FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used in patients with a history of angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor, in patients with hereditary or idiopathic angioedema or in patients with kidney impairment or anuria (a condition in which a patient cannot make or pass urine).
Maltese: Ma għandux jintuża f'pazjenti bi storja ta' anġjoedema (nefħa taħt ilġilda) assoċjata ma' trattament preċedenti b'inibitur ta' ACE, f'pazjenti b'anġjoedema ereditarja jew idjopatika jew f'pazjenti b'indeboliment tal-kliewi jew anurja (kundizzjoni li ma tħallix lill-pazjent jipproduċi jew jgħaddi l-urina).
English: Other sections of the prescribing information such as those on special warnings, interactions with other medicines, and pregnancy and lactation and side effects were also harmonised.
Maltese: Sezzjonijiet oħrajn tal-informazzjoni dwar il-preskrizzjoni bħal dawk dwar twissijiet speċjali, interazzjonijiet ma' mediċini oħra, u t-tqala u t-treddigħ u l-effetti mhux mixtieqa ġew armonizzati wkoll.
English: Vascace Plus should not be used in patients who are hypersensitive (allergic) to cilazapril or other ACE inhibitors, hydrochlorothiazide or other thiazides diuretics, or to any other ingredients of the medicine.
Maltese: Vascace Plus ma għandux jintuża f'pazjenti li għandhom sensittività eċċessiva (allerġiċi) għal cilazapril jew għal xi inibituri oħra ta' ACE, idroklorotijażide jew dijuretiċi tijażidi oħra, jew għal xi waħda missustanzi l-oħra tal-mediċina.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: II huwa vażokostrittur qawwi (sustanza li traqqaq il-vini tad-demm).
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 tad-diskussjoni xjentifika li saret fil-Kumitat, kien tal-fehma li l-SmPCs, it-tikketta u l-fuljetti ta' tagħrif għandhom ikunu armonizzati fl-UE kollha.
English: HER2 Negative
Maltese: HER2 Negattiv
English: - The active substance is eribulin.
Maltese: - Is-sustanza attiva hi eribulin.
English: Date of latest renewal: 19 November 2015
Maltese: Data tal-aħħar tiġdid: 19 ta' Novembru, 2015
English: TIME (months) NUMBER OF PATIENTS AT RISK HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 Capecitabine 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
Maltese: F'RISKJU HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 Capecitabine 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
English: Number of Events
Maltese: Numru ta' Avvenimenti
English: No in vivo data are available.
Maltese: M'hemmx dejta in vivo disponibbli.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 March 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 ta' Marzu, 2011
English: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom.
Maltese: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ir-Renju Unit.
English: OS in ITT Population HALAVEN (n=554)
Maltese: OS fil-Popolazzjoni ITT HALAVEN (n=554)
English: Common (Frequency %)
Maltese: Komuni (Frekwenza %)
English: No Grade 4 events Rare
Maltese: L-ebda każijiet ta' Grad 4 Rari
English: P value (log rank)
Maltese: Valur p (log rank)
English: Eribulin does not inhibit the CYP enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 2E1 at relevant clinical concentrations.
Maltese: Eribulin ma jinibixxix l-enzimi CYP CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 jew 2E1 f'konċentrazzjonijiet kliniċi rilevanti.
English: Nominal P value (log rank)
Maltese: Valur p nominali (log rank)
English: Please note:
Maltese: Mhux ematoloġiċi:
English: Eribulin is not a substrate of breast cancer resistance protein (BCRP), organic anion (OAT1, OAT3, OATP1B1, OATP1B3), multi-drug resistance-associated protein (MRP2, MRP4) and bile salt export pump (BSEP) transporters.
Maltese: Eribulin mhuwiex substrat tat-trasportaturi tal-proteina ta' reżistenza għall-kanċer tas-sider (BCRP), trasportaturi ta' anion organiku (OAT1, OAT3, OATP1B1, OATP1B3), trasportaturi ta' proteina assoċjata mar-reżistenza għal ħafna mediċini (MRP2, MRP4) u trasportaturi tal-bile salt export pump (BSEP).
