FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials across indications, the overall incidence of venous thromboembolic reactions ranged from 2.8% to 17.3% of Avastin-treated patients compared with 3.2% to 15.6% in the control arms.
Maltese: Fi provi kliniċi fil-firxa tal-indikazzjonijiet kollha, l-inċidenza globali ta' reazzjonijiet tromboembolitiċi venużi varjaw minn 2.8% sa 17.3% fil-pazjenti kkurati b'Avastin meta mqabbla ma' 3.2% sa 15.
English: Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients treated with Avastin across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Maltese: Trombo-emboliżmu arterjali: Żjieda fir-reazzjonijiet trombo-embolitiċi arterjali kienet osservata f'pazjenti kkurati b'Avastin fil-firxa tal-indikazzjonijiet kollha, inkluż aċċidenti cerebrovaskulari, infart mijokardijaku, attakki iskemiċi li jgħaddu u reazzjonijiet trombo-embolitiċi arterjali oħrajn.
English: Post-marketing experience Table 3 Adverse reactions reported in post-marketing setting System organ class (SOC)
Maltese: Klassi tas-sistemi u tal organi (SOC)
English: The typical value for central volume (Vc) was 2.73 L and 3.28 L for female and male patients respectively, which is in the range that has been described for IgGs and other monoclonal antibodies.
Maltese: Il-valur tipiku tal-volum ċentrali (Vc) kien ta' 2.73 L u 3.28 L għall-pazjenti nisa u rġiel rispettivament, li huwa fil-firxa li kienet deskritta għal IgGs u antikorpi monoklonali oħra.
English: Avastin is contraindicated in pregnancy (see section 4.3).
Maltese: Avastin huwa kontraindikat fit-tqala (ara sezzjoni 4.3).
English: No incompatibilities between Avastin and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Maltese: Ma ġew osservati l-ebda inkompatibilità bejn Avastin u polyvinyl chloride jew boroż tal-polyolefine jew settijiet ta' l-infużjoni.
English: Combination with platinum- or taxane-based therapies (see sections 4.4 and 4.8) Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed mainly in patients treated with platinumor taxane-based therapies in the treatment of NSCLC and mBC.
Maltese: Taħlita ma' terapiji bbażati fuq platinum jew taxane (ara sezzjonijiet 4.4 u 4.8) Kienu osservati rati ogħla ta' newtropenija severa, newtropenija bid-deni, jew infezzjoni bi jew mingħajr newtropenija severa (inkluż xi fatalitajiet) l-aktar f'pazjenti kkurati b'terapiji bbażati fuq platinum jew taxane fil-kura ta' NSCLC u mBC.
English: These therapies in combination with Avastin may increase the risk of severe side effects.
Maltese: Dawn it-terapiji flimkien ma' Avastin jistgħu jżidu r-riskju ta' effetti sekondarji severi.
English: Hypersensitivity reactions and infusion reactions (not known); with the following possible co-manifestations: dyspnoea/difficulty breathing, flushing/redness/rash, hypotension or hypertension, oxygen desaturation, chest pain, rigors and nausea/vomiting (see also section 4.4 and Hypersensitivity reactions/infusion reactions above)
Maltese: Reazzjonijiet ta' sensittività eċċessiva u reazzjonijiet għall-infużjoni (mhux magħrufa); bil-possibbiltà tal-manifestazzjonijiet li ġejjin fl-istess waqt: qtugħ ta' nifs/diffikultà biex tieħu n-nifs, fwawar/ħmura/raxx, pressjoni baxxa jew pressjoni għolja, desaturazzjoni ta' ossiġnu, uġigħ fis-sider, tertir u tqalligħ/rimettar (ara wkoll sezzjoni 4.4 u Reazzjonijiet ta' sensittività eċċessiva/reazzjonijiet għall-infużjoni fuq)
English: • muscle and joint pain, muscular weakness,
Maltese: • uġigħ fil-muskoli u fil-ġogi, debbulizza fil-muskoli,
English: Avastin will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Maltese: Avastin se jingħata flimkien ma' kura ta' kimoterapija li fiha mediċina fluoropyrimidine.
