FrancophonIA/ELRC3.0 huggingface dataset:
English: Peripheral neuropathy has been uncommonly reported in telbivudine-treated patients.
Croatian: U bolesnika liječenih telbivudinom manje često je zabilježena periferna neuropatija.
English: Preparing a dose of medicine using the dosing cup
Croatian: Priprema doze lijeka korištenjem dozirne čaše 1.
English: In the pooled analysis from NV-02B-007 (GLOBE) and NV-02B-015, by 104 weeks of treatment grade 3 or4 CK elevations (> 7x ULN) occurred in 12.6% of telbivudine-treated patients (n = 847) and 4.0% of lamivudine-treated patients (n = 846).
Croatian: U udruženoj analizi ispitivanja NV-02B-007 (GLOBE) i NV-02B-015, do 104. tjedna liječenja, porast kreatin kinaze stupnja 3 ili 4 (>7x GGN) pojavio se u 12,6% bolesnika liječenih telbivudinom te u 4,0% bolesnika liječenih lamivudinom.
English: Telbivudine 600 mg film-coated tablet
Croatian: Telbivudin 600 mg filmom obložena tableta
English: Mean HBV DNA reduction from baseline (log10 copies/ml) ± SEM % Patients HBV DNA undetectable by PCR
Croatian: HBV DNK od početne vrijednosti (log10 kopija/ml) ± SEM % bolesnika s nemjerljivim HBV
English: Exacerbations of hepatitis have also been reported in patients who have terminated treatment of hepatitis B. Post-treatment ALT flares are normally associated with increases in serum HBV DNA levels, and the majority of such cases have proven to be self-limiting.
Croatian: Porast ALT-a nakon prekida liječenja obično je povezan s povišenim razinama HBV DNK u serumu, a pokazalo se da je većina tih slučajeva samolimitirajuća.
English: Telbivudine 600 mg (n = 199)
Croatian: Telbivudin 600 mg (n = 199)
English: In HBeAg-positive patients with HBV DNA < 300 copies/ml at week 24, resistance was 1% (3/203) at 48 weeks and 9% (18/203) at week 104, whilst in patients with HBV DNA ≥ 300 copies/ml resistance was 8% (20/247) at 48 weeks and 39% (97/247) at week 104.
Croatian: Tjednu i 9% (18/203) u 104. tjednu, dok je u bolesnika s HBV DNK ≥300 kopija/ml rezistencija u 48. tjednu bila 8% (20/247), a u 104. tjednu 39% (97/247).
English: The recommended dose of Sebivo is one 600 mg tablet once a day.
Croatian: Preporučena doza Sebiva je jedna tableta od 600 mg jedanput na dan.
English: These patients had completed ≥ 52 weeks of telbivudine treatment, and had exhibited HBeAg loss for ≥ 24 weeks with HBV DNA < 5 log10 copies/ml at the last on-treatment visit.
Croatian: Navedeni bolesnici završili su liječenje telbuvidinom tijekom ≥52 tjedana, pri čemu je na dan posljednjeg dolaska radi primjene lijeka uočen gubitak HBeAg tijekom ≥24 tjedana s HBV DNA <5 log10 kopija/ml.
English: Lamivudine 100 mg (n = 386)
Croatian: Lamivudin 100 mg (n = 386)
English: ALT flares
Croatian: Porast ALT
English: Lamivudine 100 mg (n = 207)
Croatian: Lamivudin 100 mg (n = 207)
English: Tabulated list of adverse reactions
Croatian: Tabelarna lista nuspojava
English: Telbivudine 600 mg (n = 222)
Croatian: Telbivudin 600 mg (n = 222)
English: Sebivo 20 mg/ml oral solution Telbivudine
Croatian: Sebivo 20 mg/ml oralna otopina telbivudin
English: Lamivudine 100 mg (n = 224)
Croatian: Lamivudin 100 mg (n = 224)
English: Sebivo 600 mg film-coated tablets
Croatian: Sebivo 600 mg filmom obložene tablete
English: Telbivudine absorption and exposure were unaffected when a single 600 mg dose was administered with food.
