FrancophonIA/ELRC3.0 huggingface dataset:
English: In one case of overdose the patient inadvertently received 7.6 mg of eribulin (approximately 4 times the planned dose) and subsequently developed a hypersensitivity reaction (Grade 3) on Day 3 and neutropenia (Grade 3) on Day 7.
Maltese: F'każ wieħed ta' doża eċċessiva, il-pazjent irċieva 7.6 mg ta' eribulin bi żball (madwar 4 darbiet taddoża ppjanata) u sussegwentement żviluppa reazzjoni ta' sensittività eċċessiva (Grad 3) f'Jum 3 u newtropenija (Grad 3) f'Jum 7.
English: Peripheral neuropathy
Maltese: Edema periferali
English: eribulin to patients.
Maltese: Eribulin i.v.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX41
Maltese: Mediċini antineoplastiċi oħrajn, kodiċi ATC:
English: Treatment with eribulin should only be initiated in patients with ANC values ≥ 1.5 x 109/l and platelets > 100 x 109/l.
Maltese: Il-kura b'eribulin għandha tinbeda biss f'pazjenti li jkollhom valuri ANC ta' ≥ 1.5 x 109/l u plejtlits ta' > 100 x 109/l.
English: The pack sizes are cartons of 1 or 6 vials.
Maltese: Id-daqsijiet tal-pakkett huma kartuni ta' 1 jew 6 kunjetti.
English: Hypoaesthesia Lethargy Neurotoxicity
Maltese: Ipoaestesija Letarġija Newrotossiċità
English: Arthralgia and myalgia (20.4%) (G3/4: 1.0%) Back pain (12.8%) (G3/4: 1.5%) Pain in extremity (10.0%) (G3/4: 0.7%)
Maltese: Artralġja u mijalġja (20.4%) (G3/4: 1.0%) Uġigħ fid-dahar (12.8%) (G3/4:1.5%) Uġigħ fl-estremitajiet (10.0%) (G3/4: 0.7%)
English: Despite reduction to 0.62 mg/m2
Maltese: Minkejja tnaqqis għal 0.62 mg/m2
English: In vitro studies have also indicated that eribulin is not a substrate for OCT1.
Maltese: Studji in vitro indikaw ukoll illi eribulin mhuwiex sottostrat għal OCT1.
English: Despite reduction to 0.97 mg/m2
Maltese: Minkejja tnaqqis għal 0.97 mg/m2
English: Fatigue/Asthenia (53.2%) (G3/4 : 7.7%) Pyrexia (21.8%) (G3/4: 0.7%)
Maltese: Għeja kbira/Astenja (53.2%) (G3/4: 7.7%) Deni (21.8%) (G3/4: 0.7%)
English: HER2 Positive
Maltese: HER2 Pożittiv
English: nosebleed - Dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling - Swelling of soft tissues, pains (in particular chest, back and bone pain), muscle spasm or weakness - Mouth, respiratory and urinary tract infections, painful urination - Sore throat, sore or runny nose, flu-like symptoms, throat pain - Liver function test abnormalities, altered level of sugar, bilirubin, phosphates, potassium,
Maltese: - Tnaqqis fin-numru ta' plejtlits (li jista' jirriżulta fi tbenġil jew id-demm idum aktar biex jieqaf ħiereġ) - Infezzjoni b'deni, pnewmonja, tertir ta' bard - Rata mgħaġġla ta' taħbit tal-qalb, fwawar - Mejt, sturdament - Żieda fil-produzzjoni ta' dmugħ, konġuntivite (ħmura u dulur tal-wiċċ tal-għajnejn), tinfaraġ - Deidratazzjoni, ħalq xott, ponot minħabba infezzjoni virali, tbajja' bojod fil-ħalq, indiġestjoni,
English: The recommended dose of eribulin in patients with moderate hepatic impairment (Child-Pugh B) is 0.62 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Maltese: Id-doża rakkomandata ta' eribulin f'pazjenti b'indeboliment moderat tal-fwied (Child-Pugh B) hi ta' 0.62 mg/m2 mogħtija minn ġo vina fuq perijodu ta' minn 2 sa 5 minuti f'Jiem 1 u 8 ta' ċiklu ta' 21
English: The median time to Grade 2 peripheral neuropathy was 12.6 weeks (post 4 cycles).
