natgillin/translations-raw huggingface dataset:
4.2, 4.4 og 5.2) En analyse af sikkerhedsdata fra patienter, som fik capecitabin-monoterapi (kolorektalkræft), og som havde nyreinsufficiens ved baseline, viste, at der var en stigning i hyppigheden af behandlingsrelaterede bivirkninger, grad 3 og 4, sammenlignet med patienter med normal nyrefunktion (36 % hos patienter uden nyreinsufficiens n = 268 vs. henholdsvis 41 % hos patienter med let nyreinsufficiens n = 257 og 54 % hos patienter med moderat nyreinsufficiens n = 59) (se pkt.
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).
I 1. linjebehandlingen var den mediane PFS i intent-to-treat-populationen 5,8 måneder (95 % konfidensinterval 5,16,2 måneder) for capecitabin-monoterapi og 7,8 måneder (95 % konfidensinterval 7,0 - 8,3 måneder; p = 0,0002) for XELIRI.
In first-line treatment the median PFS in the intent-to-treat population was 5.8 months (95 %CI 5.1 - 6.2 months) for capecitabine monotherapy and 7.8 months (95 %CI 7.0-8.3 months; p = 0.0002) for XELIRI.
Aluminium/aluminium-blistere 3 år
Aluminium/aluminium blisters
Dosisændringer på grund af toksicitet, når capecitabin anvendes i en tre ugers-serie i kombination med andre lægemidler
Dose modifications for toxicity when capecitabine is used as a 3-weekly cycle in combination with other medicinal products
En metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin-monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer inden for flere indikationer (kolonkræft, kolorektalkræft, ventrikelkræft og brystkræft) viste, at patienter behandlet med capecitabin, som udviklede hånd- og fodsyndrom (HFS), havde en længere samlet overlevelse sammenlignet med patienter, som ikke udviklede hånd- og fodsyndrom: den mediane samlede overlevelse var 1.100 dage (95 % konfidensinterval 1.007; 1.200) versus 691 dage (95 % konfidensinterval 638; 754).
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).
Hypokaliæmi, Appetitforstyrrelser, Underernæring, Hypertriglyceridæmi
Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia
Resultaterne fra en metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin, viste, at i alle studier kombineret var kvindeligt køn statistisk signifikant associeret med en øget risiko for udviklingen af HFS og diarré og med en faldende risiko for at udvikle neutropeni.
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, female gender was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Oxaliplatin 85 mg/m² intravenøs over 2 timer
Oxaliplatin 85 mg/m² intravenous 2 hr
• hovedpine, søvnighed, svimmelhed, unormal fornemmelse i huden (følelsesløshed eller prikkende fornemmelse), smagsforandringer
• headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation),
7,5 mg/kg intravenøs over 3090 min
7.5 mg/kg intravenous 30 - 90 mins
• søvnløshed, depression
• sleeplessness (insomnia), depression
PVC/PVdC/aluminium-blistere 3 år
PVC/PVdC/Aluminium blisters
Data fra et randomiseret, kontrolleret fase II-multicenterstudie (AIO KRK 0604) støtter anvendelsen af en initial capecitabin-dosis på 800 mg/m² i 2 uger hver 3. uge i kombination med irinotecan og bevacizumab som 1. linjebehandling af patienter med metastatisk kolorektalkræft.
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.
Tabel 8: Nøgleresultater for effekt fra AIO KRK-studiet XELOX + bevacizumab
Table 8 Key efficacy results for AIO KRK study
• betændelse, der fører til nedsat funktion eller tilstopning af galdevejene (kolestatisk hepatitis),
• inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis)
- ved 2. forekomst - ved 3. forekomst - ved 4. forekomst
-2nd appearance -3rd appearance -4th appearance
Capecitabine medac anvendes til behandling af kræft i tyktarm, endetarm, mave eller bryst.
Capecitabine medac is used in the treatment of colon, rectal, gastric, or breast cancers.
