FrancophonIA/ELRC3.0 huggingface dataset:
English: Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine and alanine aminotransferase levels.
Maltese: Kien hemm bosta każi aċċidentali rapportati ta' doża eċċessiva b'tacrolimus; is-sintomi kienu jinkludu rogħda, uġigħ ta' ras, dardir u rifjut, infezzjonijiet, urtikarja, letarġija u żiediet fl-urea nitroġena tad-demm, kreatinina fis-serum u fil-livelli ta' alanine aminotransferase.
English: Each capsule contains 0.5 mg tacrolimus (as monohydrate).
Maltese: Kull kapsula fiha 0.5 mg ta' tacrolimus (bħala monoidrat)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 0.5 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Maltese: Ż-ŻGĦAR EWLENIN QARTAS TAL-ALUMINJU Advagraf 0.5 mg kapsuli ibsin li jerћu l-mediċina bil-mod (30, 50, 100 f'Qartas tal-Aluminju)
English: arthralgia, back pain, muscle spasms, pain in extremity uncommon:
Maltese: artralgija, uġigħ fid-dahar,spażmi muskolari, uġigħ fl-estremità mhux komuni:
English: PC: SN: NN:
Maltese: SN: { numru } [in-numru tas-serje]
English: PC: SN:
Maltese: {numru} [Kodiċi tal-prodott] SN:
English: Conversion of Prograf-treated patients to Advagraf Allograft transplant patients maintained on twice daily Prograf capsules dosing requiring conversion to once daily Advagraf should be converted on a 1:1 (mg:mg) total daily dose basis.
Maltese: Pazjenti kkurati b'Prograf li jaqilbu għal Advagraf Pazjenti bi trapjant allograft li kienu fuq doża ta' kapsuli Prograf darbtejn kuljum u jkollhom bżonn jaqilbu għal Advagraf darba kuljum għandhom jibdew b'doża totali ta' 1:1 (mg:mg) kuljum.
English: Herbal preparations containing St. John's Wort (Hypericum perforatum) or other herbal preparations should be avoided when taking Advagraf due to the risk of interactions that lead to either a decrease in blood concentrations of tacrolimus and reduced clinical effect of tacrolimus, or an increase in blood concentrations of tacrolimus and risk of tacrolimus toxicity (see section 4.5).
Maltese: Ma għandhomx jittieħdu preparazzjonijiet ta' ħxejjex li jkollhom il-fexfiex (Hypericum perforatum) jew mediċini ta hxejjex oħra meta jkun qed jittieħed Advagraf minħabba xi riskju ta' interazzjonijiet li jistgħu jwasslu jew għat-tnaqqis kemm fil-konċentrazzjoni fid-demm kif ukoll fl-effett terapewtiku ta' tacrolimus, jew żieda fil-livell ta tracolimus fid-demm u riskju ta tossiċità ta tacromilus (ara sezzjoni 4.5).
English: Pack sizes: 30, 50, 60 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1, 60×1 and 100×1 prolonged-release hard capsule in unit-dose perforated blisters.
Maltese: Issib ukoll ilkapsuli ibsin li jerћu l-mediċina bil-mod f'pakketti ta' 30, 50, 60 u 100 jew 30×1, 50×1, 60×1 u 100×1 kapsula li terħi l mediċina bil-mod mifrudin minn xulxin fuq l-istess folja.
English: In case of in utero exposure, monitoring of the newborn for the potential adverse events of tacrolimus is recommended (in particular effects on the kidneys).
Maltese: F'każ ta' espożizzjoni in utero, monitoraġġ tattarbija mwielda għal xi effetti avversi potenzjali ta' tacrolimus huwa rakkomandat (speċjalment effetti fuq il-kliewi ).