Maltese: Iż-żmien medjan għal newropatija periferali ta' Grad 2 kien ta' 12.6 ġimgħat (wara 4 ċikli).
English: For information relevant to the handling of cytotoxic medicinal products see section 6.6.
Maltese: Għal informazzjoni rilevanti fir-rigward tal-immaniġġjar ta' prodotti mediċinali ċitotossiċi, ara sezzjoni 6.6.
English: In the 1559 breast cancer patients the most common adverse reaction resulting in discontinuation of treatment with eribulin was peripheral neuropathy (3.4%).
Maltese: Fl-1559 pazjenti b'kanċer tas-sider, l-iktar reazzjoni avversa komuni li rriżultat fit-twaqqif tal-kura b'eribulin kienet newropatija periferali (3.4%).
English: The pharmacokinetics of eribulin are characterized by a rapid distribution phase followed by a prolonged elimination phase, with a mean terminal half-life of approximately 40 h. It has a large volume of distribution (range of means 43 to 114 l/m2).
Maltese: Il-farmakokinetika ta' eribulin hi kkaratterizzata minn fażi ta' distribuzzjoni mgħaġġla segwita minn fażi mtawla ta' eliminazzjoni, b'medja ta' half-life terminali ta' madwar 40 siegħa.
English: In vitro data indicate that eribulin is a mild inhibitor of the important drug metabolising enzyme CYP3A4.
Maltese: Dejta in vitro tindika li eribulin hu inibitur ħafif tal-enzima importanti CYP3A4 li timmetabolizza lmediċina.
English: Weight decreased (11.4%) (G3/4: 0.4%)d a
Maltese: Tnaqqis fil-piż (11.4%) (G3/4: 0.4%)d a
English: Neutropenic sepsis (0.2%) (G3/4: 0.2%)a
Maltese: Xokk Settiku (0.2%) (G3/4:0.2%)a
English: Compared to patients with normal hepatic function (n=6), eribulin exposure increased 1.8-fold and 3-fold in patients with mild and moderate hepatic impairment, respectively.
Maltese: Meta mqabbel ma' pazjenti b'funzjoni normali tal-fwied (n=6), l-espożizzjoni għal eribulin żdiedet b'1.8 darbiet u 3 darbiet f'pazjenti b'indeboliment ħafif u moderat tal-fwied, rispettivament.
English: moderate (30-50 ml/min; n=7) or severe (15-<30 ml/min; n=6) renal impairment.
Maltese: Il-farmakokinetika ta' eribulin ġiet evalwata fi studju ta' Fażi 1 f'pazjenti b'funzjoni normali tal-kliewi (Tneħħija tal-kreatinina: ≥ 80 ml/min; n=6), indeboliment moderat (30-50 ml/min; n=7) jew sever tal-kliewi (15-<30 ml/min; n=6).
English: Study 305 Updated Overall Survival ITT Population
Maltese: Studju 305 Sopravivenza Totali Aġġornata tal-Popolazzjoni ITT
English: Ewopharma AG Tel. +370 5 248 73 50
Maltese: Ewopharma d.o.o. Tel: +386 590 848 40
English: Gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, and stomatitis are among reported undesirable effects.
Maltese: Tossiċitajiet gastrointestinali, li jidhru bħala anoreksja, dardir, rimettar, dijarea, stitikezza, u stomatite huma fost l-effetti mhux mixtieqa rrappurtati.
