FrancophonIA/ELRC3.0 huggingface dataset:
English: Rivastigmine Teva hard capsules are available in blister packs of 28, 56 and 112 capsules, perforated blisters containing 50 x 1 capsules, and bottles containing 250 capsules.
Slovenian: Zdravilo Rivastigmine Teva trde kapsule je na voljo v pretisnih omotih po 28, 56 in 112 kapsul, perforiranem pretisnem omotu s 50 x 1 kapsulo ter v steklenicah po 250 kapsul.
English: Very common • Trembling
Slovenian: Zelo pogosti • tresenje
English: Some people who have accidentally taken too much Rivastigmine Teva have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Slovenian: Pri nekaterih ljudeh, ki so nehote vzeli preveč zdravila Rivastigmine Teva, je prišlo do navzee (slabosti s siljenjem na bruhanje), bruhanja, driske, visokega krvnega tlaka in halucinacij.
English: Or:
Slovenian: Ali:
English: Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer's Disease Cooperative StudyClinician's Global Impression of Change).
Slovenian: Učinkovitost so prikazali z dvema neodvisnima lestvicama, s katerima so stanje bolnikov ocenjevali v rednih presledkih med 6-mesečnim obdobjem zdravljenja, kot je prikazano v tabeli 5 spodaj: ADAS-Cog, meritev kognicije in globalna meritev ADCS-CGIC (Kooperativna študija Alzheimerjeve bolezni - zdravnikov globalni vtis o spremembi - Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change).
English: Rivastigmine interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes.
Slovenian: Rivastigmin učinkuje na svoje ciljne encime tako, da tvori kovalentni kompleks, ki jih začasno inaktivira.
English: It is also used for the treatment of dementia in patients with Parkinson's disease.
Slovenian: Uporablja se tudi za zdravljenje demence pri bolnikih s Parkinsonovo boleznijo.
English: Therefore, women on rivastigmine should not breast-feed
Slovenian: Zato ženske, ki jemljejo rivastigmin, ne smejo dojiti.
English: ADCS-CGIC Rivastigmine
Slovenian: ADCS-CGIC Rivastigmin
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE
English: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem The Netherlands
Slovenian: Swensweg 5, 2031 GA Haarlem Nizozemska
English: Worsening of Parkinson's disease
Slovenian: Poslabšanje Parkinsonove bolezni
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.
Slovenian: Pri standardnem nizu preskusov in vitro in in vivo rivastigmin ni bil mutagen, razen v preskusu kromosomskih aberacij na perifenih limfocitih človeka, pri odmerku, ki je bil 104-krat večji od največje klinične izpostavljenosti.
English: Like all medicines, Rivastigmine Teva can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Rivastigmine Teva neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: For rivastigmine no clinical data on exposed pregnancies are available.
Slovenian: Kliničnih podatkov o uporabi rivastigmina med nosečnostjo ni.
English: The use of rivastigmine in patients with severe dementia of Alzheimer's disease or associated with Parkinson's disease, other types of dementia or other types of memory impairment (e.g. age-related cognitive decline) has not been investigated and therefore the use in these patient populations is not recommended.
Slovenian: Uporabe rivastigmina pri bolnikih s hudo Alzheimerjevo demenco ali demenco, povezano s Parkinsonovo boleznijo, drugimi vrstami demence ali drugimi vrstami okvar spomina (npr. z zmanjšanjem kognitivnih funkcij, povezanim s starostjo) niso raziskovali, zato uporaba pri teh populacijah bolnikov ni priporočena.
English: 28 hard capsules 50 x 1 hard capsules 56 hard capsules 112 hard capsules
Slovenian: Pretisni omoti 28 trdih kapsul 50 x 1 trda kapsula 56 trdih kapsul 112 trdih kapsul
English: No effects on fertility or embryofoetal development were observed in rats and rabbits, except at doses related to maternal toxicity.
Slovenian: Pri podganah in kuncih niso opazili nikakršnih učinkov na plodnost ali razvoj zarodka/plodu, razen pri odmerkih, ki so bili toksični za mater.
English: It is preferable to avoid the use of Rivastigmine Teva during pregnancy, unless clearly necessary.
