FrancophonIA/ELRC3.0 huggingface dataset:
English: The FOLFIRI regimen to be used is irinotecan 180 mg/m intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400 mg / m² intravenous bolus, followed by 5-FU 2400 mg / m² continuous intravenous infusion over 46 hours.
Slovenian: Shema FOLFIRI, ki jo je treba uporabiti, obsega 90-minutno intravensko infuzijo 180 mg/m2 irinotekana in 2-urno intravensko infuzijo 400 mg/m2 folinske kisline (dl-racemat) hkrati 1. dan po Y-liniji; sledi intravenski bolus 400 mg/m2 5-fluorouracila (5-FU) in nato stalna intravenska infuzija 2400 mg/m2 5-FU v teku 46 ur.
English: A total of 1,226 patients were randomised (1:1) to receive either ZALTRAP (N = 612; 4 mg/kg as a 1 hour intravenous infusion on day 1) or placebo (N = 614), in combination with 5-fluouracil plus irinotecan [FOLFIRI: irinotecan 180 mg/m intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-FU 400 mg/m² intravenous bolus, followed by 5-FU 2,400 mg /m² continuous intravenous infusion over 46-hours].
Slovenian: Skupaj 1226 bolnikov so v razmerju 1:1 randomizirali bodisi na prejemanje zdravila ZALTRAP (n = 612, 4 mg/kg v 1-urni intravenski infuziji 1. dan) bodisi placeba (n = 614), v kombinaciji s 5-fluouracilom in irinotekanom [FOLFIRI: irinotekan 180 mg/m2 v 90-minutni intravenski infuziji ter folinska kislina (dl-racemat) 400 mg/m2 v 2-urni intravenski infuziji hkrati 1. dan po Y-liniji, nato pa 5-FU 400 mg/m2 v intravenskem bolusu, ki mu sledi 5-FU 2400 mg/m2 v stalni intravenski infuziji v teku 46 ur].
English: • pain in the mouth or throat
Slovenian: • bolečine v ustih in žrelu
English: • Protein in the urine (also called ‘proteinuria'): Very common (may affect more than 1 in 10 people) - this is very commonly seen in tests.
Slovenian: • Beljakovine v urinu (to imenujemo tudi "proteinurija"): zelo pogosto (pojavijo se lahko pri več kot 1 od 10 oseb) - To je zelo pogost izvid pri preiskavah.
English: OS in ITT population excluding patients who progressed during or within 6 months of adjuvant therapy demonstrated an HR (95 % CI) of 0.78 (0.68 to 0.90) [median OS (95 % CI) with Placebo/FOLFIRI 11.9 months (10.88 to 13.01) and with ZALTRAP/FOLFIRI 13.8 months (12.68 to 15.44)]
Slovenian: a Določeno z IVRS b OS v populaciji ZNZ (izključujoč bolnike, ki so napredovali med adjuvantnim zdravljenjem ali v 6 mesecih po njem) je pokazalo razmerje ogroženosti (95 % IZ) 0,78 (od 0,68 do 0,90) [mediano celokupno preživetje (95 % IZ) s placebo/FOLFIRI 11,9 meseca (10,88 do 13,01) in z ZALTRAP/FOLFIRI 13,8 meseca (12,68 do 15,44)]
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie 75008 Paris
Slovenian: Imetnik dovoljenja za promet sanofi-aventis groupe 54, rue La Boétie 75008 Paris Francija
English: In sexually mature male cynomolgus monkeys a decrease in sperm motility and an increase in incidence of morphological abnormalities of spermatozoa were observed.
Slovenian: Pri spolno zrelih opičjih samcih cynomolgus so ugotovili zmanjšanje gibljivosti semenčic in večjo incidenco morfoloških nepravilnosti semenčic.
English: • Connections or passageways inside the body between internal organs and skin or other tissues (also called ‘fistula'): Common (may affect up to 1 in 10 people) - these abnormal tube-like connections or passageways can form for example, between the gut and your skin.
Slovenian: • Povezave znotraj telesa med notranjimi organi in kožo ali drugimi tkivi (to imenujemo tudi "fistula"): pogosto (pojavijo se lahko pri največ 1 od 10 oseb) - Te nenormalne cevaste povezave lahko nastanejo na primer med črevesom in kožo.
English: Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles (see section 4.2).
Slovenian: V nadaljnjih ciklusih pride v poštev predhodna uporaba kortikosteroidov in/ali antihistaminikov (glejte poglavje 4.2).