English: Oropharyngeal pain Epistaxis
Maltese: Popolazzjoni pedjatrika
English: Hepatotoxicity (0.8%) (G3/4: 0.6%)
Maltese: Epatotossiċità (0.8%) (G3/4: 0.6%)
English: Dose related increased number of resorptions and decreased foetal weight were observed at doses ≥ 0.088 mg/kg and increased incidence of malformations (absence of lower jaw, tongue, stomach and spleen) was recorded at 0.133 mg/kg.
Maltese: 088 mg/kg u żieda fl-inċidenza ta' malformazzjonijiet (assenza tax-xedaq t'isfel, ilsien, stonku u milsa) kienu rreġistrati f'doża ta' 0.133 mg/kg.
English: Patients should be closely monitored for signs of peripheral motor and sensory neuropathy.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali ta' newropatija periferali motorea u tas-sensi.
English: Eribulin was positive in the mouse lymphoma mutagenesis assay and was clastogenic in the in vivo rat micronucleus assay.
Maltese: Eribulin kien pożittiv fl-assaġġ tal-mutaġenesi tal-limfoma tal-ġrieden u kien klastoġeniku fl-assaġġ tal-mikronukleu tal-firien in vivo.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
English: In the event of extravasation, treatment should be symptomatic.
Maltese: F'każ ta' ekstravażjoni, ilkura għandha tkun sintomatika.
English: Mucosal
Maltese: Liposarkoma
English: The administration of HALAVEN should be delayed on Day 1 or Day 8 for any of the following: - Absolute neutrophil count (ANC) < 1 x 109/l - Platelets < 75 x 109/l - Grade 3 or 4 non-hematological toxicities.
Maltese: - Għadd assolut ta' newtrofili (ANC) < 1 x 109/l - Plejtlits < 75 x 109/l - Tossiċitajiet mhux ematoloġiċi ta' Grad 3 jew 4.
English: 5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 ml of solution.
Maltese: Kunjett tal-ħġieġ ta' tip I, ta' 5 ml, b'tapp tal-lastku tal-butyl, miksi bit-teflon, u b'over seal talaluminju flip-off, li jkun fih 2 mg ta' soluzzjoni.
English: Study 301 Overall Survival ITT Population
Maltese: Studju 301 Sopravivenza Totali tal-Popolazzjoni ITT
English: Although data are limited, patients with bilirubin > 1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia (see also sections 4.2 and 5.2).
Maltese: Għalkemm id-dejta hi limitata, pazjenti b'bilirubina ta' > 1.5 x ULN ukoll għandhom inċidenza ogħla ta' newtropenija ta' Grad 4 u newtropenija bid-deni (ara wkoll sezzjonijiet 4.2 u 5.2).
English: The study met its primary endpoint with an overall survival (OS) result that was statistically significantly better in the eribulin group compared to TPC at 55% of events.
Maltese: L-istudju laħaq il-punt aħħari primarju tiegħu b'riżultat ta' sopravivenza totali (OS) li kien aħjar b'mod statistikament sinifikanti fil-grupp li kien qed jiġi kkurat b'eribulin meta mqabbel ma' TPC f'55% tal-avvenimenti.
English: In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1.
Maltese: Fi studju tal-ECG mhux ikkontrollat u open-label li sar fuq 26 pazjent, ġie osservat titwil tal-QT f'Jum 8, indipendentement mill-konċentrazzjoni ta' eribulin, mingħajr l-ebda titwil tal-QT osservat f'Jum 1.
English: HALAVEN may cause side effects such as tiredness (very common) and dizziness (common).
Maltese: HALAVEN jista' jikkawża effetti sekondarji bħal għeja (komuni ħafna) u sturdament (komuni).
English: It must not be mixed with other medicinal products and should not be diluted in glucose 5% infusion solution.
Maltese: M'għandux jitħallat ma' prodotti mediċinali oħrajn u m'għandux jiġi dilwit fi glucose 5% soluzzjoni għall-infużjoni.
English: - The other ingredients are ethanol and water for injections, with hydrochloric acid and sodium hydroxide possibly present in very small amounts.
