natgillin/translations-raw huggingface dataset:
For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every 3weeks, a frequency of 22% to 30% of all-grade HFS was observed in capecitabine combination therapy.
Če so bolniki kapecitabin prejemali v odmerku 1.000 mg/m2 dvakrat na dan 1. do 14. dan vsake 3 tedne v kombinaciji z drugimi zdravili, je bila pogostnost vseh stopenj sindroma roka-noga 22- do 30-%.
PVC/PVdC/Aluminium blisters Do not store above 30°C.
PVC/PVdC/aluminijevi pretisni omoti Shranjujte pri temperaturi do 30 °C.
Lacrimation increased Visual disorders, Dry eye,
Očesne bolezni povečano solzenje motnje vida, suho oko,
Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
pnevmotoraks, hemoptiza, astma, dispneja ob naporu
/FOLFOX-4+BV (EPP*: N = 937; ITT**: N=
FOLFOX-4/FOLFOX-4 + P/ FOLFOX-4 + BEVACIZUMAB (EPP*: n = 937; ITT**: n =
Atrial fibrillation, Cardiac ischaemia/infarction
srčna ishemija/infarkt
Since DNA and RNA are essential for cell division and growth, the effect of 5-FU may be to create a thymidine deficiency that provokes unbalanced growth and death of a cell.
povzroči 5-FU pomanjkanje timidina, kar izzove neuravnoteženo rast in smrt celice.
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).
Kadar se kapecitabin uporablja z drugimi zdravili v 3-tedenskih ciklih, je treba odmerke zaradi toksičnosti prilagajati v skladu z zgornjo preglednico 3 za kapecitabin in v skladu s primernim povzetkom glavnih značilnosti za drugo zdravilo oz. druga zdravila.
Contusion + For each term, the frequency count was based on ADRs of all grades.
+Pri vsakem terminu so pri določitvi pogostnosti upoštevali neželene učinke vseh stopenj.
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).
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 cikl 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).
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.
V tem preskušanju so 944 bolnikov randomizirali v zdravljenje s kapecitabinom (1.000 mg/m2 dvakrat na dan 2 tedna, sledil je enotedenski premor; te 3-tedenske cikl so ponavljali 24 tednov) v kombinaciji z oksaliplatinom (130 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne); 942 bolnikov so randomizirali v zdravljenje s 5-FU in levkovorinom v obliki bolusa.
capecitabine 1000 mg/m2 oral twice daily
kapecitabin 1.000 mg/m2 peroralno dvakrat na dan placebo ali bevacizumab
Colon, colorectal and advanced gastric cancer: meta-analysis A meta-analysis of six clinical trials (studies SO14695, SO14796, M66001, NO16966, NO16967, M17032) supports capecitabine replacing 5-FU in mono- and combination treatment in gastrointestinal cancer.
Meta-analiza šestih kliničnih preskušanj (študije SO14695, SO14796, M66001, NO16966, NO16967,
• blood clots in the veins in the lung (pulmonary embolism), collapsed lung, coughing up blood, asthma, shortness of breath on exertion
vijolične pike na koži, • krvni strdki v venah v pljučih (pljučni embolizem), sesedena pljuča, kašljanje krvi, astma, kratka sapa ob naporu,
Brivudine: a clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-Fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
(npr. kapecitabinom, 5-fluorouracilom in tegafurjem), ki je rezultat brivudinovega zaviranja dihidropirimidin dehidrogenaze.
It is therefore possible that Capecitabine Accord could affect your ability to drive a car or operate machines.
Zdravilo Kapecitabin Accord lahko povzroči omotico, slabost ali občutek utrujenosti, zato lahko vpliva na vašo sposobnost za vožnjo in upravljanje strojev.
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).
kolorektalni rak, rak želodca in rak dojk) je pokazala, da so imeli bolniki, 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 1.100 dni (95-% interval zaupanja; 1.007; 1.200) v primerjavi s 691 dnevi (95-% interval zaupanja 638; 754) z razmerjem ogroženosti 0,61 (95-% interval zaupanja;
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.
