natgillin/translations-raw huggingface dataset:
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.
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.
If severe diarrhoea persists with both dose reductions, FOLFIRI should be discontinued.
Če huda driska po obeh zmanjšanjih odmerka še traja, je treba uporabo sheme FOLFIRI prekiniti.
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.
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.
• 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.
• 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.
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).
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).
The diagnosis of PRES is confirmed by brain Magnetic Resonance Imaging (MRI).
Diagnozo se potrdi z magnetnoresonančnim slikanjem (MRS) možganov.
Your doctor will do blood tests regularly to check your white blood cell counts throughout your treatment.
Zdravnik vam bo redno kontroliral kri in bo ves čas zdravljenja spremljal število belih krvnih celic.
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.
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.
No conclusion can be drawn for patients with severe renal impairment due to very limited data available.
Glede bolnikov s hudo okvaro ledvic ni mogoče sklepati ničesar, ker je razpoložljivih podatkov zelo malo.
• you have had any abnormal tube-like connections or passageways inside the body between internal organs and skin or other tissues (also called ‘fistula').
• če ste imeli nenormalne povezave znotraj telesa med notranjimi organi in kožo ali drugimi tkivi (to imenujemo tudi "fistula").
• 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.
• 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.
• 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.
• 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.
This medicine may harm your unborn baby since it may stop new blood vessels from forming.
To zdravilo namreč lahko škoduje nerojenemu otroku - prepreči lahko nastajanje novih žil.
PRACTICAL INFORMATION FOR HEALTHCARE PROFESSIONALS ON PREPARATION AND HANDLING OF ZALTRAP 25 mg / ml CONCENTRATE FOR SOLUTION FOR INFUSION
PRAKTIČNE INFORMACIJE ZA ZDRAVSTVENO OSEBJE O PRIPRAVI IN RAVNANJU Z ZDRAVILOM ZALTRAP 25 mg/ml KONCENTRAT ZA RAZTOPINO ZA INFUNDIRANJE
Most aflibercept-induced effects were reversible after a 5-month drug free period with the exception of skeletal and nasal cavity findings.
Večina učinkov, izzvanih z afliberceptom, je bila reverzibilna po 5-mesečnem obdobju brez zdravila; izjema so skeletni učinki in učinki v nosni votlini.
Your doctor may give you medicines to stop or treat diarrhoea and being sick (vomiting).
Zdravnik vam lahko da zdravila za ustavitev ali zdravljenje driske in slabosti (bruhanja).
By blocking the growth of blood vessels, ZALTRAP helps to stop or slow down the growth of the tumour.
Z zavrtjem rasti žil zdravilo ZALTRAP pomaga ustaviti ali upočasniti rast tumorja.
• 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.
• če imate težave z ledvicami (beljakovine v urinu); zdravnik vam bo kontroliral delovanje ledvic in vam bo morda moral prilagoditi odmerek zdravila ZALTRAP.
As angiogenesis is critical to foetal development, the inhibition of angiogenesis following administration of ZALTRAP may result in adverse effects on pregnancy.
Angiogeneza je ključna za razvoj ploda, zato ima lahko zavrtje angiogeneze po uporabi zdravila ZALTRAP neželene učinke na nosečnost.
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.
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.
There are very limited data in patients with severe renal impairment; therefore, these patients should be treated with caution.
Podatkov za bolnike s hudo okvaro ledvic je zelo malo, zato je pri zdravljenju takšnih bolnikov potrebna previdnost.
5-FU bolus should be reduced and the infusion dose reduced by 20 %.
Bolus 5-FU je treba zmanjšati in odmerek za infundiranje zmanjšati za 20 %.
Febrile neutropenia or neutropenic sepsis
Febrilna nevtropenija ali nevtropenična sepsa
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.
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.
Proteinuria (1),(3) Increased serum creatinine
Bolezni sečil Zelo pogosti proteinurija (1),(3) zvišanje kreatinina v serumu
Elderly patients ≥65 years had an increased risk of diarrhoea, dizziness, asthenia, weight loss and dehydration.
Starejši bolniki, stari ≥ 65 let, imajo večje tveganje za drisko, omotico, astenijo, hujšanje in dehidracijo.
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.
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.
The patient should remain under close medical supervision to monitor any adverse reactions (see section 4.8).
Bolnik mora ostati pod skrbnim zdravniškim nadzorom za kontrolo morebitnih neželenih učinkov (glejte poglavje 4.8).
• you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
These differences do not affect exposure due to weight-based dosing and no dose modifications based on gender are required.
Zaradi odmerjanja na podlagi telesne mase te razlike ne vplivajo na izpostavljenost in odmerka ni treba prilagoditi glede na spol.
