FrancophonIA/ELRC3.0 huggingface dataset:
English: 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 (inkluż studji b'terapija awżiljarja f'kanċer tal-kolon, trattament ta' kanċer metastatiku tal-kolorektum, u trattament tal-kanċer tas-sider) u kienet osservata frekwenza ta' 63% fil-grupp ta' capecitabine/docetaxel għat-trattament ta' kanċer metastatiku tas-sider.
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' radjuterapija.
English: In this trial, 944 patients were randomised to 3-week cycles for 24 weeks with capecitabine (1000 mg/m2 twice daily for 2 weeks followed by a 1-week rest period) in combination with oxaliplatin (130 mg/m2 intravenous infusion over 2-hours on day 1 every 3 weeks); 942 patients were randomised to bolus 5-FU and leucovorin.
Maltese: F'din il-prova, 944 pazjent kienu randomised għal ċikli ta' 3 ġimgħat għal 24 ġimgħa b'capecitabine (1000 mg/m2 darbtejn kuljum għall-ġimagħtejn segwit b'perijodu ta' mistrieħ ta' ġimgħa) flimkien ma' oxaliplatin (130 mg/m2 infużjoni fil-vini fuq medda ta' sagħtejn fl-ewwel ġurnata kull 3 ġimgħat); 942 pazjent kienu randomised għall-bolus 5-FU u leucovorin.
English: - Capecitabine Teva 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine.
Maltese: - Capecitabine Teva 500 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 500 mg capecitabine.
English: 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: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni, li kienet tinkludi pazjenti b'firxa wiesa' ta' etajiet (minn 27 sa 86 sena) u li kienet tinkludi 234 (46%) pazjent li kellhom iżjed minn 65 sena jew kellhom 65 sena, l-età m'għandha l-ebda influwenza fuq il-farmakokinetika ta' 5'-DFUR u 5-FU. LAUC ta' FBAL żdiedet mal-età (20% żieda fl-età tirriżulta f'żieda ta' 15% fl-AUC ta' FBAL).
English: • lumps under the skin (lipoma)
Maltese: • għoqiedi taħt il-ġilda (lipoma)
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna ta' barra u l-folja wara EXP.
English: - Capecitabine Teva 150 mg film-coated tablets
Maltese: - Capecitabine Teva 150 mg pilloli miksija b'rita
English: Colon, colorectal and gastric cancer
Maltese: Terapija kombinata Kanċer tal-kolon, kolorektum u tal-istonku
English: • In patients with severe leukopenia, neutropenia, or thrombocytopenia,
Maltese: • F'pazjenti b'lewkopenja, newtropenja, jew tromboċitopenja severa,
English: Monotherapy
Maltese: Enċefalopatija
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: 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: Angina unstable, Angina pectoris, Myocardial ischaemia, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations
Maltese: • ġabra ta' fluwidu fil-kliewi, żieda fil-frekwenza tal-awrina matul il-lejl, inkontinenza, demm flawrina, żieda fil-krejatinina fid-demm (sinjal ta' disfunzjoni tal-kliewi)
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.
Maltese: 7 u 27.5 xhur; p=0.55 u r-rati ta' rispons kienu ta' 45.5 u 39.8%; p=0.
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).
Maltese: - ECF: epirubicin (50 mg/ m2 bħala bolus fl-ewwel jum kull 3 ġimgħat), cisplatin (60 mg/m2 mogħti bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum kull 3 ġimgħat) u 5-FU (200 mg/m2 mogħti kuljum bħala infużjoni kontinwa permezz tal-linja ċentrali).
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 ttrattati b'capecitabine wrew li fl-istudji kollha kombinati, żieda fl-età (b'żjidiet ta' 10 snin) kienet assoċjati b'mod statistikament sinifikanti ma' żieda fir-riskju ta' żvilupp ta' HFS u dijarea u ma' riskju mnaqqas ta' żvilupp ta' newtropenija.
