natgillin/translations-raw huggingface dataset:
Therefore fertility preservation strategies should be discussed with women of childbearing potential prior to starting treatment with bevacizumab.
Pred začetkom zdravljenja z bevacizumabom se je z ženskami v rodni dobi treba pogovoriti o možnostih, ki so na voljo za ohranitev plodnosti.
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.
Pri bolnikih, pri katerih se je pojavil venski trombembolični neželeni učinek, obstaja povečano tveganje za ponovitev, če prejemajo bevacizumab v kombinaciji s kemoterapijo, kot pa če prejemajo le kemoterapijo.
Caution should be exercised when bevacizumab and intravenous bisphosphonates are administered simultaneously or sequentially.
Pri sočasnem ali zaporednem dajanju bevacizumaba in intravenskih difosfonatov je potrebna previdnost.
MVASI is also used for the treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Zdravilo MVASI uporabljamo tudi za zdravljenje odraslih bolnic z napredovalim epitelijskim rakom jajčnikov, karcinomom jajcevodov ali primarnim rakom potrebušnice.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MVASI 25 mg/mL sterile concentrate bevacizumab
IME ZDRAVILA IN POT(I) UPORABE MVASI 25 mg/ml sterilni koncentrat bevacizumab i.v.
Patients treated for persistent, recurrent, or metastatic cervical cancer with bevacizumab in combination with paclitaxel and cisplatin may be at increased risk of venous thromboembolic events.
Bolnice z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska, in se zdravijo z bevacizumabom v kombinaciji s paklitakselom in cisplatinom, imajo lahko večje tveganje za venske trombembolične dogodke.
Aneurysms and artery dissections (see section 4.8)
Anevrizme in disekcije arterij (glejte poglavje 4.8)
Hypertensionb,d, Thromboemboli sm (venous)b,d
Žilne bolezni hipertenzijab,d, (venska) trombembolijab,d
These results demonstrate robustness of the analysis of PFS as shown in table 15.
Ti rezultati prikazujejo robustnost analize preživetja brez napredovanja bolezni, ki je prikazana v preglednici 15.
The safety and efficacy of bevacizumab, 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.
Varnost in učinkovitost bevacizumaba v prvi liniji zdravljenja bolnikov z neskvamoznim nedrobnoceličnim rakom pljuč so v preskušanjih E4599 in BO17704 proučevali skupaj z dodano kemoterapijo na osnovi platine.
The study did not meet its primary endpoint of demonstrating a significant improvement of event free survival (EFS) (Central Radiology Review Committee (CRRC)-assessed) when bevacizumab was added to the RT/T arm compared with RT/T alone (HR = 1.44; 95% CI: 0.90, 2.30).
Primarni cilj študije, to je dokazati značilno izboljšanje v preživetju brez dogodka (po oceni centralnega odbora za radiološki pregled (CRRS - Central Radiology Review Committee)) v skupini, zdravljeni z radioterapijo in temozolomidom z dodatkom bevacizumaba, v primerjavi s skupino, zdravljeno z radioterapijo in temozolomidom, ni bil dosežen (razmerje ogroženosti = 1,44; 95-% interval zaupanja: 0,90; 2,30).
MVASI should be discontinued in patients with life-threatening (grade 4) thromboembolic reactions, including pulmonary embolism (NCI-CTCAE v.3).
Zdravilo MVASI je treba pri bolnikih z življenjsko ogrožajočimi tromboemboličnimi neželenimi učinki, vključno s pljučno embolijo (stopnja 4, NCI-CTCAE v.3) ukiniti, bolnike s tromboemboličnimi neželenimi učinki stopnje ≤ 3 (NCI-CTCAE v.3) pa skrbno spremljati.
• Carboplatin (AUC 4, day 1) and gemcitabine (1,000 mg/m2 on days 1 and 8) and concurrent placebo every 3 weeks for 6 and up to 10 cycles followed by placebo (every 3 weeks) alone until disease progression or unacceptable toxicity.
