FrancophonIA/ELRC3.0 huggingface dataset:
English: • For Grade 2 diarrhoea, if not improved to Grade ≤ 1 within 24 hours while using anti-diarrhoeal medicinal products (e.g., loperamide) and adequate oral fluid intake, withhold dacomitinib.
Maltese: • Għal dijarea tal-Grad 2, jekk ma jkunx hemm titjib għall-Grad ≤ 1 fi żmien 24 siegħa waqt li jkunu qed jintużaw prodotti mediċinali kontra d-dijarea (eż., loperamide) u t-teħid ta' fluwidi orali adegwati, waqqaf dacomitinib.
English: Grade 3 exfoliative skin conditions were reported in 0.8% of patients (see section 4.4).
Maltese: Kundizzjonijiet esfoljattivi tal-ġilda tal-Grad 3 kienu rrappurtati f'0.8% talpazjenti (ara sezzjoni 4.4).
English: Serious adverse reactions were reported in 6.7% of patients treated with dacomitinib.
Maltese: Reazzjonijiet avversi serji kienu rrappurtati f'6.7% tal-pazjenti li kienu qed jingħataw kura b'dacomitinib.
English: Concomitant use of proton pump inhibitors (PPIs) with dacomitinib should be avoided (see section 4.5).
Maltese: L-użu konkomitanti ta' inibituri tal-pompa tal-proton (PPIs, proton pump inhibitors) ma' dacomitinib għandu jiġi evitat (ara sezzjoni 4.5).
English: Each film-coated tablet contains 121 mg of lactose monohydrate.
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita fiha 121 mg ta' lactose monohydrate.
English: Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) were reported in 22.0% of patients receiving Vizimpro and were Grades 1 to 3, with the majority Grade 1 (18.4%) (see section 4.4).
Maltese: Żieda fit-transaminase (żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, żieda fit-transaminase) ġiet irrappurtata fi 22% tal-pazjenti li kienu qed jingħataw Vizimpro u kienu ta' bejn il-Grad 1 u 3 bil-maġġoranza tal-Grad 1 (18.4%) (ara sezzjoni 4.4).
English: Very common adverse reactions in patients occurring in at least 10% of patients in Study ARCHER 1050 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 4.
Maltese: Ir-reazzjonijiet avversi komuni ħafna f'pazjenti li seħħew f'talanqas 10% tal-pazjenti fl-Istudju ARCHER 1050 huma ppreżentati fil-qosor skont il-Grad skont il-Kriterji ta' Tossiċità Komuni talIstitut Nazzjonali tal-Kanċer (NCI-CTC, National Cancer Institute-Common Toxicity Criteria) fitTabella 4.
English: INFORMATION IN BRAILLE Vizimpro 30 mg
Maltese: Vizimpro 30 mg
English: Effect of Dacomitinib on UGT Enzymes
Maltese: Effett ta' Dacomitinib fuq l-Enzimi UGT
English: Progression-Free Survival (per IRC) Number of patients with event, n (%) Median PFS in months (95% CI) HR (95% CI)
Maltese: Għadd ta' dawk li rrispondew skont irreviżjoni tal-IRC, n (%) DoR medjan f'xhur (95% CI) HR (95% CI) valur-p b'żewġ naħat
English: Hepatotoxicity and transaminases increased
Maltese: Żieda fit-transaminase
English: INFORMATION IN BRAILLE Vizimpro 45 mg
Maltese: Vizimpro 45 mg
English: This medicinal product contains < 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The primary endpoint of the study was progression-free survival (PFS) as determined by blinded Independent Radiology Central (IRC) review.
Maltese: Ċentrali Radjoloġika Indipendenti (IRC, Independent Radiology Central) blindata.
English: Interstitial lung disease (ILD)/Pneumonitis
Maltese: Mard tal-interstizju tal-pulmun (ILD)/Pnewmonite
English: 2-sided p-valueb
Maltese: .9 Doża eċċessiva
English: Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided unless such products are considered necessary (see section 4.5).
