FrancophonIA/ELRC3.0 huggingface dataset:
English: One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression.
Slovenian: Skupno 105 bolnikov so randomizirali na prejemanje 5-FU/FA + placebo, 104 bolnike pa na prejemanje 5-FU/FA + bevacizumab (5 mg/kg vsaka 2 tedna).
English: Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under bevacizumab treatment.
Slovenian: Med zdravljenjem z bevacizumabom pri bolnikih lahko obstaja tveganje za pojav venskih trombemboličnih dogodkov, vključno s pljučno embolijo.
English: Paclitaxel 135 mg/m2 intravenous over 24 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m intravenous over 3 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 1 plus bevacizumab 15 mg/kg intravenous on Day 1 (q3w)
Slovenian: • paklitaksel 135 mg/m2 intravensko v 24-urni infuziji na 1. dan in cisplatin 50 mg/m intravensko na 2. dan ter bevacizumab 15 mg/kg intravensko na 2. dan (vsake 3 tedne); ali paklitaksel 175 mg/m2 intravensko v 3-urni infuziji na 1. dan in cisplatin 50 mg/m intravensko na 2. dan ter bevacizumab 15 mg/kg intravensko na 2. dan (vsake 3 tedne); ali paklitaksel 175 mg/m2 intravensko v 3-urni infuziji na 1. dan in cisplatin 50 mg/m intravensko na 1. dan ter bevacizumab 15 mg/kg intravensko na 1. dan (vsake 3 tedne)
English: If you have high blood pressure which is not well controlled with blood pressure medicines, please consult your doctor as it is important to make sure that your blood pressure is under control before starting Zirabev treatment.
Slovenian: Če imate visok krvni tlak, ki ga ne obvladujete v zadostni meri z zdravili proti povišanemu krvnemu tlaku, se posvetujte z zdravnikom.
English: In clinical trials of ovarian cancer, Grade 3-5 wound healing complications were observed in up to 1.8% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3).
Slovenian: V kliničnih preskušanjih pri bolnicah z rakom jajčnikov so zaplete pri celjenju ran stopnje 3-5 opazili pri največ 1,8 % bolnic v skupini, ki je prejemala bevacizumab, v primerjavi z 0,1 % bolnic v kontrolni skupini (NCI-CTCAE v.3).
English: Česká Republika Pfizer, spol.
Slovenian: Česká Republika Pfizer s.r.o.
English: Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
Slovenian: Zdravilo Zirabev je v kombinaciji s paklitakselom indicirano za prvo linijo zdravljenja odraslih bolnikov z metastatskim rakom dojk.
English: Zirabev is also used for the treatment of adult patients with metastatic breast cancer.
Slovenian: Zdravilo Zirabev uporabljamo tudi za zdravljenje odraslih bolnikov z metastatskim rakom dojk.
English: If the first infusion is well tolerated, the second infusion may be administered over 60 minutes.
Slovenian: Če bolnik prvo infuzijo dobro prenese, lahko naslednjo infuzijo dajemo 60 minut.
English: Posterior Reversible Encephalopathy Syndrome (PRES), (rare) (see also section 4.4)
Slovenian: Sindrom posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome) (glejte poglavje 4.8)
English: This was a phase III randomised, double-blind, active-controlled clinical trial evaluating bevacizumab in combination with IFL as first-line treatment for metastatic carcinoma of the colon or rectum.
Slovenian: To je bilo randomizirano, dvojno slepo, z učinkovino nadzorovano klinično preskušanje 3. faze, v katerem so ocenjevali bevacizumab v kombinaciji z IFL kot prvo linijo zdravljenja metastatskega raka debelega črevesa in danke.
English: Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 weeks
Slovenian: Cisplatin in gemcitabin + bevacizumab 15 mg/kg vsake 3 tedne
English: Please discuss this with your doctor if you have metastatic cancer affecting your brain.
Slovenian: Če imate metastatski rak, ki je prizadel vaše možgane, se o tem posvetujte z zdravnikom.
English: A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Zirabev.
Slovenian: Pred začetkom zdravljenja z zdravilom Zirabev je treba razmisliti o pregledu zobovja in ustreznih preventivnih zobozdravstvenih posegih.
English: • blockage in the gut or bowel,
Slovenian: • zamašitev v črevesju ali prebavilih,
English: Proteinuria a,b
Slovenian: Bolezni sečil proteinurija a,b
English: Progression-free survival Median (months)
Slovenian: Preživetje brez napredovanja bolezni mediana (meseci)
English: ● Zirabev can increase the risk of developing a weak heart.