Croatian: Kada se jednokratna doza od 600 mg primijenila s hranom nije se promijenila niti apsorpcija telbivudina niti izloženost lijeku.
English: Malaise
Croatian: Malaksalost
English: No adjustment to the recommended dose of Sebivo is necessary in patients with hepatic impairment (see section 5.2).
Croatian: U bolesnika s oštećenjem jetre nije potrebno prilagođavati preporučenu dozu Sebiva (vidjeti dio 5.2).
English: Telbivudine 600 mg (n = 458)
Croatian: Telbivudin 600 mg (n = 458)
English: Lamivudine 100 mg (n = 463)
Croatian: Lamivudin 100 mg (n = 463)
English: Maintained undetectable HBV DNA (< 300 copies/ml) with undetectable HBV DNA at week 24
Croatian: HBeAg-negativni bolesnici (n = 209*) Održavanje nemjerljive razine HBV DNK (<300 kopija/ml) Održavanje nemjerljive razine HBV DNK (<300 kopija/ml) s nemjerljivom razinom HBV DNK u 24. tjednu
English: Telbivudine 20 mg/ml oral solution
Croatian: Telbivudin 20 mg/ml oralna otopina
English: Always put the dosing cup back onto the cap after use and cleaning.
Croatian: Nakon uporabe i čišćenja dozirnu čašu uvijek vratite na zatvarač.
English: ALT normalisation HBeAg seroconversion HBeAg loss
Croatian: HBeAg serokonverzija
English: PCR Assay (lower limit of quantification  300 copies/ml).
Croatian: PCR ispitivanje (donja granica kvantitativnog određivanja
English: Your doctor may order laboratory tests to check your kidneys are working properly before and during treatment.
Croatian: zatražiti da obavite laboratorijske pretrage da se provjeri rade li Vaši bubrezi normalno.
English: Table 4 Summary of post-treatment ALT flares - Pooled NV-02B-007 (GLOBE) and NV02B-015 studies
Croatian: Tablica 4 Sažetak porasta ALT-a nakon liječenja - udruženo NV-02B-007 (GLOBE) i NV02B-015 ispitivanje
English: Sebivo 20 mg/ml oral solution
Croatian: Sebivo 20 mg/ml oralna otopina
English: Telbivudine 600 mg (n = 384)
Croatian: Telbivudin 600 mg (n = 384)
English: Benign digestive symptoms, such as nausea, vomiting and abdominal pain, may be indicative of lactic acidosis development.
Croatian: Na razvoj laktacidoze mogu uputiti dobroćudni probavni simptomi, poput mučnine, povraćanja i boli u trbuhu.
English: Hypromellose
Croatian: Hipromeloza
English: - if you are taking any medicines that may cause muscle problems (talk to your doctor or pharmacist if you are unsure).
Croatian: U tom slučaju liječnik će Vas htjeti češće kontrolirati. - ako Vam je presađena jetra. - ako uzimate bilo koji lijek koji može izazvati probleme s mišićima (ako niste sigurni,
English: Table 3 Summary of on-treatment ALT flares - Pooled NV-02B-007 (GLOBE) and NV-02B015 studies
Croatian: Tablica 3 Sažetak porasta ALT tijekom liječenja - udruženo NV-02B-007 (GLOBE) i NV02B-015 ispitivanje
English: Numbness, tingling, pain and/or burning sensation in the arms and/or legs or around the mouth Pain in lower back or hip that may radiate into the leg (sciatica) Taste disturbance
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba) bol u zglobovima trajna mišićna slabost ili bol u mišićima (miopatija/miozitis), grč mišića bol u leđima, vratu i boku obamrlost, trnci, bol i/ili osjećaj pečenja u rukama i/ili nogama ili oko usta bol u donjem dijelu leđa ili kuku koja se može širiti u nogu (išijas) poremećaj osjeta okusa opće loše osjećanje (malaksalost)
English: Hepatic impairment
Croatian: Gubitak HBeAg
English: Approximately 42% of the dose is recovered in the urine over 7 days following a single 600 mg oral dose of telbivudine.
