natgillin/translations-raw huggingface dataset:
If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 109/L or that the platelet count drops below 75 x 10
Ako neplanirane laboratorijske pretrage tijekom ciklusa liječenja pokažu pad broja neutrofila ispod 1,0 x 109/l ili pad broja trombocita ispod 75 x 109/l potrebno je prekinuti liječenje kapecitabinom.
Xeloda should only be prescribed by a doctor experienced in the use of anticancer medicines.
Lijek Xeloda smije propisati samo liječnik s iskustvom u primjeni lijekova protiv karcinoma.
5-Fluorouracil 400 mg/m intravenous bolus, followed by
5-fluorouracil intravenski bolus 2, nakon 400 mg/m kojeg slijedi 600 mg/
• Tablet coating: hypromellose (3 mPa.s), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and talc.
• Ovojnica tablete: hipromeloza (3 mPa.s), titanijev dioksid (E171), žuti željezov oksid (E172),
However, folinic acid has an effect on the pharmacodynamics of capecitabine and its toxicity may be enhanced by folinic acid: the maximum tolerated dose (MTD) of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day whereas it is only 2000 mg/m2 per day when capecitabine was combined with folinic acid (30 mg orally bid).
Međutim, folinatna kiselina djeluje na farmakodinamiku kapecitabina te njegova toksičnost može biti povećana folinatnom kiselinom: najveća podnošljiva doza (MTD - Maximum tolerated dose) kapecitabina u monoterapiji i intermitentnom liječenju iznosi 3000 mg/m2 dnevno, a 2000 mg/m2 dnevno kad se kapecitabin daje u kombinaciji s folinatnom kiselinom (30 mg oralno dvaput dnevno).
Parameter: Progression-free Survival EPP
Parametar: preživljenje bez progresije bolesti EPP
FOLFOX-4 (PPP*: N = 252; ITT**: N= 314)
FO LFO X-4 (PPP*: N = 252; ITT**: N = 314)
• if you have liver or kidney diseases
• ako imate bolest jetre ili bubrega
Patients with certain heterozygous DPYD variants (including DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants) have been shown to have increased risk of severe toxicity when treated with capecitabine.
DPYD*2A, c.1679T>G, c.2846A>T i c.1236G>A/HapB3) imaju povećan rizik od teške toksičnosti kada se liječe kapecitabinom.
In monkeys, abortion and embryolethality were observed at high doses, but there was no evidence of teratogenicity.
U majmuna su,visoke doze izazvale pobačaj i smrt ploda, ali nije bilo dokaza teratogenosti.
Caution must be exercised in patients with central or peripheral nervous system disease, e.g. brain metastasis or neuropathy (see section 4.8).
Bolest središnjeg ili perifernog živčanog sustava Pozornost treba obratiti na bolesnike s bolešću središnjeg ili perifernog živčanog sustava, primjerice s metastazama u mozgu ili neuropatijom (vidjeti dio 4.8).
Flushing, Hypotension, Hypertensive crisis, Hot flush, Phlebitis
hipotenzija, hipertenzivna kriza, navale vrućine, flebitis
• if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati lijek Xeloda: • ako ste alergični na kapecitabin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Keep this medicine out of the sight and reach of children.
Kako čuvati lijek Xeloda Lijek čuvajte izvan pogleda i dohvata djece.
Other side effects are:
Ostale nuspojave su :
Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1000 mg/m2
Tablica 2 Izračuni standardnih i smanjenih doza prema tjelesnoj površini za početnu dozu kapecitabina od 1000 mg/ m2
Interferon alpha: the MTD of capecitabine was 2000 mg/m2 per day when combined with interferon alpha-2a (3 MIU/m2 per day) compared to 3000 mg/m2 per day when capecitabine was used alone.
MTD kapecitabina iznosila je 2000 mg/m2 dnevno u kombinaciji s interferonom alfa-2a (3 MIU/m2 dnevno), u usporedbi s 3000 mg/m2 dnevno kad se kapecitabin primjenjivao sam.
(ITT: N=127)
(n=22).
NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Roche Registration GmbH
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku
The 5 year OS rate was 78% for XELOX versus 74% for 5-FU/LV.
XELOX nasuprot 74% za 5-FU/LV.
• if you are or become dehydrated
• ako ste dehidrirali
The hazard ratio for duration of survival (overall survival) was similar to the hazard ratio for progression-free survival (hazard ratio 0.85; 95% CI 0.64 - 1.13).
