qanastek/EMEA-V3 huggingface dataset:
Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines.
Barra minn hekk, 65% tal- pazjenti kienu rċievew kimoterapija awżiljarja, inkluż 19% b’ taxanes minn qabel u 49% b’ anthracyclines minn qabel.
Patients with central nervous system metastasis, including previously treated or resected brain lesions, were excluded.
Pazjenti b’ metastasi fis- sistema nervuża ċentrali, inkluż leżjonijiet fil- moħħ ikkurati minn qabel jew li tneħħew b’ kirurġija, kienu esklużi.
In Study E2100, patients were treated until disease progression.
Fl- istudju E2100, il- pazjenti kienu kkurati sal- progressjoni tal- marda.
In situations where early discontinuation of chemotherapy was required, treatment with Avastin as a single agent continued until disease progression.
F’ sitwazzjonijiet fejn kien meħtieġ twaqqif bikri tal- kimoterapija, il- kura b’ Avastin bħala sustanza waħedha tkompliet sal - progressjoni tal- marda.
The patient characteristics were similar across the study arms.
Il- karatteristiċi tal- pazjenti fil- gruppi studjati kienu simili.
The primary endpoint of this trial was progression free survival (PFS), based on study investigators’ assessment of disease progression.
Il- mira primarja ta ’ din il- prova kienet sopravivenza mingħajr progressjoni (PFS), ibbażata fuq ir- rapport ta ’ l- investigaturi dwar l- istudju tal- progressjoni tal- marda.
In addition, an independent review of the primary endpoint was also conducted.
Barra dan, twettqet ukoll analiżi ndipendenti tal- mira primarja.
The results of this study are presented in Table 8.
Ir- riżultati ta ’ dan l- istudju huma ppreżentati f’ tabella 8.
18 Table 8
18 Tabella 8
Study E2100 Efficacy Results:
Riżultati ta ’ l- Effikaċja fi Studju E2100:
Investigator Assessment*
Valutazzjoni ta ’ l- Investigatur *
IRF Assessment
Valutazzjoni IRF
Median PFS (months)
PFS Medjan (xhur)
11.4 5.8
11. 4 5. 8
0.421
0. 421
0.483
0. 483
(95% CI) p-value
(95% CI) Valur p
(0.343; 0.516) < 0.0001
(0. 343; 0. 516) < 0. 0001
(0.385; 0.607) < 0.0001
(0. 385; 0. 607) < 0. 0001
Response rates (for patients with measurable disease)
Rati ta ’ rispons (għall- pazjenti b’ marda li tista ’ titkejjel)
Investigator Assessment
Valutazzjoni ta ’ l- Investigatur
% pts with objective response
% ta ’ pazjenti b’ rispons oġġettiv
23.4
23. 4
48.0 22.2
48. 0 22. 2
49.8
49. 8
* primary analysis
* analiżi primarja
Median OS (months) HR
OS Medjan (xhur) HR
24.8
24. 8
0.869
0. 869
26.5
26. 5
(0.722; 1.046) 0.1374
(0. 722; 1. 046) 0. 1374
The clinical benefit of Avastin as measured by PFS was seen in all pre-specified subgroups tested (including disease-free interval, number of metastatic sites, prior receipt of adjuvant chemotherapy and estrogen receptor (ER) status).
Il- benefiċċju kliniku ta ’ Avastin kif imkejjel mill- PFS intwera fis- sottogruppi taħt studju, speċifikati minn qabel, kollha (inkluż intervall mingħajr il- marda, numru ta ’ postijiet b’ metastasi, kimoterapija awżiljarja li ngħatat minn qabel, u stat ta ’ riċettur għall- estroġen (ER).
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 studies E4599 and BO17704.
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 fi studji E4599 u BO17704.
An overall survival benefit has been demonstrated in study E4599 with a 15 mg/ kg/ q3wk dose of bevacizumab.
Intwera benefiċċju globali ta ’ sopravvivenza fl- istudju E4599 b’ doża ta ’ 15 mg/ kg/ q3wk ta ’ bevacizumab.
Study BO17704 has demonstrated that both 7.5 mg/ kg/ q3wk and 15 mg/ kg/ q3wk bevacizumab doses increase progression free survival and response rate.
Studju BO17704 wera li kemm doża ta ’ 7. 5 mg/ kg/ q3wk ta ’ bevacizumab, kif ukoll dik ta ’ 15 mg/ kg/ q3wk, jżidu s- sopravivenza bla progressjoni u r- rata ta ’ rispons.
Due to the short duration of follow-up in study BO17704 no conclusions can be drawn regarding a benefit in overall survival.
Minħabba t- tul ta ’ żmien qasir tal- vista ta ’ wara fl- istudju BO17704, ma tista ’ tittieħed l- ebda konklużjoni dwar il- benefiċċju fuq is- sopravivenza globali.
E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating Avastin as first-line treatment of patients with locally advanced (stage IIIb with malignant pleural effusion), metastatic or recurrent NSCLC other than predominantly squamous cell histology.
E4599 kienet prova klinika open- label, randomised, ikkontrollata b’ mod attiv, li saret f’ ħafna ċentri li vvalutat Avastin bħala kura primarja ta ’ pazjenti b’ NSCLC avvanzat lokalment (stadju IIIb b’ effużjoni plewrali malinni), metastatiku jew rikorrenti minbarra istoloġija bi predominanza ta ’ ċelluli skwamużi.
Patients were randomized to platinum-based chemotherapy (paclitaxel 200 mg/ m2 and carboplatin AUC = 6.0, both by IV infusion) (PC) on day 1 of every 3-week cycle for up to 6 cycles or PC in combination with Avastin at a dose of 15 mg/ kg IV infusion day 1 of every 3-week cycle.
Il- pazjenti kienu randomised għal kimoterapija bbażata fuq platinum (paclitaxel 200 mg/ m2 u carboplatin AUC = 6. 0, it- tnejn permezz ta ’ infużjoni IV) (PC) fl- ewwel ġurnata ta ’ kull ċiklu ta ’ 3 - ġimgħat sa 6 ċikli jew PC flimkien ma ’ Avastin b’ doża ta ’ 15 mg/ kg bħala infużjoni IV fl- ewwel ġurnata ta ’ kull ċiklu ta ’ 3- ġimgħat.
After completion of six cycles of carboplatin-paclitaxel chemotherapy or upon premature discontinuation of chemotherapy, patients on the Avastin + carboplatin– paclitaxel arm continued to receive Avastin as a single agent every 3 weeks until disease progression.
