FrancophonIA/ELRC3.0 huggingface dataset:
English: Additive effects leading to bradycardia (which may result in syncope) have been reported with the combined use of various beta-blockers (including atenolol) and rivastigmine.
Maltese: Ġew irrappurtati effetti addittivi li jwasslu għal bradikardija (li tista tirrisulta f'sinkope) mill-użu ta' rivastigmine ma' beta-blockers varji (inkluż atenolol).
English: n (%)
Maltese: NUMRU(I)
English: Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with rivastigmine capsules.
Maltese: Tabella 2 turi reazzjonijiet avversi rrappurtati waqt studji kliniċi mwettqa f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson ikkurati bil-kapsuli ta' Rivastigmine.
English: Other medicines and Rivastigmine Actavis
Maltese: Mediċini oħra u Rivastigmine Actavis
English: Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules: Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
Maltese: Actavis 3 mg, 4.5 mgu 6 mg kapsuli ibsin: Red iron Oxide (E172), titanium dioxide E171), yellow iron oxide (E172) u gelatine.
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 ma' l-ikel, l-assorbiment (tmax) jittardja b'90 minuta u sCmaxjonqos u l-AUC jiżdied b'bejn wieħed u ieħor 30%.
English: Nervous system disorders Very common
Maltese: Disturbi fis-sistema nervuża Komuni ħafna
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: Mean baseline ± SD 25.4 ± 9.9 27.4 ± 10.4 23.1 ± 10.4 22.5 ± 10.1 Mean change at 24 weeks 1.0 ± 9.2 ± SD
Maltese: Medja tal-linja bażi ± SD 25.4 ± 9.9 27.4 ± 10.
English: INFORMATION IN BRAILLE Rivastigmine Actavis 3 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rivastigmine Actavis 3 mg
English: • Tell your caregiver that you are taking Rivastigmine Actavis.
Maltese: • Għid lil min ikun qed jikkurak li qed tieħu Rivastigmine Actavis.
English: Total plasma clearance of rivastigmine was approximately 130 l/h after a 0.2 mg intravenous dose and decreased to 70 l/h after a 2.7 mg intravenous dose.
Maltese: Wara doża minn ġol-vina ta' 0.2 mg it-tneħħija totali ta' rivastigmine mill-plażma kienet ta' bejn wieħed u ieħor 130 l/siegħa, u din naqset għal 70 l/siegħa wara doża minn ġol-vini ta' 2.7 mg.
English: Cholinergic toxicity has been reported with muscarinic symptoms that are observed with moderate poisonings such as miosis, flushing, digestive disorders including abdominal pain, nausea, vomiting and diarrhoea, bradycardia, bronchospasm and increased bronchial secretions, hyperhidrosis, involuntary urination and/or defecation, lacrimation, hypotension and salivary hypersecretion.
Maltese: Tossiċita kolinerġika ġiet irrappurtata mas-sintomi muskariniċi li huma osservati mall-ivvelenar moderat bħal: mijosi, fwawar, uġigħ fl-addome, dardir, rimettar u dijarrea, bradikardija, spasmu filbronki u żieda fit-tisfijja tal-bronki, iperidrosi, urinar involontarju u/jew defekar, lakrimazzjoni, ipotensjoni u tisfija tas-saliva.
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by rivastigmine was similar to that of AChE.
Maltese: L-inibizzjoni ta' l-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: Vascular disorders Very rare
Maltese: Disturbi fil-qalb Rari
English: Rivastigmine Placebo Rivastigmine Placebo ITT + RDO population (n=329)
Maltese: Popolazzjoni ITT + RDO (n=329)
English: The capsules are packed in blisters available in three different pack sizes (28, 56 and 112 capsules) and capsule containers of 250 capsules, but these may not all be available in your country.
Maltese: Ippakkjati f'folji li jiġu fi tliet daqsijiet (28, 56 jew 112-il kapsula) u fliexken tal-plastik ta' 250 kapsula, iżda jista' jkun li dawn ma ssibhomx f'pajjiżek.
English: Urinary infection
Maltese: Infezzjonijiet u infestazzjonijiet
English: C-rivastigmine, renal elimination was rapid and essentially complete (>90 %) within 24 hours.