• blodpropper i venerne i lungerne (pulmonær emboli), lungekollaps, ophostning af blod, astma,
• blood clots in the veins in the lung (pulmonary embolism), collapsed lung, coughing up blood,
Herpes zoster, Urinvejsinfektion, Oral candidiasis, Øvre luftvejsinfektion, Rhinitis, Influenza, +Infektion, Oral herpes
Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza,
Pyreksi, Svaghed, +Letargi,
Pyrexia, Weakness, +Lethargy, Temperature intolerance
Almene symptomer og reaktioner på administationsstedet
General disorders and administration site conditions
Jernoxid, rød (E172)
Iron oxide yellow (E172)
• væskeophobning i nyrerne, øget trang til at lade vandet om natten, inkontinens, blod i urinen,
• fluid collection in the kidneys, increased frequency of urination during the night, incontinence,
Den anbefalede initialdosis af capecitabin-monoterapi til adjuverende behandling af kolonkræft, til behandling af metastatisk kolorektalkræft eller af lokalt fremskreden eller metastatisk brystkræft er 1.250 mg/m² administreret to gange dagligt (morgen og aften, svarende til en daglig dosis på 2.500 mg/m²) i 14 dage, efterfulgt af 7 dages pause.
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.
I kombination med docetaxel er den anbefalede initialdosis af capecitabin til behandling af metastatisk brystkræft 1.250 mg/m² to gange dagligt i 14 dage efterfulgt af 7 dages pause, kombineret med docetaxel 75 mg/m² givet som 1 times intravenøs infusion hver 3. uge.
In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1,250 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.
Ved kombinationsbehandling skal den anbefalede initialdosis af capecitabin reduceres til 800-1.000 mg/m², når det administreres to gange daglig i 14 dage efterfulgt af en pause på 7 dage eller til 625 mg/m² to gange daglig, når det gives kontinuerligt (se pkt.
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).
Capecitabin var mindst ækvivalent med 5-FU/LV intravenøst mht. sygdomsfri overlevelse i protokolpopulationen (hazard ratio 0,92; 95 % konfidensinterval 0,80-1,06).
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).
XELIRI-regimerne inkluderede capecitabin 1.000 mg/m² 2 gange dagligt på dag 1 - 14 i en serie på 3 uger kombineret med irinotecan 250 mg/m² på dag 1.
The XELIRI regimens included capecitabine 1,000 mg/m² twice daily on days 1 to 14 of a 3-week cycle combined with irinotecan 250 mg/m² on day 1.
• stakåndethed, blødning fra næsen, hoste, løbende næse
• shortness of breath, nose bleeds, cough, runny nose
I den primære analyse af sygdomsfri overlevelse hos ITT-populationen, viste XELOX sig at være signifikant superior i forhold til 5-FU/LV (hazard ratio = 0,80, 95 % konfidensinterval = [0,69; 0,93], p = 0,0045).
In the primary analysis for DFS in the ITT population, XELOX was shown to be significantly superior to 5-FU/LV (HR = 0.80, 95 % CI = [0.69; 0.93]; p = 0.0045).
En metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin, viste i alle studier kombineret, at følgende kovarianter var statistisk signifikant associeret med en øget risiko for udviklingen af diarré: stigende capecitabin-startdosis (gram), længere behandlingsvarighed (uger), stigende alder (ved 10-års forøgelse) samt kvindeligt køn.
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, the following covariates were statistically significantly associated with an increased risk of developing diarrhoea: increasing capecitabine starting dose (gram), increasing duration of study treatment (weeks), increasing age (by 10 year increments), and female gender.
For capecitabindosis på 1.250 mg/m² to gange dagligt på dagene 1 til 14 hver 3. uge blev der observeret HFS i alle grader med en hyppighed på 53 % til 60 % i capecitabin-monoterapistudierne (bestående af studier i adjuverende behandling af kolonkræft, behandling af metastatisk kolorektalkræft og behandling af brystkræft).
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.
