FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of a meta-analysis of 14 clinical trials with data from over 4,700 patients treated with capecitabine showed that in all studies combined, increasing age (by 10 year increments) was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Slovenian: Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4.700 bolnikov, zdravljenih s kapecitabinom, je pokazala, da je bila višja starost (v korakih po 10 let) statistično značilno povezana z večjim tveganjem za razvoj sindroma roka-noga in driske ter manjšim tveganjem za razvoj nevtropenije, če povzamemo vse študije.
English: In this trial, 255 patients were randomised to treatment with capecitabine (1,250 mg/m² twice daily for 2 weeks followed by 1-week rest period and docetaxel 75 mg/m² as a 1 hour intravenous infusion every 3 weeks).
Slovenian: 255 bolnikov, randomizirano vključenih v preskušanje, je prejemalo zdravljenje s kapecitabinom (1.250 mg/m² dvakrat na dan 2 tedna, sledil je enotedenski premor, in docetaksel 75 mg/m² v obliki enourne intravenske infuzije vsake 3 tedne).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNI OMOT
English: • fever, swelling in the limbs, feeling ill
Slovenian: • vročina, otekanje udov, občutek bolanosti,
English: Vaginal haemorrhage
Slovenian: Brezvodna laktoza
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, INR increased/Prothrombin time prolonged
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija, anemija febrilna nevtropenija, pancitopenija, granulocitopenija, trombocitopenija, levkopenija, hemolitična anemija, zvišano INR/podaljšan protrombinski čas
English: Capecitabine is contraindicated during pregnancy.
Slovenian: Kapecitabin med nosečnostjo ni dovoljeno jemati.
English: NN:
Slovenian: Sospremenljivki:
English: Standard and reduced dose calculations according to body surface area for starting doses of Capecitabine medac of 1,250 mg/m² and 1,000 mg/m² are provided in tables 1 and 2, respectively.
Slovenian: Standardni in zmanjšani odmerki so za začetni odmerek zdravila Kapecitabin medac 1.250 mg/m² glede na telesno površino izračunani v preglednici 1, za 1.000 mg/m² pa v preglednici 2.
English: Combination treatment consisted of first-line capecitabine (1,000 mg/m² twice daily for 14 days) combined with irinotecan (250 mg/m² on day 1) (XELIRI) and second-line capecitabine (1,000 mg/m² twice daily for 14 days) plus oxaliplatin
Slovenian: Zdravljenje s kombinacijo zdravil je vključevalo zdravljenje s kapecitabinom (1.000 mg/m² dvakrat na dan 14 dni) in irinotekanom (250 mg/m² 1. dan) (XELIRI) v prvi liniji ter kapecitabinom
English: Leucovorin on Days 1 and 2, every 2 weeks 5-fluorouracil intravenous bolus/infusion, each on Days 1 and 2, every 2 weeks
Slovenian: FOLFOX-4 + bevacizumab oksaliplatin 85 mg/m² intravensko 2 h oksaliplatin 1. dan, vsake 2 tedna levkovorin 1. in 2. dan, vsake 2 tedna 5-fluorouracil intravensko bolus/infuzija, oboje 1. in 2. dan, vsake
English: 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).
Slovenian: 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 meseca).
English: Colon, colorectal and breast cancer
Slovenian: Rak kolona, kolorektalni rak in rak želodca
English: Flushing, Hypotension, Hypertensive crisis, Hot flush, Phlebitis
Slovenian: embolizem in tromboza napadi rdečice, hipotenzija, hipertenzivna kriza, vročinski oblivi, flebitis
English: INFORMATION IN BRAILLE Capecitabine medac 150 mg
Slovenian: Kapecitabin medac 150 mg
English: Day 1, prior to XELOX, every 3 weeks 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
Slovenian: 5-fluorouracil: intravenska injekcija v bolusu neposredno po levkovorinu
English: For the capecitabine dose of 1,250 mg/m² twice daily on days 1 to 14 every 3 weeks, a frequency of 53 % to 60 % of all-grades HFS was observed in capecitabine monotherapy trials (comprising studies in adjuvant therapy in colon cancer, treatment of metastatic colorectal cancer, and treatment of breast cancer) and a frequency of 63 % was observed in the capecitabine/docetaxel arm for the treatment of metastatic breast cancer.
