natgillin/translations-raw huggingface dataset:
Caution should be taken when treating these patients with Zirabev.
Pri zdravljenju teh bolnikov z zdravilom Zirabev je zato potrebna previdnost.
• ML18147: Bevacizumab 5.0 mg/kg of body weight every 2 weeks or bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin in patients with disease progression following first-line treatment with bevacizumab.
ML18147: bevacizumab 5,0 mg/kg telesne mase vsaka 2 tedna ali bevacizumab 7,5 mg/kg telesne mase vsake 3 tedne v kombinaciji s fluoropirimidinom in irinotekanom ali fluoropirimidinom in oksaliplatinom pri bolnikih, pri katerih je bolezen napredovala po prvi liniji zdravljenja z bevacizumabom.
These results suggest that close clinical observation with appropriate cardiac assessments should be considered for patients exposed to cumulative doxorubicin doses greater than 300 mg/m2 when combined with bevacizumab.
Ti rezultati kažejo, da je treba bolnike, ki prejemajo kumulativne odmerke doksorubicina, večje od 300 mg/m2, v kombinaciji z bevacizumabom, skrbno klinično opazovati in ustrezno oceniti njihovo srčno funkcijo.
Enrolment in Arm 3 was discontinued, as pre-specified, once safety of bevacizumab with the IFL regimen was established and considered acceptable.
Ko so dokazali varnost bevacizumaba skupaj s shemo IFL in jo ocenili kot sprejemljivo, so vključevanje v skupino 3 prekinili, kot so predhodno predvideli.
In locally recurrent and metastatic breast cancer trials, Grade 3-5 wound healing complications were observed in up to 1.1% of patients receiving bevacizumab compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
V preskušanjih pri bolnikih z lokalno ponavljajočim se in metastatskim rakom dojk so zaplete pri celjenju ran stopnje 3-5 opazili pri največ 1,1 % bolnikov, ki so prejemali bevacizumab, v primerjavi z največ 0,9 % bolnikov v kontrolnih skupinah (NCI-CTCAE v.3).
Exfoliative dermatitis, Dry skin, Skin discoloration
, eksfoliativni dermatitis, suha koža, obarvanje kože sindrom palmarnoplantarne eritrodisestezije
In some clinical trials anaphylactic and anaphylactoid-type reactions were reported more frequently in patients receiving bevacizumab in combination with chemotherapy than with chemotherapy alone.
V nekaterih kliničnih preskušanjih so o anafilaktičnih reakcijah in reakcijah anafilaktoidne vrste pogosteje poročali pri bolnikih, ki so prejemali bevacizumab v kombinaciji s kemoterapijo, kot pri tistih, ki so prejemali samo kemoterapijo.
Placebo + IFNa
placebo + IFN
(11.9 vs.14.3 months; p = 0.4825)
(11,9 meseca v primerjavi s 14,3 meseca; p = 0,4825)
• E3200: Bevacizumab 10 mg/kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4) in bevacizumab-naïve patients.
E3200: bevacizumab 10 mg/kg telesne mase vsaka 2 tedna v kombinaciji z levkovorinom in bolusom 5-fluorouracila, čemur je sledila infuzija 5-fluorouracila z intravensko danim oksaliplatinom (shema FOLFOX-4), pri bolnikih, ki se še niso zdravili z bevacizumabom.
(14.9 vs. 11.9 months; p = 0.1061)
(14,9 meseca v primerjavi z 11,9 meseca; p = 0,1061)
Cisplatin/Gemcitabine + bevacizumab 7.5 mg/kg q 3 weeks
Cisplatin in gemcitabin + bevacizumab 7,5 mg/kg vsake 3 tedne
(17.5 vs.15.0 months; p = 0.0584)
(17,5 meseca v primerjavi s 15,0 meseca; p = 0,0584)
The difference in ORR per independent central review was 18% (CI: 0.6%, 35.3%) between the two treatment arms in the few patients who had evaluable tumor at baseline and had a confirmed response prior to receiving any local therapy: 27/75 patients (36.0%, 95% CI: 25.2%, 47.9%) in the Chemo arm and 34/63 patients (54.0%, 95% CI: 40.9%, 66.6%) in the Bv +Chemo arm.
(IZ: 0,6 %; 35,3 %), in sicer pri maloštevilnih bolnikih, ki so imeli ob izhodišču tumor, ki ga je bilo mogoče oceniti, in potrjen odziv pred prejemom kakršnegakoli lokalnega zdravljenja: 27/75 bolnikov (36,0 %; 95 % IZ: 25,2 %; 47,9 %) v skupini, ki je prejemala kemoterapijo, in 34/63 bolnikov (54,0 %; 95 % IZ: 40,9 %; 66,6 %) v skupini, ki je prejemala bevacizumab + kemoterapijo.
