natgillin/translations-raw huggingface dataset:
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues. 
Potem ko je CHMP ocenil odgovore družbe na zadnji sklop vprašanj, so nekatera vprašanja še vedno ostala nerešena.
It was to be used in patients whose infection has persisted despite previous treatment. 
Uporabljalo naj bi se pri bolnikih, pri katerih je okužba tudi po predhodnem zdravljenju še vedno prisotna.
Further information on the orphan designation can be found here. 
Več informacij o zdravilih sirotah je na voljo tukaj.
Withdrawal of the marketing authorisation application for Arikayce (amikacin) EMA/430267/2016 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Arikayce (amikacin) EMA/430267/2016
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions. 
Vlogo so umaknili po tem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
Withdrawal of the marketing authorisation application for Arikayce (amikacin) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Arikayce (amikacin)
Because the medicine is breathed in, it also reaches the lungs more directly than amikacin given by injection. 
Ker se zdravilo vdihava, tudi pljuča doseže prej kot amikacin, ki se daje z injiciranjem.
In this medicine, amikacin is contained within microscopic fat capsules known as liposomes. 
V tem zdravilu amikacin obdaja mikroskopska maščobna kapsula, imenovana liposom.
The Committee's main concern was that the study submitted in the application did not provide enough evidence that Arikayce can permanently clear the bacteria from patients' sputum. 
Glavni pomislek odbora je bil, da študija, ki so jo predložili z vlogo, ne zagotavlja dovolj dokazov, da lahko zdravilo Arikayce trajno odstrani bakterije iz bolnikovega izmečka.
What is Arikayce? 
Kaj je zdravilo Arikayce?
In its letter notifying the Agency of the withdrawal, the company stated that its decision is based on the understanding that CHMP was not going to recommend approval of the medicine on the basis of current data. 
V dopisu, s katerim družba Agencijo obvešča o umiku vloge, je navedeno, da odločitev družbe temelji na njenem razumevanju, da CHMP na podlagi trenutnih podatkov ne bo priporočil odobritve zdravila.
On 8 June 2016, Insmed Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Arikayce intended for the treatment of Mycobacterium avium complex (MAC) lung disease. 
Družba Insmed Limited je dne 8. junija 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Arikayce, namenjenim zdravljenju pljučne bolezni, ki jo povzroča kompleks mikobakterij Mycobacterium avium.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials for Arikayce. 
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Arikayce.
The company submitted results of an early (phase 2) study in 89 adult patients with lung infections caused by MAC or similar bacteria. 
Družba je predložila rezultate zgodnje študije (2. faze) pri 89 odraslih bolnikih s pljučnimi okužbami, ki jih povzročajo kompleks mikobakterij Mycobacterium avium ali podobne bakterije.
These liposomes help reduce the rate at which the active substance is broken down, allowing it to remain in the body for longer. 
Ti liposomi pripomorejo k upočasnitvi razgrajevanja zdravilne učinkovine in podaljšajo čas njenega zadrževanja v telesu.
This study compared Arikayce with placebo (a dummy treatment) and looked mainly at how effectively the medicine cleared bacteria from patients' sputum (phlegm) after about 3 months of treatment. 
V tej študiji so primerjali zdravilo Arikayce s placebom (zdravilom brez zdravilne učinkovine) in ugotavljali, kako učinkovito je zdravilo odstranilo bakterije iz bolnikovega izmečka (sluzi) po treh mesecih zdravljenja.
What was Arikayce expected to be used for? 
Za kaj naj bi se zdravilo Arikayce uporabljalo?
Arikayce was expected to be used to treat adults with a lung infection caused by Mycobacterium avium complex (MAC), a group of bacteria commonly found in the environment, such as in soil and water. 
Zdravilo Arikayce naj bi se uporabljajo za zdravljenje odraslih s pljučno okužbo, ki jo povzroča kompleks mikobakterij Mycobacterium avium, skupina bakterij, ki so pogosto prisotne v okolju, na primer v prsti in vodi.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Arikayce did not outweigh its risks. 
Zato je CHMP v času umika menil, da koristi zdravila Arikayce ne odtehtajo z njim povezanih tveganj.
The active substance in Arikayce, amikacin, is a well-established antibiotic of the group ‘aminoglycosides' that works by disrupting bacterial production of vital proteins. 
