FrancophonIA/ELRC3.0 huggingface dataset:
English: difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2%
Slovenian: · zaradi primerljive incidence, opažene med preiskovanimi skupinami v kliničnih preskušanjih (z najmanj 10-% razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 1 do 5 po lestvici NCI-CTCAE ali najmanj 2-% razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 3 do 5 po lestvici NCI-CTCAE);
English: • redness, peeling, tenderness, pain, or blistering on the fingers or feet,
Slovenian: · rdečina, luščenje, občutljivost, bolečina ali pojav mehurjev na prstih ali nogah, · zmanjšano število rdečih krvnih celic,
English: How to store Avastin
Slovenian: Shranjevanje zdravila Avastin
English: Overall survival Median (months) Hazard ratio 95% CI
Slovenian: Celokupno preživetje mediana (meseci) razmerje ogroženosti 95-% interval zaupanja
English: Two large Phase III trials were designed to investigate the treatment effect of Avastin in combination with two individual chemotherapy agents, as measured by the primary endpoint of PFS. A clinically meaningful and statistically significant improvement in PFS was observed in both trials.
Slovenian: Za preučevanje učinka zdravljenja z zdravilom Avastin v kombinaciji z dvema posameznima kemoterapevtskima zdraviloma sta bili zasnovani dve veliki preskušanji faze III, v katerih je bil primarni cilj preživetje brez napredovanja bolezni (PFS, progression free survival).
English: Number of patients Overall survival Median time (months) 95% CI Hazard ratiob
Slovenian: Število bolnikov Celokupno preživetje mediana (meseci) 95-% interval zaupanja razmerje ogroženostib
English: Dehydration
Slovenian: Krvavitev
English: Avastin is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
Slovenian: Zdravilo Avastin se uporablja tudi za zdravljenje odraslih bolnic z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska.
English: The overall mean age was 59.4 years; 56.6% of patients had an ECOG
Slovenian: Celokupna povprečna starost je bila 59,4 let;
English: • Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516)
Slovenian: Spodaj so povzeti rezultati PFS za posamezno kemoterapevtsko zdravilo, ki je del indikacije: · študija E2100 (paklitaksel) · mediana podaljšanja PFS 5,6 meseca, razmerje ogroženosti 0,421 (p < 0,0001, 95-% interval zaupanja 0,343; 0,516)
English: Ovarian failure/fertility (see sections 4.4 and 4.6)
Slovenian: Kombinacija z zdravljenjem na osnovi platine ali taksanov (glejte poglavji 4.4 in 4.8)
English: Diarrhoea, Nausea, Vomiting, Abdominal pain
Slovenian: Bolezni prebavil diareja, navzea, bruhanje,
English: • CPB15+ arm: Five cycles of Avastin (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by continued use of Avastin (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy.
Slovenian: · CPB15+ skupina: pet ciklov zdravila Avastin (15 mg/kg telesne mase enkrat na 3 tedne, z začetkom v ciklu 2) v kombinaciji s karboplatinom (AUC 6) in 6 cikli paklitaksela
English: • dry skin, flaking and inflammation of the skin, change in skin colour,
Slovenian: · motnje v govoru, · spremembe v okušanju, · izcedek iz nosu, · suho kožo, luskavost in vnetje kože, spremembo barve kože, · hujšanje, · krvavitve iz nosu.
English: Overall approximately 50% of patients had a GOG PS of 0 at baseline, 43% a GOG PS score of 1, and 7% a GOG PS score of 2.
Slovenian: 50 % bolnic, status zmogljivosti (PS, performance status) po GOG (Gynecologic Oncology Group) ocenili z 0; 43 % so ga ocenili z 1, 7 % bolnicam pa z 2.