Slovenian: 3 tedne, je bila pogostnost vseh stopenj sindroma roka-noga v preskušanjih, pri katerih so bolniki prejemali le kapecitabin (študije adjuvantnega zdravljenja pri raku kolona, zdravljenja metastatskega kolorektalnega raka in raka dojk), 53- do 60-odstotna, pogostnost v skupini z metastatskim rakom dojk, ki je prejemala kapecitabin v kombinaciji z docetakselom, pa je bila 63-odstotna.
English: • nerve pain
Slovenian: • bolečina živca,
English: 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).
Slovenian: Glede na preživetje brez bolezni v populaciji po protokolu je bil kapecitabin vsaj ekvivalenten intravenskemu 5-FU/LV (razmerje ogroženosti 0,92; 95-odstotni interval zaupanja 0,80-1,06).
English: The film-coated tablets are peach coloured, oblong shaped, biconvex tablets of 15.9 mm in length and 8.4 mm in width, debossed with ‘500' on one side and plain on other side.
Slovenian: Kapecitabin medac 500 mg filmsko obložene tablete 500 mg filmsko obložene tablete so breskove barve, podolgovate oblike, bikonveksne tablete dolžine 15,9 mm in debeline 8,4 mm z vtisnjeno oznako “500” na eni strani in brez oznake na drugi strani.
English: The film-coated tablets are light peach coloured, oblong shaped, biconvex tablets of 11.4 mm in length and 5.3 mm in width, debossed with ‘150' on one side and plain on other side.
Slovenian: Kapecitabin medac 150 mg filmsko obložene tablete 150 mg filmsko obložene tablete so svetlo breskove barve, podolgovate oblike, bikonveksne tablete dolžine 11,4 mm in debeline 5,3 mm z vtisnjeno oznako “150” na eni strani in brez oznake na drugi strani.
English: Diabetes,
Slovenian: dermatitis,
English: Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
Slovenian: faringitis, oralna kandidoza, gripa, gastroenteritis,
English: Median 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: Pri skupini B so v shemi XELIRI uporabili kapecitabin 1.000 mg/m² dvakrat na dan 14 dni in irinotekan 250 mg/m² 1. dan. Mediana preživetja brez napredovanja bolezni je bila za FOLFIRI-bevacizumab 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 XELIRIbevacizumab; p = 0,32.
English: Hydronephrosis, Urinary incontinence, Haematuria, Nocturia, Blood creatinine increased
Slovenian: hematurija, nikturija, zvišan kreatinin v krvi
English: Capecitabine medac 300 mg film-coated tablets Hypromellose (E464), titanium dioxide (E171), talc Capecitabine medac 500 mg film-coated tablets Hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc
Slovenian: Kapecitabin medac 300 mg filmsko obložene tablete Hipromeloza (E 464), titanov dioksid (E 171), rumeni železov oksid (E 172), rdeči železov oksid (E 172), smukec.
English: Capecitabine and its metabolites are predominantly excreted in urine; 95.5 % of administered capecitabine dose is recovered in urine.
Slovenian: Kar 95,5 % zaužitega odmerka kapecitabina se izloči z urinom, z blatom pa le 2,6 % odmerka.
English: Musculoskeletal
Slovenian: • mišični krči,
English: 7.5 mg/kg intravenous 30 - 90 mins
Slovenian: 7,5 mg/kg intravensko
English: Table 8 Key efficacy results for AIO KRK study
Slovenian: Glavni rezultati o učinkovitosti za študijo AIO KRK.
English: Neutropenia, Anaemia
Slovenian: slabost, stomatitis,
English: How to take Capecitabine medac
Slovenian: Kako jemati zdravilo Kapecitabin medac
English: Capecitabine can induce the occurrence of diarrhoea, which has been observed in up to 50 % of patients.
Slovenian: Opazili so jo pri do 50 % bolnikov.
English: Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyperpigmentation, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder
Slovenian: Bolezni kože in podkožja palmarnoplantarna eritrodisestezija kožni izpuščaj, alopecija, eritem, suha koža, pruritus, hiperpigmentacij a kože, makulozni izpuščaj, luščenje kože,
English: Hyperglycaemia
Slovenian: medac GmbH
English: In addition to the ADRs described in tables 4 and 5, the following ADRs with an incidence of less than 0.1 % were associated with the use of capecitabine monotherapy based on a pooled analysis from clinical safety data from 7 clinical trials including 949 patients (2 phase III and 5 phase II clinical trials in metastatic colorectal cancer and metastatic breast cancer): cardiomyopathy, cardiac failure, sudden death, and ventricular extrasystoles.
