FrancophonIA/ELRC3.0 huggingface dataset:
English: ZALTRAP should be temporarily suspended for at least 4 weeks prior to elective surgery (see section
Slovenian: Zdravilo ZALTRAP je treba začasno prekiniti vsaj 4 tedne pred elektivno operacijo (glejte poglavje
English: Pre-existing hypertension must be adequately controlled before starting aflibercept.
Slovenian: Obstoječa hipertenzija mora biti ustrezno urejena pred začetkom zdravljenja z afliberceptom.
English: Your doctor will decide the correct dose for you.
Slovenian: Zdravnik bo presodil kateri odmerek je za vas najbolj primeren.
English: 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.
Slovenian: 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.
English: * Aflibercept is produced in a Chinese hamster ovary (CHO) K-1 mammalian expression system by recombinant DNA technology.
Slovenian: * Aflibercept je pridobljen na ekspresijskem sistemu sesalcev K-1 iz jajčnikov kitajskega hrčka (CHO) s tehnologijo rekombinantne DNA.
English: What you need to know before you are given ZALTRAP
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo ZALTRAP
English: 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.
Slovenian: 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.
English: • Grade 4 venous thromboembolic events (including pulmonary embolism)
Slovenian: • venskih trombemboličnih dogodkov 4. stopnje (vključno s pljučno embolijo)
English: In full-thickness excisional and incisional skin wound models, aflibercept administration reduced fibrous response, neovascularisation, epidermal hyperplasia/re-epithelialisation, and tensile strength.
Slovenian: V modelih ekscizijske in incizijske kožne rane skozi celotno debelino je uporaba aflibercepta zmanjšala fibrozni odziv, neovaskularizacijo, epidermalno hiperplazijo/reepitelizacijo in natezno trdnost.
English: Patients received a median number of 9 cycles of the ZALTRAP/FOLFIRI regimen.
Slovenian: Bolniki so prejeli mediano 9 ciklusov sheme ZALTRAP/FOLFIRI.
English: Patients should be monitored for signs and symptoms of GI bleeding and other severe bleeding.
Slovenian: Bolnike je treba kontrolirati glede znakov in simptomov krvavitve v prebavilih in drugih hudih krvavitev.
English: In these mild and moderate hepatic impairment patients, there was no effect on clearance of aflibercept.
Slovenian: Pri teh bolnikih z blago in zmerno okvaro jeter ni bilo učinka na očistek aflibercepta.
English: If you also have previously received or are receiving intravenous bisphosphonates dental treatment or dental surgery, (e.g. tooth extractions), should be avoided.
Slovenian: Če ste že prejemali ali prejemate intravenske difosfonate, se je treba zdravljenju zob ali zobozdravstvenemu posegu (npr. izdrtje zoba) izogibati.
English: 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.
Slovenian: 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.
English: • you are 65 years of age or older and experience diarrhoea, dizziness, weakness, weight loss, or severe loss of body fluids (called ‘dehydration').
Slovenian: • če ste stari 65 let ali več in se vam pojavi driska, omotica, šibkost, hujšanje ali huda izguba telesnih tekočin (to imenujemo "dehidracija").
English: PRES may present with altered mental status, seizure, nausea, vomiting, headache, or visual disturbances.
Slovenian: PRES se lahko pokaže s spremenjenim mentalnim stanjem, konvulzijami, navzeo, bruhanjem, glavobolom ali motnjami vida.
English: It will be given with other medicines called ‘chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Slovenian: Uporablja se skupaj z drugimi zdravili, ki jih imenujemo "kemoterapija"; med njimi so "5-fluorouracil", "folinska kislina" in "irinotekan".
English: • liver problem with an increase in liver enzymes.
Slovenian: • spremenjeno delovanje jeter z zvišanjem jetrnih encimov.
English: After dilution in the infusion bag
Slovenian: Po redčenju v infuzijski vrečki:
English: Irinotecan dose should be reduced by 15-20 % in subsequent cycles.
Slovenian: Odmerek irinotekana je treba v naslednjih ciklusih zmanjšati za 15-20 %.
English: • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
Slovenian: • razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
English: 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.
