natgillin/translations-raw huggingface dataset:
Before initiating Cyramza, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo zdravila Cyramza je treba pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anevrizma, to tveganje dobro preučiti.
Two-thirds of the patients experienced disease progression while still on first-line therapy (66.8%).
Pri dveh tretjinah bolnikov je prišlo do napredovanja bolezni, medtem ko so se še zdravili z zdravljenjem prve izbire (66,8 %).
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Pogosto (≥ 1/100 do < 1/10) Občasno (≥ 1/1.000 do < 1/100) Redko (≥ 1/10.000 do < 1/1.000)
Ask your pharmacist how to throw away medicines you no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujete s farmacevtom.
(12.5%), thrombocytopenia (4.2%), diarrhoea (2.3%) and stomatitis (2.3%).
nevtropenija (12,5 %), trombocitopenija (4,2 %), diareja (2,3 %) in stomatitis (2,3 %).
As Cyramza inhibits the development of new blood vessels, it may decrease the likelihood of you becoming pregnant or maintaining a pregnancy.
Ker zdravilo Cyramza zavira razvoj novih krvnih žil, lahko zmanjša verjetnost, da boste zanosili ali ohranili nosečnost.
By attaching to ‘VEGF receptor 2' and blocking it the medicine cuts off the blood supply to the cancer cells.
S pritrditvijo na „receptor VEGF 2“ in z zaviranjem le-tega zdravilo prekine oskrbo rakavih celic s krvjo.
The amount of protein in your urine will be checked regularly during treatment.
Med zdravljenjem bodo redno preverjali količino beljakovin v vašem urinu.
Antibodies are principally cleared by catabolism.
Protitelesa se v glavnem izločajo s katabolično razgradnjo.
- are going to have planned surgery, if you had recent surgery or if you have poor wound healing after surgery.
- boste imeli načrtovano operacijo, če ste pred kratkim imeli operacijo ali če se vam po operaciji kirurška rana slabo celi.
Treatment with Cyramza may need to be stopped temporarily until the levels of protein in the urine decrease and then treatment resumed at a lower dose, or stopped permanently if the urine protein level does not reduce sufficiently.
Zdravljenje z zdravilom Cyramza bo morda treba začasno prekiniti, dokler se ravni beljakovin v urinu ne znižajo, nato pa zdravljenje nadaljevati z nižjim odmerkom, ali pa trajno prekiniti, če se raven beljakovin v urina ne zniža v zadostni meri.
Cyramza may cause changes in laboratory tests.
Zdravilo Cyramza lahko povzroči spremembe v laboratorijskih testih.
The amount of paclitaxel or docetaxel needed depends on the surface area of your body.
Količina paklitaksela ali docetaksela, ki ga potrebujete, je odvisna od površine vašega telesa.
It is recommended that treatment be continued until disease progression or until unacceptable toxicity has occurred.
Zdravljenje je priporočljivo nadaljevati do napredovanja osnovne bolezni ali do nastopa nesprejemljive toksičnosti.
Cyramza has been administered in a Phase 1 study up to 10 mg/kg every two weeks without reaching a maximum tolerated dose.
Zdravilo Cyramza so v študiji 1. faze dajali v odmerku do 10 mg/kg vsaka dva tedna, ne da bi dosegli največji tolerančni odmerek.
Patients who discontinued one or more components of treatment because of an adverse event were permitted to continue therapy with the other treatment component(s) until disease progression or unacceptable toxicity.
ki so zaradi neželenega učinka prenehali uporabljati eno ali več komponent zdravljenja, so lahko nadaljevali zdravljenje z drugimi komponentami zdravljenja do napredovanja bolezni ali nesprejemljive toksičnosti.
Severe bleeding
Huda krvavitev
It is given with other medicines called ‘FOLFIRI chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Daje se skupaj z drugimi zdravili, imenovanimi »kemoterapija FOLFIRI«, ki vključujejo »5-fluorouracil«, »folinsko kislino« in »irinotekan«.
