natgillin/translations-raw huggingface dataset:
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.
U Tablici 4 sažete su post-hoc analize u bolesnika koji prethodno jesu i u onih koji prethodno nisu liječeni bevacizumabom; u analize nisu bili uključeni bolesnici u kojih je bolest uznapredovala tijekom ili unutar 6 mjeseci od adjuvantnog liječenja.
If any discolouration or particulate matter is observed, the reconstituted solution should be discarded.
Ako se utvrdi promjena boje ili prisutnost čestica, pripremljenu otopinu treba baciti.
If there is recurrence, the administration should be suspended until <2 grams/24 hours and then the dose reduced to 2 mg/kg.
U slučaju ponovne pojave, primjenu treba prekinuti dok proteinurija ne bude < 2 grama u 24 sata, a zatim smanjiti dozu na 2 mg/kg.
Signs may include stomach pain, being sick (vomiting), fever or chills.
Znakovi mogu uključivati bol u želucu, povraćanje, vrućicu ili zimicu.
You may be advised to have a dental check-up before you start treatment with ZALTRAP.
Prije početka liječenja lijekom ZALTRAP može Vam se savjetovati stomatološki pregled.
Overall across all clinical oncology studies, similar incidence of low titre anti-drug antibody (ADA) responses (post baseline) in the ADA assay were observed in both patients treated with placebo and ZALTRAP (3.3 % and 3.8 %, respectively).
Ukupno je u svim onkološkim kliničkim ispitivanjima u testu protutijela na lijek (engl. anti-drug antibody, ADA) primijećena podjednaka incidencija odgovora s niskim titrom protutijela na lijek (nakon početka ispitivanja) i u bolesnika koji su primali placebo i u bolesnika liječenih lijekom ZALTRAP (3,3% naspram 3,8%).
• inflammation inside the mouth
• upala u ustima
3 vials
3 godine
• polyurethane
• poliuretana
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.
32,7%; stupanj 3-4: 6,9%), uključujući infekciju mokraćnih putova, nazofaringitis, infekciju gornjih dišnih putova, upalu pluća, infekciju na mjestu katetera i infekciju zuba.
Grade 3-4 events occurred in 11 patients (1.8 %) treated with the ZALTRAP/FOLFIRI regimen and 3 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
Događaji stupnja 3-4 javili su se u 11 bolesnika (1,8%) liječenih protokolom ZALTRAP/FOLFIRI i u 3 bolesnika (0,5%) koja su primala protokol placebo/FOLFIRI.
• Protein in the urine (also called ‘proteinuria'): Very common (may affect more than 1 in 10 people) - this is very commonly seen in tests.
• Proteini u mokraći (poznato i kao ‘proteinurija'): Vrlo često (mogu se javiti u više od 1 na
One vial of 8 ml contains 200 mg of aflibercept (25 mg / ml).
Jedna bočica s 8 ml koncentrata sadrži 200 mg aflibercepta (25 mg/ml).
ZALTRAP should be suspended when proteinuria ≥2 grams per 24 hours and resumed when proteinuria < 2 grams per 24 hours.
Primjenu lijeka ZALTRAP treba privremeno prekinuti kada je proteinurija ≥ 2 grama u 24 sata i nastaviti kada proteinurija bude < 2 grama u 24 sata.
The following adverse reactions and laboratory abnormalities were reported with a ≥ 5 % difference (all grades) in patients treated with the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen (in order of decreasing frequency): leucopenia (78.3 % versus 72.4 % all grades; 15.6 %
Sljedeće nuspojave i laboratorijska odstupanja (svih stupnjeva) prijavljena su u ≥ 5% više bolesnika liječenih protokolom ZALTRAP/FOLFIRI u odnosu na bolesnike koji su primali protokol placebo/FOLFIRI (navedene prema učestalosti u padajućem nizu): leukopenija (svi stupnjevi: 78,3%
Grade 3 GI fistula formation occurred in 2 patients treated with ZALTRAP (0.3 %) and in 1 placebo-treated patient (0.2 %).
Do stvaranja gastrointestinalnih fistula stupnja 3 došlo je u 2 bolesnika liječena lijekom ZALTRAP (0,3%) te u 1 bolesnika koji je primao placebo (0,2%).
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.
(< 65; ≥ 65), spolu, prisutnosti metastaza samo u jetri, hipertenziji u anamnezi i broju zahvaćenih organa ukazale su na bolji učinak liječenja protokolom ZALTRAP/FOLFIRI nego protokolom placebo/FOLFIRI.
