FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean baseline  SD
Maltese: Medja mill-linja bażi  SD
English: Total plasma clearance of rivastigmine was approximately 130 litres/h after a 0.2 mg intravenous dose and decreased to 70 litres/h after a 2.7 mg intravenous dose, which is consistent with the non-linear, over-proportional pharmacokinetics of rivastigmine due to saturation of its elimination.
Maltese: Wara doża minn ġol-vina ta' 0.2 mg it-tneħħija totali mill-plażma ta' rivastigmine kienet ta' bejn wieħed u ieħor 130 litru/siegħa, u din naqset għal 70 litru/siegħa wara doża minn ġol-vini ta' 2.7 mg, li taqbel ma' farmakokinetika sproporzjonali, mhux linejari ta' rivastigmine minħabba li l-eliminazzjoni tiegħu tkun saturata.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: ADCS-CGIC scores <4 indicate improvement.
Maltese: Punteġġi ADCS-CGIC ta' <4 jindikaw titjib.
English: Based on evidence from in vitro and animal studies, the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Maltese: Ibbażat fuq l-evidenza ta' studji in vitro u fuq l-annimali, l-iżoenzimi tascytochrome P 450 importanti huma minimament involuti fil-metaboliżmu ta' rivastigmine.
English: INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h
Maltese: Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h
English: The backing layer is transparent to translucent and labelled with “R5” (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or “R10” (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
Maltese: Is-saff ta' wara hija trasparenti għal trasluċidi u mmarkata b "R5" (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 siegħa garża tipprovdi mediċina li tgħaddi minn ġol-ġilda) jew "R10" (Rivastigmine 3M
English: Marketing Authorisation Holder 3M Health Care Limited, 1 Morley Street,
Maltese: 3M Health Care Limited,
English: These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance-based measure of cognition) and the ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the ADCS-ADL (Alzheimer's Disease Cooperative StudyActivities of Daily Living, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities related to finances).
Maltese: Dawn jinkludu ADAS-Cog (Skala ta' Evalwazzjoni tal-Marda ta' Alzheimer - Sottoskala konjittiva, kejl talkonjizzjoni bbażata fuq il-ħila) u l-ADCS-CGIC (Studju Kooperattiv tal-Marda ta' Alzheimer - LImpressjoni Globali tat-Tabib fuq il-Bidla, evalwazzjoni globali tal-komprensjoni tal-pazjent mit-tabib li tinkludi tagħrif li tagħti l-persuna li tieħu ħsieb il-kura tas-saħħa), u l-ADCS-ADL (Studju Kooperattiv tal-Marda ta' Alzheimer - Attivitajiet ta' Kuljum, evalwazzjoni stmata mill-persuna li tieħu ħsieb il-kura tas-saħħa tal-attivitajiet ta' kuljum inkluż l-indafa personali, ħila biex jiekol, jilbes, u faċendi oħra bħal xiri, u l-ħila li jorjenta ruħu fl-ambjent kif ukoll l-involviment f'attivitajiet relatati mal-finanzi).
English: The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations ((Cmax-Cmin)/Cavg), was 0.58 for rivastigmine 4.6 mg/24 h transdermal patches, 0.77 for rivastigmine 9.5 mg/24 h transdermal patches and 0.72 for rivastigmine 13.3 mg/24 h transdermal patches, thus demonstrating a much smaller fluctuation between trough and peak concentrations than for the oral formulation (FI = 3.96 (6 mg/day) and 4.15 (12 mg/day)).
Maltese: L-indiċi ta' fluttwazzjoni (FI), kejl tad-differenza relattiva bejn l-ogħla konċentrazzjonijiet u dawk l-aktar baxxi ((Cmax-Cmin)/Cavg), kien 0.58 għal garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon 4.6 mg/24 siegħa, 0.77 għal garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon 9.5 mg/24 siegħa u 0.72 għal garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon 13.3 mg/24 siegħa, b'hekk dehret fluttwazzjoni iżgħar bejn l-ogħla konċentrazzjonijiet u dawk l-aktar baxxi minn b'dik tal-formulazzjoni orali (FI = 3.96 (6 mg/jum) u 4.15 (12 mg/jum)).