English: Reduced blood flow in the heart vessels, faster heartbeat - Bleeding, partial or complete blocking of blood vessels, reduced blood pressure - Shortness in breath, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms Stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting, abdominal pain, indigestion, constipation, passing wind, bloating, loose stools - Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver
Maltese: - Bidla fl-għoqiedi tad-demm, tnaqqis fin-numru tat-tipi kollha ta'ċelluli tad-demm (li jidhru f'testijiet tad-demm) - Deidrazzjoni (nixfa), ma tistax tgħaddi l-awrina - Riżultati tad-demm li mhumiex normali: tnaqqis ta' proteini jew zokkor, żieda fl-enzima lactate dehydrogenase - Kôma, emorraġija fil-moħħ, attakk, paraliżi, disturbi fil-moħħ, anormalitajiet fil-kliem u fil lingwa, problemi ta' memorja - Lenti tal-għajn mżellġa/mhux ċara, smigħ mhux ċar - Taħbit irregolari tal-qalb, waqfien tat-taħbit tal-qalb, tnaqqis fil-ħidma tal-qalb, taqlib fil muskolu tal-qalb, nefha tal-muskolu tal-qalb, taħbit aktar qawwi tal-qalb, ECG anormali, taħbit anormali tal-qalb u tal-polz - Għoqda demm f'vina ta' id jew ta' sieq, xokk - Diffikultajiet fin-nifs, taqlib fil-kanal respiratorju, ażma - Ostruzzjoni fil-musrana, żieda fil-livell tad-demm tal-enzima amylase, titligħ tal-kontenut tal istonku fil-grieżem, dewmien tat-tbattil tal-istonku - Infjammazzjoni tal-ġilda, sensazzjoni ta' ћruq fix-xemx - Problemi tal-ġogi - Menstruazzjoni bl-uġigħ u tneħħija anormali ta' demm
English: In the early years the initial oral dose of tacrolimus was 0.3 mg/kg/day.
Maltese: Fl-ewwel snin, id-doża orali ta' tacrolimus nbdiet bi 0.3 mg/kg/kuljum.
English: In patients unable to take oral medicinal products during the immediate post-transplant period, tacrolimus therapy can be initiated intravenously (see Summary of Product Characteristics for Prograf 5 mg/ml concentrate for solution for infusion) at a dose approximately 1/5th of the recommended oral dose for the corresponding indication.
Maltese: F'pazjenti li, fiż-żmien immedjat wara t-trapjant, ma jkunux jistgħu jieħdu prodotti mediċinali minn ħalqhom, tista' tinbdielhom il-kura b'tacrolimus mill-vina (ara s-Sommarju tal-Karatteristiċi talProdott għal Prograf 5mg/ml konċentrat gћal soluzzjoni għall-infużjoni) f'doża ta' bejn wieħed u ieħor 1/5 (wieħed minn ħamsa) tad-doża rakkomandata biex tingħata mill-ħalq għal dik l-indikazzjoni partikolari.
English: In healthy subjects, the mean half-life in whole blood is approximately 43 hours.
Maltese: F'individwi b'saħħithom, il-medja tal-half life ħajja fiddemm sħiħ hi bejn wieħed u ieħor ta' 43 siegħa.
English: Advagraf 0.5 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1 and 100×1 prolonged-release hard capsule in unit-dose perforated blisters.
Maltese: Advagraf 0.5 mg kapsuli ibsin li jerћu l-mediċina bil-mod Pakketti ta': 30, 50 u 100 kapsula li jerћu l-mediċina bil-mod f'folji jew 30×1, 50×1 u 100×1 kapsula li terħi il mediċina bil-mod mifrudin minn xulxin fuq l-istess folja.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 5 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Maltese: Ż-ŻGĦAR EWLENIN QARTAS TAL-ALUMINJU Advagraf 5 mg kapsuli ibsin li jerћu l-mediċina bil-mod (30, 50, 100 f'Qartas tal-Aluminju)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 3 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Maltese: Ż-ŻGĦAR EWLENIN QARTAS TAL-ALUMINJU Advagraf 3 mg kapsuli ibsin li jerћu l-mediċina bil-mod (30, 50, 100 f'Qartas tal-Aluminju)
English: A variety of innovations, such as techniques for early detection of Epstein-Barr (EBV) and CMV infections, bone marrow augmentation, the adjunct use of the interleukin-2 antagonist daclizumab, lower initial tacrolimus doses with target trough levels of 10 to 15 ng/ml, and most recently allograft irradiation were considered to have contributed to improved results in this indication over time.
