FrancophonIA/ELRC3.0 huggingface dataset:
English: Each tablet contains 360 mg of deferasirox.
Maltese: Kull pillola fiha 360 mg ta' deferasirox.
English: Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/- heterozygous mice in a 6-month study.
Maltese: Deferasirox ma żiedx irriskju tal-kanċer meta ngħata lill-firien fi studju ta' sentejn u ġrieden eterożigi transġeniċi p53+/- fi studju ta' 6 xhur.
English: It is recommended that serum ferritin be monitored every month to assess the patient's response to therapy and to minimise the risk of overchelation (see section 4.4).
Maltese: Huwa rrakkomandat li ferritin fis-serum ikun immonitorat kull xahar sabiex issir evalwazzjoni tar-rispons tal-pazjent għat-terapija u jitnaqqas ir-riskju ta' kelazzjoni żejda (ara sezzjoni 4.4).
English: Deferasirox did not cause other effects on fertility or reproduction.
Maltese: Deferasirox ma kellux effetti oħrajn fuq il-fertilità jew fuq ir-riproduzzjoni.
English: Deferasirox also comes as “film-coated” tablets and granules.
Maltese: Deferasirox huwa disponibbli wkoll bħala pilloli “miksija b'rita” u granijiet.
English: Nervous system disorders Common:
Maltese: Ansjetà, disturbi fl-irqad Disturbi fis-sistema nervuża Komuni:
English: Dose reduction or interruption may be also considered if abnormalities occur in levels of markers of renal tubular function and/or as clinically indicated:
Maltese: It-tnaqqis jew it-twaqqif tad-doża jista' wkoll jitqies jekk iseħħu anormalitajiet fil-livelli tal-markaturi tal-funzjoni tabulari tal-kliewi u/jew kif indikat klinikament:
English: SACHETS
Maltese: Sess
English: Stevens-Johnson syndrome1, hypersensitivity vasculitis1, urticaria1, erythema multiforme
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: There were no clinically relevant changes in deferasirox pharmacokinetics when EXJADE granules were administered with food.
Maltese: Ma kien hemm l-ebda bidla klinikament rilevanti fil-farmakokinetika ta' deferasirox meta EXJADE granijiet ingħataw mal-ikel.
English: Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of treatment and at regular intervals thereafter (every 12 months).
Maltese: Testijiet tas-smigħ u tal-għajnejn (inkluż fundoskopija) huma rakkomandati qabel tinbeda t-terapija u b'intervalli regolari minn hemm 'il quddiem (kull 12-il xahar).
English: It appeared from a post-hoc analysis of this study that, in the subgroup of patients with liver iron concentration ≥7 mg Fe/g dw treated with deferasirox dispersible tablets (20 and 30 mg/kg) or deferoxamine (35 to ≥50 mg/kg), the non-inferiority criteria were achieved.
Maltese: Minn analiżi li saret wara dan l-istudju deher li, fis-sottogrupp tal-pazjenti li kellhom konċentrazzjoni tal-ħadid fil-fwied 7 mg Fe/g piż niexef ikkurati b'deferasirox pilloli li jinxterdu (20 u 30 mg/kg) jew deferoxamine (35 sa 50 mg/kg), il-kriterji li juru li ma kienx inferjuri intlaħqu.
English: 84 dispersible tablets
Maltese: 84 pilloli li jinxterdu
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).
Maltese: Pilloli ta' lewn bajdani li jkanġi ftit fl-isfar, tondi, ċatti b'xifer imżerżaq u timbri (NVR fuq naħa u J 125 fuq l-oħra).
English: Each dispersible tablet contains 250 mg of deferasirox.
Maltese: Kull pillola li tinxtered fiha 250 mg deferasirox.
English: EXJADE 500 mg dispersible tablets deferasirox
Maltese: EXJADE 500 mg pilloli li jinxterdu deferasirox
English: 98 dispersible tablets.
Maltese: 98 pillola li jinxterdu.
English: Each tablet contains 90 mg of deferasirox.
Maltese: Kull pillola fiha 90 mg ta' deferasirox.