Croatian: Nakon peroralne primjene jednokratne doze od 600 mg telbivudina, oko 42% doze izmjereno je u mokraći nakon 7 dana.
English: Patients with ≥ one dose of study drug with evaluable baseline liver biopsies and baseline Knodell Histological Activity Index (HAI) score > 3.
Croatian: Bolesnici koji su uzeli ≥1 doze ispitivanog lijeka, s početnom biopsijom jetre koja se mogla procijeniti i početnim indeksom histološke aktivnosti po Knodellu >3. Histološki odgovor definiran kao smanjenje Knodellovog nekroinflamatornog skora za ≥2 boda u odnosu na početnu vrijednost, te bez pogoršanja prema skoru fibroze po Knodellu.
English: Renally impaired patients on haemodialysis
Croatian: Bolesnici s oštećenjem bubrega na hemodijalizi
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Često
English: No metabolites of telbivudine were detected following administration of
Croatian: C-telbivudina u ljudi nisu nađeni metaboliti telbivudina.
English: No adjustment of the recommended dose of telbivudine is necessary in patients whose creatinine clearance is  50 ml/min.
Croatian: Bolesnicima s klirensom kreatinina 50 ml/min nije potrebno prilagođavati preporučenu dozu telbivudina.
English: Tell your doctor if you are breast- feeding.
Croatian: Obavijestite svog liječnika ako dojite.
English: (n = 8) 400 mg
Croatian: Umjereno oštećena (n = 8) 400 mg
English: Ishak fibrosis score ≤ 1 (no or minimal fibrosis) was observed in
Croatian: Skor fibroze po Ishaku od ≤1 (bez ili s minimalnom fibrozom) bio je uočen u 84,2% (48/57) bolesnika.
English: Worsening
Croatian: Doziranje
English: Persistent muscle weakness or muscle pain (myopathy/myositis), muscle cramp Back, neck and flank pain
Croatian: Miopatija/miozitis, artralgija, mijalgija, bol u udovima, bol u leđima, spazam mišića, bol u vratu, bol u boku
English: Sebivo 600 mg film-coated tablets telbivudine
Croatian: Sebivo 600 mg filmom obložene tablete telbivudin
English: Blood test results show higher levels of some liver enzymes (e.g. ALT, AST), amylase, lipase or creatine kinase
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) omaglica, glavobolja kašalj proljev, mučnina, bol u trbuhu kožni osip umor nalazi krvnih pretraga koji pokazuju povišene razine nekih jetrenih enzima (npr. ALT, AST), amilaze, lipaze ili kreatin kinaze
English: Lactic acidosis
Croatian: DNK metodom PCR
English: Mild (50-80) (n = 8) 600 mg
Croatian: Blago oštećena (n = 8) 600 mg
English: Missing week 52 biopsy
Croatian: Propuštena biopsija u
English: Investigations Common
Croatian: Pretrage Često
English: Sebivo oral solution contains approximately 47 mg sodium per 600 mg dose (30 ml), which should be taken into consideration by patients on a controlled sodium diet.
Croatian: Sebivo oralna otopina sadrži otprilike 47 mg natrija u dozi od 600 mg (30 ml).
English: A positive change indicates improvement.
Croatian: Pozitivna promjena upućuje na poboljšanje.
English: These reactions are not in themselves an indication of sensitisation.
Croatian: Ove reakcije nisu same po sebi indikacija senzibilizacije.
English: They also have some additional side effects:
Croatian: Također imaju neke dodatne nuspojave:
English: It is not known if this occurs in humans.
Croatian: Nije poznato da li se to događa u ljudi.
English: In addition, a post-hoc definition of response is provided in the same table.
Croatian: Dodatno, post-hoc definicija odgovora nalazi se u istoj tablici.
English: To be swallowed whole without crushing or opening.
Croatian: Progutati cijelu bez drobljenja ili otvaranja.
English: The major metabolite NAP226-90 also did not show a genotoxic potential.
Croatian: Glavni metabolit NAP226-90 također nije pokazao genotoksični potencijal.
English: 4 times the maximum clinical exposure.