English: Stevens-Johnson syndrome/ Toxic epidermal necrolysisb
Maltese: **Sindrome ta' StevensJohnson/ Nekrolisi epidermali tossika b
English: Includes Grade 5 events.
Maltese: Tinkludi każijiet ta' Grad 5
English: Pregnant rats were treated with eribulin mesilate equivalent to 0.009, 0.027, 0.088 and 0.133 mg/kg eribulin at gestation days 8, 10 and 12.
Maltese: Firien tqal kienu kkurati b'eribulin mesilate ekwivalenti għal 0.009, 0.027, 0.088 u 0.133 mg/kg ta' eribulin f'jiem 8, 10 u 12 tat-tqala.
English: Ewopharma AG Sp. z o.o.
Maltese: Ewopharma AG Sp. z o.o. Tel.:
English: See section 4.2 for information on paediatric use.
Maltese: Ara t-taqsima 4.2 għal informazzjoni dwar l-użu pedjatriku.
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Maltese: Il-kategoriji ta' frekwenza huma definiti bħala: 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) u rari ħafna (< 1/10,000).
English: - Keep this leaflet.
Maltese: PROPORZJON TA' PAZJENTI
English: Dacarbazine HALAVEN Dacarbazine (n=152)
Maltese: Popolazzjoni ITT HALAVEN Dacarbazine HALAVEN Dacarbazine HALAVEN Dacarbazine (n=71)
English: *Disseminated intravascular coagulation b
Maltese: *Koagulazzj oni intravaskular i mxerrda b
English: Eribulin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test).
Maltese: Eribulin ma kienx mutaġeniku in vitro fl-assaġġ tal-mutazzjoni reverse batterjali (test ta' Ames).
English: Creatinine clearance was estimated with the Cockcroft-Gault formula.
Maltese: It-tneħħija talkreatinina ġiet stmata bil-formula ta' Cockcroft-Gault.
English: Objective response rate as assessed by independent review was also similar between eribulin and capecitabine; 11.0% (95% CI: 8.5, 13.9) in the eribulin group and 11.5% (95% CI: 8.9, 14.5) in the capecitabine group.
Maltese: Irrata ta' rispons oġġettiv kif evalwata minn reviżjoni indipendenti kienet ukoll simili bejn eribulin u capecitabine; 11.0% (95% CI: 8.5, 13.9) fil-grupp ta' eribulin u 11.5% (95% CI: 8.9, 14.5) fil-grupp ta' capecitabine.
English: Hydrochloric acid (for pH-adjustment)
Maltese: Hydrochloric acid (għal aġġustament tal-pH)
English: It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.
Maltese: Hu analogu sintetiku strutturalment issimplifikat ta' halichondrin B, prodott naturali iżolat mill-isponża tal-baħar Halichondria okadai.
English: Includes preferred terms of peripheral neuropathy, peripheral motor neuropathy, polyneuropathy, paraesthesia, peripheral sensory neuropathy, peripheral sensorimotor neuropathy and demyelinating polyneuropathy d
Maltese: Tinkludi termini ppreferuti ta' newropatija periferali, newropatija periferali tal-moviment, polinewropatija, parestesija, newropatija periferali tas-sensi, newropatija periferali sensorimotorea u polinewropatija b'telf ta' myelin d
English: In the EU the recommended dose refers to the base of the active substance (eribulin).
Maltese: Fl-UE, id-doża rakkomandata tirreferi għall-forma bażika tas-sustanza attiva (eribulin).
English: A study evaluated the pharmacokinetics of eribulin in patients with mild (Child-Pugh A; n=7) and moderate (Child-Pugh B; n=4) hepatic impairment due to liver metastases.