Slovenian: Poleg neželenih učinkov, opisanih v preglednicah 4 in 5, so bili s samostojnim zdravljenjem s kapecitabinom povezani naslednji neželeni učinki, katerih incidenca je bila manjša od 0,1 %: kardiomiopatija, srčno popuščanje, nenadna smrt in ventrikularne ekstrasistole.
English: Haematuria, Proteinuria, Creatinine renal clearance decreased, Dysuria
Slovenian: Bolezni sečil hematurija, proteinurija, zmanjšan ledvični očistek kreatinina, disurija akutna ledvična odpoved, ki nastopi zaradi dehidracije
English: INFORMATION IN BRAILLE Capecitabine medac 300 mg
Slovenian: Kapecitabin medac 300 mg
English: 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.
Slovenian: Porazdelitev Študije in vitro na človeški plazmi so pokazale, da se na proteine (v glavnem na albumin) veže 54 %
English: 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).
Slovenian: Kombinirano adjuvantno zdravljenje pri raku kolona Podatki iz multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja faze III pri bolnikih z rakom kolona stadija III (Dukes' C) podpirajo uporabo kapecitabina v kombinaciji z oksaliplatinom (shema XELOX) za adjuvantno zdravljenje raka kolona (preskušanje NO16968).
English: SN:
Slovenian: i.v.
English: Depressed mood,
Slovenian: • utrujenost,
English: INFORMATION IN BRAILLE Capecitabine medac 500 mg
Slovenian: Kapecitabin medac 500 mg
English: Patients with moderately impaired renal function show an increased rate of dose reduction (44 %) vs. 33 % and 32 % in patients with no or mild renal impairment and an increase in early withdrawals from treatment (21 % withdrawals during the first two cycles) vs. 5 % and 8 % in patients with no or mild renal impairment.
Slovenian: Bolnikom z zmerno ledvično okvaro je bilo pogosteje treba zmanjšati odmerek (44 %) kot bolnikom brez ledvične okvare (33 %) in bolnikom z blago ledvično okvaro (32 %).
English: Tell your doctor immediately if you experience any of these symptoms.
Slovenian: Če začutite katere od omenjenih simptomov, se nemudoma pogovorite z zdravnikom.
English: Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT) had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Slovenian: Populacijsko farmakokinetično študijo so opravili po zdravljenju 505 bolnikov s kolorektalnim rakom, ki so prejemali 1.250 mg/m² kapecitabina dvakrat na dan. Spol, prisotnost ali odsotnost zasevkov v jetrih, splošno bolnikovo stanje, celokupni bilirubin, serumski albumin, aspartat-aminotransferaza (AST) in alanin-aminotransferaza (ALT) niso statistično značilno vplivali na farmakokinetiko
English: Oxaliplatin on Day 1, every 2 weeks
Slovenian: 1. dan, pred XELOX, vsake 3 tedne
English: Combination therapy in adjuvant colon cancer
Slovenian: Kombinirano zdravljenje v prvi liniji metastatskega kolorektalnega raka
English: Light peach coloured, oblong shaped, biconvex tablet, debossed with ‘150' on the one side and plain on the other side.
Slovenian: Podolgovata, bikonveksna tableta svetlo breskove barve z vtisnjeno oznako “150” na eni strani in brez oznake na drugi strani.
English: • sweating, night sweats
Slovenian: • potenje, nočno potenje,
English: You must inform your doctor if you know that you have an allergy or over-reaction to this medicine,
Slovenian: Če imate preobčutljivostno reakcijo na to zdravilo, obvestite zdravnika,
English: Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral,
Slovenian: gastroezofagealna refluksna bolezen, bolečina v ustih, disfagija, rektalna krvavitev, bolečina v spodnjem abdomnu, oralna disestezija, oralna parestezija, oralna hipestezija, nelagodje v trebuhu
English: 127 patients were randomised to treatment with capecitabine (1,000 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).
