natgillin/translations-raw huggingface dataset:
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back before 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, Avastin will be administered in combination with paclitaxel, or topotecan, or pegylated liposomal doxorubicin.
Kadar zdravilo uporabljamo pri odraslih bolnicah z napredovalim epitelijskim rakom jajčnikov, karcinomom jajcevodov ali primarnim rakom potrebušnice, pri katerih se je bolezen ponovila prej kot po 6 mesecih po zadnji prejeti kemoterapiji, ki je vsebovala platino, bo zdravilo Avastin dano v kombinaciji s paklitakselom ali topotekanom ali pegiliranim liposomalnim doksorubicinom.
Arterial thromboembolism (see section 4.8)
Arterijska trombembolija (glejte poglavje 4.8)
Secondary endpoints
Sekundarni opazovani dogodki
Myocardial infarction was reported in up to 1.4% of patients treated with Avastin in combination with chemotherapy compared to up to 0.7% of patients treated with chemotherapy alone.
O miokardnem infarktu so poročali pri do 1,4 % bolnikov, ki so jih zdravili s kombinacijo zdravila Avastin in kemoterapije, v primerjavi z do 0,7 % bolnikov, ki so bili zdravljeni le s kemoterapijo.
Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
Bevacizumab je kot dodatek kemoterapiji, osnovani na platini, indiciran za prvo linijo zdravljenja odraslih bolnikov z inoperabilnim, napredovalim, metastatskim ali ponavljajočim se nedrobnoceličnim rakom pljuč, ki nima prevladujoče ploščatocelične histologije.
Each ml of concentrate contains 25 mg of bevacizumab, corresponding to 1.4 to 16.5 mg/ml when diluted as recommended.
En ml koncentrata vsebuje 25 mg bevacizumaba, kar po priporočeni razredčitvi ustreza koncentraciji od 1,4 mg/ml do 16,5 mg/ml.
Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents (see Section 5.1).
Bevacizumab je v kombinaciji s paklitakselom, topotekanom ali pegiliranim liposomalnim doksorubicinom indiciran za zdravljenje odraslih bolnic s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, rezistentnega na platino, ki so predhodno prejele največ dve shemi kemoterapije, z bevacizumabom ali drugimi zaviralci VEGF ali zdravili, ki delujejo na receptor VEGF, pa se še niso zdravile (glejte poglavje 5.1).
In an exploratory retrospective analysis of data from 13 completed randomised trials in patients with various tumour types, 3 patients out of 91 (3.3%) with brain metastases experienced CNS bleeding (all Grade 4) when treated with bevacizumab, compared to 1 case (Grade 5) out of 96 patients (1%) that were not exposed to bevacizumab.
V eksplorativni retrospektivni analizi podatkov iz 13 zaključenih randomiziranih kliničnih preskušanj pri bolnikih z različnimi vrstami tumorjev so 3 bolniki od 91 (3,3 %), ki so imeli zasevke v možganih,
In clinical trials across all indications the overall incidence of NCI-CTCAE v.3 Grade 3-5 bleeding reactions ranged from 0.4% to 6.9% in Avastin treated patients, compared with up to 4.5% of patients in the chemotherapy control group.
V kliničnih preskušanjih vseh indikacij je celokupna incidenca krvavitev stopnje 3 do 5 po lestvici NCI-CTCAE v.3 znašala od 0,4 do 6,9 % bolnikov, ki so se zdravili z zdravilom Avastin.
Proteinuria (see section 4.4)
Proteinurija (glejte poglavje 4.4)
The risk of developing connections between the vagina and any parts of the gut can increase if you have persistent, recurrent or metastatic cervical cancer.
Tveganje za nastanek povezav med nožnico in deli črevesa se lahko poveča, če imate rak materničnega vratu, prisoten tudi po zaključenem primarnem zdravljenju,
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back at least 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, Avastin will be administered in combination with carboplatin and gemcitabine or with carboplatin and paclitaxel.
Kadar zdravilo uporabljamo pri odraslih bolnicah z napredovalim epitelijskim rakom jajčnikov, karcinomom jajcevodov in primarnim rakom potrebušnice, pri katerih se je bolezen ponovila po 6 ali več mesecih po zadnji prejeti kemoterapiji, ki je vsebovala platino, bo zdravilo Avastin dano v kombinaciji s karboplatinom in gemcitabinom ali s karboplatinom in paklitakselom.
