FrancophonIA/ELRC3.0 huggingface dataset:
English: Capecitabine medac contains capecitabine, which itself is not a cytostatic medicine.
Slovenian: Zdravilo Kapecitabin medac vsebuje kapecitabin, ki sam nima citostatičnega učinka.
English: Abdominal distension,
Slovenian: gastritis, abdominalna distenzija,
English: • decreases in blood cells including platelets, thinning of blood (seen in tests)
Slovenian: • zmanjšanje krvnih celic, vključno s krvnimi ploščicami, redčenje krvi (razvidno iz preiskav),
English: The most commonly reported and/or clinically relevant treatment-related ADRs were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), HFS (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with pre-existing compromised renal function, and thrombosis/embolism.
Slovenian: Najpogostejši in/ali klinično pomembni, z zdravljenjem povezani neželeni učinki, o katerih so poročali, so bili bolezni prebavil (zlasti driska, slabost, bruhanje, bolečina v trebuhu, stomatitis), sindrom roka-noga (palmarno-plantarna eritrodisestezija), utrujenost, astenija, anoreksija, kardiotoksičnost, poslabšanje ledvične disfunkcije pri bolnikih z že obstoječo motnjo ledvičnega delovanja in tromboza/embolizem.
English: Capecitabine medac should only be prescribed by a doctor experienced in the use of anticancer medicines.
Slovenian: Zdravilo Kapecitabin medac lahko predpiše samo zdravnik, usposobljen za uporabo zdravil proti raku.
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, reakcije kože pri stiku s sončno svetlobo, rdečenje dlani, otekanje ali bolečina na obrazu,
English: Capecitabine medac is indicated:
Slovenian: Zdravilo Kapecitabin medac je indicirano:
English: Table 7 Key efficacy results for the non-inferiority analysis of study NO16966
Slovenian: Glavni rezultati o učinkovitosti za analizo ne-inferiornosti v študiji NO16966 OSNOVNA ANALIZA
English: If the patient becomes pregnant while receiving capecitabine, the potential hazard to the foetus must be explained.
Slovenian: Če bolnica med zdravljenjem z zdravilom kapecitabin zanosi, ji je treba razložiti možno tveganje za plod.
English: In a randomised, controlled phase III study (CAIRO), the effect of using capecitabine at a starting dose of 1,000 mg/m² for 2 weeks every 3 weeks in combination with irinotecan for the first-line treatment of patients with metastatic colorectal cancer was studied.
Slovenian: V randomizirani, kontrolirani študiji faze III (CAIRO) so proučevali učinek uporabe kapecitabina v začetnem odmerku 1.000 mg/m² 2 tedna vsake 3 tedne v kombinaciji z irinotekanom v prvi liniji zdravljenja bolnikov z metastatskim kolorektalnim rakom.
English: • dehydration, weight loss
Slovenian: • dehidracija, izguba telesne mase,
English: • if you have liver or kidney diseases,
Slovenian: • če imate jetrno ali ledvično bolezen,
English: For PVC/PVdC-aluminium blisters:
Slovenian: Za PVC/PVdC-aluminijeve pretisne omote:
English: • eye irritation, increased tears, eye redness (conjunctivitis)
Slovenian: • razdraženost oči, povečano solzenje, rdečica oči (konjunktivitis),
English: • if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD),
Slovenian: • če veste, da imate delno pomanjkanje aktivnosti encima dihidropirimidin dehidrogenaze (DPD),
English: Method of administration Capecitabine medac tablets should be swallowed with water within 30 minutes after a meal.
Slovenian: Način uporabe Tablete kapecitabina je treba pogoltniti z vodo največ 30 minut po obroku.
English: P = 0.45
Slovenian: 25,5 meseca p = 0,45
English: At the dose of 1,250 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.
Slovenian: Pri odmerku 1.250 mg/m² ob jemanju po obroku so bile na 14. dan največje plazemske koncentracije (Cmax v μg/ml) za kapecitabin, 5'-DFCR, 5'-DFUR, 5-FU in FBAL 4,67; 3,05; 12,1; 0,95 in 5,46.
English: fainting, nerve damage (neuropathy) and problems with sensation
Slovenian: omedlevica, poškodba živca (nevropatijo) in težave z zaznavanjem,
English: The 3 year DFS rate was 71 % for XELOX versus 67 % for 5-FU/LV.
Slovenian: Delež triletnega preživetja brez bolezni je bil 71 % za shemo XELOX v primerjavi s 67 % za 5-FU/LV.
