natgillin/translations-raw huggingface dataset:
• 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.
• Predrtje črevesa (to imenujemo tudi "gastrointestinalna perforacija"): občasno (pojavi se lahko pri največ 1 od 100 oseb) - Gre za luknjo v želodcu, požiralniku ali črevesu; to lahko povzroči smrt.
• 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.
• Zamašitev arterij s krvnim strdkom (to imenujemo tudi "arterijski trombembolični dogodki"): pogosto (pojavi se lahko pri največ 1 od 10 oseb) - To lahko povzroči možgansko kap ali srčni infarkt.
• toothache
• zobobol
Hypersensitivity (1)
Občasni preobčutljivost (1)
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).
Bolnikom je treba naročiti, naj ne vozijo in ne upravljajo s stroji, če se jim pojavijo simptomi, ki prizadenejo vid, zbranost ali sposobnost reagiranja (glejte poglavje 4.8).
If there is recurrence, the administration should be suspended until <2 grams/24 hours and then the dose reduced to 2 mg/kg.
V primeru ponovitve je treba uporabo prekiniti, dokler se proteinurija ne zmanjša na < 2 grama na 24 ur, potem pa odmerek zmanjšati na 2 mg/kg.
In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in 0.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 0.5 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
V ključni študiji pri bolnikih z mKRR so hude preobčutljivostne reakcije zabeležili pri 0,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 0,5 % prejemnikov sheme placebo/FOLFIRI (glejte poglavje 4.4).
Posterior reversible encephalopathy syndrome (PRES) PRES was not reported in the pivotal phase III study of MCRC patients.
V ključni študiji III. faze pri bolnikih mKRR niso zabeležili sindroma posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome).
Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Hude preobčutljivostne reakcije (vključno z bronhospazmom, dispnejo, angioedemom in anafilaksijo) (glejte poglavji 4.3 in 4.4)
Among the 1,226 randomised patients, 89.4 % and 90.2 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively, received prior oxaliplatin-based combination chemotherapy in the metastatic/advanced setting.
Od 1226 randomiziranih bolnikov je predhodno kombinirano zdravljenje na podlagi oksaliplatina pri metastatskem/napredovalem raku dobivalo 89,4 % prejemnikov sheme placebo/FOLFIRI in 90,2 % prejemnikov sheme ZALTRAP/FOLFIRI.
• swelling and numbness of the hands and feet that happens with chemotherapy (called
• oteklost in omrtvičenost dlani in stopal, ki se pojavi pri kemoterapiji (to imenujemo "sindrom palmarno-plantarne eritrodizestezije")
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).
Pri bolnikih, ki so prejemali aflibercept, so zabeležili arterijske trombembolične dogodke (ATEarterial thromboembolic events), vključno s tranzitornimi ishemičnimi atakami, cerebrovaskularnimi inzulti, angino pektoris, intrakardialnim trombom, miokardnim infarktom, arterijsko embolijo in ishemičnim kolitisom (glejte poglavje 4.8).
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.
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro, preden dobite zdravilo ZALTRAP in med zdravljenjem.
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.
Pljučna embolija se je pojavila pri 4,6 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 3,5 % prejemnikov sheme placebo/FOLFIRI.
Signs of infection may include fever, chills, cough, burning on passing water or muscle ache.
Med znaki okužbe so lahko zvišana telesna temperatura, mrzlica, kašelj, pekoč občutek pri uriniranju ali boleče mišice.
One ml of concentrate contains 25 mg aflibercept.
En mililiter koncentrata vsebuje 25 mg aflibercepta.
Signs may include stomach pain, being sick (vomiting), fever or chills.
Med znaki so lahko bolečine v trebuhu, slabost (bruhanje), zvišana telesna temperatura ali mrzlica.
Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Water for injections
6.1 Seznam pomožnih snovi saharoza natrijev klorid natrijev citrat dihidrat citronska kislina monohidrat polisorbat 20 natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat monohidrat natrijev hidroksid in/ali klorovodikova kislina (za prilagoditev pH) voda za injekcije
Severe proteinuria, nephrotic syndrome, and thrombotic microangiopathy (TMA) have been observed in patients treated with aflibercept (see section 4.8).
