FrancophonIA/ELRC3.0 huggingface dataset:
English: There have also been less common reactions of minor mucocutaneous haemorrhage in other locations, such as gingival bleeding or vaginal bleeding.
Slovenian: Manj pogosto je prihajalo tudi do manjših kožnih in sluzničnih krvavitev na drugih mestih, na primer krvavitev iz dlesni ali krvavitev iz nožnice.
English: The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Odvzeti je treba potrebno količino bevacizumaba in jo razredčiti do ustreznega volumna za dajanje z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje.
English: 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.
Slovenian: Opazili so povečano pogostnost hude nevtropenije, febrilne nevtropenije ali okužbe s hudo nevtropenijo ali brez nje (vključno z nekaj smrtnimi primeri), in sicer večinoma pri bolnikih, ki so prejemali zdravljenje na osnovi platine ali taksanov za NSCLC in mBC.
English: Adjustment for these baseline factors resulted in a treatment hazard ratio of 0.78 (95% CI [0.63; 0.96], p=0.0219), indicating a 22% reduction in the risk of death for patients in the bevacizumab + IFN alfa-2a arm compared to IFN alfa-2a arm.
Slovenian: Po prilagoditvi glede na te izhodiščne dejavnike je bilo razmerje ogroženosti za zdravljenje 0,78 (95 % IZ [0,63; 0,96], p = 0,0219), kar je pomenilo 22 % zmanjšanje tveganja za smrt pri bolnikih v skupini, ki je prejemala bevacizumab + IFN alfa-2a, v primerjavi z bolniki v skupini, ki je prejemala IFN alfa-2a.
English: ● Zirabev may increase the risk of developing serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing.
Slovenian: ● Zdravilo Zirabev lahko poveča tveganje za nastanek resnih okužb kože ali globljih plasti pod kožo, zlasti če ste imeli preluknjano črevesno steno ali težave pri celjenju ran.
English: The recommended dose is 5 mg, 7.5 mg, 10 mg or 15 mg per kilogram of your body weight.
Slovenian: Priporočeni odmerek je 5 mg, 7,5 mg, 10 mg ali 15 mg na kilogram vaše telesne mase.
English: In situations where early discontinuation of chemotherapy was required, treatment with bevacizumab as a single agent continued until disease progression.
Slovenian: V primerih, kjer je bila potrebna predčasna prekinitev kemoterapije, so do napredovanja bolezni zdravljenje nadaljevali le z bevacizumabom.
English: • AVF2192g: In combination with bolus 5-FU/FA for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen) in patients who were not optimal candidates for first-line irinotecan treatment.
Slovenian: AVF2192g: v kombinaciji z bolusom 5-FU/FA, skupaj 6 tednov v vsakem 8tedenskem ciklu (shema Roswell Park), pri bolnikih, ki niso bili najprimernejši za prvo linijo zdravljenja z irinotekanom.
English: Venous thromboembolic reactions include deep venous thrombosis, pulmonary embolism and thrombophlebitis.
Slovenian: Venski trombembolični dogodki vključujejo globoko vensko trombozo, pljučno embolijo in tromboflebitis.
English: 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).
Slovenian: Dodajanje erlotiniba bevacizumabu ni prispevalo k izboljšanju OS (HR = 1,764; p = 0,1789), trajanja objektivnega odziva na zdravljenje (6,7 meseca v primerjavi z 9,1 meseca) ali časa do napredovanja simptomov (HR = 1,172; p = 0,5076).
English: Day 1, prior to XELOX, q 3 weeks
Slovenian: 1. dan, pred shemo XELOX, vsake 3 tedne
English: Overall response rate Rate (%)
Slovenian: Celokupni odziv delež (%)
English: bevacizumab was combined with two chemotherapy regimens:
Slovenian: Bevacizumab so kombinirali z 2 kemoterapevtskima shemama:
English: Seven patients in each arm had an objective response.
Slovenian: Objektivni odziv na zdravljenje je doseglo 7 bolnikov iz vsake skupine.
