FrancophonIA/ELRC3.0 huggingface dataset:
English: A higher incidence of serum creatinine elevations and renal-related adverse reactions including serious adverse reactions was observed with Zurampic 400 mg when given alone or in combination with a xanthine oxidase inhibitor, with the highest incidence when Zurampic was given as monotherapy.
Maltese: Inċidenza akbar ta' żidiet fil-kreatinina fis-serum u reazzjonijiet avversi relatati malkliewi inkluż reazzjonijiet avversi serji ġiet osservata b'Zurampic 400 mg meta ngħata waħdu jew meta ngħata ma' inibitur ta' xanthine oxidase, bl-ogħla inċidenza tkun meta Zurampic ingħata bħala monoterapija.
English: Zurampic 200 mg film-coated tablets lesinurad
Maltese: Zurampic 200 mg pilloli miksijin b'rita lesinurad
English: Zurampic in combination with febuxostat in tophaceous gout CRYSTAL enrolled gout patients with measurable tophi.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Pack size of 100 x 1 film-coated tablet in perforated unit dose blisters.
Maltese: Daqs tal-pakkett ta' 100 x 1 pillola miksija b'rita f'forma ta' folji ta' doża waħda mtaqqbin.
English: Lesinurad exposure is increased when it is co-administered with inhibitors of CYP2C9.
Maltese: Issorvelja għal tnaqqis fl-effikaċja meta Zurampic jingħata ma' induttur ta' CYP2C9.
English: 10 film-coated tablets
Maltese: IMTAQQBA (10 PILLOLI)
English: All patients with a Major Adverse Cardiovascular Event treated with Zurampic 200 mg had a history of heart failure, stroke or myocardial infarction.
Maltese: Il-pazjenti kollha b'Avveniment Kardjovaskulari Avvers Ewlieni kkurati b'Zurampic 200 mg kellhom storja ta' insuffiċjenza kardijaka, puplesija jew infart mijokardijaku.
English: Do not take more than one (1) tablet of Zurampic per day.
Maltese: Tiħux iktar minn pillola waħda (1) ta' Zurampic kuljum.
English: 98 film-coated tablets
Maltese: 98 pillola miksijin b'rita
English: Based on these studies, Zurampic is only recommended at a dose of 200 mg once daily in combination with a xanthine oxidase inhibitor (see sections 4.2 and 4.4).
Maltese: Abbażi ta' dawn l-istudji, Zurampic huwa rrakkomandat biss f'doża ta' ta' 200 mg darba kuljum flimkien mal-inibitur ta' xanthine oxidase (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: Zurampic causes an increase in renal uric acid excretion, which may lead to transient increases in serum creatinine, renal-related adverse reactions and kidney stones.
Maltese: Zurampic jikkawża żieda fl-eliminazzjoni ta' uric acid mill-kliewi, li tista' twassal għal żidiet temporanji fil-kreatinina fis-serum, reazzjonijiet avversi relatati mal-kliewi u ġebel fil-kliewi.
English: Serious side effects - Uncommon - may affect up to 1 in 100 people Stop taking Zurampic and see a doctor straight away if you notice any of the following side effects, as these may be signs of a problem with your kidneys - you may need urgent medical treatment:
Maltese: Effetti sekondarji serji - Mhux komuni - jistgħu jaffettwaw sa persuna 1 minn kull 100 Tibqax tieħu Zurampic u kellem lil tabib minnufih jekk tinnota xi wieħed mill-effetti sekondarji li ġejjin - peress li dawn jaf ikunu sinjali ta' problema bil-kliewi tiegħek - jaf ikollok bżonn kura medika urġenti:
English: EMA/729961/2014 EMEA/H/C/001127
Maltese: EMEA/H/C/001127
English: The full EPAR for Temozolomide Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Temozolomide Hexal is a ‘generic medicine'.
Maltese: Temozolomide Hexal huwa ‘mediċina ġenerika'.
