FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP reviewed the totality of the data and consulted its Infectious Diseases Working Party on the proposed harmonised PI.
Maltese: Is-CHMP irreveda d-dejta kollha u kkonsulta lill-Grupp ta' Ħidma dwar il-Mard Infettiv tiegħu fuq l-Informazzjoni dwar il-Prodott armonizzata proposta.
English: The CHMP considered that while fluoroquinolones are widely regarded as optimal for the treatment of typhoid fever in adults, in areas with high rates of fluoroquinolones-resistance, amoxicillin remains an appropriate alternative for the treatment of typhoid fever.
Maltese: Is-CHMP ikkunsidra li filwaqt li l-fluoroquinolones jitqiesu bħala ottimi għall-kura ta' deni tat-tifojde f'adulti, f'postijiet b'rati għoljin ta' reżistenza għall-fluoroquinolones, amoxicillin jibqa' alternattiva xierqa għallkura ta' deni tat-tifojde.
English: However several retrospective studies point to indicate a good efficacy in the treatment of prosthetic joints infections.
Maltese: Madankollu diversi studji retrospettivi jindikaw effikaċja tajba fil-kura ta' infezzjonijiet ta' ġogi prostetiċi.
English: Furthermore amoxicillin is recommended in several guidelines (e.g. American College of Gastroenterology, National Institute for Health and Care Excellence) in combination with a proton pump inhibitor and clarithromycin.
Maltese: Barra minn hekk amoxicillin huwa rakkomandat f'diversi linji gwida (eż. il-Kulleġġ Amerikan tal-Gastroenteroloġija, l-Istitut Nazzjonali għall-Eċċellenza fis-Saħħa u l-Kura) flimkien ma' inibitur tal-pompa tal-protoni u clarithromycin.
English: • The committee reviewed the data submitted by the MAH in support of the proposed harmonisation of the Product Information, including clinical trials, open studies, , literature studies and reviews as well as evidence-based and consensus guidelines.
Maltese: • Il-Kumitat irreveda d-dejta sottomessa mill-MAH li tappoġġja l-armonizzazzjoni proposta talInformazzjoni dwar il-Prodott, inklużi provi kliniċi, studji miftuħin, studji u reviżjonijiet taddokumentazzjoni kif ukoll linji gwida dwar il-kunsens u bbażati fuq l-evidenza.
English: For all indications, to encourage the responsible use of antibacterial agents and to direct prescribers to take note of any existing national or local guidance and opinions on how antibacterial agents should be used the following sentence will be included in this section: “Consideration should be given to official guidance on the appropriate use of antibacterial agents”.
Maltese: In-nuqqas ta' provi kliniċi ta' kwalità tajba huwa rikonoxxut, madankollu il-ftit studji kkontrollati u mhux ikkontrollati juru l-effikaċja ta' amoxicillin għall-kura ta' meninġite batterika, b'mod partikolari meta l-patoġenu huwa magħruf li huwa suxxettibbli għal amoxicillin.
English: EMA Number
Maltese: Numru tal-MA (EU)
English: EMA/139812/2014 EMEA/H/C/000561
Maltese: EMEA/H/C/000561
English: The full EPAR for Osseor 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: Other information about Osseor
Maltese: Informazzjoni oħra dwar Osseor
English: This is a summary of the European public assessment report (EPAR) for Osseor.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Osseor.
English: In the first study, Osseor reduced the risk of new breaks in the spine by 41% over three years: 21% of the 719 women who took Osseor developed a new break in the spine, compared with 33% of the 723 who took placebo.
Maltese: Fl-ewwel studju, Osseor naqqas ir-riskju ta' ksur ġdid fis-sinsla tad-dahar b'41% fuq tliet snin: 21% tas-719-il mara li ħadu Osseor kellhom ksur ġdid fis-sinsla tad-dahar, meta mqabbla ma' 33% tas-723 mara li ħadu l-plaċebo.
English: Osseor is a medicine that contains the active substance strontium ranelate.
Maltese: Osseor huwa mediċina li fiha s-sustanza attiva ranelatu tal-istronzju.