English: If you have headache, vision changes, confusion or seizure with or without high blood pressure, please contact your doctor.
Slovenian: Če imate glavobol, spremembe vida, ste zmedeni ali imate epileptični napad z visokim krvnim tlakom ali brez njega, se obrnite na zdravnika.
English: • reduced blood supply to the brain or stroke,
Slovenian: • zmanjšan dotok krvi v možgane ali možgansko kap,
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Slovenian: Preobčutljivostne reakcije/reakcije na infuzijo (glejte poglavje 4.4 in ''Izkušnje v obdobju trženja'' spodaj)
English: Post-marketing adverse reactions are included in both Tables 1 and 2, where applicable.
Slovenian: Neželeni učinki iz obdobja trženja zdravila so vključeni v preglednici 1 in 2, kot je ustrezno.
English: 19% of the patients had received prior chemotherapy and 14% prior radiotherapy.
Slovenian: 19 % bolnikov je predhodno prejemalo kemoterapijo, 14 % pa obsevalno zdravljenje.
English: In the bevacizumab-containing arms, patients could receive bevacizumab as a single-agent every 3 weeks until disease progression or unacceptable toxicity.
Slovenian: V skupinah, ki sta prejemali bevacizumab, so bolniki lahko prejemali bevacizumab samostojno vsake 3 tedne do napredovanja bolezni ali do nesprejemljive toksičnosti.
English: The European Medicines Agency has waived the obligation to submit the results of studies, in all subsets of the paediatric population, in breast carcinoma, adenocarcinoma of the colon and rectum, lung carcinoma (small cell and non-small cell carcinoma), kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney), ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours), fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours), peritoneal carcinoma (excluding blastomas and sarcomas) and cervix and corpus uteri carcinoma.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij za vse podskupine pediatrične populacije pri karcinomu dojk, adenokarcinomu debelega črevesa in danke, karcinomu pljuč (drobnoceličnem in nedrobnoceličnem karcinomu), karcinomu ledvic in ledvičnega meha (razen nefroblastoma, nefroblastomatoze, svetloceličnega sarkoma, mezoblastnega nefroma, karcinoma ledvične sredice in rabdoidnega tumorja ledvic), karcinomu jajčnikov (razen rabdomiosarkoma in germinalnih tumorjev), karcinomu jajcevodov (razen rabdomiosarkoma in germinalnih tumorjev), peritonealnem karcinomu (razen blastoma in sarkoma) ter karcinomu materničnega vratu in materničnega telesa.
English: The pharmacokinetics of bevacizumab was well characterized by the paediatric population PK model for 70 patients in Study BO20924 ((1.4 to 17.6 years; 11.6 to 77.5 kg) and 59 patients in Study BO25041 (1 to 17 years; 11.2 to 82.3 kg).
Slovenian: Farmakokinetiko bevacizumaba so dobro opredelili z uporabo farmakokinetičnega modela pediatrične populacije pri 70 bolnikih v študiji BO20924 (od 1,4 leta do 17,6 leta; od 11,6 kg do 77,5 kg) in 59 bolnikih v študiji BO25041 (od 1 leta do 17 let; od 11,2 kg do 82,3 kg).
English: 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.
Slovenian: Bevacizumab se selektivno veže na beljakovino, imenovano humani vaskularni endotelijski rastni faktor (VEGF - vascular endothelial growth factor), ki se nahaja na notranji steni krvnih in limfnih žil v telesu.
English: 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, multi- centre phase III trial.
Slovenian: Učinkovitost in varnost bevacizumaba v kombinaciji s kemoterapijo (paklitaksel in cisplatin ali paklitaksel in topotekan) za zdravljenje bolnic z dolgotrajnim, ponavljajočim se ali metastatskim karcinomom materničnega vratu, so ocenjevali v študiji GOG-0240, randomiziranem, odprtem, multicentričnem preskušanju 3. faze s 4 skupinami.
English: a 5 mg/kg every 2 weeks.