V celotni randomizirani populaciji so analize zdravljenja s kapecitabinom v primerjavi s 5-FU/LV v preživetju brez bolezni pokazale razmerje ogroženosti 0,88 (95-% interval zaupanja 0,77−1,01; p = 0,068), v celokupnem preživetju pa 0,86 (95-% interval zaupanja 0,74−1,01;
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 zdravila Kapecitabin 1.000 mg/m2
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.
Spol Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4.700 bolnikov, zdravljenih s kapecitabinom, je pokazala, da je bil ženski spol statistično značilno povezan z večjim tveganjem za razvoj sindroma roka-noga in driske ter manjšim tveganjem za razvoj nevtropenije, če povzamemo vse študije.
The MTD of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day, whereas, when combined with radiotherapy for rectal cancer, the MTD of capecitabine is 2000 mg/m2 per day using either a continuous schedule or given daily Monday through Friday during a 6-week course of radiotherapy.
2.000 mg/m2 na dan z uporabo neprekinjene sheme ali dnevnim dajanjem od ponedeljka do petka med 6-tedensko radioterapijo.
Administration with food decreases the rate of capecitabine absorption (see section 5.2).
Trenutni podatki o varnosti in učinkovitosti zdravila priporočajo jemanje zdravila kapecitabin s hrano, ki zmanjša hitrost absorpcije zdravila (glejte poglavje 5.2).
Do not take the missed dose at all.
Ne vzemite dvojnega odmerka, da bi nadomestili izpuščeni odmerek.
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-2a (3 mio i. e./m2 na dan) je bil največji prenosljivi odmerek kapecitabina 2.000 mg/m2 na dan, pri jemanju samega kapecitabina pa
Breast cancer:
• mišični krči,
Thrombophlebitis Deep vein thrombosis, Hypertension, Petechiae, Hypotension, Hot flush, Peripheral coldness
Žilne bolezni tromboflebitis globoka venska tromboza, hipertenzija, petehija, hipotenzija,
• bruising or reaction at the injection site (caused by medicines given by injection at the same time)
• težave pri uriniranju, kri ali beljakovine v urinu, • modrica ali reakcija na mestu injiciranja (ki je posledica injiciranja zdravil na istem mestu).
Alopecia, Nail disorder Hyperhidrosis, Rash erythematous, Urticaria, Night sweats
eritematozni izpuščaj, urtikarija, nočno znojenje
You must not breast-feed if you are taking Capecitabine Accord and for 2 weeks after the last dose.
Med zdravljenjem z zdravilom Kapecitabin Accord in še 2 tedna po zadnjem odmerku zdravila ne smete dojiti.
Median progression free survival
Mediana preživetja brez napredovanja bolezni ITT
See section 5.1 for details of major studies, including study designs and major efficacy results.
vključno z njihovimi načrti in glavnimi izsledki o učinkovitosti, glejte poglavje 5.1.
Talk to your doctor before taking Capecitabine Accord, if you
Pred začetkom zdravljenja z zdravilom Kapecitabin Accord obvestite svojega zdravnika, če:
A population pharmacokinetic analysis was carried out after capecitabine treatment of 505 patients with colorectal cancer dosed at 1250 mg/m2 twice daily.
Populacijsko farmakokinetično študijo so opravili po zdravljenju 505 bolnikov s kolorektalnim rakom,
Patients with anorexia, asthenia, nausea, vomiting or diarrhoea may rapidly become dehydrated.
navzejo, drisko ali bruhajo, lahko hitro dehidrirajo.
• have diabetes
• imate sladkorno bolezen,
Monotherapy with capecitabine in adjuvant colon cancer
Samostojno zdravljenje s kapecitabinom pri metastatskem kolorektalnem raku
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 filmsko obložene tablete Kapecitabin Accord 300 mg filmsko obložene tablete Kapecitabin Accord 500 mg filmsko obložene tablete
Sepsis, Urinary tract infection, Cellulitis, Tonsillitis, Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
celulitis, tonzilitis, faringitis, oralna kandidoza, gripa, gastroenteritis,
Standard and reduced dose calculations according to body surface area for starting doses of Capecitabine Accord 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 Kapecitabin Accord 1.250 mg/m2 glede na telesno površino izračunani v preglednici 1, za 1.000 mg/m2 pa v preglednici 2.