Maltese: Wara li ngħata l-14C-rivastigmine, l-eliminazzjoni mill-kliewi kienet mgħaġġla u kienet kważi kompleta (>90%) fi żmien 24 siegħa.
English: Capsule shell: Rivastigmine Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
Maltese: Rivastigmine Actavis 1.5 mg kapsuli ibsin:Titanium dioxide (E171), yellow iron oxide (E172) u gelatine.
English: Each Rivastigmine Actavis 1.5 mg capsule contains 1.5 mg of rivastigmine.
Maltese: Kull kapsula Rivastagmine Actavis ta' 1.5 mg fiha 1.5 mg rivastigmine.
English: Therefore, caution should be exercised when rivastigmine is combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, calcium channel antagonists, digitalis glycoside, pilocarpin).
Maltese: III, antagonisti ta' calcium channel, digitalis glycoside, pilocarpin).
English: Mean change at 24 weeks 2.1 ± 8.2 ± SD
Maltese: 24 ġimgħa ± SD
English: There is no relevant use of Rivastigmine Actavis in the paediatric population in the treatment of Alzheimer's disease.
Maltese: M'hemmx użu relevanti ta' Rivastigmine Actavis fil-popolazzjoni pedjatrika għat-trattament tal-marda ta' Alzheimer.
English: Rivastigmine Actavis 6 mg hard capsules EU/1/11/693/013
Maltese: Rivastigmine Actavis 6 mg kapsuli ibsin EU/1/11/693/013
English: Rivastigmine Actavis 1.5 mg hard capsules
Maltese: Rivastigmine Actavis 1.5 mg kapsuli ibsin
English: Caution is advised in patients at higher risk of developing torsade de pointes; for example, those with uncompensated heart failure, recent myocardial infarction, bradyarrhythmias, a predisposition to hypokalaemia or hypomagnesaemia, or concomitant use with medicinal products known to induce QT prolongation and/or torsade de pointes (see sections 4.5 and 4.8).
Maltese: Huwa rakkomandata li tintuża il-kawtela f'pazjenti f'riskju akbar li jiżviluppaw torsade de pointes; per eżempju, dawk b'insuffiċjenza tal-qalb mhux ikkumpensati, infart mijokardijaku reċenti, bradiarritmija, predispożizzjoni għal ipokalemija jew ipomagnesemija, jew l-użu konkomittanti bi prodotti mediċinali magħrufa li jinduċu titwil tal-QT u / jew torsade de pointes (ara sezzjonijiet 4.5 u 4.8).
English: Hypertension Hypotension
Maltese: Indeboliment epatiku
English: Rivastigmine Actavis 6 mg hard capsules
Maltese: Rivastigmine Actavis 6 mg kapsuli ibsin
English: Rivastigmine Actavis 4.5 mg hard capsules
Maltese: Rivastigmine Actavis 4.5 mg kapsuli ibsin
English: Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine
Maltese: Titanium dioxide (E171)
English: Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine Actavis ta' 4,5 mg fiha 4.5 mg rivastigmine.
English: Placebo of parkinsonian symptoms in patients with dementia n (%)
Maltese: Plaċebo n (%)
English: EU/1/11/693/015 [112 blister]
Maltese: EU/1/11/693/015 [112 folja]
English: An initial dose of 0.03 mg/kg intravenous atropine sulfate 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: LIST OF EXCIPIENTS
Maltese: LISTA TA' SUSTANZI EĊĊIPJENTI
English: Mean baseline ± SD 24.0 ± 10.3 24.5 ± 10.6 n/a n/a
Maltese: Medja tal-linja bażi ± SD 32.6 ± 10.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 1.5 mg rivastigmine (as hydrogen tartrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kapsula waħda jkun fiha 1.5 mg rivastigmine (bħala rivastigmine hydrogen tartrate).
English: Rivastigmine Actavis 3 mg hard capsules
Maltese: Rivastigmine Actavis 3 mg kapsuli ibsin
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: Additionally there have been post-marketing cases of dizziness, tremor, headache, somnolence, confusional state, hypertension, hallucinations and malaise.
Maltese: Addizjonalment, kien hemm każijiet ta' wara it-tqegħid fis-suq ta' sturdament, sonnolenza, stat konfużjonali, ipertensjoni, alluċinazzjonijiet u sensazzjoni li tkun jkunu ma jifilħux.