Croatian: 4 puta veća od maksimalne kliničke izloženosti.
English: • Treatment usually starts with a low dose.
Croatian: - Liječenje obično započinje niskom dozom.
English: • Do not open or crush the capsules.
Croatian: - Nemojte otvarati niti lomiti kapsule.
English: Your doctor will also monitor your weight whilst you are taking this medicine.
Croatian: Liječnik će također pratiti Vašu tjelesnu težinu dok uzimate ovaj lijek.
English: • To benefit from your medicine, take it every day.
Croatian: - Da bi Vam ovaj lijek koristio, uzimajte ga svaki dan.
English: ITT + RDO population
Croatian: Populacija ITT + RDO
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nije poznato (učestalost se ne može procijeniti iz dostupnih podataka)
English: If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.
Croatian: Ako osjećate omaglicu ili pospanost nemojte upravljati vozilima i strojevima ili izvoditi bilo kakve zadatke koji zahtijevaju pozornost.
English: What Nimvastid is and what it is used for
Croatian: Što je Nimvastid i za što se koristi
English: If you find you have forgotten to take your dose of Nimvastid, wait and take the next dose at the usual time.
Croatian: Ako primijetite da ste zaboravili uzeti svoju dozu Nimvastida, pričekajte i uzmite iduću dozu u uobičajeno vrijeme.
English: Dissolve the tablet in the mouth and swallow it with or without water.
Croatian: Rastopite tabletu u ustima i progutajte ju sa ili bez vode.
English: Individual response to rivastigmine cannot be predicted.
Croatian: Individualni odgovor na rivastigmin ne može se predvidjeti.
English: Your doctor will tell you what dose of Nimvastid to take.
Croatian: Liječnik će Vam reći koju dozu Nimvastida trebate uzimati.
English: Not known
Croatian: Nije poznato
English: Rivastigmine is rapidly and completely absorbed.
Croatian: Rivastigmin se apsorbira brzo i potpuno.
English: Discontinuation should also be considered when evidence of a therapeutic effect is no longer present.
Croatian: Na prekid liječenja treba također pomišljati kad više nije prisutan dokaz terapijskog učinka.
English: Rivastigmine n (%)
Croatian: Rivastigmin n (%)
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su prema sljedećim pravilima: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nije poznato (ne može se procijeniti iz dostupnih podataka).
English: If you have not taken Nimvastid for more than three days, do not take the next dose until you have talked to your doctor.
Croatian: Ako niste uzeli Nimvastid više od tri dana, nemojte uzimati sljedeću dozu dok se niste posavjetovali sa svojim liječnikom.
English: Angina pectoris
Croatian: Angina pektoris
English: Dose titration should then be carried out as described above.
Croatian: Dozu treba nakon toga titrirati kao što je gore opisano.
English: If you take more Nimvastid than you should
Croatian: Ako uzmete više Nimvastida nego što ste trebali
English: Other medicines and Nimvastid
Croatian: Drugi lijekovi i Nimvastid
English: ITT - LOCF population
Croatian: Populacija ITT - LOCF
English: They may respond to a dose reduction.
Croatian: One mogu reagirati na smanjenje doze.
English: If this applies to you, tell your doctor and do not take Nimvastid.
Croatian: Ako se ovo odnosi na Vas, obratite se svom liječniku i nemojte uzimati Nimvastid.
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Croatian: In vitro, taj metabolit pokazuje minimalnu inhibiciju acetilkolinesteraze (<10%).
English: In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed without water.
Croatian: Kroz nekoliko sekundi ona će se početi otapati u ustima, a zatim je možete progutati bez vode.
English: If you accidentally take more Nimvastid than you should, inform your doctor.
Croatian: Ako slučajno uzmete više Nimvastida nego biste trebali, obavijestite svog liječnika.
English: Clinical studies in Alzheimer's dementia
Croatian: Klinička ispitivanja u Alzheimerovoj demenciji
English: The capsules should be swallowed whole.
Croatian: Kapsule treba cijele progutati.
