natgillin/translations-raw huggingface dataset:
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 8°C, razen če je bila raztopina pripravljena v kontroliranih in validiranih aseptičnih pogojih.
The efficacy data from trials AVF0780g and AVF2192g investigating bevacizumab in combination with 5-FU/FA chemotherapy are summarised in table 5.
Podatki o učinkovitosti iz preskušanj AVF0780g in AVF2192g, ki sta proučevali bevacizumab v kombinaciji s kemoterapevtsko shemo 5-FU/FA, so povzeti v preglednici 5.
• increase in heart rate (pulse),
• povišanje frekvence bitja srca (utripa),
Caution should be taken when treating these patients with MVASI.
Pri zdravljenju teh bolnikov z zdravilom MVASI je zato potrebna previdnost.
The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/mL (0.9%) solution for injection.
Potrebno količino bevacizumaba je potrebno odvzeti in jo razredčiti do ustreznega volumna za aplikacijo z 9 mg/ml (0,9-%) raztopino natrijevega klorida za injiciranje.
These therapies in combination with MVASI may increase the risk of severe side effects.
Ta zdravila lahko v kombinaciji z zdravilom MVASI povečajo tveganje za pojav hudih neželenih učinkov.
Do not use MVASI if you notice any particulate matter or discolouration prior to administration.
Ne uporabljajte zdravila MVASI, če opazite kakršne koli delce ali obarvanje pred dajanjem.
• shortness of breath or low levels of oxygen in the blood,
• zasoplost ali nizko vsebnost kisika v krvi,
• It is possible that MVASI may cause bleeding in and around your brain.
• možno je, da lahko zdravilo MVASI povzroči krvavitve v možganih in okoli možganov.
The primary endpoint was PFS based on investigator's assessment of disease progression based on radiological scans or CA-125 levels, or symptomatic deterioration per protocol.
Primarni cilj študije je bil preživetje brez napredovanja bolezni, ki temelji na oceni raziskovalca o napredovanju bolezni glede na radiološki posnetek ali določitvi vrednosti CA 125 oziroma na simptomatsko poslabšanje glede na protokol.
Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Študije na živalih so pokazale škodljiv vpliv na sposobnost razmnoževanja, vključno z malformacijami (glejte poglavje 5.3).
• Pregnancy (see section 4.6).
• Nosečnost (glejte poglavje 4.6).
A high proportion of patients (approximately 63% IFN/placebo; 55% bevacizumab/IFN) received a variety of non-specified post-trial anti-cancer therapies, including antineoplastic agents, which may have impacted the analysis of overall survival.
Visok delež bolnikov (približno 63 % interferon/placebo; 55 % bevacizumab/placebo) je po zaključku študije prejemal različna nespecificirana zdravljenja novotvorb, vključno z antineoplastičnimi zdravili, kar je lahko imelo vpliv na analizo celokupnega preživetja.
Efficacy results from study AVF4095g
Rezultati učinkovitosti iz študije AVF4095g
Hazard ratio was estimated from Cox proportional hazards models stratified by the duration of platinum free-interval prior to enrolling onto this study per eCRF (electronic case report form) and secondary surgical debulking status Yes/No (Yes = randomised to undergo cytoreduction or randomised to not undergo cytoreduction; No = not a candidate or did not consent to cytoreduction).
Razmerje ogroženosti so ocenili iz Coxovih modelov sorazmernih ogroženosti, stratificiranih s trajanjem intervala brez platine pred vključitvijo v to študijo glede na elektronski obrazec za poročanje o primerih (eCRF, electronic case report form) in sekundarno s statusom kirurške odstranitve Da/Ne (Da = randomizirane, da bodo imele citoredukcijo ali randomizirane, da citoredukcije ne bodo imele; Ne = ni bila kandidatka za citoredukcijo ali z njo ni soglašala).
The pharmacokinetics of bevacizumab was well characterised by the paediatric population PK model for 70 paediatric patients in study BO20924 (1.4 to 17.6 years; 11.6 to 77.5 kg) and 59 patients in study BO25041 (1 to 17 years; 11.2 to 82.3 kg).
