FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death.
Maltese: F'pazjenti b'insuffiċjenza severa tal-qalb li jkollhom funzjoni renali li tiddependi mill-attività tas-sistema renin-anġjotensin-aldosteron, kura b' inibituri ta' ACE u antagonisti tar-riċettur ta' anġjotensin kienet assoċjata ma' oligurja u/jew ażotemja li tavvanza u (rarament) insuffiċjenza akuta renali u/jew mewt.
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Dafiro HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Dafiro HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 10 mg amlodipine (bħala amlodipine besylate), 160 mg valsartan u 25 mg hydrochlorthiazide.
English: 14 film-coated tablets.
Maltese: 14-il pillola miksija b'rita.
English: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 5 mg amlodipine (bħala amlodipine besylate), 160 mg valsartan u 12.5 mg hydrochlorthiazide.
English: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 5 mg amlodipine (bħala amlodipine besylate), 160 mg valsartan u 25 mg hydrochlorthiazide.
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Maltese: Dafiro HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita huma pilloli sofor ċari, ovali b'“NVR” fuq naħa waħda u b'“VDL” fuq in-naħa l-oħra.
English: Elderly people (age 65 years and older)
Maltese: Pazjenti anzjani (età 65 sena jew aktar)
English: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Maltese: Il-volum ta' distribuzzjoni ta' valsartan fi stat fiss wara li jingħata ġol-vina huwa ta' madwar 17-il litru, li jindika li valsartan ma jinfirixx b'mod estensiv fit-tessuti.
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, yellow iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon (tip A); silica, colloidal anhydrous, stearat tal-manjesju, ipromelloża (sostituzzjoni tip 2910.3 mPa.s), makrogol 4000, talc, ossidu talħadid isfar (E172).
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon (tip A); silica, colloidal anhydrous, stearat tal-manjesju, ipromelloża (sostituzzjoni tip 2910.3 mPa.s), makrogol 4000, talc, dijossidu tattitanju (E171), ossidu tal-ħadid isfar (E172).
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Dafiro HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Dafiro HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: EU/1/09/574/032 56 x 1 film-coated tablet (unit dose) EU/1/09/574/033 98 x 1 film-coated tablet (unit dose) EU/1/09/574/034 280 x 1 film-coated tablet (unit dose)
Maltese: Dafiro HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita EU/1/09/574/049-060
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Dafiro HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Multipacks of 280 tablets, comprising 20 cartons, each containing 14 tablets.
Maltese: 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola)
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Dafiro HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Dafiro HCT individual component
Maltese: Komponent individwali ta' Dafiro HCT
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets
Maltese: Dafiro HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Dafiro HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Dafiro HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Maltese: Glukonat tal-kalċju mogħti minn ġol-vina jista' jgħin biex ireġġa' lura l-effetti tal-imblukkar tal-kanali tal-kalċju.
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets
Maltese: Dafiro HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets
Maltese: Dafiro HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita
English: If hypokalaemia develops during hydrochlorothiazide therapy, Dafiro HCT should be discontinued until stable correction of the potassium balance.
Maltese: Jekk l-ipokalimja tiżviluppa waqt it-terapija b'hydrochlorothiazide, Dafiro HCT għandu jitwaqqaf sakemm ikun hemm stabilità korretta fil-bilanċ tal-potassju.
English: Pruritus
Maltese: LOTT
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets
Maltese: Dafiro HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita
English: • ringing in the ears
Maltese: Rażi ta' skambju anjoniku
English: What Dafiro HCT looks like and contents of the pack Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Maltese: Dafiro HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita huma pilloli bojod, ovali b'“NVR” fuq naħa waħda u b'“VCL” fuq in-naħa l-oħra.
English: EU/1/09/574/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: The maximum recommended dose of Dafiro HCT is 10 mg/320 mg/25 mg.
Maltese: L-ogħla doża rrakkomandata ta' Dafiro HCT hija ta' 10 mg/320 mg/25 mg.