Maltese: Kien hemm varjetà ta' innovazzjonijiet, bħalma hi t-teknika li tinduna kmieni bl-infezzjonijiet Epstein-Barr (EBV) u CMV, żieda fil-mudullun tal-għadam, iż-żieda fl-użu tal-antagonist interleukin-2 daclizumab flistess waqt, dożi aktar baxxi fil-bidu ta' tacrolimus biex jintlaħqu l-livelli minimi ta' 10 sa 15 ng/ml, u aktar reċenti l-irradjazzjoni tal-hallograft li nħass li għenet biex ikun hemm riżultati aħjar f'din indikazzjoni aktar ma jgħaddi ż-żmien.
English: Advagraf 5 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1 and 100×1 prolonged-release hard capsules in unit-dose perforated blisters.
Maltese: Advagraf 5 mg kapsuli ibsin li jerћu l-mediċina bil-mod Pakketti ta': 30, 50 u 100 kapsula li jerћu l-mediċina bil-mod f'folji jew 30×1, 50×1 u 100×1 kapsula li terħi il mediċina bil-mod mifrudin minn xulxin fuq l-istess folja.
English: It is strongly recommended to closely monitor tacrolimus blood levels, as well as, QT prolongation (with ECG), renal function and other side effects, whenever substances which have the potential to alter CYP3A4 metabolism or otherwise influence tacrolimus blood levels are used concomitantly, and to interrupt or adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4).
Maltese: Huwa ferm irrakkomandat li jkunu ċċekkjati l-livelli ta' tacrolimus fid-demm mill-viċin kif ukoll QT imtawwal (bl-ECG), il-funzjoni renali u effetti sekondarji oħra, kull meta tacrolimus jintuża flimkien ma' sustanzi li jista' jkollhom il-potenzjal li jibdlu l-metaboliżmu ta' CYP3A4, jew jaffettwaw illivelli ta' tacrolimus fid-demm, u biex jinterrompu jew jaġġustaw id-doża ta' tacrolimus sewwa ħalli tinżamm l-espożizzjoni ta' tacrolimus simili (ara sezzjonijiet 4.2 u 4.4).
English: Advagraf 5 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 5 mg tacrolimus (as monohydrate).
Maltese: Advagraf 5 mg kapsuli ibsin li jerћu l-mediċina bil-mod Kull kapsula iebsa li terћi l-mediċina bil-mod fiha 5 mg tacrolimus (bћala monoidrat).
English: Embryofoetal toxicity was observed in rats and rabbits and was limited to doses that caused significant toxicity in maternal animals.
Maltese: Tossiċità embrijofetali ġiet osservata fil-firien u fil-fniek u kienet limitata għal dożi li kkaġunaw tossiċità sinifikanti f'annimali materni.
English: dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia Psychiatric disorders very common:
Maltese: deidrazzjoni, ipogliċemija, ipoprotenemija, iperfosfatemija
English: Advagraf 3 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1 and 100×1 prolonged-release hard capsules in unit-dose perforated blisters.
Maltese: Advagraf 3 mg kapsuli ibsin li jerћu l-mediċina bil-mod Pakketti ta': 30, 50 u 100 kapsula li jerћu l-mediċina bil-mod f'folji jew 30×1, 50×1 u 100×1 kapsula li terħi il mediċina bil-mod mifrudin minn xulxin fuq l-istess folja.
English: anaemia, thrombocytopenia, leukopenia, red blood cell analyses abnormal, leukocytosis uncommon:
Maltese: anemija, tromboċitopenija, lewkopenija, analiżi anormali taċ-ċelluli ħomor taddemm, lewkoċitożi mhux komuni:
English: In clinical practice, whole blood trough levels have generally been in the range 5 - 20 ng/ml in liver transplant recipients and 10 - 20 ng/ml in kidney and heart transplant patients in the early post-transplant period.