• karboplatin (AUC 4, dan 1) in gemcitabin (1.000 mg/m2 na dan 1 in 8) ter sočasno placebo vsake 3 tedne, od 6 do največ 10 ciklov, nato je sledil samo placebo vsake tri tedne do napredovanja bolezni ali nesprejemljive toksičnosti;
Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1,250 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 IV infusion day 1 of every 3-week cycle.
Randomizirani bolniki so prejeli kemoterapijo na osnovi platine, cisplatin 80 mg/m2 v obliki intravenske infuzije na dan 1 in gemcitabin 1.250 mg/m2 v obliki intravenske infuzije na dneva 1 in 8 vsakega tritedenskega cikla do skupno 6 ciklov ali cisplatin in gemcitabin v kombinaciji z bevacizumabom v odmerku 7,5 ali 15 mg/kg v obliki intravenske infuzije na dan 1 vsakega tritedenskega cikla.
NAME OF THE MEDICINAL PRODUCT MVASI 25 mg/mL concentrate for solution for infusion.
IME ZDRAVILA MVASI 25 mg/ml koncentrat za raztopino za infundiranje
You will be treated with MVASI once every 2 or 3 weeks.
Zdravnik vam bo predpisal ustrezni odmerek zdravila MVASI, ki ga boste prejeli enkrat na 2 ali 3 tedne.
• blockage in the gut or bowel,
• oviranje pretoka v črevesju ali mehurju,
Bevacizumab has been associated with serious cases of gastrointestinal perforation.
Bevacizumab so povezovali z resnimi primeri perforacije prebavil.
• diarrhoea, nausea, vomiting and abdominal pain.
• driska, slabost, bruhanje in bolečine v trebuhu.
MVASI may impair female fertility.
Zdravilo MVASI lahko oslabi plodnost ženske.
Number of patients Progression-free survival
Število bolnikov Preživetje brez napredovanja bolezni mediana
Trial BO17704 has demonstrated that both 7.5 mg/kg/q3wk and 15 mg/kg/q3wk bevacizumab doses increase progression-free survival and response rate.
Preskušanje BO17704 pa je pokazalo, da oba odmerka, 7,5 mg/kg telesne mase in 15 mg/kg telesne mase, dana enkrat na tri tedne, podaljšata preživetje brez napredovanja bolezni in povečata delež odgovora na zdravljenje.
Difference in response rates 95% CI for difference in response rates4
95-% IZ za razliko v deležih odgovora na zdravljenje4
EGFR mutation testing should be performed prior to initiation of treatment with the combination of MVASI and erlotinib.
Pred začetkom zdravljenja s kombinacijo zdravila MVASI in erlotiniba je treba opraviti testiranje za določanje mutacij EGFR.
Endpoint (months)
Cilji (meseci)
MVASI, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Zdravilo MVASI je v kombinaciji s karboplatinom in gemcitabinom ali v kombinaciji s karboplatinom in paklitakselom indicirano za zdravljenje odraslih bolnic, pri katerih je prišlo do prve ponovitve epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, občutljivega na platino, ki se še niso zdravile z bevacizumabom ali drugimi zaviralci VEGF ali zdravili, ki delujejo na receptor VEGF.
assessment)** Median overall survival* Hazard ratio (97.5% CI) * Overall survival analysis at clinical cut-off 31 January 2007.
Sekundarni cilji raziskave mediana preživetja brez napredovanja bolezni (ob zdravljenju)** razmerje ogroženosti (97,5-% interval zaupanja) celokupni odgovor (ocena raziskovalca)** mediana celokupnega preživetja* razmerje ogroženosti (97,5-% interval zaupanja) * Analiza celokupnega preživetja podatkov zbranih do 31. januarja 2007.
The efficacy results are presented in table 12.
Rezultati učinkovitosti so predstavljeni v preglednici 12.
In some clinical trials anaphylactic and anaphylactoid-type reactions were reported more frequently in patients receiving bevacizumab in combination with chemotherapy than with chemotherapy alone.
