FrancophonIA/ELRC3.0 huggingface dataset:
English: MVASI is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Slovenian: Zdravilo MVASI se uporablja v kombinaciji z eno od naslednjih shem kemoterapije: paklitaksel in cisplatin ali paklitaksel in topotekan.
English: Each pack of MVASI contains one vial.
Slovenian: Vsako pakiranje zdravila MVASI vsebuje 1 vialo.
English: MVASI is a biosimilar medicinal product.
Slovenian: Zdravilo MVASI je podobno biološko zdravilo.
English: • dry mouth in combination with thirst and/or reduced or darkened urine,
Slovenian: • suha usta v kombinaciji z žejo in/ali manjšim izločanjem seča ali temnejši seč,
English: Clinical safety data suggest that the incidence of hypertension is likely to be dose-dependent.
Slovenian: Podatki o klinični varnosti kažejo, da je incidenca hipertenzije najverjetneje odvisna od odmerka zdravila.
English: The majority of the patients in each treatment arm (74% and 71%) had poorly differentiated (grade 3)
Slovenian: Večina bolnic v vsaki skupini (74 % in 71 %) je imela pred začetkom zdravljenja slabo diferenciran (stopnje 3) primarni tumor.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po razredčitvi.
English: • if you develop severe high blood pressure requiring treatment with blood pressure medicines,
Slovenian: • če se pojavi zelo visok krvni tlak, ki ga je treba zdraviti z zdravili proti zvišanemu krvnemu tlaku,
English: MVASI has been developed and made to treat cancer by injecting it into the bloodstream.
Slovenian: Zdravilo MVASI so razvili in izdelali za zdravljenje raka in injiciranje v krvni obtok.
English: FOLFOX-4 or XELOX + placebo (n = 701)
Slovenian: FOLFOX-4 ali XELOX + placebo (n = 701)
English: • symptoms that suggest changes in normal brain function (headaches, vision changes, confusion, or seizures), and high blood pressure,
Slovenian: • simptomi, ki nakazujejo spremembe v normalnem delovanju možganov (glavoboli, spremembe vida, zmedenost ali epileptični napadi) in visok krvni tlak,
English: The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p = 0.1789), duration of objective response (6.7 vs. 9.1 months) or time to symptom progression (HR = 1.172; p = 0.5076).
Slovenian: Dodatek erlotiniba bevacizumabu ni prispeval k izboljšanju celokupnega preživetja (HR = 1,764; p = 0,1789), trajanja objektivnega odgovora na zdravljenje (6,7 v primerjavi z 9,1 meseca) ali časa do napredovanja simptomov (HR = 1,172; p = 0,5076).
English: MVASI must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Slovenian: Zdravilo MVASI je treba dajati pod nadzorom zdravnika z izkušnjami pri uporabi zdravil za zdravljenje novotvorb.
English: Most patients in both the CP arm (80.4%) and the CPB arm (78.9%) were white.
Slovenian: Večina bolnic tako v skupini CP (80,4 %) kot v skupini CPB (78,9 %) je bila belk.
English: Post-marketing adverse reactions are included in both tables 1 and 2, where applicable.
Slovenian: Neželeni učinki, opisani po prihodu zdravila na trg, so vključeni v preglednico 1 in 2, kjer je ustrezno.
English: In situations where early discontinuation of chemotherapy was required, treatment with bevacizumab as a single agent continued until disease progression.
Slovenian: V primerih, kjer je bila potrebna zgodnja ukinitev kemoterapije, so do napredovanja bolezni zdravljenje nadaljevali le z bevacizumabom.
English: • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Slovenian: • razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
English: Efficacy results for trials AVF0780g and AVF2192g
Slovenian: Rezultati učinkovitosti iz preskušanj AVF0780g in AVF2192g AVF0780g
English: Most patients were FIGO stage III (both 68%) followed by FIGO stage IV (13% and 14%), FIGO stage II (10% and 11%) and FIGO stage I (9% and 7%).