Wara t- tmiem tas- sitt ċikli ta ’ kimoterapija b’ carboplatin - paclitaxel jew mat- twaqqif prematur tal- kimoterapija, pazjenti fil- grupp ta ’ Avastin + carboplatin – paclitaxel komplew jirċevu Avastin bħala sustanza waħedha kull 3 ġimgħat sal- progressjoni tal- mard.
878 patients were randomised to the two arms.
878 pazjent kienu randomised għaż- żewġ gruppi.
During the study, of the patients who received trial treatment, 32.2% (136/ 422) of patients received 7-12 administrations of Avastin and 21.1% (89/ 422) of patients received 13 or more administrations of Avastin.
Waqt l- istudju, mill- pazjenti li rċevew il- kura ta ’ prova, 32. 2% (136/ 422) tal- pazjenti rċevew 7- 12- il għotja ta ’ Avastin u 21. 1% (89/ 422) tal- pazjenti rċevew 13 jew aktar għotjiet ta ’ Avastin.
19 The primary endpoint was duration of survival.
19 Il- mira primarja kienet it- tul ta ’ sopravivenza.
Results are presented in Table 9.
Ir- riżultati huma mniżżla f’ Tabella 9.
Efficacy results for study E4599
Riżultati ta ’ l- effikaċja għall- istudju E4599
Carboplatin/ Paclitaxel
Carboplatin / Paclitaxel
Carboplatin/ Paclitaxel + Avastin
Carboplatin / Paclitaxel + Avastin
15
15 mg/ kg q 3 ġimgħat Numru ta ’ Pazjenti
Median (months)
Medjan (xhur) Hazard ratio
10.3
10. 3
12.3
0. 80
0.80 (p=0.003)
12. 3 (p=0. 003)
95% CI (0.69, 0.93) Progression-Free Survival
95% CI (0. 69, 0. 93) Sopravivenza Mingħajr Progressjoni
Median (months) Hazard ratio
Medjan (xhur)
0.65 (p < 0.0001)
0. 65 (p < 0. 0001)
95% CI (0.56, 0.76) Overall Response Rate
95% CI (0. 56, 0. 76) Rata ta ’ Rispons Totali
Rate (percent)
Rata (persentaġġ)
12.9
12. 9
29.0 (p < 0.0001)
29. 0 (p < 0. 0001)
In an exploratory analysis, the extent of Avastin benefit on overall survival was less pronounced in the subgroup of patients who did not have adenocarcinoma histology.
F’ analiżi esploratorja, id- daqs tal- benefiċċju ta ’ Avastin fuq is- sopravivenza totali kienet inqas evidenti fis- sottogrupp ta ’ pazjenti li ma kellhomx istoloġija ta ’ adenokarċinoma.
Study BO17704 was a randomised, double-blind phase III study of Avastin in addition to cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with locally advanced (stage IIIb with supraclavicular lymph node metastases or with malignant pleural or pericardial effusion), metastatic or recurrent non-squamous NSCLC, who had not received prior chemotherapy.
Studu BO17704 kien studju ta ’ fażi III randomised u double- blind ta ’ Avastin flimkien ma ’ cisplatin u gemcitabine kontra plaċebo, cisplatin u gemcitabine f’ pazjenti b’ NSCLC mhux skwamuż lokalment avvanzat (stadju IIIb b’ metastasi fil- glandoli limfatiċi supraklavikulari jew b’ effużjoni malinni plewrali jew perikardijaka), metastatiku jew rikurrenti, li ma rċevewx kimoterapija minn qabel.
The primary endpoint was progression free survival (PFS).
Il- mira primarja kienet sopravivenza mingħajr progressjoni (PFS).
Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/ m2 i. v. infusion on day 1 and gemcitabine 1250 mg/ m2 i. v. 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.
L- pazjenti kienu randomised għal kimoterapija bbażata fuq platinum, cisplatin 80 mg/ m2 infużjoni i. v. fl- ewwel ġurnata u gemcitabine 1250 mg/ m2 infużjoni i. v. 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.
In the Avastin-containing arms, patients could receive Avastin as a single-agent every 3 weeks until disease progression or unacceptable toxicity.
Fil- gruppi b’ Avastin, il- pazjenti setgħu jirċievu Avastin bħala sustanza waħedha kull 3 ġimgħat sal- progressjoni tal- marda jew sa tossiċità mhux aċċettabbli.
Study results show that 94% (277 / 296) of eligible patients went on to receive single agent bevacizumab at cycle 7.
Riżultati ta ’ l- istudju juru li 94% (277 / 296) tal- pazjenti eliġibbli komplew jirċievu bevacizumab bħala sustanża waħedha f’ ċiklu 7.
The efficacy results are presented in Table 10.
Ir- riżultati ta ’ l- effikaċja huma mniżżla f’ Tabella 10.
20 Table 10
20 Tabella 10 Riżultati ta ’ l- effikaċja għall- istudju BO17704
Cisplatin/ Gemcitabine
Cisplatin/ Gemcitabine
Cisplatin/ Gemcitabine + placebo
Cisplatin/ Gemcitabine + plaċebo
+ Avastin 7.5 mg/ kg q 3 weeks
+ Avastin 7. 5 mg/ kg q 3 ġimgħat
+ Avastin 15 mg/ kg q 3 weeks
+ Avastin 15 mg/ kg q 3 ġimgħat
Number of
Numru ta ’ Pazjenti
Progression-Free Survival
Sopravivenza Mingħajr Progressjoni
(p =
6. 7
6.7 0.0026)
6. 5
(p =
(p = 0. 0026)
6.5 0.0301)
(p = 0. 0301)
[0.62; 0.91]
0. 75 [0. 62; 0. 91]
[0.68; 0.98]
0. 82 [0. 68; 0. 98]
Best Overall Response Rate a
L- Aħjar Rata ta ’ Rispons Totali a
20.1%
20. 1%
34.1% (p < 0.0001)
34. 1% (p < 0. 0001)
30.4% (p=0.0023)
30. 4% (p=0. 0023)
a patients with measurable disease at baseline
a pazjenti b’ marda li tista titkejjel fil- linja bażi
Advanced and/ or metastatic Renal Cell Cancer (mRCC)
Kanċer avvanzat u/ jew metastatiku taċ- Ċelluli Renali (mRCC)
Avastin in Combination with Interferon alfa-2a for the First-Line Treatment of Advance and/ or Metastatic Renal Cell Cancer (BO17705)
Avastin Flimkien ma ’ Interferon alfa- 2a għall- Kura Primarja ta ’ Kanċer Avvanzat u/ jew Metastatiku taċ- Ċelluli Renali (BO17705)
This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of Avastin in combination with interferon (IFN) alfa-2a (Roferon®) versus IFN alfa-2a alone as first-line treatment in mRCC.
