FrancophonIA/ELRC3.0 huggingface dataset:
English: HBeAg-positive n = 443 and 444, HBeAg-negative n = 219 and 219, for both telbivudine and lamivudine groups, respectively.
Slovenian: PCR test (spodnja meja določanja ≤300 kopij/ml) HBeAg-pozitivni n = 443 za telbivudin in n = 444 za lamivudin, HBeAg-negativni n = 219 za telbivudin in n = 219 za lamivudin.
English: Sebivo contains sodium
Slovenian: Zdravilo Sebivo vsebuje natrij
English: Your dose may be reduced if you have kidney problems.
Slovenian: Če imate težave z ledvicami, boste morda jemali nižji odmerek.
English: Maintained ALT normalisation
Slovenian: ohranjena normalna vrednost ALT
English: Telbivudine 600 mg (n = 384)
Slovenian: telbivudin 600 mg (n = 384)
English: Grade 3 or 4 CK elevations newly occurred in 15.9% of patients treated with telbivudine for 208 weeks.
Slovenian: Pri 15,9% bolnikov, ki so jih zdravili s telbivudinom do 208 tednov, so na novo opažali zvišanje CK stopnje 3 ali 4.
English: 30 ml oral solution contain 600 mg telbivudine.
Slovenian: 30 ml peroralne raztopine vsebuje 600 mg telbivudina.
English: • The mean Knodell necroinflammatory score of 7.6 (SD 2.9) at baseline improved (p < 0.0001)
Slovenian: • Povprečna ocena na Knodellovi nekroinflamatorni lestvici se je od izhodiščne vrednosti 7,6 (s standardno deviacijo (SD) 2,9) izboljšala na 1,4 (SD 0,9) (p <0,0001), kar pomeni povprečno spremembo ocene za -6,3 (SD 2,8).
English: Table 4 Summary of post-treatment ALT flares - Pooled NV-02B-007 (GLOBE) and NV02B-015 studies
Slovenian: Preglednica 4 Povzetek poslabšanj z zvišanjem ALT po zdravljenju - združeni rezultati študij NV-02B-007 (GLOBE) in NV-02B-015
English: Maintained undetectable HBV DNA (< 300 copies/ml) with undetectable HBV DNA at week 24
Slovenian: ohranjena nemerljiva koncentracija HBV DNA (<300 kopij/ml) ob nemerljivi koncentraciji HBV DNA po 24 tednih zdravljenja ohranjena normalna vrednost ALT
English: Sebivo 600 mg film-coated tablets telbivudine
Slovenian: Sebivo 600 mg filmsko obložene tablete telbivudin
English: No adjustment of the recommended dose of telbivudine is necessary in patients whose creatinine clearance is  50 ml/min.
Slovenian: Pri bolnikih z očistkom kreatinina 50 ml/min ni potrebno prilagajati priporočenega odmerka telbivudina.
English: - if you are taking any medicines that may cause muscle problems (talk to your doctor or pharmacist if you are unsure).
Slovenian: V tem primeru vas bo zdravnik hotel bolj natančno spremljati; - če imate presajena jetra; - če jemljete katero od zdravil, ki lahko povzročajo težave z mišicami (če niste prepričani, se pogovorite z zdravnikom ali s farmacevtom); - če ste okuženi z virusom HIV, z virusom hepatitisa C ali D oziroma če se zdravite s katerim od protivirusnih zdravil.
English: ALT flares
Slovenian: Okvara ledvic
English: Telbivudine absorption and exposure were unaffected when a single 600 mg dose was administered with food.
Slovenian: Pri zaužitju enkratnega 600-miligramskega odmerka telbivudina skupaj s hrano se njegovo absorpcija in izpostavljenost zdravilu ne spremenita.