English: Temozolomide Hexal temozolomide
Maltese: Temozolomide Hexal temożolomur
English: Temozolomide Hexal EMA/729961/2014
Maltese: EMA/746673/2014
English: The dose of Temozolomide Hexal depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Maltese: Id-doża ta' Temozolomide Hexal tiddependi mis-superfiċje tal-ġisem (ikkalkolati mit-tul u l-piż talpazjent) u tvarja minn 75 sa 200 mg għal kull metru kwadru, darba kuljum.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Hexal has been shown to have comparable quality and to be bioequivalent to Temodal.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Temozolomide Hexal wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Temodal.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Hexal on 15 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Temozolomide Hexal valida madwar l-Unjoni Ewropea kollha fil-15 ta' Marzu 2010.
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Hexal.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Temozolomide Hexal.
English: The active substance in Temozolomide Hexal, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Maltese: Is-sustanza attiva f'Temozolomide Hexal, it-temożolomur, tappartjeni għal grupp ta' mediċini ta' kontra l-kanċer li jissejħu aġenti alkilanti.
English: Because Temozolomide Hexal is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Maltese: Billi Temozolomide Hexal huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Temodal.
English: Temozolomide Hexal is a medicine that contains the active substance temozolomide.
Maltese: Temozolomide Hexal huwa mediċina li fiha s-sustanza attiva t-temożolomur.
English: What are the benefit and risk of Temozolomide Hexal?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Temozolomide Hexal?
English: It is used to treat malignant glioma (brain tumours) in the following groups of patients:
Maltese: Jintuża biex ifejjaq il-glijoma malinna (tumuri filmoħħ) fil-gruppi ta' dawn il-pazjenti:
English: Because Temozolomide Hexal is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Temozolomide Hexal huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Temozolomide Hexal is an anticancer medicine.
Maltese: Temozolomide Hexal huwa mediċina kontra l-kanċer.
English: Why has Temozolomide Hexal been approved?
Maltese: Għaliex ġie approvat Temozolomide Hexal?
English: What is Temozolomide Hexal?
Maltese: X'inhu Temozolomide Hexal?
English: This means that Temozolomide Hexal is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Maltese: Dan ifisser li Temozolomide Hexal jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Temodal.
English: In the body, temozolomide is converted to another compound called MTIC.
Maltese: Fil-ġisem, it-temożolomur tinbidel f'kompost imsejjaħ MTIC.
English: Content (concentration)
Maltese: Kontenut (konċntrazzjoni
English: 1 spray container
Maltese: Kontenitur tal-isprej 1
English: (Invented) name
Maltese: Isem (Ivvintat)
English: The CVMP considered that:
Maltese: Is-CVMP ikkunsidra li:
English: Member State EU/EEA
Maltese: UE/ŻEE
English: Meat: 7 days Milk: 60 hours
Maltese: Laħam: 7 ijiem Ħalib: 60 siegħa
English: Recommended dose, frequency and route of administration
Maltese: Doża rakkomandata, frekwenza u mod ta' amministrazzjoni
English: Combisyn was authorised in the United Kingdom on 30 January 2003 under Article 13(1) of Directive 2001/82/EC.
Maltese: Combisyn ġie awtorizzat fir-Renju Unit fit-30 ta' Jannar 2003 skont l-Artikolu 13(1) tadDirettiva 2001/82/KE.
English: Clavulanic acid, a naturally-occurring substance is a beta-lactamase inhibitor and chemical synergist for amoxicillin.
Maltese: Il-clavulanic acid, sustanza li tinstab b'mod naturali hija inibitur tal-beta-lactamase u synergista kimika għall-amoxicillin.
