FrancophonIA/ELRC3.0 huggingface dataset:
English: • Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival and overall survival in the eligible per-protocol population.
Maltese: ● In-nuqqas ta' inferjorità tal-kategorija li fihom XELOX meta mqabbel mal-kategoriji li fihom FOLFOX-4 fil-paragun totali ntweriet f'termini ta' sopravivenza mingħajr progressjoni u fissopravivenza totali fil-popolazzjoni eliġibbli ta' qabel il-protokoll.
English: Febrile neutropenia, Leucopenia, Neutropenia b, Thrombo-cytopenia
Maltese: Newtropenja biddeni, Lewkopenija, Newtropenija b, Tromboċitopenija
English: Each vial contains 100 mg bevacizumab.
Maltese: Kull kunjett fih 100 mg bevacizumab.
English: Both the 5 mg/kg/week and 2.5 mg/kg/week equivalent doses of bevacizumab provided a statistically significant benefit with regards to OS (HR 0.751 in study E3200; HR 0.81 in study ML18147) and PFS (HR 0.518 in study E3200; HR 0.68 in study ML18147).
Maltese: HR 0.81 flistudju ML18147) u PFS (HR 0.518 fl-istudju E3200;
English: One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression.
Maltese: Mija u ħames pazjent ġew magħżula bl-addoċċ għall-kategorija 5-FU/FA + plaċebo u 104 pazjent għall-kategorija 5-FU/FA + bevacizumab (5 mg/kg kull ġimagħtejn).
English: Addition of bevacizumab to standard of care did not demonstrate clinical benefit in clinical trial BO20924, in 71 evaluable children (from age 6 months to less than 18 years old) patients with metastatic Rhabdomyosarcoma and non-Rhabdomyosarcoma Soft Tissue Sarcoma.
Maltese: Iż-żieda ta' bevacizumab ma' kura standard ma wrietx benefiċċju kliniku fil-prova klinika BO20924, f'71 pazjent tifel u tifla (b'età minn 6 xhur sa inqas minn 18-il sena) b'Rabdomijosarkoma metastatika u Sarkoma tat-Tessut l-Artab mhux rabdomijosarkoma li setgħu jiġu evalwati.
English: (12.0 vs 15.0 months; p = 0.6267)
Maltese: 0 xhur; p = 0.6267)
English: Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Maltese: Zirabev flimkien ma' interferon alfa-2a huwa indikat għal kura primarja ta' pazjenti adulti b'kanċer taċ-ċelluli renali avanzat u/jew metastatiku.
English: Gastrointestinal haemorrhages, including rectal bleeding and melaena have been reported in colorectal cancer patients, and have been assessed as tumour-associated haemorrhages.
Maltese: Emorraġiji gastrointestinali, inkluż fsada mir-rektum u melaena kienu rrapurtati f'pazjenti b'kanċer tal-kolorektum, u kienu stmati bħala emorraġiji assoċjati mat-tumur.
English: c Based on a substudy from NSABP C-08 with 295 patients d
Maltese: F'NSABP C-08, prova ta' fażi
English: In study BO20924 of bevacizumab with current standard of care in rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma, the safety profile of bevacizumab treated children was comparable with that observed in adults treated with bevacizumab.
Maltese: Fl-istudju BO20924 ta' bevacizumab flimkien ma' kura standard attwali f'rabdomijosarkoma metastatika u sarkoma tat-tessut l-artab mhux rabdomijosarkoma, il-profil tas-sigurtà ta' tfal ittrattati b'bevacizumab kien komparabbli ma' dak osservat f'adulti ttrattati b'bevacizumab.