Med zdravljenjem z afliberceptom so zabeležili primere hude proteinurije, nefrotskega sindroma in trombotične mikroangiopatije (TMA) (glejte poglavje 4.8).
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.
V ključni študiji pri bolnikih z mKRR so proteinurijo (na podlagi kliničnih in laboratorijskih podatkov skupaj) zabeležili pri 62,2 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 40,7 % prejemnikov sheme placebo/FOLFIRI.
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 deluje kot topni slepilni receptor (decoy receptor), ki se veže na VEGF-A z večjo afiniteto kot njegovi nativni receptorji in sorodna liganda PlGF in VEGF-B.
Potential for compromised wound healing (wound dehiscence, anastomotic leakage) has been reported with aflibercept (see section 4.8).
Z afliberceptom je bila opisana možnost slabšega celjenja ran (dehiscenca rane, anastomotično iztekanje) (glejte poglavje 4.8).
In other studies, severe intracranial haemorrhage and pulmonary haemorrhage/haemoptysis including fatal events have occurred in patients receiving ZALTRAP (see section 4.4).
V drugih študijah so se bolnikom, ki so prejemali zdravilo ZALTRAP, pojavile hude intrakranialne krvavitve in pljučne krvavitve/hemoptiza (vključno s smrtnimi primeri) (glejte poglavje 4.4).
Severe diarrhoea
• hude krvavitve
Neutropenic infection/sepsis (1) Urinary tract infection Nasopharyngitis
Pogosti nevtropenična okužba/sepsa (1) okužba sečil nazofaringitis nevtropenična okužba/sepsa (1)
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.
Dogodki 3. do 4. stopnje so se pojavili pri 11 (1,8 %) prejemnikih sheme ZALTRAP/FOLFIRI in 3 (0,5 %) prejemnikih sheme placebo/FOLFIRI.
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.
V ključni študiji bolnikov z mKRR so perforacije prebavil (vseh stopenj) zabeležili pri 3 od 611 (0,5 %) prejemnikov sheme ZALTRAP/FOLFIRI in pri 3 od 605 (0,5 %) prejemnikov sheme placebo/FOLFIRI.
There was no observed impact on the pharmacokinetic profile of aflibercept in patients who were positive in the immunogenicity assays.
Pri bolnikih s pozitivnimi preskusi imunogenosti niso ugotovili vpliva na farmakokinetične značilnosti aflibercepta.
• Fistula formation
• nastanka fistule
If any discolouration or particulate matter is observed, the reconstituted solution should be discarded.
Če opazite obarvanje ali delce, morate pripravljeno raztopino zavreči.
Aflibercept administration should be suspended for ≥ 2 grams of proteinuria/24 hours and restarted when proteinuria is <2 grams/24 hours.
Uporabo aflibercepta je treba prekiniti, če je proteinurija ≥ 2 grama na 24 ur, in jo znova začeti, ko se zmanjša na < 2 grama na 24 ur.
• 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.
• Srčno popuščanje; občasno (pojavi se lahko pri največ 1 od 100 oseb) - znaki lahko vključejejo kratko sapo, ko se uležete ali ob naporu, prekomerno utrujenost ali otekanje nog.
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.
Najpogostejši nevtropenični zaplet 3. do 4. stopnje je bila febrilna nevtropenija; pojavila se je pri 4,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 1,7 % prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, hypertension (all grades) has been reported in 41.2 % of patients treated with ZALTRAP/FOLFIRI and 10.7 % of patients treated with placebo/FOLFIRI.
V ključni študiji bolnikov z mKRR se je hipertenzija (vseh stopenj) pojavila pri 41,2 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 10,7 % prejemnikov sheme placebo/FOLFIRI.
A side effect called osteonecrosis (bone damage in the jaw) has been reported in cancer patients treated with ZALTRAP.
Pri bolnikih z rakom, zdravljenih z zdravilom ZALTRAP, so poročali o neželenem učinku, imenovanem osteonekroza čeljustnic (poškodba kosti v čeljusti).
GI perforation (1)
Občasni perforacija prebavil (1)
There have been no formal studies with ZALTRAP in patients with hepatic impairment.
