FrancophonIA/ELRC3.0 huggingface dataset:
English: E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating bevacizumab as first-line treatment of patients with locally advanced (stage IIIb with malignant pleural effusion), metastatic or recurrent NSCLC other than predominantly squamous cell histology.
Slovenian: Preskušanje E4599 je bilo odprto, randomizirano, z učinkovino nadzorovano, multicentrično klinično preskušanje, v katerem so ocenjevali bevacizumab v prvi liniji zdravljenja bolnikov z lokalno napredovalim (stadij IIIb z malignim plevralnim izlivom), metastatskim ali ponavljajočim se NSCLC brez prevladujoče ploščatocelične histologije.
English: No trials have been conducted to investigate the pharmacokinetics of bevacizumab in renally impaired patients since the kidneys are not a major organ for bevacizumab metabolism or excretion.
Slovenian: Preskušanj za proučevanje farmakokinetike bevacizumaba pri bolnikih z ledvično okvaro niso opravili, saj ledvice niso pomemben organ za presnovo ali izločanje bevacizumaba.
English: Peripheral s ensory neuropathy b,
Slovenian: Bolezni živčevja periferna senzorična nevropatija b,
English: Testing for proteinuria is recommended prior to start of Zirabev therapy.
Slovenian: Pred začetkom zdravljenja z zdravilom Zirabev je priporočljivo testiranje na proteinurijo.
English: Deutschland Pfizer Pharma PFE GmbH Tel: +49 (0)800 8535555
Slovenian: Pfizer Pharma GmbH Tel: +49 (0)30 550055-51000
English: Chemotherapy + bevacizumab (n=227)
Slovenian: Kemoterapija + bevacizumab (n = 227)
English: Zirabev is a concentrate for solution for infusion.
Slovenian: Zdravilo Zirabev je koncentrat za raztopino za infundiranje.
English: Bevacizumab addition to multimodal standard of care treatment seemed to be tolerated in this paediatric population.
Slovenian: Zdi se, da so bolniki v tej pediatrični populaciji bevacizumab kot dodatek multimodalnemu standardnemu zdravljenju dobro prenašali.
English: Trial BO17704 has demonstrated that both 7.5 mg/kg/q3wk and 15 mg/kg/q3wk bevacizumab doses increase progression free survival and response rate.
Slovenian: V preskušanju BO17704 pa so dokazali, da oba odmerka, 7,5 mg/kg vsake 3 tedne in 15 mg/kg vsake 3 tedne, podaljšata preživetje brez napredovanja bolezni in povečata stopnjo odziva.
English: This was a Phase III randomised, controlled, open-label trial investigating bevacizumab 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy versus fluoropyrimidine-based chemotherapy alone in patients with mCRC who have progressed on a first- line bevacizumab-containing regimen.
Slovenian: To je bilo randomizirano, nadzorovano, odprto preskušanje 3. faze, v katerem so proučevali bevacizumab v odmerku 5,0 mg/kg vsaka 2 tedna ali 7,5 mg/kg vsake 3 tedne v kombinaciji s kemoterapijo na osnovi fluoropirimidina v primerjavi s samostojno kemoterapijo na osnovi fluoropirimidina pri bolnikih z mCRC, pri katerih je bolezen napredovala po prvi liniji zdravljenja po shemi, ki je vsebovala bevacizumab.
English: (16.2 vs. 12.0 months; p = 0.1342)
Slovenian: (16,2 meseca v primerjavi z 12,0 meseca; p = 0,1342)
English: How to use Zirabev
Slovenian: Kako uporabljati zdravilo Zirabev
English: Therapy should be withheld for elective surgery.
Slovenian: Zdravljenje je treba prekiniti tudi v primeru načrtovanega kirurškega posega.
English: (16.2 vs 17.5 months; p = 0.3769)
Slovenian: (16,2 v primerjavi s 17,5 meseca; p = 0,3769)
English: Overall survival - primary analysis Hazard ratio (95% CI)
Slovenian: Celokupno preživetje - primarna analiza razmerje ogroženosti (95 % IZ)
English: Study E3200 used a 5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-naïve patients, while study ML18147 used a 2.5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-pretreated patients.
Slovenian: V študiji E3200 so bevacizumab uporabljali v odmerku, enakovrednem 5 mg/kg/teden, pri bolnikih, ki ga pred tem še niso prejemali, medtem ko so v študiji ML18147 bevacizumab uporabljali v odmerku, enakovrednem 2,5 mg/kg/teden, pri bolnikih, ki so se z njim že zdravili.
English: • diarrhoea, nausea, vomiting and abdominal pain.
Slovenian: • drisko, siljenje na bruhanje, bruhanje in bolečine v trebuhu.
English: An increased incidence of arterial thromboembolic reactions was observed in patients treated with bevacizumab across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Slovenian: Pri bolnikih, ki so se zdravili z bevacizumabom, so pri vseh indikacijah opazili povečano pojavnost arterijskih trombemboličnih dogodkov, vključno s cerebrovaskularnimi insulti, miokardnim infarktom, prehodnimi možganskimi ishemijami in drugimi arterijskimi trombembolični dogodki.
