natgillin/translations-raw huggingface dataset:
Chemotherapy must not be administered earlier than 1 hour after the end of the cetuximab infusion.
Kemoterapije bolnik ne sme prejeti prej kot 1 uro po koncu infuzije cetuksimaba.
Medium to high-potency topical corticosteroids or oral tetracyclines have been used for the treatment of skin reactions.
Za zdravljenje kožnih reakcij so uporabili srednje do zelo močne topikalne kortikosteroide ali peroralne tetracikline.
All of these pathways involve the biodegradation of the antibody to smaller molecules, i.e. small peptides or amino acids.
V vseh teh poteh pride do biološke razgradnje protiteles na manjše molekule, t.j.
Side effects concerning the lungs
Neželeni učinki, povezani s pljuči
Cetuximab also targets cytotoxic immune effector cells towards EGFRexpressing tumour cells (antibody dependent cell-mediated cytotoxicity, ADCC).
Cetuksimab tudi usmeri citotoksične imunske efektorske celice proti tumorskim celicam z ekspresijo EGFR (od protiteles odvisna celično posredovana citotoksičnost, POCC).
Erbitux 5 mg/mL is compatible
Zdravilo Erbitux 5 mg/ml je združljivo
QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for infusion contains 5 mg cetuximab.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine za infundiranje vsebuje 5 mg cetuksimaba.
Overall, measurable HACA titres were noted in 3.4% of the patients studied, with incidences ranging from 0% to 9.6% in the target indication studies.
Pri skupaj 3,4 % bolnikov, vključenih v študije, so opažali merljive titre HAHP - incidenca je bila od 0% do 9,6% v študijah ciljanih indikacij, vendar dokončnih podatkov o nevtralizaciji cetuksimaba s protitelesi HAHP še ni.
• The other ingredients are sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide and water for injections.
• Druge sestavine zdravila so natrijev klorid, glicin, polisorbat 80, citronska kislina monohidrat, natrijev hidroksid in voda za injekcije.
Sufficient data from pregnant or lactating women are not available.
Ni zadostnih podatkov o uporabi cetuksimaba pri nosečnicah ali doječih materah.
Frequency not known (cannot be estimated from the available data) An asterisk (*) indicates that additional information on the respective undesirable effect is provided below the table.
Zvezdica (*) označuje, da so dodatne informacije o zadevnem neželenem učinku podane pod spodnjo preglednico.
• with polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets,
• s polietilenskimi (PE), poliuretanskimi (PUR), etilvinilacetatnimi (EVA), poliolefinskimi termoplastičnimi (TP) ali polivinilkloridnimi (PVC) infuzijskimi sistemi,
No new safety signals were identified in paediatric patients as reported from a phase-I study.
V študiji faze I niso poročali o novih signalih glede varnosti pri pediatričnih bolnikih.
Erbitux contains cetuximab, a monoclonal antibody.
Zdravilo Erbitux vsebuje cetuksimab, monoklonsko protitelo.
If you receive Erbitux in combination with other anticancer medicines, including fluoropyrimidines, it may be more likely that you experience heart problems which may be life-threatening.
Če prejmete zdravilo Erbitux v kombinaciji z drugimi zdravili proti raku, vključno s fluoropirimidini, je morda večja verjetnost za težave s srcem, ki lahko tudi ogrožajo vaše življenje.
Sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, water for injections
Natrijev klorid, glicin, polisorbat 80, citronska kislina monohidrat, natrijev hidroksid, voda za injekcije
• For administration with infusion pump or gravity drip (diluted with sterile sodium chloride 9 mg/mL (0.9%) solution): Take an infusion bag of adequate size of sterile sodium chloride 9 mg/mL (0.9%) solution.
• Za uporabo z infuzijsko črpalko ali s težnostno kapalno infuzijo (razredčeno s sterilno raztopino natrijevega klorida 9 mg/ml (0,9%)): Vzemite vrečko za infundiranje primerne velikosti s sterilno raztopino natrijevega klorida 9 mg/ml (0,9%).
Chemical and physical in-use stability of Erbitux 5 mg/mL has been demonstrated for 48 hours at 25ºC, if the solution is prepared as described in section 6.6.