• fistula: abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected, including connections between vagina and the gut in patients with cervical cancer.
· zasoplost ali nizko vsebnost kisika v krvi, · okužbe kože ali globljih plasti pod kožo, · fistule: nenormalne cevaste povezave med notranjimi organi in kožo ali drugimi tkivi, ki normalno niso povezani, med drugim povezave med nožnico in črevesom pri bolnicah z rakom materničnega vratu.
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.
ki so imeli ocenljiv tumor v izhodišču in potrjen odziv pred prejemom katerega koli lokalnega zdravljenja, 18 % (interval zaupanja: 0,6 %; 35,3 %): 27/75 bolnikov (36,0 %; 95-% interval zaupanja: 25,2 %; 47,9 %) iz skupine, ki je prejemala kemoterapijo, in 34/63 bolnikov (54,0 %; 95-% interval zaupanja: 40,9 %; 66,6 %) iz skupine, ki je prejemala kombinacijo bevacizumaba in kemoterapije.
Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 15 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab alone (CPB15+), had a clinically meaningful and statistically significant improvement in PFS.
V primerjavi z bolnicami, ki so bile zdravljene samo s kemoterapijo (karboplatin in paklitaksel) v prvem zdravljenju, so imele bolnice, ko so prejele bevacizumab v odmerku 15 mg/kg telesne mase enkrat na 3 tedne v kombinaciji s kemoterapijo in so nadaljevale samo z bevacizumabom (CPB15+), klinično pomembno in statistično signifikantno izboljšanje preživetja brez napredovanja bolezni.
There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving Avastin monotherapy compared to patients receiving Avastin in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).
Pri bolnikih, ki so prejemali samostojno zdravljenje z zdravilom Avastin, v primerjavi z bolniki, ki so prejemali zdravilo Avastin v kombinaciji z interferonom alfa-2a, erlotinibom ali kemoterapijami (IFL, 5-FU/LV,
Hypertension (see section 4.8)
Hipertenzija (glejte poglavje 4.8)
Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with Avastin and all patients with GI perforation had a history of prior radiation.
Predhodno obsevanje je dejavnik tveganja za perforacije prebavil pri bolnicah z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska, in se zdravijo z zdravilom Avastin - vse bolnice s perforacijami prebavil so bile predhodno obsevane.
The primary endpoint was overall survival, with secondary endpoints for the trial including progression-free survival.
Primarni končni cilj je bilo celokupno preživetje, sekundarni končni cilji preskušanja pa so vključevali tudi preživetje brez napredovanja bolezni.
Sepsis, Cellulitis, Abscess a,b
Infekcijske in parazitske bolezni sepsa, celulitis, abscesa,b, okužba,
This was a phase III randomised, double-blind, active-controlled clinical trial evaluating Avastin in combination with IFL as first-line treatment for metastatic carcinoma of the colon or rectum.
To je bilo randomizirano, dvojno slepo, aktivno kontrolirano klinično preskušanje faze III, ki je proučevalo zdravilo Avastin v kombinaciji z IFL v prvi liniji zdravljenja metastatskega raka debelega črevesa in danke.
Table 4 Efficacy results for trial AVF2107g
Rezultati preskušanja AVF2107g glede učinkovitosti AVF2107g
This has mainly been seen in combination with platinum- or taxane-based therapies in the treatment of NSCLC, mBC, and in combination with paclitaxel and topotecan in persistent, recurrent, or metastatic cervical cancer.
To so večinoma opazili pri kombiniranem zdravljenju s kemoterapijo na osnovi platine ali s taksani pri bolnikih z nedrobnoceličnim rakom pljuč, metastatskim rakom dojk in pri kombinaciji s paklitakselom in topotekanom pri bolnicah z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska.
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 dokončno ukiniti.
All of these findings were reversible upon discontinuation of bevacizumab and sunitinib malate (see Hypertension, Proteinuria, PRES in section 4.4).
Ti neželeni učinki po prekinitvi zdravljenja z bevacizumabom in sunitinibijevim malatom niso bili več prisotni (glejte odstavek Hipertenzija, Proteinurija in Sindrom posteriorne reverzibilne encefalopatije v poglavju
Age was not associated with the pharmacokinetics of bevacizumab when body weight was taken into account.