Maltese: Fil-prattika klinika, il-livelli minimi fiddemm sħiħ kienu ġeneralment fil-medda ta' bejn il-5 u l-20 ng/ml f'dawk li rċevew trapjant tal-fwied u bejn l-10 u l-20 ng/ml f'dawk li rċevew trapjant tal-kliewi u tal-qalb kmieni fl-ewwel żmien wara li jkun sar it-trapjant.
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8).
Maltese: Pazjenti gћandhom jinżammu fuq formulazzjoni waћda ta' tacrolimus bid-doża korrispondenti ta' kuljum; tibdil fil-formulazzjoni jew fid-dożaġġ irid iseћћ biss taћt superviżjoni millqrib tal-ispeċjalista tat-trapjanti (ara sezzjonijiet 4.4 u 4.8).
English: The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects).
Maltese: Il-qagħda fissa tal-volum tad-distribuzzjoni mibnija fuq ilkonċentrazzjonijiet tal-plażma hija bejn wieħed u ieħor ta' 1300 l (soġgetti b'saħħithom).
English: Tel: +386 (0) 14011 400
Maltese: Astellas Pharma d.o.o. Tel: +386 (0) 1-4011 400
English: Simeticone
Maltese: Shellac
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: ischaemic coronary artery disorders, tachycardia uncommon:
Maltese: - Is-sustanzi mhux attivi l-oħra huma:
English: Each capsule contains 3 mg tacrolimus (as monohydrate).
Maltese: Kull kapsula fiha 3mg ta' tacrolimus (bħala monoidrat)
English: Caution should be exercised when switching combination therapy from ciclosporin, which interferes with enterohepatic recirculation of mycophenolic acid, to tacrolimus, which is devoid of this effect, as this might result in changes of mycophenolic acid exposure.
Maltese: Il-monitoraġġ terapewtiku tal-mediċina ta' mycophenolic acid jista' jkun xieraq meta taqleb minn ciclosporin għal tacrolimus jew bil-maqlub.
English: EU/1/07/387/007 30 capsules EU/1/07/387/008 50 capsules EU/1/07/387/010 100 capsules EU/1/07/387/024 30×1 capsules EU/1/07/387/025 50×1 capsules EU/1/07/387/026 100×1 capsules
Maltese: EU/1/07/387/007 30 kapsula EU/1/07/387/008 50 kapsula EU/1/07/387/010 100 kapsula EU/1/07/387/024
English: Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with tacrolimus.
Maltese: Disturbi fl-għajnejn, li kultant iwasslu għal telf tal-vista, ġew irrappurtati f'pazjenti ttrattati b'tacrolimus.
English: Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.
Maltese: Wara li jsir tibdil gћal xi formulazzjoni alternattiva, irid isir monitoraġġ terapewtiku tal-mediċina u d-doża trid tiġi rranġata b'mod li jiġi żgurat li l-espożizzjoni sistemika gћal tacrolimus qed tinżamm.
English: EMA/300585/2012 EMEA/H/C/002622
Maltese: EMA/CHMP/158913/2012 EMEA/H/C/002622
English: The full EPAR for Riluzole Zentiva 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: It is available as tablets (50 mg).
Maltese: Jiġi f'pilloli (50 mg).
English: The active substance in Riluzole Zentiva, riluzole, acts on the nervous system.
Maltese: Is-sustanza attiva f'Riluzole Zentiva, ir-rilużolu, taġixxi fuq is-sistema nervuża.
English: EPAR summary for the public riluzole
Maltese: Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the European Union for Riluzole Zentiva on 7 May 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq ikkondizzjonata valida fl-Unjoni Ewropea kollha lil Riluzole Zentiva fis-7 ta' Mejju 2012.
English: They noted that there is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms, and that it has not been shown to be effective in the late stages of ALS.
Maltese: Innota li m'hemmx evidenza li Riluzole Zentiva jeżerċita effett terapewtiku fuq il-funzjoni motorja, il-funzjoni tal-pulmun, il-faxxikulazzjonijiet, is-saħħa muskolari u s-sintomi motorji u li ma ntweriex li hu effikaċi fl-aħħar stadji ta' ALS.
