natgillin/translations-raw huggingface dataset:
For these reasons, comparison of the incidence of antibodies to ZALTRAP with the incidence of antibodies to other products may be misleading.
Iz tog razloga usporedba incidencije protutijela na ZALTRAP s incidencijom protutijela na druge lijekove može navesti na krivi trag.
5.3 (4.50 to 5.55)
5,3 (4,50 do 5,55)
Aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system.
Aflibercept se proizvodi rekombinantnom DNA tehnologijom na ekspresijskom sustavu stanica sisavaca K-1 iz jajnika kineskog hrčka (CHO).
Ophthalmic / intravitreal use due to hyperosmotic properties of ZALTRAP (see section 4.4).
Oftalmološka/intravitrealna primjena, zbog hiperosmotskih svojstava lijeka ZALTRAP (vidjeti dio 4.4).
Neutropenic infection/sepsis (1)
često neutropenijska infekcija/sepsa (1)
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).
Pri preporučenom režimu doziranja od 4 mg/kg svaka dva tjedna koncentracije slobodnog aflibercepta do drugoga su ciklusa dosegle razinu približnu koncentracijama u stanju dinamičke ravnoteže, pri čemu je nakupljanje bilo zanemarivo (omjer nakupljanja iznosio je 1,2 u stanju dinamičke ravnoteže u odnosu na prvu primjenu).
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.
U bolesnika s ECOG statusom ≥ 2 ili značajnim popratnim bolestima može postojati povećan rizik od lošeg kliničkog ishoda, pa te bolesnike treba pažljivo motriti zbog moguće pojave ranih znakova kliničkog pogoršanja.
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.
Daljnja povećanja doze aflibercepta dovela su do s dozom povezanog povećanja koncentracije slobodnog aflibercepta u krvotoku, ali samo do malog dodatnog povećanja koncentracije aflibercepta vezanog za VEGF.
Patients treated with ZALTRAP have an increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events.
U bolesnika liječenih lijekom ZALTRAP postoji povećan rizik od krvarenja, uključujući teške i ponekad smrtonosne događaje krvarenja.
• haemorrhoids, bleeding or pain in the back passage
• hemoroidi, krvarenje ili bol u završnom dijelu debelog crijeva
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).
U slučaju teške reakcije preosjetljivosti (uključujući bronhospazam, dispneju, angioedem i anafilaksiju) treba obustaviti liječenje afliberceptom i primijeniti odgovarajuće mjere liječenja (vidjeti dio 4.2).
Increased AST (2) Increased ALT (2)
često povišene vrijednosti AST-a (2) povišene vrijednosti ALT-a (2)
• drop in the number of certain cells in the blood that help it to clot (thrombocytopenia)
• pad broja određenih stanica u krvi koje pomažu u zgrušavanju krvi (trombocitopenija)
/ L (see section 4.2).
(vidjeti dio 4.2).
The patient should remain under close medical supervision to monitor any adverse reactions (see section 4.8).
Bolesnik mora ostati pod strogim liječničkim nadzorom kako bi se uočile moguće nuspojave (vidjeti dio 4.8).
The side effects listed below were seen when ZALTRAP was given together with chemotherapy.
Nuspojave navedene u nastavku primijećene su kada se ZALTRAP primjenjivao zajedno s kemoterapijom.
• change of the voice, e.g. developing a hoarse voice
• promjene glasa, npr. promuklost
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.
Potreban je pojačani oprez kad se ZALTRAP primjenjuje u bolesnika s klinički značajnom kardiovaskularnom bolešću u anamnezi, poput bolesti koronarnih arterija ili kongestivnog zatajenja srca.
Treatment with anti-diarrhoeal medicinal products and rehydration can be used as needed.
Po potrebi se mogu uvesti liječenje antidijaroicima i rehidracija.
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).
Među bolesnicima liječenima protokolom ZALTRAP/FOLFIRI u kojih se razvila hipertenzija stupnja 3-4, u njih 54% je ona nastupila tijekom prva dva ciklusa liječenja (vidjeti dio 4.4).
Proteinuria (see section 4.4)
Proteinurija (vidjeti dio 4.4).
Signs may include chest pain, coughing, being short of breath, difficulty breathing or coughing up blood.
Znakovi mogu uključivati bol u prsima, kašalj, nedostatak daha, otežano disanje ili iskašljavanje krvi.
