FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee considered that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
Maltese: • Il-Kumitat ikkonsidra li interazzjoni farmakodinamika bejn il-prodotti tal-opjojdi u l-alkoħol tista' sseħħ irrispettivament mill-formulazzjoni,
English: In its detailed grounds for re-examination, the MAH referred to a competitor product in which the release of oxycodone is accelerated in the presence of alcohol as an example of a potentially clinically meaningful interaction.
Maltese: Fir-raġunijiet dettaljati tiegħu għall-evalwazzjoni mill-ġdid, il-MAH irrefera għal prodott kompetitur li fih ir-rilaxx ta' oxycodone huwa mgħaġġel fil-preżenza tal-alkoħol bħala eżempju ta' interazzjoni potenzjalment klinikament sinifikanti.
English: Considering that the proposed pharmacodynamic warning already advises against concomitant use with alcohol, considering also the limitations of the in vitro data and difficulties in its interpretation by prescribers, the majority of the Committee was of the opinion that the addition of a pharmacokinetic interaction warning based on a description of the in vitro data would not favour the clarity of the message to patients and prescribers regarding the need to avoid concomitant use with alcohol.
Maltese: Minn dawn il-kunsiderazzjonijiet kollha, inklużi l-limitazzjonjiet tad-dejta eżistenti u l-istatus attwali talgħarfien xjentifiku, jirriżulta li rakkomandazzjonijiet ġenerali għal kriterji ta' aċċettazzjoni li għandhom ikunu applikati fir-rigward tas-sinifikat kliniku tal-interazzjonijiet farmakokinetiċi mal-alkoħol ma jistgħux ikunu ddeterminati mill-Kumitat f'dan il-waqt.
English: For the suspension to be lifted, the Marketing Authorisation Holders need to provide evidence that the product has been reformulated, that it exhibits an acceptable release profile with the same quality, safety and efficacy profile of the currently authorised formulation but without the clinically significant interaction with alcohol.
Maltese: Sabiex titneħħa s-sospensjoni, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq jeħtieġu jagħtu prova li l-prodott ġie fformulat mill-ġdid, li jesebixxi profil ta' rilaxx aċċettabbli bl-istess profil ta' kwalità, sigurtà u effikaċja tal-formolazzjoni awtorizzata fil-preżent iżda mingħajr l-interazzjoni klinikament sinifikanti mal-alkoħol.
English: Further to the request from the MAH, the CHMP convened an Ad-Hoc Expert meeting including experts on technology/formulation science, pharmacokinetics and clinical/medical practice in order to deliver answers on a consultative basis to specific questions in relation to the grounds for re-examination.
Maltese: Wara t-talba tal-MAH, is-CHMP sejjaħ laqgħa ta' Esperti Ad-Hoc inklużi esperti dwar ix-xjenza tatteknoloġija/tal-formulazzjonijiet, il-farmakokinetika u l-prattika klinika/medika sabiex isibu tweġibiet fuq bażi konsultattiva għal mistoqsijiet speċifiċi rigward ir-raġunijiet għall-evalwazzjoni mill-ġdid.
English: The effect of alcohol on the dissolution rate was mild in most cases, except for one morphine formulation (morphine once-daily capsules).
Maltese: L-effett tal-alkoħol fuq ir-rata ta' dissoluzzjoni kien wieħed ħafif f'bosta każijiet, għajr għal formolazzjoni waħda tal-morfina (kapsuli tal-morfina ta' waħda kuljum).
English: • The Committee considered, however, that as a pharmacodynamic interaction with alcohol may occur, the product information of the above mentioned products should describe in a clear and harmonised manner the pharmacodynamic interaction between opioid products and alcohol,
Maltese: • Il-Kumitat qies, madankollu, li minħabba li tista' sseħħ interazzjoni farmakodinamika mal-alkoħol, l-informazzjoni dwar il-prodott tal-prodotti msemmija fuq għandha tiddeskrivi b'mod ċar u armonizzat, l-interazzjoni farmakodinamika bejn prodotti opjojdi u l-alkoħol,
English: Given the type of products and patient population involved, it is acknowledged that underreporting is considerable.
Maltese: Minħabba t-tip ta' prodotti u l-popolazzjoni tal-pazjenti involuta, huwa rikonoxxut li n-nuqqas ta' rapportar huwa wieħed konsiderevoli.
