natgillin/translations-raw huggingface dataset:
The recommended dose of Cyramza for the treatment of gastric cancer, for the treatment of advanced cancer of the colon or rectum and for the treatment of liver cancer is 8 mg per kilogram of your body weight once every 2 weeks.
Priporočeni odmerek zdravila Cyramza za zdravljenje raka želodca, za zdravljenje napredovalega raka kolona ali rektuma in za zdravljenje raka jeter je 8 mg na kilogram vaše telesne mase enkrat na dva tedna.
It is unknown whether ramucirumab is excreted in human milk.
Ni znano, ali se ramucirumab izloča v materino mleko.
Cyramza can cause blood clots in your arteries.
Zdravilo Cyramza lahko povzroči krvne strdke v vaših arterijah.
Ramucirumab is an antiangiogenic therapy and may increase the risk of gastrointestinal perforations.
Ramucirumab je antiangiogeno zdravilo in lahko poveča tveganje za gastrointestinalne perforacije.
Body weight is considered a significant co-variate of ramucirumab pharmacokinetics supporting the dosing based on body weight.
Telesna masa velja za pomembno sospremenljivko pri farmakokinetiki ramucirumaba, kar podpira odmerjanje na podlagi telesne mase.
From the side effects listed above, these are: low white blood cell counts; low platelet count in the blood; low blood levels of albumin, potassium or sodium; presence of protein in the urine.
Izmed zgoraj naštetih neželenih učinkov so to: zmanjšanje števila belih krvničk, zmanjšanje števila krvnih ploščic, nizke ravni albumina, kalija ali natrija v krvi, prisotnost beljakovin v urinu.
Based on ramucirumab's mechanism of action, it is likely that in animals, ramucirumab will inhibit angiogenesis and result in adverse effects on fertility (ovulation), placental development, developing foetuses and postnatal development.
Glede na mehanizem delovanja ramucirumaba je verjetno, da pri živalih ramucirumab zavira angiogenezo in povzroča neželene učinke na plodnost (ovulacija), razvoj placente, razvijajoče se plodove in postnatalni razvoj.
There was no clear deviation from dose proportionality in pharmacokinetics of ramucirumab from 6 mg/kg to 20 mg/kg.
Jasnega odstopanja od sorazmernosti odmerka v farmakokinetiki ramucirumaba od 6 mg/kg do 20
A hospital pharmacist, nurse or doctor will have diluted the contents of the vial with sodium chloride 9 mg/ml
Pred uporabo bolnišnični farmacevt, medicinska sestra ali zdravnik razredči vsebino viale z 9 mg/ml
Patients who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or other Grade 3 or 4 non-haematological toxicities during docetaxel treatment should have treatment withheld until resolution of the toxicity.
Pri bolnikih, pri katerih se med zdravljenjem z docetakselom pojavijo bodisi febrilna nevtropenija, število nevtrofilcev < 500 celic/mm3, ki traja več kot 1 teden, hude kožne reakcije ali druge nehematološke toksičnosti razreda 3 ali 4, je treba zdravljenje prekiniti, dokler toksičnost ne mine.
Women of childbearing potential should use effective contraception during and up to 3 months after the last dose of ramucirumab treatment.
Ženske v rodni dobi morajo med zdravljenjem z ramucirumabom in do 3 mesecev po zadnjem odmerku uporabljati učinkovito kontracepcijo.
Patients receiving any kind of therapeutic anticoagulation and/or chronic therapy with non-steroidal anti-inflammatory drugs or anti-platelet agents were excluded from the REVEL NSCLC clinical trial.
Bolniki, ki so prejemali katero koli vrsto terapevtske antikoagulacije in/ali kroničnega zdravljenja z nesteroidnimi protivnetnimi zdravili ali antiagregacijskimi zdravili, so bili izključeni iz kliničnega preskušanja REVEL NSCLC.
The most common adverse reactions observed in ramucirumab-treated patients are: neutropenia, fatigue/asthenia, leukopenia, epistaxis, diarrhoea and stomatitis.
Najpogostejši neželeni učinki, ki so jih opazili pri bolnikih, zdravljenih z ramucirumabom, so: nevtropenija, utrujenost/astenija, levkopenija, epistaksa, diareja in stomatitis.
Randomisation was stratified by geographic region, time to progression from the start of first-line therapy (<6 months versus ≥6 months) and disease measurability.