Maltese: Użu konkomitanti ta' prodotti mediċinali metabolizzati predominantement minn CYP2D6 għandu jiġi evitat sakemm prodotti bħal dawn ma jitqisux neċessarji (ara sezzjoni 4.5).
English: O-desmethyl dacomitinib accounted for 16% of human plasma radioactivity and is formed mainly by CYP2D6 and to a lesser extent CYP2C9.
Maltese: O-desmethyl dacomitinib kien jirrappreżenta 16% tar-radjuattività fil-plażma tal-bniedem u huwa ffurmat primarjament minn CYP2D6 u f'livell inqas minn CYP2C9.
English: Vizimpro in first-line treatment of NSCLC patients with EGFR-activating mutations (ARCHER 1050) The efficacy and safety of Vizimpro was studied in a Phase 3 trial (ARCHER 1050) conducted in patients with locally advanced, not amenable to curative surgery or radiotherapy, or metastatic NSCLC harbouring activating mutations of EGFR, to demonstrate the superiority of dacomitinib versus gefitinib.
Maltese: L-effikaċja u s-sigurtà ta' Vizimpro kienu studjati fi prova tal-Fażi 3 (ARCHER 1050) li saret fuq pazjenti b'NSCLC metastatiku jew lokalment avvanzat, li ma setax jiġi mmaniġġjat b'kirurġija kurattiva jew b'radjoterapija, b'mutazzjonijiet li jattivaw l-EGFR, biex tintwera s-superjorità ta'
English: How to store Vizimpro 6.
Maltese: Kif taħżen Vizimpro 6.
English: Metabolism and nutrition disorders Decreased appetite Hypokalemia b
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Tnaqqis fl-aptit Ipokalemija
English: • For Grade ≥ 3 toxicity, withhold dacomitinib until symptoms resolve to Grade ≤ 2.
Maltese: • Fil-każ ta' tossiċità ta' Grad ≥ 3, waqqaf dacomitinib sakemm issintomi jerġgħu lura għal Grad ≤ 2.
English: 662) and 0.889 (95% CI: 0.568, 1.391), respectively.
Maltese: B'mod partikolari, il-proporzjonijiet ta' periklu (HRs) għal PFS skont riċensjoni tal-IRC f'pazjenti Asjatiċi u mhux Asjatiċi kienu 0.509 (95% CI: 0.391, 0. 662) u 0.889 (95% CI: 0.568, 1.391), rispettivament.
English: Dacomitinib pharmacokinetics has not been studied in subjects with severe hepatic impairment (Child-Pugh class C).
Maltese: Ilfarmakokinetika ta' dacomitinib ma ġietx studjata f'pazjenti b'indeboliment epatiku sever (Child Pugh tal-Klassi Ċ).
English: The most common (> 0.5%) reasons for permanent discontinuations associated with adverse reactions in patients receiving dacomitinib were: rash (2.4%), interstitial lung disease (2.0%), and diarrhoea (0.8%).
Maltese: L-aktar raġunijiet komuni (> 0.5%) għal twaqqif permanenti assoċjat ma' reazzjonijiet avversi f'pazjenti li kienu qed jingħataw dacomitinib kienu raxx (2.4%), mard tal-interstizju tal-pulmun (2.0%), u dijarea (0.8%).
English: Subgroup analyses of PFS per IRC review based on baseline characteristics were consistent with those from the primary analysis of PFS.
Maltese: Analiżijiet tas-subgrupp ta' PFS skont riċensjoni mill-IRC ibbażati fuq karatteristiċi tal-linja bażi kienu konsistenti ma' dawk mill-analiżi primarja tal-PFS.
English: C] radiolabeled dacomitinib, a median of 82% of the total administered radioactivity was recovered in 552 hours; faeces (79% of dose) was the major route of excretion, with 3% of the dose recovered in urine, of which < 1% of the administered dose was unchanged dacomitinib.