English: The GOG-0218 study was a phase III multicentre, randomised, double-blind, placebo-controlled, three arm study evaluating the effect of adding Avastin to an approved chemotherapy regimen (carboplatin and paclitaxel) in patients with advanced ( Stages IIIB, IIIC and IV according to FIGO staging version dated 1988) epithelial ovarian, fallopian tube or primary peritoneal cancer.
Maltese: III, multiċentriku, randomised, double-blind, ikkontrollat bilplaċebo u bi tliet gruppi li evalwa l-effett taż-żjieda ta' Avastin ma' kors ta' kimoterapija pprovat (carboplatin u paclitaxel) f'pazjenti b'kanċer avanzat (Stadji IIIB, IIIC u IV skont il-verżjoni tal-istadji ta' FIGO datata 1988) tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew.
English: Overall response rate Rate (percent)
Maltese: Rata ta' rispons totali Rata (persentaġġ)
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all Avastin treated patients.
Maltese: Riżultat fatali kien irrappurtat f'madwar terz tal-każijiet serji ta' perforazzjonijiet gastrointestinali, li jirrappreżenta bejn 0.2%-1% tal-pazjenti kollha kkurati b'Avastin.
English: Each 16 ml vial contains 400 mg of bevacizumab.
Maltese: Kull kunjett fih 400 mg bevacizumab.
English: A third group of 33 patients received bolus 5-FU/FA + Avastin (10 mg/kg every 2 weeks).
Maltese: It-tielet grupp ta' 33 pazjent irċevew 5-FU/FA + Avastin (10 mg/kg kull ġimgħatejn) bħala bolus.
English: In clinical trials of ovarian cancer, Grade 3-5 wound healing complications were observed in up to 1.8% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3).
Maltese: Fi provi kliniċi dwar kanċer tal-ovarji, komplikazzjonijiet fil-fejqan tal-feriti ta' Grad 3-5 kienu osservati f'sa 1.8% tal-pazjenti fil-grupp ta' bevacizumab kontra 0.1% fil-grupp ta' kontroll (NCICTCAE v.3).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/300/001
English: Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1250 mg/m2 intravenous infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with Avastin at a dose of 7.5 or 15 mg/kg IV infusion day 1 of every 3-week cycle.
Maltese: L-pazjenti kienu randomised għal kimoterapija bbażata fuq platinum, cisplatin 80 mg/m2 infużjoni filvini fl-ewwel ġurnata u gemcitabine 1250 mg/m2 infużjoni fil-vini fl-ewwel u fit-tmin ġurnata ta' kull ċiklu ta' 3 ġimgħat sa 6 ċikli (CG) ma' plaċebo jew CG ma' Avastin f'doża ta' 7.5 jew 15 mg/kg infużjoni IV fl-ewwel ġurnata ta' kull ċiklu ta' 3 ġimgħat.
English: In the majority of the occasions the necessary amount of Avastin can be diluted with 0.9 % sodium chloride solution for injection to a total volume of 100 mL.
Maltese: Fil-maġġoranza talokkażjonijiet l-ammont neċessarju ta' Avastin jista' jiġi dilwit ma' soluzzjoni għall-injezzjoni ta' 0.9 % sodium chloride sa volum totali ta' 100 mL.
English: Gall bladder perforation (not known)
Maltese: Perforazzjoni tal-marrara (mhux magħruf)
English: (16.2 vs. 12.0 months; p = 0.1342)
Maltese: 12.0 xhur; p = 0.1342)
English: In most clinical trials urine protein levels of ≥ 2g/24 hrs led to the holding of Avastin until recovery to < 2g/24 hrs.
Maltese: Fil-biċċa l-kbira tal-provi kliniċi livelli ta' proteina fl-awrina ta' ≥ 2g /24 hrs wasslu għal twaqqif ta' Avastin sakemm irpiljaw għal < 2g/24 hrs.
English: Table 19 PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease 2,3 CP (n = 368)
Maltese: Tabella 19 Riżultati ta' PFS1 skont l-istadju tal-marda u l-istat ta' tneħħija minn studju BO17707 (ICON7)
English: • Paclitaxel 80 mg/m2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 every 4 weeks.
