FrancophonIA/ELRC3.0 huggingface dataset:
English: While being treated with ZALTRAP, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Slovenian: V času zdravljenja z zdravilom ZALTRAP morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
English: Results by prior bevacizumab exposure are summarised in Table 3.
Slovenian: Rezultati glede na predhodno izpostavljenost bevacizumabu so povzeti v preglednici 3.
English: Analysis for OS and PFS by ECOG PS was also performed.
Slovenian: Opravljeni sta bili tudi analizi OS in PFS glede na stanje zmogljivosti po ECOG.
English: Dehydration (1) Decreased appetite Weight loss
Slovenian: dehidracija (1) zmanjšanje apetita hujšanje
English: Patients with NYHA class III or IV congestive heart failure should not be treated with ZALTRAP.
Slovenian: Bolnikov s kongestivnim srčnim popuščanjem v razredu III ali IV po NYHA III se ne sme zdraviti z zdravilom ZALTRAP.
English: Caution should be used when retreating patients with prior hypersensitivity reactions as recurrent hypersensitivity reactions have been observed in some patients despite prophylaxis, including corticosteroids.
Slovenian: Previdnost je potrebna pri ponovnem zdravljenju bolnikov, ki so predhodno imeli preobčutljivostne reakcije, kajti pri nekaterih bolnikih so opažali ponavljajoče se preobčutljivostne reakcije kljub profilaksi, vključno s kortikosteroidi.
English: Your doctor will stop this medicine for at least 4 weeks before planned surgery and until the wound is fully healed.
Slovenian: Zdravnik bo prekinil vaše zdravljenje s tem zdravilom najmanj 4 tedne pred načrtovano operacijo; zdravila ne boste prejemali, dokler se vam rana povsem ne zaceli.
English: • DEHP free PVC containing trioctyl-trimellitate (TOTM)
Slovenian: • PVC, ki ne vsebuje DEHP, vsebuje pa trioktil-trimelitat (TOTM)
English: • Allergic reactions: Common (may affect up to 1 in 10 people) - these may happen within a few minutes after your infusion.
Slovenian: • Alergijske reakcije: pogosto (pojavijo se lahko pri največ 1 od 10 oseb) - Pojavijo se lahko v nekaj minutah po infundiranju zdravila.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given ZALTRAP and during your treatment if:
Slovenian: Opozorila in previdnostni ukrepi Posvetujte se s svojim zdravnikom, s farmacevtom ali z medicinsko sestro, preden dobite zdravilo ZALTRAP in med zdravljenjem:
English: Aflibercept binds to human VEGF-A (equilibrium dissociation constant KD of 0.5 pM for VEGF-A165 and 0.36 pM for VEGF-A121), to human PlGF (KD of 39 pM for PlGF-2), and to human VEGF-B (KD of 1.92 pM) to form a stable, inert complex which has no detectable biological activity.
Slovenian: Aflibercept se veže na človeški VEGF-A (ravnotežna konstanta disociacije KD je 0,5 pM za VEGF-A 165 in 0,36 pM za VEGF-A 121), človeški PlGF (KD je 39 pM za PlGF-2) in človeški VEGF-B (KD je 1,92 pM) ter tvori stabilen, inerten kompleks brez zaznavne biološke aktivnosti.
English: If recurrence after irinotecan and 5-FU dose reductions, reduction of ZALTRAP dose to 2 mg/kg could be considered.
Slovenian: Če pride do ponovitve po zmanjšanju odmerkov irinotekana in 5-FU, pride v poštev zmanjšanje odmerka zdravila ZALTRAP na 2 mg/kg.
English: Dose modification of FOLFIRI regimen (see section 4.2), anti-diarrhoeal medicinal products, and rehydration as needed should be instituted.
Slovenian: Odmerek sheme FOLFIRI je treba prilagoditi (glejte poglavje 4.2) ter uvesti antidiarioike in rehidracijo, kot je potrebno.
English: ZALTRAP/FOLFIRI should be discontinued and appropriate medical therapy should be administered.