Slovenian: Večina bolnic je imela po FIGO klasifikaciji bolezen stadija III (v obeh skupinah 68 %), sledile so bolnice s stadijem IV po FIGO klasifikaciji (13 % in 14 %), stadijem II po FIGO klasifikaciji (10 % in 11 %) in stadijem I po FIGO klasifikaciji (9 % in 7 %).
English: If you have headache, vision changes, confusion or seizure with or without high blood pressure, please contact your doctor.
Slovenian: Če imate glavobol, spremembe vida, ste zmedeni ali imate epileptični napad z visokim krvnim pritiskom ali brez njega, obvestite svojega zdravnika.
English: • problems with wound healing after surgery,
Slovenian: • težave s celjenjem ran po operaciji,
English: MVASI should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
Slovenian: Zdravilo MVASI mora pripraviti zdravstveno osebje v aseptičnih pogojih, da zagotovi sterilnost pripravljene raztopine.
English: Assessment of bevacizumab metabolism in rabbits following a single IV dose of 125I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Slovenian: Ocena presnove pri kuncih po enkratnem intravenskem odmerku 125I-bevacizumaba je pokazala, da ima bevacizumab podoben presnovni profil kot pričakovani za nativne molekule IgG, ki se ne vežejo na VEGF.
English: No incompatibilities between MVASI and polyvinyl chloride or polyolefin bags or infusion sets have been observed.
Slovenian: Med zdravilom MVASI in polivinil kloridom ali poliolefinskimi vrečkami ali infuzijskimi seti ni bilo inkompatibilnosti.
English: In this trial, there were two primary objectives: to show that XELOX was non-inferior to FOLFOX-4 and to show that bevacizumab in combination with FOLFOX-4 or XELOX chemotherapy was superior to chemotherapy alone.
Slovenian: V tem preskušanju sta bila primarna cilja dva: pokazati, da je shema XELOX neinferiorna shemi FOLFOX-4, in da je bevacizumab v kombinaciji s kemoterapevtskima shemama FOLFOX-4 ali XELOX superiorno samostojni kemoterapiji.
English: • MVASI may increase the risk of developing serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing.
Slovenian: • zdravilo MVASI lahko poveča tveganje za nastanek resnih okužb kože ali globljih plasti pod kožo, še posebej, če se vam je stena črevesja preluknjala ali ste imeli težave pri celjenju ran.
English: Across clinical trials, the following grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patients treated with bevacizumab with at least a 2% difference compared to the corresponding control groups: hyperglycaemia, decreased haemoglobin, hypokalaemia, hyponatraemia, decreased white blood cell count, increased international normalised ratio (INR).
Slovenian: Naslednje laboratorijske nepravilnosti stopnje 3 in 4 (NCI-CTCAE v.3) so se v kliničnih preskušanjih pri bolnikih, ki so se zdravili z bevacizumabom, v primerjavi z ustreznimi kontrolnimi skupinami pojavile z najmanj 2-% razliko: hiperglikemija, zmanjšana koncentracija hemoglobina, hipokaliemija, hiponatriemija, zmanjšano število belih krvnih celic, zvečano internacionalno normalizirano razmerje.
English: Immune system disorders Hypersensitivity reactions and infusion reactions (not known); with the following possible co-manifestations: dyspnoea/difficulty breathing, flushing/redness/rash, hypotension or hypertension, oxygen desaturation, chest pain, rigors and nausea/vomiting (see also section 4.4 and Hypersensitivity reactions/infusion reactions above)
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije ter reakcije pri infundiranju (ni znana); z naslednjimi možnimi znaki: dispneja/težave pri dihanju, pordevanje/rdečina/izpuščaj, hipotenzija ali hipertenzija, zmanjšana saturacija s kisikom, bolečina v prsnem košu, okorelost ter navzea/bruhanje (glejte tudi poglavje 4.4 ter podnaslov Preobčutljivostne reakcije/reakcije pri infundiranju, zgoraj)
English: Very rare Frequency not known
Slovenian: Neznana pogostnost
English: Proteinuria ranged in severity from clinically asymptomatic, transient, trace proteinuria to nephrotic syndrome, with the great majority as grade 1 proteinuria (NCI-CTCAE v.3).
