natgillin/translations-raw huggingface dataset:
Trial E2100 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating bevacizumab in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease.
Ispitivanje E2100 bilo je otvoreno, randomizirano, aktivno kontrolirano multicentrično kliničko ispitivanje u kojemu se ispitivala primjena bevacizumaba u kombinaciji s paklitakselom u liječenju lokalno recidivirajućeg ili metastatskog karcinoma dojke u bolesnika koji prethodno nisu primali kemoterapiju za lokalno recidivirajuću ili metastatsku bolest.
No bevacizumab
bez bevacizumaba
Each vial contains 100 mg bevacizumab in 4 mL of solution or 400 mg bevacizumab in 16 mL of solution.
Jedna bočica sadrži 100 mg bevacizumaba u 4 ml otopine ili 400 mg bevacizumaba u 16 ml otopine.
• a blood clot in your arteries,
• u slučaju krvnog ugruška u arterijama,
In a randomised phase II study (BO25041) a total of 121 patients aged ≥ 3 years to < 18 years with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG) were treated with post-operative radiation therapy (RT) and adjuvant temozolomide (T) with and without bevacizumab: 10 mg/kg every 2 weeks IV.
U randomiziranom ispitivanju faze II (BO25041) ukupno je 121 bolesnik u dobi od ≥ 3 godine do < 18 godina s novodijagnosticiranim supratentorijalnim ili infratentorijalnim cerebelarnim ili pedunkularnim gliomom visokog stupnja bio liječen poslijeoperacijskom radioterapijom (RT) i adjuvantnim temozolomidom (T) u kombinaciji s bevacizumabom i bez njega: 10 mg/kg svaka 2 tjedna intravenski.
Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed mainly in patients treated with platinumor taxane-based therapies in the treatment of NSCLC and mBC.
Povećane stope teške neutropenije, febrilne neutropenije te infekcije praćene teškom neutropenijom ili bez nje (s nekoliko smrtnih ishoda) opažene su većinom u bolesnika koji su primali kemoterapiju na bazi platinskog spoja ili taksana u liječenju karcinoma pluća nemalih stanica i metastatskog karcinoma dojke.
When used for patients with breast cancer, it will be administered with a chemotherapy medicinal product called paclitaxel.
Kada se koristi za bolesnike s rakom dojke, primjenjuje se uz kemoterapiju lijekovima paklitakselom.
Median OS (months) Hazard ratio (95% CI) (eCRF)a
Medijan OS (mjeseci) Omjer hazarda (95% CI) (eCRF)a
Patients treated with bevacizumab have an increased risk of haemorrhage, especially tumourassociated haemorrhage.
Bolesnici liječeni bevacizumabom izloženi su povećanom riziku od krvarenja, a osobito krvarenja povezanog s tumorom.
Adverse reactions reported in post-marketing setting
Tablica 3. Nuspojave prijavljene nakon stavljanja lijeka u promet
Objective response rate1
Stopa objektivnog odgovora1
The study compared the effect of adding bevacizumab to carboplatin and gemcitabine chemotherapy and continuing bevacizumab as a single agent to progression, to carboplatin and gemcitabine alone.
U ovom se ispitivanju uspoređivao učinak na progresiju kod dodavanja bevacizumaba kemoterapiji karboplatinom i gemcitabinom i zatim nastavka primjene samo bevacizumaba u odnosu na terapiju samo karboplatinom i gemcitabinom.
This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/ vincristine/prednisone (R-CHOP) plus bevacizumab to R-CHOP without bevacizumab.
U tom je kliničkom ispitivanju faze III uspoređeno liječenje kombinacijom rituksimab/ciklofosfamid/doksorubicin/vinkristin/prednizon (R-CHOP) uz bevacizumab s protokolom R-CHOP bez bevacizumaba.
• 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.
• ML18147: bevacizumab u dozi od 5,0 mg/kg tjelesne težine svaka 2 tjedna ili bevacizumab u dozi od 7,5 mg/kg tjelesne težine svaka 3 tjedna u kombinaciji s fluoropirimidinom/irinotekanom ili fluoropirimidinom/oksaliplatinom u bolesnika u kojih je došlo do progresije bolesti nakon liječenja bevacizumabom u prvoj liniji.