English: Treatment assignment was stratified by the ECOG performance status (0 versus 1 versus 2) and according to prior therapy with bevacizumab (yes or no).
Slovenian: Razvrstitev na zdravljenje je bila stratificirana glede na stanje zmogljivosti po ECOG (0 v primerjavi z 1 v primerjavi z 2) in glede na predhodno zdravljenje z bevacizumabom (da ali ne).
English: If blood pressure is not controlled, it may cause stroke, heart and kidney problems.
Slovenian: Neobvladan visok krvni tlak lahko povzroči možgansko kap ali težave s srcem ali ledvicami.
English: Caution should be exercised when Zaltrap and intravenous bisphosphonates are administered concurrently or sequentially.
Slovenian: Previdnost je potrebna, kadar se zdravilo Zaltrap in intravenski difosfonati dajejo sočasno ali zaporedno.
English: 11.7 (9.66 to 13.27) 13.8 (11.01 to 15.87)
Slovenian: 11,7 (9,66 do 13,27) 13,8 (11,01 do 15,87)
English: In other studies, PRES was reported in patients treated with aflibercept as monotherapy and in combination with other chemotherapies (see section 4.8).
Slovenian: V drugih študijah pa je bil PRES opisan pri bolnikih, ki so aflibercept prejemali v monoterapiji in v kombinaciji z drugimi kemoterapijami (glejte poglavje 4.8).
English: Infections occurred at a higher frequency in patients receiving the ZALTRAP/FOLFIRI regimen (46.2 %, all grades; 12.3 %, grade 3-4) than in patients receiving the placebo/FOLFIRI regimen (32.7%, all grades; 6.9 %, grade 3-4), including urinary tract infection, nasopharyngitis, upper respiratory tract infection, pneumonia, catheter site infection, and tooth infection.
Slovenian: Okužbe so bile med prejemniki sheme ZALTRAP/FOLFIRI pogostejše (46,2 % okužbe vseh stopenj, 12,3 % okužbe 3. do 4. stopnje) kot med prejemniki sheme placebo/FOLFIRI režim (32,7 % vseh stopenj, 6,9 % 3. do 4. stopnje); med okužbami so bile okužba sečil, nazofaringitis, okužba zgornjih dihal, pljučnica, okužba na mestu katetra in okužba zoba.
English: Proteinuria should be monitored by urine dipstick analysis and/or urinary protein creatinine ratio (UPCR) for the development or worsening of proteinuria before each aflibercept administration.
Slovenian: Proteinurijo je treba pred vsako uporabo aflibercepta kontrolirati z urinskimi testnimi trakovi in/ali z razmerjem urinskih beljakovin in kreatinina (UPCR - urinary protein creatinine ratio), da bi odkrili njen pojav ali poslabšanje.
English: In sexually mature female cynomolgus monkeys inhibition of ovarian function and follicular development was evidenced.
Slovenian: Pri spolno zrelih opičjih samicah cynomolgus so ugotovili zavrtje delovanja jajčnikov in razvoja foliklov.
English: ZALTRAP is given by a drip (infusion) into one of your veins (‘intra-venous') to treat advanced cancers of the colon or rectum.
Slovenian: Zdravilo ZALTRAP se daje s kapalno (infuzijo) v eno od ven ("intravenska uporaba") za zdravljenje napredovalega raka debelega črevesa in danke.
English: Adverse reactions and laboratory abnormalities reported in patients treated with the ZALTRAP/FOLFIRI regimen compared to patients treated with the placebo/FOLFIRI regimen are listed in Table 1 according to MedDRA system organ class and frequency categories.
Slovenian: Neželeni učinki in laboratorijske nepravilnosti, opisani pri prejemnikih sheme ZALTRAP/FOLFIRI v primerjavi s prejemniki sheme placebo/FOLFIRI, so našteti v preglednici 1 po organskih sistemih MedDRA in kategorijah pogostnosti.
English: Caution should be exercised when treating patients with history of clinically significant cardiovascular disease such as coronary artery disease, or congestive heart failure with ZALTRAP.
Slovenian: V primeru uporabe zdravila ZALTRAP pri bolnikih z anamnezo klinično pomembne kardiovaskularne bolezni (npr. bolezni koronarnih arterij ali kongestivnega srčnega popuščanja) je potrebna previdnost.
English: ZALTRAP must not be administered as an intravitreal injection (see sections 4.3 and 4.4).
