FrancophonIA/ELRC3.0 huggingface dataset:
English: Compared to patients treated with chemotherapy (paclitaxel, topotecan or PLD) alone in the recurrent platinum-resistant setting, patients who received bevacizumab at a dose of 10 mg/kg every 2 weeks (or 15 mg/kg every 3 weeks if used in combination with 1.25 mg/m2 topotecan on Days 1-5 every 3 weeks) in combination with chemotherapy and continued to receive bevacizumab until disease progression or unacceptable toxicity, had a statistically significant improvement in PFS.
Slovenian: V primerjavi z bolnicami, zdravljenimi samo s kemoterapijo (paklitakselom, topotekanom ali PLD), pri ponovitvi bolezni, rezistentni na platino, so imele bolnice, ki so prejemale bevacizumab v odmerku 10 mg/kg vsaka 2 tedna (ali 15 mg/kg vsake 3 tedne, če so ga uporabljali v kombinaciji z 1,25 mg/m2 topotekana od 1. do 5. dne vsake 3 tedne) v kombinaciji s kemoterapijo in nadaljevale z njegovim jemanjem do napredovanja bolezni ali nesprejemljive toksičnosti, statistično pomembno izboljšanje preživetja brez napredovanja bolezni.
English: 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.
Slovenian: Uporaba bevacizumaba pri pediatrični populaciji za indikacije zdravljenja rakov debelega črevesa, danke, dojk, pljuč, jajčnikov, jajcevodov, peritoneja, maternice in ledvic ni smiselna.
English: (See section 5.1).
Slovenian: (navedeno v poglavju 6),
English: Cap + Avastin (n=409)
Slovenian: kap + Avastin (n = 409)
English: CI, confidence interval; HR, Hazard ratio from unstratified Cox regression analysis; NR, not reached.
Slovenian: Razmerje ogroženosti je iz nestratificirane Coxove regresijske analize.
English: When used for patients with breast cancer, it will be administered with a chemotherapy medicinal product called paclitaxel or capecitabine.
Slovenian: Kadar ga uporabljamo za bolnike z rakom dojk, ga dajemo skupaj s kemoterapijo, to je z zdravilom paklitaksel ali kapecitabin.
English: Patients were stratified according to country and Motzer score and the treatment arms were shown to be well balanced for the prognostic factors.
Slovenian: Bolnike so stratificirali po državah in glede na oceno napovednih dejavnikov po Motzer-ju; glede slednjih sta bili obe skupini dobro uravnoteženi.
English: In patients developing PRES, early recognition of symptoms with prompt treatment of specific symptoms including control of hypertension (if associated with severe uncontrolled hypertension) is recommended in addition to discontinuation of bevacizumab therapy.
Slovenian: Pri bolnikih, pri katerih se razvije sindrom posteriorne reverzibilne encefalopatije, je poleg prekinitve zdravljenja z bevacizumabom priporočljivo zgodnje odkrivanje simptomov s hitrim zdravljenjem specifičnih simptomov, vključno z nadzorom hipertenzije (če je povezana s hudo nenadzorovano hipertenzijo).
English: The primary efficacy parameter of the trial was the duration of progression-free survival.
Slovenian: Primarni parameter učinkovitosti preskušanja je bilo trajanje preživetja brez napredovanja bolezni.
English: Overall response rate Rate (%)
Slovenian: Odgovor na zdravljenje delež (%)
English: p-Value Secondary Endpoint
Slovenian: p-vrednost Sekundarni opazovani dogodek
English: Progression-free survival and objective response rate were inferior in the Avastin monotherapy arm compared to the FOLFOX-4 arm.
Slovenian: Preživetje brez napredovanja bolezni in objektivni odgovor na zdravljenje sta bila v skupini, ki se je zdravila samo z zdravilom Avastin, inferiorna v primerjavi s skupino, ki se je zdravila po shemi FOLFOX-4.
