natgillin/translations-raw huggingface dataset:
The recommended dose of Avastin is 10 mg/ kg of body weight given once every 2 weeks or 15 mg/ kg of body weight given once every 3 weeks as an intravenous infusion.
Priporočeni odmerek zdravila Avastin je 10 mg/ kg telesne mase v enkratnem odmerku vsaka 2 tedna ali 15 mg/ kg telesne mase v enkratnem odmerku vsake 3 tedne, v obliki intravenske infuzije.
The recommended dose of Avastin is 7.5 mg/ kg or 15 mg/ kg of body weight given once every 3 weeks as an intravenous infusion.
Priporočeni odmerek zdravila Avastin je 7, 5 mg/ kg telesne mase ali 15 mg/ kg telesne mase v enkratnem odmerku na 3 tedne, v obliki intravenske infuzije.
Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/ kg and 15 mg/ kg doses.
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.
For details refer to section 5.1 Pharmacodynamic Properties, Non-small cell lung cancer (NSCLC).
Za podrobnosti glejte poglavje 5. 1 Farmakodinamske lastnosti, Nedrobnocelični rak pljuč.
Advanced and/ or metastatic Renal Cell Cancer (mRCC)
Napredovali in/ ali metastatski rak ledvičnih celic
The recommended dose of Avastin is 10 mg/ kg of body weight given once every 2 weeks as an intravenous infusion.
Priporočeni odmerek zdravila Avastin je 10 mg/ kg telesne mase v enkratnem odmerku vsaka 2 tedna, v obliki intravenske infuzije.
The safety and efficacy in children and adolescents have not been established.
Varnosti in učinkovitosti pri otrocih in mladostnikih niso ugotovili.
Avastin is not recommended for use in children and adolescents due to a lack of data on safety and efficacy (see section 5.3).
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Avastin pri otrocih in mladostnikih ni priporočljiva (glejte poglavje 5. 3).
No dose adjustment is required in the elderly.
Za starejše bolnike prilagajanje odmerka ni potrebno.
The safety and efficacy have not been studied in patients with renal impairment.
Varnosti in učinkovitosti zdravila Avastin pri bolnikih z zmanjšanim delovanjem ledvic niso proučevali.
The safety and efficacy have not been studied in patients with hepatic impairment.
Varnosti in učinkovitosti pri bolnikih z zmanjšanim delovanjem jeter niso proučevali.
• Hypersensitivity to the active substance or to any of the excipients. • Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanised antibodies. • Pregnancy (see section 4.6). • Avastin is contraindicated in patients with untreated CNS metastases (see sections 4.4 and 4.8).
• Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov. • Preobčutljivost za produkte ovarijskih celic kitajskega hrčka (CHO - Chinese hamster ovary) ali na druga rekombinantna humana ali humanizirana protitelesa. • Nosečnost (glejte poglavje 4. 6). • Zdravilo Avastin je kontraindicirano pri bolnikih z nezdravljenimi zasevki v centralnem živčnem sistemu (glejte poglavji 4. 4 in 4. 8).
Gastrointestinal perforations (see section 4.8) Patients may be at an increased risk for the development of gastrointestinal perforation when treated with Avastin.
Perforacije prebavil (glejte poglavje 4. 8) Bolniki so lahko izpostavljeni večjemu tveganju za nastanek perforacije prebavil, če se zdravijo z zdravilom Avastin.
Intra-abdominal inflammatory process may be a risk factor for gastrointestinal perforations in patients with metastatic carcinoma of the colon or rectum, therefore, caution should be
Vnetni proces znotraj trebušne votline je lahko dejavnik tveganja za perforacijo prebavil pri bolnikih z metastatskim rakom debelega črevesa in danke, zato je med zdravljenjem teh bolnikov potrebna previdnost.
Fistulae (see section 4.8) Patients may be at increased risk for the development of fistulae when treated with Avastin.