Slovenian: Proteinurija je po resnosti obsegala od klinično asimptomatske, prehodne, proteinurije v sledovih vse do nefrotskega sindroma, večinoma pa je bila proteinurija stopnje 1 (NCI-CTCAE v.3).
English: The clinical benefit, as measured by overall survival, was seen in all prespecified patient subgroups, including those defined by age, sex, performance status, location of primary tumour, number of organs involved and duration of metastatic disease.
Slovenian: Klinična korist, katere merilo je bilo celokupno preživetje, se je pokazala pri vseh že prej izbranih podskupinah, vključno s podskupinami, osnovanimi glede na starost, spol, splošno stanje zmogljivosti, lokalizacijo primarnega tumorja, število prizadetih organov in trajanje metastatske bolezni.
English: • a hole in the cartilage wall separating the nostrils of the nose,
Slovenian: • predrtje nosnega pretina (stena iz hrustanca, ki ločuje nosnici),
English: During the trial, of the patients who received trial treatment, 32.2% (136/422) of patients received 7-12 administrations of bevacizumab and 21.1% (89/422) of patients received 13 or more administrations of bevacizumab.
Slovenian: Med preskušanjem je od bolnikov, ki so prejemali zdravilo v preskušanju, 32,2 % bolnikov (136/422) prejelo 7 do 12 odmerkov bevacizumaba, 21,1 % (89/422) bolnikov pa je prejelo 13 ali več odmerkov bevacizumaba.
English: The side effects listed below were seen when MVASI was given together with chemotherapy.
Slovenian: Neželene učinke, ki so navedeni spodaj, so opazili, ko so zdravilo MVASI dajali skupaj s kemoterapijo.
English: Do not use MVASI if:
Slovenian: Zdravila MVASI ne smete prejemati:
English: Permanently discontinue MVASI in patients with tracheoesophageal (TE) fistula or any grade 4 fistula [US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v.3)].
Slovenian: Pri bolnikih s traheoezofagealno fistulo ali katero koli fistulo stopnje 4 [US National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCI-CTCAE v.3)] zdravilo MVASI dokončno ukinemo.
English: Limited information is available on the continued use of bevacizumab in patients with other fistulae.
Slovenian: Za nadaljevanje uporabe bevacizumaba pri bolnikih z drugimi fistulami so na voljo le omejeni podatki.
English: A total of 452 patients were randomised to receive either:
Slovenian: Skupno 452 bolnic so randomizirali na prejemanje ene od naslednjih shem:
English: • you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični (preobčutljivi) na bevacizumab ali katero koli drugo sestavino tega zdravila
English: • a negative effect on a woman's ability to have children (see the paragraphs below the list of side effects for further recommendations),
Slovenian: • negativni učinek na zmožnost zanositve (za nadaljnje informacije glejte spodaj),
English: • PLD 40 mg/m2 as a 1 mg/min IV infusion on day 1 only every 4 weeks.
Slovenian: PLD 40 mg/m2 kot intravenska infuzija s hitrostjo 1 mg/min samo 1. dan vsake 4 tedne.
English: • MVASI can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Slovenian: • zdravilo MVASI lahko poveča tveganje za krvavitve ali poveča tveganje za težave pri celjenju ran po operaciji.
English: In two clinical trials of metastatic renal cell carcinoma, microangiopathic haemolytic anaemia (MAHA) was reported in 7 of 19 patients treated with bevacizumab (10 mg/kg every two weeks) and sunitinib malate (50 mg daily) combination.
