natgillin/translations-raw huggingface dataset:
There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurologic disorder, which can present with the following signs and symptoms among others: seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Pri bolnikih, ki so se zdravili z bevacizumabom, so redko poročali o pojavu znakov in simptomov, povezanih s sindromom posteriorne reverzibilne encefalopatije (PRES, Posterior Reversible Encephalopathy Syndrome), redko nevrološko motnjo, ki se lahko kaže tudi z naslednjimi znaki in simptomi: epileptični napad, glavobol, spremenjeni mentalni status, motnje vida ali kortikalna slepota s sočasno hipertenzijo ali brez nje.
• allergic reactions (the signs may include difficulty breathing, facial redness, rash, low blood pressure or high blood pressure, low oxygen in your blood, chest pain, or nausea/vomiting),
• alergijske reakcije (znaki lahko vključujejo težave pri dihanju; lahko se pojavi tudi rdečica obraza, izpuščaj, nizek ali visok krvni tlak, nizka raven kisika v vaši krvi, bolečina v prsnem košu ali slabost/bruhanje),
Severe adverse reactions by frequency
Hudi neželeni učinki po pogostnosti
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1246/002
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/17/1246/002
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.
V študiji JO25567 so hipertenzijo vseh stopenj opazili pri 77,3 % bolnikov, ki so prejemali bevacizumab v kombinaciji z erlotinibom v prvi liniji zdravljenja neskvamoznega nedrobnoceličnega raka pljuč z EGFR-aktivirajočimi mutacijami, v primerjavi s 14,3 % bolnikov, zdravljenih samo z erlotinibom.
At baseline, most patients in both treatment arms had a GOG PS of 0 (CP: 82.4%: CPB; 80.7%) or 1 (CP: 16.7%: CPB; 18.1%).
Izhodiščno je imela večina bolnic v obeh zdravljenih skupinah stanje zmogljivosti po GOG (Gynecologic Oncology Group) 0 (CP: 82,4 %: CPB: 80,7 %) ali 1 (CP: 16,7 %, CPB; 18,1 %).
Clinical trials have shown that transient increases in serum creatinine (ranging between 1.5-1.9 times baseline level), both with and without proteinuria, are associated with the use of bevacizumab.
Klinična preskušanja so pokazala, da so z bevacizumabom povezana prehodna zvišanja kreatinina v serumu (v razponu med 1,5 in 1,9-kratno izhodiščno vrednostjo) s proteinurijo ali brez nje.
• presence of protein in your urine accompanied by swelling of your body,
• beljakovine v seču, ki jih spremlja otekanje telesa,
In study BO20924, bevacizumab exposure was generally lower compared to a typical adult patient at the same dose.
V študiji BO20924 je bila izpostavljenost bevacizumabu v splošnem manjša kot pri tipičnem odraslem bolniku, ki je prejemal enak odmerek.
Cases of osteonecrosis of the jaw (ONJ) have been reported in patients treated with bevacizumab, most of which occurred in patients who had identified risk factors for ONJ, in particular exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4) Cases of non-mandibular osteonecrosis have been observed in bevacizumab-treated paediatric patients (see section 4.8, Paediatric population)
Bolezni mišično- skeletnega sistema in vezivnega tkiva pri bolnikih, zdravljenih z bevacizumabom, so poročali o primerih osteonekroze čeljustnic; v večini primerov je šlo za bolnike, pri katerih so bili prisotni znani dejavniki tveganja za osteonekrozo čeljustnic, zlasti izpostavljenost intravenskim difosfonatom in/ali anamneza zobne bolezni, ki je zahtevala invazivne zobozdravstvene posege (glejte tudi poglavje 4.4) pri zdravljenju pediatričnih bolnikov z bevacizumabom so opazili primere osteonekroze izven spodnje čeljustnice (glejte poglavje 4.8, Pediatrični bolniki)
Patients and percentage of patients with best overall response of confirmed CR or PR; percentage calculated on patients with measurable disease at baseline.
Bolnice in odstotek bolnic z najboljšim celokupnim odgovorom, ocenjenim kot popolni odgovor ali delni odgovor, odstotek izračunan pri bolnicah z merljivo boleznijo ob izhodišču.
• The other ingredients are trehalose dihydrate, sodium phosphate, polysorbate 20 and water for injections.
• Pomožne snovi so trehaloza dihidrat, natrijev fosfat, polisorbat 20 in voda za injekcije.
Decreased neutrophil count, decreased white blood cell count and presence of urine protein may be associated with MVASI treatment.
