natgillin/translations-raw huggingface dataset:
Mutations of the KRAS gene at certain hot-spots (mainly codons 12 and 13) result in constitutive activation of the KRAS protein independently of EGFR signalling.
Mutacije gena KRAS na nekaterih točkah (večinoma kodonih 12 in 13) povzročijo osnovno aktivacijo beljakovine KRAS, ne glede na pošiljanje signalov faktorja RERF.
In both in vitro and in vivo assays, cetuximab inhibits the proliferation and induces apoptosis of human tumour cells that express EGFR.
Tako v in vitro kot v in vivo testih cetuksimab zavira proliferacijo in inducira apoptozo človeških tumorskih celic z ekspresijo RERF.
No conclusive data on the neutralising effect of HACAs on cetuximab is available to date.
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.
A diagnostic assay (EGFR pharmDx) was used for immunohistochemical detection of EGFR expression in tumour material.
Diagnostični test za RERF (EGFR pharmDx) je bil uporabljen za imunohistokemično ugotavljanje ekspresije RERF v tumorskem tkivu.
A tumour was considered to be EGFR-expressing, if one stained cell could be identified.
Šteli so, da tumor izraža RERF, če so našli eno obarvano celico.
Approximately 75% of the patients with metastatic colorectal cancer screened for clinical studies had an EGFR-expressing tumour and were therefore considered eligible for cetuximab treatment.
Približno 75% bolnikov z metastatskim kolorektalnim rakom, pri katerih so opravili presejalni test za klinično študijo, je imelo tumor z ekspresijo RERF, in so bili torej primerni za zdravljenje s cetuksimabom.
The efficacy and safety of cetuximab have not been documented in patients with tumours where EGFR was not detected.
Učinkovitost in varnost cetuksimaba še nista bili dokumentirani pri bolnikih s tumorji, pri katerih RERF niso odkrili.
In metastatic colorectal cancer, the incidence of KRAS mutations is in the range of 30 - 50%.
Pri metastatskem raku debelega črevesa in danke je incidenca mutacij KRAS od 30 - do 50- odstotna.
Recent data demonstrate that patients with KRAS wild-type metastatic colorectal cancer have a significantly higher chance to benefit from treatment with cetuximab or a combination of cetuximab and chemotherapy.
Najnovejši podatki so pokazali, da imajo bolniki z metastatskim kolorektalnim rakom z nemutiranim tipom KRAS pomembno večjo možnost, da jim zdravljenja s cetuksimabom ali kombinacijo cetuksimaba in kemoterapije prinaša koristi.
The 5 randomised studies investigated a total of 3734 patients with metastatic colorectal cancer, in whom EGFR expression was detectable and who had an ECOG performance status of ≤ 2.
Pet randomiziranih študij je preučilo skupno število 3734 bolnikov z metastatskim kolorektalnim rakom, pri katerih je bila ugotovljena ekspresija RERF in pri katerih je bil indeks zmogljivosti ECOG ≤ 2.
In all studies, cetuximab was administered as described in section 4.2.
Pri vseh študijah se je cetuksimab dajal tako, kot je opisano v poglavju 4. 2.
The KRAS status was recognised as predictive factor for the treatment with cetuximab in 4 of the randomised controlled studies.
Od teh so v štirih randomiziranih nadzorovanih študijah ugotovili, da je status KRAS napovedni dejavnik za zdravljenje s cetuksimabom.
KRAS mutational status was available for 1261 patients.
Mutacijski status KRAS so lahko določili pri 1261 bolnikih.
Only in study EMR 62 202-007, an analysis was not possible.
Analiza ni bila mogoča samo v študiji EMR 62 202- 007.
9 Cetuximab in combination with chemotherapy
9 Cetuksimab v kombinaciji s kemoterapijo
This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and irinotecan plus infusional 5-fluorouracil/ folinic acid (5-FU/ FA) (599 patients) to the same chemotherapy alone (599 patients).
• EMR 62 202- 013: v tej randomizirani študiji so pri bolnikih z metastatskim kolorektalnim rakom, ki še niso bili zdravljeni zaradi metastatske bolezni, primerjali kombinirano terapijo s cetuksimabom in irinotekanom ter infundiranim 5- fluorouracil/ folinsko kislino (5- FU/ FA (599 bolnikov) z enako kemoterapijo v monoterapiji.
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 64%.
Delež bolnikov s tumorji z nemutiranim tipom KRAS v populaciji bolnikov, ki so jim lahko ocenili status KRAS, je bil 64- odstoten.
