FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galattosju, defiċjenza LAPP lactase jew assorbiment ħażin ta' glukosju-galattosju m'għandhomx jieħdu din il-mediċina.
English: MEDICE Arzneimittel Pütter GmbH & Co. KG Tel.: + 48-(0)22 642 2673 e-mail: office@medice.pl
Maltese: KG Tel.: + 48-(0)22 642 2673
English: Pregnancy
Maltese: parestesija
English: − Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep such as zaleplon, zolpidem and zopiclone)
Maltese: − Benzodiazepines u ipnotiċi mhux benzodiazepines (mediċini wżati biex jgħinu fl-irqad bħal zaleplon, zolpidem u zopiclone)
English: Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone.
Maltese: It-teħid flimkien wassal għal żieda fin-nuqqas ta' attenzjoni, memorja u koordinazzjoni meta' mqabbel ma' zolpidem waħdu.
English: Vertigo positional, vertigo
Maltese: Vertigo pożizzjonali,
English: Circadin may cause drowsiness.
Maltese: Circadin jista jħeddel.
English: • Melatonin has been observed to induce CYP3A in vitro at supra-therapeutic concentrations.
Maltese: • F'konċentrazzjonijiet supra-terapewtiċi kien osservat li Melatonin jinduċi CYP3A in vitro.
English: • Circadin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system.
Maltese: • Fi studji Circadin ingħata flimkien ma' thioridazine u imipramine; sustanzi attivi li jaffettwaw is-sistema nervuża ċentrali.
English: Takeda Nederland bv Tel: +31 23 566 8777 nl.medical.info@takeda.com
Maltese: Nederland Takeda Nederland bv Tel: +31 23 566 8777
English: Eczema, erythema, hand dermatitis, psoriasis, rash generalised, rash pruritic, nail disorder
Maltese: dermatite fl-idejn, psorijasi, raxx ġeneralizzat, raxx bil-ħakk, disturbi fid-dwiefer
English: RAD Neurim Pharmaceuticals EEC SARL Teл: +33 185149776 (FR) e-mail: neurim@neurim.com
Maltese: SARL Teл: +33 185149776 (FR) e-mail: neurim@neurim.com
English: • Caution should be exercised in patients on oestrogens (e.g. contraceptive or hormone replacement therapy), which increase melatonin levels by inhibiting its metabolism by CYP1A1 and CYP1A2.
Maltese: • Għandha tintuża kawtela f'pazjenti li qed jieħdu oestrogens (eż. kontraċettivi jew terapija ta' sostituzzjoni ta' l-ormon), li jżidu il-livelli ta' melatonin billi jinibixxu l-metaboliżmu tiegħu minn CYP1A1 u CYP1A2.
English: The safety and efficacy of Circadin in children aged 0 to 18 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Circadin fit-tfal minn età ta' 0 sa 18-il sena għadhom ma ġewx determinati s'issa.
English: However, no pharmacodynamic differences between males and females were found despite differences in blood levels.
Maltese: Madankollu, ma nstabux differenzi fil-farmakodinamika bejn irġiel u nisa minkejja differenzi fil-livelli fid-demm.
English: Each prolonged-release tablet contains 2 mg melatonin.
Maltese: Kull pillola fiha 2 mg melatonin.
English: • CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced plasma concentrations of melatonin.
Maltese: • Indutturi ta' CYP1A2 bħal carbamazepine u rifampicin jistgħu jirriżultaw fi tnaqqis talkonċentrazzjonijiet fil-plażma ta' melatonin.
English: Melatonin metabolism is known to decline with age.
Maltese: Il-metaboliżmu ta' Melatonin huwa magħruf li jonqos bl-età.
English: NAME OF THE MEDICINAL PRODUCT Circadin 2 mg prolonged-release tablets melatonin
Maltese: TAL-PRODOTT MEDIĊINALI Circadin 2 mg pilloli li jerħu l-mediċina bil-mod melatonin
English: Asthenia, chest pain Fatigue, pain, thirst
Maltese: qawmien kmieni filgħodu, żieda fillibido, burdata depressa, depressjoni
English: Circadin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein.