Maltese: C] dacomitinib radjutikkettat, medjan ta' 82% tar-radjuattività totali mogħtija ġie rkuprat fi żmien 552 siegħa; l-ippurgar (79% tad-doża) kien ir-rotta ewlenija ta' eliminazzjoni, bi 3% tad-doża rkuprata fl-awrina, li minnha < 1% mid-doża mogħtija kienet dacomitinib mhux mibdul.
English: Each film-coated tablet contains 81 mg of lactose monohydrate.
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita fiha 81 mg ta' lactose monohydrate.
English: Grade 4
Maltese: Grad 3 % Grad 4
English: Symptoms may be similar to those from lung cancer.
Maltese: Is-sintomi jistgħu jkunu simili għal dawk tal-kanċer tal-pulmun.
English: INFORMATION IN BRAILLE Vizimpro 15 mg
Maltese: Vizimpro 15 mg
English: Nausea
Maltese: Disgewżja
English: The safety and efficacy of Vizimpro in the paediatric population (< 18 years of age) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Vizimpro fil-popolazzjoni pedjatrika (< 18-il sena) ma ġewx determinati s'issa.
English: Following the administration of a single 45 mg dose of dacomitinib tablets, the mean oral bioavailability of dacomitinib is 80% (range: 65% to 100%) compared to intravenous administration, with Cmax occurring 5 to 6 hours after oral dosing.
Maltese: Wara l-għoti ta' doża unika ta' 45 mg ta' pilloli ta' dacomitinib, il-bijodisponibilità orali medja ta' dacomitinib hija ta' 80% (medda: 65% sa 100%) meta mqabbel mal-għoti ġol-vini, bis-Cmax isseħħ bejn 5 u 6 sigħat wara dożaġġ mill-ħalq.
English: Nail disorder i
Maltese: ANNESS I
English: A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomised to dacomitinib compared with those randomised to gefitinib, see Table 5 and Figure 1.
Maltese: Titjib statistikament sinifikanti fil-PFS kif determinat mill-IRC intwera għall-pazjenti randomizzati għal dacomitinib meta mqabbla ma' dawk randomizzati għal gefitinib, ara t-Tabella 5 u l-Figura 1.
English: Blue film-coated, 6.35 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB15” on the other.
Maltese: Pillola blu, miksija b'rita, 6.35 mm, tonda u bikonvessa imnaqqxa b'“Pfizer” fuq naħa waħda u b'“DCB15” fuq in-naħa l-oħra.
English: Vizimpro 15 mg film-coated tablets Vizimpro 30 mg film-coated tablets Vizimpro 45 mg film-coated tablets dacomitinib
Maltese: Vizimpro 15 mg pilloli miksija b'rita Vizimpro 30 mg pilloli miksija b'rita Vizimpro 45 mg pilloli miksija b'rita
English: In a dedicated hepatic impairment trial, following a single-oral dose of 30 mg Vizimpro, dacomitinib exposure (AUCinf and Cmax) was unchanged in mild hepatic impairment (Child-Pugh A; N=8) and decreased by 15% and 20%, respectively in moderate hepatic impairment (Child-Pugh B; N=9) when compared to subjects with normal hepatic function (N=8).
Maltese: Fi prova ddedikata dwar l-indeboliment tal-fwied, wara doża unika ta' 30 mg ta' Vizimpro mill-ħalq, l-esponiment għal dacomitinib (l-AUCinf u s-Cmax) ma nbidilx f'indeboliment tal-fwied ħafif (Child-Pugh A; N=8) u naqas b'15% u b'20%, rispettivament f'indeboliment tal-fwied moderat (Child-Pugh B; N=9) meta mqabbel ma' individwi b'funzjoni tal-fwied normali (N=8).
English: PC: SN: NN:
Maltese: Puh./Tel:
English: Blue film-coated, 9.0 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other.
Maltese: Pillola blu, tonda u bikonvessa miksija b'rita ta' 9.0 mm, imnaqqxa b'“Pfizer” fuq naħa waħda u b'“DCB45” fuq in-naħa l-oħra.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għallgalactose, b'defiċjenza totali għal-lattażi (lactase), jew b'malassorbiment tal-glucose-galactose ma għandhomx jieħdu dan il-prodott mediċinali.