Placebo or bevacizumab
placebo ili bevacizumab
Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 weeks
Cisplatin/Gemcitabin + bevacizumab 15 mg/kg svaka 3 tjedna
The study evaluated the effect of adding bevacizumab to carboplatin+paclitaxel and continuing bevacizumab as a single agent until disease progression or unacceptable toxicity compared to carboplatin+paclitaxel alone.
U ovom se ispitivanju ocjenjivao učinak dodavanja bevacizumaba karboplatinu i paklitakselu i zatim nastavka primjene samo bevacizumaba do progresije bolesti ili razvoja neprihvatljive toksičnosti u odnosu na terapiju samo karboplatinom i paklitakselom.
4 mL solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
4 ml otopine u bočici (staklo tip I) s čepom (butilna guma) sadrži 100 mg bevacizumaba.
Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with MVASI and all patients with GI perforation had a history of prior radiation.
Prethodno zračenje jest čimbenik rizika za gastrointestinalnu perforaciju u bolesnica koje se lijekom MVASI liječe zbog perzistentnog, recidivirajućeg ili metastatskog karcinoma cerviksa, a sve bolesnice s gastrointestinalnom perforacijom prethodno su bile liječene zračenjem.
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 or prior bevacizumab treatment, was studied in a phase III randomised, double-blind, placebo-controlled trial (AVF4095g).
Sigurnost i djelotvornost bevacizumaba u liječenju bolesnica s recidivom epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma osjetljivih na platinu, koje nisu prethodno primale kemoterapiju za liječenje recidiva i nisu prethodno bile liječene bevacizumabom, ispitivane su u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju (AVF4095g).
Eligible patients had persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which was not amenable to curative treatment with surgery and/or radiation therapy and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Bolesnice pogodne za uključivanje u ispitivanje imale su perzistentni, recidivirajući ili metastatski planocelularni karcinom, adenoplanocelularni karcinom ili adenokarcinom cerviksa koji nije odgovorio na kurativno liječenje kirurškim zahvatom i/ili radioterapijom i prethodno nisu bile liječene bevacizumabom ili drugim VEGF inhibitorima niti lijekovima koji djeluju na VEGF receptore.
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.
Bolesnice koje se liječe bevacizumabom u kombinaciji s paklitakselom i cisplatinom zbog perzistentnog, recidivirajućeg ili metastatskog karcinoma cerviksa mogu biti izložene povećanom riziku od venskih tromboembolijskih događaja.
The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, longer progression-free survival, and a trend in longer survival, compared with 5-FU/FA chemotherapy alone (see table 5).
Dodavanjem bevacizumaba u dozi od 5 mg/kg protokolu 5-FU/FA svaka dva tjedna povećala se stopa objektivnog odgovora, produljilo se preživljenje do progresije bolesti uz tendenciju poboljšanja preživljenja u usporedbi s primjenom samo kemoterapije 5-FU/FA (vidjeti Tablicu 5).
Grade 4 hypertension (hypertensive crisis) occurred in up to 1.0% of patients treated with bevacizumab and chemotherapy compared to up to 0.2% of patients treated with the same chemotherapy alone.
Hipertenzija stupnja 4 (hipertenzivna kriza) nastupila je u najviše 1,0% bolesnika koji su primali bevacizumab u kombinaciji s kemoterapijom, u usporedbi s najviše 0,2% bolesnika liječenih samo istom tom kemoterapijom.
Detailed information about these post-marketing reactions are provided in table 3.
Dodatne informacije o tim nuspojavama nakon stavljanja lijeka u promet nalaze se u Tablici 3.
• Arterial thromboembolism (see section 4.4).
• arterijska tromboembolija (vidjeti dio 4.4).
MVASI is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
MVASI se koristi i za liječenje odraslih bolesnica s perzistentnim, recidivirajućim ili metastatskim rakom vrata maternice.
16 mL solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.
16 ml otopine u bočici (staklo tip I) s čepom (butilna guma) sadrži 400 mg bevacizumaba.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1246/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1246/001
• Infection or inflammation of the eye globe,
• infekcija ili upala očne jabučice,
This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of bevacizumab in combination with interferon (IFN) alfa-2a versus IFN alfa-2a alone as first-line treatment in mRCC.
Radi se o randomiziranom, dvostruko slijepom ispitivanju faze III kojim se uspoređivala djelotvornost i sigurnost primjene bevacizumaba u kombinaciji s interferonom (IFN) alfa-2a u odnosu na liječenje samim interferonom alfa-2a u prvoj liniji liječenja metastatskog karcinoma bubrežnih stanica.
