FrancophonIA/ELRC3.0 huggingface dataset:
English: One vial of 8 ml contains 200 mg of aflibercept (25 mg / ml).
Slovenian: Ena 8 ml viala vsebuje 200 mg aflibercepta (25 mg/ml).
English: Median OS (95 % CI) (months)
Slovenian: Mediano OS (95 % IZ) (meseci)
English: 6.90 (6.51 to 7.20)
Slovenian: 6,90 (6,51 do 7,20)
English: How to store ZALTRAP
Slovenian: Kako uporabljati zdravilo ZALTRAP
English: The recommended dose of ZALTRAP, administered as an intravenous infusion over 1 hour, is 4 mg / kg of body weight, followed by the FOLFIRI regimen.
Slovenian: Priporočeni odmerek zdravila ZALTRAP je 4 mg/kg telesne mase v 1-urni intravenski infuziji; nato sledi shema FOLFIRI.
English: 0.661 (0.512 to 0.852)
Slovenian: 0,661 (0,512 do 0,852)
English: 0.797 (0.679 to 0.936)
Slovenian: 0,797 (0,679 do 0,936)
English: Monitoring of complete blood count (CBC) with differential count is recommended at baseline and prior to initiation of each cycle of aflibercept.
Slovenian: Celotno krvno sliko z diferencialno krvno sliko je priporočljivo kontrolirati izhodiščno in pred začetkom vsakega ciklusa aflibercepta.
English: Compromised wound healing Aflibercept impaired wound healing in animal models (see section 5.3).
Slovenian: Slabše celjenje ran Aflibercept je v živalskih modelih poslabšal celjenje ran (glejte poglavje 5.3).
English: • 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.
Slovenian: • Pomožne snovi so: saharoza, natrijev klorid, natrijev citrat dihidrat, citronska kislina monohidrat, polisorbat 20, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, natrijev hidroksid in/ali klorovodikova kislina in voda za injekcije.
English: 6.7 (5.75 to 8.21)
Slovenian: 6,7 (5,75 do 8,21)
English: 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.
Slovenian: Ustrezni podatki za bolnike, ki so imeli tumorje z mutantnim tipom RAS, so pokazali razmerje ogroženosti za celokupno preživetje 0,9 (0,7-1,2); mediano celokupno preživetje z afliberceptom je bilo 12,6 meseca in s placebom 11,2 meseca.
English: 6.7 (5.72 to 8.21)
Slovenian: 6,7 (5,72 do 8,21)
English: • inflammation inside the mouth
Slovenian: • vnetje v ustih
English: 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).
Slovenian: V treh s placebom kontroliranih kliničnih študijah III. faze so bili neželeni učinki med bolniki, ki so prejemali zdravilo ZALTRAP in so izhodiščno imeli blago okvaro ledvic (n = 352), primerljivi kot med bolniki brez okvare ledvic (n = 642).
English: Cardiac failure and ejection fraction decreased
Slovenian: Srčno popuščanje in zmanjšan iztisni delež
English: 12.4 (11.17 to 13.54) 13.7 (12.71 to 16.03)
Slovenian: 12,4 (11,17 do 13,54) 13,7 (12,71 do 16,03)
English: 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).
Slovenian: V celoti so v vseh kliničnih onkoloških študijah s preskusom protiteles proti zdravilu (ADAanti-drug antibody) ugotovili podobno (poizhodiščno) incidenco odziva z nizkim titrom ADA tako pri prejemnikih placeba (3,3 %) kot pri prejemnikih zdravila ZALTRAP (3,8 %).
English: 0.777 (0.655 to 0.921)
Slovenian: 0,777 (0,655 do 0,921)
English: 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
Slovenian: Razmerje ogroženosti (95 % IZ) za celokupno preživetje je bilo 0,77 (0,64 do 0,93) za stanje zmogljivosti ECOG 0 in 0,87 (0,71 do 1,06) za stanje zmogljivosti ECOG 1.
English: ZALTRAP is a medicine used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults.
Slovenian: Zdravilo ZALTRAP uporabljamo za zdravljenje napredovalega raka črevesa in danke (deli debelega črevesa) pri odraslih.
English: Nephrotic syndrome (1) Thrombotic microangiopathy (1)
Slovenian: nefrotski sindrom (1) trombotična mikroangiopatija (1)
English: Febrile neutropenia Thrombocytopenia (2)
Slovenian: Pogosti febrilna nevtropenija febrilna nevtropenija trombocitopenija (2)
English: 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.
Slovenian: Med drugimi znaki so oteklost ene ali obeh nog, bolečine ali občutljivost v eni ali obeh nogah med stanjem ali hojo, topla koža na prizadeti nogi, pordelost kože na prizadeti nogi ali vidne vene.