English: Non-GI fistulae (see section 4.8)
Maltese: Fistuli Mhux GI (ara sezzjoni 4.8)
English: I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Maltese: I-bevacizumab indikat li l-profil metaboliku kien simili għal dak mistenni għal molekula
English: • lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),
Maltese: • feriti fil-ħanek bl-għadma tax-xedaq mikxufa li ma jfiequx u li jistgħu jkunu assoċjati ma' wġigħ u infjammazzjoni tat-tessut tal-madwar (ara l-paragrafi taħt il-lista ta' effetti sekondarji għal rakkomandazzjonijiet oħra),
English: Paclitaxel 135 mg/m intravenous over 24 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 2, every 3 weeks (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 (q3w); or
Maltese: • Paclitaxel 135 mg/m 2 ġol-vini fuq medda ta' 24 siegħa f'Jum 1 u cisplatin 50 mg/m 2 ġol-vini f'Jum 2, kull 3 ġimgħat (q3w); jew Paclitaxel 175 mg/m ġol-vini fuq medda ta' 3 sigħat f'Jum 1 u cisplatin 50 mg/m 2 ġol-vini f'Jum 2 (q3w); jew Paclitaxel 175 mg/m 2 ġol-vini fuq medda ta' 3 sigħat f'Jum 1 u cisplatin 50 mg/m 2 ġol-vini f'Jum 1 (q3w)
English: • NO16966: Bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or bevacizumab 5 mg/kg every 2 weeks in combination with leucovorin plus 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
Maltese: Bevacizumab 7.5 mg/kg tal-piż tal-ġisem kull 3 ġimgħat flimkien ma' capecitabine orali u oxaliplatin ġol-vini (XELOX) ġol-vini jew bevacizumab 5 mg/kg kull ġimagħtejn flimkien ma' leucovorin u bolus ta'5-fluorouracil, segwit minn infużjoni ta' 5fluorouracil, b'oxaliplatin (FOLFOX-4) ġol-vini.
English: Combination with platinum- or taxane-based therapies (see sections 4.4 and 4.8)
Maltese: Taħlita ta' terapiji bbażati fuq il-platinum jew taxane (ara sezzjonijiet 4.4 u 4.8)
English: NAME OF THE MEDICINAL PRODUCT Zirabev 25 mg/ml concentrate for solution for infusion.
Maltese: Zirabev 25 mg/mL konċentrat għal soluzzjoni għall-infużjoni.
English: Bevacizumab 10 mg/kg was given every 2 weeks until disease progression.
Maltese: Bevacizumab 10 mg/kg ingħata kull ġimagħtejn sal-progressjoni tal-marda.
English: Myalgia, Arthralgia, Muscular weaknes s, Back pain
Maltese: Majalġja, Artralġja, Dgħufija filmuskoli, Uġigħ fid-dahar
English: Hepatic impairment
Maltese: Enċefalopatija ipertensiva
English: Hazard ratio (95% confidence interval)
Maltese: Proporzjon ta' periklu (intervall ta' kunfidenza ta' 95%)
English: Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Maltese: Enċefalopatija ipersensittiva (rari ħafna) (ara wkoll sezzjoni 4.4 u Pressjoni għolja f'sezzjoni 4.8)
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 bevacizumab at a dose of 7.5 or 15 mg/kg intravenous infusion day 1 of every 3-week cycle.
Maltese: Il-pazjenti kienu randomized għal kimoterapija bbażata fuq il-platinum, cisplatin 80 mg/m 2 infużjoni fil-vini ta' fl-ewwel ġurnata u gemcitabine 1250 mg/m2 infużjoni fil-vini fl-ewwel jum u fit-tmin ġurnatata' kull ċiklu ta' 3 ġimgħat sa 6 ċikli (CG) ma' plaċebo jew CG ma' bevacizumab b'doża ta' 7.5 jew 15 mg/kg infużjoni ġol-vini fl-ewwel ġurnata ta' kull ċiklu ta' 3 ġimgħat.
English: For dilution and other handling recommendations, see section 6.6.
Maltese: Għad-dilwizzjoni u rakkomandazzjonijiet oħra dwar l-immaniġġjar, ara sezzjoni 6.6.
English: Patients receiving bevacizumab plus chemotherapy, with a history of arterial thromboembolism, diabetes or age greater than 65 years have an increased risk of developing arterial thromboembolic reactions during therapy.
Maltese: Pazjenti li qed jirċievu bevacizumab flimkien mal-kimoterapija, b'passat ta' tromboemboliżmu arterjali, dijabete jew età aktar minn 65 sena għandhom riskju akbar ta' żvilupp ta' reazzjonijiet tromboemboliċi arterjali waqt il-kura.