The majority of patients (76%) had experienced disease progression within 6 months from the start of first-line therapy.
Pri večini bolnikov (76 %) se je poslabšanje bolezni pojavilo v 6 mesecih po začetku zdravljenja prve izbire.
Ramucirumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Ramucirumab je človeško monoklonsko protitelo IgG1, izdelano v celicah glodavcev (NS0) s pomočjo rekombinantne DNA tehnologije.
Cyramza is available in packs of: - 1 vial of 10 ml - 2 vials of 10 ml - 1 vial of 50 ml
Zdravilo Cyramza je na voljo v pakiranjih po: - 1 vialo z 10 ml - 2 viali z 10 ml - 1 vialo z 50 ml
Eleven (2.2%) of ramucirumab treated patients and two (0.5%) of control treated patients developed ADAs.
Pri enajstih (2,2 %) bolnikih, zdravljenih z ramucirumabom, in dveh (0,5 %) bolnikih, zdravljenih s kontrolnim zdravilom, so se razvila protitelesa na zdravila.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Zahteve za predložitev rednih posodobljenih poročil o varnosti zdravila za ta zdravila, so navedene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c (7) Direktive
The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Uporaba zaviralcev disekcije VEGF poti pri bolnikih s hipertenzijo ali brez nje lahko spodbuja nastanek anevrizme in/ali disekcije arterij.
This is a specialised protein that can recognise and attach to another protein found on blood vessels called ‘VEGF receptor 2'.
To je posebna beljakovina, ki lahko prepozna in se veže na drugo beljakovino, ki jo najdemo na krvnih žilah, imenovano „receptor VEGF 2 (receptor 2 žilnega endotelijskega rastnega faktorja (VEGFvascular endothelial growth factor))“.
Elderly patients with NSCLC
Starejši bolniki z NSCLC
In case of overdose, supportive therapy should be used.
V primeru prevelikega odmerjanja uporabite podporno zdravljenje.
Patients in two Phase 3 studies, RAINBOW and REGARD were tested at multiple time-points for anti-drug antibodies (ADAs).
Bolnike v dveh študijah 3. faze, RAINBOW in REGARD, so v številnih časovnih točkah testirali glede protiteles na zdravila.
Ramucirumab therapy must be initiated and supervised by physicians experienced in oncology.
Zdravljenje z ramucirumabom morajo uvesti in nadzirati zdravniki z izkušnjami v onkologiji.
Cyramza is not recommended during pregnancy and in women of childbearing potential not using contraception.
Uporaba zdravila Cyramza ni priporočena med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC21.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC21.
- have any condition which increases the risk of bleeding.
- imate kakršno koli bolezen, ki poveča tveganje za krvavitev.
Tell your doctor if you experience any of the following other side effects:
Obvestite zdravnika, če se pri vas pojavi kateri koli od naslednjih neželenih učinkov:
Dosage and frequency of administration
Odmerek in pogostnost uporabe
Prior to being given any paclitaxel infusion, you will have blood tests to check that your blood counts are high enough and that your liver is functioning well.
Preden boste prejeli infuzijo paklitaksela, bodo opravili krvne preiskave, s katerimi bodo preverili, ali je vaša krvna slika ustrezna in ali vaša jetra delujejo primerno.
Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in na nalepki viale poleg oznake »uporabno do«.
The most frequent component of FOLFIRI to be discontinued was the 5-FU bolus.
Najpogostejša komponenta sheme FOLFIRI, s katero je bilo zdravljenje prekinjeno, je bil bolus 5-FU.
Each 10 ml vial contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free'.
Ena 10-mililitrska viala vsebuje manj kot 1 mmol (23 mg) natrija, kar v bistvu pomeni ‘brez natrija'.
Your doctor will discuss with you if the potential benefits of treatment are judged to outweigh the potential risks for you.
Zdravnik se bo pogovoril z vami, ali morebitne koristi zdravljenja odtehtajo morebitna tveganja za vas.
Randomisation was stratified by weight loss over the prior 3 months (≥ 10% versus < 10%), geographic region, and location of the primary tumour (gastric versus GEJ).
