Maltese: • carbamazepine, phenobarbital, phenytoin, primidone (mediċini għall-epilessija);
English: Maviret received a marketing authorisation valid throughout the EU on 26 July 2017.
Maltese: Maviret ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-26 ta' Lulju 2017.
English: Maviret is available as tablets that contain 100 mg glecaprevir and 40 mg pibrentasvir.
Maltese: Maviret jiġi bħala pilloli li fihom 100 mg gleċaprevir u 40 mg pibrentasvir.
English: In 8 main studies involving over 2,300 adults with hepatitis C, 99% of non-cirrhotic patients with genotype 1, the most common genotype, tested negative for the virus after 8 weeks of Maviret treatment and 97% cirrhotic patients were negative after 12 weeks.
Maltese: Fi 8 studji ewlenin li involvew 'il fuq minn 2,300 adult bl-epatite Ċ, 99 % tal-pazjenti mhux ċirrotiċi bilġenotip 1, l-aktar ġenotip komuni, ittestjaw negattivi għall-virus wara 8 ġimgħat ta' kura b'Maviret u 97 % tal-pazjenti ċirrotiċi kienu negattivi wara 12-il ġimgħa.
English: Glecaprevir blocks the action of a protein called NS3/4A protease, while pibrentasvir blocks a protein called NS5A.
Maltese: Il-gleċaprevir timblokka l-azzjoni ta' proteina li tissejjaħ proteażi ta' NS3/4A, waqt li l-pibrentasvir timblokka proteina li tissejjaħ NS5A.
English: • rifampicin (antibiotic usually used to treat tuberculosis);
Maltese: • rifampicin (antibijotiku li normalment jintuża għall-kura tat-tuberkulożi);
English: What are the risks associated with Maviret?
Maltese: X'inhuma r-riskji assoċjati ma' Maviret?
English: Maviret contains the active substances glecaprevir and pibrentasvir.
Maltese: Maviret fih is-sustanzi attivi gleċaprevir u pibrentasvir.
English: The duration of treatment depends on whether patients have liver cirrhosis (scarring of the liver) or whether they have received previous treatments with pegylated interferon and ribavirin, with or without sofosbuvir, or sofosbuvir and ribavirin.
Maltese: Id-durata tal-kura tiddependi minn jekk il-pazjenti jkollhomx ċirrożi tal-fwied (ċikatriċi tal-fwied) jew jekk irċivewx kuri preċedenti b'interferon u ribavirin pegilati, b'sofosbuvir jew mingħajru, jew b'sofosbuvir u ribavirin.
English: Maviret is an antiviral medicine used to treat adults and adolescents aged 12 years and older with chronic (long-term) hepatitis C, an infectious disease that affects the liver, which is caused by the hepatitis C virus.
Maltese: Maviret huwa mediċina antivirali li tintuża biex tikkura adulti u adoloxxenti minn 12-il sena 'l fuq b'epatite Ċ kronika (fit-tul), marda infettiva li taffettwa l-fwied, li tiġi kkawżata mill-virus tal-epatite Ċ.
English: A negative test result means that the virus was not found.
Maltese: Riżultat tat-test negattiv ifisser li l-virus ma nstabx.
English: • ethinyl estradiol-containing products (such as contraceptive medicines);
Maltese: • prodotti li fihom ethinyl estradiol (bħal mediċini kontraċettivi);
English: • atorvastatin, simvastatin (medicines for lowering cholesterol levels in the blood);
Maltese: • atorvastatin, simvastatin (mediċini biex ibaxxu l-livelli tal-kolesterol fid-demm);
English: Based on data available in adults, it is expected that Maviret is also effective in children with genotypes 5 and 6.
Maltese: Abbażi tad-data disponibbli fl-adulti, huwa mistenni li Maviret ikun effettiv ukoll fit-tfal bilġenotipi 5 u 6.
English: The medicine's effectiveness in clearing genotype 3 was slightly lower than for other genotypes (95%).
Maltese: L-effettività tal-mediċina biex tneħħi lġenotip 3 kienet ftit aktar baxxa minn dik għal ġenotipi oħra (95 %).
English: How is Maviret used?
Maltese: Kif jintuża Maviret?
English: In a study in 47 children aged between 12 and 18 years with genotypes 1 to 4 and without cirrhosis, all patients tested negative for the virus after 12 weeks of treatment.
Maltese: Fi studju fuq 47 tifel u tifla li għandhom bejn it-12 u t-18-il sena bil-ġenotipi 1 sa 4 u mingħajr ċirrożi, il-pazjenti kollha ttestjaw negattivi għall-virus wara 12-il ġimgħa ta' kura.
English: The company that markets Maviret will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Maviret.
Maltese: Il-kumpanija li tqiegħed Maviret fis-suq se tagħmel studju fuq pazjenti li preċedentement kellhom kanċer tal-fwied sabiex tevalwa r-riskju li jirritorna l-kanċer tal-fwied wara kura b'antivirali b'azzjoni diretta bħal Maviret.