• Nephrotic syndrome or thrombotic microangiopathy (TMA)
• nefrotskega sindroma ali trombotične mikroangiopatije (TMA)
• 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).
• 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).
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.
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.
Proteinuria (1),(3)
Pogosti proteinurija (1),(3)
There is no specific antidote to ZALTRAP overdose.
Za preveliko odmerjanje zdravila ZALTRAP ni specifičnega antidota.
In the event of recurrence, despite appropriate anticoagulation, aflibercept treatment should be discontinued.
Če se dogodek kljub ustrezni antikoagulaciji ponovi, je treba zdravljenje z afliberceptom prekiniti.
Population pharmacokinetics analysis and inter study comparisons did not reveal any pharmacokinetic drug-drug interaction between aflibercept and the FOLFIRI regimen.
Populacijska farmakokinetična analiza in primerjave med študijami niso odkrile farmakokinetičnih medsebojnih delovanj med afliberceptom in zdravili v shemi FOLFIRI.
ZALTRAP is to be administered only as an intravenous infusion over 1 hour.
Zdravilo ZALTRAP je namenjeno samo za intravensko infundiranje nad 1 uro.
Each vial of concentrate for solution for infusion is for single use (single-dose) only.
Ena viala koncentrata za raztopino za infundiranje je namenjena samo za enkratno uporabo (enkratni odmerek).
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.
Koncentracija končne raztopine zdravila ZALTRAP za intravensko infundiranje mora biti v razponu od 0,6 mg/ml do 8 mg/ml aflibercepta.
Elderly people should be closely monitored for the development of diarrhoea and potential dehydration (see section 4.4).
Starejše je treba natančneje kontrolirati glede pojava driske in morebitne dehidracije (glejte poglavje 4.4).
ZALTRAP treatment should be continued until disease progression or unacceptable toxicity occurs.
Zdravljenje z zdravilom ZALTRAP je treba nadaljevati do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
100 mg / 4 ml 1 vial
100 mg/4 ml 1 viala
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.
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).
Leucopenia (2) Neutropenia (2)
levkopenija (2) nevtropenija (2)
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.
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.
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).
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).
ZALTRAP should be temporarily suspended for at least 4 weeks prior to elective surgery (see section
Zdravilo ZALTRAP je treba začasno prekiniti vsaj 4 tedne pred elektivno operacijo (glejte poglavje
Pre-existing hypertension must be adequately controlled before starting aflibercept.
Obstoječa hipertenzija mora biti ustrezno urejena pred začetkom zdravljenja z afliberceptom.
Your doctor will decide the correct dose for you.
Zdravnik bo presodil kateri odmerek je za vas najbolj primeren.
Given the similar ADA assay results in patients treated with placebo or ZALTRAP, the actual incidence of immunogenicity with ZALTRAP based on these assays is likely to be overestimated.
Ker so rezultati preskusov ADA pri prejemnikih placeba in zdravila ZALTRAP tako podobni, je dejanska incidenca imunogenosti z zdravilom ZALTRAP na podlagi teh preskusov verjetno precenjena.
* Aflibercept is produced in a Chinese hamster ovary (CHO) K-1 mammalian expression system by recombinant DNA technology.
* Aflibercept je pridobljen na ekspresijskem sistemu sesalcev K-1 iz jajčnikov kitajskega hrčka (CHO) s tehnologijo rekombinantne DNA.
What you need to know before you are given ZALTRAP
Kaj morate vedeti, preden boste dobili zdravilo ZALTRAP
Consistent with target-mediated drug disposition, free aflibercept exhibits a faster (non-linear) clearance at doses below 2 mg/kg, likely due to the high affinity binding of aflibercept to endogenous VEGF.
Skladno z odstranjevanjem zdravila, ki poteka preko ciljnega mesta, ima prosti aflibercept hitrejši (nelinearen) očistek pri odmerkih pod 2 mg/kg, verjetno zaradi visoke afinitete za vezavo aflibercepta na endogeni VEGF.
• Grade 4 venous thromboembolic events (including pulmonary embolism)
• venskih trombemboličnih dogodkov 4. stopnje (vključno s pljučno embolijo)
In full-thickness excisional and incisional skin wound models, aflibercept administration reduced fibrous response, neovascularisation, epidermal hyperplasia/re-epithelialisation, and tensile strength.
V modelih ekscizijske in incizijske kožne rane skozi celotno debelino je uporaba aflibercepta zmanjšala fibrozni odziv, neovaskularizacijo, epidermalno hiperplazijo/reepitelizacijo in natezno trdnost.
Patients received a median number of 9 cycles of the ZALTRAP/FOLFIRI regimen.
