FrancophonIA/ELRC3.0 huggingface dataset:
English: The maximum daily dose is 9 g. Patients should usually start with two doses of 2.25 g (4.5 ml) per day.
Maltese: Id-doża massima ta' kuljum hi 9 g. Ġeneralment il-pazjenti għandhom jibdew b'żewġ dożi ta' 2.25 g (4.5 ml) kuljum.
English: The effects of Xyrem have also been studied in fibromyalgia patients with moderate to severe symptoms in two short-term (12-week) studies in 1,121 patients, and one long-term (up to nine months) study in 560 patients.
Maltese: L-effetti ta' Xyrem ġew studjati wkoll f'pazjenti li jbatu bil-fibromijalġija b'sintomi moderati sa serji f'żewġ studji ta' perjodu qasir (12-il ġimgħa) f'1,121 pazjent, u fi studju wieħed ta' perjodu twil (sa disa' xhur) f'560 pazjent.
English: Why has Xyrem been approved?
Maltese: Għaliex ġie approvat Xyrem?
English: Xyrem must not be used in patients with major depression, in patients with ‘succinic semialdehyde dehydrogenase deficiency' (a rare metabolic disease), or in patients being treated with opioids (such as some painkillers) or barbiturates (such as some anaesthetics and medicines used to prevent seizures).
Maltese: Xyrem ma għandux jintuża minn pazjenti li jkollhom dipressjoni kbira, f'pazjenti bi ‘succinic semialdehyde dehydrogenase deficiency' (marda metabolika rari), jew minn pazjenti li jkunu qed jieħdu xi oppjojdi (bħal mediċini għal kontra l-uġigħ) jew barbiturati (bħal xi anestetiċi u mediċini użati fit-trattament ta' aċċessjonijiet [attakki tal-qamar]).
English: The first study (136 patients) examined the effects of Xyrem on the number of cataplexy attacks over four weeks of treatment.
Maltese: L-ewwel studju (136 pazjent) eżamina l-effetti ta' Xyrem fuq numru ta' attakki ta' katalessja matul erba' ġimgħat ta' kura.
English: In all of the studies, Xyrem was given at a daily dose between 3 and 9 g and was compared with placebo (a dummy treatment).
Maltese: Fl-istudji kollha, Xyrem ingħata b'doża ta' bejn 3 u 9 g kuljum, u tqabbel ma' plaċebo (kura finta).
English: Cataplexy is a symptom of narcolepsy involving sudden muscle weakness in response to an emotional reaction such as anger, fear, joy, laughter or surprise.
Maltese: Il-kataplessja hi sintomu tan-narkolessija li tikkonsisti minn dgħufija instantanja tal-muskoli b'rispons ta' reazzjoni emozzjonali bħal rabja, biża', ferħ, daħk jew sorpriża.
English: What is the risk associated with Xyrem?
Maltese: X'inhu r-riskju assoċjat ma' Xyrem?
English: A risk management plan has been developed to ensure that Xyrem is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Xyrem jintuża bl-aktar mod sigur possibbli.
English: Although the 9-g dose was the most effective, it was linked to high levels of side effects, so the Committee recommended a starting dose of 4.5 g per day.
Maltese: Għalkemm l-aktar doża effettiva kienet 9 g, din kienet marbuta ma' livelli għoljin ta' effetti sekondarji, u allura l-Kumitat irrakkomanda doża inizjali ta' 4.5 g kuljum.
English: Xyrem is given at a dose of 4.5 to 9 g per day in two equally divided doses.
Maltese: Xyrem jingħata f'doża ta' 4.5 sa 9 g kuljum maqsuma f'żewġ dożi ndaqs.
English: The most common side effects with Xyrem (seen in more than 1 patient in 10) are dizziness, headache and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni bi Xyrem (li dehru f'aktar minn pazjent 1 minn 10) huma sturdament, uġigħ ta' ras u nawżja (dardir).
English: The second dose is taken 2.5 to 4 hours later.