Starost ob upoštevanju telesne mase na farmakokinetiko bevacizumaba ni imela vpliva.
Until mature OS results and safety data are available no definitive conclusion can be drawn on the benefit/risk balance.
O razmerju med koristmi in tveganji zdravila ne moremo dokončno sklepati.
Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01X C07
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe in imunomodulatorji, zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa.
Therefore fertility preservation strategies should be discussed with women of child-bearing potential prior to starting treatment with Avastin.
Pred začetkom zdravljenja z zdravilom Avastin se je z ženskami v rodni dobi treba pogovoriti o možnostih, ki so na voljo za ohranitev plodnosti.
Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Nausea, Vomiting, Abdominal pain
Bolezni prebavil rektalna krvavitev, stomatitis, konstipacija, diareja, navzea, bruhanje,
• The analysis of PFS as determined by the independent review committee (censoring for NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.50-0.77, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 13.1 in the CPP arm and 19.1 months in the CPB15+ arm.
· Analiza preživetja brez napredovanja bolezni, kot jo je določil odbor za neodvisni pregled (s krnjenimi podatki za zdravljenje, ki ni bilo v skladu s protokolom) kaže stratificirano razmerje ogroženosti 0,62 (95-% interval zaupanja: 0,50-0,77; p-vrednost za enostranski log rank test < 0,0001) ko primerjamo CPB15+ s CPP, z mediano preživetja brez napredovanja bolezni 13,1 v CPP skupini in 19,1 meseca v CPB15+ skupini.
Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
Bevacizumab je v kombinaciji s paklitakselom indiciran za prvo linijo zdravljenja odraslih bolnikov z metastatskim rakom dojk.
The addition of Avastin 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.
Dodatek 5 mg zdravila Avastin/kg telesne mase vsake dva tedna h kemoterapiji po shemi 5-FU/FA je povečal objektivni odgovor na zdravljenje in značilno podaljšal preživetje brez napredovanja bolezni.
Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients treated with Avastin across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Trombembolija (glejte poglavje 4.4) Arterijska trombembolija: Pri bolnikih, zdravljenih z zdravilom Avastin, so pri vseh indikacijah poročali o povečani incidenci arterijskih trombemboličnih neželenih učinkov, vključno s cerebrovaskularnimi dogodki, miokardnim infarktom, tranzitornimi ishemičnimi atakami in drugimi arterijskimi trombembolični neželenimi učinki.
• blocking of the blood vessels of the lungs by a blood clot,
· zamašitev krvnih žil v pljučih s krvnim strdkom,
Carboplatin/ Paclitaxel + Avastin 15 mg/kg q 3 weeks
Skupina 2 karboplatin, paklitaksel in Avastin 15 mg/kg na 3 tedne
This study was designed as an open-label, randomized, two-arm Phase III evaluation of bevacizumab plus chemotherapy (CT+BV) versus chemotherapy alone (CT).
Študija je bila zasnovana kot odprto, randomizirano preskušanje faze III z dvema skupinama, v katerem so ocenjevali zdravljenje z bevacizumabom in kemoterapijo v primerjavi s samo kemoterapijo.
In clinical trials, the overall incidence of arterial thromboembolic reactions ranged up to 3.8% in the Avastin containing arms compared with up to 2.1% in the chemotherapy control arms.
V kliničnih preskušanjih je bila celokupna incidenca arterijskih trombemboličnih neželenih učinkov pri bolnikih, zdravljenih z zdravilom Avastin, do 3,8 %, v kontrolnih skupinah, v katerih so prejemali kemoterapijo, pa do 2,1 %.
However two of the randomized patients discontinued the study before receiving any study treatment ^ Blinded independent review (protocol-defined primary analysis) * Exploratory analysis: final OS analysis at clinical cut off on 31 October 2017, approx. 59% of patients had died.
* Eksplorativna analiza: končna analiza celokupnega preživetja s kliničnimi podatki, zajetimi do 31. oktobra 2017; približno 59 % bolnikov je umrlo.
Each 16 ml vial contains 400 mg of bevacizumab, corresponding to 16.5 mg/ml when diluted as recommended
Ena 16 ml viala vsebuje 400 mg bevacizumaba, kar po priporočeni razredčitvi ustreza koncentraciji 16,5 mg/ml.