Din kienet prova ta ’ fażi III, randomised u double- blind imwettqa biex tivvaluta l- effikaċja u s- sigurtà ta ’ Avastin flimkien ma ’ interferon (IFN) alfa- 2a (Roferon®) kontra IFN alfa- 2a waħdu bħala kura primarja f’ mRCC.
The 649 randomized patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%, no CNS metastases and adequate organ function.
Is- 649 pazjent randomised (641 ikkurati) kellhom Karnofsky Performance Status (KPS) ta ’ ≥70%, l- ebda metastasi fis- CNS u funzjoni ta ’ l- organi adegwata.
Patients were nephrectomised for primary renal cell carcinoma.
Il- pazjenti kienu nefrotomizzati minħabba karċinoma primarja taċ- ċelluli renali.
Avastin 10 mg/ kg was given every 2 weeks until disease progression.
Avastin 10 mg/ kg ingħata kull ġimagħtejn sal- progressjoni tal- marda.
IFN alfa-2a was given up to 52 weeks or until disease progression at a recommend starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
IFN alfa- 2a ingħata sat- 52 ġimgħa jew sal- progressjoni tal - marda f’ doża rakkomandata tal- bidu ta ’ 9 MIU tliet darbiet fil- ġimgħa, li tippermetti tnaqqis fid- doża għal 3 MIU tliet darbiet fil- ġimgħa f’ 2 passi.
Patients were stratified according to country and Motzer score and the treatment arms were shown to be well balanced for the prognostic factors.
Pazjenti kienu stratifikati skond il- pajjiż u l- punteġġ Motzer u l- gruppi ta ’ kura ġew murija li kienu bbilanċjati sew għall- fatturi pronjostiċi.
At the data cut-off, 505 progression events had occurred, 111 patients remained on treatment, 287 had discontinued (discontinuations of trial treatment due to AEs were 12% with IFN alfa-2a vs.
Fil- punt ta ’ waqfien tat- tagħrif, seħħew 505 avveniment ta ’ progressjoni, 111- il pazjent baqgħu fuq il- kura, 287 kienu waqfu (twaqqif tal- kura taħt prova minħabba li AEs kienu 12% b’ IFN alfa- 2a vs.
28% with IFN alfa-2a +Avastin), and 251 died.
28% b’ IFN alfa- 2a +Avastin), u 251 mietu.
Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the Avastin arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
Sebgħa u disgħin (97) pazjent fil- grupp ta ’ IFN alfa- 2a u 131 pazjent fil- grupp ta ’ Avastin naqqsu d- doża ta ’ IFN alfa- 2a minn 9 MIU għal 6 jew 3 MIU tliet darbiet fil - ġimgħa kif speċifikat minn qabel fil- protokoll.
Dose-reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of Avastin and IFN alfa-2a based on PFS event free rates over time, as shown by a sub-group analysis.
Tnaqqis fid- doża ta ’ IFN alfa- 2a ma deherx li jaffettwa l- effikaċja tat- taħlita ta ’ Avastin u IFN alfa- 2a ibbażat fuq rati ta ’ PFS mingħajr avvenimenti, kif muri minn analiżi tas- sottogrupp.
The 131 patients in the Avastin + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the study, exhibited at 6, 12 and 18 months PFS event free rates of 73, 52 and 21% respectively, as compared to 61, 43 and 17% in the total population of patients receiving Avastin + IFN alfa-2a.
Il- 131 pazjent fil- grupp ta ’ Avastin + IFN alfa- 2a li naqqsu u żammew id - doża ta ’ IFN alfa- 2a f’ 6 jew 3 MIU waqt l- istudju, wrew rati ta ’ PFS mingħajr avvenimenti f’ 6 xhur, 12 u 18- il xahar ta ’ 73, 52 u 21% rispettivament, kif mqabbel ma ’ 61, 43 u 17% fil- popolazzjoni totali tal- pazjenti li rċievew Avastin + IFN alfa- 2a.
The addition of Avastin to IFN alfa-2a significantly increased PFS and objective tumour response rate (Table 11).
Iż- żjieda ta ’ Avastin ma ’ IFN alfa- 2a żiedet b’ mod sinifikanti PFS u r- rata oġġettiva ta ’ rispons tat- tumur (Tabella 11).
The overall survival (OS) data were not mature at the time of the interim analysis.
It- tagħrif tas- sopravivenza totali (OS) ma kienx komplut fil- ħin ta ’ l- analiżi interim.
21 Table 11
21 Tabella 11 Riżultati ta ’ l- Effikaċja għall- Istudju BO17705
Placebo+ IFNa
Plaċebo+ IFNa
Number of Patients
Numru ta ’ Pazjenti
0.63
0. 63
10.2
10. 2
0.52, 0.75
0. 52, 0. 75
(p-value < 0.0001) Objective Response Rate (%) in Patients with Measurable Disease n
(valur p < 0. 0001) Rata Oġġettiva ta ’ Rispons (%) f’ Pazjent b’ Marda li Titkejjel
Response rate
Rata ta ’ Rispons
12.8%
12. 8%
31.4%
31. 4%
Interferon alfa-2a 9 MIU 3x/ week b Bevacizumab 10 mg/ kg q 2 wk
Interferon alfa- 2a 9 MIU 3x/ ġimgħa b Bevacizumab 10 mg/ kg q ġimagħtejn
This was a randomised, double-blind, phase II clinical study 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.
Dan kien studju kliniku randomised, double- blind u ta ’ fażi II li nvestiga Avastin 10 mg/ kg fi skeda ta ’ kull ġimagħtejn bl- istess doża ta ’ Avastin flimkien ma ’ 150 mg erlotinib kuljum, f’ pazjenti b’ RCC metastatiku taċ- ċelluli ċari.
A total of 104 patients were randomised to treatment in this study, 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.
Total ta ’ 104 pazjent kienu randomised għall- kura f’ dan l- istudju, 53 għal Avastin 10 mg/ kg kull ġimagħtejn u plaċebo u 51 għal Avastin 10 mg/ kg kull ġimagħtejn u erlotinib 150 mg kuljum.
The analysis of the primary endpoint showed no difference between the Avastin + Placebo arm and the Avastin + Erlotinib arm (median PFS 8.5 versus 9.9 months).
L- analiżi tal- mira primarja ma wriet l- ebda differenza bejn il- grupp b’ Avastin + Placebo u l- grupp b’ Avastin + Erlotinib (PFS medjan 8. 5 kontra 9. 9 xhur).
Seven patients in each arm had an objective response.
Seba ’ pazjenti f’ kull grupp ta ’ kura kellhom rispons oġġettiv.