Med uporabo je zdravilo Erbitux 5 mg/ml kemično in fizikalno stabilno do 48 ur pri temperaturi 25 °C, če je raztopina pripravljena, kot je opisano v poglavju 6.6.
• with polyethylene (PE), ethyl vinyl acetate (EVA) or polyvinyl chloride (PVC) bags,
• s polietilenskimi (PE), etilvinilacetatnimi (EVA) ali polivinilkloridnimi (PVC) vrečkami,
Cetuximab pharmacokinetics were studied when cetuximab was administered as monotherapy or in combination with concomitant chemotherapy or radiation therapy in clinical studies.
Farmakokinetiko cetuksimaba so v kliničnih študijah raziskovali pri uporabi cetuksimaba v monoterapiji ali v kombinirani terapiji s sočasno kemoterapijo ali radioterapijo.
There are no data on the effect of cetuximab on human fertility.
Podatkov o učinku cetuksimaba na plodnost pri ljudeh ni.
Side effects concerning the skin
Neželeni učinki, povezani s kožo
In these patients, Erbitux is used in combination with radiation therapy or with other anticancer medicines.
Pri teh bolnikih se zdravilo Erbitux uporablja v kombinaciji z obsevanjem ali z drugimi zdravili proti raku.
FIRE-3, an investigator-sponsored clinical phase-III study, compared the treatment of FOLFIRI in combination with either cetuximab or bevacizumab in the first-line treatment of patients with KRAS exon 2 wild-type mCRC.
V klinični študiji 3. faze, FIRE-3, ki jo je sponzoriral raziskovalec, so primerjali zdravljenje s FOLFIRI v kombinaciji z bodisi cetuksimabom ali bevacizumabom kot primarno zdravljenje bolnikov z mCRC z nemutiranim tipom KRAS (eksona 2).
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced.
Če zdravilo Erbitux prejemate v kombinaciji z zdravili proti raku, ki vsebujejo platino, obstaja večja verjetnost, da se bo število belih krvničk zmanjšalo.
Radiation therapy alone
Radioterapija v monoterapiji
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)expressing, RAS wild-type metastatic colorectal cancer
Zdravilo Erbitux je indicirano za zdravljenje bolnikov z metastatskim kolorektalnim rakom z ekspresijo receptorjev za epidermalni rastni faktor (EGFR, epidermal growth factor receptor) in nemutiranim tipom RAS
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA intravenska uporaba
If you receive Erbitux in combination with other anticancer medicines, some of the side effects you may experience can also be related to the combination or the other medicines.
Če zdravilo Erbitux prejemate v kombinaciji z drugimi zdravili proti raku, so lahko nekateri neželeni učinki, ki jih boste morda imeli, povezani tudi s to kombinacijo ali z drugimi zdravili.
KRAS mutant population
Populacija z mutiranim tipom KRAS
Locoregional control months, median (95% CI) Hazard Ratio (95% CI) p-value OS months, median (95% CI) Hazard Ratio (95% CI) p-value median follow-up, months 1-year OS rate, % (95% CI) 2-year OS rate, % (95% CI) 3-year OS rate, % (95% CI) 5-year OS rate, % (95% CI) CI = confidence interval, OS = overall survival time, a '+' denotes that the upper bound limit had not been reached at cut-off
Lokalni in regionalni nadzor meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p OS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p spremljanje mediane, meseci 1-letna stopnja OS, % (95-odstotni IZ) 2-letna stopnja OS, % (95-odstotni IZ) 3-letna stopnja OS, % (95-odstotni IZ) 5-letna stopnja OS, % (95-odstotni IZ) IZ = interval zaupanja; OS (overall survival) = celokupno preživetje, '+' pomeni, da ob prekinitvi ni bila dosežena zgornja meja
FIRE-3 (First-line combination of cetuximab with FOLFIRI): The FIRE-3 study was a multicentre randomised phase-III study investigating head-to-head 5-FU, folinic acid and irinotecan (FOLFIRI) combined with either cetuximab or bevacizumab in patients with KRAS exon 2 wild-type metastatic colorectal cancer (mCRC).