Slovenian: V dveh kliničnih preskušanjih metastatskega karcinoma ledvičnih celic so poročali o mikroangiopatični hemolitični anemiji pri 7 od 19 bolnikov, ki so jih zdravili s kombinacijo bevacizumaba (10 mg/kg na vsaka dva tedna) in sunitinibijevega malata (50 mg na dan).
English: Efficacy results for trial E3200
Slovenian: Rezultati učinkovitosti za preskušanje E3200
English: IgGs are known to cross the placenta, and bevacizumab is anticipated to inhibit angiogenesis in the foetus, and thus is suspected to cause serious birth defects when administered during pregnancy.
Slovenian: Znano je, da IgG prehajajo skozi placento, zato predvidevamo, da lahko bevacizumab povzroči zavrtje angiogeneze pri plodu in tako domnevno povzroča resne okvare ploda, če ga jemljejo nosečnice.
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: Klinična korist pri bolnikih z nedrobnoceličnim rakom pljuč je bila dokazana tako za odmerek 7,5 mg/kg telesne mase kot tudi za 15 mg/kg telesne mase (glejte poglavje 5.1).
English: 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.
Slovenian: 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, imeli krvavitev v osrednjem živčevju (vsi stopnje 4) pri zdravljenju z bevacizumabom, v primerjavi z 1 primerom (stopnja 5) od 96 bolnikov (1 %), ki niso bili izpostavljeni bevacizumabu.
English: Before you are given MVASI or while you are being treated with MVASI:
Slovenian: Preden začnete zdravljenje z zdravilom MVASI ali med zdravljenjem z njim:
English: In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving bevacizumab.
Slovenian: V kliničnih preskušanjih so o proteinuriji poročali v obsegu od 0,7 do 54,7 % bolnikov, zdravljenih z bevacizumabom.
English: • Study E2100 (paclitaxel) Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516)
Slovenian: • študija E2100 (paklitaksel) mediana podaljšanja PFS 5,6 meseca, razmerje ogroženosti 0,421 (p < 0,0001, 95-% interval zaupanja 0,343; 0,516)
English: In the bevacizumab-containing arms, patients could receive bevacizumab as a single agent every 3 weeks until disease progression or unacceptable toxicity.
Slovenian: V skupinah, ki sta prejemali bevacizumab, so bolniki lahko prejemali bevacizumab samostojno vsake 3 tedne do napredovanja bolezni ali do nesprejemljive toksičnosti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1246/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/17/1246/001
English: MVASI is for intravenous use.
Slovenian: Zdravilo MVASI je za intravensko uporabo.
English: • reduction in the number of white cells in the blood, and cells that help the blood clot,
Slovenian: • zmanjšanje števila belih krvničk in celic, ki pomagajo strjevati kri,
English: However, somnolence and syncope have been reported with bevacizumab use (see table 1 in section 4.8).
Slovenian: Vendar pa so pri uporabi bevacizumaba poročali o pojavu somnolence in sinkope (glejte preglednico 1 v poglavju 4.8).
English: Objective response rate1
Slovenian: Objektivni odgovor1
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.
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: The risk of bevacizumab-associated hypertension did not correlate with the patients' baseline characteristics, underlying disease or concomitant therapy.
Slovenian: Tveganje za pojav hipertenzije ob zdravljenju z bevacizumabom ni bilo povezano z osnovnimi značilnostmi bolnikov, spremljajočimi obolenji ali ostalo terapijo, ki so jo prejemali.
English: Eye disorders Eye disorder, Lacrimation increased
Slovenian: Očesne bolezni bolezni oči, povečano solzenje
English: ** Randomised patients with measurable disease at baseline.
Slovenian: ** Randomizirane bolnice, ki so izhodiščno imele merljivo bolezen.
English: Efficacy results from study GOG-0218
Slovenian: Rezultati učinkovitosti iz študije GOG-0218
English: Randomised patients stage III optimally debulked disease2,3
Slovenian: Randomizirane bolnice z optimalno citoredukcijo, stadija III2,3
English: Testing for proteinuria is recommended prior to start of MVASI therapy.
