natgillin/translations-raw huggingface dataset:
• blood infection, urinary tract infection, infection of the skin, infections in the nose and throat, fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess,
• okužbo krvi, okužbo sečil, okužbo kože, okužbe nosu in žrela, glivične okužbe (vključno s tistimi v ustih), gripo, gastroenteritis, zobni absces,
• if you have diabetes
• imate sladkorno bolezen,
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.
Glede na farmakokinetično študijo pri bolnikih, ki imajo blago do hudo ledvično okvaro, ni dokazov za vpliv kreatininskega očistka na farmakokinetiko zdravila in 5-FU.
If you cannot swallow Xeloda tablets whole, tell your healthcare provider.
Če ne morete pogoltniti celih tablet zdravila Xeloda,
In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping capecitabine might require that your doctor adjusts your anticoagulant dose.
Če sočasno jemljete kumarinske antikoagulante (ki vsebujejo npr. fenoprokumon), vam bo zdravnik v primeru prekinitve zdravljenja s kapecitabinom morda moral prilagoditi odmerek antikoagulanta.
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).
Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4700 bolnikov, zdravljenih s kapecitabinom samim ali kapecitabinom v kombinaciji z različnimi shemami kemoterapije pri več indikacijah (rak kolona, kolorektalni rak, rak želodca in rak dojk) je pokazala, da so imeli bolniki, ki so se zdravili s kapecitabinom pri katerih se je razvil sindrom roka-noga, daljše celokupno preživetje v primerjavi z bolniki, ki niso imeli tega sindroma; mediana celokupnega preživetja je bila 1100 dni (95-% interval zaupanja; 1007; 1200) v primerjavi s 691 dnevi (95-% interval zaupanja 638; 754) z razmerjem ogroženosti 0,61 (95-% interval zaupanja; 0,56; 0,66).
In the study published by Skof et al, patients were randomised to receive either FOLFIRI or XELIRI .
V študiji, ki jo je objavil Škof s sodelavci, so bolnike randomizirali v FOLFIRI ali XELIRI.
In case of exposure of either patient or caregiver to crushed or cut Xeloda tablets adverse drug reactions could occur (see Section 4.8).
V primeru, da je zdrobljenim ali razrezanim tabletam zdravila Xeloda izpostavljen bolnik ali skrbnik, se pri njem lahko pojavijo neželeni učinki zdravila (glejte poglavje 4.8).
- 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.
• kot monoterapija za zdravljenje bolnikov z lokalno napredovalo ali metastatsko obliko raka dojk po neuspešnem zdravljenju s taksani in antraciklinsko kemoterapijo ali za zdravljenje bolnikov, pri katerih nadaljnje zdravljenje z antraciklini ni indicirano.
Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureidopropionic acid (FUPA).
Dihidropirimidinaza cepi pirimidinski obroč, pri čemer nastane 5fluoro-ureidopropionska kislina (FUPA).
• Tablet coating: hypromellose (3 mPa.s), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and talc.
• Obloga tablete: hipromeloza (3 mPa.s), titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172) in smukec.
How to take Xeloda
Kako jemati zdravilo Xeloda
Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35% increase in AUC when creatinine clearance decreases by 50%) and to FBAL (114% increase in AUC when creatinine clearance decreases by 50%).
kreatininski očistek zmanjšan za 50 %) in FBAL (114-% povečanje AUC in padec kreatinskega očistka za 50 %).
At the dose of 1250 mg/m2 on day 14 with administration after food intake, the peak plasma concentrations (Cmax in µg/ml) for capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 4.67, 3.05, 12.1, 0.95 and 5.46 respectively.
Pri odmerku 1.250 mg/m2 ob jemanju po obroku so bile na 14. dan največje plazemske koncentracije (Cmax v μg/ml) za kapecitabin, 5´-DFCR, 5´-DFUR, 5-FU in FBAL 4,67; 3,05; 12,1; 0,95 in 5,46.
Name and address of the manufacturer responsible for batch release Roche Pharma AG
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Roche Pharma AG
NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
Key efficacy results for AIO KRK study XELOX + bevacizumab
Glavni rezultati o učinkovitosti za študijo AIO KRK shema XELOX + bevacizumab
Patients with hepatic impairment due to liver metastases: According to a pharmacokinetic study in cancer patients with mild to moderate liver impairment due to liver metastases, the bioavailability of capecitabine and exposure to 5-FU may increase compared to patients with no liver impairment.