Overall efficacy results for the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen are summarised in Figure 1 and Table 2.
Ukupni rezultati djelotvornosti za protokol ZALTRAP/FOLFIRI u usporedbi s protokolom placebo/FOLFIRI sažeti su na Slici 1 i u Tablici 2.
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).
U tih su bolesnika događaji nevezani uz bubrege u načelu bili usporedivi između bolesnika s oštećenjem bubrežne funkcije i onih s normalnom bubrežnom funkcijom, izuzevši > 10% veću incidenciju dehidracije (svih stupnjeva) (vidjeti dio 4.4).
Intensity of the adverse reactions is graded according to NCI CTC version 3.0 (grade ≥ 3 = G ≥ 3).
Nacionalnog instituta za rak (NCI CTC) (stupanj ≥ 3 = G ≥ 3).
Patients should be monitored for signs and symptoms of GI bleeding and other severe bleeding.
Bolesnike treba motriti zbog moguće pojave znakova i simptoma gastrointestinalnog krvarenja ili drugog teškog krvarenja.
If severe diarrhoea recurs on a subsequent cycle, the 5-FU bolus and infusion dose should also be reduced by 20 %.
Ako se u sljedećem ciklusu ponovno pojavi težak proljev, dozu bolusne injekcije i infuzije 5-FU također treba smanjiti za 20%.
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).
U bolesnika koji su prethodno liječeni bevacizumabom prijavljen je brojčano niži učinak liječenja protokolom ZALTRAP/FOLFIRI na OS nego u bolesnika koji prethodno nisu bili izloženi bevacizumabu, ali nisu pronađeni dokazi heterogenosti učinka liječenja (test interakcije nije značajan).
It will be given with other medicines called ‘chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Primjenjuje se u kombinaciji s drugim lijekovima koji se nazivaju ‘kemoterapijom', uključujući ‘5-fluorouracil', ‘folnu kiselinu' i ‘irinotekan'.
Hypertension (see section 4.4)
Hipertenzija (vidjeti dio 4.4).
• 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').
• ako imate težak ili dugotrajan proljev, mučninu ili povraćanje - ove nuspojave mogu izazvati ozbiljan gubitak tekućine iz tijela (što se zove ‘dehidracija').
• you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• ako imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile
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.
U slučaju povrata medicinski značajne ili teške hipertenzije, unatoč optimalnom liječenju, ZALTRAP treba privremeno prekinuti dok se hipertenzija ne stavi pod kontrolu, a dozu u sljedećim ciklusima smanjiti na 2 mg/kg.
• 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.
• Nuspojava koja zahvaća živčani sustav (poznata kao‘sindrom posteriorne reverzibilne encefalopatije' ili PRES): Manje često (mogu se javiti u manje od 1 na 100 osoba) - znakovi mogu uključivati glavobolju, promjene vida, osjećaj smetenosti ili napadaje, koji mogu ili ne moraju biti praćeni visokim krvnim tlakom.
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.
U populacijskoj farmakokinetičkoj analizi podataka prikupljenih u 1507 bolesnika s različitim vrstama uznapredovalih zloćudnih tumora koji su primali ZALTRAP u kombinaciji s kemoterapijom ili bez nje, 63 bolesnika s blagim oštećenjem jetrene funkcije (ukupni bilirubin > 1,0 x - 1,5 x GGN i bilo koja vrijednost AST-a) i 5 bolesnika s umjerenim oštećenjem jetrene funkcije (ukupni bilirubin > 1,5 x
Patients with Grade 3 DVT should be treated with anticoagulation as clinically indicated, and aflibercept therapy should be continued.
Bolesnike s dubokom venskom trombozom stupnja 3 treba liječiti antikoagulantnom terapijom prema kliničkoj indikaciji te nastaviti liječenje afliberceptom.
Elderly patients ≥65 years had an increased risk of diarrhoea, dizziness, asthenia, weight loss and dehydration.
U starijih osoba u dobi od ≥ 65 godina postoji povećan rizik od proljeva, omaglice, astenije, gubitka tjelesne težine i dehidracije.
In sexually mature female cynomolgus monkeys inhibition of ovarian function and follicular development was evidenced.
U spolno zrelih ženki makaki majmuna pronađeni su dokazi inhibicije funkcije jajnika i razvoja folikula.