Maltese: - L-ingredjenti l-oħra huma ethanol u ilma għal injezzjonijiet, b'hydrochloric acid u sodium hydroxide li possibbilment ikunu preżenti f'ammonti żgħar ħafna.
English: In liposarcoma the efficacy of eribulin is supported by the pivotal Phase 3 sarcoma study (Study 309).
Maltese: Fil-liposarkoma, l-effikaċja ta' eribulin hi appoġġjata minn studju importanti ħafna ta' Fażi 3 dwar issarkoma (Studju 309).
English: Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged and irreversible mitotic blockage.
Maltese: Eribulin jeżerċita l-effetti tiegħu permezz ta' mekkaniżmu antimitotiku bbażat fuq tubulin li jwassal għall-imblokk taċ-ċiklu taċ-ċelluli G2/M, l-interruzzjoni ta' mitotic spindles, u, finalment, għall-mewt apoptotika taċ-ċelluli wara imblokk mitotiku fit-tul u irriversibbli.
English: Median (months) Hazard Ratio (95% CI)
Maltese: Medjan (xhur) Proporzjon ta' Periklu (95% CI)a
English: If not used immediately HALAVEN as the undiluted solution in a syringe should not normally be stored longer than 4 hours at 25°C and ambient lighting, or 24 hours at 2°C - 8°C.
Maltese: Jekk ma jintużax immedjatament, HALAVEN bħala s-soluzzjoni mhux dilwita f'siringa, normalment m'għandux jinħażen għal aktar minn 4 sigħat f'temperatura ta' 25°C u dawl ambjentali, jew 24 siegħa f'temperatura ta' 2°C - 8°C.
English: Time (months) NUMBER OF PATIENTS AT RISK: HALAVEN 71 63 51 43 39 34 30 20 15 12 Dacarbazine 72 59 42 33 22 17 12 11 6
Maltese: Dacarbazine 72 59 42 33 22 17 12 11 6
English: The recommended dose of eribulin in patients with mild hepatic impairment (Child-Pugh A) is 0.97 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Maltese: Id-doża rakkomandata ta' eribulin f'pazjenti b'indeboliment ħafif tal-fwied (Child-Pugh A) hi ta' 0.97 mg/m2 mogħtija minn ġo vina fuq perijodu ta' minn 2 sa 5 minuti f'Jiem 1 u 8 ta' ċiklu ta' 21
English: Cases of disseminated intravascular coagulation have been reported, typically in association with neutropenia and/or sepsis.
Maltese: Każijiet ta' koagulazzjoni intravaskulari mxerrda ġew irrappurtati, tipikament b'rabta ma' newtropenija u/jew sepsis.
English: Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin.
Maltese: Kull kunjett ta' 3 ml fih eribulin mesilate ekwivalenti għal 1.32 mg ta' eribulin.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding
Maltese: - Ipersensittività għas-sustanza attiva jew għal kwalunkwe eċċipjent elenkat fit-taqsima 6.1 - Treddigħ
English: 5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 3 ml of solution.
Maltese: Kunjett tal-ħġieġ ta' tip I, ta' 5 ml, b'tapp tal-lastku tal-butyl, miksi bit-teflon, u b'over seal talaluminju flip-off, li jkun fih 3 mg ta' soluzzjoni.
English: Dehydration (2.8 %) (G3/4: 0.5%)d
Maltese: Ipomanjesemija (2.8%) (G3/4: 0.3%) Deidratazzjoni (2.8 %) (G3/4: 0.5%)d
English: In addition there were 3 fatal events of sepsis (0.2%) and one of septic shock (0.1%).
Maltese: Barra minn hekk, kien hemm 3 avvenimenti fatali ta' sepsis (0.2%) u wieħed ta' xokk settiku (0.1%).
English: Out of the 404 sarcoma patients, 2 patients discontinued treatment with eribulin due to peripheral neuropathy.
Maltese: Mill-404 pazjent b'sarkoma, 2 pazjenti ma komplewx il-kura b'eribulin minħabba newropatija periferali.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna wara EXP.