Slovenian: Nadaljnje povečevanje odmerka aflibercepta povzroči z odmerkom povezano povečanje koncentracije prostega aflibercepta v obtoku, a le majhno dodatno povečanje koncentracije na VEGF vezanega aflibercepta.
English: FOLFIRI Dose modification when used in combination with ZALTRAP Severe stomatitis and Palmar-Plantar Erythrodysaesthesia syndrome
Slovenian: Prilagoditev odmerka FOLFIRI med uporabo v kombinaciji z zdravilom ZALTRAP Hud stomatitis in sindrom palmarno-plantarne eritrodizestezije
English: Diluted solutions of ZALTRAP should be administered using infusion sets containing a 0.2 micron polyethersulfone filter.
Slovenian: Razredčene raztopine zdravila ZALTRAP je treba dajati z infuzijskimi kompleti, ki vključujejo 0,2-mikronski polietersulfonski filter.
English: High-titre antibody responses to aflibercept were not detected in any patients.
Slovenian: Odziva na aflibercept z visokim titrom protiteles niso ugotovili pri nobenem bolniku.
English: 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.
Slovenian: 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.
English: Treatment with ZALTRAP is associated with potential for compromised wound healing (wound dehiscence, anastomotic leakage).
Slovenian: Zdravljenje z zdravilom ZALTRAP je povezano z možnostjo slabšega celjenja ran (dehiscenca rane, anastomotično iztekanje).
English: What ZALTRAP looks like and contents of the pack ZALTRAP is a concentrate for solution for infusion (sterile concentrate).
Slovenian: Izgled zdravila ZALTRAP in vsebina pakiranja Zdravilo ZALTRAP je koncentrat za raztopino za infundiranje (sterilen koncentrat).
English: Patients should be monitored for signs and symptoms of GI perforation.
Slovenian: Bolnike je treba kontrolirati glede znakov in simptomov perforacije prebavil.
English: There was no effect of age on the pharmacokinetics of free aflibercept.
Slovenian: Starost ni vplivala na farmakokinetiko prostega aflibercepta.
English: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb)
English: In the pivotal MCRC study, 28.2 % of patients were aged ≥ 65 and < 75 and 5.4 % of patients were aged ≥ 75.
Slovenian: V ključni študiji mKRR je bilo 28,2 % bolnikov starih od ≥ 65 do < 75 let, 5,4 % bolnikov pa je bilo starih ≥ 75 let.
English: (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
Slovenian: (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
English: You may be advised to have a dental check-up before you start treatment with ZALTRAP.
Slovenian: Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom ZALTRAP opravite zobozdravstveni pregled.
English: If the patient becomes pregnant while taking ZALTRAP, she should be informed of the potential hazard to the foetus.
Slovenian: Če bolnica med zdravljenjem z zdravilom ZALTRAP zanosi, jo je treba obvestiti o možnih nevarnostih za plod.
English: Circulating concentrations of VEGF-bound aflibercept increase with the aflibercept dose until most available VEGF is bound.
Slovenian: Koncentracija na VEGF vezanega aflibercepta v obtoku se povečuje z odmerkom aflibercepta, dokler ni vezana večina razpoložljivega VEGF.
English: ZALTRAP is a hyperosmotic solution, which is not formulated for compatibility with the intraocular environment.
Slovenian: Zdravilo ZALTRAP je hiperosmotska raztopina, ki ni pripravljena kompatibilno z notranjostjo očesa.
English: A population pharmacokinetic analysis was conducted with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Elderly (≥ 65 years of age) may be more likely to experience adverse reactions.
Slovenian: Verjetnost za pojav neželenih učinkov je pri starejših (≥ 65 let) lahko večja.
English: 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.
Slovenian: 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.
English: 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 %).
Slovenian: 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 %).
English: • Dilute it to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution or 5 % glucose solution for infusion.
Slovenian: • Zdravilo razredčite do potrebne količine za dajanje z 0,9 % (9 mg/ml) raztopino natrijevega klorida ali 5 % raztopino glukoze za infundiranje.
English: sanofi-aventis groupe 54, rue La Boétie 75008 Paris France
Slovenian: sanofi-aventis groupe 54, rue La Boétie 75008 Paris Francija
English: In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase, and hyperbilirubinaemia occurred in ≥ 20 % of patients.
