natgillin/translations-raw huggingface dataset:
The majority of patients included in the study were White (96%), the median age was 57 years in both treatment arms, 25% of patients in each treatment arm were 65 years of age or over, and approximately 50% of patients had an ECOG PS of 1; 7% of patients in each treatment arm had an
25 % bolnic v vsaki skupini je bilo starih 65 let ali več in približno 50 % bolnic je imelo oceno stanja zmogljivosti (PS, performance status) po ECOG (Eastern Cooperative Oncology Group) 1; 7 %
A total of 116 patients were randomised to receive bevacizumab 3 mg/kg every 2
Skupno so 116 bolnikov randomizirali v skupino, ki je prejemala 3 mg/kg bevacizumaba na 2 tedna (n = 39), v skupino, ki je prejamala 10 mg/kg bevacizumaba na 2 tedna
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), grade 3-5 venous thromboembolic events have been reported in up to 15.6% of patients treated with Avastin in combination with paclitaxel and cisplatin compared with up to 7.0% of patients treated with paclitaxel and cisplatin.
so o venskih trombemboličnih dogodkih stopnje 3 do 5 poročali pri do 15,6 % bolnic, ki so prejemale zdravilo Avastin v kombinaciji s paklitakselom in cisplatinom, in pri do 7,0 % bolnic, ki so prejemale paklitaksel in cisplatin.
METHOD OF ADMINISTRATION For intravenous use after dilution
Za intravensko uporabo po razredčitvi
● if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Avastin, in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
Preden začnete zdravljenje z zdravilom Avastin ali med zdravljenjem z njim: · svojemu zdravniku in zobozdravniku nemudoma povejte, če imate ali ste imeli bolečine v ustih,
Overall response rate Rate (percent) 95% CI p-value
Odgovor na zdravljenje delež (odstotki) 95-% interval zaupanja p-vrednost
Vascular disorders Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Žilne bolezni renalna trombotična mikroangiopatija, ki se lahko klinično izrazi kot proteinurija (ni znana) pri sočasni uporabi sunitiniba ali brez; za dodatne informacije glede proteinurije glejte poglavje 4.4 in odstavek Proteinurija v poglavju 4.8
The efficacy results are presented in Table 15 Table 15 Efficacy results for trial BO17705
Rezultati učinkovitosti preskušanja BO17705 BO17705
Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
e Rektovaginalne fistule so najpogostejše fistule v skupini fistul med prebavili in nožnico.
Gall bladder perforation (not known)
pljučna hipertenzija (ni znana)
Treatment with Avastin at 15 mg/kg every 3 weeks in combination with chemotherapy (carboplatin and paclitaxel) for 6 and up to 8 cycles, followed by Avastin until disease progression or unacceptable toxicity resulted, when data were derived from eCRF, in a clinically meaningful and statistically significant improvement in OS compared to treatment with carboplatin and paclitaxel alone.
Izsledki (po zbranih podatkih iz eCRF) so pokazali klinično pomembno in statistično značilno podaljšanje celokupnega preživetja pri skupini, ki je prejemala zdravilo Avastin v odmerku 15 mg/kg vsake 3 tedne v kombinaciji s kemoterapijo (karboplatinom in paklitakselom) od 6 do največ 8 ciklov, ki mu je sledilo zdravilo Avastin do napredovanja bolezni ali nesprejemljive toksičnosti, v primerjavi z dajanjem samo karboplatina in paklitaksela.
● If you get any side effects, talk to your doctor, pharmacist or nurse.
· Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Avastin is also used for treatment of adult patients with advanced kidney cancer.
Zdravilo Avastin uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim rakom ledvičnih celic.
Prior radiation is a major risk factor for the development of GI-vaginal fistulae and all patients with GIvaginal fistulae had a history of prior radiation.
Predhodno obsevanje je velik dejavnik tveganja za nastanek fistule med prebavili in nožnico; vse bolnice s fistulo med prebavili in nožnico so bile predhodno obsevane.
