natgillin/translations-raw huggingface dataset:
• That Thelin is teratogenic o Use of effective contraception in women of child bearing age o Possible interaction with oral contraceptives and increased risk of thromboembolism o Need to advise female patients about teratogenicity, contraception, if necessary the need for pregnancy testing and what to do if they become pregnant o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
o Bolnice, ki zanosijo, je potrebno napotiti k specialistu za teratogenost ali zdravniku, ki ima izkušnje na področju teratogenosti, ter prositi zdravnika za diagnozo, drugo mnenje in nasvet.
Cellulose, microcrystalline (E460) Lactose monohydrate Hypromellose (E464) Sodium starch glycolate Magnesium stearate (E470b) Disodium phosphate, anhydrous (E339) Ascorbyl palmitate (E304) Disodium edetate
Natrijev karboksimetilškrob Magnezijev stearat (E470b) Natrijev hidrogenfosfat, brezvodni (E339) Askorbilpalmitat (E304) Dinatrijev edetat
Always take Thelin exactly as your doctor has told you.
Pri jemanju zdravila Thelin natančno upoštevajte zdravnikova navodila.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Izgled zdravila Thelin in vsebina pakiranja
BEFORE YOU TAKE THELIN
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO THELIN
• flushed
• rdečica,
(See Annex I: Summary of Product Characteristics, section 4.2)
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
>8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
Zdravljenje je treba končati, ponovna uvedba zdravila Thelin pa ne pride v poštev.
(twice daily)
(dvakrat na dan)
Take the tablets morning and evening as prescribed by your doctor.
• Tablete jemljite zjutraj in zvečer, kot vam jih je predpisal zdravnik.
• if you are or become dehydrated
• ste ali postanete dehidrirani,
• 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.
PRIMARY ANALYSIS
OSNOVNA ANALIZA
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.
• if you have a history of eye problems as you may need extra monitoring of your eyes
• ste v preteklosti imeli bolezni oči, ker boste morda potrebovali dodatne kontrole oči,
Xeloda tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Tablete zdravila Xeloda se običajno jemljejo 14 dni, čemur sledi 7-dnevni premor (ko se tablet ne jemlje).
Xeloda tablets should not be crushed or cut.
Tablet zdravila Xeloda se ne sme drobiti ali rezati.
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.
See also section “Do not take Xeloda”.
Glejte tudi poglavje “Ne jemljite zdravila Xeloda”.
EU/1/00/163/002
EU/1/00/163/001 EU/1/00/163/002
The dose of Xeloda is based on your body surface area.
Xeloda je določen glede na vašo telesno površino.
Severe and/or Lifethreatening (grade 3-4) or considered medically relevant
Hudi in/ali življenjsko ogrožajoči (stopnja 3-4) ali klinično pomembni
• bruising or reaction at the injection site (caused by medicines given by injection at the same time)
• modrice ali reakcijo na mestu injiciranja (povzročeno z zdravili, ki se dajejo istočasno v obliki injekcije).
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Navodilo je bilo nazadnje revidirano {MM/LLLL}
Xeloda may be used either alone or in combination with other medicines.
Zdravilo Xeloda se lahko uporablja samostojno ali v kombinaciji z drugimi zdravili.
Date of latest renewal: 02 February 2006
Datum prve odobritve: 2. februar 2001 Datum zadnjega podaljšanja: 2. februar 2006
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).
• if you have brain diseases (for example, cancer that has spread to the brain, or nerve damage
• imate možgansko bolezen (npr. raka, ki se je razširil v možgane ali okvaro živcev
SPECIAL STORAGE CONDITIONS Do not store above 30°C
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C
The following headings are used to rank the ADRs by frequency: 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).
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).
Xeloda should be permanently discontinued in patients who experience a severe skin reaction during treatment.
Zdravilo Xeloda je treba trajno ukiniti pri bolnikih, pri katerih se med zdravljenjem pojavi huda kožna reakcija.
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.
Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
• if you cannot keep food or water in your body because of severe nausea and vomiting
• ne morete v sebi zadržati hrane ali tekočine zaradi hude slabosti in bruhanja,
What Xeloda is and what it is used for
Kaj je zdravilo Xeloda in za kaj ga uporabljamo
Careful monitoring of patients ≥60 years of age is advisable.