Compromised wound healing
Otežano zacjeljivanje rana
Table 2 - Main efficacy endpoints a
Tablica 2 - Glavne mjere ishoda za djelotvornosta - ITT populacija
ZALTRAP must not be administered as an intravitreal injection (see section 2 of the package leaflet).
ZALTRAP se ne smije primijeniti u obliku intravitrealne injekcije (vidjeti dio 2. Upute o lijeku).
• swelling and numbness of the hands and feet that happens with chemotherapy (called
• oticanje i utrnulost šaka i stopala koje se javlja kod kemoterapije (poznato kao ‘sindrom palmarno-plantarne eritrodizestezije')
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.
(FOLFIRI) indiciran u liječenju odraslih osoba s metastatskim kolorektalnim karcinomom (MKRK) u kojih je bolest rezistentna na ili je napredovala nakon liječenja protokolom koji sadrži oksaliplatin.
Severe diarrhoea
Ozbiljne nuspojave
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.
MKRK-om, njih 172 (28,2%) bila su u dobi ≥ 65 i < 75 godina, a 33 bolesnika (5,4%) bila su u dobi od ≥ 75 godina.
The most common grade 3-4 neutropenic complication was the occurrence of febrile neutropenia in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.7 % of patients treated with the placebo/FOLFIRI regimen.
Najčešća neutropenijska komplikacija stupnja 3-4 bila je neutropenijska vrućica, koja se javila u 4,3% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 1,7% bolesnika koji su primali protokol placebo/FOLFIRI.
One ml of concentrate for solution for infusion contains 25 mg aflibercept*.
Jedan ml koncentrata za otopinu za infuziju sadrži 25 mg aflibercepta*.
An increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events has been reported in patients treated with aflibercept (see section 4.8).
U bolesnika liječenih afliberceptom prijavljen je povećan rizik od krvarenja, uključujući teške i ponekad smrtonosne događaje krvarenja (vidjeti dio 4.8).
Venous thromboembolic events (VTE)
Venski tromboembolijski događaji (VTE)
Grade 3-4 neutropenic infection/sepsis occurred in 1.5 % of patients treated with the ZALTRAP/FOLFIRI regimen and 1.2 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Neutropenijska infekcija/sepsa stupnja 3-4 javila se u 1,5% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 1,2% bolesnika koji su primali protokol placebo/FOLFIRI (vidjeti dio 4.4).
• Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
• teških reakcija preosjetljivosti (uključujući bronhospazam, dispneju, angioedem i anafilaksiju)
Nephrotic syndrome occurred in 2 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen compared to none of the patients treated with the placebo/FOLFIRI regimen.
Nefrotski sindrom je nastupio u 2 bolesnika (0,5%) liječena protokolom ZALTRAP/FOLFIRI, no ni u jednog bolesnika koji je primao protokol placebo/FOLFIRI.
Arterial thromboembolism (1) Venous thromboembolism (1) Haemorrhage (1)
arterijska tromboembolija (1) venska tromboembolija (1) krvarenje (1)
Musculoskeletal and connective tissue disorders Uncommon
Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često osteonekroza čeljusti
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given ZALTRAP and during your treatment.
Ako se nešto od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite ZALTRAP i za vrijeme liječenja.
No metabolism studies have been conducted with aflibercept since it is a protein.
Budući da je aflibercept protein, nisu provedena ispitivanja metabolizma.
Proteinuria (1),(3) Increased serum creatinine
Poremećaji bubrega i mokraćnog sustava vrlo često proteinurija (1),(3) povišene vrijednosti kreatinina u serumu često proteinurija (1),(3)
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ZALTRAP therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Uzimajući u obzir korist dojenja za dijete i dobrobit liječenja za majku, mora se donijeti odluka hoće li se prekinuti dojenje ili privremeno ili trajno prekinuti liječenje lijekom ZALTRAP.
EXP Shelf life after dilution: see package leaflet.
Rok valjanosti Rok valjanosti nakon razrjeđivanja: vidjeti uputu o lijeku.
Fistula formation
Stvaranje fistula
Median overall survival (95 % CI) (months)
Medijan ukupnog preživljenja (95% CI) (mjeseci)
Male and female fertility are likely to be compromised during treatment with aflibercept based on studies in monkeys (see section 5.3).
Na temelju rezultata istraživanja na majmunima, postoji vjerojatnost štetnog utjecaja liječenja afliberceptom na plodnost u muškaraca i žena (vidjeti dio 5.3).
Grade 3-4 haemorrhage including GI haemorrhage, haematuria, and post-procedural haemorrhage was reported in 2.9 % of patients receiving the ZALTRAP/FOLFIRI regimen compared with 1.7 % of patients receiving the placebo/FOLFIRI regimen.
