FrancophonIA/ELRC3.0 huggingface dataset:
English: An analysis of safety data in patients ≥60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients <60 years of age.
Slovenian: Analiza varnostnih podatkov pri bolnikih, starih 60 let ali več, ki so bili zdravljeni le s kapecitabinom, in tistih, ki so prejemali kapecitabin v kombinaciji z docetakselom, je pokazala, da je pogostnost z zdravljenjem povezanih neželenih učinkov stopnje 3 in 4 ter z zdravljenjem povezanih resnih neželenih učinkov večja kot pri bolnikih, mlajših od 60 let.
English: • lumps under the skin (lipoma)
Slovenian: • podkožne bunkice (lipom)
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n=167) or XELIRI
Slovenian: Bolnike so randomizirali, da so prejeli FOLFIRI in bevacizumab (skupina A, n = 167) ali XELIRI in bevacizumab (skupina B, n = 166).
English: Elderly During capecitabine monotherapy, no adjustment of the starting dose is needed.
Slovenian: Med samostojnim zdravljenjem s kapecitabinom ni treba prilagajati začetnega odmerka.
English: Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment) Toxicity grades* Dose changes within a treatment cycle
Slovenian: Preglednica 3 Razpored zmanjšanja odmerka kapecitabina (3-tedenski cikel ali neprekinjeno zdravljenje)
English: • skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration,
Slovenian: • kožni izpuščaj, izpadanje las (alopecija), pordevanje kože, suho kožo, srbenje (pruritus),
English: The effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
Slovenian: Proučevali so vpliv antacida, ki vsebuje aluminijev hidroksid in magnezijev hidroksid, na farmakokinetiko kapecitabina.
English: - The other ingredients are: - Tablet core: lactose, microcrystalline cellulose, hypromellose, croscarmellose sodium,
Slovenian: - Druge sestavine zdravila so: - Jedro tablete: laktoza, mikrokristalna celuloza, hipromeloza, natrijev karmelozat, magnezijev stearat.
English: • Diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night.
Slovenian: • Driska: če pogostnost dnevnih iztrebljanj preseže število, ki je za vas običajno, za štiri ali več, ali če imate ponoči drisko.
English: 820 Patients were randomised to receive either sequential treatment (n=410) or combination treatment (n=410).
Slovenian: V skupino, ki je prejela zaporedno zdravljenje (n = 410) in skupino, ki je prejela kombinacijo zdravil (n = 410), so randomizirali 820 bolnikov.
English: -2nd appearance -3rd appearance
Slovenian: -drugo pojavljanje -tretje pojavljanje
English: In patients with mild renal impairment (creatinine clearance 51-80 ml/min at baseline) no adjustment of the starting dose is recommended.
Slovenian: Pri bolnikih z blagimi okvarami ledvic treba prilagoditi odmerkov pri začetnih odmerkih 1000 mg/m (kreatinski očistek pod 51-80 ml/min v izhodišču) je priporočeno, da se začetni odmerek ne spreminja.
English: 400 mg/m2 intravenous bolus, followed by 600 mg/m2 intravenous 22 hr
Slovenian: 400 mg/m2 intravensko bolus, sledi 600 mg/m intravensko 22 h placebo ali bevacizumab
English: In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping capecitabine might require that your doctor adjusts your anticoagulant dose.
Slovenian: Če sočasno jemljete kumarinske antikoagulante (ki vsebujejo na primer fenprokumon) vam bo zdravnik v primeru prekinitve zdravljenja s kapecitabinom morda moral prilagoditi odmerek antikoagulanta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/761/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/761/001
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študije medsebojnega delovanja so izvedli le pri odraslih.
English: 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.
Slovenian: 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).
English: • skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face
Slovenian: • razjede in mehurji na koži, kožne reakcije na svetlobo, pordelost dlani, zatekanje ali bolečine na obrazu
English: Each pack contains 120 tablets.