Slovenian: ● Zdravilo Zirabev lahko poveča tveganje za popuščanje srca.
English: • fever,
Slovenian: • vročino,
English: Best overall response - Primary analysis
Slovenian: Najboljši celokupni odziv - primarna analiza bolnice z odzivom na zdravljenje (stopnja odziva
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating bevacizumab 7.5 mg/kg in combination with oral capecitabine and intravenous oxaliplatin (XELOX), administered on a 3- weekly schedule; or bevacizumab 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Slovenian: To je bilo randomizirano, dvojno slepo (za bevacizumab) klinično preskušanje 3. faze, v katerem so proučevali bevacizumab v odmerku 7,5 mg/kg v kombinaciji s peroralno danim kapecitabinom in intravensko danim oksaliplatinom (shema XELOX), kar so bolniki prejemali vsake 3 tedne; oziroma bevacizumab v odmerku 5 mg/kg v kombinaciji z levkovorinom in bolusom 5-fluorouracila, čemur je sledila infuzija 5-fluorouracila z intravensko danim oksaliplatinom (shema FOLFOX-4), kar so bolniki prejemali vsaka 2 tedna.
English: This was a phase II randomised, active-controlled, open-labelled clinical trial investigating bevacizumab in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer.
Slovenian: To je bilo randomizirano, z učinkovino nadzorovano, odprto klinično preskušanje 2. faze , v katerem so proučevali bevacizumab v kombinaciji s shemo 5-FU/FA kot prvo linijo zdravljenja metastatskega raka debelega črevesa in danke.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 venous thromboembolic events have been reported in up to 15.6% of patients treated with bevacizumab in combination with paclitaxel and cisplatin compared with up to 7.0% of patients treated with paclitaxel and cisplatin.
Slovenian: V kliničnem preskušanju pri bolnicah z dolgotrajnim, ponavljajočim se ali metastatskim rakom materničnega vratu (študija GOG-0240) so o venskih trombemboličnih dogodkih stopnje 3-5 poročali pri največ 15,6 % bolnic, ki so se zdravile z bevacizumabom v kombinaciji s paklitakselom in cisplatinom, v primerjavi z največ 7,0 % bolnic, ki so se zdravile s paklitakselom in cisplatinom.
English: In clinical trials, the overall incidence of arterial thromboembolic reactions ranged up to 3.8% in the bevacizumab containing arms compared with up to 2.1% in the chemotherapy control arms.
Slovenian: V kliničnih preskušanjih je bila celokupna pojavnost arterijskih trombemboličnih dogodkov pri bolnikih v skupinah, ki so prejemale bevacizumab, največ 3,8 %, v kontrolnih skupinah, ki so prejemale kemoterapijo, pa največ 2,1 %.
English: Overall survival Median (months) Hazard ratio 95% CI
Slovenian: Celokupno preživetje mediana (meseci) razmerje ogroženosti 95 % IZ
English: • Haemorrhage, including pulmonary haemorrhage/haemoptysis, which is more common in non- small cell lung cancer patients (see section 4.4).
Slovenian: perforacije prebavil (glejte poglavje 4.4), krvavitev, vključno s krvavitvijo v pljučih/hemoptizo, ki je pogostejša pri bolnikih z nedrobnoceličnim rakom pljuč (glejte poglavje 4.4), arterijska trombembolija (glejte poglavje 4.4).
English: You should seek help immediately if you suffer from any of the below mentioned side effects.
Slovenian: Če imate kateregakoli od spodaj navedenih neželenih učinkov, nemudoma poiščite pomoč.
English: Zirabev will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Slovenian: Zdravilo Zirabev boste prejeli v kombinaciji s paklitakselom in cisplatinom ali, če ste bolnica, ki ne more prejemati zdravljenja s platino, s paklitakselom in topotekanom.
English: Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.
Slovenian: Po intravitrealnem injiciranju zaviralcev VEGF so poročali o sistemskih neželenih učinkih, vključno s krvavitvijo izven predela oči in arterijskimi trombemboličnimi dogodki.
English: 7.5 mg/kg intravenous 30-90 min
Slovenian: 7,5 mg/kg i.v.
English: Asthenia, Fatigue,
Slovenian: • utrujenost,
English: Median (months)
Slovenian: Opazovani dogodek (meseci)
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 infections have been reported in up to 24% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 13% of patients treated with paclitaxel and topotecan.