English: Consequently, the CHMP has recommended the suspension of the marketing authorisation for modified-release oral opioid products in the level III of the WHO scale for the management of pain containing a polymethacrylate-triethylcitrate coating as modified-release mechanism (see annex I).
Maltese: WHO għall-ġestjoni tal-uġigħ li fihom kisja ta' polymethacrylate-triethylcitrate bħala mekkaniżmu ta' rilaxx modifikat (ara l-Anness I)
English: An important interaction following alcohol consumption becomes progressively less likely with time due to dilution effect by gastric secretions and saliva, and gastric emptying.
Maltese: Interazzjoni kbira wara l-konsum tal-alkoħol issir inqas possibbli mal-ħin minħabba l-effett ta' dilwizzjoni permezz tat-tnixxijiet gastriċi u s-saliva, u t-tbattil gastriku.
English: Grounds for suspension of the marketing authorisation
Maltese: Raġunijiet għas-sospensjoni tal-awtorizzazzjonijiet għattqegħid fis-suq
English: • The Committee is also of the opinion that further risk minimisation measures would not adequately address the concern,
Maltese: • Il-Kumitat huwa wkoll tal-opinjoni li aktar miżuri ta' minimizzazzjoni tar-riskji ma jindirizzawx b'mod adegwat it-tħassib,
English: EMA/430267/2016 EMEA/H/C/003936
Maltese: (amikacin) EMA/430267/2016
English: What is Arikayce?
Maltese: X'inhu Arikayce?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 ta' Ġunju 2016 EMA/430267/2016 EMEA/H/C/003936
English: Arikayce is an antibiotic containing the active substance amikacin.
Maltese: Arikayce huwa impjant li fih is-sustanza attiva amikacin.
English: The active substance in Arikayce, amikacin, is a well-established antibiotic of the group ‘aminoglycosides' that works by disrupting bacterial production of vital proteins.
Maltese: Is-sustanza attiva f'Arikayce, amikacin, hija antibijotiku stabbilit sew tal-grupp 'aminoglikosidi' li taħdem billi ttellef il-produzzjoni tal-batterji ta' proteini vitali.
English: On 8 June 2016, Insmed Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Arikayce intended for the treatment of Mycobacterium avium complex (MAC) lung disease.
Maltese: Fit-8 ta' Ġunju 2016, Insmed Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) bl-intenzjoni li tixtieq tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Arikayce, għall-kura ta' Mycobacterium avium mard tal-pulmun kumpless (MAC).
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula listi ta' mistoqsijiet.
English: Arikayce was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 8 April 2014 for treating infections caused by MAC and similar bacteria.
Maltese: Arikayce kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-8 ta' April 2014, għall-kura tal-infezzjonijiet ikkawżati mill-MAC u batterji simili.
English: The company submitted results of an early (phase 2) study in 89 adult patients with lung infections caused by MAC or similar bacteria.
Maltese: Il-kumpanija ppreżentat riżultati ta' studju bikri (fażi 2) f'89 pazjent adult b'infezzjonijiet tal-pulmun ikkawżati mill-MAC jew batterji simili.
English: Withdrawal of the marketing authorisation application for Arikayce (amikacin)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Arikayce (amikacin)
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials for Arikayce.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemm l-ebda konsegwenza għall-pazjenti li bħalissa huma inklużi fi provi kliniċi għal Arikayce.
English: How is Arikayce expected to work?
Maltese: Kif huwa mistenni li jaħdem Arikayce?
English: What consequences does this withdrawal have for patients in clinical trials?
Maltese: X'inhuma l-konsegwenzi ta' dan l-irtirar għall-pazjenti fi provi kliniċi?
English: Arikayce was expected to be used to treat adults with a lung infection caused by Mycobacterium avium complex (MAC), a group of bacteria commonly found in the environment, such as in soil and water.
Maltese: Mycobacterium avium kumpless (MAC), grupp ta' batterji li jinstabu b'mod komuni fl-ambjent, bħal filħamrija u fl-ilma.
English: Based on the review of the data and the company's response to the CHMP lists of questions, the CHMP was of the provisional opinion that Arikayce could not be approved for the treatment of MAC lung infection.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta u tat-tweġibiet tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, isCHMP kien tal-idea provviżorja li Arikayce ma setax jiġi approvat għall-kura tal-infezzjoni tal-pulmun MAC.