Slovenian: 120 tablet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/761/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/761/002
English: Posology adjustments for special populations
Slovenian: Prilagoditev odmerjanja za posebne skupine Okvare jeter
English: The hazard ratio for overall survival was 0.94 (95% CI: 0.89; 1.00, p=0.0489) indicating that capecitabine-containing regimens are noninferior to 5-FU-containing regimens.
Slovenian: 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.
English: During standard fertility studies, impairment of fertility was observed in female mice receiving capecitabine; however, this effect was reversible after a drug-free period.
Slovenian: Med standardnimi študijami fertilnosti so pri mišjih samicah, ki so prejemale kapecitabin, opazili motnjo plodnosti, ki je po prenehanju jemanja izginila.
English: Oxaliplatin on Day 1, every 3 weeks Capecitabine oral twice daily for 2 weeks (followed by 1 week offtreatment)
Slovenian: peroralno dvakrat na dan oksaliplatin 1. dan, vsake 3 tedne kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1-tedenski premor)
English: 7.5 mg/kg intravenous 30-90 mins
Slovenian: 7,5 mg/kg intravensko 30
English: • difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
Slovenian: • oteženo govorjenje, izguba spomina, pomanjkanje koordinacije pri premikanju, težave z ravnotežjem, omedlevanje, poškodbe živcev (nevropatija) in težave z zaznavanjem,
English: Patients taking coumarin-derivative anticoagulants concomitantly with capecitabine should be monitored regularly for alterations in their coagulation parameters (PT or INR) and the anticoagulant dose adjusted accordingly.
Slovenian: Bolnike, ki jemljejo antikoagulante kumarinskega tipa sočasno s kapecitabinom, moramo pazljivo spremljati in meriti njihove koagulacijske parametre (protrombinski čas ali INR) ter odmerek antikoagulanta ustrezno prilagajati.
English: - In combination with docetaxel: an increased incidence of grade 3 or 4 treatment-related adverse reactions and treatment-related serious adverse reactions were observed in patients 60 years of age or more (see section 5.1).
Slovenian: - V kombinaciji z docetakselom; pri bolnikih, starejših od 60 let je bila opažena povečana pogostost pojavljanja z zdravljenjem povezanih neželenih učinkov stopnje 3 ali 4 in in z zdravljenjem povezanih resnih neželenih učinkov (glejte poglavje 5.1).
English: Maintain dose level
Slovenian: Vzdrževanje odmerka
English: Advanced gastric cancer
Slovenian: Napredovali rak želodca
English: Starting Dose
Slovenian: Začetni odmerek
English: Data from two multicentre phase II clinical trials support the use of capecitabine monotherapy for treatment of patients after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Slovenian: Podatki dveh multicentričnih kliničnih preskušanj faze II podpirajo samostojno uporabo kapecitabina za zdravljenje bolnikov po neuspelem zdravljenju s taksani in neuspelem zdravljenju z antraciklinsko kemoterapijo ter pri bolnikih, kjer antraciklini niso indicirani.
English: FOLFOX-4 or FOLFOX-4 + Bevacizumab
Slovenian: FOLFOX-4 + bevacizumab oksaliplatin
English: Palmar-plantar erythrodysaesthesi a syndrome**
Slovenian: Bolezni kože in podkožja palmarnoplantarna eritrodisestezija**
English: Capecitabine in combination with cisplatin was non-inferior to 5-FU in combination with cisplatin in terms of progression-free survival in the per protocol analysis (hazard ratio 0.81; 95% CI 0.63-1.04).
Slovenian: Kapecitabin je bil v kombinaciji s cisplatinom neinferioren kombinaciji 5-FU in cisplatina glede na preživetje brez napredovanja bolezni v analizi po protokolu (razmerje ogroženosti 0,81; 95-% interval zaupanja 0,63-1,04).
English: In combination treatment, the recommended starting dose of capecitabine should be reduced to 8001000 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).
Slovenian: 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/m dvakrat na dan, če ga dajemo neprekinjeno (glejte poglavje 5.1).