Pulmonary haemorrhage/ Haemoptysisb,d,
Srčne bolezni kongestivno srčno popuščanjeb,d,
Anaemia, Lymphopenia
letargija, vnetje sluznic
Cases of Osteonecrosis of the Jaw (ONJ) have been reported in patients treated with Avastin, most of which occurred in patients who had identified risk factors for ONJ, in particular exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4)
zlasti izpostavljenost intravenskim difosfonatom in/ali anamneza zobne bolezni, ki je zahtevala invazivne zobozdravstvene posege (glejte tudi poglavje 4.4)
Congestive heart failure a,b
Srčne bolezni kongestivno srčno popuščanjea,b,
Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2 (q3w); or Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 (q3w)
Skupno 452 bolnic so randomizirali na prejemanje ene od naslednjih shem: · paklitaksel 135 mg/m2 intravensko v 24-urni infuziji 1. dan in cisplatin 50 mg/m2 intravensko 2. dan na 3 tedne, ali paklitaksel 175 mg/m intravensko v 3-urni infuziji 1. dan in cisplatin 50 mg/m intravensko
• Paclitaxel 80 mg/m2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 every 4 weeks.
· skupina s samo kemoterapijo: · paklitaksel 80 mg/m2 z 1-urno intravensko infuzijo 1., 8., 15. in 22. dan vsake 4 tedne; · topotekan 4 mg/m2 s 30-minutno intravensko infuzijo 1., 8. in 15. dan vsake 4 tedne; lahko se daje tudi v odmerku 1,25 mg/m2 v 30 minutah od 1. do 5. dne vsake 3 tedne;
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), grade 3-5 bleeding reactions have been reported in up to 8.3% of patients treated with Avastin in combination with paclitaxel and topotecan compared with up to 4.6% of patients treated with paclitaxel and topotecan.
so o krvavitvah stopnje 3 do 5 poročali pri do 8,3 % bolnic, ki so prejemale zdravilo Avastin v kombinaciji s paklitakselom in topotekanom, in pri do 4,6 % bolnic, ki so prejemale paklitaksel in topotekan.
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, therefore, the frequency and NCI-CTCAE grade is not known.These clinically significant reactions have therefore been included in Table 2 within the column entitled “Frequency Not Known.”
O teh klinično pomembnih neželenih učinkih so poročali v kliničnih preskušanjih, a neželeni učinki stopenj 3 do 5 niso dosegli meje - najmanj 2-% razlike v primerjavi s kontrolno skupino.
400 mg/m2 IV bolus, 600 mg/m2 IV 22 h
2 h 5-fluorouracil 400 mg/m2 i.v.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Hranjenje navadno ne sme biti daljše od 24 ur pri temperaturi 2 °C do
Renal impairment
Neodprta viala
Posterior Reversible Encephalopathy Syndrome (see section 4.4) There have been rare reports of Avastin-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder.
Kongestivno srčno popuščanje (glejte poglavje 4.8) Med kliničnimi preskušanji so poročali o neželenih učinkih, skladnih s kongestivnim srčnim popuščanjem.
The main secondary efficacy endpoint was progression-free survival (PFS).Results are presented in Table 22.
Glavni sekundarni opazovani dogodek učinkovitosti je bil preživetje brez napredovanja bolezni (PFS).
Number of patients Progression-free survival Median (months) Hazard ratio
Preživetje brez napredovanja bolezni mediana (meseci) razmerje ogroženosti
The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Avastin fails to stop your tumour growing.
Število infuzij, ki jih boste prejeli, je odvisno od vašega odziva na zdravljenje.
● if you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth tell your doctor and dentist immediately.
zobeh in/ali čeljusti, otekline ali mehurji v ustih, otrplost ali občutek teže v čeljusti, ali če se vam je razmajal zob; · pred invazivnimi posegi v zobozdravstvu in oralni kirurgiji povejte svojemu zobozdravniku, da se zdravite z zdravilom Avastin, še posebej, če prejemate ali ste prejemali injekcije difosfonata v kri.
Hypertension a,b
hemoptizaa,b,
Paclitaxel (n=243)
paklitaksel (n = 243)
The trial met its primary objective of OS improvement.
Preskušanje je doseglo primarni cilj: podaljšanje celokupnega preživetja.
including pulmonary embolism (NCI-CTCAE v.3).
O venskih trombemboličnih neželenih učinkih stopnje 3 do 5 (NCI-CTCAE v.3) so poročali pri do
Topotecan+ Paclitaxel vs. Cisplatin+ Paclitaxel
Topotekan + paklitaksel proti cisplatin + paklitaksel
In addition, a prespecified analysis of the data censoring for CA-125 progression events was conducted, as well as an independent review of PFS as determined by radiological scans.
Opravljen je bil tudi neodvisni pregled preživetja brez napredovanja bolezni, ki je bilo določeno z radiološkimi posnetki.