Priporočljivo je skrbno spremljanje bolnikov, starih 60 let ali več.
Very common All grades
Zelo pogosti Vse stopnje
• if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil),
• če ste v preteklosti imeli hudo reakcijo na zdravljenje s fluoropirimidini (skupina zdravil za zdravljenje raka, kamor spada fluorouracil),
Procedures for safe handling of cytotoxic drugs should be followed.
Upoštevati je treba postopke za varno ravnanje s citotoksičnimi zdravili.
• if you have imbalances of ions in your blood (electrolyte imbalances, seen in tests)
• imate porušeno ravnotežje ionov v vaši krvi (elektrolitsko neravnovesje, opaženo v preiskavah),
Pharmacotherapeutic group: cytostatic (antimetabolite), ATC code: L01BC06
Farmakoterapevtska skupina: citostatična učinkovina (antimetaboliti), oznaka ATC: L01BC06.
Furthermore, Xeloda is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Zdravilo Xeloda se uporablja tudi za preprečevanje novega pojava raka debelega črevesa po kompletni odstranitvi tumorja z operacijo.
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.
Xeloda tablets should be swallowed whole with water within 30 minutes after a meal.
Tablete zdravila Xeloda je treba pogoltniti cele z vodo v 30 minutah po obroku.
The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'-DFUR) measured on days 1 and 14 were similar.
Parametri kapecitabina, 5´-deoksi-5-fluorocitidina (5´-DFCR) in 5´-deoksi-5-fluorouridina (5´-DFUR), ki so jih izmerili prvi in štirinajsti dan, so bili podobni.
Modified XELIRI+ bevacizumab (ITT: N= 120)
XELIRI + bevacizumab (ITT: n = 120)
• problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)
• težave z delovanjem jeter (ugotovljene pri krvnih preiskavah) in povišan bilirubin v krvi (ki se izloča preko jeter).
Parameter: Overall Survival EPP
Parameter: Celokupno preživetje EPP
• if you have severely low levels of white cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia),
• če imate zelo nizko raven belih krvnih celic ali trombocitov v krvi (levkopenija, nevtropenija ali trombocitopenija),
Severe skin reactions: Xeloda can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Hude kožne reakcije: Zdravilo Xeloda lahko izzove hude kožne reakcije, kot sta Stevens-Johnsonov sindrom in toksična epidermalna nekroliza.
Do not give Xeloda to children and adolescents.
Otrokom in mladostnikom ne dajajte zdravila Xeloda.
The Xeloda pivotal studies included females of childbearing potential and males only if they agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a reasonable period thereafter.
V ključnih študijah z zdravilom Xeloda so sodelovale ženske v rodni dobi in moški, če so se strinjali, da bodo uporabljali sprejemljivo metodo kontracepcije, da bi preprečili nosečnost v času študije in primernem obdobju po njej.
The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis.
Vgraditev 5FU zavira tudi sintezo RNA in proteinov.
Other medicines and Xeloda
Druga zdravila in zdravilo Xeloda
About 3% of the administered dose is excreted in urine unchanged
Približno 3 % kapecitabina se izločijo nespremenjeni.
Contents of the pack and other information What Xeloda contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Xeloda
• if you have or had heart problems (for example an irregular heartbeat or pains to the chest, jaw and back brought on by physical effort and due to problems with the blood flow to the heart)
• imate ali ste imeli težave s srcem (npr. neredno bitje srca ali bolečine v prsnici in za njo, ki se pojavijo pri fizičnem naporu zaradi težav s pretokom krvi v srce),
If the calculated creatinine clearance decreases during treatment to a value below 30 ml/min, Xeloda should be discontinued.
Če se izračunani kreatininski očistek med zdravljenjem zmanjša pod 30 ml/min, je treba zdravljenje z zdravilom Xeloda ukiniti.
There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Xeloda.
Obstajajo dokazi, da je dekspantenol učinkovit pri preprečevanju sindroma roka-noga pri bolnikih, zdravljenih z zdravilom Xeloda.
The enhanced toxicity may be relevant when switching from 5- FU/LV to a capecitabine regimen.
