FrancophonIA/ELRC3.0 huggingface dataset:
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku obinutuzumab
English: For FL, Gazyvaro is given at a dose of 1,000 mg on day 1, 8 and 15 of the first 21 or 28-day treatment cycle.
Maltese: Għall-FL, Gazyvaro jingħata f'doża ta' 1,000 mg fil-jiem 1, 8 u 15 tal-ewwel ċiklu ta' kura ta' 21 jew ta' 28 jum.
English: Why is Gazyvaro approved?
Maltese: Għaliex ġie approvat Gazyvaro?
English: Gazyvaro was shown to be of benefit in one main study involving 1,202 patients with previously untreated FL.
Maltese: Gazyvaro ntwera li kien ta' benefiċċju fi studju ewlieni wieħed li kien jinvolvi 1,202 pazjenti b'FL mhux ikkurata preċedentement.
English: Gazyvaro obinutuzumab
Maltese: Informazzjoni oħra dwar Gazyvaro
English: Further doses of 1,000 mg are then given on days 8 and 15 of the first cycle.
Maltese: Imbagħad aktar dożi ta' 1,000 mg jingħataw fil-jiem 8 u 15 talewwel ċiklu.
English: Because the number of patients with CLL and with FL is low, the diseases are considered ‘rare', and Gazyvaro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 October 2012 and 19 June 2015.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn CLL u minn FL huwa baxx, il-marda hija kkunsidrata ‘rari', u Gazyvaro ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl-10 ta' Ottubru 2012 u fid-19 ta' Ġunju 2015.
English: Gazyvaro is a cancer medicine used to treat adult patients with:
Maltese: Grazyvaro huwa mediċina kontra l-kanċer li tintuża fil-kura ta' pazjenti adulti:
English: Similarly, patients treated with Gazyvaro and chlorambucil lived significantly longer on average without their disease getting worse than patients treated with rituximab and chlorambucil (26.7 months versus 15.2 months).
Maltese: B'mod simili, pazjenti kkurati b'Gazyvaro u chlorambucil għexu għal żmien itwal b'mod sinifikanti mingħajr ma l-marda tagħhom iggravat meta mqabbla ma' pazjenti kkurati b'rituximab u chlorambucil (26.7 xhur kontra 15.2 xhur).
English: Gazyvaro has also been investigated in a study involving 321 patients with FL in whom treatment with rituximab had either not worked or had stopped working.
Maltese: Gazyvaro kien investigat ukoll fi studju li kien jinvolvi 321 pazjent b'FL li fihom il-kura b'rituximab jew ma ħadmitx jew kienet waqfet taħdem.
English: The active substance in Gazyvaro, obinutuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein CD20, which is found on the surface of Blymphocytes.
Maltese: Is-sustanza attiva f'Gazyvaro, l-obinutuzumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet sabiex tagħraf u teħel mal-proteina CD20, li tinstab fuq il-wiċċ tal-linfoċiti B.
English: What are the risks associated with Gazyvaro?
Maltese: X'inhuma r-riskji assoċjati ma' Gazyvaro?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gazyvaro on 23 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Gazyvaro fit-23 ta' Lulju 2014.
English: For the remaining 5 cycles, Gazyvaro 1,000 mg is given on day one only.
Maltese: Għall-5 ċikli li jifdal, Gazyvaro jingħata f'doża ta' 1,000 mg fil-jum wieħed biss.
English: In one main study involving 781 patients, those treated with Gazyvaro and chlorambucil lived significantly longer on average without their disease getting worse than patients treated with chlorambucil alone (26.7 months versus 11.1 months).
Maltese: Fi studju ewlieni wieħed li kien jinvolvi 781 pazjent, dawk ikkurati b'Gazyvaro u chlorambucil għexu għal medja itwal b'mod sinifikanti mingħajr ma l-marda tagħhom iggravat meta mqabbla ma' pazjenti kkurati bi chlorambucil biss (26.7 xhur kontra 11.1 xhur).
