FrancophonIA/ELRC3.0 huggingface dataset:
English: In the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (sUA < 6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively.
Maltese: Fl-istudju CONFIRMS, il-proporzjon ta' pazjenti li kisbu l-fini ewlieni tal-effikaċja (sUA < 6.0 mg/dL fl-aħħar żjara) għall-pazjenti b'livell ta' urate fis-serum mal-linja bażi ta' ≥ 10 mg/dL ikkurati b'febuxostat 40 mg QD kien 27% (66/249), b'febuxostat 80 mg QD 49% (125/254) u b'allopurinol 300 mg/200 mg QD 31% (72/230), rispettivament.
English: In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03; 95% CI 0.871.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
Maltese: Fil-prova CARES ta' wara r-reġistrazzjoni (ara sezzjoni 5.1 għal karattersistiċi dettaljati tal-istudju) irrata tal-avvenimenti MACE kienet tixxiebah fil-pazjenti ttrattati b'febuxostat versus allopurinol (HR 1.03; 95% CI 0.87-1.23), iżda ġiet osservata rata aktar għolja ta' mwiet kardjovaskulari (4.3% vs. 3.2% tal-pazjenti; HR 1.34; 95% CI 1.03-1.73).
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-pakkett wara ‘EXP'.
English: 14 film-coated tablets: EU/1/18/1347/001 28 film-coated tablets: EU/1/18/1347/002 56 film-coated tablets: EU/1/18/1347/003 84 film-coated tablets: EU/1/18/1347/004
Maltese: EU/1/18/1347/001 28 pillola miksija b'rita:
English: hepatitis (up to liver failure), raising of the white-cells count in the blood (leukocytosis, with or without eosinophilia) - reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles-like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis) - nervousness - feeling thirsty - ringing in the ears - blurred vision, change in vision - hair loss - mouth ulceration - inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting - increased sweating - weight decrease, increased appetite, uncontrolled loss of appetite (anorexia) - muscle and/or joint stiffness - abnormally low blood cell counts (white or red blood cells or platelets) - urgent need to urinate - changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial nephritis) - inflammation of the liver (hepatitis) - yellowing of the skin (jaundice) - liver damage - increased level of creatine phosphokinase in blood (an indicator of muscle damage) - sudden cardiac death.
Maltese: Steven-Johnson/nekrolisi epidermali tossika) - nervi - tħossok bil-għatx - żarżir fil-widnejn - vista mċajpra, bidla fil-vista - jaqa' x-xagħar - ulċeri fil-ħalq - infjammazzjoni tal-frixa: sintomi komuni huma uġigħ fl-addome, dardir u rimettar - żjieda fl-għaraq - tnaqqis fil-piż , żjieda fl-aptit, nuqqas fl-aptit bla kontroll (anoressija) - ebusija tal-muskoli u/jew tal-ġogi - għadd baxx taċ-ċelluli tad-demm b'mod anormali (ċelluli bojod jew ħomor tad-demm jew plejtlits) - bżonn urġenti li tgħaddi l-awrina - bidliet jew tnaqqis fl-ammont tal-awrina minħabba infjammazzjoni fil-kliewi (nefrite fl interstizju tat-tubuli) - infjammazzjoni tal-fwied (epatite) - tisfar il-ġilda (suffejra) - ħsara lill-fwied - żieda fil-livell ta' creatine phosphokinase fid-demm (indikatur ta' ħsara fil-muskoli) - mewt zoptu ġejja mill-qalb
English: Primary endpoints were serum uric acid area under the curve (AUCsUA1-8) and change in serum creatinine (sC) level both from baseline to Day 8.
Maltese: Il-punti aħħarin prinċipali kienu l-erja taħt il-kurva (AUC sUA1-8) ta' uric acid fis-serum u l-bidla fil-livell ta' kreatinina fis-serum (serum creatinine, sC) it-tnejn mil-linja ta' riferiment bażi sa Jum 8.