Randomizacija je bila stratificirana z geografsko regijo, časom do napredovanja bolezni od začetka zdravljenja prve izbire (<6 mesecev v primerjavi z ≥6 mesecev) in merljivostjo bolezni.
In a study conducted in animals, ramucirumab did not impair wound healing.
V študiji, opravljeni na živalih, ramucirumab ni poslabšal celjenja ran.
Based on population pharmacokinetic approach (PopPK), the mean (% coefficient of variation [CV%]) volume of distribution at steady state for ramucirumab was 5.4L (15%).
Po načelih populacijske farmakokinetike je povprečni (% koeficient variacije, CV) porazdelitveni volumen za ramucirumab v ravnotežnem stanju znašal 5,4 l (15 %).
Ramucirumab is an antiangiogenic therapy and may increase the risk of severe bleeding.
Ramucirumab je antiangiogeno zdravilo in lahko poveča tveganje za hudo krvavitev.
For patients treated with Cyramza plus paclitaxel the median duration of therapy was 19 weeks, and for patients treated with placebo plus paclitaxel the median duration of therapy was 12 weeks.
Pri bolnikih, zdravljenih z zdravilom Cyramza in paklitakselom, je bilo mediano trajanje zdravljenja 19 tednov, pri bolnikih, zdravljenih s placebom in paklitakselom, pa je bilo mediano trajanje zdravljenja 12 tednov.
Ramucirumab in combination with FOLFIRI
Ramucirumab v kombinaciji s shemo FOLFIRI
Cyramza is a cancer medicine that contains the active substance ramucirumab, which is a monoclonal antibody.
Cyramza je zdravilo proti raku, ki vsebuje učinkovino ramucirumab, ki je monoklonsko protitelo.
The primary endpoint was OS and the secondary endpoints included PFS, objective response rate (ORR) and quality of life (QoL) using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.
Primarni opazovani dogodek je bilo celokupno preživetje (OS), sekundarni opazovani dogodki pa so vključevali preživetje brez napredovanja bolezni (PFS), objektivno stopnjo odziva (ORR) in kakovost življenja, ocenjeno z uporabo vprašalnika Evropske organizacije za raziskave in zdravljenje raka (European Organisation for Research and Treatment of Cancer; EORTC) QLQ-C30.
Cyramza can increase the incidence of high blood pressure.
Zdravilo Cyramza lahko poveča pojavnost visokega krvnega tlaka.
Do not administer the solution if you notice any particulate matter or discolouration.
Ne dajajte raztopine, če opazite v njej delce ali obarvanost.
Based on PopPK, the mean (CV%) clearance of ramucirumab was 0.015 L/hour (30%) and the mean half-life was 14 days (20%).
Po načelih populacijske farmakokinetike je bil povprečni (CV %) očistek ramucirumaba 0,015 l/uro (30 %), povprečen razpolovni čas pa je znašal 14 dni (20 %).
Depending on the protein level measured, Cyramza may be temporarily discontinued.
Glede na izmerjeno raven beljakovin bo zdravljenje z zdravilom Cyramza morda treba začasno prekiniti.
An accumulation ratio of 1.5 was observed for ramucirumab when dosed every 2 weeks.
Opazili so stopnjo kopičenja 1,5, ko so ramucirumab odmerjali vsaka 2 tedna.
No animal studies have been performed to test ramucirumab for potential of carcinogenicity or genotoxicity.
Študije na živalih, s katerimi bi preučili morebiten potencial ramucirumaba za kancerogenost ali genotoksičnost, niso bile opravljene.
The relative treatment effect (assessed by HR) of Cyramza compared to placebo was generally consistent across subgroups, including age, race, aetiology of disease and reason for discontinuation of sorafenib (progressive disease vs. intolerance).
Relativni učinek zdravljenja (ocenjen s HR) zdravila Cyramza v primerjavi s placebom je bil na splošno konsistenten med podskupinami, ki so vključevale podskupine glede na starost, raso, etiologijo bolezni in razlog za prekinitev zdravljenja s sorafenibom (napredovala bolezen v primerjavi z neprenašanjem).
If a patient experiences a second Grade 1 or 2 infusion-related reaction (IRR) administer dexamethasone (or equivalent); then, for subsequent infusions, premedicate with the following or equivalent medicinal products: an intravenous histamine H1 antagonist (for example diphenhydramine hydrochloride), paracetamol and dexamethasone.
