FrancophonIA/ELRC3.0 huggingface dataset:
English: Emtricitabine in combination with other antiretroviral agents, including nucleoside analogues, non-nucleoside analogues and PIs, has been shown to be effective in the treatment of HIV infection in treatment-naïve patients and treatment-experienced patients with stable virological control.
Maltese: Emtricitabine kombinata ma' mediċini antiretrovirali oħra, fosthom analogi tan-nukleosidi, analogi mhux nukleosidi u PIs, uriet li hija effettiva fit-trattament ta' l-infezzjoni ta' l-HIV f'pazjenti li qatt ma kienu ħadu din it-terapija qabel u pazjenti esperjenzati bil-kura b'kontroll viroloġiku stabbli.
English: If Emtriva is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Maltese: Jekk Emtriva jitwaqqaf f'pazjenti infettati kemm bl-HIV kif ukoll bil-virus tal-epatite B (HBV, hepatitis B virus), dawn il-pazjenti għandhom ikunu immonitorjati mill-qrib għal evidenza jekk lepatite tmur għall-agħar (ara sezzjoni 4.4).
English: Other medicines and Emtriva
Maltese: Mediċini oħra u Emtriva
English: The adverse reactions with suspected (at least possible) relationship to treatment in adults from clinical trial and post-marketing experience are listed in Table 2 below by body system organ class and frequency.
Maltese: Ir-reazzjonjiet avversi b'rabta suspetta (almenu possibbli) mat-trattament fl-adulti minn studju kliniku u esperjenza ta' wara t-tqegħid fis-suq huma elenkati f'Tabella 2 hawn taħt skond il-klassi ta' sistema ta' l-organu fil-ġisem u skond il-frekwenza.
English: One 200 mg hard capsule every 96 hours
Maltese: Kapsula iebsa waħda ta' 200 mg kull 96 siegħa
English: Each hard capsule contains 200 mg of emtricitabine.
Maltese: Kull kapsula iebsa fiha 200 mg ta' emtricitabine.
English: Based on the results of these in vitro experiments and the known elimination pathways of emtricitabine, the potential for CYP450 mediated interactions involving emtricitabine with other medicinal products is low.
Maltese: Ibbażat fuq dawn ir-riżultati ta' dawn l-esperimenti in vitro u r-rotta ta' leliminazzjoni magħrufa ta' emtricitabine, il-kapaċità għal interazzjonijiet medjati minn CYP450 li jinvolvu emtricitabine ma' prodotti mediċinali oħra, hija baxxa.
English: Musculoskeletal and connective tissue disorders: Very common:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnetivi:
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Maltese: It-tul tat-terapija antiretrovirali kombinata, l-użu ta' kortikosterojdi, konsum ta' l-alkoħol, immunosoppressjoni severa, indiċi ogħla tal-piż tal-ġisem, fost l-oħrajn, jistgħu jkunu xi wħud mill-ħafna fatturi ta' riskju li wieħed jista' jiżviluppa din il-marda.
English: Due to this difference in bioavailability, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule.
Maltese: Minħabba din id-differenza filbiodisponibiltà, 240 mg ta' emtricitabine mogħtija bħala soluzzjoni orali għandha tipprovdi livelli ta' plażma li jixbħu li dawk osservati wara li tingħata kapsula iebsa waħda ta' 200 mg.
English: Each mL of Emtriva oral solution contains 10 mg of emtricitabine.
Maltese: U KWANTITATTIVA Kull mL ta' Emtriva soluzzjoni orali fih 10 mg ta' emtricitabine.
English: Patients with chronic hepatitis B or C infection treated with CART are at increased risk of experiencing severe, and potentially fatal, hepatic adverse events.
Maltese: Pazjenti b'epatite kronika B jew Ċ ttrattati b'CART huma f'riskju akbar li jsofru minn avvenimenti avversi epatiċi severi jew potenzjalment fatali.
English: One mL of Emtriva oral solution contains 10 mg of emtricitabine (10 mg/mL).
Maltese: emtricitabine (10 mg/mL).
English: However, limited data are available on the efficacy and safety of emtricitabine (as a 200 mg hard capsule once daily) in patients who are co-infected with HIV and HBV.