• GOG-0213 evaluated the efficacy and safety of bevacizumab in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
· Preskušanje GOG-0213 je ocenjevalo učinkovitost in varnost bevacizumaba v kombinaciji s karboplatinom in paklitakselom, ki jim je sledil bevacizumab samostojno, pri bolnicah s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, občutljivega na platino.
• CP arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) every 3 weeks for 6 and up to 8 cycles.
Skupaj so randomizirali 673 bolnic v enakih deležih v naslednji dve skupini: · skupina CP: karboplatin (AUC5) in paklitaksel (175 mg/m2 intravensko) vsake 3 tedne, od 6 do največ 8 ciklov.
Effect of antineoplastic agents on bevacizumab pharmacokinetics No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses.
Populacijske farmakokinetične analize so pokazale, da klinično pomembnega medsebojnega delovanja sočasno dane kemoterapije na farmakokinetiko bevacizumaba ni.
b
V
<2D barcode carrying the unique identifier included.>
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
In study BO25041 of Avastin added to postoperative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with Avastin.
V študiji BO25041 z zdravilom Avastin, dodanim pooperativni radioterapiji s sočasno in adjuvantno uporabo temozolomida pri pediatričnih bolnikih z novo diagnosticiranim supratentorialnim,
In a trial of patients with persistent, recurrent or metastatic cervical cancer, the incidence of GI-vaginal fistulae was 8.3% in Avastin-treated patients and 0.9% in control patients, all of whom had a history of prior pelvic radiation.
Fistule med prebavili in nožnico v študiji GOG-0240 V preskušanju pri bolnicah z rakom materničnega vratu, pri katerih je bila bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je bila metastatska, je bila incidenca fistul med prebavili in nožnico 8,3 % med prejemnicami zdravila Avastin in 0,9 % pri bolnicah v kontrolni skupini; vse te bolnice so imele v anamnezi obsevanje medeničnega predela.
CT (n=144)
kemoterapija (n = 144)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
PODATKI NA ZUNANJI OVOJNINI Škatla
Thromboembolism (arterial)b,d, Haemorrhageb,d,
Žilne bolezni hipertenzijaa,b arterijska trombembolijaa,b, krvaviteva,b,
You must not use this medicine if you are pregnant.
Nosečnost, dojenje in plodnost Če ste noseči, tega zdravila ne smete prejemati.
If this happens you should talk to your doctor, pharmacist or nurse immediately.
Če se to zgodi, se takoj posvetujte s svojim zdravnikom,
• CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration
· skupina CPB: karboplatin (AUC5) in paklitaksel (175 mg/m2 intravensko) ter sočasno zdravilo
● Superiority of the Avastin-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 (ITT - intent to treat population), je bilo v celokupni primerjavi glede na preživetje brez napredovanja bolezni dokazano, da so skupine, ki so prejemale zdravilo Avastin, superiorne skupinam, ki so prejemale samo kemoterapijo (preglednica 7).
When used for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, it will be administered in combination with carboplatin and paclitaxel.
Kadar ga uporabljamo pri bolnicah z epitelijskim rakom jajčnikov, karcinomom jajcevodov ali primarnim rakom potrebušnice,
What Avastin looks like and contents of the pack Avastin is a concentrate for solution for infusion.
Izgled zdravila Avastin in vsebina pakiranja
difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2%
· zaradi primerljive incidence, opažene med preiskovanimi skupinami v kliničnih preskušanjih (z najmanj 10-% razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 1 do 5 po lestvici NCI-CTCAE ali najmanj 2-% razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 3 do 5 po lestvici NCI-CTCAE);
• redness, peeling, tenderness, pain, or blistering on the fingers or feet,
· rdečina, luščenje, občutljivost, bolečina ali pojav mehurjev na prstih ali nogah, · zmanjšano število rdečih krvnih celic,
How to store Avastin
Shranjevanje zdravila Avastin
Overall survival Median (months) Hazard ratio 95% CI
Celokupno preživetje mediana (meseci) razmerje ogroženosti 95-% interval zaupanja
Two large Phase III trials were designed to investigate the treatment effect of Avastin in combination with two individual chemotherapy agents, as measured by the primary endpoint of PFS. A clinically meaningful and statistically significant improvement in PFS was observed in both trials.
Za preučevanje učinka zdravljenja z zdravilom Avastin v kombinaciji z dvema posameznima kemoterapevtskima zdraviloma sta bili zasnovani dve veliki preskušanji faze III, v katerih je bil primarni cilj preživetje brez napredovanja bolezni (PFS, progression free survival).
