FrancophonIA/ELRC3.0 huggingface dataset:
English: These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).
Slovenian: Med njimi so ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, Lestvica za oceno kognitivnih sposobnosti bolnikov z Alzheimerjevo boleznijo, merilo za kognicijo, ki temelji na storilnosti), CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, Zdravnikova ocena spremembe bolezni na podlagi pogovora, celostno globalno ocenjevanje bolnika, ki ga opravlja zdravnik in ki zajema tudi podatke, ki jih daje/-jo negovalec/-ci) in PDS (Progressive Deterioration Scale, Lestvica progresivnega slabšanja, negovalčeva ocena vsakodnevnih aktivnosti, na primer osebne higiene, hranjenja, oblačenja, gospodinjskih opravil, na primer nakupovanja, ohranjanje zmožnosti orientacije v okolju, pa tudi ukvarjanje z denarnimi zadevami itn.).
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.
Slovenian: Po podatkih raziskav in vitro ni pričakovati farmakokinetičnih interakcij z zdravili, ki jih presnavljajo naslednji izoencimi s citokromi: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19 in CYP2B6.
English: Patients who show signs or symptoms of dehydration resulting from prolonged vomiting or diarrhoea can be managed with intravenous fluids and dose reduction or discontinuation if recognised and treated promptly.
Slovenian: Bolnike z znaki ali simptomi dehidracije zaradi dolgotrajnega bruhanja ali driske je v primeru prepoznavanja stanja in takojšnjega ukrepanja mogoče zdraviti z intravenskim nadomeščanjem tekočin in zmanjšanjem odmerka ali prekinitvijo odmerjanja.
English: Pre-defined adverse events that may reflect worsening of parkinsonian symptoms in patients with dementia associated with Parkinson's disease
Slovenian: Vnaprej opredeljeni neželeni dogodki, ki lahko odražajo poslabšanje simptomov Parkinsonove bolezni pri bolnikih z demenco, povezano s Parkinsonovo boleznijo
English: Caution is recommended when selecting anaesthetic agents.
Slovenian: Pri izbiri anestetika se priporoča previdnost.
English: Taking the two medicines together could cause problems such as stiff limbs and trembling hands.
Slovenian: Sočasno jemanje obeh navedenih zdravil lahko povzroči težave, kot sta okorelost okončin in tresenje rok.
English: Uncommon (may affect up to 1 in 100 people) • Hyperactivity (high level of activity, restlessness)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - hiperaktivnost (povečana stopnja aktivnosti, nemir)
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.
Slovenian: V preglednici 2 so navedeni neželeni učinki, o katerih so poročali iz kliničnih študij, ki so jih izvajali pri bolnikih z demenco, povezano s Parkinsonovo boleznijo, ki so se zdravili s kapsulami rivastigmina.
English: Although a treatment effect was demonstrated in the overall study population, the data suggested that a larger treatment effect relative to placebo was seen in the subgroup of patients with moderate dementia associated with Parkinson's disease.
Slovenian: Čeprav se je terapevtski učinek pokazal pri vseh bolnikih, ki so bili vključeni v študijo, podatki kažejo, da so boljši terapevtski učinek v primerjavi s placebom opazili pri podskupini bolnikov z zmerno demenco in s Parkinsonovo boleznijo.
English: The Cmax of rivastigmine was approximately 60% higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Slovenian: Cmax rivastigmina je bila za približno 60 % večja, AUC rivastigmina pa več kot dvakrat večja pri osebah z blago do zmerno jetrno okvaro kot pri zdravih osebah.
English: Parkinsonism
Slovenian: Parkinsonizem
English: Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Slovenian: Previdnost je potrebna tudi pri predpisovanju zaviralcev holinesteraze bolnikom z anamnezo astme ali obstruktivne pljučne bolezni.
English: By blocking these enzymes, Nimvastid allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Slovenian: Zdravilo Nimvastid z zaviranjem navedenih encimov omogoča zvišanje koncentracije acetilholina v možganih in s tem pomaga pri zmanjševanju simptomov Alzheimerjeve bolezni in demence v povezavi s Parkinsonovo boleznijo.