English: See section 4.2 for dosage recommendation.
Maltese: Ara sezzjoni 4.2 għal rakkomandazzjoni dwar id-dożaġġ.
English: Hyperbilirubinaemia (1.4%) (G3/4: 0.4%)
Maltese: Iperbilirubinemija (1.4%) (G3/4: 0.4%)
English: HALAVEN must not be used during breast-feeding because of the possibility of risk to the child.
Maltese: HALAVEN ma jridx jintuża waqt it-treddigħ minħabba l-possibbiltà ta' riskju lit-tarbija.
English: NAME OF THE MEDICINAL PRODUCT HALAVEN 0.44 mg/ml solution for injection Eribulin
Maltese: HALAVEN 0.44 mg/ml soluzzjoni għall-injezzjoni eribulin
English: How to store HALAVEN
Maltese: X'fih HALAVEN
English: Dry mouth Dyspepsia (6.5%) (G3/4: 0.3%)d
Maltese: Ħalq niexef Dispepsja (6.5%) (G3/4: 0.3%)d
English: Administration of HALAVEN at a dose of 0.97 mg/m2 to patients with mild hepatic impairment and 0.62 mg/m2 to patients with moderate hepatic impairment resulted in a somewhat higher exposure than after a dose of 1.23 mg/m2 to patients with normal hepatic function.
Maltese: L-għoti ta' HALAVEN f'doża ta' 0.97 mg/m2 lil pazjenti b'indeboliment ħafif tal-fwied u 0.62 mg/m2 lil pazjenti b'indeboliment moderat tal-fwied, irriżulta f'xi ftit espożizzjoni ogħla milli wara doża ta' 1.23 mg/m2 lil pazjenti b'funzjoni normali tal-fwied.
English: Where Grade 3 or 4 reactions occurred, the actual total frequency and the frequency of Grade 3 or 4 reactions are given.
Maltese: Fejn reazzjonijiet ta' Grad 3 jew 4 seħħew, il-frekwenza totali attwali u l-frekwenza ta' reazzjonijiet ta' Grad 3 jew 4 qed jingħataw.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin
Maltese: Kull kunjett ta' 3 ml fih eribulin mesilate ekwivalenti għal 1.32 mg ta' eribulin
English: Neutrophil counts of < 0.5 x 109/l that lasted for more than 7 days occurred in 13% of breast cancer patients treated with eribulin in the EMBRACE study.
Maltese: Għadd ta' newtrofili ta' < 0.5 x 109/l li dam għal aktar minn 7 ijiem seħħ fi 13% tal-pazjenti b'kanċer tas-sider ikkurati b'eribulin fl-istudju EMBRACE.
English: The combined grouped TEAE and neutrophil laboratory abnormality frequencies were 307/404 (76.0%) and 1314/1559 (84.3%), respectively.
Maltese: (76.0%) u 1314/1559 (84.3%), rispettivament.
English: - Decrease in the number of white blood cells or red blood cells - Tiredness or weakness - Nausea, vomiting, constipation, diarrhoea - Numbness, tingling or prickling sensations - Fever - Loss of appetite, weight loss - Difficulty breathing, cough - Pain in the joints, muscles and back - Headache - Hair loss
Maltese: - Tnaqqis fin-numru ta' ċelluli bojod tad-demm jew ta' ċelluli ħomor tad-demm - Għeja jew dgħufija - Nawseja, rimettar, stitikezza, dijareja - Sensazzjonijiet ta' tmewwit, tnemnim jew tingiż - Deni - Nuqqas t'aptit, tnaqqis fil-piż - Diffikultà biex tieħu n-nifs, sogħla - Uġigħ fil-ġogi, muskoli u fid-dahar - Uġigħ ta' ras - Telf ta' xagħar
English: Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin.
Maltese: Kull kunjett ta' 2 ml fih eribulin mesilate ekwivalenti għal 0.88 mg ta' eribulin.
