FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
Slovenian: Terapevtskega učinka niso raziskovali v s placebom nadzorovanih preskušanjih, ki bi bile daljša od 6 mesecev.
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Slovenian: Kot začetni odmerek priporočamo 0,03 mg/kg atropinijevega sulfata intravensko, nadaljnji odmerki pa naj temeljijo na kliničnem odzivu.
English: Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors.
Slovenian: Rivastigmin lahko povzroča bradikardijo, ki predstavlja dejavnik tveganja za razvoj torsade de pointes, zlasti pri bolnikih z dejavniki tveganja.
English: Do not handle the tablets with wet hands as the tablets may break up.
Slovenian: Tablet ne prijemajte z mokrimi rokami, ker lahko razpadejo.
English: If after 3 months of maintenance dose treatment the patient's rate of decline in dementia symptoms is not altered favourably, the treatment should be discontinued.
Slovenian: Če se po treh mesecih slabšanje simptomov demence ne spremeni v bolnikovo korist, je treba zdravljenje prekiniti.
English: Patients without visual hallucinations
Slovenian: Bolniki brez vidnih halucinacij
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.
Slovenian: Celotni plazemski očistek rivastigmina je bil po intravenskem odmerku 0,2 mg približno 130 l/h, po intravenskem odmerku 2,7 mg pa se je zmanjšal na 70 l/h.
English: What you need to know before you take Nimvastid
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Nimvastid
English: If you forget to take Nimvastid
Slovenian: Če ste pozabili vzeti zdravilo Nimvastid
English: No clinical data on exposed pregnancies are available.
Slovenian: Kliničnih podatkov o nosečnicah, ki bi bile izpostavljene rivastigminu, ni.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer's dementia and in the treatment of dementia in patients with idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z rivastigminom za vse podskupine pediatrične populacije glede zdravljenja Alzheimerjeve demence in zdravljenja demence pri bolnikih z idiopatsko Parkinsonovo boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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: Zdravljenje mora uvesti in nadzorovati zdravnik, ki je izkušen v diagnostiki in zdravljenju Alzheimerjeve demence ali demence, povezane s Parkinsonovo boleznijo.
English: The incidence and severity of adverse reactions generally increase with higher doses.
Slovenian: Pogostnost in stopnja izraženosti neželenih učinkov se na splošno povečujeta z večanjem odmerkov.
English: Patients with moderate dementia (MMSE 10-17)
Slovenian: Bolniki z zmerno demenco (MMSE 10-17)
English: Decreased appetite Dehydration
Slovenian: Anoreksija zmanjšan apetit dehidracija
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.
Slovenian: Rezultati populacijske farmakokinetične analize so pokazali, da pri bolnikih z Alzheimerjevo boleznijo (n=75 kadilcev in 549 nekadilcev) uporaba nikotina za 23 % poveča očistek rivastigmina pri peroralnem odmerjanju rivastigmina v kapsulah v odmerkih do 12 mg/dan.
English: In animals, rivastigmine is excreted in milk.
Slovenian: Pri živalih se rivastigmin izloča v mleko.
English: Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite.
Slovenian: Rivastigmin se hitro in obsežno presnavlja (razpolovni čas v plazmi traja približno 1 uro); primarno s hidrolizo, ki jo katalizira holinesteraza, v dekarbamilirani presnovek.
English: Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.
Slovenian: Sočasno jemanje obeh navedenih zdravil lahko povzroči težave, kot je počasno bitje srca (bradikardija), zaradi česar lahko pride do omedlevice oziroma izgube zavesti.
English: Rivastigmine interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes.
Slovenian: Rivastigmin s svojima tarčnima encimoma reagira tako, da z njima oblikuje kovalentno vezan kompleks, ki encima začasno inaktivira.
English: The capsules should be swallowed whole.
Slovenian: Kapsule mora pogoltniti cele.
English: If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Slovenian: Če kaj od navedenega velja za vas, vas bo zdravnik med zdravljenjem morda moral natančneje spremljati.
English: Patients with severe hepatic impairment have not been studied.
Slovenian: Uporabe zdravila pri bolnikih s hudo jetrno okvaro niso proučili.
English: Patients with visual hallucinations
Slovenian: Bolniki z vidnimi halucinacijami
English: Such events appeared to occur particularly after dose increments or high doses of rivastigmine.
Slovenian: Do takih dogodkov je prišlo predvsem po povečevanju odmerka ali po jemanju velikih odmerkov rivastigmina.
English: Other medicines and Nimvastid
Slovenian: Druga zdravila in zdravilo Nimvastid
English: ADAS-Cog Rivastigmine
Slovenian: ADAS-Cog rivastigmin
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Slovenian: In vitro kaže ta presnovek zelo majhno stopnjo zaviranja holinesteraze (< 10 %).