Slovenian: 5 mg/kg vsaka 2 tedna.
English: Proteinuria ranged in severity from clinically asymptomatic, transient, trace proteinuria to nephrotic syndrome, with the great majority as Grade 1 proteinuria (NCI-CTCAE v.3).
Slovenian: Proteinurija je po resnosti segala od klinično asimptomatske proteinurije, prehodne proteinurije, proteinurije v sledovih do nefrotskega sindroma; večinoma je šlo za proteinurijo stopnje 1 (NCICTCAE v.3).
English: ● severe high blood pressure which cannot be controlled by blood pressure medicines; or a sudden severe rise in blood pressure,
Slovenian: ● zelo visok krvni tlak, ki ga ni mogoče obvladati z zdravili proti zvišanemu krvnemu tlaku,
English: The side effects listed below were seen when bevacizumab was given together with chemotherapy.
Slovenian: Spodaj navedene neželene učinke so opazili, ko so bevacizumab dajali skupaj s kemoterapijo.
English: Results are presented in Table 11.
Slovenian: Rezultati so predstavljeni v preglednici 11.
English: The efficacy results of bevacizumab in combination with IFL-chemotherapy are displayed in Table 4.
Slovenian: Rezultate učinkovitosti bevacizumaba v kombinaciji z kemoterapijo po shemi IFL prikazuje preglednica 4.
English: Three additional studies with bevacizumab have been conducted in mCRC patients: first-line (NO16966), second-line with no previous bevacizumab treatment (E3200), and second-line with previous bevacizumab treatment following disease progression in first-line (ML18147).
Slovenian: Z bevacizumabom so pri bolnikih z mCRC izvedli 3 dodatne študije: v prvi liniji zdravljenja (NO16966), v drugi liniji zdravljenja brez predhodnega zdravljenja z bevacizumabom (E3200) in v drugi liniji zdravljenja, kjer so bolniki predhodno prejemali bevacizumab v prvi liniji, nato pa je njihova bolezen napredovala (ML18147).
English: • symptoms that suggest changes in normal brain function (headaches, vision changes, confusion, or seizures), and high blood pressure,
Slovenian: • simptome, ki kažejo na spremembe v normalnem delovanju možganov (glavoboli, spremembe vida, zmedenost ali epileptični napadi), in visok krvni tlak,
English: In study JO25567, all grade hypertension was observed in 77.3% of the patients who received bevacizumab in combination with erlotinib as first-line treatment for non-squamous NSCLC with EGFR activating mutations, compared to 14.3% of patients treated with erlotinib alone.
Slovenian: V študiji JO25567 so hipertenzijo vseh stopenj opazili pri 77,3 % bolnikov, ki so prejemali bevacizumab v kombinaciji z erlotinibom kot prvo linijo zdravljenja neploščatoceličnega NSCLC z EGFR-aktivirajočimi mutacijami, v primerjavi s 14,3 % bolnikov, ki so se zdravili samo z erlotinibom.
English: Advanced and/or metastatic renal cell cancer (mRCC)
Slovenian: Napredovali in/ali metastatski rak ledvičnih celic (mRCC - metastatic renal cell cancer)
English: ● serious infections of the skin or deeper layers under the skin,
Slovenian: ● resne okužbe kože ali globljih plasti pod kožo,
English: The trial contained two parts: an initial unblinded 2-arm part (Part I) in which patients were randomised to two different treatment groups (XELOX and FOLFOX-4) and a subsequent 2 x 2 factorial 4-arm part (Part II) in which patients were randomised to four treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + bevacizumab, FOLFOX-4 + bevacizumab).
Slovenian: Preskušanje je obsegalo 2 dela: v začetnem, odprtem delu z 2 skupinama (1. del) so bolnike randomizirali v 2 različni skupini zdravljenja (XELOX in FOLFOX-4), v poznejšem delu s 4 skupinami in faktorskim načrtom 2 × 2 (2. del) pa so bolnike randomizirali v 4 skupine zdravljenja (XELOX + placebo, FOLFOX-4 + placebo, XELOX + bevacizumab, FOLFOX4 + bevacizumab).
