FrancophonIA/ELRC3.0 huggingface dataset:
English: • The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux, and oesophagitis:
Maltese: • Il-kumpless tas-sintomu dispeptiku li sikwit huwa assoċjat ma' tbattil gastriku ttardjat, rifluss gastro-esofagali, u esofaġite:
English: Domperidone-containing medicines are available as over-the-counter (OTC) or prescription-only medicines (POM).
Maltese: Mediċini li fihom domperidone huma disponibbli bħala mediċini minn fuq il-bank (OTC) jew mediċini esklussivament bi preskrizzjoni (POM).
English: A formulation for intravenous (IV) administration was discontinued in 1985.
Maltese: Il-formulazzjoni intravenuża (IV) twaqqfet fl-1985.
English: It is therefore important that the risk is minimised by restricting the maximum dose (10 mg up to 3 times a day for adults and adolescents 12 years of age and older and weighing ≥ 35 kg), limiting treatment duration to the shortest necessary to control symptoms and contraindicating other drugs that are also known to prolong the QT-interval.
Maltese: Għalhekk huwa importanti li r-riskju jiġi minimizzat billi tiġi ristretta d-doża massima (10 mg sa 3 darbiet kuljum għall-adulti u l-adolexxenti ta' 12-il sena u aktar u li jiżnu ≥ 35 kg), jiġi limitat it-tul talkura għall-inqas żmien meħtieġ biex jiġu kkontrollati s-sintomi u jiġu kontroindikati mediċini oħrajn li huma magħrufin ukoll li jtawlu l-intervall QT.
English: Whenever approved, it is noted that the currently recommended posology varies between products, ranging from 0.25-0.5 mg/kg 3 to 4 times a day.
Maltese: Kull meta jiġi approvat, huwa nnotat li l-pożoloġija rakkomandata fil-preżent tvarja bejn prodotti, u din tvarja bejn 0.25-0.5 mg/kg 3 sa 4 darbiet kuljum.
English: • The PRAC considered that the risk of serious cardiac adverse drug reactions can be minimised by using lower doses of domperidone, limiting treatment duration and contraindicating treatment for patients at particularly high risk (patients with moderate or severe hepatic impairment, patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure) and patients concurrently taking QT-prolonging drugs or potent CYP3A4 inhibitors.
Maltese: • Il-PRAC ikkunsidra li r-riskju ta' reazzjonijiet avversi serji tal-mediċini kardijaċi jista' jiġi mminimizzat billi jintużaw dożi aktar baxxi ta' domperidone, jiġi llimitat it-tul tal-kura u tiġi kontraindikata l-kura għal pazjenti f'riskju partikolarment għoli (pazjenti b'indeboliment epatiku moderat jew sever, pazjenti li jkun magħruf li għandhom titwil eżistenti ta' intervalli ta' konduzzjoni kardijaċi, partikolarment QTc, pazjenti b'disturbi sinifikanti tal-elettroliti jew mard tal-qalb sottostanti bħal insuffiċjenza tal-qalb konġestiva) u pazjenti li fl-istess ħin ikunu qed jieħdu mediċini li jtawlu l-QT jew inibituri qawwija ta' CYP3A4.
English: The available clinical and non-clinical data consistently indicates that there is an increased risk of serious and potentially life-threatening cardiac adverse drug reactions associated with domperidone use.
Maltese: Id-dejta klinika u mhux klinika disponibbli konsistentement indikat li hemm riskju akbar ta' reazzjonijiet kardijaċi avversi serji u potenzjalment fatali assoċjati mal-użu ta' domperidone.
English: The International Birth Date for domperidone has been designated as March 1978, based on the first approval of domperidone in Belgium.
Maltese: Id-Data tat-Twelid Internazzjonali ta' domperidone ġiet innominata bħala Marzu 1978, ibbażata fuq l-ewwel approvazzjoni ta' domperidone fil-Belġju.
English: Subsequently, cardiovascular events including risk of QT-prolongation, arrhythmia and sudden cardiac death in association with other pharmaceutical forms of domperidone have since been discussed at the European level by the Pharmacovigilance Working Party (PhVWP).