Krvarenje stupnja 3-4, uključujući gastrointestinalno krvarenje, hematuriju i postproceduralno krvarenje, prijavljeno je u 2,9% bolesnika liječenih protokolom ZALTRAP/FOLFIRI te 1,7% bolesnika koji su primali protokol placebo/FOLFIRI.
Median OS (95 % CI) (months)
Medijan OS (95% CI) (mjeseci)
ZALTRAP should be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
4.2 Doziranje i način primjene ZALTRAP se mora primjenjivati pod nadzorom liječnika koji ima iskustva u primjeni antitumorskih lijekova.
Administration of ZALTRAP/FOLFIRI should be delayed until neutrophil count is 1.5 x 10
Primjenu protokola ZALTRAP/FOLFIRI treba odgoditi dok broj neutrofila ne bude ≥1,5 x 109/l ili broj trombocita ≥75 x 109/l.
Ejection fraction decreased Nervous system disorders Very common
Poremećaji živčanog sustava vrlo često
Hypersensitivity (1)
manje često preosjetljivost (1)
Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Water for injections
6.1 Popis pomoćnih tvari saharoza natrijev klorid natrijev citrat dihidrat citratna kiselina hidrat polisorbat 20 natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat hidrat natrijev hidroksid i/ili kloridna kiselina (za podešavanje pH) voda za injekcije
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 %).
(3,4%), astenija/umor (1,6%, 2,1%), proljev (2,3%), dehidracija (1%), stomatitis (1,1%), neutropenija
In the pivotal study of MCRC patients, GI perforation (all grades) was reported in 3 of 611 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
U pivotalnom ispitivanju u bolesnika s MKRK-om gastrointestinalna perforacija (svih stupnjeva) bila je prijavljena u 3 od 611 bolesnika (0,5%) liječenih protokolom ZALTRAP/FOLFIRI i u 3 od 605 bolesnika (0,5%) koji su primali protokol placebo/FOLFIRI.
In the pivotal study for MCRC, compromised wound healing was reported in 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 5 patients (0.8 %) treated with the placebo/FOLFIRI regimen.
U pivotalnom ispitivanju u bolesnika s MKRK-om otežano zacjeljivanje rana bilo je prijavljeno u 3 bolesnika (0,5%) liječena protokolom ZALTRAP/FOLFIRI i u 5 bolesnika (0,8%) koji su primali protokol placebo/FOLFIRI.
Additional adverse reactions and laboratory abnormalities reported with a ≥5 % difference (all grades) in patients treated with the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen
Dodatne nuspojave i laboratorijska odstupanja (svih stupnjeva) prijavljena u ≥ 5% više bolesnika liječenih protokolom ZALTRAP/FOLFIRI u odnosu na bolesnike koji su primali protokol placebo/FOLFIRI
As determined per IVRS
Interactive Voice Response System, IVRS)
Aflibercept acts as a soluble decoy receptor that binds to VEGF-A, with higher affinity than its native receptors, as well as the related ligands PlGF and VEGF-B. By acting as a ligand trap, aflibercept prevents binding of endogenous ligands to their cognate receptors and thereby blocks receptor mediated signaling.
Aflibercept djeluje kao topljivi lažni receptor koji se veže za VEGF-A većim afinitetom nego njegovi prirodni receptori, a veže se i za povezane ligande PlGH i VEGF-B.
Dyspnoea Epistaxis
ZALTRAP/FOLFIRI
Nephrotic syndrome (1) Thrombotic microangiopathy (1)
trombotička mikroangiopatija (1)
Grade 3-4 neutropenia was observed in 36.7 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 29.5 % patients treated with the placebo/FOLFIRI regimen.
Neutropenija stupnja 3-4 primijećena je u 36,7% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 29,5% bolesnika koji su primali protokol placebo/FOLFIRI.
Pulmonary embolism occurred in 4.6 % of patients treated with the ZALTRAP/FOLFIRI regimen and 3.5 % of patients treated with the placebo/FOLFIRI regimen.
Plućna embolija javila se u 4,6% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 3,5% bolesnika koji su primali protokol placebo/FOLFIRI.
Table 3 - OS and PFS by prior bevacizumab exposure a
Rezultati prema prethodnoj izloženosti bevacizumabu sažeti su u Tablici 3. Tablica 3 - OS i PFS prema prethodnoj izloženosti bevacizumabua - ITT populacija
What ZALTRAP looks like and contents of the pack ZALTRAP is a concentrate for solution for infusion (sterile concentrate).
ZALTRAP je koncentrat za otopinu za infuziju (sterilni koncentrat).