English: If you accidentally take more Nimvastid than you should, inform your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila Nimvastid, kot bi smeli Če nehote vzamete več zdravila Nimvastid, kot bi smeli, obvestite svojega zdravnika.
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: Glede na presnovo rivastigmina se zdi medsebojno delovanje z drugimi zdravili malo verjetno, čeprav lahko rivastigmin zavre presnovo drugih učinkovin, v katero je vključena butirilholinesteraza.
English: Gastrointestinal disorders such as nausea, vomiting and diarrhoea are dose-related, and may occur particularly when initiating treatment and/or increasing the dose (see section 4.8).
Slovenian: Prebavne motnje, na primer navzea, bruhanje in driska, so povezane z velikostjo odmerka in se lahko pojavijo zlasti na začetku zdravljenja in/ali ob povečanju odmerka (glejte poglavje 4.8).
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 na miših in podganah pri največjem odmerku, ki so ga živali še prenašale, niso opazili nobenih znakov kancerogenosti; vendar je bila izpostavljenost rivastigminu in njegovim presnovkom manjša od izpostavljenosti pri ljudeh.
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: Cmax in AUC rivastigmina sta bili pri osebah z zmerno ledvično okvaro več kot dvakrat večji kot pri zdravih osebah, pri osebah s hudo ledvično okvaro pa ni bilo sprememb.
English: HDPE container: boxes of 200 or 250 hard capsules are available.
Slovenian: Vsebnik (HDPE): na voljo so škatle po 200 ali 250 trdih kapsul.
English: Other side effects seen with rivastigmine transdermal patches and which may occur with the orodispersible tablets:
Slovenian: Drugi neželeni učinki, ki so jih opažali pri uporabi rivastigmin transdermalnih obližev in bi se lahko pojavili tudi pri uporabi orodisperzibilnih tablet:
English: HDPE container: 200 or 250 hard capsules in a box.
Slovenian: Vsebnik (HDPE): 200 ali 250 trdih kapsul, v škatli.
English: ITT: Intent-To-Treat; RDO: Retrieved Drop Outs
Slovenian: RDO (Retrieved Drop Outs) - upoštevani izpadli primeri
English: There have been rare post-marketing reports of patients experiencing allergic dermatitis (disseminated) when administered rivastigmine irrespective of the route of administration (oral, transdermal).
Slovenian: V redkih poročilih iz obdobja po prihodu zdravila na trg so opisovali bolnike, pri katerih je pri aplikaciji rivastigmina prišlo do alergijskega dermatitisa (diseminirane oblike) ne glede na način vnosa zdravila (peroralno ali transdermalno).
English: • Do not open or crush the capsules.
Slovenian: - Kapsul ne odpirajte in ne drobite.
English: As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Slovenian: Ker je rivastigmin zaviralec holinesteraze, lahko med anestezijo zelo poveča učinke mišičnih relaksantov tipa sukcinilholina.
English: Cardiovascular betablockers are expected to be associated with the greatest risk, but reports have also been received in patients using other beta-blockers.
Slovenian: Z največjim tveganjem naj bi bili povezani tisti antagonisti adrenergičnih receptorjev beta, ki delujejo na kardiovaskularni sistem, vendar so o težavah poročali tudi pri bolnikih, ki so uporabljali druge antagoniste adrenergičnih receptorjev beta.
English: The patients studied had an MMSE (Mini-Mental State Examination) score of 10-24.
Slovenian: Pri proučevanih bolnikih so bili rezultati MMSE (Mini-Mental State Examination - kratek preskus spoznavnih sposobnosti) med 10 in 24.
English: Patients with clinically significant renal or hepatic impairment might experience more adverse reactions (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih s klinično pomembno ledvično ali jetrno okvaro je lahko število neželenih učinkov večje (glejte poglavji 4.2 in 5.2).
