FrancophonIA/ELRC3.0 huggingface dataset:
English: PVC/aluminium blisters
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Cumulative HBeAg seroconversion rates in patients with undetectable HBV DNA at week 24 (%)
Maltese: Rati ta' serokonverżjoni kumulattivi ta' f'pazjenti b'HBV DNA li ma setgħux jitkejlu f'ġimgħa 24 (%)
English: Other medicines and Sebivo
Maltese: Mediċini oħra u Sebivo
English: Elderly (age above 65 years)
Maltese: Persuni anzjani (età 'l fuq minn 65 sena)
English: Out of the 680 telbivudine-treated patients initially included in the pivotal study NV-02B-007 (GLOBE), 517 (76%) enrolled into study CLDT600A2303 for continued telbivudine treatment for up to 208 weeks.
Maltese: NV-02B-007 (GLOBE), 517 (76%) issieħbu fl-istudju CLDT600A2303 sabiex jissuktaw bilkura b'telbivudine sa 208 ġimgħat.
English: EU/1/07/388/001 28 film-coated tablets EU/1/07/388/002 98 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/388/001
English: 1 bottle containing 300 ml oral solution [folding box only] 1 cup + 1 oral syringe [folding box only]
Maltese: Flixkun wieħed li jkun fih 300 ml ta' soluzzjoni orali [kaxxa li tintlewa biss] Tazza waħda + siringa tal-ħalq waħda [kaxxa li tintlewa biss] 300 ml [tikketta tal-flixkun biss]
English: If you experience muscle pain, severe and persistent stomach pain with nausea and vomiting, severe and persistent trouble breathing, tiredness or abdominal discomfort while taking Sebivo, call your doctor immediately.
Maltese: Jekk tħoss uġigħ fil-muskoli, uġigħ sever u persistenti fl-istonku bi tqalligħ u rimettar, problemi severi u persistenti biex tieħu n-nifs, għeja jew skonfort addominali waqt li tkun qed tieħu Sebivo, sejjaħ littabib tiegħek immedjatament.
English: The incidence of post-treatment alanine aminotransferase (ALT) flares in the two treatment arms are further described in Table 4 below.
Maltese: In-numru ta' drabi meta kien hemm żiediet f'daqqa ta' alanine aminotransferase (ALT) fiż-żewġ fergħat ta' kura huma deskritti aktar f'Tabella 4 hawn taħt.
English: Sebivo 600 mg film-coated tablets telbivudine
Maltese: Informazzjoni għall-utent Sebivo 600 mg pilloli miksija b'rita Telbivudine
English: The cumulative genotypic rates by week 104 were 25.1% (115/458) for HBeAg-positive patients and 10.8% (24/222) for HBeAg-negative patients.
Maltese: 1% (115/458) għall-pazjenti HBeAg-pożittivi u 10.
English: Therefore, close clinical monitoring is recommended in these patients.
Maltese: Għaldaqstant, huwa rrakkomandat monitoraġġ kliniku mill-qrib ta' dawn il-pazjenti.
English: Maintained undetectable HBV DNA (< 300 copies/ml) with undetectable HBV DNA at week 24
Maltese: HBV DNA li baqgħu ma setgħux jitkejlu (<300 kopja/ml) b'HBV DNA li ma setgħux jitkejlu f'ġimħa 24
English: Tiredness (fatigue)
Maltese: TWISSIJA(IET) SPEĊJALI
English: Table 6 Histological improvement and change in Ishak Fibrosis Score at week 52 in NV-02B007 (GLOBE) study
Maltese: Ishak mat-52 ġimgħa fl-istudju NV-02B007 (GLOBE)
English: Mean HBV DNA reduction from baseline (log10 copies/ml) ± SEM % Patients HBV DNA undetectable by PCR
Maltese: HBV DNA li baqgħu ma setgħux jitkejlu (<300 kopja/ml)
English: Table 1 Dosing regimen adjustment of Sebivo in patients with renal impairment
Maltese: Tabella 1 Aġġustar tal-mod kif jingħataw id-dożaggi ta' Sebivo f'pazjenti b'indeboliment renali
English: 4.2 Posology and method of administration
Maltese: Monitoraġġ matul it-trattament
English: It is not known whether the risk of myopathy during treatment with telbivudine is increased with concurrent administration of other medicinal products associated with myopathy (e.g. statins, fibrates, or ciclosporin).
Maltese: Mhux magħruf jekk ir-riskju ta' mijopatija waqt kura b'telbivudine jiżdiedx bl-għotja fl-istess ħin ta' prodotti mediċinali oħrajn li huma assoċjati ma' mijopatija (eż statini, fibrati, jew ciclosporin).
