natgillin/translations-raw huggingface dataset:
• High blood pressure (also called ‘hypertension'): Very common (may affect more than 1 in 10 people) - this may develop or get worse.
• Visok krvni tlak (poznat i kao ‘hipertenzija'): Vrlo često (mogu se javiti u više od 1 na 10 osoba) - hipertenzija se može razviti ili pogoršati.
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.
Intravenska primjena aflibercepta u makaki majmuna svakih tjedan dana/svaka dva tjedna tijekom najviše 6 mjeseci uzrokovala je promjene na kostima (utjecaj na ploču rasta te aksijalni i apendikularni kostur), u nosnoj šupljini, na bubrezima, jajnicima i nadbubrežnoj žlijezdi.
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 kojem su sudjelovali bolesnici s MKRK-om.
The safety of ZALTRAP in combination with FOLFIRI was evaluated in 1,216 patients previously treated for metastatic colorectal cancer, of which 611 patients were treated with ZALTRAP 4 mg/kg every two weeks (one cycle) and 605 patients were treated with placebo/FOLFIRI in a phase III study.
Sažetak sigurnosnog profila Sigurnost primjene lijeka ZALTRAP u kombinaciji s protokolom FOLFIRI ocijenjena je u ispitivanju faze III u kojem je sudjelovalo 1216 bolesnika prethodno liječenih zbog metastatskog kolorektalnog karcinoma, od kojih je njih 611 primalo ZALTRAP u dozi od 4 mg/kg svaka dva tjedna (jedan ciklus), a 605 protokol placebo/FOLFIRI.
ZALTRAP is given by a drip (infusion) into one of your veins (‘intra-venous') to treat advanced cancers of the colon or rectum.
ZALTRAP se primjenjuje kapanjem (infuzijom) u jednu od vena (‘intravenski') za liječenje uznapredovalog raka debelog crijeva ili završnog dijela debelog crijeva.
• Arterial thromboembolic events (ATE)
• arterijskih tromboembolijskih događaja (ATE)
ZALTRAP should be discontinued in patients with life-threatening (Grade 4) thromboembolic events (including pulmonary embolism) (see section 4.2).
Primjenu lijeka ZALTRAP treba prekinuti u bolesnika s tromboembolijskim događajima opasnim po život (stupanj 4) (uključujući plućnu emboliju) (vidjeti dio 4.2).
If severe diarrhoea persists with both dose reductions, FOLFIRI should be discontinued.
Ako se težak proljev nastavi i nakon tih smanjenja, treba obustaviti primjenu protokola FOLFIRI.
Stratified log-rank test p-value Overall Response Rate (CR+PR) (95 % CI) (%)
Stopa ukupnog odgovora (CR+PR) (95% CI) (%)c
Other signs include swelling in one or both legs, pain or tenderness in one or both legs while standing or walking, warmth of the skin on the affected leg, red or discoloured skin in the affected leg or visible veins.
Drugi znakovi mogu uključivati oticanje jedne ili obje noge, bol ili osjetljivost na dodir u jednoj ili obje noge pri stajanju ili hodanju, toplinu kože na zahvaćenoj nozi, crvenilo kože ili promjenu boje kože na zahvaćenoj nozi ili vidljive vene.
• Cardiac failure and ejection fraction decreased
• zatajenja srca i smanjene ejekcijske frakcije
• Inspect the ZALTRAP vial visually prior to use.
• Prije uporabe vizualno pregledajte bočicu lijeka ZALTRAP.
This is because it is not known if the medicine passes into breast milk.
Naime, nije poznato izlučuje li se ovaj lijek u majčino mlijeko.
• The other ingredients are: 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.
• Drugi sastojci su: saharoza, natrijev klorid, natrijev citrat dihidrat, citratna kiselina hidrat, polisorbat 20, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat hidrat, natrijev hidroksid i/ili kloridna kiselina i voda za injekcije.
GI perforation (1) Rectal haemorrhage Fistula (1) Aphthous stomatitis Proctalgia
gastrointestinalna perforacija (1) rektalno krvarenje fistula (1) aftozni stomatitis proktalgija
For additional toxicities related to irinotecan, 5-FU, or folinic acid, refer to the current respective summary of product characteristics.
Za dodatne toksičnosti povezane s irinotekanom, 5-FU ili folnom kiselinom vidjeti važeći Sažetak opisa svojstava lijeka za svaki od navedenih lijekova.
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
(1) Vidjeti "Opis odabranih nuspojava" u ovome dijelu (2) Na temelju laboratorijskih vrijednosti (postoci u bolesnika u kojih su provedene laboratorijske procjene)
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.
Hipertenzija stupnja 3 (koja zahtijeva prilagođavanje postojeće antihipertenzivne terapije ili liječenje više nego jednim lijekom) prijavljena je u 1,5% bolesnika koji su primali protokol placebo/FOLFIRI te u 19,1% bolesnika liječenih protokolom ZALTRAP/FOLFIRI.
Patients with prior bevacizumab (n (%))
Bolesnici prethodno liječeni bevacizumabom (n (%))
Clinical data suggest that no change in starting dose is required in patients with mild to moderate renal impairment.
Klinički podaci pokazuju da nije potrebna prilagodba početne doze u bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije.
0.862 (0.676 to 1.100)
0,862 (0,676 do 1,100)
Hazard ratio (95 % CI)
Omjer hazarda (95% CI)
Each vial of concentrate for solution for infusion is for single use (single-dose) only.
Jedna bočica koncentrata za otopinu za infuziju namijenjena je isključivo za jednokratnu (jednodoznu)
• urinary tract infection
• infekcija mokraćnih putova
Cardiac failure and ejection fraction decreased have been reported in patients treated with ZALTRAP.
Zatajenje srca i smanjena ejekcijska frakcija prijavljeni su u bolesnika liječenih lijekom ZALTRAP.
0.777 (0.655 to 0.921)
0,777 (0,655 do 0,921)
6.90 (6.51 to 7.20)
6,90 (6,51 do 7,20)
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.
U pivotalnom ispitivanju u bolesnika s MKRK-om arterijski tromboembolijski događaji (uključujući tranzitornu ishemijsku ataku, cerebrovaskularni incident, anginu pektoris, intrakardijalni tromb, infarkt miokarda, arterijsku emboliju i ishemijski kolitis) prijavljeni su u 2,6% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 1,5% bolesnika koji su primali protokol placebo/FOLFIRI.
If recurrence, 5-FU bolus and infusion doses should additionally be reduced by 20 % in subsequent cycles.
Ako se ponovno javi, doze bolusne injekcije i infuzije 5-FU u sljedećim ciklusima treba smanjiti za dodatnih 20%.
Due to hyperosmolality (1000 mOsmol/kg) of the ZALTRAP concentrate, undiluted ZALTRAP concentrate must not be administered as an intravenous push or bolus.
Zbog hiperosmolarnosti (1000 mOsmol/kg) ZALTRAP koncentrata, nerazrijeđeni ZALTRAP koncentrat ne smije se primijeniti brzom niti bolusnom intravenskom injekcijom.
Caution should be exercised when Zaltrap and intravenous bisphosphonates are administered concurrently or sequentially.
Potreban je oprez kod istodobne ili uzastopne primjene lijeka Zaltrap i intravenskih bisfosfonata.
Patients with no prior bevacizumab excluding adjuvant only (n ( %))
Bolesnici koji su prethodno primali bevacizumab, izuzevši samo adjuvantno liječenje(n (%))
0.661 (0.512 to 0.852)
0,661 (0,512 do 0,852)
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)]
a Određeno korištenjem sustava interaktivnog glasovnog odgovora b OS u ITT populaciji, izuzevši bolesnike u kojih je bolest uznapredovala tijekom ili unutar 6 mjeseci od adjuvantnoga liječenja, ukazalo je na omjer hazarda (95% CI) od 0,78 (0,68 do 0,90) [medijan OS-a (95% CI) uz placebo/FOLFIRI iznosio je 11,9 mjeseci (10,88 do 13,01), a uz ZALTRAP/FOLFIRI 13,8 mjeseci (12,68 do 15,44)]
5-FU bolus should be reduced and the infusion dose reduced by 20 %.
Treba smanjiti dozu bolusne injekcije i infuzije 5-FU za 20%.
In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
U pivotalnom ispitivanju bolesnika s MKRK-om prijavljene su teške reakcije preosjetljivosti u bolesnika liječenih protokolom ZALTRAP/FOLFIRI (vidjeti dio 4.8).
Clinical data suggest that no change in aflibercept dose is required in patients with mild to moderate hepatic impairment.
Klinički podaci pokazuju da nije potrebna prilagodba doze aflibercepta u bolesnika s blagim do umjerenim oštećenjem jetrene funkcije.
11.7 (9.96 to 13.77) 12.5 (10.78 to 15.47)
11,7 (9,96 do 13,77) 12,5 (10,78 do 15,47)
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.
Omjer hazarda (95% CI) preživljenja bez progresije bolesti iznosio je 0,76 (0,63 do 0,91) za ECOG status 0 i 0,75 (0,61 do 0,92) za ECOG status 1.
Due to hyperosmolality (1000 mOsmol / kg) of the ZALTRAP concentrate, undiluted ZALTRAP concentrate must not be administered as an intravenous push or bolus.
Zbog hiperosmolalnosti (1000 mOsmol/kg) ZALTRAP koncentrata, nerazrijeđeni ZALTRAP koncentrat ne smije se primijeniti brzom niti bolusnom intravenskom injekcijom.
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.
U bolesnika se ZALTRAP primjenjuje u intravenskoj dozi od 4 mg/kg svaka dva tjedna, pri čemu se u krvotoku postižu koncentracije slobodnog aflibercepta veće od koncentracija aflibercepta vezanog za
6.7 (5.75 to 8.21)
6,7 (5,75 do 8,21)
For contraindications related to FOLFIRI components (irinotecan, 5-FU, and folinic acid), refer to the current respective summary of product characteristics.
Za kontraindikacije povezane s lijekovima protokola FOLFIRI (irinotekanom, 5-FU ili folnom kiselinom) vidjeti važeći Sažetak opisa svojstava lijeka za svaki od tih lijekova.
• Low white blood cell count (also called ‘neutropenia'): Very common (may affect more than 1 in 10 people) - this can cause serious infections.
• Nizak broj bijelih krvnih stanica (poznato i kao ‘neutropenija'): Vrlo često (mogu se javiti u više od 1 na 10 osoba) - može izazvati teške infekcije.
6.7 (5.72 to 8.21)
6,7 (5,72 do 8,21)
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.
Proteinuriju treba kontrolirati tako da se prije svake primjene aflibercepta provjeri mogući razvoj ili pogoršanje proteinurije analizom urina pomoću test trakica i/ili određivanjem omjera proteina i kreatinina u mokraći.
Other signs may include swelling in one or both legs, pain or tenderness in one or both legs, discolouration and warmth of the skin on the affected leg or visible veins.
Drugi znakovi mogu uključivati oticanje jedne ili obje noge, bol ili osjetljivost na dodir u jednoj ili obje noge, promjenu boje i toplinu kože na zahvaćenoj nozi ili vidljive vene.
Monitoring of complete blood count (CBC) with differential count is recommended at baseline and prior to initiation of each cycle of aflibercept.
Preporučuje se kontrola kompletne krvne slike (KKS) i diferencijalne krvne slike na početku liječenja i prije početka svakog ciklusa aflibercepta.
Aflibercept administration should be suspended for ≥ 2 grams of proteinuria/24 hours and restarted when proteinuria is <2 grams/24 hours.
Primjenu aflibercepta treba prekinuti kada je proteinurija u 24 sata ≥ 2 grama i ponovno uvesti kada proteinurija u 24 sata bude < 2 grama.
Arterial thromboembolic events (ATE)
Arterijski tromboembolijski događaji (ATE)
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.
ZALTRAP/FOLFIRI u usporedbi s bolesnicima koji su primali protokol placebo/FOLFIRI navedeni su u Tablici 1 prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
Compromised wound healing Aflibercept impaired wound healing in animal models (see section 5.3).
Otežano zacjeljivanje rana Aflibercept je u životinjskim modelima otežao zacjeljivanje rana (vidjeti dio 5.3).
In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase, and hyperbilirubinaemia occurred in ≥ 20 % of patients.
U pivotalnom ispitivanju MKRK-a u ≥ 20% bolesnika pojavili su se anemija, mučnina, povraćanje, konstipacija, alopecija, povišene vrijednosti alkalne fosfataze i hiperbilirubinemija.
Aflibercept should not be administered to patients with severe haemorrhage (see section 4.2).
Aflibercept se ne smije primjenjivati u bolesnika s teškim krvarenjem (vidjeti dio 4.2).
A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Zaltrap.
Prije početka liječenja lijekom Zaltrap treba razmotriti provođenje stomatološkog pregleda i primjerenih preventivnih stomatoloških mjera.
12.4 (11.17 to 13.54) 13.9 (12.72 to 15.64)
12,4 (11,17 do 13,54) 13,9 (12,72 do 15,64)
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 %)].
MKRK-om pozitivni nalazi testa na neutralizirajuća protutijela također su primijećeni u većem broju u bolesnika koji su primali protokol placebo/FOLFIRI [2/526 (0,38%)] nego u onih liječenih protokolom ZALTRAP/FOLFIRI [1/521 (0,19%)].
Aflibercept should be discontinued in patients with compromised wound healing requiring medical intervention (see section 4.2).
Treba prekinuti primjenu aflibercepta u bolesnika s otežanim zacjeljivanjem rana koje zahtijevaju medicinsku intervenciju (vidjeti dio 4.8).
0.766 (0.645 to 0.908)
0,766 (0,645 do 0,908)
ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) have been observed in patients treated with aflibercept (see section 4.8).
U bolesnika liječenih afliberceptom primijećeni su arterijski tromboembolijski događaji (uključujući tranzitornu ishemijsku ataku, cerebrovaskularni incident, anginu pektoris, intrakardijalni tromb, infarkt miokarda, arterijsku emboliju i ishemijski kolitis) (vidjeti dio 4.8).
There are no data regarding the administration of aflibercept in patients with severe hepatic impairment.
Nema podataka o primjeni aflibercepta u bolesnika s teškim oštećenjem jetrene funkcije.
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).
proljev, neutropenija, proteinurija, povišene vrijednosti aspartat aminotransferaze (AST), stomatitis, umor, trombocitopenija, povišene vrijednosti alanin aminotransferaze (ALT), hipertenzija, gubitak tjelesne težine, smanjen tek, epistaksa, bol u abdomenu, disfonija, povišene vrijednosti kreatinina u serumu i glavobolja (vidjeti Tablicu 1).
One ml of concentrate contains 25 mg aflibercept.
Jedan ml koncentrata sadrži 25 mg aflibercepta.
Compromised wound healing (1)
otežano zacjeljivanje rana (1)
There have been no formal studies with ZALTRAP in patients with hepatic impairment (see section 5.2).
Nisu provedena službena ispitivanja lijeka ZALTRAP u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
6.9 (6.37 to 7.20)
6,9 (6,37 do 7,20)
• Blocking of the veins by a blood clot (also called ‘venous thrombo-embolic events'): Common (may affect up to 1 in 10 people) - this may include a blood clot in the lungs or legs.
• Začepljenje vene zbog krvnog ugruška (poznato i kao ‘venski tromboembolijski događaji'): Često (mogu se javiti u manje od 1 na 10 osoba) - može uključivati krvni ugrušak u plućima ili nogama.
If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive or use machines (see section 4.8).
Bolesnicima treba savjetovati da ne upravljaju vozilima i ne rukuju strojevima ako primijete simptome koji im utječu na vid, koncentraciju ili sposobnost reagiranja (vidjeti dio 4.8).
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 %)].
U pivotalnom ispitivanju u bolesnika s MKRK-om pozitivni odgovori u ADA testu primijećeni su u većem broju u bolesnika koji su primali protokol placebo/FOLFIRI [18/526 (3,4%)] nego u onih liječenih protokolom ZALTRAP/FOLFIRI [8/521 (1,5%)].
0.788 (0.671 to 0.925)
0,788 (0,671 do 0,925)
In patients receiving ZALTRAP, the adverse reactions in patients with mild renal impairment at baseline in three Phase III placebo-controlled clinical studies (N = 352) were comparable with those of patients without renal impairment (N = 642).
U tri placebom kontrolirana klinička ispitivanja faze III nuspojave u bolesnika liječenih lijekom ZALTRAP koji su na početku liječenja imali blago oštećenje bubrežne funkcije (N=352) bile su usporedive s nuspojavama primijećenima u bolesnika s normalnom bubrežnom funkcijom (N=642).
ZALTRAP should be discontinued for (see section 4.4):
Liječenje lijekom ZALTRAP mora se prekinuti u slučaju (vidjeti dio 4.4):
In the pivotal study of MCRC patients, proteinuria (compiled from clinical and laboratory data) was reported in 62.2 % patients treated with the ZALTRAP/FOLFIRI regimen compared to 40.7 % patients treated with the placebo/FOLFIRI regimen.
U pivotalnom ispitivanju u bolesnika s MKRK-om proteinurija (prikupljeno iz kliničkih i laboratorijskih podataka) je prijavljena u 62,2% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 40,7% bolesnika koji su primali protokol placebo/FOLFIRI.
6.9 (6.24 to 7.20)
6,9 (6,24 do 7,20)
Infections and infestations Very common
Infekcije i infestacije vrlo često infekcija (1)
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.
U analizi ukupnog preživljenja po podskupinama, u populaciji bolesnika u dobi od < 65 godina i
ZALTRAP must not be administered as an intravitreal injection (see section 4.3).
ZALTRAP se ne smije primijeniti u obliku intravitrealne injekcije (vidjeti dio 4.3).
Stratified hazard ratio (95 % CI)
Stratificirani omjer hazarda (95% CI)
Cardiac failure and ejection fraction decreased
Zatajenje srca i smanjena ejekcijska frakcija
• Holes in the gut (also called ‘gastro-intestinal perforation'): Uncommon (may affect up to 1 in 100 people) - this is a hole in the stomach, food pipe, gut or bowel.
• Pukotine u probavnom sustavu (poznate i kao ‘gastrointestinalne perforacije'): Manje često (mogu se javiti u manje od 1 na 100 osoba) - to je pukotina u želucu, jednjaku ili crijevima koja može uzrokovati smrt.
• Fistula formation
• stvaranja fistule
One patient treated with the ZALTRAP/FOLFIRI regimen presenting with proteinuria and hypertension was diagnosed with thrombotic microangiopathy (TMA).
Jednom je bolesniku s proteinurijom i hipertenzijom liječenom protokolom ZALTRAP/FOLFIRI dijagnosticirana trombotička mikroangiopatija (TMA).
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].
Ukupno je 1226 bolesnika randomizirano (1:1) da primaju ili ZALTRAP (N=612; 4 mg/kg u obliku jednosatne intravenske infuzije primijenjene 1. dana) ili placebo (N=614) u kombinaciji s 5-fluorouracilom i irinotekanom [FOLFIRI: intravenska infuzija irinotekana u dozi od 180 mg/m2
If recurrence, the treatment should be suspended until <2 grams per 24 hours and then the dose reduces to 2 mg/kg.
U slučaju ponovne pojave, liječenje treba prekinuti dok proteinurija ne bude < 2 grama u 24 sata, a zatim smanjiti dozu na 2 mg/kg.
• Gastrointestinal (GI) perforation
• gastrointestinalne perforacije
• Blocking of the arteries by a blood clot (also called ‘arterial thrombo-embolic events'): Common (may affect up to 1 in 10 people) - this may lead to a stroke or heart attack.
• Začepljenje arterije zbog krvnog ugruška (poznato i kao ‘arterijski tromboembolijski događaji'): Često (mogu se javiti u manje od 1 na 10 osoba) - može prouzročiti moždani ili srčani udar.
0.758 (0.661 to 0.869)
0,758 (0,661 do 0,869)
• Heart failure (also called cardiac failure); Uncommon (may affect up to 1 in 100 people) - Signs may include shortness of breath when you lie down or when you exert yourself, excessive tiredness or leg swelling.
• Zatajenje srca: Manje često (mogu se javiti u manje od 1 na 100 osoba) - znakovi mogu uključiti nedostatak zraka kada ležite ili kad se naprežete, pretjeran umor ili oticanje nogu.
One vial of 4 ml contains 100 mg of aflibercept (25 mg / ml).
Jedna bočica s 4 ml koncentrata sadrži 100 mg aflibercepta (25 mg/ml).
• The diluted solution should be inspected visually for particulate matter and discolouration prior to administration.
• Razrijeđenu otopinu treba prije primjene vizualno pregledati kako bi se utvrdilo sadrži li čestice i je li promijenila boju.
Dehydration (all grades) has been observed in 9.0 % of patients treated with ZALTRAP/FOLFIRI and 3.0 % of patients treated with placebo/FOLFIRI.
Dehidracija (svih stupnjeva) je primijećena u 9,0% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 3,0% bolesnika koji su primali protokol placebo/FOLFIRI.
Table 1 - Adverse reactions reported in patients treated with the ZALTRAP/FOLFIRI regimen from the MCRC study
Tablica 1 - Nuspojave prijavljene u bolesnika liječenih protokolom ZALTRAP/FOLFIRI u ispitivanju
Treatment with ZALTRAP is associated with potential for compromised wound healing (wound dehiscence, anastomotic leakage).
Liječenje lijekom ZALTRAP može otežati zacjeljivanje rana (dehiscijencija rane, iscjedak iz anastomoze).
* Aflibercept is produced in a Chinese hamster ovary (CHO) K-1 mammalian expression system by recombinant DNA technology.
* Aflibercept se proizvodi tehnologijom rekombinantne DNA na ekspresijskom sustavu stanica sisavaca K-1 iz jajnika kineskog hrčka (engl.