Fistula (glejte poglavje 4. 8) Bolniki so lahko izpostavljeni večjemu tveganju za nastanek fistule, če se zdravijo z zdravilom Avastin.
Permanently discontinue Avastin in patients with TE (tracheoesophageal) fistula or any grade 4 fistula.
Pri bolnikih s traheoezofagealno fistulo ali katerokoli fistulo stopnje 4 zdravilo Avastin dokončno ukinemo.
In cases of internal fistula not arising in the GI tract, discontinuation of Avastin should be considered
V primerih notranjih fistul izven prebavil, je potrebno razmisliti o ukinitvi zdravljenja z zdravilom Avastin.
Wound Healing Complications (see section 4.8) Avastin may adversely affect the wound healing process.
Zapleti pri celjenju ran (glejte poglavje 4. 8) Zdravilo Avastin lahko neugodno vpliva na proces celjenja ran.
Hypertension (see section 4.8) An increased incidence of hypertension was observed in Avastin-treated patients.
Hipertenzija (glejte poglavje 4. 8) Incidenca hipertenzije je bila večja pri bolnikih zdravljenih z zdravilom Avastin.
Pre existing hypertension should be adequately controlled before starting Avastin treatment.
Obstoječo hipertenzijo je treba pred začetkom zdravljenja z zdravilom Avastin ustrezno uravnati.
Avastin should be permanently discontinued, if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Zdravilo Avastin dokončno opustimo, če klinično pomembne hipertenzije ni mogoče ustrezno uravnati z antihipertenzivnimi zdravili ali če se je pri bolniku pojavila hipertenzivna kriza ali hipertenzivna encefalopatija.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) (see section 4.8) There have been rare reports of Avastin-treated patients developing signs and symptoms that are consistent with Reversible Posterior Leukoencephalopathy Syndrome (RPLS), 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.
Sindrom reverzibilne posteriorne levkoencefalopatije (glejte poglavje 4. 8) Pri bolnikih, ki so se zdravili z zdravilom Avastin, so redko poročali o pojavu znakov in simptomov, povezanih s sindromom reverzibilne posteriorne levkoencefalopatije, 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.
A diagnosis of RPLS requires confirmation by brain imaging.
Diagnozo sindroma reverzibilne posteriorne levkoencefalopatije potrdimo s slikovnimi preiskavami možganov.
In patients developing RPLS, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Avastin.
Če se pri bolniku pojavi sindrom reverzibilne posteriorne levkoencefalopatije, je poleg prekinitve zdravljenja z zdravilom Avastin priporočljivo zdravljenje specifičnih simptomov, vključno z uravnavo hipertenzije.
The safety of reinitiating Avastin therapy in patients previously experiencing RPLS is not known.
Varnost ponovne uvedbe zdravljenja z zdravilom Avastin pri bolnikih, pri katerih se je ta sindrom pojavil, ni znana.
Proteinuria (see section 4.8) Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with Avastin.
Proteinurija (glejte poglavje 4. 8) Bolnike z anamnezo hipertenzije spremlja večje tveganje za razvoj proteinurije, če jih zdravimo z zdravilom Avastin.
There is evidence suggesting that Grade 1 [US National Cancer Institute- Common Toxicity Criteria (NCI-CTC) version 2.0] proteinuria may be related to the dose.
Obstajajo dokazi, da je proteinurija prve stopnje (Ameriški Nacionalni inštitut za raka – skupni kriteriji toksičnosti (NCI- CTC), verzija 2. 0) lahko povezana z odmerkom.
Therapy should be permanently discontinued in patients who develop Grade 4 proteinuria (nephrotic syndrome).
Pri bolnikih, pri katerih se pojavi proteinurija četrte stopnje (nefrotični sindrom), je treba zdravljenje dokončno ukiniti.
Arterial Thromboembolism (see section 4.8) In five randomised clinical trials, the incidence of arterial thromboembolic events including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs) was higher in patients receiving Avastin in combination with chemotherapy compared to those who received chemotherapy alone.