Randomizacija je bila stratificirana z izgubo telesne mase v obdobju predhodnih 3 mesecev (≥ 10 % proti < 10 %), geografsko regijo in mestom primarnega tumorja (želodec proti gastro-ezofagealnemu prehodu).
f Includes one case of nephrotic syndrome
f Vključuje en primer nefrotičnega sindroma.
Other medicines and Cyramza
Druga zdravila in zdravilo Cyramza
Aspirin use at doses up to 325 mg/day was permitted (see section 5.1).
Dovoljena je bila uporaba zdravila Aspirin v odmerkih do 325 mg/dan (glejte poglavje 4.4).
- Abnormal urine test (‘proteinuria'): Cyramza may increase the risk of developing or worsening of abnormal levels of protein in the urine.
Nenormalni rezultati urinskega testa („proteinurija“): Zdravilo Cyramza lahko poveča tveganje za razvoj ali poslabšanje nenormalnih ravni beljakovin v urinu.
Table 5 provides details of dose delays or dose reductions of components of FOLFIRI at the next cycle based on maximum grade of specific adverse drug reactions.
V Tabeli 5 so navedene podrobnosti glede zamika ali zmanjšanja odmerkov posameznih komponent sheme FOLFIRI ob naslednjem ciklu, ob upoštevanju najvišjega razreda neželenih učinkov zdravila.
As angiogenesis is critical to maintenance of pregnancy and to foetal development, the inhibition of angiogenesis following ramucirumab administration may result in adverse effects on pregnancy, including the foetus.
Ker je angiogeneza ključnega pomena za ohranjanje nosečnosti in razvoj ploda, lahko zaviranje angiogeneze po dajanju ramucirumaba povzroči neželene učinke na nosečnost, vključno s plodom.
If you experience any symptoms affecting your ability to concentrate and react, do not drive or use machines until the effect goes away.
Če se pri vas pojavijo simptomi, ki bi vplivali na vašo sposobnost koncentracije in reagiranja, ne upravljajte z vozili in stroji, dokler ti učinki ne izzvenijo.
Based on simulations using the PopPK model, steady state would be attained by the sixth dose.
Na podlagi simulacij z uporabo modela populacijske farmakokinetike naj bi bilo ravnotežno stanje doseženo s šestim odmerkom.
Ramucirumab is a human receptor-targeted antibody that specifically binds VEGF Receptor 2 and blocks binding of VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand stimulated activation of VEGF Receptor 2 and its downstream signalling components, including p44/p42 mitogen-activated protein kinases, neutralising ligand-induced proliferation and migration of human endothelial cells.
Ramucirumab je humano protitelo, ciljno usmerjeno na receptorje, ki se specifično veže na receptor VEGF 2 ter zavira vezavo VEGF-A, VEGFC in VEGF-D. Posledično ramucirumab zavira z ligandom stimulirano aktivacijo receptorja VEGF 2 in njegovih nadaljnjih signalnih komponent, vključno s proteinskimi kinazami p44/p42, aktiviranimi z mitogenom, nevtralizacijo z ligandom povzročene proliferacije ter migriranjem humanih endotelijskih celic.
What Cyramza is and what it is used for
Kaj je zdravilo Cyramza in za kaj ga uporabljamo
Includes: fatigue and asthenia.
Vključuje: utrujenost in astenijo.
However, since ramucirumab is an antiangiogenic therapy and may have the potential to adversely affect wound healing, ramucirumab treatment should be withheld for at least 4 weeks prior to scheduled surgery.
Ker pa je ramucirumab antiangiogeno zdravilo in lahko negativno vpliva na celjenje ran, je treba zdravljenje z ramucirumabom vsaj 4 tedne pred načrtovanim kirurškim posegom prekiniti.
If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ºC to 8 ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Če zdravila ne uporabite takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas ne sme biti daljši od 24 ur pri temperaturi od 2 do 8 ºC, razen če je bilo redčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
Once the urine protein level has decreased to a certain level, treatment may be restarted with a lower dose.
