FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Dogodki 3. do 4. stopnje so se pojavili pri 11 (1,8 %) prejemnikih sheme ZALTRAP/FOLFIRI in 3 (0,5 %) prejemnikih sheme placebo/FOLFIRI.
English: 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.
Slovenian: 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.
English: There was no observed impact on the pharmacokinetic profile of aflibercept in patients who were positive in the immunogenicity assays.
Slovenian: Pri bolnikih s pozitivnimi preskusi imunogenosti niso ugotovili vpliva na farmakokinetične značilnosti aflibercepta.
English: • Fistula formation
Slovenian: • nastanka fistule
English: If any discolouration or particulate matter is observed, the reconstituted solution should be discarded.
Slovenian: Če opazite obarvanje ali delce, morate pripravljeno raztopino zavreči.
English: Aflibercept administration should be suspended for ≥ 2 grams of proteinuria/24 hours and restarted when proteinuria is <2 grams/24 hours.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 75 x 10
Slovenian: 75008 Paris
English: A side effect called osteonecrosis (bone damage in the jaw) has been reported in cancer patients treated with ZALTRAP.
Slovenian: Pri bolnikih z rakom, zdravljenih z zdravilom ZALTRAP, so poročali o neželenem učinku, imenovanem osteonekroza čeljustnic (poškodba kosti v čeljusti).
English: GI perforation (1)
Slovenian: Občasni perforacija prebavil (1)
English: There have been no formal studies with ZALTRAP in patients with hepatic impairment.
Slovenian: Formalnih študij z zdravilom ZALTRAP pri bolnikih z okvaro jeter niso izvedli.
English: • ZALTRAP is a single-use vial.
Slovenian: • Zdravilo ZALTRAP je viala za enkratno uporabo.
English: Dehydration (all grades) has been observed in 9.0 % of patients treated with ZALTRAP/FOLFIRI and 3.0 % of patients treated with placebo/FOLFIRI.
Slovenian: Dehidracija (vseh stopenj) se je pojavila pri 9,0 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 3,0 % prejemnikov sheme placebo/FOLFIRI.
English: 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).
Slovenian: 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).
English: Administration of ZALTRAP/FOLFIRI should be delayed until neutrophil count is 1.5 x 10
Slovenian: Uporabo sheme ZALTRAP/FOLFIRI je treba odložiti, dokler ni število nevtrofilcev  1,5 x 109/l ali število trombocitov  75 x 109/l.
English: 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.
Slovenian: 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.
English: 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 %
Slovenian: 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.
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: If you experience changes in your vision or confusion, your doctor may stop your treatment with ZALTRAP.
Slovenian: • če ste imeli napade krčev (epileptične napade), ali če ste zmedeni ali imate motnje vida bo zdravnik morda prekinil vaše zdravljenje z zdravilom ZALTRAP.
English: Respiratory, thoracic and mediastinal disorders Very common
Slovenian: Neznani anevrizme in disekcije arterij Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti dispneja epistaksa disfonija
English: ZALTRAP 25 mg / ml sterile concentrate aflibercept
Slovenian: ZALTRAP 25 mg/ml koncentrat za raztopino za infundiranje aflibercept
English: 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.
Slovenian: Nefrotski sindrom se je pojavil pri 2 (0,5 %) prejemnikih sheme ZALTRAP/FOLFIRI, med prejemniki sheme placebo/FOLFIRI pa se ni pojavil.
English: One patient treated with the ZALTRAP/FOLFIRI regimen presenting with proteinuria and hypertension was diagnosed with thrombotic microangiopathy (TMA).
Slovenian: Pri bolnikih, zdravljenih s shemo ZALTRAP/FOLFIRI, je bila opisana trombocitopenija.
English: Grade 3-4 ATE occurred in 1.7 % of patients treated with ZALTRAP and 1.0 % of patients treated with placebo (see section
Slovenian: ATE 3. do 4. stopnje so se pojavile pri 1,7 % prejemnikov zdravila ZALTRAP in pri 1,0 % prejemnikov placeba (glejte poglavje
English: 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.
Slovenian: VTE 3. do 4. stopnje so se pojavili pri 7,9 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 6,3 % prejemnikov sheme placebo/FOLFIRI.
English: Patients with no prior bevacizumab (n (%)) Median OS (95 % CI) (months)
Slovenian: Bolniki, ki predhodno niso bili zdravljeni z bevacizumabom (n (%)) Mediano preživetje brez napredovanja (95 % IZ) (meseci)
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
English: 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.
Slovenian: 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.
English: Fistula formation
Slovenian: Nastanek fistule
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: No metabolism studies have been conducted with aflibercept since it is a protein.
Slovenian: Ker je aflibercept beljakovina, z njim niso izvedli študij presnove.
English: 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.
Slovenian: 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.
English: GI perforation including fatal GI perforation has been reported in patients treated with ZALTRAP.
Slovenian: Pri prejemnikih zdravila ZALTRAP so bile opisane perforacije prebavil, vključno s smrtnim izidom.