English: In vitro studies indicated that CYP2D6 was the major CYP isozyme involved in the formation of O-desmethyl dacomitinib, while CYP3A4 contributed to the formation of other minor oxidative metabolites.
Maltese: Studji in vitro indikaw li CYP2D6 kien l-isożim tas-CYP ewlieni involut fil-formazzjoni ta' O-desmethyl dacomitinib, filwaqt li CYP3A4 ikkontribwixxa għall-formazzjoni ta' metaboliti ossidattivi minuri oħra.
English: Following oral administration of a single 45-mg dose of [
Maltese: Wara l-għoti ta' doża unika ta' 45-mg ta' [
English: Blue film-coated, 7.5 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Maltese: Pillola blu, tonda u bikonvessa miksija b'rita ta' 7.5 mm, imnaqqxa b'“Pfizer” fuq naħa waħda u b'“DCB30” fuq in-naħa l-oħra.
English: Dacomitinib is a pan-human epidermal growth factor receptor (HER) (EGFR/HER1, HER2, and HER4) inhibitor, with activity against mutated EGFR with deletions in exon 19 or the L858R substitution in exon 21.
Maltese: Dacomitinib huwa inibitur tar-riċettur tal-fattur tat-tkabbir epidermali tal-bniedem (HER) (EGFR/HER1, HER2, u HER4), b'attività kontra mutazzjonijiet ta' EGFR bi tħassir f'exon 19 jew bissostituzzjoni L858R f'exon 21.
English: Diarrhoea, including severe diarrhoea, has been very commonly reported during treatment with Vizimpro (see section 4.8).
Maltese: Dijarea, inkluż dijarea severa, ġiet irrappurtata b'mod komuni ħafna waqt il-kura b'Vizimpro (ara sezzjoni 4.8).
English: What you need to know before you take Vizimpro 3.
Maltese: X'għandek tkun taf qabel ma tieħu Vizimpro 3.
English: There is no known antidote for dacomitinib.
Maltese: Ma hemm l-ebda antidotu magħruf għal dacomitinib.
English: The inhibition of CYP2D6 translated into approximately a 90% reduction in metabolite exposure and an approximate 37% increase in dacomitinib exposure.
Maltese: L-inibizzjoni ta' CYP2D6 wasslet għal tnaqqis ta' madwar 90% fl-esponiment għall-metabolit u żieda ta' madwar 37% flesponiment għal dacomitinib.
English: Non-clinical safety studies showed reversible epithelial atrophy in the cervix and vagina of rats (see section 5.3).
Maltese: Studji mhux kliniċi dwar is-sigurtà wrew atrofija epiteljali riversibbli fiċ-ċerviċi u fil-vaġina fil-firien (ara sezzjoni 5.3).
English: Vizimpro is for oral use.
Maltese: Vizimpro huwa għal użu orali.
English: Dose modification and management for Vizimpro adverse reactions Adverse reactions
Maltese: Modifiki tad-doża rakkomandati għal reazzjonijiet avversi b'Vizimpro
English: Dacomitinib is not directly reactive toward DNA as evidenced by the negative response in the bacterial reverse mutation assay and did not induce chromosome damage in a bone marrow micronucleus assay at concentrations up to approximately 60-70 times the unbound AUC or Cmax at the recommended human dose.
Maltese: Dacomitinib mhuwiex direttament reattiv lejn id-DNA kif muri mirrispons negattiv fl-assaġġ tar-retromutazzjoni batterjali u ma kkawżax ħsara kromożomali f'assaġġ talmikronukleu tal-mudullun f'konċentrazzjonijiet sa madwar 60-70 darba l-AUC jew is-Cmax mhux marbuta fid-doża rakkomandata għall-bniedem.
English: Abbreviations: CI=confidence interval; HR=hazard ratio; IRC=independent radiologic central; ITT=Intent-To-Treat; N=total number; PFS=progression-free survival.