English: What was Arikayce expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Arikayce?
English: In this medicine, amikacin is contained within microscopic fat capsules known as liposomes.
Maltese: F'din il-mediċina, amikacin jinżamm fi ħdan kapsuli mikroskopiċi tax-xaħam magħrufa bħala liposomi.
English: This study compared Arikayce with placebo (a dummy treatment) and looked mainly at how effectively the medicine cleared bacteria from patients' sputum (phlegm) after about 3 months of treatment.
Maltese: Dan l-istudju qabbel Arikayce mal-plaċebo (kura finta) u ħares prinċipalment fuq kemm il-mediċina kklerjat il-batterji mill-bżieq tal-pazjent (bili) b'mod effettiv wara 3 xhur ta' kura.
English: These liposomes help reduce the rate at which the active substance is broken down, allowing it to remain in the body for longer.
Maltese: Dawn il-liposomi inaqqsu r-rata ta' tkissir tas-sustanza attiva, u jħalluha tibqa' fil-ġisem għal aktar żmien.
English: Because the medicine is breathed in, it also reaches the lungs more directly than amikacin given by injection.
Maltese: Minħabba li l-mediċina tittieħed man-nifs, din tilħaq ukoll il-pulmun b'mod aktar dirett milli amikacin mogħti b'injezzjoni.
English: 8501 Novo mesto Slovenia
Maltese: 8501 Novo mesto Is-Slovenja
English: +Infection, Oral herpes
Maltese: +Infezzjoni, Herpes orali
English: HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000 Malta
Maltese: HHF 003, Hal Far Industrial Estate Birżebbuġa, BBG 3000 Malta
English: Ethnic factors.
Maltese: Fatturi etniċi.
English: FBAL is a metabolite without antiproliferative activity.
Maltese: FBAL huwa metabolit mingħajr attività kontra l-proliferazzjoni.
English: 95% CI
Maltese: CI ta' 95%
English: North Harrow, Middx HA1 4HF
Maltese: North Harrow, Middx HA1 4HF Ir-Renju Unit
English: Modified XELIRI+ bevacizumab (ITT: N= 120)
Maltese: XELIRI modifikat + bevacizumab (ITT: N= 120)
English: - Fever: if you have a temperature of 38°C or greater.
Maltese: - Deni: jekk ikollok temperatura ta' 38°C jew iżjed.
English: • Grade 1
Maltese: • Grad 1
English: The AUC0- values in g•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3.
Maltese: Il-valuri ta' AUC0- f' μg•h/ml kienu ta' 7.75, 7.24, 24.6, 2.03 u 36.3.
English: The AUC of 5-FU was 30%-35% higher on day 14.
Maltese: L-AUC ta' 5-FU kienet 30%-35% ogħla fl-14-il jum.
English: Renal impairment (see section 4.2, 4.4, and 5.2):
Maltese: Indeboliment tal-kliewi (ara sezzjoni 4.2, 4.4, u 5.2):
English: See section 2 "Ecansya contains lactose".
Maltese: Ara sezzjoni 2 "Ecansya fih lactose".
English: XELOX or XELOX+ Bevacizumab
Maltese: XELOX+ Bevacizumab
English: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, United Kingdom Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, Ir-Renju Unit Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta
English: UAB KRKA Lietuva Tel: + 370 5 236 27 40
Maltese: KRKA Lietuva Tel: + 370 5 236 27 40
English: Date of latest renewal: 9 December 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' April 2012 Data tal-aħħar tiġdid: 9 ta' Diċembru 2016
English: Hazard ratio 95% CI P value
Maltese: Proporzjon ta' periklu CI ta' 95% Valur p
English: Anorexia
Maltese: Anoreksja
English: Atrial fibrillation, Cardiac ischaemia/infarction
Maltese: Fibrillazzjoni atrijali, Iskemija/infart kardijaku
English: PRIMARY ANALYSIS XELOX+BV (EPP*: N=967; ITT**: N=1017)
Maltese: ANALIŻI PRIMARJA XELOX/ XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
English: - metastatic colorectal cancer (see section 5.1).
Maltese: - kanċer metastatiku tal-kolorektum (ara sezzjoni 5.1).
