natgillin/translations-raw huggingface dataset:
Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.
Po intravitrealnem injiciranju zaviralcev VEGF so poročali o sistemskih neželenih učinkih, vključno s krvavitvijo izven predela oči in arterijskimi trombemboličnimi dogodki.
Asthenia, Fatigue,
• utrujenost,
Median (months)
Opazovani dogodek (meseci)
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.
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.
Seventy-one patients were randomised to receive bolus 5-FU/FA or 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks).
Randomizirali so 71 bolnikov, in sicer na prejemanje bolusa 5-FU/FA ali 5-FU/FA + bevacizumab (5 mg/kg vsaka 2 tedna).
● a blood clot in the blood vessels of your lungs,
● krvni strdek v krvnih žilah pljuč,
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.
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.
Eye disorder, Lacrimation increased
Očesne bolezni očesna bolezen, močnejše solzenje
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.
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.
Paclitaxel/ bevacizumab (n=252)
paklitaksel in bevacizumab (n = 252)
Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with bevacizumab.
Pri bolnikih, mlajših od 18 let, ki so se zdravili z bevacizumabom, so poročali o propadanju kostnega tkiva (osteonekrozi) v kosteh, razen v čeljustnici.
Zirabev is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Zdravilo Zirabev uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim rakom pljuč.
Patients may be at increased risk for the development of fistulae when treated with bevacizumab.
Pri bolnikih, ki se zdravijo z bevacizumabom, lahko obstaja povečano tveganje za nastanek fistule.
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.
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.
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.
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.
If a dose of Zirabev is missed
Če ste izpustili odmerek zdravila Zirabev:
5-fluorouracil intravenous bolus/infusion, each on days 1 and 2
bolus/infuzija, oboje 1. in 2. dan placebo ali bevacizumab
Therapy should be permanently discontinued in patients who develop nephrotic syndrome (NCI-CTCAE v.3).
Pri bolnikih, pri katerih se pojavi nefrotski sindrom (NCI-CTCAE v.3), je treba zdravljenje trajno prekiniti.
4.5 Interaction with other medicinal products and other forms of interaction Effect of antineoplastic agents on bevacizumab pharmacokinetics
Vpliv zdravil z delovanjem na novotvorbe na farmakokinetiko bevacizumaba
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.
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.
Age was not associated with the pharmacokinetics of bevacizumab when body weight was taken into account.
Starost ob upoštevanju telesne mase ni bila povezana s farmakokinetiko bevacizumaba.
Other special populations Elderly patients
Starejši bolniki
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.
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.
Paclitaxel/ bevacizumab (n=229)
paklitaksel in bevacizumab (n = 229)
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.
Zdravilo Zirabev uporabljamo kot dodatek kemoterapiji na osnovi platine v obdobju največ 6 ciklov zdravljenja, nato pa zdravilo Zirabev uporabljamo samostojno do napredovanja bolezni.
200 mg/m2 intravenous 2 h
2 uri 200 mg/m 2 i.v.
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
• 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)
Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Bolezni dihal, prsnega koša in mediastinalnega prostora perforacija nosnega pretina (neznana) pljučna hipertenzija (neznana) disfonija (pogosto)
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).
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).
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.
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.
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Vivian Corporation Ltd. Tel: +35621 344610
Metastatic carcinoma of the colon or rectum (mCRC)
Metastatski karcinom debelega črevesa in danke (mCRC)
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.
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.
Zirabev 25 mg/ml concentrate for solution for infusion bevacizumab
Zirabev 25 mg/ml koncentrat za raztopino za infundiranje bevacizumab
A reduction of circulating VEGF concentration has been demonstrated following intravitreal anti-VEGF therapy.
Dokazali so, da se po intravitrealnem zdravljenju z zaviralci vaskularnega endotelijskega rastnega faktorja (VEGF - vascular endothelial growth factor) zmanjša koncentracija VEGF v krvnem obtoku.
• a hole in the stomach or intestines,
• predrtje želodca ali črevesja,
Suomi/Finland Pfizer PFE Finland Oy Puh/Tel: +358 (0)9 430 040
Puh/Tel: +358 (0)9 430 040
Gall bladder perforation (not known)
Bolezni prebavil razjeda v prebavilih (neznana)
Paclitaxel (n=354)
Celokupno preživetje paklitaksel (n = 354)
Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with bevacizumab.
Pri bolnikih s hipertenzijo v anamnezi, ki se zdravijo z bevacizumabom, lahko obstaja povečano tveganje za pojav proteinurije.
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: +32 (0)2 554 62 11
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A. / N.V.
Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy.
Pred začetkom zdravljenja in med zdravljenjem je priporočljivo spremljanje proteinurije z urinskimi testnimi lističi.
For intravenous use after dilution Read the package leaflet before use
Pred uporabo preberite priloženo navodilo!
The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Priporočeni odmerek zdravila Zirabev je 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna v obliki intravenske infuzije.
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).
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).
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.
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.
Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and topotecan 0.75 mg/m2
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)
• 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).
● 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).