Slovenian: Testiranje za proteinurijo je priporočljivo pred začetkom zdravljenja z zdravilom MVASI.
English: There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurologic disorder, which can present with the following signs and symptoms among others: seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Slovenian: Pri bolnikih, ki so se zdravili z bevacizumabom, so redko poročali o pojavu znakov in simptomov, povezanih s sindromom posteriorne reverzibilne encefalopatije (PRES, Posterior Reversible Encephalopathy Syndrome), redko nevrološko motnjo, ki se lahko kaže tudi z naslednjimi znaki in simptomi: epileptični napad, glavobol, spremenjeni mentalni status, motnje vida ali kortikalna slepota s sočasno hipertenzijo ali brez nje.
English: • allergic reactions (the signs may include difficulty breathing, facial redness, rash, low blood pressure or high blood pressure, low oxygen in your blood, chest pain, or nausea/vomiting),
Slovenian: • alergijske reakcije (znaki lahko vključujejo težave pri dihanju; lahko se pojavi tudi rdečica obraza, izpuščaj, nizek ali visok krvni tlak, nizka raven kisika v vaši krvi, bolečina v prsnem košu ali slabost/bruhanje),
English: Severe adverse reactions by frequency
Slovenian: Hudi neželeni učinki po pogostnosti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1246/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/17/1246/002
English: In study JO25567, all grade hypertension was observed in 77.3% of the patients who received bevacizumab in combination with erlotinib as first-line treatment for non-squamous NSCLC with EGFR activating mutations, compared to 14.3% of patients treated with erlotinib alone.
Slovenian: V študiji JO25567 so hipertenzijo vseh stopenj opazili pri 77,3 % bolnikov, ki so prejemali bevacizumab v kombinaciji z erlotinibom v prvi liniji zdravljenja neskvamoznega nedrobnoceličnega raka pljuč z EGFR-aktivirajočimi mutacijami, v primerjavi s 14,3 % bolnikov, zdravljenih samo z erlotinibom.
English: At baseline, most patients in both treatment arms had a GOG PS of 0 (CP: 82.4%: CPB; 80.7%) or 1 (CP: 16.7%: CPB; 18.1%).
Slovenian: Izhodiščno je imela večina bolnic v obeh zdravljenih skupinah stanje zmogljivosti po GOG (Gynecologic Oncology Group) 0 (CP: 82,4 %: CPB: 80,7 %) ali 1 (CP: 16,7 %, CPB; 18,1 %).
English: Clinical trials have shown that transient increases in serum creatinine (ranging between 1.5-1.9 times baseline level), both with and without proteinuria, are associated with the use of bevacizumab.
Slovenian: Klinična preskušanja so pokazala, da so z bevacizumabom povezana prehodna zvišanja kreatinina v serumu (v razponu med 1,5 in 1,9-kratno izhodiščno vrednostjo) s proteinurijo ali brez nje.
English: • presence of protein in your urine accompanied by swelling of your body,
Slovenian: • beljakovine v seču, ki jih spremlja otekanje telesa,
English: In study BO20924, bevacizumab exposure was generally lower compared to a typical adult patient at the same dose.
Slovenian: V študiji BO20924 je bila izpostavljenost bevacizumabu v splošnem manjša kot pri tipičnem odraslem bolniku, ki je prejemal enak odmerek.