English: Patients treated with Gazyvaro and bendamustine lived significantly longer on average without their disease getting worse than patients treated with bendamustine alone (29.2 months versus 13.7 months).
Maltese: Il-pazjenti kkurati b'Gazyvaro u bendamustine għexu għal medja itwal b'mod sinifikanti mingħajr ma l-marda tagħhom iggravat meta mqabbla ma' pazjenti kkurati b'bednamustine biss (29.2 xhur kontra 13.7 xhur).
English: Patients may also be given other medicines to prevent infusion-related reactions and other side effects.
Maltese: Il-pazjenti jistgħu jingħataw ukoll mediċini oħra għall-prevenzjoni ta' reazzjonijiet relatati mal-infużjoni u effetti sekondarji oħra.
English: By attaching to CD20 on Blymphocytes, obinutuzumab makes the B-lymphocytes a target for the body's immune (defence) system, which kills the B-lymphocytes.
Maltese: Meta teħel mas-CD20 fuq il-linfoċiti B, lobinutuzumab tagħmel il-linfoċiti B bħala l-mira għas-sistema immunitarja (ta' difiża) tal-ġisem, li toqtol il-linfoċiti B.
English: Gazyvaro is used together with chlorambucil (another cancer medicine) in patients for whom the cancer medicine fludarabine is not recommended;
Maltese: Grazyvaro jintuża flimkien ma' chlorambucil (mediċina oħra kontra lkanċer) f'pazjenti li għalihom mhijiex rakkomandata l-mediċina kontra l-kanċer, fludarabine;
English: In CLL and FL, cancerous B-lymphocytes multiply too quickly and replace the normal cells in the bone marrow (where blood cells are made) and in lymph nodes.
Maltese: F'CLL u FL, il-limfoċiti B kanċerużi jimmultiplikaw malajr wisq u jieħdu post iċ-ċelloli normali fil-mudullun tal-għadam (fejn joriġinaw iċ-ċelloli tad-demm) u fin-nodi linfotiċi.
English: • follicular lymphoma (FL), another type of cancer of B-lymphocytes.
Maltese: • b'limfoma follikulari (FL), tip ta' kanċer ieħor tal-limfoċiti B. Gazyvaro jintuża flimkien ma' kimoterapija (mediċini oħra kontra l-kanċer) f'pazjenti li ma kellhomx kura preċedenti għal FL avvanzata.
English: • previously untreated chronic lymphocytic leukaemia (CLL).
Maltese: • b'lewkimja limfoċitika kronika li ma ġietx ikkurata qabel (CLL).
English: How does Gazyvaro work?
Maltese: -użu ta' Gazyvaro.
English: A dose of 100 mg of Gazyvaro is given on day one of the first cycle under close supervision of an experienced doctor who should monitor the patient for infusion-related reactions.
Maltese: Tingħata doża ta' 100 mg ta' Gazyvaro f'jum wieħed tal-ewwel ċiklu taħt sorveljanza mill-qrib ta' tabib b'esperjenza li għandu jimmonitorja lill-pazjent għal reazzjonijiet relatati mal-infużjoni.
English: In case of infusion-related reactions to the first 100 mg dose, the second dose should be delayed until day 2.
Maltese: F'każ li jkun hemm reazzjonijiet relatati mal-infużjoni għall-ewwel doża ta' 100 mg, ittieni doża għandha tingħata f'jum 2.
English: In CLL, Gazyvaro has been shown to significantly delay the disease getting worse in previously untreated patients who had other medical conditions and were therefore ineligible for fludarabinebased therapy.
Maltese: F'CLL intwera li Gazyvaro jittardja b'mod sinifikanti l-marda milli tiggrava f'pazjenti li ma ngħatawx kura qabel li kellhom kundizzjonijiet mediċi oħra u li għalhekk ma kinux eliġibbli għal terapija bbażata fuq fludarabine.