4 Arterijska trombembolija (glejte poglavje 4. 8) V petih randomiziranih kliničnih preskušanjih je bila incidenca dogodkov arterijske trombembolije, vključno s cerebrovaskularnimi dogodki, tranzitornimi ishemičnimi atakami (TIA) in miokardnimi infarkti, večja pri bolnikih, ki so prejemali zdravilo Avastin v kombinaciji s kemoterapijo v primerjavi s tistimi, ki so prejemali le kemoterapijo.
Patients, receiving Avastin plus chemotherapy, with a history of arterial thromboembolism or age greater than 65 years have an increased risk of developing arterial thromboembolic events during therapy.
Bolniki, ki prejemajo zdravilo Avastin skupaj s kemoterapijo, in imajo arterijske trombembolične dogodke v anamnezi ali so stari nad 65 let, imajo med zdravljenjem povečano tveganje za razvoj arterijskih trombemboličnih dogodkov.
Therapy should be permanently discontinued in patients who develop arterial thromboembolic events.
Če se pri bolnikih pojavijo arterijski trombembolični dogodki, moramo zdravljenje opustiti.
4 Venous Thromboembolism (see section 4.8) Patients may be at risk of developing venous thromboembolic events, including pulmonary embolism under Avastin treatment.
Venska trombembolija (glejte poglavje 4. 8) Med zdravljenjem z zdravilom Avastin so bolniki lahko podvrženi povečanemu tveganju za razvoj venskih trombemboličnih dogodkov, vključno s pljučno embolijo.
Avastin should be discontinued in patients with life-threatening (Grade 4) pulmonary embolism, patients with ≤ Grade 3 need to be closely monitored.
Zdravilo Avastin je treba pri bolnikih z življenjsko ogrožajočo pljučno embolijo (stopnja 4) ukiniti, bolnike s stopnjo ≤ 3 pa skrbno spremljati.
Haemorrhage The risk of CNS haemorrhage in patients with CNS metastases receiving Avastin could not be fully evaluated, as these patients were excluded from clinical trials.
Krvavitev Tveganja za krvavitev v centralnem živčnem sistemu ob prejemanju zdravila Avastin ni mogoče oceniti v celoti pri bolnikih z zasevki v tem predelu, ker niso bili vključeni v klinična preskušanja.
Thus, Avastin should not be used in these patients (see sections 4.3 and 4.8).
Zdravila Avastin zato pri teh bolnikih ne uporabljamo (glejte poglavji 4. 3 in 4. 8).
Patients treated with Avastin have an increased risk of haemorrhage, especially tumour-associated haemorrhage.
Bolnike zdravljene z zdravilom Avastin spremlja večje tveganje za krvavitev, še posebej za krvavitev, povezano s tumorjem.
Avastin should be discontinued permanently in patients who experience Grade 3 or 4 bleeding during Avastin therapy (see section 4.8).
Pri bolnikih, pri katerih se pojavi krvavitev tretje ali četrte stopnje, zdravilo Avastin opustimo (glejte poglavje 4. 8).
There is no information on the safety profile of Avastin in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting Avastin treatment, as such patients were excluded from clinical trials.
Varnostni profil zdravila Avastin pred njegovo uvedbo pri bolnikih, ki imajo kongenitalno hemoragično diatezo ali pridobljeno koagulopatijo ali če prejemajo polni odmerek antikoagulantov za zdravljenje trombembolije, ni poznan, ker le- ti niso bili vključeni v klinična preskušanja.
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.
Vendar bolniki, pri katerih se je med zdravljenjem pojavila venska tromboza, niso imeli povečane pojavosti krvavitev stopnje 3 ali več, če so jih sočasno zdravili s polnim odmerkom varfarina in zdravilom Avastin.
Pulmonary Haemorrhage/ Haemoptysis Patients with non-small cell lung cancer treated with Avastin may be at risk of serious, and in some cases fatal, pulmonary haemorrhage/ haemoptysis.