V nekaterih kliničnih preskušanjih so o anafilaktičnih in anafilaktoidnih reakcijah pogosteje poročali pri bolnikih, ki so prejemali bevacizumab v kombinaciji s kemoterapijo, kot pri bolnikih na sami kemoterapiji.
There is no information on the safety profile of bevacizumab in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting bevacizumab treatment, as such patients were excluded from clinical trials.
Varnostni profil bevacizumaba pred njegovo uvedbo pri bolnikih, ki imajo kongenitalno hemoragično diatezo ali pridobljeno koagulopatijo ali če prejemajo polni odmerek antikoagulantov za zdravljenje trombembolije, ni poznan, ker le-ti niso bili vključeni v klinična preskušanja.
The results for all secondary endpoints (investigator assessed EFS, and ORR and OS) were consistent in showing no improvement associated with the addition of bevacizumab to the RT/T arm compared with the RT/T arm alone.
Rezultati za vse sekundarne cilje (preživetje brez dogodka po oceni raziskovalca, delež celokupnega odziva in celokupno preživetje) so bili skladni in niso pokazali izboljšanja, povezanega z dodatkom bevacizumaba v skupini, zdravljeni z radioterapijo in temozolomidom, v primerjavi s skupino, zdravljeno samo z radioterapijo in temozolomidom.
• CPB7.5+ arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks plus bevacizumab (7.5 mg/kg q3w) for up to 12 months (bevacizumab was started at cycle 2 of chemotherapy if treatment was initiated within 4 weeks of surgery or at cycle 1 if treatment was initiated more than 4 weeks after surgery).
• CPB7,5+ skupina: 6 tritedenskih ciklov karboplatina (AUC 6) in paklitaksela (175 mg/m2) ter bevacizumaba (7,5 mg/kg telesne mase enkrat na 3 tedne) do 12 mesecev (zdravljenje z bevacizumabom se je začelo pri drugem ciklu kemoterapije, če se je s terapijo začelo v prvih 4 tednih po operaciji ali pri prvem ciklu, če se je s terapijo začelo več kot 4 tedne po operaciji).
There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving bevacizumab monotherapy compared to patients receiving bevacizumab in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).
Pri bolnikih, ki so prejemali samostojno zdravljenje z bevacizumabom, v primerjavi z bolniki, ki so prejemali bevacizumab v kombinaciji z interferonom alfa-2a, erlotinibom ali kemoterapijami (IFL, 5-FU/LV, karboplatin/paklitaksel, kapecitabin, doksorubicin ali cisplatin/gemcitabin), ni bilo statistično značilnih ali klinično pomembnih razlik v očistku bevacizumaba.
The median age was 46.0 years (range: 20-83) in the chemo alone group and 48.0 years (range: 22-85) in the chemo + bevacizumab group; with 9.3% of patients in the chemo alone group and 7.5% of patients in the chemo + bevacizumab group over the age of 65 years.
Mediana starost bolnic je bila v skupini s samo kemoterapijo 46,0 let (razpon: od 20 do 83), v skupini s kemoterapijo in bevacizumabom pa 48,0 let (razpon: od 22 do 85); v skupini s samo kemoterapijo je bilo starejših od 65 let 9,3 % bolnic, v skupini s kemoterapijo in bevacizumabom pa 7,5 % bolnic.
Trial BO17704 was a randomised, double-blind phase III trial of bevacizumab 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.
Preskušanje BO17704 je bilo randomizirano, dvojno slepo preskušanje faze III, v katerem so primerjali bevacizumab v kombinaciji s cisplatinom in gemcitabinom s placebom, cisplatinom in gemcitabinom pri bolnikih z lokalno napredovalim (stadij IIIB z zasevki v supraklavikularnih bezgavkah ali maligno plevralnim ali perikardialnim izlivom), metastatskim ali ponavljajočem se neskvamoznim nedrobnoceličnim rakom pljuč.
