FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 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.
Maltese: Ir-riżultati ta' meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4700 pazjent kkurati b'capecitabine wrew li fl-istudji kollha kombinati, l-kovarjanti li ġejjin kienu assoċjati b'mod statistikament sinifikanti ma' żjieda fir-riskju ta' żvilupp ta' dijarea: żjieda fid-doża (grammi) tal-bidu ta' capecitabine, żjieda fit-tul ta' kura taħt studju (ġimgħat), żjieda fl-età (b'żjidiet ta' 10 snin), u sess femminili.
English: Thrombophlebitis Deep vein thrombosis, Hypertension, Petechiae, Hypotension, Hot flush, Peripheral coldness
Maltese: Qalba tal-pillola: anhydrous lactose, croscarmellose sodium, hypromellose,microcrystalline cellulose, magnesium stearate.
English: Capecitabine Accord 300 mg film-coated tablets Table 4 Capecitabine dose reduction shedule(3-weeklycycle or continuous treatment).
Maltese: Tabella 4 Skeda tat-tnaqqis fid-doża ta' capecitabine (ċiklu ta' 3 ġimgħat jew kura kontinwa).
English: Capecitabine Accord dose calculations
Maltese: Jekk tieħu Capecitabine Accord aktar milli suppost
English: Brivudine: a clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-Fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
Maltese: Ġiet deskritta interazzjoni ta' sinifikanza klinika bejn brivudine u fluoropyrimidines (eż. capecitabine,
English: In this treatment subgroup comparison, XELOX plus bevacizumab was similar compared to FOLFOX-4 plus bevacizumab in terms of progression-free survival (hazard ratio 1.01; 97.5% CI 0.84 - 1.22).
Maltese: FOLFOX-4 u bevacizumab f'termini ta' sopravivenza mingħajr progressjoni (hazard ratio 1.01; 97.5%
English: Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products
Maltese: Modifikazzjonijiet fid-doża għal tossiċitajiet meta Capecitabine Accord jintuża kontinwament f'taħlita ma' prodotti mediċinali oħra
English: Hypokalaemia, Hyponatraemia, Hypomagnesaemia, Hypocalcaemia, Hyperglycaemia
Maltese: Ipokalimja, Iponatrimja, Ipomagnesimja,
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 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.
Maltese: Ir-riżultati ta' meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4700 pazjent kkurati b'capecitabine wrew li fl-istudji kollha kombinati, żjieda fl-età (b'żjidiet ta' 10 snin) kienet assoċjati b'mod statistikament sinifikanti ma' żjieda fir-riskju ta' żvilupp ta' HFS u dijarea u ma' riskju mnaqqas ta' żvilupp ta' newtropenija.
English: Hand and foot syndrome also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Maltese: Sindrome tal-idejn u s-saqajn Is-sindrome tal-idejn u s-saqajn magħruf ukoll bħala reazzjoni tal-ġilda ta' l-idejn u s-saqajn jew eritrodisasteżija palmari-plantari jew eritema akrali kkaġunata mill-kemjoterapija.
English: Capecitabine is first metabolised by hepatic carboxylesterase to 5'-DFCR, which is then converted to 5'-DFUR by cytidine deaminase, principally located in the liver and tumour tissues.
Maltese: Biotrasformazzjoni Capecitabine huwa immetabolizzat l-ewwel minn carboxylesterase epatika għal 5'-DFCR, li wara huwa mibdul fi 5'-DFUR minn cytidine deaminase, li jinsab prinċipalment fil-fwied u fit-tessuti bittumur.
English: The film-coated tablets are peach colored, oblong shaped, biconvex, 15.9 mm in length and 8.4 mm in width, debossed with ‘500' on one side and plain on other side.
Maltese: 9 mm u wisa' ta' 8.4 mm, imnaqqxa bin-numru ‘500' fuq naħa waħda u lixxi fuq in-naħa l-oħra.
English: Bone marrow depression, +Febrile Neutropenia
Maltese: Depressjoni talmudullun, +Newtropenija bid-deni
English: Table 9 Key efficacy results for AIO KRK study
Maltese: Tabella 9 Riżultati ewlenin tal-effikaċja għall-istudju AIO KRK
English: Colon, colorectal and gastric cancer
Maltese: Purpura, sindrome ta' tifkira tarradjazzjoni
English: Data from a multicentre, randomised, controlled phase II study (AIO KRK 0604) supports the use of capecitabine at a starting dose of 800 mg/m2 for 2 weeks every 3 weeks in combination with irinotecan and bevacizumab for the first-line treatment of patients with metastatic colorectal cancer.