Formalnih študij z zdravilom ZALTRAP pri bolnikih z okvaro jeter niso izvedli.
• ZALTRAP is a single-use vial.
• Zdravilo ZALTRAP je viala za enkratno uporabo.
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 (vseh stopenj) se je pojavila pri 9,0 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 3,0 % prejemnikov sheme placebo/FOLFIRI.
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).
Nevtropenična okužba/sepsa 3. do 4. stopnje se je pojavila pri 1,5 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 1,2 % prejemnikov sheme placebo/FOLFIRI (glejte poglavje 4.4).
Administration of ZALTRAP/FOLFIRI should be delayed until neutrophil count is 1.5 x 10
Uporabo sheme ZALTRAP/FOLFIRI je treba odložiti, dokler ni število nevtrofilcev  1,5 x 109/l ali število trombocitov  75 x 109/l.
In the pivotal study of MCRC patients, all grades VTE occurred in 9.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 7.3 % of patients treated with the placebo/FOLFIRI regimen.
V ključni študiji pri bolnikih z mKRR so se VTE vseh stopenj pojavili pri 9,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 7,3 % prejemnikov sheme placebo/FOLFIRI.
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 %
Drugi neželeni učinki in laboratorijske nepravilnosti, zabeleženi z ≥ 5 % razliko (vse stopnje) med prejemniki sheme ZALTRAP/FOLFIRI in prejemniki sheme placebo/FOLFIRI Naslednje neželene učinke in laboratorijske nepravilnosti so zabeležili z ≥ 5 % razliko (vse stopnje) med prejemniki sheme ZALTRAP/FOLFIRI v primerjavi s prejemniki sheme placebo/FOLFIRI (v padajočem zaporedju pogostnosti): levkopenija (78,3 % v prim.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
• Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
If you experience changes in your vision or confusion, your doctor may stop your treatment with ZALTRAP.
• če ste imeli napade krčev (epileptične napade), ali če ste zmedeni ali imate motnje vida bo zdravnik morda prekinil vaše zdravljenje z zdravilom ZALTRAP.
Respiratory, thoracic and mediastinal disorders Very common
Neznani anevrizme in disekcije arterij Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti dispneja epistaksa disfonija
ZALTRAP 25 mg / ml sterile concentrate aflibercept
ZALTRAP 25 mg/ml koncentrat za raztopino za infundiranje aflibercept
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 se je pojavil pri 2 (0,5 %) prejemnikih sheme ZALTRAP/FOLFIRI, med prejemniki sheme placebo/FOLFIRI pa se ni pojavil.
One patient treated with the ZALTRAP/FOLFIRI regimen presenting with proteinuria and hypertension was diagnosed with thrombotic microangiopathy (TMA).
Pri bolnikih, zdravljenih s shemo ZALTRAP/FOLFIRI, je bila opisana trombocitopenija.
Grade 3-4 ATE occurred in 1.7 % of patients treated with ZALTRAP and 1.0 % of patients treated with placebo (see section
ATE 3. do 4. stopnje so se pojavile pri 1,7 % prejemnikov zdravila ZALTRAP in pri 1,0 % prejemnikov placeba (glejte poglavje
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.
VTE 3. do 4. stopnje so se pojavili pri 7,9 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 6,3 % prejemnikov sheme placebo/FOLFIRI.
Patients with no prior bevacizumab (n (%)) Median OS (95 % CI) (months)
Bolniki, ki predhodno niso bili zdravljeni z bevacizumabom (n (%)) Mediano preživetje brez napredovanja (95 % IZ) (meseci)
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
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.
Krvavitve 3. do 4. stopnje, vključno s krvavitvami v prebavilih, hematurijo in krvavitvami po posegih, so bile opisane pri 2,9 % prejemnikov sheme ZALTRAP/FOLFIRI in 1,7 % prejemnikov sheme placebo/FOLFIRI.
Fistula formation
Nastanek fistule
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).
Perforacija prebavil 3. do 4. stopnje se je pojavila pri 0,8 % prejemnikov zdravila ZALTRAP in pri 0,2 % prejemnikov placeba (glejte poglavje 4.4).
In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 69.2 % of patients treated with ZALTRAP/FOLFIRI and 56.5 % of patients treated with placebo/FOLFIRI.