Maltese: Ir-rabta in vitro ta' melatonin mal-proteini fil-plażma hi madwar 60%. Circadin huwa l-aktar marbut ma' albumina, alpha1-acid glycoprotein u lipoproteina ta' densità għolja.
English: Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls.
Maltese: Il-pazjenti kellhom tneħħija totali ta' 6-sulfatoxymelatonin imnaqqsa b'mod sinifikattiv meta mqabbla mal-kontrolli.
English: Hot flush
Maltese: Il-Portugall Frosst
English: Nervous system disorders were more common in the active group with 42% patients, compared to 23% in the placebo group, mainly driven by somnolence and headache more frequent in the active group.
Maltese: Disturbi fis-sistema nervuża kienu aktar komuni fil-grupp tat-trattament attiv bi 42% tal-pazjenti, meta mqabbla ma' 23% fil-grupp tal-plaċebo, ikkawżati l-aktar minn ngħas u wġigħ ta' ras aktar frekwenti fil-grupp tat-trattament attiv.
English: − Adrenergic agonists/antagonists (such as certain types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, blood pressure lowering medicines), opiate agonists/antagonists (such as medicinal products used in the treatment of drug addiction), prostaglandin inhibitors (such as nonsteroidal anti-inflammatory medicines), antidepressant medication, tryptophan and alcohol.
Maltese: − Agonisti/antagonisti adrinerġiċi (bħal ċerti tipi ta' mediċini li jintużaw biex jikkontrollaw ilpressjoni tad-demm billi jirrestrinġu l-kanali tad-demm, dekonġestjonanti tal-imnieħer, mediċini li jbaxxu l-pressjoni), agonisti/antagonisti tal-loppju (bħal prodotti mediċinali użati fil-kura talvizzju tad-droga), inibituri ta' prostaglandin (bħal mediċini anti-infjammatorji mhux sterojdi), medikazzjoni kontra d-depressjoni, tryptophan u alkoħol.
English: A five-fold variability in Cmax between different members of the same sex has also been observed.
Maltese: Ġiet ukoll osservata varjazzjoni ta' 5 darbitet f'Cmax bejn membri differenti ta' l-istess sess.
English: How to store Circadin
Maltese: Kif gћandek tieћu Circadin
English: The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly.
Maltese: L-assorbiment ta' melatonin meħud mill-ħalq huwa komplut fl-adulti u jista' jonqos sa 50% fl-anzjani.
English: Angioedema, oedema of mouth, tongue oedema
Maltese: Anġjoedima, edima filħalq, edima fl-ilsien
English: RAD Neurim Pharmaceuticals EEC SARL Τηλ : +33 185149776 (FR) e-mail: neurim@neurim.com
Maltese: Τηλ: +33 185149776 (FR) e-mail: neurim@neurim.com
English: • Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 and 8-MOP), which increases melatonin levels by inhibiting its metabolism.
Maltese: • Għandha tintuża kawtela f'pazjenti li qed jieħdu 5- jew 8-methoxypsoralen (5 u 8-MOP), li jżid il-livelli ta' melatonin billi jinibixxi l-metaboliżmu tiegħu.
English: Older People
Maltese: TA' EĊĊIPJENTI
English: Ammonio methacrylate copolymer type B Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Talc
Maltese: Calcium hydrogen phosphate dihydrate
English: • Severe chest pain due to angina
Maltese: • Uġigħ sever fis-sider ikkawżat minn anġina
English: EXP
Maltese: KG
English: Gastro-oesophageal reflux disease, gastrointestinal disorder, oral mucosal blistering, tongue ulceration, gastrointestinal upset, vomiting, bowel sounds abnormal, flatulence, salivary hypersecretion, halitosis, abdominal discomfort, gastric disorder, gastritis
Maltese: disturb gastro intestinali, infafet fil-mukuża talħalq, ulċeri flilsien, taqlib gastro-intestinali,
English: The tablets are packed in PVC/PVDC opaque blister strips with aluminium foil backing.