Slovenian: V zdravljenje s kapecitabinom (1.000 mg/m² dvakrat na dan dva tedna, čemur je sledil 7-dnevni premor), oksaliplatinom (130 mg/m² v 2-urni infuziji 1. dan vsake 3 tedne) in bevacizumabom (7,5 mg/kg v 30 do 90-minutni infuziji 1. dan vsake 3 tedne) pa so randomizirali 127 bolnikov.
English: 6.4 Special precautions for storage Aluminium/aluminium blisters
Slovenian: 6.3 Rok uporabnosti Aluminijevi/aluminijevi pretisni omoti
English: Gastroesophageal reflux disease, Oral pain,
Slovenian: gastroezofagealna refluksna bolezen, kolitis, kri v blatu
English: White to off-white, oblong shaped, biconvex tablet, debossed with ‘300' on the one side and plain on the other side.
Slovenian: Podolgovata, bikonveksna tableta bele ali skoraj bele barve z vtisnjeno oznako “300” na eni strani in brez oznake na drugi strani.
English: XELOX or XELOX+ Bevacizumab
Slovenian: XELOX/XELOX + P/
English: Insomnia, Depression Confusional state, Panic attack,
Slovenian: Psihiatrične motnje nespečnost, depresija stanje zmedenosti, panični napad, depresivno razpoloženje, zmanjšan libido
English: Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Slovenian: Kapecitabin medac 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
English: Anhydrous lactose Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Hypromellose (E464) Magnesium stearate (E572)
Slovenian: Mikrokristalna celuloza (E 460) Premrežen natrijev karmelozat (E 468)
English: Capecitabine medac 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine.
Slovenian: Kapecitabin medac 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
English: Capecitabine medac 300 mg film-coated tablets Each film-coated tablet contains 300 mg capecitabine.
Slovenian: Kapecitabin medac 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg kapecitabina.
English: Monotherapy with capecitabine in metastatic colorectal cancer Data from two identically designed, multi centre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of capecitabine for first line treatment of metastatic colorectal cancer.
Slovenian: Podatki dveh enako zasnovanih multicentričnih, randomiziranih, kontroliranih preskušanj faze III (SO14695, SO14796) podpirajo uporabo kapecitabina v prvi liniji zdravljenja metastatskega kolorektalnega raka.
English: The MTD of capecitabine was 2,000 mg/m² per day when combined with interferon alpha- 2a (3 MIU/m² per day) compared to 3,000 mg/m² per day when capecitabine was used alone.
Slovenian: Interferon alfa Pri sočasnem jemanju kapecitabina z interferonom alfa (3 mio i. e./m² na dan) je bil največji prenosljivi odmerek kapecitabina 2.000 mg/m² na dan, pri jemanju samega kapecitabina pa
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 150 mg film-coated tablets Capecitabine medac 300 mg film-coated tablets Capecitabine medac 500 mg film-coated tablets
Slovenian: Kapecitabin medac 150 mg filmsko obložene tablete Kapecitabin medac 300 mg filmsko obložene tablete Kapecitabin medac 500 mg filmsko obložene tablete
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza,
Slovenian: Infekcijske in parazitske bolezni herpes zoster, okužba sečil, oralna kandidoza, okužba zgornjih dihal,
English: Alopecia, Nail disorder Hyperhidrosis, Rash subcutaneous tissue disorders erythematous, Urticaria, Night sweats
Slovenian: eritematozni izpuščaj, urtikarija, nočno znojenje
English: In this trial, 1,987 patients were randomised to treatment with capecitabine (1,250 mg/m² twice daily for 2 weeks followed by a 1-week rest period and given as 3-week 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).
Slovenian: 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 cikle v 24 tednih) ali s 5-FU in levkovorinom (shema Mayo:
English: If no toxicity is observed in patients ≥ 60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1,250 mg/m² twice daily.
Slovenian: 60 let ali več, med zdravljenjem z zmanjšanim odmerkom kapecitabina v kombinaciji z docetakselom toksičnost ne pojavi, lahko odmerek kapecitabina previdno zvečamo na
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 Body system
Slovenian: 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: Talk to your doctor or pharmacist before taking Capecitabine medac
Slovenian: Pred začetkom uporabe zdravila Kapecitabin medac se posvetujte z zdravnikom ali farmacevtom,
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija, levkopenija,
English: The following covariates were statistically significantly associated with a decreased risk of developing diarrhoea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks.
