natgillin/translations-raw huggingface dataset:
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.
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.
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
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
Leucovorin on Days 1 and 2, every 2 weeks 5-fluorouracil intravenous bolus/infusion, each on Days 1 and 2, every 2 weeks
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
Median PFS and overall survival (OS) times were shorter for XELIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months), in addition to which excessive rates of diarrhoea were reported in patients receiving the XELIRI regimen (41 % XELIRI, 5.1 % FOLFIRI).
Mediana preživetja brez napredovanja bolezni (PFS) in celokupnega preživetja (OS) je bila krajša za XELIRI v primerjavi s FOLFIRI (PFS 5,9 v primerjavi z 9,6 meseca in OS 14,8 v primerjavi z 19,9 meseca).
Colon, colorectal and breast cancer
Rak kolona, kolorektalni rak in rak želodca
Flushing, Hypotension, Hypertensive crisis, Hot flush, Phlebitis
embolizem in tromboza napadi rdečice, hipotenzija, hipertenzivna kriza, vročinski oblivi, flebitis
Day 1, prior to XELOX, every 3 weeks 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
5-fluorouracil: intravenska injekcija v bolusu neposredno po levkovorinu
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.
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.
• nerve pain
• bolečina živca,
Capecitabine was at least equivalent to intravenous 5-FU/LV in disease-free survival in per protocol population (hazard ratio 0.92; 95 % CI 0.80 - 1.06).
Glede na preživetje brez bolezni v populaciji po protokolu je bil kapecitabin vsaj ekvivalenten intravenskemu 5-FU/LV (razmerje ogroženosti 0,92; 95-odstotni interval zaupanja 0,80-1,06).
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.
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.
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.
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.
Diabetes,
dermatitis,
Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
faringitis, oralna kandidoza, gripa, gastroenteritis,
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.
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.
Hydronephrosis, Urinary incontinence, Haematuria, Nocturia, Blood creatinine increased
hematurija, nikturija, zvišan kreatinin v krvi
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
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.
Capecitabine and its metabolites are predominantly excreted in urine; 95.5 % of administered capecitabine dose is recovered in urine.
Kar 95,5 % zaužitega odmerka kapecitabina se izloči z urinom, z blatom pa le 2,6 % odmerka.
Musculoskeletal
• mišični krči,
7.5 mg/kg intravenous 30 - 90 mins
7,5 mg/kg intravensko
Table 8 Key efficacy results for AIO KRK study
Glavni rezultati o učinkovitosti za študijo AIO KRK.
Neutropenia, Anaemia
slabost, stomatitis,
How to take Capecitabine medac
Kako jemati zdravilo Kapecitabin medac
Capecitabine can induce the occurrence of diarrhoea, which has been observed in up to 50 % of patients.
Opazili so jo pri do 50 % bolnikov.
Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyperpigmentation, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder
Bolezni kože in podkožja palmarnoplantarna eritrodisestezija kožni izpuščaj, alopecija, eritem, suha koža, pruritus, hiperpigmentacij a kože, makulozni izpuščaj, luščenje kože,
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.
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.
Haematuria, Proteinuria, Creatinine renal clearance decreased, Dysuria
Bolezni sečil hematurija, proteinurija, zmanjšan ledvični očistek kreatinina, disurija akutna ledvična odpoved, ki nastopi zaradi dehidracije
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.
Porazdelitev Študije in vitro na človeški plazmi so pokazale, da se na proteine (v glavnem na albumin) veže 54 %
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).
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).
SN:
i.v.
Depressed mood,
• utrujenost,
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.
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 %).
Tell your doctor immediately if you experience any of these symptoms.
Če začutite katere od omenjenih simptomov, se nemudoma pogovorite z zdravnikom.
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.
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
Oxaliplatin on Day 1, every 2 weeks
1. dan, pred XELOX, vsake 3 tedne
Combination therapy in adjuvant colon cancer
Kombinirano zdravljenje v prvi liniji metastatskega kolorektalnega raka
Light peach coloured, oblong shaped, biconvex tablet, debossed with ‘150' on the one side and plain on the other side.
Podolgovata, bikonveksna tableta svetlo breskove barve z vtisnjeno oznako “150” na eni strani in brez oznake na drugi strani.
• sweating, night sweats
• potenje, nočno potenje,
You must inform your doctor if you know that you have an allergy or over-reaction to this medicine,
Če imate preobčutljivostno reakcijo na to zdravilo, obvestite zdravnika,
Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral,
gastroezofagealna refluksna bolezen, bolečina v ustih, disfagija, rektalna krvavitev, bolečina v spodnjem abdomnu, oralna disestezija, oralna parestezija, oralna hipestezija, nelagodje v trebuhu
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).
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.