Variable/ statistic
Spremenljivka/ statistika
FOLFIRI Cetuxi
Cetuksimab in FOLFIRI
Cetuximab FOLFIRI Cetuximab
FOLFIRI
FOLFIRI
Cetuksimab in FOLFIRI
plus FOLFIRI
FOLFIRI
plus FOLFIRI
(N = 599)
ORR
(N = 599)
(N=599) (N=599)
(N = 172)
(N=172)
(N = 176)
(N=176)
ORR
% (95% CI) p-value PFS
% (95- odstotni IZ) Vrednost p
Hazard Ratio (95% CI) p-value
0, 85 (0, 726; 0, 998)
0.85 (0.726, 0.998) 0.0479
0, 68 (0, 501; 0, 934)
0.68 (0.501, 0.934) 0.0167
(95- odstotni IZ)
CI = confidence interval, FOLFIRI = irinotecan plus infusional 5-FU/ FA, ORR = objective response rate (patients with complete response or partial response), PFS = progression-free survival time
IZ = interval zaupanja; FOLFIRI = irinotekan in infundirani 5- FU/ FA; ORR (objective response rate) = objektivna stopnja odgovora (bolniki s popolnim odgovorom ali delnim odgovorom); PFS (progression- free survival time) = čas preživetja brez napredovanja bolezni
This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and oxaliplatin plus infusional 5-fluorouracil/ folinic acid (5-FU/ FA) (169 patients) to the same chemotherapy alone (168 patients).
Ta randomizirana študija pri bolnikih z metastatskim kolorektalnim rakom, ki še niso bili zdravljeni zaradii metastatske bolezni, je primerjala kombinacijo cetuksimaba in oksaliplatina ter infudiranega 5- fluorouracila/ folinske kisline (5- FU/ FA) (169 bolnikov) z enako kemoterapijo v monoterapiji (168 bolnikov).
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 58%.
Delež bolnikov s tumorji z nemutiranim tipom KRAS pri populaciji bolnikov, ki so jim lahko ocenili status KRAS, je bil 58- odstoten.
Cetuximab
Cetuksimab in FOLFOX
Cetuximab FOLFOX Cetuximab
Cetuksimab in FOLFOX
plus FOLFOX
(N = 169)
plus FOLFOX
(N = 168)
ORR
(N = 61)
(N=169)
(N = 73)
(N=168)
% (95- odstotni IZ) Vrednost p
(N=61)
45, 6
(N=73)
(37, 9; 53, 4) 35, 7 0, 064
% (95% CI) p-value PFS
(28, 5; 43, 5)
45.6
60, 7
(37.9, 53.4) 35.7 0.064
(47, 3; 72, 9) 37, 0 0, 011
(28.5, 43.5)
(26, 0; 49, 1)
60.7
PFS
(47.3, 72.9) 37.0 0.011
Razmerje tveganja
(26.0, 49.1)
0, 93 (0, 70; 1, 23)
Hazard Ratio (95% CI) p-value
0, 57 (0, 35; 0, 91)
0.93
(95- odstotni IZ)
(0.70, 1.23) 0.6170
Vrednost p
0.57
0, 6170
(0.35, 0.91) 0.0163
0, 0163
CI = confidence interval, FOLFOX = oxaliplatin plus infusional 5-FU/ FA, ORR = objective response rate (patients with complete response or partial response), PFS = progression-free survival time
IZ = interval zaupanja; FOLFOX = oksaliplatin in infundirani 5- FU/ FA; ORR (objective response rate) = objektivna stopnja odgovora (bolniki s popolnim odgovorom ali delnim odgovorom); PFS (progression- free survival time) = čas preživetja brez napredovanja bolezni
This randomised study in patients with metastatic colorectal cancer who had received initial combination treatment with oxaliplatin plus fluoropyrimidine for metastatic disease compared the combination of cetuximab and irinotecan (648 patients) with irinotecan alone (650 patients).
• CA225006: v tej randomizirani študiji so pri bolnikih z metastatskim kolorektalnim rakom, ki so se na začetku zdravljenja metastatske bolezni zdravili s kombinacijo oksaliplatina in fluoropirimidina, primerjali kombinacijo cetuksimaba in irinotekana (648 bolnikov) s samostojnim iritonekanom (650 bolnikov).
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 64%.
Delež bolnikov s tumorji z nemutiranim tipom KRAS pri populaciji bolnikov, ki so jim lahko ocenili status KRAS, je bil 64- odstoten.