Slovenian: Uporabo sheme ZALTRAP/FOLFIRI je treba prekiniti in uporabiti je treba ustrezno zdravljenje.
English: Diarrhoea and dehydration
Slovenian: Driska in dehidracija
English: Figure 1 - Overall survival (months) - Kaplan-Meier curves by treatment group - ITT population
Slovenian: Slika 1 - Celokupno preživetje (meseci) - Kaplan-Meierjevi krivulji po terapevtski skupinipopulacija ZNZ
English: The efficacy and safety of ZALTRAP were evaluated in a randomised, double-blind, placebo-controlled study in patients with metastatic colorectal cancer who had previously been treated with an oxaliplatin-based treatment with or without prior bevacizumab.
Slovenian: Učinkovitost in varnost zdravila ZALTRAP so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani študiji pri bolnikih z metastatskim kolorektalnim rakom, predhodno zdravljenih s terapijo na podlagi oksaliplatina, s predhodno uporabo bevacizumaba ali brez nje.
English: ZALTRAP should be used only if the potential benefit justifies the potential risk during pregnancy.
Slovenian: Zdravilo ZALTRAP se sme med nosečnostjo uporabiti le, če morebitna korist upravičuje možno tveganje.
English: • you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction and especially if you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
Slovenian: • če imate kakršne koli težave v ustih ali z zobmi, kot je bolezen zob, bolezen dlesni ali predvideno izdrtje zob in še posebej, če ste že bili zdravljeni z difosfonatom (uporablja se za zdravljenje ali preprečevanje bolezni kosti).
English: The treatment cycles on both arms were repeated every 2 weeks.
Slovenian: Cikluse zdravljenja so v obeh terapevtskih krakih ponavljali na 2 tedna.
English: Carcinogenesis and mutagenesis No studies have been conducted to evaluate carcinogenicity or mutagenicity of aflibercept.
Slovenian: Kancerogenost in mutagenost Študij za oceno kancerogenosti in mutagenosti aflibercepta niso izvedli.
English: ZALTRAP is a sterile, preservative-free and non-pyrogenic concentrate, therefore the solution for infusion should be prepared by a healthcare professional using safe-handling procedures and aseptic technique.
Slovenian: Zdravilo ZALTRAP je sterilen in apirogen koncentrat brez konzervansov, zato mora raztopino za infundiranje pripraviti zdravstveni delavec, ki uporablja varne postopke ravnanja in aseptično tehniko.
English: It is recommended that aflibercept not be initiated for at least 4 weeks following major surgery and not until the surgical wound is fully healed.
Slovenian: Priporočljivo je, da se zdravljenje z afliberceptom ne začne prej kot vsaj 4 tedne po večji operaciji in da se ne začne, dokler se rana povsem ne zaceli.
English: Aflibercept blocks the activation of VEGF receptors and the proliferation of endothelial cells, thereby inhibiting the growth of new vessels that supply tumours with oxygen and nutrients.
Slovenian: Aflibercept blokira aktivacijo receptorjev VEGF in proliferacijo endotelijskih celic; tako zavre rast novih žil, ki oskrbujejo tumorje s kisikom in hranili.
English: Oxaliplatin-based regimens were administered in combination with bevacizumab in 373 patients (30.4 %).
Slovenian: Sheme na osnovi oksaliplatina so v kombinaciji z bevacizumabom uporabili pri 373 bolnikih (30,4 %).
English: Women of childbearing potential / Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while on ZALTRAP, and should be informed of the potential hazard to the foetus.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom ZALTRAP ne zanosijo, in jih je treba obvestiti o možnih nevarnostih za plod.
English: If you are uncertain contact your doctor.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom.
English: There are no data available for patients with severe hepatic impairment (total bilirubin > 3 x ULN and any AST).
Slovenian: Podatkov za bolnike s hudo okvaro jeter (celokupni bilirubin > 3-kratna ZNM in kateri koli AST) ni.
English: Your doctor should check your blood pressure throughout your treatment.
Slovenian: Zdravnik vam mora ves čas zdravljenja kontrolirati krvni tlak.