Topotecan + Paclitaxel vs. Cisplatin + Paclitaxel
Topotekan+paklit aksel naspram Cisplatin+paklitak sel
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.
U ispitivanju GOG-0213, randomiziranom, kontroliranom, otvorenom ispitivanju faze III, ispitivale su se sigurnost i djelotvornost bevacizumaba u liječenju bolesnica s recidivom epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma osjetljivih na platinu, koje prethodno nisu primale kemoterapiju za liječenje recidiva.
Cervical cancer
Karcinom cerviksa
PFS subgroup analyses depending on recurrence since last platinum therapy are summarised in table 20.
Analize preživljenja bez progresije bolesti po podskupinama prema nastupu recidiva u odnosu na posljednju terapiju platinom sažete su u Tablici 20.
The efficacy and safety of bevacizumab in combination with chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in the treatment for patients with persistent, recurrent or metastatic carcinoma of the cervix was evaluated in study GOG-0240, a randomised, four-arm, open label, multicentre phase III trial.
Karcinom cerviksa GOG-0240 Djelotvornost i sigurnost bevacizumaba u kombinaciji s kemoterapijom (paklitakselom i cisplatinom ili paklitakselom i topotekanom) u liječenju bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa ispitivane su u ispitivanju GOG-0240 - randomiziranom, otvorenom, multicentričnom ispitivanju faze III s četiri skupine.
(16.2 vs. 17.5 months; p = 0.3769)
(16,2 naspram 17,5 mjeseci; p = 0,3769)
The GOG-0218 study was a phase III multicentre, randomised, double-blind, placebo-controlled, three arm study evaluating the effect of adding bevacizumab to an approved chemotherapy regimen (carboplatin and paclitaxel) in patients with advanced (stages IIIB, IIIC and IV according to FIGO staging version dated 1988) epithelial ovarian, fallopian tube or primary peritoneal cancer.
Ispitivanje GOG-0218 bilo je multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze III u tri skupine, koje je procjenjivalo učinak dodavanja bevacizumaba odobrenom kemoterapijskom protokolu (karboplatin i paklitaksel) u bolesnica s uznapredovalim (stadiji IIIB, IIIC i IV prema FIGO klasifikaciji, verzija iz 1988.) epitelnim karcinomom jajnika, karcinomom jajovoda ili primarnim peritonealnim karcinomom.
BO17707 was a phase III, two-arm, multicentre, randomised, controlled, open-label study comparing the effect of adding bevacizumab to carboplatin plus paclitaxel in patients with FIGO stage I or IIA (grade 3 or clear cell histology only; n = 142), or FIGO stage IIB-IV (all grades and all histological types, n = 1,386) epithelial ovarian, fallopian tube or primary peritoneal cancer following surgery (NCI-CTCAE v.3).
BO17707 bilo je multicentrično, randomizirano, kontrolirano, otvoreno ispitivanje faze III, s dvije skupine, koje je uspoređivalo učinak dodavanja bevacizumaba terapiji karboplatinom i paklitakselom u bolesnica s epitelnim karcinomom jajnika, karcinomom jajovoda ili primarnim peritonealnim karcinomom FIGO stadija I ili IIA (samo stupnja 3 ili s histologijom svijetlih stanica, n = 142) ili FIGO stadija IIB - IV (svih stupnjeva i svih histoloških tipova, n = 1386) nakon kirurškog zahvata (NCI-CTCAE v.3).
• It is possible that MVASI may increase the risk of developing holes in the gut wall.
• MVASI može povećati rizik od napuknuća u stijenci crijeva.
MVASI should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom MVASI mora pripremiti zdravstveni radnik u aseptičkim uvjetima kako bi se osigurala sterilnost pripremljene otopine.
The efficacy results of the study are presented in table 13.
Rezultati djelotvornosti za ovo ispitivanje prikazani su u Tablici 13.
Median PFS (months)
Medijan PFS-a (mjeseci)
• 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, 1. dan) i gemcitabin (1000 mg/m2, 1. i 8. dan) uz placebo svaka 3 tjedna tijekom 6, a najviše 10 ciklusa, a zatim samo placebo (svaka 3 tjedna) do progresije bolesti ili razvoja neprihvatljive toksičnosti, ili
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 (see section 4.2 for information on paediatric use).