Maltese: It-tieni doża għandha tittieħed bejn 2.5 sa 4 sigħat wara.
English: How does Xyrem work?
Maltese: Għal xiex jintuża Xyrem?
English: The company that makes Xyrem will minimise the risk of abuse of Xyrem by providing educational materials to healthcare workers and patients, strictly controlling the distribution of the medicine, and monitoring its use.
Maltese: Il-kumpanija li timmanifattura Xyrem ser timminimizza r-riskju ta' abbuż minn Xyrem billi tipprovdi materjali edukattivi għall-ħaddiema fil-kura tas-saħħa u għall-pazjenti, billi tikkontrolla d-distribuzzjoni tal-mediċina b'attenzjoni kbira u billi tissorvelja l-użu tagħha.
English: The other two studies (516 patients) examined the effects of Xyrem on excessive daytime sleepiness and other symptoms of narcolepsy, either taken alone or as an add-on to the patient's existing dose of modafinil (a stimulant medicine used to treat narcolepsy).
Maltese: Iż-żewġ studji l-oħra (516-il pazjent) eżaminaw l-effetti ta' Xyrem fuq il-bżonn eċċessiv tal-irqad matul il-jum u sintomi oħra tan-narkoplessija, sew jekk meħud waħdu u sew jekk miżjud mad-doża ta' modafinil (mediċina stimulanti li tintuża għall-kura tan-narkolessija) li l-pazjent ikun qed jieħu diġà.
English: Xyrem is used to treat adults who have narcolepsy with cataplexy.
Maltese: Xyrem jintuża għall-kura ta' adulti li jbatu bin-narkolessija bil-kataplessja.
English: The second study showed that Xyrem continued to prevent cataplexy attacks after long-term treatment: there was no change over two weeks in the number of attacks in the patients continuing to take Xyrem, compared to an increase of 21.0 attacks in those switching to placebo.
Maltese: It-tieni studju wera li Xyrem kompla jipprevjeni l-attakki tal-kataplessja wara kura fit-tul: f'pazjenti li komplew jieħdu Xyrem ma kien hemm l-ebda tibdil fin-numru ta' attakki f'ġimagħtejn waqt li kien hemm żieda ta' 21.0 f'dawk li qalbu għallplaċebo.
English: This improves the symptoms of narcolepsy.
Maltese: Dan itejjeb is-sintomi tan-narkolessija.
English: The CHMP decided that Xyrem's benefits are greater than its risks.
Maltese: Is-CHMP ddeċieda li l-benefiċċji ta' Xyrem huma akbar mir-riskji tiegħu.
English: The second study, including 56 patients who had been taking Xyrem for at least six months, compared the effects of continuing to take Xyrem at the same dose as before, with the effects of switching to placebo.
Maltese: It-tieni studju, li inkluda 56 pazjent li kienu ħadu Xyrem għal tal-anqas sitt xhur, qabbel l-effetti tat-tkomplija tal-kura bi Xyrem bl-istess doża ta' qabel, mal-effetti għall-bidla għallkura bi plaċebo.
English: What benefit has Xyrem shown during the studies?
Maltese: Liema benefiċċji wera Xyrem matul l-istudji?
English: For the full list of all side effects reported with Xyrem, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrappurtati bi Xyrem, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Xyrem?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat użu sigur u effettiv ta' Xyrem?
English: The starting dose should be halved in patients who have problems with their liver.
Maltese: Xyrem kien aktar effikaċi mill-plaċebo fit-tnaqqis tas-sintomi.
English: The data obtained in the fibromyalgia studies did not support the use of Xyrem in this condition in the European population.
Maltese: Id-dejta miksuba fl-istudju tal-fibromijalġija ma appoġġatx l-użu ta' Xyrem f'din il-kondizzjoni filpopolazzjoni Ewropea.
English: Patients who have problems with their kidneys should consider a low sodium diet.
Maltese: Fil-pazjenti li jbatu minn problemi fil-kliewi, id-doża inizjali għandha titnaqqas bin-nofs.