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 3-miligramski peroralni odmerek v poldrugi uri po zaužitju zmanjša aktivnost AChE v cerebrospinalni tekočini (CSF) za približno 40 %.
English: The recommended maximum daily dose is 6 mg twice a day.
Slovenian: Priporočeni največji dnevni odmerek je 6 mg dvakrat na dan.
English: Caution is advised in patients at higher risk of developing torsade de pointes; for example, those with uncompensated heart failure, recent myocardial infarction, bradyarrhythmias, a predisposition to hypokalaemia or hypomagnesaemia, or concomitant use with medicinal products known to induce QT prolongation and/or torsade de pointes (see sections 4.5 and 4.8).
Slovenian: Previdnost je potrebna pri bolnikih s povečanim tveganjem za torsade de pointes, na primer pri tistih z dekompenziranim srčnim popuščanjem, nedavnim miokardnim infarktom ali bradiaritmijo, pri tistih, ki so nagnjeni k razvoju hipokaliemije ali hipomagneziemije, ali pri sočasni uporabi zdravil, za katera je znano, da lahko sporožijo podaljšanje intervala QT in/ali torsade de pointes (glejte poglavji 4.5 in 4.8).
English: During therapy patient's weight should be monitored.
Slovenian: Med zdravljenjem moramo zato spremljati bolnikovo telesno maso.
English: Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g oxybutynin, tolterodine).
Slovenian: Rivastigmin lahko moti delovanje antiholinergikov (na primer oksibutinina in tolterodina).
English: Dosing recommendations to titrate according to individual tolerability must be closely followed.
Slovenian: Pri teh bolnikih je treba skrbno upoštevati priporočila o titriranju odmerkov glede na individualno prenašanje.
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.
Slovenian: Ker brahikardija predstavlja dejavnik tveganja za pojav torsades de pointes, je kombinirano uporabo rivastigmina in zdravil, ki lahko sprožijo torsades de pointes, kot so antipsihotiki, na primer nekateri fenotiazini (klorpromazin, levomepromazin), benzamidi (sulpirid, sultoprid, amisulprid, tiaprid, veraliprid), ter pimozid, haloperidol, droperidol, cisaprid, citalopram, difemanil, intravenski eritromicin, halofantrin, mizolastin, metadon, pentamidin in moksifloksacin, potrebno obravnavati previdno, morda bo potrebno tudi klinično spremljanje (EKG).
English: If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson's disease are observed during treatment, these may respond to omitting one or more doses.
Slovenian: Če med zdravljenjem opazimo neželene učinke (npr. navzeo, bruhanje, bolečine v trebuhu ali izgubo teka), hujšanje ali poslabšanje ekstrapiramidnih simptomov (npr. tremorja) pri bolnikih z demenco v povezavi s Parkinsonovo boleznijo, se utegnejo le-ti odzvati na opustitev enega ali več odmerkov.
English: No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Slovenian: V študijah na zdravih prostovoljcih med rivastigminom in digoksinom, varfarinom, diazepamom ali fluoksetinom niso opazili farmakokinetičnega medsebojnega delovanja.
English: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machinery.
Slovenian: Zaradi Alzheimerjeve bolezni se lahko postopno zmanjša sposobnost za upravljanje motornih vozil ali strojev.
English: Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms.
Slovenian: Podobno kot drugi holinomimetiki lahko rivastigmin povzroči ekstrapiramidne simptome ali njihovo poslabšanje.
English: Nimvastid may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Slovenian: Zdravilo Nimvastid lahko povzroči vrtoglavost in zaspanost, predvsem na začetku zdravljenja ali ob povečanju odmerka.
English: Other side effects seen with rivastigmine transdermal patches and which may occur with the hard capsules:
Slovenian: Drugi neželeni učinki, ki so jih opažali pri uporabi rivastigmin transdermalnih obližev in bi se lahko pojavili tudi pri uporabi trdih kapsul:
English: Infections and infestations Very rare
Slovenian: Infekcijske in parazitske bolezni zelo redko okužba sečil
English: Initial dose 1.5 mg twice a day.