English: • polypropylene
Slovenian: • polipropilena
English: Seventeen (17) patients treated with ZALTRAP (1.6 %) and two (2) placebo-treated patients (0.2 %) were also positive in the neutralising antibody assay.
Slovenian: Sedemnajst (17) prejemnikov zdravila ZALTRAP (1,6 %) in dva (2) prejemnika placeba (0,2 %) so imeli tudi pozitiven preskus na nevtralizirajoča protitelesa.
English: For minor surgery such as central venous access port placement, biopsy, and tooth extraction, aflibercept may be initiated/restarted once the surgical wound is fully healed.
Slovenian: Po manjših posegih, kot so npr. namestitev centralnega venskega dostopa, biopsija ali izdrtje zoba, je mogoče zdravljenje z afliberceptom začeti oz. ga znova uvesti, ko se kirurška rana popolnoma zaceli.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX44
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe, druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX44
English: What ZALTRAP is and what it is used for
Slovenian: Kaj je zdravilo ZALTRAP in za kaj ga uporabljamo
English: High molecular weight proteins are not cleared by the renal route, therefore renal elimination of aflibercept is expected to be minimal.
Slovenian: Beljakovine z veliko molekulsko maso se ne odstranjujejo skozi ledvice, zato je mogoče pričakovati, da je izločanje aflibercepta skozi ledvice minimalno.
English: Practical information for handling and administration of ZALTRAP for doctors, nurses and pharmacists when using this medicine is provided with this leaflet.
Slovenian: To navodilo obsega praktične informacije za ravnanje z zdravilom ZALTRAP in za njegovo dajanje, namenjene zdravnikom, medicinskim sestram in farmacevtom pri uporabi tega zdravila.
English: The medicine must be diluted before it is given.
Slovenian: Zdravilo je treba pred uporabo razredčiti.
English: Weight had an effect on free aflibercept clearance and volume of distribution resulting with a 29 % increase in aflibercept exposure in patients weighing ≥ 100 kg.
Slovenian: Telesna masa je vplivala na očistek in volumen porazdelitve prostega aflibercepta, tako da je bila pri bolnikih, ki so tehtali ≥ 100 kg, izpostavljenost afliberceptu 29 % večja.
English: If severe diarrhoea persists with both dose reductions, FOLFIRI should be discontinued.
Slovenian: Če huda driska po obeh zmanjšanjih odmerka še traja, je treba uporabo sheme FOLFIRI prekiniti.
English: Post-hoc analyses excluding patients who progressed during or within 6 months of adjuvant therapy for patients with or without prior bevacizumab treatment are summarised in Table 4.
Slovenian: Post hoc analize (izključujoč bolnike, ki so napredovali med adjuvantnim zdravljenjem ali v 6 mesecih po njem) za bolnike, predhodno zdravljene in nezdravljene z bevacizumabom, so povzete v preglednici 4.
English: • Bleeding: Very common (may affect more than 1 in 10 people) - this includes bleeding from the nose, but may also include severe bleeding in your gut and other parts of the body, which may lead to death.
Slovenian: • Krvavitev: zelo pogosto (pojavi se lahko pri več kot 1 od 10 oseb) - To vključuje krvavitev iz nosu, a lahko obsega tudi hudo krvavitev v črevesu oziroma drugih delih telesa, ki lahko povzroči smrt.
English: In these patients, non-renal events were generally comparable between patients with renal impairment and those without renal impairment, except a > 10 % higher incidence in dehydration (all grades) was noted (see section 4.4).
Slovenian: Pri teh bolnikih so bili neledvični učinki na splošno primerljivi med bolniki z okvaro ledvic in tistimi brez nje; izjema je bila dehidracija (vseh stopenj), katere incidenca je bila > 10 % večja (glejte poglavje 4.4).
English: The diagnosis of PRES is confirmed by brain Magnetic Resonance Imaging (MRI).
Slovenian: Diagnozo se potrdi z magnetnoresonančnim slikanjem (MRS) možganov.
English: Your doctor will do blood tests regularly to check your white blood cell counts throughout your treatment.
