FrancophonIA/ELRC3.0 huggingface dataset:
English: Transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by tight clothing.
Croatian: Transdermalne flastere potrebno je primjenjivati jedanput na dan na čistu, suhu, neoštećenu, zdravu kožu bez dlaka, na gornjem ili donjem dijelu leđa, nadlaktici ili prsima, na mjestu koje neće doticati uska odjeća.
English: It is possible that some patients sensitised to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form.
Croatian: Moguće je da neki bolesnici, senzitizirani na rivastigmin izlaganjem flasteru rivastigmina, ne mogu uzimati rivastigmin niti u jednom obliku.
English: Patients with severe hepatic impairment have not been studied (see sections 4.4 and 5.2).
Croatian: Nisu proučavani bolesnici s teškim oštećenjem jetre (vidjeti dijelove 4.4 and 5.2).
English: - Patients with body weight below 50 kg: Particular caution should be exercised in titrating patients with body weight below 50 kg above the recommended effective dose of 9.5 mg/24 h (see section 4.4).
Croatian: - Bolesnici tjelesne težine ispod 50 kg: Valja biti posebno oprezan kod titriranja doze u bolesnika s tjelesnom težinom ispod 50 kg iznad preporučene djelotvorne doze od 9,5 mg/24 h (vidjeti dio 4.4).
English: It is not recommended to apply the transdermal patch to the thigh or to the abdomen due to decreased bioavailability of rivastigmine observed when the transdermal patch is applied to these areas of the body.
Croatian: Ne preporučuje se postavljanje transdermalnog flastera na natkoljenciu ili na trbuh, zbog smanjene bioraspoloživosti rivastigmina, uočene kada se transdermalni flaster primjenjuje na te površine tijela.
English: Less NAP226-90 is formed following application of the transdermal patch, presumably because of the lack of presystemic (hepatic first pass) metabolism, in contrast to oral administration.
Croatian: Nakon primjene transdermalnog flastera stvara se manje NAP226-90, vjerojatno zbog nedostatka presistemskog metabolizma (prvi prolaz kroz jetru), za razliku od oralne primjene.
English: Similar to any treatment initiated in patients with dementia, therapy with rivastigmine should only be started if a caregiver is available to regularly administer and monitor the treatment.
Croatian: Kao što je slučaj s bilo kojim liječenjem koje se započinje u bolesnika s demencijom, liječenje rivastigminom treba započeti jedino ako postoji njegovatelj koji će redovito pratiti uzimanje lijeka.
English: Rivastigmine 3M Health Care Ltd. might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine or meclizine).
Croatian: Rivastigmin 3M Health Care Ltd. može utjecati na antikolinergičke lijekove (lijekovi koji se koriste za ublažavanje grčeva ili spazama u želucu (npr. diciklomin), za liječenje Parkinsonove bolesti (npr. amantadin) ili za sprječavanje putne mučnine (npr. difenhidramin, skopolamin ili meklizin).
English: If this applies to you, tell your doctor and do not apply Rivastigmine 3M Health Care Ltd. transdermal patches.
Croatian: Ako se ovo odnosi na Vas, obratite se svom liječniku i ne koristite Rivastigmin 3M Health Care Ltd. transdermalne flastere.
English: As rivastigmine has a plasma half-life of about 3.4 hours and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose all Rivastigmine 3M Health Care Ltd. transdermal patches should be removed immediately and no further transdermal patch should be applied for the next 24 hours.
Croatian: S obzirom na to da je poluvijek rivastigmina u plazmi oko 3,4 sata, a trajanje inhibicije acetilkolinesteraze oko 9 sati, preporučuje se da se u slučajevima asimptomatskog predoziranja svi Rivastigmin 3M Health Care Ltd. transdermalni flasteri moraju odmah ukloniti i novi se transdermalni flaster ne smije primijeniti sljedeća 24 sata.
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.
Croatian: Bolesnici u kojih se pojave znakovi ili simptomi dehidracije zbog dugotrajnog povraćanja ili proljeva, mogu se zbrinuti intravenskom nadoknadom tekućina te smanjenjem doze ili prekidom liječenja, ako se prepoznaju i brzo liječe.
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by oral rivastigmine was similar to the inhibition of AChE activity.
Croatian: Inhibicija aktivnosti butirilkolinesteraze u cerebrospinalnoj tekućini 14 bolesnika s Alzheimerovom bolešću, koji su bili liječeni rivastigminom, bila je slična inhibiciji aktivnosti AChE
English: In a 24-week double-blind, placebo-controlled clinical trial, skin reactions were measured at each visit using a skin irritation rating scale that rated the degree of erythema, oedema, scaling, fissures, pruritus and pain/stinging/burning at the application site.