English: 2333 BE Leiden The Netherlands
Maltese: 2333 BE Leiden L-Olanda
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D 18.
English: EU/1/13/846/002 (film-coated tablet 40 mg) EU/1/13/846/003 (film-coated tablet 80 mg)
Maltese: EU/1/13/846/002 (pillola miksija b'rita ta' 40 mg) EU/1/13/846/003 (pillola miksija b'rita ta'80 mg)
English: January 2020
Maltese: Jannar 2020
English: Sorbitol sorbitan solution Glycerol
Maltese: Soluzzjoni sorbitol sorbitan Glycerol
English: • Corticosteroids (e.g. dexamethasone, prednisolone)
Maltese: • Kortikosterojdi (eż. dexamethasone, prednisolone)
English: • Antibiotics (e.g. clarithromycin, doxycycline)
Maltese: • Antibijotiċi (eż. clarithromycin, doxycycline)
English: Analysis of rPFS utilised centrally-reviewed radiographic assessment of progression.
Maltese: L-analiżi ta' rPFS utilizzat evalwazzjoni tal-progressjoni radjografika riveduta ċentralment.
English: • Statins metabolised by CYP3A4 (e.g. atorvastatin, simvastatin)
Maltese: • Statins immetabolizzati minn CYP3A4 (eż. atorvastatine, simvastatin)
English: Placebo (N = 399)
Maltese: Plaċebo (N = 399)
English: butylhydroxyanisole (E320), and butylhydroxytoluene (E321).
Maltese: butylhydroxyanisole (E320), u butylhydroxytoluene (E321).
English: • Antipsychotics (e.g. haloperidol)
Maltese: • Antipsikotiċi (eż. haloperidol)
English: N-desmethyl enzalutamide was not metabolised by CYPs in vitro.
Maltese: N-desmethyl enzalutamide ma ġiex metabolizzat minn CYPs in vitro.
English: • Immunosuppressant (e.g. tacrolimus)
Maltese: • Immunosoppressant (eż. tacrolimus)
English: • Antithrombotics (e.g. acenocoumarol, warfarin, clopidogrel)
Maltese: • Antitrombotiċi (eż. acenocoumarol, warfarina, clopidogrel)
English: The solubility of enzalutamide is increased by caprylocaproyl macrogolglycerides as emulsifier/surfactant.
Maltese: Is-solubbiltà ta' enzalutamide tiżdied b'caprylocaproyl macrogolglycerides bħala emulsifier/surfactant.
English: nicardipine, nifedipine, propranolol, verapamil)
Maltese: diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
English: • Analgesics (e.g. fentanyl, tramadol)
Maltese: • Analġeżiċi (eż. fentanyl, tramadol)
English: • Antiepileptics (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid)
Maltese: • Antiepilettiċi (eż. carbamazepine, clonazepam, phenytoin, primidone, valproic acid)
English: BCRP, MRP2, OAT3 and OCT1 substrates
Maltese: Substrati ta' BCRP, MRP2, OAT3 u OCT1
English: Enzalutamide is 97% to 98% bound to plasma proteins, primarily albumin.
Maltese: Bejn 97% u 98% ta' enzalutamide jeħel mal-proteini fil-plażma, prinċipalment albumin.
English: • Hypnotics (e.g. diazepam, midazolam, zolpidem)
Maltese: • Ipnotiċi (eż. diazepam, midazolam, zolpidem)
English: Caprylocaproyl macrogol-8 glycerides Butylhydroxyanisole (E320) Butylhydroxytoluene (E321)
Maltese: Kontenut tal-kapsula Caprylocaproyl macrogol-8 glycerides Butylhydroxyanisole (E320) Butylhydroxytoluene (E321)
English: P-value1
Maltese: Valur p1
English: (See also section 4 ‘Possible side effects').
Maltese: (Ara ukoll Sezzjoni 4 ‘Effetti sekondarji possibbli')
English: Based on Kaplan-Meier estimates.