English: • peripheral arterial disease (obstruction of the blood flow in the arteries, usually in the legs);
Maltese: • mard fl-arterji periferiċi (obstruzzjoni fil-fluss tad-demm fl-arterji, ġeneralment fir-riġlejn);
English: EPAR summary for the public strontium ranelate
Maltese: Sommarju tal-EPAR għall-pubbliku
English: What is Osseor?
Maltese: X'inhu Osseor?
English: • ischaemic heart disease (such as angina or a heart attack);
Maltese: • mard tal-qalb iskemiku (bħal anġina jew attakk tal-qalb);
English: The most common side effects with Osseor (which may affect more than 1 in 10 people) are hypersensitivity (allergic) skin reactions (rash, itching, urticaria or itchy rash, and swelling beneath the skin known as angioedema) and pain affecting muscles, bones and joints.
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Osseor (li jistgħu jaffettwaw aktar minn persuna minn kull 10) huma reazzjonijiet ipersensittivi (allerġiċi) fil-ġilda (raxx, ħakk, urtikarja jew raxx bil-ħakk, u nefħa taħt il-ġilda magħrufa bħala anġjoedema) u uġigħ li jaffettwa l-muskoli, l-għadam u l-ġogi.
English: When looking at results of the two studies taken together, fewer women in the Osseor group developed breaks at any site outside the spine (including the hip) than in the placebo group (331 out of 3,295 with Osseor compared with 389 out of 3,256 for placebo).
Maltese: Meta ġew analizzati r-riżultati taż-żewġ studji flimkien, inqas nisa mill-grupp ta' Osseor kellhom ksur f'għadam ieħor minbarra s-sinsla tad-dahar (inkluż il-ġenbejn) milli dawk mill-grupp tal-plaċebo (331 minn 3,295 b'Osseor meta mqabbla ma' 389 minn 3,256 għall-plaċebo).
English: In the study in male patients, the bone density in the lower part of the spine increased by 7% after one year of treatment in patients taking Osseor, compared with an increase of 1.7% in patients taking placebo.
Maltese: Fl-istudju tal-pazjenti rġiel, id-densità tal-għadam fil-parti t'isfel tas-sinsla tad-dahar żdiedet b'7% wara sena trattament fil-pazjenti li kienu qed jieħdu Osseor, meta mqabbla ma' 1.7% f'pazjenti li kienu qed jieħdu l-plaċebo.
English: Nearly a quarter of the patients were over 80 years of age.
Maltese: Kważi kwart mill-pazjenti kellhom 'il fuq minn 80 sena.
English: Osseor has been studied in almost 7,000 elderly women in two large studies.
Maltese: Osseor ġie studjat f'żewġ studji kbar fi kważi 7,000 mara anzjana.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Osseor on 21 September 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Osseor valida fl-Unjoni Ewropea kollha fil-21 ta' Settembru 2004.
English: Why has Osseor been approved?
Maltese: Għaliex ġie approvat Osseor?
English: The first study included 1,649 women with osteoporosis who had already had a broken bone in the spine and the second included over 5,000 women whose osteoporosis was affecting the hip.
Maltese: Fl-ewwel studju ħadu sehem 1,649 mara bl-osteoporożi li kienu diġà sofrew minn ksur fis-sinsla tad-dahar u fit-tieni wieħed ħadu sehem iktar minn 5,000 mara li l-osteoporożi tagħhom kienet affettwat ġenbejhom.
English: What is the risk associated with Osseor?
Maltese: X'inhu r-riskju assoċjat ma' Osseor?
English: The active substance in Osseor, strontium ranelate, acts on the bone structure.
Maltese: Is-sustanza attiva f'Osseor, ir-ranelatu tal-istronzju, taġixxi fuq l-istruttura tal-għadam.
English: It is available as 2 g sachets containing granules that are made up into an oral (by mouth) suspension.
Maltese: Jiġi fi qratas ta' 2 g li jkun fihom granuli, li jintgħamlu f'sospensjoni orali (li tittieħed mill-ħalq).
English: How has Osseor been studied?
Maltese: Kif ġie studjat Osseor?