Maltese: HR=proporzjon ta' periklu; IRC=reviżjoni ċentrali radjoloġika independenti;
English: Aluminium/aluminium blister containing 10 film-coated tablets.
Maltese: Folja tal-aluminju/aluminju li fiha 10 pilloli miksija b'rita.
English: Each film-coated tablet contains 40 mg of lactose monohydrate.
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita fiha 40 mg ta' lactose monohydrate.
English: Weight decreased a Only adverse reactions with ≥ 10% incidence in the dacomitinib arm are included.
Maltese: Ġew inklużi biss reazzjonijiet avversi b'inċidenza ta' ≥ 10% fil-fergħa ta' dacomitinib.
English: The median duration of any grade and Grade ≥ 3 ILD/pneumonitis was 13 weeks and 1.5 weeks, respectively (see section 4.4).
Maltese: It-tul medjan ta' ILD/pnewmonite ta' kwalunkwe grad u ta' Grad ≥ 3 kien ta' 13-il ġimgħa u ta' 1.5 ġimgħat, rispettivament (ara sezzjoni 4.4).
English: ILD/pneumonitis, which could be fatal, has been reported in patients receiving Vizimpro (see section 4.8).
Maltese: Kien hemm rapporti ta' ILD/pnewmonite, li jistgħu jkunu fatali, f'pazjenti li kienu qed jingħataw Vizimpro (ara sezzjoni 4.8).
English: What Vizimpro looks like and contents of the pack Vizimpro 15 mg film-coated tablets are supplied as blue film-coated, round biconvex tablets, debossed with “Pfizer” on one side and “DCB15” on the other.
Maltese: Kif jidher Vizimpro u l-kontenut tal-pakkett - Il-pilloli miksijin b'rita ta' Vizimpro ta' 15 mg jiġu bħala pilloli blu, tondi u bikonvessi miksija b'rita, imnaqqxa b'“Pfizer” fuq naħa waħda u b'“DCB15” fuq in-naħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 45 mg tablets dacomitinib
Maltese: Vizimpro 45 mg pilloli dacomitinib
English: Vizimpro contains the active substance dacomitinib, which belongs to a group of medicines called protein tyrosine kinase inhibitors which are used to treat cancer.
Maltese: Vizimpro fih is-sustanza attiva dacomitinib li tappartjeni għal grupp ta' mediċini li jissejħu inibituri tal-proteina tirożina kinażi (protein tyrosine kinase inhibitors) li jintużaw biex jikkuraw il-kanċer.
English: Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
Maltese: Vizimpro, bħala monoterapija, huwa indikat għall-kura tal-ewwel linja ta' pazjenti adulti b'kanċer talpulmun taċ-ċelloli mhux żgħar (NSCLC, non-small cell lung cancer) lokalment avvanzat jew metastatiku b'mutazzjonijiet li jattivaw ir-riċettur tal-fattur tat-tkabbir epidermali (EGFR, epidermal growth factor receptor).
English: e Stomatitis includes the following PTs: Aphthous ulcer, Cheilitis, Dry mouth, Mucosal inflammation, Mouth ulceration, Oral pain, Oropharyngeal pain, Stomatitis.
Maltese: Ulċeri fil-ħalq (aphthous), Kejlite, Ħalq xott, Infjammazzjoni fil-mukuża, Ulċeri fil-ħalq, Uġigħ fil-ħalq, Uġigħ orofarinġali, Stomatite.
English: a Hypokalaemia includes the following preferred terms (PTs): Blood potassium decreased, Hypokalaemia.
Maltese: Ipokalemija tinkludi t-termini preferuti (PTs) li ġejjin:
English: Vizimpro 45 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other.
Maltese: - Il-pilloli ta' Vizimpro ta' 45 mg jiġu bħala pilloli blu, tondi u bikonvessi miksija b'rita, imnaqqxa b'“Pfizer” fuq naħa waħda u b'“DCB45” fuq in-naħa l-oħra.