English: A residue depletion study in milk should be performed in accordance with the ‘Note for guidance for the determination of withdrawal periods for milk' (EMEA/CVMP/473/98-FINAL)
Maltese: Għandu jsir studju ta' tnaqqis tar-residwi fil-ħalib skont in-‘Nota għall-gwida għaddeterminazzjoni tal-perjodi ta' rtirar għall-ħalib (EMEA/CVMP/473/98-FINALI)
English: Applicant/ Marketing Authorisation Holder
Maltese: Applikant/ Detentur talAwtorizzazzjo ni għatTqegħid fisSuq
English: Combisyn Lactating Cow Intramammary Suspension (hereinafter referred to as Combisyn) is an intramammary suspension containing amoxicillin (as amoxicillin trihydrate), clavulanic acid (as potassium clavulanate) and prednisolone.
Maltese: Combisyn Sospensjoni Intramammarja għal Baqar li Jreddgħu (minn hawn 'il quddiem imsejħa Combisyn) hija sospensjoni intramammarja li fiha l-amoxicillin (bħala amoxicillin trihydrate), ilclavulanic acid (bħala potassium clavulanate) u l-prednisolone.
English: Combisyn is intended for the treatment of mastitis in lactating cows caused by the major pathogens commonly occurring from the bovine udder (Staphylococci, Streptococci and Escherichia coli).
Maltese: Combisyn huwa maħsub għall-kura tal-mastite fil-baqar li jreddgħu li hija kkawżata mill-patoġeni ewlenin li jinstabu b'mod frekwenti fil-glandola mammarja talfrat (Staphylococci, Streptococci u Escherichia coli).
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, withdrawal periods, applicant, marketing authorisation holder in the member states
Maltese: Lista tal-isem, għamla farmaċewtika, qawwa tal-prodott mediċinali veterinarju, speċi li fuqhom għandu jintuża lprodott, mod ta' amministrazzjoni, perjodi ta' tiżmim, lapplikant, id-detentur tal-awtorizzazzjoni tal-kummerċ flIstati Membri
English: The dose-limiting pathogen is penicillinase-producing Staphylococcus aureus.
Maltese: Il-patoġenu li jillimita d-doża huwa Staphylococcus aureus li jipproduċi l-peniċillinase.
English: For applications made under Article 13(1) of Directive 2001/82/EC the applicant is not required to submit results of pharmacological, toxicological and clinical trials.
Maltese: Għall-applikazzjonijiet li saru taħt l-Artikolu 13(1) tad-Direttiva 2001/82/KE, l-applikant mhuwiex meħtieġ jissottometti r-riżultati tal-provi farmakoloġiċi, tossikoloġiċi u kliniċi.
English: There was discussion by the CVMP on applying the same pharmacokinetic parameters from classical plasma bioequivalence studies to comparative data in milk.
Maltese: Kien hemm diskussjoni mis-CVMP dwar l-applikazzjoni tal-istess parametri farmakokinetiċi minn studji klassiċi ta' bijoekwivalenza fuq il-plażma għal dejta komparattiva fil-ħalib.
English: • A comparative plasma study was carried out to measure plasma concentrations of amoxicillin, clavulanate and prednisolone following intramammary infusion.
Maltese: • Studju komparattiv tal-plażma li sar biex ikejjel il-konċentrazzjonijiet tal-amoxicillin, clavulanate u tal-prednisolone fil-plażma wara infużjoni intramammarja.
English: At the last sampling timepoint (108 hours), half of the quarter milk samples had amoxicillin concentrations above the MRL. All quarter milk samples from 84 hours onwards had clavulanic acid concentrations below the milk MRL. For prednisolone, the data showed that the levels were well below the milk MRL of 6 µg/kg from 24 hours onwards.
Maltese: Għall-prednisolone, id-dejta wriet li l-livelli kienu ħafna inqas mill-MRL għall-ħalib ta' 6 µg/kg minn 24 siegħa 'l quddiem.
English: Portugal
Maltese: Northern Ireland
English: The applicant presented comparative viscosity data between the ‘old' and ‘new' formulations of Combisyn.
Maltese: L-applikant ippreżenta dejta komparattiva dwar il-viskożità bejn il-formulazzjonijiet il-‘qodma' u l-‘ġodda' ta' Combisyn.
