FrancophonIA/ELRC3.0 huggingface dataset:
English: This population primarily consisted of children with minimal hepatitis B. A dose of 3 mg/kg once daily (up to a maximum of 100 mg daily) was used in children aged 2 to 11 years and a dose of 100 mg once daily in adolescents aged 12 years and above.
Maltese: Doża ta' 3 mg/kg kuljum (sa massimu ta' 100 mg kuljum) intużat fi tfal bejn is-sentejn u l-11-il sena u doża ta' 100 mg darba kuljum f'adolexxenti ta' minn 12-il sena 'l fuq.
English: In patients with HIV infection, cases of pancreatitis and peripheral neuropathy (or paresthesia) have been reported.
Maltese: F'pazjenti nfettati bl-HIV, każi ta' infjammazzjoni tal-frixa u newropatija periferali (jew parestiżja) ġew irrappurtati.
English: Frequency of emergence of YMDD mutant HBV and impact on the treatment response Lamivudine monotherapy results in the selection of YMDD mutant HBV in approximately 24 % of patients following one year of therapy, increasing to 69 % following 5 years of therapy.
Maltese: Frekwenza tal-ħruġ tal-mutant YMDD tal-HBV u l-effett fuq ir-rispons tat-trattament Monoterapija bil-lamivudine twassal għas-selezzjoni tal-mutant YMDD tal-HBV f'bejn wieħed u ieħor 24% ta' pazjenti wara sena ta' terapija u din tiżdied għal 69% wara 5 snin ta' terapija.
English: Zeffix 5 mg/ml oral solution lamivudine
Maltese: zeffix 5 mg/ml
English: If Zeffix is discontinued , patients should be periodically monitored both clinically and by assessment of serum liver function tests (ALT and bilirubin levels), for at least four months, and then as clinically indicated.
Maltese: Jekk Zeffix jitwaqqaf, il-pazjenti għandhom jiġu mmonitorjati perjodikament kemm klinikament u kemm permezz ta' testijiet dwar il-funzjoni tal fwied (livelli ta' ALT u bilirubin), għal erba' xhur mill-inqas, imbagħad kif klinikament indikat.
English: Improvement in bridging fibrosis occurred in 19/30 (63 %) patients without YMDD mutant and 22/44 (50 %) patients with the mutant.
Maltese: Kien hemm titjib fil-bridging tal-fibrożi f'19/30 (63%) pazjent mingħajr il-mutant YMDD
English: INSTRUCTIONS ON USE
Maltese: Mhux applikabli
English: Some clinical findings also support a possible interaction between lamivudine and cladribine.
Maltese: Xi sejbiet kliniċi ukoll jappoġġaw il-possibbiltà ta' interazzjoni bejn lamivudine u cladribine.
English: Moreover, Zeffix should not be taken with any other medicinal products containing lamivudine (see section 4.4).
Maltese: Barra minn hekk, Zeffix m'għandux jittieħed ma' prodotti mediċinali oħra li fihom lamivudine (ara sezzjoni 4.4).
English: Table 3: Post-treatment ALT Elevations in 2 Placebo-Controlled Studies in Adults
Maltese: Tabella 3: Żidiet fl-ALT ta' Wara t-Trattament f'Żewġ Studji
English: Side effects that were commonly reported in Zeffix clinical trials were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea, increases in liver enzymes and enzymes produced in the muscles (see below).
Maltese: Fi provi kliniċi dwar Zeffix, l-effetti sekondarji li ġew irrappurtati b'mod komuni kienu għeja, infezzjonijiet fl-apparat respiratorju, uġigħ ħafif tal-griżmejn, uġigħ ta' ras, uġigħ fl-istonku u uġigħ, dardir, rimettar u dijarea, żieda fl-enżimi tal-fwied u fl-enżimi prodotti mill-muskoli (ara taħt).
English: Normalisation of ALT levels occurred in 31 % (14/45) of patients receiving combined therapy versus 6 % (3/47) receiving lamivudine alone.
Maltese: Il-livell ta' ALT ġie għan-normal f'31 % (14/45) ta' pazjenti li kienu qed jirċievu terapija kkumbinata meta komparat ma' 6 % (3/47) li kienu qed jirċievu lamivudine waħdu.