The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p=0.1789), duration of objective response (6.7 vs 9.1 months) or time to symptom progression (HR = 1.172; p = 0.5076).
Iż- żjieda ta ’ erlotinib ma ’ bevacizumab ma wasslitx għal titjib f’ OS (HR = 1. 764; p=0. 1789), tul tar- rispons oġġettiv (6. 7 vs 9. 1 xhur) jew ħin sal- progressjoni tas- sintomi (HR = 1. 172; p = 0. 5076).
This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
Din kienet prova randomised ta ’ fażi II li saret biex tqabbel l- effikaċja u s- sigurtà ta ’ bevacizumab kontra l- plaċebo.
A total of 116 patients were randomized to receive bevacizumab 3 mg/ kg every 2 weeks (n=39), 10 mg/ kg every 2 weeks; (n=37), or placebo (n=40).
Total ta ’ 116- il pazjent kienu randomised biex jirċievu bevacizumab 3 mg/ kg kull ġimagħtejn (n=39), 10 mg/ kg kull ġimagħtejn; (n=37), jew plaċebo (n=40).
An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/ kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Analiżi interim uriet li kien hemm titwil sinifikanti tal- ħin sal- progressjoni tal- marda fil- grupp ta ’ 10 mg/ kg kif mqabbel mal - grupp tal- plaċebo (hazard ratio, 2. 55; p < 0. 001).
There was a small difference, of borderline significance, between the time to progression of disease in the 3 mg/ kg group and that in the placebo group (hazard ratio, 1.26; p=0.053).
Kien hemm differenza żgħira, kemm kemm sinifikat, bejn il- ħin sal- progressjoni tal- marda fil- grupp ta ’ 3 mg/ kg u dak fil- grupp tal- plaċebo (hazard ratio, 1. 26; p=0. 053).
Four patients had objective (partial) response, and all of these had received the 10 mg/ kg dose bevacizumab; the ORR for the 10 mg/ kg dose was 10%.
Erba ’ pazjenti kellhom rispons oġġettiv (parzjali), u dawn kollha kienu rċievew id - doża ta ’ 10 mg/ kg bevacizumab; l- ORR għad- doża ta ’ 10 mg/ kg kien ta ’ 10%.
The pharmacokinetic data for bevacizumab are available from eight clinical trials in patients with solid tumours.
It- tagħrif farmakokinetiku ta ’ bevacizumab huwa disponibbli minn tmin provi kliniċi f’ pazjenti b’ tumuri solidi.
In all clinical trials, bevacizumab was administered as an IV infusion.
Fil- provi kliniċi kollha, bevacizumab ingħata bħala infużjoni IV.
The rate of infusion was based on tolerability, with an initial infusion duration of 90 minutes.
Ir- rata ta ’ infużjoni kienet ibbażata fuq it- tollerabilità, b’ rata ta ’ infużjoni fil- bidu ta ’ 90 minuta.
The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/ kg.
Il- farmakokinetika ta ’ bevacizumab kienet linejari f’ dożi li varjaw minn 1 sa ’ 10 mg/ kg.
Absorption Not applicable.
Assorbiment Ma japplikax.
22 Distribution Based on a population pharmacokinetic analysis of 491 subjects receiving Avastin weekly, every 2 weeks, or every 3 weeks, in doses ranging from 1 to 20 mg/ kg, the volume of the central compartment (Vc) was 2.92 l.
22 Distribuzzjoni Ibbażat fuq analiżi tal- farmakokinetika ta ’ popolazzjoni ta ’ 491 suġġett li irċevew Avastin kull ġimgħa, kull ġimagħtejn, jew kull 3 ġimgħat, f’ dożi li varjaw minn 1 sa ’ 20 mg/ kg, il- volum tal- kompartiment ċentrali (Vc) kien ta ’ 2. 92 l.
Results also indicated that, after correcting for body weight, male subjects had a larger Vc (+ 22%) than females.
Ir- riżultati ndikaw ukoll li, wara korrezzjoni għall- piż tal- ġisem, suġġetti rġiel kellhom Vc akbar (+ 22%) minn tan- nisa.
Metabolism Assessment of bevacizumab metabolism in rabbits following a single IV dose of 125I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Metaboliżmu Analiżi tal- metaboliżmu ta ’ bevacizumab fil- fniek wara doża waħda IV ta ’ 125I- bevacizumab indikat li l- profil metaboliku kien simili għal dak mistenni minn molekola IgG nattiva li ma teħilx ma ’ VEGF.
The metabolism and elimination of bevacizumab is similar to endogenous IgG i. e. primarily via proteolytic catabolism throughout the body, including endothelial cells, and does not rely primarily on elimination through the kidneys and liver.
Il- metaboliżmu u l- eliminazzjoni ta ’ bevacizumab huma simili għal IgG endoġenu i. e. primarjament permezz ta ’ kataboliżmu proteolitiku mal- ġisem kollu, inkluż ċelluli ta ’ l- endotilju, u ma jiddependix primarjament minn eliminazzjoni mill- kliewi u l- fwied.
Binding of the IgG to the FcRn receptor result in protection from cellular metabolism and the long terminal half-life.
Twaħħil ta ’ IgG mar- riċettur ta ’ FcRn jirriżulta fi protezzjoni mill- metaboliżmu ċellulari u half- life terminali twila.
Elimination Bevacizumab clearance was 0.231 l/ day.
Eliminazzjoni Tneħħija ta ’ bevacizumab kienet ta ’ 0. 231 l/ kuljum.
The volume of the central compartment (Vc) and clearance correspond to an initial half-life of 1.4 days and a terminal half-life of about 20 days.
Il- volum tal- kompartiment ċentrali (Vc) u t - tneħħija kkorrispondew ma ’ half- life inizjali ta ’ 1. 4 ġranet u half- life terminali ta ’ madawar 20 ġurnata.
This half-life is consistent with the terminal elimination half-life for human endogenous IgG, which is 18 to 23 days.
Din il- half- life hija konsistenti ma ’ half- life ta ’ eliminazzjoni terminali ta ’ IgG endoġenu uman, li hija ta ’ 18- 23 ġurnata.
In patients with low albumin (≤ 29g/ l) and high alkaline phosphatase (≥ 484U/ l) (both markers of disease severity), clearance was approximately 20% higher than in patients with median laboratory values.
F’ pazjenti b’ albumina baxxa (≤ 29 g/ l) u alkaline phosphatase għolja (≥ 484 U/ l) (it - tnejn markaturi tas- severità tal- marda), it- tneħħija kienet ta ’ madwar 20% għola minn f’ pazjenti b’ riżultati medjana tal- laboratorju.