English: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VFL” on the other side.
Maltese: Pilloli kannella fl-isfar, b'forma ovali, konvessi fuq iż-żewġ naħat, bix-xifer tasturat, imnaqqxin b'“NVR” fuq naħa waħda u b'“VFL” fuq in-naħa l-oħra.
English: 4.9 Overdose
Maltese: .9 Doża eċċessiva Sintomi
English: EU (MA) number Invented name
Maltese: Numru tal-MA (UE)
English: Strength Pharmaceutical form
Maltese: Isem ivvintat Qawwa Għamla Farmaċewtika
English: The full EPAR and risk management plan summary for Pemetrexed Lilly 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: Pemetrexed Lilly is a ‘generic medicine'.
Maltese: Pemetrexed Lilly huwa ‘mediċina ġenerika'.
English: Pemetrexed Lilly contains the active substance pemetrexed.
Maltese: Pemetrexed Lilly fih is-sustanza attiva pemetrexed.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Maltese: Fil-ġisem, pemetrexed jinbidel f'forma attiva li timblokka l-attività tal-enzimi li huma involuti filproduzzjoni ta' ‘nukleotidi' (nucleotides - li fuqhom jinbnew DNA u RNA, il-materjal ġenetiku taċċelloli).
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Lilly.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pemetrexed Lilly.
English: Pemetrexed Lilly is a cancer medicine used to treat two types of lung cancer:
Maltese: Pemetrexed Lilly huwa mediċina kontra l-kanċer li tintuża biex tikkura żewġ tipi ta' kanċers tal-pulmun:
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Maltese: • mesoteljoma plewrika malinnja (kanċer tar-rita tal-pulmun, normalment ikkawżat minn esponiment għall-ażbestos), fejn jintuża flimkien ma' ċisplatin f'pazjenti li ma ngħatawx il-kemoterapija qabel u li l-kanċer li għandhom ma jistax jitneħħa b' intervent kirurġiku;
English: When Pemetrexed Lilly is given with cisplatin, an ‘antiemetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Maltese: Meta Pemetrexed Lilly jingħata ma' cisplatin, mediċina ‘antiemetika' (biex tipprevjeni r-remettar) u fluwidi (biex jipprevjenu ddiżidratazzjoni) għandha tingħata wkoll qabel jew wara d-doża ta' cisplatin.
English: Why is Pemetrexed Lilly approved?
Maltese: Għaliex ġie approvat Pemetrexed Lilly?
English: A risk management plan has been developed to ensure that Pemetrexed Lilly is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Pemetrexed Lilly jintuża bl-aktar mod sigur possibbli.
English: The active substance in Pemetrexed Lilly, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Pemetrexed Lilly, pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qed jiddividu ruħhom, bħaċ-ċelloli tal-kanċer) li jagħmlu parti mill-grupp tal-‘antimetaboliti'.
English: What are the benefits and risks of Pemetrexed Lilly?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pemetrexed Lilly?
English: Pemetrexed Lilly is available as a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Pemetrexed Lilly huwa disponibbli bħala trab li jsir f'soluzzjoni għal infużjoni (dripp) ġol-vina.
English: Pemetrexed Lilly pemetrexed
Maltese: Kif jintuża Pemetrexed Lilly?
English: No additional studies were needed as Pemetrexed Lilly is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Maltese: L-ebda studju addizzjonali ma kien meħtieġ minħabba li Pemetrexed Lilly huwa mediċina ġenerika li tingħata permezz ta' infużjoni u li fiha l-istess sustanza attiva bħal tal-mediċina ta' referenza, Alimta.
English: This means that Pemetrexed Lilly is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Maltese: Dan ifisser li Pemetrexed Lilly huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Alimta.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku pemetrexed
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Lilly.
Maltese: Biex jitnaqqsu l-effetti sekondarji, il-pazjenti għandhom jieħdu kortikosterojde (tip ta' mediċina li tnaqqas l-infjammazzjoni) u aċidu foliku (tip ta' vitamina), u għandhom jirċievu injezzjonijiet ta' vitamina
English: How has Pemetrexed Lilly been studied?