Slovenian: V kliničnem preskušanju pri bolnicah z dolgotrajnim, ponavljajočim se ali metastatskim rakom materničnega vratu (študija GOG-0240) so o okužbah stopnje 3-5 poročali pri največ 24 % bolnic, ki so se zdravile z bevacizumabom v kombinaciji s paklitakselom in topotekanom, v primerjavi z največ 13 % bolnic, ki so se zdravile s paklitakselom in topotekanom.
English: Seventy-one patients were randomised to receive bolus 5-FU/FA or 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks).
Slovenian: Randomizirali so 71 bolnikov, in sicer na prejemanje bolusa 5-FU/FA ali 5-FU/FA + bevacizumab (5 mg/kg vsaka 2 tedna).
English: ● a blood clot in the blood vessels of your lungs,
Slovenian: ● krvni strdek v krvnih žilah pljuč,
English: Caution should be exercised when treating patients with clinically significant cardiovascular disease such as pre-existing coronary artery disease, or congestive heart failure with Zirabev.
Slovenian: Pri bolnikih s klinično pomembno srčno-žilno boleznijo, kot sta obstoječa bolezen koronarnih arterij ali kongestivno srčno popuščanje, je pri zdravljenju z zdravilom Zirabev potrebna previdnost.
English: Eye disorder, Lacrimation increased
Slovenian: Očesne bolezni očesna bolezen, močnejše solzenje
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 bleeding reactions have been reported in up to 8.3% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 4.6% of patients treated with paclitaxel and topotecan.
Slovenian: V kliničnem preskušanju pri bolnicah z dolgotrajnim, ponavljajočim se ali metastatskim rakom materničnega vratu (študija GOG-0240) so o krvavitvah stopnje 3-5 poročali pri največ 8,3 % bolnic, ki so se zdravile z bevacizumabom v kombinaciji s paklitakselom in topotekanom, v primerjavi z največ 4,6 % bolnic, ki so se zdravile s paklitakselom in topotekanom.
English: Paclitaxel/ bevacizumab (n=252)
Slovenian: paklitaksel in bevacizumab (n = 252)
English: Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with bevacizumab.
Slovenian: Pri bolnikih, mlajših od 18 let, ki so se zdravili z bevacizumabom, so poročali o propadanju kostnega tkiva (osteonekrozi) v kosteh, razen v čeljustnici.
English: Zirabev is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Slovenian: Zdravilo Zirabev uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim rakom pljuč.
English: Patients may be at increased risk for the development of fistulae when treated with bevacizumab.
Slovenian: Pri bolnikih, ki se zdravijo z bevacizumabom, lahko obstaja povečano tveganje za nastanek fistule.
English: The recommended dose of Zirabev is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila Zirabev je 7,5 mg/kg ali 15 mg/kg telesne mase v enkratnem odmerku vsake 3 tedne v obliki intravenske infuzije.
English: The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab treated patients in the FOLFOX treatment subgroup, HR=0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Slovenian: Mediano celokupno preživetje je bilo v podskupini, ki se je zdravila po shemi FOLFOX, 20,3 meseca pri bolnikih, ki so prejemali placebo, in 21,2 meseca pri bolnikih, ki so se zdravili z bevacizumabom; HR = 0,94; 97,5 % IZ = [0,75; 1,16]; p-vrednost = 0,4937.
English: If a dose of Zirabev is missed
Slovenian: Če ste izpustili odmerek zdravila Zirabev:
English: 5-fluorouracil intravenous bolus/infusion, each on days 1 and 2
Slovenian: bolus/infuzija, oboje 1. in 2. dan placebo ali bevacizumab
English: Therapy should be permanently discontinued in patients who develop nephrotic syndrome (NCI-CTCAE v.3).
Slovenian: Pri bolnikih, pri katerih se pojavi nefrotski sindrom (NCI-CTCAE v.3), je treba zdravljenje trajno prekiniti.
English: 4.5 Interaction with other medicinal products and other forms of interaction Effect of antineoplastic agents on bevacizumab pharmacokinetics
Slovenian: Vpliv zdravil z delovanjem na novotvorbe na farmakokinetiko bevacizumaba
English: 130 mg/m2 intravenous 2 h
Slovenian: 130 mg/m2 i.v.
English: In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026.