English: • inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis)
Slovenian: • vnetje, ki zmanjša ali prepreči izločanje žolča (holestatični hepatitis)
English: oral use
Slovenian: peroralna uporaba
English: Interaction with other medicinal products
Slovenian: Medsebojno delovanje z drugimi zdravili:
English: There is no relevant use of capecitabine in the paediatric population in the indications colon, colorectal, gastric and breast cancer.
Slovenian: Pediatrična populacija Smotrne uporabe kapecitabina pri pediatrični populaciji za indikacije raka debelega črevesja, kolorektalnega raka, raka želodca ali raka na dojkah, ni.
English: Capecitabine Teva should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
Slovenian: Zdravilo Kapecitabin Teva lahko predpiše le zdravnik z ustreznim znanjem in izkušnjami z uporabo zdravil za zdravljenje novotvorb.
English: If these side effects continue, however, contact your doctor immediately.
Slovenian: Kadar pa ne izginejo, takoj pokličite zdravnika.
English: treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
Slovenian: Vendar pa, z zdravljenjem povezani neželeni učinki stopnje 3 ali 4 so bili pogostejši pri bolnikih nad 60 let starosti kot pri mlajših bolnikih.
English: In an interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57%) of S-warfarin.
Slovenian: Antikoagulantno zdravljenje s kumarinskimi derivati V raziskavi interakcij so pri jemanju enkratnega odmerka varfarina ugotovili pomembno povečanje povprečne AUC S-varfarina (+57 %).
English: Each film-coated tablet contains 150 mg capecitabine.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
English: tablets per administration (each administration to be given morning and evening)
Slovenian: 500-mg tablet za posamezno dajanje (zdravilo se daje zjutraj in zvečer)
English: TEVA Pharmaceuticals Slovakia s.r.o.
Slovenian: Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.
English: MARKETING AUTHORISATION NUMBER(S) Capecitabine Teva 150 mg film-coated tablets EU/1/12/761/001
Slovenian: Kapecitabin Teva 150 mg filmsko obložene tablete EU/1/12/761/001
English: Capecitabine Teva 500 mg film-coated tablets PVC/PE/PVDC - Aluminium blister containing 10 film-coated tablets.
Slovenian: Kapecitabin Teva 500 mg filmsko obložene tablete PVC/PE/PVDC - aluminijasti pretisni omot z 10 filmsko obloženimi tabletami.
English: HR (95% CI)
Slovenian: Razmerje ogroženosti (95-% CI)
English: Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decrease to ≤2.5 x ULN.
Slovenian: Samostojno zdravljenje s kapecitabinom lahko nadaljujemo, ko se vrednosti bilirubina znižajo pod 3,0-kratno zgornjo referenčno vrednost oziroma ko je aktivnost jetrnih aminotransferaz zmanjšana na manj kot 2,5-kratno zgornjo referenčno vrednost.
English: Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Slovenian: Priporočeni začetni odmerek kapecitabina za samostojno adjuvantno zdravljenje raka kolona, metastatskega kolorektalnega raka ali lokalno napredovalega ali metastatskega raka dojk je 1.250 mg/m dvakrat na dan (zjutraj in zvečer; celokupni dnevni odmerek znaša 2.500 mg/m 2) 14 dni, sledi 7-dnevni premor.
English: • joint swelling or stiffness, bone pain, muscle weakness or stiffness
Slovenian: • zatekanje ali togost sklepov, bolečine v kosteh, mišična oslabelost ali togost
English: The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'
Slovenian: Parametri kapecitabina, 5´-deoksi-5-fluorocitidina (5´-DFCR) in 5´-deoksi-5-fluorouridina (5´-DFUR), ki so jih izmerili prvi in štirinajsti dan, so bili podobni.
English: • During pregnancy and lactation,
Slovenian: • Nosečnost in dojenje.
English: 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).
Slovenian: 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).
English: Grade 1 hand-foot syndrome is defined as numbness, dysesthesia/paresthesia, tingling, painless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt the patient's normal activities.