English: Prior to launch of deferasirox film-coated tablets, healthcare professionals will receive introductory notification letters as follows:
Maltese: Qabel it-tnedija ta' deferasirox pilloli miksija b'rita, professjonisti fil-qasam tal-kura tas-saħħa se jirċievu ittri b'informazzjoni introduttorja kif ġej:
English: In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 10 mg/kg.
Maltese: F'pazjenti li l-LIC tagħhom ma ġiex evalwat u l-ferritin fis-serum hu ta' ≤2000 µg/l, id-doża m'għandhiex taqbeż l-10 mg/kg.
English: EXJADE 360 mg film-coated tablets
Maltese: EXJADE 360 mg pilloli miksija b'rita
English: <7 ml/kg/month of PRBC (approx. <2 units/month for an adult)
Maltese: 7 mg/kg/jum 10 mg/kg/jum <7 ml/kg/xahar ta' PRBC (madwar <2 unitajiet/xah ar għal adult)
English: One of the secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter.
Maltese: Wieħed mill-parametri sekondarji tal-effikaċja kien il-bidla ta' ferritin fisserum bejn il-linja bażi u r-raba' kwart.
English: • The maximum recommended daily dose for EXJADE dispersible tablets is 40 mg per kilogram body weight for patients receiving regular blood transfusions, 20 mg per kilogram body weight for adult patients not receiving regular blood transfusions and 10 mg per kilogram body weight for children and adolescents not receiving regular blood transfusions.
Maltese: • L-aktar doża għolja rakkomandata għal EXJADE pilloli li jinxterdu hija 40 mg għal kull kilogramma tal-piż tal-ġisem kuljum għal pazjenti li jirċievu trasfużjonijiet regolari ta' demm, 20 mg għal kull kilo li jiżnu għal pazjenti adulti li mhumiex jirċievu trasfużjonijiet regolari ta' demm u 10 mg għal kull kilo li jiżnu għal tfal u adolexxenti li mhumiex jirċievu trasfużjonijiet regolari ta' demm.
English: An interaction between deferasirox and other CYP2C8 substrates like paclitaxel cannot be excluded.
Maltese: Mhux eskluż li deferasirox u substrati oħrajn ta' CYP2C8 bħal paclitaxel ma jaqblux bejniethom.
English: Each dispersible tablet contains 500 mg of deferasirox.
Maltese: Kull pillola li tinxtered fiha 500 mg deferasirox.
English: Physicians and patients should remain alert for signs and symptoms of gastrointestinal ulceration and haemorrhage during EXJADE therapy and promptly initiate additional evaluation and treatment if a serious gastrointestinal adverse reaction is suspected.
Maltese: Tobba u pazjenti għandhom joqogħdu attenti għal sinjali u sintomi ta' ulċerazzjoni gastrointestinali u fsada waqt terapija b'EXJADE u jibdew mill-ewwel evalwazzjoni oħra u kura jekk reazzjoni avversa serja gastrointestinali tkun suspettata.
English: In patients treated with doses greater than 30 mg/kg, dose reductions in steps of 5 to 10 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 µg/l and showing a decreasing trend over time).
Maltese: F'pazjenti kkurati b'dożi ogħla minn 30 mg/kg, tnaqqis fid-doża fi stadji ta' 5 sa 10 mg/kg għandu jiġi kkunsidrat meta jinkiseb kontroll (eż. livelli ta' ferritin fis-serum jibqgħu taħt 2,500 µg/l u jidhru li qed jonqsu maż-żmien).
English: An erroneously administered single dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment.
Maltese: Doża waħda ta' 90 mg/kg mogħtija bi żball wasslet għas-sindrome ta' Fanconi li ssolviet wara t-trattament.
English: Granules in sachet (granules)
Maltese: TWISSIJA(IET) SPEĊJALI
English: EXJADE 125 mg dispersible tablets
Maltese: EXJADE 125 mg pilloli li jinxterdu
English: EXJADE 250 mg dispersible tablets deferasirox
Maltese: EXJADE 250 mg pilloli li jinxterdu deferasirox
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).
Maltese: Pilloli ta' lewn bajdani li jkanġi ftit fl-isfar, tondi, ċatti b'xifer imżerżaq u timbri (NVR fuq naħa u J 250 fuq l-oħra).