Results are presented in table 21.
Rezultati so prikazani v preglednici 21.
• The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV every 2 weeks (or bevacizumab 15 mg/kg every 3 weeks if used in combination with topotecan 1.25 mg/m2 on days 1-5 every 3 weeks).
• skupina s kemoterapijo in bevacizumabom: izbrano kemoterapijo so kombinirali z bevacizumabom, danim intravensko, v odmerku 10 mg/kg vsake 2 tedna (ali bevacizumabom v odmerku 15 mg/kg vsake 3 tedne, če so ga uporabljali skupaj s topotekanom v odmerku 1,25 mg/m2 od 1. do 5. dne vsake 3 tedne).
Each vial of 4 mL of concentrate contains 100 mg of bevacizumab.
Ena viala s 4 ml koncentrata vsebuje 100 mg bevacizumaba.
Hypersensitivity reactions/infusion reactions (see section 4.8)
Preobčutljivostne reakcije/reakcije pri infundiranju (glejte poglavje 4.8)
With gross residual disease.
S preostankom bolezni.
United States
ZDRUŽENE DRŽAVE AMERIKE
UNITED STATES
Združene Države Amerike
• 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).
• NO16966: Bevacizumab 7,5 mg/kg telesne mase vsake 3 tedne v kombinaciji s kapecitabinom peroralno in oksaliplatinom intravensko (shema XELOX) ali bevacizumab 5 mg/kg telesne mase vsaka 2 tedna v kombinaciji z levkovorinom in bolusom 5-fluorouracila, sledila je infuzija 5-fluorouracila z oksaliplatinom intravensko (shema FOLFOX-4).
Relative to control arm.
a glede na kontrolno skupino.
(p-value5 = 0.0132)
(vrednost p5 = 0,0132)
Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Bolezni dihal, prsnega koša in mediastinalnega prostora perforacija nosnega pretina (ni znana) pljučna hipertenzija (ni znana) disfonija (pogosto)
• blocking of the arteries by a blood clot,
• zamašitev arterij s krvnim strdkom,
A total of 673 patients were randomised in equal proportions to the following two treatment arms:
Skupaj so randomizirali 673 bolnic v enakih deležih v naslednji dve skupini:
The 131 patients in the bevacizumab + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the trial, 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 bevacizumab + IFN alfa-2a.
Pri 131 bolnikih iz skupine, ki je prejemala bevacizumab in interferon alfa-2a, pri katerih so zmanjšali in vzdrževali odmerek interferona alfa-2a med preskušanjem na 6 ali 3 mio i.e., so deleži preživetja brez napredovanja bolezni znašali: po 6 mesecih 73 %, po 12 mesecih 52 % in po 18 mesecih 21 %.
E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating bevacizumab 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 je bilo odprto, randomizirano, aktivno kontrolirano, multicentrično klinično preskušanje, v katerem so proučevali bevacizumab v prvi liniji zdravljenja bolnikov z lokalno napredovalim (stadij IIIB z malignim plevralnim izlivom), metastatskim ali ponavljajočim se neskvamoznim nedrobnoceličnim rakom pljuč.
• Each 4 mL vial contains 100 mg of bevacizumab, corresponding to 1.4 mg/mL when diluted as recommended.
• Ena 4 ml viala vsebuje 100 mg bevacizumaba, kar po priporočeni razredčitvi ustreza koncentraciji 1,4 mg/ml.
Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with bevacizumab.
Bolnike z anamnezo hipertenzije spremlja večje tveganje za razvoj proteinurije, če jih zdravimo z bevacizumabom.
MVASI, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
Zdravilo MVASI je kot dodatek k kemoterapiji, osnovani na platini, indicirano za prvo linijo zdravljenja odraslih bolnikov z inoperabilnim, napredovalim, metastatskim ali ponavljajočim se nedrobnoceličnim rakom pljuč, ki nima prevladujoče ploščatocelične histologije.
The efficacy results are presented in table 14.
Rezultati učinkovitosti so predstavljeni v preglednici 14.