English: There were no observed clinically significant adverse interactions in patients taking lamivudine concurrently with commonly used immunosuppressant medicinal products (e.g. cyclosporin A).
Maltese: Ma ġewx osservati xi interazzjonijiet kliniċi sostanzjalment ħżiena f'pazjenti li kienu qed jieħdu lamivudine flimkien ma' prodotti mediċinali immunosuppressanti li jintużaw ħafna (eż. cyclosporin A).
English: As anticipated due to the concomitant immunosuppression, the rate of emergence of YMDD mutant HBV after 52 weeks treatment was higher (36 % - 64 %) in the liver transplant population than in the immunocompetent CHB patients (14 % - 32 %).
Maltese: HBV li bdiet titfaċċa wara 52 ġimgħa ta' trattament kienet akbar (36%-64%) f'dawk bi trapjant tal-fwied milli f'pazjenti immunokompetenti b'CHB (14%-32%).
English: See section 3 for more information about how to take Zeffix.
Maltese: Ara sezzjoni 3 għal iktar informazzjoni fuq kif tieħu Zeffix.
English: Lamivudine had no effect on the pharmacokinetics of trimethoprim or sulphamethoxazole.
Maltese: Il-lamivudine ma' kellu ebda effett fuq il-farmakokinetika tattrimethropim jew tas-sulphamethoxazole.
English: Progression to cirrhosis occurred in 4/68 (6 %) patients with the YMDD mutant, whereas no patients without the mutant progressed to cirrhosis.
Maltese: F'4/68 (6%) pazjent bil-mutant YMDD, kien hemm avanz għal ċirrożi, filwaqt li fl-ebda pazjent mingħajr il-mutant ma kien hemm avanz għal ċirrożi.
English: The other ingredients are: sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid, propylene glycol, sodium citrate, artificial strawberry flavour, artificial banana flavour, purified water.
Maltese: Is-sustanzi l-oħra huma: sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid,
English: Development of YMDD mutant HBV is associated with reduced treatment response in some patients, as evidenced by increased HBV DNA levels and ALT elevations from previous on-therapy levels, progression of signs and symptoms of hepatitis disease and/or worsening of hepatic necroinflammatory findings.
Maltese: iżvilupp tal-mutant YMDD tal-HBV huwa assoċjat, f'xi pazjenti, ma' rispons imnaqqas għattrattament, kif muri mil-livell ogħla ta' HBV DNA u ta' ALT meta mqabbel mal-livelli ta' waqt it-terapija ta' qabel, mis-sinjali u s-sintomi avvanzati tal-mard tal-fwied u/jew is-sejbiet nekro infjammatorji epatiċi li sejrin għall-agħar.
English: Dose reduction in patients with a creatinine clearance of < 50 ml/min is necessary (see section 4.2).
Maltese: <50 ml/min (ara sezzjoni 4.2)
English: Hepatic impairment
Maltese: Rari ħafna
English: The solution is clear, colourless to pale yellow in colour with strawberry/banana flavouring.
Maltese: propylene glycol, sodium citrate, it-togħma ta' frawli/banana, ilma purifikat.
English: Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see section decompensated liver disease in combination with a second agent, without cross-resistance to lamivudine (see section 4.2).
Maltese: mard mhux ikkumpensat tal-fwied flimkien ma' sustanza oħra mingħajr cross-resistance għal lamivudine (ara sezzjoni 4.2).
English: NAME OF THE MEDICINAL PRODUCT Zeffix 100 mg film-coated tablets Lamivudine
Maltese: Kull pillola miksija b'rita fiha 100 mg lamivudine
English: Lactic acidosis Immune system disorders: Rare
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: Each film-coated tablet contains 100 mg of lamivudine.
Maltese: Kull pillola miksija b'rita fiha 100 mg lamivudine.
English: In non-controlled studies, where lamivudine was administered prior to and during transplantation, effective HBV DNA suppression and ALT normalisation was demonstrated.
Maltese: Fi studji mhux kontrollati, meta lamivudine ingħata qabel u waqt trapjant, deher trażżin effettiv ta' HBV DNA u normalizzazzjoni ta' ALT.
