natgillin/translations-raw huggingface dataset:
There is no relevant use of bevacizumab in the paediatric population in the indications for treatment of cancers of the colon, rectum, breast, lung, ovarian, fallopian tube, peritoneum, cervix and kidney.
Bevacizumab ni namenjen za uporabo pri pediatrični populaciji pri indikacijah za zdravljenje raka debelega črevesa, danke, dojk, pljuč, jajčnikov, jajcevodov, peritoneja, materničnega vratu in ledvic.
Decreased neutrophil count, decreased white blood cell count and presence of urine protein may be associated with bevacizumab treatment.
Zdravljenje z bevacizumabom je lahko povezano z zmanjšanjem števila nevtrofilcev, zmanjšanjem števila belih krvnih celic in prisotnostjo beljakovin v urinu.
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 3. faze, v katerem so primerjali bevacizumab kot dodatek cisplatinu in gemcitabinu s placebom, cisplatinom in gemcitabinom pri bolnikih z lokalno napredovalim (stadij IIIb z metastazami v supraklavikularnih bezgavkah ali malignim plevralnim ali perikardialnim izlivom), metastatskim ali ponavljajočim se neploščatoceličnim NSCLC, ki predhodno niso prejemali kemoterapije.
Cases of ONJ have been reported in cancer patients treated with bevacizumab, the majority of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Pri bolnikih z rakom, ki so se zdravili z bevacizumabom, so poročali o primerih osteonekroze čeljustnic; večina teh bolnikov se je predhodno ali sočasno zdravila z intravenskimi bisfosfonati, pri katerih je osteonekroza čeljustnic znano tveganje.
Caution should be exercised when Zirabev and intravenous bisphosphonates are administered simultaneously or sequentially.
Pri sočasnem ali zaporednem dajanju zdravila Zirabev in intravenskih bisfosfonatov je potrebna previdnost.
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 so se v telesu pojavljale izven prebavil (npr. plevrobronhialna in biliarna fistula).
No trials 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.
Preskušanj za proučevanje farmakokinetike bevacizumaba pri bolnikih z jetrno okvaro niso opravili, saj jetra niso pomemben organ za presnovo ali izločanje bevacizumaba.
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 pojavi venski trombembolični dogodek, lahko obstaja povečano tveganje za ponovitev dogodka, če prejemajo bevacizumab v kombinaciji s kemoterapijo, kot pa če prejemajo samo kemoterapijo.
In some cases underlying intra-abdominal inflammation was present, either from gastric ulcer disease, tumour necrosis, diverticulitis, or chemotherapy-associated colitis.
V nekaterih primerih je bilo prisotno spremljajoče vnetje v trebušni votlini zaradi ulkusne bolezni želodca, nekroze tumorja, divertikulitisa ali s kemoterapijo povezanega kolitisa.
Thromboembolism (arterial)
b,d trombembolija (arterijska)
Zirabev will be administered together with a chemotherapy regimen containing platinum.
Zdravilo Zirabev boste prejeli skupaj s kemoterapevtsko shemo, ki vsebuje platino.
Bevacizumab has not been shown to reduce your ability to drive or to use any tools or machines.
Vpliv na sposobnost upravljanja vozil in strojev Za bevacizumab niso dokazali, da zmanjšuje sposobnost upravljanja vozil ali uporabe orodij oziroma strojev.
XELOX or XELOX + bevacizumab
XELOX ali XELOX + bevacizumab oksaliplatin kapecitabin
The haemorrhagic reactions that have been observed in clinical trials were predominantly tumour-associated haemorrhage (see below) and minor mucocutaneous haemorrhage (e.g. epistaxis).
Krvavitve, ki so jih opazili v kliničnih preskušanjih, so bile večinoma krvavitve, povezane s tumorjem (glejte spodaj), ter manjše kožne in sluznične krvavitve (na primer epistaksa).
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 je bila 46,0 let (razpon: 20-83 let) v skupini, ki je prejemala samo kemoterapijo, in 48,0 let (razpon: 22-85 let) v skupini, ki je prejemala kemoterapijo + bevacizumab, pri čemer je bilo 9,3 % bolnic v skupini, ki je prejemala samo kemoterapijo, in 7,5 % bolnic v skupini, ki je prejemala kemoterapijo + bevacizumab, starejših od 65 let.
● It is possible that Zirabev may increase the risk of developing holes in the gut wall.
● Možno je, da zdravilo Zirabev poveča tveganje za pojav predrtja črevesne stene.
Fatal outcome was reported in 0.8% of patients receiving bevacizumab compared to 0.5% in patients receiving chemotherapy alone.