English: In addition, education materials are sent to patients and healthcare professionals prescribing Osseor reminding them of the risk of heart and circulatory problems with the medicine and of the need for regular monitoring.
Maltese: Barra minn hekk, jintbagħat materjal edukattiv lill-pazjenti u lill-professjonisti tal-kura tas-saħħa li jippreskrivu Osseor sabiex ifakkarhom fir-riskju ta' problemi tal-qalb u problemi ċirkulatorji bilmediċina u fil-bżonn li jsir monitoraġġ regolari.
English: In both studies, Osseor was compared with placebo (a dummy treatment) and the main measure of effectiveness was the reduction in the risk of a new bone break with Osseor.
Maltese: Fiż-żewġ studji, Osseor tqabbel ma' plaċebo (trattament finta) u l-kejl ewlieni tal-effikaċja kien it-tnaqqis fir-riskju ta' ksur ġdid fl-għadam b'Osseor.
English: • cerebrovascular disease (diseases affecting the blood vessels in the brain, such as stroke).
Maltese: • mard ċerebrovaskulari (mard li jaffettwa l-vini u l-arterji tad-demm fil-moħħ, bħal puplesija).
English: A risk management plan has been developed to ensure that Osseor is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Osseor jintuża bl-aktar mod sigur possibbli.
English: Osseor should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Maltese: Osseor għandu jittieħed tal-anqas sagħtejn wara li jittieħed xi ikel, ħalib, prodotti tal-ħalib jew supplimenti tal-kalċju, preferibbilment f'ħin l-irqad.
English: Osseor has also been compared with placebo in a main study involving 261 male patients at increased risk of having a broken bone.
Maltese: Osseor tqabbel ukoll ma' plaċebo fi studju ewlieni li sar fuq 261 pazjent raġel b'riskju akbar li jkollhom ksur fl-għadam.
English: Osseor is used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Maltese: Osseor jintuża fil-kura ta' osteoporożi severa (marda li ddgħajjef l-għadam) f'nisa li jkunu għaddew mill-menopawża u fi rġiel li jkunu f'riskju kbir li jkollhom ksur fl-għadam u li ma jistgħux jiġu kkurati b'mediċini oħrajn approvati għal osteoporożi.
English: Exactly how strontium works in osteoporosis is not fully understood, but it is known to stimulate bone formation and reduce bone breakdown.
Maltese: Il-kontenut tal-qartas jiżdied u jitħallat ma' tazza ilma biex jifforma sospensjoni li tinxtorob hekk kif tiġi ppreparata.
English: Osseor must not be used in patients who have or have had venous thromboembolic events (problems due to the formation of blood clots in the veins, such as in the legs or lungs).
Maltese: Osseor ma għandux jintuża fuq pazjenti li qed isofru jew sofrew minn episodji tromboemboliċi venużi (problemi li jirriżultaw mill-formazzjoni tal-emboli tad-demm fil-vini, bħal fis-saqajn jew fil-pulmun).
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Maltese: L-osteoporożi hija aktar komuni fin-nisa li jkunu għaddew mill-menopawża, meta jonqsu l-livelli talormon femminili estroġenu, peress li dan l-ormon jgħin l-għadam jibqa' f'saħħtu.
English: The CHMP decided that Osseor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Osseor huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li tingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What measures are being taken to ensure the safe and effective use of Osseor?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat użu sigur u effettiv ta' Osseor?
English: Once in the gut, strontium ranelate releases strontium, which is absorbed into the bone.
Maltese: Dan il-materjal se jfakkar ukoll lit-tobba fl-użu approvat tal-mediċina.
English: MA (EU) number (Invented) name
Maltese: Numru MA (UE) Isem (ivvintat) Qawwa
English: Pack size
Maltese: Anness A
English: Member state
Maltese: Coli
English: Hungary Symbiopharm Gmbh
Maltese: Il-Ġermanja Symbiopharm Gmbh
English: Symbioflor E. Coli
Maltese: Symbioflor E.