Slovenian: V ključni študiji mKRR so se anemija, navzea, bruhanje, zaprtost, alopecija, zvišanje alkalne fosfataze in hiperbilirubinemija pojavili pri ≥ 20 % bolnikov.
English: 4.67 (4.21 to 5.36)
Slovenian: 4,67 (4,21 do 5,36)
English: If the bleeding is severe, your doctor will stop your treatment with ZALTRAP.
Slovenian: Če je krvavitev huda, bo zdravnik prekinil vaše zdravljenje z zdravilom ZALTRAP.
English: Aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system.
Slovenian: Aflibercept je pridobljen s tehnologijo rekombinantne DNA na ekspresijskem sistemu sesalcev K-1 iz jajčnikov kitajskega hrčka (CHO).
English: Overall efficacy results for the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen are summarised in Figure 1 and Table 2.
Slovenian: Celotne rezultate učinkovitosti sheme ZALTRAP/FOLFIRI v primerjavi s shemo placebom/FOLFIRI prikazujeta slika 1 in preglednica 2.
English: The incidence of diarrhoea, dizziness, asthenia, weight decrease, and dehydration was increased by ≥5% in elderly compared to younger patients.
Slovenian: Incidenca driske, omotice, astenije, zmanjšanja telesne mase in dehidracije je bila pri starejših za ≥ 5 % večja kot pri mlajših.
English: Thrombotic and embolic events
Slovenian: Trombotični in embolični dogodki
English: The side effects listed below were seen when ZALTRAP was given together with chemotherapy.
Slovenian: Spodaj naštete neželene učinke so opazili med uporabo zdravila ZALTRAP skupaj s kemoterapijo.
English: Do not use ZALTRAP if you notice particles or discolouration of the medicine in the vial or infusion bag.
Slovenian: Zdravila ZALTRAP ne smete uporabiti, če v viali ali vrečki za infundiranje opazite delce ali spremenjeno barvo zdravila.
English: • change of the voice, e.g. developing a hoarse voice
Slovenian: • sprememba glasu npr. hripavost
English: Contact your doctor and dentist immediately during and after treatment with ZALTRAP if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Slovenian: Zdravnika in zobozdravnika morate obvestiti med ali po zdravljenju z zdravilom ZALTRAP takoj, če pride do kakršnih koli težav v ustih oziroma z zobmi, na primer do majanja zoba, bolečin ali otekline, neceljenja ran ali vnetja, saj so to lahko znaki stanja, ki ga imenujemo osteonekroza čeljustnic.
English: • A side effect which affects your nervous system (called ‘posterior reversible encephalopathy syndrome' or PRES): Uncommon (may affect up to 1 in 100 people) - signs may include headache, sight changes, feeling confused or fits with or without high blood pressure.
Slovenian: • Neželen učinek, ki prizadene živčevje (imenujemo ga tudi "sindrom posteriorne reverzibilne encefalopatije" ali, s tujo kratico, PRES): občasno (pojavi se lahko pri največ 1 od 100 oseb)Med znaki so lahko glavobol, spremembe vida, občutek zmedenosti ali napadi krčev, z visokim krvnim tlakom ali brez njega.
English: Sanofi-aventis Deutschland GmbH Industriepark Höchst D-65926 Frankfurt am Main Germany
Slovenian: Sanofi-aventis Deutschland GmbH Industriepark Höchst D-65926 Frankfurt am Main Nemčija
English: 5.4 (4.53 to 5.68)
Slovenian: 5,4 (4,53 do 5,68)
English: 5.3 (4.50 to 5.55)
Slovenian: 5,3 (4,50 do 5,55)
English: In the event of a severe hypersensitivity reaction (including bronchospasm, dyspnoea, angioedema, and anaphylaxis), aflibercept should be discontinued and appropriate medical measures should be administered (see section 4.2).
Slovenian: V primeru hude preobčutljivostne reakcije (vključno z bronhospazmom, dispnejo, angioedemom in anafilaksijo) je treba zdravljenje z afliberceptom prekiniti in ustrezno medicinsko ukrepati (glejte poglavje 4.2).
English: The tumour needs nutrients and oxygen from blood in order to grow.
Slovenian: Rakavo tkivo za rast potrebuje hranilne snovi in kisik iz krvi.