Infection, Urinary tract infection
, okužba, okužba sečil nekrotizirajoči fasciitis
• spontaneous reporting,
• srčno popuščanje,
● If you get any side effects, talk to your doctor, pharmacist or nurse.
● Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
How to store Zirabev
Shranjevanje zdravila Zirabev
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.
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.
Each vial contains 400 mg bevacizumab.
Ena viala vsebuje 400 mg bevacizumaba.
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.
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.
• comparative incidences noted between clinical trial treatment arms (with at least a 10% difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2% difference compared to the control arm for NCI-CTCAE Grade 3-5 reactions,
V preglednici 1 so po pogostnosti razvrščeni vsi neželeni učinki, za katere so ugotovili, da imajo vzročno povezavo z bevacizumabom: zaradi primerljive pojavnosti, ki so jo opazili med zdravljenimi skupinami v kliničnih preskušanjih (z najmanj 10 % razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 1-5 po NCI-CTCAE ali najmanj 2 % razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 3-5 po NCI-CTCAE); v študijah o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom; pri spontanem poročanju; v epidemioloških študijah/neintervencijskih ali opazovalnih študijah ali s presojo posameznih kliničnih primerov.
Laboratórios Pfizer, Lda.
Pfizer Biofarmacêutica, Sociedade Unipessoal Lda
The administration of Zirabev should be permanently discontinued if you develop
Dajanje zdravila Zirabev je treba trajno prekiniti, če se vam pojavi karkoli od naslednjega:
Zirabev is also used for treatment of adult patients with advanced kidney cancer.
Zdravilo Zirabev uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim rakom ledvic.
Hazard ratio b
razmerje ogroženosti p-vrednost
Leucovorin on day 1 and 2
22 ur oksaliplatin 1. dan levkovorin 1. in 2. dan 5-fluorouracil i.v.
The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Zirabev fails to stop your tumour growing.
Z zdravljenjem morate nadaljevati, dokler zdravilo Zirabev ne bo več uspešno zaustavljalo rasti tumorja.
Pfizer Italia Srl Tel: +39 06 33 18 21
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You may be advised to have a dental check-up before you start treatment with Zirabev.
Pred začetkom zdravljenja z zdravilom Zirabev boste morda morali opraviti pregled zob.
An increased incidence of hypertension was observed in bevacizumab-treated patients.
Pri bolnikih, ki so se zdravili z bevacizumabom, so opazili povečano incidenco hipertenzije.
Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Presnovne in prehranske motnje dehidracija, hiponatriemija
No significant difference was observed in the duration of overall survival between patients who received bevacizumab monotherapy compared to patients treated with FOLFOX-4.
Med bolniki, ki so prejemali bevacizumab v monoterapiji, in bolniki, ki so se zdravili po shemi FOLFOX-4, niso opazili pomembne razlike v trajanju celokupnega preživetja.
The recommended dose of Zirabev is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Priporočeni odmerek zdravila Zirabev je 15 mg/kg telesne mase v enkratnem odmerku vsake 3 tedne v obliki intravenske infuzije.
Pain, Lethargy, Mucosal inflammation
bolečina, letargija, vnetje sluznic
Asthenia, Fatigue, Pyrexia, Pain, Mucosal inflammation
Splošne težave in spremembe na mestu aplikacije astenija, utrujenost, pireksija, bolečina, vnetje sluznic letargija
The 131 patients in the bevacizumab + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the trial, exhibited at 6, 12 and 18 months PFS event free rates of 73, 52 and 21% respectively, as compared to 61, 43 and 17% in the total population of patients receiving bevacizumab + IFN alfa-2a.
Pri 131 bolnikih iz skupine, ki je prejemala bevacizumab + IFN alfa2a, pri katerih so med preskušanjem zmanjšali in vzdrževali odmerek IFN alfa-2a pri 6 ali 3 mio i.e.,
Zirabev is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Zdravilo Zirabev uporabljamo za zdravljenje odraslih bolnikov z napredovalim rakom debelega črevesa in danke.
Overall survival - follow-up analysis2 Hazard ratio (95% CI)
Celokupno preživetje - nadaljnja analiza razmerje ogroženosti (95 % IZ)
Therapy should be permanently discontinued in patients who develop arterial thromboembolic reactions.
Pri bolnikih, pri katerih se pojavijo arterijski trombembolični dogodki, je treba zdravljenje trajno prekiniti.
Each vial contains 100 mg bevacizumab.
Ena viala vsebuje 100 mg bevacizumaba.
• diarrhoea,
• drisko,
400 mg/m2 intravenous bolus,
bolus, 600 mg/m 2 i.v.
Intestinal perforation, Ileus , Intes tinal obstruction, Recto-vaginal fistulae c,d
Bolezni prebavil diareja, navzea, bruhanje, bolečina v trebuhu perforacija črevesa, ileus, obstrukcija črevesa, rektovaginalne fistule c,d bolezen prebavil, stomatitis, proktalgija perforacija prebavil a,b
Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with bevacizumab.
Pri bolnikih, ki se zdravijo z bevacizumabom, lahko obstaja povečano tveganje za nastanek perforacije prebavil in žolčnika.
Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
Pri bolnikih, pri katerih se pojavi perforacija prebavil, je treba zdravljenje trajno prekiniti.
Sodium hydroxide (for pH adjustment) Water for injections
6.1 Seznam pomožnih snovi saharoza jantarna kislina dinatrijev edetat polisorbat 80 natrijev hidroksid (za uravnavanje pH) voda za injekcije
The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
Tipična vrednost za volumen perifernega prostora (Vp), če so bevacizumab dajali sočasno z drugimi antineoplastičnimi zdravili, je pri bolnicah znašala 1,69 l, pri bolnikih pa 2,35 l. Po prilagoditvi glede na telesno maso so imeli bolniki večji volumen centralnega prostora Vc (+ 20 %) kot bolnice.
Number of patients Overall survival Median (months) 95% CI
Število bolnikov Celokupno preživetje mediana (meseci) 95 % IZ razmerje ogroženosti
5 mg/kg intravenous 30-90 min
30-90 min
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Zirabev:
Pred začetkom uporabe zdravila Zirabev se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
were reported in up to 2.7% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
O cerebrovaskularnih insultih (vključno s prehodnimi možganskimi ishemijami) so poročali pri največ 2,7 % bolnikov, ki so se zdravili z bevacizumabom v kombinaciji s kemoterapijo, v primerjavi z največ 0,5 % bolnikov, ki so se zdravili samo s kemoterapijo.
EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens
Kombinacija bevacizumaba in sunitinibijevega malata
Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of bevacizumab compounded from vials approved for intravenous administration in cancer patients.
Po neodobreni intravitrealni uporabi bevacizumaba iz vial, odobrenih za intravensko uporabo pri bolnikih z rakom, so poročali o posameznih primerih in skupini resnih neželenih učinkov na oči.
Do not use Zirabev
Ne uporabljajte zdravila Zirabev:
Congestive heart failure a,b
Srčne bolezni kongestivno srčno popuščanje a,b supraventrikularna tahikardija
Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed in patients treated with some myelotoxic chemotherapy regimens plus bevacizumab in comparison to chemotherapy alone.
Pri bolnikih, ki so se zdravili z nekaterimi mielotoksičnimi kemoterapevtskimi shemami in bevacizumabom, so v primerjavi s samo kemoterapijo opazili povečano pogostnost hude nevtropenije, febrilne nevtropenije ali okužbe s hudo nevtropenijo ali brez nje (vključno z nekaj smrtnimi primeri).
Gallbladder perforation b,c
Bolezni jeter, žolčnika in žolčevodov perforacija žolčnika b,c
NAME OF THE MEDICINAL PRODUCT Zirabev 25 mg/ml concentrate for solution for infusion.
Zirabev 25 mg/ml koncentrat za raztopino za infundiranje
Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Naus ea, Vomiting, Abdominal pain
Bolezni prebavil rektalna krvavitev, stomatitis, zaprtje, diareja, navzea, bruhanje, bolečina v trebuhu perforacija prebavil b,d perforacija črevesa, ileus, obstrukcija črevesa, rektovaginalne fistule d,e
Overall survival - Primary analysis6 Median (months)
Celokupno preživetje - primarna analiza mediana (meseci) razmerje ogroženosti [95 % IZ]
b Relative to control arm.
Glede na kontrolno skupino.
Pulmonary haemorrhage/ Haemoptysis b,d
Bolezni kože in podkožja zapleti pri celjenju ran b,d
Congestive heart failure b,d
Srčne bolezni kongestivno srčno popuščanje b,d supraventrikularna tahikardija
Non-GI fistulae (see section 4.4)
Fistule izven prebavil (glejte poglavje 4.4)
PC in combination with bevacizumab at a dose of 15 mg/kg intravenous infusion day 1 of every 3-week cycle.
infuzije (PK) na 1. dan vsakega 3-tedenskega cikla, skupaj največ 6 ciklov, ali PK v kombinaciji z bevacizumabom v odmerku 15 mg/kg v obliki i.v.
Myalgia, Arthralgia, Muscular weaknes s, Back pain
disartrija, glavobol, disgevzija cerebrovaskularni zaplet, sinkopa, somnolenca sindrom posteriorne reverzibilne encefalopatije a,b,d hipertenzivna encefalopatija
Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
2 uri 1.000 mg/m2 peroralno dvakrat na dan oksaliplatin 1. dan kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1tedenski premor brez zdravljenja)
● a hole in your gut wall,
• predrtje črevesne stene,
This was a phase III randomised, active-controlled, open-label trial investigating bevacizumab 10 mg/kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second line) with advanced colorectal cancer.
To je bilo randomizirano, z učinkovino nadzorovano, odprto preskušanje 3. faze, v katerem so proučevali bevacizumab v odmerku 10 mg/kg v kombinaciji z levkovorinom in bolusom 5fluorouracila, čemur je sledila infuzija 5-fluorouracila z i.v.
Gallbladder perforation a,b
Bolezni jeter, žolčnika in žolčevodov perforacija žolčnika a,b