Croatian: U 24-tjednom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju kožne reakcije bile su mjerene na svakom posjetu korištenjem ocjenske ljestvice nadražaja kože kojom se ocjenjivao stupanj eritema, edema, ljuštenja, pukotina, pruritusa i boli/bockanja/peckanja na mjestu primjene.
English: The exposure to rivastigmine and its metabolites was approximately equivalent to human exposure with highest doses of rivastigmine capsules and transdermal patches.
Croatian: Izloženost rivastigminu i njegovim metabolitima bila je približno jednaka izloženosti u ljudi pri najvišim dozama kapsula i
English: By blocking these enzymes, Rivastigmine 3M Health Care Ltd. allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease.
Croatian: Blokiranjem tih enzima Rivastigmin 3M Health Care Ltd. omogućava povećavanje koncentracije acetilkolina u mozgu te tako pomaže u smanjivanju simptoma
English: Functional decline was assessed by the investigator and cognitive decline was defined as a decrease in the MMSE score of >2 points from the previous visit or a decrease of >3 points from baseline.
Croatian: Funkcionalno pogoršanje ocijenio je ispitivač, a kognitivno pogoršanje definirano je kao smanjenje rezultata MMSE-a od ≥2 boda u donosu na prethodni posjet, ili smanjenje od ≥3 boda u odnosu na početnu vrijednost.
English: If treatment is interrupted for more than three days, it should be re-initiated with 4.6 mg/24 h.
Croatian: Ako se liječenje prekida na više od tri dana, treba ga ponovno početi dozom od 4,6 mg/24 h.
English: In a 48-week active-controlled clinical trial, cases of skin irritation were captured as patient or caregiver reported adverse reactions.
Croatian: U 48-tjednom aktivno kontroliranom kliničkom ispitivanju slučajevi nadražaja kože bili su zabilježeni kao nuspojave koje su prijavili bolesnici ili njegovatelji.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Croatian: Nuspojave u Tablici 1 navedene su prema MedDRA organskim sustavima i kategorijama učestalosti.
English: Age had no impact on the exposure to rivastigmine in Alzheimer's disease patients treated with rivastigmine transdermal patches.
Croatian: Dob nije imala utjecaja na izloženost rivastigminu u bolesnika s Alzheimerovom bolešću liječenih transdermalnim flasterima s rivastigminom.
English: Absorption of rivastigmine from rivastigmine transdermal patches is slow.
Croatian: Absorpcija rivastigmina iz transdermalnih flastera s rivastigminom je spora.
English: Patients with Alzheimer's disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine.
Croatian: Moguć je gubitak tjelesne težine u bolesnika s Alzheimerovom bolešću tijekom uzimanja inhibitora kolinesteraze, što uključuje i rivastigmin.
English: Table 1 displays the adverse reactions reported in 854 patients with Alzheimer's dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with rivastigmine transdermal patches for a duration of 24-48 weeks and from post-marketing data.
Croatian: Tablica 1 prikazuje nuspojave zabilježene u 854 bolesnika s Alzheimerovom demencijom liječenih u randomiziranim, dvostruko slijepim, placebom i aktivno kontroliranim kliničkim ispitivanjima s transdermalnim flasterom s rivastigminom u trajanju od 24-48 tjedana te iz podataka nakon stavljanja lijeka u promet.
English: It is not known if rivastigmine is excreted into human milk.
Croatian: Nije poznato izlučuje li se rivastigmin u majčino mlijeko u ljudi.
English: The 48-week results for the two assessment tools are summarised in Table 4.
Croatian: Rezultati iz 48 tjedana za dvije ocjenske skale sažeti su u Tablici 4.
English: The following adverse reactions have only been observed with rivastigmine capsules and oral solution and not in clinical studies with rivastigmine transdermal patches: somnolence, malaise, tremor, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Croatian: Sljedeće su nuspojave uočene samo s kapsulama i oralnom otopinom s rivastigminom, a ne u kliničkim ispitivanjima s transdermalnim flasterima s rivastigminom: pospanost, malaksalost, tremor, smetenost, pojačano znojenje (često); ulkus na dvanaesniku, angina pectoris (rijetko); gastrointestinalno krvarenje (vrlo rijetko); a neki slučajevi teškog povraćanja bili su povezani s rupturom jednjaka (nepoznato).
