FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • bleeding, including bleeding in the lungs in patients with non-small cell lung cancer,
Slovenian: vključujejo: · perforacijo črevesja, · krvavitev, vključno s krvavitvijo v pljučih pri bolnikih z nedrobnoceličnim rakom pljuč,
English: A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Avastin.
Slovenian: Pred začetkom zdravljenja z zdravilom Avastin je treba razmisliti o pregledu zobovja in primernih preventivnih zobozdravstvenih posegih.
English: Cervical Cancer
Slovenian: Rak materničnega vratu
English: • blocking of the veins of the legs by a blood clot,
Slovenian: · zamašitev ven v nogah s krvnim strdkom,
English: • sickness,
Slovenian: bolečina,
English: ● your doctor will decide when you should be given your next dose of Avastin.
Slovenian: Če je bil odmerek zdravila Avastin izpuščen: · bo vaš zdravnik odločil o tem, kdaj boste prejeli naslednji odmerek tega zdravila.
English: Avastin is also used for the treatment of adult patients with metastatic breast cancer.
Slovenian: Zdravilo Avastin uporabljamo tudi za zdravljenje odraslih bolnikov z metastatskim rakom dojk.
English: Hypersensitivity, infusion reactionsa,b,d
Slovenian: reakcije pri infundiranjua,b,d
English: • loss of appetite,
Slovenian: · zaprtje, · izgubo apetita, · zvišano telesno temperaturo,
English: Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with Avastin.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Avastin, so redko poročali o nekrotizirajočem fasciitisu, vključno s smrtnimi primeri.
English: Method and route of administration
Slovenian: Način in pot dajanja
English: Table 1: Adverse Reactions by Frequency
Slovenian: Neželeni učinki po pogostnosti
English: (p-value = 0.0062)
Slovenian: (p-vrednost = 0,0062)
English: 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.
Slovenian: 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.
English: Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.
Slovenian: Po intravitrealni injekciji zaviralcev VEGF so poročali o sistemskih neželenih učinkih, vključno s krvavitvijo izven predela oči in arterijskimi tromboemboličnimi neželenimi učinki.
English: Each 4 ml vial contains 100 mg of bevacizumab.
Slovenian: Ena 4 ml viala vsebuje 100 mg bevacizumaba.
English: 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).
Slovenian: 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).
English: Posology
Slovenian: Odgovor
English: 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.
Slovenian: 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.
English: The rate of infusion was based on tolerability, with an initial infusion duration of 90 minutes.
Slovenian: 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.
English: If the first infusion is well tolerated, the second infusion may be administered over 60 minutes.
Slovenian: Če je bolnik prvi odmerek dobro prenesel, lahko naslednjo infuzijo dajemo 60 minut.
English: 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.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT Avastin 25 mg/ml concentrate for solution for infusion.
Slovenian: IME ZDRAVILA Avastin 25 mg/ml koncentrat za raztopino za infundiranje
English: • constipation,
Slovenian: · srčno popuščanje,
English: What you need to know before you use Avastin
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Avastin Zdravila Avastin ne smete prejemati:
English: 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.
Slovenian: 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.
English: Progression-free survivalb Investigator Assessment
Slovenian: Preživetje brez napredovanja bolezni Ocena raziskovalca
English: Wound healing complications (see section 4.8)
Slovenian: Zapleti pri celjenju ran (glejte poglavje 4.8)
English: • diarrhoea,
Slovenian: Bolezni jeter,
English: In patients with NSCLC excluding predominant squamous histology, all Grade reactions were seen with a frequency of up to 9.3% when treated with Avastin plus chemotherapy compared with up to 5% in the patients treated with chemotherapy alone.
Slovenian: Pri bolnikih z nedrobnoceličnim rakom pljuč so, razen pri predominantni skvamozni histologiji, neželene učinke vseh stopenj opazili s pogostnostjo do 9,3 %, če so jih zdravili z zdravilom Avastin in kemoterapijo.
English: * Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm
Slovenian: ** Primarna analiza kliničnih podatkov zbranih do 31. januarja 2006.
English: Oxaliplatin 130 mg/m2 IV 2 h Oxaliplatin on day 1 Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
Slovenian: 2 h oksaliplatin 1. dan kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1-tedenski odmor)
English: Osteonecrosis of the jawa,b Non-mandibular osteonecrosisa,f
Slovenian: osteonekroza izven spodnje čeljustnicea,f
English: ● you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Slovenian: · če ste alergični (preobčutljivi) na celične produkte ovarija kitajskega hrčka (CHO - Chinese
English: Enrolment in Arm 3 was discontinued, as pre-specified, once safety of Avastin with the IFL regimen was established and considered acceptable.