Slovenian: V podskupini, ki se je zdravila po shemi FOLFOX, je bilo mediano PFS 8,6 meseca pri bolnikih, ki so prejemali placebo, in 9,4 meseca pri bolnikih, ki so se zdravili z bevacizumabom; razmerje ogroženosti (HR - hazard ratio) = 0,89; 97,5 % IZ = [0,73; 1,08]; p-vrednost = 0,1871.
English: Age was not associated with the pharmacokinetics of bevacizumab when body weight was taken into account.
Slovenian: Starost ob upoštevanju telesne mase ni bila povezana s farmakokinetiko bevacizumaba.
English: Other special populations Elderly patients
Slovenian: Starejši bolniki
English: In one clinical trial evaluating bevacizumab in combination with 5-fluorouracil/folinic acid, AVF2192g, patients with metastatic colorectal cancer who were not candidates for treatment with irinotecan were included.
Slovenian: Bolnike z metastatskim rakom debelega črevesa in danke, ki niso bili primerni za zdravljenje z irinotekanom, so vključili v klinično preskušanje AVF2192g, v katerem so ocenjevali bevacizumab v kombinaciji s 5-fluorouracilom in folinsko kislino.
English: Paclitaxel/ bevacizumab (n=229)
Slovenian: paklitaksel in bevacizumab (n = 229)
English: First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy Zirabev is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Zirabev as a single agent until disease progression.
Slovenian: Zdravilo Zirabev uporabljamo kot dodatek kemoterapiji na osnovi platine v obdobju največ 6 ciklov zdravljenja, nato pa zdravilo Zirabev uporabljamo samostojno do napredovanja bolezni.
English: 200 mg/m2 intravenous 2 h
Slovenian: 2 uri 200 mg/m 2 i.v.
English: Paclitaxel 135 mg/m intravenous over 24 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 2, every 3 weeks (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 (q3w); or
Slovenian: • paklitaksel 135 mg/m 2 intravensko v 24-urni infuziji na 1. dan in cisplatin 50 mg/m intravensko na 2. dan (vsake 3 tedne); ali paklitaksel 175 mg/m 2 intravensko v 3-urni infuziji na 1. dan in cisplatin 50 mg/m intravensko na 2. dan (vsake 3 tedne); ali paklitaksel 175 mg/m 2 intravensko v 3-urni infuziji na 1. dan in cisplatin 50 mg/m intravensko na 1. dan (vsake 3 tedne)
English: Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora perforacija nosnega pretina (neznana) pljučna hipertenzija (neznana) disfonija (pogosto)
English: Zirabev should be discontinued permanently in patients who experience Grade 3 or 4 bleeding during Zirabev therapy (NCI-CTCAE v.3) (see section 4.8).
Slovenian: Pri bolnikih, pri katerih se med zdravljenjem z zdravilom Zirabev pojavi krvavitev stopnje 3 ali 4 (NCI-CTCAE v.3), je treba zdravljenje z zdravilom Zirabev trajno prekiniti (glejte poglavje 4.8).
English: The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila Zirabev je 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna ali 15 mg/kg telesne mase v enkratnem odmerku vsake 3 tedne v obliki intravenske infuzije.
English: Drugsales Ltd Tel: +356 21 419 070/1/2
Slovenian: Vivian Corporation Ltd. Tel: +35621 344610
English: Metastatic carcinoma of the colon or rectum (mCRC)
Slovenian: Metastatski karcinom debelega črevesa in danke (mCRC)
English: Addition of bevacizumab to standard of care did not demonstrate clinical benefit in clinical trial BO20924, in 71 evaluable children (from age 6 months to less than 18 years old) patients with metastatic Rhabdomyosarcoma and non-Rhabdomyosarcoma Soft Tissue Sarcoma.
Slovenian: V kliničnem preskušanju BO20924 pri 71 otrocih (starih od 6 mesecev do manj kot 18 let) z metastatskim rabdomiosarkomom in drugimi vrstami sarkoma mehkega tkiva, ki jih je bilo mogoče oceniti, dodajanje bevacizumaba standardni oskrbi ni pokazalo klinične koristi.
English: Zirabev 25 mg/ml concentrate for solution for infusion bevacizumab
Slovenian: Zirabev 25 mg/ml koncentrat za raztopino za infundiranje bevacizumab
English: A reduction of circulating VEGF concentration has been demonstrated following intravitreal anti-VEGF therapy.
Slovenian: Dokazali so, da se po intravitrealnem zdravljenju z zaviralci vaskularnega endotelijskega rastnega faktorja (VEGF - vascular endothelial growth factor) zmanjša koncentracija VEGF v krvnem obtoku.