Ko raven beljakovin pade do določene mere, se lahko znova uvede zdravljenje z nižjim odmerkom.
All medicinal products were administered intravenously.
Vsa zdravila so bila dana intravensko.
To grow, cancer needs new blood vessels to develop.
Da rak lahko napreduje, potrebuje za svoj razvoj nove krvne žile.
- have lung cancer and have had recent bleeding in the lung (coughing up bright red blood) or you are regularly taking non-steroidal anti-inflammatory medicines, or medicines which affect blood clotting ability.
- imate pljučni rak in ste imeli nedavno krvavitev v pljuča (izkašljevanje svetlo rdeče krvi) ali če redno jemljete nesteroidna protivnetna zdravila ali zdravila, ki vplivajo na zmožnost strjevanja krvi.
If patients experience symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Če se pri bolnikih pojavijo simptomi, ki vplivajo na njihovo sposobnost koncentracije in reagiranja, je priporočljivo, da z vozili in stroji ne upravljajo, dokler ti učinki ne izzvenijo.
Administer via infusion pump.
Dajajte prek infuzijske črpalke.
d Includes: blood pressure increased and hypertension.
d Vključuje: povišan krvni tlak in hipertenzijo.
- have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
- imate ali ste imeli anevrizmo (povečanje in oslabitev stene krvnih žil) ali raztrganje v steni krvnih žil.
Each 50 ml vial contains approximately 85 mg sodium (main component of cooking/table salt).
Ena 50-mililitrska viala vsebuje približno 85 mg natrija (glavne sestavine kuhinjske soli).
Cyramza is for intravenous use.
Zdravilo Cyramza je za intravensko uporabo.
Exposure response relationships
Razmerja odziva na izpostavljenost
Patients were required to have adequate hepatic, renal and coagulation function.
Bolniki so morali imeti zadovoljivo koagulacijsko funkcijo ter delovanje jeter in ledvic.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Študije na živalih niso bile zadostne, da bi dokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Exposure-response analyses indicated that efficacy was correlated with ramucirumab exposure across pivotal studies.
Analize odziva na izpostavljenost so pokazale, da je bila učinkovitost soodnosna z izpostavljenostjo ramucirumabu v ključnih študijah.
Non-small cell lung cancer (NSCLC)
Nedrobnocelični pljučni rak (NSCLC)
Table 1: Criteria to be met prior to each paclitaxel administration Criteria
Tabela 1: Kriteriji, ki morajo biti izpolnjeni pred vsakim dajanjem paklitaksela Kriterij
For NCI CTCAE Grade 4 haematological toxicity or Grade 3 paclitaxel-related non-haematological toxicity, it is recommended to reduce the paclitaxel dose by 10 mg/m2 for all following cycles.
Za hematološko toksičnost stopnje 4 po NCI CTCAE ali za nehematološko toksičnost, povezano s paklitakselom, stopnje 3 je priporočljivo zmanjšanje odmerka paklitaksela za 10 mg/m2 za vse naslednje cikle.
Criteria to be met prior to each paclitaxel infusion are provided in Table 1.
Kriteriji, ki morajo biti izpolnjeni pred vsakim infundiranjem paklitaksela, so navedeni v Tabeli 1.
Based on PopPK, there was no difference in ramucirumab exposure in patients ≥65 years of age compared to patients <65 years old.
Na podlagi populacijske farmakokinetike niso opazili razlik v izpostavljenosti ramucirumabu pri bolnikih, starih ≥ 65 let, v primerjavi z bolniki, starimi < 65 let.
Ramucirumab has not been studied in patients with severe hepatic impairment (total bilirubin >3.0 ULN and any AST).
Ramucirumaba niso proučevali pri bolnikih s hudo okvarjenim delovanjem jeter (celokupni bilirubin > 3,0 ULN in kakršna koli vrednost AST).