Capecitabine Accord is indicated for the treatment of:
Kapecitabin Accord in pokličite zdravnika:
Table 9 Key efficacy results for AIO KRK study
Glavni rezulati učinkovitosti za študijo AIO KRK.
Confusional state, Panic attack, Depressed mood, Libido decreased
depresivno razpoloženje, zmanjšan libido
Hand and foot syndrome also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Sindrom roka-noga (znan tudi kot kožna reakcija na roki in nogi, palmarno-plantarna eritrodisestezija ali s kemoterapijo povzročena rdečina okončin):Sindrom 1. stopnje se kaže kot otrplost, disestezija ali parestezija,
Capecitabine Accord belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Zdravilo Kapecitabin Accord spada v skupino zdravil, ki jih imenujemo citostatiki.
Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Capecitabine Accord.
Zdravnik vam bo morda zmanjšal odmerek ali začasno prekinil zdravljenje z zdravilom Kapecitabin Accord ali oboje, kar bo pomagalo zmanjšati verjetnost, da bi se nadaljevali ali postali resni.
ADRs are added to the appropriate frequency grouping (very common or common) according to the highest incidence seen in any of the major clinical trials and are only added when they were seen in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy (see Table 5).
Dodani so samo, če so jih opazili poleg neželenih učinkov, opaženih pri samostojnem zdravljenju s kapecitabinom, ali pa so jih opazili pogosteje (spadajo v višjo skupino po pogostnosti) kot pri samostojnem zdravljenju s kapecitabinom (glejte preglednico 5).
Hypokalaemia, Hyponatraemia, Hypomagnesaemia, Hypocalcaemia, Hyperglycaemia
Presnovne in prehranske motnje zmanjšan apetit hipokaliemija, hiponatriemija, hipomagneziemija, hipokalcemija, hiperglikemija
The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see Table 8).
Glede na rezultate za celokupno preživetje je zdravljenje po shemi XELOX enakovredno zdravljenju po shemi FOLFOX-4 (glejte preglednico 8).
Grade 3 hand-foot syndrome is moist desquamation, ulceration, blistering and severe pain of the hands and/or feet and/or severe discomfort that causes the patient to be unable to work or perform activities of daily living.
Za 3. stopnjo so značilni vlažno luščenje kože, nastajanje razjed in mehurjev na koži in huda bolečina v rokah ali nogah ali obojih okončinah ali pa hudo neugodje, ki bolniku onemogoča opravljanje njegovih vsakodnevnih dejavnosti.Vztrajen ali hud sindrom roka-noga (2. stopnje ali višje) lahko sčasoma privede do izgube prstnih odtisov, kar lahko vpliva na identifikacijo bolnika.
Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection , Rhinitis, Influenza, +Infection, Oral herpes
okužba zgornjih dihal, rinitis, gripa, +okužba, oralni herpes
In vitro human plasma studies have determined that capecitabine, 5'-DFCR, 5'-DFUR and 5-FU are 54%, 10%, 62% and 10% protein bound, mainly to albumin.
Študije in vitro na človeški plazmi so pokazale, da se na proteine (v glavnem na albumin) veže 54 %
Combination therapy in adjuvant colon cancer
Kombinirano zdravljenje v drugi liniji metastatskega kolorektalnega raka
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).
Randomizirali so 120 bolnikov v spremenjeno shemo XELIRI: kapecitabin (800 mg/m2 dvakrat na dan dva tedna, čemur je sledil 7-dnevni premor), irinotekan (200 mg/m2 v 30-minutni infuziji 1. dan vsake 3 tedne) in bevacizumab (7,5 mg/kg v 30 do 90-minutni infuziji 1. dan vsake 3 tedne).