English: Finland
Maltese: IlFinlandja
English: Prior to the lifting of the suspension of the marketing authorisation, the national competent authority of the Reference Member State shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Maltese: Qabel it-tneħħija tas-sospensjoni tal-awtorizzazzjoni għat-tqegħid fis-suq, l-awtorità nazzjonali kompetenti tal-Istat Membru ta' Referenza trid tiżgura li l-kundizzjonijiet li ġejjin jiġu ssodisfati middetentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Regarding residues, the data from the comparative milk studies showed that, at the timepoint corresponding to the proposed withdrawal period of 60 hours, all quarter milk samples had concentrations of amoxicillin above the MRL for milk (4 µg/kg) and a proportion of the milk samples contained clavulanic acid at or above the MRL for milk of 200 µg/kg.
Maltese: Fir-rigward tar-residwi, id-dejta mill-istudji komparattivi fuq il-ħalib urew li, fil-punt ta' żmien li jikkorrispondi mal-perjodu ta' rtirar propost ta' 60 siegħa, il-kampjuni kollha tal-ħalib mill-glandoli mammarji kellhom konċentrazzjonijiet tal-amoxicillin 'l fuq mill-MRL għall-ħalib (4 µg/kg) u proporzjon tal-kampjuni tal-ħalib kien fihom il-clavulanic acid fi jew 'l fuq mill-MRL għall-ħalib ta' 200 µg/kg.
English: Denmark
Maltese: IdDanimark
English: Combisyn is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route.
Maltese: Għandha tiġi pprovduta dejta klinika adegwata biex tikkonferma l-effikaċja ta' Combisyn Sospensjoni Intramammarja għal Baqar li Jreddgħu.
English: • A comparative milk study was carried out to measure milk concentrations of amoxicillin and clavulanic acid.
Maltese: • Studju komparattiv tal-ħalib li sar biex ikejjel il-konċentrazzjonijiet tal-amoxicillin u talclavulanic acid fil-ħalib.
English: • A comparative milk study was carried out to measure milk concentrations of prednisolone following intramammary infusion.
Maltese: • Studju komparattiv tal-ħalib li sar biex ikejjel il-konċentrazzjonijiet tal-prednisolone filħalib wara infużjoni intramammarja.
English: When asked to further substantiate this claim, the applicant provided comparative data on the physico-chemical characteristics of the product, including viscosity, particle size and dissolution in milk, between Combisyn and the reference product.
Maltese: Meta mitlub ikompli jsostni din id-dikjarazzjoni, l-applikant ipprovda dejta komparabbli dwar il-karatteristiċi fiżiko-kimiċi tal-prodott, inkluż il-viskożità, id-daqs tal-partikula u d-dissoluzzjoni fil-ħalib, bejn Combisyn u lprodott ta' referenza.
English: The applicant further claimed that the formulation of Combisyn was sufficiently similar to the reference product to allow a waiver from the need to present in vivo data.
Maltese: L-applikant saħaq ukoll li l-formulazzjoni ta' Combisyn kienet suffiċjentement simili għall-prodott ta' referenza biex tippermetti eżenzjoni mill-ħtieġa li tiġi ppreżentata dejta in vivo.
English: Furthermore, the applicant contended that milk was not excluded from the CVMP guideline for the conduct of bioequivalence studies (reference in section 5.1 to “other biological fluid”).
Maltese: Barra minn hekk, l-applikant sostna li l-ħalib ma kienx eskluż mil-linji gwida tas-CVMP għattwettiq ta' studji ta' bijoekwivalenza (referenza f'sezzjoni 5.1 għal “fluwidu bijoloġiku ieħor”).
English: Three comparative pharmacokinetic studies were carried out with Combisyn and the reference product, all with a two-period cross-over design.
Maltese: Saru tliet studji farmakokinetiċi komparattivi b'Combisyn u l-prodott ta' referenza, kollha b'disinn cross-over fuq żewġ perjodi.
English: At the time of initial authorisation, the difficulties of attempting to demonstrate bioequivalence of intramammary preparations were less well known and the general principles applied by the applicant in conducting their package of pharmacokinetic studies were accepted.
