FrancophonIA/ELRC3.0 huggingface dataset:
English: Rivastigmine interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes.
Croatian: Rivastigmin u interakciji sa svojim ciljanim enzimima tvori kovalentno vezani kompleks koji privremeno inaktivira enzime.
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.
Croatian: Ukupni je klirens rivastigmina u plazmi bio oko 130 l/h nakon intravenske doze od 0,2 mg, a smanjio se na 70 l/h nakon intravenske doze od 2,7 mg.
English: If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Croatian: Ako se bilo što od navedenog odnosi na Vas, možda će Vas liječnik pobliže pratiti dok uzimate ovaj lijek.
English: Cardiovascular betablockers are expected to be associated with the greatest risk, but reports have also been received in patients using other beta-blockers.
Croatian: Za kardiovaskularne beta blokatore očekuje se da su povezani s većim rizikom, ali zabilježeni su slučajevi i u bolesnika koji su koristili druge beta blokatore.
English: Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Croatian: S obzirom da je raspadljiva tableta za usta lomljiva, potrebno ju je uzeti odmah nakon otvaranja blistera.
English: However, use of rivastigmine patch may lead to allergic contact dermatitis.
Croatian: Međutim, primjena rivastigminskog flastera može dovesti do alergijskog kontaktnog dermatitisa.
English: The mean actual daily dose for responders in the 6-12 mg group, corresponding to this definition, was 9.3 mg.
Croatian: Srednja vrijednost stvarne dnevne doze za osobe koje su dobro reagirale na liječenje u skupini koja je primala 6-12 mg, prema ovoj definiciji, bila je 9,3 mg.
English: Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.
Croatian: Liječenje rivastigminom treba započeti jedino ako postoji njegovatelj koji će redovito nadzirati uzima li bolesnik lijek.
English: In view of its pharmacodynamic effects and possible additive effects, rivastigmine should not be given concomitantly with other cholinomimetic substances.
Croatian: S obzirom na njegovo farmakodinamičko djelovanje i moguće aditivne učinke, rivastigmin se ne smije davati istodobno s drugim kolinomimeticima.
English: You should not breast-feed during treatment with Nimvastid.
Croatian: Ne smijete dojiti tijekom liječenja Nimvastidom.
English: Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Croatian: C, eliminacija putem bubrega bila je brza i u osnovi potpuna (>90%) unutar 24 sata.
English: Nimvastid orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Croatian: Nimvastid raspadljiva tableta za usta treba se staviti na jezik, gdje će se brzo rastopiti u slini kako bi se lakše progutala.
English: Mean baseline ± SD Mean change at 24 weeks ± SD
Croatian: Početna srednja vrijednost ± SD Srednja promjena nakon 24 tjedna ± SD
English: Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Croatian: Bolesnici s tjelesnom težinom manjom od 50 kg mogu imati više nuspojava te je vjerojatnije da će prekinuti liječenje zbog nuspojava.
English: Pharmacotherapeutic group: psychoanaleptics, anticholinesterases, ATC code: N06DA03
Croatian: Farmakoterapijska skupina: psihoanaleptici, antikolinesteraze, ATK oznaka: N06DA03
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.
Croatian: Ako nakon 3 mjeseca liječenja bolesnika dozom održavanja ne dođe do povoljne promjene u brzini smanjivanja simptoma demencije u bolesnika, liječenje treba prekinuti.
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.
Croatian: Liječenje treba započeti i nadgledati liječnik s iskustvom u dijagnosticiranju i liječenju Alzheimerove demencije ili demencije povezane s Parkinsonovom bolešću.
English: If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-tolerated dose or the treatment may be discontinued.
Croatian: Ako nuspojave i dalje traju, dnevnu dozu treba privremeno smanjiti na prethodnu dozu koju je bolesnik dobro podnosio ili se liječenje može prekinuti.
English: • The signs of Parkinson's disease get worse or getting similar signs - such as stiff muscles,
Croatian: - Pogoršanje znakova Parkinsonove bolesti ili pojava sličnih znakova - poput ukočenih mišića,
English: Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite.
Croatian: Rivastigmin se metabolizira brzo i u velikoj mjeri (poluvrijeme eliminacije u plazmi je približno 1 sat), primarno hidrolizom posredovanom kolinesterazom, u dekarbamilirani metabolit.
English: However, Nimvastid may be used in this patient population and close monitoring is necessary.
Croatian: Međutim, Nimvastid se može koristiti u ovoj populaciji bolesnika te je nužno pažljivo praćenje.
English: Balance disorder
Croatian: Poremećaj ravnoteže
English: During therapy patient's weight should be monitored.