The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see Table 10).
Glede na rezultate za celokupno preživetje je zdravljenje po shemi XELOX enakovredno zdravljenju po shemi FOLFOX-4 (glejte preglednico 10).
Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
rumeni železov oksid (E172)
• shortness of breath, nose bleeds, cough, runny nose
• vnetje ven (tromboflebitis), • kratka sapa, krvavitev iz nosu, kašelj, izcedek iz nosu,
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.
V klinični raziskavi farmakokinetičnih interakcij je po odmerku 20 mg varfarina zdravljenje s kapecitabinom povečalo AUC S-varfarina za 57 %, vrednost INR pa je narasla za 91 %.
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
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).
Mediana preživetja brez napredovanja bolezni (PFS) in celokupnega preživetja (OS) je bila krajša za XELIRI v primerjavi s FOLFIRI (PFS 5,9 v primerjavi z 9,6 meseca in OS 14,8 v primerjavi z 19,9
Dihydropyrimidinase cleaves the pyrimidine ring to yield 5fluoro-ureidopropionic acid (FUPA).
Dihidropirimidinaza cepi pirimidinski obroč, pri čemer nastane 5
• pain in the joints or in the limbs (extremities), chest or back
• bolečina v sklepih ali udih (okončinah), prsih ali hrbtu, • vročina, otekanje udov, občutek bolanosti,
Hypersensitivity
preobčutljivostne reakcije, hipestezija
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).
Glede na preživetje brez bolezni v populaciji po protokolu je bil kapecitabin vsaj ekvivalentno intravenskemu 5-FU/LV (razmerje ogroženosti 0,92; 95-% interval zaupanja 0,80−1,06).
- The other ingredients are: - Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose,microcrystalline cellulose, magnesium stearate - Tablet coating (for 150 mg): Hypromellose, titanium dioxide (E171), yellow ironoxide, red iron oxide (E172), talc - Tablet coating (for 300 mg): Hypromellose, titanium dioxide (E171), talc Tablet coating (for 500 mg): Hypromellose, titanium dioxide (E171), yellow ironoxide, red iron oxide (E172), talc
Obloga tablete (za 150 mg): hipromeloza, titanov dioksid (E171), rumeni železov oksid, rdeči železov oksid (E172), smukec.
Median progression-free survival (PFS) was 10.0 and 8.9 months; p=0.64, overall survival 25.7 and 27.5 months; p=0.55 and response rates 45.5 and 39.8%; p=0.32 for FOLFIRI-Bev and XELIRI-Bev, respectively.
Pri skupini B so v shemi XELIRI uporabili kapecitabin 1000 mg/m2 dvakrat na dan 14 dni in irinotekan 250 mg/m2 1. dan. Mediana preživetja brez napredovanja bolezni je bila za FOLFIRIbevacizumab 10,0 in za XELIRI-bevacizumab 8,9 meseca; p = 0,64, celokupno preživetje za FOLFIRI-bevacizumab je bilo 25,7 in za XELIRI-bevacizumab 27,5 meseca; p = 0,55, odgovor je bil 45,5 % za FOLFIRI-bevacizumab in 39,8 % za XELIRI-bevacizumab; p = 0,32.
Treatment
Shema zdravljenja
Capecitabine Accord 150 mg and 500 mg film-coated tablets
Kapecitabin Accord 150 mg in 500 mg filmsko obložene tablete
The most commonly reported and/or clinically relevant treatment-related adverse drug reactions (ADRs) were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), hand-foot syndrome (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with preexisting compromised renal function, and thrombosis/embolism.
sindrom roka-noga (palmarno-plantarna eritrodisestezija), utrujenost, astenija, anoreksija, kardiotoksičnost, poslabšanje ledvične disfunkcije pri bolnikih z že obstoječo motnjo ledvičnega delovanja in tromboza/embolizem.
Caution must be exercised in patients with pre-existing hypo- or hypercalcaemia (see section 4.8).