English: Number of 150 mg tablets and/or 500 mg tablets per administration (each administration to be given morning and evening)
Maltese: Numru ta' pilloli ta' 150 mg u/jew pilloli ta' 500 mg kull għotja (kull għotja għandha tingħata filgħodu u filgħaxija)
English: Discontinue permanently or If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1
Maltese: Jekk it-tabib huwa tal-fehma li huwa fl-aħjar interess tal pazjent li jkompli, interrompi sakemm riżolta għal grad 0-1
English: skin loss, skin inflammation, nail disorder
Maltese: Tqaxxir tal-ġilda, Dermatite, Disturbi filpigmentazzjoni,
English: Intestinal obstruction, Ascites, Enteritis, Gastritis,
Maltese: Panċitopenija, Granuloċitopenija, Tromboċitopenija,
English: In this trial, 1987 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin IV followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
Maltese: F'dawn il-provi, 603 pazjenti kienu randomised għattrattament b'capecitabine (1250 mg/m2 darbtejn kuljum għal ġimagħtejn segwiti minn perjodu ta' ġimgħa ta' waqfien tat-trattament u mogħtija bħala ċikli ta' 3 ġimgħat). 604 pazjenti ġew randomised għat-trattament b'5-FU u leucovorin (kors ta' Mayo: 20 mg/m2 leucovorin fil-vini segwit minn 425 mg/m2 5-FU bolus fil-vini, mill-ewwel sal-ħames jum, kull 28 jum).
English: - EOF: 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 5-FU (200 mg/m daily given by continuous infusion via a central line).
Maltese: - EOF: 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 5-FU (200 mg/m2 mogħti kuljum bħala infużjoni kontinwa permezz tal-linja ċentrali).
English: Hand-foot syndrome
Maltese: Indeboliment tal-fwied
English: Capecitabine Teva 500 mg film-coated tablets
Maltese: Capecitabine Teva 500 mg pilloli miksija b'rita
English: If grade 2 or 3 hand-foot syndrome occurs, administration of capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1.
Maltese: capecitabine għandu jiġi interrott sakemm ir-reazzjoni tieqaf jew tnaqqas fl-intensità għal grad 1.
English: • In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity
Maltese: - jekk taf li għandek defiċjenza parzjali tal-attività tal-enzima dihydropyrimidine dehydrogenase
English: Patients treated with XELIRI + bevacizumab reported a significantly higher incidence of diarrhoea, febrile neutropenia and hand-foot skin reactions than patients treated with FOLFIRI + bevacizumab with significantly increased treatment delays, dose reductions and treatment discontinuations.
Maltese: Pazjenti ttrattati b'XELIRI + bevacizumab irrappurtaw inċidenza ogħla b'mod sinifikanti ta' dijarea, newtropenija biddeni u reazzjonijiet tal-ġilda tal-idejn u tas-saqajn minn pazjenti ttrattati b'FOLFIRI + bevacizumab b'żieda sinifikanti fid-dewmien tat-trattament, tnaqqis fid-doża u twaqqif tat-trattament.
English: OTHER
Maltese: Antaċidi
English: Blister, Skin ulcer, Rash, Urticaria, Photosensitivity reaction, Palmar erythema, Swelling face, Purpura, Radiation recall syndrome
Maltese: • diffikultà biex titkellem, indeboliment fil-memorja, telf ta' koordinazzjoni fil-moviment, disturb fil-bilanċ, ħass ħażin, ħsara fin-nervaturi (newropatija) u problemi bis-sensazzjoni
English: • headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation),
Maltese: • uġigħ ta' ras, ħedla ta' ngħas, sturdament, sensazzjoni mhux normali fil-ġilda (sensazzjoni ta'
English: Gastrointestinal haemorrhage, Constipation, Upper abdominal pain, Dyspepsia, Flatulence, Dry mouth
Maltese: Fwawar, Pressjoni baxxa, Kriżi ipertensiva, Fwawar, Infjammazzjoni fil-vini
English: NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 500 mg film-coated tablets capecitabine
Maltese: Kull pillola miksija b'rita fiha 500 mg capecitabine.