FIRE-3 (Primarno zdravljenje s kombinacijo cetuksimaba in FOLFIRI): Preskušanje FIRE-3 je bila multicentrična, randomizirana študija 3. faze, v kateri so raziskovali neposredno primerjavo med 5-FU, folinsko kislino in irinotekanom (FOLFIRI) v kombinaciji z bodisi cetuksimabom ali bevacizumabom pri bolnikih z metastatskim kolorektalnim rakom (mCRC, metastatic colorectal cancer) z nemutiranim tipom KRAS (eksona 2).
Care must be taken to ensure aseptic handling when preparing the infusion.
Pri pripravi infuzije morate zagotoviti aseptične pogoje dela.
• EMR 62 202-006: This randomised study compared the combination of cetuximab and radiation therapy (211 patients) with radiation therapy alone (213 patients) in patients with locally advanced squamous cell cancer of the head and neck.
• EMR 62 202-006: V tej randomizirani študiji so primerjali kombinacijo cetuksimaba in radioterapije (211 bolnikov) z radioterapijo v monoterapiji (213 bolnikov) pri bolnikih z lokalno napredovalim rakom skvamoznih celic glave in vratu.
• irritation and redness of the eye
• draženje in rdečica oči
• blood clots in the lungs
• krvni strdki v pljučih
Handling instructions
Navodila za pripravo
Please read 'Infusion-related side effects' in section 4 for details, as they may have serious consequences for you, including life-threatening conditions.
O neželenih učinkih, povezanih z infundiranjem, si preberite v poglavju 4, saj imajo lahko resne posledice, vključno s smrtno nevarnimi stanji.
Colorectal cancer patients with RAS mutated tumours Cetuximab should not be used in the treatment of colorectal cancer patients whose tumours have RAS mutations or for whom RAS tumour status is unknown.
Cetuksimaba ne uporabljajte za zdravljenje bolnikov s kolorektalnim rakom, če imajo tumorje z mutacijo RAS ali pri katerih je tumorski status RAS neznan.
The main side effects of Erbitux are infusion-related side effects and side effects concerning the skin: Infusion-related side effects
Glavni neželeni učinki zdravila Erbitux so neželeni učinki, povezani z infundiranjem, in neželeni učinki, povezani s kožnimi reakcijami:
All subsequent weekly doses are 250 mg cetuximab per m2 each.
Vsi naslednji tedenski odmerki so vsak po 250 mg cetuksimaba na m².
However, in this study no positive effects on PFS or OS were demonstrated in patients with KRAS wild-type tumours, either.
Tudi v tej študiji niso pri bolnikih s tumorji z nemutiranim tipom KRAS dokazali pozitivnih učinkov na PFS ali OS.
Erbitux may cause side effects concerning the eyes.
Zdravilo Erbitux lahko povzroči neželene učinke, povezane z očmi.
Hypomagnesaemia is reversible following discontinuation of cetuximab.
Hipomagneziemija je po prekinitvi zdravljenja s cetuksimabom reverzibilna.
1 vial of 500 mg/100 mL
1 viala s 500 mg/100 ml
An increased frequency of severe and sometimes fatal cardiovascular events and treatment emergent deaths has been observed in the treatment of non-small cell lung cancer, squamous cell carcinoma of the head and neck and colorectal carcinoma.
Pri zdravljenju ne-drobnoceličnega pljučnega raka, raka skvamoznih celic glave in vratu in kolorektalnega raka so opazili višjo pogostnost hudih in včasih smrtnih kardiovaskularnih dogodkov in nepričakovanih smrti med zdravljenjem.
Patients with a good prognosis as indicated by tumour stage, Karnofsky performance status (KPS) and age had a more pronounced benefit, when cetuximab was added to platinum-based chemotherapy.
Bolniki z dobro prognozo, prikazano s stopnjo tumorja, Karnofskyjevim indeksom zmogljivosti (KPS, Karnofsky performance status) in starostjo, so imeli bolj poudarjeno korist, če je bil cetuksimab dodan kemoterapiji na osnovi platine.
No other formal interaction studies with cetuximab have been performed in humans.
Pri človeku niso bile opravljene nobene druge formalne študije o medsebojnem delovanju cetuksimaba z drugimi zdravili.