Maltese: Kif ġie studjat Pemetrexed Lilly?
English: It is not intended to provide practical advice on how to use Pemetrexed Lilly.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Pemetrexed Lilly.
English: The Committee recommended that Pemetrexed Lilly be approved for use in the EU.
Maltese: IlKumitat irrakkomanda li Pemetrexed Lilly ikun approvat għall-użu fl-UE.
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Maltese: Jista' jintuża wkoll bħala kura ta' manteniment f'pazjenti li ngħataw kemoterapija bbażata fuq il-platinu.
English: How is Pemetrexed Lilly used?
Maltese: Kif jaħdem Pemetrexed Lilly?
English: Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, ilfehma tas-CHMP kienet li, bħal fil-każ ta' Alimta, il-benefiċċju huwa akbar mir-riskju identifikat.
English: 4 September 2014 EMA/544268/2014
Maltese: EMA/544268/2014
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Maltese: 3660 8427 E-mail: press@ema.europa.eu
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 1 Is-CMDh huwa korp regolatorju tal-mediċini li jirrapreżenta lill-Istati Membri tal-Unjoni Ewropea (UE) 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Pavelka K, Trc T, Karpas K, Vítek P, Sedlacková M, Vlasáková V, Böhmová J, Rovenský J. The Efficacy and Safety of Diacerein in the Treatment of Painful Osteoarthritis of the Knee.
Maltese: K, Trc T, Karpas K, Vítek P, Sedlacková M, Vlasáková V, Böhmová J, Rovenský J. The Efficacy and Safety of Diacerein in the Treatment of Painful Osteoarthritis of the Knee.
English: The proportion of patients with diarrhoea in clinical trials ranged from 0% to 54.4%.
Maltese: Il-proporzjon ta' pazjenti b'dijarea fi studji kliniċi kienu jvarjaw minn 0% sa 54.4%.
English: Contact our press officers Monika Benstetter or Martin Harvey
Maltese: Ikkuntattja lill-uffiċjali tagħna tal-istampa Monika Benstetter jew Martin Harvey
English: La Revue du Praticien 1998;48:S31-S35
Maltese: S31-S35
English: The review of diacerein-containing medicines was initiated on 29 November 2012 at the request of the French medicines agency under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' mediċini li fihom diacerein inbdiet fid-29 ta' Novembru 2012 fuq talba tal-aġenzija talmediċini Franċiża skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Pelletier JP, Yaron M, Haraoui B, Cohen P, Nahir M A, Choquette D, et al. Efficacy and Safety of Diacerein in Osteoarthritis of the Knee.
Maltese: Pelletier JP, Yaron M, Haraoui B, Cohen P, Nahir M A, Choquette D, et al.
English: In November 2013, the PRAC initially recommended the suspension of the marketing authorisations for diacerein-containing medicines.
Maltese: F'Novembru 2013, il-PRAC inizjalment irrakkomanda s-suspensjoni tal-awtorizzazzjoni għattqegħid fis-suq għal mediċini li fihom diacerein.
English: Elevated serum liver enzymes and cases of symptomatic acute hepatic injury have been reported in the post-marketing phase with diacerein.
Maltese: Enzimi tal-fwied tas-serum elevati u każijiet ta' ħsara epatika akuta sintomatika ġew irrappurtati fil-fażi ta' wara t-tqegħid fis-suq b'diacerein.
English: The review of diacerein was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Ir-reviżjoni ta' diacerein twettqet mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC).
English: Singh K, Sharma R, Rai J. Diacerein as adjuvant to diclofenac sodium in osteoarthritis knee.
Maltese: Diacerein as adjuvant to diclofenac sodium in osteoarthritis knee.
English: Diacerein-containing medicines are taken by mouth and are currently authorised in the following EU Member States: Austria, Czech Republic, France, Greece, Italy, Portugal, Slovakia and Spain.