English: EU/1/11/693/007 [112 blister]
Maltese: EU/1/11/693/007 [112 folja]
English: Rivastigmine Actavis 4.5 mg hard capsules EU/1/11/693/009
Maltese: Rivastigmine Actavis 4.5 mg kapsuli ibsin EU/1/11/693/009
English: In pregnant animals, rivastigmine and/or metabolites crossed the placenta.
Maltese: F‘annimali tqal, rivastigmine u/jew metaboliti tiegħu qasmu fil-plaċenta.
English: Mean baseline ± SD 23.8 ± 10.2 24.3 ± 10.5 n/a n/a
Maltese: Medja tal-linja bażi ± SD 23.8 ± 10.
English: Each Rivastigmine Actavis 6 mg capsule contains 6 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine Actavis ta' 6 mg fiha 6 mg rivastigmine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kapsula waħda jkun fiha 4.5 mg rivastigmine (bħala rivastigmine hydrogen tartrate).
English: Seizures
Maltese: Rivastigmine
English: EU/1/11/693/014 [56 blister]
Maltese: EU/1/11/693/014 [56 folja]
English: Rivastigmine Actavis 1.5 mg hard capsules EU/1/11/693/001
Maltese: Rivastigmine Actavis 1.5 mg kapsuli ibsin EU/1/11/693/001
English: If you have to undergo surgery whilst taking Rivastigmine Actavis, tell your doctor before you are given any anaesthetics, because Rivastigmine Actavis may exaggerate the effects of some muscle relaxants during anaesthesia.
Maltese: Jekk ikollok bżonn ta' operazzjoni waqt li tkun qed tieħu Rivastigmine Actavis, għid lit-tabib qabel ma tingħata l-anestetiku, peress li Rivastigmine Actavis jista' jeżaġera l-effetti ta' xi rilassanti talmuskoli li jingħataw waqt l-anestesija.
English: - Rivastigmine Actavis 4.5 mg hard capsules, which contain off-white to slightly yellow powder, have a red cap and red body, with white imprint “RIV 4.5mg” on body.
Maltese: - Rivastigmine Actavis 4.5 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu aħmar u korp aħmar, b'timbru abjad “RIV 4.5 mg” fuq il-korp.
English: EU/1/11/693/003 [112 blister]
Maltese: EU/1/11/693/003 [112 folja]
English: EU/1/11/693/006 [56 blister]
Maltese: EU/1/11/693/006 [56 folja]
English: Rivastigmine Actavis 3 mg hard capsules EU/1/11/693/005
Maltese: Rivastigmine Actavis 3 mg kapsuli ibsin EU/1/11/693/005
English: Dementia associated with ADAS-Cog ADAS-Cog ADCS- CGIC ADCS-CGIC Parkinson's Disease
Maltese: 1 Ibbażat fuq ANCOVA bil-kura u l-pajjiż bħala fatturi u l-linja bażi ADAS-Cog bħala kovarjant.
English: EU/1/11/693/011 [112 blister]
Maltese: EU/1/11/693/011 [112 folja]
English: - Rivastigmine Actavis 3 mg hard capsules, which contain off-white to slightly yellow powder, have an orange cap and orange body, with red imprint “RIV 3mg” on body.
Maltese: - Rivastigmine Actavis 3 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu oranġjo u korp oranġjo, b'timbru aħmar “RIV 3 mg” fuq il-korp.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 6 mg rivastigmine (as hydrogen tartrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kapsula waħda jkun fiha 6 mg rivastigmine (bħala rivastigmine hydrogen tartrate).
English: Off-white to slightly yellow powder in a hard capsule with red cap and orange body, with red imprint “RIV 6mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu aħmar u korp oranġjo, u stampata bl-abjad “RIV6 mg” fuq il-korp.
English: EU/1/11/693/010 [56 blister]
Maltese: EU/1/11/693/010 [56 folja]
English: - Rivastigmine Actavis 6 mg hard capsules, which contain off -white to slightly yellow powder, have an red cap and orange body, with red imprint “RIV 6mg” on body.
Maltese: - Rivastigmine Actavis 6 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu aħmar u korp oranġjo, b'timbru aħmar “RIV 6 mg” fuq il-korp.
English: Not applicable.