English: Observed in pediatric population only
Maltese: Osservat fil-popolazzjoni pedjatrika biss
English: The safety and efficacy have not been studied in patients with hepatic impairment (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja f'pazjenti b'indeboliment tal-kliewi ma ġewx studjati (ara sezzjoni 5.2).
English: No increase in the incidence of other reactions, including gastrointestinal perforation, wound healing complications, congestive heart failure, and haemorrhage was observed in elderly patients (> 65 years) receiving bevacizumab as compared to those aged ≤ 65 years treated with bevacizumab.
Maltese: L-ebda żieda fl-inċidenza ta' reazzjonijiet oħra, inkluż perforazzjoni gastrointestinali, kumplikazzjonijiet fil-fejqan tal-feritai, insuffiċjenza tal-qalb konġestiva, u emorraġija, ma ġew osservati f'pazjenti anzjani (> 65 sena) li kienu qed jirċievu bevacizumab kif mqabbla ma' dawk b' ≤ 65 sena kkurati b'bevacizumab.
English: The overall safety profile of bevacizumab is based on data from over 5,700 patients with various malignancies, predominantly treated with bevacizumab in combination with chemotherapy in clinical trials.
Maltese: Il-profil globali tas-sigurtà ta' bevacizumab huwa bbażat fuq tagħrif minn aktar minn 5,700 pazjenti b'diversi tumuri malinni kkurati primarjament b'bevacizumab flimkien ma' kimoterapija fi provi kliniċi.
English: Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with bevacizumab (analyses shown in Table 7), consistent with the statistically significant benefit observed in the pooled analysis.
Maltese: Analiżi sekondarja tal-PFS, ibbażata fuq valutazzjonijiet tar-rispons ta' “wara l-kura”, ikkonfermat il-benefiċċju kliniku ta' superjorità sinifikanti għall-pazjenti kkurati b'bevacizumab (l-analiżi mniżżla f'Tabella 7), konsistenti mal-benefiċċju statistikament sinifikanti osservat f'analiżi miġbura.
English: Ovarian failure a,b
Maltese: Insuffiċjenza tal-ovarji a,b
English: Cerebrovascular accidents (including transient ischaemic attacks)
Maltese: • problemi bl-għajnejn (inkluż żjieda fil-produzzjoni tad-dmugħ),
English: According to the two-compartmental model, the elimination half-life is 18 days for a typical female patient and 20 days for a typical male patient.
Maltese: Skont il-mudell ta' żewġ kompartiment, il-halflife tal-eliminazzjoni hija ta' 18-il ġurnata għall-pazjenta femminili tipika u ta' 20 ġurnata għallpazjent maskili tipiku.
English: MAHA is a haemolytic disorder which can present with red cell fragmentation, anaemia, and thrombocytopenia.
Maltese: MAHA hija disturb emolitiku li tista' tidher bi frammetazzjoni taċ-ċelluli ħomor, anemija u tromboċitopenja.
English: • E3200: Bevacizumab 10 mg/kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4) in bevacizumab-naïve patients.
Maltese: Bevacizumab 10 mg/kg ta' piż tal-ġisem kull ġimagħtejn flimkien ma' leucovorin u bolus ta' 5-fluorouracil, segwit minn infużjoni ta' 5-fluorouracil, b'oxaliplatin (FOLFOX-4) ġol-vini f'pazjenti li qatt ma kienu ħadu bevacizumab qabel.
English: These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.
Maltese: Dawn jinkludu nuqqas fin-numru ta' ċelluli bojod tad-demm, speċjalment newtrofili (tip wieħed ta' ċelluli bojod tad-demm li jgħinu biex jipproteġu kontra nfezzjonijiet) fid-demm; preżenza ta' proteina fl-awrina; tnaqqis ta' potassju, sodju jew fosfru (minerali) fid-demm; żjieda tal-livell taz-zokkor fid-demm; żjieda tal-alkaline phosphatase (enzima) fid-demm; żjieda tal-kreatinina fisserum (proteina mkejla permezz ta' test tad-demm biex jiġi determinat kemm qed jaħdmu tajjeb ilkliewi tiegħek); tnaqqis tal-emoglobina (tinsab fiċ-ċelluli l-ħomor tad-demm, li jġorru l-ossiġnu), li jista' jkun sever.