English: Arterial thromboembolism (1) Venous thromboembolism (1)
Slovenian: Pogosti arterijska trombembolija (1) venska trombembolija (1)
English: What ZALTRAP contains
Slovenian: Kaj vsebuje zdravilo ZALTRAP
English: 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
Slovenian: 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
English: Arterial thromboembolism (1) Venous thromboembolism (1) Haemorrhage (1)
Slovenian: arterijska trombembolija (1) venska trombembolija (1) krvavitev (1)
English: Talk to your doctor before being given this medicine if you are breast-feeding.
Slovenian: Če dojite, se posvetujte s svojim zdravnikom, preden dobite to zdravilo.
English: 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).
Slovenian: 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).
English: Infections and infestations Very common
Slovenian: Infekcijske in parazitske bolezni Zelo pogosti okužba (1)
English: 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.
Slovenian: Proteinurija 3. do 4. stopnje se je pojavila pri 7,9 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 1,2 % prejemnikov sheme placebo/FOLFIRI.
English: Discontinue ZALTRAP in patients who experience cardiac failure and ejection fraction decreased.
Slovenian: Pri bolnikih, zdravljenih z zdravilom ZALTRAP, so poročali o srčnem popuščanju in zmanjšanem iztisnem deležu.
English: Hazard ratio (95 % CI)
Slovenian: Razmerje ogroženosti (95 % IZ)
English: 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).
Slovenian: 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).
English: One 8 ml vial of concentrate contains 200 mg aflibercept.
Slovenian: Ena viala z 8 ml koncentrata vsebuje 200 mg aflibercepta.
English: An increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events has been reported in patients treated with aflibercept (see section 4.8).
Slovenian: 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).
English: 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
Slovenian: 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.
English: One 4 ml vial of concentrate contains 100 mg aflibercept.
Slovenian: Ena viala s 4 ml koncentrata vsebuje 100 mg aflibercepta.
English: Mild to moderate hypersensitivity reactions to ZALTRAP (including flushing, rash, urticaria, and pruritus) (see section 4.4)
Slovenian: Blage do zmerne preobčutljivostne reakcije na zdravilo ZALTRAP (vključno z zardevanjem, izpuščajem, urtikarijo in srbenjem) (glejte poglavje 4.4)
English: 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.
Slovenian: Drisko 3. do 4. stopnje so zabeležili pri 19,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 7,8 % prejemnikov sheme placebo/FOLFIRI.
English: GI perforation including fatal GI perforation has been reported in patients treated with aflibercept (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z afliberceptom, so bile opisane perforacije prebavil, vključno s smrtnim izidom (glejte poglavje 4.8).
English: 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.
Slovenian: 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.
English: Cardiac failure and ejection fraction decreased have been reported in patients treated with ZALTRAP.
Slovenian: Bolnikom, ki doživijo srčno popuščanje in zmanjšan iztisni delež, prekinite zdravljenje z zdravilom ZALTRAP.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Enoodmerna viala
English: 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.
Slovenian: Pri prejemnikih sheme ZALTRAP/FOLFIRI so zabeležili večje tveganje za hipertenzijo 3. do 4. stopnje (vključno s hipertenzijo in enim primerom esencialne hipertenzije.
English: 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).
Slovenian: Med zdravljenjem s shemo ZALTRAP/FOLFIRI so opažali večjo incidenco nevtropeničnih zapletov (febrilne nevtropenije in nevtropeničnih okužb) (glejte poglavje 4.8).
English: Aflibercept administration resulted in a delay in wound healing in rabbits.
Slovenian: Uporaba aflibercepta je pri kuncih upočasnila celjenje ran.
English: Stratified on ECOG performance status (0 versus 1 versus 2) and prior bevacizumab (yes versus no).
Slovenian: 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).
English: 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.
Slovenian: Nevtropenija 3. do 4. stopnje se je pojavila pri 36,7 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 29,5 % prejemnikov sheme placebo/FOLFIRI.
English: Fistula formation involving GI and non-GI sites has occurred in patients treated with aflibercept (see section 4.8).
Slovenian: Bolnikom, zdravljenim z afliberceptom, so se pojavile fistule na gastrointestinalnih in negastrointestinalnih mestih (glejte poglavje 4.8).
English: Oropharyngeal pain Rhinorrhoea
Slovenian: Pogosti orofaringealna bolečina rinoreja
English: 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.
Slovenian: 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.
English: Hypertension (1) Haemorrhage (1)
Slovenian: Žilne bolezni Zelo pogosti hipertenzija (1) krvavitev (1)
English: ZALTRAP 25 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA ZALTRAP 25 mg/ml koncentrat za raztopino za infundiranje
English: Median overall survival (95 % CI) (months)
Slovenian: Mediano celokupno preživetje (95 % IZ)
English: Batch
Slovenian: PFSb
English: One vial of 4 ml contains 100 mg of aflibercept (25 mg / ml).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 4 ml viala vsebuje 100 mg aflibercepta (25mg/ml).