Maltese: Il-pilloli huma ppakkjati ġo strixxi tal-folja opaki tal-PVC/PVDC b'rinforz ta' fojl ta' l-aluminju.
English: What Circadin looks like and contents of the pack Circadin 2 mg prolonged-release tablets are available as white to off-white round bi-convex shaped tablets.
Maltese: Circadin 2 mg pilloli li jerħu l-mediċina bil-mod huma disponibbli bħala pilloli bojod għal offwajt, tondu u bbuzzati fuq iż-żewġ naħat.
English: In a second outpatient study with two week run in baseline period with placebo and a randomised, double blind, placebo controlled, parallel group treatment period of 3 weeks, the rate of patients who showed a clinically significant improvement in both quality of sleep and morning alertness was 26% in the Circadin group as compared to 15% in the placebo group.
Maltese: Fi studju ieħor fuq pazjenti ta' barra b'espożizzjoni ta' ġimagħtejn fil-perjodu tal-linja bażi bil-plaċebo u b'perjodu ta' kura tal-grupp ta' paragun, randomised, double blind, u kkontrollat bil-plaċebo ta' 3 ġimgħat, ir-rata ta' pazjenti li wrew titjib ta' sinifikanza klinika kemm fil-kwalità ta' l-irqad kif ukoll fil-viġilanza ta' filgħodu kienet ta' 26% fil-grupp ta' Circadin meta mqabbla ma' 15% fil-grupp bil-plaċebo.
English: 21 tablets
Maltese: 20 pillola 21 pillola 30 pillola 7 pillola
English: Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Maltese: Circadin huwa indikat bħala monoterapija għall-kura ta' perjodu qasir ta' insomnja primarja ikkaratterizzata minn kwalità ħażina ta' rqad f'pażjenti b'età ta' 55 sena jew aktar.
English: Glycosuria, proteinuria
Maltese: TWISSIJA(IET) SPEĊJALI
English: The liver is the primary site of melatonin metabolism and therefore, hepatic impairment results in higher endogenous melatonin levels.
Maltese: Il-fwied huwa l-post prinċipali għall-metaboliżmu ta' melatonin u għalhekk indeboliment epatiku jirriżulta f'livelli ogħla ta' melatonin endoġenu.
English: patients in the active group and by 77% in the placebo group.
Maltese: fil-grupp ta' Circadin meta mqabbla ma' 27% fil-grupp bil-plaċebo.
English: The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied.
Maltese: L-effett ta' indeboliment renali ta' kull stadju fuq il-farmakokinetika ta' melatonin ma ġiex studjat.
English: The following adverse reactions were reported in clinical trials and from post-marketing spontaneous reporting.
Maltese: Dawn ir-reazzjonijiet avversi li ġejjin kienu irrappurtati fi provi kliniċi u minn rappurtar spontanju wara t-tqegħid fis-suq .
English: Circadin has been administered at 5 mg daily doses in clinical trials over 12 months without significantly changing the nature of the adverse reactions reported.
Maltese: Circadin ingħata f'dożi ta' 5 mg kuljum fi provi kliniċi fuq perjodu ta' 12-il xahar mingħajr ma kien hemm tibdil sinifikanti fin-natura tar-reazzjonijiet avversi li ġew irrapurtati.
English: Because of the role of melatonin in sleep and circadian rhythm regulation, and the age related decrease in endogenous melatonin production, melatonin may effectively improve sleep quality particularly in patients who are over 55 with primary insomnia.