English: Benign digestive symptoms, such as nausea, vomiting and abdominal pain, may be indicative of lactic acidosis development.
Maltese: Sintomi ħfief tas-sistema diġestiva, bħall-tqalligħ, rimettar u uġigħ addominali, jistgħu jindikaw li tkun qed tiżviluppa aċidożi lattika.
English: Predictability at week 24
Maltese: Linja bażi sa' ġimgħa 24
English: HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies/ml).
Maltese: Għandu jkun hemm monitoraġġ tal-livelli ta' HBV DNA fl24 ġimgħa ta' trattament biex wieħed jassigura li jkun hemm trażżin virali sħiħ (HBV DNA ta' anqas minn 300 kopja/ml).
English: 30 ml oral solution contain 600 mg telbivudine.
Maltese: X'fih Sebivo - Is-sustanza attiva hi telbivudine. 30 ml ta' soluzzjoni orali fiha 600 mg telbivudine.
English: • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBeAg seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBsAg seroconversion or there is evidence of loss of efficacy.
Maltese: • F'pazjenti mingħajr ċirrożi, posittivi għall-HBeAg, il-kura għandha tibqa' tingħata għal millanqas 6-12 il xahar wara li serokonverżjoni ta' l-HBeAg (telf ta' HBeAg u telf ta' HBV DNA b'sejba ta' anti-HBe) tkun konfermata jew sakemm ikun hemm serokonverżjoni ta' HBsAg jew ikun hemm evidenza ta' tnaqqis ta' l-effikaċja.
English: No evidence of a direct toxic effect of telbivudine was seen in standard tests of reproduction toxicology.
Maltese: F'testijiet standard dwar it-tossiċità fuq is-sistema riproduttiva ma kienx hemm evidenza ta' effett tossiku dirett.
English: Moreover, in the subgroup of patients with baseline ALT levels ≥ 2x ULN (320), a significantly higher proportion of telbivudine patients than lamivudine patients achieved HBeAg seroconversions at week 104 (36% vs 28%, respectively).
Maltese: Minbarra hekk, fis-sottogrupp ta' pazjenti bil-livelli ta' ALT fil-linja bażi ≥2x ULN (320), proporzjon ogħla b'mod sinifikanti ta' pazjenti fuq telbivudine minn dawk fuq lamivudine kisbu serokonverżjoni ta' HBeAg f'ġimgħa 104 (36% vs 28%, rispettivament).
English: Maintained ALT normalisation
Maltese: Normalizzajoni tal-ALT miżmuma
English: Use within 2 months of opening the bottle.
Maltese: Iblaha sħieħa bi ftit ilma.
English: Sebivo 600 mg film-coated tablets
Maltese: Sebivo 600 mg pilloli miksija b'rita
English: - Uncommonly Sebivo can induce numbness, tingling, pain and/or burning sensations in the arms and/or legs (peripheral neuropathy).
Maltese: - Xi minn daqqiet Sebivo jista' jinduċi titrix, tnemnim, uġigħ u/jew sensazzjonijiet ta' ħruq fiddirgħajn u/jew ir-riglejn (newropatija periferali).
English: * Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 24 July 2008.
Maltese: * Noti: L-informazzjoni mogħtija f'dan id-dokument u l-Annessi tirrifletti biss l-Opinjoni tas-CHMP datata l-24 ta' Lulju 2008.
English: The final opinion was converted into a Decision by the European Commission on 19 November 2008.
Maltese: L-opinjoni finali hija konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fid-19 ta' Novembru 2008.
English: The Rapporteur and Co-Rapporteur appointed were: Dr. Ondřej Slanař and Dr. Pieter Neels, respectively.
Maltese: Ir-Rapporteur u l-Ko-Rapporteur maħtura kienu: id-dott.
English: Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP concluded that for oral formulations of norfloxacin containing medicinal products the benefit does not outweigh the risk in acute or chronic complicated pyelonephritis, and therefore adopted an opinion on 24 July 2008 recommending the variation of the Marketing Authorisations by removing the therapeutic indication “acute and chronic complicated pyelonephritis” from the Product Information for the norfloxacin containing medicinal products taken orally.
