natgillin/translations-raw huggingface dataset:
Ramucirumab should be permanently discontinued in patients who experience Grade 3 or 4 bleeding (see section 4.2).
Trajno prekinite zdravljenje z ramucirumabom pri bolnikih, pri katerih se pojavi krvavitev stopnje 3 ali 4 (glejte poglavje 4.2).
The blood pressure of patients should be monitored prior to each ramucirumab administration and treated as clinically indicated.
Pred vsakim dajanjem ramucirumaba spremljajte krvni tlak in ukrepajte glede na klinično indikacijo.
Hazard ratio (95% CI) Stratified log-rank p-value Abbreviations: CI = confidence interval
Razmerje tveganja (95 % IZ) p vrednost za stratificiran test log-rank Okrajšave: IZ = interval zaupanja
(n= 39) suggested a survival benefit in such patients (HR 0.679, 95% CI 0.327, 1.419) and demonstrated a benefit for progression free survival (PFS) (HR 0.399, 95% CI 0.194, 0.822).
Naknadne analize nestratificirane podskupine bolnikov iz študije RAINBOW, ki so bili predhodno zdravljeni s trastuzumabom (n=39) kažejo na korist za preživetje teh bolnikov (razmerje tveganja: 0,679, 95-% interval zaupanja 0,327, 1,419) in so dokazale korist za preživetje brez napredovanja bolezni (PFS) (razmerje tveganja: 0,399, 95-% interval zaupanja 0,194, 0,822).
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema trombocitopenijaa nevtropenijaa
Patients with uncontrolled hypertension were excluded from the trials: ramucirumab treatment should not be initiated in such patients until and unless their pre-existing hypertension is controlled.
zdravljenja z ramucirumabom pri takih bolnikih ne smete uvesti, dokler oziroma v kolikor obstoječa hipertenzija ni uravnana.
Placebo plus paclitaxel N=335
placebo in paklitaksel N=335
g Based on study RAISE (ramucirumab plus FOLFIRI).
g Na podlagi študije RAISE (ramucirumab in shema FOLFIRI).
d Based on study REVEL (ramucirumab plus docetaxel).
d Na podlagi študije REVEL (ramucirumab in docetaksel).
Infusion-related reactions were reported in clinical studies with ramucirumab.
V kliničnih preskušanjih z ramucirumabom so poročali o reakcijah, povezanih z infuzijo.
Respiratory, thoracic, and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa
Cyramza 10 mg/ml concentrate for solution for infusion ramucirumab
Cyramza 10 mg/ml koncentrat za raztopino za infundiranje ramucirumab
Haematological criteria in Table 2 are met and fever resolved
Hematološka merila v Tabeli 2 so izpolnjena in vročina je minila.
Neutropeniaa Leukopeniaa,c Thrombocytopeniaa
Bolezni krvi in limfatičnega sistema nevtropenijaa levkopenijaa,c trombocitopenijaa febrilna nevtropenijad
Ramucirumab should be immediately and permanently discontinued in the event of a grade 3 or 4 IRR (see section 4.4).
V primeru pojava IRR stopnje 3 ali 4 takoj in trajno prekinite uporabo ramucirumaba (glejte poglavje 4.4).
Table 3: Ramucirumab dose reductions for proteinuria Initial ramucirumab dose First dose reduction to Second dose reduction to
Tabela 3: Zmanjšanje odmerka ramucirumaba pri proteinuriji
Cyramza N=238
Zdravilo Cyramza N = 197
Patients with HCC should be selected based on a serum AFP concentration of ≥ 400 ng/ml with a validated AFP test prior to ramucirumab treatment (see section 5.1).
Testiranje alfa-fetoproteina (AFP) pri hepatocelularnem karcinomu Bolnike s hepatocelularnim karcinomom je treba pred zdravljenjem z ramucirumabom izbrati glede na koncentracijo AFP v serumu ≥ 400 ng/ml, določeno z validiranim testom za AFP (glejte poglavje 5.1).
There was an increase in median survival of 1.4 months in favour of the Cyramza plus docetaxel arm:
Opazili so porast medianega preživetja brez napredovanja bolezni za 1,2 meseca v korist skupine z zdravilom Cyramza in shemo FOLFIRI:
In RAINBOW, the incidences of Grade ≥3 hypertension, neutropenia, and leukopenia were increased with higher ramucirumab exposure.