Signs of infection may include fever, chills, cough, burning on passing water or muscle ache.
Znakovi infekcije uključuju vrućicu, zimicu, kašalj,
FOLFIRI Dose modification when used in combination with ZALTRAP Severe stomatitis and Palmar-Plantar Erythrodysaesthesia syndrome
Teški stomatitis i sindrom palmarnoplantarne eritrodizestezije
• 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.
• Krvarenje: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - uključuje krvarenje iz nosa,
A limited number of patients having moderate/severe renal impairment at baseline (N = 49) were treated with ZALTRAP.
Lijekom ZALTRAP liječen je mali broj bolesnika koji su na početku liječenja imali umjereno/teško oštećenje bubrežne funkcije (N=49).
Baseline and periodic evaluations of left ventricular function should be considered while the patient is receiving Zaltrap.
bolesnika koji primaju lijek ZALTRAP potrebno je razmotriti procjenu funkcije lijeve klijetke na početku, te periodički tijekom liječenja.
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.
U slučaju povrata medicinski značajne ili teške hipertenzije, unatoč optimalnom liječenju, treba privremeno prekinuti liječenje afliberceptom dok se hipertenzija ne stavi pod kontrolu,
Severe proteinuria, nephrotic syndrome, and thrombotic microangiopathy (TMA) have been observed in patients treated with aflibercept (see section 4.8).
U bolesnika liječenih afliberceptom primijećene su teška proteinurija, nefrotski sindrom i trombotička mikroangiopatija (TMA) (vidjeti dio 4.8).
• 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.
(vidjeti dio 4.), ako osjetite izraziti umor, slabost, omaglicu ili ako primijetite promjene u boji stolice.
• 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.
na 100 osoba) - ožiljak teško zacjeljuje ili teško ostaje zatvoren ili se zacijeljena rana ponovno otvori.
Do not re-enter the vial after the initial puncture.
Nakon prvoga probijanja čepa ne smije se ponovno iglom ulaziti u bočicu.
How to store ZALTRAP
Moguće nuspojave Kako čuvati ZALTRAP
Grade 4 hypertension (hypertensive crisis) was reported in 1 patient (0.2 %) treated with the ZALTRAP/FOLFIRI regimen.
Hipertenzija stupnja 4 (hipertenzivna kriza) prijavljena je u 1 bolesnika (0,2%) liječenog protokolom
ZALTRAP 25 mg/ml concentrate for solution for infusion
ZALTRAP 25 mg/ml koncentrat za otopinu za infuziju
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.
crvenilo kože, omaglicu ili nesvjesticu, nedostatak zraka, stezanje u prsima ili grlu ili oticanje lica.
Cardiac failure
Oštećenje funkcije bubrega
• you are 65 years of age or older and experience diarrhoea, dizziness, weakness, weight loss, or severe loss of body fluids (called ‘dehydration').
Ako se pojave promjene vida ili smetenost, liječnik će možda prekinuti liječenje lijekom ZALTRAP. • ako imate 65 godina ili više i imate proljev, omaglicu, slabost, gubitak težine ili obilan gubitak tekućine iz tijela (što se zove ‘dehidracija').
Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles.
U sljedećim se ciklusima može razmotriti premedikacija kortikosteroidima i/ili antihistaminicima.
Grade 3-4 GI perforation events occurred in 0.8 % of patients treated with ZALTRAP and 0.2 % of patients treated with placebo (see section 4.4).
Gastrointestinalne perforacije stupnja 3-4 javile su se u 0,8% bolesnika liječenih lijekom ZALTRAP te u 0,2% bolesnika koji su primali placebo (vidjeti dio 4.4).
The most common reported grades 3-4 reactions ( ≥5 % 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 neutropenia, diarrhoea, hypertension, leucopenia, stomatitis, fatigue, proteinuria, and asthenia (see Table 1).
Najčešće prijavljene reakcije stupnja 3-4 (incidencija ≥ 5%) za koje je prijavljena incidencija u skupini koja je primala protokol ZALTRAP/FOLFIRI bila najmanje 2% veća od one u skupini koja je primala protokol placebo/FOLFIRI, navedene prema učestalosti u padajućem nizu, bile su neutropenija,
These were comparable between groups, and the difference between groups did not exceed ≥ 2 % incidence for the ZALTRAP/FOLFIRI regimen.
Te su nuspojave bile slične u obje skupine, a njihova incidencija u skupini liječenoj protokolom ZALTRAP/FOLFIRI nije bila ≥ 2% veća od incidencije u skupini koja je primala placebo.