English: VTE including deep vein thrombosis (DVT) and pulmonary embolism (infrequently fatal) have been reported in patients treated with aflibercept (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali aflibercept, so zabeležili venske trombembolične dogodke (VTE - venous thromboembolic events), vključno z globoko vensko trombozo (GVT) in pljučno embolijo (v redkih primerih s smrtnim izidom) (glejte poglavje 4.8).
English: Compromised wound healing (1)
Slovenian: slabše celjenje ran (1)
English: Urinary tract infection
Slovenian: Sindrom posteriorne reverzibilne encefalopatije
English: ZALTRAP should be suspended when proteinuria ≥2 grams per 24 hours and resumed when proteinuria < 2 grams per 24 hours.
Slovenian: Zdravljenje z zdravilom ZALTRAP je treba prekiniti, če ima bolnik proteinurijo ≥ 2 grama na 24 ur, in ga znova uvesti, ko se proteinurija zmanjša na < 2 g na 24 ur.
English: Administration of the ZALTRAP/FOLFIRI should be delayed until platelet count is 75 x 10
Slovenian: Uporabo kombinacije ZALTRAP/FOLFIRI je treba odložiti, dokler ni število trombocitov  75 x 109/l (glejte poglavje 4.2).
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of GI perforation (all grades) was 0.8 % for patients treated with ZALTRAP and 0.3 % for patients treated with placebo.
Slovenian: V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca perforacij prebavil (vseh stopenj) 0,8 % med prejemniki zdravila ZALTRAP in 0,3 % med prejemniki placeba.
English: Palmar-Plantar Erythrodysaesthesia syndrome
Slovenian: Pogosti hiperpigmentiranost kože sindrom palmarno-plantarne eritrodizestezije
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with ZALTRAP or after stopping treatment.
Slovenian: Svojemu zdravniku ali medicinski sestri morate nemudoma povedati, če imate med infundiranjem zdravila ZALTRAP ali kmalu po njem katerega od teh znakov.
English: Gastrointestinal perforation
Slovenian: • perforacije prebavil
English: Leucopenia (2) Neutropenia (1),(2) Thrombocytopenia (2)
Slovenian: Bolezni krvi in limfatičnega sistema Zelo pogosti levkopenija (2) nevtropenija (1) trombocitopenija (2)
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of VTE (all grades) was 7.1 % for patients treated with ZALTRAP and 7.1 % for patients treated with placebo.
Slovenian: V vseh treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca VTE (vseh stopenj) 7,1 % med prejemniki zdravila ZALTRAP in 7,1 % med prejemniki placeba.
English: Aflibercept treatment should be discontinued in patients who develop nephrotic syndrome or TMA (see section 4.2).
Slovenian: Pri bolnikih, ki se jim pojavi nefrotski sindrom ali TMA, je treba zdravljenje z afliberceptom prekiniti (glejte poglavje 4.2).
English: Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles.
Slovenian: V naslednjih ciklusih velja razmisliti o predhodni uporabi kortikosteroidov in/ali antihistaminikov.
English: Hepatic impairment
Slovenian: Pogosti glavobol
English: Patients with prior bevacizumab (n (%))
Slovenian: OS Bolniki, predhodno zdravljeni z bevacizumabom (n
English: 11.7 (9.96 to 13.77) 12.5 (10.78 to 15.47)
Slovenian: Mediano celokupno preživetje (95 % IZ) (meseci) 11,7 (9,96 do 13,77) 12,5 (10,78 do 15,47) Razmerje ogroženosti (95 % IZ)
English: Table 3 - OS and PFS by prior bevacizumab exposure a
Slovenian: Preglednica 3 - Celokupno preživetje in preživetje brez napredovanja glede na predhodno izpostavljenost bevacizumabua - Populacija ZNZ
English: What ZALTRAP is and what it is used for What you need to know before you are given ZALTRAP How ZALTRAP is given
Slovenian: Kaj je zdravilo ZALTRAP in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo ZALTRAP Kako uporabljati zdravilo ZALTRAP Možni neželeni učinki
English: Musculoskeletal and connective tissue disorders Uncommon
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni osteonekroza čeljustnic (ONČ)
English: Metabolism and nutrition disorders Very common
Slovenian: Presnovne in prehranske motnje Zelo pogosti zmanjšanje apetita hujšanje
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of ATE (all grades) was 2.3 % for patients treated with ZALTRAP and 1.7 % for patients treated with placebo.
Slovenian: V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca ATE (vseh stopenj) med prejemniki zdravila ZALTRAP 2,3 % in med prejemniki placeba 1,7 %.
English: Haemorrhage
Slovenian: • hujšanje
English: • 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I), sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Slovenian: • 8 ml koncentrata v 10-ml viali iz prozornega borosilikatnega stekla (tipa I), zaprti s prirobljenim zamaškom s snemno zaporko in vstavljeno prevlečeno tesnilno ploščico.