English: cisplatin, irinotecan)
Slovenian: bevacizumab, cisplatina, irinotekana),
English: If grade 2 or 3 HFS occurs, administration of capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1.
Slovenian: Če se pojavi sindrom 2. ali 3. stopnje, je treba jemanje kapecitabina prekiniti, dokler simptomi ne ponehajo oziroma se ne zmanjšajo na 1. stopnjo.
English: Dose changes within a treatment cycle Dose adjustment for next cycle/dose (% of starting dose)
Slovenian: Prilagoditev odmerka za naslednji cikel/odmerek
English: A reduction of the starting dose in these patients may be considered to avoid serious toxicity.There is insufficient data to recommend a specific dose in patients with partial DPD activity as measured by specific test.
Slovenian: Na voljo ni dovolj podatkov, da bi pri bolnikih z delnim pomanjkanjem aktivnosti DPD, določenim s posebnim testom, lahko priporočili specifičen odmerek.
English: Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia
Slovenian: hipokaliemija, motnje apetita, podhranjenost, hipertrigliceridemija
English: • 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.
Slovenian: • 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.
English: A significant reduction in the risk of progression was associated with FOLFIRI (HR, 0.76; 95 % CI, 0.62-0.95; P < 0.01), a result partly due to poor tolerance to the XELIRI regimens used.
Slovenian: Signifikantno zmanjšanje tveganja za napredovanje bolezni je bilo povezano s FOLFIRI (razmerje ogroženosti 0,76; 95-% interval zaupanja, 0,62 - 0,95; p < 0,01), kar lahko delno pripišemo slabemu prenašanju sheme XELIRI.
English: Further catalytic activation of 5'-DFUR then occurs by ThyPase.
Slovenian: Nadaljnja katalitska aktivacija 5'-DFUR poteka s timidin fosforilazo.
English: A meta-analysis of 14 clinical trials with data from over 4,700 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 HFS had a longer overall survival compared to patients who did not develop HFS: median overall survival 1,100 days (95 % CI 1,007;1,200) vs 691 days (95 % CI 638;754) with a hazard ratio of 0.61 (95 % CI 0.56; 0.66).
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 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-odstotni interval zaupanja; 1.007; 1.200) v primerjavi s 691 dnevi (95-odstotni interval zaupanja 638; 754) z razmerjem ogroženosti 0,61 (95-odstotni interval zaupanja; 0,56; 0,66).
English: Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-FU.
Slovenian: Kapecitabin je necitotoksičen fluoropirimidinski karbamat v obliki prekurzorja citotoksične učinkovine 5-FU.
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 npr. fenprokumon) vam bo zdravnik v primeru prekinitve zdravljenja z zdravilom Kapecitabin medac morda moral prilagoditi odmerek antikoagulanta.
English: As this medicinal product contains anhydrous lactose as an excipient, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Zdravilo vsebuje brezvodno laktozo kot pomožno snov, zato ga ne smemo dajati bolnikom z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze.
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 bolečine, otekanje, rdečino ali mravljinčenje na rokah in/ali nogah.
English: SPECIAL STORAGE CONDITIONS For PVC/PVdC/Aluminium blisters: Do not store above 30 °C
Slovenian: Za PVC/PVdC/aluminijeve pretisne omote: Shranjujte pri temperaturi do 30 °C.
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: Survival was superior in the capecitabine + docetaxel combination arm (p = 0.0126).
Slovenian: Daljše preživetje je bilo v skupini bolnikov, ki je prejemala kombinirano zdravljenje kapecitabina in docetaksela (p = 0,0126).
English: • medicines for seizures or tremors (phenytoin)
Slovenian: • zdravil za preprečevanje epileptičnih napadov ali tremorja (fenitoina),
English: • fluid collection in the kidneys, increased frequency of urination during the night, incontinence,
Slovenian: • nabiranje tekočine v ledvicah, povečano število uriniranj ponoči, inkontinenco, kri v urinu,
English: Grade 3 HFS 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.
Slovenian: 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.
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 non-inferior to 5-FU-containing regimens.
Slovenian: Razmerje ogroženosti za celokupno preživetje je bilo 0,94 (95-odstotni interval zaupanja; 0,89; 1,00, p = 0,0489), kar kaže, da je zdravljenje, ki vključuje kapecitabin, ne-inferiorno zdravljenju, ki vključuje 5-FU.
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 na dan, za štiri ali več, ali če imate ponoči drisko.
English: 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.
Slovenian: Pogostnost pojavov neželenih učinkov stopnje 3 ali 4 pri bolnikih z zmerno ledvično okvaro (očistek kreatinina 30 do 50 ml/min na začetku zdravljenja) je v primerjavi s preostalimi skupinami povečana.