English: Contains sodium benzoate (E 211).
Maltese: Fih sodium benzoate (E 211).
English: D-90429 Nuremberg Germany
Maltese: D-90429 Nuremberg
English: Placebo n (%)
Maltese: Plaċebo n (%)
English: 28 hard capsules 56 hard capsules 112 hard capsules
Maltese: 28 kapsula iebsa 56 kapsula iebsa 112-il kapsula iebsa
English: - organizačná zložka Galvaniho 15/C
Maltese: Galvaniho 15/C
English: Maksimirska 120 HR - 10000 Zagreb
Maltese: Maksimirska 120 HR - 10000
English: 250 hard capsules
Maltese: 250 kapsula.
English: Π.T.Χατζηγeωργίου εταιρεία Ltd Γιλντίζ 31-3042 Λεμεσός Τηλέφωνο: 00357 25372425 Φαξ: 00357 25376400
Maltese: Π.T.Χατζηγeωργίου εταιρεία Ltd Γιλντίζ 31-3042 Λεμεσός Τηλέφωνο: 00357 25372425
English: Table 1 Infections and infestations
Maltese: Tabella 1 Infezzjonijiet u infestazzjonijiet
English: H-1114 Budapest Phone: +36 1 430 2890
Maltese: Budapest Phone: +36 1 430 2890
English: 50 ml oral solution 120 ml oral solution
Maltese: 50 ml ta' soluzzjoni orali 120 ml ta' soluzzjoni orali
English: Patients with Clinically Significant Response (%) Intent to Treat
Maltese: Pazjenti b'Rispons Klinikament Sinifikanti (%) Intenzjoni li tittratta
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Maltese: In vitro din is-sustanza li tifforma fil-metaboliżmu turi inibizzjoni minima għal acetylcholinesterase (<10 %).
English: E-08210 Barberà del Vallès, Barcelona Spain
Maltese: Barberà del Vallès, Barcelona Spanja
English: Hard gelatine capsules Novartis Farmacéutica S.A. Ronda Santa Maria 158 ES-08210 Barberà del Vallès Barcelona
Maltese: Kapsuli iebsin tal-ġelatina Novartis Farmacéutica S.A. Ronda Santa Maria 158 ES-08210
English: (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000);
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100, <1/10); mhux komuni (≥1/1,000, <1/100); rari (≥1/10,000, <1/1,000); rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: - Capsule fill: - Microcrystaline cellulose - Magnesium stearate - Hypromellose - Silica, colloidal anhydrous
Maltese: Mili tal-kapsula: - Microcrystalline cellulose - Magnesium stearate - Hypromellose - Silica, colloidal anhydrous
English: Sick sinus syndrome
Maltese: Sindromu ta' sinus marid
English: Eesti filiaal, Pärnu mnt 105, EE-11312 Tallinn, Tel: +372 6652401
Maltese: Sandoz d.d. Eesti filiaal, Pärnu mnt 105, EE-11312 Tallinn, Tel: +372 6652401
English: At least 4 points improvement on ADAS-Cog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Maltese: PDS * p<0.05, ** p<0.01, *** p<0.001
English: Novartis Farmacéutica, S.A. Planta de Producción Ronda de Santa Maria 158
Maltese: Planta de Producción Ronda de Santa Maria 158
English: Absolute bioavailability after a 3 mg dose is about 36%±13%.
Maltese: Iż-żieda assoluta fir-rata ta' biodisponibilità, wara doża ta' 3 mg, hija ta' madwar 36 %±13 %.
English: Motor dysfunction
Maltese: Funzjoni motorja ħażina
English: Sandoz Polska Sp.z o.o.
Maltese: Sandoz Polska Sp.z o.o. ul.