Glede na farmakokinetično študijo pri bolnikih z rakom, ki imajo blago ali zmerno jetrno okvaro zaradi zasevkov v jetrih, je biološka uporabnost kapecitabina in izpostavljenost 5-FU lahko povečana v primerjavi z bolniki brez okvare.
Median overall survival time was 703 days (95% CI: 671; 745) in patients treated with capecitabine-containing regimens and 683 days (95% CI: 646; 715) in patients treated with 5-FU-containing regimens.
Mediana celokupnega preživetja je bila pri bolnikih, katerih zdravljenje je vključevalo kapecitabin, 703 dni (95% interval zaupanja; 671; 745); pri bolnikih, katerih zdravljenje je vključevalo 5-FU, pa 683 dni (95% interval zaupanja; 646; 715).
Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do in na pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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
Če laboratorijski izvid med ciklom zdravljenja pokaže, da se je število nevtrofilcev znižalo pod 1,0 x 109/l ali da se je število trombocitov znižalo pod 75 x 109/l, je treba zdravljenje s kapecitabinom prekiniti.
• if you have liver or kidney diseases
• imate jetrno ali ledvično bolezen,
Common All grades
Pogosti Vse stopnje
Japanese patients (n=18) had about 36% lower Cmax and 24% lower AUC for capecitabine than Caucasian patients (n=22).
Po peroralnem dajanju 825 mg/m2 kapecitabina dvakrat na dan 14 dni so japonski bolniki (n = 18) imeli približno 36 % nižjo Cmax in 24 % nižjo AUC kapecitabina kakor kavkaški bolniki (n = 22).
• blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities), purple spots on the skin
• strdke krvi v globokih venah, visok ali nizek krvni tlak, vročinske valove, mrzle okončine,
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).
Pri zdravljenju s kombinacijo zdravil je treba priporočeni začetni odmerek kapecitabina zmanjšati na 800 do 1.000 mg/m2, kadar ga dajemo dvakrat na dan 14 dni, čemur sledi 7-dnevni premor, ali na 625 mg/m2 dvakrat na dan, če ga dajemo neprekinjeno (glejte poglavje 5.1).
If you are a woman who could become pregnant you should use effective contraception during treatment with XELODA and for 6 months after the last dose.
Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom Xeloda in še 6 mesecev po zadnjem odmerku zdravila uporabljati učinkovito kontracepcijo.
Xeloda should only be prescribed by a qualified physician experienced in the utilisation of antineoplastic medicinal products.
Zdravilo Xeloda lahko predpiše le zdravnik z ustreznim znanjem in izkušnjami z uporabo zdravil za zdravljenje novotvorb.
Tablet coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc.
hipromeloza, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172), smukec.
-2nd appearance -3rd appearance -4th appearance
2. pojav 3. pojav
Phase I studies evaluating the effect of capecitabine on the pharmacokinetics of either docetaxel or paclitaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel or paclitaxel (Cmax and AUC) and no effect by docetaxel or paclitaxel on the pharmacokinetics of 5'DFUR.
Raziskave faze I, ki so ocenjevale učinek kapecitabina na farmakokinetiko docetaksela ali paklitaksela in obratno, niso pokazale vplivov kapecitabina na farmakokinetiko docetaksela ali paklitaksela (Cmax in AUC).
Parameter: Overall Survival PPP
Parameter: Celokupno preživetje
However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
Pri bolnikih, starih 60 let ali več, so bili z zdravljenjem povezani neželeni učinki stopnje 3 ali 4 bolj pogosti kot pri mlajših bolnikih.
• Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose (3 mPa.s), microcrystalline cellulose, magnesium stearate.
• Jedro tablete: brezvodna laktoza, natrijev premrežen karmelozat, hipromeloza (3 mPa.s), mikrokristalna celuloza, magnezijev stearat.
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).
Razmerje ogroženosti za trajanje preživetja (celokupnega) je bilo podobno razmerju ogroženosti za preživetje brez napredovanja bolezni (razmerje ogroženosti 0,85; 95-% interval zaupanja 0,64-1,13).