Number of patients Overall survival Median time (months) 95% CI Hazard ratiob
Število bolnikov Celokupno preživetje mediana (meseci) 95-% interval zaupanja razmerje ogroženostib
Dehydration
Krvavitev
Avastin is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
Zdravilo Avastin se uporablja tudi za zdravljenje odraslih bolnic z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska.
The overall mean age was 59.4 years; 56.6% of patients had an ECOG
Celokupna povprečna starost je bila 59,4 let;
• Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516)
Spodaj so povzeti rezultati PFS za posamezno kemoterapevtsko zdravilo, ki je del indikacije: · študija E2100 (paklitaksel) · mediana podaljšanja PFS 5,6 meseca, razmerje ogroženosti 0,421 (p < 0,0001, 95-% interval zaupanja 0,343; 0,516)
Ovarian failure/fertility (see sections 4.4 and 4.6)
Kombinacija z zdravljenjem na osnovi platine ali taksanov (glejte poglavji 4.4 in 4.8)
Diarrhoea, Nausea, Vomiting, Abdominal pain
Bolezni prebavil diareja, navzea, bruhanje,
• CPB15+ arm: Five cycles of Avastin (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by continued use of Avastin (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy.
· CPB15+ skupina: pet ciklov zdravila Avastin (15 mg/kg telesne mase enkrat na 3 tedne, z začetkom v ciklu 2) v kombinaciji s karboplatinom (AUC 6) in 6 cikli paklitaksela
• dry skin, flaking and inflammation of the skin, change in skin colour,
· motnje v govoru, · spremembe v okušanju, · izcedek iz nosu, · suho kožo, luskavost in vnetje kože, spremembo barve kože, · hujšanje, · krvavitve iz nosu.
Overall approximately 50% of patients had a GOG PS of 0 at baseline, 43% a GOG PS score of 1, and 7% a GOG PS score of 2.
50 % bolnic, status zmogljivosti (PS, performance status) po GOG (Gynecologic Oncology Group) ocenili z 0; 43 % so ga ocenili z 1, 7 % bolnicam pa z 2.
0.613 [CI: 0.521, 0.721]
0,613 [IZ: 0,521; 0,721]
Hazard ratio (95% confidence interval)
Celokupno preživetje b razmerje ogroženosti (95-% interval zaupanja)
CT+BV (n=179)
kemoterapija + bevacizumab (n = 179)
• CPP arm: Five cycles of placebo (started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
(AUC 6) in 6 cikli paklitaksela (175 mg/m2), katerim je sledil samo placebo do skupno 15 mesecev zdravljenja.
The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarized in Table 24.
Eksplorativne analize preživetja brez napredovanja bolezni in celokupnega preživetja glede na uporabljeno kemoterapijo (paklitaksel, topotekan ali PLD) so povzete v preglednici
Avastin/IFN) received a variety of non-specified post-trial anti-cancer therapies, including antineoplastic agents, which may have impacted the analysis of overall survival.
Visok delež bolnikov (približno 63 % interferon/placebo; 55 % Avastin/placebo) je po zaključku študije prejemal različna nespecificirana zdravljenja novotvorb, vključno z antineoplastičnimi zdravili, kar je lahko imelo vpliv na analizo celokupnega preživetja.
The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Priporočeni odmerek zdravila Avastin je 15 mg/kg telesne mase v enkratnem odmerku na 3 tedne, v obliki intravenske infuzije.
Very Common
Pogosti
Number of patients Overall survival Median (months) 95% CI
Število bolnikov Celokupno preživetje mediana (meseci) razmerje ogroženosti (95-% interval zaupanja)
Renal thrombotic microangiopathya,b,
globoka venska tromboza renalna trombotična mikroangiopatija a,b, anevrizme in disekcije arterij
Table 2: Severe Adverse Reactions by Frequency System organ class
Hudi neželeni učinki po pogostnosti
60 years in CPP and CPB15 arms and 59 years in CPB15+ arm; and 29% of patients in CPP or CPB15 and 26% in CPB15+ were over 65 years of age.
Večina bolnic, vključenih v študijo, je bila belk (87 % v vseh treh skupinah); mediana starosti je bila 60 let v CPP in CPB15 skupini ter 59 let v CPB15+ skupini.
Paclitaxel (n=273)
paklitaksel (n = 273)
Eight hundred and thirteen patients were randomised to receive IFL + placebo (Arm 1) or IFL + Avastin (5 mg/kg every 2 weeks, Arm 2).