English: EXJADE 250 mg dispersible tablets
Maltese: EXJADE 250 mg pilloli li jinxterdu
English: CYP450-catalysed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%).
Maltese: Ilmetaboliżmu (ossidattiv) ta' deferasirox permezz tal-kataliżi b'CYP450 jidher li huwa minuri filbniedem (madwar 8%).
English: EXJADE 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox.
Maltese: Kull pillola miksija b'rita ta' EXJADE 360 mg fiha 360 mg deferasirox.
English: The results of this study suggest that there is a positive impact of deferasirox on event-free survival (EFS, a composite endpoint including non-fatal cardiac or liver events) and serum ferritin levels.
Maltese: Ir-riżultati ta' dan l-istudju jissuġġerixxu li deferasirox għandu impatt pożittiv fuq is-sopravivenza ħielsa minn episodji (EFS, endpoint kompost li jinkludi episodji kardijaċi jew epatiċi mhux fatali) u fuq il-livelli ta' ferritin fis-sermu.
English: EXJADE 500 mg dispersible tablets
Maltese: EXJADE 500 mg pilloli li jinxterdu
English: >14 ml/kg/month of PRBC (approx. >4 units/month for an adult)
Maltese: 21 mg/kg/jum 30 mg/kg/jum >14 ml/kg/xahar ta' PRBC (madwar >4 unitajiet/xah ar għal adult)
English: >33% above pretreatment average and Decreases <LLN* (<90 ml/min)
Maltese: Il-bqija >33% ogħla mill-medja ta' qabel ittrattament u/jew Tnaqqis <LLN* (<90 ml/min)
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other).
Maltese: Pilloli ta' lewn bajdani li jkanġi ftit fl-isfar, tondi, ċatti b'xifer imżerżaq u timbri (NVR fuq naħa u J 500 fuq l-oħra).
English: While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with film-coated tablet doses above 21 mg/kg cannot be excluded.
Maltese: Filwaqt li fi studji kliniċi ma kienu osservati l-ebda żidiet fil-każijiet avversi fil-kliewi wara żidiet fid-doża ta' EXJADE pilloli li jinxterdu għal dożi ogħla minn 30 mg/kg, żieda fir-riskju ta' każijiet avversi fil-kliewi b'dożi ta' granijiet minn 21 mg/kg ma tistax tiġi eskluża.
English: Total exposure (AUC) was approximately doubled when taken along with a high-fat breakfast (fat content >50% of calories) and by about 50% when taken along with a standard breakfast.
Maltese: L-esponiment totali (AUC) kien madwar id-doppju meta ttieħed ma' kolazzjon b'livell għoli ta' xaħam (kontenut ta' xaħam >50% tal-kaloriji) u żdied b'madwar 50% meta ttieħed ma' kolazzjon normali.
English: • Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-qartas u fuq il-kartuna wara EXP/JIS.
English: • EXJADE 180 mg film-coated tablets are medium blue and stamped “180” on one side and
Maltese: • Il-pilloli miksija b'rita EXJADE 180 mg huma blu medju u ttimbrati b'“180” fuq naħa minnhom u “NVR” fuq in-naħa l-oħra.
English: EXJADE dispersible tablets must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.5 and 5.2).
Maltese: EXJADE pilloli li jinxterdu għandu jittieħed darba kuljum fuq stonku vojt mill-inqas 30 minuta qabel l-ikel, preferibbilment fl-istess ħin kuljum (ara sezzjonijiet 4.5 u 5.2).
English: Each sachet contains 360 mg of deferasirox.
Maltese: Kull qartas fih 360 mg ta' deferasirox.
English: • EXJADE 90 mg film-coated tablets are light blue and stamped “90” on one side and “NVR” on the other.
Maltese: • Il-pilloli miksija b'rita EXJADE 90 mg huma blu ċari u ttimbrati b'“90” fuq naħa minnhom u
English: EXJADE 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox.
Maltese: Kull pillola miksija b'rita ta' EXJADE 90 mg fiha 90 mg deferasirox.
English: Monthly
Maltese: Lott
English: The most frequent reactions reported during chronic treatment in clinical studies conducted with deferasirox dispersible tablets in adult and paediatric patients include gastrointestinal disturbances (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash.