Pharmacokinetics in Special Populations The population pharmacokinetics were analysed to evaluate the effects of demographic characteristics.
Farmakokinetika f’ Popolazzjonijiet Speċjali Il- farmakokinetika tal- popolazzjoni ġiet analizzata sabiex jiġu evalwati l- effetti ta ’ karatteristiċi demografiċi.
The results showed no significant difference in the pharmacokinetics of bevacizumab in relation to age.
Ir- riżultati ma wrew l- ebda differenza sinifikanti fil- farmakokinetika ta ’ bevacizumab f’ relazzjoni ma ’ l- età.
The pharmacokinetics of bevacizumab have been studied in a limited number of paediatric patients.
Il- farmakokinetika ta ’ bevacizumab ġiet studjata f’ numru limitat ta ’ pazjenti pedjatriċi.
The resulting pharmacokinetic data suggest that the volume of distribution and clearance of bevacizumab were comparable to that in adults with solid tumours.
It- tagħrif farmakokinetiku li rriżulta jissuġġerixxi li l- volum ta ’ distribuzzjoni u t- tneħħija ta ’ bevacizumab kienu komparabbli ma ’ dawk f’ adulti b’ tumuri solidi.
No studies have been conducted to investigate the pharmacokinetics of bevacizumab in renally impaired patients since the kidneys are not a major organ for bevacizumab metabolism or excretion.
Peress li l- kliewi m’ humiex l- organu maġġur għall- metaboliżmu jew l - eskrezzjoni ta ’ bevacizumab, ma sarux studji sabiex jinvestigaw il- farmakokinetika ta ’ bevacizumab f’ pazjenti b’ indeboliment renali.
No studies have been conducted to investigate the pharmacokinetics of bevacizumab in patients with hepatic impairment since the liver is not a major organ for bevacizumab metabolism or excretion.
Peress li l- fwied m’ huwiex l- organu maġġur għall- metaboliżmu jew l - eskrezzjoni ta ’ bevacizumab, ma sarux studji sabiex jinvestigaw il- farmakokinetika ta ’ bevacizumab f’ pazjenti b’ indeboliment tal- fwied.
In studies of up to 26 weeks duration in cynomolgus monkeys, physeal dysplasia was observed in young animals with open growth plates, at bevacizumab average serum concentrations below the expected human therapeutic average serum concentrations.
Fi studju li dam sa 26 ġimgħa f’ xadini cynomolgus, ġiet osservata physeal dysplasia f’ annimali frieħ bi plejt ta ’ tkabbir miftuħa, b’ konċentrazzjonijiet fis- serum ta ’ bevacizumab anqas mill - konċentrazzjonijiet fis- serum medji terapewtiċi stmati fil- bniedem.
In rabbits, bevacizumab was shown to inhibit wound healing at doses below the proposed clinical dose.
Fil- fniek, bevacizumab intwera li jinibixxi l- fejqan tal- ferita f’ dożi inqas mid- doża klinika proposta.
Effects on wound healing were shown to be fully reversible.
Effetti fuq il- fejqan tal- ferita intwerew li kienu riversibbli.
Studies to evaluate the mutagenic and carcinogenic potential of bevacizumab have not been performed.
Ma sarux studji biex jivvalutaw il- potenzjal mutaġeniku u karċinoġeniku ta ’ bevacizumab.
No specific studies in animals have been conducted to evaluate the effect on fertility.
Ma sarux studji speċifiċi fl- annimali biex jivvalutaw l- effett fuq il- fertilità.
An adverse effect on female fertility can however be expected as repeat dose toxicity studies in animals have shown inhibition of the maturation of ovarian follicles and a decrease/ absence of corpora lutea and associated decrease in ovarian and uterus weight as well as a decrease in the number of menstrual cycles.
Iżda huwa mistenni li jkun hemm effett avvers fuq il- fertilità fin- nisa minħabba li studji ta ’ tossiċità b’ doża ripetuta fl- annimali wrew impediment fil- maturazzjoni tal- follikoli ta ’ l- ovarju u tnaqqis/ nuqqas għal kollox tal- corpora lutea u tnaqqis assoċjat fil- piż tal- ovarju u ta ’ l- utru, kif ukoll tnaqqis fin- numru ta ’ ċikli menstruwali.
Bevacizumab has been shown to be embryotoxic and teratogenic when administered to rabbits.
Bevacizumab intwera li kien embrijotossiku u teratoġeniku meta ngħata lill- fniek.
Observed effects included decreases in maternal and foetal body weights, an increased number of foetal resorptions and an increased incidence of specific gross and skeletal foetal malformations.
Riżultati avversi fil- fetu
23 Adverse foetal outcomes were observed at all tested doses, of which the lowest dose resulted in average serum concentrations approximately 3 times larger than in humans receiving 5 mg/ kg every 2 weeks.
23 kienu osservati fid- dożi kollha studjati, li minnhom l- anqas doża rriżultat f’ konċentrazzjonijiet medji fis- serum ta ’ madwar 3 darbiet akbar milli fil- bnedmin li rċevew 5 mg/ kg kull ġimagħtejn.
Trehalose dihydrate Sodium phosphate Polysorbate 20 Water for injections
Trehalose dihydrate Sodium phosphate Polysorbate 20 Ilma għall- injezzjoni
A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Kien osservat profil ta ’ degradazzjoni li jiddependi mil- konċentrazzjoni meta dilwit ma ’ soluzzjonijiet ta ’ glukosju (5%).
Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/ ml (0.9%) solution for injection.
Stabilità kimika u fiżika ta ’ waqt l- użu ntweriet għal 48 siegħa f’ 2°C sa ’ 30°C f’ soluzzjoni għall - injezzjoni ta ’ 9 mg/ ml (0. 9%) sodium chloride.
From a microbiological point of view, the product should be used immediately.
Mid- derha mikrobijoloġika, dan il- prodott għandu jintuża minnufih.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax minnufih, il- ħin u l- kondizzjonijiet ta ’ ħażna ta ’ waqt l- użu huma r - responsabbilita ta ’ min qed jużah u normalment ma jkunx aktar minn 24 siegħa f’ 2°C sa ’ 8°C, sakemm id- dilwazzjoni ma saritx taħt kondizzjonijiet ikkontrollati u assettiċi ivvalidati.
Store in a refrigerator (2°C-8°C).
Aħżen fil- friġġ (2°C- 8°C).
Keep the vial in the outer carton in order to protect from light.
Tiffriżax Żomm il- kunjett fil- pakkett ta ’ barra sabiex tilqa ’ mid- dawl.