Slovenian: V nosečnosti se je priporočljivo izogibati uporabi zdravila Rivastigmine Teva, razen če je nujno potrebno.
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.
Slovenian: v teh študijah je bilo klinično pomembno izboljšanje vnaprej opredeljeno kot izboljšanje rezultata ADAS-Cog za vsaj 4 točke, izboljšanje rezultata CIBIC-Plus, ali vsaj 10-odstotno izboljšanje rezultata PDS.
English: Capsule shell - titanium dioxide (E171), gelatin and ink used for imprinting Black S-1-17822/S-117823 (shellac glaze-45% in ethanol containing iron oxide black, N-butyl alcohol, isopropyl alcohol, propylene alcohol and ammonium hydroxide).
Slovenian: Ovoj kapsule - titanov dioksid (E171), želatina in črnilo za tisk Black S-1-17822/S-1-17823 (glazura iz šelaka - 45 % v etanolu, ki vsebuje črni železov oksid, N-butilni alkohol, izopropilni alkohol, propilenglikol in amonijev hidroksid).
English: In view of its pharmacodynamic effects, rivastigmine should not be given concomitantly with other cholinomimetic substances and might interfere with the activity of anticholinergic medicinal products.
Slovenian: Zaradi farmakodinamskih učinkov se rivastigmin ne sme dajati sočasno z drugimi holinomimetiki, lahko pa tudi vpliva na delovanje antiholinergičnih zdravil.
English: If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily to reduce the possibility of adverse reactions (e.g. vomiting).
Slovenian: Če se zdravljenje prekine za več kot nekaj dni, ga je treba začeti znova pri odmerku 1,5 mg dvakrat na dan, da se zmanjša možnost neželenih učinkov (npr. bruhanja).
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).
Slovenian: V nekaterih primerih so zaradi teh dogodkov zdravljenje z rivastigminom prekinili (npr. pri zdravljenju z rivastigminom so zaradi tremorja prekinili 1,7 % zdravljenj, pri placebu pa 0 %).
English: In other cases, rivastigmine has been discontinued (see section 4.8).
Slovenian: V drugih primerih so zdravljenje z rivastigminom prekinili (glejte poglavje 4.8).
English: When normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the maximum human dose, a multiple of approximately 6-fold was achieved in animals.
Slovenian: Če so izpostavljenost rivastigminu in njegovim presnovkom normalizirali glede na telesno površino, je bila izpostavljenost približno enakovredna največjem priporočenem odmerku pri človeku, 12 mg/dan; vendar so v primerjavi z največjim odmerkom pri človeku, pri živalih dosegli 6-krat večji odmerek.
English: In animals, rivastigmine crosses the placenta and is excreted into milk.
Slovenian: Pri živalih rivastigmin prehaja skozi placento in se izloča v mleko.
English: The secondary definition of response required a 4-point or greater improvement on the ADAS-Cog, no worsening on the CIBIC-Plus, and no worsening on the PDS.
Slovenian: Za sekundarno opredelitev odziva je bilo potrebno izboljšanje rezultata ADAS-Cog za 4 točke ali več, odsotnost poslabšanja rezultata CIBIC-Plus, in odsotnost poslabšanja rezultata PDS.
English: However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more adverse reactions (see sections 4.4 and 5.2).
Slovenian: Vendar se je treba zaradi povečane izpostavljenosti pri bolnikih pri teh populacijah natančno ravnati po priporočilih, naj se odmerjanje titrira glede na posameznikovo prenašanje, saj je pri bolnikih s klinično pomembno okvaro ledvic ali jeter lahko število neželenih učinkov večje (glejte poglavji 4.4 in 5.2).
English: This medicinal product does not require any special storage instructions.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila.
English: Activity of the enzyme returns to baseline levels about 9 hours after the maximum inhibitory effect has been achieved.
Slovenian: Aktivnost encima se vrne na izhodiščno raven približno po 9 urah po doseženem največjem zaviralnem učinku.
English: However a greater treatment effect was seen in Parkinson's disease patients with moderate dementia.
Slovenian: Vendar so večji učinek zdravljenja opazili pri bolnikih s Parkinsonovo boleznijo z zmerno demenco.