Omjer hazarda za trajanje preživljenja (ukupno preživljenje) bio je sličan omjeru rizika preživljenja bez progresije bolesti (omjer hazarda 0,85; 95% CI 0,64 do 1,13).
No significant differences occurred in the exposure to other metabolites (5'-DFCR, 5'-DFUR, and 5-FU).
Nije bilo značajnih razlika u izloženosti drugim metabolitima (5'-DFCR,
Patients treated with XELIRI experienced excessive gastrointestinal toxicity compared with FOLFIRI (diarrhoea 48% and 14% for XELIRI and FOLFIRI respectively).
U bolesnika liječenih XELIRI protokolom zabilježena je znatno veća gastrointestinalna toksičnost u usporedbi s FOLFIRI protokolom (proljev u 48% bolesnika koji su primali XELIRI i 14%
Patients with severe diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
Proljev Bolesnike s teškim proljevom treba pažljivo nadzirati te im u slučaju dehidracije nadoknađivati tekućinu i elektrolite.
Each pack contains 120 film-coated tablets (12 blisters of 10 tablets).
Svako pakiranje sadrži 120 filmom obloženih tableta (12 blistera po 10 tableta).
Capecitabine in combination with cisplatin was non-inferior to 5-FU in combination with cisplatin in terms of progression-free survival in the per protocol analysis (hazard ratio 0.81; 95% CI 0.63 - 1.04).
Kapecitabin u kombinaciji s cisplatinom nije bio inferioran kombinaciji 5-FU i cisplatina s obzirom na preživljenje bez znakova progresije bolesti u analizi prema protokolu (omjer hazarda 0,81; 95% CI 0,63 do 1,04).
In lactating mice, considerable amounts of capecitabine and its metabolites were found in milk.
mlijeku mišica u fazi laktacije nađena je znatna količina kapecitabina i njegovih metabolita.
Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Toksičnost koja ograničava dozu Toksičnost koja ograničava dozu uključuje proljev, abdominalnu bol, mučninu, stomatitis i sindrom šaka-stopalo (kožna reakcija na šakama i stopalima, palmarno-plantarna eritrodizestezija).
Each pack contains 60 film-coated tablets (6 blisters of 10 tablets).
Svako pakiranje sadrži 60 filmom obloženih tableta (6 blistera po 10 tableta).
Lacrimal duct stenosis (rare), Corneal disorders(rare), keratitis (rare), punctate keratitis (rare)
poremećaji rožnice (rijetko), keratitis (rijetko), keratitis punctata (rijetko)
Folinic acid/folic acid: a combination study with capecitabine and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of capecitabine and its metabolites.
Ispitivanje kombinirane primjene kapecitabina i folinatna kiseline pokazalo je da folinatna kiselina nema većeg utjecaja na farmakokinetiku kapecitabina i njegovih metabolita.
You must not breast-feed if you are taking Xeloda and for 2 weeks after the last dose.
Ako uzimate lijek Xeloda, ne smijete dojiti tijekom liječenja i još 2 tjedna nakon posljednje doze.
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.
Ako ste muškarac i imate partnericu koja može zatrudnjeti, morate koristiti učinkovitu metodu kontracepcije tijekom liječenja lijekom Xeloda i još 3 mjeseca nakon posljednje doze.
Standard and reduced dose calculations according to body surface area for starting doses of Xeloda of 1250 mg/m2 and 1000 mg/m2 are provided in tables 1 and 2, respectively.
Izračuni standardnih i smanjenih doza prema površini ljudskog tijela za početne doze lijeka Xeloda od 1250 mg/m2 i 1000 mg/m2 navedeni su u Tablici 1, odnosno Tablici 2.
Table 4 Summary of related ADRs reported in patients treated with capecitabine monotherapy Body System Very Common
Tablica 4 Sažetak povezanih nuspojava prijavljenih u bolesnika koji su liječeni kapecitabinom kao monoterapijom Organski sustav
Neurotoxicity, Tremor, Neuralgia, Hypersensitivity reaction, Hypoaesthesia
neuralgija, reakcija preosjetljivosti, hipoestezija
Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection , Rhinitis, Influenza, +Infection, Oral herpes
Herpes zoster, infekcija mokraćnog sustava, oralna kandidijaza, infekcija gornjeg dišnog sustava, rinitis, gripa, +infekcija, oralni herpes
Hyperglycaemia
hipertrigliceridemija
- metastatic colorectal cancer (see section 5.1).