Maltese: Mhux applikkabli.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency 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: EU/1/11/693/002 [56 blister]
Maltese: EU/1/11/693/002 [56 folja]
English: Each Rivastigmine Actavis 3 mg capsule contains 3 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine Actavis ta' 3 mg fiha 3 mg rivastigmine.
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-CIBICPlus (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: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10 % improvement on the PDS.
Maltese: F'dawn listudji, it-titjib klinikament rilevanti kien definit a priori bħala mill-anqas titjib b'4 punti flADASCog, bħala titjib fis-CIBIC-Plus, jew titjib b'tal-anqas 10% fil-PDS.
English: ADAS-Cog: improvement of at least 4 points CIBIC-Plus: improvement PDS: improvement of at least 10%
Maltese: ADAS-Cog: titjib ta' millanqas 4 punti
English: Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Maltese: Trattament ta' sintomi ta' dimenzja li jkunu ħfief għal moderatament severi f'pazjenti bil-marda ta' Parkinson idjopatika.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 3 mg rivastigmine (as hydrogen tartrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kapsula waħda jkun fiha 3 mg rivastigmine (bħala rivastigmine hydrogen tartrate).
English: Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Maltese: 2 Għall-konvenjenza qed tintwera l-medja tad-dejta, l-analiżi kategorika saret bit-test Elteren ITT: Intenzjoni li jingħata t-trattament;
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR CAPSULE CONTAINER
Maltese: KARTUNA GĦALL-KONTENITUR TAL-KAPSULI
English: Off-white to slightly yellow powder in a hard capsule with red cap and red body, with white imprint “RIV 4.5mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu u korp aħmar, u stampata bl-abjad “RIV4.5 mg” fuq il-korp.
English: In healthy young men, an oral 3 mg dose decreases acetylcholinesterase (AChE) activity in CSF by approximately 40 % within the first 1.5 hours after administration.
Maltese: F'ġuvnotti b'saħħithom, doża mill-ħalq ta' 3 mg tnaqqas l-attività tat-tip acetylcholinesterase (AChE) fis-CSF bejn wieħed u ieħor b'40% fi żmien l-ewwel 1.5 sigħat wara li tkun ingħatat.
English: Effects of rivastigmine on human fertility are not known.
Maltese: Effetti ta' rivastigmine fuq il-fertilita umana mhumiex magħrufa.
English: Off-white to slightly yellow powder in a hard capsule with orange cap and orange body, with red imprint “RIV 3mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu u korp oranġjo, u stampata bl-aħmar “RIV 3 mg” fuq il-korp.
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 4.5 mg capsules rivastigmine
Maltese: Rivastigmine Actavis 4.5 mg kapsuli ibsin rivastigmine
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 1.5 mg capsules rivastigmine
Maltese: Rivastigmine Actavis 1.5 mg kapsuli ibsin rivastigmine
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 3 mg capsules rivastigmine
Maltese: Rivastigmine Actavis 3 mg kapsuli ibsin rivastigmine
English: The following additional adverse reactions have been observed with rivastigmine 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 Rivastigmine: thewdin, deni, tnaqqis fl-aptit, inkontinenza fl-awrina (komuni), attività psikomotorili eċċessiva (mhux komuni), eritema, urtikarja, nfafet, dermatite allerġika (mhux magħrufa).
English: Dyskinesia Hypokinesia Cogwheel rigidity
Maltese: FULJETT TA' TAGĦRIF
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 6 mg capsules rivastigmine
Maltese: Rivastigmine Actavis 6 mg kapsuli ibsin rivastigmine
English: Dose titration: Adverse reactions (e.g. hypertension and hallucinations in patients with Alzheimer's dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson's disease) have been observed shortly after dose increase.
Maltese: Ġew osservati reazzjonijiet avversi (eż. pressjoni għolja u alluċinazzjonijiet f'pazjenti b' dimenzja ta' Alzheimer u sintomi ekstrapiramidali marru għall-agħar, l-aktar tregħid, f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson) ftit wara li ġiet miżjuda d-doża.
English: Insomnia
Maltese: Immaniġjar
English: Off-white to slightly yellow powder in a hard capsule with yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu isfar u korp isfar, u stampata bl-aħmar “RIV 1.5 mg” fuq il-korp.
English: The results for clinically relevant responders pooled from two flexible dose studies out of the three pivotal 26-week multicentre studies in patients with mild-to-moderately severe Alzheimer's Dementia, are provided in Table 4 below.