6.4 Special precautions for storage Aluminium/aluminium blisters
6.3 Rok uporabnosti Aluminijevi/aluminijevi pretisni omoti
Gastroesophageal reflux disease, Oral pain,
gastroezofagealna refluksna bolezen, kolitis, kri v blatu
White to off-white, oblong shaped, biconvex tablet, debossed with ‘300' on the one side and plain on the other side.
Podolgovata, bikonveksna tableta bele ali skoraj bele barve z vtisnjeno oznako “300” na eni strani in brez oznake na drugi strani.
XELOX or XELOX+ Bevacizumab
XELOX/XELOX + P/
Insomnia, Depression Confusional state, Panic attack,
Psihiatrične motnje nespečnost, depresija stanje zmedenosti, panični napad, depresivno razpoloženje, zmanjšan libido
Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Kapecitabin medac 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
Anhydrous lactose Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Hypromellose (E464) Magnesium stearate (E572)
Mikrokristalna celuloza (E 460) Premrežen natrijev karmelozat (E 468)
Capecitabine medac 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine.
Kapecitabin medac 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
Capecitabine medac 300 mg film-coated tablets Each film-coated tablet contains 300 mg capecitabine.
Kapecitabin medac 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg kapecitabina.
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.
Podatki dveh enako zasnovanih multicentričnih, randomiziranih, kontroliranih preskušanj faze III (SO14695, SO14796) podpirajo uporabo kapecitabina v prvi liniji zdravljenja metastatskega kolorektalnega raka.
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.
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
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
Kapecitabin medac 150 mg filmsko obložene tablete Kapecitabin medac 300 mg filmsko obložene tablete Kapecitabin medac 500 mg filmsko obložene tablete
Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza,
Infekcijske in parazitske bolezni herpes zoster, okužba sečil, oralna kandidoza, okužba zgornjih dihal,
Alopecia, Nail disorder Hyperhidrosis, Rash subcutaneous tissue disorders erythematous, Urticaria, Night sweats
eritematozni izpuščaj, urtikarija, nočno znojenje
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).
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:
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.
60 let ali več, med zdravljenjem z zmanjšanim odmerkom kapecitabina v kombinaciji z docetakselom toksičnost ne pojavi, lahko odmerek kapecitabina previdno zvečamo na
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
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
Talk to your doctor or pharmacist before taking Capecitabine medac
Pred začetkom uporabe zdravila Kapecitabin medac se posvetujte z zdravnikom ali farmacevtom,
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema nevtropenija, levkopenija,
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.
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.
Gastrointestinal haemorrhage, Constipation, Upper abdominal pain, Dyspepsia, Flatulence, Dry mouth
bolečina v trebuhu krvavitev iz prebavil, zaprtje, bolečina v zgornjem delu trebuha, dispepsija, flatulenca, suha usta črevesna obstrukcija,
5 mg/kg intravenous 30 - 90 mins
5 mg/kg intravensko
skin loss, skin inflammation, nail disorder
obarvanje kože, izguba kože, vnetje kože, spremembe na nohtih,
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).
V kombinaciji z drugimi zdravili je lahko običajni odmerek za odrasle manjši od 1.250 mg/m² telesne površine.
1,250 mg/m²
Polni odmerek 1.250 mg/m²
Contents of the pack and other information
Shranjevanje zdravila Kapecitabin medac Vsebina pakiranja in dodatne informacije
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.
FOLFIRI + bevacizumab s XELIRI + bevacizumab, niso pokazali signifikantne razlike med zdravljenjema v preživetju brez napredovanja bolezni ali celokupnem preživetju.
Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 7 mg anhydrous lactose.
Kapecitabin medac 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 7 mg brezvodne laktoze.
Back pain, Arthralgia pain, Facial pain, Musculoskeletal stiffness, Muscular weakness
Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija, artralgija, bolečina v ekstremitetah bolečina v čeljusti, mišični spazmi, trizmus, mišična šibkost
NAME OF THE MEDICINAL PRODUCT Capecitabine medac 300 mg film-coated tablets capecitabine
IME ZDRAVILA Kapecitabin medac 300 mg filmsko obložene tablete kapecitabin
Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1,000 mg/m²
Standardni in zmanjšani odmerki glede na telesno površino za začetni odmerek kapecitabina 1.000 mg/m² Odmerek 1.000 mg/m² (dvakrat na dan)
NAME OF THE MEDICINAL PRODUCT Capecitabine medac 500 mg film-coated tablets capecitabine
IME ZDRAVILA Kapecitabin medac 500 mg filmsko obložene tablete kapecitabin
LIST OF EXCIPIENTS Also contains anhydrous lactose and sodium, read the package leaflet before use.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi brezvodno laktozo in natrij.
Capecitabine medac 300 mg film-coated tablets Each film-coated tablet contains 15 mg anhydrous lactose.
Kapecitabin medac 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 15 mg brezvodne laktoze.
Capecitabine medac 300 mg film-coated tablets
Kapecitabin medac 300 mg filmsko obložene tablete
Palmar-plantar erythrodysaesthesia syndrome**
Stopnja toksičnosti*
supports these results with a HR of 0.78 (95 % CI = [0.67; 0.92]; p = 0.0024) for XELOX vs. 5-FU/LV.
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).
Musculoskeletal and connective tissue disorders
mišično-skeletna togost, mišična šibkost
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
+zvišana telesna temperatura, z infuzijo povezana reakcija, reakcija na mestu injiciranja, bolečina na mestu infundiranja, bolečina na mestu injiciranja
Capecitabine medac 500 mg film-coated tablets
Kapecitabin medac 500 mg filmsko obložene tablete
• if you cannot keep food or water in your body because of severe nausea and vomiting,
• 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),
Hepatic failure (rare), Cholestatic hepatitis (rare)
žolčnika in žolčevodov hiperbilirubinemi ja, nenormalni testi jetrne funkcije zlatenica odpoved jeter (redki), holestatični hepatitis (redki)
Capecitabine medac 150 mg film-coated tablets
Kapecitabin medac 150 mg filmsko obložene tablete
Peach coloured, oblong shaped, biconvex tablet, debossed with ‘500' on the one side and plain on the other side.
Podolgovata, bikonveksna tableta breskove barve z vtisnjeno oznako “500” na eni strani in brez oznake na drugi strani.
Deep vein thrombosis, Hypertension, Petechiae,
Žilne bolezni tromboflebitis globoka venska tromboza, hipertenzija, petehija, hipotenzija, vročinski oblivi, mrzle okončine
+Neutropenia, +Leukopenia, +Anaemia, +Neutropenic fever, Thrombocytopenia
+anemija, zvišana telesna temperatura z nevtropenijo, trombocitopenija depresija kostnega mozga,
Capecitabine medac contains sodium
Zdravilo Kapecitabin medac vsebuje natrij
In these trials, 603 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).
V teh študijah so 603 randomizirane bolnike zdravili s kapecitabinom v tritedenskem ciklu jemanja 1.250 mg/m²/dvakrat na dan 14 dni, čemur je sledil enotedenski premor,
Oxaliplatin on Day 1, every 3 weeks capecitabine oral twice daily for 2 weeks (followed by 1 week off- treatment)
XELOX + be vacizumab oksaliplatin 130 mg/m² intravensko 2 h oksaliplatin 1. dan, vsake 3 tedne kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1-tedenski premor)
Neurotoxicity, Tremor, Neuralgia,
Bolezni živčevja glavobol, letargija,
Hiccups,
omotica,
fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess
glivična okužba, okužba, zobni absces
(130 mg/m² on day 1).
(1.000 mg/m² dvakrat na dan 14 dni) in oksaliplatinom (130 mg/m² 1. dan) v drugi liniji.
• swelling (oedema), chills and rigors
• otekanje (edeme), mrzlica in tresavica.
- 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).
- ECF: epirubicin (50 mg/m² kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m² v 2-urni infuziji 1. dan vsake 3 tedne) in 5-FU (200 mg/m² na dan v kontinuirani infuziji skozi centralni venski kateter); - ECX: epirubicin (50 mg/m² kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m² v 2-urni infuziji 1. dan vsake 3 tedne) in kapecitabin (625 mg/m² dvakrat na dan neprekinjeno); - EOF: epirubicin (50 mg/m² kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m² v 2-urni infuziji 1. dan vsake tri tedne) in 5-FU (200 mg/m² na dan v kontinuirani infuziji skozi centralni venski kateter);
How to store Capecitabine medac
Shranjevanje zdravila Kapecitabin medac
Dose level 1,250 mg/m² (twice daily)
1.250 mg/m² dvakrat na dan.
NAME OF THE MEDICINAL PRODUCT Capecitabine medac 150 mg film-coated tablets capecitabine
IME ZDRAVILA Kapecitabin medac 150 mg filmsko obložene tablete
• bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort,
• zaprtje črevesja, nabiranje tekočine v trebuhu, vnetje tankega ali debelega črevesa, bolečine v trebušnem predelu, zgaga (refluks hrane iz želodca), kri v izločkih,
Discontinue permanently
dispneja ob naporu
Toxic leukoencephalopathy (very rare)
vazospazem (redki)
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg capecitabine.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 300 mg kapecitabina.
Following a mean duration of follow-up for the study population of 26.2 months, treatment responses were as shown below:
Odgovori na zdravljenje so po povprečnem trajanju spremljanja študijske populacije