Krvavitev v pljučih/ hemoptiza Pri bolnikih z nedrobnoceličnim rakom pljuč, ki se zdravijo z zdravilom Avastin, lahko obstaja tveganje za resno in v nekaterih primerih smrtno krvavitev v pljučih/ hemoptizo.
Patients with recent pulmonary haemorrhage/ haemoptysis (> 2.5 ml of red blood) should not be treated with Avastin.
Bolnike, ki so nedavno imeli krvavitev v pljučih/ hemoptizo (> 2, 5 ml rdeče krvi), z zdravilom Avastin ne smemo zdraviti.
Congestive Heart Failure (CHF) (see section 4.8) Events consistent with CHF were reported in clinical trials.
Kongestivno srčno popuščanje (glejte poglavje 4. 8) Med kliničnimi preskušanji so poročali o dogodkih, skladnih s kongestivnim srčnim popuščanjem.
The symptoms ranged from asymptomatic declines in left ventricular ejection fraction to symptomatic CHF, requiring treatment or hospitalisation.
Simptomi so bili od asimptomatskega zmanjšanja iztisnega deleža levega prekata do simptomatskega kongestivnega srčnega popuščanja, za katerega pa je bilo potrebno zdravljenje ali hospitalizacija.
Most of the patients who experienced CHF had metastatic breast cancer and had received previous treatment with anthracyclines, prior radiotherapy to the left chest wall or other risk factors for CHF, such as pre-existing coronary heart disease or concomitant cardiotoxic therapy.
Večina bolnikov, pri katerih se je pojavilo kongestivno srčno popuščanje, je imela metastatski rak dojk in je predhodno prejela zdravljenje z antraciklini, radioterapijo na levi strani prsnega koša ali je imela druge dejavnike tveganja za kongestivno srčno popuščanje, kot je obstoječa koronarna srčna bolezen ali sočasna kardiotoksična terapija.
Caution should be exercised when treating patients with clinically significant cardiovascular disease or pre-existing congestive heart failure with Avastin.
Pri zdravljenju bolnikov s klinično pomembno kardiovaskularno boleznijo ali predhodno obstoječim kongestivnim srčnim popuščanjem z zdravilom Avastin je potrebna previdnost.
Neutropenia (see section 4.8) Increased rates of severe neutropenia, febrile neutropenia, or infection with severe neutropenia (including some fatalities) have been observed in patients treated with some myelotoxic chemotherapy regimens plus Avastin in comparison to chemotherapy alone.
Nevtropenija (glejte poglavje 4. 8) Pri bolnikih, zdravljenih z nekaterimi mielotoksičnimi kemoterapevtskimi shemami in zdravilom Avastin so v primerjavi s samo kemoterapijo opazili večji pojav hude nevtropenije, febrilne nevtropenije ali okužbe s hudo nevtropenijo (vključno s smrtnimi primeri).
No clinically relevant pharmacokinetic interaction of co-administered chemotherapy on Avastin disposition has been observed based on the results of a population PK analysis.
Populacijska farmakokinetična analiza je pokazala, da klinično pomembnega farmakokinetičnega medsebojnega delovanja med sočasno dano kemoterapijo in razporeditvijo zdravila Avastin ni.
There was no difference in clearance of Avastin in patients treated with single-agent Avastin compared to patients receiving Avastin in combination with the bolus-IFL regimen.
Razlike med očistkom zdravila Avastin pri bolnikih, ki so jih zdravili samo z zdravilom Avastin v primerjavi z bolniki, ki so prejemali zdravilo Avastin skupaj s shemo irinotekan/ 5- FU/ folinska kislina (IFL) v obliki bolusa, ni bilo.
The effect of other co-administered chemotherapies on Avastin clearance is considered not clinically significant.
Vpliv drugih sočasno danih kemoterapij na očistek zdravila Avastin ne smatramo za klinično pomemben.