Slovenian: Ko je bila varnost kombinacije IFL in zdravila Avastin dokazana in sprejeta, je bilo vključevanje v tretjo skupino prekinjeno, kot je bilo že prej predvideno.
English: CT (n=182)
Slovenian: kemoterapija (n = 182)
English: 95% CI
Slovenian: 5,5-NR
English: The recommended dose of Avastin is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila Avastin je 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna ali 15 mg/kg telesne mase v enkratnem odmerku vsake 3 tedne, v obliki intravenske infuzije.
English: The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab treated patients in the FOLFOX treatment subgroup, HR=0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Slovenian: Pri podskupini bolnikov, ki so prejemali zdravljenje po shemi XELOX, je mediana celokupnega preživetja znašala 19,2 meseca, če so prejemali placebo, in 21,4 meseca, če so se zdravili z bevacizumabom; razmerje ogroženosti = 0,84; 97,5-% interval zaupanja = [0,68; 1,04]; p-vrednost = 0,0698.
English: Paclitaxel/ Avastin (n=252)
Slovenian: paklitaksel/Avastin (n = 252)
English: As Avastin may adversely impact wound healing, patients who had major surgery within the last 28 days were excluded from participation in phase III clinical trials.
Slovenian: Bolniki, ki so imeli večjo operacijo v zadnjih 28 dneh pred pričetkom zdravljenja, niso bili vključeni v klinična preskušanja faze III, saj lahko zdravilo Avastin negativno vpliva na celjenje ran.
English: (p-value = 0.0012)
Slovenian: (p-vrednost = 0,0012)
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) were treated with post operative radiation therapy (RT) and adjuvant temozolomide (T) with and without bevacizumab: 10 mg/kg every 2 weeks IV.
Slovenian: V randomizirani študiji faze II (BO25041) so s pooperativno radioterapijo in adjuvantnim temozolomidom v kombinaciji z intravenskim bevacizumabom (v odmerku 10 mg/kg vsaka dva tedna) ali brez njega zdravili skupno 121 bolnikov, starih od ≥ 3 do < 18 let, z novo diagnosticiranim supratentorialnim ali infratentorialnim cerebralnim ali pedunkularnim gliomom visoke stopnje.
English: 7.5 mg/kg IV 30-90 min
Slovenian: 7,5 mg/kg i.v.
English: The recommended dose of Avastin when used in addition to erlotinib is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila Avastin, ko ga uporabljamo kot dodatek erlotinibu, je 15 mg/kg telesne mase v enkratnem odmerku na 3 tedne, v obliki intravenske infuzije.
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 raziskave, je bila v celokupni primerjavi glede na preživetje brez napredovanja bolezni in celokupno preživetje dokazana neinferiornost skupin, ki so se zdravile po shemi XELOX, v primerjavi s skupinami, ki so se zdravile po shemi FOLFOX-4.
English: • diarrhoea, nausea, vomiting and abdominal pain.
Slovenian: · utrujenost, · driska, slabost, bruhanje in bolečine v trebuhu.
English: (p-value = 0.0036)
Slovenian: (p-vrednost = 0,0036)
English: Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1).
Slovenian: 7,5 mg/kg telesne mase kot tudi za 15 mg/kg telesne mase (glejte poglavje 5.1).
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.8) Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with Avastin.
Slovenian: Venska trombembolija (glejte poglavje 4.8) Med zdravljenjem z zdravilom Avastin so bolniki lahko podvrženi povečanemu tveganju za razvoj venskih trombemboličnih neželenih učinkov, vključno s pljučno embolijo.
English: • CPB7.5+ arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks plus Avastin (7.5 mg/kg q3w) for up to 12 months (Avastin was started at cycle 2 of chemotherapy if treatment was initiated within 4 weeks of surgery or at cycle 1 if treatment was initiated more than 4 weeks after surgery).
Slovenian: Skupno je bilo randomiziranih 1528 bolnic v enakih razmerjih v naslednji dve skupini: · CP skupina: 6 tritedenskih ciklov karboplatina (AUC 6) in paklitaksela (175 mg/m2) · CPB7,5 + skupina: 6 tritedenskih ciklov karboplatina (AUC 6) in paklitaksela (175 mg/m2) ter zdravila Avastin (7,5 mg/kg telesne mase enkrat na 3 tedne) do 12 mesecev (zdravljenje z zdravilom Avastin se je začelo pri drugem ciklu kemoterapije, če se je s terapijo začelo v prvih 4 tednih po operaciji ali pri prvem ciklu, če se je s terapijo začelo več kot 4 tedne po operaciji).