Maltese: Ibbażat fuq l-evalwazzjoni tad-dejta disponibbli attwalment u r-rapporti ta' valutazzjoni tarRapporteurs, is-CHMP ikkonkluda illi għal formulazzjonijiet orali ta' prodotti mediċiniali li fihom norfloxacin il-benefiċċju mhumiex ikbar mir-riskju fi pjelonefrite akuta jew kronika kkumplikata, u għalhekk adotta opinjoni fl-24 ta' Lulju 2008 fejn irrakkommanda l-varjazzjoni talAwtorizzazzjonijiet għat-Tqegħid fis-Suq billi titneħħa l-indikazzjoni terapewtika “pjelonefrite akuta jew kronika kkumplikata” mill-Informazzjoni tal-Prodott għal prodotti mediċinali li fihom norfloxacin li jiġu meħuda b'mod orali.
English: Norfloxacin containing medicinal products, which are only available as an oral formulation, do not provide adequate serum levels for the treatment of concomitant bacteraemia.
Maltese: Norfloxacin fi prodotti mediċinali, li huma disponibbli biss bħala formulazzjoni orali, ma jipprovdux livelli xierqa ta' serum għat-trattament ta' batterjemija konkomitanti.
English: The referral procedure started on 20 September 2007.
Maltese: Il-proċedura ta' referenza bdiet fl-20 ta' Settembru 2007.
English: - Complicated pyelonephritis can be treated orally or intravenously (according to local treatment policy and diagnostic criteria used for defining complicated infection).
Maltese: - Il-pjelonefrite kkumplikata tista' tiġi ttrattata oralment jew fil-vina (skont politika ta' trattament lokali u kriterji dijanjostiċi użati għad-definizzjoni ta' infezzjoni kkumplikata).
English: On 14 September 2007, Belgium referred the matter to the EMEA under Article 31 of Directive 2001/83/EC and asked the CHMP to give its opinion on whether the marketing authorisations for oral formulations of medicinal products containing norfloxacin in the treatment of acute or chronic complicated or uncomplicated pyelonephritis should be maintained, varied, suspended or withdrawn across the European Union following the re-assessment of norfloxacin benefit/risk balance.
Maltese: Fl-14 ta' Settembru 2007, il-Belġju rrefera l-kwistjoni lill-EMEA skont l-Artikolu 31 tad-Direttiva 2001/83/KE u talab lis-CHMP sabiex jagħti l-opinjoni tiegħu dwar jekk l-awtorizzazzjonijiet għattqegħid fis-suq għal formulazzjonijiet orali ta' prodotti mediċinali li fihom norfloxacin fit-trattament ta' pjelonefrite akuta jew kronika kumplikata jew mhux kumplikata għandha tinżamm, tiġi varjata, sospiża jew imneħħija mill-Unjoni Ewropea kollha wara valutazzjoni mill-ġdid tal-bilanċ talbenefiċċju/riskju tan-norfloxacin.
English: Norfloxacin is a broad-spectrum, quinolone bactericidal agent indicated for the treatment of acute or chronic complicated or uncomplicated pyelonephritis due to susceptible organisms.
Maltese: Norfloxacin huwa aġent broad-spectrum batteriċida kwinolon indikat għal trattament ta' pjelonefrite akuta jew kronika jew pjelonefrite mhux ikkumplikata dovuta għal organiżmi suxxettibbli.
English: - Pyelonephritis is often associated with bacteraemia.
Maltese: - Il-pjelonefrite hija sikwit assoċjata mal-batterjemija.
English: - There are other alternative treatments available for the above-mentioned indication.
Maltese: - Hemm trattamenti alternattivi oħrajn disponibbli għall-indikazzjoni msemmija hawn fuq.
English: 13 January 2009 EMEA/660192/2008 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL Norfloxacin containing medicinal products International non-proprietary name (INN): norfloxacin BACKGROUND INFORMATION *
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): norfloxacin
English: ITT + RDO population
Maltese: Popolazjoni ITT + RDO population
English: Norge KRKA Sverige AB
Maltese: KRKA Sverige AB
English: Rivastigmine n (%)
Maltese: Rivastigmine n (%) Plaċebo n (%)
English: - The active substance is rivastigmine hydrogen tartrate.
Maltese: - Is-sustanza attiva hi rivastigmine hydrogen tartrate.
English: At least 4 points improvement on ADASCog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Maltese: Titjib ta' mill-inqas 4 punti fl-ADAS-Cog u li ma jiħżienux is-CIBIC-Plus u PDS *p<0.05, **p<0.01, ***p<0.001
English: Capsule content Microcrystalline cellulose Hypromellose Silica, colloidal anhydrous Magnesium stearate
Maltese: Il-kontenut tal-kapsula Microcrystalline cellulose Hypromellose Silica, colloidal anhydrous Magnesium stearate
English: Patients with moderate dementia (MMSE 10-17)
Maltese: Pazjenti b'dimenzja moderata (MMSE 10-17)
English: ITT - LOCF population
Maltese: Popolazzjoni ITT - LOCF
English: Absolute bioavailability after a 3 mg dose is about 36%±13%.