Maltese: Minħabba l-funzjoni ta' melatonin fir-regolazzjoni ta' l-irqad u tar-ritmi ċirkadjani, u t-tnaqqis filproduzzjoni ta' melatonin endoġenu relatat ma' l-età, melatonin jista' jtejjeb il-kwalità ta' l-irqad b'mod effettiv, speċjalment f'pazjenti b'età ta' aktar minn 55 sena li għandhom insomnja primarja.
English: Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably secreted into human milk.
Maltese: Melatonin endoġenu kien imkejjel fil-ħalib tas-sider tal-bniedem u għalhekk probabbilment melatonin exoġenu jintreħa fil-ħalib uman.
English: • Vertigo (a feeling of dizziness or “spinning”)
Maltese: • Vertigo (sensazzjoni ta' sturdament jew li “kollox qed idur bik”)
English: • Alcohol should not be taken with Circadin, because it reduces the effectiveness of Circadin on sleep.
Maltese: • L-alkoħol m'għandux jittieħed flimkien ma' Circadin, għax inaqqas l-effettività ta' Circadin fuq l-irqad.
English: Currently available data are described in section 5.1.
Maltese: Id-data disponibbli attwalment hija deskritta fis-sezzjoni 5.1.
English: Uncommon: (may affect up to 1 in 100 people)
Maltese: Mhux komuni: (jistgħu jaffettwaw sa persuna waħda minn kull 100)
English: Liver function test abnormal, weight increased
Maltese: Test tal-funzjoni tal-fwied mhux normali, żieda filpiż
English: MEDICE Arzneimittel Pütter GmbH & Co. KG Tel: +49 (0)2371 9370 info@medice.de
Maltese: Tel: +49 (0)2371 9370
English: In an outpatient study with 2 week run-in baseline period with placebo, a randomised, double blind, placebo controlled, parallel group treatment period of 3 weeks and 2 week withdrawal period with placebo, the rate of patients who showed a clinically significant improvement in both quality of sleep and morning alertness was 47% in the Circadin group as compared to 27% in the placebo group.
Maltese: Fi studju fuq pazjenti ta' barra b'espożizzjoni ta' ġimagħtejn fil-perjodu tal-linja bażi bil-plaċebo, b'perjodu ta' kura tal-grupp ta' paragun, randomised, double blind, u kkontrollat bil-plaċebo ta' 3 ġimgħat u perjodu ta' ġimagħtejn ta' rtirar bil-plaċebo, ir-rata ta' pazjenti li wrew titjib ta' sinifikanza klinika kemm fil-kwalità ta' l-irqad kif ukoll fil-viġilanza ta' filgħodu kienet ta' 47%
English: Package Leaflet: Information for the patient Circadin 2 mg prolonged-release tablets Melatonin
Maltese: Informazzjoni għall-pazjent Circadin 2 mg pilloli li jerħu l-mediċina bil-mod
English: - Smoking may make Circadin less effective, because the components of tobacco smoke can increase the breakdown of melatonin by the liver.
Maltese: - It-tipjip jista' jnaqqas l-effikaċja ta' Circadin, peress li l-komponenti tad-duħħan tat-tabakk jistgħu jżidu t-tifrik ta' melatonin mill-fwied.
English: Administration of daily doses of up to 300 mg of melatonin without causing clinically significant adverse reactions have been reported in the literature.
Maltese: L-għotja ta' dożi kuljum sa' 300 mg ta' melatonin mingħajr ma toħloq reazzjonijiet avversi ta' sinifikanza klinika ġew irrappurtati fil-letteratura.
English: Melatonin is associated with the control of circadian rhythms and entrainment to the light-dark cycle.
Maltese: Melatonin huwa assoċjat mal-kontroll tar-ritmi ċirkadjani u marbut maċ-ċiklu tad-dawl u tad-dlam.
English: This finding is compatible with the short half-life of melatonin in humans.
Maltese: Din issejba hi kompatibbli mal-half-life qasira ta' melatonin fil-bniedem.
English: Quality of life was improved significantly with Circadin 2 mg compared to placebo.