English: Caution is recommended when selecting anaesthetic agents.
Croatian: Pri odabiru anestetika preporučuje se oprez.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: • Patient reminder card
Croatian: • Karticu s podsjetnikom za bolesnika
English: Unchanged rivastigmine is found in trace amounts in the urine; renal excretion of the metabolites is the major route of elimination after transdermal patch administration.
Croatian: Nepromijenjeni rivastigmin nalazi se u tragovima u mokraći; glavni put eliminacije je izlučivanje metabolita putem bubrega nakon primjene transdermalnog flastera.
English: Every 24 hours take off the previous patch before putting ONE new patch on to ONLY ONE of the following possible locations.
Croatian: Svaka 24 sata uklonite prethodni flaster prije nego što stavite JEDAN novi flaster na SAMO JEDNO od sljedećih
English: The backing layer is transparent to translucent, labelled with “R5” in a repeated pattern.
Croatian: Potporni sloj je transparentan do proziran s oznakom „R5“ u ponavljajućem uzorku.
English: When doses higher than 13.3 mg/24 h were used in the above-mentioned placebo-controlled study, insomnia and cardiac failure were observed more frequently than with 13.3 mg/24 h or placebo, suggesting a dose effect relationship.
Croatian: Kada su se doze više od 13,3 mg/24 h primjenjivale u gore navedenom placebo ispitivanju, nesanica i zatajenje srca bili su učestaliji nego kod 13,3 mg/24 h ili placeba, što upućuje na povezanost doze i učinka.
English: Total plasma clearance of rivastigmine was approximately 130 litres/h after a 0.2 mg intravenous dose and decreased to 70 litres/h after a 2.7 mg intravenous dose, which is consistent with the non-linear, over-proportional pharmacokinetics of rivastigmine due to saturation of its elimination.
Croatian: Ukupni klirens rivastigmina iz plazme bio je otprilike 130 litara/h nakon intravenske doze od 0,2 mg i smanjio se na 70 litara/h nakon intravenske doze od 2,7 mg, što je u skladu s nelinearnom, neproporcionalnom farmakokinetikom rivastigmina zbog zasićenja njegovom eliminacijom.
English: Although less pronounced than with the oral formulation, exposure to rivastigmine (Cmax and AUC) increased over-proportionally by a factor of 2.6 and 4.9 when escalating from 4.6 mg/24 h to 9.5 mg/24 h and to 13.3 mg/24 h, respectively.
Croatian: Iako je manje izraženo nego kod oralne formulacije, izloženost rivastigminu (Cmax i AUC) povećala se neproporcionalno za faktor od 2,6 i 4,9 kada se doza povećava s 4,6 mg/24 h na 9,5 mg/24 h odnosno 13,3 mg/24 h.
English: Weight loss
Croatian: Gubitak tjelesne težine
English: Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g. increasing erythema, oedema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal.
Croatian: Valja posumnjati na alergijski kontaktni dermatitis ako se reakcije s mjesta primjene prošire na površinu kože koja nije bila pokrivena flasterom, ako postoji dokaz intenzivnije lokalne reakcije (npr. pojačani eritem, edem, papule, vezikule) i ako u roku od 48 sati nakon uklanjanja flastera ne dođe do značajnog poboljšanja simptoma.
English: Overdose with rivastigmine transdermal patches resulting from misuse/dosing errors (application of multiple patches at a time) has been reported in the post-marketing setting.
Croatian: Predoziranje transdermalnim flasterima s rivastigminom koje je posljedica neodgovarajuće primjene/pogreške u doziranju (primjene više flastera istodobno) zabilježeno je nakon stavljanja lijeka u promet.
English: The backing layer is transparent to translucent, labelled with “R10” in a repeated pattern.
Croatian: Potporni sloj je transparentan do proziran s oznakom „R10“ u ponavljajućem uzorku.
English: Most skin reactions were limited to the application site and resulted in discontinuation in only 2.4% of the patients in the rivastigmine 9.5 mg/24 h transdermal patch group.
Croatian: Većina kožnih reakcija bila je ograničena na mjesto primjene i rezultirala je prekidom liječenja u samo 2,4% bolesnika u skupini koja je primjenjivala transdermalni flaster s rivastigminom u dozi od 9,5 mg/24 h.
English: Your doctor will tell you which Rivastigmine 3M Health Care Ltd. transdermal patch is most suitable for you.
Croatian: Liječnik će Vam reći koji je Rivastigmin 3M Health Care Ltd. transdermalni flaster najprikladniji za Vas.