English: Ophthalmic / intravitreal use due to hyperosmotic properties of ZALTRAP (see section 4.4).
Slovenian: Oftalmična/intravitrealna uporaba zaradi hiperosmotskih lastnosti zdravila ZALTRAP (glejte poglavje
English: Stratified hazard ratio (95 % CI)
Slovenian: Stratificirano razmerje ogroženosti (95 % IZ)
English: 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).
Slovenian: V ključni študiji pri bolnikih z mKRR so poročali o hudih preobčutljivostnih reakcijah pri prejemnikih sheme ZALTRAP/FOLFIRI (glejte poglavje 4.8).
English: 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.
Slovenian: Pri bolnikih, ki so imeli tumorje z divjim tipom RAS, je bilo razmerje ogroženost (95 % IZ) za OS 0,7 (0,5-1,0); mediano celokupno preživetje z afliberceptom je bilo 16,0 mesecev in s placebom 11,7 meseca.
English: Table 1 - Adverse reactions reported in patients treated with the ZALTRAP/FOLFIRI regimen from the MCRC study
Slovenian: Preglednica 1- Neželeni učinki opisani pri prejemnikih sheme ZALTRAP/FOLFIRI v študiji mKRR Organski sistem
English: Signs may include chest pain, coughing, being short of breath, difficulty breathing or coughing up blood.
Slovenian: Med znaki so lahko bolečine v prsih, kašelj, kratka sapa, težko dihanje ali izkašljevanje krvi.
English: Stratified log-rank test p-value Overall Response Rate (CR+PR) (95 % CI) (%)
Slovenian: Celokupni delež odziva (CR+PR) (95 % IZ) (%)c
English: It may also present itself as a sudden numb or weak feeling in the face, arms, or legs.
Slovenian: Kaže se lahko tudi kot nenadna omrtvelost ali občutek šibkosti obraza, rok ali nog.
English: Off-label intravitreal use
Slovenian: Neodobrena intravitrealna uporaba
English: • Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Slovenian: • hudih preobčutljivostnih reakcij (vključno z bronhospazmom, dispnejo, angioedemom in anafilaksijo) (glejte poglavji 4.3 in 4.4)
English: • painful sores in the mouth
Slovenian: • boleče razjede v ustih
English: • High blood pressure (also called ‘hypertension'): Very common (may affect more than 1 in 10 people) - this may develop or get worse.
Slovenian: • Visok krvni tlak (imenujemo ga tudi "hipertenzija"): zelo pogosto (pojavi se lahko pri več kot 1 od 10 oseb) - Visok krvni tlak se lahko pojavi na novo ali se poslabša.
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: • Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Signs may include chest pain or heaviness in the chest, sudden numb or weak feeling in the face, arms, or legs.
Slovenian: Med znaki so lahko bolečina v prsih ali tiščanje v prsih, nenaden občutek omrtvičenosti ali šibkosti v obrazu, rokah ali nogah.
English: No dose adjustments of ZALTRAP is required in the elderly people.
Slovenian: Starejšim bolnikom odmerka zdravila ZALTRAP ni treba prilagoditi.
English: ZALTRAP must not be administered as an intravitreal injection (see section 2 of the package leaflet).
Slovenian: Zdravila ZALTRAP se ne sme uporabiti kot intravitrealne injekcije (glej poglavje 2 tega navodila).
English: You may have side effects that affect your sight, concentration or ability to react.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pojavijo se vam lahko neželeni učinki, ki prizadenejo vid, zbranost ali sposobnost reagiranja.
English: • The diluted solution should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: • Razredčeno raztopino je treba pred uporabo pregledati in se prepričati, da ne vsebuje delcev in da ni obarvana.
English: • 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.
Slovenian: • Zamašitev ven s krvnim strdkom (to imenujemo tudi "venski trombembolični dogodki"): pogosto (pojavi se lahko pri največ 1 od 10 oseb) - To lahko vključuje krvni strdek v pljučih ali nogah.
English: A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Zaltrap.
Slovenian: Pred začetkom zdravljenja z zdravilom Zaltrap je treba razmisliti o pregledu zobovja in primernih preventivnih zobozdravstvenih posegih.
English: 0.766 (0.645 to 0.908)
Slovenian: 0,766 (0,645 do 0,908)
English: What ZALTRAP is used for
Slovenian: Za kaj uporabljamo zdravilo ZALTRAP
English: Patients should be monitored for signs and symptoms of cardiac failure and ejection fraction decreased.
Slovenian: Bolnike je treba spremljati glede pojava znakov in simptomov srčnega popuščanja in zmanjšanega iztisnega deleža.
English: Clinical data suggest that no change in aflibercept dose is required in patients with mild to moderate hepatic impairment.
Slovenian: Klinični podatki kažejo, da bolnikom z blago do zmerno okvaro jeter odmerka aflibercepta ni treba prilagoditi.
