natgillin/translations-raw huggingface dataset:
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%).
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%).
Testing for proteinuria is recommended prior to start of Avastin therapy.
Testiranje za proteinurijo je priporočljivo pred začetkom zdravljenja z zdravilom Avastin.
Table 13 Efficacy results for trial BO17704
Rezultati učinkovitosti za preskušanje BO17704
A third group of 110 patients received bolus 5-FU/FA + Avastin (Arm 3).
Tretja skupina 110 bolnikov je prejela bolus 5-FU/FA + Avastin (skupina 3).
Treatment was given until progressive disease or unacceptable toxicity.
Bolnike so zdravili do napredovanja bolezni ali do nesprejemljive toksičnosti.
• 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,
Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
· Preobčutljivost za produkte ovarijskih celic kitajskega hrčka (CHO - Chinese hamster ovary) ali na druga rekombinantna humana ali humanizirana protitelesa.
5-Fluorouracil: IV bolus injection immediately after leucovorin
injekcija v bolusu neposredno po levkovorinu
Patients with renal impairment: The safety and efficacy have not been studied in patients with renal impairment (see section 5.2).
Bolniki z jetrno okvaro: varnosti in učinkovitosti pri bolnikih z okvaro jeter niso proučevali (glejte poglavje 5.2).
Severe side effects, which may be very common (affects more than 1 user in 10), include:
Hudi neželeni učinki, ki so lahko zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov), vključujejo:
In situations where early discontinuation of chemotherapy was required, treatment with Avastin 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 zdravilom Avastin.
The majority of patients had EOC (87.7%) followed by PPC (6.9%) and FTC (3.7%) or a mixture of the three origins (1.7%).
Večina bolnic je imela epitelijski rak jajčnikov (87,7 %), sledil je primarni peritonealni karcinom (6,9 %), nato karcinom jajcevodov (3,7 %) ali kombinacijo vseh treh (1,7 %).
FOLFOX-4 or FOLFOX-4 + Avastin
FOLFOX-4 ali FOLFOX-4 + Avastin
At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72).
V času končne primarne analize neodvisni centralni pregled med obema zdravljenima skupinama ni pokazal statistično pomembne razlike v primarnem cilju študije, preživetju brez dogodka; razmerje ogroženosti je bilo 0,93 (95-% interval zaupanja: 0,61; 1,41; vrednost p = 0,72).
Avastin 10 mg/kg was given every 2 weeks until disease progression.
Zdravilo Avastin so prejemali v odmerku 10 mg/kg vsaka dva tedna do napredovanja bolezni.
Avastin is for single-use only, as the product contains no preservatives.
Zdravilo Avastin je le za enkratno uporabo in ne vsebuje konzervansov.
Avastin is a concentrate for solution for infusion.
Avastin je koncentrat za raztopino za infundiranje.
Table 16 Efficacy results from study GOG-0218
Rezultati učinkovitosti iz študije GOG-0218
Four patients had objective (partial) response, and all of these had received the 10 mg/kg dose bevacizumab; the ORR for the 10 mg/kg dose was 10%.
Štirje bolniki so imeli objektivni (delni) odgovor, vsi so prejeli bevacizumab v odmerku 10 mg/kg.
Presentation may include seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Motnja se lahko kaže z epileptičnimi napadi, glavoboli, spremenjenim mentalnim statusom, motnjami vida ali kortikalno slepoto s sočasno hipertenzijo ali brez nje.
The most frequently observed adverse reactions across clinical trials in patients receiving Avastin were hypertension, fatigue or asthenia, diarrhoea and abdominal pain.
Najpogostnejši neželeni učinki, ki so se pojavili pri bolnikih, zdravljenih z zdravilom Avastin v kliničnih preskušanjih, so bili hipertenzija, utrujenost ali astenija, diareja in bolečina v trebuhu.
Advanced and/or metastatic renal cell cancer (mRCC)
Napredovali in/ali metastatski rak ledvičnih celic
Comparison Other Factor
Drugi faktor
(p-value 0.3360)
(p-vrednost 0,3360)
The efficacy results of the study are presented in Table 14.
Rezultati učinkovitosti študije so predstavljeni v preglednici 14.
