natgillin/translations-raw huggingface dataset:
Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle 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).
Prilagodbe doze zbog toksičnosti kada se kapecitabin primjenjuje u ciklusima od 3 tjedna u kombinaciji s drugim lijekovima moraju se provoditi u skladu s gore navedenom Tablicom 3 za kapecitabin te u skladu s odgovarajućim sažetkom opisa svojstava drugog lijeka (lijekova).
Dose level 1000 mg/m2 (twice daily)
Doza od 1000 mg/m2 (dvaput dnevno)
• have brain diseases (for example cancer that has spread to the brain) or nerve damage
• imate bolest mozga (na primjer rak koji se proširio na mozak) ili oštećenja živaca (neuropatija) • imate poremećaj razine kalcija (vidljivo u nalazima krvi)
• fever, swelling in the limbs, feeling ill
• vrućica, oticanje udova, osjećaj da ste bolesni
Currently, no comparative data are available on capecitabine monotherapy in colorectal cancer in comparison with first line combination regimens.
Za sada nema podataka o usporedbi monoterapije kapecitabinom i kombinirane terapije u prvoj liniji liječenja kolorektalnoga karcinoma Kombinirana terapija u prvoj liniji liječenja metastatskog kolorektalnog karcinoma
Talk to your doctor before taking Capecitabine Accord, if you
Prije početka liječenja Kapecitabinom Accord, porazgovarajte s liječnikom ako
Coumarin-derivative anticoagulants
Antikoagulacijska terapija derivatima kumarina
The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/min at baseline) is increased compared to the overall population.
stupnja u bolesnika s umjerenim oštećenjem bubrežne funkcije (početni klirens kreatinina 30-50 ml/min) povećana je u odnosu na ukupnu populaciju.
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 debelog crijeva, 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 dan (95% CI 15,0; 17,0) s omjerom rizika od 0,61 (95% CI 0,56; 0,66).
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 izbjegnu trudnoću za vrijeme liječenja kapecitabinom.
This includes any possible side effects not listed in this leaflet (see section 4).
To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 30 x 1 film-coated tablets 60 x 1 film-coated tablets 120 x 1 film-coated tablets
30 filmom obloženih tableta 60 filmom obloženih tableta 120 filmom obloženih tableta
Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection , Rhinitis, Influenza, +Infection, Oral herpes
oralna kandidijaza, infekcija gornjeg dišnog sustava, rinitis, gripa, +infekcija, oralni herpes
Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E5) Magnesium stearate
Jezgra tablete laktoza, bezvodna celuloza, mikrokristalična (E460) karmelozanatrij, umrežena hipromeloza (E5) magnezijev stearat.
In this trial, 944 patients were randomised to 3-week cycles for 24 weeks with capecitabine (1000 mg/m2 twice daily for 2 weeks followed by a 1-week rest period) in combination with oxaliplatin (130 mg/m2 intravenous infusion over 2-hours on day 1 every 3 weeks); 942 patients were randomised to bolus 5-FU and leucovorin.
U tom ispitivanju slučajnim odabirom 944 bolesnika liječeno je kapecitabinom u 3-tjednim ciklusima tijekom 24 tjedna (1000 mg/m2 dvaput dnevno u trajanju od 2 tjedna, nakon čega slijedi jednotjedna pauza) u kombinaciji s oksaliplatinom (130 mg/m2 u intravenskoj infuziji kroz 2 sata prvog dana ciklusa, svaka 3 tjedna); 942 bolesnika randomizirano je za liječenje bolusom 5-FU i leukovorinom.
• difficulty speaking, impaired memory, loss of movement coordination, balance disorder, fainting, nerve damage (neuropathy) and problems with sensation
• poteškoće pri govoru, slabljenje pamćenja, gubitak koordinacije pokreta, poremećaji ravnoteže,
Capecitabine Accord 150 mg
Kapecitabin Accord 150 mg
Capecitabine Accord 300 mg
Kapecitabin Accord 300 mg
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, slobodnoj platini ili ukupnoj platini.
activity (see section 4.4),
Accord (vidjeti dio 4.3).