Slovenian: Zdravila ZALTRAP se ne sme uporabiti kot intravitrealne injekcije (glejte poglavji 4.3 in 4.4).
English: The most common reported form of bleeding was minor (grade 1-2) epistaxis occurring in 27.7 % of patients treated with the ZALTRAP/FOLFIRI regimen.
Slovenian: Najpogostejša opisana vrsta krvavitev je bila manjša (1. do 2. stopnja) epistaksa, ki se je pojavila pri 27,7 % prejemnikov sheme ZALTRAP/FOLFIRI.
English: There are no data regarding the administration of aflibercept in patients with severe hepatic impairment.
Slovenian: Podatkov o uporabi aflibercepta pri bolnikih s hudo okvaro jeter ni.
English: ZALTRAP may affect male and female fertility.
Slovenian: Zdravilo ZALTRAP lahko neugodno vpliva na plodnost moških in žensk.
English: For contraindications related to FOLFIRI components (irinotecan, 5-FU, and folinic acid), refer to the current respective summary of product characteristics.
Slovenian: Za kontraindikacije zdravil v kombinaciji FOLFIRI (irinotekan, 5-FU in folinska kislina) glejte veljavne povzetke glavnih značilnosti teh zdravil.
English: In case of recurrent medically significant or severe hypertension, despite optimal treatment, aflibercept should be suspended until the hypertension is controlled and the aflibercept dose should be reduced to 2 mg/kg for subsequent cycles.
Slovenian: Ob ponovitvi medicinsko signifikantne ali hude hipertenzije, ki se pojavi kljub optimalnemu zdravljenju, je treba zdravljenjez afliberceptom prekiniti, dokler ni hipertenzija urejena, odmerek aflibercepta pa je treba v naslednjih ciklusih zmanjšati na 2 mg/kg.
English: • kidney problem with an increase in creatinine (a marker of kidney function)
Slovenian: • spremenjeno delovanje ledvic z zvišanjem kreatinina (kazalo delovanja ledvic)
English: If this should happen to you, your doctor will stop your treatment with ZALTRAP.
Slovenian: Če se vam to zgodi, bo zdravnik prekinil vaše zdravljenje z zdravilom ZALTRAP.
English: Treatment with corticosteroids and/or antihistamines can be used as clinically indicated.
Slovenian: Uporabiti je mogoče kortikosteroide in/ali antihistaminike, kot je klinično indicirano.
English: Number of death events, n (%) Median overall survival (95 % CI) (months)
Slovenian: OS Število smrtnih dogodkov, n (%) Mediano celokupno preživetje (95 % IZ) (meseci)
English: This population pharmacokinetic analysis revealed no clinically meaningful differences in clearance or systemic exposure (AUC) of free aflibercept in patients with moderate and mild renal impairment at the 4 mg/kg dose of ZALTRAP as compared to the overall population studied.
Slovenian: Ta populacijska farmakokinetična analiza pri bolnikih z zmerno in blago okvaro ledvic ob uporabi odmerka 4 mg/kg zdravila ZALTRAP ni odkrila klinično pomembnih razlik v očistku ali sistemski izpostavljenosti (AUC) prostemu afliberceptu v primerjavi s celotno preučevano populacijo.
English: • Cardiac failure and ejection fraction decreased
Slovenian: • srčnega popuščanja in zmanjšanega iztisnega deleža
English: Due to hyperosmolality (1000 mOsmol / kg) of the ZALTRAP concentrate, undiluted ZALTRAP concentrate must not be administered as an intravenous push or bolus.
Slovenian: Zaradi hiperosmolalnosti (1000 mOsmol/kg) koncentrata zdravila ZALTRAP se nerazredčenega koncentrata ne sme uporabljati intravensko s potiskom ali v bolusu.
English: Osteonecrosis of the jaw (ONJ) Cases of ONJ have been reported in cancer patients treated with Zaltrap, several of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Slovenian: O osteonekrozi čeljustnic so poročali pri bolnikih z rakom, zdravljenih z zdravilom Zaltrap, od katerih se jih je več predhodno ali sočasno zdravilo z intravenskimi difosfonati, za katere je osteonekroza čeljustnic ugotovljeno tveganje.
English: 12.06 (11.07 to 13.08) 13.50 (12.52 to 14.95)
Slovenian: 12,06 (11,07 do 13,08) 13,50 (12,52 do 14,95)
English: Patients with ECOG performance status ≥ 2 or having significant co-morbidities may be at greater risk for a poor clinical outcome and should be carefully monitored for early clinical deterioration.