Randomiziranih je bilo 813 bolnikov, ki so prejeli IFL + placebo (skupina 1) ali
Avastin vs. No Avastin
Avastin proti brez zdravila Avastin
Number of patients Overall survival Median time (months) 95% CI Hazard ratioc p-value
mediana celokupnega preživetja (meseci) razmerje ogroženosti (95-% interval zaupanja) p-vrednost
MARKETING AUTHORISATION HOLDER
Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
Median (months) Hazard ratio [95% CI]
mediana (meseci) razmerje ogroženosti [95-% interval zaupanja]
Peripheral sensory neuropathy a
Interferon alfa-2a so prejemali do
Osteonecrosis of the jaw (ONJ) (see section 4.8)
Osteonekroza čeljustnic (glejte poglavje 4.8)
Median (months) Hazard ratio (95% CI) p-value
Mediana (meseci) Razmerje ogroženosti (95-% interval zaupanja) p-vrednost
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), grade 3-5 infections have been reported in up to 24% of patients treated with Avastin in combination with paclitaxel and topotecan compared with up to 13% of patients treated with paclitaxel and topotecan.
so o okužbah stopnje 3 do 5 poročali pri do 24 % bolnic, ki so prejemale zdravilo Avastin v kombinaciji s paklitakselom in topotekanom, in pri do 13 % bolnic, ki so prejemale paklitaksel in topotekan.
BO17707 was a Phase III, two arm, multicentre, randomised, controlled, open-label study comparing the effect of adding Avastin to carboplatin plus paclitaxel in patients with FIGO stage I or IIA (Grade
BO17707 je bila multicentrična, randomizirana, kontrolirana, odprta študija faze III, ki je vključevala dve skupini, kjer so primerjali učinek dodajanja zdravila Avastin h karboplatinu in paklitakselu po operaciji, pri bolnicah z epitelijskim rakom jajčnikov, primarnim peritonealnim karcinomom ali karcinomom jajcevodov stadija I ali II A po klasifikaciji FIGO (stopnje 3 ali s samo čisto celično histologijo; n = 142) ali stadija II B - IV po klasifikaciji FIGO (vse stopnje in vsi histološki tipi, n = 1386) (NCI-CTCAE v.3).
● an abnormal tube-like connection or passage between the windpipe and the gullet, between internal organs and skin, between the vagina and any parts of the gut or between other tissues that are not normally connected (fistula), and are judged by your doctor to be severe,
ali če se krvni tlak nenadoma zelo zviša, · beljakovine v seču, ki jih spremlja otekanje telesa, · predrtje stene črevesja, · neobičajna povezava ali prehod, podoben cevi, med sapnikom in požiralnikom, med notranjimi organi in kožo, med nožnico in katerim koli delom črevesa ali med drugimi tkivi, ki normalno niso povezani (fistula), in jih vaš zdravnik oceni kot resne, · resne okužbe kože ali globljih plasti pod kožo, · krvni strdek v arterijah, · krvni strdek v krvnih žilah pljuč, · kakršna koli huda krvavitev.
● If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Pomembno je namreč, da bo vaš krvni tlak pred začetkom zdravljenja z zdravilom Avastin ustrezno uravnan; · če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile;
Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of Avastin-treated patients.
Pri bolnikih, ki so prejemali le kemoterapijo, so neželene učinke opazili pri do 5 % bolnikov.
The percentage of patients with an ECOG PS of 1 or ≥ 2 was 38.7% and 5.0% in the CT arm, and 29.8% and 9.0% in the
V skupini s kemoterapijo in bevacizumabom je imelo 29,8 % bolnic stanje zmogljivosti po ECOG 1, 9,0 % bolnic pa stanje zmogljivosti po ECOG ³ 2.
The recommended dose of Avastin, 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.
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.
No significant difference was observed in the duration of overall survival between patients who received Avastin monotherapy compared to patients treated with FOLFOX-4.
Med bolniki, ki so prejemali zdravilo Avastin kot samostojno zdravljenje, in bolniki, ki so jih zdravili po shemi FOLFOX-4, niso opazili pomembne razlike v trajanju celokupnega preživetja.
Oxaliplatin 85 mg/m2 IV 2 h Oxaliplatin on day 1 Leucovorin on day 1 and 2
Oksaliplatin 85 mg/m i.v.
• changes in speech,
· spremembo glasu in hripavost.