Povečana toksičnost je lahko pomembna, ko shemo 5-FU/LV zamenjamo s kapecitabinom.
PVC/PVDC blisters
PVC/PVDC pretisni omoti
The European Medicines Agency has waived the obligation to conduct studies with Xeloda in all subsets of the paediatric population in adenocarcinoma of the colon and rectum, gastric adenocarcinoma and breast carcinoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za izvedbo študij z zdravilom Xeloda za vse podskupine pediatrične populacije z adenokarcinomom kolona in rektuma, želodčnim adenokarcinomom in rakom dojk (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
• če veste, da nimate nobene aktivnosti encima dihidropirimidin dehidrogenaze (DPD),
• if you have severe liver or kidney problems,
• če imate hude težave z jetri ali ledvicami,
The pooled analysis includes 3097 patients treated with capecitabine-containing regimens and 3074 patients treated with 5-FU-containing regimens.
Skupna analiza je zajela 3097 bolnikov, katerih zdravljenje je vključevalo kapecitabin, in 3074 bolnikov, katerih zdravljenje je vključevalo 5-FU.
Table 9 Key efficacy results for the non-inferiority analysis of Study NO16967
Glavni rezultati o učinkovitosti za analizo ne-inferiornosti v študiji NO16967
*PPP=per-protocol population; **ITT=intent-to-treat population
*PPP = populacija po protokolu (per-protocol population); **ITT = populacija, ki so jo nameravali zdraviti (intent-to-treat population), CI = interval zaupanja (confidence interval)
What Xeloda is and what it is used for What you need to know before you take Xeloda How to take Xeloda
Kaj je zdravilo Xeloda in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xeloda Kako jemati zdravilo Xeloda Možni neželeni učinki
Dehydration may cause acute renal failure, especially in patients with pre-existing compromised renal function or when capecitabine is given concomitantly with known nephrotoxicmedicinal products.
Dehidracija lahko povzroči akutno ledvično odpoved, še posebno pri bolnikih z že obstoječim okrnjenim delovanjem ledvic ali kadar kapecitabin dajemo sočasno z nefrotoksičnimi zdravili.
Elderly patients (see section 4.2):
Starejši bolniki (glejte poglavje 4.2)
Patients with baseline neutrophil counts of <1.5 x 109/L and/or thrombocyte counts of <100 x 109/L should not be treated with capecitabine.
Bolnikov, ki imajo pred zdravljenjem število nevtrofilcev < 1,5 x 109/l in/ali število trombocitov < 100 x 109/l, ne zdravimo s kapecitabinom.
If you forget to take Xeloda
Če ste pozabili vzeti zdravilo Xeloda
For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Xeloda are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjusment according to toxicity.
Bolnike z delnim pomanjkanjem DPD (kot so tisti s heterozigotnimi mutacijami v genu DPYD), za katere smatramo, da koristi zdravila Xeloda odtehtajo tveganja (upoštevaje primernost druge nefluoropirimidinske sheme kemoterapije), je treba zdraviti izredno previdno in jih pogosto spremljati ter prilagoditi odmerek glede na toksičnost.
There is no data on Xeloda and impact on fertility.
Podatkov o vplivu zdravila Xeloda na plodnost ni.
Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus (e.g. DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants), which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of lifethreatening or fatal toxicity and should not be treated with Xeloda (see section 4.3).
Čeprav pomanjkanja DPD ne moremo natančno določiti, je znano, da imajo bolniki z določenimi homozigotnimi ali določenimi sestavljenimi heterozigotnimi mutacijami v lokaciji gena DPYD (npr. z različicami DPYD*2A, c.1679T>G, c.2846A>T in c.1236G>A/HapB3), ki lahko povzročijo popolno ali skoraj popolno pomanjkanje encimske aktivnosti DPD (določene z laboratorijskim testom), največje tveganje za življensko ogrožujočo ali smrtno toksičnost in jih ne smemo zdraviti z zdravilom Xeloda (glejte poglavje 4.3).