English: • a hole in the stomach or intestines,
Slovenian: • predrtje želodca ali črevesja,
English: Suomi/Finland Pfizer PFE Finland Oy Puh/Tel: +358 (0)9 430 040
Slovenian: Puh/Tel: +358 (0)9 430 040
English: Gall bladder perforation (not known)
Slovenian: Bolezni prebavil razjeda v prebavilih (neznana)
English: Paclitaxel (n=354)
Slovenian: Celokupno preživetje paklitaksel (n = 354)
English: Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with bevacizumab.
Slovenian: Pri bolnikih s hipertenzijo v anamnezi, ki se zdravijo z bevacizumabom, lahko obstaja povečano tveganje za pojav proteinurije.
English: België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: +32 (0)2 554 62 11
Slovenian: België/Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A. / N.V.
English: Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy.
Slovenian: Pred začetkom zdravljenja in med zdravljenjem je priporočljivo spremljanje proteinurije z urinskimi testnimi lističi.
English: For intravenous use after dilution Read the package leaflet before use
Slovenian: Pred uporabo preberite priloženo navodilo!
English: The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila Zirabev je 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna v obliki intravenske infuzije.
English: Zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
Slovenian: Bevacizumab je indiciran za zdravljenje odraslih bolnic z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska, v kombinaciji s paklitakselom in cisplatinom ali, alternativno, s paklitakselom in topotekanom pri bolnicah, ki ne morejo dobivati zdravljenja s platino (glejte poglavje 5.1).
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-240), 1.8% of bevacizumab-treated patients and 1.4% of control patients were reported to have had nongastrointestinal vaginal, vesical, or female genital tract fistulae.
Slovenian: V kliničnem preskušanju pri bolnicah z dolgotrajnim, ponavljajočim se ali metastatskim rakom materničnega vratu (GOG-240) so poročali, da je imelo fistule med nožnico, mehurjem ali spolovili in organi izven prebavil 1,8 % bolnic, ki so se zdravile z bevacizumabom, in 1,4 % bolnic iz kontrolne skupine.
English: Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and topotecan 0.75 mg/m2
Slovenian: paklitaksel 175 mg/m2 intravensko v 3-urni infuziji na 1. dan in topotekan 0,75 mg/m intravensko v 30-minutni infuziji na 1.-3. dan (vsake 3 tedne)
English: • Superiority of the bevacizumab-containing arms versus the chemotherapy alone arms in the overall comparison was demonstrated in terms of progression-free survival in the ITT population (Table 7).
Slovenian: ● V populaciji bolnikov, ki so jo nameravali zdraviti (Intent-To-Treat [ITT] population), so v celokupni primerjavi dokazali, da so bile skupine, ki so prejemale bevacizumab, superiorne skupinam, ki so prejemale samo kemoterapijo, v smislu preživetja brez napredovanja bolezni (preglednica 7).
English: Infection, Urinary tract infection
Slovenian: , okužba, okužba sečil nekrotizirajoči fasciitis
English: • spontaneous reporting,
Slovenian: • srčno popuščanje,
English: ● If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: ● Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: How to store Zirabev
Slovenian: Shranjevanje zdravila Zirabev
English: Prior radiation is a major risk factor for the development of GI-vaginal fistulae and all patients with GI- vaginal fistulae had a history of prior radiation.
Slovenian: Predhodno obsevanje je pomemben dejavnik tveganja za nastanek fistule med prebavili in nožnico; vse bolnice s fistulo med prebavili in nožnico so se predhodno zdravile z obsevanjem.
English: Each vial contains 400 mg bevacizumab.
Slovenian: Ena viala vsebuje 400 mg bevacizumaba.
English: This was a randomised, double-blind, phase II clinical trial investigating bevacizumab 10 mg/kg in a 2 weekly schedule with the same dose of bevacizumab in combination with 150 mg daily erlotinib, in patients with metastatic clear cell RCC. A total of 104 patients were randomised to treatment in this trial, 53 to bevacizumab 10 mg/kg every 2 weeks plus placebo and 51 to bevacizumab 10 mg/kg every 2 weeks plus erlotinib 150 mg daily.
Slovenian: To je bilo randomizirano, dvojno slepo klinično preskušanje 2. faze, v katerem so proučevali bevacizumab v odmerku 10 mg/kg vsaka 2 tedna v primerjavi z enakim odmerkom bevacizumaba v kombinaciji s 150 mg erlotiniba na dan pri bolnikih z metastatskim svetloceličnim RCC.