Slovenian: Zdravnik vam bo redno kontroliral kri in bo ves čas zdravljenja spremljal število belih krvnih celic.
English: If you experience any of these symptoms, talk to your doctor immediatley since your doctor may want to treat your symptoms and stop your treatment with ZALTRAP.
Slovenian: Če se vam pojavi kateri od teh simptomov, se takoj posvetujte s svojim zdravnikom, kajti morda bo moral zdraviti vaše simptome in končati zdravljenje z zdravilom ZALTRAP.
English: No conclusion can be drawn for patients with severe renal impairment due to very limited data available.
Slovenian: Glede bolnikov s hudo okvaro ledvic ni mogoče sklepati ničesar, ker je razpoložljivih podatkov zelo malo.
English: • you have had any abnormal tube-like connections or passageways inside the body between internal organs and skin or other tissues (also called ‘fistula').
Slovenian: • če ste imeli nenormalne povezave znotraj telesa med notranjimi organi in kožo ali drugimi tkivi (to imenujemo tudi "fistula").
English: • you have any bleeding problems or if you notice any bleeding after treatment (see section 4) or if you feel extreme tiredness, weakness, dizziness, or have changes in the colour of your stool.
Slovenian: • če imate težave s krvavitvami, če opazite krvavitve po zdravljenju (glejte poglavje 4), če občutite hudo utrujenost, šibkost ali omotico, ali če opazite spremenjeno barvo blata.
English: • you have had a tooth removed or any form of surgery in the last 4 weeks, or you are going to have an operation or a dental or medical procedure, or you have a wound after surgery that has not healed.
Slovenian: • če so vam izdrli zob, če ste v zadnjih 4 tednih imeli kakršen koli poseg, če imate predvideno kakšno operacijo, zobozdravstven ali zdravstven poseg, ali če imate po operaciji rano, ki se ni zacelila.
English: This medicine may harm your unborn baby since it may stop new blood vessels from forming.
Slovenian: To zdravilo namreč lahko škoduje nerojenemu otroku - prepreči lahko nastajanje novih žil.
English: PRACTICAL INFORMATION FOR HEALTHCARE PROFESSIONALS ON PREPARATION AND HANDLING OF ZALTRAP 25 mg / ml CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: PRAKTIČNE INFORMACIJE ZA ZDRAVSTVENO OSEBJE O PRIPRAVI IN RAVNANJU Z ZDRAVILOM ZALTRAP 25 mg/ml KONCENTRAT ZA RAZTOPINO ZA INFUNDIRANJE
English: Most aflibercept-induced effects were reversible after a 5-month drug free period with the exception of skeletal and nasal cavity findings.
Slovenian: Večina učinkov, izzvanih z afliberceptom, je bila reverzibilna po 5-mesečnem obdobju brez zdravila; izjema so skeletni učinki in učinki v nosni votlini.
English: Your doctor may give you medicines to stop or treat diarrhoea and being sick (vomiting).
Slovenian: Zdravnik vam lahko da zdravila za ustavitev ali zdravljenje driske in slabosti (bruhanja).
English: By blocking the growth of blood vessels, ZALTRAP helps to stop or slow down the growth of the tumour.
Slovenian: Z zavrtjem rasti žil zdravilo ZALTRAP pomaga ustaviti ali upočasniti rast tumorja.
English: • you have kidney problems (protein in the urine), since your doctor will monitor your kidney function and may need to adjust your dose of ZALTRAP.
Slovenian: • če imate težave z ledvicami (beljakovine v urinu); zdravnik vam bo kontroliral delovanje ledvic in vam bo morda moral prilagoditi odmerek zdravila ZALTRAP.
English: As angiogenesis is critical to foetal development, the inhibition of angiogenesis following administration of ZALTRAP may result in adverse effects on pregnancy.
Slovenian: Angiogeneza je ključna za razvoj ploda, zato ima lahko zavrtje angiogeneze po uporabi zdravila ZALTRAP neželene učinke na nosečnost.
English: Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, and on infusion sets for administration, see section 6.6.