English: 14 film-coated tablets: EU/1/18/1347/005 28 film-coated tablets: EU/1/18/1347/006 56 film-coated tablets: EU/1/18/1347/007 84 film-coated tablets: EU/1/18/1347/008
Maltese: EU/1/18/1347/006 56 pillola miksija b'rita:
English: Abdominal pain, abdominal distension, gastrooesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort Rare
Maltese: Artralġja, artrite, mijalġja, bugħawwieġ, djgħufija fil-muskoli, spażmi fil-muskoli, ebusija fil-muskoli, bursite Rari
English: Febuxostat Krka 120 mg
Maltese: Krka 120 mg
English: Tumor Lysis Syndrome:
Maltese: Sindrome tal-Lisi tat-Tumur:
English: Each film-coated tablet contains 120 mg febuxostat.
Maltese: Kull pillola miksija b'rita fiha 120 mg febuxostat.
English: The proportion of patients with serum urate levels of <6.0 mg/dL (357 μmol/L) at the final visit was greater than 80% (81-100%) at each febuxostat dose.
Maltese: Il-proporzjon ta' pazjenti b'livelli ta' urate fis-serum ta' <6.0 mg/dL (357 μmol/L) fl-aħħar żjara kien akbar minn 80% (81-100%) ma' kull doża ta' febuxostat.
English: Possible side effects
Maltese: Effetti vaskulari:
English: The FACT study showed the statistically significant superiority of both febuxostat 80 mg and febuxostat 120 mg QD treatment arms versus the conventionally used dose of allopurinol 300 mg treatment arm in reducing and maintaining sUA below 6 mg/dL (357 μmol/L).
Maltese: L-istudju FACT wera superjorità statistikament sinifikanti taż-żewġ gruppi ta' kura ta' febuxostat 80 mg u ta' febuxostat 120 mg QD versus il-grupp ta' kura ta' doża konvenzjonali ta' allopurinol 300 mg, biex inaqqsu u jżommu l-sUA taħt 6 mg/dL (357 µmol/L).
English: In this subgroup febuxostat achieved the primary efficacy endpoint (sUA < 6.0 mg/dL at the last 3 visits) in 41% (80 mg QD), 48% (120 mg QD), and 66% (240 mg QD) of patients compared to 9% in the allopurinol 300 mg/100 mg QD and 0 % in the placebo groups.
Maltese: F'dan is-sottogrupp febuxostat laħaq l-mira primarja tal-effikaċja (sUA < 6.0 mg/dL fl-aħħar 3 żjajar) f'41% (80 mg QD), 48% (120 mg QD), u 66% (240 mg QD) tal-pazjenti meta mqabbel ma' 9% filgrupp ta' allopurinol 300 mg/100 mg QD u 0 % fil-grupp tal-plaċebo.
English: Febuxostat Krka 80 mg
Maltese: Krka 80 mg
English: Clinical Outcomes: proportion of patients requiring treatment for a gout flare APEX study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for gout flare compared to febuxostat 80 mg (28%), allopurinol 300 mg (23%) and placebo (20%).
Maltese: Waqt il-perijodu ta' 8-ġimgħat ta' profilassi, proporzjon akbar ta' pazjenti fil-grupp ta' kura b'120 mg febuxostat (36%) kienu jeħtieġu kura għall-aggravar tal-gotta meta mqabbla ma' febuxostat 80 mg (28%), allopurinol 300 mg (23%) u plaċebo (20%).
English: Atrial fibrillation, palpitations, ECG abnormal, left bundle branch block (see section Tumor Lysis Syndrome), sinus tachycardia (see section Tumor Lysis Syndrome) Rare
Maltese: Fibrillazzjoni atrijali, palpitazzjonijiet, ECG anormali, blokk fil-fergħa tal-qabda tax-xellug (ara s-sezzjoni Sindrome tal-Lisi tat-Tumur), takikardja sinusali (ara sezzjoni Sindrome tal-Lisi tat-Tumur)
English: Stop taking this medicine and contact your doctor immediately or go to an emergency department nearby if the following rare (may affect up to 1 in 1,000 people) side effects occur, because a serious allergic reaction might follow: - anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and precautions”) - potentially life-threatening skin rashes characterised by formation of blisters and shedding of the skin and inner surfaces of body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (Stevens- Johnson Syndrome/ Toxic Epidermal Necrolysis), or by enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (drug reaction with eosinophilia and systemic symptoms-DRESS) (see section 2) - generalised skin rashes.