English: This patient group has not been studied.
Maltese: Dan il-grupp ta' pazjenti ma ġiex studjat.
English: The updated OS analysis showed a survival benefit for the eribulin group compared to TPC both in capecitabine pre-treated patients with a HR of 0.787 (95% CI: 0.645, 0.961), and for the capecitabine-naïve patients with a corresponding HR of 0.865 (95% CI: 0.606, 1.233).
Maltese: 787 (95% CI 0.645, 0.961), u għal pazjenti li qatt ma ngħataw capecitabine fil-passat b'HR korrispondenti ta' 0.865 (95% CI 0.606, 1.233).
English: By independent review, the median progression free survival (PFS) was 3.7 months for eribulin compared to 2.2 months for the TPC arm (HR 0.865, 95% CI: 0.714, 1.048, p=0.137).
Maltese: Skont reviżjoni indipendenti, il-medjan tas-sopravivenza ħielsa mill-progressjoni (PFS) kien ta' 3.7 xhur għal eribulin meta mqabbel ma' 2.2 xhur għall-parti tal-istudju dwar TPC (HR 0.865, 95% CI:
English: In some patients with normal/abnormal liver enzymes prior treatment with eribulin, increased levels of liver enzymes have been reported with initiation of eribulin treatment.
Maltese: F'xi pazjenti b'enzimi normali/anormali tal-fwied qabel il-kura b'eribulin, livelli ogħla ta' enzimi talfwied ġew irrappurtati mal-bidu tal-kura b'eribulin.
English: HALAVEN (n=508)
Maltese: Parametru ta' Effikaċja HALAVEN (n=508)
English: The recommended dose of eribulin as the ready to use solution is 1.23 mg/m2 which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle.
Maltese: Id-doża rakkomandata ta' eribulin bħala s-soluzzjoni lesta għall-użu hi ta' 1.23 mg/m2 li għandha tingħata minn ġo vina fuq perijodu ta' 2 sa 5 minuti f'Jiem 1 u 8 ta' kull ċiklu ta' 21 jum.
English: HALAVEN will be given to you by a doctor or nurse as an injection into a vein, over a period of 2 to 5 minutes.
Maltese: HALAVEN ser jingħatalek minn tabib jew infermiera bħala injezzjoni ġo vina, fuq perijodu ta' 2 sa 5 minuti.
English: Hyperhidrosis Palmar plantar erythrodysaesthesia (1.0%) (G3/4: 0.1%)d
Maltese: Eritrodisestesija tal-idejn u tas-saqajn (1.0%) (G3/4: 0.1%)d
English: ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias or concomittant treatment with medicinal products known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities.
Maltese: Monitoraġġ b'ECG hu rakkomandat jekk it-terapija tinbeda f'pazjenti b'insuffiċjenza konġestiva tal-qalb, bradiarritmiji, jew kura fl-istess ħin bi prodotti mediċinali magħrufa li jtawlu lintervall tal-QT, li jinkludu antiarritimiċi ta' Klassi
English: Eisai Ltd. Τηλ: + 44 (0)208 600 1400
Maltese: Τηλ: +44 (0)208 600 1400
English: HALAVEN contains ethanol (alcohol) This medicine contains small amounts of ethanol (alcohol), less than 100 mg in a vial.
Maltese: Dan il-prodott mediċinali fih ammonti żgħar ta' ethanol (alkoħol), anqas minn 100 mg f'kull doża.
English: In response evaluable patients, the objective response rate by the RECIST criteria was 12.2% (95% CI: 9.4%, 15.5%) by independent review for the eribulin arm compared to 4.7% (95% CI: 2.3%, 8.4%) for the TPC arm.
Maltese: F'pazjenti li setgħu jiġu evalwati, ir-rata ta' rispons oġġettiv skont il-kriterja RECIST kienet ta' 12.2% (95% CI: 9.4%, 15.