Slovenian: Bolnike z zmogljivostjo določeno po lestvici ECOG ≥ 2 oz. bolnike s pomembnimi sočasnimi boleznimi, je treba skrbno spremljati, da bi lahko zgodaj ugotovili poslabšanje kliničnega stanja.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (pojavijo se lahko pri do 1 od 100 oseb)
English: In case of recurrent medically significant or severe hypertension, despite optimal treatment, ZALTRAP should be suspended until the hypertension is controlled and the dose reduced to 2 mg / kg for subsequent cycles.
Slovenian: V primeru ponovitve medicinsko signifikantne ali hude hipertenzije, ki se pojavi kljub optimalnemu zdavljenju, je treba zdravljenje z zdravilom ZALTRAP prekiniti, dokler ni hipertenzija urejena, odmerek v naslednjih ciklusih pa zmanjšati na 2 mg/kg.
English: Neutropenia and neutropenic complications
Slovenian: Nevtropenija in nevtropenični zapleti
English: 0.817 (0.714 to 0.935)
Slovenian: 0,817 (0,714 do 0,935)
English: ZALTRAP will be given with other chemotherapy medicines including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Slovenian: Zdravilo ZALTRAP boste dobivali skupaj z drugimi zdravili za kemoterapijo; med takšnimi so "5-fluorouracil", "folinska kislina" in "irinotekan".
English: The most common adverse reactions (all grades, ≥ 20 % incidence) reported at least 2 % greater incidence for the ZALTRAP/FOLFIRI regimen as compared to the placebo/FOLFIRI regimen in order of decreasing frequency were leucopenia, diarrhoea, neutropenia, proteinuria, increased aspartate aminotransferase (AST), stomatitis, fatigue, thrombocytopenia, increased alanine aminotransferase (ALT), hypertension, weight loss, decreased appetite, epistaxis, abdominal pain, dysphonia, increased serum creatinine, and headache (see Table 1).
Slovenian: Najpogostejši neželeni učinki (vseh stopenj, incidenca ≥ 20 %), katerih incidenca je bila s shemo ZALTRAP/FOLFIRI vsaj 2 % večja od incidence s shemo placebo/FOLFIRI, so bili (v padajočem zaporedju pogostnosti): levkopenija, driska, nevtropenija, proteinurija, zvišana aspartat aminotransferaza (AST), stomatitis, utrujenost, trombocitopenija, zvišana alanin aminotransferaza (ALT), hipertenzija, zmanjšanje telesne mase, zmanjšanje apetita, epistaksa, bolečine v trebuhu, disfonija, zvišan kreatinin v serumu in glavobol (glejte preglednico 1).
English: Hypertension
Slovenian: hipertenzija
English: Zaltrap may increase blood pressure (see section 4) and your doctor will need to monitor your blood pressure and may adjust your blood pressure medicines or your dose of ZALTRAP.
Slovenian: • če imate visok krvni tlak; zdravilo ZALTRAP namreč lahko zviša krvni tlak (glejte poglavje 4) zato vam bo zdravnik moral kontrolirati krvni tlak in vam lahko prilagodi zdravila, ki jih prejemate za krvni tlak, ali odmerek zdravila ZALTRAP.
English: If recurrence, 5-FU bolus and infusion doses should additionally be reduced by 20 % in subsequent cycles.
Slovenian: V primeru ponovitve je treba bolusne in infuzijske odmerke 5-FU v naslednjih ciklusih dodatno zmanjšati za 20 %.
English: Dehydration (1)
Slovenian: Pogosti dehidracija (1)
English: Clinical data suggest that no change in starting dose is required in patients with mild to moderate renal impairment.
Slovenian: Klinični podatki kažejo, da bolnikom z blago do zmerno okvaro ledvic začetnega odmerka ni treba prilagoditi.
English: ZALTRAP should be discontinued in patients with life-threatening (Grade 4) thromboembolic events (including pulmonary embolism) (see section 4.2).
Slovenian: Zdravljenje z zdravilom ZALTRAP je treba prekiniti pri bolnikih s smrtno nevarnimi (4. stopnja) trombemboličnimi dogodki (vključno s pljučno embolijo) (glejte poglavje 4.2).
English: Other signs include feeling confused, problems with sight, walking, coordination or balance, problems in saying words or slurring of speech.
Slovenian: Med drugimi znaki so občutek zmedenosti, težave z vidom, hojo, usklajenostjo (koordinacijo) gibov ali z ravnotežjem, težave pri izgovarjanju besed ali nejasen govor.