• you have illnesses where your gut is inflamed, such as an infected section of the bowel wall (also called ‘diverticulitis'), stomach ulcers or colitis.
• ako imate bolest kod koje dolazi do upale crijeva, poput infekcije dijela crijevne stijenke (naziva se i ‘divertikulitis'), želučane vrijedove ili kolitis.
Diluted solutions of ZALTRAP should be administered using infusion sets containing a 0.2 micron polyethersulfone filter.
Razrijeđena otopina lijeka ZALTRAP mora se primijeniti setovima za infuziju koji sadrže polietersulfonski filtar veličine 0,2 mikrona.
If this happens, do not drive or use any tools or machines.
nemojte upravljati vozilima niti rukovati alatima i strojevima.
Circulating concentrations of VEGF-bound aflibercept increase with the aflibercept dose until most available VEGF is bound.
Koncentracije aflibercepta vezanog za VEGF u krvotoku povećavaju se s dozom aflibercepta sve dok većina dostupnog VEGF-a nije vezana.
Patients received a median number of 9 cycles of the ZALTRAP/FOLFIRI regimen.
Bolesnici su primili medijan od 9 ciklusa liječenja protokolom ZALTRAP/FOLFIRI.
• kidney problem with an increase in creatinine (a marker of kidney function)
• tegobe s bubrezima uz povišene vrijednosti kreatinina (biljega bubrežne funkcije)
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.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na bočici iza oznake "Rok valjanosti".
A side effect called osteonecrosis (bone damage in the jaw) has been reported in cancer patients treated with ZALTRAP.
Nuspojava koja se naziva osteonekroza (oštećenje kostiju čeljusti) prijavljena je u bolesnika s karcinomom koji su liječeni lijekom ZALTRAP.
Corresponding data in patients with RAS mutant type tumours showed a HR for OS of 0.9 (0.7-1.2) with median 12.6 and 11.2 months for aflibercept and placebo, respectively.
Odgovarajući podaci u bolesnika s RAS mutiranim tipovima tumora pokazali su omjer hazarda za ukupno preživljenje od 0,9 (0,7-1,2) s medijanom od 12,6 mjeseci za aflibercept odnosno 11,2 mjeseca za placebo.
Patients should be monitored for signs and symptoms of GI perforation.
Bolesnike treba motriti zbog moguće pojave znakova i simptoma gastrointestinalne perforacije.
Aflibercept administration resulted in a delay in wound healing in rabbits.
Primjena aflibercepta uzrokovala je otežano zacjeljivanje rana u kunića.
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.
Približno je 10% bolesnika (10,4% bolesnika koji su primali protokol placebo/FOLFIRI i 9,8% bolesnika liječenih protokolom ZALTRAP/FOLFIRI) prethodno primalo adjuvantnu kemoterapiju na bazi oksaliplatina, a bolest im je progredirala tijekom ili unutar 6 mjeseci nakon završetka adjuvantne kemoterapije.
(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
(3) Skup kliničkih i laboratorijskih podataka (4) Nije prijavljeno u ispitivanju MKRK-a; međutim, PRES je prijavljen u bolesnika iz drugih ispitivanja koji su liječeni afliberceptom u monoterapiji ili u kombinaciji s drugim kemoterapijama, osim protokola FOLFIRI
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.
Tjelesna težina utjecala je na klirens i volumen distribucije slobodnog aflibercepta pa je u bolesnika tjelesne težine ≥ 100 kg izloženost afliberceptu bila 29% veća.
This is because ZALTRAP may increase the risk of developing holes in the gut wall.
Naime, ZALTRAP može povećati rizik od nastanka pukotina u stijenci crijeva.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C and for 8 hours at 25°C.
Dokazana je kemijska i fizikalna stabilnost razrijeđenog lijeka tijekom 24 sata na temperaturi od 2°C
Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie 75008 Paris
Nositelj odobrenja za stavljanje lijeka u promet sanofi-aventis groupe 54, rue La Boétie 75008 Paris Francuska
Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main Germany
Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt na Majni
200 mg / 8 ml 1 vial
200 mg/8 ml
• an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
• proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije)
Aneurysms and artery dissections
nepoznato aneurizme i disekcije arterije
Your doctor may give you medicines to stop or treat diarrhoea and being sick (vomiting).
Liječnik će Vam možda dati lijekove za zaustavljanje ili liječenje proljeva i povraćanja.