English: The overall rates of discontinuation due to adverse events were 8.8% in the CT arm and 43.6% in the CT + BV arm (mostly due to Grade 2-3 adverse events) and the median time to discontinuation in the CT + BV arm was 5.2 months compared with 2.4 months in the CT arm.
Slovenian: Skupni delež prekinitev zaradi neželenih učinkov je bil 8,8 % v skupini s kemoterapijo in 43,6 % v skupini s kemoterapijo in bevacizumabom (večinoma zaradi neželenih učinkov stopnje 2 do 3), mediani čas do prekinitve je bil v skupini s kemoterapijo in bevacizumabom 5,2 meseca v primerjavi z 2,4 meseca v skupini s kemoterapijo.
English: a Hazard ratio was estimated from Cox proportional hazards models stratified by the duration of platinum free-interval prior to enrolling onto this study per eCRF (electronic case report form) and secondary surgical debulking status Yes/No
Slovenian: a Razmerje ogroženosti so ocenili iz Coxovih modelov sorazmernih ogroženosti, stratificiranih s trajanjem intervala brez platine pred vključitvijo v to študijo glede na elektronski obrazec za poročanje o primerih (eCRF, electronic case report form) in sekundarno s statusom kirurške odstranitve Da/Ne (Da = randomizirane, da bodo imele citoredukcijo ali randomizirane, da citoredukcije ne bodo imele; Ne = ni bila kandidatka za citoredukcijo ali z njo ni soglašala).
English: This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) plus bevacizumab to RCHOP without bevacizumab.
Slovenian: V kliničnem preskušanju faze III so primerjali shemo rituksimab/ciklofosfamid/doksorubicin/vinkristin/prednizon (R-CHOP) in bevacizumab s shemo R-CHOP brez bevacizumaba.
English: In clinical trials, the incidence of arterial thromboembolic reactions including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs) was higher in patients receiving Avastin in combination with chemotherapy compared to those who received chemotherapy alone.
Slovenian: V kliničnih preskušanjih je bila incidenca arterijskih trombemboličnih neželenih učinkov, vključno s cerebrovaskularnimi neželenimi učinki, tranzitornimi ishemičnimi atakami (TIA) in miokardnimi infarkti, večja pri bolnikih, ki so prejemali zdravilo Avastin v kombinaciji s kemoterapijo v primerjavi s tistimi, ki so prejemali le kemoterapijo.
English: In addition, in study AVF3694g the incidences of all Grade CHF were similar between the anthracycline + Avastin (6.2%) and the anthracycline + placebo arms (6.0%).
Slovenian: Dodatno so bile v preskušanju AVF3694g incidence kongestivnega srčnega popuščanja katere koli stopnje podobne v skupini z antraciklinom in zdravilom Avastin (6,2 %) v primerjavi s skupino z antraciklinom in placebom (6,0 %).
English: Other special populations
Slovenian: Druge posebne populacije Starejši bolniki
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje
English: Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see Section 5.1).
Slovenian: Bevacizumab je v kombinaciji z erlotinibom indiciran za prvo linijo zdravljenja odraslih bolnikov z inoperabilnim, napredovalim, metastatskim ali ponavljajočim se neskvamoznim nedrobnoceličnim rakom pljuč z EGFR-aktivirajočimi mutacijami (EGFR - Epidermal Growth Factor Receptor) (glejte poglavje 5.1).
English: In these studies, bevacizumab was administered at the following dosing regimens in combination with FOLFOX-4 (5-FU/LV/oxaliplatin), XELOX (capecitabine/oxaliplatin), and fluoropyrimidine/irinotecan and fluoropyrimidine/oxaliplatin:
Slovenian: V teh študijah so bevacizumab v kombinaciji s shemo FOLFOX-4 (5-FU/LV/oksaliplatin), shemo XELOX (kapecitabin/oksaliplatin) in fluoropirimidinom/irinotekanom in fluoropirimidinom/oksaliplatinom aplicirali po naslednji shemi odmerjanja:
English: In a phase III trial in the adjuvant treatment of patients with colon cancer, a substudy with premenopausal women has shown a higher incidence of new cases of ovarian failure in the bevacizumab group compared to the control group.