English: If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
Maltese: Jekk l-infużjoni ta' 60 minuta hija ttollerata sew, kull infużjonij sussegwenti tista' tingħata fuq medda ta' 30 minuta.
English: This was a phase II randomised, double-blind, active-controlled clinical trial evaluating the efficacy and safety of bevacizumab in combination with 5-FU/FA as first-line treatment for metastatic colorectal cancer in patients who were not optimal candidates for first-line irinotecan treatment.
Maltese: II randomized, double-blind, u active-controlled li stmat l-effikaċja u s-sigurtà ta' bevacizumab f'taħlita ma' kimoterapija b'5-FU/FA għall-kura primarja ta' kanċer metastatiku tal-kolon jew rektum li ma kienux kandidati idejali għall-kura primarja b'irinotecan.
English: After correcting for body weight, male patients had a larger Vc (+ 20%) than female patients.
Maltese: Wara aġġustament għall-piż tal-ġisem, pazjenti rġiel kellhom Vc akbar (+ 20%) minn pazjenti nisa.
English: b 10 mg/kg every 2 weeks.
Maltese: 10 mg/kg kull ġimagħtejn.
English: The pharmacokinetics of bevacizumab was well characterized by the paediatric population PK model for 70 patients in Study BO20924 ((1.4 to 17.6 years; 11.6 to 77.5 kg) and 59 patients in Study BO25041 (1 to 17 years; 11.2 to 82.3 kg).
Maltese: Fi Studju BO20924, il-farmakokinetika ta' bevacizumab kienet ikkaratterizzata tajjeb permezz tamudell tal-PK tal-popolazzjoni pedjatrika f'70 pazjent pedjatriku (1.4 sa 17.6 snin; 11.6 sa 77.5 kg) Abbażi ta' simulazzjonijiet ta' mudell tal-PK tal-popolazzjoni, l-esponiment għal bevacizumab kien anqas f'pazjenti pedjatriċi minn Studju BO20924 meta mqabbel ma' pazjent adult tipiku fl-istess doża, u kellu tendenza jkun aktar baxx kif il-piż tal-ġisem naqas.
English: The safety and efficacy of bevacizumab in children less than 18 years old have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' bevacizumab fit-tfal ta' età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Later infusions may be given to you over 30 minutes.
Maltese: Infużjonijiet aktar jistgħu jingħatawlek fuq medda ta' 30 minuta.
English: The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with bevacizumab.
Maltese: Iż-żieda osservata fil-kreatinina fis-serum ma ġietx assoċjata ma' inċidenza ogħla ta' manifestazzjonijiet kliniċi ta' indeboliment renali f'pazjenti ttrattati b'bevacizumab.
English: Zirabev is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Maltese: Zirabev mogħti flimkien ma' wieħed mir-korsijiet ta' kimoterapija li ġejjin: paclitaxel u cisplatin jew paclitaxel u topotecan.
English: Patients treated for persistent, recurrent, or metastatic cervical cancer with bevacizumab are at increased risk of fistulae between the vagina and any part of the GI tract (Gastrointestinal-vaginal fistulae).
Maltese: Pazjenti kkurati b'bevacizumab għall-kanċer persistenti, rikorrenti jew metastatiku tal-għonq tal-utru huma f'riskju akbar ta' fistuli bejn il-vaġina u kwalunkwe parti tal-apparat GI (Fistuli gastrointestinali-vaġinali).
English: An increased incidence of post-operative bleeding or wound healing complication occurring within 60 days of major surgery was observed if the patient was being treated with bevacizumab at the time of surgery.
Maltese: Żjieda fl-inċidenza ta' fsada ta' wara operazzjoni jew komplikazzjoni fil-fejqan tal-ferita li seħħet sa 60 ġurnata wara kirurġija maġġuri kienet osservata jekk il-pazjent kien ikkurat b'bevacizumab fil-ħin tal-kirurġija.
English: Table 2 provides the frequency of severe adverse reactions.
Maltese: Tabella 2 tipprovdi l-frekwenza tar- reazzjonijiet avversi severi.
English: In adults, the results showed no significant difference in the pharmacokinetics of bevacizumab in relation to age.