English: 7.5 mg/kg intravenous 30-90 mins
Maltese: 7.5 mg/kg fil-vini 30-90 mins
English: 5 mg/kg intravenous 30-90 mins
Maltese: 5 mg/kg fil-vini 30-90 mins
English: Palmar-plantar erythrodysaesth esia syndrome**
Maltese: Sindrome ta' eritrodisasteżija palmari-plantari**
English: FOLFOX-4 or FOLFOX-4 + Bevacizumab
Maltese: FOLFOX-4 + Bevacizumab
English: Cardiotoxicity (see section 4.4):
Maltese: Kardjotossiċità (ara sezzjoni 4.4):
English: Combination therapy
Maltese: Terapija kombinata
English: The median time to progression was 93 and 98 days.
Maltese: Iż-żmien medjan għall-progressjoni kien ta' 93 u 98 jum.
English: 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.
Maltese: Studji in vitro dwar il-plażma umana wrew li capecitabine, 5'-DFCR, 5'-DFUR u 5-FU huma 54%, 10%, 62% u 10% mwaħħla mal-proteini, prinċipalment ma' l-albumina.
English: 24.4 months
Maltese: 24.4 xhur
English: The elimination half-life (t1/2 in hours) of capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 0.85, 1.11, 0.66, 0.76 and 3.23 respectively.
Maltese: Il-half-life tal-eliminazzjoni (t1/2 f'siegħat) ta' capecitabine, 5'-DFCR, 5'-DFUR, 5-FU u FBAL kienu ta' 0.85, 1.11, 0.66, 0.76 u 3.23 rispettivament.
English: • Risk management plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: 3 weeks).
Maltese: 3 snin.
English: The 5 year OS rate was 78% for XELOX versus 74% for 5-FU/LV.
Maltese: Ir-rata ta' OS ta' 5 snin kienet 78% għal XELOX kontra 74% għal 5-FU/LV.
English: The time to peak plasma concentrations (Tmax in hours) were 1.50, 2.00, 2.00, 2.00 and 3.34.
Maltese: Il-ħin għall-konċentrazzjonijiet massimi fil-plażma (Tmax f'siegħat) kienu ta' 1.50, 2.00, 2.00, 2.00 u 3.34.
English: 150 mg 300 mg 500 mg Dose per administration (mg)
Maltese: 150 mg 300 mg 500 mg Doża kull għotja (mg)
English: Insomnia, Depression
Maltese: Nuqqas ta' rqad, Depressjoni
English: FOLFOX-4 (PPP*: N=252; ITT**: N=314)
Maltese: FOLFOX-4 (PPP*: N = 252;
English: Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E-5) Magnesium stearate
Maltese: Il-qalba tal-pillola Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E-5) Magnesium stearate
English: The median duration of survival was 10.5 months (capecitabine + cisplatin) versus 9.3 months (5-FU + cisplatin).
Maltese: 5 xhur (capecitabine + cisplatin) versus 9.3 xhur (5-FU + cisplatin).
English: The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'-DFUR) measured on days 1 and 14 were similar.
Maltese: Il-parametri ta' capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) u 5'-deoxy-5-fluorouridine (5'-DFUR) mkejla fl-ewwel u fl-14-il jum kienu jixxiebħu.
English: The frequency of the heterozygous DPYD*2A genotype in the DPYD gene in Caucasian patients is around 1%, 1.1% for c.2846A>T, 2.6-6.3% for c.1236G>A/HapB3 variants and 0.07 to 0.1% for c.1679T>G.
Maltese: Il-frekwenza tal-ġenotip eterozigotiku DPYD*2A fil-ġene DPYD f'pazjenti Kawkasi hija ta' madwar 1%, 1.1% għal c.2846A>T, 2.6-6.3% għal varjanti c.1236G>A/HapB3 u 0.07 sa 0.1% għal c.1679T>G.
English: The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m2/day.
Maltese: Il-farmakokinetika ta' capecitabine ġiet ikkalkulata fuq firxa ta' doża ta' 502-3514 mg/m2/kuljum.
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
Maltese: Titanium dioxide (E171) Iron oxide red (E172)
English: The median time to progression was 140 days (capecitabine) vs. 144 days (Mayo regimen).