English: The following adverse reactions have only been observed with rivastigmine capsules and oral solution and not in clinical studies with rivastigmine transdermal patches: somnolence, malaise, tremor, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Maltese: Ir-reazzjonijiet avversi li ġejjin dehru biss bil-kapsuli u soluzzjoni orali ta' rivastigmine u mhux flistudji kliniċi b'garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda: ngħas, nuqqas ta' saħħa, tregħid, konfużjoni, żieda fl-għaraq (komuni); ulċeri fid-duwodenu, anġina pektoris (rari); emorraġija gastrointestinali (rari ħafna); u xi każijiet ta' rimettar sever kienu assoċjati ma tiċrit fl-esofagu (mhux
English: • Risk Management Plan (RMP)
Maltese: • Miżuri oħra li jnaqqsu r-riskju
English: Polyester and ethyl vinyl acetate
Maltese: - Is-sustanzi l-oħra huma polyester, ethyl vinyl acetate, acrylate copolymer adhesive u
English: Rivastigmine 3M Health Care Ltd. might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine or meclizine).
Maltese: Rivastigmine 3M Health Care Ltd. jista' jinterferixxi ma' mediċini antikolinerġiċi li wħud minnhom huma mediċini li jintużaw biex itaffu weġgħat fl-istonku jew spażmi (eż. dicyclomine), għal kura talmarda ta' Parkinson (e.g. amantadine) jew biex jevitaw it-tqalligħ waqt iċ-ċaqliq (eż. diphenhydramine, scopolamine, jew meclizine).
English: 48-week active comparator controlled study
Maltese: Studju ta' paragun attiv ikkontrollat ta' 48 ġimgħa
English: 9.5 mg/24 h transdermal patches.
Maltese: 9.5 mg/24 siegħa.
English: - The other ingredients are polyester, ethyl vinyl acetate, acrylate copolymer adhesive and isopropyl myristate.
Maltese: - Polyester u ethyl vinyl acetate Matriċi li jkun fiha l-mediċina (DIA): - Acrylate copolymer adhesive - Isopropyl myristate
English: - Hepatic impairment: Patients with clinically significant hepatic impairment might experience more adverse reactions (see sections 4.2 and 5.2).
Maltese: - Indeboliment renali: Pazjenti b'indeboliment renali klinikament sinifikanti jista' jkollhom aktar reazzjonijiet avversi (ara sezzjonijiet 4.2 u 5.2).
English: The inter-patient variability in a steady-state study in Alzheimer's dementia was at most 45% (Cmax) and 43% (AUC0-24h) after use of the transdermal patch, and 71% and 73%, respectively, after administration of the oral form.
Maltese: Il-varjabbilità bejn il-pazjenti fi stat fiss fl-istudju fuq id-dimenzja ta' Alzheimer kienet mhux aktar minn 45% (Cmax) u 43% (AUC0-24h) wara lużu tal-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda, u 71% u 73% rispettivament, wara l
English: The patches are available in packs containing 7, 30, 60 and 90 pouches.
Maltese: Il-garżi jiġu f'pakketti li jkun fihom 7, 30, 60 jew 90 qartas.
English: Patients with severe hepatic impairment have not been studied (see sections 4.4 and 5.2).
Maltese: Pazjenti b'indeboliment epatiku sever ma kinux studjati (ara sezzjonijiet 4.4 u 5.2).
English: Vascular disorders Not known Gastrointestinal disorders Common
Maltese: Disturbi gastrointestinali Komuni
English: The backing layer is transparent to translucent, labelled with “R10” in a repeated pattern.
Maltese: Is-saff li jirinforza huwa trasparenti għal trasluċidu, immarkat b' mudell ripetut ta' "R10".
English: The clinical benefit of rivastigmine should be reassessed on a regular basis.
Maltese: Il-benefiċċju kliniku ta' rivastigmine għandu jerġa' jiġi evalwat fuq bażi regolari.
English: Psychiatric disorders Common
Maltese: Attività psikomotorili eċċessiva
English: Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20-30% lower when applied to the abdomen or thigh.
Maltese: Esponiment (AUC∞) għal rivastigmine (u l-metabolu NAP266-90) kien l-ogħla meta l-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda kienet applikata man-naħa ta' isfel tad-dahar, sider jew parti ta' fuq tad-driegħ u madwar 20-30% aktar baxxa meta tkun applikata mal-addome jew koxxa.
English: Each patch consists of a combination of a removable, transparent, split release liner, a functional layer containing drug-inadhesive (DIA) matrix, and a protective backing layer.
Maltese: Kull garża tikkonsisti minn taħlita ta' inforra li tista' titneħħa, trasparenti, 'split release', saff funzjonali li fih matriċi bi droga fil-kolla (DIA), u saff li jirrinforza u protettiv.
English: Functional decline was assessed by the investigator and cognitive decline was defined as a decrease in the MMSE score of >2 points from the previous visit or a decrease of >3 points from baseline.
Maltese: It-tnaqqis funzjonali ġie evalwat millinvestigatur u t-tnaqqis konjittiv kien definit bħala tnaqqis fil-punteġġ MMSE ta' >2 punti mill-viżta ta' qabel jew tnaqqis ta' >3 punti mil-linja bażi.
English: What Rivastigmine 3M Health Care Ltd. looks like and contents of the pack The transdermal patches are rectangular with rounded corners, approximately 2.5 cm by 1.8 cm (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or 3.5 cm by 2.6 cm (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
Maltese: Kif jidher Rivastigmine 3M Health Care Ltd. u l-kontenut tal-pakkett Il-garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda huma rettangolari b'kantunieri ttundjati, ta' qies madwar 2.5 ċm x 1.8 ċm (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda) jew 3.5 ċm x 2.6 ċm (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda).
English: Pruritus, erythema, urticaria, vesicles, allergic dermatitis, disseminated
Maltese: Pressjoni għolja Dardir, rimettar, dijarea, dispepsja, uġigħ addominali
English: They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Maltese: Dawn jistgħu jħossu aktar reazzjonijiet avversi, u huwa aktar probabbli li jkollha titwaqqfilhom il-kura minħabba reazzjonijiet avversi.
English: ADCS-CGIC
Maltese: Punteġġi ADCS-CGIC ta' <4
English: Rivastigmine 9.5 mg/24 h
Maltese: Rivastigmine 9.5mg/
English: Dehydration
Maltese: Deidrazzjoni
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Maltese: Fil-bidu huwa rrikkmandat li tintuża doża ta' 0.03 mg/kg atropine sulphate minn ġol-vina, bid-dożi ta' wara din ibbażati fuq ir-rispons kliniku.
English: Rare
Maltese: Tqala
English: Application site pruritus led to discontinuation in 1.1% of the patients from each of the treatment groups during the total 48-week double-blind treatment phase.
Maltese: Ħakk fis-sit tal-applikazzjoni wassal għal waqfien f'1.1% tal-pazjenti minn kull wieħed mill-gruppi ta' kura matul il-fażi ta' kura totali double-blind ta' 48 ġimgħa.
English: Rivastigmine 3M Health Care Ltd. can be used with food, drink and alcohol.
Maltese: Rivastigmine 3M Health Care Ltd. jista' jintuża mal-ikel, ix-xorb u l-alkoħol.
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by oral rivastigmine was similar to the inhibition of AChE activity.
Maltese: L-inibizzjoni tal-attività tat-tip butyrylcholinesterase fis-CSF ta' 14-il pazjent bil-marda ta' Alzheimer li kienu kkurati b'rivastigmine orali kienet simili għall-inibizzjoni tal-attività ta' AChE.
English: Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Maltese: Rivastigmine jagħmel parti minn klassi ta' sustanzi li jissejħu impedituri ta' cholinesterase.
English: Patients with Alzheimer's disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine.
Maltese: Pazjenti bil-marda ta' Alzheimer jistgħu jitilfu l-piż waqt li jkunu qed jieħdu inibituri ta' cholinesterase, inkluż rivastigmine.
English: INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h
Maltese: Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h
English: Population/Visit
Maltese: Popolazzjoni/Viżta
English: solarium) for long periods of time.
Maltese: solarju) għal perijodi twal ta' żmien.
English: Rivastigmine may exacerbate or induce extrapyramidal symptoms.
Maltese: Prekawzjonijiet u twissijiet oħrajn Rivastigmine jista' jaggrava jew jikkawża sintomi ekstrapiramidali.
English: The most commonly reported skin irritation events during the first 24 weeks of the double-blind period with rivastigmine 13.3 mg/24 h transdermal patches and rivastigmine 9.5 mg/24 h transdermal patches, respectively were application site erythema (5.7% vs 4.6%) and application site pruritus (3.6% vs 2.8%).
Maltese: L-avvenimenti ta' irritazzjoni tal-ġilda l-aktar komuni matul l-ewwel 24 ġimgħa tal-perjodu double-blind bil-garża Rivastigmine 3M Health Care Ltd. li tipprovdi mediċina li tgħaddi minn ġol-ġilda 13.3 mg/24 siegħa u garża Exelon li tipprovdi mediċina li tgħaddi minn ġol-ġilda 9.5 mg/24 siegħa, rispettivament kienu eritema fis-sit tal-applikazzjoni (5.7% vs 4.6%) u ħakk fis-sit tal-applikazzjoni (3.6% vs 2.8%).
English: According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Maltese: Minħabba l-metaboliżmu tiegħu, mhux mistenni li jkun hemm interazzjonijiet metaboliċi ma' prodotti mediċinali oħra, għalkemm rivastigmine jista' jinibixxi l-metaboliżmu medjat minn butyrylcholinesterase ta' sustanzi oħrajn.
English: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain
Maltese: Dardir, rimettar, dijarea, dispepsja, uġigħ addominali
English: Patients involved in the active comparator controlled study had an initial baseline MMSE score of 10-24.
Maltese: Pazjenti li ħadu sehem fl-istudju ta' paragun attiv ikkontrollat kellhom punteġġ MMSE inizjali tallinja bażi ta' 10-24.
English: However, due to increased exposure in these populations as observed with the oral forms, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant hepatic impairment might experience more adverse reactions.
Maltese: Ma nstabet l-ebda evidenza ta' kanċeroġeniċità fi studji orali u topiċi fuq ġrieden u fi studju orali filfirien meta ngħatat id-doża massima tollerata.
English: Elimination was absorption rate limited (flip-flop kinetics), which explains the longer t½ after transdermal patch (3.4 h) versus oral or intravenous administrations (1.4 to 1.7 h).
Maltese: Leliminazzjoni kienet limitata mir-rata ta' assorbiment (kinetika flip-flop), li tispjega għalhiex it-t½ ikun itwal wara l-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda (3.4 sigħat kontra l-għotjiet orali jew minn ġol-vini (1.4 sa 1.7 sigħat).
English: Table 1 displays the adverse reactions reported in 854 patients with Alzheimer's dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with rivastigmine transdermal patches for a duration of 24-48 weeks and from post-marketing data.
Maltese: Tabella 1 turi r-reazzjonijiet avversi rrappurtati fi 854 pazjent bid-dimenzja ta' Alzheimer ikkurati fi studji kliniċi randomizzati, double-blind u kkontrollati bi plaċebo u b'mod attiv bil-garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon u doża mmirata ta' 9.5 mg/24 siegħa għal perjodu ta' 24-48 ġimgħa u mid-data ta' wara t-tqegħid tal-prodott fis-suq.
English: CI - confidence interval.
Maltese: WAĦDA ġdida.
English: Application site skin reactions (e.g. application site erythema, application site pruritus, application site oedema, application site dermatitis, application site irritation), asthenic conditions (e.g. fatigue,
Maltese: Mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli) - Reazzjoni allerġika fuq il-post ta' applikazzjoni tal-garża, bħalma huma nfafet jew
English: In the 24-week doubleblind study, the most commonly observed symptoms (skin irritation rating scale) with rivastigmine 9.5 mg/24 h transdermal patches were very slight (21.8%), mild (12.5%) or moderate (6.5%) erythema or very slight (11.9%), mild (7.3%) or moderate (5.0%) pruritus.
Maltese: Fl-istudju doubleblind ta' 24 ġimgħa, l-aktar sintomi li dehru ta' spiss (skala ta' stima tal-irritazzjoni tal-ġilda) b'garżi ta' rivastigmine li jipprovdu mediċina li tgħaddi minn ġol-ġilda 9.5 mg/24 siegħa kienu ħmura ħafifa ħafna (21.8%), ħafifa (12.5%) jew moderata (6.5%) jew ħakk ħafif ħafna (11.9%), ħafif (7.3%) jew moderat (5.0%).
English: The study was designed to compare the efficacy of the 13.3 mg/24 h transdermal patch against the 9.5 mg/24 h transdermal patch during a 48-week double-blind treatment phase in Alzheimer's disease patients who demonstrated functional and cognitive decline after an initial 24-48 week openlabel treatment phase while on a maintenance dose of 9.5 mg/24 h transdermal patch.
Maltese: L-istudju ġie maħsub b'mod li jqabbel l-effikaċja tal-garża Exelon li tipprovdi mediċina li tgħaddi minn ġol-ġilda 13.3 mg/24 siegħa mal-garża Exelon li tipprovdi mediċina li tgħaddi minn ġol-ġilda 9.5 mg/24 siegħa matul fażi ta' kura double-blind ta' 48 ġimgħa f'pazjenti bilmarda ta' Alzheimer li wrew tnaqqis funzjonali u konjittiv wara fażi inizjali ta' trattament open-label ta' 24-48 ġimgħa waqt li kienu qed jingħataw doża ta' manteniment ta' garża Exelon li tipprovdi mediċina li tgħaddi minn ġol-ġilda 9.5 mg/24 siegħa.
English: Although less pronounced than with the oral formulation, exposure to rivastigmine (Cmax and AUC) increased over-proportionally by a factor of 2.6 and 4.9 when escalating from 4.6 mg/24 h to 9.5 mg/24 h and to 13.3 mg/24 h, respectively.
Maltese: Għalkemm mhux daqs kemm jiġri bil-formulazzjoni orali, l-esponiment għal rivastigmine (Cmax u AUC) żdied b'mod sproporzjonat b'fattur ta' 2.6 u 4.9 meta saret iż-żieda minn 4.6 mg/24 siegħa għal 9.5 mg/24 siegħa u għal 13.3 mg/24 siegħa, rispettivament.
English: - Patients with body weight below 50 kg: Particular caution should be exercised in titrating patients with body weight below 50 kg above the recommended effective dose of 9.5 mg/24 h (see section 4.4).
Maltese: - Pazjenti b'piż tal-ġisem ta' inqas minn 50 kg: Għandha tiġi eżerċitata kawtela speċjali fittitrazzjoni pazjenti b'piż ta' inqas minn 50 kg għad-doża effettiva rakkomandata ta' 9.5 mg/24 siegħa (ara sezzjoni 4.4).
English: Other medicines and Rivastigmine 3M Health Care Ltd.
Maltese: Mediċini oħra u Rivastigmine 3M Health Care Ltd.
English: NAP226-90) and bodyweight was observed in Alzheimer's dementia patients.
Maltese: Relazzjoni bejn l-esponiment għas-sustanza attiva fi stat fiss (rivastigmine u l-metabolu NAP226-90) u l-piż tal-ġisem deher f'pazjenti bid-dimenzja ta' Alzheimer.
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and oral rivastigmine.
Maltese: Ma ġew osservati l-ebda effetti ħżiena fuq ilkonduttività kardijaka, meta ngħataw digoxin u rivastigmine fl-istess ħin.
English: N is the number of patients with an assessment at baseline (last assessment in the initial open-label phase) and with at least 1 post-baseline assessment (for the LOCF).
Maltese: N huwa n-numru ta' pazjenti b'evalwazzjoni fil-linja bażi (l-aħħar evalwazzjoni fil-fażi open-label inizjali) u b'mill-inqas evalwazzjoni 1 ta' wara l-linja bażi (għal-LOCF).
English: The backing layer is transparent to translucent, labelled with “R5” in a repeated pattern.
Maltese: Is-saff li jirinforza huwa trasparenti għal trasluċidu, immarkat b' mudell ripetut ta' "R5".
English: Common (may affect up to 1 in 10 people) - Loss of appetite - Feeling dizzy - Feeling agitated or sleepy - Urinary incontinence (inability to retain adequate urine)
Maltese: Komuni (jista' jaffettwa sa persuna waħda minn kull 10) - Nuqqas ta' aptit - Tħossok stordut - Tħossok aġitat ħafna jew bin-ngħas - Inkontinenza urinarja (nuqqas ta' kapaċità li żżomm l-awrina b'mod adegwat)
English: Rivastigmine interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes.
Maltese: Rivastigmine jkollu interazzjoni mal-enzimi speċifiċi tiegħu billi jifforma kumpless marbut b'mod kovalenti li temporanjament jagħmel l-enzimi inattivi.
English: If well tolerated and only after a minimum of six months of treatment at 9.5 mg/24 h, the treating physician may consider increasing the dose to 13.3 mg/24 h in patients who have demonstrated a meaningful cognitive deterioration (e.g. decrease in the MMSE) and/or functional decline (based on physician judgement) while on the recommended daily effective dose of 9.5 mg/24 h (see section 5.1).
Maltese: Jekk ikun ittollerat tajjeb u biss wara minimu ta' sitt xhur ta' kura b'9.5 mg/24 siegħa, it-tabib li jkun qed jikkura jista' jikkunsidra li jżid id-doża għal 13.3 mg/24 siegħa f'pazjenti li wrew deterjorazzjoni konjittiva qawwija (eż. tnaqqis fl-MMSE) u/jew tnaqqis funzjonali (skont il-ġudizzjoni tat-tabib) waqt li jingħataw d-doża effettiva ta' kuljum rakkomandata ta' 9.5 mg/24h (ara sezzjoni 5.1).
English: Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with rivastigmine capsules or oral solution can be switched to Rivastigmine 3M Health Care Ltd. transdermal patches as follows: - A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Maltese: Mit-tqabbil tal-esponimenti ta' rivastigmine orali u dak li jgħaddi minn ġol-ġilda (ara sezzjoni 5.2), pazjenti ikkurati bil-kapsuli rivastigmine jew soluzzjoni orali jistgħu jinqalbu għall-garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Rivastigmine 3M Health Care Ltd. kif ġej:
English: As suggested by compartmental modelling, 9.5 mg/24 h transdermal patches exhibited exposure similar to that provided by an oral dose of 12 mg/day.
Maltese: Hekk kif indikat minn mudellar tal-kompartimenti, garżi li jipprovdu mediċina li tgħaddi minn ġolġilda 9.5 mg/24 siegħa urew esponiment simili għal dak li jinkiseb b'doża orali ta' 12 mg/jum.
English: Each transdermal patch of 4.15 cm2 contains 7.17 mg of rivastigmine.
Maltese: Kull garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda ta' 4,15 cm2 fiha 7,17 mg ta' rivastigmine.
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 għandu jwettaq l-attivitajiet u interventi ta' farmakovigilanza kif inhu maqbul fl-RMP ppreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għatTqegħid fis-Suq u kwalunkwe aġġornament sussegwenti tal-RMP.
English: Rivastigmine is weakly bound to plasma proteins (approximately 40%).
Maltese: Rivastigmine huwa marbut b'mod dgħajjef mal-proteini fil-plażma (bejn wieħed u ieħor 40%).
English: Rivastigmine 13.3 mg/24 h
Maltese: Rivastigmine 13.3mg/24 siegħa