Maltese: Studju evalwa l-farmakokinetika ta' eribulin f'pazjenti b'indeboliment ħafif (Child-Pugh A; n=7) u moderat tal-fwied (Child-Pugh B; n=4) minħabba metastasi tal-fwied.
English: EU/1/11/678/002 6 vials
Maltese: EU/1/11/678/002 6 kunjetti
English: Eribulin exposure (AUC and Cmax) was unaffected by ketoconazole, a CYP3A4 and P glycoprotein (Pgp) inhibitor, and rifampicin, a CYP3A4 inducer.
Maltese: L-espożizzjoni għal Eribulin (AUC u Cmax) ma ġietx affettwata minn ketoconazole, inibitur ta' CYP3A4 u P glikoproteina (Pgp), u rifampicin, induttur ta' CYP3A4.
English: The HER2 status of the patients was: 16.1% positive, 74.2% negative and 9.7% unknown, whilst 18.9% of patients were triple negative.
Maltese: L-istatus HER2 tal-pazjenti kien: 16.1% pożittiv, 74.2% negattiv u 9.7% mhux magħruf, filwaqt li 18.9% tal-pazjenti kienu negattivi tripli.
English: Uncommon (Frequency %)
Maltese: Mhux komuni (Frekwenza %)
English: They were randomized 2:1 to receive either HALAVEN, or treatment of physician's choice (TPC), which consisted of 97% chemotherapy (26% vinorelbine, 18% gemcitabine, 18% capecitabine, 16% taxane, 9% anthracycline, 10% other chemotherapy), or 3% hormonal therapy.
Maltese: Huma ntgħażlu b'mod każwali 2:1 biex jirċievu jew HALAVEN, jew il-kura tal-għażla tat-tabib (TPC), li kienet tikkonsisti f'97% kimoterapija (26% vinorelbine, 18% gemcitabine, 18% capecitabine, 16% taxane, 9% anthracycline, 10% kimoterapija oħra), jew 3% terapija ormonali.
English: EU/1/11/678/004 6 vials
Maltese: EU/1/11/678/004 6 kunjetti
English: HALAVEN is usually given on Days 1 and 8 of every 21-day cycle.
Maltese: HALAVEN normalment jingħata f'Jiem 1 u 8 ta' kull ċiklu ta' 21 jum.
English: Eribulin is mainly (up to 70%) eliminated through biliary excretion.
Maltese: Eribulin jiġi eliminat primarjament (sa 70%) permezz ta' tneħħija biljari.
English: The plasma protein binding of eribulin (100-1000 ng/ml) ranged from 49% to 65% in human plasma.
Maltese: It-twaħħil ta' eribulin mal-proteini fil-plażma (100-1000 ng/ml) varja minn 49% sa 65% fil-plażma tal-bniedem.
English: Eribulin has a low clearance (range of means 1.16 to 2.42 l/h/m2).
Maltese: Eribulin għandu tneħħija baxxa (medda ta' medji minn 1.16 sa 2.42 l/siegħa/m2).
English: Hazard Ratio (95% CI) p-value (log rank)
Maltese: Medjan (xhur) Proporzjon ta' Periklu (95% CI) valur p (log rank)
English: Overall survival Number of Events Median months Hazard Ratio (95% CI) Nominal pvalue Progression-free survival Number of Events Median months Hazard Ratio (95% CI) Nominal pvalue
Maltese: Sopravivenza totali Numru ta' Avvenimenti Medjan (xhur) Proporzjon ta' Periklu (95% CI) Valur p nominali Sopravivenza ħielsa mill-progressjoni Numru ta' Avvenimenti Medjan xhur Proporzjon ta' Periklu (95% CI) Valur p nominali
English: It should not be diluted in glucose 5% infusion solution.
Maltese: M'għandhiex tiġi dilwita fi glucose 5% soluzzjoni għallinfużjoni.