Maltese: Ir-riżultati ta' pazjenti li wrew titjib klinikament rilevanti, li kienu miġbura minn żewġ studji bid-doża flessibbli minn 3 studji multiċentriċi pivitali ta' 26 ġimgħa fuq pazjenti li kienu jbatu minn dimenzja ta' Alzheimer ta' severità ħafifa għal moderatament severa, jinsabu f'Tabella 4 hawn taħt.
English: Dementia associated with ADAS-Cog ADAS-Cog ADAS-Cog ADAS-Cog Parkinson's Disease
Maltese: ADAS-Cog Plaċebo
English: Adjusted treatment difference p-value versus placebo n/a
Maltese: It-Tnejn It-Tlieta L-Erbgħa Il-Ħamis
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 6 mg rivastigmine.
Maltese: Rivastigmine Actavis 6 mg kapsuli ibsin Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 6 mg rivastigmine.
English: Printing ink:
Maltese: Żieda tad-doża:
English: Cardiovascular betablockers are expected to be associated with the greatest risk, but reports have also been received in patients using other beta-blockers.
Maltese: Madanakollu waslu rapporti ukoll meta pazjenti kienu qed jużaw beta-blockers oħra.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/013[ 28 blister]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/693/013[ 28 folja]
English: You should not breast-feed during treatment with Rivastigmine Actavis.
Maltese: M'għandekx tredda' waqt li qed tingħata trattament b'Rivastigmine Actavis.
English: • Urinary tract infection
Maltese: Disturbi gastro-intestinali
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristic, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi talProdott, sezzjoni 4.2).
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine.
Maltese: Ir-reazzjonijiet avversi li ġejjin, elenkati hawn taħt f'Tabella 1, kienu miġbura minn pazjenti kkurati b' Rivastigmine għal dimenzja t'Alzheimer.
English: The ink may or may not contain potassium hydroxide.
Maltese: Il-linka jista jkun ikollha jew ma jkollhiex potassium hydroxide.
English: Cmax and AUC of rivastigmine were more than twice as high in subjects with moderate renal impairment compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in subjects with severe renal impairment.
Maltese: Is-Cmax u l-AUC ta' rivastigmine kienu aktar minn darbtejn ogħla f'pazjenti li kellhom indeboliment renali moderat meta dawn kienu mqabbla ma' individwi b'saħħithom; madankollu ma kien hemm lebda tibdiliet fis-Cmax u l-AUC ta' rivastigmine f'pazjenti li kellhom indeboliment renali serju.
English: Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite.
Maltese: Rivastigmine huwa mmetabolizzat malajr u b'mod estensiv f'metabolu decarbamylated (half-life filplażma, madwar siegħa), l-aktar b'idroliżi mmedjata minn cholinesterase.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/005[ 28 blister]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/693/005[ 28 folja]
English: Mean baseline ± SD 32.6 ± 10.4 33.7 ± 10.3 20.6 ± 7.9 20.7 ± 7.9 Mean change at 24 weeks 2.6 ± 9.4 ± SD
Maltese: F'każ li l-pazjent jibda' jirremetti ħafna meta jingħata kura b'rivastigmine, id-doża għandha tiġi aġġustata hekk kif irrikkmandat f'sezzjoni 4.2.
English: 1.5 mg twice a day.
Maltese: Doża tal-bidu 1.5 mg darbtejn kuljum
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/009[ 28 blister]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/693/009[ 28 folja]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/001[ 28 blister]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/693/001[ 28 folja]
English: Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors.
Maltese: Rivastigmine jista' jikkawża bradikardija li tikkostitwixxi fattur ta' riskju fl-okkorrenza ta' torsade de pointes, l-aktar f'pazjenti b'fatturi ta' riskju.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3 mg rivastigmine.
Maltese: Rivastigmine Actavis 3 mg kapsuli ibsin Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 3 mg rivastigmine.
English: Rivastigmine Actavis is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Rivastigmine Actavis jintuża għat-trattament ta' pazjenti adulti b'dimenzja ta' Alzheimer minn ħafifa sa moderata, disturb progressiv tal-moħħ li bil-mod il-mod jaffettwa l-memorja, l-ħila intellettwali u limġiba.