English: Active substance + Strength
Maltese: Sustanza attiva + Qawwa
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 February 2017 EMA/141732/2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 ta' Frar 2017 EMA/141732/2017
English: More information on these medicines can be found on EMA's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar tagħrif dwar dawn il-mediċini jinstab fuq is-sit elettroniku tal-EMA: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: (sofosbuvir) and Viekirax (ombitasvir / paritaprevir / ritonavir).
Maltese: (dasabuvir), Harvoni (sofosbuvir / ledipasvir), Olysio (simeprevir), Sovaldi (sofosbuvir) and Viekirax (ombitasvir / paritaprevir / ritonavir).
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 23/2/2017.
Maltese: L-opinjoni tas-CHMP tressqet quddiem il-Kummissjoni Ewropea, li ħarġet deċiżjoni legalment vinkolanti applikabbli fl-Istati Membri kollha tal-UE fit-23/2/2017.
English: • Direct-acting antiviral medicines (including Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) are effective treatments for long-term hepatitis C that can be used without interferons (medicines known to have troublesome side effects).
Maltese: • Mediċini antivirali b'azzjoni diretta (inkluż Daklinza, Exviera, Harvoni, Olysio, Sovaldi u Viekirax) huma kuri effettivi għal epatite Ċ fit-tul li jistgħu jintużaw mingħajr interferoni (mediċini magħrufa li għandhom effetti sekondarji li jistgħu jikkawżaw il-problemi).
English: On 15 December 2016, the European Medicines Agency (EMA) confirmed its recommendation to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines.
Maltese: Fil-15 ta' Diċembru 2016, l-Aġenzija Ewropea għall-Mediċini (l-EMA), ikkonfermat ir-rakkomandazzjoni tagħha li jiġu skrinjati l-pazjenti kollha għall-epatite B qabel jibdew kura b'antivirali b'azzjoni diretta għall-epatite Ċ; il-pazjenti infettati b'kemm il-virus tal-epatite B kif ukoll tal-epatite Ċ għandhom jiġu mmonitorjati u mmaniġġjati skont il-linji gwida kliniċi attwali.
English: The review of direct-acting antivirals was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Ir-reviżjoni tal-antivirali b'azzjoni diretta twettqet mill-Kumitat dwar il-Valutazzjoni tar-Riskji talFarmakoviġilanza (il-PRAC).
English: The review of direct-acting antivirals for the treatment of hepatitis C was initiated on 17 March 2016 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni tal-antivirali b'azzjoni diretta għall-kura tal-epatite Ċ inbdiet fis-17 ta' Marzu 2016 fuq talba mill-Kummissjoni Ewropea, skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004.
English: Direct-acting antivirals (marketed in the EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 are important medicines for treating chronic (long term) hepatitis C, a disease of the liver caused by hepatitis C virus.
Maltese: L-antivirali b'azzjoni diretta (li huma mqiegħda fis-suq fl-UE bħala Daklinza, Exviera, Harvoni, Olysio, Sovaldi u Viekirax)1 huma mediċini importanti għall-kura tal-epatite Ċ kronika (fit-tul), marda tal-fwied ikkawżata mill-virus tal-epatite Ċ.
English: On 14 April 2016 the scope of the review was extended to include the risk of liver cancer, in addition to the potential risk of hepatitis B re-activation.
Maltese: Fl14 ta' April 2016, il-kamp ta' applikazzjoni tar-reviżjoni ġie estiż biex jinkludi r-riskju tal-kanċer talfwied, barra mir-riskju potenzjali għar-riattivazzjoni tal-epatite B.
English: 1 Since the start of this review, two other direct-acting antivirals, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir), have been authorised in the EU.
Maltese: 1 Sa mill-bidu ta' din ir-reviżjoni, żewġ antivirali b'azzjoni diretta oħrajn, Epclusa (sofosbuvir / velpatasvir) u Zepatier (elbasvir / grazoprevir), ġew awtorizzati fl-UE.
English: The PRAC recommendation to include a warning in the prescribing information about hepatitis B reactivation and how to minimise it was endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP).
Maltese: Ir-rakkomandazzjoni tal-PRAC biex tiġi inkluża twissija fl-informazzjoni tal-preskrizzjoni dwar irriattivazzjoni tal-epatite B u dwar kif din tiġi mminimizzata ġiet approvata mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-EMA.