Maltese: Fi żmien tal-awtorizzazzjoni inizjali, id-diffikultajiet tat-tentattivi biex tintwera lbijoekwivalenza ta' preparazzjonijiet intramammarji kienu inqas magħrufin u l-prinċipji ġenerali applikati mill-applikant fit-twettiq tal-pakkett ta' studji farmakokinetiċi kienu ġew aċċettati.
English: The plasma data showed that, overall, the confidence intervals were within the acceptance limits for amoxicillin and prednisolone.
Maltese: Id-dejta tal-plażma wriet li, b'mod ġenerali, l-intervalli ta' fiduċja kienu fil-limiti tal-aċċettazzjoni għallamoxicillin u għall-prednisolone.
English: Therefore the CVMP concluded that the particulars submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC and recommended the refusal of granting the Marketing Authorisation in the Concerned Member States and the suspension of the existing Marketing Authorisation in the Reference Member State.
Maltese: Għalhekk is-CVMP ikkonkluda li d-dettalji sottomessi b'appoġġ tal-applikazzjoni ma jikkonformawx mal-Artikolu 13 tad-Direttiva 2001/82/KE u rrakkomanda r-rifjut tal-għoti tal-Awtorizzazzjoni għatTqegħid fis-Suq fl-Istati Membri Kkonċernati u s-sospensjoni tal-Awtorizzazzjoni għat-Tqegħid fis-Suq eżistenti fl-Istat Membru ta' Referenza.
English: Strengths
Maltese: Anness
English: • the data submitted in support of this application failed to show that bioequivalence had been demonstrated by appropriate bioavailability studies between the test and reference products;
Maltese: • id-dejta sottomessa b'appoġġ għal din l-applikazzjoni naqset milli turi li l-bijoekwivalenza ntweriet permezz ta' studji xierqa ta' bijodisponibiltà bejn it-test u l-prodotti ta' referenza;
English: EMA/488729/2014 EMEA/H/C/000623
Maltese: EMEA/H/C/000623
English: It is available as tablets (0.5 mg and 1 mg) and as an oral solution (0.05 mg/ml).
Maltese: Huwa disponibbli bħala pilloli (0.5 mg u 1 mg) u bħala soluzzjoni orali (0.05 mg/ml).
English: The full EPAR for Baraclude can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Baraclude jinsab fuq is-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Baraclude is an antiviral medicine that contains the active substance entecavir.
Maltese: Baraclude huwa mediċina antivirali li fiha s-sustanza attiva entecavir.
English: This is a summary of the European public assessment report (EPAR) for Baraclude.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Baraclude.
English: The active substance in Baraclude, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Maltese: Is-sustanza attiva f'Baraclude, entecavir, hija antivirali li jappartjeni għall-klassi tal-analogi nukleosidi.
English: Children weighing less than 32.6 kg should be given the oral solution, while those weighing 32.6 kg and above can also be given the 0.5 mg tablets.
Maltese: Tfal li jiżnu inqas minn 32.6 kg għandhom jingħataw soluzzjoni orali, filwaqt li dawk li jiżnu 32.6 kg u iktar jistgħu jingħataw ukoll il-pilloli ta' 0.5 mg.
English: The most common side effects seen with Baraclude are headache (seen in 9% of patients), fatigue (tiredness, 6%), dizziness (4%) and nausea (feeling sick, 3%).
Maltese: L-aktar effetti sekondarji komuni li dehru b'Baraclude kienu l-uġigħ ta' ras (li dehret f'9% tal-pazjenti), għeja (6%), sturdament (4%) u nawżja (tħossok ma tiflaħx, 3%).
English: Baraclude was also more effective than lamivudine in patients refractory to lamivudine: 55% of patients treated with Baraclude had improvements in the condition of their liver, against 28% of those treated with lamivudine.