English: 0.613 [CI: 0.521, 0.721]
Slovenian: 0,613 [IZ: 0,521; 0,721]
English: Hazard ratio (95% confidence interval)
Slovenian: Celokupno preživetje b razmerje ogroženosti (95-% interval zaupanja)
English: CT+BV (n=179)
Slovenian: kemoterapija + bevacizumab (n = 179)
English: • CPP arm: Five cycles of placebo (started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Slovenian: (AUC 6) in 6 cikli paklitaksela (175 mg/m2), katerim je sledil samo placebo do skupno 15 mesecev zdravljenja.
English: The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarized in Table 24.
Slovenian: Eksplorativne analize preživetja brez napredovanja bolezni in celokupnega preživetja glede na uporabljeno kemoterapijo (paklitaksel, topotekan ali PLD) so povzete v preglednici
English: Avastin/IFN) received a variety of non-specified post-trial anti-cancer therapies, including antineoplastic agents, which may have impacted the analysis of overall survival.
Slovenian: Visok delež bolnikov (približno 63 % interferon/placebo; 55 % Avastin/placebo) je po zaključku študije prejemal različna nespecificirana zdravljenja novotvorb, vključno z antineoplastičnimi zdravili, kar je lahko imelo vpliv na analizo celokupnega preživetja.
English: Myalgia
Slovenian: Dojenje
English: The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila Avastin je 15 mg/kg telesne mase v enkratnem odmerku na 3 tedne, v obliki intravenske infuzije.
English: Very Common
Slovenian: Pogosti
English: Number of patients Overall survival Median (months) 95% CI
Slovenian: Število bolnikov Celokupno preživetje mediana (meseci) razmerje ogroženosti (95-% interval zaupanja)
English: Renal thrombotic microangiopathya,b,
Slovenian: globoka venska tromboza renalna trombotična mikroangiopatija a,b, anevrizme in disekcije arterij
English: Table 2: Severe Adverse Reactions by Frequency System organ class
Slovenian: Hudi neželeni učinki po pogostnosti
English: 5 mg/kg IV 30-90 min
Slovenian: 30-90 min
English: 60 years in CPP and CPB15 arms and 59 years in CPB15+ arm; and 29% of patients in CPP or CPB15 and 26% in CPB15+ were over 65 years of age.
Slovenian: Večina bolnic, vključenih v študijo, je bila belk (87 % v vseh treh skupinah); mediana starosti je bila 60 let v CPP in CPB15 skupini ter 59 let v CPB15+ skupini.
English: Paclitaxel (n=273)
Slovenian: paklitaksel (n = 273)
English: Eight hundred and thirteen patients were randomised to receive IFL + placebo (Arm 1) or IFL + Avastin (5 mg/kg every 2 weeks, Arm 2).
Slovenian: Randomiziranih je bilo 813 bolnikov, ki so prejeli IFL + placebo (skupina 1) ali
English: Avastin vs. No Avastin
Slovenian: Avastin proti brez zdravila Avastin
English: Number of patients Overall survival Median time (months) 95% CI Hazard ratioc p-value
Slovenian: mediana celokupnega preživetja (meseci) razmerje ogroženosti (95-% interval zaupanja) p-vrednost
English: MARKETING AUTHORISATION HOLDER
Slovenian: Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
English: Median (months) Hazard ratio [95% CI]
Slovenian: mediana (meseci) razmerje ogroženosti [95-% interval zaupanja]
English: Peripheral sensory neuropathy a
Slovenian: Interferon alfa-2a so prejemali do
English: Osteonecrosis of the jaw (ONJ) (see section 4.8)
Slovenian: Osteonekroza čeljustnic (glejte poglavje 4.8)
English: Median (months) Hazard ratio (95% CI) p-value
Slovenian: Mediana (meseci) Razmerje ogroženosti (95-% interval zaupanja) p-vrednost
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), grade 3-5 infections have been reported in up to 24% of patients treated with Avastin in combination with paclitaxel and topotecan compared with up to 13% of patients treated with paclitaxel and topotecan.
Slovenian: so o okužbah stopnje 3 do 5 poročali pri do 24 % bolnic, ki so prejemale zdravilo Avastin v kombinaciji s paklitakselom in topotekanom, in pri do 13 % bolnic, ki so prejemale paklitaksel in topotekan.