English: Table 3 Summary of on-treatment ALT flares - Pooled NV-02B-007 (GLOBE) and NV-02B015 studies
Slovenian: Preglednica 3 Povzetek poslabšanj z zvišanjem ALT med zdravljenjem - združeni rezultati študij NV-02B-007 (GLOBE) in NV-02B-015
English: Table 1 Dosing regimen adjustment of Sebivo in patients with renal impairment
Slovenian: Preglednica 1 Prilagajanje sheme odmerjanja zdravila Sebivo pri bolnikih z okvaro ledvic očistek kreatinina (ml/min)
English: Malaise
Slovenian: Dojenje
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
Slovenian: Občasni (lahko prizadenejo do 1 od 100 ljudi) bolečine v sklepih trdovratna šibkost mišic ali bolečina v mišicah (miopatija/miozitis), mišični krči bolečine v hrbtu, vratu in ledvenem predelu odrevenelost, mravljinčenje, bolečina in/ali pekoč občutek v rokah in/ali nogah ali okrog ust bolečine v križu ali kolku, ki lahko sevajo v nogo (išias) motnje okušanja splošno slabo počutje
English: One isolated rtM204V mutation and two rtM204I/V/M mutations were reported in telbivudine-treated patients experiencing viral breakthrough up to week 208.
Slovenian: Pri bolnikih, ki so prejemali telbivudin in pri katerih je do konca 208. tedna prišlo do virusnega preboja, so opazili eno samo mutacijo rtM204V in dve mutaciji rtM204I/V/M.
English: Benign digestive symptoms, such as nausea, vomiting and abdominal pain, may be indicative of lactic acidosis development.
Slovenian: Razvoj laktacidoze lahko nakazujejo običajno nenevarni prebavni simptomi, kot so navzea, bruhanje in bolečine v trebuhu.
English: Discard the solution left in the cup into the sink.
Slovenian: Raztopino, ki je ostala v odmerni posodici, izlijte v odtok.
English: Patients who achieve HBV DNA levels < 3 log10 copies/ml by week 24 had optimal responses to treatment; conversely patients with HBV DNA levels > 4 log10 copies/ml at 24 weeks had less favourable outcomes at week 52.
Slovenian: V nasprotju z njimi so bili pri bolnikih, ki so imeli po 24. tednu količino HBV DNA >4 log10 kopij/ml, rezultati po 52. tednu manj ugodni.
English: ALT normalisation assessed only in patients with ALT > ULN at baseline.
Slovenian: Normalizacijo ALT so ocenjevali samo pri bolnikih, ki so imeli izhodiščno vrednost ALT nad zgornjo mejo normalnih vrednosti.
English: ESRD/ Haemodialysis (n = 6) 200 mg
Slovenian: (n = 6) 200 mg končna ledvična odpoved / hemodializa (n = 6) 200 mg
English: Rash
Slovenian: Rasa
English: Excipients
Slovenian: Starostniki
English: How to take Sebivo
Slovenian: Kako jemati zdravilo Sebivo
English: Race There are no significant race-related differences in telbivudine pharmacokinetics.
Slovenian: Farmakokinetične lastnosti telbivudina se glede na raso bistveno ne razlikujejo.
English: There is no information on intentional overdose of telbivudine, but one subject was given an unintentional overdose which was asymptomatic.
Slovenian: Vendar pa je ena oseba pomotoma prejela prevelik odmerek in ni imela nobenih simptomov.
English: Cough
Slovenian: Spol
English: Mean HBV DNA reduction from baseline (log10 copies/ml) ± SEM % Patients HBV DNA undetectable by PCR
Slovenian: povprečno zmanjšanje koncentracije HBV DNA od izhodišča (log10 kopij/ml) ± SE
English: Ishak fibrosis score ≤ 1 (no or minimal fibrosis) was observed in
Slovenian: Oceno ≤1 na Ishakovi lestvici fibroze (kar pomeni brez fibroze ali z minimalno stopnjo fibroze) so opažali pri 84,2% (48/57) bolnikov.
English: Depending on the results of these tests your doctor may advise you to change how often you take Sebivo.