However, patients who developed venous thrombosis while receiving therapy did not appear to have an increased rate of Grade 3 or above bleeding when treated with a full dose of warfarin and Avastin concomitantly (NCI-CTCAE v.3).
Vendar bolniki, pri katerih se je med zdravljenjem pojavila venska tromboza, niso imeli povečane pojavosti krvavitev stopnje 3 ali več (NCI-CTCAE v.3), če so jih sočasno zdravili s polnim odmerkom varfarina in zdravilom Avastin.
Limited information is available on the continued use of Avastin in patients with other fistulae.
Za nadaljevanje uporabe zdravila Avastin pri bolnikih z drugimi fistulami so na voljo le omejeni podatki.
Tumour-associated haemorrhage was also seen rarely in other tumour types and locations, including cases of central nervous system (CNS) bleeding in patients with CNS metastases (see section 4.4).
Krvavitev, povezana s tumorjem, je bila redkeje opisana pri bolnikih z drugimi vrstami in lokalizacijami tumorjev, vključno s primeri krvavitve v osrednjem živčevju pri bolnikih z zasevki v osrednjem živčevju (glejte poglavje 4.4).
**Randomized Patients with Measurable Disease at Baseline.
**Randomizirane bolnice, ki so izhodiščno imele merljivo bolezen.
Table 12 Efficacy results for trial E4599
Rezultati učinkovitosti za preskušanje E4599
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 Avastin.
Klinična preskušanja so pokazala, da so z zdravilom Avastin povezana prehodna zvišanja kreatinina v serumu (v razponu med 1,5 in 1,9-kratno izhodiščno vrednostjo) s proteinurijo ali brez nje.
Permanently discontinue Avastin 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 Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE v.3)] zdravilo Avastin dokončno ukinemo.
Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.
Zaradi tega ker preprečuje biološko delovanje VEGF, vaskularizacija tumorja nazaduje, preostala vaskulatura tumorja se normalizira, nastajanje nove vaskulature tumorja pa se prepreči.
Trial results show that 94% (277 / 296) of eligible patients went on to receive single agent bevacizumab at cycle 7.
da je 94 % (277/296) primernih bolnikov s 7. ciklom nadaljevalo s samostojnim zdravljenjem z bevacizumabom.
Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate.
Bevacizumab je v kombinaciji s kapecitabinom indiciran za prvo linijo zdravljenja odraslih bolnikov z metastatskim rakom dojk, pri katerih zdravljenje z drugimi možnostmi kemoterapije, vključno s taksani ali antraciklini, ni primerno.
Avastin was combined with two chemotherapy regimens:
Zdravilo Avastin so dajali v kombinaciji z dvema kemoterapevtskima shemama zdravljenja:
Avastin has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Avastin nima oziroma ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
In addition, an independent review of the primary endpoint was also conducted.
Dodatno je bil izveden neodvisni pregled primarnega cilja raziskave.
Close observation of the patient during and following the administration of bevacizumab is recommended as expected for any infusion of a therapeutic humanised monoclonal antibody.
Priporočljivo je, da se bolnika med ter po dajanju bevacizumaba skrbno spremlja, kot je to običajno pri katerikoli infuziji terapevtskega humaniziranega monoklonskega protitelesa.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/4 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg/4 ml
Decreased neutrophil count, decreased white blood cell count and presence of urine protein may be associated with Avastin treatment.
Zmanjšanje števila nevtrofilcev, zmanjšanje števila levkocitov in prisotnost beljakovin v seču so lahko povezani z zdravljenjem z zdravilom Avastin.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution Read the package leaflet before use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po razredčitvi Pred uporabo preberite priloženo navodilo
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
The addition of Avastin to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see Table 4).
Dodatek zdravila Avastin k shemi IFL je statistično značilno podaljšal celokupno preživetje, preživetje brez napredovanja bolezni in celokupen odgovor na zdravljenje teh bolnikov (glejte preglednico 4).
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 4 ml
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala (4 ml)
Results from the primary analysis and the follow-up analysis are presented by Avastin Treatment and by Trial Treatment in Table 25 and Table 26, respectively.
Rezultati primarne analize in analize po spremljanju so predstavljeni glede na zdravljenje z zdravilom Avastin (preglednica 25) in glede na preizkušano zdravljenje (preglednica 26).