For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Capecitabine Accord 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.
i za koje se smatra da koristi liječenja lijekom Kapecitabin Accord nadmašuju rizike (uzimajući u obzir prikladnost nekog drugog kemoterapijskog protokola koji ne uključuje fluoropirimidin), liječenje treba provoditi uz izniman oprez i sa čestim praćenjem uz prilagodbu doze sukladno toksičnosti.
Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival in the eligible patient population and the intent-to-treat population (see Table 8).
Utvrđeno je da liječenje XELOX protokolom nije inferiorno u odnosu na liječenje FOLFOX-4 protokolom kad se uspoređuje preživljenje bez progresije bolesti u populaciji pogodnih bolesnika i populaciji bolesnika predviđenih za liječenje (vidjeti Tablicu 8).
Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
pneumotoraks, hemoptiza, astma, dispneja pri naporu
Titanium dioxide (E171)
Ovojnica tablete hipromeloza (6cps) talk titanijev dioksid (E171)
Confusional state, Panic attack, Depressed mood, Libido decreased
Psihijatrijski poremećaji nesanica, depresija stanje smetenosti, napad panike, depresivno raspoloženje, smanjeni libido
You must not breast-feed if you are taking Capecitabine Accord and for 2 weeks after the last dose.
Accord ne smijete dojiti tijekom liječenja i još 2 tjedna nakon posljednje doze.
Capecitabine Accord 500 mg
Kapecitabin Accord 500 mg
• have liver or kidney diseases
• imate bolest jetre ili bubrega
Hand-foot syndrome (HFS) (see section 4.4)
Sindrom šaka-stopalo (vidjeti dio 4.4)
5-Fluorouracil 400 mg/m2 intravenous bolus, followed by
5-fluorouracil intravenski bolus 400 mg/m2, nakon kojeg slijedi 600 mg/ m2 intravenski/22 sata placebo ili bevacizumab
Uncommon ADRs reported for capecitabine in combination therapy are consistent with the ADRs reported for capecitabine monotherapy or reported for monotherapy with the combination medicinal product (in literature and/or respective summary of product characteristics).
Manje česte nuspojave koje su prijavljene kod kapecitabina u kombiniranoj terapiji su u skladu s nuspojavama prijavljenima kod monoterapije kapecitabinom ili prijavljenima kod monoterapije lijekom koji se može primjenjivati u kombinaciji sa kapecitabinom (kombinacijski lijek)
Day 1, prior to FOLFOX-4, every 2 weeks
5 mg/kg intravenski/3090 min prvog dana, prije FOLFOX-4 protokola, svaka 2 tjedna
Monotherapy with capecitabine in metastatic colorectal cancer Data from two identically-designed, multicentre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of capecitabine for first line treatment of metastatic colorectal cancer.
Podaci dobiveni iz faze III dvaju jednako oblikovanih, multicentričnih, randomiziranih i kontroliranih kliničkih ispitivanja (SO14695; SO14796) podržavaju primjenu kapecitabina u prvoj liniji liječenja metastatskog kolorektalnog karcinoma.
• bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth
• krvarenje iz crijeva, zatvor, bolovi u gornjem dijelu trbuha, probavne tegobe, prekomjerni vjetrovi, suhoća usta
Capecitabine Accord 300 mg film-coated tablets Table 4 Capecitabine dose reduction shedule(3-weeklycycle or continuous treatment).
Kapecitabin Accord 150 mg i 500 mg filmom obložene tablete Tablica 3 Raspored smanjivanja doze kapecitabina (ciklusi od 3 tjedna ili kontinuirano liječenje)
Median progression free survival
Medijan preživljenja bez progresije bolesti ITT
Combination therapy with capecitabine and docetaxel in locally advanced or metastatic breast cancer Data from one multicentre, randomised, controlled phase III clinical trial support the use of capecitabine in combination with docetaxel for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Podaci dobiveni iz faze III jednog multicentričnog, randomiziranog i kontroliranog kliničkog ispitivanja podržavaju uporabu kapecitabina u kombinaciji s docetakselom u liječenju bolesnica s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspješne citotoksične kemoterapije, koja je uključivala antracikline.
For PVC/PVdC-aluminium blisters (perforated unit dose) Do not store above 30°C.