Each ml of concentrate contains 25 mg of bevacizumab.
En ml koncentrata vsebuje 25 mg bevacizumaba.
Zirabev may impair female fertility.
Zdravilo Zirabev lahko zmanjša plodnost ženske.
55% bevacizumab/IFN) received a variety of non-specified post-trial anti-cancer therapies, including antineoplastic agents, which may have impacted the analysis of overall survival.
Velik delež bolnikov (približno 63 % IFN in placebo; 55 % bevacizumab in IFN) je po zaključku preskušanja prejemal različna neopredeljena zdravila za zdravljenje novotvorb, vključno z antineoplastičnimi zdravili, kar je lahko vplivalo na analizo celokupnega preživetja.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
CHF Grade 3 or higher reactions were somewhat more frequent among patients receiving bevacizumab in combination with chemotherapy than in patients receiving chemotherapy alone.
Neželeni učinki, povezani s KSP 3. ali višje stopnje, so bili nekoliko pogostejši pri bolnikih, ki so prejemali bevacizumab v kombinaciji s kemoterapijo, v primerjavi s tistimi, ki so prejemali samo kemoterapijo.
The recommended dose of Zirabev, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
Priporočeni odmerek zdravila Zirabev, ki ga dajemo v obliki intravenske infuzije, je 5 mg/kg ali 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna ali 7,5 mg/kg ali 15 mg/kg telesne mase v enkratnem odmerku vsake 3 tedne.
There was a small difference, of borderline significance, between the time to progression of disease in the 3 mg/kg group and that in the placebo group (hazard ratio, 1.26; p=0.053).
Med skupino, ki je prejemala bevacizumab v odmerku 3 mg/kg, in skupino, ki je prejemala placebo, je obstajala majhna, mejna statistično pomembna razlika v času do napredovanja bolezni (razmerje ogroženosti 1,26; p = 0,053).
Anorexia, Hypomagnesaemia, Hyponatraemia
Presnovne in prehranske motnje anoreksija, hipomagneziemija, hiponatriemija dehidracija
• inflammation of the moist lining of mouth and gut, lungs and air passages, reproductive,
• vnetje vlažne sluznice ust in črevesja, pljuč in dihalnih poti, spolovil in sečil,
Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with bevacizumab.
Pri bolnikih, ki so se zdravili z bevacizumabom, so redko poročali o nekrotizirajočem fasciitisu, vključno s smrtnimi primeri.
Do not use Zirabev if you notice any particulate matter or discolouration prior to administration.
Zdravila Zirabev ne uporabite, če pred dajanjem opazite prisotnost kakršnihkoli trdnih delcev ali obarvanje.
Table 10 Trial E2100 efficacy results Progression-free survival
Preglednica 10 Rezultati učinkovitosti v preskušanju E2100
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), GI perforations (all grade) were reported in 3.2% of patients, all of whom had a history of prior pelvic radiation.
V kliničnem preskušanju pri bolnicah z dolgotrajnim, ponavljajočim se ali metastatskim rakom materničnega vratu (študija GOG-0240) so poročali o perforacijah prebavil (vseh stopenj) pri 3,2 % bolnic; vse te bolnice so imele v anamnezi obsevanje medeničnega predela.
Patients treated for persistent, recurrent, or metastatic cervical cancer with bevacizumab are at increased risk of fistulae between the vagina and any part of the GI tract (Gastrointestinal-vaginal fistulae).
Pri bolnicah z dolgotrajnim, ponavljajočim se ali metastatskim rakom materničnega vratu, ki se zdravijo z bevacizumabom, obstaja povečano tveganje za nastanek fistule med nožnico in katerimkoli delom prebavil (fistule med prebavili in nožnico).
(14.9 vs. 17.5 months; p = 0.4146)
(14,9 meseca v primerjavi s 17,5 meseca; p = 0,4146)
In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Zirabev.
Če se pri bolnikih pojavi PRES, je poleg prekinitve zdravljenja z zdravilom Zirabev priporočljivo zdravljenje specifičnih simptomov, vključno z obvladovanjem hipertenzije.
• NO16966: Bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or bevacizumab 5 mg/kg every 2 weeks in combination with leucovorin plus 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
NO16966: bevacizumab 7,5 mg/kg telesne mase vsake 3 tedne v kombinaciji s kapecitabinom peroralno in oksaliplatinom intravensko (shema XELOX) ali bevacizumab 5 mg/kg telesne mase vsaka 2 tedna v kombinaciji z levkovorinom in bolusom 5-fluorouracila, čemur je sledila infuzija 5-fluorouracila z intravensko danim oksaliplatinom (shema FOLFOX-4).