U kliničkom ispitivanju BO20924, dodavanje bevacizumaba standardnoj terapiji nije pokazalo kliničku korist kod 71 pedijatrijskog bolesnika kojeg se moglo ocijeniti (u dobi od 6 mjeseci do manje od 18 godina) s metastatskim rabdomiosarkomom i sarkomom mekog tkiva koji nije rabdomiosarkom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
The majority of patients included in the study were white (96%), the median age was 57 years in both treatment arms, 25% of patients in each treatment arm were 65 years of age or over, and approximately 50% of patients had an ECOG PS of 1; 7% of patients in each treatment arm had an ECOG PS of 2.
Većina bolesnica obuhvaćenih ispitivanjem bila je bijele rase (96%), medijan dobi u obje je skupine iznosio 57 godina, a 25% bolesnica u svakoj skupini imalo je 65 ili više godina.
• 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).
• skupina CPB7,5+: karboplatin (AUC 6) i paklitaksel (175 mg/m2) tijekom 6 trotjednih ciklusa uz bevacizumab (7,5 mg/kg svaka 3 tjedna) do najviše 12 mjeseci (primjena bevacizumaba započela je u drugom ciklusu kemoterapije ako je od kirurškog zahvata do liječenja prošlo manje od 4 tjedna ili u prvom ciklusu ako je od kirurškog zahvata do liječenja prošlo više od 4 tjedna).
This was a phase III randomised, double-blind, active-controlled clinical trial evaluating bevacizumab in combination with IFL as first-line treatment for metastatic carcinoma of the colon or rectum.
Riječ je o randomiziranom, dvostruko slijepom, aktivno kontroliranom kliničkom ispitivanju faze III, u kojemu se proučavala primjena bevacizumaba u kombinaciji s IFL-om kao prva linija liječenja metastatskog karcinoma kolona ili rektuma.
Wound healing complicationsa,b, Palmar-plantar erythrodysaesthesia syndrome
Poremećaji kože i potkožnog tkiva komplikacije pri zacjeljivanju ranaa,b, sindrom palmarnoplantarne eritrodizestezije
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back at least 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, MVASI will be administered in combination with carboplatin and gemcitabine or with carboplatin and paclitaxel.
Kada se koristi za odrasle bolesnice s uznapredovalim epitelnim rakom jajnika, rakom jajovoda ili primarnim peritonealnim rakom u kojih se bolest vratila najmanje 6 mjeseci nakon posljednje primjene kemoterapije koja je sadržavala platinu, MVASI će se davati u kombinaciji s karboplatinom i gemcitabinom ili karboplatinom i paklitakselom.
Investigator assessed PFS analysis with data cut-off date of 30 November 2010.
Analiza preživljenja bez progresije bolesti po procjeni ispitivača, prema podacima do 30. studenog 2010.
• If you have any further questions, ask your doctor, pharmacist or nurse.
- Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
• serious infections of the skin or deeper layers under the skin,
• u slučaju ozbiljne infekcije kože ili dubljih potkožnih slojeva,
Clear to slightly opalescent, colourless to slightly yellow liquid.
Bistra do blago opalescentna, bezbojna do svijetložuta tekućina.
Grade 3-5 reactions have been observed in up to 2.3% of patients treated with bevacizumab plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Krvarenja stupnja 3-5 opažena su u do 2,3% bolesnika liječenih kombinacijom kemoterapije i bevacizumaba u usporedbi s < 1% u bolesnika liječenih samo kemoterapijom (NCICTCAE v.3).
The efficacy results are presented in table 14.
Rezultati djelotvornosti prikazani su u Tablici 14.
• CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration.
• skupina CP: karboplatin (AUC 6) i paklitaksel (175 mg/m2) u 6 trotjednih ciklusa.
(p-value 0.3360)
(p-vrijednost = 0,3360)
The main secondary efficacy endpoint was progression-free survival (PFS).
Glavna sekundarna mjera ishoda za djelotvornost bilo je preživljenje bez progresije bolesti (PFS).
The efficacy results are presented in table 12.
Rezultati djelotvornosti prikazani su u Tablici 12.
A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with MVASI.
Prije započinjanja liječenja lijekom MVASI treba razmisliti o pregledu zuba i odgovarajućim preventivnim stomatološkim postupcima.
Myocardial infarction was reported in up to 1.4% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.7% of patients treated with chemotherapy alone.