Če se pri bolniku pojavi ponovna reakcija stopnje 1 ali 2 (IRR), mu dajte deksametazon (ali enakovredno zdravilo); nato pa za nadaljnja infundiranja uporabite premedikacijo z naslednjimi zdravili ali z njimi enakovrednimi zdravili: intravenski antagonist histaminskih receptorjev H1 (npr. difenhidraminijev klorid), paracetamol in deksametazon.
Patients treated with Cyramza experienced a statistically significant improvement in OS, compared to placebo (Table 12).
Pri bolnikih, zdravljenih z zdravilom Cyramza, je prišlo do statistično značilnega izboljšanja celokupnega preživetja v primerjavi s placebom (Tabela 12).
The pharmacokinetics of irinotecan and its active metabolite, SN-38, were not affected when co-administered with ramucirumab.
Na farmakokinetiko irinotekana in njegovega aktivnega presnovka, SN-38, sočasno dajanje ramucirumaba ni vplivalo.
NSCLC patients with recent pulmonary bleeding (>2.5 ml or bright red blood) as well as patients with evidence of baseline tumour cavitation, regardless of histology, or those with any evidence of tumour invasion or encasement of major blood vessels have been excluded from clinical trials (see section 4.3).
Bolniki z NSCLC in nedavno pljučno krvavitvijo (> 2,5 ml ali svetlo rdeča kri) in bolniki, pri katerih obstajajo dokazi o kavitaciji izhodiščnega tumorja ne glede na histologijo, ali bolniki, pri katerih obstajajo kakršni koli dokazi o tumorski invaziji ali zaprtju glavnih krvnih žil, so bili izključeni iz kliničnih preskušanj (glejte poglavje 4.3).
Paclitaxel dose reductions may be applied based upon the grade of toxicity experienced by the patient.
Odmerek docetaksela je mogoče zmanjšati na podlagi razreda toksičnosti, ki se pojavi pri bolniku.
Calculate the dose and volume of ramucirumab needed to prepare the infusion solution.
Izračunajte odmerek in prostornino ramucirumaba, ki sta potrebna za pripravo raztopine za infundiranje.
Posology adjustments for ramucirumab
Prilagajanje odmerjanja za ramucirumab
EU/1/14/957/002 - 2 vials of 10 ml.
EU/1/14/957/002 - 2 viale po 10 ml
Spontaneous development of fistula (see section 4.4).
Spontani nastanek fistule (glejte poglavje 4.4).
In the REACH-2 study for HCC, a relevant exposure-efficacy association was observed for ramucirumab which showed that only patients with above-median exposure experienced an improvement in OS, compared to placebo, and these exposure-efficacy relationships remained after attempts to adjust for other prognostic factors.
V študiji REACH-2 pri hepatocelularnem karcinomu so pri ramucirumabu opazili pomembno povezavo med izpostavljenostjo in učinkovitostjo, ki je pokazala, da je do izboljšanja celokupnega preživetja v primerjavi s placebom prišlo samo pri bolnikih, pri katerih je bila izpostavljenost nad mediano, in da se je povezanost med izpostavljenostjo in učinkovitostjo ohranila tudi po poskusu prilagoditve za druge napovedne dejavnike.
Proteinuriaa,f
Bolezni sečil proteinurijaa,f
Elective surgery or impaired wound healing
Načrtovan kirurški poseg ali slabo celjenje ran
Tell your doctor immediately if you experience any of the following serious side effects that have been observed during Cyramza treatment (see also What you need to know before you are given
Če opazite katerega koli od naslednjih resnih neželenih učinkov, ki so jih opazili med zdravljenjem z zdravilom Cyramza, takoj obvestite svojega zdravnika (glejte tudi Kaj morate vedeti, preden boste uporabili zdravilo Cyramza):
Your doctor will make sure that if you already have high blood pressure, it is brought under control before starting Cyramza.
Vaš zdravnik bo poskrbel, da bo vaš krvni tlak pod nadzorom, preden bo uvedel zdravilo Cyramza.
Common side effects (may affect up to 1 in 10 people): - hole in the wall of your gut: this is a hole that develops in the stomach, gut or bowel.
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - luknjice v črevesni steni: to je luknjica v želodcu ali črevesju.
As a risk to breast-fed newborns/infants cannot be excluded, breast-feeding should be discontinued during treatment with Cyramza and for at least 3 months after the last dose.