English: P-2740-255 Porto Salvo
Maltese: P-2740-255
English: Oral solution Novartis Pharma GmbH Roonstrasse 25
Maltese: Soluzzjoni orali Novartis Pharma GmbH Roonstrasse 25
English: Date of first authorization: 11/12/2009 Date of first renewal: 11/07/2014
Maltese: Data tal-ewwel awtorizzazzjoni: 11/12/2009 Data tal-ewwel tiġdid: 11/07/2014
English: Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi ppreżentati f'Tabella 1 u f'Tabella 2 huma kklassifikati skond is-sistema tal klassi tas-sistema ta' l-organu (tal-MedDRA) u l-kategorija tal-frekwenza.
English: Rivastigmine HEXAL 1.5 mg hard capsules Rivastigmine HEXAL 3 mg hard capsules Rivastigmine HEXAL 4.5 mg hard capsules Rivastigmine HEXAL 6 mg hard capsules
Maltese: Rivastigmine HEXAL 1.5 mg kapsuli ibsin Rivastigmine HEXAL 3 mg kapsuli ibsin Rivastigmine HEXAL 4.5 mg kapsuli ibsin Rivastigmine HEXAL 6 mg kapsuli ibsin
English: - The other ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide red iron oxide, titanium dioxide, and shellac.
Maltese: - Is-sustanzi l-oħra huma hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide, red iron oxide, titanium dioxide,u shellac.
English: HEXAL AG Industriestraße 25 83607 Holzkirchen Germany
Maltese: Industriestraße 25 83607 Holzkirchen
English: The major metabolite NAP226-90 also did not show a genotoxic potential.
Maltese: Il-metabolit ewlieni NAP226-90 ma weriex potenzjal ġenotossiku wkoll.
English: Pruritus, allergic dermatitis (disseminated)
Maltese: Prurite, dermatite allerġika (mifruxa)
English: LV-1010 Riga Phone: +371 67892007
Maltese: Riga Phone: +371 67892007
English: ADCS-CGIC Placebo
Maltese: ADCS-CGIC
English: Only for carton box: PC:
Maltese: Għall-kaxxa tal-kartun biss: PC:
English: Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products metabolised by the following cytochromes isoemzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6.
Maltese: Abbażi ta' studji in vitro, l-ebda interazzjoni farmakokinetika mhi mistennija ma' prodotti mediċinali metabolizzati mill-iżoenzimi taċ-ċitokromi li ġejjin: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9,
English: Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g. oxybutynin, tolterodine).
Maltese: Rivastigmine jista' jfixkel l-attività ta' prodotti mediċinali tat-tip antikolinerġiċi (eż. oxybutynin, tolterodine).
English: These events led to the discontinuation of rivastigmine in some cases (e.g. discontinuations due to tremor 1.7% on rivastigmine vs 0% on placebo).
Maltese: Dawn il-każijiet wasslu għat-twaqqif ta' rivastigmine f'xi pazjenti (eż. twaqqif minħabba t-tregħid 1.7% fuq rivastigmine kontra 0% fuq plaċebo).
English: Clinical studies in Alzheimer's dementia
Maltese: Studji Kliniċi f'dimenzja ta' Alzheimer
English: BG-1766 Sofia
Maltese: Representative office Sandoz d.d. BG-1766 Sofia
English: It readily crosses the blood brain barrier and has an apparent volume of distribution in the range of 1.8-2.7 l/kg.
Maltese: Huwa jaqsam malajr il-barriera ta' bejn il-moħħ u d-demm u għandu volum apparenti ta' distribuzzjoni b'firxa ta' bejn 1.8-2.7 l/kg.
English: • Swallow your medicine straight from the syringe.
Maltese: • Ibla' l-mediċina tiegħek direttament mis-siringa.
English: Adjusted treatment difference p-value versus placebo n/a
Maltese: Differenza fil-kura aġġustata n/a valur-p kontra l-plaċebo
English: Rivastigmine 6-12 mg N=473
Maltese: Kejl tar-Rispons Rivastigmine 6-12 mg N=473
English: One of the excipients in Rivastigmine HEXAL oral solution is sodium benzoate.
Maltese: Waħda mis-sustanżi mhux attivi ta' Rivastigmine HEXAL soluzzjoni orali hija sodium benzoate.