Maltese: Madankollu, informazzjoni limitata hija disponibbli dwar is-sigurtà u l-effikaċja ta' emtricitabine (bħala kapsula iebsa ta' 200 mg darba kuljum) f'pazjenti infettati wkoll bl-HIV u bl-HBV.
English: Elderly patients are more likely to have decreased renal function; therefore caution should be exercised when treating elderly patients with Emtriva.
Maltese: Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta pazjenti anzjani jkunu qed jingħataw it-trattament b'Emtriva.
English: Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution (24 mL) should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Maltese: Minħabba d-differenza fil-biodisponibiltà ta' emtricitabine bejn l-għamliet ta' kapsuli iebsin u s-soluzzjoni orali, 240 mg ta' emtricitabine mogħtija bħala soluzzjoni orali (24 mL), għandhom jagħtu livelli ta' plażma bħal dawk li jkunu osservati wara l-għoti ta' kapsula iebsa waħda ta' 200 mg ta' emtricitabine (ara sezzjoni 5.2).
English: • Your doctor will prescribe Emtriva with other antiretroviral medicines.
Maltese: • It-tabib tiegħek ser jagħtik riċetta għal Emtriva flimkien ma' mediċini antiretrovirali oħra.
English: The methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
Maltese: Methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216) jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jittardjaw).
English: The mean AUC in 77 infants, children and adolescents receiving 6 mg/kg emtricitabine once daily as oral solution or 200 mg emtricitabine as hard capsules once daily was similar to the mean AUC of 10.0 µg·h/mL in 20 adults receiving 200 mg hard capsules once daily.
Maltese: L-AUC medja f'77 tarbija, tfal u adolexxenti li kienu jirċievu 6 mg/kg ta' emtricitabine darba kuljum bħala soluzzjoni orali jew 200 mg ta' emtricitabine bħal kapsuli iebsin darba kuljum, kienet tixbah lillmedja ta' l-AUC ta' 10.
English: How much 10 mg/mL solution to take (mL)
Maltese: Kemm għandek tieħu soluzzjoni ta' 10 mg/mL (mL)
English: Animal studies do not indicate harmful effects of emtricitabine on fertility.
Maltese: Studji f'annimali ma jurux effetti ħżiena fuq il-fertilità minn emtricitabine.
English: Paediatric population: The recommended dose of Emtriva for children aged 4 months and over and adolescents up to 18 years of age weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, once daily.
Maltese: Id-doża rakkomandata ta' Emtriva għat-tfal minn età ta' 4 xhur u aktar u adolexxenti sa 18-il sena li jiżnu mill-inqas 33 kg u li huma kapaċi jibilgħu kapsuli iebsin, hija ta' kapsula iebsa waħda ta' 200 mg, li tittieħed mill-ħalq, darba kuljum.
English: Table 1: Dose interval guidelines for 200 mg hard capsules adjusted according to creatinine clearance
Maltese: Tabella 1: Linji gwida għall-intervall tad-doża għall-kapsuli iebsin ta' 200 mg aġġustati skont it tneħħija tal-krejatinina
English: Elderly: There are no safety and efficacy data available in patients over the age of 65 years.
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja f'pazjenti ta' 'l fuq minn 65 sena.
English: Where available, resistance testing may be appropriate.
Maltese: Fejn ikun possibbli, l-ittestjar tar-reżistenza jista' jkun adattat.
English: Therefore Emtriva is not recommended for use in those aged less than 4 months (for pharmacokinetic data in this age group, see section 5.2).
Maltese: Għalhekk Emtriva mhux rakkomandat għall-użu fi trabi ta' anqas minn 4 xhur (għal tagħrif farmakokinetiku fil-grupp ta' din l-età, ara sezzjoni 5.2).
English: Emtriva has not been studied in patients over the age of 65.
Maltese: Emtriva ma ġiex studjat f'pazjenti li jkollhom iktar minn 65 sena.
English: Administration of Emtriva 200 mg hard capsules with a high-fat meal or administration of Emtriva 10 mg/mL oral solution with a low-fat or high-fat meal did not affect systemic exposure (AUC0-∞) of emtricitabine; therefore Emtriva 200 mg hard capsules and Emtriva 10 mg/mL oral solution may be administered with or without food.