Za PVC/PVdC-aluminijske blistere (perforirane djeljive na jedinične doze)
Rare side effects (may affect up to 1 in 1,000 people) include:
Rijetke nuspojave (mogu se javiti u do 1 na 1 000 osoba) uključuju:
Posology adjustments during treatment General
Promjene doze tijekom ciklusa liječenja
The analysis for the secondary endpoint of RFS supports these results with a HR of 0.78 (95% CI=[0.67; 0.92]; p=0.0024) for XELOX vs. 5-FU/LV.
Analiza za sekundarnu mjeru ishoda ispitivanja, preživljenje bez znakova povrata bolesti potvrđuje te rezultate s omjerom hazarda od 0,78 (95% CI=[0,67; 0,92]; p=0,0024) za XELOX u odnosu na 5-FU/LV.
capecitabine 1000 mg/m2 oral twice daily
1000 mg/m2 oralno dvaput dnevno
Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1250 mg/m2.
Izračuni doze Kapecitabina Accord Tablica 1 Izračuni standardnih i smanjenih doza prema tjelesnoj površini za početnu dozu kapecitabina od 1250 mg/m2.
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.
Podaci iz analiza nakon još jedne dodatne godine praćenja također su sadržani u Tablici 8.
Capecitabine Accord 150 mg and 500 mg film-coated tablets
Kapecitabin Accord 150 mg i 500 mg filmom obložene tablete
-for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
- adjuvantno liječenje bolesnika nakon operacije karcinoma debelog crijeva stadija III (stadij C prema
Leucovorin 200 mg/m2 intravenous 2 hr
200 mg/m2 intravenski/2 sata
Hypokalaemia, Hyponatraemia, Hypomagnesaemia, Hypocalcaemia, Hyperglycaemia
Poremećaji metabolizma i prehrane smanjen apetit hipokalemija, hiponatremija, hipomagnezemija, hipokalcemija, hiperglikemija
Adjuvant treatment in patients with stage III colon cancer is recommended for a duration of 6 months.
U bolesnika s karcinomom debelog crijeva stadija III preporučeno trajanje adjuvantnog liječenja je 6 mjeseci.
120 Patients were randomised to a modified XELIRI regimen with capecitabine 800 mg/m2 twice daily for two weeks followed by a 7-day rest period), irinotecan (200 mg/m2 as a 30 minute infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks) ; 127 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for two weeks followed by a 7-day rest period), oxaliplatin (130 mg/m2 as a 2 hour infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks).
120 bolesnika randomizirano je za liječenje modificiranim XELIRI protokolom, koji je obuhvaćao kapecitabin (u dozi od 800 mg/m2 dvaput dnevno tijekom dva tjedna, nakon čega slijedi pauza od 7 dana), irinotekan (200 mg/m2 kao 30-minutna infuzija 1. dana svaka 3 tjedna) i bevacizumab (7,5 mg/kg kao infuzija u trajanju od 30 do 90 minuta 1. dana svaka 3 tjedna).
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets capecitabine
Kapecitabin Accord 150 mg filmom obložene tablete Kapecitabin Accord 300 mg filmom obložene tablete Kapecitabin Accord 500 mg filmom obložene tablete kapecitabin
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets
Kapecitabin Accord 150 mg filmom obložene tablete Kapecitabin Accord 300 mg filmom obložene tablete Kapecitabin Accord 500 mg filmom obložene tablete
Table 9 Key efficacy results for AIO KRK study
Ključni podaci o djelotvornosti ispitivanja AIO KRK
Monotherapy with capecitabine in adjuvant colon cancer
Karcinom debelog crijeva i kolorektalni karcinom Monoterapija kapecitabinom u adjuvantnom liječenju karcinoma debelog crijeva
XELOX or
XELOX ili oksaliplatin
Dihydropyrimidinase cleaves the pyrimidine ring to yield 5fluoro-ureidopropionic acid (FUPA).
Dihidropirimidinaza cijepa pirimidinski prsten i nastaje 5
Capecitabine Accord should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
4.2 Doziranje i način primjene Kapecitabin Accord može propisati samo liječnik specijalist s iskustvom u primjeni antineoplastičnih lijekova.
Capecitabine was at least equivalent to intravenous 5-FU/LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80-1.06).
intravenski prema analizi preživljenja bez znakova bolesti u populaciji bolesnika liječenih po protokolu (omjer hazarda 0,92; 95% CI 0,80-1,06).
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).