English: Hard capsule
Maltese: Kull kapsula Rivastigmine
English: - Capsule shell: - Gelatin - Titanium dioxide (E171) - Yellow iron oxide (E172) - Red iron oxide (E172)
Maltese: Qoxra tal-kapsula: - Gelatin - Titanium dioxide (E171) - Yellow iron oxide (E172) - Red iron oxide (E172)
English: Rivastigmine HEXAL 2 mg/ml oral solution
Maltese: Rivastigmine HEXAL 2 mg/ml soluzzjoni orali
English: 50 ml or 120 ml bottle.
Maltese: Flixkun ta' 50 ml jew 120 ml.
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 104 times the maximum 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 ta' 104 darbiet ogħla mill esponiment kliniku.
English: Parkinsonism
Maltese: Parkinson
English: ADCS-CGIC Rivastigmine
Maltese: ADCSCGIC Rivastigmine
English: Adjusted treatment difference p-value versus placebo
Maltese: Differenza tal-kura aġġustata valur-p kontra plaċebo
English: • Take the syringe out of its protective case.
Maltese: • Wara, erfa' s-siringa lura fil-kontenitur protettiv.
English: Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required.
Maltese: rivastigmine ma' prodotti mediċinali li jinduċu torsades de pointes bħal antipsikotiċi, i.e., xi phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine u moxifloxacine, għandha tiġi osservata b'kawtela, u monitoraġġ kliniku (ECG) jista' wkoll ikun meħtieġ.
English: Patients with mild dementia (MMSE 18-24)
Maltese: (MMSE 18-24)
English: ADAS-Cog: improvement of at least 4 points CIBIC-Plus: improvement PDS: improvement of at least 10%
Maltese: CIBIC-Plus: titjib PDS: titjib ta' mill-anqas 10 % Titjib ta' millanqas 4 punti flADAS-Cog u li ma jiħżienux is
English: • Urinary incontinence (inability to retain adequate urine)
Maltese: • Konfużjoni qawwija • Inkontinenza tal-awrina (inabilità biex iżżomm awrina adegwata)
English: - Capsule shell: - Gelatin - Titanium dioxide (E171) - Yellow iron oxide (E172)
Maltese: Qoxra tal-kapsula: - Gelatin - Titanium dioxide (E171) - Yellow iron oxide (E172)
English: The mean actual daily dose for responders in the 6-12 mg group, corresponding to this definition, was 9.3 mg.
Maltese: minn 6 mg sa 12-il mg li tikkorrispondi ma' din id-definizzjoni hija ta' 9.3 mg.
English: Representative office Sandoz d.d.
Maltese: Sandoz d.d. Representative Office in Latvia
English: Rare Very rare
Maltese: Rari ħafna
English: ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Maltese: RDO: Dawk li waqfu u ġew lura; LOCF: L-aħħar osservazzjoni trasferita 'l quddiem
English: Administration of rivastigmine oral solution with food delays absorption (tmax) by 74 min and lowers Cmax by 43% and increases AUC by approximately 9%.
Maltese: Meta rivastigmine bħala soluzzjoni orali jingħata ma' l-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: - Printing ink: - Shellac - Titanium dioxide (E171)
Maltese: Inka tal-istampar: - Shellac - Titanium dioxide (E171)
English: The active substance of Rivastigmine HEXAL is rivastigmine.
Maltese: Is-sustanza attiva ta' Rivastigmine HEXAL hija rivastigmine.
English: Placebo N=444
Maltese: N=444
English: Rivastigmine HEXAL 2 mg/ml oral solution rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine HEXAL 2 mg/ml soluzzjoni orali rivastigmine (bħala hydrogen tartrate)
English: Dose titration
Maltese: Titration tad-doża
English: A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 nonsmokers) following rivastigmine oral capsule doses of up to 12 mg/day.