Aneurysms and artery dissections, Renal thrombotic microangiopathy a,b
, globoka venska tromboza anevrizme in disekcije arterij, renalna trombotična mikroangiopatija a,b
Hypersensitivity, Infusion reactions a,b,c
Bolezni imunskega sistema preobčutljivost, reakcije na infuzijo a,b,c
Hypersensitivity, Infusion reactions a,b,d
Bolezni imunskega sistema preobčutljivost, reakcije na infuzijo a,b,d
Number of patients Progression-free survival
Preživetje brez napredovanja bolezni
In a trial of patients with persistent, recurrent or metastatic cervical cancer, the incidence of GI-vaginal fistulae was 8.3% in bevacizumab-treated patients and 0.9% in control patients, all of whom had a history of prior pelvic radiation.
V preskušanju pri bolnicah z dolgotrajnim, ponavljajočim se ali metastatskim rakom materničnega vratu je bila pojavnost fistul med prebavili in nožnico 8,3 % pri bolnicah, ki so se zdravile z bevacizumabom, in 0,9 % pri bolnicah v kontrolni skupini; vse te bolnice so imele v anamnezi obsevanje medeničnega predela.
The primary endpoint was overall survival, with secondary endpoints for the trial including progression-free survival.
Primarni opazovani dogodek je bilo celokupno preživetje, sekundarni opazovani dogodki preskušanja pa so vključevali tudi preživetje brez napredovanja bolezni.
B-cell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
V kliničnem preskušanju pri bolnikih z difuznim velikoceličnim B-limfomom, ki so prejemali bevacizumab skupaj s kumulativnim odmerkom doksorubicina, večjim od 300 mg/m2, so opazili večjo pojavnost KSP.
Bevacizumab may impair female fertility (see sections 4.6 and 4.8).
Bevacizumab lahko zmanjša plodnost pri ženskah (glejte poglavji 4.6 in 4.8).
Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Bolezni živčevja hipertenzivna encefalopatija (zelo redko) (glejte tudi poglavje 4.4 in ''Hipertenzija'' v poglavju 4.8) sindrom posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome) (redko) (glejte tudi poglavje 4.4)
• Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival and overall survival in the eligible per-protocol population.
● V populaciji, ki je bila primerna glede na protokol, so v celokupni primerjavi dokazali neinferiornost skupin, ki so se zdravile po shemi XELOX, v primerjavi s skupinami, ki so se zdravile po shemi FOLFOX-4, v smislu preživetja brez napredovanja bolezni in celokupnega preživetja.
6.3 Shelf life Vial (unopened)
Viala (neodprta)
Patients treated with bevacizumab have an increased risk of haemorrhage, especially tumour-associated haemorrhage.
Pri bolnikih, ki se zdravijo z bevacizumabom, obstaja povečano tveganje za krvavitev, zlasti za krvavitev, povezano s tumorjem.
d Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
Rektovaginalne fistule so najpogostejše fistule v skupini fistul med prebavili in nožnico.
Aneurysms and artery dissections, Renal thrombotic microangiopathy b,c
, globoka venska tromboza anevrizme in disekcije arterij, renalna trombotična mikroangiopatija b,c
Fistula b,d
b,d krvavitev b,d
Zirabev should be discontinued in patients with life-threatening (Grade 4) thromboembolic reactions, including pulmonary embolism (NCI-CTCAE v.3).
Pri bolnikih z življenjsko ogrožajočimi (stopnja 4) trombemboličnimi dogodki, vključno s pljučno embolijo (NCI-CTCAE v.3), je treba zdravljenje z zdravilom Zirabev prekiniti.
Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by intravenous infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or
Bolnike so randomizirali na kemoterapijo na osnovi platine (paklitaksel 200 mg/m2) in karboplatin z vrednostjo površine pod krivuljo (AUC) 6,0, pri čemer so bolniki oboje prejemali v obliki i.v.
The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, significantly longer progression-free survival, and a trend in longer survival as compared to 5-FU/FA chemotherapy alone.
Dodajanje bevacizumaba v odmerku 5 mg/kg vsaka 2 tedna shemi 5-FU/FA je povečalo objektivni odziv na zdravljenje in pomembno podaljšalo preživetje brez napredovanja bolezni.
Progression-free survival Median time (months) Hazard ratio p-value
Preživetje brez napredovanja bolezni mediani čas (meseci) razmerje ogroženosti p-vrednost
Proteinuria b,d
Bolezni sečil proteinurija b,d
Number of patients Overall survival Median (months) Hazard ratio
Število bolnikov celokupno preživetje mediana (meseci) razmerje ogroženosti
(17.5 vs.14.3 months; p = 0.0609)
(17,5 meseca v primerjavi s 14,3 meseca; p = 0,0609)
What Zirabev is and what it is used for What you need to know before you use Zirabev How to use Zirabev
Kaj je zdravilo Zirabev in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zirabev Kako uporabljati zdravilo Zirabev Možni neželeni učinki
You should seek help as soon as possible if you suffer from any of the below mentioned side effects.