Maltese: Mediċini li fihom diacerein jittieħdu mill-ħalq u attwalment huma awtorizzati fl-Istati Membri tal-UE li ġejjin: l-Awstrija, ir-Repubblika Ċeka, Franza, il-Greċja, l-Italja, il-Portugall, is-Slovakkja u Spanja.
English: It works by blocking the actions of interleukin-1 beta, a protein involved in the inflammation and destruction of cartilage that play a role in the development of symptoms of degenerative joint diseases such as osteoarthritis.
Maltese: Jaħdem billi jimblokka l-azzjonijiet ta' interleukin-1 beta, proteina involuta fl-infjammazzjoni u d-distruzzjoni tal-qarquċa li għandha rwol fl-iżvilupp ta' sintomi ta' mard deġenerattiv tal-ġogi bħal osteoartrite.
English: On 19 March 2014, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed recommendations to restrict the use of diacerein-containing medicines in order to manage the risks of severe diarrhoea and effects on the liver.
Maltese: Fid-19 ta' Marzu 2014, il-Grupp ta' Ko-ordinazzjoni għal Rikonoxximent Reċiproku u Proċeduri Deċentralizzati - Uman (CMDh)1 approva rakkomandazzjonijiet biex jiġi ristritt l-użu ta' mediċini li fihom diacerein sabiex jiġu ġestiti r-riskji ta' dijarea severa u effetti fuq il-fwied.
English: − diacerein is not recommended in patients aged 65 years or above.
Maltese: − diacerein mhuwiex rakkomandat f'pazjenti ta' 65 sena jew aktar.
English: With regard to safety, loose stools or diarrhoea were the most frequently reported adverse events in clinical studies with diacerein at a dose of 100 mg per day.
Maltese: Fir-rigward tas-sigurtà, ippurgar maħlul jew dijarea kienu l-avvenimenti avversi l-aktar irrappurtati b'mod frekwenti fi studji kliniċi b'diacerein f'doża ta' 100 mg kuljum.
English: • If you are taking diacerein and you are 65 years or above, contact your doctor to discuss your treatment.
Maltese: • Jekk qed tieħu diacerein u għandek 65 sena jew aktar, kellem lit-tabib tiegħek biex tiddiskuti l-kura tiegħek.
English: Contact your doctor if you have symptoms of liver problems.
Maltese: Kellem lit-tabib tiegħek jekk għandek sintomi ta' problemi tal-fwied.
English: Diacerein is a slow-acting medicine of the class ‘anthraquinones' used to treat joint diseases such as osteoarthritis (swelling and pain in the joints).
Maltese: Diacerein hija mediċina li taħdem bil-mod, tal-klassi ta' ‘anthraquinones' li jintużaw fil-kura ta' mard tal-ġogi bħal osteoartrite (nefħa u uġigħ fil-ġogi).
English: • You should not take diacerein if you have or have had liver problems.
Maltese: • M'għandekx tieħu diacerein jekk għandek jew kellek problemi tal-fwied.
English: Restrictions intended to limit risks of severe diarrhoea and effects on the liver
Maltese: Restrizzjonijiet intiżi biex jillimitaw ir-riskji ta' dijarea severa u effetti fuq ilfwied
English: It is also advised that patients start treatment on half the normal dose (i.e. 50 mg daily instead of 100 mg) and should stop taking diacerein if diarrhoea occurs.
Maltese: Huwa wkoll irrakkomandat li pazjenti jibdew il-kura fuq nofs id-doża normali (jiġifieri 50 mg kuljum minflok 100 mg) u għandhom jieqfu jieħdu diacerein jekk ikollhom dijarrea.
English: The PRAC's final recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which endorsed the recommendations and adopted a position by majority vote.