Maltese: • Paclitaxel 80 mg/m2 bħala infużjoni IV ta' siegħa fi Ġranet 1, 8, 15, u 22 kull 4 ġimgħat.
English: *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Maltese: *Bevacizumab huwa antikorp monoklonali rikombinant umanizzat, prodott permezz ta' teknoloġija ta' DNA f'ċelluli tal-Ovarji tal-ĦamstSer Ċiniż.
English: The safety and efficacy of Avastin, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in trials E4599 and BO17704.
Maltese: Is-sigurtà u l-effikaċja ta' Avastin, flimkien ma' kimoterapija bbażata fuq platinum, fil-kura primarja ta' pazjenti b'kanċer fil-pulmun mhux skwamuż, taċ-ċelluli mhux żgħar (NSCLC), kienu nvestigati fil-proviE4599 u BO17704.
English: (p-value = 0.0036)
Maltese: (valur p = 0. 0036)
English: 60 years in CPP and CPB15 arms and 59 years in CPB15+ arm; and 29% of patients in CPP or CPB15 and 26% in CPB15+ were over 65 years of age.
Maltese: Il-maġġoranza tal-pazjenti inklużi fl-istudju kienu Bojod (87% fit-tliet gruppi kollha); l-età medjana kienet 60 sena fil-gruppi CPP u CPB15 u 59 sena fil-grupp CPB15+; u 29% tal-pazjenti f'CPP jew CPB15 u 26% f'CPB15+ kellhom età 'l fuq minn 65 sena.
English: • CPB15+ arm: Five cycles of Avastin (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by continued use of Avastin (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy.
Maltese: • Grupp CPB15+: Ħames ċikli ta' Avastin (15 mg/kg q3w inbeda f'ċiklu 2) flimkien ma' carboplatin (AUC 6) u paclitaxel (175 mg/m2) għal 6 ċikli segwit minn użu kontinwu ta' Avastin (15 mg/kg q3w) bħala sustanza waħedha għal total sa 15-il xahar ta' terapija.
English: Wound healing complicationsb,d,
Maltese: Insuffiċjenza konġestiva tal-qalbb,d,
English: Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4.8) There have been rare reports of Avastin-treated patients developing signs and symptoms that are consistent with PRES, a rare neurologic disorder, which can present with the following signs and symptoms among others: seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Maltese: Sindrome ta' Enċefalopatija Riversibbli Posterjuri (PRES) (ara sezzjoni 4.8) Kien hemm rapporti rari ta' pazjenti kkurati b'Avastin li żviluppaw sinjali u sintomi li huma konsistenti ma' PRES, marda newroloġika rari, li tista' tippreżenta ruħa bis-sinjali u s-sintomi li ġejjin, fost oħrajn: eċċessjonijiet, uġigħ ta' ras, stat mentali alterat, problemi tal-vista, jew telf tal-vista kortikali, bi jew bla pressjoni għolja assoċjata.
English: Pulmonary hypertensiona, Nasal septum perforationa
Maltese: Pressjoni pulmonari għoljaċ, Perforazzjoni tas-septum talimnieħer ċ
English: Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 15 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab alone (CPB15+), had a clinically meaningful and statistically significant improvement in PFS.
Maltese: Meta mqabbel ma' pazjenti kkurati b'kimoterapija (carboplatin u paclitaxel) biss f'sitwazzjoni primarja, il-pazjenti li rċevew bevacizumab b'doża ta' 15 mg/kg q3w flimkien ma' kimoterapija u komplew jirċievu bevacizumab waħdu (CPB15+), kellhom titjib klinikament u statistikament sinifikanti f'PFS.
English: Rectal haemorrhage
Maltese: Reazzjonijiet allerġiċi
English: Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.
Maltese: Reazzjonijiet avversi sistemiċi inkluż emorraġiji mhux okulari u reazzjonijiet arterjali tromboembolitiċi kienu rrappurtati wara injezzjoni ġol-vitriju ta' inibituri ta' VEGF,.
English: • CPB arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) and concurrent Avastin (15 mg/kg) every 3 weeks for 6 and up to 8 cycles, followed by Avastin (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity.