In the absence of PD, discontinuation of one component of study treatment in the erlotinib + Avastin arm did not lead to discontinuation of the other component of study treatment as specified in the study protocol.
V skupini, zdravljeni z erlotinibom in zdravilom Avastin, 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.
When used for patients with kidney cancer, it will be administered with another type of medicine called interferon.
Kadar ga uporabljamo pri bolnikih z rakom ledvičnih celic, ga dajemo skupaj z drugim zdravilom, ki se imenuje interferon.
In Study BO20924, bevacizumab exposure was generally lower compared to a typical adult patient at the same dose.
V študiji BO20294 je bila izpostavljenost bevacizumabu v splošnem manjša kot pri tipičnem odraslem bolniku, ki je prejemal enak odmerek.
Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of treated patients.
Proteinurijo stopnje 4 (nefrotski sindrom) so opazili pri do 1,4 % zdravljenih bolnikov.
Objective response rate (%) in Patients with measurable disease
Objektivni odgovor (%) pri bolnikih z merljivo boleznijo n
Results are presented in Table 12.
Rezultati so predstavljeni v preglednici 12.
Three additional studies with bevacizumab have been conducted in mCRC patients: first-line (NO16966), second-line with no previous bevacizumab treatment (E3200), and second-line with previous bevacizumab treatment following disease progression in first-line (ML18147).
Z bevacizumabom so pri bolnikih z metastatskim rakom debelega črevesa in danke izvedli tri dodatne študije: v prvi (NO16966) in drugi liniji zdravljenja brez predhodnega jemanja bevacizumaba (E3200) ter v drugi liniji zdravljenja, kjer so bolniki predhodno prejemali bevacizumab v prvi liniji, nato pa je njihova bolezen napredovala (ML18147).
In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving Avastin.
V kliničnih preskušanjih so o proteinuriji poročali v obsegu od 0,7 do 54,7 % bolnikov, zdravljenih z zdravilom Avastin.
In the majority of the occasions the necessary amount of Avastin can be diluted with 0.9 % sodium chloride solution for injection to a total volume of 100 mL.
V večini primerov lahko potrebno količino zdravila Avastin razredčimo z 0,9-% raztopino natrijevega klorida za injiciranje do končnega volumna
In patients in AVF3694g who received treatment with anthracyclines and who had not received anthracyclines before, no increased incidence of all Grade CHF was observed in the anthracycline + bevacizumab group compared to the treatment with anthracyclines only.
V preskušanju AVF3694g pri bolnikih, ki so prejemali zdravljenje z antraciklini in ki se predhodno še niso zdravili z antraciklini, niso opazili povečane incidence kongestivnega srčnega popuščanja katere koli stopnje v skupini z antraciklinom in bevacizumabom v primerjavi z zdravljenjem s samimi antraciklini.
Use of irinotecan- or oxaliplatin-containing regimen was switched depending on first-line usage of either oxaliplatin or irinotecan.
Kombinacijo, z irinotekanom ali oksaliplatinom, so bolnikom zamenjali glede na to, ali so v prvi liniji uporabljali oksaliplatin ali irinotekan.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 400 mg/16 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 400 mg/16 ml
In patients who only received bevacizumab in combination with chemotherapy and did not continue to receive bevacizumab alone (CPB15), no clinically meaningful benefit in PFS was observed.
Pri bolnicah, ki so prejele bevacizumab v kombinaciji s kemoterapijo in niso nadaljevale s prejemanjem samega bevacizumaba (CPB15), niso opazili klinično pomembne koristi v preživetju brez napredovanja bolezni.
The VEGF protein causes blood vessels to grow within tumours, these blood vessels provide the tumour with nutrients and oxygen.
Beljakovina VEGF v tumorjih omogoča rast krvnih žil, ki tumor preskrbujejo s hrano in kisikom.
Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaed,e,
intestinalna perforacija, ileus, intestinalna obstrukcija, rektovaginalne fistuled,e,
In addition, hypertension (including hypertensive crisis), elevated creatinine, and neurological symptoms were observed in some of these patients.
Pri nekaterih bolnikih so opazili tudi hipertenzijo (vključno s hipertenzivno krizo), povečane vrednosti kreatinina in nevrološke simptome.