English: • AVF4095g evaluated the efficacy and safety of bevacizumab in combination with carboplatin and gemcitabine, followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Slovenian: · Preskušanje AVF4095g je ocenjevalo učinkovitost in varnost bevacizumaba v kombinaciji s karboplatinom in gemcitabinom, ki jim je sledil bevacizumab samostojno, pri bolnicah s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, občutljivega na platino.
English: The addition of bevacizumab to fluoropyrimidine-based chemotherapy resulted in a statistically significant prolongation of survival in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen (ITT = 819) (see Table 9).
Slovenian: Dodatek bevacizumaba kemoterapiji na osnovi fluoropirimidina je statistično značilno podaljšal preživetje pri bolnikih z metastatskim rakom debelega črevesa in danke, pri katerih je po prvi liniji zdravljenja, ki je vključevalo bevacizumab,
English: You could also experience redness or flushing of the skin or a rash, chills and shivering, feeling sick (nausea) or being sick (vomiting).
Slovenian: Med znaki so lahko: težave pri dihanju ali bolečina v prsnem košu; lahko se pojavi tudi rdečina ali pordevanje kože ali izpuščaj, mrazenje in drgetanje, slabost ali bruhanje.
English: • MO22224 evaluated the efficacy and safety of bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Slovenian: · Preskušanje MO22224 je ocenjevalo učinkovitost in varnost bevacizumaba v kombinaciji s paklitakselom, topotekanom ali pegiliranim liposomalnim doksorubicinom pri bolnicah s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, rezistentnega na platino.
English: % pts with objective response p-value
Slovenian: % bolnic z objektivnim odgovorom p-vrednost
English: Paclitaxel/ Avastin (n=229)
Slovenian: paklitaksel/Avastin (n = 229)
English: Grade 3-5 (NCI-CTCAE v.3) venous thromboembolic reactions have been reported in up to 7.8% of patients treated with chemotherapy plus bevacizumab compared with up to 4.9% in patients treated with chemotherapy alone (across indications, excluding persistent, recurrent, or metastatic cervical cancer).
Slovenian: 7,8 % bolnikov, ki so jih zdravili s kemoterapijo in bevacizumabom, v primerjavi z do 4,9 % pri bolnikih, ki so jih zdravili samo s kemoterapijo (pri vseh indikacijah, razen pri bolnicah z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska).
English: Progression-free survival
Slovenian: Preživetje brez napredovanja bolezni
English: Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Slovenian: Bevacizumab je v kombinaciji s karboplatinom in gemcitabinom ali v kombinaciji s karboplatinom in paklitakselom indiciran za zdravljenje odraslih bolnic, pri katerih je prišlo do prve ponovitve epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma,
English: 7.5% of patients in the Chemo+Avastin group over the age of 65 years.
Slovenian: 26 % v CPB15+ skupini je bilo starih več kot 65 let.
English: A GOG PS of 2 at baseline was reported in 0.9% of patients in the CP arm and in 1.2% of patients in the CPB arm.“ The primary efficacy endpoint was overall survival (OS).
Slovenian: O izhodiščnem stanju zmogljivosti po GOG 2 so poročali pri 0,9 % bolnic v skupini CP in pri 1,2 % bolnic v skupini CPB.
English: Hazard ratio Best overall response ratea
Slovenian: razmerje ogroženosti Najboljši celokupni odgovor delež a
English: Paclitaxel (n=354)
Slovenian: paklitaksel (n = 354)
English: Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
Slovenian: Zdravljenje opustimo pri bolnikih, pri katerih se je pojavila perforacija prebavil.
English: An increased incidence of CHF has been observed in a clinical trial of patients with diffuse large Bcell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
Slovenian: V kliničnem preskušanju, ki je vključevalo bolnike z difuznim velikoceličnim B limfomom, ki so prejemali bevacizumab skupaj s kumulativnim odmerkom doksorubicina, ki je presegal 300 mg/m2, so opazili večjo incidenco kongestivnega srčnega popuščanja.
English: This was a phase II randomised, active-controlled, open-labelled clinical trial investigating Avastin in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer.