Infarkt miokarda prijavljen je u najviše 1,4% bolesnika koji su primali bevacizumab u kombinaciji s kemoterapijom u usporedbi s najviše 0,7% bolesnika liječenih samo kemoterapijom.
CHF grade 3 or higher reactions were somewhat more frequent among patients receiving bevacizumab in combination with chemotherapy than in patients receiving chemotherapy alone.
Kongestivno zatajenje srca stupnja 3 ili višeg stupnja bilo je nešto češće u bolesnika koji su primali bevacizumab u kombinaciji s kemoterapijom nego u bolesnika koji su primali samo kemoterapiju.
FOLFOX-4 + bevacizumab
FOLFOX-4 + bevacizumab oksaliplatin
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 otvoreno, randomizirano, aktivno kontrolirano, multicentrično kliničko ispitivanje u kojemu se procjenjivala primjena bevacizumaba u prvoj liniji liječenja bolesnika s lokalno uznapredovalim (stadij IIIb sa zloćudnim pleuralnim izljevom), metastatskim ili recidivirajućim karcinomom pluća nemalih stanica u kojem histološki ne prevladavaju skvamozne stanice.
The results of this study are summarised in table 17.
Rezultati ovog ispitivanja sažeti su u Tablici 17.
(17.5 vs.15.0 months; p = 0.0584)
(17,5 naspram 15,0 mjeseci; p = 0,0584)
Fatal outcome was reported in 0.8% of patients receiving bevacizumab compared to 0.5% in patients receiving chemotherapy alone.
Smrtni je ishod prijavljen u 0,8% bolesnika koji su primali bevacizumab te u 0,5% bolesnika koji su primali samo kemoterapiju.
The primary endpoint was progression-free survival, secondary endpoints for the trial included the duration of overall survival.
Primarna mjera ishoda bila je preživljenje bez progresije bolesti, dok su sekundarne mjere ishoda obuhvaćale i trajanje ukupnog preživljenja.
• post-authorisation safety studies,
• iz ispitivanja sigurnosti primjene lijeka nakon dobivanja odobrenja,
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.
Ispitivanje BO17704 bilo je randomizirano, dvostruko slijepo ispitivanje faze III u kojem je bevacizumab kao dodatak cisplatinu i gemcitabinu uspoređivan s placebom, cisplatinom i gemcitabinom u bolesnika s lokalno uznapredovalim (stadij IIIb s metastazama u supraklavikularnim limfnim čvorovima ili sa zloćudnim pleuralnim ili perikardijalnim izljevom), metastatskim ili recidivirajućim neskvamoznim karcinomom pluća nemalih stanica, koji ranije nisu primali kemoterapiju.
Gastrointestinal (GI) perforations and Fistulae (see section 4.4)
Gastrointestinalne perforacije i fistule (vidjeti dio 4.4)
Paclitaxel/ bevacizumab (n = 368)
Paklitaksel/ bevacizumab (n = 368)
Sepsis, Abscessb,d, Cellulitis, Infection, Urinary tract infection
Sepsa, apscesb,d, celulitis, infekcija, infekcija mokraćnih putova nekrotizirajući fasciitisa
• Each 4 mL vial contains 100 mg of bevacizumab, corresponding to 1.4 mg/mL when diluted as recommended.
- Jedna bočica od 4 ml sadrži 100 mg bevacizumaba, što odgovara 1,4 mg/ml kada se razrijedi sukladno preporuci.
These results demonstrate robustness of the primary analysis of PFS as shown in table 17.
Ti rezultati pokazuju robusnost analize preživljenja bez progresije bolesti koja je prikazana u Tablici 17.
The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarised in table 23.
Eksploracijske analize PFS-a i OS-a prema kemoterapijskoj kohorti pokazale su poboljšanja u svim kohortama (paklitaksel, topotekan i PLD) nakon dodavanja bevacizumaba.
The primary endpoint was progression-free survival, with secondary endpoints including objective response rate and overall survival.
Primarna mjera ishoda bilo je preživljenje bez progresije bolesti, dok su sekundarne mjere ishoda obuhvaćale stopu objektivnog odgovora i ukupno preživljenje.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1246/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1246/002
MVASI is also used for the treatment of adult patients with metastatic breast cancer.
MVASI se koristi i za liječenje odraslih bolesnika s metastatskim rakom dojke.
• blocking of the arteries by a blood clot,
• začepljenje arterija zbog krvnog ugruška,