English: Since the start of this review, two other direct-acting antivirals, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir), have been authorised in the EU.
Maltese: Sa mill-bidu ta' din ir-reviżjoni, żewġ antivirali b'azzjoni diretta oħrajn, Epclusa (sofosbuvir / velpatasvir) u Zepatier (elbasvir / grazoprevir), ġew awtorizzati fl-UE.
English: It looked into cases2 of returning signs and symptoms of previously inactive hepatitis B infection (re-activation) when patients were treated with direct-acting antivirals for hepatitis C.
Maltese: Dan ta ħarsa lejn il-każijiet2 ta' sinjali u sintomi li rritornaw ta' infezzjoni (riattivazzjoni) tal-epatite B inattiva preċedenti meta l-pazjenti ġew ikkurati b'antivirali b'azzjoni diretta għall-epatite Ċ.
English: • Cases of hepatitis B re-activation (with severe consequences) have been reported in patients coinfected with hepatitis B and C viruses treated with direct-acting antivirals.
Maltese: • Ġew irrappurtati każijiet ta' riattivazzjoni tal-epatite B (b'konsegwenzi severi) f'pazjenti koinfettati bil-virusijiet tal-epatite B u tal-epatite Ċ ikkurati b'antivirali b'azzjoni diretta.
English: The hepatitis B re-activation is thought to be the consequence of the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of activity of direct-acting antivirals against hepatitis B virus.
Maltese: Hu maħsub li r-riattivazzjoni tal-epatite B hija l-konsegwenza tat-tnaqqis mgħaġġel indott minn kura fil-virus tal-epatite Ċ (peress li hu magħruf li koinfezzjoni trażżan l-virus tal-epatite B) u n-nuqqas ta' attività tal-antivirali b'azzjoni diretta kontra l-virus tal-epatite B.
English: • Hepatitis B re-activation is thought to be caused by the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of antihepatitis B activity of direct-acting antivirals.
Maltese: • Huwa maħsub li r-riattivazzjoni tal-epatite B hija kkawżata minn tnaqqis mgħaġġel indott minn kura fil-virus tal-epatite Ċ (peress li hu magħruf li koinfezzjoni trażżan l-virus tal-epatite B) u nnuqqas ta' attività tal-antivirali b'azzjoni diretta kontra l-virus tal-epatite B.
English: The frequency of such re-activation appears to be low.
Maltese: Il-frekwenza ta' tali riattivazzjoni tidher li hi baxxa.
English: • If you also have hepatitis B virus infection, direct-acting antivirals for hepatitis C may cause the hepatitis B infection to become active again.
Maltese: • Jekk għandek ukoll infezzjoni tal-virus tal-epatite B, l-antivirali b'azzjoni diretta għall-epatite Ċ jistgħu jwasslu biex l-infezzjoni tal-epatite B terġa' ssir attiva.
English: You may also receive treatment for hepatitis B.
Maltese: Int tista' tirċievi wkoll kura għall-epatite B.
English: Re-activation of hepatitis B may cause serious liver problems.
Maltese: Ir-riattivazzjoni tal-epatite B tista' tikkawża problemi serji fil-fwied.
English: In this context, further research is also needed on the risk of new liver cancers in patients with chronic hepatitis C and cirrhosis (liver scarring) that are treated with directacting antivirals.
Maltese: riskju ta' kanċers tal-fwied ġodda f'pazjenti b'epatite Ċ kronika u b'ċirrożi (ċikatriċi fil-fwied) li jiġu kkurati b'antivirali b'azzjoni diretta.
English: The CHMP's opinion was passed to the European Commission, which issued a legally binding decision valid throughout the EU.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni legalment vinkolanti valida madwar l-UE kollha.
English: In addition to data on hepatitis B re-activation, EMA also reviewed data suggesting that patients treated with direct-acting antivirals who have previously been treated for liver cancer could be at risk of their cancer returning early.