English: Table 3 Adverse reactions reported in post-marketing setting
Slovenian: Preglednica 3 Neželeni učinki, o katerih so poročali v obdobju trženja
English: • redness, peeling, tenderness, pain, or blistering on the fingers or feet,
Slovenian: • rdečino, luščenje, občutljivost, bolečina ali pojav mehurjev na prstih ali stopalih,
English: What Zirabev is and what it is used for
Slovenian: Kaj je zdravilo Zirabev in za kaj ga uporabljamo
English: 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.
Slovenian: Bolečina v ustih, zobeh in/ali čeljusti, otekline ali razjede v ustih, odrevenelost ali občutek teže v čeljusti ali razmajanost zoba.
English: Results from the primary analysis and the follow-up analysis are presented by bevacizumab Treatment and by Trial Treatment in Table 14 and Table 15, respectively.
Slovenian: Rezultati primarne analize in nadaljnje analize spremljanja glede na zdravljenje z bevacizumabom in zdravljenje v okviru preskušanja so predstavljeni v preglednici 14 oziroma preglednici 15.
English: Cisplatin/Gemcitabine + placebo
Slovenian: Cisplatin in gemcitabin + placebo
English: Table 14 Efficacy results from study GOG-0240 by bevacizumab treatment
Slovenian: Preglednica 14 Rezultati učinkovitosti v študiji GOG-0240 glede na zdravljenje z bevacizumabom
English: Before you are given Zirabev or while you are being treated with Zirabev:
Slovenian: Preden prejmete zdravilo Zirabev ali med zdravljenjem z zdravilom Zirabev:
English: The most frequently observed adverse reactions across clinical trials in patients receiving bevacizumab were hypertension, fatigue or asthenia, diarrhoea and abdominal pain.
Slovenian: Najpogostnejši neželeni učinki, ki so jih opazili v kliničnih preskušanjih pri bolnikih, ki so se zdravili z bevacizumabom, so bili hipertenzija, utrujenost ali astenija, diareja in bolečina v trebuhu.
English: Most of the patients who experienced CHF had metastatic breast cancer and had received previous treatment with anthracyclines, prior radiotherapy to the left chest wall or other risk factors for CHF were present.
Slovenian: Večina bolnikov, pri katerih se je pojavilo KSP, je imela metastatski rak dojk in je predhodno prejemala zdravljenje z antraciklini, zdravljenje z obsevanjem leve strani prsnega koša ali pa so pri njih obstajali drugi dejavniki tveganja za KSP.
English: GI-vaginal fistulae in study GOG-0240
Slovenian: Fistule med prebavili in nožnico v študiji GOG-0240
English: Zirabev has been developed and made to treat cancer by injecting it into the bloodstream.
Slovenian: Zdravilo Zirabev so razvili in izdelali za zdravljenje raka z injiciranjem v krvni obtok.
English: a 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks
Slovenian: 5,0 mg/kg vsaka 2 tedna ali 7,5 mg/kg vsake 3 tedne
English: In Study BO20924, bevacizumab exposure was generally lower compared to a typical adult patient at the same dose.
Slovenian: V študiji BO20924 je bila izpostavljenost bevacizumabu v splošnem manjša kot pri tipičnem odraslem bolniku, ki je prejemal enak odmerek.
English: Bevacizumab has been associated with serious cases of gastrointestinal perforation.
Slovenian: Bevacizumab je povezan z resnimi primeri perforacije prebavil.
English: The addition of bevacizumab to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Slovenian: Dodajanje bevacizumaba k IFN-alfa-2a je pomembno podaljšalo PFS in pomembno povečalo objektivni odziv tumorja na zdravljenje.