English: The second Phase 3 study in earlier line metastatic breast cancer, Study 301, was an open-label, randomized, study in patients (n=1102) with locally advanced or metastatic breast cancer to investigate the efficacy of HALAVEN monotherapy compared to capecitabine monotherapy in terms of OS and PFS as co-primary endpoint.
Maltese: It-tieni studju ta' Fażi 3 dwar pazjenti b'kanċer metastatiku tas-sider li kienu fi stadju iktar bikri tattrattament tagħhom, Studju 301, kien studju open-label, li fih il-parteċipanti ntgħażlu b'mod każwali, f'pazjenti (n = 1102) b'kanċer tas-sider lokalment avvanzat jew metastatiku, biex jinvestiga l-effikaċja ta' HALAVEN mogħti waħdu meta mqabbel ma' capecitabine mogħti waħdu f'termini ta' OS u PFS bħala punt aħħari koprimarju.
English: Febrile neutropenia occurred in < 5% of patients treated with eribulin.
Maltese: Newtropenija bid-deni seħħet f'< 5% ta' pazjenti li kienu kkurati b'eribulin.
English: After administration of 14C-eribulin to patients, approximately 82% of the dose was eliminated in faeces and 9% in urine indicating that renal clearance is not a significant route of eribulin elimination.
Maltese: Wara l-għoti ta' 14C-eribulin lil pazjenti, madwar 82% tal-doża ġiet eliminata fl-ippurgar u 9% fl awrina, li jindika li tneħħija mill-kliewi mhijiex rotta sinifikanti tat-tneħħija ta' eribulin.
English: Conjunctivitis
Maltese: Epatotossiċità
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 0.88 mg eribulin in 2 ml
Maltese: Fih 0.88 mg ta' eribulin f'2 ml
English: Eribulin mesilate is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents.
Maltese: Eribulin mesilate hu inibitur tad-dinamika tal-mikrotubuli li jappartjeni għall-klassi halichondrin ta' mediċini antineoplastiċi.
English: HALAVEN is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease (see section 5.1).
Maltese: HALAVEN hu indikat għall-kura ta' pazjenti adulti b'kanċer tas-sider lokalment avvanzat jew metastatiku li jkunu marru għall-agħar wara mill-inqas kors kimoterapewtiku wieħed għal mard avvanzat (ara sezzjoni 5.1).
English: No drug-drug interactions are expected with CYP3A4 inhibitors and inducers.
Maltese: L-ebda interazzjonijiet bejn mediċina u oħra mhuma mistennija b'inibituri u indutturi ta' CYP3A4.
English: Study 309 - Overall Survival in the Liposarcoma Subgroup
Maltese: Globali fis-Sottogrupp tal-Liposarkoma
English: NAME OF THE MEDICINAL PRODUCT HALAVEN 0.44 mg/ml solution for injection
Maltese: HALAVEN 0.44 mg/ml soluzzjoni għall-injezzjoni
English: Some patients with moderately or severely impaired renal function (creatinine clearance <50 ml/min) may have increased eribulin exposure and may need a reduction of the dose.
Maltese: Xi pazjenti b'indeboliment moderat jew sever fil-funzjoni tal-kliewi (tneħħija tal-krejatinina ta' <50 ml/min), jista' jkollhom żieda fl-esponiment ta' eribulin u jista' jkollhom bżonn ta' tnaqqis fid-doża.
English: Eribulin is embryotoxic, foetotoxic, and teratogenic in rats.
Maltese: Eribulin hu embrijotossiku, fetotossiku, u teratoġeniku fil-firien.
English: The safety profile of eribulin in elderly patients (≥ 65 years of age) was similar to that of patients <65 years of age except for asthenia/fatigue which showed an increasing trend with age.
Maltese: Il-profil tas-sigurtà ta' eribulin f'pazjenti anzjani (≥ 65 sena) kien simili għal dak ta' pazjenti ta' < 65 sena ħlief għal astenja/għeja li wrew żieda fl-andament mal-età.