Maltese: II, b'aktar minn ċentru wieħed, randomised u kkontrollat (AIO KRK 0604) issostni l-użu ta' capecitabine b'doża tal-bidu ta' 800 mg/m2 għal ġimagħtejn kull 3 ġimgħat flimkien ma' irinotecan u bevacizumab għall-kura primarja ta' pazjenti b'kanċer metastatiku tal-kolorektum.
English: EU/1/12/762/007 EU/1/12/762/008 EU/1/12/762/009 EU/1/12/762/010 EU/1/12/762/011 EU/1/12/762/012 EU/1/12/762/022 EU/1/12/762/023 EU/1/12/762/024
Maltese: EU/1/12/762/011 EU/1/12/762/012 EU/1/12/762/022 EU/1/12/762/023 EU/1/12/762/024
English: Data from a randomised multicentre, phase III study comparing capecitabine to 5-FU and oxaliplatin to cisplatin in patients with advanced gastric cancer supports the use of capecitabine for the first-line treatment of advanced gastric cancer (REAL-2).
Maltese: Tagħrif minn studju ta' fazi III randomized u multicentre li qabbel capecitabine ma' 5-FU u oxaliplatin ma' cisplatin f'pazjenti b'kanċer avvanzat ta' l-istonku jissapportja l-użu ta' capecitabine bħala kura primarja ta' kanċer avvanzat ta' l-istonku (REAL-2).
English: The rate of withdrawal due to adverse events was higher in the XELOX combination therapy arm (21 %) as compared with that of the 5-FU/LV monotherapy arm (9 %) in the ITT population.
Maltese: (21%) meta mqabbla ma' dik tal-grupp ta' 5-FU/LV bħala monoterapija (9%).
English: The enzyme involved in the final conversion to 5-FU, thymidine phosphorylase (ThyPase), is found in tumour tissues, but also in normal tissues, albeit usually at lower levels.
Maltese: thymidine phosphorylase (ThyPase), tinstab f'tessuti bit-tumur, iżda wkoll f'tessuti normali,
English: Capecitabine Accord 300 mg film-coated tablets capecitabine
Maltese: Capecitabine Accord 300 mg pilloli miksijin b'rita capecitabine
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, antimetaboliti, analogi pirimidiniċi, Kodiċi
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.
Maltese: Barra mill-ADRs deskritti f'Tabelli 4 u 5, ibbażat fuq analiżi globali minn tagħrif dwar is-sigurtà klinika minn 7 provi kliniċi li kienu jinkludu 949 pazjent (2 provi kliniċi ta' fażi
English: • Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Maltese: • Sindrome ta' Steven-Johnson: jekk ikollok raxx juġgħa ta' lewn aħmar jew jagħti fil-vjola li jinfirex u nfafet u/jew leżjonijiet oħra jibdew jidhru fil-membrani mukużi (eż. ħalq u xufftejn), b'mod partikolari jekk qabel kellek sensittività għad-dawl, infezzjonijiet tas-sistema respiratorju (eż. bronkite) u/jew deni.
English: Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 Possible side effects.
Maltese: forom qawwija tal-effetti sekondarji elenkati taħt sezzjoni 4 Effetti sekondarji possibbli.
English: Dyspnoea, Epistaxis, Cough, Rhinorrhoea
Maltese: Qtugħ ta' nifs, Epistassi, Sogħla,
English: Capecitabine Accord 300 mg film-coated tablets Each film-coated tablet contains 15 mg anhydrous lactose Capecitabine Accord 500 mg film-coated tablets Each film-coated tablet contains 25 mg anhydrous lactose For the full list of excipients, see section 6.1.
Maltese: F'taħlita ma' mediċini oħra id-doża tas-soltu għall-aduti tista' tkun inqas minn 1250 mg/m2 ta' erja tas-superfiċje tal-ġisem, u jista' jkollok bżonn tieħu l-pilloli fuq perjodu ta' ħin differenti (e.ż. kujum,
English: For the dosing schedule of XELOX and FOLFOX-4 (without addition of placebo or bevacizumab), refer to Table 7.
Maltese: Għall-iskeda ta' dożaġġ ta' XELOX u FOLFOX-4 (mingħajr iżżjieda ta' plaċebo jew bevacizumab), irreferi għal Tabella 7.