English: Administration of bevacizumab or its parental murine antibody to xenotransplant models of cancer in nude mice resulted in extensive anti-tumour activity in human cancers, including colon, breast,
Slovenian: Injiciranje bevacizumaba ali njegovega izvornega mišjega protitelesa v heterotransplantatne modele raka pri golih miškah je povzročilo obsežno protitumorsko aktivnost v tumorjih človeškega izvora,
English: • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections),
Slovenian: • razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij),
English: ● It is possible that Zirabev can increase the risk of bleeding in your lungs, including coughing or spitting blood.
Slovenian: ● Možno je, da zdravilo Zirabev poveča tveganje za krvavitev v pljučih, vključno z izkašljevanjem ali pljuvanjem krvi.
English: A total of 116 patients were randomised to receive bevacizumab 3 mg/kg every 2 weeks (n=39), 10 mg/kg every 2 weeks; (n=37), or placebo (n=40).
Slovenian: Skupno so randomizirali 116 bolnikov na bevacizumab v odmerku 3 mg/kg vsaka 2 tedna (n = 39), bevacizumab v odmerku 10 mg/kg vsaka 2 tedna (n = 37) ali placebo (n = 40).
English: 95% CI for difference in response rates p-value (Chi-squared test)
Slovenian: 95 % IZ za stopnje odziva razlika v stopnjah odziva 95 % IZ za razliko v stopnjah odziva p-vrednost (test hi-kvadrat)
English: b For additional information refer below within section “Further information on selected serious adverse reactions”
Slovenian: Za dodatne informacije glejte poglavje ''Dodatne informacije o določenih resnih neželenih učinkih'' v nadaljevanju.
English: Median PFS (on treatment)**
Slovenian: Sekundarni opazovani dogodki mediano PFS (med zdravljenjem)**
English: • serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing,
Slovenian: • resne okužbe kože ali globljih plasti pod kožo, zlasti če ste imeli preluknjano črevesno steno ali težave pri celjenju ran,
English: Analyses of the clinical safety data suggest that the occurrence of hypertension and proteinuria with bevacizumab therapy are likely to be dose-dependent.
Slovenian: Analize kliničnih podatkov o varnosti kažejo, da je pojav hipertenzije in proteinurije med zdravljenjem z bevacizumabom verjetno odvisen od njegovega odmerka.
English: EGFR monoclonal antibodies should not be administered for the treatment of mCRC in combination with bevacizumab-containing chemotherapy.
Slovenian: Monoklonskih protiteles proti EGFR za zdravljenje mCRC ne smemo uporabljati v kombinaciji s kemoterapijo, ki vključuje bevacizumab.
English: At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72).
Slovenian: Neodvisni centralni pregled primarnega opazovanega dogodka EFS v času končne primarne analize ni pokazal statistično pomembne razlike med zdravljenima skupinama; HR je bilo 0,93 (95 % IZ: 0,61; 1,41; p-vrednost = 0,72).
English: The efficacy results are presented in Table 12.
Slovenian: Rezultati učinkovitosti so predstavljeni v preglednici 12.
English: Hypersensitivity reactions and infusion reactions (not known); with the following possible co-manifestations: dyspnoea/difficulty breathing, flushing/redness/rash, hypotension or hypertension, oxygen desaturation, chest pain, rigors and nausea/vomiting (see also section 4.4 and Hypersensitivity reactions/infusion reactions above)
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije in reakcije na infuzijo (neznana); z naslednjimi možnimi znaki: dispneja/težko dihanje, vročinski oblivi/rdečina/izpuščaj, hipotenzija ali hipertenzija, zmanjšana nasičenost s kisikom, bolečina v prsnem košu, okorelost in navzea/bruhanje (glejte tudi poglavje 4.4 in ''Preobčutljivostne reakcije/reakcije na infuzijo'' zgoraj)
English: Metastatic breast cancer (mBC)
Slovenian: Metastatski rak dojk (mBC - metastatic breast cancer)
English: Zirabev is for single-use only, as the product contains no preservatives.
Slovenian: Zdravilo Zirabev je le za enkratno uporabo, saj ne vsebuje konzervansov.
English: The clinical benefit of bevacizumab 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 oestrogen receptor (ER) status).