Zmanjšanje števila nevtrofilcev, zmanjšanje števila levkocitov in prisotnost beljakovin v seču so lahko povezani z zdravljenjem z zdravilom MVASI.
In the absence of PD, discontinuation of one component of study treatment in the erlotinib + bevacizumab arm did not lead to discontinuation of the other component of study treatment as specified in the study protocol.
V skupini, zdravljeni z erlotinibom in bevacizumabom, v odsotnosti napredovanja bolezni ukinitev enega od zdravil, uporabljenega v študiji, ni vodila do ukinitve drugega zdravila, kar je bilo v skladu s protokolom študije.
5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks.
5,0 mg/kg vsaka 2 tedna ali 7,5 mg/kg vsake 3 tedne.
Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Preobčutljivostne reakcije/reakcije pri infundiranju (glejte poglavje 4.4 ter podnaslov Izkušnje po prihodu zdravila na trg, spodaj)
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.
V štirih preskušanjih faze III (AVF2119g, E2100, BO17708 in AVF3694g) so pri bolnikih z metastatskim rakom dojk o kongestivnem srčnem popuščanju stopnje 3 ali več (NCICTCAE v.3) poročali pri največ 3,5 % bolnikov, zdravljenih z bevacizumabom v kombinaciji s kemoterapijo, v primerjavi z največ 0,9 % bolnikov v kontrolnih skupinah.
• redness, peeling, tenderness, pain, or blistering on the fingers or feet,
• rdečina, luščenje, občutljivost, bolečina ali pojav mehurjev na prstih ali nogah,
A total of 1,873 patients were randomised in equal proportions to the following three arms:
Skupno je bilo randomiziranih 1.873 bolnic v enakem razmerju v naslednje tri skupine:
The primary endpoint of this trial was progression-free survival (PFS), based on trial investigators' assessment of disease progression.
Primarni cilj tega preskušanja je bilo preživetje brez napredovanja bolezni (PFS), osnovano na oceni napredovanja bolezni s strani raziskovalcev.
If this happens you should talk to your doctor, pharmacist or nurse immediately.
Če se to zgodi, se takoj posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
• infections of the skin or deeper layers under the skin,
• okužbe kože ali globljih plasti pod kožo,
How to use MVASI
Kako uporabljati zdravilo MVASI
• runny nose,
• izcedek iz nosu,
Bevacizumab may adversely affect the wound healing process.
Bevacizumab lahko neugodno vpliva na proces celjenja ran.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/4 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg/4 ml
However, patients who developed venous thrombosis while receiving therapy did not appear to have an increased rate of grade 3 or above bleeding when treated with a full dose of warfarin and bevacizumab concomitantly (NCI-CTCAE v.3).
Vendar bolniki, pri katerih se je med zdravljenjem pojavila venska tromboza, niso imeli povečane pojavosti krvavitev stopnje 3 ali več (NCI-CTCAE v.3), če so jih sočasno zdravili s polnim odmerkom varfarina in bevacizumabom.
Front-line treatment of ovarian cancer
Prvo zdravljenje raka jajčnikov
Dose reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of bevacizumab and IFN alfa-2a based on PFS event free rates over time, as shown by a subgroup analysis.
Zmanjšanje odmerka interferona alfa-2a ni vplivalo na učinkovitost kombinacije bevacizumaba in interferona alfa-2a, kar je z deležem preživetja brez napredovanja bolezni v tem času potrdila analiza podskupine.
Caution should be exercised when treating patients with clinically significant cardiovascular disease such as pre-existing coronary artery disease, or congestive heart failure with bevacizumab.
Pri zdravljenju z bevacizumabom je pri bolnikih s klinično pomembno kardiovaskularno boleznijo, kot je predhodno obstoječa bolezen koronarnih arterij ali kongestivno srčno popuščanje, potrebna previdnost.
• serious infections of the skin or deeper layers under the skin,
• resne okužbe kože ali globljih plasti pod kožo,
The frequency of GI-vaginal fistulae in the group treated with bevacizumab + chemotherapy was higher in patients with recurrence within the field of prior radiation (16.7%) compared with patients with no prior radiation and/or no recurrence inside the field of prior radiation (3.6%).
Pogostnost fistul med prebavili in nožnico v skupini, zdravljeni z bevacizumabom in kemoterapijo, je bila večja pri bolnicah s ponovitvijo bolezni v področju predhodnega obsevanja (16,7 %) v primerjavi z bolnicami brez predhodnega obsevanja in/ali brez ponovitve znotraj polja predhodnega obsevanja (3,6 %).