Pelvic Pain
OVOJNINAH Viala
Cases of non-mandibular osteonecrosis have been observed in Avastin treated paediatric patients (see section 4.8, Paediatric population).
pri zdravljenju pediatričnih bolnikov z zdravilom Avastin so opazili primere osteonekroze izven spodnje čeljustnice (glejte poglavje 4.8,
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 nakazujejo, da je treba bolnike, ki prejemajo kumulativne odmerke doksorubicina, višje od 300 mg/m2,
● Avastin can increase the risk of developing a weak heart.
· zdravilo Avastin lahko poveča tveganje za opešanje srca.
Randomised patients with stage III suboptimally debulked disease3
Randomizirane bolnice s suboptimalno citoredukcijo, stadija III 3
Overall Survival* (months)
Mediana celokupnega preživetja (meseci)
A total of 484 patients with measurable disease were randomised 1:1 to either: • Carboplatin (AUC4, Day 1) and gemcitabine (1000 mg/m2 on Days 1 and 8) and concurrent placebo every 3 weeks for 6 and up to 10 cycles followed by placebo (every 3 weeks) alone until disease progression or unacceptable toxicity
V dve skupini v razmerju 1:1 so randomizirali skupno 484 bolnic z merljivo boleznijo: · karboplatin (AUC4, dan 1) in gemcitabin (1000 mg/m2 na dan 1 in 8) ter sočasno placebo vsake
PFS subgroup analyses by disease stage and debulking status are summarised in Table 19.
Analize podskupin preživetja brez napredovanja bolezni, glede na stadij bolezni in stopnjo kirurškega zmanjšanja bolezni so povzete v preglednici 19.
Diluted medicinal product
Razredčeno zdravilo
Placebo or Avastin
22 h placebo ali Avastin
However, sleepiness and fainting have been reported with Avastin use.
Vendar pa so pri uporabi zdravila Avastin poročali o zaspanosti in omedlevici.
• decreased number of cells in the blood, including white cells that help to fight against infections
· zmanjšano število krvnih celic, vključno z belimi krvnimi celicami, ki pomagajo pri boju proti okužbam (ob tem se lahko pojavi zvišana telesna temperatura), in celicami, ki pomagajo strjevati kri,
Treatment of platinum-sensitive recurrent disease: Avastin is administered in combination with either carboplatin and gemcitabine for 6 cycles and up to 10 cycles or in combination with carboplatin and paclitaxel for 6 cycles and up to 8 cycles, followed by continued use of Avastin as single agent until disease progression.The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Zdravljenje ponovitve bolezni, občutljive na platino: zdravilo Avastin dajemo v kombinaciji bodisi s karboplatinom in gemcitabinom od 6 do največ 10 ciklov ali v kombinaciji s karboplatinom in paklitakselom od 6 do največ 8 ciklov, nato pa nadaljujemo z dajanjem zdravila Avastin samostojno do napredovanja bolezni.
Study MO22224 evaluated the efficacy and safety of bevacizumab in combination with chemotherapy for platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Študija MO22224 je ocenjevala učinkovitost in varnost bevacizumaba v kombinaciji s kemoterapijo pri bolnicah s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, rezistentnega na platino.
• bleeding, including bleeding in the lungs in patients with non-small cell lung cancer,
vključujejo: · perforacijo črevesja, · krvavitev, vključno s krvavitvijo v pljučih pri bolnikih z nedrobnoceličnim rakom pljuč,
A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Avastin.
Pred začetkom zdravljenja z zdravilom Avastin je treba razmisliti o pregledu zobovja in primernih preventivnih zobozdravstvenih posegih.
Cervical Cancer
Rak materničnega vratu
• blocking of the veins of the legs by a blood clot,
· zamašitev ven v nogah s krvnim strdkom,
• sickness,
bolečina,
● your doctor will decide when you should be given your next dose of Avastin.
Če je bil odmerek zdravila Avastin izpuščen: · bo vaš zdravnik odločil o tem, kdaj boste prejeli naslednji odmerek tega zdravila.
Avastin is also used for the treatment of adult patients with metastatic breast cancer.
Zdravilo Avastin uporabljamo tudi za zdravljenje odraslih bolnikov z metastatskim rakom dojk.