10 A significant difference in overall survival time could not be shown in this study.
10 V tej študiji niso mogli pokazati pomembne razlike v skupnem času preživetja.
Following disease progression, treatment with EGFR-targeting agents was initiated in 50% of patients in the irinotecan-alone arm, which most likely impacted survival results.
Po napredovanju bolezni so zdravljenje z zdravili, ki delujejo na RERF začeli pri 50% bolnikov v skupini, ki je prejemala samo irinotekan, kar je najverjetneje vplivalo na rezultate preživetja.
Objective response rate and progression free survival time were significantly improved with cetuximab.
Objektivna stopnja odgovora in čas preživetja brez napredovanja bolezni sta se pri jemanju cetuksimaba bistveno izboljšala.
However, as no independent review of imaging data was conducted, these results have to be interpreted with caution.
Vendar neodvisnega pregleda podatkov slikanja niso opravili, zato je treba te rezultate interpretirati previdno.
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 zadnjem zdravljenjem pred vstopom v študijo primerjali kombinacijo cetuksimaba in irinotekana (218 bolnikov) s samostojnim cetuksimabom (111 bolnikov).
The combination of cetuximab with irinotecan compared to cetuximab alone reduced the overall risk of disease progression by 46% and significantly increased objective response rate.
Kombinacija cetuksimaba in irinotekana je v primerjavi s samostojnim cetuksimabom zmanjšala skupno tveganje napredovanja bolezni za 46% in pomembno povečala objektivno stopnjo odgovora.
In the randomised trial, the improvement in overall survival time did not reach statistical significance; however, in the follow-up treatment, nearly 50% of the patients of the cetuximab alone arm received a combination of cetuximab and irinotecan after progression of disease, which may have influenced overall survival time.
V randomiziranem preskušanju izboljšanje skupnega časa preživetja ni doseglo statistične pomembnosti, vendar pa je med sledenjem skoraj 50% bolnikov, ki so prejemali samo cetuksimab, prejelo kombinacijo cetuksimaba in iritonekana po napredovanju bolezni, kar je morda vplivalo na rezultate skupnega časa preživetja.
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).
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 59%.
Delež bolnikov s tumorji z nemutiranim tipom KRAS v populaciji bolnikov, ki so jim lahko ocenili KRAS, je bil 59- odstoten.
Addition of cetuximab to best supportive care reduced the overall risk of death in the overall study population by 23% and the overall risk of disease progression by 32%.
Dodajanje cetuksimaba k najboljši podporni oskrbi je zmanjšalo skupno tveganje smrti v celotni populaciji bolnikov, ki so sodelovali v študiji, za 23% in skupno tveganje napredovanja bolezni za 32%.
Preliminary data from patients with KRAS wild-type tumours showed a more pronounced beneficial effect of cetuximab on overall survival time and progression free survival time.
Preliminarni podatki pri bolnikih s tumorji z nemutiranim tipom KRAS so pokazali bolj izrazit ugodni učinek cetuksimaba na skupen čas preživetja in čas preživetja brez napredovanja bolezni.
Immunohistochemical detection of EGFR expression was not performed since more than 90% of patients with squamous cell cancer of the head and neck have tumours that express EGFR.
Imunohistokemičnega določanja ekspresije RERF niso izvajali, ker se REFR izraža v tumorjih pri več kot 90% bolnikih z rakom skvamoznih celic glave in vratu.
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.
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.
Cetuximab was started one week before radiation therapy and administered at the doses described in section 4.2 until the end of the radiation therapy period.
Cetuksimab so začeli dajati en teden pred radioterapijo in so ga dajali do konca obdobja radioterapije, v odmerkih opisanih v poglavju 4. 2.
11 The efficacy data generated in this study are summarised in the table below:
11 Podatki o učinkovitosti, ki so bili zbrani v tej študiji, so povzeti v spodnji preglednici:
Radiation therapy + cetuximab (N=211)
Radioterapija in cetuksimab (N = 211)
Radiation therapy alone (N=213)
Radioterapija v monoterapiji (N = 213)
Locoregional control
Lokalni in regionalni nadzor
months, median (95% CI)
meseci, mediana (95- odstotni IZ)
Hazard Ratio (95% CI) p-value OS
0, 68 (0, 52; 0, 89)
0.68 (0.52, 0.89) 0.005
(95- odstotni IZ)
Hazard Ratio (95% CI) p-value
0, 74 (0, 56; 0, 97)
0.74 (0.56, 0.97) 0.032
(95- odstotni IZ)
CI = confidence interval, OS = overall survival time, a '+ 'denotes that the upper bound limit had not been reached at cut-off
IZ = interval zaupanja; OS (overall survival) = skupni čas preživetja, '+' pomeni, da ob prekinitvi ni bila dosežena zgornja meja
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 zmoglivosti (KPS - Karnofsky performance status) in starostjo, so imeli bolj poudarjeno korist, če je bil cetuksimab dodan radioterapiji.