Maltese: rivastigmine bi 23% f'pazjenti bil-marda ta' Alzheimer (n=75 persuna li jpejpu u 549 persuna li ma jpejpux) wara dożi orali sa 12 mg/jum ta' kapsuli ta' rivastigmine.
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Maltese: Studji kliniċi f'dimenzja assoċjata mal-marda ta' Parkinson L-effikaċja ta' rivastigmine f'dimenzja assoċjata mal-marda ta' Parkinson intweriet fi studju ċentrali ta' 24-ġimgħa multiċentriku, double-blind, kontrollat bil-plaċebo u bil-fażi ta' l-estenzjoni tiegħu ta' 24-ġimgħa open-label.
English: They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.
Maltese: Ippakkjati f'folji li jiġu f'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: The oral solution is packaged with an oral dosing syringe in a plastic tube container.
Maltese: siringa orali, f'kontenitur f'forma ta' tubu tal-plastik.
English: Cardiac arrhythmia (e.g. bradycardia, atrioventricular block, atrial fibrillation and tachycardia)
Maltese: imblukkar atrijo-ventrikulari, fibrillazzjoni ta' l-atrija u takikardija)
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: 3 mg tnaqqas l-attività tat-tip acetylcholinesterase (AChE) fis-CSF bejn wieħed u ieħor b'40 % fi żmien l-ewwel 1.5 siegħa wara li tkun ingħatat.
English: - Printing ink: - Shellac - Red iron oxide (E172)
Maltese: Inka tal-istampar: - Shellac - Red iron oxide (E172)
English: Placebo N=472
Maltese: N=472
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Maltese: Tabella 3 telenka n-numru u l-perċentwali ta' pazjenti b'każijiet minn prova klinika speċifika ta 24gimgha kondotta b'rivastigmine f'pazjenti b'dimenzja assoċjata mal-marda ta Parkinson b'avversi li kienu definiti minn qabel li jistgħu jirriflettu aggravar tas-sintomi ta' Parkinson.
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: Effetti addittivi li jwasslu għal bradikardija (li tista' tirriżulta f'sinkope) ġew irrappurtati bl-użu kombinat ta' diversi imblokkaturi beta (li jinkludu atenolol) u rivastigmine.
English: Rivastigmine HEXAL 3 mg and 6 mg hard capsules:
Maltese: Rivastigmine HEXAL 3 mg u 6 mg kapsuli ibsin:
English: HOW TO STORE RIVASTIGMINE HEXAL
Maltese: Tiħux Rivastigmine HEXAL
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 mill-plażma ta' rivastigmine kienet ta' bejn wieħed u ieħor 130 l/h, u din naqset għal 70 l/h wara doża minn ġol-vini ta' 2.7 mg.
English: Only for carton box: Rivastigmine HEXAL 2 mg/ml
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine HEXAL 2 mg/ml
English: Sandoz dd
Maltese: Sandoz Pharmaceuticals DD
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 matul studji kliniċi mwettqa f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson ikkurati b'kapsuli ta' rivastigmine.
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Maltese: F'każijiet oħra, rivastigmine ġie mwaqqaf (ara sezzjoni 4.8).
English: Bradycardia Arial fibrillation Atrioventricular block Sick sinus syndrome
Maltese: Fibrillazzjoni ta' l-atriju Blokk atrijo-ventrikulari Sindromu tas-sinus marid
English: Fatigue and asthenia Gait disturbance Parkinson gait
Maltese: Disturbi fil-mixi Parkinson fil-mixi
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: Tossiċità kolinerġika ġiet irrapportata b'sintomi muskariniċi li huma osservati b'avvelenamenti moderati bħal mijosi, fwawar, disturbi diġestivi inkluż uġigħ addominali, nawsja, rimettar u dijarea, bradikardja, bronkospażmu u żieda fit-tnixxijiet tal-bronki, iperidrożi, awrina u/jew ippurgar b'mod involontarju, lakrimazzjoni, pressjoni baxxa u tnixxija eċċessiva tal-bżieq.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4,5 mg rivastigmine.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 4.5 mg rivastigmine.