Croatian: Tijekom liječenja potrebno je pratiti tjelesnu težinu bolesnika.
English: Effects of rivastigmine on human fertility are not known.
Croatian: Učinci rivastigmina na plodnost u ljudi nisu poznati.
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).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja s rivastigminom u svim podskupinama pedijatrijske populacije u liječenju Alzheimerove demencije te u liječenju demencije u bolesnika s idiopatskom Parkinsonovom bolešću (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Patients with moderate dementia (MMSE 10-17)
Croatian: Bolesnici s umjerenom demencijom (MMSE 10-17)
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.
Croatian: S obzirom na to da je poluvijek rivastigmina u plazmi oko l sat, a trajanje inhibicije acetilkolinesteraze oko 9 sati, preporučuje se da se u slučajevima asimptomatskog predoziranja u iduća 24 sata ne daju daljnje doze rivastigmina.
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.
Croatian: Ako se, tijekom primjene Nimvastida, morate podvrgnuti operaciji, obavijestite liječnika prije nego što Vam primjeni bilo koji anestetik, jer Nimvastid može tijekom anestezije pojačati učinke nekih mišićnih relaksansa.
English: Dementia associated with Parkinson's Disease
Croatian: Demencija povezana s Parkinsonovom bolešću
English: Patients with mild dementia (MMSE 18-24)
Croatian: Bolesnici s blagom demencijom (MMSE 18-24)
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Croatian: Preporučuje se početna doza intravenskog atropin sulfata od 0,03 mg/kg, dok sljedeće doze ovise o kliničkom odgovoru.
English: Additive effects leading to bradycardia (which may result in syncope) have been reported with the combined use of various beta-blockers (including atenolol) and rivastigmine.
Croatian: Aditivni učinci koji dovode do bradikardije (koja može rezultirati sinkopom) bili su zabilježeni uz kombiniranu primjenu raznih beta blokatora (uključujući atenolol) i rivastigmina.
English: Decreased appetite Dehydration
Croatian: Smanjeni apetit Dehidracija
English: Adjusted treatment difference p-value versus placebo
Croatian: Prilagođena razlika u liječenju p-vrijednost u odnosu na placebo
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.
Croatian: Djelotvornost rivastigmina utvrđena je korištenjem tri nezavisne, područno specifične ljestvice za procjenu, koje su upotrebljavane u periodičkim intervalima tijekom razdoblja liječenja od 6 mjeseci.
English: Care should be exercised in treating patients with active gastric or duodenal ulcers or patients predisposed to these conditions.
Croatian: Treba pažljivo postupati pri liječenju bolesnika s aktivnim želučanim ili duodenalnim ulkusima ili bolesnika koji su predisponirani za ta stanja.
English: difficulty in carrying out movements
Croatian: otežanog izvođenja pokreta
English: Cholinomimetics may induce or exacerbate urinary obstruction and seizures.
Croatian: Kolinomimetici mogu inducirati ili pogoršati urinamu opstrukciju i napadaje.
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).
Croatian: U nekim su slučajevima ti događaji doveli do prekida liječenja rivastigminom (npr. prekidi liječenja zbog tremora u 1,7% bolesnika na rivastigminu u odnosu na 0% na placebu).
English: You may have side effects more often when you start your medicine or when your dose is increased.
Croatian: Možda ćete češće imati nuspojave kad počnete uzimati svoj lijek ili kod povećanja doze.
English: (on carton label only)
Croatian: (samo na kutiji)
English: If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day.
Croatian: Ako se ova doza nakon najmanje dva tjedna liječenja dobro podnosi, doza se može povećati na 3 mg dva puta dnevno.
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.
Croatian: Preračunata na tjelesnu površinu, izloženost rivastigminu i njegovim metabolitima bila je približno jednaka maksimalnoj preporučenoj dozi za ljude od 12 mg/dan; no, u usporedbi s maksimalnom dozom za ljude, u životinja je postignut približno njen 6-struki višekratnik.
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.
Croatian: U peroralnim ispitivanjima na mužjacima i ženkama štakora nisu zabilježeni štetni učinci rivastigmina na plodnost ili reproduktivna svojstva roditeljske generacije ili njihovog potomstva.
English: Extrapyramidal symptoms (including worsening of Parkinson's disease)
Croatian: Ekstrapiramidalni simptomi (uključujući pogoršanje Parkinsonove bolesti)
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.
Croatian: Populacijska farmakokinetička analiza pokazala je da nakon doza rivastigmina u oralnim kapsulama do 12 mg/dan, u bolesnika s Alzheimerovom bolešću, uporaba nikotina povećava oralni klirens rivastigmina za 23% (n=75 pušača i 549 nepušača).