Single-use vial (Type I glass) with a butyl rubber stopper containing 100 mg of bevacizumab in 4 ml of concentrate for solution for infusion.
Kunjett li jintuża darba (ħġieġ ta ’ Tip I) b’ tapp tal- lasktu butyl li fiha 100 mg ta ’ bevacizumab f’ 4 ml ta ’ konċentrat ta ’ soluzzjoni għall- infużjoni.
Single-use vial (Type I glass) with a butyl rubber stopper containing 400 mg of bevacizumab in 16 ml of concentrate for solution for infusion.
Kunjett li jintuża darba (ħġieġ ta ’ Tip I) b’ tapp tal- lasktu butyl li fiha 400 mg ta ’ bevacizumab f’ 16 ml ta ’ konċentrat ta ’ soluzzjoni għall- infużjoni.
Pack of 1 vial containing 4 ml.
Pakkett ta ’ kunjett wieħed li fih 4 ml.
Pack of 1 vial containing 16 ml.
Pakkett ta ’ kunjett wieħed li fih 16 ml.
Avastin does not contain any antimicrobial preservative; therefore, care must be taken to ensure the sterility of the prepared solution.
Avastin ma fih l- ebda preservattiv antimikrobiku; għalhekk, irid ikun hemm attenzjoni sabiex tiġi assikurata l- isterilità tas- soluzzjoni ppreparata.
Avastin should be prepared by a healthcare professional using aseptic technique.
Avastin irid jiġi ppreparat minn professjonist fil- kura tas- saħħa permezz ta ’ teknika asettika.
Withdraw the necessary amount of bevacizumab and dilute to the required administration volume with 0.9% sodium chloride solution for injection.
Iġbed l - ammont neċessarju ta ’ bevacizumab u ddilwixxi sal- volum tal- għoti meħtieġ b’ soluzzjoni għall - injezzjoni ta ’ 0. 9% sodium chloride.
The concentration of the final bevacizumab solution should be kept within the range of 1.4-16.5 mg/ ml.
Il- konċentrazzjoni tas- soluzzjoni finali ta ’ bevacizumab għandha tinżamm fil- firxa ta ’ 1. 4- 16. 5 mg/ ml.
24 Discard any unused portion left in a vial, as the product contains no preservatives.
24 Armi kull fdal fil- kunjett li ma ntużax, minħabba li l- prodott ma fihx preservattivi.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Prodotti mediċinali li jingħataw fid- demm iridu jiġu spezzjonati viżwalment għall- frak jew tibdil fil- kulur qabel l- għotji.
No incompatibilities between Avastin and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Ma ġew osservati l- ebda inkompatibilità bejn Avastin u polyvinyl chloride jew boroż tal- polyolefine jew settijiet ta ’ l- infużjoni.
EU/ 1/ 04/ 300/ 001 – 100 mg/ 4 ml vial EU/ 1/ 04/ 300/ 002 – 400 mg/ 16 ml vial
EU/ 1/ 04/ 300/ 001 – kunjett ta ’ 100 mg/ 4 ml EU/ 1/ 04/ 300/ 002 – kunjett ta ’ 400 mg/ 16 ml
12 January 2005
12 ta ’ Jannar 2005
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA ATTIVA U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
26 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
1 DNA Way South San Francisco, CA 94080-4990 USA
1 DNA Way South San Francisco, CA 94080- 4990 L- Istati Uniti
1000 New Horizons Way Vacaville, CA 95688 USA
1000 New Horizons Way Vacaville, CA 95688 L- Istati Uniti
1 Antibody Way Oceanside, CA 92056 USA
1 Antibody Way Oceanside, CA 92056 L- Istati Uniti
Medicinal product subject to restricted medical prescription (See Annex:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness:
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Mmaniġġjar ta ’ Riskji Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq jikkommetti ruħu li jwettaq l- istudji u l - attivitajiet ta ’ Farmakoviġilanza oħra kif iddettaljat fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f’ verżjoni 4. 0 tal- Pjan ta ’ Mmaniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2. tal- applikazzjoni tal- Awtorizazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mis - CHMP.
27 ● Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached ● At the request of the EMEA
27 Barra minn hekk, għandu jiġi sottomess RMP aġġornat ● Meta tinkiseb informazzjoni ġdida li jista ’ jkollha impatt fuq Speċifikazzjonijiet ta ’ Sigurtà attwali, Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskji. ● Fi żmien 60 ġurnata minn meta tintlaħaq mira mportanti (farmakoviġilanza jew tnaqqis ta ’ riskji). ● Mat- talba ta ’ l- EMEA
CARTON
PAKKETT
Avastin 25 mg/ ml concentrate for solution for infusion Bevacizumab
Avastin 25 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Bevacizumab
Each vial contains 100 mg bevacizumab.
Kull kunjett fih 100 mg bevacizumab
Trehalose dihydrate, sodium phosphate, polysorbate 20, water for injections.
Trehalose dihydrate, sodium phosphate, polysorbate 20, ilma għall- injezzjoni.
Concentrate for solution for infusion 100 mg 1 vial of 4 ml
100 mg Kunjett ta ’ 4 ml
For intravenous use after dilution Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
This medicinal product does not contain any preservative
Dan il- prodott mediċinali ma fihx preservattivi.
Not applicable
Ma japplikax
For intravenous use after dilution
Għall- użu ġol- vini wara d- diluzzjoni.
Each vial contains 400 mg bevacizumab.
Kull kunjett fih 400 mg bevacizumab
Concentrate for solution for infusion 400 mg 1 vial of 16 ml
400 mg Kunjett ta ’ 16 ml
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mil- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Avastin is and what it is used for 2.
X’ inhu Avastin u għalxiex jintuża 2.
Before you use Avastin 3.
Qabel ma tuża Avastin 3.
How to use Avastin 4.
Kif għandek tuża Avastin 4.
How to store Avastin 6.
Kif taħżen Avastin 6.
WHAT AVASTIN IS AND WHAT IT IS USED FOR
X’ INHU AVASTIN U GĦALXIEX JINTUŻA
Avastin is a medicine used for the treatment of advanced cancer in the large bowel, i. e., in the colon or rectum.
Avastin huwa mediċina li tintuża għall- kura ta ’ kanċer avvanzat fil- musrana l- kbira, i. e. fil- kolon jew rektum.
Avastin will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Avastin se jingħata flimkien ma ’ kura ta ’ kimoterapija li fiha mediċina fluoropyrimidine.
Avastin is also used for the treatment of metastatic breast cancer.
Avastin jintuża wkoll għall- kura ta ’ kanċer tas- sider li mmetastatizza.
When used for patients with breast cancer, it will be administered with a chemotherapy called paclitaxel.