Maltese: Għalhekk, jew aġġustament ta' l-intervall tad-doża (permezz ta' kapsuli iebsin Emtriva ta' 200 mg) jew tnaqqis tad-doża ta' kuljum ta' emtricitabine (permezz ta' soluzzjoni orali Emtriva ta' 10 mg/mL) ikun meħtieġ fil-pazjenti kollha bi tneħħija tal-krejatinina ta' < 30 mL/min.
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Maltese: Fi tfal li ommhom ħadet NRTIs waqt it-tqala, il-benefiċċju mill-protezzjoni kontra l-HIV kien ikbar mir-riskju ta' l-effetti sekondarji.
English: Recommended dose interval for 200 mg hard capsules
Maltese: Informazzjoni għall utent Emtriva 200 mg kapsuli iebsin
English: Exacerbations of hepatitis after discontinuation of treatment: In HIV infected patients co-infected with HBV, exacerbations of hepatitis may occur after discontinuation of treatment (see section 4.4).
Maltese: F'pazjenti infettati bl-HIV li jkunu infettati wkoll bl-HBV, jistgħu jseħħu epatite li tmur għall-agħar wara t-twaqqif tal-kura (ara sezzjoni 4.4).
English: General disorders and administration site conditions: Common:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: Such exacerbations have been seen following discontinuation of emtricitabine treatment in HBV infected patients without concomitant HIV infection and have been detected primarily by serum alanine aminotransferase (ALT) elevations in addition to re-emergence of HBV DNA.
Maltese: Aggravar bħal dan kien osservat wara li twaqqaf it-trattament b'emtricitabine f'pazjenti infettati bl-HBV mingħajr infezzjoni konkomitanti bl-HIV, u dan kien osservat primarjament permezz ta' żidiet fil-livell ta' alanine aminotransferase fis-serum (ALT) flimkien mad-dehra mill-ġdid tad-DNA tal-HBV.
English: Emtriva oral solution is a clear, orange to dark orange solution that comes in bottles containing 170 mL with a measuring cup.
Maltese: Emtriva soluzzjoni orali hija soluzzjoni trasparenti ta' kulur oranġjo tagħti fl-oranġjo skur li tiġi pprovduta fi fliexken ta' 170 mL b'tazza tal-kejl.
English: The YMDD mutation confers resistance to both emtricitabine and lamivudine.
Maltese: Il-mutazzjoni YMDD tikkawża reżistenza kemm għal emtricitabine u anke għal lamivudine.
English: There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age.
Maltese: M'hemmx informazzjoni dwar l-effikaċja u hemm biss informazzjoni limitata ħafna dwar is-sigurtà ta' emtricitabine fi trabi ta' anqas minn 4 xhur.
English: Emtricitabine is not recommended as monotherapy for the treatment of HIV infection.
Maltese: It-terapija għandha tinbeda minn tabib b'esperjenza fl-immaniġġjar ta' infezzjoni HIV.
English: Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.
Maltese: Xorta tista' tgħaddi l-HIV meta tkun qiegħed tieħu din il-mediċina, għalkemm ir-riskju jonqos b'terapija antiretrovirali effettiva.
English: 3 This adverse reaction, which was identified through post-marketing surveillance, was not observed in randomised controlled clinical trials in adults or paediatric HIV clinical trials of emtricitabine.
Maltese: 3 Din ir-reazzjoni avversa li kienet identifikata minn sorveljanza ta' wara t-tqegħid fis-suq ma kinitx osservata fi studji kliniċi kkontrollati randomised fuq persuni adulti u fi studji kliniċi fuq persuni pedjatriċi bl-HIV dwar emtricitabine.
English: • The other ingredients are:
Maltese: • Adulti:
English: Caution should be exercised when emtricitabine is co-administered with medicinal products that are eliminated by active tubular secretion as such co-administration may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product, due to competition for this elimination pathway (see section 4.5).
Maltese: Għandha tingħata attenzjoni partikulari meta emtricitabine tkun mogħtija ma' prodotti mediċinali oħra li huma eliminati permezz ta' sekrezzjoni tubulari attiva peress li dan l-għoti flimkien jista' jwassal għal żieda ta' konċentrazzjonijiet ta' serum ta' emtricitabine jew ta' prodott mediċinali li jkunu ttieħdu flimkien minħabba l-kompetizzjoni għal dan ir-rotta ta' l-eliminazzjoni (ara sezzjoni 4.5).