English: GI perforation (1) Rectal haemorrhage Fistula (1) Aphthous stomatitis Proctalgia
Slovenian: perforacija prebavil (1) krvavitev iz danke fistula (1) aftozni stomatitis proktalgija
English: There have been no formal studies with ZALTRAP in patients with renal impairment (see section 5.2).
Slovenian: Formalnih študij z zdravilom ZALTRAP pri bolnikih z okvaro ledvic niso izvedli (glejte poglavje 5.2).
English: Pregnancy, breast-feeding and fertility
Slovenian: Plodnost, nosečnost in dojenje
English: Invasive dental procedures should, if possible, be avoided in patients treated with Zaltrap and who have previously received or are receiving intravenous bisphosphonates (see section 4.8).
Slovenian: Pri bolnikih, ki prejemajo zdravilo Zaltrap in so predhodno prejemali ali trenutno prejemajo intravenske difosfonate, se je invazivnim zobozdravstvenim posegom treba izogniti, če je le mogoče (glejte poglavje 4.8).
English: If recurrence, the treatment should be suspended until <2 grams per 24 hours and then the dose reduces to 2 mg/kg.
Slovenian: V primeru ponovitve je treba zdravljenje prekiniti, dokler se proteinurija ne zmanjša na < 2 g na 24 ur, nato pa odmerek zmanjšati na 2 mg/kg.
English: Grade 3 GI fistula formation occurred in 2 patients treated with ZALTRAP (0.3 %) and in 1 placebo-treated patient (0.2 %).
Slovenian: Fistula na prebavilih 3. stopnje se je pojavila 2 prejemnikoma zdravila ZALTRAP (0,3 %) in 1 prejemniku placeba (0,2 %).
English: 6.9 (6.37 to 7.20)
Slovenian: 6,9 (6,37 do 7,20)
English: The concentrate is a clear, colourless to pale yellow solution.
Slovenian: Koncentrat je bistra, brezbarvna do bledorumena raztopina.
English: 0.788 (0.671 to 0.925)
Slovenian: 0,788 (0,671 do 0,925)
English: Male and female fertility are likely to be compromised during treatment with aflibercept based on studies in monkeys (see section 5.3).
Slovenian: Na podlagi študij pri opicah je med zdravljenjem z afliberceptom verjetno poslabšanje plodnosti tako pri moških kot pri ženskah (glejte poglavje 5.3).
English: Therapeutic use of G-CSF at first occurrence of grade ≥ 3 neutropenia and secondary prophylaxis may be considered in patients who may be at increased risk for neutropenia complications.
Slovenian: Pri bolnikih z možnim večjim tveganjem za nevtropenične zaplete prideta v poštev terapevtska uporaba G-CSF ob prvem pojavu nevtropenije ≥ 3. stopnje in sekundarna profilaksa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg/4 ml
English: 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).
Slovenian: Najpogostejši neželeni učinki 3. do 4. stopnje (incidenca ≥ 5 %), katerih incidenca je bila s shemo ZALTRAP/FOLFIRI vsaj 2 % večja od incidence s shemo placebo/FOLFIRI, so bili (v padajočem zaporedju pogostnosti): nevtropenija, driska, hipertenzija, levkopenija, stomatitis, utrujenost, proteinurija in astenija (glejte preglednico 1).
English: • polyurethane
Slovenian: • poliuretana
English: 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.
Slovenian: Med drugimi znaki so lahko oteklost ene ali obeh nog, bolečina ali občutljivost ene ali obeh nog, obarvanje ali topla koža na prizadeti nogi ali vidne vene.
English: 6.9 (6.24 to 7.20)
Slovenian: 6,9 (6,24 do 7,20)
English: • drop in the number of certain cells in the blood that help it to clot (thrombocytopenia)
Slovenian: • zmanjšanje števila določenih krvnih celic, ki sodelujejo pri strjevanju (trombocitopenija)
English: EU/1/12/814/001 1 vial (100 mg/4 ml) EU/1/12/814/002 3 vials (100 mg/4 ml) EU/1/12/814/003 1 vial (200 mg/8 ml)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/12/814/001 1 viala (100 mg/4 ml)
English: Aflibercept should not be administered to patients with severe haemorrhage (see section 4.2).
Slovenian: Aflibercepta se ne sme uporabljati pri bolnikih s hudo krvavitvijo (glejte poglavje 4.2).
English: Patients with no prior bevacizumab excluding adjuvant only (n ( %))
Slovenian: Bolniki, predhodno zdravljeni z bevacizumabom, izključujoč samo adjuvantno zdravljenje (n (%))
English: ZALTRAP must not be administered as an intravitreal injection (see section 4.3).