English: Patients with Clinically Significant Response (%) Intent to Treat
Croatian: Bolesnici s klinički značajnim odgovorom (%) Populacija planirana za liječenje (ITT)
English: Use of scopolamine as an antidote is not recommended.
Croatian: Ne preporučuje se primjena skopolamina kao antidota.
English: Absolute bioavailability after a 3 mg dose is about 36%±13%.
Croatian: Apsolutna bioraspoloživost nakon doze od 3 mg iznosi oko 36%±13%.
English: It is important to note that the scales used in this indication vary and direct comparisons of results for different therapeutic agents are not valid.
Croatian: Važno je napomenuti da se ljestvice korištene u ovoj indikaciji razlikuju, a izravne usporedbe rezultata za različita terapijska sredstva nisu važeća.
English: • Your doctor will slowly increase your dose depending on how you respond to treatment.
Croatian: - Liječnik će polako povećavati dozu, ovisno o Vašem odgovoru na liječenje.
English: While bioavailability of rivastigmine is greater in elderly than in young healthy volunteers, studies in Alzheimer patients aged between 50 and 92 years showed no change in bioavailability with age.
Croatian: Dok je bioraspoloživost rivastigmina veća u starijih nego u mladih zdravih dobrovoljaca, ispitivanja na bolesnicima s Alzheimerovom bolešću u dobi između 50 i 92 godine nisu pokazala da se bioraspoloživost mijenja s dobi.
English: Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
Croatian: Terapijski učinak nije proučavan u placebo kontroliranim ispitivanjima duljim od 6 mjeseci.
English: CARTON FOR BLISTERS AND CONTAINER, AND LABEL FOR CONTAINER
Croatian: KUTIJA ZA BLISTER I SPREMNIK I ETIKETA ZA SPREMNIK
English: What Nimvastid is and what it is used for What you need to know before you take Nimvastid How to take Nimvastid
Croatian: Što je Nimvastid i za što se koristi Što morate znati prije nego počnete uzimati Nimvastid Kako uzimati Nimvastid
English: CYP2C9, CYP2C8, CYP2C19, or CYP2B6.
Croatian: CYP2C9, CYP2C8, CYP2C19 ili CYP2B6.
English: What Nimvastid looks like and contents of the pack
Croatian: Kako Nimvastid izgleda i sadržaj pakiranja
English: Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
Croatian: Na temelju ANCOVA, s liječenjem i državom kao faktorima, i početnom ADAS-Cog kao kovarijatom.
English: Such events appeared to occur particularly after dose increments or high doses of rivastigmine.
Croatian: Čini se da su se takvi događaji javljali osobito nakon povećavanja doze ili visokih doza rivastigmina.
English: Your doctor will regularly check if the medicine is working for you.
Croatian: Liječnik će redovito provjeravati djeluje li lijek.
English: Rivastigmine should not be used during pregnancy unless clearly necessary.
Croatian: Rivastigmin se ne bi trebao primjenjivati tijekom trudnoće, osim u slučaju jasne potrebe.
English: Motor dysfunction
Croatian: Motorička disfunkcija
English: Peak plasma concentrations are reached in approximately 1 hour.
Croatian: Vršne se koncentracije u plazmi postižu za približno 1 sat.
English: Do not take Nimvastid - if you are allergic to rivastigmine (the active substance in Nimvastid) or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Nimvastid - ako ste alergični na rivastigmin (djelatnu tvar Nimvastida) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Activity of the enzyme returns to baseline levels about 9 hours after the maximum inhibitory effect has been achieved.
Croatian: Aktivnost enzima vraća se na početne razine za oko 9 sati nakon što se postigne maksimalno inhibitorno djelovanje.
English: It readily crosses the blood brain barrier and has an apparent volume of distribution in the range of 1.8-2.7 l/kg.
Croatian: Brzo prolazi kroz krvnomoždanu barijeru te ima prividni volumen distribucije u rasponu od 1,8 do 2,7 l/kg.
English: Taking the two medicines together could cause problems such as stiff limbs and trembling hands.
Croatian: Uzimanje tih dvaju lijekova zajedno moglo bi uzrokovati probleme kao što su ukočeni udovi i drhtanje ruku.