English: Hyperglycaemia Hypophosphataemia Hypocalcaemia
Maltese: Ipergliċemija Ipofosfatemija Ipokalċimija
English: Adverse Reactions - all Grades Very Common (Frequency %)
Maltese: Reazzjonijiet Avversi - il-Gradi kollha Komuni Ħafna (Frekwenza %)
English: Diluted solutions of HALAVEN (0.018 mg/ml to 0.18 mg/ml eribulin in sodium chloride 9 mg/ml (0.9%)) solution for injection should not be stored longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: Soluzzjonijiet dilwiti ta' HALAVEN (0.018 mg/ml sa 0.18 mg/ml ta' eribulin fi sodium chloride 9 mg/ml (0.9%)) soluzzjoni għall-injezzjoni m'għandhomx jinħażen għal aktar minn 24 siegħa f'temperatura ta' 2°C - 8°C, ħlief jekk id-dilwizzjoni tkun saret f'kundizzjonijiet asettiċi kkontrollati u vverifikati.
English: Alanine aminotransferase increased (7.6%) (G3/4: 1.9%)d
Maltese: Żieda f'alanine aminotransferase (7.6%) (G3/4: 1.9%)d
English: Nausea (35.7%) (G3/4: 1.1%)d
Maltese: Nawseja (35.7%) (G3/4: 1.1%)d
English: Neutropenia (53.6%) (G3/4: 46.0%) Leukopenia (27.9%) (G3/4: 17.0%) Anaemia (21.8%) (G3/4: 3.0%)
Maltese: Newtropenija (53.6%) (G3/4: 46.0%) Lewkopenija (27.9%) (G3/4: 17.0%) Anemija (21.8%) (G3/4: 3.0%)
English: Capecitabine
Maltese: Capecitabine b
English: The HER2 status of the patients was: 15.3% positive, 68.5% negative and 16.2% unknown, whilst 25.8% of patients were triple negative.
Maltese: 3% pożittiv, 68.5% negattiv u 16.2% mhux magħruf, filwaqt li 25.
English: HALAVEN was not studied in patients with severe hepatic impairment (Child-Pugh C).
Maltese: HALAVEN ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh C).
English: Gamma glutamyl transferase increased (1.7%) (G3/4: 0.9%)d
Maltese: Żieda f'gamma glutamyl transferase (1.7%) (G3/4: 0.9%)d
English: In the 404 sarcoma patient population, 90 patients (22.3%) treated with eribulin were ≥ 65 years of age.
Maltese: Fil-popolazzjoni ta' 404 pazjent b'sarkoma, 90 pazjent (22.3%) ikkurati b'eribulin kellhom ≥ 65 sena.
English: Musculoskeletal pain Musculoskeletal chest pain
Maltese: Uġigħ muskoloskeletriku Uġigħ muskoloskeletriku fis-sider
English: Treatment effects of eribulin were limited to patients with liposarcoma (45% dedifferentiated, 37% myxoid/round cell and 18% pleomorphic in Study 309) based on pre-planned subgroup analyses of OS and PFS.
Maltese: L-effetti tal-kura b'eribulin kienu limitati għal pazjenti b'liposarkoma (45% dedifferenzjati, 37% ċelluli myxoid/tondi u 18% pleomorfiċi fi Studju 309) ibbażati fuq analiżi ta' sottogrupp ippjanata minn qabel ta' OS u PFS.
English: In the phase 3 sarcoma study (Study 309), 26% of the eribulin treated patients received G-CSF.
Maltese: Fl-istudju ta' fażi 3 dwar is-sarkoma (Studju 309), 26% tal-pazjenti kkurati b'eribulin irċivew G-CSF.
English: Out of 1963 breast cancer and soft tissue sarcoma patients who received eribulin at the recommended dose in clinical trials there was one fatal event each of neutropenic sepsis (0.1%) and febrile neutropenia (0.1%).
Maltese: Minn 1963 pazjent b'kanċer tas-sider u sarkoma tat-tessut artab li rċivew eribulin fid-doża rakkomandata fil-provi kliniċi, kien hemm avveniment fatali wieħed ta' sepsis newtropenika u (0.1%) u avveniment fatali wieħed ta' newtropenija bid-deni (0.1%).