Maltese: Ibbażat fuq stimi Kaplan-Meier.
English: Xtandi contains sorbitol
Maltese: Xtandi fih sorbitol
English: Contains sorbitol (E420).
Maltese: Fih sorbitol (E420).
English: 9785-CL-0222 (TERRAIN) study (chemotherapy-naïve patients with metastatic CRPC)
Maltese: Studju 9785-CL-0222 (TERRAIN) (pazjenti li qatt ma ħadu kimoterapija b'CRPC metastatiku)
English: Tablet coating Hypromellose Talc
Maltese: Kisja tal-pillola Hypromellose Talc
English: The AUC and Cmax of caffeine decreased by 11% and 4% respectively.
Maltese: L-AUC u s-Cmax tal-kaffeina naqqas b'11% u 4%
English: Enzalutamide was not phototoxic in vitro.
Maltese: Enzalutamide ma kienx fototossiku in vitro.
English: • Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate.
Maltese: Hypromellose acetate succinate, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate.
English: Enzalutamide was negative for genotoxicity in a standard battery of in vitro and in vivo tests.
Maltese: Enzalutamide ttestja negattiv għal ġenotossiċità f'batterija standard ta' testijiet in vitro u in vivo.
English: • HIV antivirals (e.g. indinavir, ritonavir)
Maltese: • Antivirali għall-HIV (eż. indinavir, ritonavir)
English: • Calcium channel blockers (e.g. diltiazem, felodipine, nicardipine, nifedipine, verapamil)
Maltese: • Imblokkaturi tal-kanali tal-kalċju (eż. diltiazem, felodipine, nicardipine, nifedipine, verapamil)
English: Enzalutamide is extensively metabolised.
Maltese: Enzalutamide jiġi metabolizzat b'mod estensiv.
English: Hazard Ratio (95% CI)2 P-value3
Maltese: Proporzjon ta' Periklu (CI ta' 95%)2 Valur-P3
English: Soft capsule.
Maltese: Kapsula ratba.
English: 28 soft capsules
Maltese: 28 kapsula ratba
English: The HR is relative to placebo with < 1 favouring enzalutamide.
Maltese: L-HR huwa relattiv għall plaċebo b'< 1 favur enzalutamide.
English: • Tablet coating: Hypromellose, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172).
Maltese: Hypromellose, talc, macrogol 8000, diossidu tat-titanju (E171), u iron oxide yellow (E172).
English: Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate
Maltese: Qalba tal-pillola Hypromellose acetate succinate Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate
English: Xtandi contains sorbitol (E420).
Maltese: Xtandi fih sorbitol (E420).
English: P-gp substrates
Maltese: Substrati ta' P-gp
English: - The active substance is enzalutamide.
Maltese: - Is-sustanza attiva hi enzalutamide.
English: Table 1: Adverse reactions identified in controlled clinical trials and post-marketing MedDRA System organ class Adverse reaction and frequency
Maltese: Tabella 1: Reazzjonijiet avversi identifikati fi-provi kliniċi kkontrollati u wara t-tqegħid fis- suq Klassifika tas-sistema talorgani MedDRA
English: The active metabolite is 95% bound to plasma proteins.
Maltese: 95% talmetabolit attiv jeħel mal-proteini fil-plażma.
English: PSA Response was 22.1% (95% CI: 15.6, 29.7).
Maltese: Ir-rispons PSA kien 22.1% (CI ta' 95%: 15.6, 29.7).
English: Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Maltese: Il-kategoriji ta' frekwenza huma ddefiniti kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna
English: • Cardiac glycosides (e.g. digoxin)
Maltese: • Glikosidi kardijaċi (eż. digoxin)
English: Astellas Pharma Tlf: + 47 66 76 46 00
Maltese: Tlf: + 47 66 76 46 00
English: Common: fall
Maltese: Komuni: ansjetà
English: In vitro, N-desmethyl enzalutamide is metabolised to the carboxylic acid metabolite by carboxylesterase 1, which also plays a minor role in the metabolism of enzalutamide to the carboxylic acid metabolite.