Farmakokinetika bevacizumaba je bila dobro opredeljena z uporabo farmakokinetičnega modela pediatrične populacije za 70 pediatričnih bolnikov iz študije BO20924 (1,4 do 17,6 let; 11,6 do 77,5 kg) in za 59 bolnikov iz študije BO25041 (1 do 17 let; 11,2 do 82,3 kg).
• reduced blood supply to the brain or stroke,
• zmanjšan dotok krvi v možgane ali kap,
In most clinical trials of bevacizumab, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
V večino kliničnih preskušanj z bevacizumabom bolniki, ki so imeli kongestivno srčno popuščanje pred pričetkom zdravljenja (NYHA - New York Heart Association II−IV), niso bili vključeni, zato informacije o tveganju za kongestivno srčno popuščanje pri tej populaciji niso na voljo.
In Part II, treatment assignment was double-blind with respect to bevacizumab.
delu je bila določitev zdravljenja glede uporabe bevacizumaba dvojno slepa.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 25 mg of bevacizumab*.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml koncentrata vsebuje 25 mg bevacizumaba*.
In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of postoperative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting bevacizumab.
V kliničnih preskušanjih metastatskega raka debelega črevesa in danke ni bilo povečanega tveganja za pooperativno krvavitev ali zaplete pri celjenju ran pri bolnikih, ki so imeli večjo operacijo 28 do 60 dni pred začetkom zdravljenja z bevacizumabom.
Infections and infestations Necrotising fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation (rare) (see also section 4.4)
Infekcijske in parazitske bolezni nekrotizirajoči fasciitis, ponavadi sekundaren zapletom pri celjenju ran, perforaciji prebavil ali nastanku fistule (redko) (glejte tudi poglavje 4.4)
Combination with platinum- or taxane-based therapies (see sections 4.4 and 4.8)
Kombinacija z zdravljenjem na osnovi platine ali taksanov (glejte poglavji 4.4 in 4.8)
The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/mL to 16.5 mg/mL.
Koncentracija končne raztopine bevacizumaba mora biti od 1,4 do 16,5 mg/ml.
Overall survival3
Celokupno preživetje3
• 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,
• resne okužbe kože ali globljih plasti pod kožo, še posebno, če ste imeli luknje v črevesni steni ali težave pri celjenju ran,
Combination of bevacizumab and sunitinib malate
Kombinacija bevacizumaba in sunitinibijevega malata
Patients with non-small cell lung cancer treated with bevacizumab may be at risk of serious, and in some cases fatal, pulmonary haemorrhage/haemoptysis.
Pri bolnikih z nedrobnoceličnim rakom pljuč, ki se zdravijo z bevacizumabom, lahko obstaja tveganje za resno in v nekaterih primerih smrtno krvavitev v pljučih/hemoptizo.
• feeling of numbness or tingling in hands or feet,
• občutek otrplosti ali zbadanja v dlaneh ali nogah,
MVASI infusions should not be administered or mixed with glucose solutions.
Infuzije zdravila MVASI se ne sme dajati ali mešati skupaj z raztopinami glukoze.
The pharmacokinetic results show that the clearance and volume of distribution of bevacizumab were comparable between paediatric and adult patients when normalised by body weight, with exposure trending lower as body weight decreased.
Farmakokinetični rezultati kažejo, da sta bila po normiranju glede na telesno maso očistek in volumen porazdelitve bevacizumaba med pediatričnimi in odraslimi bolniki primerljiva, z izpostavljenostjo, ki se je z manjšanjem telesne mase zmanjševala.
• It is possible that MVASI can increase the risk of bleeding in your lungs, including coughing or spitting blood.
• možno je, da lahko zdravilo MVASI poveča tveganje za krvavitve v pljučih, vključno s kašljanjem in izpljuvanjem krvi.
0.80 (p = 0.003) 95% CI (0.69; 0.93)
0,80 (p = 0,003) 95-% interval zaupanja (0,69; 0,93)
MVASI is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Zdravilo MVASI se uporablja v kombinaciji z eno od naslednjih shem kemoterapije: paklitaksel in cisplatin ali paklitaksel in topotekan.