Table 26 Overall survival results from study GOG-0240 by Trial Treatment Treatment
Rezultati celokupnega preživetja v študiji GOG-0240 glede na preizkušano zdravljenje
Posterior Reversible Encephalopathy Syndrome (PRES), (rare) (see also section 4.4)
sindrom posteriorne reverzibilne encefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome) (redko) (glejte tudi poglavje
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)
The primary endpoint was progression-free survival based on investigator assessment using modified RECIST 1.0.
Primarni cilj preskušanja je bilo preživetje brez napredovanja bolezni, glede na oceno raziskovalca, z uporabo kriterija RECIST 1.0.
Patients with NSCLC of known squamous cell histology or mixed cell type with predominant squamous cell histology were excluded from subsequent phase III trials, while patients with unknown tumour histology were included.
Bolniki s ploščatoceličnim nedrobnoceličnim rakom pljuč ali mešanim celičnim tipom s prevladujočo ploščatocelično histologijo v nadaljnja preskušanja faze III niso bili vključeni, bolniki z neznano histologijo tumorja pa so bili.
For dilution and other handling recommendations, see section 6.6.
Za redčitev in ostala priporočila glede ravnanja z zdravilom glejte poglavje 6.6.
Dose-reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of Avastin and IFN alfa-2a based on PFS event free rates over time, as shown by a sub-group analysis.
Zmanjšanje odmerka interferona alfa-2a ni vplivalo na učinkovitost kombinacije zdravila Avastin in interferona alfa-2a, kar je z deležem preživetja brez napredovanja bolezni v tem času potrdila analiza podskupine.
The primary endpoint was duration of survival.
Primarni cilj študije je bilo trajanje preživetja.
In two subsequent studies in patients with treated brain metastases (which included around 800 patients), one case of Grade 2 CNS haemorrhage was reported in 83 subjects treated with bevacizumab (1.2%) at the time of interim safety analysis (NCI-CTCAE v.3).
V dveh kasnejših kliničnih preskušanjih, pri bolnikih z zdravljenimi zasevki v možganih (vključenih je bilo okoli 800 bolnikov), so v času vmesne analize varnosti poročali o enem primeru krvavitve v osrednjem živčevju stopnje 2 od 83 bolnikov, zdravljenih z bevacizumabom (1,2 %) (NCI-CTCAE v.3).
The European Medicines Agency has waived the obligation to submit the results of studies, in all subsets of the paediatric population, in breast carcinoma, adenocarcinoma of the colon and rectum, lung carcinoma (small cell and non-small cell carcinoma), kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney), ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours), fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours), peritoneal carcinoma (excluding blastomas and sarcomas) and cervix and corpus uteri carcinoma.
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij za vse skupine pediatrične populacije pri raku dojk, adenokarcinomu debelega črevesa in danke, raku pljuč (drobnoceličnem in nedrobnoceličnem), raku ledvic in ledvičnega meha (razen nefroblastoma, nefroblastomatoze, svetloceličnega sarkoma, mezoblastnega nefroma, raka ledvične sredice in rabdoidnega ledvičnega tumorja), raku jajčnikov (razen rabdomiosarkoma in germinalnih tumorjev),
Table 17 PFS1 results by disease stage and debulking status from study GOG-0218
Rezultati preživetja brez napredovanja bolezni1, glede na stadij bolezni in stopnjo citoredukcije iz študije GOG-0218
The risk of Avastin-associated hypertension did not correlate with the patients' baseline characteristics, underlying disease or concomitant therapy.
Tveganje za pojav hipertenzije ob zdravljenju z zdravilom Avastin ni bilo povezano z osnovnimi značilnostmi bolnikov, spremljajočimi obolenji ali ostalo terapijo, ki so jo prejemali.
The clinical benefit of Avastin as measured by PFS was seen in all pre-specified subgroups tested (including disease-free interval, number of metastatic sites, prior receipt of adjuvant chemotherapy and oestrogen receptor (ER) status).
Klinična korist zdravila Avastin, merjena kot preživetje brez napredovanja bolezni, je bila opažena v vseh preiskovanih, vnaprej določenih podskupinah (vključno z intervalom brez bolezni, številom metastatskih mest, predhodnim prejetjem adjuvantne kemoterapije in statusom estrogenskih receptorjev).