Maltese: In vitro, N-desmethyl enzalutamide jiġi metabolizzat għall-metabolit carboxylic acid minn carboxylesterase 1, li għandu wkoll rwol minuri fil-metaboliżmu ta' enzalutamide għall-metabolit carboxylic acid.
English: • Betablockers (e.g. bisoprolol, propranolol)
Maltese: • Imblokkaturi beta (eż. bisoprolol, propranolol)
English: • Thyroid agents (e.g. levothyroxine)
Maltese: • Aġenti tat-tirojde (eż. levothyroxine)
English: This medicine contains 57.8 mg sorbitol (a type of sugar) per soft capsule.
Maltese: Din il-mediċina fiha 57.8 mg sorbitol (tip ta' zokkor) f'kull kapsula ratba.
English: ¥ As evaluated by narrow SMQs of ‘Convulsions' including convulsion, grand mal convulsion, complex partial seizures, partial seizures, and status epilepticus.
Maltese: Kif evalwat minn SMQs dojoq ta' ‘Konvulżjonijiet' inklużi konvulżjoni, konvulżjoni grand mal, aċċessjonijiet parzjali kumplessi, aċċessjonijiet parzjali, u status ta' epilepticus.
English: Astellas d.o.o.
Maltese: Sp.z.o.o.
English: MDV3100-14 (PROSPER) study (patients with non-metastatic CRPC)
Maltese: Studju MDV3100-14 (PROSPER) (pazjenti b'CRPC mhux metastatiku)
English: Enzalutamide (160 mg once daily) did not cause a clinically relevant change in the AUC or Cmax of caffeine (CYP1A2 substrate) or pioglitazone (CYP2C8 substrate).
Maltese: Enzalutamide (160 mg darba kuljum) ma kkawżax bidla klinikament rilevanti fl-AUC jew fis-Cmax tal kaffeina (substrat ta' CYP1A2) jew pioglitazone (substrat ta' CYP2C8).
English: PSA Response was 23.2% (95% CI: 13.9, 34.9).
Maltese: Ir-rispons PSA kien 23.2% (CI ta' 95%: 13. 9, 34.9).
English: Patients were required to have a PSA doubling time ≤ 10 months, PSA ≥ 2 ng/mL, and confirmation of non-metastatic disease by blinded independent central review (BICR).
Maltese: PSA ≤ 10 xhur, PSA ≥ 2 ng/mL, u konferma ta' marda mhux metastatika permezz ta' reviżjoni ċentrali indipendenti blinded (BICR, blinded independent central review).
English: Titanium dioxide (E171) Purified water
Maltese: Diossidu tat-titanju (E171) Ilma purifikat
English: Placebo N = 468
Maltese: N = 468
English: Number of Events (%) Median, months (95% CI)1
Maltese: Numru ta' Avvenimenti (%) Medjan, xhur (CI ta' 95%)1
English: The active substance is enzalutamide.
Maltese: Is-sustanza attiva hi enzalutamide.
English: P-value is derived from a log rank test stratified by ECOG performance status score (0-1 vs. 2) and mean pain score
Maltese: Il-valur P inkiseb minn log rank test isseparat skont il-punteġġ ta' stat ta' prestazzjoni ECOG (0-1 vs. 2) u l-punteġġ ta'
English: Common: gynaecomastia
Maltese: Komuni: ġinekomastija
English: Each carton contains 4 wallets (112 soft capsules).
Maltese: Kull kartuna fiha 4 kartieri (112-il kapsula ratba).
English: The AUC of pioglitazone increased by 20% while Cmax decreased by 18%.
Maltese: L-AUC ta' pioglitazone żdied b'20% filwaqt li s-Cmax naqas bi 18%.
English: Patients with serum creatinine > 177 μmol/L (2 mg/dL) were excluded from clinical trials.