Cetuximab in combination with platinum-based chemotherapy in recurrent and/ or metastatic disease
Cetuksimab v kombinaciji s kemoterapijo na osnovi platine pri ponavljajoči se in/ ali metastatski bolezni
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).
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 v monoterapiji (220 bolnikov).
The efficacy data generated in this study are summarised in the table below:
12 Podatki o učinkovitosti, ki so bili zbrani v tej študiji, so povzeti v spodnji preglednici:
Cetuximab + CTX
Cetuksimab in KOP
CTX
KOP
(N=220)
(N = 220)
months, median (95% CI) Hazard Ratio (95% CI) p-value PFS
meseci, mediana (95- odstotni IZ)
(0.644, 0.986) 0.0362
(0, 644; 0, 986)
7.4 (6.4, 8.3)
0, 0362
months, median (95% CI) Hazard Ratio (95% CI) p-value ORR
meseci, mediana (95- odstotni IZ)
(0.431, 0.672) < 0.0001
razmerje tveganja (95- odstotni IZ)
3.3 (2.9, 4.3)
0, 538
% (95% CI) p-value
(0, 431; 0, 672)
35.6 (29.3, 42.3)
< 0, 0001
CI = confidence interval, CTX = platinum-based chemotherapy, ORR = objective response rate, OS = overall survival time, PFS = progression-free survival time
IZ = interval zaupanja; KOP = kemoterapija na osnovi platine; ORR (objective response rate) = objektivna stopnja odgovora; OS (overall survival) = skupni čas preživetja; PFS (progression- free survival time) = čas preživetja brez napredovanja bolezni
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.
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 skupnem času preživetja.
12 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Intravenous infusions of cetuximab exhibited dose-dependent pharmacokinetics at weekly doses ranging from 5 to 500 mg/ m² body surface area.
Pri intravenskem infundiranju cetuksimaba so ugotavljali od odmerka odvisno farmakokinetiko s tedenskimi odmerki od 5 do 500 mg/ m² telesne površine.
When cetuximab was administered at an initial dose of 400 mg/ m² body surface area, the mean volume of distribution was approximately equivalent to the vascular space (2.9 l/ m² with a range of 1.5 to 6.2 l/ m²).
Ko so cetuksimab dajali v začetnem odmerku 400 mg/ m² telesne površine, je bil srednji porazdelitveni volumen približno enak znotrajžilnemu prostoru (2, 9 l/ m², razpon od 1, 5 do 6, 2 l/ m²).
The mean Cmax (± standard deviation) was 185±55 microgram per ml.
Srednja vrednost Cmax (± standardna deviacija) je bila 185 ± 55 mikrogramov/ ml.
The mean clearance was 0.022 l/ h per m² body surface area.
Srednja vrednost očistka je bila 0, 022 l/ h/ m² telesne površine.
Mean peak cetuximab concentrations were 155.8 microgram per ml in week 3 and 151.6 microgram per ml in week 8, whereas the corresponding mean trough concentrations were 41.3 and 55.4 microgram per ml, respectively.
Srednja največja koncentracija cetuksimaba je bila 155, 8 mikrograma/ ml v 3. tednu in 151, 6 mikrograma/ ml v 8. tednu, ustrezna srednja najmanjša koncentracija pa je bila 41, 3 mikrograma/ ml in 55, 4 mikrograma/ ml.
In a study of cetuximab administered in combination with irinotecan, the mean cetuximab trough levels were 50.0 microgram per ml in week 12 and 49.4 microgram per ml in week 36.
V študiji kombinirane terapije s cetuksimabom in irinotekanom je bila srednja najmanjša koncentracija 50, 0 mikrograma/ ml v 12. tednu in 49, 4 mikrograma/ ml v 36. tednu.
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. majhne peptide ali aminokisline.
Pharmacokinetics in special populations
13 Farmakokinetika v posebnih skupinah bolnikov
Dose-dependent skin alterations, starting at dose levels equivalent to those used in humans, were the major findings observed in toxicity studies with Cynomolgus monkeys (a chronic repeat-dose toxicity study and an embryo-foetal development study).