V študiji RAINBOW so se incidence hipertenzije, nevtropenije in levkopenije stopnje ≥3 povečale z višjo izpostavljenostjo ramucirumabu.
Cmin prior to administration of the second, fourth and seventh dose of ramucirumab were 23.5 μg/ml (range of 2.9-76.5 μg/ml), 44.1 μg/ml (range of 4.2-137 μg/ml) and 60.2 μg/ml (range of
V serumu bolnikov s hepatocelularnim karcinomom so bile geometrične srednje vrednosti ramucirumaba Cmin pred dajanjem drugega, četrtega in sedmega odmerka ramucirumaba 23,5 μg/ml (obseg 2,9-76,5 μg/ml), 44,1 μg/ml (obseg 4,2-137 μg/ml) oziroma 60,2 μg/ml (obseg 18,3-123 μg/ml).
Following the dose regimen of 10 mg/kg ramucirumab every 3 weeks, the geometric means of ramucirumab Cmin were 28.3 μg/ml (range of 2.5-108 μg/ml) and 38.4 μg/ml (range of 3.1-128 μg/ml)
Ob upoštevanju režima odmerjanja 10 mg/kg ramucirumaba vsake 3 tedne je geometrično povprečje vrednosti Cmin za ramucirumab v serumu bolnikov z NSCLC znašalo 28,3 μg/ml (razpon 2,5108 μg/ml) in 38,4 μg/ml (razpon 3,1-128 μg/ml) pred dajanjem tretjega oziroma petega odmerka ramucirumaba, danega v kombinaciji z docetakselom.
Pre-specified analyses for OS and PFS by stratification factors were performed.
Opravljene so bile vnaprej določene analize za celokupno preživetje in preživetje brez napredovanja bolezni s faktorji stratifikacije.
Read the paclitaxel or docetaxel package leaflet for further information.
Za več informacij preberite navodila za uporabo paklitaksela oziroma docetaksela.
Haematological criteria in Table 2 are met
Hematološka merila v Tabeli 2 so izpolnjena.
Female fertility is likely to be compromised during treatment with ramucirumab based on studies in animals (see section 5.3).
da bo plodnost žensk med zdravljenjem z ramucirumabom slabša (glejte poglavje 5.3).
- if there is X-ray evidence that the lung cancer has a cavity or hole in it or if the lung cancer is close to major blood vessels.
- če ste alergični na ramucirumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6) - če obstajajo rentgenski dokazi, da ima pljučni rak luknjo ali votel del ali da je pljučni rak v bližini glavnih krvnih žil.
Days 8 and 15: ≥1.0 x 109/L
8. in 15. dan: ≥ 1,0 x 109/l
Progression-free survival was statistically significantly improved in patients receiving Cyramza as compared with patients receiving placebo (HR 0.483; 95%CI: 0.376 to 0.620; p<0.0001), corresponding to a 52% reduction in the risk of progression or death and an increase in median PFS to 2.1 months for Cyramza from 1.3 months for placebo.
Preživetje brez poslabšanja bolezni je bilo statistično bistveno boljše pri bolnikih, ki so prejemali zdravilo Cyramza, v primerjavi z bolniki, ki so prejemali placebo (razmerje tveganja: 0,483; 95-odstotni interval zaupanja: 0,376 do 0,620; p < 0,0001), kar ustreza 52-odstotnemu zmanjšanju tveganja napredovanja bolezni ter povečanju v medianem preživetju brez poslabšanja bolezni na 2,1 meseca za zdravilo Cyramza z 1,3 meseca za placebo.
Figure 8: Kaplan-Meier curves of Overall Survival for Cyramza versus placebo in REACH-2
Slika 8: Kaplan-Meierjeve krivulje celokupnega preživetja za zdravilo Cyramza v primerjavi s placebom v študiji REACH-2
Patients with a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders, a recent history of severe (Grade ≥3) bleeding or who had experienced an arterial thrombotic event (ATE) in the 12 months
Bolniki z anamnezo nenadzorovanih dednih ali pridobljenih krvavitev ali trombotskih motenj ali z nedavno hudo (d ≥ 3) krvavitvijo in bolniki, pri katerih je v
Ramucirumab therapy should be temporarily discontinued if there are wound healing complications, until the wound is fully healed (see section 4.4).
V primeru zapletov pri celjenju ran začasno prekinite zdravljenje z ramucirumabom, dokler ni rana v celoti zaceljena (glejte poglavje 4.4).