English: Rivastigmine 6-12 mg N=379
Croatian: Rivastigmin 6-12 mg N=379
English: Rivastigmine 6-12 mg N=473
Croatian: Rivastigmin 6-12 mg N=473
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).
Croatian: U bolesnika s Alzheimerovom demencijom ili demencijom uzrokovanom Parkinsonovom bolešću, određene živčane stanice u mozgu odumiru, što ima za posljedicu nisku koncentraciju neurotransmitera acetilkolina (tvari koja omogućuje živčanim stanicama da međusobno komuniciraju).
English: Calcium silicate
Croatian: Kalcijev silikat
English: Patients who develop application site reactions suggestive of allergic contact dermatitis to rivastigmine patch and who still require rivastigmine treatment should only be switched to oral rivastigmine after negative allergy testing and under close medical supervision.
Croatian: Bolesnici u kojih se razviju reakcije na mjestu primjene koje ukazuju na alergijski kontaktni dermatitis na rivastigminski flaster te koje još treba liječiti rivastigminom, treba samo prebaciti na oralni rivastigmin nakon negativnog testa na alergiju te pod strogim liječničkim nadzorom.
English: In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
Croatian: U slučaju teškog povraćanja povezanog s liječenjem rivastigminom, nužno je prikladno podesiti dozu kao što se preporučuje u dijelu 4.2.
English: Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Croatian: Nepromijenjeni rivastigmin nije nađen u mokraći; glavni put eliminacije je izlučivanje metabolita putem bubrega.
English: Caution when Nimvastid is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions).
Croatian: Potreban je oprez kod uzimanja Nimvastida zajedno s beta blokatorima (lijekovima kao što je atenolol koji se koristi za liječenje hipertenzije, angine i drugih srčanih stanja).
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).
Croatian: Ako se liječenje prekida na više od tri dana, treba ga ponovno početi dozom od 1,5 mg dva puta na dan, kako bi se smanjila mogućnost nuspojava (npr. povraćanja).
English: Tip the tablet out onto your hand.
Croatian: Istresite tabletu na svoju ruku.
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.
Croatian: Međutim, u ovih populacija bolesnika, zbog veće izloženosti, nužno je pažljivo pratiti preporuke o doziranju glede titriranja prema individualnoj podnošljivosti jer bolesnici s klinički značajnim oštećenjem bubrega ili jetre mogu razviti više nuspojava ovisnih o dozi.
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30%.
Croatian: Primjena rivastigmina s hranom odgađa apsorpciju (tmax) za 90 minuta te snižava Cmax i povećava AUC za otprilike 30%.
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.
Croatian: Daljnja se povećanja na dozu od 4,5 mg, a zatim na 6 mg dva puta dnevno, trebaju također zasnivati na dobroj podnošljivosti trenutne doze, a mogu se razmatrati nakon najmanje dva tjedna liječenja s tom dozom.
English: - if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.
Croatian: - ako imate kožnu reakciju koja se širi izvan područja flastera, ako postoji intenzivnija lokalna reakcija (poput mjehurića, pojačane upale kože, oticanja) te ako se one ne povuku unutar 48 sati od uklanjanja transdermalnog flastera.
English: Cholinesterase inhibitors, including rivastigmine, have been associated with weight loss in these patients.
Croatian: Primjena inhibitora kolinesteraze, uključujući rivastigmin, bila je u tih bolesnika povezana s gubitkom tjelesne težine.
English: Hallucination, visual Depression
Croatian: Halucinacije, vidne Depresija
English: There is no relevant use of Nimvastid in the paediatric population in the treatment of Alzheimer's disease.
Croatian: Nema relevantne primjene Nimvastida u pedijatrijskoj populaciji u liječenju Alzheimerove bolesti.
English: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machinery.
Croatian: Alzheimerova bolest može postepeno smanjiti sposobnost upravljanja vozilima ili narušiti sposobnost rada sa strojevima.
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.
Croatian: Iako se učinak liječenja pokazao u cjelokupnoj ispitivanoj populaciji, podaci su upućivali da je, u odnosu na placebo, veći učinak liječenja viđen u podskupini bolesnika s umjerenom demencijom povezanom s Parkinsonovom bolešću.
English: Patients without visual hallucinations
Croatian: Bolesnici bez vidnih halucinacija
English: Uncommon (may affect up to 1 in 100 people) • Uneven heartbeat and poor control of movements
Croatian: Manje često (mogu se javiti u do 1 na 100 ljudi) - Nepravilni otkucaji srca i slaba kontrola pokreta
English: Nimvastid might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
Croatian: Nimvastid može utjecati na antikolinergičke lijekove (lijekove koji se koriste za ublažavanje grčeva ili spazama u želucu, za liječenje Parkinsonove bolesti ili za sprečavanje mučnine na putovanju).