Slovenian: večji kumulativni odmerek kapecitabina (0,1*kg) in večji odmerek v prvih šestih tednih, pa sta bili statistično značilno povezani z manjšim tveganjem za razvoj driske.
English: Gastrointestinal haemorrhage, Constipation, Upper abdominal pain, Dyspepsia, Flatulence, Dry mouth
Slovenian: bolečina v trebuhu krvavitev iz prebavil, zaprtje, bolečina v zgornjem delu trebuha, dispepsija, flatulenca, suha usta črevesna obstrukcija,
English: 5 mg/kg intravenous 30 - 90 mins
Slovenian: 5 mg/kg intravensko
English: skin loss, skin inflammation, nail disorder
Slovenian: obarvanje kože, izguba kože, vnetje kože, spremembe na nohtih,
English: In combination with other medicines the usual dose for adults may be less than 1,250 mg/m² of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).
Slovenian: V kombinaciji z drugimi zdravili je lahko običajni odmerek za odrasle manjši od 1.250 mg/m² telesne površine.
English: 1,250 mg/m²
Slovenian: Polni odmerek 1.250 mg/m²
English: Lipoma
Slovenian: Kapecitabin
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Kapecitabin medac Vsebina pakiranja in dodatne informacije
English: Data from a randomised clinical study (Souglakos et al, 2012) comparing FOLFIRI + bevacizumab with XELIRI + bevacizumab showed no significant differences in PFS or OS between treatments.
Slovenian: FOLFIRI + bevacizumab s XELIRI + bevacizumab, niso pokazali signifikantne razlike med zdravljenjema v preživetju brez napredovanja bolezni ali celokupnem preživetju.
English: Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 7 mg anhydrous lactose.
Slovenian: Kapecitabin medac 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 7 mg brezvodne laktoze.
English: Back pain, Arthralgia pain, Facial pain, Musculoskeletal stiffness, Muscular weakness
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija, artralgija, bolečina v ekstremitetah bolečina v čeljusti, mišični spazmi, trizmus, mišična šibkost
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 300 mg film-coated tablets capecitabine
Slovenian: IME ZDRAVILA Kapecitabin medac 300 mg filmsko obložene tablete kapecitabin
English: Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1,000 mg/m²
Slovenian: Standardni in zmanjšani odmerki glede na telesno površino za začetni odmerek kapecitabina 1.000 mg/m² Odmerek 1.000 mg/m² (dvakrat na dan)
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 500 mg film-coated tablets capecitabine
Slovenian: IME ZDRAVILA Kapecitabin medac 500 mg filmsko obložene tablete kapecitabin
English: LIST OF EXCIPIENTS Also contains anhydrous lactose and sodium, read the package leaflet before use.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi brezvodno laktozo in natrij.
English: Capecitabine medac 300 mg film-coated tablets Each film-coated tablet contains 15 mg anhydrous lactose.
Slovenian: Kapecitabin medac 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 15 mg brezvodne laktoze.
English: Capecitabine medac 300 mg film-coated tablets
Slovenian: Kapecitabin medac 300 mg filmsko obložene tablete
English: Palmar-plantar erythrodysaesthesia syndrome**
Slovenian: Stopnja toksičnosti*
English: supports these results with a HR of 0.78 (95 % CI = [0.67; 0.92]; p = 0.0024) for XELOX vs. 5-FU/LV.
Slovenian: Analiza preživetja brez ponovitve bolezni (sekundarni cilj preskušanja) te rezultate podpira; razmerje ogroženosti je bilo 0,78 za shemo XELOX v primerjavi s 5-FU/LV (95-odstotni interval zaupanja 0,67-0,92; p = 0,0024).
English: Musculoskeletal and connective tissue disorders
Slovenian: mišično-skeletna togost, mišična šibkost
English: 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
Slovenian: +zvišana telesna temperatura, z infuzijo povezana reakcija, reakcija na mestu injiciranja, bolečina na mestu infundiranja, bolečina na mestu injiciranja
English: Capecitabine medac 500 mg film-coated tablets
Slovenian: Kapecitabin medac 500 mg filmsko obložene tablete
English: • if you cannot keep food or water in your body because of severe nausea and vomiting,
Slovenian: • ne morete v sebi zadržati hrane ali tekočine zaradi hude slabosti in bruhanja, • če imate premalo ali preveč ionov v krvi (neravnovesje elektrolitov, razvidno iz preiskav),