In patients with metastatic colorectal cancer, cetuximab is used in combination with chemotherapy or as a single agent (see section 5.1).
Pri bolnikih z metastatskim rakom debelega črevesa in danke se cetuksimab uporablja v kombinaciji s kemoterapijo ali kot samostojno zdravilo (glejte poglavje 5.1).
Repeat this procedure until the calculated volume has been reached.
Ponavljajte ta postopek, dokler ne dosežete izračunanega volumna.
How to use Erbitux
Kako uporabljati zdravilo Erbitux
Uncommon side effects (may affect up to 1 in 100 people)
Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 bolnikov)
Use a gravity drip or an infusion pump for administration.
Za infundiranje uporabite težnostno kapalno infuzijo ali infuzijsko črpalko.
Each vial of 100 mL contains 500 mg cetuximab (5 mg/mL).
Ena viala s 100 ml vsebuje 500 mg cetuksimaba (5 mg/ml).
If you receive Erbitux in combination with an anticancer medicine containing fluoropyrimidines, it is more likely that you experience the following side effects of this other medicine:
Če zdravilo Erbitux prejemate v kombinaciji z zdravilom proti raku, ki vsebuje fluoropirimidin, je verjetneje, da boste imeli naslednje neželene učinke, povezane z drugim zdravilom:
Connect the infusion line to the syringe, set and control the rate as explained in section 4.2 and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution.
Priključite infuzijsko linijo na brizgo, nastavite in nadzirajte hitrost infuzije, kot je opisano v poglavju 4.2, in po polnjenju linije začnite z infundiranjem zdravila Erbitux ali sterilne raztopine natrijev klorid
Patients with a good prognosis as indicated by tumour stage, Karnofsky performance status (KPS) and age had a more pronounced benefit, when cetuximab was added to radiation therapy.
Bolniki z dobro prognozo, prikazano s stopnjo tumorja, Karnofskyjevim indeksom zmogljivosti (KPS, Karnofsky performance status) in starostjo, so imeli bolj poudarjeno korist, če je bil cetuksimab dodan radioterapiji.
Remove an adequate volume of the sodium chloride solution from the infusion bag, using an appropriate sterile syringe with a suitable needle.
Z ustrezno sterilno brizgo, na kateri je primerna igla, iz vrečke z raztopino natrijevega klorida odvzemite ustrezen volumen.
In contrast to progression free survival time, no benefit in overall survival time could be demonstrated in patients with KPS ≤ 80 who were 65 years of age or older.
V primerjavi s preživetjem brez napredovanja bolezni pri bolnikih, ki so imeli KPS ≤ 80 in so bili stari 65 let ali več, ni bilo mogoče pokazati koristi pri celokupnem preživetju.
Tumour samples from approximately 81% of patients were analysed retrospectively for KRAS expression, of which 55% were KRAS wild-type.
Retrospektivno so za ekspresijo gena KRAS analizirali vzorce tumorja približno 81 % bolnikov, pri čemer je bilo 55 % z nemutiranim tipom KRAS.
• CA225025: This randomised study in patients with metastatic colorectal cancer who had received prior oxaliplatin-, irinotecan- and fluoropyrimidine-based treatment for metastatic disease compared the addition of cetuximab as a single agent to best supportive care (BSC) (287 patients) with best supportive care (285 patients).
• CA225025: v tej randomizirani študiji so pri bolnikih z metastatskim kolorektalnim rakom, ki so predhodno prejemali zdravljenje na osnovi oksaliplatina, iritonekana in fluoropirimidina, primerjali dodajanje cetuksimaba kot samostojnega zdravila k najboljši podporni oskrbi (NPO) (287 bolnikov) z najboljšo podporno oskrbo (285 bolnikov).
Cetuximab blocks binding of endogenous EGFR ligands resulting in inhibition of the function of the receptor.
Tako zavira vezavo endogenih ligandov na EGFR in povzroči zavoro delovanja receptorja.
• platelet count < 100000/mm³
• število trombocitov < 100.000/mm³
Cetuximab plus FOLFOX4
FOLFOX4 Cetuksimab in FOLFOX4
Symptoms may include bronchospasm, urticaria, increase or decrease in blood pressure, loss of consciousness or shock.