Median (months)
Mediana časa (meseci)
Once bevacizumab is bound to VEGF, tumour growth is prevented by blocking the growth of the blood vessels which provide the nutrients and oxygen to the tumour.
Bevacizumab se veže na VEGF in prepreči rast tumorja tako, da zavira rast krvnih žil, ki ga oskrbujejo s hrano in kisikom.
These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen),
To vključuje zmanjšanje števila belih krvnih celic v krvi, še posebno nevtrofilcev (vrsta belih krvnih celic, ki pomaga varovati pred okužbami), prisotnost beljakovin v seču, zmanjšanje ravni kalija, natrija ali fosforja (mineral) v krvi, zvišan sladkor v krvi, zvečanje alkalne fosfataze (encim),
0.823 [CI: 0.680, 0.996]
0,823 [IZ: 0,680; 0,996]
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity (see section 5.1).
Zdravljenje je priporočljivo nadaljevati do napredovanja osnovne bolezni ali do nesprejemljivih toksičnih učinkov (glejte poglavje 5.1).
The secondary endpoint of Overall Survival (OS) was not mature .
Sekundarni cilj študije, celokupno preživetje, ni bilo zrelo.
The safety and efficacy of the recommended dose (5 mg/kg of body weight every two weeks) in metastatic carcinoma of the colon or rectum were studied in three randomised, active-controlled clinical trials in combination with fluoropyrimidine-based first-line chemotherapy.
Varnost in učinkovitost priporočenega odmerka (5 mg/kg telesne mase vsaka dva tedna) v kombinaciji s kemoterapijo prve izbire na osnovi fluoropirimidina so proučevali v treh randomiziranih, aktivno kontroliranih kliničnih preskušanjih pri bolnikih z metastatskim rakom debelega črevesa in danke.
A total of 361 patients were enrolled into this study and administered either chemotherapy (paclitaxel, topotecan, or pegylated liposomal doxorubicin (PLD) alone or in combination with bevacizumab:
Vanjo so skupaj vključili 361 bolnic, ki so prejele samo kemoterapijo (paklitaksel, topotekan ali pegilirani liposomalni doksorubicin (PLD)) ali kemoterapijo v kombinaciji z bevacizumabom:
In Study BO25041, bevacizumab exposure was similar compared to a typical adult at the same dose.
študiji BO25041 je bila izpostavljenost bevacizumabu podobna kot pri tipičnem odraslem bolniku, ki je prejemal enak odmerek.
The overall incidence of NCI-CTC Grade 3 and 4 hypertension in patients receiving Avastin ranged from 0.4% to 17.9%.
Celokupna incidenca hipertenzije stopnje 3 in 4 po NCI-CTC je bila pri bolnikih, ki so se zdravili z zdravilom Avastin, od 0,4 do 17,9 %.
Pregnancy (see section 4.6).
· Nosečnost (glejte poglavje 4.6).
• Haemorrhage, including pulmonary haemorrhage/haemoptysis, which is more common in non small cell lung cancer patients (see section 4.4).
· krvavitev, vključno s krvavitvijo v pljučih/hemoptizo, ki je pogostejša pri bolnikih z nedrobnoceličnim rakom pljuč (glejte poglavje 4.4),
Table 20 Efficacy results from study AVF4095g
Rezultati učinkovitosti iz študije AVF4095g
In most cases hypertension was controlled adequately using standard antihypertensive treatment appropriate for the individual situation of the affected patient.
V večini primerov je bila hipertenzija ustrezno uravnana s standardnimi antihipertenzivnimi zdravili,
Each vial contains 100 mg bevacizumab in 4 ml of solution or 400 mg bevacizumab in 16 ml of solution.
Ena viala vsebuje 100 mg bevacizumaba v 4 ml raztopine ali 400 mg bevacizumaba v 16 ml raztopine.
The incidence of CNS bleeding in patients with untreated CNS metastases receiving bevacizumab has not been prospectively evaluated in randomised clinical trials.
Incidenca krvavitev v osrednjem živčevju pri bolnikih z nezdravljenimi zasevki v osrednjem živčevju, ki so prejemali bevacizumab, ni bila prospektivno ocenjena v randomiziranih kliničnih preskušanjih.