natgillin/translations-raw huggingface dataset:
Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, ASAT and ALAT had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
ki so prejemali 1.250 mg/m2 kapecitabina dvakrat na dan. Spol, prisotnost ali odsotnost zasevkov v jetrih, splošno bolnikovo stanje, celokupni bilirubin, serumski albumin, AST in ALT niso statistično značilno vplivali na farmakokinetiko 5'-DFUR, 5-FU in FBAL.
If you are a male patient and your female partner could become pregnant, you should use effective contraception during treatment with Capecitabine Accord and for 3 months after the last dose.
Če ste bolnik in bi vaša partnerka lahko zanosila, morate med zdravljenjem z zdravilom Kapecitabin Accord in še 3 mesece po zadnjem odmerku zdravila uporabljati učinkovito kontracepcijo.
Each pack contains 30 x 1, 60 x 1 or 120 x 1 film-coated tablets.
Vsako pakiranje vsebuje 30 x 1, 60 x 1 ali 120 x 1 filmsko obloženih tablet.
The median follow up at the time of the primary analyses in the intent-to-treat population was 1.5 years; data from analyses following an additional 1 year of follow up are also included in Table 8.
ki so jo nameravali zdraviti, je bila 1,5 leta; podatki iz analize po dodatnem enoletnem spremljanju so prav tako vključeni v preglednico 8.
Capecitabine Accord is available in blister packs containing 30, 60 or 120 film-coated tablets or in perforated unit dose blister packs containing 30 x 1, 60 x 1 or 120 x 1 film-coated tablets.
Zdravilo Kapecitabin Accord je na voljo v pretisnih omotih po 30, 60 ali 120 filmsko obloženih tablet ali v perforiranih pretisnih omotih za enkratni odmerek po 30 x 1, 60 x 1 ali 120 x 1 filmsko obloženih tablet.
Aluminium/aluminium or PVC/PVdC/Aluminium blister containing 30, 60 or 120 film-coated tablets.
Aluminijevi/aluminijevi ali PVC/PVdC/aluminijevi pretisni omoti v pakiranju po 30, 60 ali 120 filmsko obloženih tablet.
In this trial, 1002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:
bolnika randomizirana v eno od naslednjih štirih skupin po 2x2 faktorskem načrtu:
(neuropathy)
(nevropatija),
PRIMARY ANALYSIS XELOX/ XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
OSNOVNA ANALIZA XELOX/XELOX + P/ XELOX + BEVACIZUMAB (EPP*: n = 967; ITT**: n =
If you get any side effects, talk to your doctor or pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
For the dosing schedule of XELOX and FOLFOX-4 (without addition of placebo or bevacizumab), refer to Table 7.
Odmerjanje zdravljenja po shemah XELOX in FOLFOX-4 (brez dodatka placeba ali bevacizumaba) je opisano v preglednici 7.
Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E5) Magnesium stearate
Jedro tablete brezvodna laktoza mikrokristalna celuloza (E460) premrežen natrijev karmelozat hipromeloza (E5) magnezijev stearat
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.
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.
Palmar-plantar erythrodysaesthesia syndrome**
Bolezni kože in podkožja palmarnoplantarna eritrodisestezija**
• gout medicines (allopurinol),
• zdravil proti protinu (alopurinola),
820 Patients were randomised to receive either sequential treatment (n=410) or combination treatment (n=410).
V skupino, ki je prejela zaporedno zdravljenje (n = 410) in skupino, ki je prejela kombinacijo zdravil (n = 410), so randomizirali 820
There is no data on capecitabine and impact on fertility.
Plodnost Podatkov o vplivu kapecitabina na plodnost ni.
• 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,
• okužba krvi, okužba sečil, vnetje kože, vnetja nosi in grla, glivična vnetja (vključno z vnetji v ustih), gripa, gastroenteritis, zobni ognojek, • bule pod kožo (lipome),
The hazard ratio for overall survival was 0.94 (95% CI: 0.89; 1.00, p=0.0489) indicating that capecitabine -containing regimens are non-inferior to 5-FU-containing regimens.
Razmerje ogroženosti za celokupno preživetje je bilo 0,94 (95-% interval zaupanja; 0,89; 1,00, p = 0,0489), kar kaže, da je zdravljenje, ki vključuje kapecitabin, neinferiorno zdravljenju, ki vključuje 5-FU.
• blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities), purple spots on the skin
• strdki krvi v globokih venah, visok ali nizek krvni tlak, vročinski oblivi, hladni udi (okončine),
The AUC of FBAL increased with age (20% increase in age results in a 15% increase in the AUC of FBAL).
povečanje v letih daje 15-% povečanje AUC za FBAL).
XELOX was demonstrated to be non-inferior to FOLFOX-4 in terms of progression-free survival in the perprotocol population and intent-to-treat population (see Table 10).
Zdravljenje po shemi XELOX je bilo ne-inferiorno zdravljenju po shemi FOLFOX-4 glede na preživetje brez napredovanja bolezni v populaciji po protokolu in populaciji, ki so jo nameravali zdraviti (glejte preglednico 10).
Table 7 Treatment regimens in study NO16966 (mCRC)
Sheme zdravljenja v študiji NO16966 (metastatski kolorektalni rak).
• sleeplessness (insomnia), depression
• dehidracija, izguba telesne mase, • nespečnost (insomnijo), depresija,
• know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
• veste, da imate delno pomanjkanje aktivnosti encima dihidropirimidin dehidrogenaze (DPD),
cisplatin, irinotecan)
bevacizumaba, cisplatina, irinotekana),
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. fenprokumon) vam bo zdravnik v primeru prekinitve zdravljenja z zdravilom Kapecitabin Accord morda moral prilagoditi odmerek antikoagulanta.
Dose level 1250 mg/m2 (twice daily)
Odmerek 1.250 mg/m2 (dvakrat na dan)
Capecitabine Accord is used in the treatment of colon, rectal, gastric, or breast cancers.
Zdravilo Kapecitabin Accord se uporablja za zdravljenje raka debelega črevesa, danke, želodca in raka dojk.
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
Dehydration
Dehidracija:
• inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis)
• vnetje, ki vodi v moteno ali zavrto izločanje žolča (holestatični hepatitis),
604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m2 leucovorin intravenous followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days).
604 randomizirane bolnike pa 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).
Median overall survival time was 703 days (95% CI: 671; 745) in patients treated with capecitabine -containing regimens and 683 days (95% CI:
% interval zaupanja; 671; 745); pri bolnikih, katerih zdravljenje je vključevalo 5-FU, pa 683 dni (95-%
Capecitabine Accord should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
Zdravilo Kapecitabin Accord lahko predpiše le zdravnik z ustreznim znanjem in izkušnjami z uporabo zdravil za zdravljenje novotvorb.
PVC/PVdC/Aluminium perforated unit dose blister containing 30, 60 or 120 film-coated tablets.
PVC/PVdC/aluminijevi perforirani pretisni omot za enkratni odmerek v pakiranju po 30, 60 ali 120 filmsko obloženih tablet.
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.
Lacrimal duct stenosis (rare), Corneal disorders(rare), keratitis (rare), punctate keratitis (rare)
vnetje oči zmanjšana ostrina vida, diplopija stenoza solznega voda (redki), bolezni roženice (redki), keratitis (redki), keratitis punctata (redki)
Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely and the anticoagulant dose adjusted accordingly (see section 4.5).
Bolnikom, ki sočasno prejemajo kapecitabin in peroralni kumarinski antikoagulant, je treba skrbno spremljati antikoagulantni odziv (INR ali protrombinski čas) ter ustrezno prilagajati odmerek antikoagulanta
Oxaliplatin
Oksaliplatin:
ITT *EPP=eligible patient population; **ITT=intent-to-treat population.
*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
Toxicity grades* Dose changes within a treatment cycle Dose adjustment for next cycle/dose (% of starting dose)
Prilagoditev odmerka za naslednji cikel/odmerek
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
In addition to the above, when capecitabine is used alone, the very common side effects which may affect more than 1 in 10 people are:
Poleg zgoraj omenjenih, se lahko, kadar se kapecitabin uporablja samostojno, zelo pogosto (pri več kot
The elimination half-life (t1/2 in hours) of capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 0.85, 1.11, 0.66, 0.76 and 3.23 respectively.
Razpolovne dobe izločanja (t1/2 v urah) kapecitabina, 5'-DFCR, 5'-DFUR, 5-FU in FBAL so bile 0,85;
• headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation), taste changes
• glavobol, zaspanost, omotica, nenormalni občutek na koži (otrplost ali občutek ščemenja),
Careful monitoring and prompt treatment interruption is recommended if the patient develops a grade 2, 3 or 4 adverse event during treatment and subsequent dose adjustment as outlined in Table 3 above.
Če se pri bolniku med zdravljenjem pojavijo neželeni dogodki stopnje 2, 3 ali 4, ga je priporočljivo skrbno nadzorovati in takoj prekiniti zdravljenje, nadaljnje odmerke pa prilagoditi v skladu z zgornjo preglednico 3.
Median overall survival
Mediana celokupnega preživetja ITT
Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Toksičnosti, ki lahko omejijo odmerjanje Med toksičnosti, ki lahko omejijo odmerjanje, uvrščajo drisko, bolečino v trebuhu, slabost, stomatitis in sindrom roka-noga (reakcija na dlaneh in podplatih, palmarno-plantarna eritrodisestezija).
What Capecitabine Accord looks like and contents of the pack
Izgled zdravila Kapecitabin Accord in vsebina pakiranja
Japanese patients had also about 25% lower Cmax and 34% lower AUC for FBAL than Caucasian patients.
nižjo Cmax in 34 % nižjo AUC za FBAL.
• diabetes, decrease in blood potassium, malnutrition, increased blood triglycerides
• sladkorna bolezen, zmanjšanje kalija v krvi,, povečana raven trigliceridov v krvi,
Skin toxicity, characterised bydegenerative/regressive changes, was observed with capecitabine.
Opazili so tudi toksični učinek kapecitabina na kožo, znan kot degenerativne/regresivne spremembe.
How to take Capecitabine Accord
Kako jemati zdravilo Kapecitabin Accord
-for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Zdravilo Kapecitabin Accord je indicirano za: - adjuvantno zdravljenje bolnikov po operaciji raka kolona stadija III (Dukes' C) (glejte poglavje 5.1); - zdravljenje metastatske oblike kolorektalnega raka (glejte poglavje 5.1);
In the allrandomised population, capecitabine was shown to be superior to 5-FU/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).
V celotni randomizirani populaciji je bil kapecitabin superioren v primerjavi s 5-FU/LV v preživetju brez bolezni (razmerje ogroženosti 0,849; 95-% interval zaupanja 0,739−0,976; p = 0,0212), kot tudi v celokupnem preživetju (razmerje ogroženosti 0,828; 95-% interval zaupanja 0,705−0,971; p = 0,0203).
• fluid collection in the kidneys, increased frequency of urination during the night, incontinence, blood in the urine, increase in blood creatinine (sign of kidney dysfunction)
• nabiranje tekočine v ledvicah, povečano število uriniranj ponoči, inkontinenca, kri v urinu,
NCIC CTC grade 2 diarrhoea is defined as an increase of 4 to 6 stools/day or nocturnal stools, grade 3 diarrhoea as an increase of 7 to 9 stools/day or incontinence and malabsorption.
Driska stopnje 2 je po NCIC CTC opredeljena kot povečana potreba po izpraznitvi črevesa 4- do 6krat na dan ali kot nočne povečane potrebe po izpraznitvi črevesa.
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).
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,
• difficulty speaking, impaired memory, loss of movement coordination, balance disorder, fainting, nerve damage (neuropathy) and problems with sensation
• težave z govorjenjem, moten spomin, izguba koordinacije gibanja, motnja ravnotežja,
Cardiac arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia), angina pectoris, myocardial infarction, heart failure and cardiomyopathy have been reported in patients receiving capecitabine.
(vključno z ventrikularno fibrilacijo, torsade de pointes in bradikardijo), angina pektoris, miokardni infarkt, srčno popuščanje in kardiomiopatija.
• Stomatitis: if you have pain, redness, swelling or sores in your mouth.
• Stomatitis: če imate bolečino, rdečino, otekanje ali rane v ustih in/ali žrelu.
• narrowing or blockage of tear duct (lacrimal duct stenosis)
• zoženje ali blokado solznega kanala (stenozo solznega kanala), • odpoved jeter,
However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
ali 4 bolj pogosti kot pri mlajših bolnikih.
• Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction),If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.
• Nedavno ali sočasno zdravljenje z brivudinom (glede medsebojnega delovanja med zdravili glejte poglavji 4.4 in 4.5).
Cutaneous lupus erythematosus (rare), Severe skin reactions such as StevensJohnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.)
urtikarija, fotosenzitivne reakcije, palmarni eritem, oteklost obraza, purpura, kožna reakcija po obsevanju eritematozni lupus s spremembami na koži (redki), hude kožne reakcije, kot sta StevensJohnsonov sindrom in toksična epidermalna nekroliza (zelo redki) (glejte poglavje 4.4)
For the capecitabine dose of 1250 mg/m2 twice daily on days 1 to 14 every 3 weeks, a frequency of 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.