Maltese: Tkomplix tieħu din il-mediċina u ikkuntattja lit-tabib tiegħek minnufih jew mur fid-dipartiment talemerġenza li jkun l-aktar qrib jekk l-effetti sekondarji rari li ġejjin (1 f'kull 1,000 persuna) jseħħu, għax wara tista' sseħħ reazzjoni allerġika serja: - reazzjonijiet anafilattiċi, sensittività eċċessiva għall-mediċina (ara wkoll sezzjoni 2 “Avviżi u prekawzjonijiet”) - raxxijiet li jistgħu jkunu ta' theddida għall-ħajja li għandhom karatteristika li jiffurmaw ponot u titqaxxar il-ġilda u s-superfiċji interni tad-daħliet fil-ġisem, eż ħalq u ġenitali, ulċeri bl-uġigħ filħalq u/jew partijiet ġenitali, flimkien ma' deni, grieżem misluħin u għeja (Sindrome ta' Stevens Johnsons/Nekrolisi Epidermali Tossika), jew b'għenieqed limfatiċi minfuħa, fwied minfuħ, epatite (sa insuffiċjenza tal-fwied), għadd aktar għoli taċ-ċelluli bojod tad-demm (reazzjoni talmediċina b'eosinofilja u sintomi sistemiċi -DRESS) (ara sezzjoni 2) - raxx tal-ġilda mal-ġisem kollu
English: Pancytopenia, thrombocytopenia, agranulocytosis*
Maltese: Pankrejatite, ulċera fil-ħalq
English: The primary efficacy endpoint in the APEX and FACT studies was the proportion of patients whose last 3 monthly serum uric acid levels were < 6.0 mg/dL (357 μmol/L).
Maltese: Il-fini ewlieni tal-effikaċja flistudji APEX u FACT kien il-proporzjon ta' pazjenti li kellhom l-aħħar 3 livelli ta' kull xahar ta' uric acid fis-serum < 6.0 mg/dL (357 µmol/L).
English: Long-term, open label extension studies
Maltese: Studji ta' estenzjoni fit-tul open label
English: Dyspnoea, bronchitis, upper respiratory tract infection, cough
Maltese: Qtugħ ta' nifs, bronkite, infezzjoni fil-passaġġ respiratorju ta' fuq, sogħla
English: Should you experience allergic reactions to Febuxostat Krka, stop taking this medicine (see also section 4).
Maltese: Jekk ikollok reazzjonijiet allerġiċi għal Febuxostat Krka, waqqaf din il-mediċina (ara wkoll sezzjoni 4).
English: Rash (including various types of rash reported with lower frequencies, see below) Uncommon
Maltese: Raxx (inklużi għadd ta' tipi ta' raxx differenti irrappurtati b'frekwenzi aktar baxxi, ara hawn taħt) Mhux komuni
English: Each film-coated tablet contains 80 mg febuxostat.
Maltese: Kull pillola miksija b'rita fiha 80 mg febuxostat.
English: Fatigue, chest pain, chest discomfort Rare
Maltese: Dijabete mellitus, iperlipidemija, tnaqqis fl-aptit, żieda fil-piż Rari
English: España KRKA Farmacéutica, S.L.
Maltese: KRKA Pharma Dublin, Ltd.
English: Other medicines and Febuxostat Krka
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Febuxostat Krka is indicated in adults.
Maltese: Kif jidher Febuxostat Krka u l-kontenut tal-pakkett:
English: The primary endpoint in CARES was the time to first occurrence of MACE, a composite of non-fatal MI, non-fatal stroke, CV death and unstable angina with urgent coronary revascularization.
Maltese: L-iskop finali primarju f'CARES kien iż-żmien għall-ewwel okkorrenza ta' MACE, kompost ta' MI mhux fatali, puplesija mhux fatali, mewt CV u anġina mhux stabbli b'rivaskularizzazzjoni urġenti talqalb.
English: Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
Maltese: Krka hu indikat għal trattament ta' iperuriċimja kronika f'kundizzjonijiet fejn diġà seħħet depożizzjoni ta' urate (inkluż passat, jew preżenza ta' artrite tofus u/jew tal-gotta).
English: The results of the study showed that the co-administration of febuxostat 80 mg QD with theophylline 400 mg single dose has no effect on the pharmacokinetics or safety of theophylline.