Maltese: Iż-żmien medju għall-progressjoni kien ta' 140 jum (capecitabine) vs. 144 jum (kors ta' Mayo).
English: Standard antidiarrhoeal treatments (e.g. loperamide) may be used.
Maltese: Jista' jintuża trattament stàndard kontra d-dijarea (eż. loperamide).
English: BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT
English: The 3 year DFS rate was 71% for XELOX versus 67% for 5-FU/LV.
Maltese: Ir-rata ta' DFS ta' 3 snin kienet 71% għal XELOX kontra 67% għal 5-FU/LV.
English: Leucovorin 200 mg/m2
Maltese: Leucovorin 200 mg/m 2 fil-vini 2
English: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (capecitabine + docetaxel) vs. 29.7% (docetaxel alone); p = 0.0058.
Maltese: Ir-rati oġġettivi tar-respons totali fil-popolazzjoni li ġiet randomised (valutazzjoni investigattiva) kienu ta' 41.6% (capecitabine + docetaxel) vs. 29.7% (docetaxel waħdu); p = 0.0058.
English: België/Belgique/Belgien KRKA Belgium, SA.
Maltese: België/Belgique/Belgien
English: intravenous 2 hr
Maltese: 22 hr
English: Oxaliplatin 85 mg/m2 intravenous 2 hr
Maltese: Oxaliplatin 85 mg/m 2 fil-vini 2
English: The median time to progression was 186 days (capecitabine + docetaxel) vs. 128 days (docetaxel alone).
Maltese: Iż-żmien medju għall-progressjoni kien ta' 186 jum (capecitabine + docetaxel) vs. 128 jum (docetaxel waħdu).
English: Tinnitus, Hypoacusis
Maltese: Tinnitus, Ipoakusis
English: All indications:
Maltese: Indikazzjonijet kollha:
English: The median progression-free survival was 5.6 months (capecitabine + cisplatin) versus 5.0 months (5-FU + cisplatin).
Maltese: Il-medjan tas-sopravivenza mingħajr progressjoni kien ta' 5.6 xhur (capecitabine + cisplatin) versus 5.0 xhur (5-FU + cisplatin).
English: Body Surface Area (m
Maltese: Erja tassuperfiċje talġisem (m
English: Parameter: Overall Survival PPP
Maltese: Sopravivenza Globali PPP
English: Further catalytic activation of 5'-DFUR then occurs by thymidine phosphorylase (ThyPase).
Maltese: Wara sseħħ aktar attivazzjoni katalitika ta' 5'-DFUR minn thymidine phosphorylase (ThyPase).
English: Colon, colorectal and advanced gastric cancer: meta-analysis A meta-analysis of six clinical trials (studies SO14695, SO14796, M66001, NO16966, NO16967, M17032) supports capecitabine replacing 5-FU in mono- and combination treatment in gastrointestinal cancer.
Maltese: Kanċer tal-kolon, tal-kolorektum u kanċer avvanzat tal-istonku: meta-analiżi Meta-analiżi ta' sitt provi kliniċi (studji SO14695, SO14796, M66001, NO16966, NO16967, M17032) isostnu is-sostituzzjoni ta' 5-FU minn capecitabine fi trattament waħdu u ta' taħlita f'kanċer gastrointestinali.
English: Each pack contains 30, 60 or 120 film-coated tablets.
Maltese: Kull pakkett fih 30, 60 jew 120 pillola miksija b'rita.
English: Hepatic failure (rare), Cholestatic hepatitis (rare)
Maltese: Insuffiċjenza tal-fwied (rari), Epatite kolestatika (rari)
English: cisplatin, irinotecan), - medicines used to treat folic acid deficiency.
Maltese: bevacizumab, cisplatin, irinotecan), - mediċini użati biex jittrattaw defiċjenza ta' folic acid.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC06.
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, antimetaboliti, Kodiċi ATC:
English: Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, ASAT and ALAT had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Maltese: Is-sess, il-preżenza jew in-nuqqas ta' metastasi fil-fwied fil-linja bażi, Karnofsky Performance Status, bilirubin totali, albumina fis-serum, ASAT u ALAT ma kellhom l-ebda effett statistikament sinifikattiv fuq il-farmakokinetika ta' 5'-DFUR, 5-FU u FBAL.