Maltese: Il-kwalità tal-ħajja tjiebet b'mod sinifikattiv b'Circadin 2 mg meta mqabbla ma' plaċebo.
English: España
Maltese: Is-Spanja
English: - Circadin can make you feel drowsy, you should be careful if the drowsiness affects you as it may impair your ability on tasks such as driving.
Maltese: L-użu ta' Circadin m'hux magħruf li jikkawża effetti ta' rtirar wara li tintemm l-kura.
English: Do not use this medicine after the expiry date which is stated on the carton (EXP).
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna (JIS).
English: Whether or not these active substances interfere with the dynamic or kinetic effects of Circadin or vice versa has not been studied.
Maltese: Ma ġiex studjat jekk dawn is-sustanzi attivi ifixklux l-effetti dinamiċi jew kinetiċi ta' Circadin jew vice versa.
English: PHARMACEUTICAL FORM Prolonged-release tablet.
Maltese: Prodott mediċinali li jingħata bir-riċetta tat-tabib.
English: • if you are pregnant or breast-feeding,
Maltese: Nasofarinġite,
English: ITT 95% CI
Maltese: ITT CI ta' 95%
English: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, United Kingdom
Maltese: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, Ir-Renju Unit
English: - The active substance is capecitabine.
Maltese: Is-sustanza attiva hi capecitabine.
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 09th January 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' April 2012 Data tal-aħħar tiġdid: Jannar 09, 2017
English: PRIMARY ANALYSIS XELOX/ XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
Maltese: XELOX/ XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
English: The median time to progression was 93 and 98 days.
Maltese: Iż-żmien medjan għallprogressjoni kien ta' 93 u 98 jum.
English: 7.5 mg/kg intravenous 30-90 mins
Maltese: 7.5 mg/kg ġol-vini 30-90 mins
English: Finally, β-ureido-propionase cleaves FUPA to α-fluoro-β-alanine (FBAL) which is cleared in the urine.
Maltese: Finalment, β-ureido-propionase jkisser FUPA għal α-fluoro-β-alanine (FBAL) li jitneħħa fl-awrina.
English: Muskuloskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletrali u talconnective tissue
English: 5 mg/kg intravenous 30-90 mins
Maltese: 5 mg/kg ġol-vini 30-90 mins
English: Tablet coating Hypromellose (6cps) Talc
Maltese: Il-kisja tal-pillola Hypromellose (6cps) Talc
English: The 5 year OS rate was 78% for XELOX versus 74% for 5-FU/LV.
Maltese: snin kienet 78% għal XELOX kontra 74% għal 5-FU/LV.
English: FOLFOX-4 (PPP*: N = 252; ITT**: N= 314)
Maltese: FOLFOX-4 (PPP*: N = 252;
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 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 ta' l-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: • Medicines used to treat folic acid deficiency.
Maltese: • mediċini użati biex jikkuraw defiċjenza ta' folic acid.
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: The AUC of FBAL increased with age (20% increase in age results in a 15% increase in the AUC of FBAL).
Maltese: L-AUC ta' FBAL żdiedet ma' l-età (20% żjieda fl-età tirriżulta f'żjieda ta' 15% fl-AUC ta' FBAL).