Maltese: Il-bijodisponibilità assoluta wara doża ta' 3 mg hi ta' madwar 36% ± 13%.
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Maltese: In vitro, dan il-metabolit juri inibizzjoni minima għal acetylcholinesterase (<10 %).
English: ADAS-Cog Placebo
Maltese: ADAS-Cog Plaċebo
English: Patients with Clinically Significant Response (%) Intent to Treat
Maltese: Pazjenti b'Rispons Klinikament Sinifikanti (%) Intenzjoni li Tittratta
English: Pharmacotherapeutic group: psychoanaleptics, anticholinesterases, ATC code: N06DA03
Maltese: Kategorija farmakoterapewtika: psikoanalettiċi, anticholinesterases, Kodiċi ATC:
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: ADCS-CGIC Placebo
Maltese: ADCS-CGIC Plaċebo
English: Spearmint flavour (peppermint oil, maize maltodextrin) Peppermint flavour (maltodextrine, gum arabic, sorbitol E420, corn mint oil, L-menthol) Crospovidone
Maltese: Togħma ta' nagħniegħ (peppermint oil, maize maltodextrin) Togħma ta' pepeprmint (maltodextrine, gum arabic, sorbitol E420, corn mint oil, L-menthol) Crospovidone
English: Container: 200 hard capsules 250 hard capsules
Maltese: Reċipjent: 200 kapsula iebsa 250 kapsula iebsa
English: Hyperhydrosis Allergic dermatitis (disseminated)
Maltese: Iperidrożi Dermatite allerġika (mifruxa)
English: Pruritus, allergic dermatitis (disseminated)
Maltese: Ħakk, dermatite allerġika (mifruxa)
English: 4 times the maximum clinical exposure.
Maltese: 4 darbiet mill esponiment kliniku massimu.
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 CIBIC-Plus: titjib PDS: titjib ta' mill-inqas
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: Skont studji in vitro, mhix mistennija ebda interazzjoni farmakokinetika bi prodotti mediċinali metabolizzati mill-iżoenzimi tas-cytochrome li ġejjin: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, jew CYP2B6.
English: Adjusted treatment difference p-value versus placebo
Maltese: Differenza aġġustata tal-kura Valur p kontra il-plaċebo
English: The major metabolite NAP226-90 also did not show a genotoxic potential.
Maltese: Il-metabolit ewlieni NAP226-90 ukoll ma weriex potenzjal ġenotossiku.
English: Marketing Authorisation Holder and Manufacturer KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja
English: Patients with mild dementia (MMSE 18-24)
Maltese: Pazjenti b'dimenzja ħafifa (MMSE 18-24)
English: Clinical studies in Alzheimer's dementia
Maltese: Studji kliniċi f'dimenzja ta' Alzheimer
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 talkonvenzjonijiet 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: 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: Peress li bradikardija tikkostitwixxi fattur ta' riskju fl-okkorrenza ta' torsades de pointes, ilkombinazzjoni ta' rivastigmine ma' prodotti mediċinali li jinduċu torsades de pointes bħal antipsikotiċi jiġifieri 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'attenzjoni u jista' jkun meħtieġ ukoll monitoraġġ kliniku (ECG).
English: Very rare (may affect up to 1 in 10,000 people)
Maltese: Rari ħafna (jista' jaffettwa sa persuna waħda minn kull 10,000)
English: Dose titration
Maltese: Intenzjoni li Tittratta
English: (on carton label only)
Maltese: (fuq it-tikketta tal-kartuna biss)
English: Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonjiet avversi f'Tabella 1 u Tabella 2 huma mniżżla skont is-sistema tal-klassifika tal-orgni u l-kategorija tal-frekwenza f'MedDRA.
English: Nimvastid contains sorbitol E420
Maltese: Nimvastid fih sorbitol E420
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, spearmint flavour (peppermint oil, maize maltodextrin), peppermint flavour (maltodextrine, gum arabic, sorbitol E420, corn mint oil, L-menthol), crospovidone, calcium silicate, magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma mannitol, microcrystalline cellulose, hydroxypropylcellulose, togħma ta' nagħniegħ (peppermint oil, maize maltodextrin), togħma ta' pepeprmint (maltodextrine, gum arabic, sorbitol E420, corn mint oil, L-menthol), crospovidone, calcium silicate, magnesium stearate.