Tag ikke Capecitabine medac:
Do not take Capecitabine medac
I alt blev 156 patienter randomiseret til behandling med 5-FU (800 mg/m² dagligt som kontinuerlig infusion på dag 1 til 5 hver 3. uge) og cisplatin (80 mg/m² som en 2-timers infusion på dag 1 hver 3. uge).
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 1, every 3 weeks).
Kolonkræft, kolorektalkræft og fremskreden ventrikelkræft, metaanalyse
Colon, colorectal and advanced gastric cancer: meta-analysis
For henholdsvis FOLFIRI plus bevacizumab og XELIRI plus bevacizumab var den mediane PFS 10,0 og 8,9 måneder; p = 0,64, samlet overlevelse var 25,7 og 27,5 måneder; p = 0,55, og responsrater 45,5 % og 39,8 %; p = 0,32.
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.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/802/001-014
MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/001-014
Ødem i underekstremiteter, Hypertension, +Embolisme og tromboser
Vascular disorders Lower limb oedema, Hypertension, +Embolism and thrombosis
Trombocytopeni
Thrombophlebitis
I den egnede patientpopulation og intent-to-treat-populationen blev der demonstreret non-inferioritet af XELOX-armen sammenlignet med FOLFOX-4-armen med hensyn til progressionsfri overlevelse (progression-free survival, PFS) (se tabel 7).
Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival (PFS) in the eligible patient population and the intent-to-treat population (see table 7).
Febril neutropeni, Pancytopeni, Granulocytopeni, Thrombocytopeni, Leukopeni, Hæmolytisk anæmi, Øget INR/forlænget protrombintid
Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, INR increased/Prothrombin time prolonged
• hikke, stemmeændringer
• hiccups, change in voice
Hver 150 mg filmovertrukket tablet indeholder 150 mg capecitabin Hver 300 mg filmovertrukket tablet indeholder 300 mg capecitabin Hver 500 mg filmovertrukket tablet indeholder 500 mg capecitabin
Each 150 mg film-coated tablet contains 150 mg capecitabine Each 300 mg film-coated tablet contains 300 mg capecitabine Each 500 mg film-coated tablet contains 500 mg capecitabine
Mikrokrystallinsk cellulose (E 460) Croscarmellosenatrium (E468) Hypromellose (E464) Magnesiumstearat (E572)
Anhydrous lactose Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Hypromellose (E464) Magnesium stearate (E572)
Oxaliplatin 130 mg/m² intravenøs over 2 timer
Oxaliplatin 130 mg/m² intravenous 2 hr
I dette studie blev 1.987 patienter randomiseret til behandling med capecitabin (1.250 mg/m² to gange dagligt i 2 uger, efterfulgt af en uges pause, givet som 3-ugers-serier i 24 uger) eller til behandling med 5-FU og leucovorin (Mayo Clinic-regime: 20 mg/m² leucovorin intravenøst, efterfulgt af 425 mg/m² 5-FU intravenøst som bolus på dag 1 til 5, hver 28. dag i 24 uger).
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).
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2012
Capecitabine medac 150 mg filmovertrukne tabletter Capecitabine medac 300 mg filmovertrukne tabletter Capecitabine medac 500 mg filmovertrukne tabletter capecitabin
Capecitabine medac 150 mg film-coated tablets Capecitabine medac 300 mg film-coated tablets Capecitabine medac 500 mg film-coated tablets capecitabine
I arm-B bestod det anvendte XELIRI-regime af 1.000 mg/m² capecitabin 2 gange dagligt i 14 dage plus 250 mg/m² irinotecan på dag 1.
For Arm B, the XELIRI regimen used capecitabine 1,000 mg/m² twice daily for 14 days + irinotecan 250 mg/m² on day 1.
Efter capecitabin-behandling af 505 patienter med kolorektalkræft, som fik 1.250 mg/m² to gange dagligt, blev der foretaget en populationsfarmakokinetisk analyse.
A population pharmacokinetic analysis was carried out after capecitabine treatment of 505 patients with colorectal cancer dosed at 1,250 mg/m² twice daily.
5-Fluorouracil: intravenøs bolus injektion umiddelbart efter leucovorin
Day 1, prior to XELOX, every 3 weeks 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
I den samlede randomiseringspopulation blev capecitabin vist at være bedre end 5-FU/LV mht. sygdomsfri overlevelse (hazard ratio 0,849; 95 % konfidensinterval 0,739 - 0,976; p = 0,0212) og mht. samlet overlevelse (hazard ratio 0,828; 95 % konfidensinterval 0,705 - 0,971; p = 0,0203).
In the all-randomised population, capecitabine was shown to be superior to 5-FU/LV for disease-free survival (hazard ratio 0.849; 95 % CI 0.739-0.976; p = 0.0212), as well as for overall survival (hazard ratio 0.828; 95 % CI 0.705-0.971; p = 0.0203).
Capecitabine medac-dosisberegninger
Capecitabine medac dose calculations
Resultaterne fra en metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin, viste, at i alle studier kombineret, var stigende alder (ved 10-års forøgelse) statistisk signifikant associeret med en øget risiko for udviklingen af HFS og diarré og med en faldende risiko for at udvikle neutropeni.
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.
Leucovorin 200 mg/m² intravenøs over 2 timer
Leucovorin 200 mg/m² intravenous 2 hr
Monoterapi med capecitabin ved metastatisk kolorektalkræft Data fra to identisk designede, randomiserede, kontrollerede, kliniske multicenterstudier i fase III (SO14695; SO14796) støtter anvendelsen af capecitabin til 1. linjebehandling af metastatisk kolorektalkræft.
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.
5.1) til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
• in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Aluminium/aluminium- eller PVC/PVdC/aluminium-blistere.
6.5 Nature and contents of container Aluminium/aluminium or PVC/PVdC/Aluminium blisters.
I testene hos den samlede randomiseringspopulation for forskel mellem capecitabin og 5-FU/LV mht. sygdomsfri og samlet overlevelse var hazard ratios hhv. 0,88 (95 % konfidensinterval 0,77 - 1,01; p = 0,068) og 0,86 (95 % konfidensinterval 0,74 - 1,01; p = 0,060).
In the all-randomised population, tests for difference of capecitabine vs 5-FU/LV in disease-free and overall survival showed hazard ratios of 0.88 (95 % CI 0.77 - 1.01; p = 0.068) and 0.86 (95 % CI 0.74 - 1.01; p = 0.060), respectively.
Parameter: Progressionsfri overlevelse PPP ITT Parameter: Samlet overlevelse PPP ITT *PPP = per protokol-population; **ITT = intent-to-treat-population
ITT *PPP = per-protocol population; **ITT = intent-to-treat population.
Ældre patienter (≥ 65 år) havde, sammenlignet med yngre patienter, flere bivirkninger af grad 3 og 4, inklusive dem, som førte til seponering, når capecitabin blev anvendt i kombination med andre lægemidler.
When capecitabine was used in combination with other medicinal products, elderly patients (≥ 65 years) experienced more grade 3 and grade 4 adverse drug reactions (ADRs), including those leading to discontinuation, compared to younger patients.
Kolon- og kolorektalkræft
Colon and colorectal cancer
150 mg 300 m g
150 mg 300 mg 500 mg
Aluminium/aluminium-blistere Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
This medicine does not require any special storage conditions.
Capecitabine medac forårsage svimmelhed, kvalme og træthed.
Capecitabine medac may make you feel dizzy, nauseous or tired.
Bivirkningerne er anført i frekvensgruppering ud fra den højeste hyppighed set i et af de store kliniske studier.
ADRs are added according to the highest incidence seen in any of the major combination trials.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/802/029-042
MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/029-042
• Grad 2 - ved 1. forekomst
• Grade 2 -1st appearance
I disse studier blev 236 patienter behandlet med capecitabin (1.250 mg/m² to gange dagligt i 2 uger efterfulgt af en uges pause).
In these trials, a total of 236 patients were treated with capecitabine (1,250 mg/m² twice daily for 2 weeks followed by 1-week rest period).