Bolniki so prejeli mediano 9 ciklusov sheme ZALTRAP/FOLFIRI.
Patients should be monitored for signs and symptoms of GI bleeding and other severe bleeding.
Bolnike je treba kontrolirati glede znakov in simptomov krvavitve v prebavilih in drugih hudih krvavitev.
In these mild and moderate hepatic impairment patients, there was no effect on clearance of aflibercept.
Pri teh bolnikih z blago in zmerno okvaro jeter ni bilo učinka na očistek aflibercepta.
If you also have previously received or are receiving intravenous bisphosphonates dental treatment or dental surgery, (e.g. tooth extractions), should be avoided.
Če ste že prejemali ali prejemate intravenske difosfonate, se je treba zdravljenju zob ali zobozdravstvenemu posegu (npr. izdrtje zoba) izogibati.
In the event of a mild to moderate hypersensitivity reaction to ZALTRAP (including flushing, rash, urticaria, and pruritus), aflibercept should be temporarily suspended until the reaction is resolved.
V primeru blage do zmerne preobčutljivostne reakcije na zdravilo ZALTRAP (vključno z zardevanjem, izpuščajem, urtikarijo in srbenjem) je treba uporabo aflibercepta začasno prekiniti, dokler reakcija ne mine.
• you are 65 years of age or older and experience diarrhoea, dizziness, weakness, weight loss, or severe loss of body fluids (called ‘dehydration').
• če ste stari 65 let ali več in se vam pojavi driska, omotica, šibkost, hujšanje ali huda izguba telesnih tekočin (to imenujemo "dehidracija").
PRES may present with altered mental status, seizure, nausea, vomiting, headache, or visual disturbances.
PRES se lahko pokaže s spremenjenim mentalnim stanjem, konvulzijami, navzeo, bruhanjem, glavobolom ali motnjami vida.
It will be given with other medicines called ‘chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Uporablja se skupaj z drugimi zdravili, ki jih imenujemo "kemoterapija"; med njimi so "5-fluorouracil", "folinska kislina" in "irinotekan".
• liver problem with an increase in liver enzymes.
• spremenjeno delovanje jeter z zvišanjem jetrnih encimov.
After dilution in the infusion bag
Po redčenju v infuzijski vrečki:
Irinotecan dose should be reduced by 15-20 % in subsequent cycles.
Odmerek irinotekana je treba v naslednjih ciklusih zmanjšati za 15-20 %.
• an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
• razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
Further increases in the aflibercept dose resulted in dose-related increases in circulating free aflibercept concentrations but only small further increases in the VEGF-bound aflibercept concentration.
Nadaljnje povečevanje odmerka aflibercepta povzroči z odmerkom povezano povečanje koncentracije prostega aflibercepta v obtoku, a le majhno dodatno povečanje koncentracije na VEGF vezanega aflibercepta.
FOLFIRI Dose modification when used in combination with ZALTRAP Severe stomatitis and Palmar-Plantar Erythrodysaesthesia syndrome
Prilagoditev odmerka FOLFIRI med uporabo v kombinaciji z zdravilom ZALTRAP Hud stomatitis in sindrom palmarno-plantarne eritrodizestezije
Diluted solutions of ZALTRAP should be administered using infusion sets containing a 0.2 micron polyethersulfone filter.
Razredčene raztopine zdravila ZALTRAP je treba dajati z infuzijskimi kompleti, ki vključujejo 0,2-mikronski polietersulfonski filter.
High-titre antibody responses to aflibercept were not detected in any patients.
Odziva na aflibercept z visokim titrom protiteles niso ugotovili pri nobenem bolniku.
In preclinical tumour models, biologically active doses of aflibercept correlated with those necessary to produce circulating concentrations of free aflibercept in excess of VEGF-bound aflibercept.
V predkliničnih tumorskih modelih so biološko aktivni odmerki aflibercepta korelirali z odmerki, kakršni so potrebni za doseganje koncentracije prostega aflibercepta v obtoku, ki presega na VEGF vezani aflibercept.
Treatment with ZALTRAP is associated with potential for compromised wound healing (wound dehiscence, anastomotic leakage).
Zdravljenje z zdravilom ZALTRAP je povezano z možnostjo slabšega celjenja ran (dehiscenca rane, anastomotično iztekanje).
What ZALTRAP looks like and contents of the pack ZALTRAP is a concentrate for solution for infusion (sterile concentrate).
Izgled zdravila ZALTRAP in vsebina pakiranja Zdravilo ZALTRAP je koncentrat za raztopino za infundiranje (sterilen koncentrat).