Zdravilna učinkovina v zdravilu Arikayce, amikacin, je dobro uveljavljen antibiotik iz skupine „aminoglikozidov“, ki deluje tako, da pri bakterijah prekine tvorbo življenjsko pomembnih beljakovin.
Arikayce is an antibiotic containing the active substance amikacin. 
Zdravilo Arikayce je antibiotik, ki vsebuje zdravilno učinkovino amikacin.
How is Arikayce expected to work? 
Kako naj bi zdravilo Arikayce delovalo?
Based on the review of the data and the company's response to the CHMP lists of questions, the CHMP was of the provisional opinion that Arikayce could not be approved for the treatment of MAC lung infection. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor začasno menil, da zdravila Arikayce ni mogoče odobriti za zdravljenje pljučne okužbe s kompleksom mikobakterij Mycobacterium avium.
Arikayce was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 8 April 2014 for treating infections caused by MAC and similar bacteria. 
Zdravilo Arikayce je bilo dne 8. aprila 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje okužb, ki jih povzročajo kompleks mikobakterij Mycobacterium avium in podobne bakterije.
No special requirements. 
Ni posebnih zahtev.
Ethnic factors. 
Etnični dejavniki.
Immediate admission to hospital is recommended. 
Priporoča se takojšen sprejem v bolnišnico.
The clinical relevance of these differences is unknown. 
Klinični pomen teh razlik ni poznan.
Median Time to Event (Days) 
Mediana časa do dogodka (dnevi)
Interaction studies have only been performed in adults. 
Študije medsebojnega delovanja so izvedli le pri odraslih.
This 21 day period is one treatment cycle. 
To 21-dnevno obdobje je en cikel zdravljenja.
• Risk management plan (RMP) 
• Načrt za obvladovanje tveganj (RMP)
This advice is applicable to all indications and to all special populations. 
Ta nasvet velja za vse indikacije in za vse posebne skupine bolnikov.
- Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual. 
- Slabost: če izgubite tek in je količina hrane, ki jo dnevno zaužijete, mnogo manjša kot ponavadi.
It cannot be excluded that other rare variants may also be associated with an increased risk of severe toxicity. 
Ni mogoče izključiti, da so lahko tudi druge redke različice povezane s povečanim tveganjem za hudo toksičnost.
Tell your doctor immediately if you experience any of these symptoms. 
Nemudoma povejte zdravniku, če opazite katerega koli od teh simptomov.
All measures should be initiated to prevent systemic infections and dehydration. 
Uvesti je treba vse ukrepe za preprečevanje sistemskih okužb in dehidracije.
Median survival was 384 and 373 days. 
Mediana preživetja je bila 384 in 373 dni.
This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines. 
To je zelo pomembno, ker lahko jemanje več zdravil hkrati poveča ali oslabi njihov učinek.
See table 6 for treatment regimens. 
Glejte preglednico 6 za sheme zdravljenja.
Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it. 
Zdravnik vam bo povedal, kolikšen odmerek morate jemati, kdaj ga vzeti in kako dolgo bo zdravljenje trajalo.
- Vomiting: if you vomit more than once in a 24-hour time period. 
- Bruhanje: če bruhate več kot enkrat v 24 urah.
- Take the tablets morning and evening as prescribed by your doctor. 
- Tablete jemljite zjutraj in zvečer, kot vam jih je predpisal zdravnik.
- It is important that you take all your medicine as prescribed by your doctor. 
- Pomembno je, da jemljete vsa zdravila tako, kot vam je predpisal zdravnik.
Date of latest renewal: 9 December 2016 
Datum prve odobritve: 20. april 2012 Datum zadnjega podaljšanja: 9. december 2016
- Fever: if you have a temperature of 38°C or greater. 
- Zvišana telesna temperatura: če imate telesno temperaturo 38 °C ali več.
This increase is likely due to a change in renal function. 
Razlog za povečanje je verjetno sprememba ledvičnega delovanja.
OTHER SPECIAL WARNING (S), IF NECESSARY 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
- Infection: if you experience signs of infection caused by bacteria or virus, or other organisms. 
- Okužba: če imate znake okužbe, ki jo povzroči bakterija ali virus ali drugi organizmi.
but there was no evidence of teratogenicity. 
Dokazov o teratogenosti ni bilo.
Body Surface Area (m 
Telesna površina (m
The median follow up at the time of the analysis was 6.9 years. 
Mediana spremljanja v času analize je bila 6,9 leta.