Number of 150 mg tablets and/or 500 mg tablets per administration (each administration to be given morning and evening)
Število 150- in/ali 500-mg tablet za posamezno dajanje (zdravilo se daje zjutraj in zvečer)
Interrupt until resolved to grade 0-1
• Stopnja 2 1. pojav prekinitev, dokler ni dosežena stopnja 0−1
- first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see section 5.1).
• za prvo linijo zdravljenja napredovalega raka želodca v kombinaciji s shemo na osnovi platine (glejte poglavje 5.1).
Finally, β-ureido-propionase cleaves FUPA to α-fluoro-βalanine (FBAL) which is cleared in the urine.
Na koncu beta-ureido-propionaza cepi FUPA v alfa-fluorobeta-alanin (FBAL), ki se izloči z urinom.
• medicines used to treat folic acid deficiency.
• zdravil za zdravljenje pomanjkanja folne kisline.
These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use (see also section “Elderly” below).
Priporočila za prilagajanje odmerkov pri ledvični okvari veljajo za samostojno in kombinirano zdravljenje (glejte tudi spodnji odstavek Starejši bolniki).
5-Fluorouracil: intravenous bolus injection immediately after leucovorin
intravenska injekcija v bolusu neposredno po levkovorinu
- in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
• v kombinaciji z docetakselom (glejte poglavje 5.1) za zdravljenje bolnikov z lokalno napredovalo ali metastatsko obliko raka dojk po neuspešni citotoksični kemoterapiji.
• if you have calcium imbalances (seen in blood tests)
• imate porušeno ravnovesje kalcija (opaženo pri krvni preiskavi),
Elderly: Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46%) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Na osnovi podatkov populacijske farmakokinetične študije, ki je zajela bolnike z velikim razponom v letih (27 do 86 let) in 234 bolnikov (46 %), starih 65 let ali starejših, so ugotovili, da starost ne vpliva na farmakokinetiko 5´-DFUR in 5-FU.
Brivudine: a clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-Fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
Brivudin: Opisali so klinično pomembno medsebojno delovanje med brivudinom in fluoropirimidini (npr. kapecitabinom, 5-fluorouracilom in tegafurjem), ki je rezultat brivudinovega zaviranja dihidropirimidin dehidrogenaze.
• Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
• Stevens-Johnsonov sindrom: če dobite boleč, rdeč ali škrlaten izpuščaj, ki se širi, ali se začnejo pojavljati mehurji in/ali druge poškodbe na sluznici (npr. v ustih in na ustnicah), še posebno, če ste bili občutljivi na svetlobo ali imeli okužbe dihal (npr. bronhitis) in/ali zvišano telesno temperaturo.
Table 7 Key efficacy results for the non-inferiority analysis of Study NO16966
Glavni rezultati o učinkovitosti za analizo ne-inferiornosti v študiji NO16966
If you have an unrecognised DPD deficiency and take Xeloda, you are at an increased risk of acute early-onset of severe forms of the side effects listed under section 4 Possible side effects.
Če ne veste, da imate pomanjkanje DPD in vzamete zdravilo Xeloda, imate večje tveganje za nenaden, zgodnji pojav hudih oblik neželenih učinkov, navedenih v poglavju 4, Možni neželeni učinki.
Cardiovascular toxicity (e.g. PR- and QT-interval prolongation) was detectable in cynomolgus monkeys after intravenous administration (100 mg/kg) but not after repeated oral dosing (1379 mg/m2/day).
Toksično delovanje na srce in ožilje (podaljšanje intervalov PR in QT) so opazili pri opicah cynomolgus po intravenskem dajanju (100 mg/kg), po večkratnem peroralnem dajanju (1379 mg/m2/dan) pa ne.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/163/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/163/001
• DPD Deficiency: if you have a known DPD deficiency, you are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by XELODA (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity).
• Pomanjkanje DPD: če je znano, da imate pomanjkanje DPD, imate večje tveganje za nenaden, zgodnji pojav toksičnosti in hude, življenjsko ogrožujoče ali smrtne neželene učinke, povzročene z zdravilom Xeloda (npr. stomatitis, vnetje sluznic, drisko, nevtropenijo in nevrotoksičnost).