Each pack of MVASI contains one vial.
Vsako pakiranje zdravila MVASI vsebuje 1 vialo.
MVASI is a biosimilar medicinal product.
Zdravilo MVASI je podobno biološko zdravilo.
• dry mouth in combination with thirst and/or reduced or darkened urine,
• suha usta v kombinaciji z žejo in/ali manjšim izločanjem seča ali temnejši seč,
Clinical safety data suggest that the incidence of hypertension is likely to be dose-dependent.
Podatki o klinični varnosti kažejo, da je incidenca hipertenzije najverjetneje odvisna od odmerka zdravila.
The majority of the patients in each treatment arm (74% and 71%) had poorly differentiated (grade 3)
Večina bolnic v vsaki skupini (74 % in 71 %) je imela pred začetkom zdravljenja slabo diferenciran (stopnje 3) primarni tumor.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po razredčitvi.
• if you develop severe high blood pressure requiring treatment with blood pressure medicines,
• če se pojavi zelo visok krvni tlak, ki ga je treba zdraviti z zdravili proti zvišanemu krvnemu tlaku,
MVASI has been developed and made to treat cancer by injecting it into the bloodstream.
Zdravilo MVASI so razvili in izdelali za zdravljenje raka in injiciranje v krvni obtok.
FOLFOX-4 or XELOX + placebo (n = 701)
FOLFOX-4 ali XELOX + placebo (n = 701)
• symptoms that suggest changes in normal brain function (headaches, vision changes, confusion, or seizures), and high blood pressure,
• simptomi, ki nakazujejo spremembe v normalnem delovanju možganov (glavoboli, spremembe vida, zmedenost ali epileptični napadi) in visok krvni tlak,
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).
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).
MVASI must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Zdravilo MVASI je treba dajati pod nadzorom zdravnika z izkušnjami pri uporabi zdravil za zdravljenje novotvorb.
Most patients in both the CP arm (80.4%) and the CPB arm (78.9%) were white.
Večina bolnic tako v skupini CP (80,4 %) kot v skupini CPB (78,9 %) je bila belk.
Post-marketing adverse reactions are included in both tables 1 and 2, where applicable.
Neželeni učinki, opisani po prihodu zdravila na trg, so vključeni v preglednico 1 in 2, kjer je ustrezno.
In situations where early discontinuation of chemotherapy was required, treatment with bevacizumab as a single agent continued until disease progression.
V primerih, kjer je bila potrebna zgodnja ukinitev kemoterapije, so do napredovanja bolezni zdravljenje nadaljevali le z bevacizumabom.
• an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
• razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
Efficacy results for trials AVF0780g and AVF2192g
Rezultati učinkovitosti iz preskušanj AVF0780g in AVF2192g AVF0780g
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%).
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 %).
If you have headache, vision changes, confusion or seizure with or without high blood pressure, please contact your doctor.
Če imate glavobol, spremembe vida, ste zmedeni ali imate epileptični napad z visokim krvnim pritiskom ali brez njega, obvestite svojega zdravnika.
• problems with wound healing after surgery,
• težave s celjenjem ran po operaciji,
MVASI should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
Zdravilo MVASI mora pripraviti zdravstveno osebje v aseptičnih pogojih, da zagotovi sterilnost pripravljene raztopine.
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.
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.
No incompatibilities between MVASI and polyvinyl chloride or polyolefin bags or infusion sets have been observed.
Med zdravilom MVASI in polivinil kloridom ali poliolefinskimi vrečkami ali infuzijskimi seti ni bilo inkompatibilnosti.
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.
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.
• 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.
• 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.
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).
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.
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)
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)
Very rare Frequency not known
Neznana pogostnost
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).
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).
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.
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.
• a hole in the cartilage wall separating the nostrils of the nose,
• predrtje nosnega pretina (stena iz hrustanca, ki ločuje nosnici),
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.
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.
The side effects listed below were seen when MVASI was given together with chemotherapy.