Hypersensitivity, infusion reactionsa,b,d
reakcije pri infundiranjua,b,d
• loss of appetite,
· zaprtje, · izgubo apetita, · zvišano telesno temperaturo,
Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with Avastin.
Pri bolnikih, ki so prejemali zdravilo Avastin, so redko poročali o nekrotizirajočem fasciitisu, vključno s smrtnimi primeri.
Method and route of administration
Način in pot dajanja
Table 1: Adverse Reactions by Frequency
Neželeni učinki po pogostnosti
(p-value = 0.0062)
(p-vrednost = 0,0062)
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 Avastin in comparison to chemotherapy alone.
Opazili so večji pojav hude nevtropenije, febrilne nevtropenije ali okužbe s hudo nevtropenijo ali brez nje (vključno s smrtnimi primeri); to so večinoma opazili pri bolnikih, ki so prejemali zdravljenje na osnovi platine ali taksanov pri nedrobnoceličnem raku pljuč ter metastatskem raku dojk.
Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.
Po intravitrealni injekciji zaviralcev VEGF so poročali o sistemskih neželenih učinkih, vključno s krvavitvijo izven predela oči in arterijskimi tromboemboličnimi neželenimi učinki.
Each 4 ml vial contains 100 mg of bevacizumab.
Ena 4 ml viala vsebuje 100 mg bevacizumaba.
Grade 3-5 reactions have been observed in up to 2.3% of patients treated with Avastin plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Neželene učinke stopnje 3 do 5 so opazili pri do 2,3 % bolnikov, ki so bili zdravljeni z zdravilom Avastin in kemoterapijo (NCI-CTCAE v.3).
This was a randomised, double-blind, phase II clinical trial investigating Avastin 10 mg/kg in a 2 weekly schedule with the same dose of Avastin 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 Avastin 10 mg/kg every 2 weeks plus placebo and 51 to Avastin 10 mg/kg every 2 weeks plus erlotinib 150 mg daily.
Skupno so v zdravljenje v tem preskušanju randomizirali 104 bolnike; 53 v skupino, ki je prejemala zdravilo Avastin 10 mg/kg vsake 2 tedna in placebo, ter 51 v skupino, ki je prejemala zdravilo Avastin 10 mg/kg vsake 2 tedna in 150 mg erlotiniba na dan.
The rate of infusion was based on tolerability, with an initial infusion duration of 90 minutes.
V vseh kliničnih preskušanjih so bevacizumab uporabljal v obliki intravenske infuzije, katere hitrost je bila odvisna od prenašanja, njeno prvo dajanje pa je trajalo 90 minut.
If the first infusion is well tolerated, the second infusion may be administered over 60 minutes.
Če je bolnik prvi odmerek dobro prenesel, lahko naslednjo infuzijo dajemo 60 minut.
Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 7.5 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab for up to 18 cycles had a statistically significant improvement in PFS.
V primerjavi z bolnicami, ki so kot prvo zdravljenje prejele samo kemoterapijo (karboplatin in paklitaksel), so bolnice, ki so prejele bevacizumab v odmerku 7,5 mg/kg telesne mase enkrat na 3 tedne v kombinaciji s kemoterapijo in nadaljevale z do 18 cikli bevacizumaba, imele statistično signifikantno izboljšanje preživetja brez napredovanja bolezni.
NAME OF THE MEDICINAL PRODUCT Avastin 25 mg/ml concentrate for solution for infusion.
IME ZDRAVILA Avastin 25 mg/ml koncentrat za raztopino za infundiranje
• constipation,
· srčno popuščanje,
What you need to know before you use Avastin
Kaj morate vedeti, preden boste uporabili zdravilo Avastin Zdravila Avastin ne smete prejemati:
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 je prejemala zdravljenje po shemi FOLFOX, je bila mediana preživetja brez napredovanja bolezni 8,6 meseca pri bolnikih, ki so prejemali placebo, ter 9,4 meseca pri bolnikih, ki so se zdravili z bevacizumabom; razmerje ogroženosti = 0,89, 97,5-% interval zaupanja = [0,73; 1,08]; p-vrednost = 0,1871.
Progression-free survivalb Investigator Assessment
Preživetje brez napredovanja bolezni Ocena raziskovalca
Wound healing complications (see section 4.8)
Zapleti pri celjenju ran (glejte poglavje 4.8)
• diarrhoea,
Bolezni jeter,