English: If you develop such a connection or passageway during treatment, your doctor will stop your treatment with ZALTRAP.
Slovenian: Če se vam takšna povezava pojavi med zdravljenjem, bo zdravnik prekinil vaše zdravljenje z zdravilom ZALTRAP.
English: Positive results in the neutralising antibody assay in the MCRC pivotal study were also higher in patients treated with the placebo/FOLFIRI regimen [2/526 (0.38 % )] than with the ZALTRAP/FOLFIRI regimen [1/521 (0.19 %)].
Slovenian: Tudi pozitivni rezultati preskusa nevtralizirajočih protiteles v ključni študiji pri bolnikih z mKRR je bil višji pri prejemnikih sheme placebo/FOLFIRI [2/526 (0,38 %)] kot pri prejemnikih sheme ZALTRAP/FOLFIRI [1/521 (0,19 %)].
English: Number of events, n (%) Median PFS (95 % CI) (months)
Slovenian: Število dogodkov, n (%) Mediano PFS (95 % IZ) (meseci)
English: 0.645 (0.498 to 0.835)
Slovenian: 0,645 (0,498 do 0,835)
English: Signs may include feeling very tired, weak, and/or dizzy, or having changes in the colour of your stool.
Slovenian: Med znaki so lahko huda utrujenost, šibkost in/ali omotica ali spremenjena barva blata.
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje (sterilen koncentrat).
English: 0.812 (0.634 to 1.042)
Slovenian: 0,812 (0,634 do 1,042)
English: Grade 4 hypertension (hypertensive crisis) was reported in 1 patient (0.2 %) treated with the ZALTRAP/FOLFIRI regimen.
Slovenian: Hipertenzija 4. stopnje (hipertenzivna kriza) je bila opisana pri 1 prejemniku (0,2 %) sheme ZALTRAP/FOLFIRI.
English: • an increase in protein in the urine, an increase in cholesterol in the blood, and swelling from excess fluid (oedema) (also called ‘nephrotic syndrome')
Slovenian: • zvišanje beljakovin v urinu, zvišanje holesterola v krvi in otekanje zaradi prekomerne tekočine
English: Demographics were well balanced between the treatment arms (age, race, ECOG performance status, and prior bevacizumab status).
Slovenian: Demografske značilnosti (starost, rasa, stanje po ECOG in predhodno zdravljenje z bevacizumabom) so bile med terapevtskima krakoma dobro uravnotežene.
English: ZALTRAP Treatment delay and dose modification
Slovenian: Odložitev zdravljenja ali prilagoditev odmerka zdravila ZALTRAP
English: ZALTRAP should be temporarily suspended until hypertension is controlled.
Slovenian: Zdravljenje z zdravilom ZALTRAP je treba začasno prekiniti, dokler hipertenzija ni urejena.
English: Note: Adverse reactions are reported using MedDRA version MEDDRA13.1 and graded using NCI CTC version 3.0 (1) See “Description of selected adverse reactions” in this section (2) Based on laboratory values (percentages done on patients with laboratory assessments) (3) Compilation of clinical and laboratory data
Slovenian: Opomba: Neželeni učinki so navedeni z uporabo MedDRA verzija MEDDRA 13.1 in stopenj po NCI CTC verzija 3.0 (1) Glejte "Opis izbranih neželenih učinkov" v tem poglavju.
English: Treatment with corticosteroids and/or antihistamines can be initiated as clinically indicated.
Slovenian: Uvesti je mogoče zdravljenje s kortikosteroidi in/ali antihistaminiki, kot je klinično indicirano.
English: In the pivotal study of MCRC patients, ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) were reported in 2.6 % of patients treated with the ZALTRAP/FOLFIRI regimen and 1.5 % of patients treated with the placebo/FOLFIRI regimen.
Slovenian: V ključni študiji pri bolnikih z mKRR so arterijske trombembolične dogodke (vključno s tranzitorno ishemično atako, cerebrovaskularnim inzultom, angino pektoris, intrakardialnim trombom, miokardnim infarktom, arterijsko embolijo in ishemičnim kolitisom) zabeležili pri 2,6 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 1,5 % prejemnikov sheme placebo/FOLFIRI.
English: ZALTRAP contains the active substance aflibercept, a protein that works by blocking the growth of new blood vessels within the tumour.