English: This is a summary of the European public assessment report (EPAR) for Riluzole Zentiva.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Riluzole Zentiva.
English: Riluzole Zentiva is used in patients with amyotrophic lateral sclerosis (ALS).
Maltese: Riluzole Zentiva jintuża fuq pazjenti bi sklerożi laterali amijotrofika (amyotrophic lateral sclerosisALS).
English: Other information about Riluzole Zentiva
Maltese: Informazzjoni oħra dwar Riluzole Zentiva
English: Across the studies, Riluzole Zentiva was given as 50, 100 or 200 mg per day, and for up to 18 months.
Maltese: F'kull studju Riluzole Zentiva ngħata f'50, 100 jew 200 mg kuljum sa 18-il xahar.
English: In adult and elderly patients, it is given as 100 mg a day (50 mg every 12 hours).
Maltese: F'adulti u pazjenti anzjani, dan jingħata b'100 mg kuljum (50 mg kull 12-il siegħa).
English: The effectiveness of Riluzole Zentiva has been compared with that of placebo (a dummy treatment) in three studies involving a total of 1,282 patients.
Maltese: L-effikaċja ta' Riluzole Zentiva tqabblet ma' dik ta' plaċebo (trattament finta) fi tliet studji fuq total ta' 1,282 pazjent.
English: Riluzole Zentiva 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day.
Maltese: Riluzole Zentiva 50 mg/kuljum ma kienx aktar effikaċi mill-plaċebo, u l-għoti ta' 200 mg/kuljum ma kienx aktar effikaċi minn 100 mg/kuljum.
English: The most common side effects seen with Riluzole Zentiva (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests (increased in liver enzymes levels).
Maltese: L-aktar effetti sekondarji komuni li dehru bl-użu ta' Riluzole Zentiva (f'aktar minn pazjent 1 f'10) huma dardir (tħossok ma tiflaħx), astenja (debbulizza) u test tal-fwied anormali (żieda fil-livelli ta' enzimi talfwied).
English: Riluzole Zentiva is a medicine containing the active substance riluzole.
Maltese: Riluzole Zentiva huwa mediċina li fiha s-sustanza attiva rilużolu.
English: What is Riluzole Zentiva?
Maltese: Għal xiex jintuża Riluzole Zentiva?
English: Why has Riluzole Zentiva been approved?
Maltese: Għaliex ġie approvat Riluzole Zentiva?
English: The CHMP decided that Riluzole Zentiva's benefits are greater than its risks to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Riluzole Zentiva huma akbar mir-riskji tiegħu fit-titwil tal-ħajja jew taż-żmien qabel ikun meħtieġ tintuża l-ventilazzjoni mekkanika għal pazjenti bi sklerożi amijotrofika laterali.
English: The company that makes Rilutek has agreed that its scientific data can be used for Riluzole Zentiva (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Rilutek qablet li d-dejta xjentifika tagħha tista' tintuża għal Riluzole Zentiva (‘kunsens infurmat').
English: ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
Maltese: L-ALS hija tip ta' marda tan-newroni motorji, meta attakki fuq iċ-ċelloli tan-nervituri responsabbli mill-bgħit tal-messaġġi lill-muskoli jikkaġunaw dgħjufija, tpaħpiħ muskolari u paraliżi.
English: How has Riluzole Zentiva been studied?
Maltese: Kif jintuża Riluzole Zentiva?
English: For the full list of all side effects reported with Riluzole Zentiva, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati bl-użu ta' Riluzole Zentiva, ara l-fuljett ta' tagħrif.
English: It is thought that the destruction of nerve cells in motor neurone disease may be caused by too much glutamate, a neurotransmitter (chemical messenger).
Maltese: Hemm l-ipoteżi li l-qerda ta' ċelloli fil-mard tan-newroni motorji tista' tiġi kkawżata minn aktar glutammina, newrotrasmettitur (messaġġier kimiku), milli meħtieġ.
English: This medicine is the same as Rilutek, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Rilutek, li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: What is the risk associated with Riluzole Zentiva?