English: All of these findings were reversible upon discontinuation of bevacizumab and sunitinib malate (see Hypertension, Proteinuria, PRES in section 4.4).
Slovenian: Po prekinitvi zdravljenja z bevacizumabom in sunitinibijevim malatom so bile vse ugotovitve reverzibilne (glejte ''Hipertenzija'', ''Proteinurija'' in ''Sindrom posteriorne reverzibilne encefalopatije'' v poglavju 4.4).
English: Congestive heart failure (CHF) (see section 4.8)
Slovenian: Kongestivno srčno popuščanje (KSP) (glejte poglavje 4.8)
English: Bvb + IFNa
Slovenian: bv b + IFN
English: These clinically significant adverse reactions were reported in clinical trials but the grade 3-5 reactions did not meet the threshold of at least a 2% difference compared to the control arm. Table 2 also includes clinically significant adverse reactions that were observed only in the postmarketing setting,
Slovenian: O teh klinično pomembnih neželenih učinkih so poročali v kliničnih preskušanjih, vendar neželeni učinki stopnje 3-5 niso dosegli praga vsaj 2 % razlike v primerjavi s kontrolno skupino.
English: Effect of bevacizumab on the pharmacokinetics of other antineoplastic agents
Slovenian: Vpliv bevacizumaba na farmakokinetiko drugih zdravil z delovanjem na novotvorbe
English: Zirabev is for intravenous use.
Slovenian: Zdravilo Zirabev je namenjeno za intravensko uporabo.
English: Paclitaxel/ bevacizumab (n=368)
Slovenian: paklitaksel in bevacizumab (n = 368)
English: Two of the eight cases did not have radiological confirmation via MRI.
Slovenian: V kliničnih preskušanjih so poročali o 8 primerih PRES. Dveh od teh 8 primerov niso radiološko potrdili z magnetnoresonančnim slikanjem.
English: Cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.6 )
Slovenian: Prirojene in dedne genetske okvare pri ženskah, ki so se zdravile z bevacizumabom samim ali v kombinaciji z znano embriotoksičnimi kemoterapevtiki, so opazili primere nenormalnosti ploda (glejte poglavje 4.6)
English: Number of patients Overall survival Median time (months) 95% CI
Slovenian: Število bolnikov Celokupno preživetje mediani čas (meseci) 95 % IZ
English: ● a blood clot in your arteries,
Slovenian: ● krvni strdek v arterijah,
English: Caution should be taken when treating these patients with Zirabev.
Slovenian: Pri zdravljenju teh bolnikov z zdravilom Zirabev je zato potrebna previdnost.
English: • 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Enrolment in Arm 3 was discontinued, as pre-specified, once safety of bevacizumab with the IFL regimen was established and considered acceptable.
Slovenian: Ko so dokazali varnost bevacizumaba skupaj s shemo IFL in jo ocenili kot sprejemljivo, so vključevanje v skupino 3 prekinili, kot so predhodno predvideli.
English: 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).
Slovenian: 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).
English: Exfoliative dermatitis, Dry skin, Skin discoloration
Slovenian: , eksfoliativni dermatitis, suha koža, obarvanje kože sindrom palmarnoplantarne eritrodisestezije
English: 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.
Slovenian: 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.
English: Placebo + IFNa
Slovenian: placebo + IFN
English: (11.9 vs.14.3 months; p = 0.4825)
Slovenian: (11,9 meseca v primerjavi s 14,3 meseca; p = 0,4825)
English: • 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.
Slovenian: 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.
English: (14.9 vs. 11.9 months; p = 0.1061)
Slovenian: (14,9 meseca v primerjavi z 11,9 meseca; p = 0,1061)
English: Cisplatin/Gemcitabine + bevacizumab 7.5 mg/kg q 3 weeks
Slovenian: Cisplatin in gemcitabin + bevacizumab 7,5 mg/kg vsake 3 tedne
English: (17.5 vs.15.0 months; p = 0.0584)
Slovenian: (17,5 meseca v primerjavi s 15,0 meseca; p = 0,0584)
English: 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.
Slovenian: (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.
English: Each ml of concentrate contains 25 mg of bevacizumab.
Slovenian: En ml koncentrata vsebuje 25 mg bevacizumaba.
English: Zirabev may impair female fertility.
Slovenian: Zdravilo Zirabev lahko zmanjša plodnost ženske.
English: 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.
Slovenian: 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.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: CHF Grade 3 or higher reactions were somewhat more frequent among patients receiving bevacizumab in combination with chemotherapy than in patients receiving chemotherapy alone.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Anorexia, Hypomagnesaemia, Hyponatraemia
Slovenian: Presnovne in prehranske motnje anoreksija, hipomagneziemija, hiponatriemija dehidracija
English: • inflammation of the moist lining of mouth and gut, lungs and air passages, reproductive,
Slovenian: • vnetje vlažne sluznice ust in črevesja, pljuč in dihalnih poti, spolovil in sečil,
English: Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with bevacizumab.