Slovenian: Glede na izvide teh preiskav vam bo morda svetoval spremembo časovnih razmikov, v katerih jemljete zdravilo Sebivo; - če imate cirozo jeter (resno bolezen, ki povzroča, da se jetra zabrazgotinijo).
English: The recommended dose of Sebivo is 30 ml of oral solution (600 mg telbivudine) once a day.
Slovenian: Priporočeni odmerek zdravila Sebivo je 30 ml peroralne raztopine (600 mg telbivudina) enkrat na dan. Peroralno raztopino Sebivo vzemite vsak dan približno ob isti uri.
English: Pack sizes: 28 or 98 film-coated tablets
Slovenian: PVC/aluminijevi pretisni omoti velikosti pakiranj: 28 ali 98 filmsko obloženih tablet Na trgu morda ni vseh navedenih pakiranj.
English: CARTON
Slovenian: Serija
English: Worsening
Slovenian: Odmerjanje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
English: The recommended dose of Sebivo is one 600 mg tablet once a day.
Slovenian: Priporočeni odmerek zdravila Sebivo je ena 600-miligramska tableta enkrat na dan. Tableto vzemite vsak dan približno ob isti uri.
English: HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies/ml).
Slovenian: Za zagotavljanje popolne virusne supresije (vrednost HBV DNA manj kot 300 kopij/ml) je treba vrednosti HBV DNA izmeriti po 24 tednih zdravljenja.
English: Histological response defined as a ≥ 2 point decrease in Knodell Necroinflammatory Score from baseline with no worsening of the Knodell Fibrosis Score.
Slovenian: histološki odziv izboljšanje brez izboljšanja stopnja fibroze po Ishaku izboljšanje brez spremembe poslabšanje brez biopsije po 52. tednu bolniki, ki so prejeli vsaj en odmerek študijskega zdravila, z izhodiščno biopsijo jeter, ki je bila primerna za ocenjevanje, in z izhodiščnim indeksom histološke aktivnosti po Knodellu >3 (Knodell Histological Activity Index - HAI) histološki odziv opredeljen kot znižanje od izhodišča za ≥2 točki na Knodellovi nekroinflamatorni lestvici (Knodell Necroinflammatory Score) brez sočasnega poslabšanja na Knodellovi fibrozni lestvici (Knodell Fibrosis Score) stopnje fibroze po Ishakovi fibrozni lestvici (Ishak Fibrosis Score); izboljšanje izmerjeno kot znižanje za ≥1 točko na Ishakovi fibrozni lestvici po 52. tednu glede na izhodiščno vrednost *p = 0,0024
English: This request was based on the following reasons:
Slovenian: Zahteva je temeljila na naslednjih razlogih:
English: The final opinion was converted into a Decision by the European Commission on 19 November 2008.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 19. novembra 2008.
English: The referral procedure started on 20 September 2007.
Slovenian: Napotitveni postopek se je začel 20. septembra 2007.
English: * Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 24 July 2008.
Slovenian: * Opombe: Informacije, podane v tem dokumentu in dodatkih, odražajo samo mnenje CHMP z dne 24. julija 2008.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so navedeni v Dodatku II.
English: The Rapporteur and Co-Rapporteur appointed were: Dr. Ondřej Slanař and Dr. Pieter Neels, respectively.
Slovenian: Poročevalec in soporočevalec sta bila: dr. Ondřej Slanař oziroma dr. Pieter Neels.
English: Written explanations were provided by the Marketing Authorisation Holder by 25 February and 20 June 2008.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil dne 25. februarja in 20. junija 2008.
English: - Pyelonephritis is often associated with bacteraemia.
Slovenian: - pielonefritis je pogosto povezan z bakteremijo.
English: The same objections are obviously valid for the oral treatment of uncomplicated pyelonephritis.
Slovenian: Enaki zadržki očitno veljajo za peroralno zdravljenje nezapletenega pielonefritisa.