Histidine monohydrochloride Sodium chloride Glycine (E640) Polysorbate 80 (E433) Water for injections
Histidinijev klorid Natrijev klorid Glicin (E640) Polisorbat 80 (E433) Voda za injiciranje
11% of patients treated with Cyramza and 6% of patients on placebo discontinued therapy due to adverse events.
11 % bolnikov, zdravljenih z zdravilom Cyramza, in 6 % bolnikov, ki so prejemali placebo, je zdravljenje prekinilo zaradi neželenih učinkov.
The recommended dose of paclitaxel is 80 mg for every square metre (m²) of your body's surface area once every week for 3 weeks followed by 1 week without treatment.
Priporočeni odmerek paklitaksela je 80 mg za vsak kvadratni meter (m²) površine vašega telesa enkrat na teden 3 tedne, ki jim sledi 1 teden brez zdravljenja.
No liver metastases: ALT/AST ≤3 x ULN Liver metastases: ALT/AST ≤5 x ULN
Metastaze jeter: ALT/AST ≤5 x ULN
If you are receiving Cyramza in combination with either paclitaxel or docetaxel on the same day, Cyramza will be given first.
Če prejemate zdravilo Cyramza v kombinaciji s paklitakselom ali docetakselom na isti dan, boste najprej prejeli zdravilo Cyramza.
Prior to chemotherapy, patients should have a complete blood count.
Pred kemoterapijo je treba bolnikom odvzeti kri za popolno krvno sliko.
See prescribing information for paclitaxel, for components of FOLFIRI and for docetaxel, as applicable, for premedication requirements and additional information.
Glejte navodila za predpisovanje paklitaksela, sheme FOLFIRI in docetaksela, kot je ustrezno, za pogoje premedikacije in dodatne informacije.
ADRs of aneurysms and artery dissections have a frequency of ‘not known'.
Neželeni učinki in arterijske disekcije imajo nepoznano pogostnost.
If you are of East Asian origin, you may receive a reduced docetaxel starting dose of 60 mg per every m2 of your body's surface area once every 3 weeks.
Če ste vzhodnoazijskega porekla, boste morda prejeli zmanjšan začetni odmerek docetaksela 60 mg na en m2 površine vašega telesa, enkrat na vsake 3 tedne.
- have severe liver disease (‘cirrhosis') and associated conditions, such as excessive accumulation of fluid in your abdomen (‘ascites').
- imate hudo bolezen jeter (cirozo) in povezane težave, kot je prekomerno kopičenje tekočine v vašem trebuhu (vodenica).
There are no data from the use of ramucirumab in pregnant women.
V zvezi z uporabo ramucirumaba pri nosečnicah ni podatkov.
- Inflammation of the mouth (‘stomatitis'): Cyramza, when given in combination with chemotherapy may increase the risk of developing inflammation of the mouth.
Vnetje ustne sluznice (»stomatitis«): Zdravilo Cyramza lahko v kombinaciji s kemoterapijo poveča tveganje za razvoj vnetja v ustih.
A majority (75%) of patients randomised in the study received prior platinum and fluoropyrimidine combination therapy without anthracycline.
Večina bolnikov (75 %), ki so bili vključeni v študijo, je pred tem prejemala kombinirano zdravljenje s platino in fluoropirimidinom brez antraciklina.
Based on PopPK, the following covariates were found to have no impact on ramucirumab disposition: age, sex, race, albumin levels.
Po načelih populacijske farmakokinetike so odkrili, da naslednje sospremenljivke nimajo vpliva na dispozicijo ramucirumaba: starost, spol, rasa, ravni albumina.
Symptoms may include sweating or other signs of infection, such as headache, pain in the limbs or decreased appetite.
Simptomi lahko vključujejo potenje ali druge znake okužbe, kot so npr. glavobol, bolečina v udih ali zmanjšan apetit.
*The 28 day time period begins on day 1 of the cycle subsequent to the ADR.
*28-dnevno obdobje se začne na 1. dan cikla po pojavu neželenega učinka zdravila.
Cyramza should not be administered or mixed with dextrose solutions.