English: These may be signs of a condition called Stevens Johnson syndrome/toxic epidermal necrolysis.
Maltese: Dawn jistgħu jkunu sinjali ta' kundizzjoni msejħa sindrome ta' Stevens-Johnson/nekrolisi epidermali tossika.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains eribulin mesilate equivalent to 0.44 mg eribulin.
Maltese: U KWANTITATTIVA 1 ml fih eribulin mesilate ekwivalenti għal 0.44 mg ta' eribulin.
English: Study 309 ITT Population
Maltese: Studju 309
English: In the OS update, the HR for eribulin versus TPC was 0.90 (95% CI: 0.71, 1.14) in favour of eribulin for taxane-refractory patients and 0.73 (95% CI: 0.56, 0.96) for patients not taxane-refractory.
Maltese: Fl-aġġornament ta' OS, l-HR ta' eribulin kontra TPC kien 0.90 (95% CI 0.71, 1.14) favur eribulin għal pazjenti li kienu refrattarji għal taxane u 0.73 (95% CI 0.56, 0.96) għal pazjenti mhux refrattarji għal taxane.
English: Diarrhoea (18.7%) (G3/4: 0.8%) Vomiting (18.1%) (G3/4: 1.0%)
Maltese: Dijarea (18.7%) (G3/4: 0.8%) Rimettar (18.1%) (G3/4: 1.0%)
English: Aspartate aminotransferase increased (7.7%) (G3/4: 1.4%)
Maltese: Żieda f'aspartate aminotransferase (7.7%) (G3/4: 1.4%)
English: ANC < 0.5 x 109/l lasting more than 7 days ANC < 1 x 109/l neutropenia complicated by fever or infection
Maltese: ANC < 0.5 x 109/l li ddum iktar minn 7 ijiem ANC < 1 x 109/l newtropenija kkumplikata minn deni jew infezzjoni
English: Progression free survival assessed by independent review was similar between eribulin and capecitabine with medians of 4.1 months vs 4.2 months (HR 1.08; [95% CI: 0.932, 1.250]) respectively.
Maltese: Sopravivenza mingħajr progressjoni evalwata minn reviżjoni indipendenti kienet simili bejn eribulin u capecitabine b'medjani ta' 4.1 xhur vs 4.2 xhur (HR 1.08; [95% CI: 0.932, 1.250]) rispettivament.
English: Ethanol anhydrous,Water for injections,Hydrochloric acid,Sodium hydroxide See leaflet for further information
Maltese: Ethanol anhydrous, ilma għall-injezzjonijiet, hydrochloric acid, sodium hydroxide Aqra l-fuljett ta' tagħrif għal aktar informazzjoni
English: They were randomized 1:1 to receive either eribulin 1.23 mg/m2 on days 1 and 8 of a 21 day cycle or dacarbazine 850 mg/m2, 1000 mg/m2 or 1200 mg/m2 (dose determined by the investigator prior to randomization),
Maltese: Dawn intgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew eribulin 1.23 mg/m2 f'jiem 1 u 8 ta' ċiklu ta' 21 jum, jew dacarbazine 850 mg/m2, 1000 mg/m2 jew 1200 mg/m2 (doża stabbilita mill investigatur qabel l-għażla b'mod każwali), kull 21 jum.
English: The median time to Grade 2 peripheral neuropathy was 18.4 weeks.
Maltese: Iż-żmien medjan għal newropatija periferali ta' Grad 2 kien ta' 18.4 ġimgħat.
English: There is no evidence that eribulin mesilate is a vesicant or an irritant.
Maltese: M'hemm l-ebda evidenza li eribulin mesilate hu vesikant jew irritant.
English: Fatal cases of febrile neutropenia, neutropenic sepsis, sepsis and septic shock have been reported.