Kožne spremembe, odvisne od odmerka, ki se pojavijo pri stopnjah odmerjanja, ki so enake kot pri človeku, so glavne ugotovitve, ki so jih opazili v študijah toksičnosti pri opicah vrste Cynomolgus (študiji kronične toksičnosti ponavljajočih se odmerkov in študiji razvoja zarodka/ ploda).
An embryo-foetal toxicity study in Cynomolgus monkeys revealed no signs of teratogenicity.
Študija toksičnosti za zarodek/ plod pri opicah vrste Cynomolgus ni pokazala znakov teratogenosti.
Non-clinical data on genotoxicity and local tolerance including accidental administration by routes other than the intended infusion revealed no special hazard for humans.
Predklinični podatki o genotoksičnosti in lokalni toleranci, vključno z nenamernim dajanjem po drugih poteh (t. j. ne z infuzijo), niso pokazali nobenih posebnih nevarnosti za človeka.
However, in preclinical wound healing models EGFR selective tyrosine kinase inhibitors were shown to retard wound healing.
V predkliničnih modelih celjenja ran pa se je izkazalo, da za RERF selektivni zaviralci tirozinske kinaze upočasnijo celjenje ran.
Sodium dihydrogen phosphate Disodium phosphate Sodium chloride Water for injections
Natrijev dihidrogenfosfat Natrijev hidrogenfosfat Natrijev klorid Voda za injekcije
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smete mešati z drugimi zdravili.
A separate infusion line must be used.
Uporabiti morate ločeno infuzijsko linijo.
Chemical and physical in-use stability of Erbitux 2 mg/ ml has been demonstrated for 20 hours at 25ºC.
14 Med uporabo je zdravilo Erbitux 2 mg/ ml kemično in fizikalno stabilno do 20 ur pri temperaturi 25 °C.
For storage conditions after opening, see section 6.3.
Za pogoje shranjevanja po odprtju zdravila glejte poglavje 6. 3.
50 ml of solution in a vial (Type I glass) with a stopper (teflon-coated bromobutyl rubber) and a seal (aluminium).
50 ml raztopine v viali (iz stekla tipa I) z zamaškom (iz bromobutilne gume s teflonsko prevleko) in zaporko (iz aluminija).
Pack size of 1.
Pakiranje z 1 vialo.
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.
These particles do not affect the quality of the product.
Ti delci ne vplivajo na kakovost zdravila.
Nevertheless, the solution must be filtered with an in-line filter of 0.2 micrometer or 0.22 micrometer nominal pore size during administration.
Kljub temu morate raztopino med dajanjem zdravila filtrirati z linijskim filtrom z velikostjo por 0, 2 mikrometra ali 0, 22 mikrometra.
14 Erbitux 2 mg/ ml is compatible • with polyethylene, ethyl vinyl acetate or polyvinyl chloride bags, • with polyethylene, ethyl vinyl acetate, polyvinyl chloride, polybutadiene or polyurethane infusion sets, • with polyethersulfone, polyamide or polysulfone in-line filters.
Zdravilo Erbitux 2 mg/ ml je združljivo • s polietilenskimi, etilvinilacetatnimi ali polivinilkloridnimi vrečkami, • s polietilenskimi, etilvinilacetatnimi, polivinilkloridnimi, polibutadienskimi ali poliuretanskimi infuzijskimi sistemi, • s polietersulfonskimi, poliamidnimi ali polisulfonskimi linijskimi filtri.
Erbitux 2 mg/ ml must be prepared as follows:
Zdravilo Erbitux 2 mg/ ml mora biti pripravljeno, kot sledi:
• In-line filtration with an infusion pump or gravity drip:
• Linijska filtracija z infuzijsko črpalko ali s težnostno kapalno infuzijo:
Take an appropriate sterile syringe (minimum 50 ml) and attach a suitable needle.
Vzemite ustrezno sterilno brizgo (najmanj 50 ml) in nanjo pritrdite primerno iglo.
Insert a suitable in-line filter into the infusion line and prime it with Erbitux or sterile sodium chloride 9 mg/ ml (0.9%) solution before starting the infusion.
Preden začnete z dajanjem infuzije, vstavite primeren linijski filter v infuzijsko linijo in jo napolnite z zdravilom Erbitux ali sterilno raztopino natrijev klorid 9 mg/ ml (0, 9%) raztopina za injiciranje.
Set and control the rate as explained in section 4.2.
Nastavite in nadzirajte hitrost infuzije, kot je opisano v poglavju 4. 2.
• In-line filtration with a syringe pump:
15 • Linijska filtracija s črpalko za brizgo: