FrancophonIA/ELRC3.0 huggingface dataset:
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Hija tippermetti monitoraġġ kontinwu tal-bilanċ ta 'benefiċċju / riskju tal-prodott mediċinali.
English: Cmax for fidaxomicin and OP-1118 in plasma were 22% and 33% lower following a high fat meal vs fasting, but the extent of exposure (AUC0-t) was equivalent.
Maltese: Cmax għal fidaxomicin u OP-1118 fil-plażma kienu 22% u 33% inqas wara ikla b'kontenut għoli ta' xaħam vs wara s-sawm, iżda l-ammont ta' espożizzjoni (AUC0-t) kien ekwivalenti.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Also no crossresistance has been discovered with any other antibiotic class including β-lactams, macrolides, metronidazole, quinolones, rifampin, and vancomycin.
Maltese: macrolides, metronidazole, quinolones, rifampin, u vancomycin.
English: Fidaxomicin and the metabolite OP-1118 are substrates of P-gp.
Maltese: Fidaxomicin u l-metabolit OP-1118 huma substrati ta' P-gp. Studji
English: This metabolite also shows antimicrobial activity (see section 5.1).
Maltese: Dan il-metabolit juri wkoll attività antimikrobijali (ara sezzjoni 5.1).
English: Fidaxomicin is a substrate of P-gp.
Maltese: Fidaxomicin hu substrat ta' P-gp.
English: Inhibition of the Clostridial RNA polymerase occurs at a concentration 20-fold lower than that for the E. coli enzyme (1 μM vs. 20 μM), partly explaining the significant specificity of fidaxomicin activity.
Maltese: RNA polymerase iseħħ f'konċentrazzjoni li hi 20 darba iktar baxxa minn dik tal-enzima E. coli (1 μM vs 20 μM), u dan jispjega parzjalment l-ispeċifiċità sinifikanti tal-attività ta' fidaxomicin.
English: The half life of fidaxomicin is approximately 8-10 h.
Maltese: Il-half-life ta' fidaxomicinhi ta' madwar 8 sa 10 sigħat.
English: DIFICLIR is an antibiotic which contains the active substance fidaxomicin.
Maltese: DIFICLIR huwa antibijotiku li fih is-sustanza attiva fidaxomicin.
English: Effect on the intestinal flora
Maltese: Effett fuq il-flora intestinali
English: NN:
Maltese: Tel.:
English: In vitro metabolism studies showed that the formation of OP-1118 is not dependent on CYP450 enzymes.
Maltese: Studji in vitro tal-metaboliżmu wrew li l-formazzjoni ta' OP-1118 ma tiddependix fuq enzimi CYP450.
English: Fidaxomicin (200 mg twice daily) had a small but not clinically relevant effect on digoxin exposure.
Maltese: Fidaxomicin (200 mg darbtejn kuljum) kellu effett żgħir iżda mhux klinikament rilevanti fuq lespożizzjoni għal digoxin.
English: − dry mouth, altered taste (dysgeusia)
Maltese: − ħalq xott, disturbi fit-togħma (dysgeusia)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 December 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 5 ta` Diċenbru 2011
English: Elimination through urine is negligible (<1%).
Maltese: L-eliminazzjoni flawrina hija negliġibbli (< 1%).
English: Twenty-four percent of patients met at least one of the following three criteria at baseline for scoring severity: body temperature >38.5°C, leukocyte count >15,000, or creatinine value ≥1.5 mg/dl.
Maltese: Erba' u għoxrin fil-mija tal-pazjenti ssodisfaw mill-inqas wieħed mittliet kriterji li ġejjin fil-linja bażi għas-severità tal-punteġġ: temperatura tal-ġisem ta' >38.5°C, għadd ta' lewkoċiti ta' >15,000, jew valur tal-kreatinina ta' ≥1.5 mg/dl.
English: Fidaxomicin is an antibiotic belonging to the macrocyclic class of antibacterials.
Maltese: Fidaxomicin huwa antibijotiku li jappartjeni għall-klassi makroċiklika ta' antibatteriċi.
English: In the pivotal clinical trials the rate of recurrence in the 30 days following treatment was assessed as a secondary endpoint.
Maltese: Fil-provi kliniċi importanti ħafna, ir-rata ta' rikorrenza fit-30 jum wara l-kura ġiet evalwata bħala punt aħħari sekondarju.
English: Coating:
Maltese: Kisja:
English: The recommended dose is one tablet (200 mg) twice daily (one tablet every 12 hours) for 10 days.
Maltese: Id-doża rakkomandata hija 200 mg (pillola waħda) li tingħata darbtejn kuljum (darba kull 12-il siegħa) għal 10 ijiem.
English: Fidaxomicin does not have a clinically significant effect on the exposure of rosuvastatin, a substrate for the transporters OATP2B1 and BCRP.
Maltese: Fidaxomicin ma kellux effett kliniku sinifikanti fuq l-espożizzjoni ta 'rosuvastatin, substrat għatt trasportaturi OATP2B1 u BCRP.
English: As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see section 4.4 and 5.2).
Maltese: Peress lir-rilevanza klinika ta 'din iż-żieda fl-espożizzjoni ma tkunx ċara, l-għoti flimkien ta' inibituri qawwija ta 'P gp, bħal cyclosporine:, ketoconazole, erythromycin, clarithromycin, verapamil, amiodarone u dronedarone mhumiex rakkomandat (ara sezzjoni 4.4 u 5.2).
English: Under conditions of clinical use, fidaxomicin has no clinically relevant effect on the exposure of rosuvastatin, a substrate for OATP2B1 and BCRP (see section 4.5).
Maltese: fidaxomicin mgħandux l-ebda effett klinikament rilevanti fuq l-espożizzjoni ta' rosuvastatin, substrat għal OATP2B1 u BCRP (ara sezzjoni 4.5).
English: Capsule shaped tablets of 14 mm, white to off-white in colour, debossed with “FDX” on one side and “200” on the other side.
Maltese: Pilloli forma ta' kapsula ta' 14 mm, ta' kulur abjad jew abjad jagħti fil-griż, imnaqqxa bl-ittri “FDX” fuq naħa u bin-numru “200” fuq in-naħa l-oħra.
English: There was very limited accumulation of fidaxomicin or OP-1118 in plasma following administration of 200 mg fidaxomicin every 12 hours for 10 days.
Maltese: Kien hemm akkumulazzjoni limitata ħafna ta' fidaxomicin jew OP-1118 fil-plażma wara l-għoti ta' 200 mg ta' fidaxomicin kull 12-il siegħa għal 10 ijiem.
English: In healthy adults, Cmax is approximately 9.88 ng/ml and AUC0-t is 69.5 ng•hr/ml following administration of 200 mg fidaxomicin, with a Tmax of 1.75 hours.
Maltese: 9.88 ng/ml u l-AUC0-t huwa 69.5 ng-siegħa/ml wara li jingħataw 200 mg ta' fidaxomicin, b'Tmax ta'
English: As a topical agent, systemic PK/PD relationships cannot be established, however in vitro data show fidaxomicin to have time-dependent bactericidal activity and suggest time over MIC may be the parameter most predicative of clinical efficacy.
Maltese: Bħala sustanza topika, ma jistgħux jiġu stabbiliti relazzjonijiet sistemiċi PK/PD, madankollu data in vitro turi li fidaxomicin għandu attività batteriċida li tiddependi fuq iż-żmien, u tagħti indikazzjoni li l-perjodu ta' żmien diviż bl-MIC jista' jkun l-aktar parametru predikattiv tal-effikaċja klinika.
English: Uncommon side effects (may affect up to 1 in 100 people)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwawsa persuna 1 minn kull 100) − tnaqqis fl-aptit
English: Reproductive and fertility parameters showed no statistically significant differences in rats treated with fidaxomicin at doses up to 6.3 mg/kg/day (intravenous).
Maltese: F'termini ta' statistika, il-parametri tar-riproduzzjoni u l-fertilità ma wrew l-ebda differenzi sinifikanti fil-firien li ngħatalhom fidaxomicin f'dożi sa 6.3 mg/kg/kuljum (ġol-vini).
English: Data from an open label, single arm study in CDI patients with concomitant inflammatory bowel disease (IBD) indicated no major difference in plasma concentrations of fidaxomicin or its main metabolite OP-1118 in patients with IBD as compared with patients without IBD in other studies.
Maltese: Data minn studju open label u single arm f'pazjenti b'CDI b'mard tal-musrana infjammatorju (IBD, inflammatory bowel disease) konkomitanti ma kienet tindika l-ebda differenza kbira fil konċentrazzjonijiet fil-plażma ta' fidaxomicin jew il-metabolita prinċipali tiegħu OP-1118 f'pazjenti b'IBD meta mqabbla ma' pazjenti li m'għandhomx IBD fi studji oħra.
English: It interferes with RNA polymerase at a distinct site from that of rifamycins.
Maltese: Huwa jxekkel lil RNA polymerase f'post differenti minn dak ta' rifamycins.
English: Fidaxomicin is a topically acting drug that cannot be used to treat systemic infections; therefore the establishment of a clinical breakpoint is not relevant.
Maltese: Fidaxomicin huwa mediċina li taġixxi topikament u li ma tistax tintuża bħala kura għal infezzjonijiet sistemiċi; għalhekk il-ħolqien ta' breakpoint kliniku mhuwiex rilevanti.
English: Reporting of side effects
Maltese: Rapurtaġġ ta effetti sekondarji.
English: The rate of recurrence (including relapses) was significantly lower with fidaxomicin (14.1% versus 26.0% with a 95% CI of [-16.8%, -6.8%]), however these trials were not prospectively designed to prove prevention of reinfection with a new strain.
Maltese: 0% b'95% CI ta' [-16.8%, -6.8%]), madankollu dawn il-provi ma kinux maħsuba b'mod prospettiv biex jagħtu prova tal-prevenzjoni ta' infezzjoni mill-ġdid b'razza ġdida.
English: Specific mutations of RNA polymerase are associated with reduced susceptibility to fidaxomicin.
Maltese: polymerase huma assoċjati ma' tnaqqis fis-suxxettibilità għal fidaxomicin.
English: Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see sections 4.5 and 5.2).
Maltese: erythromycin, clarithromycin, verapamil, dronedarone u amiodarone mhuwiex rakkomandat (ara sezzjonijiet 4.5 u 5.2).
English: Fidaxomicin is bactericidal and inhibits RNA synthesis by bacterial RNA polymerase.
Maltese: Fidaxomicin huwa batteriċida u jimpedixxi s-sintesi tal-RNA minn RNA polymerase batterjali.
English: What DIFICLIR looks like and contents of the pack DIFICLIR 200 mg film-coated tablets are capsule shaped tablets, white to off-white in colour, with “FDX” on one side and “200” on the other side.
Maltese: DIFICLIR jiġi f'pilloli tal-200 mg forma ta' kapsuli miksija b'rita, ta' kulur abjad jagħti fil-griż, imnaqqxa bl-ittri “FDX” fuq naħa u bin-numru “200” fuq in-naħa l-oħra.
English: DIFICLIR 200 mg film-coated tablets Fidaxomicin
Maltese: DIFICLIR 200 mg pilloli miksija b'rita fidaxomicin
English: Metabolism and nutrition disorders decreased appetite
Maltese: Disturbi fil metaboliżmu u n-nutrizzjoni tnaqqis fl-aptit
English: Fidaxomicin has been shown to inhibit C. difficile sporulation in vitro.
Maltese: Fidaxomicin wera li jimpedixxi l-isporulazzjoni ta' C. difficilein vitro.
English: The maximum fidaxomicin and OP-1118 plasma levels in CDI patients with concomitant IBD were within the range of levels found in CDI patients without IBD.
Maltese: fidaxomicin u OP-1118 f'pazjenti b'CDI b'IBD konkomitanti kienu fil-firxa tal-livelli li nstabu f'pazjenti b'CDI li m'għandhomx IBD.
English: The main elimination pathways of systemically available fidaxomicin have not been characterized.
Maltese: Il-passaġġi ewlenin taleliminazzjoni ta' fidaxomicin disponibbli sistemikament ma ġewx ikkaratterizzati.
English: Nervous system disorders dizziness, headache, dysgeusia
Maltese: Disturbi fissistema nervuża sturdament, uġigħ ta' ras, tibdil fit-togħma
English: Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118.
Maltese: L-għoti ta 'dożi singoli ta' l gp cyclosporine A P u fidaxomicin f'voluntiera b'saħħithom, irriżulta f'żieda ta‛ 4 u 2 darbiet fl fidaxomicin Cmax u AUC, rispettivament u
English: Patients with fulminant colitis and patients with multiple episodes (defined as more than one prior episode within the previous 3 months) of CDI were excluded in the studies.
Maltese: Pazjenti b'kolite fulminanti u pazjenti b'episodji multipli (definiti bħala iktar minn episodju wieħed fil-passat li seħħ fl-aħħar 3 xhur) ta' CDI, ġew esklużi fl-istudji.
English: Description of the patient population in clinical trials
Maltese: Deskrizzjoni tal-popolazzjoni ta' pazjenti fil-provi kliniċi
English: Effect of fidaxomicin on other transporters
Maltese: L-effett ta' fidaxomicin fuq trasportaturi oħra
English: 20 x 1 film-coated tablet.
Maltese: 100 x 1 pillola miksija b'rita. 20 x 1 pillola miksija b'rita.
English: Hrvatska
Maltese: FOLJA
English: Fidaxomicin and OP-1118 levels were approximately 2 times higher in patients ≥ 65 years compared to patients < 65 years.
Maltese: Il-livelli ta' fidaxomicin u OP-1118 kienu bejn wieħed u ieħor darbtejn ogħla f'pazjenti ta' ≥ 65 sena meta mqabbla ma' pazjenti ta' < 65 sena.
English: Following a single dose of 200 mg fidaxomicin, the majority of the administered dose (over 92%) was recovered in the stool as fidaxomicin or its metabolite OP-1118 (66%).
Maltese: Wara doża waħda ta' fidaxomicin ta' 200mg, il-biċċa l-kbira tad-doża mogħtija (iktar minn 92%) instabet fl-ippurgar bħala fidaxomicin jew il-metabolit tiegħu OP-1118 (66%).
English: Gram negative organisms are intrinsically not susceptible to fidaxomicin.
Maltese: L-organiżmi negattivi għal Gram huma intrinsikament mhux suxxettibbli għal fidaxomicin.
English: DIFICLIR is indicated in adults for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) (see section 5.1).
Maltese: DIFICLIR hu indikat għall-użu fl-adulti għall-kura ta' infezzjonijiet minnClostridium difficile (CDI), magħrufa wkoll bħala dijarea marbuta mal-infezzjoni C. difficile (CDAD) (ara sezzjoni 5.1).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 200 mg of fidaxomicin.
Maltese: − Is-sustanza attiva hi fidaxomicin.Kull pillola miksija b'rita fiha 200 mg ta' fidaxomicin.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq lattivitajietmeħtieġa ta' farmakovigilanza u jintervjeni kif maqbul fil-RMP ppreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suqu kwalunkwe aġġornament maqbul sussegwentital-RMP.
English: Each film-coated tablet contains 200 mg of fidaxomicin.
Maltese: Kull pillola miksija b'rita fiha 200 mg ta' fidaxomicin.
English: In CDI patients, average peak plasma levels of fidaxomicin and its main metabolite OP-1118 tend to be 2- to 6-fold higher than in healthy adults.
Maltese: F'pazjenti b'CDI, il-medja tal-livelli massimi fil-plażma ta' fidaxomicin u l-metabolit ewlieni tiegħu OP-1118 għandhom tendenza li jkunu minn 2 sa 6 darbiet ogħla minn dawk f'adulti b'saħħithom.
English: Method of administration DIFICLIR is intended for oral use.
Maltese: DIFICLIR huwa intenzjonat għal użu orali.
English: Limited data suggest that there is no major difference in plasma concentration of fidaxomicin or OP-1118 between patients with reduced renal function (creatinine clearance < 50 ml/min) and patients with normal renal function (creatinine clearance ≥ 50 ml/min).
Maltese: Data limitata tissuġġerixxi li m'hemm l-ebda differenza maġġuri fil-konċentrazzjoni ta' fidaxomicin jew OP-1118 fil-plażma bejn pazjenti b'funzjoni tal-kliewi mnaqqsa (tneħħija tal-krejatinina ta' < 50
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini. D.
English: Not known side effects (frequency cannot be estimated from the available data) − swelling of the face and throat (angioedema), trouble breathing (dyspnea)
Maltese: Effetti sekondarji mhux magħrufa (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli) − nefħa tal-wiċċ u l-gerżuma (anġjodema), problemi tan-nifs (dispneja)
English: The epidemiological cut-off value for fidaxomicin and C. difficile, distinguishing the wild-type population from isolates with acquired resistance traits, is ≥1.0 mg/L.
Maltese: Il-valur ta' limitu epidemjoloġikugħal fidaxomicin u C. difficile, li jiddistingwi l-popolazzjoni tat-tip selvaġġ mill-iżolati li jkollhom karatteristiċi ta' reżistenza akkwiżiti, huwa ≥ 1.0 mg/l.
English: Fidaxomicin had no effects on fertility when evaluated in rats (see section 5.3).
Maltese: Fertilità Fidaxomicin ma kellu ebda effetti fuq il-fertilità meta ġie ttestjat fil-firien (ara sezzjoni 5.3).
English: Do not take DIFICLIR
Maltese: Twissijiet u prekawzjonijiet
English: How to take DIFICLIR
Maltese: X'fih DIFICLIR
English: Tel: +386 (0) 1 401 1400
Maltese: Astellas Pharma d.o.o. Tel: +386 (0) 1 401 1417
English: There are limited data available on the use of fidaxomicin in severe cases of the disease (e.g. pseudomembranous colitis).
Maltese: Hemm data limitata disponibbli dwar l-użu ta' fidaxomicin f'każijiet severi tal-marda (eż. kolite psewdomembranuża).
English: As a precautionary measure, it is preferable to avoid the use of DIFICLIR during pregnancy.
Maltese: Bħala prekawzjonihu preferribli li ma jintużax DIFICLIR waqt it-tqala.
English: − This medicine has been prescribed for you only.
Maltese: Mediċini oħra u DIFICLIR
English: CLINICAL PARTICULARS
Maltese: PRODOTT MEDIĊINALI
English: Table 1 displays adverse reactions associated with twice daily administration of fidaxomicin in the treatment of C. difficile infection, reported in at least two patients, presented by system organ class.
Maltese: Sommarju tabulat ta' reazzjonijiet avversi Tabella 1 turi r-reazzjonijiet avversi relatati mal-għoti ta' fidaxomicin darbtejn kuljum għall-kura tal infezzjoni minn C. difficile, irrappurtati f'mill-inqas żewġ pazjenti, ippreżentati f'kategoriji skont il klassi tal-organi tas-sistema.
English: Astellas Pharma S.p.A. Tel: +39 02 921381
Maltese: Tel: +39 02 921381
English: In vitro studies showed that fidaxomicin and the metabolite OP-1118 are inhibitors of the transporters BCRP, MRP2 and OATP2B1, but were not found to be substrates.
Maltese: In vitro wrew li fidaxomicin u l-metabolit OP-1118 huma inħiibituri tatl-trasportaturi BCRP,
English: DIFICLIR 200 mg film-coated tablets
Maltese: DIFICLIR 200 mg pilloli miksija b'rita
English: 20 x 1 film-coated tablet in alu/alu perforated unit dose blisters.
Maltese: 100 x 1 pilloli f'folji alu/alu perforati ta' doża waħda. 20 x 1 pillola f'folji alu/alu perforati ta' doża waħda.
English: Limited data from patients with an active history of chronic hepatic cirrhosis in the Phase 3 studies showed that median plasma levels of fidaxomicin and OP-1118 may be approximately 2- and 3-fold higher, respectively, than in non-cirrhotic patients.
Maltese: Indeboliment tal-fwied Data limitata minn pazjenti bi storja attiva ta' ċirrożi kronika fil-fwied fl-istudji ta' Fażi 3 wera li l livelli medjani fil-plażma ta' fidaxomicin u OP-1118 jistgħu jkunu madwar 2 u 3 darbiet ogħla, rispettivament, minn dawk f'pazjenti li ma jbatux biċ-ċirrożi.
English: − The active substance is fidaxomicin.
Maltese: fidaxomicin.
English: − dizziness, headache
Maltese: Jekk tieqaf tieħu DIFICLIR
English: Effect of P-gp inhibitors on fidaxomicin
Maltese: L-effett ta 'P-gp fuq fidaxomicin
English: Core tablets:
Maltese: Kategorija farmakoterapewtika:
English: Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Minħabba d-data klinika limitata dwar din il-popolazzjoni, DIFICLIR għandu jintuża b'kawtela f'pazjenti b'indeboliment sever tal-kliewi(ara sezzjonijiet 4.4 u 5.2).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Maltese: Professjonisti tas-saħħahuma mitluba li jirrappurtaw kwalunkwe rejazzjoni ħażina suspettata permezz tas-sistema ta 'rappurtar nazzjonali elenkati fl-Appendiċi V.
English: Luxembourg/Luxemburg Astellas Pharma B.V.
Maltese: Suomi/Finland Astellas Pharma Puh/Tel:
English: Co-administration of 200 mg fidaxomicin twice daily with a single dose of 10 mg rosuvastatin to healthy subjects did not have a clinically significant effect on the AUCinf of rosuvastatin.
Maltese: L-għoti ta' 200 mg ta' fidaxomicin darbtejn kuljum ma' doża waħda ta' 10 mg ta' rosuvastatin lil individwi b'saħħithom, ma kellux effett klinikament sinifikanti fuq l-AUCinf ta' rosuvastatin.
English: The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' fidaxomicin fi tfal li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: A main metabolite, OP-1118, is formed through hydrolysis of the isobutyryl ester.
Maltese: Ma saret ebda analiżi estensiva tal-metaboliti fil-plażma, minħabba l-livelli baxxi ta' assorbiment sistemiku ta' fidaxomicin.Metabolit ewlieni, OP-1118, jifforma mill-idroliżi tal-isobutyryl ester.
English: Pregnancy and breast-feeding
Maltese: UŻU TAL-PRODOTT MEDIĊINALI
English: However, a larger effect on P-gp substrates with lower bioavailability more sensitive to intestinal P-gp inhibition such as dabigatran etexilat cannot be excluded.
Maltese: Madankollu, effett ikbar fuq is-substrati ta' P-gp b'bijodisponibilità iktar baxxa iktar sensittiv għal inibizzjoni ta' P-gp intestinali bħal dabigatran etexilat ma tistax tiġi eskluża.
English: Busuttil Ltd. Tel: +356 21 447184
Maltese: Tel: +356 21 447184
English: Slovenská republika Astellas Pharma s.r.o.
Maltese: Astellas Pharma s.r.o., organizačná zložka
English: − cyclosporin (a medicine used to dampen down the body's immune reactions, used e.g. after an organ or bone marrow transplant, for psoriasis or eczema, or for rheumatoid arthritis or nephrotic syndrome)
Maltese: - cyclosporin (mediċina li tintuża biex tnaqqas ir-reazzjonijiet immuni tal-ġisem, eż. tintuża wara trapjant ta' xi organu jew tal-mudullun, għal psorjasi jew ekżema, jew għal artrite rewmatojde jew sindrome nefrotiku)
English: Astellas Pharma Europe B.V.
Maltese: Astellas Pharma Europe B.V. Elisabethhof 19
English: Tel.: +48 225451 111
Maltese: Astellas Pharma Sp. z o.o. Tel.: +48 225451 111
English: Acute hypersensitivity reactions, such as angioedema and dyspnea, have been reported during post-marketing (see section 4.3 and 4.4).
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula Reazzjonijiet ta' sensittività eċċessiva akuta, bħal anġjoedema u qtugħ ta' nifs, ġew irrappurtati wara t tqegħid fis-suq (ara sezzjoni 4.3 u 4.4).
English: 18 October 2012
Maltese: 18 ta' Ottubru 2012
English: EMA/CHMP/816079/2012
Maltese: / kloridrat tal-doneżepil) EMA/CHMP/816079/2012
English: It was expected to be available as tablets (20 mg/10 mg).
Maltese: Kien mistenni jiġi f'pilloli (20 mg/10 mg).
English: The company that applied for authorisation is H. Lundbeck A/S, Denmark.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija H. Lundbeck A/S, id-Danimarka.
English: What is Acrescent?
Maltese: X'inhu Acrescent?
English: Acrescent was expected to be used to treat moderate to moderately severe Alzheimer's disease, in patients who are already taking a daily dose of 20 mg memantine and 10 mg donepezil.
Maltese: Acrescent kien mistenni jintuża fil-kura tal-marda tal-Alzheimer moderata għal moderatament severa, f'pazjenti li diġà jkunu qegħdin jieħdu doża ta' kuljum ta' 20 mg memantina u 10 mg donepeżil.
English: Acrescent is a medicine that contains two active substances, memantine hydrochloride and donepezil hydrochloride.
Maltese: Acrescent huwa mediċina li fiha żewġ sustanzi attivi, il-kloridrat tal-memantina u l-kloridrat taldoneżepil.