English: BO17707 was a Phase III, two arm, multicentre, randomised, controlled, open-label study comparing the effect of adding Avastin to carboplatin plus paclitaxel in patients with FIGO stage I or IIA (Grade
Slovenian: BO17707 je bila multicentrična, randomizirana, kontrolirana, odprta študija faze III, ki je vključevala dve skupini, kjer so primerjali učinek dodajanja zdravila Avastin h karboplatinu in paklitakselu po operaciji, pri bolnicah z epitelijskim rakom jajčnikov, primarnim peritonealnim karcinomom ali karcinomom jajcevodov stadija I ali II A po klasifikaciji FIGO (stopnje 3 ali s samo čisto celično histologijo; n = 142) ali stadija II B - IV po klasifikaciji FIGO (vse stopnje in vsi histološki tipi, n = 1386) (NCI-CTCAE v.3).
English: ● an abnormal tube-like connection or passage between the windpipe and the gullet, between internal organs and skin, between the vagina and any parts of the gut or between other tissues that are not normally connected (fistula), and are judged by your doctor to be severe,
Slovenian: ali če se krvni tlak nenadoma zelo zviša, · beljakovine v seču, ki jih spremlja otekanje telesa, · predrtje stene črevesja, · neobičajna povezava ali prehod, podoben cevi, med sapnikom in požiralnikom, med notranjimi organi in kožo, med nožnico in katerim koli delom črevesa ali med drugimi tkivi, ki normalno niso povezani (fistula), in jih vaš zdravnik oceni kot resne, · resne okužbe kože ali globljih plasti pod kožo, · krvni strdek v arterijah, · krvni strdek v krvnih žilah pljuč, · kakršna koli huda krvavitev.
English: ● If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Slovenian: Pomembno je namreč, da bo vaš krvni tlak pred začetkom zdravljenja z zdravilom Avastin ustrezno uravnan; · če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile;
English: Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of Avastin-treated patients.
Slovenian: Pri bolnikih, ki so prejemali le kemoterapijo, so neželene učinke opazili pri do 5 % bolnikov.
English: The percentage of patients with an ECOG PS of 1 or ≥ 2 was 38.7% and 5.0% in the CT arm, and 29.8% and 9.0% in the
Slovenian: V skupini s kemoterapijo in bevacizumabom je imelo 29,8 % bolnic stanje zmogljivosti po ECOG 1, 9,0 % bolnic pa stanje zmogljivosti po ECOG ³ 2.
English: The recommended dose of Avastin, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
Slovenian: 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna ali 7,5 mg/kg ali 15 mg/kg telesne mase v enkratnem odmerku vsake 3 tedne.
English: No significant difference was observed in the duration of overall survival between patients who received Avastin monotherapy compared to patients treated with FOLFOX-4.
Slovenian: Med bolniki, ki so prejemali zdravilo Avastin kot samostojno zdravljenje, in bolniki, ki so jih zdravili po shemi FOLFOX-4, niso opazili pomembne razlike v trajanju celokupnega preživetja.
English: Oxaliplatin 85 mg/m2 IV 2 h Oxaliplatin on day 1 Leucovorin on day 1 and 2
Slovenian: Oksaliplatin 85 mg/m i.v.
English: • changes in speech,
Slovenian: · spremembo glasu in hripavost.
English: Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 plus bevacizumab 15 mg/kg IV on Day 1 (q3w)
Slovenian: 2. dan (na 3 tedne), ali paklitaksel 175 mg/m2 intravensko v 3-urni infuziji 1. dan in cisplatin 50 mg/m2 intravensko
English: Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by IV infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or PC in combination with Avastin at a dose of 15 mg/kg IV infusion day 1 of every 3-week cycle.
Slovenian: Randomizirani bolniki so na dan 1 vsakega tritedenskega cikla do skupno 6 ciklov prejeli kemoterapijo na osnovi platine (paklitaksel 200 mg/m2 in karboplatin AUC = 6,0, oboje z i.v.