Simptomi lahko vključujejo bronhospazem, urtikarijo, zvišanje ali znižanje krvnega tlaka, izgubo zavesti ali šok; v redkih primerih so opazili angino pectoris, miokardni infarkt ali asistolijo.
• COIN: This was an open-label, 3-arm, randomised study in 2445 patients with inoperable metastatic or locoregional colorectal cancer who had not received prior treatment for metastatic disease and compared oxaliplatin plus fluoropyrimidines (infusional 5-fluorouracil/folinic acid [OxMdG] or capecitabine [XELOX]) in combination with cetuximab to the same chemotherapy regimen alone.
• COIN: To je bila odprta randomizirana študija s 3 skupinami pri 2.445 bolnikih z neoperabilnim metastatskim ali lokalnim in regionalnim kolorektalnim rakom, ki se pred tem niso zdravili za metastatsko boleznijo, in v kateri so primerjali oksaliplatin plus fluoropirimidin (infundirani 5-fluorouracil/folinsko kislino [OxMdG] ali kapecitabin [XELOX]) v kombinaciji s cetuksimabom ter zdravljenje samo s kemoterapijo.
Erbitux may cause infusion-related side effects.
Zdravilo Erbitux lahko povzroči neželene učinke, povezane z infundiranjem.
Erbitux may be administered via a gravity drip, an infusion pump or a syringe pump.
Zdravilo Erbitux lahko bolniku dajete s težnostno kapalno infuzijo ali z uporabo infuzijske črpalke ali črpalke za brizgo.
Severe infusion-related side effects include:
Hudi neželeni učinki, povezani z infundiranjem, so:
CI = confidence interval, OxMdG = oxaliplatin plus infusional 5-FU/FA, OS = overall survival time, PFS = progression-free survival time
IZ = interval zaupanja, OxMdG = oksaliplatin in infundirani 5-FU/FA, OS (overall survival) = celokupno preživetje, PFS (progression-free survival time) = čas preživetja brez napredovanja bolezni
OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR % (95% CI) p-value CI = confidence interval, CTX = platinum-based chemotherapy, ORR = objective response rate, OS = overall survival time, PFS = progression-free survival time
OS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p PFS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p ORR % (95-odstotni IZ) vrednost p IZ = interval zaupanja; KOP = kemoterapija na osnovi platine; ORR (objective response rate) = objektivna stopnja odgovora; OS (overall survival) = celokupno preživetje, PFS (progression-free survival time) = čas preživetja brez napredovanja bolezni
No non-clinical data on the effect of cetuximab on wound healing are available to date.
Doslej ni na voljo predkliničnih podatkov o učinku cetuksimaba na celjenje ran.
Mucositis may lead to epistaxis.
Mukozitis lahko povzroči epistakso.
A separate infusion line must be used for the infusion, and the line must be flushed with sterile sodium chloride 9 mg/mL (0.9%) solution for injection at the end of infusion.
Linijo morate ob koncu infundiranja sprati s sterilno raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje.
PHARMACEUTICAL FORM Solution for infusion.
FARMACEVTSKA OBLIKA raztopina za infundiranje brezbarvna raztopina
Erbitux 5 mg/mL solution for infusion Cetuximab
Erbitux 5 mg/ml raztopina za infundiranje cetuksimab
Tumour samples from approximately 81% of patients were analysed retrospectively for KRAS expression.
Retrospektivno so za ekspresijo gena KRAS analizirali vzorce tumorja približno 81 % bolnikov.
KRAS wild-type population
Populacija z nemutiranim tipom KRAS
Connect the infusion line and prime it with the diluted Erbitux before starting the infusion.
Preden začnete z dajanjem infuzije, priključite infuzijsko linijo in jo napolnite z razredčenim zdravilom Erbitux.
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 63%.
Delež bolnikov s tumorji z nemutiranim tipom KRAS v populaciji bolnikov, ki so jim lahko ocenili status KRAS, je bil 63-odstoten.
Erbitux is usually infused into a vein (given as a drip) once a week.
Zdravilo Erbitux se navadno infundira (vkapava) v veno enkrat na teden.
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 57%.
Delež bolnikov s tumorji z nemutiranim tipom KRAS pri populaciji bolnikov, ki so jim lahko ocenili status KRAS, je bil 57-odstoten.