Maltese: Ir-rakkomandazzjoni finali tal-PRAC intbagħtet lill-Grupp ta' Ko-ordinazzjoni għal Rikonoxximent Reċiproku u Proċeduri Deċentralizzati - Uman (CMDh), li approva r-rakkomandazzjonijiet u adotta pożizzjoni b'vot ta' maġġoranza.
English: The proportion of patients who develop drug-induced liver injury following treatment with diacerein is estimated to be 0.03%.
Maltese: Il-propozjon ta' pazjenti li jiżviluppaw ħsara fil-fwied ikkawżata mill-mediċina huwa stmat li hu 0.03%.
English: • If you have diarrhoea while taking diacerein, stop taking your medicine and contact your doctor to discuss which other treatments you can take.
Maltese: • Jekk ikollok dijarea waqt li tieħu diacerein, tibqax tieħu l-mediċina u kellem lit-tabib tiegħek biex tiddiskuti liema kuri oħrajn għandek tieħu.
English: However, following re-examination, the PRAC considered additional proposals to manage diacerein's risks and was satisfied that with new restrictions diacerein's benefits would outweigh its risks.
Maltese: Madankollu, wara eżaminazzjoni mill-ġdid, il-PRAC ikkunsidra proposti addizzjonali biex jiġu ġestiti r-riskji ta' diacerein u kien sodisfatt li birrestrizzjonijiet il-ġodda, il-benefiċċji ta' diacerein huma akbar mir-riskji tiegħu.
English: Diacerein is a medicine used to treat joint diseases such as osteoarthritis (swelling and pain in the joints).
Maltese: Diacerein huwa mediċina li tintuża fil-kura ta' mard tal-ġogi bħal osteoartrite (nefħa u uġigħ fil-ġogi).
English: (Invented)name Strength Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Pack size l t o r
Maltese: Daqs talpakkett t x
English: Invented name Strength Pharmaceutical Form
Maltese: Qawwa Għamla farmaċewtika
English: Route of administration Packaging
Maltese: Mnejn jingħata Il-pakkett
English: The full EPAR for Bortezomib Sun 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: Bortezomib Sun bortezomib
Maltese: Informazzjoni oħra dwar Bortezomib Sun
English: Bortezomib Sun is a ‘generic medicine'.
Maltese: Bortezomib Sun huwa 'mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Bortezomib Sun.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Bortezomib Sun.
English: When given into a vein, the solution is injected through a catheter (a thin sterile tube).
Maltese: Meta tingħata ġol-vina, issoluzzjoni hija injettata minn ġo katiter (tubu sterili rqiq).
English: The active substance in Bortezomib Sun, bortezomib, is a proteasome inhibitor.
Maltese: Is-sustanza attiva f'Bortezomib Sun, bortezomib, hija inibitur ta' proteasome.
English: This means that Bortezomib Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Velcade.
Maltese: Dan ifisser li Bortezomib Sun huwa simili għall-'mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Velcade.
English: Why is Bortezomib Sun approved?
Maltese: Għaliex ġie approvat Bortezomib Sun?
English: Bortezomib Sun is a cancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Maltese: Bortezomib Sun huwa mediċina kontra l-kanċer li tintuża għall-kura ta' majeloma multipla, kanċer fiddemm, fil-gruppi ta' pazjenti li ġejjin:
English: Cancer cells are more sensitive than normal cells to the effects of proteasome inhibitors like bortezomib.
Maltese: Iċ-ċelloli tal-kanċer huma aktar sensittivi minn ċelloli normali għall-effetti ta' inibituri ta' proteasome bħal bortezomib.
English: The company provided data from the published literature on bortezomib.
Maltese: Il-kumpanija pprovdiet data minn dokumentazzjoni ppubblikata dwar borteżomib.
English: For mantle cell lymphoma, Bortezomib Sun is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Maltese: Għal linfoma taċ-ċelloli mantle, Bortezomib Sun jintuża flimkien ma' ritussimab, ċiklofosfamide, dossorubiċin u predniżon.
English: Other information about Bortezomib Sun
Maltese: Kif jintuża Bortezomib Sun?