English: Avastin may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Slovenian: Zdravilo Avastin lahko poškoduje nerojenega otroka,
English: Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with Avastin.
Slovenian: O propadanju kostnega tkiva (osteonekrozi) v drugih kosteh, ne v čeljustnici, so poročali pri bolnikih,
English: Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see Section 5.1).
Slovenian: Bevacizumab je indiciran za zdravljenje odraslih bolnic z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska, v kombinaciji s paklitakselom in cisplatinom ali, alternativno, s paklitakselom in topotekanom pri bolnicah, ki ne morejo dobivati zdravljenja s platino (glejte poglavje 5.1).
English: Gastrointestinal ulcera
Slovenian: supraventrikularna tahikardija
English: Gastrointestinal perforationb,d,
Slovenian: bolečine v trebuhu perforacija prebavilb,d,
English: • CPB arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) and concurrent Avastin (15 mg/kg) every 3 weeks for 6 and up to 8 cycles, followed by Avastin (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity.
Slovenian: Avastin (15 mg/kg) vsake 3 tedne, od 6 do največ 8 ciklov, ki jim je sledilo samo zdravilo Avastin (15 mg/kg vsake 3 tedne) do napredovanja bolezni ali nesprejemljive toksičnosti.
English: Objective Response Rate (ORR) Patients included in analysis Rate
Slovenian: Število bolnikov, vključenih v analizo delež
English: • Gastrointestinal perforations (see section 4.4).
Slovenian: · perforacije prebavil (glejte poglavje 4.4),
English: AVF2192g: In combination with bolus 5-FU/FA for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen) in patients who were not optimal candidates for first-line irinotecan treatment.
Slovenian: Shemo prejemajo bolniki, ki niso bili najprimernejši za prvo linijo zdravljenja z irinotekanom, in sicer skupaj 6 tednov v 8-tedenskih ciklih (shema Roswell Park).
English: Asthenia, Fatigue, Pyrexia, Pain, Mucosal inflammation
Slovenian: epistaksa, dispneja, hipoksija pljučna hipertenzijac, perforacija nosnega pretinac
English: Immune system disorders
Slovenian: Bolezni imunskega sistema preobčutljivost,
English: • abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,
Slovenian: · nenormalno visok krvni tlak v krvnih žilah pljuč, zaradi česar mora desna stran srca delati močneje kot navadno, · predrtje nosnega pretina (stena iz hrustanca, ki ločuje nosnici), · luknja v želodcu ali črevesju, · odprta rana ali luknja v sluznici želodca ali tankega črevesa (znaki so lahko bolečina v trebuhu,
English: A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Slovenian: Če so bevacizumab razredčili s 5-% raztopino glukoze, so opazili od koncentracije odvisen razpad tega zdravila.
English: Cisplatin+ Paclitaxel
Slovenian: Cisplatin + paklitaksel
English: Wound healing complicationsb,d,
Slovenian: d, krvavitev b,d,
English: Secondary Endpoints
Slovenian: Rezultati za vse sekundarne cilje
English: Objective response rate Rate
Slovenian: Objektivni odgovor na zdravljenje Delež
English: Avastin should be discontinued permanently in patients who experience Grade 3 or 4 bleeding during Avastin therapy (NCI-CTCAE v.3) (see section 4.8).
Slovenian: Zdravilo Avastin je treba pri bolnikih z življenjsko ogrožajočimi tromboemboličnimi neželenimi učinki, vključno s pljučno embolijo (stopnja 4, NCI-CTCAE v.3) ukiniti, bolnike s tromboemboličnimi neželenimi učinki stopnje ≤ 3 (NCI-CTCAE v.3) pa skrbno spremljati.
English: b 10 mg/kg every 2 weeks.