English: United Kingdom GlaxoSmithKline UK Ltd
Maltese: GlaxoSmithKline (Cyprus) Ltd
English: Microcrystalline cellulose
Maltese: Ko-infezzjoni bl-HIV
English: Some people taking Zeffix or other similar medicines are more at risk of serious side effects.
Maltese: Xi persuni li jkunu qed jieħdu Zeffix jew mediċini simili oħra huma f'riskju akbar ta' effetti sekondarji serji.
English: • In patients with HBeAg positive chronic hepatitis B (CHB) without cirrhosis, treatment should be administered for at least 6-12 months after HBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection) is confirmed, to limit the risk of virological relapse, or until HBsAg seroconversion or there is loss of efficacy (see section 4.4).
Maltese: • F'pazjenti bl-epatite B kronika (CHB) mingħajr ċirrożi, pożittiva għall-HbeAg, it-trattament għandu jingħata għallinqas għal 6 xhur sa 12-il xahar wara li tiġi kkonfermata s serokonverżjoni ta' l-HbeAg (telf ta' HbeAg u HBV DNA bi skoperta ta' HbeAB), biex jitnaqqas ir-riskju li l-pazjent jirkadi viroloġikament, jew sas-serokonverżjoni tal-HbsAg,
English: In a long-term follow-up study of patients who had previously seroconverted and discontinued lamivudine, late virological relapse occurred in 39 % of the subjects.
Maltese: Fi studju ta' tkomplija fit-tul ta' pazjenti li kellhom serokonverżjoni qabel u waqqfu l-lamivudine, 39% tas-suġġetti marru lura viroloġikament wara żmien twil.
English: Forty patients (HBeAg negative or HBeAg positive) with either decompensated liver disease or recurrent HBV following liver transplantation and YMDD mutant were enrolled into an open label arm of study NUC20904.
Maltese: Erbgħin pazjent (negattivi għal HBeAg jew pożittivi għal HBeAg) b'mard mhux ikkumpensat talfwied jew b'HBV li reġa' tfaċċa wara trapjant tal-fwied u bil-mutant YMDD daħlu wkoll f'parti open label tal-istudju NUC20904.
English: The safety and efficacy of Zeffix in infants, children and adolescents aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Zeffix fit-trabi, tfal u adoloxxenti b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Experience in patients with HBeAg positive CHB and compensated liver disease In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication [34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ml)}, normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 1618 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
Maltese: L-inċidenza tal-mutant YMDD tal-HBV kienet simili għal dik osservata fl-adulti u kienet tvarja bejn 19% (31/166) fil-ġimgħa 52 sa 45% (53/118) f'pazjenti li baqgħu kontinwament fuq it-trattament għal 24 xahar.
English: Pyriprole, interacts with a receptor involved in transmitting neural impulses (GABA receptor).
Maltese: Pyriprole, jinteraġixxi ma' riċettur involut fit-trasmissjoni tal-impulsi newrali (riċettur GABA).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Prac-tic to on 18 December 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Prac-tic fit-18 ta' Diċembru 2006.
English: This summary was last updated in December 2012.
Maltese: Diċembru 2012.
English: What is Prac-tic?
Maltese: X'inhu Prac-tic?
English: Dogs from various breeds, age groups and weight that were infested with fleas or ticks were either treated with Prac-tic or with other products authorised in the EU for this indication.
Maltese: Klieb minn diversi razez, gruppi ta' età u piż li kienu infestati bil-briegħed jew bil-qurdien, ġew ittrattati bi Prac-tic jew bi prodotti oħra awtorizzati fl-UE għal din l-indikazzjoni.
English: Prac-tic is a spot-on solution that contains pyriprole as active substance.
Maltese: Prac-tic huwa soluzzjoni spot-on li fiha pyriprole bħala s-sustanza attiva.
English: Other information about Prac-tic:
Maltese: Tagħrif ieħor dwar Prac-tic:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Prac-tic exceed the risks for the approved indications and recommended that Prac-tic be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Prac-tic jisbqu r-riskji għall-indikazzjonijiet approvati u rrakkomanda li Prac-tic jingħata awtorizzazzjoni għattqegħid fis-suq.