Maltese: Ir-riżultati tal-istudju wrew li meta febuxostat 80 mg QD ingħata ma' doża waħda ta' theophylline 400 mg ma kienx hemm effett fuq il-farmakokinetika jew sigurtà ta' theophylline.
English: Febuxostat Krka tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body.
Maltese: Pilloli Febuxostat Krka fihom is-sustanza attiva febuxostat u jintuzaw għall-kura tal-gotta, li hija assoċjata ma' kimika żejda msejħa uric acid (urate) fil-ġisem.
English: CARES Study was a multicenter, randomized, double-blind, non inferiority trial comparing CV outcomes with febuxostat versus allopurinol in patients with gout and a history of major CV disease including MI, hospitalization for unstable angina, coronary or cerebral revascularization procedure, stroke, hospitalized transient ischemic attack, peripheral vascular disease, or diabetes mellitus with evidence of microvascular or macrovascular disease.
Maltese: MI, rikoverar l-isptar għal anġina mhux stabbli, proċedura ta' vaskularizzazzjoni mill-ġdid ta' arterja fil-qalb jew fil-moħħ, puplesija, rikoverar l-isptar għal attakk iskemiku temporanju, mard vaskulari periferali, jew dijabete mellitus bi xhieda ta' mard mikrovaskulari jew makrovaskulari.
English: If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat Krka 120 mg once daily may be considered.
Maltese: Jekk wara 2-4 ġimgħat il-uric acid fis-serum ikun > 6 mg/dL (357 µmol/L), jista' jiġi kkunsidrat Febuxostat Krka 120 mg darba kuljum.
English: In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03;95% CI 0.871.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
Maltese: 1.03; 95% CI 0.87-1.23), iżda ġiet osservata rata aktar għolja ta' mwiet kardjovaskulari (4.3% vs. 3.2% tal-pazjenti; HR 1.34; 95% CI 1.03-1.73).
English: Mean AUC sUA1-8 (mgxh/dl) was significantly lower with febuxostat (514.0 ± 225.71 vs 708.0 ± 234.42; least square means difference: -196.794 [95% confidence interval: -238.600; -154.988]; p <.0001).
Maltese: 71 vs 708.0 ± 234.42; l-inqas kwadru jfisser differenza: -196.794 [95% intervall ta' kunfidenza:
English: The efficacy of febuxostat was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study described below) that were conducted in 4101 patients with hyperuricaemia and gout.
Maltese: L-effikaċja ta' febuxostat intweriet f'tlett studji pivotali ta' Fażi 3 (iż-żewġ studji pivitali APEX u FACT, u l-istudju ieħor addizzjonali CONFIRMS deskritti hawn taħt) li twettqgħu f'4101 pazjent b'iperuriċimja u gotta.
English: In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
Maltese: Filprova ewlenija tas-Sindrome tal-Lisi tat-Tumur febuxostat 120 mg kuljum kien mogħti lil pazjenti b'diversi programmi ta' kura kimoterapewtika, li jinkludu antikorpi monoklonali, mingħajr tħassib dwar is-sigurtà.
English: Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine.
Maltese: Żjieda tal-glucose fid-demm, jittawwal il-ħin tat-tromboplastin parzjali attivat, jonqos il-għadd taċ-ċelluli ħomor fid-demm, żjieda tal-alkaline phosphatase fid-demm, żieda fil-creatine phosphokinase fid-demm* * Reazzjonijiet avversi ġejjin minn esperjenza ta' wara t-tqegħid fis-suq ** Dijarea mhux infettiva li toħroġ mal-kura u testijiet anormali tal-funzjoni tal-fwied fl-istudji talFażi 3 kombinati huma aktar frekwenti f'pazjenti kkurati fl-istess waqt b'colchicine *** Ara sezzjoni 5.1 għall-frekwenzi tal-aggravar tal-gotta fl-istudji kontrollati randomized ta' Fażi 3 individwali.
English: The proportion of subjects requiring treatment for a gout flare (APEX and FACT Study) was numerically lower in the groups that achieved an average post-baseline serum urate level <6.0 mg/dL, <5.0 mg/dL, or <4.0 mg/dL compared to the group that achieved an average post-baseline serum urate level ≥6.0 mg/dL during the last 32 weeks of the treatment period (Week 20-Week 24 to Week 49 - 52 intervals).