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-odstotni interval zaupanja; 671; 745); pri bolnikih, katerih zdravljenje je vključevalo 5-FU, pa 683 dni (95-odstotni interval zaupanja; 646; 715).
English: • if you have severely low levels of white cells or platelets in the blood (leukopenia, neutropenia or thrombocytopenia),
Slovenian: • če imate izredno nizko raven belih krvnih celic ali krvnih ploščic v krvi (levkopenija,
English: • skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration,
Slovenian: • kožni izpuščaj, izpadanje las (alopecijo), pordečitev kože, suha koža, srbečica (pruritus),
English: XELOX showed a trend towards superior OS with a HR of 0.87 (95 % CI = [0.72; 1.05]; p = 0.1486) which translates into a 13 % reduction in risk of death.
Slovenian: Shema XELOX je pokazala trend k večjemu celokupnemu preživetju z razmerjem ogroženosti 0,87 (95-odstotni interval zaupanja 0,72-1,05; p = 0,1486), kar pomeni 13 % zmanjšanje tveganja za smrt.
English: Median PFS was 7.6 months for FOLFIRI, 5.9 months for mIFL (p = 0.004) for the comparison with FOLFIRI), and 5.8 months for XELIRI (p = 0.015).
Slovenian: Mediana preživetja brez napredovanja bolezni je bila 7,6 meseca za FOLFIRI, 5,9 meseca za mIFL (p = 0,004) za primerjavo s FOLFIRI) in 5,8 meseca za XELIRI (p = 0,015).
English: The rate of withdrawal due to adverse events was higher in the XELOX combination therapy arm (21 %) as compared with that of the 5-FU/LV monotherapy arm (9 %) in the ITT population.
Slovenian: Delež prekinitev zdravljenja zaradi neželenih učinkov je bil v populaciji, ki so jo nameravali zdraviti (ITT), v skupini s shemo kombiniranega zdravljenja XELOX višji (21 %) v primerjavi s skupino z monoterapijo s 5-FU/LV (9 %).
English: FOLFOX-4 or FOLFOX-4 + Bevacizumab
Slovenian: FOLFOX-4 + BEVACIZ
English: blood in the urine, increase in blood creatinine (sign of kidney dysfunction)
Slovenian: povečana raven kreatinina v krvi (znak nepravilnega delovanja jeter),
English: For terms marked with a “+”, the frequency count was based on grade 3 - 4 ADRs.
Slovenian: Za termine, označene s »+«, so pri določitvi pogostnosti upoštevali le neželene učinke stopnje 3 ali 4.
English: • if you 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),
Slovenian: čeljusti in hrbtu, ki so posledica fizičnega napora in težav s pretokom krvi do srca),
English: The following headings are used to rank the ADRs by frequency: very common (≥ 1/10),
Slovenian: Neželeni učinki so razvrščeni po njihovi pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni
English: The median PFS was 5.6 months (capecitabine + cisplatin) versus 5.0 months (5-FU + cisplatin).
Slovenian: Mediana preživetja brez napredovanja bolezni je bila 5,6 meseca (kapecitabin + cisplatin) v primerjavi s 5,0 meseca (5-FU + cisplatin).
English: 150 mg 300 mg 500 mg
Slovenian: 150 mg 300 mg 500 mg Enkratni odmerek (mg)
English: Studies with capecitabine monotherapy indicate that capecitabine has activity in advanced gastric cancer.
Slovenian: Študije s samostojnim zdravljenjem s kapecitabinom kažejo na to, da je kapecitabin učinkovito pri napredovalem raku želodca.
English: DPD activity is the rate limiting step.
Slovenian: Na hitrost pretvorbe ključno vpliva DPD.
English: If these side effects continue, however, contact your doctor immediately.
Slovenian: Če se pojavijo, se takoj posvetujte z zdravnikom.
English: In combination treatment, the recommended starting dose of capecitabine should be reduced to 800-1,000 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/m² dvakrat na dan, če ga dajemo neprekinjeno (glejte poglavje 5.1).