Careful monitoring during the first cycle of treatment is recommended for all patients. 
Skrbno spremljanje med prvim ciklom zdravljenja je priporočljivo za vse bolnike.
This is calculated from your height and weight. 
Ta se izračuna iz vaše višine in telesne mase.
The requirements for submission of PSURs 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 web-portal. 
Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Therefore, in the absence of serious toxicity the dose could be increased while carefully monitoring the patient. 
Zato je v odsotnosti resne toksičnosti odmerek mogoče povečati in bolnika pozorno spremljati.
The AUC of 5-FU was 30%-35% higher on day 14. 
AUC 5-FU je bila od 30 do 35 % višja štirinajstega dne.
These findings are expected effects of fluoropyrimidine derivatives. 
Te ugotovitve so posledica učinkov derivatov fluoropirimidina.
• Periodic safety update reports (PSURs) 
• Redno posodobljena poročila o varnosti zdravila (PSUR)
Once the dose has been reduced, it should not be increased at a later time. 
Ko je odmerek zmanjšan, ga pozneje ne smemo več zvečati.
Ecansya tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken). 
Tablete zdravila Ecansya se običajno jemljejo 14 dni, čemur sledi 7-dnevni premor (ko se tablet ne jemlje).
Interrupt until resolved to grade 0-1 
1. pojav prekinitev, dokler ni dosežena stopnja 0−1
See also section "Do not take Ecansya". 
Glejte tudi poglavje "Ne jemljite zdravila Ecansya".
It is not known whether capecitabine is excreted in human breast milk. 
Ni znano, ali se kapecitabin izloča v človeško mleko.
Median overall survival ITT 
Mediana celokupnega preživetja ITT
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. 
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov proizvajalca, odgovornega za sprostitev zadevne serije.
Ecansya tablets should not be crushed or cut. 
Tablet zdravila Ecansya se ne sme drobiti ali rezati.
Hand and foot skin reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan. 
Kožna reakcija na rokah in nogah lahko povzroči izgubo prstnih odtisov, kar bi lahko vplivalo na vašo identifikacijo s prstnimi odtisi.
Ecansya may be used either alone or in combination with other medicines. 
Zdravilo Ecansya se lahko uporablja samostojno ali v kombinaciji z drugimi zdravili.
If you cannot swallow Ecansya tablets whole, tell your healthcare provider. 
Če ne morete pogoltniti celih tablet zdravila Ecansya, obvestite zdravstvenega delavca.
FBAL is a metabolite without antiproliferative activity. 
FBAL je presnovek brez antiproliferativnega učinka.
Your doctor will prescribe a dose and treatment regimen that is right for you. 
Zdravnik vam bo predpisal odmerek in režim zdravljenja, ki bo namenjen le vam.
These reactions occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within one month after stopping capecitabine. 
Ti učinki so se pojavili v nekaj dneh do celo nekaj mesecev po začetku zdravljenja s kapecitabinom, v nekaterih primerih celo čez en mesec po prenehanju zdravljenja s kapecitabinom.
- Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water. 
- Tablete zaužijte v 30 minutah po koncu obroka (zajtrka in večerje); tablete pogoltnite cele z vodo.
Food interaction 
Interakcije s hrano
North Harrow, Middx HA1 4HF 
North Harrow, Middx HA1 4HF Velika Britanija
The consequences of a reduced dose for efficacy are currently uncertain. 
Trenutno ni znano, kakšne so posledice zmanjšanih odmerkov na učinkovitost.
Instead, continue your regular dosing schedule and check with your doctor. 
Nadaljujte z rednim urnikom jemanja in se posvetujte z zdravnikom.
Do not take Ecansya - if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Ecansya - če ste alergični na kapecitabin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
See leaflet for further information. 
Za nadaljnje informacije glejte navodilo za uporabo.
- If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used. 
- Če obstajajo kontraindikacije za katero od zdravil, ki se uporablja v kombinaciji, se tega zdravila ne sme uporabljati.
ADDITIONAL 6 MONTHS OF FOLLOW UP 
DODATNO ŠESTMESEČNO SPREMLJANJE
In the event of grade 2-4 acute toxicity, treatment must be discontinued immediately. 
V primeru akutne toksičnosti stopnje 2−4 je treba zdravljenje nemudoma prekiniti.
Manufacturer 
Proizvajalec
Ecansya has minor or moderate influence on the ability to drive and use machines. 