English: The most common side effects in dogs are local reactions at the place where the product has been applied: change in the fur colour, hair loss and itchiness, as well as change in appearance of the fur (greasy appearance and clumpiness).
Maltese: L-effetti sekondarji l-aktar komuni fil-klieb huma reazzjonijiet lokali fil-post fejn ikun ġie applikat ilprodott: tibdil fil-kulur tal-pil, twaqqigħ tal-pil u ħakk, kif ukoll tibdil fid-dehra fil-pil (dehra maħmuġa u tgħaqqid).
English: It is given to dogs with pre-filled spot-on pipettes, i.e. small plastic containers which are already filled with the correct amount of Prac-tic needed to treat one dog (Pract-tic is available in 4 different sizes for different dog sizes).
Maltese: Dan jingħata lill-klieb b'pipetti spot-on mimlijin għal-lest, jiġifieri kontenituri żgħar tal-plastik li diġà jkunu mimlijin bid-doża korretta ta' Prac-tic meħtieġa għat-trattament ta' kelb wieħed (Pract-tic huwa disponibbli f'erba' daqsijiet differenti għal daqsijiet ta' klieb differenti).
English: Once applied, it remains active for at least 4 weeks.
Maltese: Ladarba jiġi applikat, huwa jibqa' attiv għal mill-anqas 4 ġimgħat.
English: The effectiveness of pyriprole against flea and tick infestations in dogs was investigated in laboratory studies and in field trials.
Maltese: L-effikaċja ta' pyriprole kontra l-infestazzjonijiet bil-briegħed u l-qurdien fil-klieb kienet investigata fi studji fil-laboratorju u fi provi fuq il-post.
English: People with known hypersensitivity to the phenylpyrazole class compounds or any of the excipients should avoid contact with Prac-tic.
Maltese: Persuni b'sensittività eċċessiva magħrufa għall-komposti tal-klassi ta' phenylpyrazole jew għal xi wieħed mill-eċċipjenti għandhom jevitaw il-kuntatt ma' Prac-tic.
English: Adult fleas are killed before they lay eggs; since Prac-tic completely eliminates egg production, it breaks the flea life cycle.
Maltese: Il-briegħed adulti jinqatlu qabel ma jbidu; billi Prac-tic jelimina kompletament il-produzzjoni tal-bajd, huwa jkisser iċ-ċiklu tal-ħajja tal-briegħed.
English: What is the risk associated with Prac-tic?
Maltese: X'riskji huma assoċjati ma' Prac-tic?
English: The medicine killed fleas within 24 hours and ticks within 48 hours after treatment and its effectiveness lasted for at least 4 weeks.
Maltese: Il-mediċina qatlet il-briegħed fi żmien 24 siegħa u l-qurdien fi żmien 48 siegħa wara t-trattament u l-effikaċja tiegħu damet għal mill-anqas 4 ġimgħat.
English: Prac-tic is an “ectoparasiticide”, which means that it will kill parasites that live on the skin or in the fur of animals, such as fleas and ticks.
Maltese: Prac-tic huwa “ektoparassitiċida”, li jfisser li joqtol parassiti li jgħixu fuq il-ġilda jew fil-pil tal-annimali, bħall-briegħed u l-qurdien.
English: How has Prac-tic been studied?
Maltese: Kif ġie studjat Prac-tic?
English: How does Prac-tic work?
Maltese: Għal xiex jintuża Prac-tic?
English: EPAR summary for the public
Maltese: Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR)
English: Prac-tic should not be used in dogs less than 8 weeks old or less than 2 kg bodyweight since it has not sufficiently been studied in these animals.
Maltese: Prac-tic ma għandux jintuża fi klieb ta' inqas minn 8 ġimgħat jew li jiżnu anqas minn 2 kg billi ma ġiex studjat biżżejjed f'dawn l-annimali.
English: Skin contact with the pipette content should be avoided.
Maltese: Għandu jiġi evitat il-kuntatt tal-ġilda mal-kontenut tal-pipetta.
English: Prac-tic is used to treat and to prevent tick and flea infestations in dogs.