English: Magnesium stearate.
Croatian: Magnezijev stearat
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.
Croatian: Nimvastid se primjenjuje u liječenju poremećaja pamćenja u odraslih bolesnika s blagom do umjerenom Alzheimerovom bolešću, progresivnim poremećajem mozga koji postupno utječe na pamćenje, intelektualne sposobnosti i ponašanje.
English: The mouth should be empty before placing the tablet on the tongue.
Croatian: Ne smijete imati ništa u ustima prije stavljanja tablete na jezik.
English: Hyperhydrosis Allergic dermatitis (disseminated)
Croatian: Hiperhidroza Alergijski dermatitis (diseminirani)
English: Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms.
Croatian: Poput drugih kolinomimetika, rivastigmin može pogoršati ili inducirati ekstrapiramidalne simptome.
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.
Croatian: Rivastigmin je inhibitor acetilkolinesteraze i butirilkolinesteraze karbamatnog tipa, za kojeg se smatra da olakšava kolinergičku neurotransmisiju usporavanjem razgradnje acetilkolina kojeg otpuštaju funkcionalno intaktni kolinergički neuroni.
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: Na alergijski kontaktni dermatitis treba posumnjati ako se reakcije na mjestu primjene prošire izvan opsega flastera, ako postoji dokaz intenzivnije lokalne reakcije (npr. povećanje eritema, edema, papula, vezikula) te ako se simptomi ne povuku značajno unutar 48 sati nakon skidanja flastera.
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.
Croatian: U bolesnika s Alzheimerovom bolešću inhibicija AChE u cerebrospinalnoj tekućini rivastigminom bila je ovisna o dozi sve do 6 mg dva puta na dan, što je bila najviša ispitivana doza.
English: Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors.
Croatian: Rivastigmin može uzrokovati bradikardiju koja predstavlja rizični čimbenik za pojavu torsades de pointes, pretežito u bolesnika s rizičnim čimbenicima.
English: In animals, rivastigmine is excreted in milk.
Croatian: U životinja se rivastigmin izlučuje u mlijeko.
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine.
Croatian: Sljedeće nuspojave, navedene ispod u Tablici 1, prikupljene su u bolesnika s Alzheimerovom demencijom liječenih rivastigminom.
English: How to take Nimvastid
Croatian: Kako uzimati Nimvastid
English: Pruritus, allergic dermatitis (disseminated)
Croatian: Svrbež, alergijski dermatitis (diseminirani)
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by rivastigmine was similar to that of AChE.
Croatian: Inhibicija aktivnosti butirilkolinesteraze u cerebrospinalnoj tekućini 14 bolesnika s Alzheimerovom bolešću, koji su bili liječeni rivastigminom, bila je slična inhibiciji AChE.
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.
Croatian: Blokiranjem tih enzima, Nimvastid omogućava povećavanje koncentracije acetilkolina u mozgu te tako pomaže u smanjivanju simptoma Alzheimerove bolesti i demencije povezane s Parkinsonovom bolešću.
English: Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4).
Croatian: Prethodna anamneza reakcija na mjestu primjene koje ukazuju na alergijski kontaktni dermatitis s rivastigminskim flasterom (vidjeti dio 4.4).
English: Rivastigmine orodispersible tablets may be used as an alternative to rivastigmine capsules.
Croatian: Rivastigmin raspadljive tablete za usta mogu se koristiti kao zamjena za rivastigmin kapsule.
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: Neki bolesnici senzibilizirani na rivastigmin izlaganjem rivastigminskom flasteru možda neće moći uzimati rivastigmin u bilo kojem obliku.
English: Some people who have accidentally taken too much Nimvastid have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Croatian: Neki ljudi koji su slučajno uzeli previše Nimvastida su osjećali mučninu, povraćali, imali proljev, visoki krvni tlak i halucinacije.
English: Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.
Croatian: Utvrđeno je da su bolesnice u kliničkim ispitivanjima bile osjetljivije od muških bolesnika na gastrointestinalne nuspojave i gubitak tjelesne težine.
English: Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Croatian: Nuspojave u Tablici 1 i 2 navedene su prema MedDRA organskim sustavima i kategorijama učestalosti.
English: At least 4 points improvement on ADASCog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Croatian: CIBIC-Plus i PDS *p<0,05, **p<0,01, ***p<0,001