Slovenian: V kliničnem preskušanju faze III z bevacizumabom v adjuvantnem zdravljenju bolnikov z rakom na debelem črevesu je bila v podštudiji, ki je vključevala predmenopavzalne ženske, incidenca okvare jajčnikov večja pri skupini, ki je jemala bevacizumab v primerjavi s kontrolno skupino.
English: Bevacizumab clearance was approximately 30% faster in patients with low levels of serum albumin and 7% faster in subjects with higher tumour burden when compared with a typical patient with median values of albumin and tumour burden.
Slovenian: Očistek bevacizumaba je bil približno 30 % hitrejši pri bolnikih z nizkimi vrednostmi serumskega albumina in
English: This group of medical terms may involve the same underlying pathophysiology (e.g. arterial thromboembolic reactions include cerebrovascular accident, myocardial infarction, transient ischaemic attack and other arterial thromboembolic reactions).
Slovenian: Skupina medicinskih terminov ima lahko isto osnovno patofiziologijo (npr. arterijski trombembolični neželeni učinki vključujejo cerebrovaskularni zaplet, miokardni infarkt, tranzitorno ishemično atako in druge arterijske trombembolične neželene učinke).
English: • Seeing flashes of light with floaters, progressing to a loss of some of your vision,
Slovenian: · bliskanje v vidnem polju z motnjavami, kar vodi do delne izgube vida,
English: The efficacy and safety of Avastin 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.
Slovenian: Učinkovitost in varnost zdravila Avastin v kombinaciji s kemoterapijo (paklitaksel in cisplatin ali paklitaksel in topotekan) za zdravljenje bolnic z rakom materničnega vratu, pri katerih je bila bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je bila metastatska, so ugotavljali v študiji GOG-0240, randomiziranem, odprtem, multicentričnem preskušanju faze III s štirimi skupinami bolnic.
English: Patients who had received prior therapy with bevacizumab or prior systemic anticancer therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, or hormonal therapy) or previous radiotherapy to the abdomen or pelvis were excluded from the study.
Slovenian: Bolnice, ki so predhodno prejemale zdravljenje z bevacizumabom ali predhodno sistemsko zdravljenje za rak jajčnikov (npr. kemoterapijo, zdravljenje z monoklonskimi protitelesi, zdravljenje z zaviralci tirozin kinaze ali hormonsko zdravljenje) ali predhodno radioterapijo trebuha ali medenice niso bile vključene v študijo.
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.4) Avastin has been associated with serious cases of gastrointestinal perforation.
Slovenian: Perforacije in fistule prebavil (glejte poglavje 4.4) Zdravilo Avastin so povezovali z resnimi primeri perforacije prebavil.
English: Trial E2100 was an open-label, randomised, active controlled, multicentre clinical trial evaluating Avastin 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.
Slovenian: Preskušanje E2100 je bilo odprto, randomizirano, aktivno kontrolirano multicentrično klinično preskušanje, ki je proučevalo zdravilo Avastin v kombinaciji s paklitakselom pri bolnikih z lokalno ponovitvijo ali razsojem raka dojk, ki predhodno niso prejeli kemoterapije za lokalno recidivno ali metastatsko bolezen.
English: An overall survival benefit has been demonstrated in trial E4599 with a 15 mg/kg/q3wk dose of bevacizumab.
Slovenian: Korist v celokupnem preživetju so dokazali v preskušanju E4599 z odmerkom bevacizumaba 15 mg/kg telesne mase, danim enkrat na tri tedne.
English: The study evaluated the effect of adding Avastin to carboplatin+paclitaxel and continuing Avastin as a single agent until disease progression or unacceptable toxicity compared to carboplatin+paclitaxel alone.