Dukesovoj klasifikaciji) (vidjeti dio 5.1). - metastatskog kolorektalnog karcinoma (vidjeti dio 5.1).
Patients with renal impairment: Based on a pharmacokinetic study in cancer patients with mild to severe renal impairment, there is no evidence for an effect of creatinine clearance on the pharmacokinetics of intact drug and 5-FU.
Bolesnici s oštećenjem bubrežne funkcije: Prema ispitivanjima farmakokinetike u bolesnika s karcinomom i s blagim do umjerenim oštećenjem bubrežne funkcije, nema dokaza da klirens kreatinina utječe na farmakokinetiku nepromijenjenog lijeka i 5-FU.
• blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities), purple spots on the skin
• krvni ugrušci u dubokim venama, visok ili nizak krvni tlak, navale vrućine, hladni udovi
Periodic Safety Update Reports
· Periodička izvješća o neškodljivosti
Antacid: the effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
Ispitivan je učinak antacida koji sadrže aluminij hidroksid i magnezij hidroksid na farmakokinetiku kapecitabina.
Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache
Poremećaji živčanog sustava parestezija, dizestezija, periferna neuropatija, periferna senzorna neuropatija, disgeuzija, glavobolja neurotoksičnost, tremor,
MARKETING AUTHORISATION NUMBER(S) EU/1/00/163/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/163/001
How to take Xeloda
Kako uzimati lijek Xeloda
Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Preporučena početna doza kapecitabina primijenjenog kao monoterapija u adjuvantnom liječenju karcinoma kolona, liječenju metastatskog kolorektalnog karcinoma ili u liječenju lokalno uznapredovalog ili metastatskog karcinoma dojke iznosi 1250 mg/m² i uzima se dvaput dnevno (ujutro i navečer; što je jednako ukupnoj dnevnoj dozi od 2500 mg/m²) tijekom 14 dana, nakon čega slijedi 7
• Hand-and-foot skin-reaction: if you have pain, swelling, redness or tingling of hands and/or feet
• kožna reakcija na šakama i stopalima: ako osjećate bol, imate otečene i crvene šake i/ili stopala.
Thrombophlebitis Deep vein thrombosis, Hypertension,
Krvožilni poremećaji tromboflebitis duboka venska tromboza, hipertenzija, petehije,
In first-line treatment the median progression-free survival in the intent-to-treat population was 5.8 months (95%CI 5.1 - 6.2 months) for capecitabine monotherapy and 7.8 months (95%CI 7.0 - 8.3 months; p=0.0002) for XELIRI.
U prvoj liniji liječenja medijan vremena preživljenja bez progresije bolesti u populaciji bolesnika predviđenih za liječenje iznosio je 5,8 mjeseci (95% CI 5,1 - 6,2 mjeseca) za monoterapiju kapecitabinom i 7,8 mjeseci (95% CI 7,0 - 8,3 mjeseca; p=0,0002) za XELIRI protokol.
In the allrandomised population, capecitabine was shown to be superior to 5FU/LV for disease-free survival (hazard ratio 0.849; 95% CI 0.739 - 0.976; p = 0.0212), as well as for overall survival (hazard ratio 0.828; 95% CI 0.705 - 0.971; p = 0.0203).
U cjelokupnoj randomiziranoj populaciji kapecitabin se pokazao superiornijim u odnosu na 5-FU/LV u preživljenju bez znakova bolesti (omjer hazarda 0,849; 95% CI: 0,739 - 0,976; p = 0,0212) kao i u sveukupnom preživljenju (omjer hazarda 0,828; 95% CI: 0,705 - 0,971; p = 0,0203).
Dose changes within a treatment cycle
Promjene doze tijekom liječenja u
Elderly patients (see section 4.2):
Posebne populacije Stariji bolesnici (vidjeti dio 4.2)
• 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: ako dobijete bolan crveni ili ljubičasto-crveni osip koji se širi i počnu se javljati mjehurići i/ili druga oštećenja na sluznici (npr. u ustima i na usnicama),
- as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
- kao monoterapija za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha kemoterapijskog protokola koji se sastojao od kombinacije taksana i antraciklina ili u slučajevima u kojima daljnje liječenje antraciklinima nije indicirano.