Slovenian: To je bilo randomizirano, aktivno kontrolirano, odprto klinično preskušanje faze II, v katerem so proučevali kombinacijo zdravila Avastin s 5-FU/FA kot prvo linijo zdravljenja metastatskega raka debelega črevesa in danke.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Slovenian: Skupina 1 karboplatin in paklitaksel
English: • blocking of the arteries by a blood clot,
Slovenian: · zamašitev arterij s krvnim strdkom, · zamašitev ven s krvnim strdkom,
English: ● Keep this leaflet.
Slovenian: · Navodilo shranite.
English: weeks (n=39), 10 mg/kg every 2 weeks; (n=37), or placebo (n=40).
Slovenian: (n = 37) in v skupino, ki je prejemala placebo (n = 40).
English: • The primary analysis of investigator-assessed PFS (censoring for CA-125 progressions and NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.52-0.75, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 12.0 months in the CPP arm and 18.2 months in the CPB15+ arm.
Slovenian: · Primarna analiza preživetja brez napredovanja bolezni, ocenjena s strani raziskovalca (s krnjenimi podatki za napredovanje bolezni glede na CA 125 in zdravljenja, ki ni bilo v skladu s protokolom) kaže stratificirano razmerje ogroženosti 0,62 (95-% interval zaupanja: 0,520,75; p-vrednost za enostranski log rank test < 0,0001) ko primerjamo CPB15+ s CPP, z mediano preživetja brez napredovanja bolezni 12,0 mesecev v CPP skupini in 18,2 meseca v CPB15+ skupini.
English: • symptoms that suggest changes in normal brain function (headaches, vision changes, confusion, or seizures), and high blood pressure,
Slovenian: · negativni učinek na zmožnost zanositve (za nadaljnje informacije glejte spodaj), · bolezen možgan s simptomi, ki vključujejo epileptični napad, glavobol, zmedenost in spremembe vida (sindrom posteriorne reverzibilne encefalopatije ali PRES), · simptomi, ki nakazujejo spremembe v normalnem delovanju možganov (glavoboli, spremembe vida, zmedenost ali epileptični napadi) in visok krvni tlak,
English: In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Avastin.
Slovenian: Če se pri bolniku pojavi sindrom posteriorne reverzibilne encefalopatije, je poleg prekinitve zdravljenja z zdravilom Avastin priporočljivo zdravljenje specifičnih simptomov, vključno z uravnavo hipertenzije.
English: The recommended dose of Avastin is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila Avastin je 7,5 mg/kg telesne mase ali 15 mg/kg telesne mase v enkratnem odmerku na 3 tedne, v obliki intravenske infuzije.
English: Study JO25567 was a randomized, open-label, multi-center Phase II study conducted in Japan to evaluate the efficacy and safety of Avastin used in addition to erlotinib in patients with non-squamous NSCLC with EGFR activating mutations (exon 19 deletion or exon 21 L858R mutation) who had not received prior systemic therapy for Stage IIIB/IV or recurrent disease.
Slovenian: Študija JO25567 je bila randomizirana, odprta, multicentrična študija faze II, izvedena na Japonskem, v kateri so ocenjevali učinkovitost in varnost zdravila Avastin, uporabljenega kot dodatek erlotinibu pri bolnikih z neskvamoznim nedrobnoceličnim rakom pljuč z EGFR-aktivirajočimi mutacijami
English: Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1250 mg/m2 intravenous infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with Avastin at a dose of 7.5 or 15 mg/kg IV infusion day 1 of every 3-week cycle.
Slovenian: Randomizirani bolniki so prejeli kemoterapijo na osnovi platine, cisplatin 80 mg/m2 v obliki intravenske infuzije na dan 1 in gemcitabin 1250 mg/m2 v obliki intravenske infuzije na dneva 1 in 8
English: Median PFS (months) Hazard ratio (95% CI)
Slovenian: mediana PFS (meseci) razmerje ogroženosti (95-% IZ)
English: Difference in Response Rates 95% CI for Difference in Response Rates4
Slovenian: 95-% IZ za razliko v deležih odgovora na zdravljenje
English: Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Slovenian: Zdravilo Avastin uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim rakom pljuč.
English: This was a phase III randomised, active-controlled, open-label trial investigating Avastin 10 mg/kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second line) with advanced colorectal cancer.
Slovenian: Avastin v odmerku 10 mg/kg v kombinaciji z levkovorinom in bolusom 5-fluorouracila, sledila je infuzija 5-fluorouracila z oksaliplatinom intravensko (shema FOLFOX-4) pri bolnikih z napredovalim rakom debelega črevesa in danke, ki so bili predhodno zdravljeni (druga linija).