FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablets are light peach colored, 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: Tablete so svetlo breskove barve, podolgovate oblike, bikonveksne, dolžine 11,4 mm in debeline 5,3 mm, z vtisnjeno oznako "150" na eni strani in brez oznake na drugi strani.
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: 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/m2 administered twice daily (morning and evening; equivalent to
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: 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: 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 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 XELIRI-bevacizumab; p = 0,32.
English: Combination treatment consisted of first-line capecitabine (1000 mg/m 2 twice daily for 14 days) combined with irinotecan (250 mg /m 2 on day 1) (XELIRI) and second-line capecitabine (1000 mg/m2 twice daily for 14 days) plus oxaliplatin (130 mg/m2 on day 1).
Slovenian: Zaporedno zdravljenje je vključevalo zdravljenje s kapecitabinom (1.250 mg/m2 dvakrat na dan 14 dni) v prvi liniji, z irinotekanom (350 mg/m 2 1. dan) v drugi liniji in s kombinacijo kapecitabina (1.000 mg/m 2 dvakrat na dan 14 dni) in oksaliplatina (130 mg/m 2 1. dan) v tretji liniji.
English: Lipoma
Slovenian: KRKA
English: Angina unstable, Angina pectoris, Myocardial ischaemia/infarction, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations
Slovenian: Srčne bolezni nestabilna angina pektoris, angina pektoris, miokardna ishemija/infarkt, atrijska fibrilacija, aritmija, tahikardija, sinusna tahikardija, palpitacije ventrikularna fibrilacija (redki), podaljšanje intervala QT (redki), torsade de pointes (redki), bradikardija (redki), vazospazem (redki)
English: In the absence of safety and efficacy data in patients with hepatic impairment, capecitabine use should be carefully monitored in patients with mild to moderate liver dysfunction, regardless of the presence or absence of liver metastasis.
Slovenian: Zato moramo uporabo kapecitabina pri bolnikih z blago do zmerno motnjo delovanja jeter, ne glede na to, ali imajo zasevek v jetrih ali ne, pazljivo spremljati.
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: Ti temeljijo na skupni analizi kliničnih podatkov o varnosti, zbranih iz sedmih kliničnih preskušanj, ki so vključevala 949 bolnikov (klinična preskušanja metastatskega kolorektalnega raka in metastatskega raka dojk, 2 faze III in 5 faze II).
English: Ecansya belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Slovenian: Zdravilo Ecansya spada v skupino zdravil, ki jih imenujemo citostatiki.
English: Premedication with antiemetics according to the oxaliplatin summary of product characteristics is recommended for patients receiving the capecitabine plus oxaliplatin combination.
Slovenian: Pri kombiniranem zdravljenju s kapecitabinom ter oksaliplatinom se priporoča premedikacija z antiemetiki v skladu s povzetkom glavnih značilnosti za oksaliplatin.
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: heartburn (reflux of food from the stomach), blood in the stool - jaundice (yellowing of skin and eyes) - skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face - joint swelling or stiffness, bone pain, muscle weakness or stiffness - fluid collection in the kidneys, increased frequency of urination during the night, incontinence,
Slovenian: kratko sapo ob naporu, - zaporo črevesja, nabiranje tekočine v trebuhu, vnetje tankega in debelega črevesa, želodca ali požiralnika, bolečino v spodnjem delu trebuha, neugodje v želodcu, zgago (refluks hrane iz želodca), kri v blatu, - zlatenico (porumenelost kože in oči), - razjedo in mehurčke na koži, reakcijo kože s svetlobo, pordevanje dlani, otekanje ali bolečino obraza, - otekanje ali togost sklepov, bolečino v kosteh, mišično šibkost ali togost, - zadrževanje tekočine v ledvicah, pogostejše uriniranje ponoči, inkontinenco, kri v urinu,
English: Combination therapy with capecitabine and docetaxel in locally advanced or metastatic breast cancer Data from one multicentre, randomised, controlled phase III clinical trial support the use of capecitabine in combination with docetaxel for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Slovenian: Podatki kontroliranega, randomiziranega, multicentričnega kliničnega preskušanja faze III podpirajo uporabo kapecitabina v kombinaciji z docetakselom za zdravljenje lokalne napredovale ali metastatske oblike raka dojk po neuspeli citotoksični antraciklinski kemoterapiji.
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: The tablets are white to off white, oblong shaped, biconvex tablets of 14.6 mm in length and 6.7 mm in width, debossed with "300" on one side and plain on other side.
Slovenian: Tablete so bele ali kremne bele barve, podolgovate oblike, bikonveksne, dolžine 14,6 mm in debeline 6,7 mm, z vtisnjeno oznako "300" na eni strani in brez oznake na drugi strani.