Maltese: Prac-tic jintuża għall-kura u l-prevenzjoni ta' infestazzjonijiet bil-qurdien u l-briegħed fil-klieb.
English: As a precautionary measure, direct contact with the treated dog should be avoided and children should not be allowed to play with a treated animal until the application site is dry.
Maltese: Bħala miżura ta' prekawzjoni, għandu jiġi evitat kuntatt dirett mal-kelb ittrattat u t-tfal ma għandhomx jitħallew jilagħbu ma' annimal ittrattat sakemm is-sit tal-applikazzjoni ma jkunx niexef.
English: Data were provided on the pharmaceutical quality, the tolerance of the product in dogs and the safety in humans (people in contact with the product) and the environment.
Maltese: Kienet ipprovduta dejta dwar il-kwalità farmaċewtika, it-tolleranza tal-prodott fil-klieb u s-sigurtà talbnedmin (nies f'kuntatt mal-prodott) u l-ambjent.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jinstab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: Why has Prac-tic been approved?
Maltese: Għaliex ġie appruvat Prac-tic?
English: Two field studies were conducted in dogs at veterinary practices in several European countries and different geographic regions.
Maltese: Saru żewġ studji fuq il-post fil-klieb fi prattiċi veterinarji f'diversi pajjiżi Ewropej u reġjuni ġeografiċi differenti.
English: The results of the field trials showed that Prac-tic is effective in the treatment and prevention of flea and tick infestations in dogs.
Maltese: Ir-riżultati tal-provi fuq il-post urew li Prac-tic huwa effettiv fil-kura u l-prevenzjoni ta' infestazzjonijiet bil-briegħed u l-qurdien fil-klieb.
English: What benefit has Prac-tic shown during the studies?
Maltese: Liema benefiċċju wera Prac-tic waqt l-istudji?
English: Packaging
Maltese: Il-Pakkett
English: 50 x 1 tablet(unit dose) 105 tablets
Maltese: 50 x 1 pillola ta' doża waħda
English: Package size
Maltese: Daqs tal-Pakkett
English: EMA/347706/2014 EMEA/H/C/000690
Maltese: EMEA/H/C/000690
English: EPAR summary for the public sorafenib
Maltese: Sommarju tal-EPAR għall-pubbliku sorafenib
English: • hepatocellular carcinoma (11 April 2006)
Maltese: • karċinoma epatoċellolari (11 ta' April 2006)
English: The summaries of the opinions of the Committee for Orphan Medicinal Products for Nexavar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
English: Other information about Nexavar
Maltese: Informazzjoni oħra dwar Nexavar
English: The active substance in Nexavar, sorafenib, is a protein kinase inhibitor.
Maltese: Is-sustanza attiva f'Nexavar, is-sorafenib, hija inibitur tal-proteina kinażi.
English: This is a summary of the European public assessment report (EPAR) for Nexavar.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nexavar.
English: Nexavar is a cancer medicine that contains the active substance sorafenib.
Maltese: Nexavar huwa mediċina li fiha s-sustanza attiva sorafenib.
English: The most important serious side effects are myocardial infarction (heart attack) or ischaemia (reduced oxygen supply to the heart), gastrointestinal perforation (a hole that develops in the wall of the gut), drug-induced hepatitis (a disease of the liver), haemorrhage (bleeding) and hypertension or hypertensive crisis (high blood pressure).
Maltese: L-effetti sekondarji serji l-aktar importanti huma infart mijokardijaku (attakk talqalb) jew iskemija (tnaqqis ta' ossiġnu għall-qalb), perforazzjoni gastrointestinali (toqba li tiżviluppa fir-rita tal-imsaren), epatite ikkawżata mid-drogi (marda tal-fwied), emorraġija (fsada) u ipertensjoni jew kriżi ipertensiva (pressjoni għolja tad-demm).
English: The first study involved 602 patients with hepatocellular carcinoma; the second involved 903 patients with advanced renal cell carcinoma in whom one previous anticancer treatment had stopped working; and the third study involved 417 patients with differentiated thyroid carcinoma that had progressed or spread locally or to other parts of the body and did not respond to treatment with radioactive iodine.