Slovenian: Zdravila ZALTRAP se ne sme uporabiti kot intravitrealne injekcije (glejte poglavje 4.3).
English: There have been no formal studies with ZALTRAP in patients with renal impairment.
Slovenian: Formalnih študij z zdravilom ZALTRAP pri bolnikih z okvaro ledvic niso izvedli.
English: ZALTRAP should be discontinued for (see section 4.4):
Slovenian: Zdravljenje z zdravilom ZALTRAP je treba prekiniti v primeru (glejte poglavje 4.4):
English: A limited number of patients having moderate/severe renal impairment at baseline (N = 49) were treated with ZALTRAP.
Slovenian: Z zdravilom ZALTRAP so bili zdravljeni le maloštevilni bolniki (n = 49), ki so imeli izhodiščno zmerno ali hudo okvaro ledvic.
English: ZALTRAP/FOLFIRI Treatment delay or dose modification Neutropenia or thrombocytopenia (see sections 4.4 and 4.8)
Slovenian: Odložitev zdravljenja ali prilagoditev odmerka sheme ZALTRAP/FOLFIRI Nevtropenija ali trombocitopenija (glejte poglavji 4.4 in 4.8)
English: 0.758 (0.661 to 0.869)
Slovenian: 0,758 (0,661 do 0,869)
English: One ml of concentrate for solution for infusion contains 25 mg aflibercept*.
Slovenian: En mililiter koncentrata za raztopino za infundiranje vsebuje 25 mg aflibercepta*.
English: Aflibercept should be discontinued in patients with compromised wound healing requiring medical intervention (see section 4.2).
Slovenian: Uporabo aflibercepta je treba prekiniti pri bolnikih s slabšim celjenjem ran, ki zahteva zdravniško ukrepanje (glejte poglavje 4.2).
English: • 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.
Slovenian: • 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.
English: • 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.
Slovenian: • 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.
English: • toothache
Slovenian: • zobobol
English: Hypersensitivity (1)
Slovenian: Občasni preobčutljivost (1)
English: 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).
Slovenian: 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).
English: If there is recurrence, the administration should be suspended until <2 grams/24 hours and then the dose reduced to 2 mg/kg.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Posterior reversible encephalopathy syndrome (PRES) PRES was not reported in the pivotal phase III study of MCRC patients.
Slovenian: V ključni študiji III. faze pri bolnikih mKRR niso zabeležili sindroma posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome).
English: Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Slovenian: Hude preobčutljivostne reakcije (vključno z bronhospazmom, dispnejo, angioedemom in anafilaksijo) (glejte poglavji 4.3 in 4.4)
English: 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.
Slovenian: 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.
English: • swelling and numbness of the hands and feet that happens with chemotherapy (called
Slovenian: • oteklost in omrtvičenost dlani in stopal, ki se pojavi pri kemoterapiji (to imenujemo "sindrom palmarno-plantarne eritrodizestezije")
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Pljučna embolija se je pojavila pri 4,6 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 3,5 % prejemnikov sheme placebo/FOLFIRI.
English: Signs of infection may include fever, chills, cough, burning on passing water or muscle ache.
Slovenian: Med znaki okužbe so lahko zvišana telesna temperatura, mrzlica, kašelj, pekoč občutek pri uriniranju ali boleče mišice.
English: One ml of concentrate contains 25 mg aflibercept.
Slovenian: En mililiter koncentrata vsebuje 25 mg aflibercepta.
English: Signs may include stomach pain, being sick (vomiting), fever or chills.
Slovenian: Med znaki so lahko bolečine v trebuhu, slabost (bruhanje), zvišana telesna temperatura ali mrzlica.
English: Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Water for injections
Slovenian: 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
English: Severe proteinuria, nephrotic syndrome, and thrombotic microangiopathy (TMA) have been observed in patients treated with aflibercept (see section 4.8).
Slovenian: Med zdravljenjem z afliberceptom so zabeležili primere hude proteinurije, nefrotskega sindroma in trombotične mikroangiopatije (TMA) (glejte poglavje 4.8).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Potential for compromised wound healing (wound dehiscence, anastomotic leakage) has been reported with aflibercept (see section 4.8).
Slovenian: Z afliberceptom je bila opisana možnost slabšega celjenja ran (dehiscenca rane, anastomotično iztekanje) (glejte poglavje 4.8).
English: In other studies, severe intracranial haemorrhage and pulmonary haemorrhage/haemoptysis including fatal events have occurred in patients receiving ZALTRAP (see section 4.4).
Slovenian: 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).
English: Severe diarrhoea
Slovenian: • hude krvavitve
English: Neutropenic infection/sepsis (1) Urinary tract infection Nasopharyngitis
Slovenian: Pogosti nevtropenična okužba/sepsa (1) okužba sečil nazofaringitis nevtropenična okužba/sepsa (1)