English: Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
Slovenian: Peroralne študije pri brejih podganah niso pokazale nikakršnega teratogenega potenciala rivastigmina.
English: Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10 - 24.
Slovenian: Bolniki, ki so sodelovali v študiji so imeli rezultat MMSE (kratek preizkus spoznavnih sposobnosti - MiniMental State Examination) 10 - 24.
English: Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Slovenian: Simptomatsko zdravljenje blage do zmerne Alzheimerjeve demence.
English: Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Slovenian: Podobno so večji učinek opazili pri bolnikih s Parkinsonovo boleznijo z vidnimi halucinacijami (glejte poglavje 5.1).
English: • Aggression , feeling restless
Slovenian: • agresivnost, občutek nemira
English: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia or dementia associated with Parkinson's disease.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje mora začeti in nadzirati zdravnik z izkušnjami v diagnosticiranju in zdravljenju Alzheimerjeve demence ali demence, povezane s Parkinsonovo boleznijo.
English: Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Slovenian: Rivastigmin je zaviralec acetil- in butirilholinesteraze karbamatnega tipa, za katerega menijo, da pomaga pri holinergični nevrotransmisiji tako, da upočasni razgradnjo acetilholina, ki ga sproščajo funkcionalno intaktni holinergični nevroni.
English: Patients with mild dementia (MMSE 18-24)
Slovenian: Bolniki z blago demenco (MMSE
English: Aggression, restlessness
Slovenian: Agresivnost, nemir
English: Children Rivastigmine is not recommended for use in children.
Slovenian: Uporaba rivastigmina pri otrocih ni priporočljiva.
English: Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
Slovenian: Pri uporabi rivastigmina pri bolnikih s sindromom bolnega sinusnega vozla ali motnjami prevodnosti (sinuatrialni blok, atrioventrikularni blok) je potrebna previdnost (glejte poglavje 4.8).
English: Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
Slovenian: V preskušanjih, nadzorovanih s placebom učinka zdravljenja niso raziskovali dlje kot 6 mesecev.
English: Other side effects seen with Rivastigmine transdermal patches and which may occur with hard capsules:
Slovenian: Drugi neželeni učinki, ki so jih opažali pri uporabi transdermalnih obližev in bi se lahko pojavili tudi pri uporabi trdih kapsul: Pogosti
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Slovenian: Neugodnih učinkov na srčno prevodnost po sočasni uporabi digoksina in rivastigmina niso opazili.
English: If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily.
Slovenian: Če se zdravljenje prekine za več kot nekaj dni, ga je treba začeti znova pri odmerku 1,5 mg dvakrat na dan.
English: 4.9 Overdose Symptoms
Slovenian: 4.9 Preveliko odmerjanje Simptomi
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
English: During therapy patient's weight should be monitored.
Slovenian: Med zdravljenjem je treba spremljati telesno maso bolnikov.
English: In this leaflet: What Rivastigmine Teva is and what it is used for
Slovenian: KAJ JE ZDRAVILO RIVASTIGMINE TEVA IN ZA KAJ GA UPORABLJAMO
English: The recommended maximum daily dose is 6 mg twice a day.
Slovenian: Priporočen največji dnevni odmerek je 6 mg dvakrat na dan.
English: Hyperhydrosis
Slovenian: Hiperhidroza
English: What Rivastigmine Teva looks like and contents of the pack
Slovenian: Izgled zdravila Rivastigmine Teva in vsebina pakiranja
English: INFORMATION IN BRAILLE Rivastigmine Teva 1.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Rivastigmine Teva 1,5 mg
English: Patients with severe hepatic impairment have not been studied (see section 4.4).
Slovenian: Bolnikov s hudo jetrno okvaro niso raziskovali (glejte poglavje 4.4).
English: Take special care with Rivastigmine Teva
Slovenian: Bodite posebno pozorni pri jemanju zdravila Rivastigmine Teva
English: The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine.
Slovenian: Uporaba rivastigmina ne vpliva na povečanje protrombinskega časa, ki ga povzroči varfarin.
English: You should not breast-feed during treatment with Rivastigmine Teva.