English: Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache
Maltese: Newrotossiċità, Tregħid, Nevralġija, Reazzjoni ta' sensittività eċċessiva, Ipoestesija
English: Deutschland TEVA GmbH Tel: +49 73140208
Maltese: Tel: +49 73140208
English: Capecitabine Teva 150 mg film-coated tablets
Maltese: Capecitabine Teva 150 mg pilloli miksija b'rita
English: Urticaria, Night sweats
Maltese: gastroenterite, axxess tas-snien
English: XELOX showed a trend towards superior OS with a HR of 0.87 (95% CI=[0.72; 1.05]; p=0.1486) which translates into a 13% reduction in risk of death.
Maltese: XELOX wera tendenza lejn OS superjuri b'HR ta' 0.87 (95% CI=[0.
English: Neurotoxicity, Tremor, Neuralgia,
Maltese: Fibrillazzjoni atrijali, Arritmija,
English: Body temperature increased ** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4)
Maltese: Żieda tat-temperatura tal-ġisem ** Abbażi tal-esperjenza ta' wara t-tqegħid fis-suq, sindrome ta' eritrodisasteżija palmari-plantari persistenti jew severa eventwalment tista' twassal għal telf tal-marki tas-swaba (ara sezzjoni 4.4)
English: NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 150 mg film-coated tablets capecitabine
Maltese: Capecitabine Teva 150 mg pilloli miksijin b'rita Capecitabine
English: Capecitabine Teva 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine.
Maltese: Capecitabine Teva 500 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 500 mg capecitabine.
English: Antacid
Maltese: Anzjani
English: Progression-free Survival after 6 months ITT
Maltese: Sopravivenza mingħajr progressjoni wara 6 xhur
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
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/m administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Maltese: Mogħti bħala monoterapija, d-doża rakkomandata tal-bidu ta' capecitabine fit-trattament awżiljarju tal-kanċer tal-kolon, fit-trattament ta' kanċer tal-kolorektum li mmetastatizza jew ta' kanċer tas-sider lokalment avvanzat jew li mmetastatizza hija ta' 1250 mg/m2 mogħtija darbtejn kuljum (fil-għodu u fil-għaxija; ekwivalenti għal doża totali ta' kuljum ta' 2500 mg/m2) għal 14-il ġurnata segwit minn perjodu ta' waqfien ta' sebat ijiem.
English: The hazard ratio for duration of survival (overall survival) was similar to the hazard ratio for progression-free survival (hazard ratio 0.85; 95% CI 0.64-1.13).
Maltese: Il-hazard ratio għat-tul tas-sopravivenza (sopravivenza totali) kien simili għall-hazard ratio tas-sopravivenza mingħajr progressjoni (hazard ratio 0.85; 95%
English: • Diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night.
Maltese: • Dijarea: jekk ikollok żieda ta' 4 episodji jew aktar ta' purgar meta mqabbel mal-ippurgar normali tiegħek ta' kuljum jew kwalunkwe dijarea matul il-lejl.
English: Stomatitis, Abdominal pain
Maltese: Uġigħ addominali
English: 604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m2 leucovorin intravenous followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days).
Maltese: (program ta' Mayo Clinic: 20 mg/m2 leucovorin fil-vini segwit minn 425 mg/m2 5-FU IV bolus fil-vini, mill-ewwel sal-ħames jum, kull 28 jum għal 24 ġimgħa).
English: Dysphagia, Abdominal pain lower,
Maltese: Anġina instabbli, Anġina pectoris,
English: Breast-feeding
Maltese: capecitabine
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 (ML17032).
Maltese: III multicentre, randomised u kkontrollata f'pazjenti b'kanċer avvanzat tal-istonku jissapportja l-użu ta' capecitabine għat-trattament primarju ta' kanċer avvanzat tal-istonku (ML17032).
English: Parameter: Overall Survival PPP
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: Capecitabine Teva should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
Maltese: Capecitabine kien nieqes minn tossiċitajiet epatiċi u tas-CNS.
English: An analysis of safety data in patients ≥60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients <60 years of age.
Maltese: Analiżi ta' tagħrif dwar is-sigurtà f'pazjenti b'età ta' ≥60 sena ttrattati b'monoterapija ta' capecitabine u analiżi ta' pazjenti ttrattati b'terapija mħallta ta' capecitabine flimkien ma' docetaxel uriet żieda flinċidenza ta' reazzjonijiet avversi ta' grad 3 u 4 u ta' reazzjonijiet avversi serji relatati mat-trattament meta mqabbla ma' pazjenti b'età ta' <60 sena.