Ecansya ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Dose reduction should be applied as necessary (see section 4.2). 
Odmerek je treba zmanjšati, kot je to potrebno (glejte poglavje 4.2).
25.5 months 
25,5 meseca
Most adverse reactions are reversible and do not require permanent discontinuation of therapy, although doses may need to be withheld or reduced. 
Večina neželenih učinkov je reverzibilnih in ne zahteva dokončne prekinitve zdravljenja, vendar je včasih treba odmerjanje začasno prekiniti ali zmanjšati.
Reduced dose 
Zmanjšani odmerek
The AUC of FBAL increased with age (20% increase in age results in a 15% increase in the AUC of FBAL). 
AUC za FBAL je z leti naraščala (20- % povečanje v letih daje 15- % povečanje AUC za FBAL).
All treatment cycles were administered at intervals of 3 weeks. 
Vsi cikli zdravljenja so bili dani v intervalih po 3 tedne.
The dose of Ecansya is based on your body surface area. 
Odmerek zdravila Ecansya je določen glede na vašo telesno površino.
Rare/Very Rare (Post-Marketing Experience) 
Redki/zelo redki (izkušnje po prihodu zdravila na trg)
This interaction, which leads to increased fluoropyrimidine toxicity, is potentially fatal. 
To medsebojno delovanje, ki poveča toksičnost fluoropirimidina, je lahko smrtno.
In animal studies effects on fertility were observed (see section 5.3). 
V študijah na živalih so ugotovili vpliv na plodnost (glejte poglavje 5.3).
The patients who are tested negative for the above-mentioned alleles may still have a risk of severe adverse events. 
Bolniki z negativnimi testi na zgoraj omenjene alele imajo lahko kljub temu tveganje za hude neželene učinke.
Capecitabine is activated via several enzymatic steps (see section 5.2). 
Kapecitabin se aktivira prek več encimov (glejte poglavje 5.2).
ADDITIONAL 1 YEAR OF FOLLOW UP 
DODATNO ENOLETNO SPREMLJANJE
Other side effects are: 
Drugi neželeni učinki so:
- difficulty in urination, blood or protein in the urine - bruising or reaction at the injection site (caused by medicines given by injection at the same time) 
- težave pri uriniranju, kri ali beljakovine v urinu, - modrice ali reakcijo na mestu injiciranja (povzročeno z zdravili, ki se dajejo istočasno v obliki injekcije).
Data on the frequency of these DPYD variants in other populations than Caucasian is limited. 
Podatkov o pogostnosti teh različic DPYD pri drugih populacijah razen belcev je malo.
Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue). 
Šele po absorpciji v telesu se spremeni v aktivno citostatično zdravilo (bolj v tumorskem tkivu kot v zdravih tkivih).
Permanent discontinuation should be considered based on clinical assessment of the onset, duration and severity of the observed toxicities. 
O trajni ukinitvi zdravljenja je treba razmisliti glede na klinično oceno začetka, trajanja in resnosti opaženih toksičnosti.
Do not crush or cut tablets. 
Tablet ne drobite in ne režite.
Day 1, prior to XELOX, every 3 weeks 
1. dan, pred XELOX, vsake 3 tedne
Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 Possible side effects). 
Nemudoma obvestite zdravnika, če vas skrbi kateri koli od neželenih učinkov ali če opazite kateri koli dodatni neželeni učinek, ki ni naveden v tem navodilu (glejte poglavje 4, Možni neželeni učinki).
If you have taken brivudine you must wait for at least 4 weeks after stopping brivudine before starting to take capecitabine. 
Če ste jemali brivudin, morate po končanem jemanju brivudina počakati najmanj 4 tedne, preden začnete jemati kapecitabin.
Careful monitoring of patients 60 years of age is advisable. 
Priporočljivo je skrbno spremljanje bolnikov, starih 60 let ali več.
The following are the recommended dose modifications for toxicity. 
Sledijo priporočila za prilagajanje odmerkov pri toksičnosti.
Cytochrome P-450 2C9 substrates: Other than warfarin, no formal interaction studies between capecitabine and other CYP2C9 substrates have been conducted. 
Substrati citokroma P-450 2C9: Razen z varfarinom, formalnih študij medsebojnega delovanja med kapecitabinom in drugimi substrati CYP2C9 niso izvedli.
Do not take a double dose to make up for a forgotten dose. 