U tim je ispitivanjima skupina od 603 bolesnika randomizirana na liječenje kapecitabinom (1250 mg/m²/dvaput dnevno tijekom 2 tjedna, nakon čega je slijedio 1
Cutaneous lupus erythematosus (rare), Severe skin reactions such as StevensJohnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.)
poremećaj pigmentacije, promjene na noktima plik, vrijed kože, osip, urtikarija, fotosenzibilna reakcija, palmarni eritem, oticanje lica, purpura, reakcija na ozračenom mjestu kožni lupus eritematozus (rijetko), teške kožne reakcije poput StevensJohnsonova sindroma i toksične epidermalne nekrolize (vrlo rijetko) (vidjeti dio 4.4)
Common side effects (may affect up to 1 in 10 people) include:
Česte nuspojave (mogu se javiti u do 1 na 10 osoba) uključuju:
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.
DFUR, 5-FU i FBAL u plazmi (Cmax u µg/ml) iznosile su 4,67; 3,05; 12,1; 0,95 i 5,46.
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 3week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin intravenous followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
(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 (protokol Mayo klinike: 20 mg/m2 leukovorina intravenski i 425 mg/m2 5-FU intravenski u bolusu od prvog do petog dana, svakih 28 dana u razdoblju od 24 tjedna).
Vaginal haemorrhage
• neuobičajeno krvarenje iz vagine
• In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD)
• Bolesnici s poznatim potpunim nedostatkom aktivnosti dihidropirimidin dehidrogenaze (DPD) (vidjeti dio 4.4),
Capecitabine Accord 150 mg film-coated tablets Each film-coated tablet contains 150 mg of capecitabine.
Kapecitabin Accord 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg kapecitabina.
Premedication with antiemetics according to the oxaliplatin summary of product characteristics is recommended for patients receiving the capecitabine plus oxaliplatin combination.
Za bolesnike koji primaju kombinaciju kapecitabina i oksaliplatine preporučuje se premedikacija antiemeticima u skladu sa sažetkom opisa svojstava lijeka za oksaliplatin.
1250 mg/m2
Puna doza 1250 mg/m2
For PVC/PVdC/Aluminium blisters Do not store above 30°C.
Za PVC/PVdC/aluminij blistere
Each film-coated tablet contains 500 mg capecitabine
Jedna filmom obložena tableta sadrži 500 mg kapecitabina
• blood clots in the veins in the lung (pulmonary embolism), collapsed lung, coughing up blood, asthma, shortness of breath on exertion
(ekstremiteti), ljubičaste mrlje na koži • krvni ugrušci u venama u plućima (plućna embolija), kolaps pluća, iskašljavanje krvi, astma,
Colon, colorectal and gastric cancer
Karcinom debelog crijeva, kolorektalni karcinom i karcinom želuca
Hepatic failure (rare), Cholestatic hepatitis (rare)
Hiperbilirubinemij a, odstupanja u testovima jetrene funkcije žutica zatajenje jetre (rijetko), kolestatski hepatitis (rijetko)
Median PFS and overall survival (OS) times were shorter for XELIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months), in addition to which excessive rates of diarrhoea were reported in patients receiving the XELIRI regimen (41% XELIRI, 5.1% FOLFIRI).
Medijani preživljenja bez progresije bolesti (PFS) i ukupnog preživljenja (OS) bili su kraći kod primjene XELIRI protokola u odnosu na FOLFIRI (PFS 5,9 naspram 9,6 mjeseci, a OS 14,8 naspram
Neutropenia, Anaemia
povraćanje, mučnina,
Capecitabine Accord 300 mg film-coated tablets The film-coated tablets are white to off white, oblong shaped, biconvex, 14.6 mm in length and 6.7 mm in width, debossed with ‘300' on one side and plain on other side.
Kapecitabin Accord 300 mg filmom obložene tablete su bijele do gotovo bijele boje, duguljaste, bikonveksne filmom obložene tablete, duljine 14,6 mm i širine 6,7 mm s utisnutom oznakom „300“ na jednoj i bez oznake na drugoj strani.
Folinic acid/folic acid
Aluminij/aluminij blisteri
Capecitabine Accord 500 mg film-coated tablets are peach coloured, oblong shaped, biconvex, film-coated tablets of 15.9 mm in length and 8.4 mm in width, debossed with ‘500' on one side and plain on other side.