Zdravila Cyramza se ne sme dajati ali mešati z raztopinami dekstroze.
If you experience an infusion-related reaction during treatment, the time taken to give your infusion will be increased for the rest of that infusion and for all future infusions.
Če se med zdravljenjem pri vas pojavi reakcija, povezana z infuzijo, bo čas dajanja vaše infuzije podaljšan ob tem in vseh prihodnjih infundiranjih.
e Includes: blood pressure increased, hypertension, and hypertensive cardiomyopathy.
e Vključuje: povišan krvni tlak, hipertenzijo in hipertenzivno kardiomiopatijo.
- Infusion-related reaction: Infusion-related reactions may happen during treatment because Cyramza is given as an intravenous infusion via a drip (see section 3).
Reakcija, povezana z infuzijo: Med zdravljenjem se lahko pojavijo reakcije, povezane z infuzijo, saj zdravilo Cyramza dajemo intravensko (kapalna infuzija) (glejte poglavje 3).
In both treatment arms, patients who experienced neutropenia had a longer median OS compared to patients who did not experience neutropenia.
V obeh skupinah zdravljenja je bilo pri bolnikih z nevtropenijo katerega koli razreda preživetje daljše kot pri bolnikih, pri katerih se nevtropenija ni pojavila.
Overall survival, months Median (95% CI)
Celokupno preživetje, meseci Mediana (95 % IZ)
If the patient becomes pregnant while being treated with ramucirumab, she should be informed of the potential risk to the maintenance of pregnancy and the risk to the foetus.
Če bolnica zanosi med zdravljenjem z ramucirumabom, je treba bolnico obvestiti o možnem tveganju za ohranitev nosečnosti in o tveganju za plod.
If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C.
Če zdravila ne uporabite takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas ne sme biti daljši od 24 ur pri temperaturi od 2 ºC do 8 ºC.
What you need to know before you are given Cyramza You must not be given Cyramza
Kaj morate vedeti, preden boste uporabili zdravilo Cyramza Ne smete prejeti zdravila Cyramza
The median relative dose intensity of Cyramza was 98.6% and of placebo was 99.6%.
Mediana intenzivnost relativnega odmerka zdravila Cyramza je znašala 98,6 %, placeba pa 99,6 %.
The primary QoL analysis showed similar time to deterioration for all Lung Cancer Symptom Scale (LCSS) scores between treatment arms.
Primarna analiza kakovosti življenja (QoL) je pri obeh skupinah zdravljenja pokazala podoben čas do poslabšanja vseh ocen na lestvicah simptomov pljučnega raka (Lung Cancer Symptom Scale; LCSS).
Ramucirumab therapy should be temporarily discontinued for at least 4 weeks prior to elective surgery.
Zdravljenje z ramucirumabom je treba začasno prekiniti vsaj 4 tedne pred načrtovanim kirurškim posegom.
The impact of ramucirumab has not been evaluated in patients with serious or non-healing wounds.
Vpliv ramucirumaba ni bil ocenjen pri bolnikih s hudimi ranami oz. z ranami, ki se ne celijo.
1,200 mg/m2 over 46-48 hours a 5-FU = 5-fluorouracil.
1.200 mg/m2 v 46-48 urah a 5-FU = 5-fluorouracil
Includes: leukopenia and white blood cell count decreased.
Vključuje: levkopenijo in zmanjšano število belih krvnih celic.
The concentrate is a clear to slightly opalescent and colourless to slightly yellow solution, pH 6.0.
Koncentrat je prozorna do rahlo opalescentna in brezbarvna do nekoliko rumenkasta raztopina s pH 6,0.
Randomisation was stratified by geographic region, tumour KRAS status (mutant or wild-type), and time to disease progression (TTP) after commencing first-line treatment (<6 months versus ≥6 months).
Randomizacija je bila stratificirana po geografski regiji, statusu KRAS tumorja (mutanten ali divjega tipa) in času do napredovanja bolezni po začetku zdravljenja prve izbire (< 6 mesecev v primerjavi z ≥ 6 meseci).
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA