FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: U zdravih, mladih muškaraca, oralna doza od 3 mg smanjuje aktivnost acetilkolinesteraze (AChE) u cerebrospinalnoj tekućini za približno 40% unutar prvih 1,5 sati nakon primjene.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Rivastigmine may exacerbate or induce extrapyramidal symptoms.
Croatian: Rivastigmin može pogoršati ili izazvati ekstrapiramidne simptome.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
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 (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja rivastigmina u svim podskupinama pedijatrijske populacije u liječenju Alzheimerove demencije (vidjeti dio 4.2 za
English: Table 1
Croatian: Tablica 1
English: After the peak, plasma concentrations slowly decrease over the remainder of the 24-hour period of application.
Croatian: Nakon postizanja vršne vrijednosti, koncentracije u plazmi polako se smanjuju tijekom preostala 24 sata primjene.
English: - if you have, or have ever had, asthma or a severe respiratory disease.
Croatian: - ako imate ili ste imali astmu ili tešku bolest dišnih puteva.
English: Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Croatian: Simptomatsko liječenje blage do umjereno teške Alzheimerove demencije.
English: Therefore, the patient/caregiver should avoid contact with the eyes after handling of the patch (see section 4.4).
Croatian: Stoga bolesnik/njegovatelj treba izbjegavati kontakt s očima nakon rukovanja flasterom (vidjeti dio 4.4).
English: You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.
Croatian: Možda ćete htjeti isprobati neka druga mjesta za stavljanje novog flastera, kako biste našli ona koja su Vam najugodnija i na
English: In animals, rivastigmine is excreted into milk.
Croatian: U životinja se rivastigmin izlučuje u mlijeko.
English: The dose of rivastigmine released from the transdermal patch over 24 hours (mg/24 h) cannot be directly equated to the amount (mg) of rivastigmine contained in a capsule with respect to plasma concentration produced over 24 hours.
Croatian: Doza rivastigmina koja se oslobađa iz transdermalnog flastera tijekom 24 sata (mg/24 h) ne može se izravno povezati s količinom (mg) rivastigmina sadržanom u kapsuli kada je riječ o koncentraciji u plazmi koja se postiže tijekom 24 sata.
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 od 0,03 mg/kg atropin sulfata intravenski, a ostale doze ovise o kliničkom odgovoru.
English: Used transdermal patches should be folded in half, with the adhesive side inwards, placed in the original pouch and discarded safely and out of the sight and reach of children.
Croatian: Iskorišteni transdermalni flaster treba presaviti na pola, pri čemu ljepljiva strana treba biti okrenuta prema unutra, te staviti u originalnu vrećicu i sigurno ukloniti izvan dohvata i pogleda djece.
English: Misuse of the medicinal product and dosing errors resulting in overdose Misuse of the medicinal product and dosing errors with rivastigmine transdermal patches have resulted in serious adverse reactions; some cases have required hospitalisation, and rarely led to death (see section 4.9).
Croatian: Neodgovarajuća primjena lijeka i pogreške u doziranju koje rezultiraju predoziranjem Neodgovarajuća primjena lijeka i pogreške u doziranju s transdermalnim flasterima s rivastigminom imale su za posljedicu ozbiljne nuspojave; neki su slučajevi zahtijevali hospitalizaciju, a rijetko imali i smrtni ishod (vidjeti dio 4.9).
English: EU/1/14/911/001 EU/1/14/911/002 EU/1/14/911/003 EU/1/14/911/004
Croatian: EU/1/14/911/004
English: According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Croatian: Prema njegovom metabolizmu, metaboličke interakcije s drugim lijekovima ne čine se vjerojatne, iako rivastigmin može inhibirati metabolizam drugih tvari posredovan butirilkolinesterazom.
English: Table 4
Croatian: Tablica 4
English: In some other dermal toxicity studies, a mild irritant effect on the skin of laboratory animals, including controls, was observed.
Croatian: U drugim ispitivanjima kožne toksičnosti opažen je blago nadražujući učinak na kožu laboratorijskih životinja, uključujući i kontrolne životinje.
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: Bolesnike u kojih dođe do reakcije na mjestu primjene, koja upućuje na alergijski kontaktni dermatitis na flaster rivastigmina, a kojima je još uvijek potrebno liječenje rivastigminom, trebalo bi samo prebaciti na oralni rivastigmin nakon negativnih rezultata alergološkog testiranja i pod strogim nadzorom liječnika.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Rivastigmine 3M Health Care Ltd. is marketed, at launch and after launch of the transdermal patch all physicians who are expected to prescribe Rivastigmine 3M Health Care Ltd. are provided with an information pack containing the following elements:
Croatian: Nositelj odobrenja dužan je osigurati da, nakon razgovora i usuglašavanja s nacionalnim nadležnim tijelom u svakoj državi članici u kojoj se Rivastigmin 3M Health Care Ltd. nalazi na tržištu, pri stavljanju i nakon stavljanja u promet transdermalnog flastera, svi liječnici za koje se očekuje da će propisivati Rivastigmin 3M Health Care Ltd. imaju informacijski paket koji sadrži sljedeće elemente:
English: Compared to a patient with a body weight of 65 kg, the rivastigmine steady-state concentrations in a patient with a body weight of 35 kg would be approximately doubled, while for a patient with a body weight of 100 kg the concentrations would be approximately halved.
Croatian: U usporedbi s bolesnikom tjelesne težine od 65 kg, koncentracije rivastigmina u stanju dinamičke ravnoteže u bolesnika s tjelesnom težinom od 35 kg bile bi otprilike dvostruko veće, dok bi za bolesnika tjelesne težine od 100 kg koncentracije bile otprilike dvostruko manje.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu
English: Based on evidence from in vitro and animal studies, the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Croatian: Na temelju dokaza iz in vitro i ispitivanja u životinja, glavni izoenzimi citokroma P450 minimalno su uključeni u metabolizam rivastigmina.
English: With multiple dosing (such as at steady state), after the previous transdermal patch is replaced with a new one, plasma concentrations initially decrease slowly for about 40 minutes on average, until absorption from the newly applied transdermal patch becomes faster than elimination, and plasma levels begin to rise again to reach a new peak at approximately 8 hours.
Croatian: Uz višestruko doziranje (kao što je u stanju dinamičke ravnoteže), nakon što se prethodni transdermalni flaster zamijeni novim, koncentracije u plazmi u početku se polako smanjuju tijekom prosječno otprilike 40 minuta, dok apsorpcija iz novoprimijenjenog transdermalnog flastera ne postane brža od eliminacije te razine u plazmi počnu rasti dok ne dostignu novu vršnu vrijednost za otprilike 8 sati.
English: Rivastigmine 3M Health Care Ltd. 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: Rivastigmin 3M Health Care Ltd. se primjenjuje u liječenju poremećaja pamćenja u odraslih bolesnika s blagom do umjerenom Alzheimerovom demencijom, progresivnim poremećajem mozga koji postupno utječe na pamćenje, intelektualne sposobnosti i ponašanje.
English: The transdermal patch should not be applied to skin that is red, irritated or cut.
Croatian: Transdermalni flaster ne smije se primjenjivati na kožu koja je crvena, nadražena ili ima posjekotine.
English: Therefore, women on rivastigmine should not breast-feed.
Croatian: Zbog toga žene koje uzimaju rivastigmin ne smiju dojiti.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u
English: Rivastigmine is rapidly and extensively metabolised with an apparent elimination half-life in plasma of approximately 3.4 hours after removal of the transdermal patch.
Croatian: Rivastigmin se metabolizira brzo i u velikoj mjeri uz prividni poluživot eliminacije u plazmi od otprilike 3,4 sata nakon uklanjanja transdermalnog flastera.
English: The patches are available in packs containing 7, 30, 60 and 90 pouches.
Croatian: Transdermalni flasteri dostupni su u pakiranjima koja sadrže 7, 30, 60 i 90 vrećica.
English: - After removing a patch, fold it in half with the sticky sides on the inside and press them together.
Croatian: - Nakon što skinete flaster presavinite ga na pola tako da su ljepljive strane okrenute prema unutra i pritisnite ih jednu o drugu.
English: If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.
Croatian: Ako će Vam to pomoći, možete na flaster napisati, primjerice,
English: Furthermore, rivastigmine may induce syncope or delirium.
Croatian: Nadalje, rivastigmin može dovesti do sinkope ili delirija.
English: Skin application site reactions
Croatian: Kožne reakcije na mjestu primjene
English: - Do not expose the patch to any external heat sources (e.g. excessive sunlight, saunas, solarium)
Croatian: - Ne izlažite flaster vanjskim izvorima topline (npr. prekomjernoj sunčevoj svjetlosti, sauni,
English: Where symptoms have occurred, they have included nausea, vomiting and diarrhoea, hypertension or hallucinations.
Croatian: Kada su se pojavili, simptomi su uključivali mučninu, povraćanje i proljev, hipertenziju ili halucinacije.
English: Clinically relevant improvement was defined a priori as at least 4-point improvement on the ADAS-Cog, no worsening on the ADCS-CGIC, and no worsening on the ADCS-ADL.
Croatian: Klinički značajno poboljšanje definirano je unaprijed kao poboljšanje od najmanje 4 boda na ADAS-Cog-u, izostanak pogoršanja na ADCS-CGIC-u, te izostanak pogoršanja
English: 9.5 mg/24 h is the recommended daily effective dose which should be continued for as long as the patient continues to demonstrate therapeutic benefit.
Croatian: 9,5 mg/24 h je preporučena dnevna djelotvorna doza s kojom treba nastaviti dokle god bolesnik od nje ima terapijske koristi.
English: Application site pruritus led to discontinuation in 1.1% of the patients from each of the treatment groups during the total 48-week double-blind treatment phase.
Croatian: Pruritus na mjestu primjene doveo je do prekida liječenja u 1,1% bolesnika iz svake terapijske skupine tijekom cjelokupne 48tjedne faze dvostruko slijepog liječenja.
English: Gastrointestinal disorders such as nausea, vomiting and diarrhoea are dose-related, and may occur when initiating treatment and/or increasing the dose (see section 4.8).
Croatian: Gastrointestinalni poremećaji poput mučnine, povraćanja i proljeva ovisni su o dozi te se mogu javiti osobito kod početka liječenja i/ili povećavanja doze (vidjeti dio 4.8).
English: Some people who have accidentally taken too much Rivastigmine 3M Health Care Ltd. have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Croatian: Neki ljudi koji su slučajno primijenili previše Rivastigmina 3M Health Care Ltd. su osjećali mučninu, povraćali, imali proljev, visoki krvni tlak i halucinacije.
English: When administered to rabbit eyes in primary eye irritation studies, rivastigmine caused reddening and swelling of the conjunctiva, corneal opacities and miosis which persisted for 7 days.
Croatian: Kada je bio primijenjen na oči zečeva u ispitivanjima primarnog nadražaja očiju, rivastigmin je uzrokovao crvenilo i oticanje očne spojnice, zamućenje rožnice i miozu koja je trajala 7 dana.
English: Treatment should be temporarily interrupted if gastrointestinal adverse reactions are observed until these adverse reactions resolve.
Croatian: Liječenje treba privremeno prekinuti ako dođe do gastrointestinalnih nuspojava, dok se te nuspojave ne povuku.
English: Rivastigmine capsules 12 mg/day
Croatian: Kapsule s rivastigminom 12 mg/dan
English: Pruritus, erythema, urticaria, vesicles, allergic dermatitis, disseminated
Croatian: Svrbež, eritem, urtikarija, vezikule, alergijski dermatitis, diseminirane
English: The effect of bodyweight on active substance exposure suggests special attention to patients with very low body weight during up-titration (see section 4.4).
Croatian: Učinak tjelesne težine na izloženost djelatnoj tvari upućuje na potrebu posvećivanja posebne pozornosti bolesnicima s vrlo niskom tjelesnom težinom tijekom titracije na višu dozu (vidjeti dio 4.4).
English: Talk to your doctor before using Rivastigmine 3M Health Care Ltd.: - if you have, or have ever had, an irregular heartbeat.
Croatian: Obratite se svom liječniku prije nego primijenite Rivastigmin 3M Health Care Ltd.: - ako imate ili ste imali nepravilne otkucaje srca.
English: left upper chest or right upper chest (avoid breast)
Croatian: • gornji dio lijevog ili desnog dijela prsnog koša (izbjegavati dojke)
English: Tear the pouch open where indicated and remove the patch from the pouch.
Croatian: Otvorite vrećicu gdje je naznačeno i izvadite flaster iz vrećice.
English: Atrioventricular block, atrial fibrillation, tachycardia, sick sinus
Croatian: Atrioventrikularni blok, fibrilacija atrija, tahikardija, sindrom bolesnog
English: Efficacy was established by the use of independent, domain-specific assessment tools which were applied at regular intervals during the 24-week treatment period.
Croatian: Djelotvornost je ustanovljena primjenom neovisnih skala za ocjenu određenih područja koje su se primjenjivale u redovnim razmacima tijekom 24 tjedna liječenja.
English: No effects on fertility or embryofoetal development were observed in rats and rabbits, except at doses related to maternal toxicity.
Croatian: Nisu zabilježeni nikakvi učinci na plodnost ili embriofetalni razvoj u štakora i zečeva, osim pri dozama
English: - if you have, or have ever had, an active stomach ulcer.
Croatian: - ako imate ili ste imali aktivni čir želuca.
English: When and for how long to apply your Rivastigmine 3M Health Care Ltd. transdermal patch - To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
Croatian: Kada i koliko dugo koristiti Rivastigmin 3M Health Care Ltd. transdermalni flaster - Da biste imali koristi od liječenja trebate stavljati novi flaster svaki dan, po mogućnosti u isto doba dana.
English: ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward 1 Based on ANCOVA with treatment and country as factors and baseline value as a covariate.
Croatian: Last Observation Carried Forward - prijenos 1 Na temelju ANCOVA-e s liječenjem i zemljom kao čimbenicima te početnom vrijednošću kao kovarijatama.
English: Oral and topical repeated-dose toxicity studies in mice, rats, rabbits, dogs and minipigs revealed only effects associated with an exaggerated pharmacological action.
Croatian: Ispitivanja toksičnosti nakon ponovljenih oralnih i topičkih doza u miševa, štakora, zečeva, pasa i patuljastih svinja otkrila su samo učinke povezane s prekomjernim farmakološkim djelovanjem.
English: Symptomatic treatment for other adverse reactions should be given as necessary.
Croatian: Simptomatsko liječenje zbog drugih nuspojava treba primijeniti prema potrebi.
English: Carefully titrate and monitor these patients for adverse reactions (e.g. excessive nausea or vomiting) and consider reducing the maintenance dose to the 4.6 mg/24 h transdermal patch if such adverse reactions develop.
Croatian: Potrebno je pažljivo titrirati i nadzirati te bolesnike zbog nuspojava (npr. prekomjerne mučnine ili povraćanja) i razmotriti smanjivanje doze za održavanje na transdermalni flaster u dozi od 4,6 mg/24 h ako se razviju takve
English: Most cases of misuse of the medicinal product and dosing errors have involved not removing the old patch when putting on a new one and the use of multiple patches at the same time.
Croatian: Većina slučajeva neodgovarajuće primjene lijeka i pogrešaka u doziranju uključivala je neuklanjanje starog flastera kod stavljanja novog te primjenu više flastera istodobno.
English: The next most common adverse reactions are gastrointestinal in nature including nausea and vomiting.
Croatian: Sljedeće po učestalosti nuspojave su gastrointestinalne prirode, uključujući mučninu i povraćanje.
English: OTHER Apply one patch per day.
Croatian: Primijeniti jedan flaster dnevno.
English: In patients with Alzheimer's disease, inhibition of AChE in CSF by oral 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 oralnim rivastigminom bila je ovisna o dozi sve do 6 mg dva puta na dan, što je bila najviša ispitivana doza.
English: rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Croatian: Nakon primjene rivastigmina označenog s 14C, eliminacija putem bubrega bila je brza i u osnovi potpuna (>90%) unutar 24 sata.
English: In view of its pharmacodynamic effects, rivastigmine should not be given concomitantly with other cholinomimetic substances and might interfere with the activity of anticholinergic medicinal products.
Croatian: S obzirom na njegovo farmakodinamičko djelovanje, rivastigmin se ne smije davati istodobno s drugim kolinomimeticima te može utjecati na djelovanje antikolinergika.
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 pokrivenog flasterom, 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: You should wash your hands with soap and water after removing the patch.
Croatian: Operite ruke sapunom i vodom nakon što ste skinuli flaster.
English: Elimination was absorption rate limited (flip-flop kinetics), which explains the longer t½ after transdermal patch (3.4 h) versus oral or intravenous administrations (1.4 to 1.7 h).
Croatian: Eliminacija je bila ograničena brzinom apsorpcije (flip-flop kinetika), što objašnjava duži t½ nakon transdermalnog flastera (3,4 h) u usporedbi s oralnom ili intravenskom primjenom (1,4 do 1,7 h).
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 exceeding 104 times the foreseen clinical exposure.
Croatian: U standardnoj bateriji in vitro i in vivo testova, rivastigmin nije bio mutagen, osim u testu kromosomske aberacije na perifernim limfocitima ljudi u dozi koja je bila 104 puta veća od predviđene kliničke izloženosti.
English: At steady state, trough levels are approximately 50% of peak levels, in contrast to oral administration, with which concentrations fall off to virtually zero between doses.
Croatian: U ravnotežnom stanju najniže razine iznose otprilike 50% vršnih razina, za razliku od oralne primjene kod koje koncentracije između doza padaju gotovo na nulu.
English: Concomitant administration of rivastigmine with commonly prescribed medicinal products, such as antacids, antiemetics, antidiabetics, centrally acting antihypertensives, beta blockers, calcium channel blockers, inotropic agents, antianginals, non-steroidal anti-inflammatory agents, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with an alteration in the kinetics of rivastigmine or an increased risk of clinically relevant untoward effects.
Croatian: Istodobna primjena rivastigmina s često propisivanim lijekovima kao što su antacidi, antiemetici, antidijabetici, antihipertenzivi sa središnjim djelovanjem, beta blokatori, blokatori kalcijevih kanala, inotropni lijekovi, antianginalni lijekovi, nesteroidni protuupalni lijekovi, estrogeni, analgetici, benzodiazepini i antihistaminici, nije bila povezana s promjenom u kinetici rivastigmina ili s povećanim rizikom od klinički relevantnih nepovoljnih učinaka.
English: Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20-30% lower when applied to the abdomen or thigh.
Croatian: Izloženost (AUC∞) rivastigminu (i metabolitu NAP266-90) bila je najveća kada je transdermalni flaster bio postavljen na gornji dio leđa, prsa ili nadlakticu te otprilike 20-30% niža kad je bio
English: If a patch falls off, apply a new one for the rest of the day, then replace it at the same time as usual the next day.
Croatian: Ako se flaster odlijepi, stavite novi do kraja dana te ga zamijenite u uobičajeno vrijeme drugi dan.
English: It may harm them,
Croatian: Može im naškoditi, čak i ako su
English: - Fast or uneven heartbeat - High blood pressure - Fits (seizures) - Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite) - Changes in tests which show how well the liver is working - Feeling restless
Croatian: - Brzi ili neujednačeni otkucaji srca - Visoki krvni tlak - Napadaji - Poremećaji jetre (žutilo kože, žute bjeloočnice, abnormalno tamna mokraća ili neobjašnjiva mučnina, povraćanje, umor i gubitak apetita) - Promijenjene vrijednosti na pretragama koje pokazuju koliko dobro radi jetra - Osjećaj nemira
English: Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease.
Croatian: Stoga rivastigmin može imati ublažavajuće djelovanje na kolinergički posredovane deficite kognitivne funkcije kod demencije povezane s Alzheimerovom i