Kapecitabin Accord 500 mg filmom obložene tablete su boje breskve, duguljaste, bikonveksne filmom obložene tablete, duljine 15,9 mm i širine 8.4 mm s utisnutom oznakom „500“ na jednoj i bez oznake na drugoj strani.
Mucosal inflammation, Pain in limb, Pain, Chills, Chest pain, Influenza-like illness, +Fever, Infusion related reaction, Injection site reaction, Infusion site pain, Injection site pain
+vrućica, reakcije na infuziju, reakcije na mjestu injiciranja, bol na mjestu davanja infuzije, bol na mjestu injiciranja
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 faze III multicentričnog, randomiziranog kontroliranog kliničkog ispitivanja u bolesnika s karcinomom debelog crijeva stadija III (Dukes C) podržavaju primjenu kapecitabina u kombinaciji s oksaliplatinom (XELOX) u adjuvantnom liječenju bolesnika s karcinomom debelog crijeva
Capecitabine Accord 150 mg film-coated tablets Each film-coated tablet contains 7 mg anhydrous lactose.
Kapecitabin Accord 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 7 mg laktoze, bezvodne.
Aphasia, Memory impairment, Ataxia, Syncope, Balance disorder, Sensory disorder, Neuropathy peripheral
Poremećaji živčanog sustava glavobolja, letargija, omaglica, parestezije, disgeuzija afazija, oštećenje pamćenja, ataksija, sinkopa, poremećaj ravnoteže, poremećaji osjeta, periferna neuropatija toksična leukoencefalopa tija (vrlo rijetko)
7.5 mg/kg intravenous 30-90 mins
7,5 mg/kg intravenski/30 - 90 min prvoga dana, prije XELOX protokola, svaka 3 tjedna
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).
Podaci iz multicentričnog, randomiziranog, kontroliranog kliničkog ispitivanja faze III u bolesnika s karcinomom debelog crijeva stadija III (stadij C prema Dukesovoj klasifikaciji) podržavaju primjenu kapecitabina u adjuvantnom liječenju bolesnika s karcinomom debelog crijeva (ispitivanje XACT;
Dose limiting toxicities
Stupnjevi toksičnosti*
Interaction with other medicinal products
Interakcije s drugim lijekovima Brivudin
Biotransformation
Organski sustav
Capecitabine Accord 150 mg film-coated tablets capecitabine
Kapecitabin Accord 150 mg filmom obložene tablete kapecitabin
Capecitabine Accord 150 mg film-coated tablets are light peach coloured, oblong shaped, biconvex, film-coated tablets of 11.4 mm in length and 5.3 mm in width, debossed with ‘150' on one side and plain on other side.
Kapecitabin Accord 150 mg filmom obložene tablete su svijetle boje breskve, duguljaste, bikonveksne filmom obložene tablete, duljine 11,4 mm i širine 5,3 mm s utisnutom oznakom „150“ na jednoj i bez oznake na drugoj strani.
Capecitabine Accord 150 mg film-coated tablets The film-coated tablets are light peach colored, oblong shaped, biconvex, 11.4 mm in length and 5.3 mm in width, debossed with ‘150' on one side and plain on other side.
Kapecitabin Accord 150 mg filmom obložene tablete Filmom obložene tablete su duguljaste, bikonveksne, svijetle boje breskve, duljine 11,4 mm i širine 5,3 mm s utisnutom oznakom ''150'' s jedne strane i bez oznake na drugoj strani.
Capecitabine Accord 300 mg film-coated tablets
Kapecitabin Accord 300 mg filmom obložene tablete
These reactions occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within one month after stopping capecitabine.In a clinical pharmacokinetic interaction study, after a single 20 mg dose of warfarin, capecitabine treatment increased the AUC of S-warfarin by 57% with a 91% increase in INR value.
To se događa unutar nekoliko dana do nekoliko mjeseci nakon početka liječenja kapecitabinom, a u nekoliko slučajeva unutar mjesec dana nakon prestanka uzimanja kapecitabina.
Skin toxicity, characterised bydegenerative/regressive changes, was observed with capecitabine.
Primijećeno je da kapecitabin može izazvati i kožnu toksičnost koja se manifestirala promjenama degenerativno regresivne naravi.