English: On 14 September 2007, Belgium referred the matter to the EMEA under Article 31 of Directive 2001/83/EC and asked the CHMP to give its opinion on whether the marketing authorisations for oral formulations of medicinal products containing norfloxacin in the treatment of acute or chronic complicated or uncomplicated pyelonephritis should be maintained, varied, suspended or withdrawn across the European Union following the re-assessment of norfloxacin benefit/risk balance.
Slovenian: Belgija je 14. septembra 2007 zadevo napotila na agencijo EMEA v skladu s členom 31 Direktive 2001/83/ES in zaprosila Odbor za zdravila za uporabo v humani medicini (CHMP), naj poda svoje mnenje, ali je treba dovoljenja za promet z zdravilom za peroralne pripravke zdravil, ki vsebujejo norfloksacin, pri zdravljenju akutnega ali kronično zapletenega ali nezapletenega pielonefritisa, ohraniti, spremeniti, preklicati ali umakniti v Evropski uniji zaradi ponovne ocene razmerja med koristmi in tveganji pri uporabi norfloksacina.
English: Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP concluded that for oral formulations of norfloxacin containing medicinal products the benefit does not outweigh the risk in acute or chronic complicated pyelonephritis, and therefore adopted an opinion on 24 July 2008 recommending the variation of the Marketing Authorisations by removing the therapeutic indication “acute and chronic complicated pyelonephritis” from the Product Information for the norfloxacin containing medicinal products taken orally.
Slovenian: Na podlagi trenutno razpoložljivih podatkov in poročil o oceni zdravila poročevalca je CHMP zaključil, da pri peroralnih pripravkih med zdravili, ki vsebujejo norfloksacin, koristi ne odtehtajo tveganja pri zdravljenju akutnega ali kroničnega zapletenega pielonefritisa, in zato dne 24. julija 2008 sprejel mnenje, v katerem priporoča spremembo dovoljenja za promet z zdravilom s črtanjem terapevtske indikacije „akutni in kronični zapleteni pielonefritis“ iz informacij o zdravilih, ki vsebujejo norfloksacin in se jemljejo peroralno.
English: In case of oral treatment, second generation fluoroquinolones are superior to norfloxacin because they present higher serum and tissue levels.
Slovenian: V primeru peroralnega zdravljenja je druga generacija fluorokinolonov boljša od norfloksacina, ker zagotavlja višje koncentracije v serumu in tkivih.
English: Norfloxacin is a broad-spectrum, quinolone bactericidal agent indicated for the treatment of acute or chronic complicated or uncomplicated pyelonephritis due to susceptible organisms.
Slovenian: Norfloksacin je kinolonska baktericidna učinkovina s širokim spektrom delovanja, indicirana za zdravljenje akutnega in kronično zapletenega pielonefritisa zaradi dovzetnih organizmov.
English: Norfloxacin containing medicinal products, which are only available as an oral formulation, do not provide adequate serum levels for the treatment of concomitant bacteraemia.
Slovenian: Zdravila, ki vsebujejo norfloksacin in so na voljo samo kot peroralni pripravki, ne zagotavljajo zadostne serumske koncentracije za zdravljenje sočasne bakteremije; - za zdravljenje navedenih indikacij so na voljo tudi druga zdravila.
English: Second generation fluoroquinolones such as ciprofloxacin, ofloxacin and levofloxacin show higher serum concentrations and a much better tissue distribution than norfloxacin.
Slovenian: Druga generacija fluorokinolonov, kot so na primer ciprofloksacin, ofloksacin in levofloksacin, kažejo višje serumske koncentracije in boljšo porazdelitev po tkivih kot norfloksacin; - zapleteni pielonefritis se lahko zdravi peroralno ali intravenozno (v skladu z lokalno politiko zdravljenja in diagnostičnimi merili za določanje zapletenih okužb).
English: 13 January 2009 EMEA/660192/2008 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL Norfloxacin containing medicinal products International non-proprietary name (INN): norfloxacin BACKGROUND INFORMATION *
Slovenian: Mednarodno nelastniško ime (INN): norfloksacin
English: A positive change indicates improvement.