English: In massive overdose, atropine can be used.
Croatian: U slučaju masivnog predoziranja može se primijeniti atropin.
English: If you forget to take Nimvastid
Croatian: Ako ste zaboravili uzeti Nimvastid
English: Patients with severe hepatic impairment have not been studied.
Croatian: Bolesnici s teškim oštećenjem jetre nisu proučavani.
English: Put the tablet on the tongue as soon as it is removed from the packaging.
Croatian: Stavite tabletu na jezik čim ju izvadite iz pakiranja.
English: They should not be pushed through the foil in the blister pack as this will cause damage to the tablet.
Croatian: One se ne smiju potiskivati kroz foliju u blister pakiranju jer to uzrokuje oštećenje tablete.
English: Elevated liver function tests Hepatitis
Croatian: Povišeni rezultati testova funkcije jetre Hepatitis
English: Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.
Croatian: Uzimanje tih dvaju lijekova zajedno moglo bi uzrokovati probleme kao što su usporavanje otkucaja srca (bradikardija) koje dovodi do nesvjestice ili gubitka svijesti.
English: What you need to know before you take Nimvastid
Croatian: Što morate znati prije nego počnete uzimati Nimvastid
English: Dosing recommendations to titrate according to individual tolerability must be closely followed.
Croatian: Moraju se strogo pratiti preporuke za titraciju u skladu s individualnom podnošljivošću.
English: Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment 24 hours after the overdose.
Croatian: Većina slučajeva slučajnog predoziranja nije bila povezana s nekim od kliničkih znakova ili simptoma, a gotovo su svi bolesnici, na koje se to odnosilo, nastavili liječenje rivastigminom 24 sata nakon predoziranja.
English: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration.
Croatian: Najčešće zabilježene nuspojave su one gastrointestinalne, uključujući mučninu (38%) i povraćanje (23%), osobito tijekom titracije.
English: Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
Croatian: Liječenje dozom održavanja može se nastaviti tako dugo dok za bolesnika postoji korist od liječenja.
English: As a consequence of rivastigmine's interaction with its target enzyme, the increase in bioavailability is about 1.5-fold greater than that expected from the increase in dose.
Croatian: Kao posljedica interakcije rivastigmina s njegovim ciljnim enzimom, povećanje bioraspoloživosti je oko 1,5 puta veće od onoga koje se očekuje od povećanja doze.
English: In more severe cases nicotinic effects might develop such as muscular weakness, fasciculations, seizures and respiratory arrest with possible fatal outcome.
Croatian: U težim slučajevima mogu se razviti nikotinski učinci kao što su slabost mišića, fascikulacije, napadaji i respiratorni arest s mogućim smrtnim ishodima.
English: The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose.
Croatian: Djelotvorna doza je 3 do 6 mg dva puta na dan; da bi se postigla maksimalna korist od liječenja, bolesnike treba održavati na najvišoj dozi koju dobro podnose.
English: The tablets are round and white.
Croatian: Tablete su okrugle i bijele.
English: Patients and caregivers should be instructed accordingly.
Croatian: O tome bolesnici i njegovatelji trebaju dobiti odgovarajuće upute.
English: Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day.
Croatian: Zbog toga je potrebno redovito provjeravati kliničku korist primjene rivastigmina, osobito u bolesnika koji se liječe dozama manjim od 3 mg dva puta dnevno.
English: In these cases, treatment should be discontinued (see section 4.3).
Croatian: U ovim slučajevima, liječenje treba prekinuti (vidjeti dio 4.3).
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 (CSF) za približno 40% unutar prvih 1,5 sati nakon primjene.
English: Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action.
Croatian: Ispitivanja toksičnosti ponovljenih doza u štakora, miševa i pasa otkrila su samo učinke povezane s prekomjernim farmakološkim djelovanjem.
English: Protein binding of rivastigmine is approximately 40%.
Croatian: Rivastigmin se veže na proteine plazme približno 40%.
English: The incidence and severity of adverse reactions generally increase with higher doses.
Croatian: Incidencija i težina nuspojava općenito se povećavaju pri većim dozama.