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).
Med skupino, ki je prejemala 3 mg/kg bevacizumaba, in skupino, ki je prejemala placebo, je obstajala majhna, mejna statistično značilna razlika v času do napredovanja bolezni (razmerje ogroženosti 1,26; p = 0,053).
In a single-arm study (PBTC-022), 18 children with recurrent or progressive non-pontine high-grade glioma (including 8 with glioblastoma [WHO grade IV], 9 with anaplastic astrocytoma [grade III] and 1 with anaplastic oligodendroglioma [grade III]) were treated with bevacizumab (10 mg/kg) two weeks apart and then with bevacizumab in combination with CPT-11 (125-350 mg/m2) once every two weeks until progression.
V študiji (PBTC-022), ki je vključevala eno skupino, je 18 otrok s ponavljajočim se ali napredovalim gliomom visoke stopnje malignosti, ki se ni nahajal v možganskem deblu, bilo zdravljenih z bevacizumabom (10 mg/kg) v razmiku dveh tednov in nato z bevacizumabom v kombinaciji s CPT-11 (125-350 mg/m2) enkrat na dva tedna do napredovanja bolezni (8 otrok je imelo glioblastom [stopnje IV po lestvici SZO], 9 anaplastični astrocitom [stopnje III po lestvici SZO] in 1 anaplastični oligodenrogliom [stopnje III po lestvici SZO]).
85 mg/m2 IV 2 h
Oksaliplatin 85 mg/m2 i.v.
• a blood clot in your arteries,
• krvni strdek v arterijah,
Effect of bevacizumab on the pharmacokinetics of other antineoplastic agents
Vpliv bevacizumaba na farmakokinetiko drugih zdravil za zdravljenje novotvorb
5-fluorouracil IV bolus/infusion, each on days 1 and 2
bolus/infuzija, vsak 1. in 2. dan placebo ali bevacizumab
• 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.
• E3200: Bevacizumab 10 mg/kg telesne mase enkrat na 2 tedna v kombinaciji z levkovorinom in bolusom 5-fluorouracila, sledila je infuzija 5-fluorouracila z oksaliplatinom intravensko (shema FOLFOX-4) pri bolnikih, ki še niso bili zdravljeni z bevacizumabom.
Each vial of 16 mL of concentrate contains 400 mg of bevacizumab.
Ena viala s 16 ml koncentrata vsebuje 400 mg bevacizumaba.
The difference in ORR per independent central review was 18% (CI: 0.6%, 35.3%) between the two treatment arms in the few patients who had evaluable tumour at baseline and had a confirmed response prior to receiving any local therapy: 27/75 patients (36.0%, 95% CI: 25.2%, 47.9%) in the chemo arm and 34/63 patients (54.0%, 95% CI: 40.9%, 66.6%) in the BV + chemo arm.
Po neodvisnem centralnem pregledu je bila razlika v deležu celokupnega odziva med redkimi bolniki iz obeh zdravljenih skupin, ki so imeli ocenljiv tumor v izhodišču in potrjen odziv pred prejemom katerega koli lokalnega zdravljenja, 18 % (interval zaupanja: 0,6 %; 35,3 %): 27/75 bolnikov (36,0 %; 95-% interval zaupanja: 25,2 %; 47,9 %) iz skupine, ki je prejemala kemoterapijo, in 34/63 bolnikov (54,0 %; 95-% interval zaupanja: 40,9 %; 66,6 %) iz skupine, ki je prejemala kombinacijo bevacizumaba in kemoterapije.
GOG-0213, a phase III randomised controlled open label trial, studied the safety and efficacy of bevacizumab in the treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who have not received prior chemotherapy in the recurrent setting.
Randomizirano, kontrolirano, odprto preskušanje faze III GOG-0213 je proučevalo varnost in učinkovitost bevacizumaba pri zdravljenju bolnic s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, občutljivega na platino, ki pri ponovnem pojavu bolezni še niso prejele kemoterapije.