English: Japanese patients had also about 25% lower Cmax and 34% lower AUC for FBAL than Caucasian patients.
Maltese: Pazjenti Ġappuniżi kellhom ukoll Cmax għal FBAL 25% inqas u AUC 34% inqas minn pazjenti
English: Sore throat, Dysaesthesia pharynx
Maltese: tnemnim jew tingiż), bidliet fit-togħma
English: Hypotension, Hot flush, Peripheral coldness
Maltese: Disturbi fil-bilanċ, Disturbi fis-sensi, Newropatija periferali
English: • muscle spasm
Maltese: Prothrombin imtawwal
English: Pregnancy
Maltese: Depressjoni
English: The major metabolite excreted in urine is FBAL, which represents 57% of the administered dose.
Maltese: Il-metabolit maġġuri mneħħi mill-ġisem fl-awrina huwa FBAL, li jirrappreżenta 57% tad-doża mogħtija.
English: You must inform your doctor if you know that you have an allergy or over-reaction to this medicine, - if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil), - if you are pregnant or breast-feeding, - if you have severely low levels of white cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia), - if you have severe liver or kidney problems, - if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD), - if you are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.
Maltese: - jekk inti tqila jew qed tredda', - jekk għandek livelli baxxi ħafna ta' ċelluli bojod jew plejtlits fid-demm (lewkopenija, newtropenija jew tromboċitopenija), - jekk għandek problemi severi tal-fwied jew tal-kliewi, - jekk taf li għandek nuqqas komplut tal-attività tal-enżima dihydropyrimidine dehydrogenase (DPD), - jekk qed tiġi ttrattat issa jew kont ittrattat fl-aħħar 4 ġimgħat b'brivudine bħala parti minn terapija għal herpes zoster (ġidri r-riħ jew ħruq ta' Sant'Antnin).
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: Skont studju farmakokinetiku f'pazjenti bil-kanċer, b'indeboliment tal-fwied ħafif għal moderat minħabba metastasi fil-fwied, il-biodisponibiltà ta' capecitabine u l-espożizzjoni għal 5-FU jistgħu jiżdiedu meta mqabbla ma' pazjenti bl-ebda indeboliment tal-fwied.
English: Lower limb oedema, Hypertension, +Embolism and thrombosis
Maltese: Edima fir-riġlejn, Pressjoni għolja, Emboliżmu u trombożi
English: Uncommon ADRs reported for capecitabine in combination therapy are consistent with the ADRs reported for capecitabine monotherapy or reported for monotherapy with the combination medicinal product (in literature and/or respective summary of product characteristics).
Maltese: ADRs mhux komuni rrapportati għal capecitabine f'terapija kombinata huma konsistenti mal-ADRs irrapportati għall-monterapija b'capecitabine jew irrapportati għall-monoterapija bil-prodott mediċinali kkombinat
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5
Maltese: It-tneħħija tal-krejatinina instabet li tinfluwenza l-espożizzjoni sistematika għal 5'
English: There are no side effects caused by stopping treatment with capecitabine.
Maltese: M'hemm l-ebda effetti sekondarji kkawżati minn waqfien tat-trattament b'capecitabine.
English: • skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration,
Maltese: • emboli ta' demm fil-vini tal-pulmun (emboliżmu pulmonari), kollass tal-pulmun, tisgħol id demm, ażżma, qtugħ ta' nifs meta tistrapazza
English: Renal and urinary disorders
Maltese: Disturbi fil kliewi u fis sistema urinarja
English: Alopecia, Nail disorder Hyperhidrosis, Rash erythematous,
Maltese: Dijabete, Ipokalimja, Disturbi fl-aptit,
English: Based on a pharmacokinetic study in cancer patients with mild to severe renal impairment, there is no evidence for an effect of creatinine clearance on the pharmacokinetics of intact drug and 5-FU.