Pri bolnikih, ki imajo hipokalciemijo ali hiperkalciemijo pred začetkom zdravljenja, je potrebna previdnost (glejte poglavje
Uncommon side effects (may affect up to 1 in 100 people) include:
Občasni neželeni učinki (pojavijo se pri do 1 od 100 bolnikov) vključujejo:
Constipation, Dyspepsia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis,
bolečina v zgornjem delu trebuha, dispepsija, flatulenca, suha usta črevesna obstrukcija, ascites, enteritis, gastritis,
combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks.
tedna, sledil je enotedenski premor, in docetaksel 75 mg/m2 v obliki enourne intravenske infuzije vsake 3 tedne).
Capecitabine Accord 300 mg film-coated tablets Each film-coated tablet contains 300 mg of capecitabine.
Kapecitabin Accord 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg kapecitabina.
Caution must be exercised in patients with history of significant cardiac disease, arrhythmias and angina pectoris (see section 4.8).
aritmije in angino pektoris, je treba obravnavati posebno pozorno (glejte poglavje 4.8).
Capecitabine Accord 150 mg film-coated tablets Each film-coated tablet contains 150 mg of capecitabine.
Kapecitabin Accord 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
ADRs considered by the investigator to be possibly, probably, or remotely related to the administration of capecitabine are listed in Table 5 for capecitabine given as monotherapy and in Table 6 for capecitabine given in combination with different chemotherapy regimens in multiple indications.
Neželeni učinki, ki so po mnenju raziskovalca morda, verjetno ali nejasno povezani z jemanjem kapecitabina, so navedeni v preglednici 5 za samostojno zdravljenje s kapecitabinom in v preglednici 6
Capecitabine Accord 500 mg film-coated tablets Each film-coated tablet contains 500 mg of capecitabine.
Kapecitabin Accord 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
For combination with irinotecan, the recommended starting dose is 800 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period combined with irinotecan 200 mg/m2 on day 1.
Za kombinacijo z irinotekanom je priporočeni začetni odmerek 800 mg/m2, kadar ga dajemo dvakrat na dan 14 dni,
Pain in jaw , Muscle spasms, Trismus, Muscular weakness
bolečina v ekstremitetah bolečina v čeljusti, mišični spazmi, trizmus, mišična šibkost
Neutropenia, Anaemia
tremor, nevralgija,
Each film-coated tablet contains 500 mg capecitabine
Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
Each film-coated tablet contains 300 mg capecitabine
Ena filmsko obložena tableta vsebuje 300 mg kapecitabina.
Table 6 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
Povzetek neželenih učinkov, povezanih z uporabo kapecitabina v kombinaciji z drugimi zdravili, o katerih so poročali poleg neželenih učinkov, opaženih pri samostojnem zdravljenju s kapecitabinom ali pa so jih opazili pogosteje (spadajo v višjo skupino po pogostnosti) kot pri samostojnem zdravljenju s kapecitabinom.
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.
V prvi liniji zdravljenja je bila mediana preživetja brez napredovanja bolezni v populaciji, ki so jo nameravali zdraviti, 5,8 meseca (95-% interval zaupanja 5,1−6,2 meseca) za samostojno zdravljenje s kapecitabinom in 7,8 meseca (95-% interval zaupanja
Rare side effects (may affect up to 1 in 1,000 people) include:
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov) vključujejo:
FOLFOX-4 + Bevacizumab
FOLFOX-4 in placebo, XELOX in bevacizumab ter FOLFOX-4 in bevacizumab.
Each film-coated tablet contains 150 mg capecitabine
Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
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, the following covariates were statistically significantly associated with an increased risk of developing diarrhoea: increasing capecitabine starting dose (gram), increasing duration of study treatment (weeks), increasing age (by 10 year increments), and female gender.
Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4.700 bolnikov, zdravljenih s kapecitabinom, je pokazala, da so bile z večjim tveganjem za razvoj driske statistično značilno povezane naslednje sospremenljivke, povzete iz vseh študij: večji začetni odmerek kapecitabina