Maltese: Pazjenti bi kreatinina fis-serum > 177 μmol/L
English: - The other ingredients of the soft capsule are caprylocaproyl macrogol-8 glycerides,
Maltese: - Is-sustanzi l-oħra tal-kapsula ratba huma caprylocaproyl macrogol-8 glycerides,
English: The mean apparent volume of distribution (V/F) of enzalutamide in patients after a single oral dose is 110 L (29% CV).
Maltese: Il-volum medju evidenti tad-distribuzzjoni (V/F) ta' enzalutamide f'pazjenti wara doża orali waħda huwa 110 L (CV ta' 29%).
English: * Spontaneous reports from post-marketing experience
Maltese: * Rapporti spontanji minn esperjenza ta' wara t-tqegħid fis-suq
English: The analysis included 587 skeletal-related events, of which 389 events (66.3%) were radiation to bone, 79 events (13.5%) were spinal cord compression, 70 events (11.9%) were pathologic bone fracture, 45 events (7.6%) were change in antineoplastic therapy to treat bone pain, and 22 events (3.7%) were surgery to bone.
Maltese: L-analiżi inkludiet 587 avveniment relatati mal-iskeletru, li minnhom 389 avveniment (66.3%) kienu radjazzjoni lill-għadam, 79 avveniment (13.5%) kienu kompressjoni tas-sinsla, 70 avveniment (11.9%) kien ksur patoloġiku tal-għadam, 45 avveniment (7.6%) kien bidla fit-terapija antineoplastika biex tikkura wġigħ fl-għadam, u 22 avveniment (3.7%) kien operazzjoni fl-għadam.
English: - The ingredients of the ink are iron oxide black (E172) and polyvinyl acetate phthalate.
Maltese: - Is-sustanzi tal-linka huma iron oxide black (E172) u polyvinyl acetate phthalate.
English: Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C9, CYP2C19, and uridine 5'-diphospho-glucuronosyltransferase (UGTs - glucuronide conjugating enzymes).
Maltese: L-enzimi li jistgħu jiġu indotti jinkludu CYP3A fil-fwied u l-imsaren, CYP2B6, CYP2C9, CYP2C19, u uridine 5'-diphospho-glucuronosyltransferase (UGTs - enzimi ta'
English: PC: SN: NN:
Maltese: BPI-SF:
English: The median age was 69 years (range 41 - 92) and the racial distribution was 93% Caucasian, 4% Black, 1% Asian, and 2% Other.
Maltese: L-età medjana kienet 69 sena (fil-medda ta' 41 - 92) u ddistribuzzjoni razzjali kienet 93% Kawkasi, 4% Suwed, 1% Asjatiċi, u 2% Oħrajn.
English: Common: ischemic heart disease† Not known*: QT-prolongation (see sections 4.4 and 4.5)
Maltese: Mhux magħruf*: titwil tal-QT (ara sezzjonijiet 4.4 u 4.5)
English: In vivo studies have shown that enzalutamide is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19.
Maltese: Studji in vivo wrew li enzalutamide huwa induttur qawwi ta' CYP3A4 u induttur moderat ta' CYP2C9 u CYP2C19.
English: Hazard ratio < 1 favours enzalutamide.
Maltese: Proporzjon ta' Periklu <1 jiffavorixxi enzalutamide
English: There is no antidote for enzalutamide.
Maltese: M'hemm ebda antidotu għal enzalutamide.
English: - Medicines used to treat certain psychiatric disorders such as depression and schizophrenia (e.g. clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
Maltese: (eż. clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
English: Xtandi is a medicine that works by blocking the activity of hormones called androgens (such as testosterone).
Maltese: Xtandi huwa mediċina li taħdem billi timblokka l-attività ta' ormoni msejħa androġeni (bħal testosteron).
English: Xtandi is indicated for:
Maltese: Xtandi hu indikat għal:
English: Results from this analysis were consistent with those from the interim analysis (Table 3, Figure 4).