Maltese: m'hemm l-ebda evidenza ta' effett tat-tneħħija tal-krejatinina fuq il-farmakokinetika tal-mediċina intatta u ta' 5-FU.
English: Parameter: Progression-free Survival PPP ITT Parameter: Overall Survival PPP ITT *PPP=per-protocol population; **ITT=intent-to-treat population
Maltese: Iż-żmien għall-progressjoni tal-marda kien superjuri fil-grupp ta' trattament kombinat b'capecitabine u docetaxel (p<0.
English: Capecitabine Teva with food and drink You should take Capecitabine Teva no later than 30 minutes after meals.
Maltese: Pilloli Capecitabine Teva miksijin b'rita għandhom jinbelgħu mal-ilma fi żmien 30 minuta wara ikla.
English: The XELIRI regimens included capecitabine 1000 mg/m2 twice daily on days 1 to 14 of a three-week cycle combined with irinotecan 250 mg/m2 on day1.
Maltese: Il-korsijiet ta' XELIRI kienu jinkludu capecitabine 1000 mg/m2 darbtejn kuljum fi ġranet 1 sa 14 ta' ċiklu ta' tliet ġimgħat flimkien ma' irinotecan 250 mg/m2 f'jum 1.
English: In addition to the ADRs described in tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of capecitabine monotherapy with an incidence of less than 0.1%.
Maltese: Barra mill-ADRs deskritti fit-tabelli 4 u 5, u bbażat fuq analiżi globali minn tagħrif kliniku dwar issigurtà minn 7 provi kliniċi, enċefalopatija wkoll kienet assoċjata mal-użu ta' capecitabine bħala monoterapija b'inċidenza ta' inqas minn 0.1%.
English: Dehydration
Maltese: Disfonija
English: Reduced dose 750 mg/m2
Maltese: 750 mg/m2
English: fluoro-ureidopropionic acid (FUPA).
Maltese: Oxaliplatin fl-Ewwel Ġurnata, kull ġimagħtejn
English: Careful monitoring of patients ≥60 years of age is advisable.
Maltese: Sorveljanza bir-reqqa ta' pazjenti li għandhom ≥60 sena huwa rakkomandat.
English: If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 109/L or that the platelet count drops below 75 x 10
Maltese: Jekk valutazzjonijiet tal-laboratorju mhux ipprogrammati waqt ċiklu ta' trattament juru li l-għadd tan-newtrofili waqa' taħt 1.0 x 109/L jew jekk l-għadd tal-plejtlits jaqa' taħt 75 x 109/L, it-trattament b'capecitabine għandu jitwaqqaf.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Capecitabine Teva 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Maltese: Capecitabine Teva 150 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 150 mg capecitabine.
English: • vein inflammation
Maltese: Intolleranza għattemperatura
English: This summary was last updated in 02-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 02-2008.
English: It is available in a 0.5 ml vial and in a 0.5 ml prefilled syringe.
Maltese: Huwa jiġi f'kunjett ta' 0.5 ml u f'siringa mimlija għal-lest ta' 0.5 ml.
English: The marketing authorisation was renewed on 10 February 2002 and on 10 February 2007.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fl-10 ta' Frar 2002 u fl-10 ta' Frar 2007.
English: Twinrix Paediatric is identical to the vaccine Twinrix Adult, which has been available in the European Union (EU) since 1996.
Maltese: Twinrix Paediatric huwa identiku għall-vaċċin Twinrix Adult, li ilu disponibbli fl-Unjoni Ewropea (UE) sa mill-1996.
English: This document is a summary of the European Public Assessment Report (EPAR).
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta''Valutazzjoni Pubblika Ewropew (EPAR).
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Maltese: L-antiġeni tal-wiċċ tal-vajrus ta' l-epatite B jsiru permezz ta' metodu magħruf bħala ‘teknoloġija rekombinanti tad-DNA': huma jsiru minn ħmira li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l-proteini.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TWINRIX PAEDIATRIC EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) TWINRIX PAEDIATRIC
English: Further studies looked at the persistence of antibody levels after vaccination.
Maltese: Aktar studji ħarsu lejn il-persistenza ta' livelli ta' antikorpi wara t-tilqim.