Maltese: L-aktar reazzjonijiet frekwenti li kienu rappurtati waqt kura kronika b'deferasirox pilloli li jinxterdu f'pazjenti adulti u pedjatriċi jinkludu disturbi gastrointestinali (l-aktar tqalligħ, rimettar, dijarea jew uġigħ addominali) u raxx tal-ġilda.
English: EXJADE 180 mg film-coated tablets
Maltese: EXJADE 180 mg pilloli miksija b'rita
English: Multipack: 294 (3 packs of 98) dispersible tablets.
Maltese: Pakkett multiplu: 294
English: 252 dispersible tablets
Maltese: 252 pillola li jinxterdu
English: EXJADE 500 mg dispersible tablets are also available in multipacks containing 294 (3 packs of 98) dispersible tablets.
Maltese: EXJADE 500 mg pilloli li jinxterdu huma disponibbli ukoll f'pakketti multipli li fihom 294
English: Deferasirox should not be reintroduced in patients who have experienced a hypersensitivity reaction due to the risk of anaphylactic shock (see section 4.3).
Maltese: Deferasirox m'għandux jiġi introdott mill-ġdid f'pazjenti li esperjenzaw reazzjoni ta' sensittività eċċessiva minħabba r-riskju ta' xokk anafilattiku (ara sezzjoni 4.3).
English: Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with deferasirox.
Maltese: Tubulopatija tal-kliewi kienet irrappurtata l-biċċa l-kbira fi tfal u adoloxxenti b'talassemija beta kkurati b'deferasirox.
English: After a high-fat meal, only AUC was mildly increased (by 18%).
Maltese: Wara ikla b'ħafna xaħam, l-AUC biss żdied bi ftit (bi 18%).
English: • Recommendations for treatment of non-transfusion-dependent thalassaemia (NTDT) syndromes: o Information that only one course of treatment is proposed for NTDT patients o A warning on the necessity of closer monitoring of liver iron concentration and serum ferritin in the paediatric population o A warning on the currently unknown safety consequences of long-term treatment in the paediatric population
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja u fuq il-kartuna wara
English: PVC/PE/PVDC/Aluminium blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC/PVDC/aluminju
English: Serum ferritin assessed by monthly monitoring reflected changes in liver iron concentration indicating that trends in serum ferritin can be used to monitor response to therapy.
Maltese: Dan jindika li t-tendenzi tal-ferritin fis-serum jistgħu jintużaw sabiex ikun monitorat ir-rispons għat-terapija.
English: For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE dispersible tablets that is numerically half that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 20 mg/kg/day of EXJADE dispersible tablets).
Maltese: Għall-pazjenti li jkunu sejrin tajjeb bil-kura ta' deferoxamine, id-doża tal-bidu ta' EXJADE pilloli li jinxterdu li tiġi numerikament nofs dik ta' deferoxamine għandha tkun ikkunsidrata (eż. pazjent li qed jirċievi 40 mg/kg/jum ta' deferoxamine għal 5 ijiem fil-ġimgħa (jew ekwivalenti), jista' jinqaleb għal doża tal-bidu ta' 20 mg/kg/jum ta' EXJADE pilloli li jinxterdu).
English: These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).
Maltese: Dawn l-effetti sekondarji huma meqjusa bħala mhux komuni (jistgħu jaffettwaw persuna f'kull 100) jew rari (jistgħu jaffettwaw persuna f'1,000).
English: The majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication.
Maltese: 1, nekrolisi tossika tal-epidermide (TEN) Disturbi fil-kliewi u fis-sistema urinarja Komuni ħafna:
English: EXJADE 90 mg film-coated tablets
Maltese: EXJADE 90 mg pilloli miksija b'rita
English: Bioavailability of deferasirox film-coated tablets was 36% greater than that with dispersible tablets.
Maltese: Bijodisponibilità ta' deferasirox pilloli miksija b'rita kienet 36% ogħla minn dik bil-pilloli li jinxterdu.
English: EXJADE 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox.
Maltese: Kull pillola miksija b'rita ta' EXJADE 180 mg fiha 180 mg deferasirox.