Meta jintuża għall- pazjenti b’ kanċer tas- sider, jiġi amministrat ma ’ kimoterapija msejħa paclitaxel.
Avastin is also used for the treatment of advanced non-small cell lung cancer.
Avastin jintuża wkoll għall- kura ta ’ kanċer avvanzat, taċ- ċelluli mhux żgħar fil- pulmun.
Avastin will be administered together with a chemotherapy regimen containing platinum.
Avastin se jingħata flimkien ma ’ kors ta ’ kimoterapija li fih platinum.
Avastin is also used for treatment of advanced kidney cancer.
Avastin jintuża wkoll għall- kura ta ’ kanċer avvanzat tal- kliewi.
When used for patients with kidney cancer, it will be administered with another type of medicine called an interferon.
Meta jintuża għall- pazjenti b’ kanċer tal- kliewi, ser jingħata ma ’ tip ta ’ mediċina oħra li tissejjaħ interferon.
Avastin contains the active substance bevacizumab, which is a humanised monoclonal antibody.
Avastin fih is- sustanza attiva bevacizumab, li huwa antikorp monoklonali umanizzat.
Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body.
Antikorpi monoklonali huma proteini li speċifikament jagħrfu u jingħaqdu ma ’ proteini uniċi oħra fil- ġisem.
Bevacizumab binds selectively to a protein called human vascular endothelial growth factor (VEGF), which is found on the lining of blood and lymph vessels in the body.
Bevacizumab jingħaqad b’ mod selettiv ma ’ proteina msejħa fattur ta ’ l- iżvilupp ta ’ l- endotelju vaskulari uman (VEGF), li tinstab fuq ir- rita ta ’ ġewwa ta ’ vini/ arterji tad- demm u tal- kanali tal- limfa fil- ġisem.
VEGF causes blood vessels to grow within tumours, these blood vessels provide the tumour with nutrients and oxygen.
VEGF tikkawża l- iżvilupp ta ’ kanali tad- demm ġo tumuri; dawn il- kanali tad- demm jipprovdu nutrijenti u ossiġnu lit- tumur.
Once bevacizumab is bound to VEGF, it stops VEGF working properly.
Kif bevacizumab jingħaqad ma ’ VEGF, iwaqqaf lil VEGF milli taħdem kif suppost.
This has the effect of preventing tumour growth by blocking the growth of the blood vessels providing the nutrients and oxygen to the tumour.
Dan għandu effett li jimpedixxi lit- tumur milli jikber billi jimblokka l - iżvilupp tal- kanali tad- demm li jipprovdu n- nutrijenti u l- ossiġnu lit- tumur.
Each pack of Avastin concentrate for solution for infusion contains one vial.
Kull pakkett ta ’ Avastin konċentrat għal soluzzjoni għall- infużjoni fih kunjett wieħed.
This vial contains either 4 ml or 16 ml of a slightly opaque, colourless to pale brown sterile liquid concentrate.
Dan il- kunjett fih 4 ml jew 16 ml ta ’ konċentrat likwidu sterili, kemmxejn opak, bla kulur għal kannella ċar.
The concentrate must be diluted before use to make a solution for intravenous infusion.
Il - konċentrat għandu jiġi dilwit qabel l- użu biex jipprovdi soluzzjoni għall- infużjoni ġol- vini.
BEFORE YOU USE AVASTIN
QABEL MA TUŻA AVASTIN
Do not use Avastin if:
Tużax Avastin:
- you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of Avastin.
sustanzi l- oħra ta ’ Avastin.
- you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għall- prodotti derivati minn ċelluli ta ’
recombinant human or humanised antibodies.
l- ovarju ta ’ ħamster ċiniż jew għal xi antikorpi rikombinati umani jew umanizzati oħra.
- you have cancer in your brain which has not been treated.
- jekk għandek kanċer f’ moħħok li ma ġiex ikkurat.
- you are pregnant.
- jekk inti tqila.
Take special care with Avastin:
Oqgħod attent ħafna b’ Avastin:
- if you have conditions causing inflammation inside the abdomen (e. g. diverticulitis, stomach
- jekk għandek kondizzjonijiet li jikkawżaw infjammazzjoni addominali (e. ż. divertikulożi, ulċeri
ulcers, colitis associated with chemotherapy), as it is possible that Avastin may increase the risk of developing holes in the gut wall.
ta ’ l- istonku, kolite assoċjata ma ’ kimoterapija), għax huwa possibli li Avastin jista ’ jżid ir - riskju li jiżviluppaw perforazzjonijiet fil- ħajt addominali.
- if you are going to have an operation, if you have had major surgery within the last 28 days or if
- jekk se tagħmel operazzjoni, jekk kellek operazzjoni maġġuri f’ dawn l- aħħar 28 ġurnata, jew
you still have an unhealed wound following surgery, you should not receive this medicine as Avastin can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
jekk għad għandek ferita ta ’ wara operazzjoni li għada ma fieqitx, m’ għandex tingħata din il - mediċina għax Avastin jista ’ jżid ir- riskju ta ’ fsada jew iżid ir- riskju ta ’ problemi fil- fejqan tal - ferita wara operazzjoni.
- if you have high blood pressure which is not well controlled with blood pressure medicines as
- jekk għandek pressjoni tad- demm għolja li mhix ikkontrollata sew b’ mediċini għall- pressjoni
Avastin can increase the incidence of high blood pressure.
tad- demm għolja għax Avastin jista ’ jżid l- inċidenza ta ’ pressjoni tad- demm għolja.
Your doctor should make sure that your blood pressure is under control before starting Avastin treatment.
It- tabib tiegħek għandu jaċċerta ruħu li l- pressjoni tad- demm tiegħek hija taħt kontroll qabel tinbeda kura b’ Avastin.
- if you have high blood pressure, as you may have a higher risk of having protein in your urine.
- jekk għandek pressjoni tad- demm għolja, għax jista ’ jkollok riskju akbar ta ’ proteina fl- awrina.
- if you are over 65 years old and also have had blood clots in your arteries (a type of blood
- jekk għandek aktar minn 65 sena u kellek embolu (demm magħqud) fl- arterji tiegħek (tip ta ’
vessel) in the past, as these factors can increase the risk of further blood clots in the arteries.
kanal tad- demm) fil- passat, għax dawn il- fatturi jistgħu jkomplu jżidu r- riskju ta ’ aktar emboli fl- arterji.
- if you or your family tend to suffer from bleeding problems or you are taking medicines to thin
- jekk int jew il- familja tiegħek għandkom tendenza li ssofru minn problemi ta ’ fsada jew qed
the blood for the treatment of blood clots.
tieħu mediċini li jraqqu d- demm għall- kura ta ’ emboli.