Maltese: Sussegwentement, avvenimenti kardjovaskulari inkluż riskju ta' titwil tal-QT, arritmija u mewta kardijaka għall-għarrieda b'rabta ma' forom farmaċewtiċi oħra ta' domperidone sadanittant ġew diskussi fil-livell Ewropew mill-Grupp ta' Ħidma tal-Farmakoviġilanza (PhVWP).
English: o Is not favourable for high dose oral formulations (higher than 10 mg).
Maltese: o Mhuwiex favorevoli għall-formulazzjonijiet orali ta' doża għolja (ogħla minn 10 mg).
English: o epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain o bloating, eructation, flatulence o nausea and vomiting o heartburn with or without regurgitations of gastric contents in the mouth
Maltese: o sens epigastriku ta' mili, xaba' kmieni, sensazzjoni ta' nefħa addominali, uġigħ fin-naħa ta' fuq tal-addome o nefħa, tifwiq, gass o dardir u rimettar o ħruq ta' stonku bi jew mingħajr rimettar tal-kontenut gastriku fil-ħalq
English: Domperidone is not approved in all Member States for paediatric use in the subpopulation under 12 years of age and adolescents weighing <35 kg.
Maltese: Domperidone mhuwiex approvat fl-Istati Membri għall-użu pedjatriku fis-subpopolazzjoni taħt it-12-il sena u adolexxenti li jiżnu <35 kg.
English: • The PRAC considered that domperidone is associated with an increased risk of serious cardiac adverse drug reaction, including QT prolongation and sudden cardiac death.
Maltese: • Il-PRAC ikkunsidra li domperidone huwa assoċjat ma' riskju akbar ta' reazzjonijiet avversi serji għal mediċini kardijaċi, inkluż titwil tal-QT u mewt kardijaku għall-għarrieda.
English: The extrapolation of existing pharmacokinetic data allows for a conclusion that the 30 mg suppository administered twice a day should be equivalent to the 10 mg oral formulation administered 3 times a day.
Maltese: L-estrapolazzjoni ta' dejta farmakokinetika eżistenti tippermetti li tinstilet il-konklużjoni li s-suppożitorju ta' 30 mg li jingħata darbtejn kuljum għandu jkun ekwivalenti għall-10 mg ta' formulazzjoni orali li tingħata 3 darbiet kuljum.
English: The PRAC also considered that the combination domperidone/cinnarizine, which contains 15 mg domperidone (higher than the newly recommended individual dose), has a negative benefit-risk balance.
Maltese: Il-PRAC ikkunsidra wkoll li l-kombinazzjoni domperidone/cinnarizine, li fiha 15 mg domperidone (ogħla mid-doża individwali li għadha kif ġiet rakkomandata), għandha bilanċ tal-benefiċċju-riskju negattiv.
English: • The PRAC considered that the pharmacokinetic data supporting the rectal formulations is limited, and therefore recommended that further data be generated to allow for a comparison between the oral and rectal formulations.
Maltese: • Il-PRAC ikkunsidra li d-dejta farmakokinetika li ssostni l-formulazzjonijiet tar-rektum hija limitata, u għalhekk irrakkomanda li tkun iġġenerata aktar dejta sabiex ikun jista' jsir tqabbil bejn il-formulazzjonijiet orali u tar-rektum.
English: For all indications other than “relief of symptoms of nausea and vomiting”, there is extremely limited evidence of efficacy of domperidone, and therefore the potential benefits are considered to be outweighed by the identified cardiac risk.
Maltese: Għall-indikazzjonijiet kollha minbarra "serħan mis-sintomi tad-dardir u rimettar", hemm evidenza limitata ħafna ta' effikaċja tad-domperidone, u għalhekk il-benefiċċji potenzjali huma kkunsidrati li jegħlbu r-riskju kardijaku identifikat.
English: The CMDh, having considered the PRAC recommendation dated 6 March 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation or revocation as applicable of the marketing authorisations of domperidone-containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Maltese: Is-CMDh, wara li qies ir-rakkomandazzjoni tal-PRAC datata 6 ta' Marzu, 2014 skont l-Artikolu 107k(1) u (2) tad-Direttiva 2001/83/KE, laħaq pożizzjoni dwar il-varjazzjoni jew ir-revoka kif applikabbli talawtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom domperidone, li għalihom issezzjonijiet rilevanti tas-sommarju tal-karatteristiċi tal-prodott u fuljett ta' tagħrif huma stabbiliti flAnness
English: Off-label use of domperidone is known to exist for conditions such as GERD, gastroparesis and stimulation of lactation.
Maltese: Huwa magħruf li jeżisti użu bla tikketta ta' domperidone għal kondizzjonijiet bħal GERD, gastroparesi u stimulazzjoni tat-treddigħ.
English: A possible association between domperidone and QT-prolongation and cardiac adverse events was identified in the mid-1980s, when high and rapidly administered intravenous doses were used as an anti-emetic during cytotoxic treatment in cancer patients.
Maltese: F'nofs is-snin tmenin, ġiet identifikata assoċjazzjoni possibbli bejn domperidone u titwil tal-QT u avvenimenti avversi kardijaċi, meta dożi intravenużi għoljin u amministrati b'mod rapidu ntużaw bħala anti-emetiċi matul kura ċitotossika f'pazjenti bil-kanċer.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of domperidone-containing medicinal products remains favourable subject to the conditions to the marketing authorisations, and taking into account the amendments to the product information and other risk minimisation measures recommended.
Maltese: Konsegwentament, il-PRAC ikkonkluda li l-bilanċ benefiċċju-riskju ta' prodotti mediċinali li fihom domperidone jibqa' favorevoli soġġett għall-kondizzjonijiet għall-awtorizzazzjonijiet għat-tqegħid fissuq, filwaqt li jitqiesu l-emendi għall-informazzjoni tal-prodott u miżuri oħrajn ta' minimizzazzjoni tarriskju rakkomandati.
English: However it is important that this be confirmed in an appropriate pharmacokinetic study.
Maltese: Madankollu huwa importanti li dan jiġi kkonfermat fi studju farmakokinetiku xieraq.
English: • Extend the timeframe for the submission of the final study report on condition 1 (generation of paediatric efficacy data).
Maltese: • Jittawlu l-iskadenzi għas-sottomissjoni tar-rapport finali tal-istudju bil-kondizzjoni 1 (ġenerazzjoni ta' dejta dwar l-effikaċja pedjatrika).
English: − oral formulations dosed higher than 10 mg
Maltese: − formulazzjonijiet orali b'doża ogħla minn 10 mg
English: • The PRAC was of the opinion that existing data, although limited, are indicative of efficacy in the indication ‘relief of symptoms of nausea and vomiting'.
Maltese: • Il-PRAC kien tal-fehma li d-dejta eżistenti, għalkemm limitata, hija indikattiva tal-effikaċja għall-indikazzjoni ‘serħan mis-sintomi ta' dardir u rimettar'.
English: • The PRAC was also of the opinion that existing data on the efficacy of domperidone in indications other than ‘relief of symptoms of nausea and vomiting' are very limited, and therefore the potential benefit is outweighed by the cardiac risk.
Maltese: • Il-PRAC kien ukoll tal-fehma li d-dejta eżistenti dwar l-effikaċja ta' domperidone f'indikazzjonijiet oħrajn minbarra ‘serħan mis-sintomi ta' dardir u rimettar' hija limitata ħafna, u għalhekk il-benefiċċju potenzjali huwa inqas mir-riskju tal-qalb.
English: For the reasons mentioned above, it is critical that patients are given the lowest possible effective dose and the PRAC considered that a recommendation for 0.25 mg/kg up to 3 times a day was appropriate.
Maltese: Għar-raġunijiet imsemmija hawn fuq, huwa kritiku li l-pazjenti jingħataw id-doża effettiva l-aktar baxxa possibbli u lPRAC ikkunsidra li rakkomandazzjoni ta' 0.25 mg / kg sa 3 darbiet kuljum kienet xierqa.
English: Domperidone is authorised also as a fixed-dose combination product with cinnarizine and indicated for the prevention and treatment of symptoms associated with motion sickness.
Maltese: Domperidone huwa awtorizzat ukoll bħala prodott ikkombinat ta' doża fissa ma' cinnarizine u huwa indikat għall-prevenzjoni u kura ta' sintomi assoċjati ma' dardir.
English: • The PRAC noted that, in the combination domperidone/cinnarizine, domperidone is dosed at a 15 mg which is higher than the newly recommended individual dose.
Maltese: • Il-PRAC innota li, fil-kombinazzjoni domperidone/cinnarizine, domperidone jingħata b'doża ta' 15 mg, li hija doża ogħla mid-doża individwali li għadha kif ġiet rakkomandata.
English: As a consequence of the new maximum recommended doses, the PRAC considered that certain formulations such as tablets dosed at 20 mg and suppositories dosed at 60 mg have a negative benefit-risk balance and should therefore be revoked.
Maltese: Bħala konsegwenza tad-dożi ġodda massimi rakkomandati, il-PRAC ikkunsidra li ċerti formulazzjonijiet bħal pilloli b'doża ta' 20 mg u suppożitorji b'doża ta' 60 mg għandhom bilanċ tal-benefiċċju-riskju negattiv u għalhekk għandhom jiġu revokati.
English: The CMDh considered the below PRAC recommendation with regards to domperidone-containing medicinal products:
Maltese: Is-CMDh ikkunsidra r-rakkomandazzjoni tal-PRAC ta' hawn taħt fir-rigward tal-prodotti mediċinali li fihom domperidone:
English: o Is favourable in the relief of the symptoms of nausea and vomiting.
Maltese: o Huwa favorevoli fis-serħan mis-sintomi ta' dardir u rimettar.
English: • The PRAC considered that the data supporting the efficacy of domperidone in the paediatric population are limited and recommended that further data be generated to confirm the efficacy in this patient population.
Maltese: • Il-PRAC ikkunsidra li d-dejta li ssostni l-effikaċja ta' domperidone fil-popolazzjoni pedjatrika hija limitata u rrakkomanda li tkun iġġenerata aktar dejta sabiex tiġi kkonfermata l-effikaċja f'dawn il-pazjenti.
English: In addition, the data supporting the efficacy of the combination domperidone/cinnarizine for motion sickness are limited, do not demonstrate the superiority of the combination over the single component product and therefore do not justify exposing patients to the additional risk associated to a combination product.
Maltese: Barra minn hekk, id-dejta li ssostni l-effikaċja tal-kombinazzjoni domperidone/cinnarizine għad-dardir hija limitata, ma turix is-superjorità tal-kombinazzjoni fuq il-prodott komponent waħdieni u għalhekk ma tiġġustifikax li l-pazjenti jiġu esposti għar-riskju addizzjonali assoċjat ma' prodott ta' kombinazzjoni.
English: It should also be contraindicated in patients with moderate to severe hepatic impairment and in co-administration with potent CYP3A4 inhibitors, due to the expected increase in plasma levels of domperidone.
Maltese: Għandu jkun kontraindikat ukoll f'pazjenti b'indeboliment minn moderat sa qawwi tal-fwied u fil-koamministrazzjoni flimkien ma' inibituri qawwija ta' CYP3A4, minħabba ż-żieda mistennija fil-livelli ta' domperidone fil-plażma.
English: In October 2011 the PhVWP agreed on amendments to the product information, and the Marketing Authorisation Holder of the originator product was requested to conduct a pharmacoepidemiological study and a thorough QTc study.
Maltese: F'Ottubru 2011, ilPhVWP qabel dwar l-emendi għall-informazzjoni tal-prodott, u d-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq tal-prodott oriġinatur intalab iwettaq studju farmakoepidemjoloġiku u studju QTc birreqqa.
English: 2 - Detailed explanation for the differences from the PRAC recommendation
Maltese: 2 - Spjegazzjoni dettaljata għad-differenzi mir-rakkomandazzjoni tal-PRAC
English: Baseline 264 34.4 268 34.9
Maltese: Linja bażi 264 34.4 268 34.9
English: The in vivo micronucleus test was negative.
Maltese: It-test tal-mikronukleju in vivo kien negattiv.
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Maltese: In vitro din is-sustanza turi inibizzjoni minima ta' acetylcholinesterase (<10%).
English: Aggression
Maltese: Aggressjoni
English: You may require medical attention.
Maltese: Jista' jkollok bżonn attenzjoni medika.
English: Rivastigmine capsules 12 mg/day
Maltese: Rivastigmine kapsuli 12 mg/jum
English: Table 4
Maltese: Tabella 4
English: Pharmacotherapeutic group: psychoanaleptics, anticholinesterases, ATC code: N06DA03
Maltese: Kategorija farmakoterapewtika: psikoanalettiċi, anticholinesterases; Kodiċi ATC:
English: p-value versus placebo *p<0.05 versus placebo
Maltese: Valur-p kontra l-plaċebo * p≤0.05 versus plaċebo
English: 3M Health Care Limited, 1 Morley Street, Loughborough, Leicestershire, LE11 1EP
Maltese: 1 Morley Street, Loughborough, Leicestershire, LE11 1EP Ir-Renju Unit
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Kategoriji tal-frekwenza huma ddefiniti bl-użu tal-konvenzjonijiet li ġejjin: komuni ħafna (1/10); komuni (1/100 sa <1/10); mhux komuni (1/1,000 sa <1/100); rari (1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Maintenance dose
Maltese: Doża ta' manteniment
English: Atrioventricular block, atrial fibrillation, tachycardia, sick sinus
Maltese: Imblokk atrijoventrikulari, fibrillazzjoni tal-atriju, takikardija, sindrome ta' sinus marid
English: Cmax is reached after 10-16 hours.
Maltese: Cmax jintlaħaq wara 10-16-il siegħa.
English: • Periodic Safety Update Reports
Maltese: • Rapporti perjodiċi ta 'aġġornament tas-sigurtà
English: Available in packs containing 7, 30, 60 and 90 pouches.
Maltese: Jiġi f'pakketti li jkun fihom 7, 30, 60 u 90 qartas.
English: Anorexia, decreased appetite
Maltese: Anoressija, tnaqqis fl-aptit
English: Renal impairment
Maltese: - Indeboliment renali:
English: Mean score  SD p-value versus placebo ADCS-ADL
Maltese: Medja tal-punteġġ  SD Valur-p kontra l-plaċebo ADCS-ADL
English: No target organ toxicity was observed.
Maltese: Ma ġiet osservata lebda tossiċità ta' organi li jintlaqtu.
English: Nervous system disorders Common
Maltese: Disturbi fis-sistema nervuża Komuni
English: Metabolism is primarily via cholinesterase-mediated hydrolysis to the metabolite NAP226-90.
Maltese: Il-metaboliżmu huwa medjat l-aktar permezz ta' idroliżi minn cholinesterase għall-metabolu NAP226-90.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 and published on the European medicines web-portal
Maltese: Madankollu, id-detentur tal-awtorizzazzjoni għat-tqegħid fissuq għandu jissottometti rapporti perjodiċi ta' aġġornament tas-sigurta' għal dan il-prodott mediċinali jekk il-prodott jiġi inkluż fil-lista ta 'dati ta' referenza tal-Unjoni (lista EURD) prevista taħt l-Artikolu 107c (7) tad-Direttiva 2001/83/EC u pubblikata fuq il-web-portal tal-mediċini tal-Ewropa.
English: The single-dose inter-subject variability in rivastigmine pharmacokinetic parameters (normalised to dose/kg bodyweight) was 43% (Cmax) and 49% (AUC0-24h) after transdermal administration versus 74% and 103%, respectively, after the oral form.
Maltese: Il-varjabbilità bejn l-individwi b'doża waħda fil-parametri tal-farmakokinetika ta' rivastigmine (normalizzat għad-doża/kg piż tal-ġisem) kienet 43% (Cmax) u 49% (AUC0-24h) wara l-użu minn ġolġilda kontra 74% u 103%, rispettivament, wara l-forma orali.
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.
English: DLSM - difference in least square means.
Maltese: DLSM - differenza fl-inqas medji kwadri.
English: Heat-sealed pouches made of paper/aluminium/acrylonitrile-methacrylate copolymer laminate.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kull qartas reżistenti għas-sħana huwa magħmul minn karta/ aluminium/acrylonitrile-methacrylate copolymer laminate.