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: 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: Table 8 Key efficacy results for the non-inferiority analysis of Study NO16966
Maltese: Tabella 8 Riżultati importanti ta' l-effikaċja għall-analiżi ta' nuqqas ta' inferjorità ta' Studju NO16966
English: Table 7 Treatment regimens in study NO16966 (mCRC)
Maltese: Tabella 7 Korsijiet ta' kura fl-istudju NO16966 (mCRC)
English: Oxaliplatin 85 mg/m2 intravenous 2 hr
Maltese: Oxaliplatin 85 mg/m2 ġol-vini 2 hr
English: - The other ingredients are: - Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose,microcrystalline cellulose, magnesium stearate - Tablet coating (for 150 mg): Hypromellose, titanium dioxide (E171), yellow ironoxide, red iron oxide (E172), talc - Tablet coating (for 300 mg): Hypromellose, titanium dioxide (E171), talc Tablet coating (for 500 mg): Hypromellose, titanium dioxide (E171), yellow ironoxide, red iron oxide (E172), talc
Maltese: Kisja tal-pillola (għal 300 mg): Hypromellose, titanium dioxide (E171), talc Kisja tal-pillola (għal 500 mg): Hypromellose, titanium dioxide (E171), yellow ironoxide, red iron oxide (E172), talc
English: Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Maltese: Fibrillazzjoni talventrikolu (rari), Titwil ta' QT (rari), Torsade de pointes (rari), Bradikardija
English: Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E5) Magnesium stearate
Maltese: Il-qalba tal-pillola Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E5) Magnesium stearate
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 ta' l-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: Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Maltese: Capecitabine Accord jista' jikkawża reazzjonijiet severi fil-ġilda bħas-sindrome ta' Stevens-Johnson u nekrolisi tossika tal-epidermide.
English: Leucovorin 200 mg/m2 intravenous 2 hr
Maltese: Leucovorin 200 mg/m2 ġol-vini 2 hr
English: Interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
Maltese: Interazzjonijiet ma' allopurinol ġew osservati għal 5-FU; bi tnaqqis possibbli ta' l-effikaċja ta' 5-FU.
English: Jaundice
Maltese: Ġisem
English: +Neutropenia, +Leucopenia, +Anaemia, +Neutropenic fever, Thrombocytopenia
Maltese: +Newtropenija, +Lewkopenija, +Anemija, +Deni newtropeniku,
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: Hand-foot syndrome (HFS) (see section 4.4)
Maltese: Sindrome tal-idejn u s-saqajn (HFS) (ara sezzjoni 4.4)
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 ilfarmakokinetika ta' 5'-DFUR, 5-FU u FBAL.
English: 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 1 every 3 weeks) ; 127 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for two weeks followed by a 7-day rest period), oxaliplatin (130 mg/m2 as a 2 hour infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks).
Maltese: 120 pazjent kienu randomised għall-kors modifikat ta' XELIRI b'capecitabine (800 mg/m2 darbtejn kuljum għal ġimagħtejn segwit minn perjodu mingħajr kura ta' 7 ijiem), irinotecan (200 mg/m2 bħala infużjoni ta' 30 minuta f'jum 1 kull 3 ġimgħat), u bevacizumab (7.5 mg/kg bħala infużjoni ta' 30 sa 90 minuta f'jum 1 kull 3 ġimgħat); 127 pazjent kienu randomised għall-kura b'capecitabine (1000 mg/m2 darbtejn kuljum għal ġimagħtejn segwit minn perjodu mingħajr kura ta' 7 ijiem), oxaliplatin (130 mg/m2 bħala infużjoni ta' sagħtejn f'jum 1 kull 3 ġimgħat), u bevacizumab (7.5 mg/kg bħala infużjoni ta' 30 sa 90 minuta f'jum 1 kull 3 ġimgħat).
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see Table 8).
Maltese: huwa ekwivalenti għal FOLFOX-4 f'termini ta' sopravivenza globali (ara Tabella 8).
English: Aluminium/aluminium or PVC/PVdC/Aluminium blister containing 30, 60 or 120 film-coated tablets.
Maltese: Aluminju/aluminju jew folja tal-PVC/PVdC/Aluminju folja li fiha 30, 60 jew 120 pillola miksijin b'rita.
English: • a medicine to treat cancer (interferon alpha)
Maltese: • mediċina biex tikkura l-kanċer (interferon alpha)
English: Each pack contains 30 x 1, 60 x 1 or 120 x 1 film-coated tablets.
Maltese: Kull pakkett fih 30 x 1, 60 x 1 jew 120 x 1 pillola miksija b'rita.