Maltese: Ir-riżultati minn din l-analiżi kienu konsistenti ma' dawk mill-analiżi interim (Tabella 3, Figura 4).
English: EU/1/13/846/001 112 soft capsules
Maltese: EU/1/13/846/001 112-il kapsula ratba
English: For the non-metastatic subgroup (N = 139) a total of 19 out of 70 (27.1%) patients treated with enzalutamide and 49 out of 69 (71.0%) patients treated with bicalutamide had PFS events (68 total events).
Maltese: Għas-sottogrupp li mhux metastatiku (N = 139) total ta' 19 minn 70 (27.1%) pazjent ikkurat b'enzalutamide u 49 minn 69 (71.0%) pazjent ikkurat b'bicalutamide kellhom avvenimenti ta' PFS (68 avveniment b'kollox).
English: MDV3100-09 (STRIVE) study (chemotherapy-naïve patients with non-metastatic/metastatic CRPC)
Maltese: Studju MDV3100-09 (STRIVE) (pazjenti li qatt ma ħadu kimoterapija b'CRPC mhux metastatiku/metastatiku)
English: Co-administration with warfarin and coumarin-like anticoagulants should be avoided.
Maltese: Għandha tiġi evitata l-koamministrazzjoni ma' warfarina u antikoagulanti bħal coumarin.
English: • the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).
Maltese: • kura ta' rġiel adulti b'kanċer mhux metastatiku tal-prostata reżistenti għall-kastrazzjoni (CRPC) ta' riskju għoli (ara sezzjoni 5.1).
English: Median PFS was 19.4 months (95% CI: 16.5, not reached) in the enzalutamide group versus 5.7 months (95% CI: 5.6, 8.1) in the bicalutamide group [HR = 0.24 (95% CI: 0.18, 0.32), p < 0.0001].
Maltese: Il-PFS medjana ta' 19.4 xhur (CI ta' 95%: 16.5, ma ntlaħaqx) fil-grupp ta' enzalutamide kontra 5.7 xhur (CI ta' 95%: 5.6, 8.1) fil-grupp ta' bicalutamide [HR = 0.24 (CI ta' 95%: 0.18, 0.32, p < 0.0001].
English: In vitro data indicate that enzalutamide may be an inhibitor of the efflux transporter P-gp.
Maltese: Dejta in vitro tindika li enzalutamide jista' jkun inibitur tat-trasportatur tal-effluss P-gp.
English: Astellas Pharma AB Tel: + 46 (0)40-650 15 00
Maltese: Tel: + 46 (0)40-650 15 00
English: Xtandi 40 mg soft capsules enzalutamide
Maltese: Xtandi 40 mg kapsuli rotob enzalutamide
English: The median age was 71 years (range 42 - 93) and the racial distribution was 77% Caucasian, 10% Asian, 2% Black and 11% other or unknown races.
Maltese: Il-medjan tal-età kien ta' 71 sena (medda ta' 42 - 93) u d-distribuzzjoni razzjali kienet 77% Kawkasi, 10% Asjatiċi, 2% Suwed u 11% razez oħrajn jew mhux magħrufa.
English: Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS).
Maltese: Il-punti aħħarin tal-effikaċja koprimarja kienu sopravivenza globali u sopravivenza radjografika mingħajr progressjoni (rPFS).
English: Elimination The mean apparent clearance (CL/F) of enzalutamide in patients ranges from 0.520 and 0.564 L/h.
Maltese: Eliminazzjoni It-tneħħija apparenti medja (CL/F) ta' enzalutamide fil-pazjenti tvarja minn 0.520 sa 0.564
English: Enzalutamide is contraindicated in women who are or may become pregnant (see sections 4.3, 5.3, and 6.6).
Maltese: Enzalutamide huwa kontraindikat f'nisa li huma tqal jew li jistgħu joħorġu tqal (ara sezzjonijiet 4.3, 5.3, u 6.6).