Slovenian: Pri bolnikih, ki so se zdravili z bevacizumabom, so redko poročali o nekrotizirajočem fasciitisu, vključno s smrtnimi primeri.
English: Do not use Zirabev if you notice any particulate matter or discolouration prior to administration.
Slovenian: Zdravila Zirabev ne uporabite, če pred dajanjem opazite prisotnost kakršnihkoli trdnih delcev ali obarvanje.
English: Table 10 Trial E2100 efficacy results Progression-free survival
Slovenian: Preglednica 10 Rezultati učinkovitosti v preskušanju E2100
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: (14.9 vs. 17.5 months; p = 0.4146)
Slovenian: (14,9 meseca v primerjavi s 17,5 meseca; p = 0,4146)
English: In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Zirabev.
Slovenian: Če se pri bolnikih pojavi PRES, je poleg prekinitve zdravljenja z zdravilom Zirabev priporočljivo zdravljenje specifičnih simptomov, vključno z obvladovanjem hipertenzije.
English: • 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).
Slovenian: 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).
English: Aneurysms and artery dissections, Renal thrombotic microangiopathy a,b
Slovenian: , globoka venska tromboza anevrizme in disekcije arterij, renalna trombotična mikroangiopatija a,b
English: Hypersensitivity, Infusion reactions a,b,c
Slovenian: Bolezni imunskega sistema preobčutljivost, reakcije na infuzijo a,b,c
English: Hypersensitivity, Infusion reactions a,b,d
Slovenian: Bolezni imunskega sistema preobčutljivost, reakcije na infuzijo a,b,d
English: Number of patients Progression-free survival
Slovenian: Preživetje brez napredovanja bolezni
English: 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.
Slovenian: 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.
English: The primary endpoint was overall survival, with secondary endpoints for the trial including progression-free survival.
Slovenian: Primarni opazovani dogodek je bilo celokupno preživetje, sekundarni opazovani dogodki preskušanja pa so vključevali tudi preživetje brez napredovanja bolezni.
English: B-cell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
Slovenian: 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.
English: Bevacizumab may impair female fertility (see sections 4.6 and 4.8).
Slovenian: Bevacizumab lahko zmanjša plodnost pri ženskah (glejte poglavji 4.6 in 4.8).
English: Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Slovenian: 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)
English: • 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.
Slovenian: ● 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.
English: 6.3 Shelf life Vial (unopened)
Slovenian: Viala (neodprta)
English: Patients treated with bevacizumab have an increased risk of haemorrhage, especially tumour-associated haemorrhage.
Slovenian: Pri bolnikih, ki se zdravijo z bevacizumabom, obstaja povečano tveganje za krvavitev, zlasti za krvavitev, povezano s tumorjem.
English: d Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
Slovenian: Rektovaginalne fistule so najpogostejše fistule v skupini fistul med prebavili in nožnico.
English: Aneurysms and artery dissections, Renal thrombotic microangiopathy b,c
Slovenian: , globoka venska tromboza anevrizme in disekcije arterij, renalna trombotična mikroangiopatija b,c
English: Fistula b,d
Slovenian: b,d krvavitev b,d
English: Zirabev should be discontinued in patients with life-threatening (Grade 4) thromboembolic reactions, including pulmonary embolism (NCI-CTCAE v.3).
Slovenian: Pri bolnikih z življenjsko ogrožajočimi (stopnja 4) trombemboličnimi dogodki, vključno s pljučno embolijo (NCI-CTCAE v.3), je treba zdravljenje z zdravilom Zirabev prekiniti.
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Progression-free survival Median time (months) Hazard ratio p-value
Slovenian: Preživetje brez napredovanja bolezni mediani čas (meseci) razmerje ogroženosti p-vrednost
English: Proteinuria b,d
Slovenian: Bolezni sečil proteinurija b,d
English: Number of patients Overall survival Median (months) Hazard ratio
Slovenian: Število bolnikov celokupno preživetje mediana (meseci) razmerje ogroženosti
English: (17.5 vs.14.3 months; p = 0.0609)
Slovenian: (17,5 meseca v primerjavi s 14,3 meseca; p = 0,0609)
English: What Zirabev is and what it is used for What you need to know before you use Zirabev How to use Zirabev
Slovenian: Kaj je zdravilo Zirabev in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zirabev Kako uporabljati zdravilo Zirabev Možni neželeni učinki
English: You should seek help as soon as possible if you suffer from any of the below mentioned side effects.
Slovenian: Če imate kateregakoli od spodaj navedenih neželenih učinkov, čim prej poiščite pomoč.
English: 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)
Slovenian: 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).
English: a patients with measurable disease at baseline
Slovenian: a bolniki z merljivo boleznijo ob izhodišču
English: Therefore fertility preservation strategies should be discussed with women of child-bearing potential prior to starting treatment with Zirabev.
Slovenian: Pred začetkom zdravljenja z zdravilom Zirabev se je treba z ženskami v rodni dobi pogovoriti o strategijah za ohranitev plodnosti.
English: 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.
Slovenian: 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.