English: Cases of osteonecrosis of the jaw (ONJ) have been reported in patients treated with bevacizumab, 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) Cases of non-mandibular osteonecrosis have been observed in bevacizumab-treated paediatric patients (see section 4.8, Paediatric population)
Slovenian: Bolezni mišično- skeletnega sistema in vezivnega tkiva pri bolnikih, zdravljenih z bevacizumabom, so poročali o primerih osteonekroze čeljustnic; v večini primerov je šlo za bolnike, pri katerih so bili prisotni znani dejavniki tveganja za osteonekrozo čeljustnic, zlasti izpostavljenost intravenskim difosfonatom in/ali anamneza zobne bolezni, ki je zahtevala invazivne zobozdravstvene posege (glejte tudi poglavje 4.4) pri zdravljenju pediatričnih bolnikov z bevacizumabom so opazili primere osteonekroze izven spodnje čeljustnice (glejte poglavje 4.8, Pediatrični bolniki)
English: Patients and percentage of patients with best overall response of confirmed CR or PR; percentage calculated on patients with measurable disease at baseline.
Slovenian: Bolnice in odstotek bolnic z najboljšim celokupnim odgovorom, ocenjenim kot popolni odgovor ali delni odgovor, odstotek izračunan pri bolnicah z merljivo boleznijo ob izhodišču.
English: • The other ingredients are trehalose dihydrate, sodium phosphate, polysorbate 20 and water for injections.
Slovenian: • Pomožne snovi so trehaloza dihidrat, natrijev fosfat, polisorbat 20 in voda za injekcije.
English: Decreased neutrophil count, decreased white blood cell count and presence of urine protein may be associated with MVASI treatment.
Slovenian: Zmanjšanje števila nevtrofilcev, zmanjšanje števila levkocitov in prisotnost beljakovin v seču so lahko povezani z zdravljenjem z zdravilom MVASI.
English: In the absence of PD, discontinuation of one component of study treatment in the erlotinib + bevacizumab arm did not lead to discontinuation of the other component of study treatment as specified in the study protocol.
Slovenian: V skupini, zdravljeni z erlotinibom in bevacizumabom, v odsotnosti napredovanja bolezni ukinitev enega od zdravil, uporabljenega v študiji, ni vodila do ukinitve drugega zdravila, kar je bilo v skladu s protokolom študije.
English: 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks.
Slovenian: 5,0 mg/kg vsaka 2 tedna ali 7,5 mg/kg vsake 3 tedne.
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Slovenian: Preobčutljivostne reakcije/reakcije pri infundiranju (glejte poglavje 4.4 ter podnaslov Izkušnje po prihodu zdravila na trg, spodaj)
English: In four phase III trials (AVF2119g, E2100, BO17708 and AVF3694g) in patients with metastatic breast cancer CHF grade 3 (NCI-CTCAE v.3) or higher was reported in up to 3.5% of patients treated with bevacizumab in combination with chemotherapy compared with up to 0.9% in the control arms.
Slovenian: V štirih preskušanjih faze III (AVF2119g, E2100, BO17708 in AVF3694g) so pri bolnikih z metastatskim rakom dojk o kongestivnem srčnem popuščanju stopnje 3 ali več (NCICTCAE v.3) poročali pri največ 3,5 % bolnikov, zdravljenih z bevacizumabom v kombinaciji s kemoterapijo, v primerjavi z največ 0,9 % bolnikov v kontrolnih skupinah.
English: • redness, peeling, tenderness, pain, or blistering on the fingers or feet,
Slovenian: • rdečina, luščenje, občutljivost, bolečina ali pojav mehurjev na prstih ali nogah,
English: A total of 1,873 patients were randomised in equal proportions to the following three arms:
Slovenian: Skupno je bilo randomiziranih 1.873 bolnic v enakem razmerju v naslednje tri skupine:
English: The primary endpoint of this trial was progression-free survival (PFS), based on trial investigators' assessment of disease progression.
Slovenian: Primarni cilj tega preskušanja je bilo preživetje brez napredovanja bolezni (PFS), osnovano na oceni napredovanja bolezni s strani raziskovalcev.
English: If this happens you should talk to your doctor, pharmacist or nurse immediately.
Slovenian: Če se to zgodi, se takoj posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: • infections of the skin or deeper layers under the skin,
Slovenian: • okužbe kože ali globljih plasti pod kožo,