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.
Protokol FOLFIRI koji se primjenjuje uključuje intravensku infuziju irinotekana u dozi od 180 mg/m2 tijekom 90 minuta i intravensku infuziju folne kiseline (dl racemična) u dozi od 400 mg/m² tijekom2 sata, koje se primjenjuju 1. dana istodobno kroz Y-liniju, nakon čega slijedi intravenska bolusna injekcija 5-fluorouracila (5-FU) u dozi od 400 mg/m², a nakon nje kontinuirana intravenska infuzija 5-FU u dozi od 2400 mg/m² tijekom 46 sati.
Treatment with corticosteroids and/or antihistamines can be initiated as clinically indicated.
Može se započeti liječenje kortikosteroidima i/ili antihistaminicima ako je klinički indicirano.
A population pharmacokinetic analysis was conducted with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy.
Provedena je populacijska farmakokinetička analiza podataka prikupljenih u 1507 bolesnika s različitim vrstama uznapredovalih zloćudnih tumora koji su primali ZALTRAP u kombinaciji s kemoterapijom ili bez nje.
Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles (see section 4.2).
U sljedećim se ciklusima može razmotriti premedikacija kortikosteroidima i/ili antihistaminicima (vidjeti dio 4.2).
Treatment assignment was stratified by the ECOG performance status (0 versus 1 versus 2) and according to prior therapy with bevacizumab (yes or no).
Liječenje je dodijeljeno prema stratifikaciji na temelju ECOG statusa (0 naspram 1 naspram 2) i prethodnog liječenja bevacizumabom (da ili ne).
Signs may include chest pain or heaviness in the chest, sudden numb or weak feeling in the face, arms, or legs.
Znakovi mogu uključivati bol ili težinu u prsima, iznenadnu utrnulost ili slabost u licu, rukama ili nogama.
In patients with RAS wild type tumours the HR (95 % CI) for OS was 0.7 (0.5-1.0) with a median OS of 16.0 months for patients treated with aflibercept, and 11.7 months for the patients treated with placebo.
U bolesnika s RAS divljim tipom tumora, omjer hazarda (95% CI) za OS bio je 0,7 (0,5-1,0) s medijanom ukupnog preživljenja od 16,0 mjeseci za bolesnike liječene afliberceptom te 11,7 mjeseci za bolesnike koji su primali placebo.
In the pivotal MCRC study, 28.2 % of patients were aged ≥ 65 and < 75 and 5.4 % of patients were aged ≥ 75.
U pivotalnom ispitivanju MKRK-a 28,2% bolesnika bilo je u dobi ≥ 65 i < 75 godina, a 5,4%
0.817 (0.714 to 0.935)
0,817 (0,714 do 0,935)
Posterior reversible encephalopathy syndrome (PRES) PRES was not reported in the pivotal Phase III study of MCRC patients.
Sindrom posteriorne reverzibilne encefalopatije (PRES) PRES nije prijavljen u pivotalnom ispitivanju faze III u bolesnika s MKRK-om.
ZALTRAP should be temporarily suspended for at least 4 weeks prior to elective surgery (see section
Primjena lijeka ZALTRAP mora se privremeno prekinuti najmanje 4 tjedna prije elektivnog kirurškog zahvata (vidjeti dio 4.4).
ZALTRAP 25 mg / ml sterile concentrate aflibercept
ZALTRAP 25 mg/ml sterilni koncentrat aflibercept
Overall objective response rate by IRC
Ukupna stopa objektivnog odgovora prema procjeni neovisnog ocjenjivačkog povjerenstva
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.
Najčešće prijavljen oblik krvarenja bila je blaga epistaksa (stupnja 1-2), koja se javila u 27,7% bolesnika liječenih protokolom ZALTRAP/FOLFIRI.
Very common (may affect more than 1 in 10 people)
Vrlo česte (mogu se javiti u više od 1 na 10 osoba):
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.
U bolesnika s karcinomom koji su liječeni lijekom Zaltrap prijavljeni su slučajevi osteonekroze čeljusti, pri čemu je nekoliko bolesnika prethodno ili istodobno liječeno intravenskim bisfosfonatima, za koje je osteonekroza čeljusti identificiran rizik.