Slovenian: Sindrom 1. stopnje se kaže kot otrplost, disestezija ali parestezija, mravljinčenje, neboleče otekanje ali rdečina rok in nog ali obojih okončin oziroma kot neugodje, ki ne vpliva na bolnikove normalne dejavnosti.
English: Monotherapy with capecitabine after failure of taxanes, anthracycline containing chemotherapy, and for whom anthracycline therapy is not indicated
Slovenian: Samostojno zdravljenje s kapecitabinom po neuspešnem zdravljenju s kemoterapijo, ki je vključevala taksane in antracikline ter zdravljenje bolnikov, za katere antraciklini niso indicirani
English: Data from a multicentre, randomised, controlled phase III clinical trial in patients with advanced gastric cancer supports the use of capecitabine for the first-line treatment of advanced gastric cancer (ML17032).
Slovenian: Podatki iz multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja faze III pri bolnikih z napredovalim rakom želodca podpirajo uporabo kapecitabina v prvi liniji zdravljenja napredovalega raka želodca (ML17032).
English: Data from a multicentre, randomised, controlled phase II study (AIO KRK 0604) supports the use of capecitabine at a starting dose of 800 mg/m2 for 2 weeks every 3 weeks in combination with irinotecan and bevacizumab for the first-line treatment of patients with metastatic colorectal cancer.
Slovenian: Podatki multicentrične, randomizirane, kontrolirane študije faze II (AIO KRK 0604) podpirajo uporabo kapecitabina v začetnem odmerku 800 mg/m2 tedna vsake 3 tedne v kombinaciji z irinotekanom in bevacizumabom v prvi liniji zdravljenja bolnikov z metastatskim kolorektalnim rakom.
English: Brivudine
Slovenian: Brivudin
English: Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1000 mg/m2
Slovenian: Preglednica 2 Standardni in zmanjšani odmerki glede na telesno površino za začetni odmerek kapecitabina 1000 mg/m Odmerek 1000 mg/m
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Slovenian: 256 bolnikov, randomizirano vključenih v preskušanje, je prejemalo le docetaksel (100 mg/m v obliki enourne intravenske infuzije vsake 3 tedne).
English: 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).
Slovenian: 604 randomizirane bolnike pa s 5-FU in levkovorinom (shema Mayo: 20 mg/m2 levkovorina intravensko, sledilo je 425 mg/m
English: A combination study with capecitabine and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of capecitabine and its metabolites.
Slovenian: Kombinacijska študija kapecitabina in folinske kisline je pokazala, da ta nima velikega vpliva na farmakokinetične lastnosti kapecitabina in njegovih presnovkov, pač pa vpliva na njegove farmakodinamične lastnosti.
English: In this trial, 160 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for 2 weeks followed by a 7-day rest period) and cisplatin (80 mg/m2 as a 2-hour infusion every 3 weeks).
Slovenian: V tem preskušanju so 160 bolnikov randomizirali v zdravljenje s kapecitabinom (1.000 mg/m2 dvakrat na dan 2 tedna, sledil je 7-dnevni premor) in cisplatinom (80 mg/m2, v 2-urni infuziji vsake 3 tedne).
English: Finally, β-ureido-propionase cleaves FUPA to α-fluoro-β-alanine
Slovenian: Na koncu beta-ureido-propionaza cepi FUPA v alfa-fluorobeta-alanin (FBAL), ki se izloči z urinom.
English: Insufficient safety and efficacy data are available in patients with hepatic impairment to provide a dose adjustment recommendation.
Slovenian: Za priporočitev spremembe odmerkov pri bolnikih z okvaro jeter ni zadostnih podatkov o varnosti in učinkovitosti.
English: Combination therapy in adjuvant colon cancer
Slovenian: Kombinirano adjuvantno zdravljenje pri raku kolona
English: 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 HFS (all grades) occurred in 2066
Slovenian: Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4.700 bolnikov, zdravljenih s kapecitabinom samim ali v kombinaciji z različnimi shemami kemoterapije pri več indikacijah (rak kolona, kolorektalni rak, rak želodca in rak dojk) je pokazala, da se je sindrom roka-noga (vseh stopenj) pojavil pri 2.066 bolnikih (43 %).