O smrtnem izidu so poročali pri 0,8 % bolnikov, ki so prejemali bevacizumab, v primerjavi z 0,5 % bolnikov, ki so prejemali samo kemoterapijo.
Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Zdravilo Zirabev je v kombinaciji s kemoterapijo na osnovi fluoropirimidina indicirano za zdravljenje odraslih bolnikov z metastatskim karcinomom debelega črevesa in danke.
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 stopnje 4 (hipertenzivna kriza) se je pojavila pri največ 1,0 % bolnikov, ki so se zdravili z bevacizumabom in kemoterapijo, v primerjavi z največ 0,2 % bolnikov, ki so se zdravili samo z enako kemoterapijo.
The overall mean age was 59.4 years; 56.6% of patients had an ECOG performance status of 0, 43% had a value of 1 and 0.4% had a value of 2.
Celokupna povprečna starost je bila 59,4 leta; splošno stanje zmogljivosti po ECOG (Eastern Cooperative Oncology Group) so pri 56,6 % bolnikov ocenili z 0, pri 43 % z 1 in pri 0,4 % z 2. 15,5 % bolnikov je predhodno prejemalo obsevalno zdravljenje, 28,4 % pa kemoterapijo.
Hazard ratio (97.5% CI)
razmerje ogroženosti (97,5 % IZ)
Zirabev, 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 Zirabev je kot dodatek kemoterapiji na osnovi platine indicirano za prvo linijo zdravljenja odraslih bolnikov z inoperabilnim, napredovalim, metastatskim ali ponavljajočim se nedrobnoceličnim rakom pljuč, ki nima prevladujoče ploščatocelične histologije.
Other reactions with a higher frequency seen in patients over 65 were Grade 3-4 leucopenia and thrombocytopenia (NCI-CTCAE v.3); and all Grade neutropenia, diarrhoea, nausea, headache and fatigue as compared to those aged ≤ 65 years when treated with bevacizumab (see sections 4.4 and 4.8 under Thromboembolism).
Drugi neželeni učinki z večjo pogostnostjo, ki so jih med zdravljenjem z bevacizumabom opazili pri bolnikih, starejših od 65 let, v primerjavi z bolniki, starimi ≤ 65 let, so bili levkopenija in trombocitopenija stopnje 3-4 (NCI-CTCAE v.3) ter nevtropenija, diareja, navzea, glavobol in utrujenost vseh stopenj (glejte poglavji 4.4 in 4.8., ''Trombembolija'').
The administration of Zirabev should be temporarily discontinued
Dajanje zdravila Zirabev je treba začasno prekiniti:
4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
Štiri ml raztopine v viali (steklo tipa I) z zamaškom (butilna guma), ki vsebuje 100 mg bevacizumaba.
Zirabev will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Zdravilo Zirabev boste prejeli v kombinaciji s kemoterapevtskim zdravljenjem, ki vsebuje zdravilo na osnovi fluoropirimidina.
In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years treated with bevacizumab.
V literaturi so pri bolnikih, mlajših od 18 let, ki so se zdravili z bevacizumabom, poročali o primerih osteonekroze izven spodnje čeljustnice.
The incidence of venous thromboembolic reactions in clinical trials was similar in patients receiving bevacizumab in combination with chemotherapy compared to those receiving the control chemotherapy alone.
Pojavnost venskih trombemboličnih dogodkov v kliničnih preskušanjih je bila pri bolnikih, ki so prejemali bevacizumab v kombinaciji s kemoterapijo, in bolnikih v kontrolni skupini, ki so prejemali samo kemoterapijo, podobna.
Objective response rate Rate
Objektivni odziv na zdravljenje delež
Of the 452 patients randomized at baseline, the majority of patients were white (80.0% in the Chemo alone group and 75.3% in the Chemo+bevacizumab group), had squamous cell carcinoma (67.1% in the Chemo alone group and 69.6% in the Chemo+bevacizumab group), had persistent/recurrent disease (83.6% in the Chemo alone group and 82.8% in the Chemo+bevacizumab group), had 1-2 metastatic sites (72.0% in the Chemo alone group and 76.2% in the Chemo+bevacizumab group), had lymph node involvement (50.2% in the Chemo alone group and 56.4% in the
Od 452 bolnic, ki so jih randomizirali ob izhodišču, je bila večina belk (80,0 % v skupini, ki je prejemala samo kemoterapijo, in 75,3 % v skupini, ki je prejemala kemoterapijo + bevacizumab), večina je imela ploščatocelični karcinom (67,1 % v skupini, ki je prejemala samo kemoterapijo, in 69,6 % v skupini, ki je prejemala kemoterapijo + bevacizumab), dolgotrajno/ponavljajočo se bolezen (83,6 % v skupini, ki je prejemala samo kemoterapijo, in 82,8 % v skupini, ki je prejemala kemoterapijo + bevacizumab), metastaze na 1-2 mestih (72,0 % v skupini, ki je prejemala samo kemoterapijo, in 76,2 % v skupini, ki je prejemala kemoterapijo + bevacizumab), prizadete bezgavke (50,2 % v skupini, ki je prejemala samo kemoterapijo, in 56,4 % v skupini, ki je prejemala kemoterapijo + bevacizumab) ter interval brez platine, ki je trajal ≥ 6 mesecev (72,5 % v skupini, ki je prejemala samo kemoterapijo, in 64,4 % v skupini, ki je prejemala kemoterapijo + bevacizumab).
Fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy
kemoterapija na osnovi fluoropirimidina in irinotekana ali fluoropirimidina in oksaliplatina kemoterapija na osnovi fluoropirimidina in irinotekana ali fluoropirimidina in oksaliplatina + bevacizumab
These therapies in combination with Zirabev may increase the risk of severe side effects.
Ta zdravila lahko v kombinaciji z zdravilom Zirabev povečajo tveganje za pojav hudih neželenih učinkov.
16 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.
Šestnajst ml raztopine v viali (steklo tipa I) z zamaškom (butilna guma), ki vsebuje 400 mg bevacizumaba.
In patients with NSCLC excluding predominant squamous histology, all Grade reactions were seen with a frequency of up to 9.3% when treated with bevacizumab plus chemotherapy compared with up to 5% in the patients treated with chemotherapy alone.
Pri bolnikih z NSCLC, razen pri prevladujoči ploščatocelični histologiji, so neželene učinke vseh stopenj opazili s pogostnostjo največ 9,3 %, če so jih zdravili z bevacizumabom in kemoterapijo, pri bolnikih, ki so se zdravili samo s kemoterapijo, pa s pogostnostjo največ 5 %.
(12.0 vs 15.0 months; p = 0.6267)
(12,0 meseca v primerjavi s 15,0 meseca; p = 0,6267)
Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1250 mg/m2 intravenous infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with bevacizumab at a dose of 7.5 or 15 mg/kg intravenous infusion day 1 of every 3-week cycle.
Bolnike so randomizirali na kemoterapijo na osnovi platine, cisplatin 80 mg/m 2 v obliki intravenske infuzije na 1. dan in gemcitabin 1.250 mg/m2 v obliki intravenske infuzije na 1. in 8. dan vsakega 3tedenskega cikla do največ 6 ciklov (CG) s placebom ali CG z bevacizumabom v odmerku 7,5 mg/kg ali 15 mg/kg v obliki i.v.
Intravitreal use Zirabev is not formulated for intravitreal use.
Zdravilo Zirabev ni namenjeno intravitrealni uporabi.
● if you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth tell your doctor and dentist immediately.
● zdravniku in zobozdravniku nemudoma povejte, če imate ali ste imeli bolečine v ustih, zobeh in/ali čeljusti, otekline ali razjede v ustih, če se vam pojavi odrevenelost ali občutek teže v čeljusti ali če se vam je razmajal zob;
These reactions included infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitritis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular haemorrhage such as vitreous haemorrhage or retinal haemorrhage and conjunctival haemorrhage.
Med njimi so bili infekcijski endoftalmitis, intraokularno vnetje, kot so sterilni endoftalmitis, uveitis in vitritis, odstop mrežnice, raztrganje pigmentnega epitelija mrežnice, povišan očesni tlak, intraokularna krvavitev, kot so vitrealna ali retinalna krvavitev in konjunktivalna krvavitev.
The incidence of AEs, including Grade ≥3 AEs and SAEs, was similar between the two treatment arms.
Pojavnost neželenih učinkov, vključno z neželenimi učinki stopnje ≥ 3 in resnimi neželenimi učinki, je bila pri obeh zdravljenih skupinah podobna.
In clinical trials across all indications the overall incidence of NCI-CTCAE v.3 Grade 3-5 bleeding reactions ranged from 0.4% to 6.9% in bevacizumab treated patients, compared with up to 4.5% of patients in the chemotherapy control group.
V kliničnih preskušanjih pri vseh indikacijah je celokupna pojavnost krvavitev stopnje 3-5 po NCICTCAE v.3 znašala od 0,4 % do 6,9 % bolnikov, ki so se zdravili z bevacizumabom, v primerjavi z največ 4,5 % bolnikov v kontrolni skupini, ki se je zdravila s kemoterapijo.