The addition of bevacizumab to IFN alfa-2a significantly increased PFS and objective tumour response rate.
Dodatek bevacizumaba k interferonu alfa-2a je pomembno podaljšal preživetje brez napredovanja bolezni in pomembno povečal objektivni odgovor na zdravljenje.
Posterior reversible encephalopathy syndrome (see section 4.4)
Sindrom posteriorne reverzibilne encefalopatije (glejte poglavje 4.4)
5-FU/FA + bevacizumab
5-FU/FA + bevacizumab b
The primary endpoint was progression-free survival, with secondary endpoints including objective response rate and overall survival.
Primarni opazovani dogodek je bil preživetje brez napredovanja bolezni, sekundarni opazovani dogodki pa so vključevali objektivni odgovor in celokupno preživetje.
Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
Rektovaginalne fistule so najpogostejše fistule v skupini fistul med prebavili in nožnico.
Sepsis, Abscessb,d, Cellulitis, Infection, Urinary tract infection
Infekcijske in parazitske bolezni sepsa, abscesb,d, celulitis, okužba, okužba sečil nekrotizirajoči fasciitisa
Bevacizumab was combined with two chemotherapy regimens:
Bevacizumab so dajali v kombinaciji z dvema kemoterapevtskima shemama zdravljenja:
Each mL of concentrate contains 25 mg of bevacizumab, corresponding to 1.4 to 16.5 mg/mL when diluted as recommended.
En ml koncentrata vsebuje 25 mg bevacizumaba, kar po priporočeni razredčitvi ustreza koncentraciji od 1,4 mg/ml do 16,5 mg/ml.
• loss of body weight,
• zvišano telesno temperaturo,
Cisplatin/Gemcitabine + bevacizumab 7.5 mg/kg q 3 weeks
cisplatin/gemcitabin/ placebo cisplatin/gemcitabin/ bevacizumab 7,5 mg/kg na 3 tedne cisplatin/gemcitabin/ bevacizumab 15 mg/kg na 3 tedne
Oxaliplatin on day 1
2 h oksaliplatin 1. dan
What MVASI contains
Kaj vsebuje zdravilo MVASI
• AVF0780g: In combination with bolus 5-fluorouracil/folinic acid (5-FU/FA) for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen).
• AVF0780g: v kombinaciji z bolusom 5-fluorouracila/folinske kisline (5-FU/FA).
(16.2 vs. 12.0 months; p = 0.1342)
(16,2 proti 12,0 meseca; p =
Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with bevacizumab through:
Za te neželene učinke so določili, da imajo vzročno povezavo z bevacizumabom:
• you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
• če ste alergični (preobčutljivi) na celične produkte ovarija kitajskega hrčka (CHO - Chinese
• Each 16 mL vial contains 400 mg of bevacizumab, corresponding to 16.5 mg/mL when diluted as recommended.
• Ena 16 ml viala vsebuje 400 mg bevacizumaba, kar po priporočeni razredčitvi ustreza koncentraciji 16,5 mg/ml.
• Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
• Preobčutljivost za produkte ovarijskih celic kitajskega hrčka (CHO - Chinese Hamster Ovary)
Number of patients Overall survival Median (months) Hazard ratio (95% confidence interval)
Število bolnikov Celokupno preživetje mediana (meseci) razmerje ogroženosti (95-% interval zaupanja)
(12.0 vs. 15.0 months;
(12,0 proti 15,0 meseca; p =
Uncommon (≥ 0.1% to < 1%) reports of fistulae that involve areas of the body other than the gastrointestinal tract (e.g. bronchopleural and biliary fistulae) were observed across various indications.
Občasno (≥ 0,1 % do < 1 %) so pri različnih indikacijah poročali o fistulah, ki se v telesu pojavljajo izven prebavil (plevrobronhialna in žolčna fistula).
Severe side effects, which may be common (may affect up to 1 in 10 people), include:
Hudi neželeni učinki, ki so lahko pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov), vključujejo: