FrancophonIA/ELRC3.0 huggingface dataset:
English: Substances that are inducers of CYP3A4, such as rifampicin, carbamazepine, barbiturates and St John´s wort (Hypericum perforatum) are likely to decrease the plasma concentrations of darifenacin.
Maltese: Sustanzi li jattivaw CYP3A4 bħal rifampicin, carbamazepine, barbiturates u St John's Wort (Hypericum perforatum) x'aktarx inaqqsu il-konċentrazzjonijiet ta' darifenacin fil-plażma.
English: Incontinence episodes per week
Maltese: Tnaqqis f'episodji ta' inkontinenza kull ġimgħa
English: PHARMACEUTICAL FORM AND CONTENTS 14 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 14-il pillola
English: Do not take Emselex:
Maltese: Tieħux Emselex:
English: Baseline (median)
Maltese: Linja bażi (medjan)
English: Antimuscarinic agents
Maltese: Sustanzi antimuskariniċi
English: Emselex has been administered in clinical trials at doses up to 75 mg (five times maximum therapeutic dose).
Maltese: Waqt provi kliniċi Emselex ingħata f'dożi sa 75 mg (ħames darbiet l-ogħla doża terapewtika).
English: Darifenacin was not teratogenic in rats and rabbits at doses up to 50 and 30 mg/kg/day, respectively.
Maltese: Id-darifenacin ma kienx teratoġeniku fil-firien u l-fniek meta ngħata f'dożi sa 50 u 30 mg/kg kuljum, rispettivament.
English: • certain anticonvulsants (carbamazepine, barbiturates),
Maltese: • ċerti mediċini kontra l-aċċessjonijiet(carbamazepine, barbiturates),
English: Darifenacin is metabolised by CYP3A4 and CYP2D6.
Maltese: Darifenacin jiġi mmetabolizzat permezz ta' CYP3A4 u CYP2D6.
English: A small study of subjects (n=24) with varying degrees of renal impairment (creatinine clearance between 10 ml/min and 136 ml/min) given darifenacin 15 mg once daily to steady state demonstrated no relationship between renal function and darifenacin clearance (see section 4.2).
Maltese: Studju żgħir ta' individwi (n=24) b'indeboliment tal-kliewi fi gradi diversi (tneħħija tal-krejatinina bejn 10 ml/min u 136 ml/min) meta 15 mg ta' darifenacin ingħataw kuljum għal stat fiss ma wera lebda relazzjoni bejn il-funzjoni renali u t-tneħħija ta' darifenacin (ara sezzjoni 4.2).
English: • There are some medicines such as ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis), verapamil (a medicine used to lower blood pressure, to correct heart rhythm or to treat angina pectoris), antifungal medicines (e.g. ketoconazole and itraconazole) and some antiviral medicines (e.g. ritonavir) that must not be taken with Emselex.
Maltese: • hemm xi mediċini bħal ciclosporin (mediċina wżata fit-trapjanti biex tilqa' kontra r-riġett talorganu jew għal kundizzjonijiet oħra, eż. artrite rewmatika jew dermatite atopika), verapamil (mediċina wżata biex tbaxxi l-pressjoni, biex tirregola r-ritmu tal-qalb jew biex tikkura anġina pectoris), mediċini kontra l-mard tal-moffa (eż.ketoconazole u itraconazole) u xi mediċini kontra mard virali (eż ritonavir) li m'għandekx teħodhom ma' Emselex.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropea dwar il-Mediċini: http://www.ema.europa.eu
English: Pharmacotherapeutic group: Urologicals, drugs for urinary frequency and incontinence; ATC code: G04BD10.
Maltese: Uroloġiċi, mediċini għall-frekwenza ta 'l-awrina u inkontinenza, Kodiċi ATC:
English: Darifenacin AUC24 and Cmax from 30 mg once-daily dosing in subjects who are extensive metabolisers were 95% and 128% higher when erythromycin (moderate CYP3A4 inhibitor) was co-administered with darifenacin than when darifenacin was taken alone.
Maltese: L-AUC24 u s-Cmax ta' Darifenacin minn dużaġġ ta' 30 mg darba kuljum f'persuni li huma metabolizzaturi estensivi, kienu 95% u 128% aktar għolja meta erythromycin (inibitur moderat ta' CYP3A4) kien mogħti ma' darifenacin milli meta darifenacin ittieħed waħdu.
English: Darifenacin is a moderate inhibitor of the enzyme CYP2D6.
Maltese: Darifenacin huwa inibitur moderat ta' CYP2D6.
English: Darifenacin 30 mg once daily (two times greater than the recommended daily dose) co-administered with digoxin at steady state resulted in a small increase in digoxin exposure (AUC: 16% and Cmax: 20%).
Maltese: Meta 30 mg darifenacin (id-doppju tad-doża rrakkomandata kuljum) ingħata ma' digoxin fi stat fiss, wassal għal żieda żgħira fl-esponiment għal digoxin (AUC: 16% u Cmax : 20%).
English: Estimated darifenacin clearance is 40 litres/hour.
Maltese: It tneħħija ta' darifenacin hija stmata li hi 40 litru/siegħa.
English: (PVC/PVDC/alu blisters)
Maltese: (PVC/PVDC/alu folji)
English: Clear PVC/CTFE/aluminium or PVC/PVDC/aluminium blisters in cartons containing 7, 14, 28, 49, 56 or 98 tablets as unit pack or in multipacks containing 140 (10x14) tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji trasparenti tal-PVC/CTFE/aluminium jew tal-PVC/PVDC/aluminium f'kartuniet li jkun fihom 7, 14, 28, 49, 56 jew 98 pillola f'pakketti waħidhom jew f'pakketti b'ħafna li jkun fihom 140 (10x14) pillola.
English: Effects of other medicinal products on darifenacin Darifenacin metabolism is primarily mediated by the cytochrome P450 enzymes CYP2D6 and CYP3A4.
Maltese: Effetti ta' prodotti mediċinali oħrajn fuq darifenacin Il-metaboliżmu ta' darifenacin huwa primarjament medjat bl-enzimi taċ-ċitokroma P450, CYP2D6 u CYP3A4.
English: • certain medicines used to treat heart problems (e.g. flecainide, verapamil and digoxin),
Maltese: • ċerti mediċini li jintużaw għal problemi tal-qalb (eż. flecainide, verapamil u digoxin),
English: Emselex 7.5 mg once daily Placebo
Maltese: Emselex 7.5 mg darba kuljum Plaċebo
English: Concomitant treatment with potent CYP2D6 inhibitors results in an increase in exposure (e.g. of 33% with 20 mg paroxetine at the 30 mg dose of darifenacin).
Maltese: Kura fl-istess ħin b'inibituri potenti ta' CYP2D6 twassal għal żieda fl-esponiment (eż. ta' 33% b'20 mg paroxetine, bid-doża ta' 30 mg darifenacin).
English: In one pharmacokinetic study the steady-state exposure in poor metabolisers was 164% and 99% higher during treatment with 7.5 mg and 15 mg once daily, respectively.
Maltese: Fi studju farmakokinetiku f'metabolizzaturi dgħajfa l-esponiment fi stat fiss kien 164% u 99% ogħla waqt il-kura b'7.5 mg u 15 mg darba kuljum, rispettivament.
English: Darifenacin should not be used together with potent CYP3A4 inhibitors (see section 4.3) such as protease inhibitors (e.g. ritonavir), ketoconazole and itraconazole.
Maltese: (ara sezzjoni 4.3) bħal inibituri tal-protease (eż. ritonavir), ketoconazole u itraconazole.
English: Co-administration of darifenacin 7.5 mg with the potent CYP3A4 inhibitor ketoconazole 400 mg resulted in a 5-fold increase in steady-state darifenacin AUC.
Maltese: Meta darifenacin 7.5 mg ingħata malinibitur qawwi ta' CYP3A4 ketoconazole 400 mg, l-AUC ta' darifenacin fi stat fiss żdiedet b'5darbiet.
English: (PVC/CTFE/alu blisters)
Maltese: (PVC/CTFE/alu folji)
English: The increase in digoxin exposure could be caused by competition between darifenacin and digoxin for P-glycoprotein.
Maltese: Iż-żieda fl-esponiment għal digoxin jista' jkun li tkun ġejja minn kompetizzjoni bejn darifenacin u digoxin għall-glikoproteina-P.
English: As seen in Table 2 below, a pooled analysis of 3 of the studies for the treatment with both Emselex 7.5 mg and 15 mg provided a statistically significant improvement in the primary endpoint, reduction in incontinence episodes, versus placebo.
Maltese: Kif jidher f'Tabella 2 hawn taħt, analiżi miġbura minn 3 mill-istudji għall-kura kemm b'Emselex 7.5 mg, kif ukoll bi 15 mg uriet titjib statistikament sinifikanti fl-ewwel endpoint ewlieni, tnaqqis f'episodji ta' inkontinenza, kontra plaċebo.
English: • antiviral medicines (e.g. nelfinavir and ritonavir),
Maltese: • mediċini kontra mard virali (eż nelfinavir u ritonavir),
English: However, protein binding of darifenacin was affected by moderate hepatic impairment.
Maltese: Madanakollu, t-twaħħil ta' darifenacin mal-proteini kien effettwat minn indeboliment moderat talfwied.
English: Due to extensive first-pass metabolism darifenacin has a bioavailability of approximately 15% and 19% after 7.5 mg and 15 mg daily doses at steady state.
Maltese: Minħabba metaboliżmu first-pass estensiv, darifenacin għandu bijodisponibiltà ta' madwar 15% u 19% wara dożi ta' 7.5 mg u 15 mg kuljum fi stat fiss.
English: Treatment with Emselex administered at dosages of 7.5 mg and 15 mg daily has been investigated in four double-blind, Phase III, randomised, controlled clinical studies in male and female patients with symptoms of overactive bladder.
Maltese: Kura b'Emselex mogħtija b'dożi ta' 7.5 mg u 15 mg kuljum kienet investigata f'erba' studji kliniċi double-blind, tal-Fażi III, kkontrollati u randomised, b'pazjenti rġiel u nisa b'sintomi ta' bużżieqa talawrina attiva żżejjed.
English: At steady state, peak-to-trough fluctuations in darifenacin concentrations are small (PTF: 0.87 for 7.5 mg and 0.76 for 15 mg), thereby maintaining therapeutic plasma levels over the dosing interval.
Maltese: Fi stat fiss, il-bidliet mill-ogħla konċentrazzjoni ta' darifenacin sa dik l-aktar baxxa huma żgħar (PTF: 0.87 għal 7.5 mg u 0.76 għal 15 mg), b'hekk jinżammu l-livelli terapewtiċi fil-plażma matul l-intervall ta' bejn doża u oħra.
English: 26-28, rue Edward Steichen L-2540 Luxembourg
Maltese: Merus Labs Luxco II S.à R.L. 26-28, rue Edward Steichen L-2540
English: If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Maltese: Jekk ikun hemm infezzjoni fissistema tal-awrina, għandha tinbeda terapija antibatterika xierqa.
English: Emselex 7.5 mg and 15 mg were associated with statistically significant improvements over placebo in some aspects of quality of life as measured by the Kings Health Questionnaire including incontinence impact, role limitations, social limitations and severity measures.
Maltese: Emselex 7.5 mg u 15 mg kienu assoċjati ma' titjib statistikament sinifikanti meta mqabbla ma' plaċebo f'ċerti aspetti tal-kwalità tal-ħajja hekk kif imkejla permezz tal-Kwestjonarju King Health li kien jinkludi impatt tal-inkontinenza, limitazzjonijiet ta' rwoli, limitazzjonijiet soċjali u miżuri ta' severità.
English: A similar trend is also seen for the discontinuation rates.
Maltese: Tendenza simili tidher ukoll għar-rati ta' twaqqif tal-kura.
English: At the dose of 50 mg/kg/day in rats (59 times the AUC0-24h of free plasma concentration at MRHD), delay in the ossification of the sacral and caudal vertebrae was observed.
Maltese: Meta ngħata lill-firien f'doża ta' 50 mg/kg kuljum (59 darba aktar mill-AUC0-24h tal-konċentrazzjoni ta' plażma ħielsa fl-ogħla doża rrakkomandata għall-bniedem), kien osservat dewmien flossifikazzjoni tal-vertebra sakrali u kawdali.
English: Emselex reduces the activity of an overactive bladder.
Maltese: Emselex inaqqas l-attività ta' bużżieqa tal-awrina attiva żżejjed.
English: Other medicines and Emselex
Maltese: Mediċini oħra u Emselex
English: What Emselex looks like and contents of the pack Emselex 15 mg prolonged-release tablets are round, convex light peach tablets and are debossed with “DF” on one side and “15” on the other.
Maltese: Kif jidher Emselex u l-kontenut tal-pakkett Emselex 15 mg pilloli li jerħu l-mediċina bil-mod huma pilloli tondi, konvessi lewn il-ħawħ, imnaqqxa b'”DF” fuq naħa u “15” fuq l-oħra.
English: Emselex should be used with caution in patients with risk of decreased gastrointestinal motility, gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis.
Maltese: Emselex għandu jintuża b'attenzjoni f'pazjenti b'riskju ta' tnaqqis fil-motilità gastrointestinali, jew firrifluss gastroesofagali u/jew li qed jieħdu fl-istess ħin prodotti mediċinali (bħal bisphosphonates orali) li jistgħu jikkawżaw jew jaggravaw infjammazzjoni tal-esofagu.
English: However, the patient discontinuation rates due to these adverse reactions were low (dry mouth: 0%0.9% and constipation: 0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).
Maltese: Madankollu, ir-rata ta' pazjenti li kellhom iwaqqfuh minħabba dawn ir-reazzjonijiet avversi kienet żgħira (ħalq xott: 0% - 0.9% u stitikezza: 0.6% - 2.2% għal darifenacin, skont id-doża, u 0% u 0.3% għall-plaċebo, għall-ħalq xott u stitikezza, rispettivament).
English: When co-administered with moderate CYP3A4 inhibitors such as erythromycin, clarithromycin, telithromycin, fluconazole and grapefruit juice, the recommended starting dose of darifenacin should be 7.5 mg daily.
Maltese: Meta jingħata flimkien ma' inibituri moderati ta' CYP3A4 bħal erythromycin, clarithromycin, telithromycin, fluconazole jew meraq tal-grejpfrut, id-doża tal-bidu rakkomandata għandha tkun 7.5 mg kuljum.
English: Abdominal pain, nausea, dyspepsia
Maltese: Uġigħ addominali, nawsja, dispepsja
English: White round, convex tablet, debossed with “DF” on one side and “7.5” on the reverse.
Maltese: Pillola tonda bajda, konvessa, imnaqqxa b'“DF” fuq naħa u “7.5” fuq l-oħra.
English: Change from baseline (median)
Maltese: Tibdil milllinja bażi (medjan)
English: Table 1: Adverse reactions with Emselex 7.5 mg and 15 mg prolonged-release tablets
Maltese: Tabella 1: Reazzjonijiet avversi b'Emselex 7.5 mg u 15 mg pilloli li jerħu l-mediċina bil-mod
English: Emselex belongs to a class of medicines which relax the muscles of the bladder.
Maltese: Emselex huwa mediċina li tagħmel parti minn klassi ta' mediċini li jirilassaw il-muskoli tal-bużżieqa tal-awrina.
English: Each tablet contains 15 mg darifenacin (as hydrobromide).
Maltese: Kull pillola fiha 15 mg darifenacin (bħala hydrobromide).
English: The elimination half-life of darifenacin following chronic dosing is approximately 13-19 hours.
Maltese: Il-half life tal-eliminazzjoni ta' darifenacin wara li jingħataw dożaġġi b'mod kroniku hija ta' madwar 13-19-il siegħa.
English: Each tablet contains 7.5 mg darifenacin (as hydrobromide).
Maltese: Kull pillola fiha 7.5 mg darifenacin (bħala hydrobromide).
English: Urinary tract infection
Maltese: Disturbi gastro-intestinali
English: The tablets are available in blister packs containing 7, 14, 28, 49, 56 or 98 tablets or in multipacks containing 140 (10x14) tablets.
Maltese: Il-pilloli jiġu f'pakketti b'folji li jkun fihom 7, 14, 28, 49, 56 jew 98 pillola jew f'pakketti b'ħafna li jkun fihom 140 (10x14) pillola.
English: How to store Emselex 6.
Maltese: Kif taħżen Emselex 6.
English: Emselex is for oral use.
Maltese: Emselex mhux irrakkomandat waqt it-tqala.
English: Rash, dry skin, pruritus, hyperhidrosis
Maltese: Raxx, ġilda xotta, ħakk, iperidrożi
English: Doubling the darifenacin dose from 7.5 mg to 15 mg result in a 150% increase in steady-state exposure.
Maltese: Meta d-doża ta' darifenacin tkun irdoppjata minn 7.5 mg għal 15 mg, ikun hemm żieda ta' 150% flesponiment waqt stat fiss.
English: However, there is a risk of increased exposure in this population (see section 5.2).
Maltese: Madankollu, f'dawn il-pazjenti hemm riskju li jkun hemm esponiment ogħla (ara sezzjoni 5.2).
English: Light peach round, convex tablet debossed with “DF” on one side and “15” on the reverse.
Maltese: Pillola tonda lewn il-ħawħ, konvessa, imnaqqxa b'“DF” fuq naħa u “15” fuq l-oħra.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg darifenacin (as hydrobromide).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 7.5 mg darifenacin (bħala hydrobromide).
English: Patients with moderate hepatic impairment (Child Pugh B) should only be treated if the benefit outweighs the risk, and the dose should be restricted to 7.5 mg daily (see section 5.2).
Maltese: Pazjenti li jsofru minn indeboliment moderat tal-fwied (Child-Pugh B) għandhom jiġu kkurati biss jekk il-benefiċċju jkun akbar mir-riskju, u d-doża għandha tkun limitata għal 7.5 mg kuljum (ara sezzjoni 5.2).
English: Dizziness, dysgeusia, somnolence
Maltese: Sturdament, disgweżja, ngħas
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg darifenacin (as hydrobromide).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 15 mg darifenacin (bħala hydrobromide).
English: In patients receiving substances that are potent CYP2D6 inhibitors (e.g. paroxetine, terbinafine, cimetidine and quinidine) the recommended starting dose should be 7.5 mg daily.
Maltese: Għal pazjenti li qed jirċievu sustanzi li huma inibituri qawwija ta' CYP2D6 (eż. paroxetine, terbinafine, cimetidine u quinidine), id-doża tal-bidu rrakkomandata għandha tkun 7.5 mg kuljum.
English: Due to genetic differences, about 7% of the Caucasians lack the CYP2D6 enzyme and are said to be poor metabolisers.
Maltese: Minħabba differenzi fl-għamla ġenetika, madwar 7% tan-nies Kawkasiċi għandhom nuqqas tal-enzima CYP2D6 u jitqiesu bħala metabolizzaturi dgħajfa.
English: In peri and post-natal studies in rats, dystocia, increased foetal deaths in utero and toxicity to post-natal development (pup body weight and development land marks) were observed at systemic exposure levels up to 11 times the AUC0-24h of free plasma concentration at MRHD.
Maltese: Fi studji ta' waqt u wara t-twelid fuq firien, kienu osservati distoċja, żieda fl-imwiet tal-feti in utero, u tossiċità għall-iżvilupp ta' wara t-twelid (imfassla fuq markaturi tal-piż tal-ġisem u l-iżvilupp tal-wild) f'livelli ta' esponimenti sistemiċi sa 11-il darba aktar mill-AUC0-24h tal-konċentrazzjoni ta' plażma ħielsa fl-ogħla doża rrakkomandata għall-bniedem.
English: Emselex 7.5 mg prolonged-release tablets Darifenacin
Maltese: Emselex 7.5 mg pilloli li jerħu l-mediċina bil-mod darifenacin
English: Toxic megacolon.
Maltese: Pressjoni għolja
English: Other transporter-related interactions cannot be excluded.
Maltese: Interazzjonijiet oħrajn relatati massistemi ta' trasport ma jistgħux jiġu esklużi.
English: Unbound darifenacin exposure was estimated to be 4.7-fold higher in subjects with moderate hepatic impairment than subjects with normal hepatic function (see section 4.2).
Maltese: L-esponiment ta' darifenacin mhux imwaħħal kien stmat li jkun 4.7 darbiet ogħla f'dawk li jkollhom indeboliment moderat tal-fwied minn dawk li jkollhom funzjoni epatika normali (ara sezzjoni 4.2).
English: Severe hepatic impairment (Child Pugh C).
Maltese: Li jkollhom indeboliment qawwi tal-fwied (Child-Pugh C) Li jkollhom kolite bl-ulċeri serja
English: The three main metabolic routes are as follows: monohydroxylation in the dihydrobenzofuran ring; dihydrobenzofuran ring opening and
Maltese: Monohydroxylation fid-dihydrobenzofuran ring
English: Table 2: Pooled analysis of data from three Phase III clinical studies assessing fixed doses of 7.5 mg and 15 mg Emselex
Maltese: III fejn ġew valutati dożi fissi ta' 7.5 mg u 15 mg Emselex
English: Following administration of an oral dose of 14C-darifenacin solution to healthy volunteers, approximately 60% of the radioactivity was recovered in the urine and 40% in the faeces.
Maltese: Wara li tingħata doża mill-ħalq ta' soluzzjoni ta' 14C-darifenacin lil voluntiera b'saħħithom, madwar 60% tar-radjuattività kienet irkuprata fl-awrina u 40% fl-ippurgar.
English: Emselex 15 mg prolonged-release tablets Darifenacin
Maltese: Emselex 15 mg pilloli li jerħu l-mediċina bil-mod darifenacin
English: The incidence of adverse reactions with the doses of Emselex 7.5 mg and 15 mg decreased during the treatment period up to 6 months.
Maltese: L-inċidenza ta' reazzjonijiet avversi b'dożi ta' Emselex ta' 7.5 mg u 15 mg naqset tul il-perijodu ta' kura sa 6 xhur.
English: As with any other antimuscarinic agents, concomitant use of medicinal products that possess antimuscarinic properties, such as oxybutynin, tolterodine and flavoxate, may result in more pronounced therapeutic and side effects.
Maltese: Bħal ma jiġri bis-sustanzi antimuskariniċi l-oħrajn kollha, l-użu ta' prodotti mediċinali oħra li għandhom effetti antimuskariniċi bħal oxybutynin, tolterodine u flavoxate, jista' jwassal għal effetti terapewtiċi u sekondarji aktar qawwija.
English: 56 tablets (PVC/PVDC/alu blisters)
Maltese: 56 pillola (PVC/PVDC/alu folji)
English: NAME OF THE MEDICINAL PRODUCT Emselex 15 mg prolonged-release tablets
Maltese: Emselex 15 mg darba kuljum
English: • if you have severe liver problems.
Maltese: • jekk għandek problemi tal-fwied.
English: However, a population pharmacokinetic analyses of Phase III data indicated that on average steady-state exposure is 66% higher in poor metabolisers than in extensive metabolisers.
Maltese: III indikat li bħala medja l-esponiment fi stat fiss ikun 66% ogħla f'metabolizzaturi dgħajfa milli f'metabolizzaturi estensivi.
English: Investigations Uncommon
Maltese: Komuni ħafna
English: There were no effects on reproductive organs in either sex in dogs treated for 1 year at oral doses up to 6 mg/kg/day (82 times the AUC0-24h of free plasma concentration at MRHD).
Maltese: Ma kienx hemm effetti fuq l-organi riproduttivi la tal-klieb irġiel u lanqas tan-nisa kkurati għal sena b'dożi sa 6 mg/kg kuljum mill-ħalq (82 darba aktar mill-AUC0-24h talkonċentrazzjoni ta' plażma ħielsa fl-ogħla doża rrakkomandata għall-bniedem).
English: Mild hepatic impairment had no effect on the pharmacokinetics of darifenacin.
Maltese: Indeboliment ħafif tal-fwied ma kellu l-ebda effett fuq il-farmakokinetika ta' darifenacin.
English: A population pharmacokinetic analysis of patient data indicated that darifenacin exposure was 23% lower in males than females (see section 5.1).
Maltese: Analiżi farmakokinetika tal-popolazzjoni ta' tagħrif miġbur minn pazjenti indika li l-esponiment għal darifenacin kien 23% aktar baxx fl-irġiel milli fin-nisa (ara sezzjoni 5.1).
English: The potentiation of anticholinergic effects with antiparkinson agents and tricyclic antidepressants may also occur if antimuscarinic agents are used concurrently with such medicinal products.
Maltese: L-effetti antikolinerġiċi ta' mediċini li jintużaw kontra l-marda ta' Parkinson u mediċini kontra d-dipressjoni tat-tip triċikliċi jistgħu jkunu aktar qawwija meta jingħataw ma' mediċini antimuskariniċi.
English: What Emselex looks like and contents of the pack Emselex 7.5 mg prolonged-release tablets are round, convex white tablets and are debossed with “DF” on one side and “7.5” on the other.
Maltese: Emselex 7.5 mg pilloli li jerħu l-mediċina bil-mod huma tondi, bojod, konvessi, imnaqqxa b'“DF” fuq naħa u “7.5” fuq l-oħra.
English: At the dose of 30 mg/kg/day in rabbits (28 times the AUC0-24h of free plasma concentration at MRHD), maternal toxicity and foetotoxicity (increased post implantation loss and decreased number of viable foetuses per litter) were observed.
Maltese: Meta ngħata lill-fniek f'doża ta' 30 mg/kg kuljum (28 darba aktar mill-AUC0-24h tal-konċentrazzjoni ta' plażma ħielsa fl-ogħla doża rrakkomandata għallbniedem), kienu osservati tossiċità fl-omm u fil-fetu (żieda fil-korrimenti ta' feti wara li jeħlu mal-utru u tnaqqis fl-għadd ta' feti vijabbli f'kull boton).
English: 98 tablets (PVC/PVDC/alu blisters)
Maltese: 98 pillola (PVC/PVDC/alu folji)
English: A population pharmacokinetic analysis of patient data indicated a trend for clearance to decrease with age (19% per decade based on Phase III population pharmacokinetic analysis of patients aged 6089 years), see section 4.2.
Maltese: Analiżi farmakokinetika tal-popolazzjoni ta' tagħrif miġbur minn pazjenti indika tendenza għal tnaqqis tal-eliminazzjoni mal-età (19% għal kull għaxar snin ibbażat fuq analiżi farmakokinetika talpopolazzjoni ta' Fażi
English: In patients receiving substances that are potent CYP2D6 inhibitors, such as paroxetine, terbinafine, quinidine and cimetidine, treatment should start with the 7.5 mg dose.
Maltese: F'pazjenti li qed jieħdu sustanzi li huma inibituri potenti ta' CYP2D6 bħal paroxetine, terbinafine, quinidine u cimetidine, it-trattament għandu jibda bid-doża ta' 7.5 mg.
English: 56 tablets (PVC/CTFE/alu blisters)
Maltese: 56 pillola (PVC/CTFE/alu folji)
English: 98 tablets (PVC/CTFE/alu blisters)
Maltese: 98 pillola (PVC/CTFE/alu folji)
English: 49 tablets (PVC/PVDC/alu blisters)
Maltese: 49 pillola (PVC/PVDC/alu folji)
English: 7 tablets (PVC/CTFE/alu blisters)
Maltese: 7 pilloli (PVC/CTFE/alu folji)