For patients with TTP ≥6 months after commencing first-line treatment the HR of OS was 0.86 (95% CI: 0.73 to 1.01), and 0.86 (95% CI: 0.64 to 1.13) in patients with TTP <6 months after commencing first-line treatment.
Pri bolnikih s časom do napredovanja bolezni ≥ 6 mesecev po začetku zdravljenja prve izbire je bil RT za celokupno preživetje 0,86 (95 % IZ: 0,73 do 1,01) in 0,86 (95 % IZ: 0,64 do
The concentrate for solution for infusion (or sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow solution in a glass vial with a rubber stopper.
Izgled zdravila Cyramza in vsebina pakiranja Koncentrat za raztopino za infundiranje (ali sterilni koncentrat) je bistra ali rahlo opalescentna in brezbarvna ali nekoliko rumenkasta tekočina v stekleni viali z gumijastim zamaškom.
ADRs of haemangioma and thrombotic microangiopathy were reported in ramucirumab clinical trials at a frequency of common (1.5%) and rare (0.03%), respectively, and through post-marketing reporting.
Neželeni učinki iz drugih virov V kliničnih preskušanjih z ramucirumabom so poročali o neželenih učinkih hemangiomu s pogostnostjo »pogosti« (1,5 %) in trombotični mikroangiopatiji s pogostnostjo »redki« (0,03 %).
Cyramza treatment will be permanently stopped if you:
Zdravljenje z zdravilom Cyramza bo trajno prekinjeno
Hypoalbuminaemiaa Hyponatraemiaa
Presnovne in prehranske hipoalbuminemijaa motnje hiponatriemijaa
REGARD, a multinational, randomised, double-blind study of Cyramza plus BSC versus placebo plus BSC, was conducted in 355 patients with locally recurrent and unresectable, or metastatic gastric cancer (including GEJ adenocarcinoma) following platinum- or fluoropyrimidine-containing chemotherapy.
REGARD, mednarodna, randomizirana, dvojno slepa študija z zdravilom Cyramza in najboljšo podporno nego v primerjavi s placebom in najboljšo podporno nego, je bila opravljena s 355 bolniki z lokalno napredovalim in neoperabilnim ali metastatskim rakom želodca (vključno z adenokarcinomom gastro-ezofagealnega prehoda) po zdravljenju s kemoterapijo, ki je vsebovala platino ali fluoropirimidin.
The infusion rate of ramucirumab should be reduced by 50% for the duration of the infusion and all subsequent infusions if the patient experiences a grade 1 or 2 IRR.
Če se pri bolniku pojavi IRR stopnje 1 ali 2, zmanjšajte hitrost infundiranja ramucirumaba za 50 % v času tega infundiranja in za vsa nadaljnja infundiranja.
Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1).
Zdravilo Cyramza je v kombinaciji s paklitakselom indicirano za zdravljenje odraslih bolnikov z napredovalim rakom želodca ali adenokarcinomom gastro-ezofagealnega prehoda z napredovalo boleznijo po predhodni kemoterapiji, ki je vključevala platino in fluoropirimidin (glejte poglavje 5.1).
Following the dose regimen of 8 mg/kg every 2 weeks, the geometric means of ramucirumab Cmin prior to administration of the fourth and seventh dose of ramucirumab given as a single agent in advanced gastric cancer patients' serum were 49.5 μg/ml (range of 6.3-228 μg/ml) and 74.4 μg/ml (range of 13.8-234 μg/ml), respectively.
Po režimu odmerjanja 8 mg/kg vsaka 2 tedna so bile pred dajanjem četrtega in sedmega odmerka ramucirumaba, danega v obliki monoterapije, v serumu bolnikov z napredovalim rakom želodca dosežene geometrične srednje vrednosti ramucirumaba Cmin 49,5 μg/ml (obseg 6,3-228 μg/ml) in
If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU.
Če se je diareja izboljšala do razreda ≤ 1, 5-FU zmanjšajte za 1 odmerno raven.
REACH-2 efficacy results are shown in Table 12 and Figure 8.
Rezultati učinkovitosti so prikazani v Tabeli 10 in na Slikah 4 in 5.