Maltese: Ir-riżultati ma wrew l-ebda differenza sinifikanti fil-farmakokinetika ta' bevacizumab f'relazzjoni mal-età.
English: Haemorrhage (see section 4.4)
Maltese: Fistuli Mhux GI (ara sezzjoni 4.4)
English: Table 3 Adverse reactions reported in post-marketing setting
Maltese: Tabella 3 Reazzjonijiet avversi rrappurtati fl-ambjent ta' wara t-tqegħid fis-usq
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Maltese: Reazzjonijiet ta' sensittività eċċessiva/reazzjonijiet tal-infużjoni (ara sezzjoni 4.4 u Esperjenza ta' wara t-tqegħid fis-suq taħt)
English: Posterior reversible encephalopathy syndrome (see section 4.4)
Maltese: Sindrome ta' enċefalopatija riversibbli posterjuri (PRES - Posterior reversible encephalopathy syndrome) (ara sezzjoni 4.8)
English: Foetal abnormalities a,b
Maltese: Anormalitajiet fil-fetu a,b
English: • ML18147: Bevacizumab 5.0 mg/kg of body weight every 2 weeks or bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin in patients with disease progression following first-line treatment with bevacizumab.
Maltese: Bevacizumab 5.0 mg/kg ta' piż tal-ġisem kull ġimagħtejn jew bevacizumab 7.5 mg/kg ta' piż tal-ġisem kull 3 ġimgħat flimkien ma' fluoropyrimidine/irinotecan jew fluoropyrimidine/oxaliplatin f'pazjenti bi progressjoni tal-marda wara kura preferita b'bevacizumab.
English: The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Fil-maġġoranza tal-okkażjonijiet, lammont neċessarju ta' Zirabev jista' jiġi dilwit ma' soluzzjoni għall-injezzjoni ta' 0.9% sodium chloride sa volum totali ta' 100 ml.
English: Thrombo-embolism (venous)
Maltese: Tromboemboliżmu (venuż)
English: 1 vial of 16 ml 400 mg/16 ml
Maltese: Kunjett 1 ta' 4 ml 100 mg/4 ml
English: Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 1 (q3w)
Maltese: Paclitaxel 175 mg/m 2 ġol-vini fuq medda ta' 3 sigħat f'Jum 1 u topotecan 0.75 mg/m 2 ġol vini fuq medda ta' 30 minuta fi ġranet 1-3 (q3w)
English: Eight hundred and thirteen patients were randomised to receive IFL + placebo (Arm 1) or IFL + bevacizumab (5 mg/kg every 2 weeks, Arm 2).
Maltese: Tmien mija u tlettax-il pazjent ġew magħżula bl-addoċċ biex jirċievu IFL + plaċebo (Kategorija 1) jew IFL + bevacizumab (5 mg/kg kull ġimagħtejn, Kategorija 2).
English: Major or massive pulmonary haemorrhage/haemoptysis has been observed primarily in trials in patients with non-small cell lung cancer (NSCLC).
Maltese: Emorraġija tal-pulmun/emoptiżi maġġuri jew massiva kienet osservata primarjament fi provi b'pazjenti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun (NSCLC).
English: a 5 mg/kg every 2 weeks.
Maltese: 5 mg/kg kull ġimagħtejn.
English: Bevacizumab is contraindicated in pregnancy (see section 4.3).
Maltese: Bevacizumab huwa kontraindikat fit-tqala (ara sezzjoni 4.3).
English: • a brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES),
Maltese: • kondizzjoni fil-moħħ b'sintomi li jinkludu aċċessjonijiet (attakki epilettiċi), uġigħ ta' ras, konfużjoni u bidliet fil-vista (Sindrome ta' Enċefalopatija Posterjuri Riversibbli jew PRES (Posterior Reversible Encephalopathy Syndrome)),
English: • hole in the gall bladder (symptoms and signs may include abdominal pain, fever, and nausea/vomiting).
Maltese: • toqba fil-bużżieqa tal-marrara (sintomi u sinjali jistgħu jinkludu wġigħ addominali, deni u tqalligħ/rimettar).
English: The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/kg.
Maltese: Ilfarmakokinetika ta' bevacizumab kienet lineari f'dożi li varjaw minn 1 sa 10 mg/kg.