English: As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Croatian: Kao inhibitor kolinesteraze, rivastigmin može tijekom anestezije pojačati djelovanje mišićnih relaksansa sukcinilkolinskog tipa.
English: The results for clinically relevant responders from the 24-week placebo-controlled study are provided in Table 3.
Croatian: Rezultati za osobe s klinički značajnim odgovorima iz 24-tjednog placebom kontroliranog ispitivanja navedeni su u Tablici
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and oral rivastigmine.
Croatian: Nisu zapaženi neželjeni učinci na srčano provođenje nakon istodobne primjene digoksina i oralnog rivastigmina.
English: Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in intensity.
Croatian: Kod primjene flastera rivastigmina, mogu se pojaviti kožne reakcije na mjestu primjene i obično su blagog ili umjerenog intenziteta.
English: If you have not applied a patch for three days, do not apply the next one before you have talked to your doctor.
Croatian: Ako niste stavljali flaster tri dana, prije nego što stavite sljedeći flaster posavjetujte se sa svojim liječnikom.
English: If well tolerated and only after a minimum of six months of treatment at 9.5 mg/24 h, the treating physician may consider increasing the dose to 13.3 mg/24 h in patients who have demonstrated a meaningful cognitive deterioration (e.g. decrease in the MMSE) and/or functional decline (based on physician judgement) while on the recommended daily effective dose of 9.5 mg/24 h (see section 5.1).
Croatian: Ako se dobro podnosi i tek nakon najmanje šest mjeseci liječenja dozom od 9,5 mg/24 h, liječnik može razmotriti povećavanje doze na 13,3 mg/24 h u bolesnika u kojih se dokaže značajno pogoršanje kognitivnih funkcija (npr. smanjenje na MMSE-u) i/ili funkcionalnih sposobnosti (na temelju prosudbe liječnika) dok uzimaju preporučenu dnevnu djelotvornu dozu od 9,5 mg/24 h (vidjeti dio 5.1).
English: In animals, rivastigmine crosses the placenta and is excreted into milk.
Croatian: U životinja rivastigmin prolazi kroz posteljicu i izlučuje se u mlijeko.
English: Consider using the 4.6 mg/24 h transdermal patch both as initial and maximum dose in these patients.
Croatian: Potrebno je razmotriti korištenje transdermalnog flastera od 4,6 mg/24 h kao početne i kao maksimalne doze u tih bolesnika.
English: Mean change at week 24  SD -0.6  6.4 p-value versus placebo
Croatian: Srednja promjena nakon 24 tjedna  SD -0,6  6,4 p-vrijednost u odnosu na placebo ADCS-CGIC
English: Mean score  SD p-value versus placebo ADCS-ADL
Croatian: Srednji rezultat  SD p-vrijednost u odnosu na placebo ADCS-ADL
English: Rivastigmine 3M Health Care Ltd. transdermal patches may cause fainting or severe confusion.
Croatian: Rivastigmin 3M Health Care Ltd. transdermalni flasteri mogu uzrokovati nesvjesticu ili jaku smetenost.
English: Take off your patch and tell your doctor straight away, if you notice any of the side effects above.
Croatian: Odmah skinite flaster i obavijestite svog liječnika ako primijetite bilo koju od navedenih nuspojava.
English: No clinical data on exposed pregnancies are available.
Croatian: Za rivastigmin nema kliničkih podataka o izloženosti u trudnoći.
English: No evidence of carcinogenicity was found in oral and topical studies in mice and in an oral study in rats at the maximum tolerated dose.
Croatian: Nije utvrđen dokaz kancerogenosti kod oralne i topičke primjene u ispitivanjima na miševima te kod oralne primjene u štakora pri maksimalnoj dozi koju su životinje podnosile.
English: What Rivastigmine 3M Health Care Ltd. is and what it is used for What you need to know before you use Rivastigmine 3M Health Care Ltd. How to use Rivastigmine 3M Health Care Ltd.
Croatian: Što je Rivastigmin 3M Health Care Ltd. i za što se koristi Što morate znati prije nego počnete primjenjivati Rivastigmin 3M Health Care Ltd.
English: As suggested by compartmental modelling, 9.5 mg/24 h transdermal patches exhibited exposure similar to that provided by an oral dose of 12 mg/day.
Croatian: Kao što ukazuje model odjeljaka, transdermalni flasteri u dozi od 9,5 mg/24 h pokazali su izloženost sličnu onoj koja se postiže oralnom dozom od 12 mg/dan.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.
English: - to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8) - to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8) - to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases.