Maltese: L-ewwel studju involva 602 pazjenti b'karċinoma epatoċellolari; it-tieni involva 903 pazjenti b'karċinoma taċ-ċellola renali avvanzata li fihom tip wieħed ta' kura kontra l-kanċer waqaf jaħdem; u t-tielet studju involva 417-il pazjent b'karċinoma tat-tirojde differenzjata li pprogressat jew infirxet lokalment jew għal partijiet oħra tal-ġisem u li ma rrispondewx għall-kura b'jodju radjuattiv.
English: • hepatocellular carcinoma (a type of liver cancer);
Maltese: • karċinoma epatoċellolari (tip ta' kanċer fil-fwied);
English: • renal cell carcinoma (29 July 2004)
Maltese: • karċinoma taċ-ċellola renali (29 ta' Lulju 2004)
English: The most common side effects with Nexavar are diarrhoea, rash, alopecia (hair loss), infection, hand foot skin reaction (rash and pain on the palms of the hands and soles of the feet) and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni ta' Nexavar huma dijarea, raxx, alopeċja (telf tax-xagħar), infezzjoni, reazzjoni tal-idejn, is-saqajn u l-ġilda (raxx u wġigħ fuq il-pali tal-idejn u l-pali tas-saqajn) u eżawriment (għeja).
English: Why has Nexavar been approved?
Maltese: Għaliex ġie approvat Nexavar?
English: • advanced renal cell carcinoma (a type of kidney cancer) when anticancer treatment with interferon alfa or interleukin 2 has failed or cannot be used;
Maltese: • karċinoma taċ-ċellola renali avvanzata (tip ta' kanċer fil-kliewi) meta l-kura ta' kontra l-kanċer b'interferon alfa jew interleukin 2 ma tkunx ħadmet jew ma tkunx tista' tintuża;
English: • papillary thyroid cancer and follicular thyroid cancer (13 November 2013) The full EPAR for Nexavar 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: What is Nexavar?
Maltese: Għal xiex jintuża Nexavar?
English: The treatment is continued as long as the patient continues to benefit from it without too many side effects.
Maltese: Il-kura ddum sakemm il-pazjent ikun qed jibbenefika mill-mediċina mingħajr ħafna effetti sekondarji.
English: • differentiated thyroid carcinoma (a type of cancer originating from the follicular cells of the thyroid gland) when the cancer has progressed or spread locally or to other parts of the body and does not respond to treatment with radioactive iodine.
Maltese: • karċinoma tat-tirojde differenzjata (tip ta' kanċer li joriġina miċ-ċelloli follikulari tal-glandola tat tirojde) meta l-kanċer ikun ipprogressa jew ikun infirex lokalment jew għal partijiet oħra tal-ġisem u ma jirrispondix għall-kura b'jodju radjuattiv.
English: The patients taking Nexavar lived for longer without their disease getting worse (167 days, around five and a half months) than those who took placebo (84 days, around three months).
Maltese: Il-pazjenti li ħadu Nexavar għexu iżjed fit-tul mingħajr mal-marda tagħhom qalbet għall-agħar (167 jum, madwar ħames xhur u nofs) minn dawk li ħadu l-plaċebo (84 jum, madwar tliet xhur).
English: How has Nexavar been studied?
Maltese: Kif ġie studjat Nexavar?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nexavar on 19 July 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Nexavar valida fl-Unjoni Ewropea kollha fid-19 ta' Lulju 2006.
English: In the study of renal cell carcinoma, the patients taking Nexavar survived for an average of 19.3 months, compared with 15.9 months in those taking placebo.
Maltese: Fl-istudju ta' karċinoma taċ-ċellola renali, il-pazjenti li ħadu Nexavar issopravivew medja ta' 19.3 xhur meta mqabbla ma' 15.
English: Because the numbers of patients with these diseases are low, the diseases are considered ‘rare', and Nexavar was designated an ‘orphan medicine' (a medicine used in rare diseases).
Maltese: Minħabba li l-għadd ta' pazjenti b'dan il-mard huwa baxx, il-mard huwa kkonsidrat ‘rari', u Nexavar ġie denominat bħala ‘mediċina orfni' (mediċina użata f'mard rari).