FrancophonIA/ELRC3.0 huggingface dataset:
English: Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg. - The other ingredients are sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye
Maltese: - Is-sustanzi l-oħra huma sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye
English: Patients involved in the placebo-controlled study had an MMSE (Mini-Mental State Examination) score of 10-20.
Maltese: Pazjenti li ħadu sehem fl-istudju kkontrollat bi plaċebo kellhom punteġġ MMSE (Eżami Żgħir tal-Istat Mentali) ta' 10-20.
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 10
Maltese: Rivastigmine ma kienx mutaġeniku f'ġabra ta' testijiet standard in vitro u in vivo, ħlief f'test ta' aberrazzjoni tal-kromosomi f'limfoċiti umani periferali meta ngħatat doża li qabżet l-10
English: - Prometax 9.5 mg/24 h transdermal patches: Each patch releasing 9.5 mg of rivastigmine per 24 hours is 10 cm and contains 18 mg of rivastigmine.
Maltese: Kull garża terħi 9.5 mg ta' rivastigmine kull 24 siegħa, hija 10 cm u fiha 18 mg rivastigmine.
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 lgħoti tal-għamla orali.
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: Prometax 1.5 mg hard capsules rivastigmine
Maltese: Prometax 1.5 mg kapsuli ibsin rivastigmine
English: The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations ((Cmax-Cmin)/Cavg), was 0.58 for Prometax 4.6 mg/24 h transdermal patches, 0.77 for Prometax 9.5 mg/24 h transdermal patches and 0.72 for Prometax 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: 72 għal garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Prometax 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: Adhesive matrix
Maltese: Mhux applikabbli.
English: Musculoskeletal stiffness Rigors
Maltese: Disturbi fl-ekwilibriju Riġidità muskolu-skeletrali Ebusija tal-ġisem
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30%.
Maltese: Meta rivastigmine jingħata mal-ikel, l-assorbiment (tmax) jittardja b'90 minuta u s-Cmax jonqos u l-AUC jiżdied b'bejn wieħed u ieħor 30%.
English: N=444
Maltese: Plaċebo N=444
English: C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Maltese: C-rivastigmine, l-eliminazzjoni mill-kliewi kienet mgħaġġla u kienet kważi kompleta (>90%) fi żmien 24 siegħa.
English: Each Prometax 3.0 mg capsule contains 3.0 mg of rivastigmine.
Maltese: Kull kapsula Prometax ta' 3.0 mg fiha 3.0 mg rivastigmine.
English: 1 capsule contains 6.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Maltese: Kapsula waħda jkun fiha 6.0 mg rivastigmine bħala rivastigmine hydrogen tartrate.
English: 1 capsule contains 1.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
Maltese: Kapsula waħda jkun fiha 1.5 mg rivastigmine bħala rivastigmine hydrogen tartrate.
English: [folding box only]
Maltese: [kaxxa li tintlewa biss]
English: Bradykinesia
Maltese: Bradikajneżja
English: Table 1 displays the adverse reactions reported in 1,670 patients with Alzheimer's dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with Prometax transdermal patches for a duration of 24-48 weeks and from post-marketing data.
Maltese: Tabella 1 turi r-reazzjonijiet avversi rrappurtati fi 1,670 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 Prometax 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: Cogwheel rigidity
Maltese: TAGĦRIF
English: The outside of the backing layer is beige and labelled with “Prometax”, “9.5 mg/24 h” and “BHDI”.
Maltese: In-naħa ta' barra tas-saff ta' wara huwa bex u tikkettat b'“Prometax”, “9.5 mg/24 h” u “ BHDI”.
English: Prometax 4.5 mg hard capsules rivastigmine
Maltese: Prometax 4.5 mg kapsuli ibsin rivastigmine
English: - Prometax 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “ENA 713 6 mg” on the body.
Maltese: - Prometax 6.0 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu aħmar u korp oranġjo, b'timbru aħmar “ENA 713 6 mg” fuq il-korp.
English: You should not breast-feed during treatment with Prometax.
Maltese: M'għandekx tredda' waqt li qed tingħata trattament b'Prometax.
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by rivastigmine was similar to that of AChE.
Maltese: L-inibizzjoni tal-attività tat-tip butyrylcholinesterase fis-CSF ta' 14-il pazjent bil-marda ta' Alzheimer li kienu kkurati b'rivastigmine kienet simili għal dik ta' AChE.
English: Prometax 4.5 mg hard capsules
Maltese: Prometax 4.5 mg kapsuli ibsin
English: Prometax 3.0 mg hard capsules rivastigmine
Maltese: Prometax 3.0 mg kapsuli ibsin rivastigmine
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 Prometax li tipprovdi mediċina li tgħaddi minn ġol-ġilda 13.3 mg/24 siegħa mal-garża Prometax 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 Prometax li tipprovdi mediċina li tgħaddi minn ġol-ġilda 9.5 mg/24 siegħa.
English: • Do not store above 25°C.
Maltese: • Taħżinx f'temperatura 'l fuq minn 25°C.
English: The DLSM, 95% CI, and p-value are based on an ANCOVA (analysis of covariance) model adjusted for country and baseline ADAS-cog score.
Maltese: Id-DLSM, 95% CI, u Valur p huma bbażati fuq mudell ANCOVA (analiżi ta' kovarjanza) aġġustat għall-pajjiż u għall-punteġġ ADAS-cog tal-linja bażi. * p<0.05
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 3.0 mg rivastigmine.
English: - Prometax 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “ENA 713 3 mg” on the body.
Maltese: - Prometax 3.0 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu oranġjo u korp oranġjo, b'timbru aħmar “ ENA 713 3 mg” fuq il-korp.
English: Prometax 6.0 mg hard capsules
Maltese: Prometax 6.0 mg kapsuli ibsin
English: Other medicines and Prometax
Maltese: Mediċini oħra u Prometax
English: The patients studied had an MMSE (Mini-Mental State Examination) score of 10-24.
Maltese: Żgħir tal-Istat Mentali) ta' 10-24.
English: Mean baseline  SD Mean change at week 24  SD -0.1  9.1 p-value versus placebo * p≤0.05 versus placebo ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward Based on ANCOVA with treatment and country as factors and baseline value as a covariate.
Maltese: Medja mill-linja bażi  SD Medja tal-bidla f'ġimgħa 24  SD Valur-p kontra l-plaċebo * p≤0.05 versus plaċebo ITT: Intenzjoni-Li-Tikkura; LOCF: L-Aħħar
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: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Prometax 1.5 mg hard capsules
Maltese: Prometax 1.5 mg kapsuli ibsin
English: What Prometax looks like and contents of the pack - Prometax 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on the body.
Maltese: Kif jidher Prometax u l-kontenut tal-pakkett - Prometax 1.5 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu isfar u korp isfar, b'timbru aħmar “ ENA 713 1,5 mg” fuq il-korp.
English: The patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.
Maltese: Jiġi f'pakketti li jkun fihom 7 jew 30 qartas u f'pakketti b'ħafna li jkollhom 60 jew 90 qartas.
English: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8);
Maltese: imblukkar atrijuventrikulari) (ara sezzjoni 4.8);
English: Polyester film, fluoropolymer-coated
Maltese: Pankreatite Disturbi fil-fwied u fil-marrara
English: Prometax 3.0 mg hard capsules
Maltese: Prometax 3.0 mg kapsuli ibsin
English: 1 transdermal patch of 15 cm contains 27 mg rivastigmine and delivers 13.3 mg/24 h.
Maltese: Garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda 1 ta' 15 cm2 fiha 27 mg ta' rivastigmine u terħi 13.3 mg/24 siegħa.
English: No dose adjustment is necessary in patients with renal impairment (see section 4.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment renali (ara sezzjoni 4.2).
English: Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “ENA 713 3 mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu oranġjo u korp oranġjo, u stampata bl-aħmar “ENA 713 3 mg” fuq il-korp.
English: Administration of rivastigmine oral solution with food delays absorption (tmax) by 74 min and lowers Cmax by 43% and increases AUC by approximately
Maltese: Meta rivastigmine bħala soluzzjoni orali jingħata mal-ikel, l-assorbiment (tmax) jittardja b'74 minuta u is-Cmax jonqos b'43% u l-AUC jiżdied b'bejn wieħed u ieħor 9%.
English: While bioavailability of rivastigmine is greater in elderly than in young healthy volunteers, studies in Alzheimer patients aged between 50 and 92 years showed no change in bioavailability with age.
Maltese: Filwaqt li l-biodisponibilità ta' rivastigmine hija ogħla fl-anzjani milli fil-voluntiera żgħażagħ b'saħħithom, studji fuq pazjenti li jbatu mill-marda ta' Alzheimer li kellhom bejn 50 u 92 sena ma wrew l-ebda tibdil fil-biodisponibilità bl-eta`.
English: - Prometax 4.6 mg/24 h transdermal patches: Each patch releasing 4.6 mg of rivastigmine per 24 hours is 5 cm and contains 9 mg of rivastigmine.
Maltese: Kull garża terħi 4.6 mg ta' rivastigmine kull 24 siegħa, hija 5 cm u fiha 9 mg rivastigmine.
English: N is the number of patients with an assessment at baseline (last assessment in the initial openlabel 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: 1 capsule contains 4.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
Maltese: Kapsula waħda jkun fiha 4.5 mg rivastigmine bħala rivastigmine hydrogen tartrate.
English: Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “ENA 713 6 mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu aħmar u korp oranġjo, u stampata bl-aħmar “ENA 713 6 mg” fuq il-korp.
English: 1 capsule contains 3.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Maltese: Kapsula waħda jkun fiha 3.0 mg rivastigmine bħala rivastigmine hydrogen tartrate.
English: In two 24-week double-blind, placebo-controlled clinical trials, skin reactions were measured at each visit using a skin irritation rating scale.
Maltese: Fi studji kliniċi double-blind, ikkontrollati bil-plaċebo u li damu 24 ġimgħa, ir-reazzjonijiet tal-ġilda tkejlu waqt kull viżta billi ntużat skala li tkejjel l-irritazzjoni tal-ġilda.
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Maltese: Rivastigmine jaħdem billi jimblokka l-enzimi li jfarrku lacetylcholine: acetylcholinesterase u butyrylcholinesterase.
English: Otherwise your doctor will restart your treatment on Prometax 4.6 mg/24 h.
Maltese: Inkella t-tabib tiegħek jerġa' jibda t-trattament tiegħek b'Prometax b'4.6 mg/24 h.
English: Prometax capsules 12 mg/day N = 256
Maltese: Prometax 15 ċm N = 265
English: Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ENA 713 4,5 mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu aħmar u korp aħmar, u stampata blabjad“ENA 713 4,5 mg” fuq il-korp.
English: Elevated liver function tests
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Store in an upright position.
Maltese: Uġigħ addominali u dispepsja
English: However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent 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: What Prometax looks like and contents of the pack Prometax oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug.
Maltese: Prometax soluzzjoni orali jiġi bħala 50 ml jew 120 ml soluzzjoni ċara, safra (bażi ta' 2.0 mg/ml), fi flixkun magħmul minn ħġieġ kannella, b'għatu li ma jinfetaħx mit-tfal, b'kisja tal-fowm, b'tubu biex tbill, u b'tapp li jipożizzjona lilu nnifsu.
English: • Tell your caregiver that you are taking Prometax.
Maltese: • Għid lil min ikun qed jikkurak li qed tieħu Prometax.
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with Prometax.
Maltese: Ir-reazzjonijiet avversi li ġejjin, elenkati hawn taħt f'Tabella 1, kienu miġbura minn pazjenti kkurati b'Prometax għal dimenzja t'Alzheimer.
English: The mean actual daily dose for responders in the 6-12 mg group, corresponding to this definition, was 9.3 mg.
Maltese: Id-doża medja attwali ta' kuljum għal dawk li wrew rispons fil-grupp ta' minn 6 mg sa 12-il mg li tikkorrispondi ma' din id-definizzjoni hija ta' 9.3 mg.
English: Hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva rivastigmine, għal derivattivi tat-tip carbamate jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: 1 transdermal patch of 5 cm contains 9 mg rivastigmine and delivers 4.6 mg/24 h.
Maltese: Garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda 1 ta' 5 cm2 fiha 9 mg ta' rivastigmine u terħi 4.6 mg/24 siegħa.
English: Clinical monitoring is recommended for these adverse reactions.
Maltese: Huwa rrikkmandat monitoraġġ kliniku għal dawn irreazzjonijiet avversi.
English: 1 transdermal patch of 10 cm contains 18 mg rivastigmine and delivers 9.5 mg/24 h.
Maltese: Garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda 1 ta' 10 cm2 fiha 18 mg ta' rivastigmine u terħi 9.5 mg/24 siegħa.
English: EU/1/98/092/023-026 EU/1/98/092/035-038
Maltese: EU/1/98/092/035-038
English: Muscle rigidity
Maltese: • Wisq riq u deidrazzjoni
English: The following additional adverse reactions have been observed with Prometax transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Maltese: Ir-reazzjonijiet avversi li ġejjin dehru bil-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda Prometax: thewdin, deni, tnaqqis fl-aptit, inkontinenza fl-awrina (komuni), attività psikomotorili eċċessiva (mhux komuni), eritema, urtikarja, nfafet, dermatite allerġika (mhux magħrufa).
English: SACHET
Maltese: Sturdament
English: EU/1/98/092/027-030 EU/1/98/092/039-042
Maltese: EU/1/98/092/039-042
English: Prometax 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: Prometax jista' jinterferixxi ma' mediċini antikolinerġiċi li wħud minnhom huma mediċini li jintużaw biex itaffu weġgħat fl-istonku jew spażmi (eż. dicyclomine), għal kura tal-marda ta' Parkinson (e.g. amantadine) jew biex jevitaw it-tqalligħ waqt iċ-ċaqliq (eż. diphenhydramine, scopolamine, jew meclizine).
English: Alpha-tocopherol
Maltese: Matriċi li jkun fiha l-mediċina Alpha-tocopherol
English: It was rated as severe in ≤2.2% of patients in these studies and in ≤3.7% of patients treated with Prometax transdermal patches in a Japanese study.
Maltese: Fi studju fil-Ġappun, din tkejlet bħala gravi fi ≤2.2% tal-pazjenti f'dawn l-istudji u fi ≤3.7% tal-pazjenti ttrattati b'Prometax garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda.
English: times the maximum clinical exposure.
Maltese: darbiet ogħla millesponiment kliniku.
English: • to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8);
Maltese: • lill-pazjenti b'ulċeri attivi fl-istonku jew tad-duwodenu jew pazjenti li huma predisposti għal dawn il-kondizzjonijiet għaliex rivastigmine jista' jżid is-sekrezzjonijiet tal-istonku (ara sezzjoni 4.8);
English: Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10-24.
Maltese: Il-pazjenti involuti f'dan l-istudju kellhom punteġġ ta' MMSE (Eżami Żgħir talIstat Mentali) ta' 10-24.
English: Prometax 4.6 mg/24 h transdermal patch rivastigmine
Maltese: Prometax 4.6 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda rivastigmine
English: Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action.
Maltese: Studji tat-tossiċità bid-doża ripetuta li saru fuq firien, ġrieden u klieb, wrew biss effetti assoċjati ma' azzjoni farmakoloġika esaġerata.
English: The incidence of application site skin reactions leading to discontinuation was higher in the Asian population with 4.9% and 8.4% in the Chinese and Japanese population respectively.
Maltese: L-inċidenza ta' reazzjonijiet tal-ġilda fejn tiġi applikata li jwasslu sabiex jitwaqqaf il-prodott kienet ogħla fost il-popolazzjoni Asjatika b'4.9% u bi 8.4% fost il-popolazzjoni Ċiniża u Ġappuniża rispettivament.
English: • Stomach ulcer
Maltese: • Ulċera fl-imsaren
English: N=472
Maltese: Plaċebo N=472
English: Mean baseline  SD
Maltese: Kif timla s-siringa
English: Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Maltese: Lek Pharmaceuticals d.d. Tel: +386 1 580 33 27
English: The Cmax of rivastigmine was approximately 60% higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Maltese: Is-Cmax ta' rivastigmine kien bejn wieħed u ieħor 60% ogħla u l-AUC ta' rivastigmine kien aktar minn darbtejn ogħla f'pazjenti li kellhom indeboliment epatiku ħafif għal moderat, meta dawn kienu mqabbla ma' individwi b'saħħithom.
English: 30 transdermal patches.
Maltese: Bidla pożittiva tindika titjib.
English: EU/1/98/092/029 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/030 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/041 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/042 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
Maltese: EU/1/98/092/041 60 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA) EU/1/98/092/042 90 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA)
English: These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, 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 relating to finances, etc.).
Maltese: Dawn jinkludu l-ADAS-Cog (Skala ta' Evalwazzjoni tal-Marda ta' Alzheimer - Sottoskala konjittiva, sistema ta' kejl tal-konjizzjoni bbażata fuq il-ħila), is-CIBIC-Plus (Intervista mit-Tabib Imsejsa fuq Impressjoni ta' Change-Plus, stima globali komprensiva tal-pazjent mit-tabib, li tinkorpora l-involviment ta' min ikun qed jieħu ħsieb il-kura tas-saħħa), u l-PDS (Skala ta' Deterjorazzjoni Progressiva, stima magħmula minn min ikun qed jieħu ħsieb il-kura tas-saħħa, tal-attivitajiet tal-ħajja ta' kuljum li jinkludu l-iġene personali, l-ikel, l-ilbies, il-faċendi tad-dar bħax-xiri, iż-żamma tal-ħila li wieħed jorjenta ruħu fl-ambjent tal-madwar, kif ukoll l-involviment f'attivitajiet relatati ma' finanzi eċċ.).
English: Particular caution must be exercised in titrating these patients (see sections 4.2 and 5.2).
Maltese: Għandu jkun hemm attenzjoni speċjali meta tiġi miżjuda d-doża f'dawn ilpazjenti (ara sezzjonijiet 4.2 u 5.2).
English: Backing layer
Maltese: Użu orali
English: • Stomach pain
Maltese: • Wisq riq
English: When normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the maximum human dose, a multiple of approximately 6-fold was achieved in animals.
Maltese: Meta ġew imqabbla skont l-erja tas-superfiċje tal-ġisem, lesponiment għal rivastigmine u l-metaboli tiegħu kienet bejn wieħed u ieħor ekwivalenti għad-doża massima rrikkmandata ta' 12 mg kuljum; madankollu, meta mqabbla mad-doża massima fil-bniedem, livelli ta' bejn wieħed u ieħor 6 darbiet aktar kienu milħuqa fl-annimali.
English: Prometax 13.3 mg/24 h transdermal patch rivastigmine
Maltese: Prometax 13.3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda rivastigmine
English: EU/1/98/092/019-022 EU/1/98/092/031-034
Maltese: EU/1/98/092/031-034
English: • Do not open or crush the capsules.
Maltese: • M'għandekx tiftaħ jew tfarrak il-kapsuli.
English: FOLDING BOX
Maltese: Pressjoni baxxa