Neželene učinke, ki so navedeni spodaj, so opazili, ko so zdravilo MVASI dajali skupaj s kemoterapijo.
Do not use MVASI if:
Zdravila MVASI ne smete prejemati:
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)].
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.
Limited information is available on the continued use of bevacizumab in patients with other fistulae.
Za nadaljevanje uporabe bevacizumaba pri bolnikih z drugimi fistulami so na voljo le omejeni podatki.
A total of 452 patients were randomised to receive either:
Skupno 452 bolnic so randomizirali na prejemanje ene od naslednjih shem:
• you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
• če ste alergični (preobčutljivi) na bevacizumab ali katero koli drugo sestavino tega zdravila
• a negative effect on a woman's ability to have children (see the paragraphs below the list of side effects for further recommendations),
• negativni učinek na zmožnost zanositve (za nadaljnje informacije glejte spodaj),
• PLD 40 mg/m2 as a 1 mg/min IV infusion on day 1 only every 4 weeks.
PLD 40 mg/m2 kot intravenska infuzija s hitrostjo 1 mg/min samo 1. dan vsake 4 tedne.
• MVASI can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
• zdravilo MVASI lahko poveča tveganje za krvavitve ali poveča tveganje za težave pri celjenju ran po operaciji.
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.
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).
Efficacy results for trial E3200
Rezultati učinkovitosti za preskušanje E3200
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.
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.
Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1).
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).
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, 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.
Before you are given MVASI or while you are being treated with MVASI:
Preden začnete zdravljenje z zdravilom MVASI ali med zdravljenjem z njim:
In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving bevacizumab.
V kliničnih preskušanjih so o proteinuriji poročali v obsegu od 0,7 do 54,7 % bolnikov, zdravljenih z bevacizumabom.
• Study E2100 (paclitaxel) Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516)
• študija E2100 (paklitaksel) mediana podaljšanja PFS 5,6 meseca, razmerje ogroženosti 0,421 (p < 0,0001, 95-% interval zaupanja 0,343; 0,516)
In the bevacizumab-containing arms, patients could receive bevacizumab as a single agent every 3 weeks until disease progression or unacceptable toxicity.
V skupinah, ki sta prejemali bevacizumab, so bolniki lahko prejemali bevacizumab samostojno vsake 3 tedne do napredovanja bolezni ali do nesprejemljive toksičnosti.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1246/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/17/1246/001
MVASI is for intravenous use.
Zdravilo MVASI je za intravensko uporabo.
• reduction in the number of white cells in the blood, and cells that help the blood clot,
• zmanjšanje števila belih krvničk in celic, ki pomagajo strjevati kri,
However, somnolence and syncope have been reported with bevacizumab use (see table 1 in section 4.8).
Vendar pa so pri uporabi bevacizumaba poročali o pojavu somnolence in sinkope (glejte preglednico 1 v poglavju 4.8).
Objective response rate1
Objektivni odgovor1
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.
O izhodiščnem stanju zmogljivosti po GOG 2 so poročali pri 0,9 % bolnic v skupini CP in pri 1,2 % bolnic v skupini CPB.
The risk of bevacizumab-associated hypertension did not correlate with the patients' baseline characteristics, underlying disease or concomitant therapy.
Tveganje za pojav hipertenzije ob zdravljenju z bevacizumabom ni bilo povezano z osnovnimi značilnostmi bolnikov, spremljajočimi obolenji ali ostalo terapijo, ki so jo prejemali.
Eye disorders Eye disorder, Lacrimation increased
Očesne bolezni bolezni oči, povečano solzenje
** Randomised patients with measurable disease at baseline.
** Randomizirane bolnice, ki so izhodiščno imele merljivo bolezen.
Efficacy results from study GOG-0218
Rezultati učinkovitosti iz študije GOG-0218
Randomised patients stage III optimally debulked disease2,3
Randomizirane bolnice z optimalno citoredukcijo, stadija III2,3
Testing for proteinuria is recommended prior to start of MVASI therapy.
Testiranje za proteinurijo je priporočljivo pred začetkom zdravljenja z zdravilom MVASI.