Slovenian: Med zdravljenjem z zdravilom Rivastigmine Teva ne smete dojiti.
English: According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Slovenian: Na podlagi presnove je videti, da presnovne interakcije z drugimi zdravili niso verjetne, vendar lahko rivastigmin zavira presnovo drugih snovi, ki jo uravnava butirilholinesteraza.
English: If you take more Rivastigmine Teva than you should If you accidentally take more Rivastigmine Teva than you should, inform your doctor.
Slovenian: Če nehote vzamete več zdravila Rivastigmine Teva, kot bi smeli, obvestite svojega zdravnika.
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.
Slovenian: Klinične študije pri demenci, povezani s Parkinsonovo boleznijo Učinkovitost rivastigmina pri demenci, povezani s Parkinsonovo boleznijo so pokazali v 24-tedenski multicentrični, dvojno slepi, s placebom nadzorovani osrednji študiji in naknadni 24-tedenski odprti fazi.
English: Caution is recomemended when selecting anaesthetic agents.
Slovenian: Pri izbiri anestetika je priporočena previdnost.
English: Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease and Parkinson's disease.
Slovenian: Zato rivastigmin zmanjša holinergični primanjkljaj pri demenci, povezani z Alzheimerjevo in Parkinsonovo boleznijo.
English: Do not use Rivastigmine Teva after the expiry date that is stated on the carton.
Slovenian: Zdravila Rivastigmine Teva ne smete uporabljati po izteku roka uporabnosti, ki je naveden na zunanji ovojnini.
English: No evidence of carcinogenicity was found in studies in mice and rats at the maximum tolerated dose, although the exposure to rivastigmine and its metabolites was lower than the human exposure.
Slovenian: V študijah pri miših in podganah z največjim odmerkom, ki so ga živali prenašale, niso ugotovili nikakršnih dokazov za kancerogenost, vendar je bila izpostavljenost rivastigminu in njegovim presnovkom manjša kot pri človeku.
English: Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Slovenian: Simptomatsko zdravljenje blage do zmerne demence pri bolnikih z idiopatsko Parkinsonovo boleznijo.
English: Yellow iron oxide (E 172)
Slovenian: rdeči železov oksid (E 172)
English: Very rare Not known
Slovenian: Zelo redki Neznana
English: • High blood pressure
Slovenian: Zelo redki • visok krvni tlak
English: If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-tolerated dose or the treatment may be discontinued.
Slovenian: Če se neželeni učinki ne prenehajo, je treba dnevni odmerek začasno zmanjšati na prejšnjega, ki ga je bolnik še dobro prenašal, ali prekiniti zdravljenje.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva Pharma B.V.
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.
Slovenian: Pri zdravih mladih moških peroralni 3-miligramski odmerek zmanjša aktivnost acetilholinesteraze (AChE) v cerebrospinalni tekočini za približno 40 % v prvi 1,5 uri po uporabi.
English: Re-initiation of therapy:
Slovenian: Ponoven začetek zdravljenja:
English: Total patients studied Total patients with pre-defined AE(s) Tremor
Slovenian: Skupno število bolnikov v študiji Skupno število bolnikov z vnaprej opredeljenimi neželenimi dogodki
English: Slow heart beat and fainting may also occur.
Slovenian: Lahko pride tudi do počasnega utripa srca in omedlevice.
English: Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.
Slovenian: V kliničnih študijah so ugotovili, da so bolnice bolj dovzetne za gastrointestinalne neželene učinke in izgubo telesne mase kot moški bolniki.
English: Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms.
Slovenian: Kot drugi holinomimetiki, lahko tudi rivastigmin poslabša ali sproži ekstrapiramidalne simptome.
English: 2 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
Slovenian: ITT: Intent-To-Treat (namera zdravljenja); RDO: Retrieved Drop Outs (nadomeščeni izpadli); LOCF: Last Observation Carried Forward (zadnje opažanje preneseno naprej).
English: In patients with Alzheimer's disease, inhibition of AChE in CSF by rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested.
Slovenian: Pri bolnikih z Alzheimerjevo boleznijo je bilo zaviranje AChE v cerebrospinalni tekočini odvisno od odmerka do 6 mg rivastigmina dvakrat na dan, kar je bil največji preskušeni odmerek.