V ključni študiji pri bolnikih z mKRR so drisko (vseh stopenj) zabeležili pri 69,2 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 56,5 % prejemnikov sheme placebo/FOLFIRI.
No metabolism studies have been conducted with aflibercept since it is a protein.
Ker je aflibercept beljakovina, z njim niso izvedli študij presnove.
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.
Od teh bolnikov jih je v študiji III. faze 611 prejemalo 4 mg/kg zdravila ZALTRAP vsaka dva tedna (en ciklus), 605 bolnikov pa kombinacijo placebo/FOLFIRI.
GI perforation including fatal GI perforation has been reported in patients treated with ZALTRAP.
Pri prejemnikih zdravila ZALTRAP so bile opisane perforacije prebavil, vključno s smrtnim izidom.
Arterial thromboembolism (1) Venous thromboembolism (1)
Pogosti arterijska trombembolija (1) venska trombembolija (1)
What ZALTRAP contains
Kaj vsebuje zdravilo ZALTRAP
An increased risk of grade 3-4 hypertension (including hypertension and one case of essential hypertension) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section
Pri bolnikih, zdravljenih s shemo ZALTRAP/FOLFIRI so zabeležili večje tveganje za hipertenzijo 3. do 4. stopnje (vključno s hipertenzijo in enim primerom esencialne hipertenzije) (glejte poglavje
Arterial thromboembolism (1) Venous thromboembolism (1) Haemorrhage (1)
arterijska trombembolija (1) venska trombembolija (1) krvavitev (1)
Talk to your doctor before being given this medicine if you are breast-feeding.
Če dojite, se posvetujte s svojim zdravnikom, preden dobite to zdravilo.
Grade 3-4 dehydration was reported in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.3 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Dehidracijo 3. do 4. stopnje so zabeležili pri 4,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 1,3 % prejemnikov sheme placebo/FOLFIRI (glejte poglavje 4.4).
Infections and infestations Very common
Infekcijske in parazitske bolezni Zelo pogosti okužba (1)
Grade 3-4 proteinuria occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.2 % of patients treated with the placebo/FOLFIRI regimen.
Proteinurija 3. do 4. stopnje se je pojavila pri 7,9 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 1,2 % prejemnikov sheme placebo/FOLFIRI.
Discontinue ZALTRAP in patients who experience cardiac failure and ejection fraction decreased.
Pri bolnikih, zdravljenih z zdravilom ZALTRAP, so poročali o srčnem popuščanju in zmanjšanem iztisnem deležu.
Hazard ratio (95 % CI)
Razmerje ogroženosti (95 % IZ)
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).
Slabše celjenje ran 3. do 4. stopnje se je pojavilo pri 0,2 % prejemnikov zdravila ZALTRAP in pri nobenem prejemniku placeba (glejte poglavje 4.4).
One 8 ml vial of concentrate contains 200 mg aflibercept.
Ena viala z 8 ml koncentrata vsebuje 200 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).
Pri bolnikih, zdravljenih z afliberceptom, je opisano večje tveganje za krvavitve, vključno s hudimi krvavitvami in včasih krvavitvami s smrtnim izidom (glejte poglavje 4.8).
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
V ključni študiji pri bolnikih z mKRR so fistule (analne, enterovezikalne, enterokutane, kolovaginalne, intestinalne) zabeležili pri 9 od 611 (1,5 %) prejemnikov sheme ZALTRAP/FOLFIRI in pri 3 od 605 (0,5 %) prejemnikov sheme placebo/FOLFIRI.
One 4 ml vial of concentrate contains 100 mg aflibercept.
Ena viala s 4 ml koncentrata vsebuje 100 mg aflibercepta.
Mild to moderate hypersensitivity reactions to ZALTRAP (including flushing, rash, urticaria, and pruritus) (see section 4.4)
Blage do zmerne preobčutljivostne reakcije na zdravilo ZALTRAP (vključno z zardevanjem, izpuščajem, urtikarijo in srbenjem) (glejte poglavje 4.4)
Grade 3-4 diarrhoea was reported in 19.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 7.8 % of patients treated with the placebo/FOLFIRI regimen.