Results from a dedicated drug-drug interaction study, demonstrated no significant effect of bevacizumab on the pharmacokinetics of irinotecan and its active metabolite SN38.
Rezultati študije medsebojnega delovanja zdravilo- zdravilo so pokazali, da bevacizumab nima pomembnega vpliva na farmakokinetiko irinotekana in njegovega aktivnega presnovka SN38.
5 Results from one study in metastatic colorectal cancer patients demonstrated no significant effect of bevacizumab on the pharmacokinetic of capecitabine and its metabolites, and on the pharmacokinetics of oxaliplatin, as determined by measurement of free and total platinum.
Rezultati ene od študij pri bolnikih z metastatskim rakom debelega črevesa in danke so pokazali, da bevacizumab nima pomembnega vpliva na farmakokinetiko kapecitabina in njegovih presnovkov ter na farmakokinetiko oksaliplatina, kar so dokazali z določanjem proste in celokupne platine.
Results from one study in renal cancer patients demonstrated no significant effect of bevacizumab on the pharmacokinetics of interferon alfa-2a.
Rezultati ene od študij pri bolnikih z rakom ledvic so pokazali, da bevacizumab nima pomembnega vpliva na farmakokinetiko interferona alfa- 2a.
The potential effect of bevacizumab on the pharmacokinetics of cisplatin and gemcitabine was investigated in non-squamous NSCLC patients.
Pri bolnikih z neskvamoznim nedrobnoceličnim rakom pljuč so proučevali vpliv bevacizumaba na farmakokinetiko cisplatina in gemcitabina.
Study results demonstrated no significant effect of bevacizumab on the pharmacokinetics of cisplatin.
Rezultati študije so pokazali, da bevacizumab ne vpliva signifikantno na farmakokinetiko cisplatina.
Due to high inter-patient variability and limited sampling, the results from that study do not allow firm conclusions to be drawn on the impact of bevacizumab on gemcitabine pharmacokinetics.
Zaradi velike variabilnosti med bolniki in omejenega vzorčenja iz rezultatov študije ne moremo zagotovo sklepati o vplivu bevacizumaba na farmakokinetiko gemcitabina.
In two clinical studies 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 študijah 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 sunitinibijevim malatom (50 mg na dan).
All of these findings were reversible upon discontinuation of bevacizumab and sunitinib malate (see Hypertension, Proteinuria, RPLS in section 4.4 Special warnings and precautions for use).
Ti neželeni učinki po prekinitvi zdravljenja z bevacizumabom in sunitinibijevim malatom niso bili več prisotni (glejte odstavek Hipertenzija, Proteinurija in Sindrom reverzibilne posteriorne levkoencefalopatije v poglavju 4. 4 Posebna opozorila in previdnostni ukrepi).
Pregnancy There are no data on the use of Avastin in pregnant women.
Nosečnost Ni podatkov o uporabi zdravila Avastin pri nosečnicah.
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).
Avastin is contraindicated (see section 4.3) in pregnancy.
Zdravilo Avastin je kontraindicirano (glejte poglavje 4. 3) med nosečnostjo.
Women of childbearing potential have to use effective contraception during (and up to 6 months after treatment).
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 6 mesecev po njem.
Lactation It is not known whether bevacizumab is excreted in human milk.
6 Dojenje Ni znano, ali se bevacizumab izloča v materino mleko.
As maternal IgG is excreted in milk and bevacizumab could harm infant growth and development (see section 5.3), women must discontinue breast-feeding during therapy and not breast feed for at least six months following the last dose of Avastin.
Dojiti ne smejo še vsaj 6 mesecev po zadnjem odmerku zdravila Avastin.
No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso opravili.
However, there is no evidence that Avastin treatment results in an increase in adverse events that might lead to impairment of the ability to drive or operate machinery or impairment of mental ability.
Ni podatkov, da bi zdravljenje z zdravilom Avastin imelo neželene učinke, ki bi poslabšali sposobnost vožnje in upravljanja s stroji ali zmanjšali mentalne sposobnosti.