Maltese: Il-proporzjon ta' individwi li kellhom bżonn kura għall-irkadar tal-gotta (Studju APEX u FACT) kien numerikament aktar baxx fil-gruppi li laħqu livell medju ta' urate fis-serum wara l-linja bażi ta' <6.0 mg/dL, <5.0 mg/dL, jew <4.0 mg/dL meta mqabbel mal-grupp li laħaq livell medju ta' urate fisserum wara l-linja bażi ta' ≥6.0 mg/dL waqt l-aħħar 32 ġimgħa tal-perjodu ta' kura (intervalli Ġimgħa 20-Ġimgħa 24 sa Ġimgħa 49 - 52).
English: 240 mg febuxostat was used to evaluate the safety of febuxostat at twice the recommended highest dose.
Maltese: Intuża 240 mg febuxostat biex tiġi vvalutata s-sigurtà ta' febuxostat f'doża d-doppju tal-ogħla doża rrakkomandata.
English: Febuxostat Krka should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment.
Maltese: Krka għandu jinbeda jumejn qabel il-bidu ta' terapija ċitotossika u jitkompla għal mill-inqas 7 ijiem: madanakollu t-trattament jista' jiġi mtawwal għal 9 ijiem skont it-tul tal-kimoterapija fuq ġudizzju mediku.
English: Reduction in serum uric acid level to <6.0 mg/dL (357 μmol/L) was noted by the Week 2 visit and was maintained throughout treatment.
Maltese: Tnaqqis fil-livell ta' uric acid fis-serum għal <6.0 mg/dL (357 µmol/L) kien innutat maż-żjara ta' Ġimgħa 2 u kien miżmum tul il-kura.
English: Febuxostat Krka is available in boxes containing 14, 28, 56 or 84 film-coated tablets in blisters.
Maltese: Krka jiġu f'kaxxi li fihom 14, 28, 56 jew 84 pillola miksija b'rita ġo folji.
English: Denmark Valera Pharmaceuticals Ireland Ltd. 25-28 North Wall Quay, Dublin, Ireland
Maltese: Danimarka Valera Pharmaceuticals Ireland Ltd. 25-28 North Wall Quay, Dublin, l-Irlanda
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: O Resumo das Características do Medicamento, rótulo e folheto informativo válidos são as versões finais concluídas no procedimento do Grupo de Coordenação.
English: With an efficacy of 98-100% in serum testosterone reduction further active comparator studies are redundant and thus not necessary.
Maltese: B'effikaċja ta' 98-100% tnaqqis fit-testosteron fis-serum, aktar studji komparattivi attivi huma żejda u għalhekk mhux neċessarji.
English: Late in the clinical course, it is androgen independent, and is refractory to hormonal therapy.
Maltese: Tard fil-kors kliniku, huwa indipendenti mill-androġeni, u huwa refrattarju għal terapija ormonali.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VANTAS (see Annex I)
Maltese: SOMMARJU GLOBALI TA' L-EVALWAZZJONI TA' VANTAS (Ara Anness I)
English: In the past, testosterone suppression was achieved by bilateral orchiectomy (surgical castration).
Maltese: Fl-imgħoddi, soppressjoni ta' testosteron kienet tinkiseb permezz ta' orkidektomija bilaterali (kastrazzjoni kirurġika).
English: Serum testosterone concentrations that correspond to castration levels have generally been set at less than 50 ng/dL (1.7 nmol/L), given the known variability of values in reference laboratories.
Maltese: Konċentrazzjonijiet ta' testosteron fis-serum li jikkorispondu ma' livelli ta' kastrazzjoni ġew iffissati b'mod ġenerali għal inqas minn 50 ng/dL (1.7 nmol/L), mogħtija l-varjabilità tal-valuri fil-laboratorji ta' referenza.
English: Vantas is a new LHRH agonist and this pharmacological class was introduced for the treatment of advanced prostate cancer more than 20 years ago.
Maltese: Vantas huwa l-agonist LHRH ġdid u din il-klassi farmakoloġika ġiet introdotta għattrattament ta' kanċer tal-prostata avvanzat aktar minn 20 sena ilu.