English: Dose or dose interval adjustment is required in all patients with creatinine clearance < 30 mL/min (see sections 4.2, 4.4 and
Maltese: Aġġustament fid-doża jew fl-intervall tad-doża jkun meħtieġ fil-pazjenti kollha li għandhom tneħħija tal-krejatinina ta' < 30 mL/min (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Fertility
Maltese: newtropenja
English: HIV/HBV co-infected patients: The adverse reaction profile in patients co-infected with HBV is similar to that observed in patients infected with HIV without co-infection with HBV.
Maltese: Il-profil tar-reazzjonijiet avversi f'pazjenti infettati wkoll blHBV jixbah lil dak osservat f'pazjenti infettati bl-HIV biss mingħajr infezzjoni bl-HBV.
English: • pain
Maltese: OĦRAJN
English: • dizziness, weakness, difficulty sleeping, abnormal dreams
Maltese: • sturdament, dgħufija, diffikultà biex torqod, ħolm anormali
English: • Infants, children and adolescents weighing 40 kg or less: the dose of Emtriva 10 mg/mL oral solution is calculated according to your body weight.
Maltese: • Trabi, tfal u adolexxenti li jiżnu 40 kg jew inqas: id-doża ta' Emtriva 10 mg/mL soluzzjoni orali hija kkalkulata skond il-piż tal-ġisem tiegħek.
English: As a general rule, it is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV to the infant.
Maltese: Bħala regola ġenerali, huwa rakkomandat li nisa infettati bl-HIV ma jreddgħux lit-trabi tagħhom taħt l-ebda ċirkustanza sabiex jevitaw li jgħaddu HIV lit-tarbija.
English: Discontinuation of Emtriva therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
Maltese: It-twaqqif tat-terapija b'Emtriva f'pazjenti infettati kemm bl-HIV kif ukoll bl-HBV jista' jkun assoċjat ma' epatite li tmur għall-agħar severa u akuta (ara sezzjoni 4.4).
English: What Emtriva is and what it is used for Emtriva is a treatment for Human Immunodeficiency Virus (HIV) infection in adults, children and infants aged 4 months and over.
Maltese: Emtriva hi trattament għall-infezzjoni mill-Virus ta' l-Immunodefiċjenza Umana (HIV) fl-adulti, fit-tfal u trabi minn età ta' 4 xhur u aktar.
English: In addition to the adverse reactions experienced by adults, anaemia and skin discolouration occurred more frequently in clinical trials involving HIV infected paediatric patients (see section 4.8).
Maltese: Flimkien mar-reazzjonijiet avversi li jkollom l-adulti, anemija u telf tal-kulur tal-ġilda seħħew b'mod iktar frekwenti fi studji kliniċi li kienu jinvolvu pazjenti pedjatriċi infettati bl-HIV (ara sezzjoni 4.8).
English: Recommended dose of Emtriva 10 mg/mL oral solution every 24 hours
Maltese: Doża rakkomandata ta' Emtriva 10 mg/mL soluzzjoni orali kull 24 siegħa
English: Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product due to competition for this elimination pathway.
Maltese: L-għoti ta' emtricitabine flimkien ma' prodotti mediċinali li huma eliminati permezz ta' sekrezzjoni tubulari attiva tista' twassal għal żieda ta' konċentrazzjonijiet fis-serum ta' emtricitabine jew tal-prodott mediċinali li jkun qed jingħata miegħu minħabba kompetizzjoni għal din ir-rotta ta' l-eliminazzjoni.
English: Each capsule has a white opaque body with a light blue opaque cap, of dimensions 19.4 mm x 6.9 mm. Each capsule is printed with “200 mg” on the cap and “GILEAD” and [Gilead logo] on the body in black ink.
Maltese: Kull kapsula hija bajda opakab'għatu ċelesti opak ċar, b'daqs ta' 19.4 mm x 6.9 mm.