Slovenian: a 10 mg/kg vsaka 2 tedna b glede na kontrolno skupino
English: Renal thrombotic microangiopathy b,c
Slovenian: globoka venska tromboza renalna trombotična mikroangiopatijab,c, anevrizme in disekcije arterij
English: Progression-free survival Median time (months) Hazard ratio p-value
Slovenian: mediana preživetja brez napredovanja bolezni (meseci) razmerje ogroženosti (95-% interval zaupanja) p-vrednost
English: Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of Avastin compounded from vials approved for intravenous administration in cancer patients.
Slovenian: Po neodobreni intravitrealni uporabi vial zdravila Avastin, ki so odobrene za intravensko uporabo pri rakavih bolnikih, so poročali o posameznih primerih in o skupini resnih neželenih učinkov, povezanih z očmi.
English: Avastin is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Slovenian: Zdravilo Avastin uporabljamo za zdravljenje odraslih bolnikov z napredovalim rakom debelega črevesa in danke.
English: Patients older than 65 years have an increased risk of experiencing the following side effects :
Slovenian: Pri bolnikih, starejših od 65 let, je večje tveganje za naslednje neželene učinke: · krvni strdki v arterijah, ki lahko vodijo do kapi ali srčnega napada,
English: Pulmonary embolism, Hypoxia, Dysphoniaa
Slovenian: Presnovne in prehranske motnje anoreksija, hipomagneziemija hiponatriemija dehidracija
English: This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of Avastin in combination with interferon (IFN) alfa-2a versus IFN alfa-2a alone as first-line treatment in mRCC.
Slovenian: Učinkovitost in varnost zdravila Avastin v kombinaciji z interferonom alfa-2a v primerjavi s samim interferonom alfa-2a v prvi liniji zdravljenja metastatskega raka ledvičnih celic sta bili ovrednoteni v randomiziranem, dvojno slepem kliničnem preskušanju faze III.
English: • lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),
Slovenian: občutek napihnjenosti, črna stolica ali kri v stolici ali kri v bruhanju), · krvavitev iz spodnjega dela debelega črevesa, · lezije v dlesnih z izpostavljeno čeljustnico, ki se ne pozdravijo in so lahko povezane z bolečino in vnetjem okoliških tkiv (za nadaljnja priporočila glejte spodaj), · luknja v žolčniku (simptomi in znaki lahko vključujejo bolečino v trebuhu, povišano telesno temperaturo in slabost/bruhanje).
English: Progression-free survival - Primary analysis6 Median PFS (months)1
Slovenian: Sekundarni opazovani dogodki Preživetje brez napredovanja bolezni - primarna analiza6 Mediana preživetja brez napredovanja (meseci) Razmerje ogroženosti [95-% IZ]
English: Non-GI Fistulae (see section 4.8)
Slovenian: Fistule izven prebavil (glejte poglavje 4.8)
English: Common (affects 1 to 10 users in 100) side effects, which were not severe, include: • voice changes and hoarseness.
Slovenian: Pogosti neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov), ki pa niso bili hudi,
English: Please talk to your doctor since blood clots can lead to heart attack and stroke.
Slovenian: Posvetujte se s svojim zdravnikom, saj lahko krvni strdki privedejo do srčnega napada in kapi; · zdravilo Avastin lahko prav tako poveča tveganje za pojav krvnih strdkov v venah (tip krvnih žil);
English: HR (95% CI) p-value
Slovenian: Razmerje ogroženosti (95-% interval zaupanja) p-vrednost
English: Hazard ratio
Slovenian: razmerje ogroženosti
English: Febrile neutropenia, Leucopenia, Neutropeniab, Thrombo-cytopenia
Slovenian: Bolezni krvi in limfatičnega sistema febrilna nevtropenija, levkopenija, nevtropenijaa, trombocitopenija anemija, limfopenija
English: No trials have been conducted to investigate the pharmacokinetics of bevacizumab in renally impaired patients since the kidneys are not a major organ for bevacizumab metabolism or excretion.
Slovenian: Preskušanj za proučevanje farmakokinetike bevacizumaba pri bolnikih z okvaro ledvic niso opravili,
English: 15 mg/kg q 3 weeks
Slovenian: 5 mg/kg i.v.