A total of 156 patients were randomised to treatment with 5-FU (800 mg/m2 per day, continuous infusion on days 1 to 5 every 3 weeks) and cisplatin (80 mg/m2 as a 2-hour infusion on day
Ukupno 156 bolesnika randomizirano je za liječenje s 5-FU (800 mg/m2 dnevno, kontinuirana infuzija od prvog do petog dana svaka tri tjedna) i cisplatinom (80 mg/m2 u obliku dvosatne infuzije 1. dan, svaka 3 tjedna).
A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that patients on capecitabine who developed hand-foot syndrome (HFS) had a longer overall survival compared to patients who did not develop HFS: median overall survival 1100 days (95% CI 1007;1200) vs 691 days (95% CI 638;754) with a hazard ratio of 0.61 (95% CI 0.56; 0.66).
(karcinom kolona, kolorektalni karcinom, uznapredovali karcinom želuca i karcinom dojke) je pokazala da bolesnice koje su liječene kapecitabinom, a koje su razvile sindrom šaka-stopalo (HFS), imaju duži period ukupnog preživljenja u usporedbi s bolesnicama koje nisu razvile HFS: medijan ukupnog preživljenja iznosio je 1100 dana (95% CI 1007; 1200) u usporedbi s 691 danom (95% CI 638;754) s omjerom rizika od 0,61 (95% CI 0,56; 0,66).
Table 5 Summary of related ADRs reported in patients treated with capecitabine in combination treatment in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy Body System
Tablica 5 Sažetak povezanih nuspojava prijavljenih u bolesnika liječenih kapecitabinom u kombiniranom liječenju, a koje su dodatno primijećene uz one već zabilježene kod monoterapije kapecitabinom ili su se javljale s većom učestalošću od onih kod monoterapije kapecitabinom
+Neutropenia, +Leucopenia, Anaemia, +Neutropenic fever, Thrombocytopenia
+neutropenija, +leukopenija, +anemija, +febrilna neutropenija, trombocitopenija depresija koštane srži, +febrilna neutropenija
Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (p=0.09), and 18.9 months for XELIRI (p=0.27).
Medijan OS-a bio je 23,1 mjesec za FOLFIRI, 17,6 mjeseci za mIFL (p=0,09) te 18,9 mjeseci za XELIRI
• Grade 4 -1st appearance
· Stupanj 4 -1. pojavljivanje
In the all-randomised population, tests for difference of capecitabine vs 5-FU/LV in disease-free and overall survival showed hazard ratios of 0.88 (95% CI 0.77 - 1.01; p = 0.068) and 0.86 (95% CI 0.74 - 1.01; p = 0.060), respectively.
U cjelokupnoj randomiziranoj populaciji testovi za utvrđivanje razlike između kapecitabina i 5-FU/LV u preživljenju bez znakova bolesti i ukupnom preživljenju pokazali su omjere rizika od 0,88 (95% CI 0,77 - 1,01; p = 0,068), odnosno 0,86 (95% CI 0,74 - 1,01; p = 0,060).
The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
faktorijalnog dijela u kojem je 1401 bolesnik randomiziran u jednu od četiri različite terapijske skupine: XELOX i placebo, FOLFOX-4 i placebo, XELOX i bevacizumab te FOLFOX-4 i bevacizumab.
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).
varijantama DPYD*2A, c.1679T>G, c.2846A>T i c.1236G>A/HapB3), koje mogu uzrokovati potpun ili gotovo potpun izostanak enzimske aktivnosti DPD-a (određuje se laboratorijskim testovima), imaju najveći rizik od po život opasne ili smrtonosne toksičnosti te se ne smiju liječiti lijekom Xeloda
Capecitabine has minor or moderate influence on the ability to drive and use machines.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Kapecitabin malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Full dose 1000 mg/m2
Puna doza 1000 mg/m2
The following covariates were statistically significantly associated with a decreased risk of developing diarrhoea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks.
povećana kumulativna doza kapecitabina (0,1*kg) i povećanje intenziteta relativne doze u prvih šest tjedana.
Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decrease to ≤ 2.5 x ULN.
Monoterapija kapecitabinom može se nastaviti kada vrijednosti bilirubina padnu £3,0 x iznad gornje granice normale, odnosno ako jetrene aminotransferaze padnu £ 2,5 x iznad gornje granice normale.