English: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Maltese: Termini jirrappreżentaw grupp ta' avvenimenti li jiddeskrivu kunċett mediku minflok kondizzjoni waħda jew terminu ppreferut tal-MedDRA (Dizzjunarju Mediku għal Attivitajiet Regolatorji - Medical Dictionary for Regulatory Affairs).
English: Progression-free survival and objective response rate were inferior in the bevacizumab monotherapy arm compared to the FOLFOX-4 arm.
Maltese: Sopravivenza mingħajr progressjoni u rata tar-rispons oġġettiv kienu inferjuri fil-kategorija ta' monoterapija ta' bevacizumab meta mqabbel mal-kategorija ta' FOLFOX-4.
English: Palmar-plantar erythrodysaesth esia syndrome
Maltese: Effetti sistemiċi wara użu ġol-vitriju
English: The addition of bevacizumab to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Maltese: Albumina baxxa u ammont għoli ta' tumur ġeneralment huma indikattivi tas-severità tal-marda.
English: Vascular disorders Hypertension b,d
Maltese: Disturbi vaskulari Pressjoni għolja b,d
English: Posterior reversible encephalopathy syndrome (PRES) (see section 4.8) There have been rare reports of bevacizumab-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: Kien hemm rapporti rari ta' pazjenti kkurati b' bevacizumab li żviluppaw sinjali u sintomi li huma konsistenti ma' PRES, marda newroloġika rari, li tista' tippreżenta ruħha bis-sinjali u s-sintomi li ġejjin, fost oħrajn: eċċessjonijiet, uġigħ ta' ras, stat mentali alterat, problemi tal-vista, jew telf talvista kortikali, bi jew mingħajr pressjoni għolja assoċjata.
English: intravenous bolus injection immediately after leucovorin
Maltese: Injezzjoni bolus ġol-vini minnufih wara leucovorin
English: Bevacizumab clearance was approximately 30% faster in patients with low levels of serum albumin and 7% faster in subjects with higher tumour burden when compared with a typical patient with median values of albumin and tumour burden.
Maltese: Ittneħħija ta' bevacizumab kienet madwar 30% aktar malajr f'pazjenti b'livelli baxxi ta' albumina fis-serum u 7% aktar malajr f'individwi b'ammont ogħla ta' tumur meta mqabbel ma' pazjent tipiku b'valuri medjani u ta' albumina u ammont tat-tumur.
English: • Haemorrhage, including pulmonary haemorrhage/haemoptysis, which is more common in non- small cell lung cancer patients (see section 4.4).
Maltese: Emorraġija, inkluż emorraġija fil-pulmun/emoptisi li hija aktar komuni f'pazjenti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun (ara sezzjoni 4.4).
English: Patients may be at risk of developing infusion/hypersensitivity reactions.
Maltese: Reazzjonijiet ta' sensittività eċċessiva/reazzjonijiet tal-infużjoni hawn fuq)
English: Patients who have experienced a venous thromboembolic reaction may be at higher risk for a recurrence if they receive bevacizumab in combination with chemotherapy versus chemotherapy alone.
Maltese: Waqt kura b'bevacizumab, il-pazjenti jistgħu jkunu f'riskju li jiżviluppaw reazzjonijiet ta' tromboemboliżmu fil-vini, inkluż emboliżmu pulmonari.
English: Dehydration, Hyponatraemia
Maltese: Deidratazzjoni, Iponatremija
English: Post-marketing adverse reactions are included in both Tables 1 and 2, where applicable.
Maltese: Reazzjonijiet avversi wara t-tqegħid fis-suq huma inklużi kemm f'Tabella 1 kif ukoll f'Tabella 2, fejn japplika.
English: The pharmacokinetic data for bevacizumab are available from ten clinical trials in patients with solid tumours.
Maltese: It-tagħrif farmakokinetika ta' bevacizumab huwa disponibbli minn għaxar provi kliniċi f'pazjenti b'tumuri solidi.
English: Overall survival - follow-up analysis2 Hazard ratio (95% CI)
Maltese: Sopravivenza globali - analiżi ta' segwitu Proporzjon ta' periklu (CI ta' 95%)