Slovenian: Previdnostni ukrepi pred ravnanjem z zdravilom in njegovo uporabo Za navodila o redčenju zdravila pred uporabo in infuzijskih kompletih za dajanje glejte poglavje 6.6.
English: There are very limited data in patients with severe renal impairment; therefore, these patients should be treated with caution.
Slovenian: Podatkov za bolnike s hudo okvaro ledvic je zelo malo, zato je pri zdravljenju takšnih bolnikov potrebna previdnost.
English: 5-FU bolus should be reduced and the infusion dose reduced by 20 %.
Slovenian: Bolus 5-FU je treba zmanjšati in odmerek za infundiranje zmanjšati za 20 %.
English: Febrile neutropenia or neutropenic sepsis
Slovenian: Febrilna nevtropenija ali nevtropenična sepsa
English: Aflibercept has been shown to be embryotoxic and teratogenic when administered intravenously to pregnant rabbits every 3 days during the organogenesis period (gestation days 6 to18) at doses approximately 1 to 15 times the human dose of 4 mg/kg every 2 weeks.
Slovenian: Aflibercept se je izkazal za embriotoksičnega in teratogenega, če je bil pri brejih kunkah med obdobjem organogeneze (od 6. do 18. dne gestacije) vsak 3 dan uporabljen intravensko v odmerkih, ki so bili približno od 1- do 15-krat tolikšni, kot je odmerek za človeka 4 mg/kg vsaka 2 tedna.
English: Proteinuria (1),(3) Increased serum creatinine
Slovenian: Bolezni sečil Zelo pogosti proteinurija (1),(3) zvišanje kreatinina v serumu
English: Elderly patients ≥65 years had an increased risk of diarrhoea, dizziness, asthenia, weight loss and dehydration.
Slovenian: Starejši bolniki, stari ≥ 65 let, imajo večje tveganje za drisko, omotico, astenijo, hujšanje in dehidracijo.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in na nalepki viale poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: The patient should remain under close medical supervision to monitor any adverse reactions (see section 4.8).
Slovenian: Bolnik mora ostati pod skrbnim zdravniškim nadzorom za kontrolo morebitnih neželenih učinkov (glejte poglavje 4.8).
English: • you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Slovenian: • če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
English: These differences do not affect exposure due to weight-based dosing and no dose modifications based on gender are required.
Slovenian: Zaradi odmerjanja na podlagi telesne mase te razlike ne vplivajo na izpostavljenost in odmerka ni treba prilagoditi glede na spol.
English: • Nephrotic syndrome or thrombotic microangiopathy (TMA)
Slovenian: • nefrotskega sindroma ali trombotične mikroangiopatije (TMA)
English: • Pain in the mouth, teeth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth: Uncommon (may affect up to 1 in 100 people) - These symptoms could be signs of bone damage in the jaw (osteonecrosis).
Slovenian: • Bolečina v ustih, zobeh in/ali čeljusti, oteklost ali neceljenje ran v ustni votlini ali čeljusti, vnetje, odrevelenost ali občutek pritiska v čeljusti ali majanje zoba: občasno (pojavijo se lahko pri največ 1 od 100 oseb) - ti simptomi so lahko znaki poškodbe kosti v čeljusti (osteonekroze).
English: ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
Slovenian: Zdravilo ZALTRAP je v kombinaciji s kemoterapijo z irinotekanom/5-fluorouracilom/folinsko kislino (FOLFIRI) indicirano pri odraslih bolnikih z metastatskim kolorektalnim rakom (mKRR), ki je odporen na ali je napredoval po zdravljenju s shemo, ki je vključevala oksaliplatin.
English: Proteinuria (1),(3)
Slovenian: Pogosti proteinurija (1),(3)
English: There is no specific antidote to ZALTRAP overdose.
Slovenian: Za preveliko odmerjanje zdravila ZALTRAP ni specifičnega antidota.
English: In the event of recurrence, despite appropriate anticoagulation, aflibercept treatment should be discontinued.
Slovenian: Če se dogodek kljub ustrezni antikoagulaciji ponovi, je treba zdravljenje z afliberceptom prekiniti.