Slovenian: Študija je ocenjevala učinek dodajanja zdravila Avastin h kombinaciji karboplatina in paklitaksela ter nadaljevanja zdravljenja s samim zdravilom Avastin do napredovanja bolezni ali nesprejemljive toksičnosti v primerjavi z dajanjem samo karboplatina in paklitaksela.
English: Table 6 Treatment regimens in trial NO16966 (mCRC) Treatment
Slovenian: Sheme zdravljenja v preskušanju NO16966 (metastatski rak debelega črevesa in danke)
English: In a randomized phase II study (BO20924) a total of 154 patients aged ≥ 6 months to <18 years with newly diagnosed metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma were treated with standard of care (Induction IVADO/IVA+/- local therapy followed by Maintenance Vinorelbine and cyclophosphamide) with or without bevacizumab (2.5 mg/kg/week) for a total duration of treatment of approximately 18 months.
Slovenian: V randomizirani študiji faze II (BO20924) je skupno 154 bolnikov, starih ≥ 6 mesecev do < 18 let, z novo diagnosticiranim metastatskim rabdomiosarkomom in ostalimi mehkotkivnimi sarkomi prejemalo standardno zdravljenje (indukcijo IVADo/IVA z lokalnim zdravljenjem ali brez njega, ki ji je sledilo vzdrževalno zdravljenje z vinorelbinom in ciklofosfamidom) z bevacizumabom ali brez njega (2,5 mg/kg/teden) v približno 18-mesečnem obdobju celotnega zdravljenja.
English: Analyses of the clinical safety data suggest that the occurrence of hypertension and proteinuria with Avastin therapy are likely to be dose-dependent.
Slovenian: Podatki o klinični varnosti zdravila kažejo, da je pojav hipertenzije in proteinurije med zdravljenjem z zdravilom Avastin verjetno odvisen od njegovega odmerka.
English: Hypertensive encephalopathyc
Slovenian: hipertenzivna encefalopatijac
English: Avastin is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Avastin as a single agent until disease progression.
Slovenian: Zdravilo Avastin dodajamo h kemoterapiji, osnovani na platini, do 6 ciklov, nato pa zdravilo Avastin dajemo samostojno do napredovanja bolezni.
English: The safety of reinitiating Avastin therapy in patients previously experiencing PRES is not known.
Slovenian: Varnost ponovne uvedbe zdravljenja z zdravilom Avastin pri bolnikih, pri katerih se je ta sindrom pojavil, ni znana.
English: Bevacizumab has been shown to be embryotoxic and teratogenic when administered to rabbits.
Slovenian: Bevacizumab se je pri kuncih pokazal kot embriotoksičen in teratogen.
English: The haemorrhagic reactions that have been observed in clinical trials were predominantly tumourassociated haemorrhage (see below) and minor mucocutaneous haemorrhage (e.g. epistaxis).
Slovenian: Krvavitve, ki so jih opazili v kliničnih preskušanjih, so bile večinoma krvavitve, povezane s tumorjem (glejte spodaj), in manjše kožne in sluznične krvavitve (na primer epistaksa).
English: (12.0 vs 15.0 months; p = 0.6267)
Slovenian: (12,0 proti 15,0 meseca; p = 0,6267)
English: HR (95% CI) p-value # A total of 154 patients (ECOG Performance Status 0 or 1) were randomized.
Slovenian: Celokupno preživetje* (meseci) mediana razmerje ogroženosti (95-% interval zaupanja) p-vrednost # Skupno je bilo randomiziranih 154 bolnikov (s stanjem zmogljivosti po ECOG 0 ali 1).
English: Reactions were reported at various time points during treatment ranging from one week to greater than 1 year from initiation of Avastin, with most reactions occurring within the first 6 months of therapy.
Slovenian: Med zdravljenjem so o neželenih učinkih poročali v različnih časovnih obdobjih, od enega tedna do več kot 1 leta po začetku zdravljenja z zdravilom Avastin.
English: Serious wound healing complications, including anastomotic complications, with a fatal outcome have been reported.