English: 2-sided p-valuec
Maltese: STRIXXI BIL-FOLJI
English: Grade 3 rash and erythematous skin condition adverse reactions were the most frequently reported Grade 3 adverse reactions (25.5%).
Maltese: Il reazzjonijiet avversi relatati mal-ġilda kienu ta' bejn il-Grad 1 u 3. Reazzjonijiet avversi ta' raxx u ta' kundizzjonijiet eritematużi tal-ġilda tal-Grad 3 kienu l-aktar reazzjonijiet avversi tal-Grad 3 rrappurtati b'mod frekwenti (25.5%).
English: Dry sking Pruritus h
Maltese: Skin fissure Ġilda xotta Ħakk
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 30 mg tablets dacomitinib
Maltese: Vizimpro 30 mg pilloli dacomitinib
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 15 mg tablets dacomitinib
Maltese: Vizimpro 15 mg pilloli dacomitinib
English: The aqueous solubility of dacomitinib is pH dependent, with low (acidic) pH resulting in higher solubility.
Maltese: Is-solubilità ta' dacomitinib fl-ilma tiddependi fuq il-pH, b'pH baxx (aċiduż) iwassal għal solubilità ogħla.
English: • Withhold dacomitinib during ILD/Pneumonitis diagnostic evaluation.
Maltese: • Waqqaf dacomitinib waqt li tkun qed issir valutazzjoni dijanjostika ta' ILD/ pnewmonite.
English: Pruritus g
Maltese: Ġilda xotta
English: Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib (see section 4.2).
Maltese: Il-pazjenti jista' jkollhom bżonn interruzzjoni u/jew tnaqqis fid-doża tat-terapija b'dacomitinib (ara sezzjoni 4.2).
English: It is available in blister packs of 30 film-coated tablets (tablets).
Maltese: Jiġi bħala pakketti b'folji ta' 30 pillola miksija b'rita (pilloli).
English: The stratification factors were Race (Japanese vs mainland Chinese and other East Asian vs non-East Asian) and EGFR mutation status (exon 19 deletion vs the L858R mutation in exon 21) at randomisation per IWRS.
Maltese: Il-fatturi ta' stratifikazzjoni kienu r-Razza (Ġappuniżi kontra Ċiniżi kontinentali u Asjatiċi oħra tal-Lvant kontra Asjatiċi mhux tal-Lvant) u l-istat tal-mutazzjoni tal-EGFR (tħassir tal-exon 19 kontra l-mutazzjoni L858R fl-exon 21) waqt ir-randomizzazzjoni skont l-IWRS.
English: • Procainamide, used to treat heart arrhythmias
Maltese: • Procainamide, tintuża għall-kura ta' arritmiji tal-qalb
English: Gastrointestinal disorders Diarrhoea d
Maltese: Disturbi gastro-intestinali Dijarea
English: • Long-acting medicines for reducing stomach acid, such as proton pump inhibitors (for ulcers, indigestion and heartburn).
Maltese: • Mediċini li jaġixxu fit-tul għat-tnaqqis tal-aċidu fl-istonku, bħal inibituri tal-pompa tal-protoni (għal ulċeri, indiġestjoni u ħruq ta' stonku).
English: • Skin rash (very common)
Maltese: • Raxx tal-ġilda (komuni ħafna)
English: h Nail disorder includes the following PTs: Ingrowing nail, Nail bed bleeding, Nail bed inflammation, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Maltese: Dwiefer li jikbru 'l ġewwa, Fsada fil-bażi tad-dwiefer, Infjammazzjoni fil-bażi tad-dwiefer, Tibdil fil-kulur tad-dwiefer, Disturb fid-dwiefer, Infezzjoni fid-dwiefer, Tossiċità tad-dwiefer, Onikoklażi, Onikoliżi, Onikomadeżi, Paronikja.
English: • If Grade 2 rash, erythematous or exfoliative skin conditions persist for 72 hours despite treatment, withhold dacomitinib.