Slovenian: Pozitivna sprememba pomeni izboljšanje.
English: Rivastigmine is rapidly and completely absorbed.
Slovenian: Rivastigmin se hitro in popolnoma absorbira.
English: It is not known if this occurs in humans.
Slovenian: Ni znano, ali je tako tudi pri ljudeh.
English: Last Observation Carried Forward
Slovenian: Zadnje opazovanje preneseno naprej
English: The major metabolite NAP226-90 also did not show a genotoxic potential.
Slovenian: Tudi najpomembnejši presnovek NAP226-90 ni kazal genotoksičnega potenciala.
English: 4 times the maximum clinical exposure.
Slovenian: 4-krat večji od največje klinične izpostavljenosti.
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Slovenian: Zdravnik vam bo povedal, ali vam vaša bolezen dovoljuje, da varno upravljate vozila in uporabljate stroje.
English: Patients with Clinically Significant Response (%) Intent to Treat
Slovenian: Bolniki s klinično pomembnim odzivom (%) Namen zdraviti
English: These adverse reactions occur more commonly in women.
Slovenian: Ti neželeni učinki se pojavljajo pogosteje pri ženskah.
English: Individual response to rivastigmine cannot be predicted.
Slovenian: Individualnega odziva na rivastigmin ne moremo predvideti.
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.
Slovenian: Če zdravila Nimvastid niste jemali že več kot tri dni, ne vzemite naslednjega odmerka, dokler se ne pogovorite s svojim zdravnikom.
English: Rivastigmine n (%)
Slovenian: Rivastigmin n (%)
English: If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.
Slovenian: Če ste omotični ali zaspani, ne vozite, ne uporabljajte strojev in ne izvajajte opravil, ki zahtevajo zbranost.
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).
Slovenian: Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
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.
Slovenian: Čeprav je biološka uporabnost rivastigmina večja pri starejših kot pri mladih, zdravih prostovoljcih, študije pri bolnikih z Alzheimerjevo boleznijo, starih od 50 do 92 let, niso pokazale, da bi se biološka uporabnost s starostjo spreminjala.
English: • Treatment usually starts with a low dose.
Slovenian: - Zdravljenje se običajno začne z majhnim odmerkom.
English: Patients and caregivers should be instructed accordingly.
Slovenian: Bolnike in njihove negovalce je treba o tem ustrezno poučiti.
English: In addition, a post-hoc definition of response is provided in the same table.
Slovenian: Ista preglednica vsebuje tudi post-hoc opredelitev odziva.
English: Your doctor will regularly check if the medicine is working for you.
Slovenian: Zdravnik bo redno preverjal, ali vam zdravilo koristi.
English: Your doctor will tell you what dose of Nimvastid to take.
Slovenian: Zdravnik vam bo povedal, kakšen odmerek zdravila Nimvastid morate jemati.
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.
Slovenian: Dobro prehaja skozi krvnomožgansko pregrado in ima navidezni volumen porazdelitve v območju 1,8-2,7 l/kg.
English: Dissolve the tablet in the mouth and swallow it with or without water.
Slovenian: Tableto raztopite v ustih in jo pogoltnite z vodo ali brez nje.
English: If this applies to you, tell your doctor and do not take Nimvastid.
Slovenian: Če kaj od navedenega velja za vas, povejte svojemu zdravniku in ne jemljite zdravila Nimvastid.
English: ITT - LOCF population
Slovenian: Skupina ITT - LOCF
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
Slovenian: Izboljšanje za vsaj 4 točke pri ADAS-Cog brez poslabšanja pri CIBICPlus in PDS *p < 0,05, **p < 0,01, ***p < 0,001
English: If you find you have forgotten to take your dose of Nimvastid, wait and take the next dose at the usual time.
Slovenian: Če ugotovite, da ste pozabili vzeti odmerek zdravila Nimvastid, počakajte in ob običajnem času vzemite naslednji odmerek.