Croatian: - u bolesnika s bolešću sinusnog čvora ili smetnjama provođenja (sinus-atrijski blok, atrioventrikularni blok) (vidjeti dio 4.8) - u bolesnika s aktivnim želučanim ili duodenalnim ulkusima ili bolesnika koji su predisponirani za ta stanja, budući da rivastigmin može povećati gastrično izlučivanje (vidjeti dio 4.8) - bolesnicima koji imaju predispozicije za urinamu opstrukciju i napadaje, budući da kolinomimetici mogu izazvati ili pogoršati te bolesti - u bolesnika koji u anamnezi imaju astmu ili opstruktivnu bolest pluća.
English: However, these events did not occur at a higher frequency with rivastigmine 13.3 mg/24 h transdermal patches than with placebo.
Croatian: Međutim, ti se događaji nisu javljali učestalije s transdermalnim flasterima s 13,3 mg/24 h rivastigmina nego s placebom.
English: Efficacy was established by the use of ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance-based measure of cognition) and the ADCS-IADL (Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living) assessing instrumental activities which include maintaining finances, meal preparation, shopping, ability to orient oneself to surroundings, ability to be left unattended.
Croatian: Djelotvornost je bila ustanovljena primjenom ADAS-Cog-a (procjena kognitivnih funkcija na temelju radnih sposobnosti) i ADCS-IADL-a (procjena instrumentalnih aktivnosti svakodnevnog života) kojima su se ocjenjivale instrumentalne aktivnosti koje su uključivale vođenje financija, pripremu obroka, kupnju, sposobnost orijentacije u okolini, sposobnost provođenja vremena bez nadzora.
English: However, due to increased exposure in these populations as observed with the oral forms, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant hepatic impairment might experience more adverse reactions.
Croatian: Međutim, u ovih skupina bolesnika, zbog veće izloženosti, koja je bila uočena kod oralnih formulacija, nužno je pažljivo pratiti preporuke o doziranju glede titriranja prema individualnoj podnošljivosti, jer bolesnici s klinički značajnim oštećenjem jetre mogu razviti više nuspojava.
English: Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of rivastigmine transdermal patch.
Croatian: Kožne reakcije na mjestu primjene (obično blagi do umjereni eritem na mjestu primjene), najučestalije su nuspojave uočene s primjenom transdermalnih flastera s rivastigminom.
English: - if you have, or have ever had, seizures.
Croatian: - ako imate ili ste imali napadaje.
English: This may indicate a potential for rivastigmine transdermal patches to induce mild erythema in patients.
Croatian: To može upućivati na mogućnost da transdermalni flasteri s rivastigminom uzrokuju blagi eritem u bolesnika.
English: The metabolite-to-parent AUC∞ ratio was around 0.7 after transdermal patch administration versus 3.5 after oral administration, indicating that much less metabolism occurred after dermal compared to oral treatment.
Croatian: Omjer AUC∞ metabolita u odnosu na osnovni lijek bio je oko 0,7 nakon primjene transdermalnog flastera u usporedbi s 3,5 nakon oralne primjene, što upućuje na znatno smanjeni metabolizam nakon kožnog u usporedbi s oralnim liječenjem.
English: - Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.
Croatian: - Zatim dlanom čvrsto pritisnite flaster najmanje 30 sekundi kako biste bili sigurni da su se rubovi dobro zalijepili.
English: You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.
Croatian: (izgubiti previše tekućine) ako povraćanje ili proljev potraju.
English: The inter-patient variability in a steady-state study in Alzheimer's dementia was at most 45% (Cmax) and 43% (AUC0-24h) after use of the transdermal patch, and 71% and 73%, respectively, after administration of the oral form.
Croatian: Varijabilnost između bolesnika s Alzheimerovom demencijom u stanju dinamičke ravnoteže bila je najviše 45% (Cmax) i 43% (AUC0-24h) nakon primjene transdermalnog flastera te 71% i 73% nakon primjene oralne
English: PHARMACEUTICAL PARTICULARS
Croatian: FARMAKOLOŠKA SVOJSTVA
English: After oral administration, Cmax and AUC of rivastigmine were more than twice as high in Alzheimer patients with moderate renal impairment compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in Alzheimer patients with severe renal impairment.
Croatian: Nakon oralne primjene Cmax i AUC rivastigmina bili su više nego dvostruko veći u ispitanika s umjerenim oštećenjem bubrega; no, u ispitanika s Alzheimerovom bolešću s teškim oštećenjem bubrega nije bilo promjena u Cmax i AUC vrijednostima rivastigmina.