English: The MTD of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day, whereas, when combined with radiotherapy for rectal cancer, the MTD of capecitabine is 2000 mg/m2 per day using either a continuous schedule or given daily Monday through Friday during a 6-week course of radiotherapy.
Maltese: L-MTD ta' capecitabine waħdu bl-użu ta' kors intermittenti hija ta' 3000 mg/m2 kuljum, filwaqt, meta kkombinat ma' radjuterapija għall-kanċer fir-rektum, l-MTD ta' capecitabine hija 2000 mg/m2 kuljum bl-użu ta' programm kontinwu jew mogħti kuljum mit-Tnejn sal-Ġimgħa waqt kors ta' sitt ġimgħat ta'
English: The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/min at baseline) is increased compared to the overall population.
Maltese: 4 f'pazjenti b'indeboliment moderat tal-kliewi (tneħħija tal-krejatinina ta' 30-50 ml/min fil-linja bażi) hija ikbar meta mqabba mal-populazzjoni totali.
English: Capecitabine Accord 150 mg film-coated tablets capecitabine
Maltese: Capecitabine Accord 150 mg pilloli miksijin b'rita capecitabine
English: Confusional state, Panic attack, Depressed mood, Libido decreased
Maltese: Attakk ta' paniku, Burdata depressa, Tnaqqis fil-libido
English: -for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Maltese: - għall-kura awżiljarja ta' pazjenti wara kirurġija ta' kanċer tal-kolon ta' stadju III (stadu ta' Dukes' C)
English: • infections of the lungs or respiratory tract system (e.g. pneumonia or bronchitis)
Maltese: • infezzjonijiet fil-pulmun jew fis-sistema tal-apparat respiratorju (eż. pulmonite jew bronkite),
English: Constipation, Dyspepsia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis,
Maltese: Ulċerazzjoni filħalq, Gastrite,
English: 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.
Maltese: Għad-doża ta' 1250 mg/m2 capecitabine darbtejn kuljum fi ġranet 1 sa 14 kull 3 ġimgħat, kienet osservata frekwenza ta' HFS ta' kull grad ta' 53% sa 60% fil-provi ta' monoterapija b'capecitabine
English: As this medicinal product contains anhydrous lactose as an excipient, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Peress li dan il-prodott mediċinali fih lactose anidru bħala eċċipjent, pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, nuqqas ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: See Table 7 for treatment regimens.
Maltese: Ara Tabella 7 għall-korsijiet ta' kura.
English: Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decrease to ≤ 2.5 x ULN.
Maltese: Il-kura b'capecitabine li tittieħed waħidha tista' titkompla meta l-bilirubin jonqos għal ≤3.0 x ULN jew l-aminotransferases epatiċi jitnaqqsu għal ≤ 2.5 x ULN.
English: When capecitabine was used in combination with other medicinal products, elderly patients (≥65 years) experienced more grade 3 and grade 4 adverse drug reactions, including those leading to discontinuation, compared to younger patients.
Maltese: Meta capecitabine intuża flimkien ma' prodotti mediċinali oħra, pazjenti anzjani (≥65 sena) kellhom esperjenza akbar ta' reazzjonijiet avversi għall-mediċina ta' grad 3 u grad 4, inkluż dawk li wasslu għat-twaqqif, meta mqabbel ma' pazjenti iżgħar.
English: Table 5 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, SO14695, and SO14796).
Maltese: (studji M66001, SO14695, u SO14796).
English: Magnesium stearate
Maltese: Sopravivenza mingħajr Progrssjoni
English: Reduced dose 750 mg/m2
Maltese: Doża mnaqqsa 750 mg/m2
English: Montagnani et al used the results from the above three studies to provide an overall analysis of randomised studies comparing FOLFIRI and XELIRI treatment regimens in the treatment of mCRC.
Maltese: Montagnani et al użaw ir-riżultati mit-tliet studji ta' fuq biex jipprovdu analiżi globali tal-istudji randomised li qabblu korsijiet ta' kura ta' FOLFIRI u XELIRI fil-kura ta' mCRC.
English: Elderly: Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46%) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Maltese: sena jew kellhom 65 sena, l-età m'għandha l-ebda influwenza fuq il-farmakokinetika ta' 5'-DFUR u
English: Administration with food decreases the rate of capecitabine absorption (see section 5.2).
Maltese: f'indeboliment moderat n=59, rispettivament) (ara sezzjoni 5.2).