English: The proposal of the applicant/MAH to include five pharmacovigilance safety concerns in the Risk Management Plan is endorsed (two relate specifically to the unique Vantas formulation while the other three are classified as class effects: expulsions, cellulitis, flare, osteoporosis and QT prolongation).
Maltese: Il-proposta ta' l-applikant/MAH biex tinkludi ħames konsiderazzjonijiet dwar is-sigurtà fuq il-farmakoviġilanza fil-Pjan ta' Maniġment tar-Riskju hija awtorizzata (tnejn għandhom x'jaqsmu speċifikament malformolazzjoni unika ta' Vantas waqt li t-tlieta l-oħra huma kklassifikati bħala effetti ta' klassijiet: espulsjonijiet, ċellulite, tħeġġiġ, osteoporożi u prolongazzjoni tal-QT).
English: The achievement of castrate levels of testosterone is an acceptable surrogate endpoint in hormone sensitive advanced prostate cancer which can be translated into less pain from bone metastases, improvement in urinary flow, and in some cases slowing of tumour progression, although a clear-cut survival benefit has not been demonstrated.
Maltese: Il-kisba ta' livelli ta' testosteron ta' kastrazzjoni hija punt ta' tmiem sostitut aċċettabbli f'kanċer tal-prostata sensittiv għal ormoni avvanzat li jista' jiġi tradott f'anqas uġigħ minn metastasi fl-għadam, titjib fil-passaġġ ta' l-awrina, u f'xi każijiet ittardjar tal-progressjoni tat-tumur, għalkemm ma ntweriex benefiċċju ta' sopravivenza ċar.
English: Strength Pharmaceutica l form
Maltese: Qawwa Għamla farmaċewtika
English: Furthermore, reduction of testosterone to castrate levels has been accepted as a valid surrogate for clinical efficacy in advanced prostate cancer by the CHMP in 2004 as part of scientific advice from the SAWP.
Maltese: Barra dan, tnaqqis ta' testosteron għal-livelli ta' kastrazzjoni ġie aċċettat bħala sostitut validu għal effikaċja klinika f'kanċer tal-prostata avvanzat mis-CHMP fl-2004 bħala parti mill-parir xjentifiku mill-SAWP.
English: Thus, the documented pharmacological endpoint serum testosterone < 50 ng/dL, documented for Vantas in studies 302, 301 and in addition in the Long Term Extension of Study 301 is an acceptable primary efficacy endpoint in patients with advanced prostate cancer.
Maltese: Għalhekk il-punt ta' tmiem farmakoloġiku ta' testosteron fisserum dokumentat ta' 50 ng/dL (1.7 nmol/L), dokumentat għal Vantas fl-istudji 302, 301 u addizzjonalment fl-Istudju ta' Estensjoni 301 fuq Tul ta' Żmien huwa punt tat-tmiem ta' effikaċja primarja aċċettabbli f'pazjenti b'kanċer tal-prostata avvanzat.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Maltese: ANNESS I LISTA TA' L-ISMIJIET, GĦAMLA FARMAĊEWTIKA, IL-QAWWA TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, APPLIKANT U D-DETENTUR TA' LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Content (concentration)
Maltese: Mnejn jingħata Kontenut (konċentrazzjoni
English: Another LHRH agonist could be used, but this is superfluous considering the meta-analysis presented by Applicant, orchidectomy is not acceptable when reversible methods are available, DES is obsolete and non-steroidal anti-androgens may have inferior efficacy when used as monotherapy.
Maltese: Jista' jintuża agonist LHRH ieħor, imma dan huwa superfluwu meta wieħed jikkonsidra l-meta-analiżi ppreżentata mill-Applikant, l-orkidektomija mhix aċċettabbli fejn hemm metodi riversibbli, DES m'għadux jintuża u anti-androġeni mhux sterojdi jista' jkollhom effikaċja inferjuri meta użati bħala monoterapija.
English: Early in its natural cycle, prostate cancer is androgen dependent.
Maltese: Kmieni fiċ-ċiklu naturali tiegħu, il-kanċer tal-prostata huwa dipendenti fuq l-androġeni.