Maltese: X'inhu r-riskju assoċjat ma' Riluzole Zentiva?
English: 19 May 2011
Maltese: 19 ta' Mejju 2011
English: What is Arimidex?
Maltese: X'inhu Arimidex?
English: Arimidex is a medicine that contains the active substance anastrozole.
Maltese: Arimidex huwa mediċina li fiha s-sustanza attiva anastrozole.
English: Questions and answers on Arimidex (anastrozole, 1 mg tablets) EMA/405019/2011
Maltese: Mistoqsijiet u tweġibiet dwar Arimidex (anastrozole, pilloli 1 mg) EMA/211634/2011
English: Arimidex was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Ġiet identifikata l-ħtieġa li Arimidex ikun armonizzat mill-Grupp ta' Koordinazzjoni għal Proċeduri Reċiproċi u Deċentralizzati - Umani (CMD(h)).
English: Questions and answers on Arimidex (anastrozole, 1 mg tablets)
Maltese: Mistoqsijiet u tweġibiet dwar Arimidex (anastrozole, pilloli 1 mg)
English: The Committee also harmonised other sections of the SmPC, including the Special Warnings, which state that tamoxifen and oestrogen-containing therapies should not be given with Arimidex and that Arimidex should be used with caution in patients with severe kidney problems or moderate to severe liver problems.
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħrajn tal-SmPC, inkluż Twissijiet Speċjali, li jiddikjaraw li kuri li fihom it-tamoxifen u l-estroġenu ma għandhomx jingħataw ma' Arimidex u li Arimidex għandu jintuża b'attenzjoni f'pazjenti li jkollhom problemi serji fil-kliewi jew problemi fil-fwied moderati għal severi.
English: The recommended dose for adults, including elderly patients, is one 1 mg tablet once a day.
Maltese: Id-doża rakkomandata għall-adulti, inkluż pazjenti anzjani, hija pillola ta' 1 mg darba kuljum.
English: The European Medicines Agency has completed a review of Arimidex.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Arimidex.
English: On 22 July 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Arimidex in the EU.
Maltese: Fit-22 ta' Lulju 2010, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP biex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Arimidex fl-UE.
English: • Patients known to be hypersensitive (allergic) to the active substance anastrozole, or to any of the other ingredients.
Maltese: • Ikun magħruf li għandhom sensittività eċċessiva (allerġiċi) għas-sustanza attiva anastrozole, jew għal kwalunkwe sustanza oħra tiegħu.
English: Why was Arimidex reviewed?
Maltese: Għaliex ġie rivedut Arimidex?
English: • Adjuvant (add-on) treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women, including those who have received two to three years of adjuvant tamoxifen (another anti-cancer medicine).
Maltese: • Kura ta' kanċer tas-sider avvanzat b'riċettur tal-ormoni pożittiv f'nisa li jkunu għaddew mill menopawża. ‘Riċettur tal-ormoni pożittiv' tfisser li l-kanċer biex jikber jiddependi mill-preżenza tal estroġenu.
English: The medicine is available in all Member States of the European Union as well as Iceland and Norway.
Maltese: Il-mediċina hija disponibbli fl-Istati Membri kollha tal-Unjoni Ewropea kif ukoll fl-Islanda u fin-Norveġja.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tad-dejta sottomessa u d-diskussjoni xjentifika li saret fil-Kumitat, kien tal-opinjoni li l-SmPCs, tikketta u fuljett ta' tagħrif għandhom jiġu armonizzati fl-UE kollha.
English: Arimidex belongs to a group of medicines called ‘aromatase inhibitors' which reduce the amount of the hormone oestrogen made in the body by blocking the action of an enzyme in the body called ‘aromatase'.
Maltese: Arimidex jagħmel parti minn grupp ta' mediċini msejħa ‘inibituri tal-aromatase' li jnaqqsu l-ammont tal-ormon estroġenu magħmul fil-ġisem billi jimblokka lazzjoni ta' enzima fil-ġisem imsejħa ‘aromatase'.