Sindrom roka-noga (HFS- Hand-foot syndrome ) (glejte poglavje 4.4) Če so bolniki kapecitabin prejemali v odmerku 1.250 mg/m2 dvakrat na dan od 1. do 14. dneva vsake 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-%.
If you are a woman who could become pregnant you should use effective contraception during treatment with Capecitabine Accord and for 6 months after the last dose.
Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom Kapecitabin Accord in še 6 mesecev po zadnjem odmerku zdravila uporabljati učinkovito kontracepcijo.
In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good ECOG performance status at baseline (0 versus ≥1).
(0,1*kg), večji odmerek v prvih šestih tednih, daljše zdravljenje (tedni), višja starost (v korakih po 10 let), ženski spol, dobro stanje zmogljivosti po ECOG ob vključitvi (0 v primerjavi z ≥ 1).
Hyperbilirubinemia, Liver function test abnormalities
žolčnika in žolčevodov hiperbilirubinemija, nenormalni testi jetrne funkcije zlatenica odpoved jeter
Patients with low or absent DPD activity, an enzyme involved in fluorouracil degradation, are at increased risk for severe, life-threatening, or fatal adverse reactions caused by fluorouracil.
Bolniki z zmanjšano ali odsotno aktivnostjo DPD, encima, ki je vpleten v razgradnjo fluorouracila,
Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyper-pigmentation, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder
alopecija, eritem, suha koža, pruritus, hiperpigmentacija kože, makulozni izpuščaj, luščenje kože, dermatitis, motnje pigmentacije, spremembe na nohtih žulj, razjede na koži, kožni izpuščaj,
• have liver or kidney diseases
• imate jetrno ali ledvično bolezen,
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).
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 X-ACT, M66001).
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
** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4)
bolečina v prsnem košu edem, mrazenje, bolezen, podobna gripi, rigor, zvišana telesna temperatura ** Na podlagi izkušenj po prihodu zdravila na trg lahko vztrajen ali hud sindrom palmarno-plantarne eritrodisestezije sčasoma privede do izgube prstnih odtisov (glejte poglavje 4.4).
For PVC/PVdC-aluminium blisters (perforated unit dose) Do not store above 30°C.
Za PVC/PVdC-aluminijeve pretisne omote (perforirani pretisni omot za enkratni odmerek) Shranjujte pri temperaturi do 30 °C.
• have or had heart problems (for example an irregular heart beat) or pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart
čeljusti in hrbtu, ki so posledica fizičnega napora in težav s pretokom krvi do srca,
Coumarin-derivative anticoagulants
Kumarinski antikoagulanti:
The primary efficacy analyses in the per protocol population demonstrated non-inferiority in overall survival for capecitabine- vs 5-FU-based regimens (hazard ratio 0.86; 95% CI 0.8 - 0.99) and for oxaliplatin- vs cisplatin-based regimens (hazard ratio 0.92; 95% CI 0.80 - 1.1).
Analiza primarne učinkovitosti pri populaciji po protokolu je za celokupno preživetje dokazala, da so sheme osnovane na kapecitabinu neinferiorne shemam osnovanim na 5-FU (razmerje ogroženosti 0,86; 95 % interval zaupanja 0,80−0,99), sheme osnovane na oksaliplatinu pa neinferiorne shemam osnovanim na cisplatinu (razmerje ogroženosti 0,92; 95 % interval zaupanja 0,80−1,10).
• 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
• zaprtje črevesja, nabiranje tekočine v trebuhu, vnetje tankega ali debelega črevesa, bolečine v trebušnem predelu, zgaga (refluks hrane iz želodca), kri v izločkih,
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.
Ženskam v rodni dobi je treba svetovati naj ne zanosijo, medtem ko se zdravijo s kapecitabinom.
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 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).
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. For Aluminium-aluminium blisters
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.
Posology adjustments during treatment General
Prilagajanje odmerjanja med zdravljenjem: Splošno
Do not take a double dose to make up for a forgotten dose.Instead, continue your regular dosing schedule and check with your doctor.
Nadaljujte z rednim urnikom jemanja in se posvetujte z zdravnikom.
• 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 Capecitabine Accord (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,
Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products should be made according to Table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
Kadar se kapecitabin uporablja neprekinjeno v kombinaciji z drugimi zdravili, je treba odmerke zaradi toksičnosti prilagajati v skladu z zgornjo preglednico 3 za kapecitabin in v skladu s primernim povzetkom glavnih značilnosti za drugo oz. druga zdravila.