English: Excipient: sorbitol E420.
Maltese: µg sorbitol E420.
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'batterija ta' testijiet standard in vitro u in vivo, għajr f'test ta' aberazzjoni kromosomali f'limfoċiti umani periferali meta ngħatat doża ta' 10
English: Vascular disorders Very rare
Maltese: Disturbi vaskulari Rari ħafna
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 irrapportati effetti addittivi li jwasslu għal bradikardija (li tista' tirriżulta f'sinkope) bl-użu kkombinat ta' diversi imblukkaturi beta (inkluż atenolol) u rivastigmine.
English: Other medicines and Nimvastid
Maltese: Mediċini oħra u Nimvastid
English: Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 mg hard capsules Rivastigmine
Maltese: Nimvastid 1.5 mg kapsuli ibsin Nimvastid 3 mg kapsuli ibsin Nimvastid 4.5 mg kapsuli ibsin Nimvastid 6 mg kapsuli ibsin Rivastigmine
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 ttregħid 1.7% fuq rivastigmine kontra 0% tal-plaċebo).
English: Hallucinations Aggression, restlessness
Maltese: Aggressjoni, irrikwitezza
English: In addition, a post-hoc definition of response is provided in the same table.
Maltese: Barra dan, definizzjoni post-hoc ta' reazzjoni hija mogħtija fl-istess tabella.
English: Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172) Gelatine
Maltese: Il-qoxra tal-kapsula Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172) Gelatine
English: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration.
Maltese: L-aktar reazzjonijiet avversi (ADRs) komuni rrapportati huma dawk gastrointestinali, li jinkludu dardir (38%) u remettar (23%), speċjalment waqt li tkun qed tiġi miżjuda d-doża.
English: Nimvastid 1.5 mg orodispersible tablets Nimvastid 3 mg orodispersible tablets Nimvastid 4.5 mg orodispersible tablets Nimvastid 6 mg orodispersible tablets Rivastigmine
Maltese: Nimvastid 1.5 mg pilloli li jinħallu fil-ħalq Nimvastid 3 mg pilloli li jinħallu fil-ħalq Nimvastid 4.5 mg pilloli li jinħallu fil-ħalq Nimvastid 6 mg pilloli li jinħallu fil-ħalq Rivastigmine
English: The active substance of Nimvastid is rivastigmine.
Maltese: Is-sustanza attiva f'Nimvastid hija rivastigmine.
English: - The other ingredients for Nimvastid 1.5 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content, and titanium dioxide (E171), yellow iron oxide (E172) and gelatine in the capsule shell.
Maltese: - Is-sustanzi l-oħra għal kapsuli ta' Nimvastid 1.5 mg huma microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate bħala kontenut tal-kapsula, u titanium dioxide (E171), yellow iron oxide (E172) u gelatine fil-qoxra tal-kapsula.
English: Parkinson's disease (worsening) Bradykinesia
Maltese: Marda ta' Parkinson (taggrava) Bradikinesja Diskinesja
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji ta' intolleranza għal fruttozju m'għandhomx jieħdu din il-mediċina.
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 non-smokers) following rivastigmine oral capsule doses of up to 12 mg/day.
Maltese: Analiżi farmakokinetika tal-popolazzjoni wriet li l-użu tan-nikotina jżid it-tneħħija orali ta' rivastigmine bi 23% f'pazjenti bil-marda ta' Alzheimer (n=75 li jpejpu u 549 li ma jpejpux) wara dożi sa 12-il mg/jum f'forma ta' kapsula orali ta' rivastigmine.
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 min u Cmax jonqos u l-AUC jiżdied b'madwar 30%.
English: Titanium dioxide (E171), Yellow iron oxide (E172), Gelatine
Maltese: Il-qoxra tal-kapsula Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine
English: How to take Nimvastid
Maltese: X'fih Nimvastid
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-perċentwal ta' pazjenti minn studju kliniku speċifiku ta' 24 ġimgħa li sar b'rivastigmine f'pazjenti bid-dimenzja assoċjata mal-marda ta' Parkinson b'każijiet avversi li kienu ddefiniti minn qabel li jistgħu jirriflettu aggravament tas-sintomi tal-marda ta' Parkinson.
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: It-Tabella 2 turi reazzjonijiet avversi rrapportati waqt studji kliniċi mwettqa f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson ittrattati bil-kapsuli rivastigmine.