English: Rivastigmine Teva might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
Slovenian: (zdravil, ki se uporabljajo za lajšanje želodčnih krčev ali spazmov, za zdravljenje Parkinsonove bolezni ali za preprečevanje potovalne bolezni).
English: Subjects with hepatic impairment:
Slovenian: Bolniki z ledvično okvaro:
English: Very common (affects more than 1 patient in 10) Common (affects 1 to 10 patients in 100) Uncommon (affects 1 to 10 patients in 1,000) Rare (affects 1 to 10 patients in 10, 000) Very rare (affects less than 1 patient in 10,000) Not known (frequency cannot be estimated from the available data)
Slovenian: Pogostnosti so opredeljene, kot sledi: zelo pogosti (pojavijo se pri več kot 1 bolniku od 10 bolnikov) pogosti (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov) občasni (pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov) redki (pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov) zelo redki (pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov) neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: Care should be exercised in treating patients with active gastric or duodenal ulcers or patients predisposed to these conditions.
Slovenian: Pri zdravljenju bolnikov z aktivnimi razjedami želodca ali dvanajstnika, ali bolnikov, ki so tem boleznim nagnjeni, je potrebna previdnost.
English: Rivastigmine Teva 1.5 mg hard capsules Rivastigmine Teva 3 mg hard capsules Rivastigmine Teva 4.5 mg hard capsules Rivastigmine Teva 6 mg hard capsules Rivastigmine
Slovenian: Rivastigmine Teva 1,5 mg trde kapsule Rivastigmine Teva 3 mg trde kapsule Rivastigmine Teva 4,5 mg trde kapsule Rivastigmine Teva 6 mg trde kapsule rivastigmin
English: This medicinal product does not require any special storage conditions Medicines should not be disposed of via wastewater or household waste.
Slovenian: Zdravil ne smete odstraniti v odpadne vode ali gospodinjske odpadke.
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.
Slovenian: V tabeli 4 spodaj so navedeni rezultati za bolnike, ki so se klinično pomembno odzivali na zdravljenje, zbrane iz dveh študij s prožnimi odmerki med tremi ključnimi 26-tedenskimi multicentričnimi študijami pri bolnikih z blago do zmerno Alzheimerjevo demenco.
English: Table 5
Slovenian: Tabela 5
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.
Slovenian: Pri bolnikih z zmerno ledvično okvaro sta bili vrednosti Cmax in AUC rivastigmina več kot dvakrat večji, kot pri zdravih osebah; vendar pri osebah s hudo ledvično okvaro sprememb vrednosti Cmax in AUC rivastigmina niso opazili.
English: The efficacy of rivastigmine has been established through the use of three independent, domain specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods.
Slovenian: Učinkovitost rivastigmina so ugotovili s tremi neodvisnimi orodji za ocenjevanje, specifičnimi za to področje.
English: - 50 x 1 capsules in PVC/Alu push through perforated unit dose blisters Not all pack sizes may be marketed.
Slovenian: - 50 x 1 kapsula v pretisnem omotu iz PVC/Alu, perforiranem za enkratne odmerke.
English: Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90 %) within 24 hours.
Slovenian: V 24 urah po uporabi 14C-rivastigmina je bilo izločanje skozi ledvice hitro in skoraj popolno
English: Protein binding of rivastigmine is approximately 40 %.
Slovenian: Približno 40 % rivastigmina se veže na beljakovine plazme.
English: The active substance is rivastigmine
Slovenian: Zdravilna učinkovina je rivastigmin.
English: Teva Nederland B.V. Tel: +31 (0) 800 0228400
Slovenian: Tel: +31 (0) 800 0228400 Norge
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.
Slovenian: Titracija odmerkov: Kmalu po povečanju odmerka so opazili neželene učinke (npr. hipertenzijo in halucinacije pri bolnikih z Alzheimerjevo demenco ter poslabšanje ekstrapiramidnih simptomov, zlasti tremorja, pri bolnikih z demenco, povezano s Parkinsonovo boleznijo).