English: EU/1/14/911/001 EU/1/14/911/002 EU/1/14/911/003 EU/1/14/911/004
Maltese: EU/1/14/911/002
English: Concomitant administration of rivastigmine with commonly prescribed medicinal products, such as antacids, antiemetics, antidiabetics, centrally acting antihypertensives, beta blockers, calcium channel blockers, inotropic agents, antianginals, non-steroidal anti-inflammatory agents, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with an alteration in the kinetics of rivastigmine or an increased risk of clinically relevant untoward effects.
Maltese: L-għotja fl-istess ħin ta' rivastigmine ma' prodotti mediċinali li jiġu ordnati ta' spiss, bħal antaċidi, antiemetiċi, antidijabetiċi, mediċini tal-pressjoni li jaħdmu b'mod ċentrali, imblukkaturi beta, imblukkaturi tal-kanali tal-calcium, sustanzi inotropiċi, mediċini għall-anġina, aġenti mhux setrojdali kontra l-infjammazzjoni, estroġeni, analġesiċi, benzodiażepini u antiistaminiċi, ma kinetx assoċjata ma' tibdil fil-kinetika ta' rivastigmine jew żieda fir-riskju ta' effetti ħżiena klinikament rilevanti.
English: LIST OF EXCIPIENTS Also contains polyester, ethyl vinyl acetate, acrylate copolymer adhesive and isopropyl myristate.
Maltese: Fiha wkoll polyester, ethyl vinyl acetate, acrylate copolymer adhesive u isopropyl myristate.
English: In a 24-week double-blind, placebo-controlled clinical trial, skin reactions were measured at each visit using a skin irritation rating scale that rated the degree of erythema, oedema, scaling, fissures, pruritus and pain/stinging/burning at the application site.
Maltese: Fi prova klinika double-blind u kkontrollata bi plaċebo ta' 24 ġimgħa, ir-reazzjonijiet tal-ġilda kienu mkejla ma' kull żjara permezz ta' skala tar-rata ta' irritazzjoni tal-ġilda li stmat il-grad ta' ħmura, edema, qxur, qsim, ħakk u uġigħ/tingiż/ħruq fejn ġiet applikata.
English: Tabulated list of adverse reactions
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella
English: Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Maltese: Trattament ta' sintomi ta' dimenzja ta' Alzheimer li jkunu ħfief għal moderatament severa.
English: The active substance of Rivastigmine 3M Health Care Ltd. is rivastigmine.
Maltese: Is-sustanza attiva f' Rivastigmine 3M Health Care Ltd. hija rivastigmine.
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 exceeding 104 times the foreseen clinical exposure.
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-104 darbiet lesponiment kliniku mbassar.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonjiet avversi f'Tabella 1 huma mniżżla skont is-sistema tal-klassifika tal-orgni u l-kategorija tal-frekwenza f'MedDRA.
English: Hepatic impairment
Maltese: - Indeboliment epatiku:
English: The metabolite-to-parent AUC∞ ratio was around 0.7 after transdermal patch administration versus 3.5 after oral administration, indicating that much less metabolism occurred after dermal compared to oral treatment.
Maltese: Il-proporzjon AUC∞ tal-metabolu mal-mediċina oriġinali kien madwar 0.7 wara l-amministrazzjoni ta' garża kontra 3.5 wara li ngħata mill-ħalq, li jindika li seħħ ħafna anqas metaboliżmu wara kura millġilda meta mqabbla mal-kura orali.
English: In massive overdose, atropine can be used.
Maltese: Fil-każ ta' doża eċċessiva massiva, jista' jintuża atropine.
English: No pharmacokinetic interaction was observed between oral rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Maltese: Fi studji fuq voluntiera b'saħħithom, ma dehret l-ebda interazzjoni farmakokinetika bejn rivastigmine u digoxin, warfarin, diazepam, jew fluoxetine.
English: Rare (may affect up to 1 in 1,000 people) - Falling
Maltese: Rari (jista' jaffettwa sa persuna waħda minn kull 1,000)
English: ITT-LOCF population
Maltese: Popolazzjoni ITT-LOCF
English: Rivastigmine 9.5 mg/24 h n Mean n Mean DLSM 95% CI p-value
Maltese: siegħa n Medja n Medja DLSM 95% CI Valur p