English: • That deferasirox causes rises in serum creatinine in some patients o The need to monitor serum creatinine
Maltese: • Li deferasirox jikkawża żieda tal-kreatinina fis-serum f'xi pazjenti o Il-bżonn li l-kreatinina fis-serum tkun monitorata
English: Each sachet contains 90 mg of deferasirox.
Maltese: Kull qartas fih 90 mg deferasirox.
English: In patients whose serum ferritin level has reached the target (usually between 500 and 1,000 µg/l), dose reductions in steps of 5 to 10 mg/kg should be considered to maintain serum ferritin levels within the target range and to minimise the risk of overchelation.
Maltese: F'pazjenti li l-livell ta' ferritin fis-serum tagħhom jilħaq il-mira (s-soltu bejn 500 and 1,000 µg/l), tnaqqis fid-doża fi stadji ta' 5 sa 10 mg/kg għandu jiġi kkunsidrat biex il-livelli ta' ferritin fis-serum jinżammu fil-medda tal-mira u jitnaqqas ir-riskju ta' kelazzjoni żejda.
English: 1, nephrolithiasis renal tubular necrosis General disorders and administration site conditions Uncommon:
Maltese: Il-materjal edukattiv għat-tabib dwar Exjade għandu jkollha:
English: In post-marketing reports, a high proportion of cases of metabolic acidosis occurred in children in the context of Fanconi syndrome.
Maltese: Fir-rapporti ta' wara t-tqegħid fis-suq, seħħ proporzjon għoli ta' każijiet ta' aċidożi metabolika fit-tfal fil-kuntest tas-sindrome Fanconi.
English: While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with EXJADE dispersible tablet doses above 30 mg/kg cannot be excluded.
Maltese: Filwaqt li fi studji kliniċi ma kienu osservati l-ebda żidiet fil-każijiet avversi fil-kliewi wara żidiet fid-doża ta' EXJADE pilloli li jinxterdu għal dożi ogħla minn 30 mg/kg, żieda fir-riskju ta' każijiet avversi fil-kliewi b'dożi ta' EXJADE pillola li tinxterd ta' aktar minn 30 mg/kg ma tistax tiġi eskluża.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016 EMA/425762/2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 ta' Ġunju 2016
English: Noxafil is an antifungal medicine containing the active substance posaconazole, a member of the group of triazole antifungals.
Maltese: Noxafil huwa mediċina antifungali li fiha s-sustanza attiva posaconazole, membru tal-grupp ta' antifungali triazole.
English: It contains the active substance posaconazole.
Maltese: Fih is-sustanza attiva posaconazole.
English: More information about Noxafil can be found on the Agency's website: ema.europa.eu/Find_medicine.
Maltese: Aktar informazzjoni dwar Noxafil tista' tinsab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find_medicine.
English: Noxafil, a medicine for serious fungal infections, is available by mouth as tablets (100 mg) and oral suspension (40 mg/ml), but the recommended doses for the two forms are different.
Maltese: Noxafil, mediċina għal infezzjonijiet fungali serji, huwa disponibbli mill-ħalq bħala pilloli (100 mg) u sospensjoni orali (40 mg/ml), iżda d-dożi rakkomandati għaż-żewġ forom huma differenti.
English: The recommended oral dosage is 300 mg once a day with the tablets (after a loading dose of 300 mg twice daily on day 1) and 200 mg three to four times a day (600 to 800 mg daily) with the oral suspension.
Maltese: Id-dożaġġ orali rakkomandat huwa ta' 300 mg darba kuljum bil-pilloli (wara doża tal-bidu ta' 300 mg darbtejn kuljum fil-jum 1) u ta' 200 mg tlieta sa erba' darbiet kuljum (600 għal 800 mg kuljum) bis-sospensjoni orali.
English: The CHMP opinion will now be sent to the European Commission for a legally binding decision applicable in all EU Member States.
Maltese: Issa, l-opinjoni tal-CHMP ser tintbagħat lill-Kummissjoni Ewropea għal deċiżjoni legalment vinkolanti applikabli fl-Istati Membri kollha tal-UE.
English: Prescriptions should indicate which dose form is intended
Maltese: Il-preskrizzjonijiet jenħtieġ li jindikaw liema forma tad-doża hija intenzjonata
English: It is used when other medicines do not work or cannot be given, to treat adults with the serious fungal infections invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, or coccidioidomycosis.