The overall safety profile of Avastin is based on data from over 3,500 patients with various malignancies, predominantly treated with Avastin in combination with chemotherapy in clinical trials.
Celotni varnostni profil zdravila Avastin temelji na podatkih več kot 3500 bolnikov z različnimi malignimi boleznimi, ki so se v kliničnih preskušanjih večinoma zdravili z zdravilom Avastin v kombinaciji s kemoterapijo.
6 The most serious adverse drug reactions were:
Najresnejši neželeni učinki so bili:
• Gastrointestinal perforations (see section 4.4). • Haemorrhage, including pulmonary haemorrhage/ haemoptysis, which is more common in non- small cell lung cancer patients (see section 4.4). • Arterial thromboembolism (see section 4.4).
• perforacije prebavil (glejte poglavje 4. 4), • krvavitev, vključno s krvavitvijo v pljučih/ hemoptizo, ki je pogostejša pri bolnikih z nedrobnoceličnim rakom pljuč (glejte poglavje 4. 4), • arterijska trombembolija (glejte poglavje 4. 4).
The most frequently observed adverse drug 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.
Table 1 lists adverse drug reactions associated with the use of Avastin in combination with different chemotherapy regimens in multiple indications.
V preglednici 1 so našteti neželeni učinki, ki so povezani z uporabo zdravila Avastin v kombinaciji z različnimi shemami kemoterapije pri več indikacijah.
These reactions had occurred either with at least a 2% difference compared to the control arm (NCI-CTC grade 3-5 reactions) or with at least a 10% difference compared to the control arm (NCI-CTC grade 1-5 reactions), in at least one of the major clinical trials.
Ti neželeni učinki so se pojavili z najmanj 2% razliko v primerjavi s kontrolno skupino (neželeni učinki stopnje 3 do 5 po lestvici NCI- CTC) ali pa z najmanj 10% razliko v primerjavi s kontrolno skupino (neželeni učinki stopnje 1 do 5 po lestvici NCI - CTC) v vsaj enem od večjih kliničnih preskušanj.
Very Common (≥ 10%) and Common (≥ 1% - < 10%).
Našteti neželeni učinki v tej preglednici spadajo v naslednji skupini: zelo pogosti (≥ 10%) in pogosti (≥ 1% − < 10%).
Adverse drug reactions are added to the appropriate category in the table below according to the highest incidence seen in any of the major clinical trials.
Neželeni učinki so v spodnji preglednici razdeljeni v ustrezno skupino glede na najvišjo incidenco, ki so jo opazili v kateremkoli izmed večjih kliničnih preskušanj.
Within each frequency grouping adverse drug reactions are presented in the order of decreasing seriousness.
V razvrstitvah pogostnosti so vsi neželeni učinki navedeni po padajoči resnosti.
Some of the adverse drug reactions are reactions commonly seen with chemotherapy, (e. g. palmar-plantar erythrodysaesthesia syndrome with capecitabine and peripheral sensory neuropathy with paclitaxel or oxaliplatin); however, an exacerbation by Avastin therapy can not be excluded.
Nekateri izmed neželenih učinkov so učinki, ki jih pogosto opazimo v povezavi s kemoterapijo (npr. palmarno- plantarno eritrodisestezijo s kapecitabinom in periferno senzorično nevropatijo s paklitakselom ali oksaliplatinom), vendar pa ne moremo izključiti, da zdravljenje z zdravilom Avastin k njihovemu poslabšanju ne prispeva.
Table 1:
7 Preglednica 1.
Very Common and Common Adverse Drug Reactions
pogosti in pogosti neželeni učinki
NCI-CTC Grade 3-5 Reactions (≥ 2% difference between the study arms in at
Neželeni učinki stopnje 3 do 5 po NCI- CTC lestvici (≥ 2% razlika med preiskovanimi skupinami v
All Grade Reactions (≥ 10% difference
Neželeni učinki vseh stopenj (≥ 10% razlika med