Add a sufficient quantity of sodium chloride 9 mg/ml (0.9%) solution for injection to the container to make the total volume 250 ml.
vsebnik dodajte zadostno količino raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje, da bo skupna prostornina znašala 250 ml. Vsebnik morate nežno obrniti, da zagotovite zadostno mešanje.
during treatment with Cyramza or anytime thereafter: - Blocking of the arteries by a blood clot (‘arterial thromboembolic events'):
Takoj se posvetujte z zdravnikom ali medicinsko sestro, če kar koli od naslednjega velja za vas (ali če niste prepričani) med zdravljenjem z zdravilom Cyramza ali po njem: Krvni strdki v arterijah (arterijski trombembolični dogodki):
RAISE was a global, randomised, double-blind, study of Cyramza plus FOLFIRI versus placebo plus FOLFIRI, in patients with mCRC, who had disease progression on or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
Študija RAISE je bila globalna, randomizirana, dvojno slepa študija učinkov zdravila Cyramza in sheme FOLFIRI v primerjavi z učinki placeba in sheme FOLFIRI pri bolnikih z metastatskim kolorektalnim rakom, z napredovanjem bolezni ob ali po predhodnem zdravljenju prve izbire z bevacizumabom, oksaliplatinom in fluoropirimidinom.
Ramucirumab therapy should be temporarily discontinued in the event of severe hypertension, until controlled with medical management.
V primeru hude hipertenzije začasno prekinite zdravljenje z ramucirumabom, dokler hipertenzija ni nadzorovana z ustreznimi zdravstvenimi ukrepi.
REACH-2 was a global, randomised, double-blind study of Cyramza plus BSC versus placebo plus BSC that randomised (2:1) 292 patients with HCC who had a serum AFP ≥ 400 ng/ml at study entry.
Vanjo je bilo randomiziranih (2 : 1) 292 bolnikov s hepatocelularnim karcinomom, ki so imeli ob vstopu v študijo vrednost AFP v serumu ≥ 400 ng/ml.
10 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
6.5 Vrsta ovojnine in vsebina 10 ml raztopine v viali (iz stekla tipa I) z zamaškom iz klorobutilne gume, aluminijasto zaporko in polipropilenskim pokrovčkom.
ORR % (95% CI) p-value Abbreviations: CI = confidence interval, CR = complete response, ORR = objective response rate and PR = partial response
Preživetje brez napredovanja bolezni, meseci Mediana (95 % IZ) Razmerje tveganja (95 % IZ) p-vrednost za stratificiran test logrank Objektivna stopnja odziva (CR + PR) ORR % (95 % IZ) p-vrednost Okrajšave: IZ = interval zaupanja, CR = popoln odziv, ORR = objektivna stopnja odziva in PR = delni odziv
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 10 ml vial
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 10-mililitrska viala
Name and address of the manufacturers of the biological active substance ImClone Systems LLC
Ime in naslov izdelovalcev, biološke učinkovine
Also, patients receiving any kind of therapeutic anticoagulation and/or chronic therapy with non-steroidal anti-inflammatory drugs or other antiplatelets agents or those with untreated, clinically unstable brain/CNS metastases were excluded Aspirin use at doses up to 325 mg/day was permitted.
Prav tako so bili izključeni bolniki, ki so prejemali kakršno koli zdravljenje proti strjevanju krvi in/ali kronično zdravljenje z nesteroidnimi protivnetnimi zdravili ali drugimi zaviralci agregacije trombocitov, ter bolniki z nezdravljenimi, klinično nestabilnimi metastazami v možganih/osrednjem živčnem sistemu.
Ramucirumab should be used with caution in patients with severe liver cirrhosis (Child-Pugh B or C), cirrhosis with hepatic encephalopathy, clinically significant ascites due to cirrhosis, or hepatorenal syndrome.
Ramucirumab je treba uporabljati previdno pri bolnikih s hudo cirozo jeter (Child-Pugh razred B ali
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Med ramucirumabom in paklitakselom niso opazili medsebojnega delovanja.
You may be given another medicine to reduce the risk of an infusion-related reaction before you receive Cyramza.
Premedikacija Preden boste prejeli prvi odmerek zdravila Cyramza, boste morda prejeli zdravila za zmanjšanje tveganja za reakcijo, povezano z infuzijo.
Paclitaxel at 80 mg/m2 was administered by intravenous infusion on days 1, 8, and 15 of each 28-day cycle.