Ne vzemite dvojnega odmerka, da bi nadomestili izpuščeni odmerek.
For hand-foot syndrome and hyperbilirubinemia, see section 4.4. 
Za sindrom roka--noga in hiperbilirubinemijo glejte poglavje 4.4.
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Patients taking capecitabine should be informed of the need to interrupt treatment immediately if moderate or severe toxicity occurs. 
Bolniki, ki jemljejo kapecitabin, morajo biti obveščeni glede takojšnje prekinitve zdravljenja, če se pojavijo zmerne ali hude toksičnosti.
If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 10 
Če laboratorijski izvid med ciklom zdravljenja pokaže, da se je število nevtrofilcev znižalo pod 1,0 x 10
Severe and/or Lifethreatening (grade 34) or considered medically relevant 
Hudi in/ali življenjsko ogrožajoči (stopnja 3-4) ali klinično pomembni
Stevens-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.) 
Stevens- Johnsono v sindrom in toksična epidermalna nekroliza (zelo redki) (glejte poglavje 4.4)
Since metabolism of R-warfarin was not affected, these results indicate that capecitabine downregulates isozyme 2C9, but has no effect on isozymes 1A2 and 3A4. 
Ker na presnovo R-varfarina ni bilo vpliva, ti rezultati nakazujejo, da kapecitabin zavira izoencim 2C9, ne vpliva pa na izoencima 1A2 in 3A4.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Your doctor may instruct you to restart treatment at a lower dose. 
Morda vam bo predpisal nadaljevanje zdravljenja z manjšimi odmerki.
Persistent or severe hand-foot syndrome (Grade 2 and above) can eventually lead to loss of fingerprints which could impact patient identification. 
Vztrajen ali hud sindrom roka-noga (2. stopnje ali višje) lahko sčasoma privede do izgube prstnih odtisov, kar lahko vpliva na identifikacijo bolnika.
24.4 months 
24,4 meseca
Fatal cases have been reported following this drug interaction. 
V povezavi s tem medsebojnim delovanjem so poročali o smrtnih primerih.
Previous therapy should have included an anthracycline. 
Predhodno zdravljenje naj bi vključevalo antraciklin.
• Grade 1 
• Stopnja 1
No dose has been proven safe for patients with complete absence of DPD activity. 
Za bolnike s popolno odsotnostjo aktivnosti DPD ni varen noben odmerek.
Pharmacokinetics in special populations 
Farmakokinetika pri posebnih skupinah
Ecansya should be permanently discontinued in patients who experience a severe skin reaction during treatment. 
Zdravilo Ecansya je treba trajno ukiniti pri bolnikih, pri katerih se med zdravljenjem pojavi huda kožna reakcija.
Progression-free Survival after 6 months ITT 
Preživetje brez napredovanja bolezni po 6 mesecih ITT
Each pack contains 30, 60 or 120 film-coated tablets. 
Eno pakiranje vsebuje 30, 60 ali 120 filmsko obloženih tablet.
Day 1, prior to FOLFOX-4, every 2 weeks 
1. dan, pred FOLFOX-4, vsake 2 tedna
The major metabolite excreted in urine is FBAL, which represents 57% of the administered dose. 
Glavni presnovek, ki se izloča z urinom, je FBAL, katerega delež je 57 % zaužitega odmerka.
The inclusion of bevacizumab in a combination regimen has no effect on the starting dose of capecitabine. 
Vključitev bevacizumaba v kombinacijo nima vpliva na začetni odmerek kapecitabina.
About 3% of the administered dose is excreted in urine unchanged. 
Približno 3 % kapecitabina se izločijo nespremenjeni.
Severe skin reactions: Ecansya can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis. 
Hude kožne reakcije: Zdravilo Ecansya lahko izzove hude kožne reakcije, kot sta Stevens-Johnsonov sindrom in toksična epidermalna nekroliza.
Since DNA and RNA are essential for cell division and growth, the effect of 5-FU may be to create a thymidine deficiency that provokes unbalanced growth and death of a cell. 
Ker sta RNA in DNA bistveni za rast in delitev celice, povzroči 5-FU pomanjkanje timidina, kar izzove neuravnoteženo rast in smrt celice.
5-Fluorouracil: intravenous bolus injection immediately after leucovorin 
5- fluorouracil: intravenska injekcija v bolusu neposredno po levkovorinu
( 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). 
Neželeni učinki so razvrščeni po njihovi pogostnosti: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).