English: Rare side effects (may affect up to 1 in 1,000 people) include:
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna) jinkludu:
English: Intestinal obstruction, Ascites, Enteritis, Gastritis, Dysphagia, Abdominal pain lower, Oesophagitis, Abdominal discomfort,
Maltese: Kandidajasi orali, Influwenza, Gastroenterite, Infezzjoni millmoffa, Infezzjoni, Axxess f'sinna
English: • muscle spasm
Maltese: • sulluzzu, tibdil fil-vuċi
English: In reproductive toxicity studies in animals, capecitabine administration caused embryolethality and teratogenicity.
Maltese: Fi studji dwar it-tossiċità riproduttiva fl-annimali, l-għoti ta' capecitabine kkawża mewt ta' l-embriju u teratoġeniċità.
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/Prothrombin time prolonged
Maltese: Skond studji immuno-istokimikali, jidher li l-biċċa l-kbira ta' thymidine phosphorylase jinstab f'ċelluli stromali tat-tumur.
English: The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis.
Maltese: L-inkorporazzjoni ta' 5-FU twassal wkoll għall-inibizzjoni tas-sintesi ta' l-RNA u tal-proteini.
English: For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Capecitabine Accord are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjusment according to toxicity.
Maltese: u fejn il-benefiċċji ta' Capecitabine Accord huma kkunsidrati li jkunu akbar mir-riskji (filwaqt li titqies l-adegwatezza ta' kors kimoterapewtiku alternattiv mhux fluoropyrimidine), dawn il-pazjenti għandhom ikunu kkurati b'kawtela kbira u monitoraġġ frekwenti mal-aġġustament fid-doża skont ittossiċità.
English: Hiccups, Pharyngolaryngeal pain, Dysphonia
Maltese: Uġigħ filgriżmejn, Disasteżija talfarinġi
English: Reproductive system and breast disorders
Maltese: Disturbi fis sistema riproduttiva u fis-sider
English: Haematuria, Proteinuria, Creatinine renal clearance decreased, Dysuria
Maltese: Ematurja, Proteina fl-awrina, Tnaqqis fit-tneħħija tal krejatinina millkliewi, Disurja
English: There was a small increase in plasma concentrations of capecitabine and one metabolite (5'-DFCR); there was no effect on the 3 major metabolites (5'-DFUR, 5-FU and FBAL).
Maltese: Kien hemma żjieda żgħira fil-konċentrazzjonijiet fil-plażma ta' capecitabine u metabolit wieħed (5'-DFCR); ma kien hemm l-ebda effett fuq il-3 metaboliti maġġuri
English: Patients with hepatic impairment due to liver metastases: According to a pharmacokinetic study in cancer patients with mild to moderate liver impairment due to liver metastases, the bioavailability of capecitabine and exposure to 5-FU may increase compared to patients with no liver impairment.
Maltese: Pazjenti b'indeboliment tal-fwied minħabba metastasi fil-fwied: Skond studju farmakokinetiku f'pazjenti bil-kanċer, b'indeboliment tal-fwied ħafif għal moderat minħabba metastasi fil-fwied, ilbiodisponibiltà ta' capecitabine u l-espożizzjoni għal 5-FU jistgħu jiżdiedu meta mqabbla ma' pazjenti bl-ebda indeboliment tal-fwied.
English: • inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis)
Maltese: • insuffiċjenza tal-fwied • infjammazzjoni li twassal għal disfunzjoni jew sadd fis-sekrezzjoni tal-bili (epatite kolestatika)
English: Posology adjustments during treatment General
Maltese: Sopravivenza Globali
English: • Keep this leaflet.
Maltese: Stat ta' konfużjoni,
English: Diabetes, Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia
Maltese: Nutrizzjoni ħażina, Ipertrigliċeridemija
English: However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
Maltese: Madankollu, reazzjonijiet avversi ta' grad 3 jew 4 li huma relatati mal-kura kienu aktar frekwenti f'pazjenti li għandhom ≥60 sena meta mqabbla ma' pazjenti iżgħar.
English: Do not pass it on to others.
Maltese: mingħajr perjodu ta' waqfien).
English: • know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
Maltese: • jekk taf li ma għandek ebda attività tal-enżima dihydropyrimidine dehydrogenase (DPD)
English: site conditions
Maltese: Parameter:
English: Capecitabine Accord should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
Maltese: Accord jista' jirrekjiedi li t-tabib tiegħek ibiddel id-doża tal-antikoagulanti tiegħek.
English: For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every 3weeks, a frequency of 22% to 30% of all-grade HFS was observed in capecitabine combination therapy.