English: The most commonly observed adverse reactions at these doses were similar to those observed at the therapeutic dose.
Slovenian: Najpogosteje opaženi neželeni učinki, ki so jih opazili med uporabo teh odmerkov, so bili podobni kot med uporabo terapevtskega odmerka.
English: • Diarrhoea and dehydration: Very common (may affect more than 1 in 10 people) for diarrhoea and Common (may affect up to 1 in 10 people) for dehydration - severe diarrhoea and being sick (vomiting) can cause you to lose too much body fluid (called ‘dehydration') and body salts (electrolytes).
Slovenian: • Driska in dehidracija: zelo pogosto (pojavi se lahko pri več kot 1 od 10 oseb) driska in pogosto (pojavi se lahko pri največ 1 od 10 oseb) dehidracija - Huda driska in slabost (bruhanje) lahko povzročita prekomerno izgubo telesnih tekočin (to imenujemo "dehidracija") in telesnih soli (elektrolitov).
English: Grade 3 hypertension (requiring adjustment in existing anti-hypertensive therapy or treatment with more than one medicinal product) was reported in 1.5 % of patients treated with the placebo/FOLFIRI regimen and 19.1 % of patients treated with the ZALTRAP/FOLFIRI regimen.
Slovenian: Hipertenzija 3. stopnje (ki je zahtevala prilagoditev obstoječega antihipertenzivnega zdravljenja ali zdravljenje z več kot enim zdravilom) je bila opisana pri 1,5 % prejemnikov sheme placebo/FOLFIRI in pri 19,1 % prejemnikov sheme ZALTRAP/FOLFIRI.
English: Among those patients treated with the ZALTRAP/FOLFIRI regimen developing grade 3-4 hypertension, 54 % had onset during the first two cycles of treatment (see section 4.4).
Slovenian: Med tistimi prejemniki sheme ZALTRAP/FOLFIRI, ki se jim je razvila hipertenzija 3. do 4. stopnje, se je pri 54 % pojavila v prvih dveh ciklusih zdravljenja (glejte poglavje 4.4).
English: Of the 1,226 patients randomised in the study, the median age was 61 years, 58.6 % were male, 97.8 % had a baseline ECOG performance status (PS) of 0 or 1, and 2.2 % had a baseline ECOG performance status (PS) of 2.
Slovenian: Pri 1226 v študiji randomiziranih bolnikih je bila mediana starost 61 let, 58,6 % je bilo moških, 97,8 % jih je imelo izhodiščno stanje zmogljivosti po ECOG 0 ali 1 in 2,2 % jih je imelo izhodiščno stanje zmogljivosti po ECOG 2.
English: Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main Germany
Slovenian: Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main Nemčija
English: In a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy, 63 patients with mild hepatic impairment (total bilirubin > 1.0 x - 1.5 x ULN and any AST) and 5 patients with moderate hepatic impairment (total bilirubin > 1.5 x - 3 x ULN and any AST) were treated with ZALTRAP.
Slovenian: Populacijska farmakokinetična analiza je zajela podatke 1507 bolnikov z različnimi vrstami napredovalih malignomov, ki so prejemali zdravilo ZALTRAP s kemoterapijo ali brez nje; med temi bolniki je zdravilo ZALTRAP prejemalo 63 bolnikov z blago okvaro jeter (celokupni bilirubin > 1,0- do 1,5-kratna ZNM in kateri koli AST) in 5 bolnikov z zmerno okvaro jeter (celokupni bilirubin > 1,5- do 3-kratna ZNM in kateri koli AST).
English: A numerically lower treatment effect on OS with the ZALTRAP/FOLFIRI regimen was reported for patients with prior bevacizumab as compared to patients without prior bevacizumab exposure, with no evidence of heterogeneity in treatment effect (non significant interaction test).
Slovenian: S shemo ZALTRAP/FOLFIRI je bil pri bolnikih, predhodno zdravljenih z bevacizumabom, opisan številsko manjši učinek zdravljenja na celokupno preživetje kot pri bolnikih, ki predhodno niso prejemali bevacizumaba; heterogenosti v učinku zdravljenja niso ugotovili (test interakcije ni bil značilen).
English: • Wounds which heal slowly or not at all: Uncommon (may affect up to 1 in 100 people) - this is when a scar has trouble healing or staying closed, or if a healed wound re-opens.