English: Foetal abnormalitiesa,b
Slovenian: (venska) trombembolijaa,b,
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below) In some clinical trials anaphylactic and anaphylactoid-type reactions were reported more frequently in patients receiving Avastin in combination with chemotherapy than with chemotherapy alone.
Slovenian: V nekaterih kliničnih preskušanjih so o anafilaktičnih in anafilaktoidnih reakcijah pogosteje poročali pri bolnikih, ki so prejemali zdravilo Avastin v kombinaciji s kemoterapijo, kot pri bolnikih na sami kemoterapiji.
English: Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy.
Slovenian: Pred začetkom zdravljenja in med njim je priporočljivo spremljanje proteinurije z urinskimi testnimi lističi.
English: The safety and efficacy of Avastin in the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer was studied in three phase III trials (AVF4095g , MO22224 and GOG-0213) with different patient populations and chemotherapy regimens.
Slovenian: III (AVF4095g, MO22224 in GOG-0213) pri različni populaciji bolnic in shemah kemoterapije.
English: CT+BV (n=142)
Slovenian: kemoterapija + bevacizumab (n = 142)
English: The median age was 46.0 years (range: 20−83) in the Chemo alone group and 48.0 years
Slovenian: Mediana starost bolnic je bila v skupini s samo kemoterapijo 46,0 let (razpon: od 20 do 83), v skupini s kemoterapijo in zdravilom Avastin pa 48,0 let (razpon: od 22 do 85); v skupini s samo kemoterapijo je bilo starejših od 65 let 9,3 % bolnic, v skupini s kemoterapijo in zdravilom Avastin pa 7,5 % bolnic.
English: EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens No interaction studies have been performed.
Slovenian: Monoklonska protitelesa z delovanjem na EGFR, v kombinaciji s kemoterapevtskimi shemami, ki vključujejo bevacizumab
English: Proteinuria a,b
Slovenian: Bolezni sečil proteinurijaa,b
English: Hypersensitivity reactions/infusion reactions (see section 4.8) Patients may be at risk of developing infusion/hypersensitivity reactions.
Slovenian: Preobčutljivostne reakcije/reakcije pri infundiranju (glejte poglavje 4.4 ter podnaslov Izkušnje po prihodu zdravila na trg, spodaj)
English: Osteonecrosis of the jaw b,c
Slovenian: bolečine v hrbtu osteonekroza čeljustnicb,c
English: Venous thromboembolism (see section 4.8)
Slovenian: CTCAE v.3) (glejte poglavje 4.8).
English: • heart failure,
Slovenian: mišična oslabelost,
English: The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
Slovenian: kar je v območju, ki so ga opisali za imunoglobuline G in druga monoklonska protitelesa.Tipična vrednost za periferni volumen (Vp), če so bevacizumab dajali sočasno z drugimi antineoplastičnimi zdravili, je pri bolnicah znašala 1,69 l, pri bolnikih pa 2,35 l. Po prilagoditvi glede na telesno maso so imeli bolniki večji volumen osrednjega prostora (+20 %) kot bolnice.
English: Caution should be exercised when Avastin and intravenous bisphosphonates are administered simultaneously or sequentially.
Slovenian: Avastin in intravenskih difosfonatov je potrebna previdnost.
English: Infection, Urinary tract infection
Slovenian: okužba sečil nekrotizirajoči fasciitisa
English: Tumour-associated haemorrhage (see section 4.4)
Slovenian: Krvavitev, povezana s tumorjem (glejte poglavje 4.4)
English: Median
Slovenian: Zdravljenje
English: OTHER SPECIAL WARNING(S), IF NECESSARY This medicinal product does not contain any preservative
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: Take with water.
Slovenian: Vzemite z vodo.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: {Ime in naslov } <{tel}> <{faks}> <{e-mail}>
English: In these cases observation is recommended.
Slovenian: V teh primerih priporočamo opazovanje.