Slovenian: Zdravilo ZALTRAP vsebuje zdravilno učinkovino aflibercept, to je beljakovina, ki deluje tako, da ustavi rast novih žil v tumor.
English: Also contains sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide and/or hydrochloric acid and water for injections.
Slovenian: Vsebuje tudi saharozo, natrijev klorid, natrijev citrat dihidrat, citronsko kislino monohidrat, polisorbat 20, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, natrijev hidroksid in/ali klorovodikovo kislino in vodo za injekcije.
English: Dyspnoea Epistaxis Dysphonia
Slovenian: Priprava raztopine za infundiranje
English: Patients treated with ZALTRAP have an increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events.
Slovenian: Bolniki, zdravljeni z zdravilom ZALTRAP, imajo večje tveganje za krvavitve, vključno s hudimi krvavitvami in včasih krvavitvami s smrtnim izidom.
English: Tel.: 0800 04 36 996 Tel. aus dem Ausland: +49 69 305 70 13
Slovenian: Tel. aus dem Ausland: +49 69 305 70 13
English: 100 mg / 4 ml 200 mg / 8 ml
Slovenian: 200 mg/8 ml
English: There are very limited data available for patients with severe renal impairment treated with aflibercept.
Slovenian: Podatkov za bolnike s hudo okvaro ledvic, zdravljene z afliberceptom, je zelo malo.
English: Signs of allergic reaction may include rash or itching, skin redness, feeling dizzy or faint, being short of breath, tight chest or throat, or swelling of the face.
Slovenian: Med znaki alergijske reakcije so lahko izpuščaj ali srbenje, pordelost kože, omotica ali omedlevica, kratka sapa, tiščanje v prsih ali žrelu, ali oteklost obraza.
English: If severe diarrhoea recurs on a subsequent cycle, the 5-FU bolus and infusion dose should also be reduced by 20 %.
Slovenian: Če se huda driska med naslednjim ciklusom ponovi, je treba bolus 5-FU zmanjšati in odmerek za infundiranje tudi zmanjšati za 20 %.
English: The hazard ratio (95 % CI) of progression free survival was 0.76 (0.63 to 0.91) for ECOG performance status 0 and 0.75 (0.61 to 0.92) for ECOG performance status 1.
Slovenian: Razmerje ogroženosti (95 % IZ) za preživetje brez napredovanja je bilo 0,76 (0,63 do 0,91) za stanje zmogljivosti ECOG 0 in 0,75 (0,61 do 0,92) za stanje zmogljivosti ECOG 1.
English: In sub-group analysis of overall survival, a benefit consistent with the overall population was observed in patients < 65 years old and ≥ 65 years old who received the ZALTRAP/FOLFIRI regimen.
Slovenian: V analizi podskupin glede celokupnega preživetja je bila korist, skladna s tisto za splošno populacijo, ugotovljena med prejemniki sheme ZALTRAP/FOLFIRI tako med bolniki, starimi < 65 let, kot med starimi ≥ 65 let.
English: Monitoring of complete blood count (CBC) with platelets is recommended at baseline, prior to initiation of each cycle of aflibercept, and as clinically necessary.
Slovenian: Celotno krvno sliko je priporočljivo kontrolirati izhodiščno, pred začetkom vsakega ciklusa aflibercepta in kot je klinično potrebno.
English: In the pivotal study of MCRC patients, positive responses in the ADA assay were observed at higher levels in patients treated with the placebo/FOLFIRI regimen [18/526 (3.4 %)] than with the ZALTRAP/FOLFIRI regimen [8/521 (1.5 %)].
Slovenian: V ključni študiji pri bolnikih z mKRR so pozitiven odziv na preskusu ADA ugotovili z višjo ravnjo pri prejemnikih sheme placebo/FOLFIRI [18/526 (3,4 %)] kot pri prejemnikih sheme ZALTRAP/FOLFIRI [8/521 (1,5 %)].
English: 0.862 (0.676 to 1.100)
Slovenian: 0,862 (0,676 do 1,100)
English: • Low white blood cell count (also called ‘neutropenia'): Very common (may affect more than 1 in 10 people) - this can cause serious infections.
Slovenian: • Majhno število belih krvnih celic (to imenujemo tudi "nevtropenija"): zelo pogosto (pojavi se lahko pri več kot 1 od 10 oseb) - povzroči lahko resne okužbe.
English: • Arterial thromboembolic events (ATE)
Slovenian: • arterijskih trombemboličnih dogodkov (ATE - arterial thromboembolic events)