Patients should be monitored for signs and symptoms of GI perforation.
Bolnike je treba kontrolirati glede znakov in simptomov perforacije prebavil.
There was no effect of age on the pharmacokinetics of free aflibercept.
Starost ni vplivala na farmakokinetiko prostega aflibercepta.
Very common (may affect more than 1 in 10 people)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb)
In the pivotal MCRC study, 28.2 % of patients were aged ≥ 65 and < 75 and 5.4 % of patients were aged ≥ 75.
V ključni študiji mKRR je bilo 28,2 % bolnikov starih od ≥ 65 do < 75 let, 5,4 % bolnikov pa je bilo starih ≥ 75 let.
(4) Not reported in MCRC study; however, PRES was reported in patients from other studies treated with aflibercept as monotherapy and in combination with chemotherapies other than FOLFIRI
(4) PRES ni bil opisan v študiji mKRR, opisan pa je bil v drugih študijah pri bolnikih, ki so bili zdravljeni z afliberceptom kot monoterapijo ali v kombinaciji z drugimi kemoterapijami razen FOLFIRI
You may be advised to have a dental check-up before you start treatment with ZALTRAP.
Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom ZALTRAP opravite zobozdravstveni pregled.
If the patient becomes pregnant while taking ZALTRAP, she should be informed of the potential hazard to the foetus.
Če bolnica med zdravljenjem z zdravilom ZALTRAP zanosi, jo je treba obvestiti o možnih nevarnostih za plod.
Circulating concentrations of VEGF-bound aflibercept increase with the aflibercept dose until most available VEGF is bound.
Koncentracija na VEGF vezanega aflibercepta v obtoku se povečuje z odmerkom aflibercepta, dokler ni vezana večina razpoložljivega VEGF.
ZALTRAP is a hyperosmotic solution, which is not formulated for compatibility with the intraocular environment.
Zdravilo ZALTRAP je hiperosmotska raztopina, ki ni pripravljena kompatibilno z notranjostjo očesa.
A population pharmacokinetic analysis was conducted with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy.
Populacijska farmakokinetična analiza je bila opravljena s podatki 1507 bolnikov z različnimi vrstami napredovalih malignomov, ki so prejemali zdravilo ZALTRAP s kemoterapijo ali brez nje.
This population included; 549 patients with mild renal impairment (CL CR between 50-80 ml/min), 96 patients with moderate renal impairment (CL CR between 30-50 ml/min), and 5 patients with severe renal impairment (CL CR < 30 ml/min).
V tej populaciji je bilo 549 bolnikov z blago okvaro ledvic (CLCR od 50 do 80 ml/min), 96 bolnikov z zmerno okvaro ledvic (CLCR od 30 do 50 ml/min) in 5 bolnikov s hudo okvaro ledvic (CLCR < 30 ml/min).
Elderly (≥ 65 years of age) may be more likely to experience adverse reactions.
Verjetnost za pojav neželenih učinkov je pri starejših (≥ 65 let) lahko večja.
The signs of a blood clot may vary depending on where it appears (e.g. lungs, leg, heart or brain) but may include symptoms such as chest pain, coughing, being short of breath or having difficulty breathing.
Znaki krvnega strdka se lahko razlikujejo glede na to, kje se strdek pojavi (npr. v pljučih, nogi, srcu ali možganih), a med simptomi so lahko bolečina v prsih, kašelj, kratka sapa ali težko dihanje.
The most frequent adverse reactions leading to permanent discontinuation in ≥ 1 % of patients treated with the ZALTRAP/FOLFIRI regimen were vascular disorders (3.8 %) including hypertension (2.3 %), infections (3.4 %), asthenia/fatigue (1.6 %, 2.1 %),diarrhoea (2.3 %), dehydration (1 %), stomatitis (1.1 %), neutropenia (1.1 %), proteinuria (1.5 %), and pulmonary embolism (1.1 %).
Najpogostejši neželeni učinki, ki so povzročili trajno prenehanje zdravljenja pri ≥ 1 % bolnikov, ki so prejemali shemo ZALTRAP/FOLFIRI, so bili žilne bolezni (3,8 %) vključno s hipertenzijo (2,3 %), okužbe (3,4 %), astenija/utrujenost (1,6 %, 2,1 %), driska (2,3 %), dehidracija (1 %), stomatitis (1,1 %), nevtropenija (1,1 %), proteinurija (1,5 %) in pljučna embolija (1,1 %).
• Dilute it to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution or 5 % glucose solution for infusion.
• Zdravilo razredčite do potrebne količine za dajanje z 0,9 % (9 mg/ml) raztopino natrijevega klorida ali 5 % raztopino glukoze za infundiranje.