This was a phase II randomised, double-blind, active-controlled clinical trial evaluating the efficacy and safety of bevacizumab in combination with 5-FU/FA as first-line treatment for metastatic colorectal cancer in patients who were not optimal candidates for first-line irinotecan treatment.
To je bilo randomizirano, dvojno slepo, z učinkovino nadzorovano klinično preskušanje 2. faze, v katerem so ocenjevali učinkovitost in varnost bevacizumaba v kombinaciji s shemo 5-FU/FA kot prvo linijo zdravljenja bolnikov z metastatskim rakom debelega črevesa in danke, ki niso bili najprimernejši kandidati za prvo linijo zdravljenja z irinotekanom.
Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.
Če ste noseči, med zdravljenjem s tem zdravilom zanosite ali načrtujete zanositev v bližnji prihodnosti, o tem takoj obvestite zdravnika.
Some of the adverse reactions are reactions commonly seen with chemotherapy; however, bevacizumab may exacerbate these reactions when combined with chemotherapeutic agents.
Nekateri izmed neželenih učinkov so učinki, ki jih pogosto opazimo pri kemoterapiji, vendar jih lahko bevacizumab poslabša, kadar ga uporabljamo v kombinaciji s kemoterapevtiki.
a 10 mg/kg every 2 weeks b Relative to control arm
10 mg/kg vsaka 2 tedna glede na kontrolno skupino
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).
Neželene učinke stopnje 3-5 so opazili pri največ 2,3 % bolnikov, ki so se zdravili z bevacizumabom in kemoterapijo, v primerjavi z < 1 % bolnikov, ki so prejemali samo kemoterapijo (NCI-CTCAE v.3).
A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Pri redčenju bevacizumaba z raztopino glukoze (5 %), so opazili od koncentracije odvisen profil razpada.
Anti-tumour activity was not observed in two earlier studies among a total of 30 children aged > 3 years old with relapsed or progressive high-grade glioma when treated with bevacizumab and irinotecan (CPT-11).
V 2 predhodnih študijah pri skupno 30 otrocih, starih > 3 leta, s ponavljajočim se ali napredovalim gliomom visoke stopnje, ki so se zdravili z bevacizumabom in irinotekanom (CPT-11), niso opazili protitumorske aktivnosti.
Zirabev is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
Zdravilo Zirabev uporabljamo tudi za zdravljenje odraslih bolnic z dolgotrajnim, ponavljajočim se ali metastatskim rakom materničnega vratu.
It should not be administered as an intravenous push or bolus.
Zdravila ne smemo dajati v obliki hitre intravenske infuzije ali bolusa.
In all clinical trials, bevacizumab was administered as an intravenous infusion.
V vseh kliničnih preskušanjih so bevacizumab dajali v obliki i.v.
The primary endpoints of the trial were objective response rate and progression-free survival.
Primarna opazovana dogodka v preskušanju sta bila objektivni odziv na zdravljenje in preživetje brez napredovanja bolezni.
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.
Preskušanje E4599 je bilo odprto, randomizirano, z učinkovino nadzorovano, multicentrično klinično preskušanje, v katerem so ocenjevali bevacizumab v prvi liniji zdravljenja bolnikov z lokalno napredovalim (stadij IIIb z malignim plevralnim izlivom), metastatskim ali ponavljajočim se NSCLC brez prevladujoče ploščatocelične histologije.
No trials 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.
Preskušanj za proučevanje farmakokinetike bevacizumaba pri bolnikih z ledvično okvaro niso opravili, saj ledvice niso pomemben organ za presnovo ali izločanje bevacizumaba.
Peripheral s ensory neuropathy b,
Bolezni živčevja periferna senzorična nevropatija b,
Testing for proteinuria is recommended prior to start of Zirabev therapy.
Pred začetkom zdravljenja z zdravilom Zirabev je priporočljivo testiranje na proteinurijo.
Deutschland Pfizer Pharma PFE GmbH Tel: +49 (0)800 8535555
Pfizer Pharma GmbH Tel: +49 (0)30 550055-51000
Zirabev is a concentrate for solution for infusion.
Zdravilo Zirabev je koncentrat za raztopino za infundiranje.
Bevacizumab addition to multimodal standard of care treatment seemed to be tolerated in this paediatric population.
Zdi se, da so bolniki v tej pediatrični populaciji bevacizumab kot dodatek multimodalnemu standardnemu zdravljenju dobro prenašali.
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.
V preskušanju BO17704 pa so dokazali, da oba odmerka, 7,5 mg/kg vsake 3 tedne in 15 mg/kg vsake 3 tedne, podaljšata preživetje brez napredovanja bolezni in povečata stopnjo odziva.