Maltese: Każijiet fatali ta' newtropenija bid-deni, sepsis newtropenika, sepsis, u xokk settiku ġew irrappurtati.
English: At relevant clinical concentrations, eribulin did not inhibit BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3 transporter-mediated activity.
Maltese: F'konċentrazzjonijiet kliniċi rilevanti, eribulin ma inibixxiex l-attività tat-trasportaturi medjata minn BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 u OATP1B3.
English: Caution and monitoring for adverse events is recommended with concomitant use of substances that have a narrow therapeutic window and that are eliminated mainly via CYP3A4-mediated metabolism (eg alfentanil, cyclosporine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus).
Maltese: Il-kawtela u l-monitoraġġ għall-avvenimenti avversi huma rakkomandati bl-użu fl-istess ħin ta' sustanzi li għandhom tieqa terapewtika dejqa u li huma eliminati primarjament permezz tal-metaboliżmu medjat minn CYP3A4 (eż. alfentanil, cyclosporine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus).
English: Study 309 Leiomyosarcoma Subgroup
Maltese: Studju 309 Sottogrupp ta' Leiomijosarkoma
English: Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal (ULN) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Maltese: Pazjenti b'alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) ta' >3 x tal-limitu ta' fuq tan-normal (ULN) kellhom inċidenza ogħla ta' newtropenija ta' Grad 4 u newtropenija bid-deni.
English: Other undesirable effects include fatigue, alopecia, increased liver enzymes, sepsis and musculoskeletal pain syndrome.
Maltese: Effetti mhux mixtieqa oħrajn jinkludu għeja, alopeċja, żieda fl-enzimi tal-fwied, sepsis u s-sindrome ta' wġigħ muskuloskeletriku.
English: A 1.5-fold (90% CI: 0.9-2.5) higher dose-normalised AUC(0-inf) was observed in patients with moderate and severe renal impairment.
Maltese: Ġiet osservata AUC(0-inf) ogħla b'1.5 darbiet aktar (90% CI: 0.9-2.5) mid-doża normalizzata f'pazjenti b'indeboliment moderat jew sever tal-kliewi.
English: (22.5%) (G3/4: 0.7%)d Hypokalaemia (6.8%) Decreased appetite (G3/4: 2.0%)
Maltese: (22.5%) (G3/4: 0.7%)d Ipokalemija (6.8%) (G3/4:
English: Study 309 - Progression Free Survival in the Liposarcoma Subgroup
Maltese: Studju 309 - Sopravivenza Mingħajr Progressjoni fis-Sottogrupp tal-Liposarkoma
English: Neutropenia was reported as a Treatment Emergent Adverse Event (TEAE) in 151/404 (37.4% for all grades) in the sarcoma population, compared with 902/1559 (57.9% for all grades) in the breast cancer population.
Maltese: Newtropenija ġiet irrappurtata bħala Avveniment Avversi li Żviluppa mill-Kura (TEAE) f'151/404 (37.4% għall-gradi kollha) fil-popolazzjoni b'sarkoma, meta mqabbla ma' 902/1559 (57.9% għallgradi kollha) fil-popolazzjoni b'kanċer tas-sider.