English: 30 film-coated tablets
Slovenian: filmsko obložena tableta
English: Capecitabine was devoid of hepatic and CNS toxicities.
Slovenian: Kapecitabin ni toksično učinkoval na jetra in centralni živčni sistem.
English: Hand-foot syndrome (see section 4.4): For the capecitabine dose of 1250 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-%, pogostnost v skupini z metastatskim rakom dojk, ki je prejemala kapecitabin v kombinaciji z docetakselom, pa je bila 63-%.
English: It is therefore possible that Ecansya could affect your ability to drive a car or operate machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Ecansya lahko povzroči omotico, slabost ali občutek utrujenosti, zato lahko vpliva na vašo sposobnost za vožnjo in upravljanje strojev.
English: Lacrimal duct stenosis (rare), Corneal disorders(rare), keratitis (rare), punctate keratitis (rare)
Slovenian: Očesne bolezni povečano solzenje, konjunktivitis, vnetje oči zmanjšana ostrina vida, diplopija stenoza solznega voda (redki), bolezni roženice (redki), keratitis (redki), keratitis punctata (redki)
English: - sleeplessness (insomnia), depression - headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation), taste changes - eye irritation, increased tears, eye redness (conjunctivitis) - inflammation of the veins (thrombophlebitis) - shortness of breath, nose bleeds, cough, runny nose - cold sores or other herpes infections - infections of the lungs or respiratory system (e.g. pneumonia or bronchitis) - bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth - skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration,
Slovenian: spremembo okusa, - vnetje oči, povečano solzenje, rdeče oči (konjunktivitis), - vnetje ven (tromboflebitis), - kratko sapo, krvavitev iz nosu, kašelj, izcedek iz nosu, - mehurčke na ustnicah in druge okužbe s herpesom, - okužbe pljuč in respiratornega sistema (npr. pljučnico ali bronhitis), - krvavitev iz črevesja, zaprtje, bolečino v zgornjem delu trebuha, slabo prebavo, pline (vetrove),
English: Posology adjustments for special populations
Slovenian: Prilagajanje odmerjanja pri posebnih skupinah bolnikov:
English: During capecitabine monotherapy, no adjustment of the starting dose is needed.
Slovenian: Zanje prilagajanje začetnega odmerka pri samostojnem zdravljenju s kapecitabinom ni potrebno.
English: Colon, colorectal and gastric cancer
Slovenian: Rak kolona, kolorektalni rak in rak želodca
English: Body System Very Common
Slovenian: Organski sistem
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, ASAT and 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, AST in ALT niso statistično značilno vplivali na farmakokinetiko 5'-DFUR, 5-FU in FBAL.
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: Sospremenljivki: 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: Ventricular fibrillation (rare),
Slovenian: 5-fluoro-ureidopropionska kislina (FUPA).
English: In combination with other medicines the usual dose for adults may be less than 1250 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 1250 mg/m 2 telesne površine.
English: Mucosal inflammation, Pain in limb, Pain, Chills, Chest pain, Influenza-like illness,
Slovenian: +letargija, temperaturna intoleranca vnetje sluznic, bolečina v okončinah, bolečina, mrazenje, bolečina v prsnem košu, bolezen podobna gripi,
English: The tablets are peach colored, 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: Tablete so bele ali kremne bele barve, podolgovate oblike, bikonveksne, dolžine 15,9 mm in debeline 8,4 mm, z vtisnjeno oznako "500" na eni strani in brez oznake na drugi strani.
English: Renal impairment
Slovenian: Jetrna okvara
English: Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia
Slovenian: Presnovne in prehranske motnje zmanjšan apetit hipokaliemija, hiponatriemija, hipomagneziemija, hipokalcemija, hiperglikemija
English: In combination treatment, the recommended starting dose of capecitabine should be reduced to 800 - 1000 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
English: Colon and colorectal cancer:
Slovenian: Rak kolona in kolorektalni rak
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: 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 Organski sistem
English: Ecansya 500 mg film-coated tablets
Slovenian: Ecansya 500 mg filmsko obložene tablete
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 (redki)
English: You must not take Ecansya if you are pregnant or think you might be.
Slovenian: Če ste noseči ali če obstaja sum na nosečnost, zdravila Ecansya ne smete jemati.
English: Sequential treatment consisted of first-line capecitabine (1250 mg/m2 twice daily for 14 days), second-line irinotecan (350 mg/m2 on day
Slovenian: Zdravljenje s kombinacijo zdravil je vključevalo zdravljenje s kapecitabinom (1.000 mg/m 2 dvakrat na dan 14 dni) in irinotekanom (250 mg/m 2 1. dan) (XELIRI) v prvi liniji ter kapecitabinom
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureidopropionic acid (FUPA).