Maltese: • grupp ta' CPB: Carboplatin (AUC5) u paclitaxel (175 mg/m2 IV) u Avastin fl-istess waqt (15 mg/kg) kull 3 ġimgħat għal 6 ċikli u sa 8 ċikli, segwit minn Avastin (15 mg/kg kull 3 ġimgħat) waħdu sal-progressjoni tal-marda jew sal-okkorrenza ta' tossiċità inaċċettabbli.
English: • GOG-0213 evaluated the efficacy and safety of bevacizumab in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Maltese: • GOG-0213 evalwa l-effikaċja u s-sigurtà ta' bevacizumab flimkien ma' carboplatin u paclitaxel, segwit minn bevacizumab bħala sustanza waħedha f'pazjenti b'kanċer rikorrenti tal-epitelju talovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew sensittiv għall-platinu.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 16 ml
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni Kunjett ta' 16 ml
English: In clinical trials across all indications the overall incidence of NCI-CTCAE v.3 Grade 3-5 bleeding reactions ranged from 0.4% to 6.9% in Avastin treated patients, compared with up to 4.5% of patients in the chemotherapy control group.
Maltese: Fi provi kliniċi bl-indikazzjonijiet kollha, l-inċidenza globali ta' reazzjonijiet ta' fsada ta' NCICTCAE v.3 Grad 3 - 5 varjat minn 0.4% sa 6.9% fil-pazjenti kkurati b'Avastin, meta mqabbla ma' inċidenza sa 4.5% tal-pazjenti fil-grupp ta' kontroll b'kimoterapija.
English: Rate (n) p-value
Maltese: Rata (n)
English: For further information on proteinuria see section 4.4 and Proteinuria in section 4.8.
Maltese: Għall-aktar tagħrif dwar proteina fl-awrina ara sezzjoni 4.4 u Proteina fl-awrina f'sezzjoni 4.8.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Most patients in both the CP arm (80.4%) and the CPB arm (78.9%) were White.
Maltese: 4%) kif ukoll fil-grupp ta' CPB (78.9%) kienu Bojod.
English: There were no objective (partial or complete) radiological responses (MacDonald criteria).
Maltese: Ma kien hemm l-ebda rispons komplet u żewġ risponsi parzjali (kriterji Macdonald).
English: If this is well-tolerated the second infusion may be given over 60 minutes.
Maltese: Jekk din tiġi ttollerata tajjeb it-tieni infużjoni tista' tingħatalek fuq medda ta' 60 minuta.
English: The efficacy data from trials AVF0780g and AVF2192g investigating Avastin in combination with 5-FU/FA-chemotherapy are summarised in Table 5.
Maltese: It-tagħrif dwar l-effikaċja mill-provi AVF0780g u AVF2192g li studjaw lil Avastin f'taħlita ma' kimoterapija b'5-FU/FA huma miġbura f'Tabella 5.
English: (p-value < 0.0001)
Maltese: (valur p < 0.0001)
English: Thromboembolism (see section 4.4)
Maltese: Trombo-emboliżmu (ara sezzjoni 4.4)
English: Grade 3 hypertension was 60.0% in patients treated with Avastin in combination with erlotinib compared to 11.7% in patients treated with erlotinib alone.
Maltese: Pressjoni għolja ta' Grad 3 seħħet f'60.0% tal-pazjenti ttrattati b'Avastin flimkien ma' erlotinib meta mqabbel ma' 11.7% f'pazjenti ttrattati b'erlotinib waħdu.
English: Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of treated patients.
Maltese: Grad 4 (sindrome nefrotika) kienet osservata f'mhux aktar minn 1.4% tal-pazjenti kkurati.
English: Median PFS (months)
Maltese: PFS Medjan (xhur)
English: Ovarian failureb,c,d
Maltese: Insuffiċjenza tal ovarjib,ċ,d
English: • loss of appetite,
Maltese: • nuqqas ta' aptit,
English: Proteinuria a,b
Maltese: Proteina flawrina a,b,
English: Hypertension (see section 4.4)
Maltese: Emorraġija (ara sezzjoni 4.4)
English: 15.5% had received prior radiotherapy and 28.4% prior chemotherapy.