*EPP=eligible patient population; **ITT=intent-to-treat population
EPP ITT *EPP = primerna populacija bolnikov (eligible patient population); **ITT = populacija bolnikov, ki so jih nameravali zdraviti (intent-to-treat population); CI = interval zaupanja (confidence interval); P = placebo
Xeloda 500 mg film-coated tablets Pack size of 120 film-coated tablets (12 blisters of 10 tablets)
Xeloda 500 mg filmsko obložene tablete Velikost pakiranja: 120 filmsko obloženih tablet (12 pretisnih omotov po 10 tablet)
53% to 60% of all-grades HFS was observed in capecitabine monotherapy trials (comprising studies in adjuvant therapy in colon cancer, treatment of metastatic colorectal cancer, and treatment of breast cancer) and a frequency of 63% was observed in the capecitabine/docetaxel arm for the treatment of metastatic breast cancer.
3 tedne, je bila pogostnost vseh stopenj sindroma roka-noga v preskušanjih, pri katerih so bolniki prejemali le kapecitabin (študije adjuvantnega zdravljenja pri raku kolona, zdravljenja metastatskega kolorektalnega raka in raka dojk), 53- do 60-%, pogostnost v skupini z metastatskim rakom dojk, ki je prejemala kapecitabin v kombinaciji z docetakselom, pa je bila 63-%.
Table 8
Preglednica 8.
Xeloda is used in the treatment of colon, rectal, gastric, or breast cancers.
Zdravilo Xeloda se uporablja za zdravljenje raka debelega črevesa, danke, želodca in raka dojk.
Discontinue treatment permanently
4. pojav dokončna prekinitev zdravljenja
In an interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57%) of S-warfarin.
Antikoagulantno zdravljenje s kumarinskimi derivati: V raziskavi interakcij so pri jemanju enkratnega odmerka varfarina ugotovili pomembno povečanje povprečne AUC S-varfarina (+57 %).
An analysis of safety data in patients treated with capecitabine monotherapy (colorectal cancer) with baseline renal impairment showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions compared to patients with normal renal function (36% in patients without renal impairment n=268, vs. 41% in mild n=257 and 54% in moderate n=59, respectively) (see section 5.2).
Bolniki z ledvično okvaro (glejte poglavja 4.2, 4.4 in 5.2) Analiza varnostnih podatkov pri bolnikih z ledvično okvaro, ki so jih zdravili samo s kapecitabinom (zaradi kolorektalnega raka) je pokazala, da je incidenca z zdravljenjem povezanih neželenih učinkov stopnje 3 in 4 pri teh bolnikih večja, kot pri bolnikih z normalnim delovanjem ledvic ((36 % pri bolnikih brez ledvične okvare, n = 268, v primerjavi z 41 % pri bolnikih z blago ledvično okvaro, n = 257, in 54 % pri bolnikih z zmerno ledvično okvaro, n = 59) (glejte poglavje 5.2).
Hand-foot syndrome (see section 4.4): For the capecitabine dose of 1250 mg/m2 twice daily on days 1 to 14 every 3 weeks, a frequency of
Sindrom roka-noga (glejte poglavje 4.4) Če so bolniki kapecitabin prejemali v odmerku 1.250 mg/m2 dvakrat na dan od 1. do 14. dneva vsake
Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle in combination with other medicinal products
Prilagajanje odmerkov zaradi toksičnosti, kadar se kapecitabin uporablja z drugimi zdravili v 3tedenskih ciklih
Capecitabine 1000 mg/m oral twice daily
kapecitabin 1.000 mg/m2 peroralno dvakrat na dan placebo ali bevacizumab
Following a mean duration of follow-up for the study population of 26.2 months, treatment responses were as shown below:
Odgovori na zdravljenje so po povprečnem trajanju spremljanja študijske populacije 26,2 meseca prikazani v preglednici 9.
Xeloda is indicated for the treatment of: -for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
• za adjuvantno zdravljenje bolnikov po operaciji raka kolona stadija III (Dukes C) (glejte poglavje 5.1).
For terms marked with a “+”, the frequency count was based on grade 3-4 ADRs.
"+", so pri določitvi pogostnosti upoštevali le neželene učinke stopnje 3 ali 4.
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.
Interferon alfa: Pri sočasnem jemanju kapecitabina z interferonom alfa (3 mio i.e./m2 na dan) je bil največji prenosljivi odmerek kapecitabina 2.000 mg/m2 na dan, pri jemanju samega kapecitabina pa 3.000 mg/m2 na dan.
In these trials, a total of 236 patients were treated with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
V preskušanjih je bilo 236 bolnikov zdravljenih s kapecitabinom (odmerek 1250 mg/m2 dvakrat na dan 2 tedna, sledi en teden premora).
• blood clots in the veins in the lung (pulmonary embolism), collapsed lung, coughing up blood, asthma, shortness of breath on exertion
• strdke krvi v venah in pljučih (pulmonalni embolizem), kolaps pljuč, izkašljevanje krvi, astmo,
However, the on-treatment PFS analysis did not confirm the results of the general PFS and OS analysis: the hazard ratio of XELOX versus FOLFOX-4 was 1.24 with 97.5% CI 1.07 - 1.44.
Analiza preživetja brez napredovanja bolezni ob zdravljenju (ontreatment progression-free survival) ni potrdila rezultata celotne analize preživetja brez napredovanja bolezni in celokupnega preživetja: razmerje ogroženosti za zdravljenje po shemi XELOX v primerjavi s FOLFOX-4 je bilo 1,24 (97,5-% interval zaupanja 1,07−1,44).
Oxaliplatin 85 mg/m intravenous
FOLFOX-4 + bevacizumab oksaliplatin 85 mg/m2 intravensko
Full dose 1000 mg/m2
Polni odmerek 1.000 mg/m2
Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose (3 mPa.s), microcrystalline cellulose, magnesium stearate.
Jedro tablete brezvodna laktoza, premrežen natrijev karmelozat, hipromeloza (3 mPa.s), mikrokristalna celuloza, magnezijev stearat.
• if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
• Pri bolnikih z znano popolno odsotnostjo aktivnosti dihidropirimidin dehidrogenaze (DPD)
Monotherapy with capecitabine in adjuvant colon cancer Data from one multicentre, randomised, controlled phase III clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine for the adjuvant treatment of patients with colon cancer (XACT Study; M66001).
Samostojno adjuvantno zdravljenje s kapecitabinom pri raku kolona Podatki iz multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja faze III pri bolnikih z rakom kolona stadija III (Dukes C) podpirajo uporabo kapecitabina za adjuvantno zdravljenje bolnikov z rakom kolona (študija XACT, M66001).
It is therefore possible that Xeloda could affect your ability to drive a car or operate machines.
Zdravilo Xeloda lahko povzroči omotico, slabost ali občutek utrujenosti, zato lahko vpliva na vašo sposobnost za vožnjo in upravljanje strojev.
Fatigue, Asthenia
• utrujenost,
Xeloda with food and drink You should take Xeloda no later than 30 minutes after meals.
Zdravilo Xeloda morate vzeti najpozneje 30 minut po obroku.
You must not breast-feed if you are taking Xeloda and for 2 weeks after the last dose.
Med zdravljenjem z zdravilom Xeloda in še 2 tedna po zadnjem odmerku zdravila ne smete dojiti.
If you get any side effects, talk to your doctor or pharmacist or nurse.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali medicinsko sestro.
Each pack contains 60 film-coated tablets (6 blisters of 10 tablets).
Eno pakiranje vsebuje 60 filmsko obloženih tablet (6 pretisnih omotov po 10 tablet).
Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1000 mg/m2
Standardni in zmanjšani odmerki glede na telesno površino za začetni odmerek kapecitabina 1.000 mg/m2
• bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth
• krvavitev iz črevesja, zaprtje, bolečino v zgornjem delu trebuha, slabo prebavo, pline (vetrove), suha usta,
Capecitabine in combination therapy:
Kapecitabin v kombinaciji z drugimi zdravili
Advanced gastric cancer:
Napredovali rak želodca
• bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort, heartburn (reflux of food from the stomach), blood in the stool jaundice (yellowing of skin and eyes)
• zaporo črevesja, nabiranje tekočine v trebuhu, vnetje tankega in debelega črevesa, želodca ali požiralnika, bolečino v spodnjem delu trebuha, neugodje v želodcu, zgago (refluks hrane iz želodca), kri v blatu,
Each pack contains 120 film-coated tablets (12 blisters of 10 tablets).
Eno pakiranje vsebuje 120 filmsko obloženih tablet (12 pretisnih omotov po 10 tablet).
In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7- day rest period, combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks.
Priporočeni začetni odmerek kapecitabina v kombinaciji z docetakselom za zdravljenje metastatskega raka dojk je 1.250 mg/m2 dvakrat na dan 14 dni, sledi 7-dnevni premor, odmerek docetaksela pa je 75 mg/m2 vsake 3 tedne v obliki enourne intravenske infuzije.