English: Deficiency of DPD may lead to increased toxicity of capecitabine (see section 4.3 and 4.4).
Maltese: Defiċjenza ta' DPD tista' twassal għal żieda fit-tossicità ta' capacitabine (ara sezzjoni 4.3 u 4.4).
English: Progression-free Survival after 6 months ITT
Maltese: Sopravivenza mingħajr progressjoni wara 6 xhur ITT
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureidopropionic acid (FUPA).
Maltese: Dihydropyrimidinase jkisser iċ-ċirku ta' pyrimidine biex jipproduċi 5-fluoro-ureido-propionic acid (FUPA).
English: Not applicable *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Maltese: *Skont il-Kriterji Komuni tat-Tossiċità (verżjoni 1) tal-Grupp ta' Provi Kliniċi tal-Istitut Nazzjonali tal-Kanċer tal-Kanada (NCIC CTG), jew il-Kriterji ta' Terminoloġija Komuni għall-Avvenimenti Avversi (CTCAE) tal-Programm ta' Valutazzjoni tat-Terapija tal-Kanċer, Istitut Nazzjonali tal-Kanċer tal-Istati Uniti, verżjoni 4.0.
English: Median overall survival ITT
Maltese: Sopravivenza globali medjana ITT
English: Elderly (see section 4.2):
Maltese: Anzjani (ara sezzjoni 4.2):
English: For hand-foot syndrome and hyperbilirubinemia, see section 4.4.
Maltese: Għas-sindrome tal-idejn-saqajn u iperbilirubinimja, ara sezzjoni 4.4.
English: Median overall survival time was 703 days (95% CI: 671; 745) in patients treated with capecitabine-containing regimens and 683 days (95% CI: 646; 715) in patients treated with 5-FU-containing regimens.
Maltese: Iż-żmien medjan ta' sopravivenza globali kien 703 ijiem (95% CI: 671; 745) f'pazjenti ttrattati b'korsijiet li fihom capecitabine u 683 jum (95% CI: 646; 715) f'pazjenti trattati b'korsijiet li fihom 5-FU.
English: This 21 day period is one treatment cycle.
Maltese: Dan il-perjodu ta' 21 ġurnata huwa ċiklu wieħed ta' trattament.
English: Kipa Pharmacal Ltd. Τηλ: + 357 24 651 882
Maltese: Τηλ: + 357 24 651 882
English: Lacrimal duct stenosis (rare), Corneal disorders(rare), keratitis (rare), punctate keratitis (rare)
Maltese: Stenożi tal-kanal tad-dmugħ (rari), Disturbi fil-kornea (rari), Keratite (rari), Keratite ttikkjata (rari)
English: Interaction studies have only been performed in adults.
Maltese: Studji ta' interazzjoni twettqu biss f'adulti.
English: At the dose of 1250 mg/m2 on day 14 with administration after food intake, the peak plasma concentrations (Cmax in µg/ml) for capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 4.67, 3.05, 12.1, 0.95 and 5.46 respectively.
Maltese: B'doża ta' 1250 mg/m2 fl-14-il jum bl-għoti wara t-teħid tal-ikel, il-konċentrazzjonijiet massimi fil-plażma (Cmax f'µg/ml) ta' capecitabine, 5'-DFCR, 5'-DFUR, 5-FU u FBAL kienu ta' 4.67, 3.05, 12.1, 0.95 u 5.46 rispettivament.
English: Ecansya contains lactose
Maltese: Ecansya fih lactose
English: In a clinical pharmacokinetic interaction study, after a single 20 mg dose of warfarin, capecitabine treatment increased the AUC of S-warfarin by 57% with a 91% increase in INR value.
Maltese: Fi studju kliniku farmakokinetiku dwar l-interazzjonijiet, wara doża waħda ta' 20 mg ta' warfarin, ittrattament b'capecitabine żied l-AUC ta' S-warfarin b'57% b'żieda ta' 91% fil-valur tal-INR.
English: Table 6 Treatment regimens in study NO16966 (mCRC) Treatment
Maltese: Tabella 6 Korsijiet ta' trattament fl-istudju NO16966 (mCRC) Trattament Doża tal-Bidu
English: Coumarin-derivative anticoagulation.
Maltese: Antikoagulazzjoni b'derivattiv ta' coumarin