English: Mean baseline ± SD Mean change at 24 weeks ± SD
Slovenian: Povprečje ob izhodišču ± SD Povprečna sprememba po 24 tednih ± SD
English: Biotranformation
Slovenian: Biotransformacija
English: Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment 24 hours after the overdose.
Slovenian: Pri večini bolnikov, ki so nenamerno vzeli prevelik odmerek, se niso pojavili klinični znaki ali simptomi in skoraj vsi ti bolniki so nadaljevali zdravljenje z rivastigminom24 ur po prevelikem odmerjanju.
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 9 ur potem, ko doseže največji zaviralni učinek.
English: The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose.
Slovenian: Učinkoviti odmerek je 3 do 6 mg dvakrat na dan. Za dosego največjega zdravilnega učinka moramo bolnika vzdrževati na največjem odmerku, ki ga še dobro prenašajo.
English: Hyperhydrosis Allergic dermatitis (disseminated)
Slovenian: Hiperhidroza alergijski dermatitis (diseminirana oblika)
English: Patients with mild dementia (MMSE 18-24)
Slovenian: Bolniki z blago demenco (MMSE 18-24)
English: Nimvastid 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.
Slovenian: Zdravilo Nimvastid uporabljamo za zdravljenje odraslih bolnikov z blago do zmerno hudo Alzheimerjevo demenco, to je napredujoča bolezen možganov, ki postopoma prizadene spomin in intelektualne sposobnosti ter vpliva na vedenje bolnika.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Slovenian: Pri bolnikih z Alzheimerjevo demenco ali z demenco zaradi Pakinsonove bolezni določene celice v možganih odmrejo, to pa povzroči znižano koncentracijo nevrotransmiterja acetilholina (to je snov, ki omogoča živčnim celicam, da komunicirajo med seboj).
English: In oral studies with male and female rats, no adverse effects of rivastigmine were observed on fertility or reproductive performance of either the parent generation or the offspring of the parents.
Slovenian: V študijah peroralnega odmerjanja podganjim samcem in samicam niso opažali nobenega neželenega delovanja rivastigmina na plodnost ali sposobnost razmnoževanja niti pri starševski generaciji niti pri potomcih teh staršev.
English: Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Slovenian: Pri bolnikih, ki imajo manj kot 50 kg, je lahko število neželenih učinkov večje, obstaja pa tudi večja verjetnost, da bodo zaradi neželenih učinkov zdravljenje prekinili.
English: Dementia associated with Parkinson's Disease
Slovenian: Demenca, povezana s Parkinsonovo boleznijo
English: Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Slovenian: C, je bilo ledvično izločanje hitro, saj se je dejansko ves (> 90 %) izločil v 24 urah.
English: In other cases, rivastigmine has been discontinued (see section 4.8).
Slovenian: V drugih primerih so rivastigmin ukinili (glejte poglavje 4.8).
English: In more severe cases nicotinic effects might develop such as muscular weakness, fasciculations, seizures and respiratory arrest with possible fatal outcome.
Slovenian: V hujših primerih se lahko razvijejo tudi nikotinski učinki, kot so mišična šibkost, fascikulacije, konvulzije in zastoj dihanja, ki se lahko konča tudi s smrtjo.
English: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration.
Slovenian: Najpogosteje so poročali o gastrointestinalnih neželenih učinkih, med drugim o navzei (38 %) in bruhanju (23 %), posebno med titriranjem odmerka.
English: In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
Slovenian: Če bolnik, ki se zdravi z rivastigminom, bruha, mu je treba ustrezno prilagoditi odmerek zdravila, kot je priporočeno v poglavju 4.2.
English: The tablets are round and white.
Slovenian: Tablete so bele in okrogle oblike.
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 dose-dependent adverse reactions.
Slovenian: Vendar se je treba zaradi povečane izpostavljenosti zdravilu pri teh populacijah natančno ravnati po priporočilih, naj se odmerjanje titrira glede na individualno prenašanje, saj je pri bolnikih s klinično pomembno okvaro ledvic ali jeter lahko število od odmerka odvisnih neželenih učinkov večje.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Caution is recommended in treating patients predisposed to such diseases.
Slovenian: Pri zdravljenju bolnikov, ki so nagnjeni k takim boleznim, je zato potrebna previdnost.
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: Klinično pomembno izboljšanje v teh študijah je bilo pri ADAS-Cog opredeljeno kot izboljšanje za vsaj 4 točke, pri CIBIC-Plus kot izboljšanje, pri PDS pa vsaj kot desetodstotno izboljšanje.