English: In infants and children older than 4 months, the majority of patients achieved or maintained complete suppression of plasma HIV-1 RNA through 48 weeks (89% achieved ≤ 400 copies/mL and 77% achieved ≤ 50 copies/mL).
Maltese: Fit-trabi u fit-tfal li kellhom iktar minn 4 xhur, il-maġġoranza tal-pazjenti laħqu jew żammew soppressjoni kompleta tal-RNA tal-HIV-1 tal-plażma matul 48 ġimgħa (89% laħqu ≤ 400 kopja/mL u 77% laħqu ≤ 50 kopja/mL).
English: Patients with renal insufficiency can also be managed by administration of Emtriva 200 mg hard capsules at modified dose intervals.
Maltese: Pazjenti b'insuffiċjenza renali jistgħu jiġu mmaniġġjati wkoll bl-għoti ta' Emtriva 200 mg kapsuli iebsin f'intervalli ta' dożaġġ modifikati.
English: Emtricitabine exposure may be markedly increased in patients with severe renal insufficiency (creatinine clearance < 30 mL/min) receiving daily doses of 200 mg emtricitabine as hard capsules or 240 mg as the oral solution.
Maltese: L-esponiment għal emtricitabine jista' jiżdied b'mod sinifikanti f'pazjenti b'insuffiċjenza renali severa (tneħħija tal-krejatinina ta' < 30 mL/min) li jirċievu dożi ta' 200 mg ta' emtricitabine bħala kapsuli iebsin, jew 240 mg ta' soluzzjoni orali kuljum.
English: Children aged 4 months and over, who weigh at least 33 kg may either take one 200 mg hard capsule daily or may take emtricitabine as the oral solution up to a maximum of 240 mg once daily.
Maltese: Tfal li li għandhom 4 xhur u aktar, li jiżnu mill-inqas 33 kg jistgħu jieħdu jew kapsula iebsa waħda ta' 200 mg kuljum jew jieħdu emtricitabine bħala soluzzjoni orali sa massimu ta' 240 mg darba kuljum.
English: In case of concomitant antiviral therapy for hepatitis B or C, please also refer to the relevant Summary of Product Characteristics for these medicinal products.
Maltese: Fil-każ ta' terapija antivirali konkomitanti għall-epatite B jew Ċ, jekk jogħġbok ara S-Sommarju tal-Karatteristiċi tal-Prodott rilevanti għal dawn il-prodotti mediċinali.
English: • Look out for infections.
Maltese: • Oqgħod attent/a għall-infezzjonijiet.
English: Table 1 below provides dose interval adjustment guidelines for the 200 mg hard capsules according to the degree of renal insufficiency.
Maltese: Tabella 1 t'hawn taħt tipprovdi l-linji gwida ta' l-aġġustament fl-intervall tad-doża għall-kapsuli iebsin ta' 200 mg skond il-grad ta' insuffiċjenza renali.
English: There is a separate Package Leaflet for Emtriva 200 mg hard capsules.
Maltese: Kull kapsula iebsa ta' Emtriva fiha 200 mg ta' emtricitabine.
English: Administration of up to 1,200 mg emtricitabine has been associated with the adverse reactions listed above (see section 4.8).
Maltese: L-għoti ta' emtricitabine sa 1,200 mg ġie konness mar-reazzjonijiet avversi elenkati hawn fuq.
English: • Talk to your doctor if you have a history of liver disease, including hepatitis.
Maltese: • Kellem lit-tabib tiegħek jekk inti għandek passat mediku ta' mard tal-fwied, li jinkludi lepatite.
English: elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia Hepatobiliary disorders: Common:
Maltese: amylase għoli li jinkludi amylase pankreatika għolja, lipase fis-serum għoli, rimettar, uġigħ addominali, dispepsja
English: It must be used in combination with other antiretrovirals.
Maltese: Għandha tintuża flimkien ma' antiretrovirali oħra.
English: After opening: Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: • Children and adolescents up to 18 years of age who weigh at least 33 kg and who are able to swallow hard capsules: one 200 mg hard capsule, each day with or without food.
Maltese: • Tfal u adolexxenti sa 18-il sena li jiżnu mill-inqas 33 kg u li jistgħu jibilgħu kapsuli iebsin: kapsula iebsa waħda ta' 200 mg kuljum ma' l-ikel jew mingħajr ikel.