In addition to the above, when Xeloda is used alone, very common side effects, which may affect more than 1 in 10 people are:
Poleg zgoraj omenjenih neželenih učinkov se lahko pri samostojni uporabi zdravila Xeloda zelo pogosto (pri več kot 1 od 10 bolnikov) pojavijo naslednji neželeni učinki:
Table 6 Treatment regimens in study NO16966 (mCRC) Treatment
Sheme zdravljenja v študiji NO16966 (metastatski kolorektalni rak)
Posology adjustments for special populations:
Prilagajanje odmerjanja pri posebnih skupinah bolnikov:
If no toxicity is observed in patients ≥60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1250 mg/m2 twice daily.
Če se pri bolnikih, starih 60 let ali več, med zdravljenjem z zmanjšanim odmerkom kapecitabina v kombinaciji z docetakselom toksičnost ne pojavi, lahko odmerek kapecitabina previdno zvečamo na 1.250 mg/m2 dvakrat na dan.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo Peroralna uporaba
Dose changes within a treatment cycle
Prilagoditev odmerka med ciklom zdravljenja
Discontinue permanently or If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1
• Stopnja 4 1. pojav dokončna prekinitev zdravljenja ali če zdravnik meni, da je njegovo nadaljevanje najboljše za bolnika, prekinitev, dokler ni dosežena stopnja 0−1
Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment) Toxicity grades*
Shema za zmanjšanje odmerka pri zdravljenju s kapecitabinom (3-tedenski cikli ali neprekinjeno zdravljenje)
Xeloda contains anhydrous lactose
Zdravilo Xeloda vsebuje brezvodno laktozo
(neuropathy)
(nevropatijo)),
Dose adjustment for next cycle/dose (% of starting dose)
Prilagoditev odmerka za naslednji cikel/odmerek
If you are a male patient and your female partner could become pregnant, you should use effective contraception during treatment with XELODA and for 3 months after the last dose.
Če ste bolnik in bi vaša partnerka lahko zanosila, morate med zdravljenjem z zdravilom Xeloda in še 3 mesece po zadnjem odmerku zdravila uporabljati učinkovito kontracepcijo.
If you take more Xeloda than you should, contact your doctor as soon as possible before taking the next dose.
Če ste vzeli večji odmerek zdravila Xeloda, kot bi smeli Če ste vzeli večji odmerek zdravila Xeloda, kot bi smeli, se takoj posvetujte z zdravnikom, še preden boste zaužili naslednjega.
Capecitabine dose reduction decreases systemic exposure to 5-FU more than doseproportionally, due to non-linear pharmacokinetics for the active metabolite.
Če zmanjšamo odmerek kapecitabina, se sistemska izpostavljenost 5-FU zaradi nelinearne farmakokinetike aktivnega presnovka zmanjša bolj kot sorazmerno z odmerkom.
FOLFOX-4 or FOLFOX-4 + Bevacizumab
FOLFOX-4 + BEVACIZUMAB
Uncommon side effects (may affect up to 1 in 100 people) include:
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) vključujejo:
MARKETING AUTHORISATION NUMBER(S) EU/1/00/163/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/163/002
Recommended posology (see section 5.1):
Odmerjanje Priporočeno odmerjanje (glejte poglavje 5.1):
What Xeloda looks like and contents of the pack
Izgled zdravila Xeloda in vsebina pakiranja
XELOX or XELOX+ Bevacizumab
XELOX + BEVACIZUMAB
Xeloda contains capecitabine, which itself is not a cytostatic medicine.
Zdravilo Xeloda vsebuje kapecitabin, ki sam nima citostatičnega učinka.
Xeloda should only be prescribed by a doctor experienced in the use of anticancer medicines.
Zdravilo Xeloda lahko predpiše le zdravnik z izkušnjami pri zdravljenju raka.
Hazard ratio 95% CI
razmerje ogroženosti 95-% CI p vrednost
Confusional state, Panic attack, Depressed mood, Libido decreased
• zmedeno stanje, napade panike, depresivno razpoloženje, zmanjšan libido,
Children and adolescents Xeloda is not indicated in children and adolescents.
Zdravilo Xeloda ni namenjeno otrokom in mladostnikom.
- metastatic colorectal cancer (see section 5.1).
• za zdravljenje metastatske oblike kolorektalnega raka (glejte poglavje 5.1).