Slovenian: Dihidropirimidinaza cepi pirimidinski obroč, pri čemer nastane
English: There are no side-effects caused by stopping treatment with capecitabine.
Slovenian: Po prenehanju zdravljenja s kapecitabinom se ne pojavijo neželeni učinki.
English: Ecansya 300 mg film-coated tablets
Slovenian: Ecansya 300 mg filmsko obložene tablete
English: What Ecansya looks like and contents of the pack Ecansya 150 mg film-coated tablets (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: Ecansya 150 mg filmsko obložene tablete (tablete) so svetlo breskove barve, podolgovate oblike, bikonveksne, dolžine 11,4 mm in debeline 5,3 mm, z vtisnjeno oznako "150" na eni strani in brez oznake na drugi strani.
English: In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks.
Slovenian: Priporočeni začetni odmerek kapecitabina v kombinaciji z docetakselom za zdravljenje metastatskega raka dojk je 1.250 mg/m2 dvakrat na dan 14 dni, sledi 7-dnevni premor, odmerek docetaksela pa je
English: Hepatic failure (rare), Cholestatic hepatitis (rare)
Slovenian: Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija, nenormalni testi jetrne funkcije zlatenica odpoved jeter (redki), holestatični hepatitis (redki)
English: Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1000 mg/m2
Slovenian: Standardni in zmanjšani odmerki glede na telesno površino za začetni odmerek kapecitabina 1.000 mg/m Odmerek 1.000 mg/m 2 (dvakrat na dan)
English: 120 film-coated tablets
Slovenian: 30 filmsko obloženih tablet 60 filmsko obloženih tablet 120 filmsko obloženih tablet
English: Ecansya 500 mg film-coated tablets - Aluminium/aluminium blisters 30 film-coated tablets: EU/1/12/763/013 60 film-coated tablets: EU/1/12/763/014 120 film-coated tablets: EU/1/12/763/015
Slovenian: Ecansya 500 mg filmsko obložene tablete - Al/Al pretisni omoti 30 filmsko obloženih tablet: EU/1/12/763/013 60 filmsko obloženih tablet: EU/1/12/763/014 120 filmsko obloženih tablet: EU/1/12/763/015
English: A total of 156 patients were randomised to treatment with 5-FU (800 mg/m2 per day, continuous infusion on days 1 to 5 every 3 weeks) and cisplatin (80 mg/m2 as a 2-hour infusion on day
Slovenian: V zdravljenje s 5-FU (800 mg/m 2 na dan, v kontinuirani infuziji od 1. do 5. dne vsake 3 tedne) in cisplatinom (80 mg/m2, v 2-urni infuziji 1. dan, vsake 3 tedne) pa so skupno randomizirali 156 bolnikov.
English: Alopecia, Nail disorder Hyperhidrosis, Rash erythematous, Urticaria, Night sweats
Slovenian: Bolezni kože in podkožja alopecija, spremembe na nohtih hiperhidroza, eritematozni izpuščaj, urtikarija, nočno znojenje
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
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: How to store Ecansya
Slovenian: Shranjevanje zdravila Ecansya
English: - PVC/PVdC/aluminium blisters 30 film-coated tablets: EU/1/12/763/016 60 film-coated tablets: EU/1/12/763/017 120 film-coated tablets: EU/1/12/763/018
Slovenian: - PVC/PVdC/Al pretisni omoti 30 filmsko obloženih tablet: EU/1/12/763/016 60 filmsko obloženih tablet: EU/1/12/763/017 120 filmsko obloženih tablet: EU/1/12/763/018
English: - Ecansya 300 mg film-coated tablets Hypromellose (6cps)
Slovenian: - Ecansya 300 mg filmsko obložene tablete hipromeloza (6cps) smukec titanov dioksid (E171)
English: Parameter: Overall Survival PPP
Slovenian: Parameter: Preživetje brez napredovanja bolezni PPP ITT Parameter: Celokupno preživetje PPP ITT
English: - ECF: epirubicin (50 mg/ m2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m2 as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m2 daily given by continuous infusion via a central line).
Slovenian: - ECF: epirubicin (50 mg/m 2 kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m 2 v 2-urni infuziji
English: - PVC/PVdC/aluminium blisters 30 film-coated tablets: EU/1/12/763/004 60 film-coated tablets: EU/1/12/763/005 120 film-coated tablets: EU/1/12/763/006
Slovenian: - PVC/PVdC/Al pretisni omoti 30 filmsko obloženih tablet: EU/1/12/763/004 60 filmsko obloženih tablet: EU/1/12/763/005 120 filmsko obloženih tablet: EU/1/12/763/006
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
Slovenian: - Ecansya 500 mg filmsko obložene tablete hipromeloza (6cps) smukec titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
English: Ecansya 150 mg film-coated tablets
Slovenian: Ecansya 150 mg filmsko obložene tablete
English: There are no studies in pregnant women using capecitabine; however, it should be assumed that capecitabine may cause foetal harm if administered to pregnant women.
Slovenian: Predvidevamo, da lahko kapecitabin povzroči okvare ploda, če bi ga ženske jemale med nosečnostjo.
English: Ecansya 150 mg film-coated tablets - Aluminium/aluminium blisters 30 film-coated tablets: EU/1/12/763/001 60 film-coated tablets: EU/1/12/763/002 120 Film-coated tablets: EU/1/12/763/003
Slovenian: Ecansya 150 mg filmsko obložene tablete - Al/Al pretisni omoti 30 filmsko obloženih tablet: EU/1/12/763/001 60 filmsko obloženih tablet: EU/1/12/763/002 120 filmsko obloženih tablet: EU/1/12/763/003
English: PVC/PVdC/aluminium blisters EU/1/12/763/016 30 film-coated tablets EU/1/12/763/017 60 film-coated tablets EU/1/12/763/018 120 film-coated tablets
Slovenian: PVC/PVdC/Al pretisni omoti EU/1/12/763/016 30 filmsko obloženih tablet EU/1/12/763/017 60 filmsko obloženih tablet EU/1/12/763/018 120 filmsko obloženih tablet
English: Ecansya 300 mg film-coated tablets - Aluminium/aluminium blisters 30 film-coated tablets: EU/1/12/763/007 60 film-coated tablets: EU/1/12/763/008 120 film-coated tablets: EU/1/12/763/009
Slovenian: Ecansya 300 mg filmsko obložene tablete - Al/Al pretisni omoti 30 filmsko obloženih tablet: EU/1/12/763/007 60 filmsko obloženih tablet: EU/1/12/763/008 120 filmsko obloženih tablet: EU/1/12/763/009
English: +Anaemia, Neutropenic fever, Thrombocytopenia
Slovenian: +zvišana telesna temperatura z nevtropenijo, trombocitopenija depresija kostnega mozga, febrilna nevtropenija
English: PVC/PVdC/aluminium blisters EU/1/12/763/010 30 film-coated tablets EU/1/12/763/011 60 film-coated tablets EU/1/12/763/012 120 film-coated tablets
Slovenian: PVC/PVdC/Al pretisni omoti EU/1/12/763/010 30 filmsko obloženih tablet EU/1/12/763/011 60 filmsko obloženih tablet EU/1/12/763/012 120 filmsko obloženih tablet
English: PVC/PVdC/aluminium blisters EU/1/12/763/004 30 film-coated tablets EU/1/12/763/005 60 film-coated tablets EU/1/12/763/006 120 film-coated tablets
Slovenian: PVC/PVdC/Al pretisni omoti EU/1/12/763/004 30 filmsko obloženih tablet EU/1/12/763/005 60 filmsko obloženih tablet EU/1/12/763/006 120 filmsko obloženih tablet
English: Thrombophlebitis Deep vein thrombosis, Hypertension,
Slovenian: Žilne bolezni tromboflebitis globoka venska tromboza, hipertenzija, petehija, hipotenzija, vročinski oblivi, mrzle okončine
English: Oxaliplatin on Day 1, every 3 weeks Capecitabine oral twice daily for 2 weeks (followed by 1 week offtreatment)
Slovenian: XELOX ali XELOX + bevacizumab oksaliplatin 130 mg/m intravensko 2 h oksaliplatin 1. dan, vsake 3 tedne kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1-tedenski premor)
English: Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1250 mg/m
Slovenian: Standardni in zmanjšani odmerki glede na telesno površino za začetni odmerek kapecitabina 1.250 mg/m Odmerek 1.250 mg/m 2 (dvakrat na dan)
English: Treatment should be discontinued if progressive disease or intolerable toxicity is observed.
Slovenian: Če bolezen napreduje ali bolnik ne prenaša toksičnosti, je treba zdravljenje prekiniti.
English: B. PACKAGE LEAFLET
Slovenian: PRILOGA III
English: Aphasia, Memory impairment, Ataxia, Syncope, Balance disorder, Sensory disorder, Neuropathy peripheral
Slovenian: Bolezni živčevja glavobol, letargija, omotica, parestezija, motnje okusa afazija, motnje spomina, ataksija, sinkopa, motnje ravnotežja, motnje zaznavanja, periferna nevropatija toksična levkoencefalopatija (zelo redki)
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov nenormalno delovanje jeter