Maltese: Barra mid-data dwar ir-riattivazzjoni tal-epatite B, l-EMA rrevediet ukoll data li tissuġġerixxi li lpazjenti kkurati b'antivirali b'azzjoni diretta li qabel ġew ikkurati għall-kanċer tal-fwied jistgħu jkunu f'riskju li l-kanċer jirritorna kmieni.
English: Companies marketing these medicines have been asked to perform a prospective study to assess the risk of recurrence of previously treated hepatocellular carcinoma, and a prospective cohort study in patients with cirrhosis to assess the incidence and type of de novo hepatocellular carcinoma.
Maltese: Il-kumpaniji li jqiegħdu dawn il-mediċini fis-suq intalbu jwettqu studju prospettiv biex jiġi vvalutat ir-riskju ta' rikorrenza ta' karċinoma epatoċellulari kkurata preċedentament, u studju koorti prospettiv f'pazjenti b'ċirrożi biex jiġu vvalutati l-inċidenza u t-tip ta' karċinoma epatoċellulari de novo.
English: 31 March 2016 EMA/174254/2016
Maltese: EMA/174254/2016
English: More information on Exjade, including its indications in full, can be found on the Agency's website: ema.europa.eu/Findmedicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Findmedicine/Human medicines/European public assessment reports.
English: Excipient: lactose
Maltese: Eċċipjent: lattożju
English: Oval, blue tablets containing 90 mg (light blue), 180 mg (medium blue) and 360 mg (dark blue)
Maltese: Pilloli ovali, blu li fihom 90 mg (blu ċar), 180 mg (blu medju) u 360 mg (blu skur)
English: Dispersible tablets (to be discontinued)
Maltese: Pilloli li jinħallu (li sejrin jitwaqqfu)
English: Film-coated tablets containing 90, 180 and 360 mg are equivalent to dispersible tablets containing 125, 250 and 500 mg, respectively.
Maltese: Il-pilloli miksijin b'rita li fihom 90, 180 u 360 mg huma ekwivalenti għall-pilloli li jinħallu li fihom 125, 250 u 500 mg, rispettivament.
English: Educational material to raise awareness of dose variation between different types of tablets
Maltese: Materjal edukattiv għas-sensibilizzazzjoni dwar il-varjazzjoni tad-doża bejn it-tipi differenti ta' pilloli
English: Round, white tablets containing 125 mg, 250 mg and 500 mg (all white)
Maltese: Pilloli tondi, bojod li fihom 125 mg, 250 mg u 500 mg (kollha bojod)
English: Contains lactose
Maltese: Fih lattożju
English: Exjade contains the active substance deferasirox which is an ‘iron chelator'.
Maltese: Exjade fih is-sustanza attiva deferasirox li hija ‘kelatur tal-ħadid'.
English: Swallowed whole with some water or crushed and sprinkled on soft food (e.g. yogurt or apple sauce)
Maltese: Jinbelgħu sħaħ bi ftit ilma jew imfarrka u mferrxa fuq ikel artab (eż. jogurt jew zalza tat-tuffieħ)
English: • Exjade (deferasirox) is now available as film-coated tablets in addition to the already authorised dispersible tablets.
Maltese: • Exjade (deferasirox) issa huwa disponibbli bħala pilloli miksijin b'rita flimkien mal-pilloli li jinħallu diġà awtorizzati.
English: • The following table describes the differences between the two formulations: Film-coated tablets
Maltese: • It-tabella li ġejja tiddeskrivi d-differenzi bejn iż-żewġ formulazzjonijiet: Pilloli miksijin b'rita
English: • To avoid errors, prescriptions for Exjade must specify the type of formulation (dispersible tablets or film-coated tablets), the prescribed dose in mg/kg/day, and the calculated dose per day with the strength of film-coated or dispersible tablets.
Maltese: • Sabiex jiġu evitati l-iżbalji, ir-riċetti tat-tabib ta' Exjade għandhom jispeċifikaw it-tip ta' formulazzjoni (pilloli li jinħallu jew pilloli miksijin b'rita), id-doża mogħtija b'riċetta f'mg/kg/jum, u d-doża kkalkolata għal kull jum bil-qawwa tal-pilloli miksijin b'rita jew li jinħallu.