Ker pa tveganja za dojene novorojenčke/dojenčke ni mogoče izključiti, morajo ženske med zdravljenjem z zdravilom Cyramza prekiniti dojenje in ne smejo dojiti še vsaj 3 mesece po zadnjem odmerku.
Severe bleeding: NCI CTCAE Grade 3 or 4 bleeding (see section 4.4).
Huda krvavitev: krvavitev stopnje 3 ali 4 po NCI CTCAE (glejte poglavje 4.4).
Patients enrolled into the study had disease progression on or after prior sorafenib therapy or were intolerant to sorafenib.
Bolnikom, vključenim v študijo, je bolezen napredovala ob ali po predhodnem zdravljenju s sorafenibom oziroma ti bolniki sorafeniba niso prenašali.
The remainder (25%) received prior platinum and fluoropyrimidine combination therapy with anthracycline.
Preostali bolniki (25 %) so pred tem prejemali kombinirano zdravljenje s platino in fluoropirimidinom z antraciklinom.
If the urine protein is ≥2+ on a dipstick, a 24 hour urine collection should be performed.
Če beljakovine v urinu znašajo ≥ 2+ na merilni paličici, opravite odvzem vzorcev urina v obdobju 24 ur.
Hepatic encephalopathy or hepatorenal syndrome (see section 4.4).
Hepatična encefalopatija ali hepatorenalni sindrom (glejte poglavje 4.4).
Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Prior to each paclitaxel infusion, patients should have a complete blood count and blood chemistry performed to evaluate hepatic function.
Pred vsakim infundiranjem paklitaksela je treba pri bolnikih pregledati celotno krvno sliko in izvide kemičnih preiskav krvi, da se oceni delovanje jeter.
Clinical data suggest that no dose adjustments are required in patients with mild or moderate hepatic impairment.
Klinični podatki kažejo, da prilagajanje odmerkov pri bolnikih z blago ali zmerno okvaro jeter ni potrebno.
There are no data on the effect of ramucirumab on human fertility.
Ni podatkov o vplivu ramucirumaba na plodnost pri človeku.
Aseptically transfer the calculated volume of ramucirumab to the intravenous container.
Aseptično prenesite izračunano prostornino ramucirumaba v vsebnik za intravensko infuzijo.
Symptomatic treatment should be instituted promptly if stomatitis occurs.
V primeru pojava stomatitisa je treba takoj uvesti simptomatsko zdravljenje.
Excipients: histidine, histidine monohydrochloride, sodium chloride, glycine, polysorbate 80, water for injections.
Pomožne snovi: histidin, histidinijev klorid, natrijev klorid, glicin, polisorbat 80, voda za injekcije.
Efficacy, as measured by improvements in OS, was associated with increasing ramucirumab exposure range produced by 8 mg/kg ramucirumab given every 2 weeks and by 10 mg/kg ramucirumab given every 3 weeks.
Učinkovitost, merjena z izboljšanjem celokupnega preživetja, je bila povezana s povečanjem obsega izpostavljenosti ramucirumabu, ki ga je omogočil odmerek ramucirumaba 8 mg/kg, dan vsaka 2 tedna, in odmerek ramucirumaba 10 mg/kg, dan vsake 3 tedne.
There are limited safety data available for patients with severe renal impairment (creatinine clearance 15 to 29 ml/min) treated with ramucirumab (see sections 4.2 and 5.2).
Podatkov o varnosti za bolnike s hudo okvaro ledvic (kreatininski očistek od 15 do 29 ml/min), ki bi bili zdravljeni z ramucirumabom, ni (glejte poglavji 4.2 in 5.2).
In severe cases, symptoms may include breathing distress caused by narrowing of the airways, faster heartbeat, and feeling faint.
V hujših primerih lahko simptomi vključujejo dihalno stisko, ki jo povzroči zoženje dihalnih poti, pospešen srčni utrip in občutek omedlevice.
No patients had neutralising antibodies to ramucirumab.
Noben bolnik ni imel nevtralizacijskih protiteles za ramucirumab.
The FOLFIRI regimen was: irinotecan 180 mg/m2 administered over 90 minutes and folinic acid 400 mg/m2 administered, simultaneously over 120 minutes; followed by bolus 5-fluorouracil(5-FU) 400 mg/m2 over 2 to 4 minutes; followed by 5-FU 2400 mg/m2 administered by continuous infusion over 46 to 48 hours.