Slovenian: Začetni odmerek 1,5 mg dvakrat na dan.
English: Based on evidence from animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Slovenian: Raziskave na živalih dokazujejo, da pri presnovi rivastigmina le v zelo majhni meri sodelujejo glavni izoencimi s citokromom P450.
English: Slow heartbeat and fainting may also occur.
Slovenian: Lahko pride tudi do počasnega utripa srca in omedlevice.
English: Balance disorder Musculoskeletal stiffness Rigors
Slovenian: Motnje ravnotežja Otrdelost mišic in skeleta Rigor (okorelost)
English: Your doctor will also monitor your weight whilst you are taking this medicine.
Slovenian: Med jemanjem tega zdravila bo zdravnik spremljal tudi vašo telesno maso.
English: Orodispersible tablet.
Slovenian: Orodisperzibilna tableta.
English: How to take Nimvastid
Slovenian: Kako jemati zdravilo Nimvastid
English: Musculoskeletal stiffness Rigors
Slovenian: Mišična rigidnost
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: Zaradi teh težav so pri nekaterih bolnikih prekinili zdravljenje z rivastigminom (npr. pri zdravljenju z rivastigminom je bilo 1,7 % prekinitev zaradi tremorja, pri zdravljenju s placebom pa nobene).
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: Rivastigmin bi zato lahko izboljšal holinergično posredovano poslabšanje kognitivnih funkcij pri demenci, povezani z Alzheimerjevo in Parkinsonovo boleznijo.
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.
Slovenian: Poročali so o holinergičnem toksičnem delovanju z muskarinskimi simptomi, ki jih opažajo pri zmernih zastrupitvah, obsegajo pa lahko miozo, pordevanje, prebavne motnje, vključno z bolečinami v trebuhu, navzeo, bruhanjem in diarejo, ter bradikardijo, bronhospazem in povečano bronhialno sekrecijo, prekomerno znojenje, nehoteno uriniranje in/ali defekacijo, solzenje, hipotenzijo in prekomerno sekrecijo žlez slinavk.
English: Orodispersible tablet
Slovenian: orodisperzibilna tableta
English: Excipient: sorbitol E420.
Slovenian: Pomožna snov: sorbitol (E420).
English: Patients with dementia and Parkinson's disease These patients have some side effects more often.
Slovenian: Bolniki z demenco v povezavi s Parkinsonovo boleznijo Pri teh bolnikih so nekateri neželeni učinki bolj pogosti, poleg tega pa se pri njih pojavljajo nekateri dodatni neželeni učinki:
English: If you are pregnant, the benefits of using Nimvastid must be assessed against the possible effects on your unborn child. Nimvastid should not be used during pregnancy unless clearly necessary.
Slovenian: V primeru, da ste noseči, je treba pretehtati koristi uporabe zdravila Nimvastid in možne učinke na nerojenega otroka.
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: Združeni so iz dveh študij s prilagojenimi odmerki od treh ključnih 26-tedenskih multicentričnih študij, v katere so bili vključeni bolniki z blago do zmerno hudo Alzheimerjevo demenco.
English: Cholinomimetics may induce or exacerbate urinary obstruction and seizures.
Slovenian: Holinomimetiki lahko povzročijo ali poslabšajo zaporo sečnih izvodil in epileptične napade.
English: Capsule content Microcrystalline cellulose Hypromellose Silica, colloidal anhydrous Magnesium stearate
Slovenian: Vsebina kapsule mikrokristalna celuloza hipromeloza silicijev dioksid, koloidni, brezvodni magnezijev stearat
English: Some people who have accidentally taken too much Nimvastid have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Slovenian: Pri nekaterih ljudeh, ki so nehote vzeli preveč zdravila Nimvastid, je prišlo do navzee (slabosti s siljenjem na bruhanje), bruhanja, driske, zvišanega krvnega tlaka in halucinacije.