Erbitux may cause side effects concerning the skin.
Zdravilo Erbitux lahko povzroči neželene učinke, povezane z vašo kožo.
There is limited experience in the use of cetuximab in combination with radiation therapy in colorectal cancer.
Izkušnje z uporabo cetuksimaba skupaj z radioterapijo pri raku debelega črevesa in danke so omejene.
Common ( 1/100 to < 1/10)
Pogosti (≥ 1/100 do < 1/10)
Before starting treatment for metastatic cancer of the large intestine your doctor will test your cancer cells if they contain the normal (wild-type) or mutant form of RAS. You must not receive Erbitux in combination with other anticancer treatment containing oxaliplatin if your cancer cells contain the mutant form of RAS.
Pred začetkom zdravljenja metastatskega raka debelega črevesa bo zdravnik testiral vaše rakave celice, ali vsebujejo običajni (nemutirani) ali mutirani tip RAS.
Evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with Erbitux.
Pred začetkom zdravljenja z zdravilom Erbitux mora biti potrjeno, da gre za status nemutiranega tipa RAS (genov KRAS in NRAS).
Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion.
Med samo infuzijo in še najmanj 1 uro po zaključku infuzije je potrebno skrbno nadzorovanje bolnika.
Uncommon ( 1/1,000 to < 1/100)
Občasni (≥ 1/1.000 do < 1/100)
The KRAS exon 2 status was recognised as predictive factor for the treatment with cetuximab in 4 of the randomised controlled studies (EMR 62 202-013, EMR 62 202-047, CA225006, and CA225025).
Od teh so v štirih randomiziranih nadzorovanih študijah (EMR 62 202-013, EMR 62 202-047, CA225006 in CA225025) ugotovili, da je status gena KRAS (eksona 2) napovedni dejavnik za zdravljenje s cetuksimabom.
• EMR 62 202-002: This randomised study in patients with recurrent and/or metastatic squamous cell cancer of the head and neck who had not received prior chemotherapy for this disease compared the combination of cetuximab and cisplatin or carboplatin plus infusional 5-fluorouracil (222 patients) to the same chemotherapy alone (220 patients).
• EMR 62 202-002: V tej randomizirani študiji na bolnikih s ponavljajočim in/ali metastatskim rakom skvamoznih celic glave in vratu, ki pred tem niso prejemali kemoterapije za to bolezen, so primerjali kombinacijo cetuksimaba in cisplatina ali karboplatina skupaj z 5-fluorouracilom v infuziji (222 bolnikov) z enako kemoterapijo brez cetuksimaba (220 bolnikov).
• EMR 62 202-007: This randomised study in patients with metastatic colorectal cancer after failure of irinotecan-based treatment for metastatic disease as the last treatment before study entry compared the combination of cetuximab and irinotecan (218 patients) with cetuximab monotherapy (111 patients).
• EMR 62 202-007: v tej randomizirani študiji so pri bolnikih z metastatskim kolorektalnim rakom po neuspešnem zdravljenju metastatske bolezni z irinotekanom kot zadnjim zdravljenjem pred vstopom v študijo primerjali kombinacijo cetuksimaba in irinotekana (218 bolnikov) s samostojnim cetuksimabom (111 bolnikov).
Further post-hoc analyses on mutations on RAS genes other than KRAS exon 2 have been evaluated.
Post-hoc so poleg gena KRAS (eksona 2) ocenili tudi analize mutacij na genih RAS.
What Erbitux contains
Kaj vsebuje zdravilo Erbitux
If you receive Erbitux with radiation therapy, some of the side effects you may experience can also be related to this combination, such as:
Če zdravilo Erbitux prejemate v kombinaciji z obsevanjem, so lahko nekateri neželeni učinki, ki se bodo morda pojavili, povezani s to kombinacijo:
What is inthis leaflet
Kaj vsebuje navodilo
Each vial of 20 mL contains 100 mg cetuximab.
Ena viala z 20 ml vsebuje 100 mg cetuksimaba.
In all indications, Erbitux is administered once a week.
Zdravilo Erbitux pri vseh indikacijah infundirajte enkrat na teden.