The primary efficacy endpoint was overall survival (OS).
Primarni opazovani dogodek učinkovitosti je bil celokupno preživetje (OS, overall survival).
In patients in AVF3694g who received treatment with anthracyclines and who had not received anthracyclines before, no increased incidence of all grade CHF was observed in the anthracycline + bevacizumab group compared to the treatment with anthracyclines only.
V preskušanju AVF3694g pri bolnikih, ki so prejemali zdravljenje z antraciklini in ki se predhodno še niso zdravili z antraciklini, niso opazili povečane incidence kongestivnega srčnega popuščanja katere koli stopnje v skupini z antraciklinom in bevacizumabom v primerjavi z zdravljenjem s samimi antraciklini.
Secondary endpoint Progression-free survival (PFS)
Sekundarni opazovani dogodek Preživetje brez napredovanja bolezni (PFS)
Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with bevacizumab.
O propadanju kostnega tkiva (osteonekrozi) v drugih kosteh, ne v čeljustnici, so poročali pri bolnikih, mlajših od 18 let, ko so se ti zdravili z bevacizumabom.
A third group of 110 patients received bolus 5-FU/FA + bevacizumab (Arm 3).
Tretja skupina 110 bolnikov je prejela bolus 5-FU/FA + bevacizumab (skupina 3).
MVASI is for single-use only, as the product contains no preservatives.
Zdravilo MVASI je le za enkratno uporabo in ne vsebuje konzervansov.
Proteinuriaa,b
Bolezni sečil proteinurijaa,b
XELOX or
XELOX ali
The most frequently observed adverse reactions across clinical trials in patients receiving bevacizumab were hypertension, fatigue or asthenia, diarrhoea and abdominal pain.
Najpogostnejši neželeni učinki, ki so se pojavili pri bolnikih, zdravljenih z bevacizumabom v kliničnih preskušanjih, so bili hipertenzija, utrujenost ali astenija, diareja in bolečina v trebuhu.
A total of 1,528 patients were randomised in equal proportions to the following two arms:
Skupno je bilo randomiziranih 1.528 bolnic v enakih razmerjih v naslednji dve skupini:
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 400 mg/16 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 400 mg/16 ml
Pre-existing hypertension should be adequately controlled before starting MVASI treatment.
Obstoječo hipertenzijo je treba pred začetkom zdravljenja z zdravilom MVASI ustrezno uravnati.
No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of co-administered interferon alfa 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
Klinično pomembnega medsebojnega delovanja bevacizumaba na farmakokinetiko sočasno danega interferona alfa-2a, erlotiniba (in njegovega aktivnega presnovka OSI-420), kemoterapevtika irinotekana (in njegovega aktivnega presnovka SN38), kapecitabina, oksaliplatina (kot je dokazano z merjenjem proste in celokupne platine) in cisplatina niso opazili.
MVASI will be administered in combination with erlotinib.
Zdravilo MVASI boste prejeli v kombinaciji z erlotinibom.
Treatment regimens in trial NO16966 (mCRC)
Sheme zdravljenja v preskušanju NO16966 (metastatski rak debelega črevesa in danke)
Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine, peripheral sensory neuropathy with paclitaxel or oxaliplatin, nail disorders or alopecia with paclitaxel and paronychia with erlotinib.
Primeri vključujejo palmarno-plantarno eritrodisestezijo s pegiliranim liposomalnim doksorubicinom ali kapecitabinom, periferno senzorično nevropatijo s paklitakselom ali oksaliplatinom, bolezni nohtov ali alopecijo s paklitakselom in paronihijo z erlotinibom.
• Haemorrhage, including pulmonary haemorrhage/haemoptysis, which is more common in non small cell lung cancer patients (see section 4.4).
• krvavitev, vključno s krvavitvijo v pljučih/hemoptizo, ki je pogostejša pri bolnikih z nedrobnoceličnim rakom pljuč (glejte poglavje 4.4),
MVASI will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Zdravilo MVASI se uporablja v kombinaciji s paklitakselom in cisplatinom ali, alternativno, s paklitakselom in topotekanom pri bolnicah, ki ne morejo dobivati zdravljenja s platino.
In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the bevacizumab-containing arms compared with up to 14% in the control arms.
V kliničnih preskušanjih, z izjemo študije JO25567, je bila celokupna incidenca hipertenzije (vseh stopenj) pri skupinah bolnikov, zdravljenih z bevacizumabom, do 42,1 % v primerjavi z do 14 % pri bolnikih, zdravljenih v primerjalnih skupinah.