English: • Aggression, feeling restless
Slovenian: - agresivnost, občutek nemira - neredno bitje srca
English: However, a greater treatment effect was seen in Parkinson's disease patients with moderate dementia.
Slovenian: Boljši terapevtski učinek so opazili pri tistih bolnikih s Parkinsonovo boleznijo, ki so imeli zmerno demenco.
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 bile bolnice bolj dovzetne za gastrointestinalne neželene učinke in hujšanje kot bolniki.
English: Nimvastid 1.5 mg orodispersible tablets Nimvastid 3 mg orodispersible tablets Nimvastid 4.5 mg orodispersible tablets Nimvastid 6 mg orodispersible tablets Rivastigmine
Slovenian: Nimvastid 1,5 mg orodisperzibilne tablete Nimvastid 3 mg orodisperzibilne tablete Nimvastid 4,5 mg orodisperzibilne tablete Nimvastid 6 mg orodisperzibilne tablete rivastigmin
English: Total patients studied Total patients with pre-defined AE(s) Tremor
Slovenian: vsi proučevani bolniki vsi bolniki z neželenimi dogodki Tremor
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristic, Section 4.2.)
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: What Nimvastid looks like and contents of the pack
Slovenian: Izgled zdravila Nimvastid in vsebina pakiranja
English: Container: 200 hard capsules 250 hard capsules
Slovenian: Vsebnik: 200 trdih kapsul 250 trdih kapsul
English: Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 mg hard capsules Rivastigmine
Slovenian: Nimvastid 1,5 mg trde kapsule Nimvastid 3 mg trde kapsule Nimvastid 4,5 mg trde kapsule Nimvastid 6 mg trde kapsule rivastigmin
English: Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
Slovenian: Če bolnik ta odmerek po najmanj dveh tednih zdravljenja dobro prenaša, ga lahko povečamo na 3 mg dvakrat na dan. Tudi poznejše povečanje odmerka na 4,5 mg in nato na 6 mg dvakrat na dan mora temeljiti na dobrem prenašanju trenutnega odmerka in lahko pride v poštev po najmanj dveh tednih zdravljenja s tem odmerkom.
English: In pregnant animals, rivastigmine and/or metabolites crossed the placenta.
Slovenian: Nosečnost Pri brejih živalih so rivastigmin in/ali njegovi presnovki prehajali skozi posteljico.
English: The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine.
Slovenian: Rivastigmin ne vpliva na podaljšanje protrombinskega časa, ki ga povzroči varfarin.
English: Marketing Authorisation Holder and Manufacturer KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
English: Nimvastid should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Slovenian: Zdravila Nimvastid ne smete jemati sočasno z metoklopramidom (zdravilom, ki ga uporabljamo za ublažitev ali preprečevanje navzee (slabosti s siljenjem na bruhanje) in bruhanja).
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 z nagnjenostjo k tem boleznim je zato potrebna previdnost.
English: Therefore, caution should be exercised when rivastigmine is combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, calcium channel antagonists, digitalis glycoside, pilocarpin).
Slovenian: Iz teh razlogov je potrebna previdnost pri uporabi rivastigmina v kombinaciji z antagonisti adrenergičnih receptorjev beta, pa tudi v kombinaciji z drugimi zdravili, ki povzročajo bradikardijo (na primer z antiaritmiki razreda III, antagonisti kalcijevih kanalčkov, glikozidi digitalisa in pilokarpinom).
English: You may have side effects more often when you start your medicine or when your dose is increased.
Slovenian: Neželeni učinki bodo morda pogostejši na začetku jemanja zdravila in ob povečanju odmerka.
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Slovenian: Pri nekaterih bolnikih je bilo hudo bruhanje povezano z rupturo požiralnika (glejte poglavje 4.8).
English: The active substance of Nimvastid is rivastigmine.
Slovenian: Učinkovina v zdravilu Nimvastid je rivastigmin.