English: Emtriva is also available as a 10 mg/mL oral solution for use in infants aged 4 months and over, children and patients who are unable to swallow hard capsules and patients with renal insufficiency.
Maltese: Emtriva hija disponibbli ukoll bħala soluzzjoni orali ta' 10 mg/mL għall-użu fi trabi minn età ta' 4 xhur u aktar, tfal jew pazjenti li ma jistgħux jibilgħu kapsuli iebsin u pazjenti b'insuffiċjenza renali.
English: If you would like to switch from taking Emtriva oral solution to Emtriva hard capsules, please talk to your doctor.
Maltese: Jekk trid taqleb minn Emtriva soluzzjoni orali għal Emtriva kapsuli iebsin, jekk jogħġbok kellem lit-tabib tiegħek.
English: Ref. EMEA/138069/2008
Maltese: EMEA/138069/2008
English: London, 24 April 2008 Doc.
Maltese: Londra, 24 ta' April 2008 Dok. Ref.
English: It contains the active substance clofarabine.
Maltese: Fih is-sustanza attiva klofarabina.
English: International non-proprietary name (INN): clofarabine
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): klofarabina (clorafabine)
English: Evoltra was designated as an orphan medicine for this condition on 8 May 2003.
Maltese: Evoltra kien ikkwalifikat bħala mediċina orfni għal din ilkondizzjoni fit-8 ta' Mejju 2003.
English: What is Evoltra?
Maltese: X'inhu Evoltra?
English: On 18 March 2008, Bioenvision Ltd, a wholly owned subsidiary of Genzyme Corporation, officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Evoltra.
Maltese: Fit-18 ta' Marzu 2008, Bioenvision Ltd, kumpanija totalment sussidjarja ta' Genzyme Corporation, b'mod uffiċjali għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal modifika fl-awtorizzazzjoni għat-tqegħid fis-suq ta' Evoltra.
English: Clofarabine is an analogue of adenine, which is part of the DNA, the fundamental genetic material of cells.
Maltese: Klorafabina hija analogu tal-adenina, li hija parti mid-DNA, ilmaterjal ġenetiku fundamentali taċ-ċelloli.
English: In the body, clofarabine takes the place of adenine, and interferes with the enzymes involved in making genetic material.
Maltese: Fil-ġisem, klofarabina tissostitwixxi l-adenina, u jinterferixxi mal-enzimi involuti fil-produzzjoni tal-materjal ġenetiku.
English: How is Evoltra expected to work?
Maltese: Kif kien mistenni li jaħdem Evoltra?
English: It belongs to the group of anti-cancer medicines called ‘antimetabolites'.
Maltese: Tappartjeni għall-grupp ta' mediċini ta' kontra l-kanċer magħrufa bħala ‘antimetaboliti'.
English: What is happening for Evoltra for treatment of ALL in children?
Maltese: X'qiegħed jiġri dwar l-użu ta' Evoltra fit-trattament ta' tfal bi ALL ?
English: The company presented results from one main study involving 66 patients aged 65 years or older with AML, who had not been treated before and were considered to be unsuitable for intensive chemotherapy.
Maltese: Il-kumpanija ppreżentat riżultati minn studju ewlieni li kien jinvolvi 66 pazjent ta' età ta' 65 sena jew aktar li kellhom AML, li qatt ma rċevew trattament qabel u li ma kinux ikkunsidrati idonei għal kimoterapija intensiva.
English: Evoltra is already used to treat children with acute lymphoblastic leukaemia (ALL, cancer of the lymphocytes, a type of white blood cell).
Maltese: Evoltra diġà jintuża fit-trattament ta' tfal li jkollhom lewċemija akuta linfoblastika (ALL, kanċer tallinfoċiti, tip ta' ċellola bajda tad-demm).
English: The main measure of effectiveness was the number of patients who went into ‘remission' (clearance of leukaemia from the bone marrow and complete or partial recovery of blood cell counts to normal levels).
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li esperjenzaw ‘remissjoni' (meta titneħħa l-lewċemija mill-mudullun talgħadam u l-irkupru komplet jew parzjali tal-livelli normali tal-għadd ta' ċelloli tad-demm).