Hazard ratio (95% CI) (registration form)b
p-vrednost razmerje ogroženosti (95-% IZ) (registracijski obrazec)b
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.
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij za vse skupine pediatrične populacije pri raku dojk, adenokarcinomu debelega črevesa in danke, raku pljuč (drobnoceličnem in nedrobnoceličnem), raku ledvic in ledvičnega meha (razen nefroblastoma, nefroblastomatoze, svetloceličnega sarkoma, mezoblastnega nefroma, raka ledvične sredice in rabdoidnega ledvičnega tumorja), raku jajčnikov (razen rabdomiosarkoma in germinalnih tumorjev), raku jajcevodov (razen rabdomiosarkoma in germinalnih tumorjev), primarnem peritonealnem karcinomu (razen blastoma in sarkoma) in raku materničnega vratu ter materničnega telesa.
The main secondary efficacy endpoint was progression-free survival (PFS).
Glavni sekundarni opazovani dogodek učinkovitosti je bil preživetje brez napredovanja bolezni (PFS).
• MVASI may cause bleeding, especially tumour-related bleeding.
• zdravilo MVASI lahko povzroči krvavitve, posebno krvavitve, povezane s tumorjem.
Grade 3 hypertension was 60.0% in patients treated with bevacizumab in combination with erlotinib compared to 11.7% in patients treated with erlotinib alone.
Hipertenzijo stopnje 3 so opazili pri 60,0 % bolnikov, zdravljenih z bevacizumabom v kombinaciji z erlotinibom, v primerjavi z 11,7 % bolnikov, zdravljenih samo z erlotinibom.
Bevacizumab vs. No bevacizumab
Bevacizumab proti brez bevacizumaba
• pain, including headache, back pain and pain in the pelvis and anal regions,
• bolečino, vključno z glavobolom, bolečine v hrbtu in bolečine v predelu medenice in zadnjika,
The overall incidence of NCI-CTC grade 3 and 4 hypertension in patients receiving bevacizumab ranged from 0.4% to 17.9%.
Celokupna incidenca hipertenzije stopnje 3 in 4 po NCI-CTC je bila pri bolnikih, ki so se zdravili z bevacizumabom, od 0,4 do 17,9 %.
The 649 randomised patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%, no CNS metastases and adequate organ function.
V klinično preskušanje je bilo randomiziranih 649 bolnikov (641 pa zdravljenih), njihovo stanje zmogljivosti po Karnofskem je bilo ≥ 70 %, bili so brez zasevkov v osrednjem živčevju, imeli so ustrezno organsko funkcijo.
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).
Klinična korist bevacizumaba, merjena kot preživetje brez napredovanja bolezni, je bila opažena v vseh preiskovanih, vnaprej določenih podskupinah (vključno z intervalom brez bolezni, številom metastatskih mest, predhodnim prejetjem adjuvantne kemoterapije in statusom estrogenskih receptorjev).
Trehalose dihydrate, sodium phosphate, polysorbate 20, water for injections.
SEZNAM POMOŽNIH SNOVI Trehaloza dihidrat, natrijev fosfat, polisorbat 20, voda za injekcije.
What MVASI looks like and contents of the pack
Izgled zdravila MVASI in vsebina pakiranja
• AVF2107g: A weekly schedule of irinotecan/bolus 5-fluorouracil/folinic acid (IFL) for a total of 4 weeks of each 6 week-cycle (Saltz regimen).
• AVF2107g: tedenska shema irinotekana/bolusa 5-fluorouracila/folinske kisline (IFL), ki jo bolnik prejema 4 tedne zapored v 6-tedenskih ciklih (shema Saltz).
The addition of bevacizumab to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see table 4).
Dodatek bevacizumaba k shemi IFL je statistično značilno podaljšal celokupno preživetje, preživetje brez napredovanja bolezni in celokupen odgovor na zdravljenje teh bolnikov (glejte preglednico 4).
Fluoropyrimidine/irinotecan or Fluoropyrimidine/oxaliplatin based chemotherapy + bevacizumaba
kemoterapija na osnovi fluoropirimidina/irinotekana ali fluoropirimidina/oksaliplatina kemoterapija na osnovi fluoropirimidina/irinotekana ali fluoropirimidina/oksaliplatina + bevacizumaba
In study BO20924 of bevacizumab with current standard of care in metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma, the safety profile of bevacizumab-treated children was comparable with that observed in adults treated with bevacizumab.