Če imate kateregakoli od spodaj navedenih neželenih učinkov, čim prej poiščite pomoč.
In a randomized phase II study (BO25041) a total of 121 patients aged ≥ 3 years to <18 years with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG)
V randomizirani študiji 2. faze (BO25041) so s pooperativnim obsevalnim zdravljenjem (RTradiotherapy) in adjuvantnim zdravljenjem s temozolomidom (T) v kombinaciji z intravensko danim bevacizumabom v odmerku 10 mg/kg vsaka 2 tedna ali brez njega zdravili skupno 121 bolnikov, starih od ≥ 3 let do < 18 let, z novo diagnosticiranim supratentorialnim ali infratentorialnim cerebelarnim ali pedunkularnim gliomom visoke stopnje (HGG - high-grade glioma).
a patients with measurable disease at baseline
a bolniki z merljivo boleznijo ob izhodišču
Therefore fertility preservation strategies should be discussed with women of child-bearing potential prior to starting treatment with Zirabev.
Pred začetkom zdravljenja z zdravilom Zirabev se je treba z ženskami v rodni dobi pogovoriti o strategijah za ohranitev plodnosti.
Myocardial infarction was reported in up to 1.4% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.7% of patients treated with chemotherapy alone.
O miokardnem infarktu so poročali pri največ 1,4 % bolnikov, ki so se zdravili z bevacizumabom v kombinaciji s kemoterapijo, v primerjavi z največ 0,7 % bolnikov, ki so se zdravili samo s kemoterapijo.
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.
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).
Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under bevacizumab treatment.
Med zdravljenjem z bevacizumabom pri bolnikih lahko obstaja tveganje za pojav venskih trombemboličnih dogodkov, vključno s pljučno embolijo.
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)
• 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)
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.
Če imate visok krvni tlak, ki ga ne obvladujete v zadostni meri z zdravili proti povišanemu krvnemu tlaku, se posvetujte z zdravnikom.
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).
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).
Česká Republika Pfizer, spol.
Česká Republika Pfizer s.r.o.
Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
Zdravilo Zirabev je v kombinaciji s paklitakselom indicirano za prvo linijo zdravljenja odraslih bolnikov z metastatskim rakom dojk.
Zirabev is also used for the treatment of adult patients with metastatic breast cancer.
Zdravilo Zirabev uporabljamo tudi za zdravljenje odraslih bolnikov z metastatskim rakom dojk.
If the first infusion is well tolerated, the second infusion may be administered over 60 minutes.
Če bolnik prvo infuzijo dobro prenese, lahko naslednjo infuzijo dajemo 60 minut.
Posterior Reversible Encephalopathy Syndrome (PRES), (rare) (see also section 4.4)
Sindrom posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome) (glejte poglavje 4.8)
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.
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.
Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 weeks
Cisplatin in gemcitabin + bevacizumab 15 mg/kg vsake 3 tedne
Please discuss this with your doctor if you have metastatic cancer affecting your brain.
Če imate metastatski rak, ki je prizadel vaše možgane, se o tem posvetujte z zdravnikom.
A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Zirabev.
Pred začetkom zdravljenja z zdravilom Zirabev je treba razmisliti o pregledu zobovja in ustreznih preventivnih zobozdravstvenih posegih.
• blockage in the gut or bowel,
• zamašitev v črevesju ali prebavilih,
Proteinuria a,b
Bolezni sečil proteinurija a,b
Progression-free survival Median (months)
Preživetje brez napredovanja bolezni mediana (meseci)
● Zirabev can increase the risk of developing a weak heart.
● Zdravilo Zirabev lahko poveča tveganje za popuščanje srca.
• fever,
• vročino,
Best overall response - Primary analysis
Najboljši celokupni odziv - primarna analiza bolnice z odzivom na zdravljenje (stopnja odziva
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.
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.
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.
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.
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.
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.
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.
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 %.
Overall survival Median (months) Hazard ratio 95% CI
Celokupno preživetje mediana (meseci) razmerje ogroženosti 95 % IZ
• Haemorrhage, including pulmonary haemorrhage/haemoptysis, which is more common in non- small cell lung cancer patients (see section 4.4).
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).
You should seek help immediately if you suffer from any of the below mentioned side effects.
Če imate kateregakoli od spodaj navedenih neželenih učinkov, nemudoma poiščite pomoč.
Zirabev will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
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.