English: Population pharmacokinetics analysis and inter study comparisons did not reveal any pharmacokinetic drug-drug interaction between aflibercept and the FOLFIRI regimen.
Slovenian: Populacijska farmakokinetična analiza in primerjave med študijami niso odkrile farmakokinetičnih medsebojnih delovanj med afliberceptom in zdravili v shemi FOLFIRI.
English: ZALTRAP is to be administered only as an intravenous infusion over 1 hour.
Slovenian: Zdravilo ZALTRAP je namenjeno samo za intravensko infundiranje nad 1 uro.
English: Each vial of concentrate for solution for infusion is for single use (single-dose) only.
Slovenian: Ena viala koncentrata za raztopino za infundiranje je namenjena samo za enkratno uporabo (enkratni odmerek).
English: 11.1 (8.5 to 13.8)
Slovenian: 11,1 (8,5 do 13,8)
English: The concentration of the final ZALTRAP solution for intravenous infusion should be kept within the range of 0.6 mg / ml to 8 mg / ml of aflibercept.
Slovenian: Koncentracija končne raztopine zdravila ZALTRAP za intravensko infundiranje mora biti v razponu od 0,6 mg/ml do 8 mg/ml aflibercepta.
English: Elderly people should be closely monitored for the development of diarrhoea and potential dehydration (see section 4.4).
Slovenian: Starejše je treba natančneje kontrolirati glede pojava driske in morebitne dehidracije (glejte poglavje 4.4).
English: ZALTRAP treatment should be continued until disease progression or unacceptable toxicity occurs.
Slovenian: Zdravljenje z zdravilom ZALTRAP je treba nadaljevati do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: 100 mg / 4 ml 1 vial
Slovenian: 100 mg/4 ml 1 viala
English: Adverse reactions in Table 1 are defined as either any adverse clinical reaction or laboratory abnormality having ≥ 2 % greater incidence (all grades) in the aflibercept treatment group in comparison to the placebo treatment group in the MCRC study including those that do not meet this threshold but were consistent with the anti-VEGF class and were seen in any study with aflibercept.
Slovenian: Neželeni učinki v Preglednici 1 so opredeljeni kot tisti, ki so imeli v študiji mKRR katerikoli neželen klinični učinek ali laboratorijsko nepravilnost z ≥ 2 % večjo incidenco (vse stopnje) v skupini z afliberceptom kot v skupini s placebom (vključno s tistimi, ki niso dosegli tega praga, a so se skladali s skupino anti-VEGF in so bili zabeleženi v kateri koli študiji z afliberceptom).
English: Leucopenia (2) Neutropenia (2)
Slovenian: levkopenija (2) nevtropenija (2)
English: Other subgroup analyses for overall survival and progression free survival according to age (< 65; ≥ 65), gender, presence of liver metastasis only, history of prior hypertension, and number of organs involved, showed a treatment effect favouring the ZALTRAP/FOLFIRI regimen over the placebo/FOLFIRI regimen.
Slovenian: Druge analize podskupin glede celokupnega preživetja in preživetja brez napredovanja glede na starost (< 65 let, ≥ 65 let), spol, prisotnost samo jetrnih metastaz, anamnezo predhodne hipertenzije in število prizadetih organov so pokazale terapevtski učinek v korist sheme ZALTRAP/FOLFIRI v primerjavi s shemo placebo/FOLFIRI.
English: At the recommended dose regimen of 4 mg/kg every two weeks, concentration of free aflibercept were near steady-state levels by the second cycle of treatment with essentially no accumulation (accumulation ratio of 1.2 at steady-state compared to the first administration).
Slovenian: Med uporabo priporočene odmerne sheme 4 mg/kg vsaka dva tedna je bila koncentracija prostega aflibercept do drugega ciklusa zdravljenja blizu koncentraciji v stanju dinamičnega ravnovesja, praktično brez kopičenja (razmerje kopičenja 1,2 v stanju dinamičnega ravnovesja v primerjavi s prvo uporabo).