English: • Your doctor will slowly increase your dose depending on how you respond to treatment.
Slovenian: - Zdravnik vam bo odmerek počasi povečeval glede na vaš odziv na zdravljenje.
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.
Slovenian: Zato moramo klinično korist rivastigmina redno ocenjevati, posebno pri bolnikih, ki se zdravijo z odmerki, manjšimi od 3 mg dvakrat na dan.
English: Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
Slovenian: ANCOVA z zdravljenjem in državo kot faktorjema in izhodiščnim ADAS-Cog kot sospremenljivko.
English: Peak plasma concentrations are reached in approximately 1 hour.
Slovenian: Največjo plazemsko koncentracijo doseže približno v 1 uri.
English: ITT + RDO population
Slovenian: Skupina ITT + RDO
English: Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
Slovenian: Vzdrževalno zdravljenje lahko nadaljujemo, dokler ima bolnik od tega terapevtske koristi.
English: Absolute bioavailability after a 3 mg dose is about 36%±13%.
Slovenian: Absolutna biološka uporabnost po odmerku 3 mg je približno 36- ± 13-odstotna.
English: CARTON FOR BLISTERS AND CONTAINER, AND LABEL FOR CONTAINER
Slovenian: ŠKATLA ZA PRETISNE OMOTE IN VSEBNIK TER NALEPKA ZA VSEBNIK
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.
Slovenian: Učinkovitost rivastigmina so ugotavljali z uporabo treh neodvisnih, področno specifičnih metod ocenjevanja v rednih časovnih presledkih med šestmesečnimi obdobji zdravljenja.
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30%.
Slovenian: Jemanje rivastigmina skupaj s hrano upočasni absorpcijo (tmax) za 90 minut in zmanjša Cmax ter poveča AUC za približno 30 %.
English: Discontinuation should also be considered when evidence of a therapeutic effect is no longer present.
Slovenian: O prekinitvi zdravljenja razmišljamo tudi takrat, kadar ni več znakov terapevtskega učinka.
English: Protein binding of rivastigmine is approximately 40%.
Slovenian: Na beljakovine se veže približno 40 % rivastigmina.
English: What Nimvastid is and what it is used for
Slovenian: Kaj je zdravilo Nimvastid in za kaj ga uporabljamo
English: Effects of rivastigmine on human fertility are not known.
Slovenian: Vpliv rivastigmina na plodnost pri ljudeh ni znan.
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Slovenian: Klinične študije pri demenci, povezani s Parkinsonovo boleznijo Učinkovitost rivastigmina pri demenci, povezani s Parkinsonovo boleznijo, so pokazali v 24-tedenski multicentrični, dvojno slepi, s placebom kontrolirani osnovni študiji in njeni 24-tedenski odprti podaljšani fazi.
English: Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action.
Slovenian: Študije toksičnosti ponavljajočih se odmerkov na podganah, miših in psih so razkrile le učinke, povezane s pretiranim farmakološkim delovanjem.
English: Rivastigmine 6-12 mg N=379
Slovenian: rivastigmin 6-12 mg N = 379
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.
Slovenian: Zdravljenje z rivastigminom se sme začeti le, če je na voljo negovalec, ki bo poskrbel, da bo bolnik redno jemal zdravila.
English: Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer's Disease Cooperative StudyClinician's Global Impression of Change).
Slovenian: Učinkovitost so dokazali z uporabo dveh neodvisnih lestvic, s katerima so bolnike ocenjevali v rednih presledkih med 6mesečnim obdobjem zdravljenja, kot kaže preglednica 5 spodaj: ADAS-Cog, merilo za kognicijo, in globalno merilo ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change /Kooperativna študija Alzheimerjeve bolezni-globalni klinični vtis sprememb).
English: Rivastigmine should not be used during pregnancy unless clearly necessary.
Slovenian: Rivastigmina se ne sme predpisovati nosečnicam, razen če je nujno potrebno.