Slovenian: Klinično korist bevacizumaba, ki so jo izmerili glede na PFS, so opazili v vseh preiskovanih, vnaprej določenih podskupinah (vključno z intervalom brez bolezni, številom metastatskih mest, predhodnim prejemanjem adjuvantne kemoterapije in statusom estrogenskih receptorjev (ER)).
English: Your doctor should advise you about using contraception during treatment with Zirabev and for at least 6 months after the last dose of Zirabev.
Slovenian: Zdravnik vam mora svetovati, da med zdravljenjem z zdravilom Zirabev in še najmanj 6 mesecev po zadnjem odmerku zdravila Zirabev uporabljate kontracepcijo.
English: 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).
Slovenian: Pri bolnikih, ki so prejemali bevacizumab v monoterapiji, ni bilo statistično ali klinično pomembnih razlik v očistku bevacizumaba v primerjavi z bolniki, ki so prejemali bevacizumab v kombinaciji z interferonom alfa-2a, erlotinibom ali kemoterapevtiki (IFL, 5-FU/LV, karboplatin/paklitaksel, kapecitabin, doksorubicin ali cisplatin/gemcitabin).
English: You could also experience redness or flushing of the skin or a rash, chills and shivering, feeling sick (nausea) or being sick (vomiting).
Slovenian: Lahko se pojavi tudi rdečina ali zardevanje kože ali izpuščaj, mrzlica in drgetanje, občutek siljenja na bruhanje (navzea) ali bruhanje.
English: During the trial, of the patients who received trial treatment, 32.2% (136/422) of patients received 7-12 administrations of bevacizumab and 21.1% (89/422) of patients received 13 or more administrations of bevacizumab.
Slovenian: Med preskušanjem je od bolnikov, ki so prejemali zdravljenje v okviru preskušanja, 32,2 % (136/422) bolnikov prejelo 7-12 odmerkov bevacizumaba, 21,1 % (89/422) bolnikov pa je prejelo 13 ali več odmerkov bevacizumaba.
English: There is evidence suggesting that all Grade (US National Cancer Institute- Common Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Slovenian: Obstajajo dokazi, ki kažejo, da je proteinurija vseh stopenj [Merila NCI za poenoteno terminologijo neželenih dogodkov, različica 3.0 (NCI-CTCAE v.3)] lahko povezana z odmerkom.
English: In two subsequent studies in patients with treated brain metastases (which included around 800 patients), one case of Grade 2 CNS haemorrhage was reported in 83 subjects treated with bevacizumab (1.2%) at the time of interim safety analysis (NCI-CTCAE v.3).
Slovenian: V 2 kasnejših študijah pri bolnikih z zdravljenimi metastazami v možganih (ki sta vključevali približno 800 bolnikov) so v času vmesne analize varnosti poročali o 1 primeru krvavitve v CŽS stopnje 2 pri skupno 83 preskušancih, ki so se zdravili z bevacizumabom (1,2 %) (NCI-CTCAE v.3).
English: In four phase III trials (AVF2119g, E2100, BO17708 and AVF3694g) in patients with metastatic breast cancer CHF Grade 3 (NCI-CTCAE v.3) or higher was reported in up to 3.5% of patients treated with bevacizumab in combination with chemotherapy compared with up to 0.9% in the control arms.
Slovenian: V 4 preskušanjih 3. faze (AVF2119g, E2100, BO17708 in AVF3694g) pri bolnikih z metastatskim rakom dojk so o KSP 3. ali višje stopnje (NCI-CTCAE v.3) poročali pri največ 3,5 % bolnikov, ki so se zdravili z bevacizumabom v kombinaciji s kemoterapijo, v primerjavi z največ 0,9 % bolnikov v kontrolnih skupinah.
English: In cases of internal fistula not arising in the gastrointestinal tract, discontinuation of Zirabev should be considered.
Slovenian: V primerih notranjih fistul, ki ne izhajajo iz prebavil, je treba razmisliti o prekinitvi zdravljenja z zdravilom Zirabev.