V študiji BO20924 z bevacizumabom v kombinaciji s trenutnim standardnim zdravljenjem metastatskega rabdomiosarkoma in ostalih mehkotkivnih sarkomov je bil varnostni profil bevacizumaba pri zdravljenih otrocih primerljiv s tistim pri odraslih, zdravljenih z bevacizumabom.
Efficacy results from study MO22224 Primary endpoint
Rezultati učinkovitosti iz študije MO22224
Ovarian failure/fertility
Okvara jajčnikov/plodnost
Pre-specified PFS analyses were conducted, all with a cut-off date of 29 September 2009.
Narejene so bile vnaprej določene analize preživetja brez napredovanja bolezni, vse s podatki zbranimi do 29. septembra 2009.
Progression-free survival by time from last platinum therapy to recurrence
Preživetje brez napredovanja bolezni prikazano glede na čas od zadnjega zdravljenja, ki je vsebovalo platino, do ponovitve bolezni
This does not necessarily mean that these side effects were strictly caused by MVASI.
To pa ne pomeni, da je neželene učinke povzročilo le zdravilo MVASI.
In clinical trials with bevacizumab, congestive heart failure (CHF) was observed in all cancer indications studied to date, but occurred predominantly in patients with metastatic breast cancer.
V kliničnih preskušanjih z bevacizumabom so kongestivno srčno popuščanje opazili pri vseh indikacijah raka, ki so jih preiskovali do sedaj, pojavilo pa se je predvsem pri bolnikih z metastatskim rakom dojk.
5.8% of the overall randomised patient population had stage IIIB disease.
5,8 % celotne populacije randomiziranih bolnic je imelo bolezen stadija III B. Glede na kontrolno skupino.
PFS1 results by disease stage and debulking status from study GOG-0218
Rezultati preživetja brez napredovanja bolezni1, glede na stadij bolezni in stopnjo citoredukcije iz študije GOG-0218
Ovarian failure/fertility (see sections 4.4 and 4.6)
Okvara jajčnikov/plodnost (glejte poglavji 4.4 in 4.6)
Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, bevacizumab therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy.
Med možnimi dejavniki tveganja so ploščatocelična histologija, zdravljenje z antirevmatičnimi/protivnetnimi zdravili, zdravljenje z antikoagulanti, predhodna radioterapija, zdravljenje z bevacizumabom, anamneza ateroskleroze, centralna lokalizacija tumorja in razpad tumorjev med zdravljenjem.
• an open sore or hole in the lining of the stomach or small intestine (the signs may include abdominal pain, feeling bloated, black tarry stools or blood in your stools (faeces) or blood in your vomit),
• odprta rana ali luknja v sluznici želodca ali tankega črevesa (znaki so lahko bolečina v trebuhu, občutek napihnjenosti, črno blato ali kri v blatu ali kri v bruhanju),
Both the 5 mg/kg/week and 2.5 mg/kg/week equivalent doses of bevacizumab provided a statistically significant benefit with regards to OS (HR 0.751 in study E3200; HR 0.81 in study ML18147) and PFS (HR 0.518 in study E3200; HR 0.68 in study ML18147).
Oba odmerka bevacizumaba, ekvivalentna 5 mg/kg/teden in 2,5 mg/kg/teden, sta zagotovila statistično značilno korist v smislu celokupnega preživetja (razmerje ogroženosti 0,751 v študiji E3200; razmerje ogroženosti 0,81 v študiji ML18147) in preživetja brez napredovanja bolezni (razmerje ogroženosti 0,518 v študiji E3200; razmerje ogroženosti 0,68 v študiji ML18147).
FOLFOX-4 or XELOX + bevacizumab (n = 699)
FOLFOX-4 ali XELOX + bevacizumab (n = 699)
Patients may be at increased risk for the development of fistulae when treated with bevacizumab.
Bolniki so lahko izpostavljeni večjemu tveganju za nastanek fistule, če se zdravijo z bevacizumabom.
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).
V dveh kasnejših kliničnih preskušanjih, pri bolnikih z zdravljenimi zasevki v možganih (vključenih je bilo okoli 800 bolnikov), so v času vmesne analize varnosti poročali o enem primeru krvavitve v osrednjem živčevju stopnje 2 od 83 bolnikov, zdravljenih z bevacizumabom (1,2 %) (NCI-CTCAE v.3).
In study BO25041, bevacizumab exposure was similar compared to a typical adult at the same dose.
V študiji BO25041 je bila izpostavljenost bevacizumabu podobna kot pri tipičnem odraslem bolniku, ki je prejemal enak odmerek.
• Infection or inflammation of the eye globe,
• okužba ali vnetje očesnega zrkla,