- if you have been coughing or spitting blood or had any bleeding in your lungs.
- Jekk kont qed tisgħol jew tobżoq id- demm, jew kellek fsada fil- pulmun tiegħek.
- if you have ever received anthracyclines (for example doxorubicin, a specific type of
- jekk riċentament irċievejt anthracyclines (per eżempju doxorubicin, tip speċifiku ta ’
chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease as Avastin can increase the risk of developing a weak heart.
kimoterapija użat biex jikkura xi kanċers) jew ħadt radjuterapija f’ sidrek, jew jekk għandek mard tal- qalb għax Avastin jista ’ jżid ir- riskju li tiżviluppa qalb dgħajfa.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Jekk jogħoġbok kellem lit- tabib tiegħek anké jekk dawn il- dikjarazzjonijiet kienu jgħoddu għalik xi darba fil- passat.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Please tell your doctor if you have recently received, or are receiving, radiotherapy.
Jekk jogħġbok għid lit- tabib tiegħek jekk dan l- aħhar irċevejt, jew qed tirċievi, radjuterapija.
Pregnancy and breast feeding You must not use this medicine if you are pregnant.
Tqala u Treddigħ M’ għandekx tuża din il- mediċina jekk inti tqila.
Avastin may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Avastin jista ’ jikkawża ħsara lit- tarbija fil- ġuf għax jista ’ jwaqqaf il- formazzjoni ta ’ kanali tad- demm ġodda.
Your doctor should advise you about using contraception during treatment with Avastin and for at least 6 months after the last dose of Avastin.
It- tabib tiegħek għandu javżak dwar l- użu ta ’ kontraċezzjoni waqt kura b’ Avastin u għal ta ’ l- anqas 6 xhur wara l- aħħar doża ta ’ Avastin.
Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.
Għid lit- tabib tiegħek minnufiħ jekk inti tqila, tinqabad tqila waqt kura b’ din il- mediċina, jew qed tippjana li tinqabad tqila fil- futur qarib.
You must not breast-feed your baby during treatment with Avastin and for at least 6 months after the last dose of Avastin, as this medicine may interfere with the growth and development of your baby.
39 M’ għandekx tredda ’ lit- tarbija tiegħek waqt kura b’ Avastin u għal ta ’ l- anqas 6 xhur wara l- aħħar doża ta ’ Avastin, għax din il- mediċina tista ’ tinterfieri mat- tkabbir u l- iżvilupp tat- tarbija tiegħek.
39 Ask your doctor or pharmacist for advice before taking any medicine.
Staqsi lit- tabib jew lill- ispiżjar tiegħek għall- parir qabel tieħu xi mediċina.
Avastin has not been shown to impair your ability to drive or to use any tools or machines.
Avastin ma ntweriex li jnaqqas l- abilità tiegħek li ssuq jew tħaddem għodda jew magni.
HOW TO USE AVASTIN
KIF GĦANDEK TUŻA AVASTIN
Dosage and frequency of administration The dose of Avastin needed depends on your body weight and the kind of cancer to be treated.
Dożaġġ u frekwenza tal- għotja Id- doża ta ’ Avastin li għandek bżonn tiddependi fuq il- piż tiegħek u t- tip ta ’ kanċer li għandu jiġi kkurat.
The recommended dose is 5, 7.5, 10 or 15 mg per kilogram of your body weight.
Id- doża rakkomandata hija ta ’ 5, 7. 5, 10 jew 15 mg għal kull kilogramma tal- piż tiegħek.
Your doctor will prescribe a dose of Avastin that is right for you.
It - tabib tiegħek se jippreskrivilek doża ta ’ Avastin li hi tajba għalik.
You will be treated with Avastin once every 2 or 3 weeks.
Se tkun ikkurat/ a b’ Avastin darba kull gimagħtejn jew kull 3 ġimgħat.
The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Avastin fails to stop your tumour growing.
In- numru ta ’ infużjonijiet li tirċievi se jiddependu fuq kif qed tirrispondi għall- kura; għandek tkompli tirċievi din il- mediċina sakemm Avastin jfalli milli jwaqqaf il - kobor tat- tumur tiegħek.
Method and route of administration Avastin is a concentrate for solution for infusion.
Metodu u rotta tal- għotja Avastin huwa konċentrat għal soluzzjoni għall- infużjoni.
Depending on the dose prescribed for you, some or all of the contents of the Avastin vial will be diluted with saline solution before use.
Skond id- doża preskritta lilek, biċċa mil - kontenut tal- kunjett ta ’ Avastin, jew il- kunjett kollu se tiġi dilwita ma ’ soluzzjoni ta ’ melħ qabel l- użu.
A doctor or nurse will give you this diluted Avastin solution by intravenous infusion.
Tabib jew ners se ttik din is- soluzzjoni dilwita ta ’ Avastin permezz ta ’ infużjoni ġol- vini.
The first infusion will be given to you over 90 minutes.
L- ewwel infużjoni se tingħatalek fuq medda ta ’ 90 minuta.
If this is well-tolerated the second infusion may be given over 60 minutes.
Jekk din tiġi ttollerata tajjeb it- tieni infużjoni tista ’ tingħatalek fuq medda ta ’ 60 minuta.
Later infusions may be given to you over 30 minutes.
Infużjonijiet oħra jistgħu jingħatawlek fuq medda ta ’ 30 minuta.
The administration of Avastin should be temporarily discontinued:
L- għotja ta ’ Avastin għandha tiġi mwaqqfha temporanjament:
- if you develop severe high blood pressure requiring treatment with blood pressure medicines,
- jekk tiżviluppa pressjoni tad- demm għolja ħafna, li tirrekjedi kura b’ mediċini għall- pressjoni
- if you have problems with wound healing following surgery,
- jekk ikollok problema bil- fejqan tal- ferita wara operazzjoni,
- if you undergo surgery.
- jekk tagħmel operazzjoni.
The administration of Avastin should be permanently discontinued if you develop:
L- għotja ta ’ Avastin għandha tiġi mwaqqfha għal kollox jekk tiżviluppa:
- severe high blood pressure which cannot be controlled by blood pressure medicines; or a
- pressjoni tad- demm għolja ħafna, li ma ’ tistax tiġi ikkontrollata b’ mediċini għall- pressjoni
sudden severe rise in blood pressure,
għolja; jew f’ daqqa għolietlek ħafna l- pressjoni tad- demm,
- presence of protein in your urine accompanied by swelling of your body,
- il- preżenza ta ’ proteini fl- awrina flimkien ma nefħa f’ ġismek,