English: • gout medicines (allopurinol)
Slovenian: • zdravil proti protinu (alopurinola),
English: Sepsis, Urinary tract infection, Cellulitis, Tonsillitis,
Slovenian: okužba spodnjih dihal sepsa, okužba sečil, celulitis, tonzilitis,
English: P = 0.30
Slovenian: 2 h
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: Titanium dioxide (E171) Iron oxide red (E172)
Slovenian: Titanov dioksid (E 171) Rdeči železov oksid (E 172) Rumeni železov oksid (E 172)
English: Folinic acid/folic acid
Slovenian: Folinska/folna kislina
English: In the largest study (BICC-C), patients were randomised to receive either open label FOLFIRI (n = 144), bolus 5-FU (mIFL) (n = 145) or XELIRI (n = 141) and were additionally randomised to receive either double-blind treatment with celecoxib or placebo.
Slovenian: V največji študiji (BICC-C) so bolnike randomizirali, da so kot odprto zdravljenje prejeli FOLFIRI (n = 144), 5-FU v bolusu (mIFL) (n = 145) ali XELIRI (n = 141).
English: Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (HFS, hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Slovenian: 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).
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/m² 5-FU v obliki intravenskega bolusa vsakih 28 dni - na prvi do peti dan).
English: HR (95 % CI)
Slovenian: Razmerje ogroženosti (95 % CI)
English: However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥ 60 years of age compared to younger patients.
Slovenian: Pri bolnikih, starih 60 let ali več, so bili z zdravljenjem povezani neželeni učinki stopnje 3 ali 4 bolj pogosti kot pri mlajših bolnikih.
English: Leucovorin 200 mg/m² intravenous 2 hr
Slovenian: 2 tedna levkovorin 200 mg/m² intravensko
English: Capecitabine medac should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
Slovenian: Zdravilo Kapecitabin medac lahko predpiše le zdravnik z ustreznim znanjem in izkušnjami z uporabo zdravil za zdravljenje novotvorb.
English: Oedema, Chills, Influenza-like illness, Rigors, Body temperature increased
Slovenian: bolezen, podobna gripi, rigor, zvišana telesna temperatura
English: Patients with renal impairment (see section 4.2, 4.4, and 5.2) 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).
Slovenian: Analiza varnostnih podatkov pri bolnikih z ledvično okvaro, ki so jih zdravili samo s kapecitabinom (zaradi kolorektalnega raka) je pokazala, da je incidenca z zdravljenjem povezanih neželenih učinkov stopnje 3 in 4 pri teh bolnikih večja, kot pri bolnikih z normalnim delovanjem ledvic (36 % pri bolnikih brez ledvične okvare, n = 268, v primerjavi z 41 % pri bolnikih z blago ledvično okvaro, n = 257, in 54 % pri bolnikih z zmerno ledvično okvaro, n = 59) (glejte poglavje 5.2).
English: • diabetes, decrease in blood potassium, malnutrition, increased blood triglycerides
Slovenian: • sladkorna bolezen, zmanjšanje kalija v krvi, povečana raven trigliceridov v krvi,
English: In patients with moderate renal impairment at baseline, a dose reduction to 75 % for a starting dose of 1,250 mg/m² is recommended.
Slovenian: Bolnikom z zmerno ledvično okvaro in začetnim odmerkom 1.250 mg/m² je priporočljivo zmanjšati odmerek na 75 %.
English: 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.
Slovenian: Za kombinacijo z irinotekanom je priporočeni začetni odmerek 800 mg/m², kadar ga dajemo dvakrat na dan 14 dni, čemur sledi 7-dnevni premor, irinotekan pa damo 1. dan v odmerku 200 mg/m².
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 1,250 mg/m² administered twice daily (morning and evening; equivalent to 2,500 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/m² dvakrat na dan (zjutraj in zvečer; celokupni dnevni odmerek znaša 2.500 mg/m²) 14 dni, sledi 7-dnevni premor.
English: 6.5 Nature and contents of container Aluminium/aluminium or PVC/PVdC/Aluminium blisters.
Slovenian: Aluminijevi/aluminijevi ali PVC/PVdC/aluminijevi pretisni omoti.
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 2 tedna vsake 3 tedne v kombinaciji z irinotekanom in bevacizumabom v prvi liniji zdravljenja bolnikov z metastatskim kolorektalnim rakom.
English: If you are a woman who could become pregnant you should use effective contraception during treatment with Capecitabine medac and for 6 months after the last dose.
Slovenian: Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom Kapecitabin medac in še 6 mesecev po zadnjem odmerku zdravila uporabljati učinkovito kontracepcijo.
English: • if you have severe liver or kidney problems,
Slovenian: • če imate hujše jetrne bolezni ali težave z jetri ali ledvicami,
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/m² v obliki enourne intravenske infuzije vsake 3 tedne).
English: What Capecitabine medac looks like and contents of the pack
Slovenian: Izgled zdravila Kapecitabin medac in vsebina pakiranja