Slovenian: Poročali so o resnih zapletih pri celjenju ran s smrtnim izidom, vključno z zapleti pri anastomozah.
English: Due date the MAH should discuss any further outcome data on the combination of bevacizumab + erlotinib in this indication (e.g. data from the ongoing ACCRU study, NCT number NCT01532089) (due date: Q2 2019)
Slovenian: podatke iz potekajoče študije ACCRU, številka NCT: NCT01532089) (do: 2. četrtletje 2019)
English: Combination of bevacizumab and sunitinib malate In two clinical trials of metastatic renal cell carcinoma, microangiopathic haemolytic anaemia (MAHA) was reported in 7 of 19 patients treated with bevacizumab (10 mg/kg every two weeks) and sunitinib malate (50 mg daily) combination.
Slovenian: V dveh kliničnih preskušanjih metastatskega karcinoma ledvičnih celic so poročali o mikroangiopatični hemolitični anemiji pri 7 od 19 bolnikov, ki so jih zdravili s kombinacijo bevacizumaba (10 mg/kg na vsaka dva tedna) in sunitinibijevega malata (50 mg na dan).
English: 4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
Slovenian: 4 ml raztopine v viali (steklo tipa I) z zamaškom (butilna guma), ki vsebuje 100 mg bevacizumaba.
English: Number of patients Progression-free survival
Slovenian: Število bolnikov Celokupno preživetje
English: Objective response rate
Slovenian: Delež objektivnih odgovorov
English: Capecitabine 1000 mg/m2 oral bid Placebo or
Slovenian: Kapecitabin 1000 mg/m peroralno dvakrat na dan placebo ali Avastin
English: In clinical trials across indications, the overall incidence of venous thromboembolic reactions ranged from 2.8% to 17.3% of Avastin-treated patients compared with 3.2% to 15.6% in the control arms.
Slovenian: V kliničnih preskušanjih vseh indikacij je celokupna incidenca venskih trombemboličnih neželenih učinkov znašala od 2,8 do 17,3 % pri bolnikih, zdravljenih z zdravilom Avastin, v primerjavi s kontrolnimi skupinami, kjer je znašala od 3,2 do 15,6 %.
English: Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of patients treated with Avastin.
Slovenian: Proteinurijo četrte stopnje (nefrotski sindrom) so opazili pri do 1,4 % bolnikov, zdravljenih z zdravilom Avastin.
English: ● It is possible that Avastin may increase the risk of developing holes in the gut wall.
Slovenian: · možno je, da lahko zdravilo Avastin poveča tveganje za pojav preluknjanja stene črevesja.
English: Fatal outcome was reported in 0.8% of patients receiving Avastin compared to 0.5% in patients receiving chemotherapy alone.
Slovenian: O smrtnem izidu so poročali pri 0,8 % bolnikov, zdravljenih z zdravilom Avastin, v primerjavi z 0,5 % bolnikov, ki so prejemali le kemoterapijo.
English: The GOG-0218 study was a phase III multicentre, randomised, double-blind, placebo-controlled, three arm study evaluating the effect of adding Avastin 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.
Slovenian: GOG-0218 Študija GOG-0218 je bila multicentrična, randomizirana, dvojno slepa, s placebom primerjana študija faze III, ki je vključevala tri skupine, kjer so ocenjevali vpliv dodajanja zdravila Avastin k odobrenemu režimu kemoterapije (karboplatin in paklitaksel) pri bolnicah z napredovalim (stadiji III B, III C in IV po klasifikaciji FIGO, verzija iz leta 1988) epitelijskim rakom jajčnikov, karcinomom jajcevodov in primarnim peritonealnim karcinomom.
English: The results of these analyses were very similar to the primary PFS results.
Slovenian: Rezultati te analize so bili zelo podobni osnovnim rezultatom za preživetje brez napredovanja bolezni.