Maltese: 5% kienu rċevew radjuterapija minn qabel u 28.4% kimoterapija minn qabel.
English: This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
Maltese: II li saret biex tqabbel l-effikaċja u s-sigurtà ta' bevacizumab kontra l-plaċebo.
English: Treatment was given until progressive disease or unacceptable toxicity.
Maltese: Il-kura ingħatat sal-progressjoni talmarda jew sa tossiċità inaċċettabbli.
English: Cerebrovascular accidents (including transient ischaemic attacks) were reported in up to 2.7% of patients treated with Avastin in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
Maltese: Aċċidenti cerebrovaskulari (inkluż attakki iskemiċi li jgħaddu) kienu rrappurtati f'mhux aktar minn 2.7% tal-pazjenti kkurati b'Avastin flimkien ma' kimoterapija meta mqabbla ma' mhux aktar minn 0.5% tal-pazjenti kkurati b'kimoterapija biss.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), grade 3-5 infections have been reported in up to 24% of patients treated with Avastin in combination with paclitaxel and topotecan compared with up to 13% of patients treated with paclitaxel and topotecan.
Maltese: Minn prova klinika f'pazjenti b'kanċer persistenti, rikorrenti jew metastatiku tal-għonq tal-utru (studju GOG-0240), infezzjonijiet ta' grad 3-5 kienu rrappurtati f'sa 24% tal-pazjenti kkurati b'Avastin flimkien ma' paclitaxel u topotecan meta mqabbel ma' sa 13% tal-pazjenti kkurati b'paclitaxel u topotecan.
English: After discontinuation of bevacizumab treatment, ovarian function recovered in 86.2% of these evaluable women.
Maltese: Wara l-waqfien tal-kura b'bevacizumab, il-funzjoni tal-ovarji irkuprat f'86.2% ta' dawn in-nisa li setgħu jiġu evalwati.
English: Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see Section 5.1).
Maltese: Bevacizumab, flimkien ma' paclitaxel u cisplatin jew, b'mod alternattiv, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu terapija bi platinu, huwa indikat għat-trattament ta' pazjenti adulti b'karċinoma persistenti, rikorrenti, jew metastatika tal-għonq tal-utru (ara Sezzjoni 5.1).
English: This was a randomised, double-blind, phase II clinical trial investigating Avastin 10 mg/kg in a 2 weekly schedule with the same dose of Avastin in combination with 150 mg daily erlotinib, in patients with metastatic clear cell RCC. A total of 104 patients were randomised to treatment in this trial, 53 to Avastin 10 mg/kg every 2 weeks plus placebo and 51 to Avastin 10 mg/kg every 2 weeks plus erlotinib 150 mg daily.
Maltese: Total ta' 104 pazjent kienu randomised għall-kura f'din il-prova, 53 għal Avastin 10 mg/kg kull ġimagħtejn u plaċebo u 51 għal Avastin 10 mg/kg kull ġimagħtejn u erlotinib 150 mg kuljum.
English: Conclusions on the impact of bevacizumab on gemcitabine pharmacokinetics cannot be drawn.
Maltese: Ma jistgħux jittieħdu konklużjonijiet dwar l-impatt ta' bevacizumab fuq il-farmakokinetika ta' gemcitabine.
English: Fistulaa,b,
Maltese: Fistula a,b
English: (14.9 vs. 11.9 months; p = 0.1061)
Maltese: 11.9 xhur; p = 0.1061)
English: The safety and efficacy of the recommended dose (5 mg/kg of body weight every two weeks) in metastatic carcinoma of the colon or rectum were studied in three randomised, active-controlled clinical trials in combination with fluoropyrimidine-based first-line chemotherapy.
Maltese: Is-sigurtà u l-effikaċja tad-doża rakkomandata (5 mg/kg ta' piż tal-ġisem kull ġimagħtejn) f'karċinoma metastatika tal-kolon jew rektum ġew studjati fi 3 provi kliniċi randomised u active-controlled f'taħlita ma' kimoterapija primarja bbażata fuq fluorinopyrimidine.
English: FIGO staging version dated 1988 was used in this trial.
Maltese: F'din il-prova intużat il-verżjoni tal-istadji ta' FIGO datata 1988.