Režim sheme FOLFIRI je bil: irinotekan 180 mg/m2, dan v 90 minutah, in folinska kislina 400 mg/m2, dana sočasno v 120 minutah; sledil je bolus 5-fluorouracila (5-FU) 400 mg/m2, dan v 2 do 4 minutah; sledil je odmerek 5-FU 2400 mg/m2, dan z neprekinjeno infuzijo v 46 do 48 urah.
- severe bleeding in your gut: symptoms may include extreme tiredness, weakness, dizziness or changes in the colour of your stools.
- huda krvavitev v črevesju: simptomi lahko vključujejo izjemno utrujenost, šibkost, omotico ali spremembe v barvi vašega blata.
Symptoms of a stroke may include sudden numbness or weakness of the arm, leg and face, feeling confused, difficulty speaking or understanding others, sudden difficulty in walking or loss of balance or coordination or sudden dizziness.
Simptomi možganske kapi lahko vključujejo nenadno otopelost ali šibkost roke, noge in obraza, občutke zmedenosti, težave z govorom ali razumevanjem drugih, nenadne težave s hoji ali izgubo ravnotežja ali koordinacije ali pa nenadno omotico.
Table 4: FOLFIRI dose reductions FOLFIRI componenta
Tabela 4: Zmanjšanje odmerkov sheme FOLFIRI
Palmar-plantar erthyrodysaesthesia syndromeg
Bolezni kože in podkožja sindrom palmarno-plantarne eritrodisestezijeg
Eligible patients were Child Pugh A (score < 7), had creatinine clearance ≥ 60 ml/min, and ECOG PS of 0 or 1.
Primerni bolniki so imeli stanje bolezni razreda A po lestvici Child-Pugh (rezultat < 7), očistek kreatinina ≥ 60 ml/min in stanje zmogljivosti po lestvici ECOG 0 ali 1.
Criteria to be met prior to FOLFIRI are provided in Table 2.
Merila, ki jih je treba izpolnjevati pred jemanjem sheme FOLFIRI, so navedena v Tabeli 2.
Table 5: Dose modification of FOLFIRI components due to specific ADRs
Tabela 5: Prilagajanje odmerkov komponent sheme FOLFIRI zaradi specifičnih neželenih učinkov zdravila
Your doctor or nurse will check for side effects during your infusion.
Vaš zdravnik ali medicinska sestra bosta med vašo infuzijo pozorna na neželene učinke.
This cancer treatment will be given to you by a doctor or nurse.
Kako uporabljati zdravilo Cyramza To zdravilo proti raku vam bo dal zdravnik ali medicinska sestra.
Patients were randomised in a 2:1 ratio to receive an intravenous infusion of Cyramza 8 mg/kg (n= 238) or placebo (n= 117) every 2 weeks.
Bolniki so bili randomizirani v razmerju 2:1 za prejemanje intravenske infuzije zdravila Cyramza 8 mg/kg (n=238) ali placeba (n=117) vsaka 2 tedna.
Pack of 1 vial of 50 ml.
Pakiranje z 1 vialo s 50 ml.
Reproductive toxicity studies with ramucirumab have not been performed, however, animal models link angiogenesis, VEGF and VEGF Receptor 2 to critical aspects of female reproduction, embryo-foetal development, and postnatal development.
Študije vpliva na sposobnost razmnoževanja z ramucirumabom niso bile opravljene, kljub temu pa živalski modeli povezujejo angiogenezo, žilni endotelijski rastni faktor (VEGF) in receptor žilnega endotelijskega rastnega faktorja 2 s ključnimi vidiki ženske reprodukcije, embriofetalnim razvojem in postnatalnim razvojem.
After dilution, Cyramza is administered as an intravenous infusion over approximately 60 minutes.
Po redčenju se zdravilo Cyramza daje kot intravenska infuzija v približno 60 minutah.
Following the dose regimen of 8 mg/kg ramucirumab every 2 weeks in combination with FOLFIRI,
Ob upoštevanju režima odmerjanja 8 mg/kg ramucirumaba vsaka 2 tedna v kombinaciji s shemo
Patients were required to have ECOG PS 0 or 1 and to have disease progression within 6 months of the last dose of first-line therapy.
Bolniki so morali imeti indeks stanja zmogljivosti ECOG 0 ali 1, njihova bolezen pa je morala v zadnjih šestih mesecih od zadnjega odmerka zdravljenja prve izbire napredovati.
The metabolism of ramucirumab has not been studied.