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
Slovenian: V skupini standardnih testov in vitro in in vivo rivastigmin ni bil mutagen, razen v testu kromosomskih aberacij v človeških perifernih levkocitih v odmerku, ki je bil za 10
English: If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily to reduce the possibility of adverse reactions (e.g. vomiting).
Slovenian: Če zdravljenje prekinemo za več kot tri dni, ga moramo spet začeti z odmerkom 1,5 mg dvakrat na dan, da zmanjšamo možnost neželenih učinkov (na primer bruhanja).
English: In view of its pharmacodynamic effects and possible additive effects, rivastigmine should not be given concomitantly with other cholinomimetic substances.
Slovenian: Zaradi farmakodinamičnih učinkov in možnosti aditivnega delovanja se rivastigmina ne sme uporabljati skupaj z drugimi holinomimetičnimi snovmi.
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 neželeni učinki vztrajajo, moramo dnevni odmerek začasno zmanjšati na odmerek, ki ga bolnik še dobro prenaša, oziroma prekiniti zdravljenje.
English: If you have to undergo surgery whilst taking Nimvastid, tell your doctor before you are given any anaesthetics, because Nimvastid may exaggerate the effects of some muscle relaxants during anaesthesia.
Slovenian: Če jemljete zdravilo Nimvastid in morate na operacijo, povejte zdravniku, da jemljete to zdravilo, preden dobite kakršnokoli anestezijo, saj lahko Nimvastid poveča učinke nekaterih mišičnih relaksantov.
English: (on carton label only)
Slovenian: (le na škatli)
English: Rivastigmine orodispersible tablet is bioequivalent to rivastigmine capsules, with a similar rate and extent of absorption.
Slovenian: Orodisperzibilna tableta rivastigmina je bioekvivalentna kapsulam rivastigmina ter ima podobno hitrost in obseg absorpcije.
English: The use of this medicinal product is contraindicated in patients with known hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Slovenian: Uporaba tega zdravila je kontraindicirana pri bolnikih, ki imajo ugotovljeno preobčutljivost na učinkovino rivastigmin, druge derivate karbamata ali katero koli pomožno snov, navedeno v poglavju
English: Less than 1% of the administered dose is excreted in the faeces.
Slovenian: Manj kot 1 % zaužitega odmerka se izloči z blatom.
English: Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10-24.
Slovenian: Bolniki, vključeni v to študijo, so imeli rezultat MMSE (Mini-Mental State Examination - kratek preskus spoznavnih sposobnosti) med 10 in 24.
English: To be swallowed whole without crushing or opening.
Slovenian: Kapsulo morate pogoltniti celo, ne da bi jo prej zdrobili ali odprli.
English: There is no relevant use of Nimvastid in the paediatric population in the treatment of Alzheimer's disease.
Slovenian: Zdravila Nimvastid ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
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: Izpostavljenost rivastigminu in njegovim presnovkom, preračunana na telesno površino, je bila približno enakovredna največjemu priporočenemu odmerku za ljudi, to je 12 mg na dan; v primerjavi z največjim odmerkom za ljudi je bil pri živalih dosežen približno njegov 6-kratni mnogokratnik.
English: As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours.
Slovenian: Ker traja plazemski razpolovni čas rivastigmina približno 1 uro, zaviranje acetilholinesteraze pa približno 9 ur, priporočamo, da bolnik 24 ur po morebitnem asimptomatičnem prevelikem odmerku ne jemlje nadaljnjih odmerkov rivastigmina.
English: The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.
Slovenian: Kapsule in orodisperzibilne tablete lahko uporabljamo tudi za zdravljenje demence pri odraslih bolnikih s Parkinsonovo boleznijo.
English: Rivastigmine 6-12 mg N=473
Slovenian: Merilo odziva rivastigmin 6-12 mg n = 473
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 use in these patient populations is not recommended.
Slovenian: Uporabe rivastigmina pri bolnikih s hudo demenco in Alzheimerjevo boleznijo ali z demenco, povezano s Parkinsonovo boleznijo, z drugimi vrstami demence ali drugimi vrstami spominskih okvar (npr. starostnega kognitivnega upada) niso raziskali, zato ni priporočena.
English: However, Nimvastid may be used in this patient population and close monitoring is necessary.
Slovenian: Zdravilo Nimvastid se pri teh bolnikih kljub temu lahko uporabi, potrebno pa je natančno spremljanje zdravljenja.
English: Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Slovenian: Simptomatsko zdravljenje blage do zmerno hude Alzheimerjeve demence.
English: What Nimvastid is and what it is used for What you need to know before you take Nimvastid How to take Nimvastid
Slovenian: Kaj je zdravilo Nimvastid in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Nimvastid Kako jemati zdravilo Nimvastid Možni neželeni učinki
English: Rivastigmine should be administered twice a day, with morning and evening meals.