Maltese: Baraclude kien ukoll aktar effettiv minn lamivudina f'pazjenti refrattorji għal lamivudina: 55% talpazjenti li ġew ikkurati b'Baraclude kellhom titjib fil-kondizzjoni tal-fwied tagħhom, kontra 28% ta' dawk li ġew ikkurati b'lamivudina.
English: The study looked at the reductions in levels of the virus in the blood and the number of patients who developed antibody to a viral protein (known as e-antigen) and no longer had e-antigen in their blood after 48 weeks of treatment.
Maltese: L-istudju ħares lejn it-tnaqqis ta' livelli tal-virus fid-demm u n-numru ta' pazjenti li żviluppaw antikorpi għal proteina virali (magħrufa bħala antiġen-e) u ma kellhom ebda antiġen-e f'demmhom wara 48 ġimgħa ta' kura.
English: In a children's study, 180 children aged 2 to 18 years who had chronic hepatitis B were randomly selected to be given either Baraclude or placebo (a dummy treatment).
Maltese: Fi studju fit-tfal, 180 tifel u tifla ta' età minn 2 sa 18-il sena li kellhom epatite B kronika ntgħażlu b'mod każwali biex jingħataw jew Baraclude jew plaċebo (kura finta).
English: Baraclude is used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Maltese: Baraclude jintuża biex jikkura epatite B kronika (fit-tul) (marda tal-fwied li tittieħed, ikkawżata millvirus tal-epatite B).
English: Baraclude was also compared with another medicine, adefovir dipivoxil, in 195 patients with chronic hepatitis B with decompensated liver disease.
Maltese: Baraclude tqabbel ma' mediċina oħra, adefovir dipivoxil, f'195 pazjent li jbatu bl-epatite B kronika b'mard fil-fwied mhux ikkumpensat.
English: A risk management plan has been developed to ensure that Baraclude is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Baraclude jintuża bl-aktar mod sigur possibbli.
English: The CHMP concluded that Baraclude's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP ikkonkluda li l-benefiċċji ta' Baraclude huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Baraclude on 26 June 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Baraclude fis-26 ta' Ġunju 2006.
English: Why has Baraclude been approved?
Maltese: Għaliex ġie approvat Baraclude?
English: How does Baraclude work?
Maltese: Baraclude jittieħed darba kuljum.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: It-tul tal-kura huwa determinat b'kemm jirrispondi tajjeb il-pazjent.
English: What is Baraclude?
Maltese: X'inhu Baraclude?
English: Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose.
Maltese: Il-pazjenti li ma kinux ikkurati qabel b'analogu nukleosidu jingħataw doża ta' 0.5 mg, filwaqt li dawk li ngħataw lamivudina fil-passat, iżda li l-infezzjoni tagħhom m'għadhiex tirrispondi aktar) għalih jingħataw doża ta' 1 mg.
English: The third study was carried out in 293 patients whose infection was no longer responding to lamivudine treatment.
Maltese: It-tielet studju sar fuq 293 pazjent li kellhom infezzjoni li ma baqgħetx tirrispondi għall-kura ta' lamivudina.
English: Resistance to entecavir (when a virus becomes insensitive to the antiviral) has been seen in lamivudine-refractory patients.
Maltese: Ir-reżistenza għal entecavir (meta virus ma jibqax sensittiv għal antivirali) dehret f'pazjenti li huma refrattorji għal-lamivudine.
English: In adults with compensated liver disease, Baraclude was more effective than lamivudine in patients who had not been treated with nucleoside analogues before: an improvement in the condition of the liver was seen in just over 70% of the patients treated with Baraclude, against just over 60% of the patients treated with lamivudine.
Maltese: F'adulti b'mard fil-fwied ikkumpensat, Baraclude kien iktar effettiv minn lamivudina f'pazjenti li ma kinux ġew ikkurati b'analogi nukleosidi qabel: titjib fil-kondizzjoni tal-fwied deher fi ftit aktar minn 70% tal-pazjenti kkurati b'Baraclude, kontra ftit aktar minn 60% tal-pazjenti kkurati b'lamivudina.