Maltese: Jintuża meta mediċini oħrajn ma jaħdmux jew ma jistgħux jingħataw, biex jikkuraw adulti bl-infezzjonijiet fungali serji asperġillożi invażiva, fużarjożi, kromoblastomijakosi, majċetoma, jew koċċidijoidomikożi.
English: • The SmPC and patient information leaflet for Noxafil are being updated to strengthen warnings about the differences between the two formulations, and the outer cartons will be revised to further differentiate the two and to include a warning statement that they cannot be simply substituted without adjusting the dose.
Maltese: • L-SmPC u l-fuljett ta' tagħrif għall-pazjent għal Noxafil qegħdin jiġu aġġornati biex jissaħħu ttwissijiet dwar id-differenzi bejn iż-żewġ formulazzjonijiet, u l-kartuniet ta' fuq barra ser jiġu riveduti biex aktar jiddifferenzjaw it-tnejn u biex jinkludu dikjarazzjoni ta' twissija li ma jistgħux jiġu sempliċiment sostitwiti mingħajr ma tiġi aġġustata d-doża.
English: Doses of the liquid (200 mg, one 5-ml spoonful) are taken three or four times a day.
Maltese: Id-dożi tal-likwidu (200 mg, mgħarfa waħda ta' 5 ml) jittieħdu tliet jew erba' darbiet kuljum.
English: • Noxafil tablets and oral suspension are not interchangeable due to the differences between these two formulations in the frequency of dosing, administration with food and plasma drug concentration achieved.
Maltese: • Il-pilloli u s-sospensjoni orali ta' Noxafil mhumiex interskambjabbli minħabba d-differenzi bejn iżżewġ formulazzjonijiet fil-frekwenza tad-dożaġġ, it-teħid mal-ikel u l-konċentrazzjoni tal-mediċina fil-plażma miksuba.
English: • The usual dose of tablets is three tablets (300 mg) twice a day on the first day, then 300 mg once a day.
Maltese: • Id-doża tas-soltu tal-pilloli hija tliet pilloli (300 mg) darbtejn kuljum fl-ewwel jum, imbagħad 300 mg darba kuljum.
English: It is also used in patients with weakened immune systems (such as transplant patients) to treat thrush (fungal infection of the throat or mouth due to Candida) or prevent invasive fungal infections.
Maltese: Jintuża wkoll f'pazjenti b'sistemi immunitarji mdgħajfa (bħal pazjenti tat-trapjanti) biex jittratta thrush (infezzjoni fungali tal-griżmejn jew tal-ħalq minħabba Candida) jew biex jipprevjeni infezzjonijiet fungali invażivi.
English: Healthcare professionals will also receive a letter in the coming weeks reminding them of the problem.
Maltese: Il-professjonisti fil-qasam tal-kura tas-saħħa ser jirċievu wkoll ittra fil-ġimgħat li ġejjin li tfakkarhom bil-problema.
English: • Patients should not switch between taking Noxafil tablets and Noxafil oral suspension without talking to their doctor or pharmacist first as it may result in a decreased effectiveness or an increased risk of side effects.
Maltese: • Il-pazjenti ma jenħtieġx li jaqilbu bejn li jieħdu pilloli ta' Noxafil u sospensjoni orali ta' Noxafil mingħajr ma jkellmu lit-tabib jew spiżjar tagħhom l-ewwel peress li dan jista' jwassal f'effikaċja mnaqqsa jew f'riskju miżjud ta' effetti sekondarji.
English: • Noxafil is a medicine used to treat serious infections caused by fungi, when other medicines cannot be used or are not effective.
Maltese: • Noxafil huwa mediċina użata biex tikkura infezzjonijiet serji kkawżati minn fungi, meta mediċini oħrajn ma jistgħux jintużaw jew mhumiex effettivi.
English: Similarly, there are reports of patients given tablets instead of oral solution, leading to overdosage and side effects.
Maltese: Bl-istess mod, hemm rapporti ta' pazjenti li ngħataw pilloli minflok soluzzjoni orali, u dan wassal għal dożi eċċessivi u għal effetti sekondarji.