Slovenian: Bolnik mora rivastigmin jemati dvakrat na dan, z jutranjim in večernim obrokom.
English: Motor dysfunction
Slovenian: Motorične motnje
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: Sekundarna opredelitev odziva je zahtevala izboljšanje pri ADAS-Cog za najmanj 4 točke in nobenega poslabšanja pri CIBIC-Plus in PDS.
English: ADCS-CGIC Rivastigmine
Slovenian: ADCS-CGIC rivastigmin
English: As a consequence of rivastigmine's interaction with its target enzyme, the increase in bioavailability is about 1.5-fold greater than that expected from the increase in dose.
Slovenian: Posledica medsebojnega delovanja rivastigmina in tarčnega encima je povečanje biološke uporabnosti, ki je za 1,5-krat večja, kot bi pričakovali glede na povečanje odmerka.
English: Put the tablet on the tongue as soon as it is removed from the packaging.
Slovenian: Tableto položite na jezik, takoj ko jo stresete iz ovitka.
English: Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Slovenian: V preglednici 1 in preglednici 2 so neželeni učinki navedeni glede na organski sistem po MedDRA klasifikaciji in glede na kategorijo pogostnosti.
English: No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Slovenian: V študijah na živalih zaradi občutljivosti uporabljenih živalskih modelov ni bilo mogoče ugotoviti varnega območja za dajanje zdravila ljudem.
English: Rivastigmine orodispersible tablets may be used as an alternative to rivastigmine capsules.
Slovenian: Orodisperzibilne tablete rivastigmina se lahko predpisujejo kot alternativa kapsulam rivastigmina.
English: In these cases, treatment should be discontinued (see section 4.3).
Slovenian: V opisanih primerih je treba zdravljenje prekiniti (glejte poglavje 4.3).
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.
Slovenian: Preglednica 3 navaja število (n) in odstotek bolnikov iz specifične 24-tedenske klinične študije z rivastigminom pri bolnikih z demenco, povezano s Parkinsonovo boleznijo, z vnaprej opredeljenimi neželenimi dogodki, ki lahko odražajo poslabšanje simptomov Parkinsonove bolezni.
English: You should not breast-feed during treatment with Nimvastid.
Slovenian: Med zdravljenjem z zdravilom Nimvastid ne smete dojiti.
English: ADAS-Cog: improvement of at least 4 points CIBIC-Plus: improvement PDS: improvement of at least 10%
Slovenian: CIBIC-Plus: izboljšanje PDS: izboljšanje za najmanj 10 %
English: Similarly a larger treatment effect was observed in those patients with visual hallucinations (see Table 6).
Slovenian: Boljši učinek so opazili tudi pri tistih bolnikih z vidnimi halucinacijami (glejte preglednico 6).
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine.
Slovenian: Neželene učinke, navedene v spodnji preglednici 1, so zbrali pri bolnikih z Alzheimerjevo demenco, zdravljenih z rivastigminom.
English: Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Slovenian: Simptomatsko zdravljenje blage do zmerno hude demence pri bolnikih z idiopatsko Parkinsonovo boleznijo.
English: Date of first authorisation: 11/5/2009 Date of latest renewal: DD month YYYY
Slovenian: Datum prve odobritve: 11. maj 2009 Datum zadnjega podaljšanja: 16. januar 2014
English: No adverse effects of rivastigmine were observed on fertility or reproductive performance in rats (see section 5.3).
Slovenian: Pri podganah niso opažali neželenih učinkov na plodnost in sposobnost razmnoževanja (glejte poglavje 5.3).
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: Previdnost je potrebna pri uporabi rivastigmina pri bolnikih s sindromom bolnega sinusnega vozla ali s prevodnimi motnjami (sinuatrialni blok, atrioventrikularni blok) (glejte poglavje 4.8).
English: Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Slovenian: Opazili so ga tudi pri tistih bolnikih s Parkinsonovo boleznijo, ki so imeli vidne halucinacije (glejte poglavje 5.1).
English: Additionally there have been post-marketing cases of dizziness, tremor, headache, somnolence, confusional state, hypertension, hallucinations and malaise.
Slovenian: Poleg tega je v času trženja zdravila prišlo do primerov omotičnosti, tremorja, glavobola, somnolence, stanja zmedenosti, hipertenzije, halucinacij in splošnega slabega počutja.
English: Possible dose adjustments or temporarily stopping treatment can be considered if needed.
Slovenian: Razmisliti je treba o morebitni spremembi odmerka ali začasni prekinitvi zdravljenja.