English: Study E3200 used a 5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-naïve patients, while study ML18147 used a 2.5 mg/kg/week equivalent dose of bevacizumab in bevacizumabpretreated patients.
Maltese: Fi studju E3200 intużat doża ekwivalenti għal 5 mg/kg/ġimgħa ta' bevacizumab f'pazjenti li qatt ma ħadu bevacizumab qabel, waqt li fi istudju ML18147 intużat doża ekwivalenti għal 2.5 mg/kg/ġimgħa ta' bevacizumab f'pazjenti li qabel kienu kkurati b'bevacizumab.
English: ● It is possible that Avastin can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
Maltese: • Huwa possibbli li Avastin jista' jikkawża sensittività eċċessiva u/jew reazzjonijiet għallinfużjoni (reazzjonijiet relatati mal-injezzjoni tiegħek tal-mediċina).
English: Eight hundred and thirteen patients were randomised to receive IFL + placebo (Arm 1) or IFL + Avastin (5 mg/kg every 2 weeks, Arm 2).
Maltese: Tmien mija u tlettax-il pazjent kienu magħżula bl-addoċċ biex jirċievu IFL + placebo (Kategorija 1) jew IFL + Avastin (5 mg/kg kull ġimgħatejn, Kategorija 2).
English: Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Maltese: Bevacizumab, flimkien ma' carboplatin u paclitaxel huwa ndikat bħala kura preferita ta' pazjenti adulti b'kanċer avanzat (Federazzjoni Internazzjonali tal-Ginekoloġija u l-Obstetrija (FIGO) istadji
English: Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents (see Section 5.1).
Maltese: Bevacizumab flimkien ma' paclitaxel, topotecan, jew doxorubicin liposomali pegilat huwa indikat għall-kura ta' pazjenti adulti b'kanċer rikorrenti tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew reżistenti għall-platinu li rċevew mhux aktar minn żewġ korsijiet ta' kimoterapija qabel u li ma rċevewx terapija b'bevacizumab jew b'inibituri ta' VEGF oħra jew sustanzi li jimmiraw riċettur ta' VEGF qabel (ara Sezzjoni 5.1).
English: Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2 (q3w); or Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 (q3w)
Maltese: • Paclitaxel 135 mg/m2 IV fuq medda ta' 24 siegħa f'Jum 1 u cisplatin 50 mg/m2 IV f'Jum 2, kull 3 ġimgħat (q3w); jew Paclitaxel 175 mg/m2 IV fuq medda ta' 3 sigħat f'Jum 1 u cisplatin 50 mg/m2 IV f'Jum 2 (q3w); jew Paclitaxel 175 mg/m2 IV fuq medda ta' 3 sigħat f'Jum 1 u cisplatin 50 mg/m2 IV f'Jum 1 (q3w)
English: Avastin should be discontinued permanently in patients who experience Grade 3 or 4 bleeding during Avastin therapy (NCI-CTCAE v.3) (see section 4.8).
Maltese: Avastin għandu jitwaqqaf għal kollox f'pazjenti li jkollhom esperjenza ta' fsada ta' Grad 3 jew 4 waqt kura b'Avastin (NCI-CTCAE v.3) (ara sezzjoni 4.8).
English: Table 20 Efficacy results from study AVF4095g
Maltese: Riżultati tal-effikaċja mill-istudju AVF4095g
English: For patients in study AVF3694g who received anthracyclines concomitantly with bevacizumab, the incidences of Grade 3 or higher CHF for the respective bevacizumab and control arms were similar to those in the other studies in metastatic breast cancer: 2.9% in the anthracycline + bevacizumab arm and 0% in the anthracycline + placebo arm.
Maltese: Għall-pazjenti fi studju AVF3694g li rċevew anthracyclines flimkien ma' bevacizumab, l-inċidenzi ta' CHF ta' Grad 3 jew ogħla għall-gruppi rispettivi ta' bevacizumab u kontroll kienu simili għal dawk fl-istudji l-oħra dwar kanċer metastatiku tas-sider: 2.9% fil-grupp ta' bevacizumab + anthracycline u 0% fil-grupp ta' anthracycline + plaċebo.