Exploratory biomarker analyses were undertaken in the VELOUR trial including analyses of RAS mutational status in 482 of 1,226 patients (n = 240 aflibercept; 242 placebo).
mutacijskog statusa u 482 od 1226 bolesnika (n=240 aflibercept; 242 placebo).
It is unknown whether aflibercept is excreted in human milk.
Nije poznato izlučuje li se aflibercept u majčino mlijeko.
There was no margin of exposure to patients in relation to these effects.
Nije utvrđena granica izloženosti za navedene učinke u ljudi.
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.
Ženama reproduktivne dobi mora se savjetovati da izbjegavaju trudnoću za vrijeme liječenja lijekom ZALTRAP i treba ih upoznati s mogućim rizicima za plod.
In other studies, PRES was reported in patients treated with aflibercept as monotherapy and in combination with other chemotherapies (see section 4.8).
U drugim je ispitivanjima PRES prijavljen u bolesnika liječenih afliberceptom u monoterapiji i u kombinaciji s drugim kemoterapijama (vidjeti dio 4.8).
ZALTRAP should be temporarily suspended until hypertension is controlled.
Primjenu lijeka ZALTRAP treba privremeno prekinuti dok se hipertenzija ne stavi pod kontrolu.
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.
U nekliničkim tumorskim modelima biološki aktivne doze aflibercepta bile su u korelaciji s dozama potrebnima za postizanje koncentracije slobodnog aflibercepta u krvotoku koja bi bila veća od koncentracije aflibercepta vezanog za VEGF.
ZALTRAP will be given with other chemotherapy medicines including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
ZALTRAP će se primjenjivati u kombinaciji s drugim kemoterapijskim lijekovima, uključujući ‘5-fluorouracil', ‘folnu kiselinu' i ‘irinotekan'.
More than one vial could be needed for the preparation of the infusion solution.
Za pripremu otopine za infuziju možda će biti potrebno više od jedne bočice.
Sanofi-aventis Deutschland GmbH Industriepark Höchst D-65926 Frankfurt am Main Germany
Sanofi-aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt na Majni
PRES may present with altered mental status, seizure, nausea, vomiting, headache, or visual disturbances.
PRES se može manifestirati promjenom mentalnog statusa, napadajem, mučninom, povraćanjem,
Off-label intravitreal use
Neodobrena intravitrealna primjena
11.7 (9.66 to 13.27) 13.8 (11.01 to 15.87)
11,7 (9,66 do 13,27) 13,8 (11,01 do 15,87)
12.06 (11.07 to 13.08) 13.50 (12.52 to 14.95)
12,06 (11,07 do 13,08) 13,50 (12,52 do 14,95)
What ZALTRAP is used for
Za što se koristi ZALTRAP
The hazard ratio (95 % CI) of overall survival was 0.77 (0.64 to 0.93) for ECOG performance status 0 and 0.87 (0.71 to 1.06) for ECOG
Omjer hazarda (95% CI) za ukupno preživljenje iznosio je 0,77 (0,64 do 0,93) za ECOG status 0 i 0,87 (0,71 do 1,06) za ECOG status 1.
ZALTRAP must not be administered as an intravitreal injection (see sections 4.3 and 4.4).
ZALTRAP se ne smije primijeniti u obliku intravitrealne injekcije (vidjeti dio 4.3 i 4.4).
Monitoring of complete blood count (CBC) with platelets is recommended at baseline, prior to initiation of each cycle of aflibercept, and as clinically necessary.
Preporučuje se kontrola kompletne krvne slike (KKS) i broja trombocita na početku liječenja, prije početka svakog ciklusa aflibercepta i kada je to klinički potrebno.
0.645 (0.498 to 0.835)
0,645 (0,498 do 0,835)
Do not use ZALTRAP if you notice particles or discolouration of the medicine in the vial or infusion bag.
Nemojte primijeniti ZALTRAP ako su njemu vidljive čestice ili je lijek u bočici ili infuzijskoj vrećici promijenio boju.
0.812 (0.634 to 1.042)
0,812 (0,634 do 1,042)
Signs may include feeling very tired, weak, and/or dizzy, or having changes in the colour of your stool.
Znakovi mogu uključivati izrazit umor, slabost i/ili omaglicu te promjene u boji stolice.
Patients should be monitored for signs and symptoms of cardiac failure and ejection fraction decreased.
U bolesnika je potrebno pratiti moguće znakove i simptome zatajenja srca i smanjene ejekcijske frakcije.