Dysphonia Oropharyngeal pain
Osteonekroza čeljusti
GI perforation including fatal GI perforation has been reported in patients treated with aflibercept (see section 4.8).
U bolesnika liječenih afliberceptom prijavljena je gastrointestinalna perforacija, uključujući smrtonosnu gastrointestinalnu perforaciju (vidjeti dio 4.8).
Leucopenia (2) Neutropenia (1),(2) Thrombocytopenia (2)
Poremećaji krvi i limfnog sustava vrlo često leukopenija (2) neutropenija (1),(2) trombocitopenija (2)
One 8 ml vial of concentrate contains 200 mg aflibercept.
Jedna bočica od 8 ml koncentrata sadrži 200 mg aflibercepta.
Grade 3-4 compromised wound healing occurred in 0.2 % of patients treated with ZALTRAP and none of patients treated with placebo (see section 4.4).
Otežano zacjeljivanje rana stupnja 3-4 javilo se u 0,2% bolesnika liječenih lijekom ZALTRAP, no ni u jednog bolesnika koji je primao placebo (vidjeti dio 4.4).
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of nephrotic syndrome was 0.5 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
U tri placebom kontrolirana klinička ispitivanja faze III (populacije s kolorektalnim karcinomom, karcinomom gušterače i karcinomom pluća) incidencija nefrotskog sindroma iznosila je 0,5% u bolesnika liječenih lijekom ZALTRAP i 0,1% u bolesnika koji su primali placebo (vidjeti dio 4.4).
In the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 9 of 611 patients (1.5 %) treated with the ZALTRAP/FOLFIRI
U pivotalnom ispitivanju u bolesnika s MKRK-om fistule (analne, enterovezikalne, enterokutane, kolovaginalne i crijevne) su prijavljene u 9 od 611 bolesnika (1,5%) liječenih protokolom ZALTRAP/FOLFIRI i u 3 od 605 bolesnika (0,5%) koji su primali protokol placebo/FOLFIRI.
There have been no formal studies with ZALTRAP in patients with hepatic impairment.
Nisu provedena službena ispitivanja lijeka ZALTRAP u bolesnika s oštećenjem bubrežne funkcije.
An increased risk of grade 3-4 hypertension (including hypertension and one case of essential hypertension) has been observed in patients receiving the ZALTRAP/FOLFIRI regimen.
U bolesnika liječenih protokolom ZALTRAP/FOLFIRI primijećen je povećan rizik od hipertenzije stupnja 3-4 (uključujući hipertenziju i jedan slučaj esencijalne hipertenzije).
Neutropenic infection/sepsis (1) Urinary tract infection Nasopharyngitis
infekcija mokraćnih putova nazofaringitis neutropenijska infekcija/sepsa (1)
Aflibercept treatment should be discontinued in patients who develop fistula (see section 4.2).
U bolesnika u kojih nastane fistula treba obustaviti liječenje afliberceptom (vidjeti dio 4.2).
Discontinue ZALTRAP in patients who experience cardiac failure and ejection fraction decreased.
U bolesnika koji dožive zatajenje srca i smanjenu ejekcijsku frakciju potrebno je prekinuti liječenje lijekom ZALTRAP.
Administration of the ZALTRAP/FOLFIRI should be delayed until platelet count is 75 x 10
Primjenu protokola ZALTRAP/FOLFIRI treba odgoditi dok broj trombocita ne bude ≥ 75 x 109/l (vidjeti dio 4.2).
One 4 ml vial of concentrate contains 100 mg aflibercept.
Jedna bočica od 4 ml koncentrata sadrži 100 mg aflibercepta.
Median PFS (95 % CI) (months)
Medijan PFS-a (95% CI) (mjeseci)
Grade 3-4 fistula occurred in 0.2 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Fistule stupnja 3-4 nastale su u 0,2% bolesnika liječenih lijekom ZALTRAP te u 0,1% bolesnika koji su primali placebo (vidjeti dio 4.4).
Grade 3-4 VTE occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen and in 6.3 % of patients treated with the placebo/FOLFIRI regimen.
Venski tromboembolijski događaji stupnja 3-4 javili su se u 7,9% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 6,3% bolesnika koji su primali protokol placebo/FOLFIRI.
There have been no formal studies with ZALTRAP in patients with renal impairment.
Nisu provedena službena ispitivanja lijeka ZALTRAP u bolesnika s oštećenjem funkcije bubrega
Description of selected adverse reactions
Opis odabranih nuspojava Krvarenje
Aflibercept should be discontinued in patients that develop PRES (see section 4.2).
U bolesnika u kojih se razvije PRES treba obustaviti liječenje afliberceptom (vidjeti dio 4.2).