English: Study 305 - Updated Overall Survival ( ITT Population)
Maltese: Studju 305 - Sopravivenza Globali Aġġornata (Popolazzjoni ITT)
English: HALAVEN 71 Dacarbazine
Maltese: HALAVEN 71
English: Dyspnoea (15.2%)a (G3/4: 3.5%)a Cough (15.0%) (G3/4: 0.5%)
Maltese: Dispneja (15.2%)a (G3/4: 3.5% a Sogħla (15.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: Abdominal pain Stomatitis (11.1%) (G3/4: 1.0%)
Maltese: Stomatite (11.1%) (G3/4: 1.0%)
English: Peripheral neuropathyc (35.9%) (G3/4: 7.3%) Headache (17.5%) (G3/4: 0.7%)
Maltese: Newropatija periferaliċ (35.9%) (G3/4: 7.3%) Uġigħ ta' ras (17.5%) (G3/4: 0.7%)
English: 6 vials of 3 ml
Maltese: 6 kunjetti ta' 3 ml
English: The overall survival in patients in HER2 negative and HER2 positive patients in the eribulin and control groups in Study 305 and Study 301 is shown below:
Maltese: Is-sopravivenza globali f'pazjenti HER2 negattivi u HER2 pożittivi fil-gruppi ta' eribulin u talkontroll fi Studju 305 u Studju 301 qed tintwera hawn taħt:
English: Pulmonary embolism (1.3%) (G3/4: 1.1%)a
Maltese: Emboliżmu pulmonari (1.3%) (G3/4: 1.1%)
English: Lymphopenia (5.7%) (G3/4: 2.1%) Febrile neutropenia (4.5%) (G3/4: 4.4%)
Maltese: Limfopenija (5.7%) (G3/4: 2.1%) Newtropenija bid-deni (4.5%) (G3/4: 4.4%)
English: aCox proportional hazard bStratified by geographic region, HER2/neu status
Maltese: aProporzjon ta' periklu Cox bStratifikat skont ir-reġjun ġeografiku, HER2/neu status
English: Constipation (22.3%) (G3/4: 0.7%)d
Maltese: Stitikezza (22.3%) (G3/4: 0.7%)d
English: The dose may be diluted in up to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Id-doża tista' tiġi dilwita f'sa 100 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: 6 vials of 2 ml
Maltese: 6 kunjetti ta' 2 ml
English: Haematological:
Maltese: Ematoloġiċi:
English: Platelets < 25 x 109/l thrombocytopenia Platelets < 50 x 109/l thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion Non-haematological:
Maltese: Plejtlits < 25 x 109/l tromboċitopenija Plejtlits < 50 x 109/l tromboċitopenija kkumplikata minn emorraġija jew li tkun teħtieġ trasfużjoni ta' demm jew plejtlits
English: Using aseptic technique HALAVEN can be diluted up to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Bl-użu tat-teknika asettika, HALAVEN jista' jiġi dilwit sa 100 ml b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: Urinary tract infection (8.5%) (G3/4: 0.7%) Pneumonia (1.6%) (G3/4: 1.0%) Oral candidiasis Oral herpes Upper respiratory tract infection Nasopharyngitis Rhinitis
Maltese: Infezzjoni fl-apparat talawrina (8.5%) (G3/4: 0.7%) Pnewmonja (1.6%) (G3/4: 1.0%) Kandidjasi tal-ħalq Herpes orali
English: Thrombocytopenia (4.2%) (G3/4: 0.7%)
Maltese: Tromboċitopenija (4.2%) (G3/4: 0.7%)
English: Of the 1559 breast cancer patients treated with the recommended dose of eribulin, 283 patients (18.2%) were ≥ 65 years of age.
Maltese: Mill-1559 pazjenti b'kanċer tas-sider ikkurati bid-doża rakkomandata ta' eribulin, 283 pazjent (18.2%) kellhom ≥ 65 sena.
English: Bone pain (6.7%) (G3/4: 1.2%) Muscle spasms (5.3%) (G3/4: 0.1%)
Maltese: Uġigħ fl-għadam (6.7%) (G3/4: 1.2%) Spażmi tal-muskoli (5.3%) (G3/4: 0.1%)
English: Development of Grade 3 or 4 peripheral neuropathy occurred in 7.4% of breast cancer patients and 3.5% of sarcoma patients.
Maltese: L-iżvilupp ta' newropatija periferali ta' Grad 3 jew 4 seħħ f'7.4% ta' pazjenti b'kanċer tas-sider u 3.5% tal-pazjenti b'sarkoma.
English: Study 301 - Overall Survival (ITT Population)
Maltese: Studju 301 Sopravivenza Totali (Popolazzjoni ITT)
English: Mouth ulcers
Maltese: Ulċerazzjoni talħalq