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), · strdki v zelo majhni krvni žili (ali žilah) v ledvicah,
English: You will be treated with Avastin once every 2 or 3 weeks.
Slovenian: Zdravnik vam bo predpisal ustrezni odmerek zdravila Avastin, ki ga boste prejeli enkrat na 2 ali 3 tedne.
English: The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with Avastin.
Slovenian: Opaženo zvišanje kreatinina v serumu pri bolnikih, zdravljenih z zdravilom Avastin, ni bilo povezano z višjo incidenco kliničnih manifestacij ledvične okvare.
English: Table 25 Efficacy results from study GOG-0240 by Avastin Treatment
Slovenian: Rezultati učinkovitosti v študiji GOG-0240 glede na zdravljenje z zdravilom Avastin
English: The adverse reactions listed in this section fall into the following frequency categories: Very common
Slovenian: V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (³ 1/10),
English: When Avastin is administered in combination with topotecan (given on days 1-5, every 3 weeks), the recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Kadar zdravilo Avastin dajemo v kombinaciji s topotekanom (danim od 1. do 5. dne, vsake 3 tedne), je priporočeni odmerek zdravila Avastin 15 mg/kg telesne mase v enkratnem odmerku na 3 tedne v obliki intravenske infuzije.
English: Patients who have experienced a venous thromboembolic reaction may be at higher risk for a recurrence if they receive Avastin in combination with chemotherapy versus chemotherapy alone.
Slovenian: Pri bolnikih, pri katerih se je pojavil venski trombembolični neželeni učinek, obstaja povečano tveganje za ponovitev, če prejemajo zdravilo Avastin v kombinaciji s kemoterapijo, kot pa če prejemajo le kemoterapijo.
English: In clinical trials with Avastin, congestive heart failure (CHF) was observed in all cancer indications studied to date, but occurred predominantly in patients with metastatic breast cancer.
Slovenian: Kongestivno srčno popuščanje V kliničnih preskušanjih z zdravilom Avastin 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.
English: • Arterial thromboembolism (see section 4.4).
Slovenian: · arterijska trombembolija (glejte poglavje 4.4).
English: % patients with objective response p -value
Slovenian: % bolnikov z objektivnim odgovorom p-vrednost
English: • Redness of the eye, small particles or spots in your vision (floaters), eye pain,
Slovenian: · okužba ali vnetje očesnega zrkla, · pordelost očesa, majhni delci ali madeži v vidnem polju (motnjave), bolečina v očesu,
English: Avastin may impair female fertility.
Slovenian: Zdravilo Avastin lahko oslabi plodnost ženske.
English: 3.7% of the overall randomised patient population had Stage IIIB disease.
Slovenian: 3,7 % celotne populacije randomiziranih bolnic je imelo bolezen stadija III B. 4 Glede na kontrolno skupino.
English: Addition of Avastin to RT/T did not demonstrate clinical benefit in study BO25041 in 60 evaluable children patients with newly diagnosed supratentorial or infratentorial cerebellar or peduncular highgrade glioma (HGG) (See section 4.2 for information on paediatric use).
Slovenian: V študiji BO25041 dodatek zdravila Avastin k radioterapiji in temozolomidu ni pokazal klinične koristi pri 60 ocenjenih otroških bolnikih z novo diagnosticiranim supratentorialnim, infratentorialnim cerebralnim ali pedunkularnim gliomom visoke stopnje (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The only variables that showed statistically significant correlations with bleeding were Avastin therapy and squamous cell histology.
Slovenian: Statistično značilno povezavo s krvavitvijo so našli le pri zdravljenju z zdravilom Avastin in ploščatocelični histologiji.
English: In most clinical trials urine protein levels of ≥ 2g/24 hrs led to the holding of Avastin until recovery to < 2g/24 hrs.
Slovenian: V večini kliničnih preskušanj so koncentracije beljakovin v seču ³ 2 g/24 ur povzročile prekinitev zdravljenja z zdravilom Avastin, dokler ni prišlo do zmanjšanja