Capecitabine in combination therapy:
Kapecitabin u kombiniranom liječenju
FOLFOX-4 or FOLFOX-4 + Bevacizumab
FOLFOX-4 ili FOLFOX-4 i bevacizumab oksaliplatin 85 mg/m intravenski
• if you have diarrhoea
• ako imate proljev
• bruising or reaction at the injection site (caused by medicines given by injection at the same time)
• modrice ili reakcija na mjestu injekcije (posljedica primjene lijekova injekcijom u isto vrijeme) Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba):
In combination treatment, the recommended starting dose of capecitabine should be reduced to 800 - 1000 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m2 twice daily when administered continuously (see section 5.1).
800 - 1000 mg/m2 kada se primijenjuje dvaput dnevno tijekom 14 dana, nakon čega slijedi 7 dana pauze ili na 625 mg/m² dvaput dnevno pri kontinuiranoj (svakodnevnoj) primjeni (vidjeti dio 5.1).
If you stop taking Xeloda
Ako prestanete uzimati lijek Xeloda:
However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
³ 60 godina češće se razvijaju nuspojave 3. ili 4. stupnja nego u mlađih bolesnika.
• Grade 2 -1st appearance
· Stupanj 2 -1. pojavljivanje
Full dose 1250 mg/m2
Puna doza 1250 mg/m2
Oxaliplatin: no clinically significant differences in exposure to capecitabine or its metabolites, free platinum or total platinum occurred when capecitabine was administered in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab.
Oksaliplatin Kod primjene kapecitabina u kombinaciji s oksaliplatinom ili u kombinaciji s oksaliplatinom i bevacizumabom nisu uočene klinički značajne razlike u izloženosti kapecitabinu ili njegovim metabolitima, slobodnom platinu ili ukupnom platinu.
• 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).
• nedostatak DPD-a: ako imate nedostatak DPD-a, imate povećan rizik od akutnog ranog nastupa toksičnosti i teških, po život opasnih ili smrtonosnih nuspojava koje uzrokuje lijek
Cutaneous lupus erythematosus (rare), Severe skin reactions such as StevensJohnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.)
StevensJohnsonova sindroma i toksične epidermalne nekrolize (vrlo rijetko) (vidjeti dio
Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyperpigmentation, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder
osip, alopecija eritem, suha koža, svrbež, hiperpigmentacija kože, makularni osip, ljuštenje kože, dermatitis,
Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with capecitabine.
Žene reproduktivne dobi potrebno je savjetovati da tijekom liječenja kapecitabinom izbjegavaju trudnoću.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/163/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/163/002
-2nd appearance -3rd appearance
-2. pojavljivanje -3. pojavljivanje
The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, female gender was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Rezultati metaanalize 14 kliničkih ispitivanja sa više od 4700 bolesnika liječenih kapecitabinom pokazali su da je u svim ispitivanjima zajedno ženski spol statistički značajno povezan s povećanim rizikom razvoja sindroma šaka-stopalo i proljeva te sa smanjenim rizikom razvoja neutropenije.
LIST OF EXCIPIENTS Also contains anhydrous lactose See package leaflet for further information.
Također sadrži bezvodnu laktozu.Vidjeti uputu o lijeku za dodatne informacije.
In this trial, 1987 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin IV followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
tom ispitivanju slučajnim odabirom 1987 bolesnika liječeno je kapecitabinom (1250 mg/m2 dvaput dnevno kroz 2 tjedna nakon čega slijedi jednotjedna pauza, ciklusi u 3-tjednim intervalima u razdoblju od 24 tjedna) ili 5-FU i leukovorinom (Mayo protokol: 20 mg/m2 leukovorina i.v. i 425 mg/m2 5-FU intravenski u bolusu od prvog do petog dana, svakih 28 dana u razdoblju od 24 tjedna).
Data from one multicentre, randomised, controlled phase 3 clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine in combination with oxaliplatin (XELOX) for the adjuvant treatment of patients with colon cancer (NO16968 study).
Podaci iz multicentričnog, randomiziranog kontroliranog kliničkog ispitivanja faze III u bolesnika s karcinomom kolona stadija III (Dukes C) podržavaju primjenu kapecitabina u kombinaciji s oksaliplatinom (XELOX) u adjuvantnom liječenju bolesnika s karcinomom kolona (ispitivanje NO16968).