Det skal du vide, før du begynder at tage Capecitabine medac
What you need to know before you take Capecitabine medac
(herunder i munden), influenza, gastroenteritis (tarminfektion), tandbylder
fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess
SÆRLIGE OPBEVARINGSBETINGELSER PVC/PVdC/-aluminium-blistere:
For PVC/PVdC-aluminium blisters:
hudtab, betændelse i huden, neglelidelser
skin loss, skin inflammation, nail disorder
Sammenlignet med hele populationen er hyppigheden af bivirkninger af grad 3 eller 4 forøget hos patienter med moderat nyreinsufficiens (creatininclearance 30-50 ml/min) (se pkt.
The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30 - 50 ml/min) is increased compared to the overall population (see sections 4.2 and 4.3).
Blod og lymfesystem +Neutropeni, +Leukopeni, +Anæmi, +Neutropenisk feber,
+Neutropenia, +Leukopenia, +Anaemia, +Neutropenic fever, Thrombocytopenia
Tabel 5 viser de bivirkninger, der er forbundet med anvendelsen af capecitabin administreret i kombination med forskellige kemoterapiregimer inden for flere indikationer.
Table 5 lists ADRs associated with the use of capecitabine in combination with different chemotherapy regimens in multiple indications based on safety data from over 3,000 patients.
Urinvejsinfektion, Cellulitis, Tonsillitis, Faryngitis, Oral candidiasis, Influenza, Gastroenteritis, Svampeinfektion, Infektion, Tandbyld
Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
• blødning fra tarmen, forstoppelse, smerter i den øvre del af maven, fordøjelsesbesvær, luft i maven, tør mund
• bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth
Nedre abdominale smerter,
Abdominal distension,
120 patienter blev randomiseret til at få et modficeret XELIRI-regime med capecitabin (800 mg/m² 2 gange dagligt i to uger efterfulgt af 7 dages pause), irinotecan (200 mg/m² som infusion over 30 minutter på dag 1 hver tredje uge) og bevacizumab (7,5 mg/kg som infusion over 30 til 90 minutter på dag 1 hver tredje uge).
120 Patients were randomised to a modified XELIRI regimen with capecitabine 800 mg/m² twice daily for two weeks followed by a 7-day rest period), irinotecan (200 mg/m² as a 30 minute infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1every 3 weeks);
• sår og blister på huden, hudreaktion ved udsættelse for sollys, rødfarvning af håndfladerne,
• skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face
Tabel 2 Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en initialdosis af capecitabin på 1.000 mg/m² Dosisniveau på 1.000 mg/m² (to gange dagligt)
Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1,000 mg/m²
I dette studie blev 160 patienter randomiseret til behandling med capecitabin (1.000 mg/m² to gange dagligt i 2 uger efterfulgt af 7 dages pause) og cisplatin (80 mg/m² som en 2timers infusion hver 3. uge).
In this trial, 160 patients were randomised to treatment with capecitabine (1,000 mg/m² twice daily for 2 weeks followed by a 7-day rest period) and cisplatin (80 mg/m² as a 2-hour infusion every 3 weeks).
Livstruende toksiciteter, der manifesterer sig som akut overdosis, kan forekomme hos patienter med uopdaget DPD-mangel behandlet med capecitabin samt hos de patienter, der testes negative for specifikke DPYD-variationer (se pkt.
In patients with unrecognised DPD deficiency treated with capecitabine as well as in those patients who test negative for specific DPYD variations, life-threatening toxicities manifesting as acute overdose may occur (see section 4.9).
XELOX+BV (EPP*: N = 967; ITT**:
XELOX/ XELOX+P/ XELOX+BV (EPP*: N = 967; ITT**: N = 1,017)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/802/015-028
MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/015-028
I dette studie randomiseredes 255 patienter til behandling med capecitabin (1.250 mg/m² to gange dagligt i 2 uger efterfulgt af en uges pause og behandling med docetaxel 75 mg/m² som 1 times intravenøs infusion hver 3. uge).
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).