English: +Neutropenia, +Leucopenia, +Anaemia, +Neutropenic fever, Thrombocytopenia
Slovenian: +nevtropenija, +levkopenija, +anemija, +zvišana telesna temperatura z nevtropenijo, trombocitopenija depresija kostnega mozga, +febrilna nevtropenija
English: Capecitabine Teva is used in the treatment of colon, rectal, gastric, or breast cancers.
Slovenian: Zdravilo Kapecitabin Teva se uporablja za zdravljenje raka debelega črevesa, danke, želodca in raka dojk.
English: 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.
Slovenian: 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.
English: (n=18) had about 36% lower Cmax and 24% lower AUC for capecitabine than Caucasian patients (n=22).
Slovenian: Etnični dejavniki Po peroralnem dajanju 825 mg/m 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).
English: 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).
Slovenian: 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).
English: In this treatment subgroup comparison, XELOX plus bevacizumab was similar compared to FOLFOX-4 plus bevacizumab in terms of progression-free survival (hazard ratio 1.01; 97.5% CI 0.84-1.22).
Slovenian: V tej primerjavi podskupin je bilo preživetje brez napredovanja bolezni v skupini, ki se je zdravila po shemi XELOX v kombinaciji z bevacizumabom, podobno kot v skupini, ki se je zdravila po shemi FOLFOX-4 v kombinaciji z bevacizumabom (razmerje ogroženosti 1,01; 97,5-% interval zaupanja 0,84−1,22).
English: • shortness of breath, nose bleeds, cough, runny nose
Slovenian: • zadihanost, krvavenje iz nosu, kašljanje, izcedek iz nosu
English: 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.
Slovenian: v kombinaciji z radioterapijo za rak danke pa je največji prenosljivi odmerek kapecitabina 2.000 mg/m2 na dan z uporabo neprekinjene sheme ali dnevnim dajanjem od ponedeljka do petka med
English: How to take Capecitabine Teva
Slovenian: Kako jemati zdravilo Kapecitabin Teva
English: Oxaliplatin
Slovenian: Oksaliplatin
English: XELOX or XELOX+ Bevacizumab
Slovenian: shema XELOX +
English: Table 5 Summary of related ADRs reported in patients treated with capecitabine in combination treatment in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy
Slovenian: Preglednica 5 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
English: Hypo- or hypercalcaemia has been reported during capecitabine treatment.
Slovenian: Med zdravljenjem s kapecitabinom so opazili hipokalciemijo ali hiperkalciemijo.
English: • Hand-and-foot skin-reaction: if you have pain, swelling, redness or tingling of hands and/or feet
Slovenian: • Kožna reakcija na rokah in nogah: če imate boleče, otekle in rdeče roke in/ali noge.
English: Leucovorin 200 mg/m2 intravenous 2 hr
Slovenian: 200 mg/m2 intravensko 2 h
English: Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache
Slovenian: Bolezni živčevja parestezija, disestezija, periferna nevropatija, periferna senzorična nevropatija, disgevzija,
English: Colon and colorectal cancer
Slovenian: Rak kolona in kolorektalni rak
English: Cardiovascular toxicity (e.g. PR- and QT-interval prolongation) was detectable in cynomolgus monkeys after intravenous administration (100 mg/kg) but not after repeated oral dosing (1379 mg/m2/day).
Slovenian: Toksično delovanje na srce in ožilje (podaljšanje intervalov PR in QT) so opazili pri opicah cynomolgus po intravenskem dajanju (100 mg/kg), po
English: If you are a woman who could become pregnant you should use effective contraception during treatment with Capecitabine Teva and for 6 months after the last dose.
Slovenian: Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom Kapecitabin Teva in še 6 mesecev po zadnjem odmerku zdravila uporabljati učinkovito kontracepcijo.