Maltese: • Jekk ir-raxx jew il-kundizzjonijiet eritematiċi jew esfoljattivi talġilda tal-Grad 2 jippersistu għal 72 siegħa minkejja l-kura, waqqaf dacomitinib.
English: Vizimpro 30 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Maltese: - Il-pilloli ta' Vizimpro ta' 30 mg jiġu bħala pilloli blu, tondi u bikonvessi miksija b'rita, imnaqqxa b'“Pfizer” fuq naħa waħda u b'“DCB30” fuq in-naħa l-oħra.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 45 mg dacomitinib (as dacomitinib monohydrate).
Maltese: Kull pillola miksija b'rita fiha 45 mg ta' dacomitinib (bħala dacomitinib monohydrate).
English: Conjunctivitis includes the following PTs: Blepharitis, Conjunctivitis, Dry eye, Noninfective conjunctivitis.
Maltese: Blefarite, Konġuntivite, Għajnejn xotti, Konġuntivite mhux infettiva.
English: The pharmacokinetics in patients requiring haemodialysis have not been studied.
Maltese: Il-farmakokinetika f'pazjenti li kienu jeħtieġu emodijalisi ma ġietx studjata.
English: The adverse reactions observed at doses greater than 45 mg once daily were primarily gastrointestinal, dermatological, and constitutional (e.g., fatigue, malaise, and weight loss).
Maltese: Ir-reazzjonijiet avversi osservati f'dożi ta' aktar minn 45 mg darba kuljum kienu primarjament gastrointestinali, dermatoloġiċi, u kostituzzjonali (eż., għeja, telqa, u telf ta' piż).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg dacomitinib (as dacomitinib monohydrate).
Maltese: Kull pillola miksija b'rita fiha 30 mg ta' dacomitinib (bħala dacomitinib monohydrate).
English: Environmental risk assessment studies have shown that dacomitinib has the potential to be very persistent, bioaccumulative and toxic to the environment (see section 6.6).
Maltese: Studji ta' valutazzjoni tar-riskju ambjentali wrew li dacomitinib għandu l-potenzjal li jkun persistenti ħafna, bijoakkumulattiv u tossiku għall-ambjent (ara sezzjoni 6.6).
English: • For Grade ≥ 3 diarrhoea, withhold dacomitinib.
Maltese: Ma sarux studji dwar il-fertilità b'dacomitinib.
English: Dacomitinib was not mutagenic in a bacterial reverse mutation (Ames) assay, and not clastogenic or aneugenic in the in vivo bone marrow micronucleus assay in male and female rats.
Maltese: Dacomitinib ma kienx mutaġeniku f'assaġġ ta' retromutazzjoni batterjali (Ames), u ma kienx klastoġeniku jew anewġeniku fl-assaġġ in vivo tal-mikronukleu tal-mudullun fil-firien irġiel u nisa.
English: The median duration of any grade and Grade ≥ 3 diarrhoea was 20 weeks and 1 week, respectively (see section 4.4).
Maltese: It-tul medjan ta' dijarea ta' kwalunkwe grad u ta' Grad ≥ 3 kien ta' 20 ġimgħa u ta' ġimgħa waħda, rispettivament (ara sezzjoni 4.4).
English: There was no effect on reproductive organs in male rats given ≤ 2 mg/kg/day for 6 months (approximately 1.1 times the unbound AUC at the recommended human dose), or in dogs given ≤ 1 mg/kg/day for 9 months (approximately 0.3 times the unbound AUC at the recommended human dose).
Maltese: Ma kien hemm l-ebda effett fuq l-organi riproduttivi f'firien irġiel li ngħataw ≤ 2 mg/kg/kuljum għal 6 xhur (madwar 1.1 darbiet l-AUC mhux marbut fid-doża rakkomandata tal-bniedem), jew fi klieb li ngħataw ≤ 1 mg/kg/kuljum għal 9 xhur (madwar 0.3 darbiet l-AUC mhux marbut fid-doża rakkomandata tal-bniedem).