Bone marrow depression, +Febrile Neutropenia
+febrilna nevtropenija
Dose level 1000 mg/m
Odmerek 1.000 mg/m
In patients with severe leukopenia, neutropenia, or thrombocytopenia, In patients with severe hepatic impairment,
• Pri bolnikih s hudo levkopenijo, nevtropenijo ali trombocitopenijo.
• Hand-and-foot skin-reaction: if you have pain, swelling, redness or tingling of hands and/or feet
• Kožna reakcija na rokah in nogah: če imate boleče, otekle, rdeče ali skeleče roke ali noge ali oboje okončine.
What you need to know before you take Xeloda
Kaj morate vedeti, preden boste vzeli zdravilo Xeloda Ne jemljite zdravila Xeloda:
Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Xeloda.
Zdravnik vam bo morda zmanjšal odmerek ali začasno prekinil zdravljenje z zdravilom Xeloda ali oboje, kar bo pomagalo zmanjšati verjetnost, da bi se nadaljevali ali postali resni.
LIST OF EXCIPIENTS Also contains anhydrous lactose See package leaflet for further information.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi brezvodno laktozo.
STOP taking Xeloda immediately and contact your doctor if any of these symptoms occur:
Če se pojavi kateri koli od navedenih simptomov, takoj PRENEHAJTE z jemanjem zdravila Xeloda in pokličite zdravnika:
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).
V tem preskušanju so randomizirali 1.987 bolnikov v zdravljenje s kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna, sledil je enotedenski premor, dobili so 3-tedenske cikle v 24 tednih) ali s 5-FU in levkovorinom (shema Mayo: 20 mg/m2 levkovorina intravensko, sledilo je 425 mg/m2 5-FU v obliki intravenskega bolusa vsakih 28 dni - na prvi do peti dan 24 tednov).
FOLFOX-4/FOLFOX-4+P/ FOLFOX-4+BV (EPP*: N = 937; ITT**: N= 1017)
FOLFOX-4/FOLFOX-4 + P/
Appetite decreased Hypokalaemia, Hyponatraemia, Hypomagnesaemia,
Presnovne in prehranske motnje zmanjšan apetit hipokaliemija, hiponatriemija, hipomagneziemija, hipokalcemija, hiperglikemija
Dose level 1250 mg/m
Odmerek 1.250 mg/m
Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1250 mg/m2
Standardni in zmanjšani odmerki glede na telesno površino za začetni odmerek kapecitabina 1.250 mg/m2
• if you have diarrhoea
• imate drisko,
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.
Standardni in zmanjšani odmerki so za začetni odmerek zdravila Xeloda 1.250 mg/m2 glede na telesno površino izračunani v preglednici 1, za 1.000 mg/m2 pa v preglednici 2.
• skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face joint swelling or stiffness, bone pain, muscle weakness or stiffness
• razjedo in mehurčke na koži, reakcijo kože s svetlobo, pordevanje dlani, otekanje ali bolečino obraza,
Contents of the pack and other information
Shranjevanje zdravila Xeloda Vsebina pakiranja in dodatne informacije
Very rare side effects (may affect up to 1 in 10,000 people) include: severe skin reaction such as skin rash, ulceration and blistering which may involve ulcers of the mouth, nose, genitalia, hands, feet and eyes (red and swollen eyes)
• hude kožne reakcije, kot so kožni izpuščaj, razjede in mehurji, ki lahko vključujejo razjede v ustih, nosu, na spolovilih, rokah, nogah in v očeh (rdeče in zatekle oči).
Reduced dose 625 mg/m2
Zmanjšani odmerek (50 %) 625 mg/m2
Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/Prothrombin time prolonged
Bolezni krvi in limfatičnega sistema nevtropenija, anemija febrilna nevtropenija, pancitopenija, granulocitopenija, trombocitopenija, levkopenija, hemolitična anemija, zvišano internacionalno normalizirano razmerje/podaljšan protrombinski čas
How to store Xeloda
Shranjevanje zdravila Xeloda
In this trial, 255 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period and docetaxel 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
255 bolnikov, randomizirano vključenih v preskušanje, je prejemalo zdravljenje s kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna, sledil je enotedenski premor, in docetaksel 75 mg/m2 v obliki enourne intravenske infuzije vsake 3 tedne).