Paklitaksel v odmerku 80 mg/m2 je bil dan z intravenskim infundiranjem 1., 8. in 15. dan vsakega 28-dnevnega cikla.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 50 ml vial
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 50-mililitrska viala
Ramucirumab should be permanently discontinued in patients who experience gastrointestinal perforations (see section 4.2).
Trajno prekinite zdravljenje z ramucirumabom pri bolnikih, pri katerih se pojavijo gastrointestinalne perforacije (glejte poglavje 4.2).
Withhold 5-FU for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 dose levels for 5-FU.
Prekinite dajanje 5-FU za največ 28* dni do izboljšanja učinka do razreda ≤ 1, nato odmerek 5-FU zmanjšajte za
One ml of concentrate contains 10 mg ramucirumab.
En mililiter koncentrata vsebuje 10 mg ramucirumaba.
Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 levels for
Zamaknite 5-FU in irinotekan za največ 28* dni do izboljšanja učinka do razreda ≤ 1, nato odmerek
Severe gastrointestinal haemorrhage, including fatal events, were reported in patients with gastric cancer treated with ramucirumab in combination with paclitaxel, and in patients with mCRC treated with ramucirumab in combination with FOLFIRI.
Pri bolnikih z rakom želodca, ki so se zdravili z ramucirumabom v kombinaciji s paklitakselom, in pri bolnikih z metastatskim kolorektalnim rakom, ki so se zdravili z ramucirumabom v kombinaciji s shemo FOLFIRI, so poročali o hudih gastrointestinalnih krvavitvah, vključno s smrtnimi primeri.
Ramucirumab should be temporarily discontinued for severe hypertension until controlled with medical management.
Pri hudi hipertenziji začasno prekinite zdravljenje z ramucirumabom, dokler hipertenzija ni nadzorovana z ustreznimi zdravstvenimi ukrepi.
The final total volume in the container should be 250 ml.
Skupna končna prostornina v vsebniku mora znašati 250 ml. Vsebnik morate nežno obrniti, da zagotovite zadostno mešanje.
f Based on study RAINBOW (ramucirumab plus paclitaxel) and study RAISE (ramucirumab plus FOLFIRI).
f Na podlagi študije RAINBOW (ramucirumab in paklitaksel) in študije RAISE (ramucirumab in shema
Overall survival was statistically significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (HR 0.807; 95% CI: 0.678 to 0.962; p=0.0169).
Celokupno preživetje je bilo statistično bistveno boljše pri bolnikih, ki so prejemali zdravilo Cyramza in paklitaksel, v primerjavi z bolniki, ki so prejemali placebo in paklitaksel (razmerje tveganja: 0,807; 95-odstotni interval zaupanja: 0,678 do 0,962; p = 0,0169).
A consistent improvement (ramucirumab plus docetaxel vs placebo plus docetaxel) was observed in important subgroups for PFS and OS. OS subgroup results included the following: non-squamous histology (HR 0.83; 95% CI: 0.71 to 0.97; median OS [mOS]: 11.1 vs 9.7 months) and squamous histology (HR 0.88; 95% CI: 0.69 to 1.13; mOS: 9.5 vs 8.2 months); patients with prior maintenance (HR 0.69; 95% CI: 0.51 to 0.93; mOS: 14.4 vs 10.4 months); time since start of prior therapy <9 months (HR 0.75; 95% CI: 0.64 to 0.88; mOS: 9.3 vs 7.0 months); patients <65 years old (HR 0.74, 95% CI: 0.62, 0.87; mOS: 11.3 vs 8.9 months).
(RT: 0,83; 95 % IZ: 0,71 do 0,97; mediano celokupno preživetje [mOS]: 11,1 v primerjavi z 9,7 meseca) in ploščatocelična histologija (RT: 0,88; 95 % IZ: 0,69 do 1,13; mOS: 9,5 v primerjavi z 8,2 meseca); bolniki s predhodnim vzdrževanjem (RT; 0,69; 95 % IZ: 0,51 do 0,93; mOS: 14,4 v primerjavi z 10,4 meseca); čas od začetka predhodnega zdravljenja < 9 mesecev (RT: 0,75; 95 %
Premedication is recommended with a histamine H1 antagonist (for example diphenhydramine) prior to infusion of ramucirumab.
Pred infundiranjem ramucirumaba je priporočljiva premedikacija z antagonistom histaminskih receptorjev H1 (npr. z difenhidraminom).
In RAISE, the incidence of Grade ≥3 neutropenia was increased with higher ramucirumab exposure.