This was a Phase III randomised, controlled, open-label trial investigating bevacizumab 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy versus fluoropyrimidine-based chemotherapy alone in patients with mCRC who have progressed on a first- line bevacizumab-containing regimen.
To je bilo randomizirano, nadzorovano, odprto preskušanje 3. faze, v katerem so proučevali bevacizumab v odmerku 5,0 mg/kg vsaka 2 tedna ali 7,5 mg/kg vsake 3 tedne v kombinaciji s kemoterapijo na osnovi fluoropirimidina v primerjavi s samostojno kemoterapijo na osnovi fluoropirimidina pri bolnikih z mCRC, pri katerih je bolezen napredovala po prvi liniji zdravljenja po shemi, ki je vsebovala bevacizumab.
(16.2 vs. 12.0 months; p = 0.1342)
(16,2 meseca v primerjavi z 12,0 meseca; p = 0,1342)
How to use Zirabev
Kako uporabljati zdravilo Zirabev
Therapy should be withheld for elective surgery.
Zdravljenje je treba prekiniti tudi v primeru načrtovanega kirurškega posega.
(16.2 vs 17.5 months; p = 0.3769)
(16,2 v primerjavi s 17,5 meseca; p = 0,3769)
Overall survival - primary analysis Hazard ratio (95% CI)
Celokupno preživetje - primarna analiza razmerje ogroženosti (95 % IZ)
Study E3200 used a 5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-naïve patients, while study ML18147 used a 2.5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-pretreated patients.
V študiji E3200 so bevacizumab uporabljali v odmerku, enakovrednem 5 mg/kg/teden, pri bolnikih, ki ga pred tem še niso prejemali, medtem ko so v študiji ML18147 bevacizumab uporabljali v odmerku, enakovrednem 2,5 mg/kg/teden, pri bolnikih, ki so se z njim že zdravili.
• diarrhoea, nausea, vomiting and abdominal pain.
• drisko, siljenje na bruhanje, bruhanje in bolečine v trebuhu.
An increased incidence of arterial thromboembolic reactions was observed in patients treated with bevacizumab across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Pri bolnikih, ki so se zdravili z bevacizumabom, so pri vseh indikacijah opazili povečano pojavnost arterijskih trombemboličnih dogodkov, vključno s cerebrovaskularnimi insulti, miokardnim infarktom, prehodnimi možganskimi ishemijami in drugimi arterijskimi trombembolični dogodki.
All of these findings were reversible upon discontinuation of bevacizumab and sunitinib malate (see Hypertension, Proteinuria, PRES in section 4.4).
Po prekinitvi zdravljenja z bevacizumabom in sunitinibijevim malatom so bile vse ugotovitve reverzibilne (glejte ''Hipertenzija'', ''Proteinurija'' in ''Sindrom posteriorne reverzibilne encefalopatije'' v poglavju 4.4).
Congestive heart failure (CHF) (see section 4.8)
Kongestivno srčno popuščanje (KSP) (glejte poglavje 4.8)
Bvb + IFNa
bv b + IFN
These clinically significant adverse reactions were reported in clinical trials but the grade 3-5 reactions did not meet the threshold of at least a 2% difference compared to the control arm. Table 2 also includes clinically significant adverse reactions that were observed only in the postmarketing setting,
O teh klinično pomembnih neželenih učinkih so poročali v kliničnih preskušanjih, vendar neželeni učinki stopnje 3-5 niso dosegli praga vsaj 2 % razlike v primerjavi s kontrolno skupino.
Effect of bevacizumab on the pharmacokinetics of other antineoplastic agents
Vpliv bevacizumaba na farmakokinetiko drugih zdravil z delovanjem na novotvorbe
Zirabev is for intravenous use.
Zdravilo Zirabev je namenjeno za intravensko uporabo.
Paclitaxel/ bevacizumab (n=368)
paklitaksel in bevacizumab (n = 368)
Two of the eight cases did not have radiological confirmation via MRI.
V kliničnih preskušanjih so poročali o 8 primerih PRES. Dveh od teh 8 primerov niso radiološko potrdili z magnetnoresonančnim slikanjem.
Cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.6 )
Prirojene in dedne genetske okvare pri ženskah, ki so se zdravile z bevacizumabom samim ali v kombinaciji z znano embriotoksičnimi kemoterapevtiki, so opazili primere nenormalnosti ploda (glejte poglavje 4.6)
Number of patients Overall survival Median time (months) 95% CI
Število bolnikov Celokupno preživetje mediani čas (meseci) 95 % IZ
● a blood clot in your arteries,
● krvni strdek v arterijah,