Maltese: Għad-doża ta' 1000 mg/m2 capecitabine darbtejn kuljum fi ġranet 1 sa 14 kull 3 ġimgħat, kienet osservata frekwenza ta' HFS ta' kull grad ta' 22% sa 30%
English: 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 in the eligible patient population and the intent-to-treat population (see Table 8).
Maltese: Injezzjoni bolus ġol-vini immedjatament wara leucovorin F'paragun globali ntwera li l-gruppi li fihom XELOX ma kienux inferjuri meta mqabbla ma' gruppi li fihom FOLFOX-4 f'termini ta' sopravivenza mingħajr progressjoni fil-popolazzjoni ta' pazjenti eliġibbli u tal-popolazzjoni b'intenzjoni li jiġu kkurati (ara Tabella 8).
English: 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).
Maltese: f'pazjenti mingħajr indeboliment tal-kliewi n=268, vs. 41% f'indeboliment ħafif n=257 u 54%
English: - EOX: epirubicin (50 mg/m2 as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m2 given as a 2 hour infusion on day 1 every three weeks), and capecitabine (625 mg/m2 twice daily continuously).
Maltese: - EOX: epirubicin (50 mg/m2 bħala bolus fl-ewwel jum kull 3 ġimgħat), oxaliplatin (130 mg/m2 mogħti bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum kull 3 ġimgħat), u capecitabine
English: At the end of treatment, 37% of patients in the XELIRI and 26% of patients in the FOLFIRI arm were without evidence of the disease (p=0.56).
Maltese: Fl-aħħar tal-kura, 37% tal-pazjenti fil-grupp ta' XELIRI u 26% tal-pazjenti fil-grupp ta'
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 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.
Maltese: Ir-riżultati ta' meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4700 pazjent kkurati b'capecitabine wrew li fl-istudji kollha kombinati, sess femminili kien assoċjati b'mod statistikament sinifikanti ma' żjieda fir-riskju ta' żvilupp ta' HFS u dijarea u ma' riskju mnaqqas ta' żvilupp ta'
English: Capecitabine Accord 150 mg film-coated tablets Each film-coated tablet contains 150 mg of capecitabine.
Maltese: Capecitabine Accord 150 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 150 mg ta' capecitabine.
English: 185 Bureaux de la Colline 92213 Saint Cloud Cedex France
Maltese: 185 Bureaux de la Colline 92213 Saint Cloud Cedex Franza
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1232/001
Maltese: FIS-SUQ EU/1/17/1232/001
English: Delpharm Reims 10 rue Colonnel Charbonneaux 51100 Reims
Maltese: Delpharm Reims 10 rue Colonnel Charbonneaux 51100
English: Manufacturer Delpharm Reims 10 rue Colonel Charbonneaux 51100 Reims
Maltese: Delpharm Reims 10 rue Colonel Charbonneaux 51100
English: Small mean reductions in haemoglobin [-0.95 g/dL (95% CI: -1.38, -0.53)] and platelet count [-44.1 × 109/L (95% CI: -57.6,
Maltese: Tnaqqis żgħir fil-medja tal-emoglobina [-0.95 g/dL (95% CI: -1.38, -0.53)] u l-għadd tal-plejtlits [-44.1 × 109/L (95% CI: -57.6, -30.7)]
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 november 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 10 ta' Novembru, 2017
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness
Maltese: Newropatija periferali, ataksja, amneżija, parasteżija, ipoestesija, uġigħ ta' ras,
English: Luxembourg/Luxemburg Gen. Orph
Maltese: Luxembourg/Luxemburg Gen.
English: What Miglustat Gen.Orph contains - The active substance is miglustat 100 mg. - The other ingredients are sodium starch glycolate (type A), povidone (K30), magnesium stearate, gelatin, titanium dioxide (E171).
Maltese: - Is-sustanzi mhux attivi l-oħra huma: sodium starch glycollate (tip A), povidone (K30), magnesium stearateġelatina, titanium dioxide (E171)
English: INFORMATION IN BRAILLE Miglustat Gen.Orph
Maltese: INFORMAZZJONI BIL-BRAILLE Miglustat Gen.Orph
English: Box of 12 blisters, each blister containing 7 capsules providing a total of 84 capsules.
Maltese: Kaxxa ta' 12-il folja, kull folja fiha 7 kapsuli għal total ta' 84 kapsula.
English: Sodium starch glycolate (Type A),
Maltese: Kontenut tal-kapsula Sodium starch glycolate (Tip A), Povidone (K30), Magnesium stearate