V študiji RAISE se je incidenca nevtropenije stopnje ≥3 povečala z višjo izpostavljenostjo ramucirumabu.
Severe gastrointestinal haemorrhage (see section 4.4) Arterial thromboembolic events (see section 4.4)
gastrointestinalna perforacija (glejte poglavje 4.4) huda gastrointestinalna krvavitev (glejte poglavje 4.4)
In REVEL, the incidences of Grade ≥3 febrile neutropenia and hypertension were increased with higher ramucirumab exposure.
V študiji REVEL so se incidence febrilne nevtropenije in hipertenzije stopnje ≥3 povečale z višjo izpostavljenostjo ramucirumabu.
Randomisation was stratified by geographic region, gender, prior maintenance, and ECOG PS. Cyramza at 10 mg/kg or placebo and docetaxel at 75 mg/m2 were each administered by intravenous infusion on day 1 of a 21-day cycle.
Zdravilo Cyramza v odmerku 10 mg/kg ali placebo in docetaksel v odmerku 75 mg/m2 so dajali z intravensko infuzijo na 1. dan 21-dnevnega cikla.
If a patient experiences a Grade 1 or 2 infusion-related reaction premedication must be given for all subsequent infusions.
infusion-related reaction) stopnje 1 ali 2 po skupnih kriterijih terminologije neželenih dogodkov, je treba premedikacijo uporabiti za vsa nadaljnja infundiranja.
One ml of concentrate for solution for infusion contains 10 mg ramucirumab.
En mililiter koncentrata za raztopino za infundiranje vsebuje 10 mg ramucirumaba.
≤ Grade 1 (National Cancer Institute Common
Nacionalnega inštituta za rakava obolenja)
Chemotherapy-related gastrointestinal toxicity
povezana s kemoterapijo
Pre-specified subgroup analyses for both PFS and OS according to age (<65 and ≥65 years), gender, race, ECOG PS (0 or ≥1), number of organs involved, liver metastases only, site of primary tumour (colon or rectum), carcinoembryonic antigen levels (<200 μg/L, ≥200 μg/L), all showed a treatment effect favouring Cyramza plus
ali ≥ 1), število vključenih organov, izključno jetrne metastaze, mesto primarnega tumorja (kolon ali rektum), ravni karcinoembrionskega antigena (< 200 μg/l, ≥ 200 μg/l), ki so vse pokazale učinek zdravljenja v korist zdravila Cyramza in sheme FOLFIRI pred placebom in shemo FOLFIRI.
Hazard ratio (95% CI) Stratified log-rank p-value Progression free survival, months Median (95% CI)
Razmerje tveganja (95 % IZ) p vrednost za stratificiran test log-rank Preživetje brez napredovanja bolezni, meseci
Progression-free survival was statistically significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (HR 0.635; 95% CI: 0.536 to 0.752; p<0.0001).
Preživetje brez poslabšanja bolezni je bilo statistično bistveno boljše pri bolnikih, ki so prejemali zdravilo Cyramza in paklitaksel, v primerjavi z bolniki, ki so prejemali placebo in paklitaksel (razmerje tveganja: 0,635; 95-odstotni interval zaupanja: 0,536 do 0,752; p < 0,0001).
Cyramza treatment will be temporarily stopped if you:
Zdravljenje z zdravilom Cyramza bo morda treba začasno prekiniti,
Cyramza 10 mg/ml concentrate for solution for infusion
IME ZDRAVILA Cyramza 10 mg/ml koncentrat za raztopino za infundiranje
Docetaxel dose adjustments
Prilagajanje odmerka docetaksela
No dose modification.
Prilagajanje odmerka ni potrebno.
There are no data regarding ramucirumab administration in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Podatkov o dajanju ramucirumaba pri bolnikih s hudo okvarjenim delovanjem jeter ni (glejte poglavji 4.4 in 5.2) Zmanjšanja odmerkov niso potrebna.
Concentrate for solution for infusion 500 mg/50 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 mg/50 ml
In the pooled data from REACH-2 and REACH (patients with alpha fetoprotein ≥ 400 ng/ml), the incidences of Grade ≥ 3 hypertension was increased with higher ramucirumab exposure.
≥ 400 ng/ml) so se incidence hipertenzije stopnje ≥ 3 povečale z višjo izpostavljenostjo ramucirumabu.