Presnove ramucirumaba niso proučevali.
Each 10 ml vial contains approximately 17 mg sodium.
Ena 10-mililitrska viala vsebuje približno 17 mg natrija.
Discard any unused portion of ramucirumab left in a vial, as the product contains no antimicrobial preservatives.
Morebitno neuporabljeno učinkovino ramucirumab, ki ostane v viali, zavrzite, saj izdelek ne vsebuje antimikrobnih konzervansov.
Clinical data suggest that no dose adjustments are required in patients with mild, moderate or severe renal impairment (see sections 4.4 and 5.2).
Klinični podatki kažejo, da prilagoditve odmerkov pri bolnikih z blago, zmerno ali hudo okvarjenim delovanjem ledvic niso potrebne (glejte poglavji 4.4 in 5.2) Zmanjšanja odmerkov niso potrebna.
This medicine is given by infusion via a drip over a period of approximately 60 minutes.
To zdravilo se daje v obliki intravenske infuzije (kapalna infuzija) v času približno 60 minut.
Symptoms may include: extreme tiredness, weakness, dizziness or changes in the colour of your stools.
Simptomi lahko vključujejo: izjemno utrujenost, šibkost, omotico ali spremembo barve vašega blata.
A single dose of ramucirumab did not impair wound healing in monkeys using a full-thickness incisional model.
Enkratni odmerek ramucirumaba ni poslabšal celjenja ran pri opicah z uporabljenim modelom reza skozi vso debelino kože.
Neutropenia or Thrombocytopenia
Nevtropenija ali trombocitopenija
Improvements in OS and PFS were consistently observed in pre-specified subgroups based on age, sex, race and in most other pre-specified subgroups.
Izboljšanja v preživetju in preživetju brez poslabšanja bolezni so konsistentno opažali v vnaprej določenih podskupinah, ki so temeljile na starosti, spolu, rasi v večini drugih vnaprej določenih podskupin.
Based on PopPK, ramucirumab exposure was similar in patients with mild renal impairment (creatinine clearance [CrCl] ≥60 to <90 ml/min), moderate renal impairment (CrCl ≥30 to <60 ml/min) or severe renal impairment (CrCl 15 to 29 ml/min) as compared to patients with normal renal function (CrCl ≥90 ml/min).
Na podlagi populacijske farmakokinetike je bila izpostavljenost ramucirumabu pri bolnikih z blago okvarjenim delovanjem ledvic (izračunani kreatininski očistek [CrCl] ≥ 60 do < 90 ml/min) in zmerno okvarjenim delovanjem ledvic (CrCl ≥ 30 do < 60 ml/min) ali hudo okvarjenim delovanjem ledvic (CrCl 15 do 29 ml/min) podobna kot pri bolnikih z normalnim delovanjem ledvic (CrCl ≥ 90
- have liver cancer and have had previous bleeding from enlarged veins in your food pipe (oesophagus) or have high blood pressure in the portal vein, which carries the blood from the bowel and spleen to the liver.
- imate raka jeter in ste predhodno krvaveli iz povečanih ven v požiralniku ali imate povišan krvni tlak v portalni veni, ki prenaša kri iz črevesja in vranice v jetra.
For East Asian patients, a reduced docetaxel starting dose of 60 mg/m2 on day 1 of a 21 day cycle should be considered.
Pri vzhodnoazijskih bolnikih je treba razmisliti o manjšanju začetnega odmerka docetaksela na 60 mg/m2 na 1. dan 21-dnevnega cikla.
Dose reductions for individual components of FOLFIRI may be made for specific toxicities.
Pri specifičnih toksičnostih je mogoče zmanjšati odmerke posameznih komponent sheme FOLFIRI.
The median duration of docetaxel therapy was 14.1 weeks for the ramucirumab plus docetaxel arm (with a median of 4.0 infusions received) and 12.0 weeks for the placebo plus docetaxel arm (with a median of 4.0 infusions received).
Mediano trajanje zdravljenja z docetakselom je znašalo 14,1 tedna v skupini z ramucirumabom in docetakselom (z mediano vrednostjo 4,0 prejete infuzije) in 12,0 tedna v skupini s placebom in docetakselom (z mediano vrednostjo 4,0 prejete infuzije).
Table 2: Criteria to be met prior to FOLFIRI administration Criteria
Tabela 2: Merila, ki jih je treba izpolnjevati pred dajanjem sheme FOLFIRI