Drisko 3. do 4. stopnje so zabeležili pri 19,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 7,8 % prejemnikov sheme placebo/FOLFIRI.
GI perforation including fatal GI perforation has been reported in patients treated with aflibercept (see section 4.8).
Pri bolnikih, zdravljenih z afliberceptom, so bile opisane perforacije prebavil, vključno s smrtnim izidom (glejte poglavje 4.8).
In the pivotal study of MCRC patients, episodes of bleeding/haemorrhage (all grades) was reported in 37.8 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 19.0 % of patients treated with the placebo/FOLFIRI regimen.
V ključni študiji pri bolnikih z mKRR so krvavitve (vseh stopenj) zabeležili pri 37,8 % prejemnikov sheme ZALTRAP/FOLFIRI in 19,0 % prejemnikov sheme placebo/FOLFIRI.
Cardiac failure and ejection fraction decreased have been reported in patients treated with ZALTRAP.
Bolnikom, ki doživijo srčno popuščanje in zmanjšan iztisni delež, prekinite zdravljenje z zdravilom ZALTRAP.
In the pivotal study of MCRC patients, neutropenia (all grades) has been reported in 67.8 % of patients treated with ZALTRAP/FOLFIRI and 56.3 % of patients treated with placebo/FOLFIRI.
V ključni študiji pri bolnikih z mKRR so nevtropenijo (vseh stopenj) zabeležili pri 67,8 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 56,3 % prejemnikov sheme placebo/FOLFIRI.
Grade 3-4 GI perforation events occurred in all 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and in 2 patients (0.3 %) treated with the placebo/FOLFIRI regimen.
Perforacija prebavil 3. do 4. stopnje se je pojavila pri 3 (0,5 %) prejemnikih sheme placebo/FOLFIRI in pri 2 (0,3 %) prejemnikih sheme placebo/FOLFIRI.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT(I) UPORABE ZDRAVILA Enoodmerna viala
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.
Pri prejemnikih sheme ZALTRAP/FOLFIRI so zabeležili večje tveganje za hipertenzijo 3. do 4. stopnje (vključno s hipertenzijo in enim primerom esencialne hipertenzije.
A higher incidence of neutropenic complications (febrile neutropenia and neutropenic infection) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Med zdravljenjem s shemo ZALTRAP/FOLFIRI so opažali večjo incidenco nevtropeničnih zapletov (febrilne nevtropenije in nevtropeničnih okužb) (glejte poglavje 4.8).
Aflibercept administration resulted in a delay in wound healing in rabbits.
Uporaba aflibercepta je pri kuncih upočasnila celjenje ran.
Stratified on ECOG performance status (0 versus 1 versus 2) and prior bevacizumab (yes versus no).
Vrednost p za stratificirani Cochran-MantelHaenszelov test a Stratificiran glede na stanje zmogljivosti po ECOG (0 v primerjavi z 1 v primerjavi z 2) in predhodni bevacizumab (da v primerjavi z ne).
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.
Nevtropenija 3. do 4. stopnje se je pojavila pri 36,7 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 29,5 % prejemnikov sheme placebo/FOLFIRI.
Fistula formation involving GI and non-GI sites has occurred in patients treated with aflibercept (see section 4.8).
Bolnikom, zdravljenim z afliberceptom, so se pojavile fistule na gastrointestinalnih in negastrointestinalnih mestih (glejte poglavje 4.8).
Oropharyngeal pain Rhinorrhoea
Pogosti orofaringealna bolečina rinoreja
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.
V ključni študiji pri bolnikih z mKRR so slabše celjenje ran zabeležili pri 3 (0,5 %) prejemnikih sheme ZALTRAP/FOLFIRI in pri 5 (0,8 %) prejemnikih sheme placebo/FOLFIRI.
Hypertension (1) Haemorrhage (1)
Žilne bolezni Zelo pogosti hipertenzija (1) krvavitev (1)
ZALTRAP 25 mg/ml concentrate for solution for infusion
IME ZDRAVILA ZALTRAP 25 mg/ml koncentrat za raztopino za infundiranje
Median overall survival (95 % CI) (months)
Mediano celokupno preživetje (95 % IZ)
Batch
PFSb