Slovenian: • Rane, ki se celijo počasi ali se sploh ne celijo: občasno (pojavijo se lahko pri največ 1 od 100 oseb) - rana se težko celi, težko ostane zaprta, ali pa se zaceljena rana znova odpre.
English: Weekly/every two weeks intravenous administration of aflibercept to cynomolgus monkeys for up to 6 months resulted in changes in the bone (effects on growth plate and the axial and appendicular skeleton), nasal cavity, kidney, ovary, and adrenal gland.
Slovenian: Pri opicah cynomolgus je intravenska uporaba aflibercepta vsak teden ali vsaka dva tedna v obdobju do 6 mesecev povzročila spremembe v kosteh (vpliv na rastno ploščico ter na aksialno in apendikularno okostje), nosni votlini, ledvicah, jajčnikih in nadledvični žlezi.
English: Of the 611 patients treated with the ZALTRAP/FOLFIRI regimen in the pivotal study of MCRC patients, 172 (28.2 %) were aged ≥ 65 and < 75 and 33 (5.4 %) were age ≥ 75.
Slovenian: Od 611 bolnikov, zdravljenih s shemo ZALTRAP/FOLFIRI v ključni študiji pri bolnikih z mKRR, je bilo 172 (28,2 %) starih od ≥ 65 do < 75 let, 33 (5,4 %) pa je bilo starih ≥ 75 let.
English: Approximately 10 % of patients (10.4 % and 9.8 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively) received prior oxaliplatin-based adjuvant chemotherapy and progressed on or within 6 months of completion of adjuvant chemotherapy.
Slovenian: Približno 10 % bolnikov (10,4 % prejemnikov sheme placebo/FOLFIRI in 9,8 % prejemnikov sheme ZALTRAP/FOLFIRI) je predhodno prejemalo adjuvantno kemoterapijo na osnovi oksaliplatina, bolezen pa jim je napredovala med adjuvantno kemoterapijo ali v 6 mesecih po njenem koncu.
English: In patients, ZALTRAP is administered at the dose of 4 mg/kg intravenously every two weeks for which there is an excess of circulating free aflibercept compared to VEGF-bound aflibercept.
Slovenian: Pri bolnikih se zdravilo ZALTRAP uporablja v odmerku 4 mg/kg intravensko vsaka dva tedna; pri tem obstaja v obtoku presežek prostega aflibercepta v primerjavi z afliberceptom, vezanim na VEGF.
English: • Inspect the ZALTRAP vial visually prior to use.
Slovenian: • Vialo z zdravilom ZALTRAP morate pred uporabo pregledati.
English: • polyethylene lined PVC
Slovenian: • s polietilenom prevlečenega PVC
English: Zaltrap may reduce the number of white cells in your blood and your doctor will monitor your white blood cell count and may give you additional medicines to increase it.
Slovenian: • če imate premajhno število belih krvnih celic; zdravilo ZALTRAP lahko zmanjša število belih krvnih celic zato vam bo zdravnik kontroliral število belih krvnih celic in vam bo morda predpisal dodatna zdravila za povečanje njihovega števila.
English: PFS (based on tumour assessment by the IRC): Significance threshold is set to 0.0001
Slovenian: b Preživetje brez napredovanja (na podlagi ocene tumorja, ki jo je opravil IRC): meja značilnosti je postavljena na 0,0001. c Celokupni delež objektivnega odziva po IRC
English: • you have severe or long-lasting diarrhoea, feel sick (nausea) or are being sick (vomiting) - these could cause severe loss of body fluids (called ‘dehydration').
Slovenian: • če imate hudo ali dolgotrajno drisko, siljenje na bruhanje ali bruhanje - to lahko povzroči hudo izgubo telesnih tekočin (imenovano "dehidracija").
English: 200 mg / 8 ml 1 vial
Slovenian: 200 mg/8 ml 1 viala
English: For additional toxicities related to irinotecan, 5-FU, or folinic acid, refer to the current respective summary of product characteristics.
Slovenian: Glede toksičnih učinkov, povezanih z irinotekanom, 5-FU ali folinsko kislino, glejte veljavne povzetke glavnih značilnosti teh zdravil.