FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reactions have only been observed with rivastigmine capsules and oral solution and not in clinical studies with rivastigmine transdermal patches: somnolence, malaise, tremor, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Slovenian: Naslednje neželene učinke so opažali samo pri uporabi kapsul in peroralne raztopine z rivastigminom, ne pa v kliničnih študijah s transdermalnimi obliži z rivastigminom: somnolenco, splošno slabo počutje, tremor, zmedenost, povečano potenje (pogosto); razjede dvanajstnika, angino pektoris (redko); krvavitev v prebavila (zelo redko); in nekaj primerov hudega bruhanja, ki je bilo povezano z rupturo
English: Based on evidence from in vitro and animal studies, the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Slovenian: Raziskave in vitro in raziskave na živalih dokazujejo, da pri presnovi rivastigmina le v zelo majhni meri sodelujejo glavni izoencimi s citokromom P450.
English: LIST OF EXCIPIENTS Also contains polyester, ethyl vinyl acetate, acrylate copolymer adhesive and isopropyl myristate.
Slovenian: Vsebuje tudi: poliester, etilvinilacetat, adhezivni akrilatni kopolimer in izopropilmiristat.
English: What Rivastigmine 3M Health Care Ltd. is and what it is used for
Slovenian: Kaj je zdravilo Rivastigmin 3M Health Care Ltd. in za kaj ga uporabljamo
English: Each patch consists of a combination of a removable, transparent, split release liner, a functional layer containing drug-inadhesive (DIA) matrix, and a protective backing layer.
Slovenian: En obliž je sestavljen iz odstranljive, prozorne opne, iz funkcijske plasti, ki vsebuje matriks ''zdravilo-v-adhezivu'' (DIA - drugin-adhesive), in iz zaščitne krovne plasti.
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.
Slovenian: 1 Na podlagi ANCOVA z zdravljenjem in državo kot faktorjema in izhodiščno vrednostjo kot sospremenljivko.
English: As suggested by compartmental modelling, 9.5 mg/24 h transdermal patches exhibited exposure similar to that provided by an oral dose of 12 mg/day.
Slovenian: Kot nakazuje modeliranje kompartmentov, je izpostavljenost zdravilu iz transdermalnega obliža 9,5 mg/24 h podobna kot pri peroralnem odmerku približno 12 mg/dan.
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.
Slovenian: Po uporabi transdermalni obliž prepognite na pol z lepljivo stranjo navznoter, vložite v originalno vrečko in varno zavrzite nedosegljivo otrokom.
English: Every 24 hours take off the previous patch before putting ONE new patch on to ONLY ONE of the following possible locations.
Slovenian: Vsakih 24 ur najprej odstranite prešnji obliž, nato pa namestite EN nov obliž na SAMO ENO od naslednjih
English: • Do not cut the patch into pieces.
Slovenian: • Obliža ne smete rezati na manjše dele.
English: If well tolerated and only after a minimum of six months of treatment at 9.5 mg/24 h, the treating physician may consider increasing the dose to 13.3 mg/24 h in patients who have demonstrated a meaningful cognitive deterioration (e.g. decrease in the MMSE) and/or functional decline (based on physician judgement) while on the recommended daily effective dose of 9.5 mg/24 h (see section 5.1).
Slovenian: Če bolnik ta odmerek dobro prenaša, lahko po najmanj šestih mesecih zdravljenja z odmerkom 9,5 mg/24 h lečeči zdravnik razmisli o zvišanju odmerka na 13,3 mg/24 h, in sicer pri bolnikih, pri katerih kaže, da je med zdravljenjem s priporočenim dnevnim učinkovitim odmerkom 9,5 mg/24 h prišlo do pomembnega kognitivnega poslabšanja (na primer do poslabšanja rezultata MMSE) in/ali funkcionalnega upada (po zdravnikovi presoji) (glejte poglavje 5.1).
English: Therefore, in patients with dementia treated with rivastigmine, the ability to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Slovenian: Zato mora lečeči zdravnik pri bolnikih z demenco, ki jemljejo rivastigmin, redno ocenjevati sposobnost za upravljanje motornih vozil ali zapletenih strojev.
English: Each transdermal patch of 8.3 cm2 contains 14.33 mg of rivastigmine.
Slovenian: En transdermalni obliž velikosti 8,3 cm2 vsebuje 14,33 mg rivastigmina.
English: - If the patch falls off, a new one should be applied for the rest of the day, then it should be replaced at the same time as usual the next day.
Slovenian: - Če se obliž odlepi, je treba namestiti nov obliž za preostanek tega dne, nato pa novi obliž naslednji dan zamenjati ob istem času kot običajno.
English: Each patch is sealed in a pouch that protects it until you are ready to put it on. Do not open the pouch or remove a patch until just before you apply it.
Slovenian: Vsak obliž je zaprt v vrečki, ki ga ščiti, dokler ga ne želite namestiti.
English: Each transdermal patch of 4.15 cm2 contains 7.17 mg of rivastigmine.
Slovenian: En transdermalni obliž velikosti 4,15 cm2 vsebuje 7,17 mg rivastigmina.
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.
Slovenian: V stanju dinamičnega ravnovesja je spodnja meja fluktuacije koncentracije približno 50% vrednosti zgornje meje, v nasprotju s peroralnim odmerjanjem, pri katerem se koncentracije med odmerjanji znižajo praktično na nič.
English: However, use of rivastigmine patch may lead to allergic contact dermatitis.
Slovenian: Te reakcije same po sebi še ne kažejo na senzitizacijo, vendar lahko uporaba rivastigmina v transdermalnem obližu povzroči alergijski kontaktni dermatitis.
English: Efficacy was established by the use of ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance-based measure of cognition) and the ADCS-IADL (Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living) assessing instrumental activities which include maintaining finances, meal preparation, shopping, ability to orient oneself to surroundings, ability to be left unattended.
Slovenian: Učinkovitost so ugotavljali z metodama ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, Lestvica za oceno kognitivnih sposobnosti bolnikov z Alzheimerjevo boleznijo, merilo kognitivne zmogljivosti, ki temelji na izvrševanju aktivnosti) in ADCS-IADL (Alzheimer's Disease Cooperative StudyInstrumental Activities of Daily Living, ocena zahtevnejših vsakodnevnih aktivnosti), s katero je mogoče oceniti bolnikove sposobnosti izvajanja aktivnosti, med katere sodijo ukvarjanje z denarnimi zadevami, pripravljanje obrokov, nakupovanje, zmožnosti orientacije v okolju in samostojnost do te mere, da je bolnika mogoče pustiti brez nadzora.
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.
Slovenian: Tem bolnikom je treba odmerek titrirati previdno in jih skrbno spremljati glede neželenih učinkov (na primer pretirane navzee ali bruhanja) ter v primeru, da pride do teh neželenih učinkov, razmisliti o znižanju vzdrževalnega odmerka na 4,6 mg/24 h.
English: However, these events did not occur at a higher frequency with rivastigmine 13.3 mg/24 h transdermal patches than with placebo.
Slovenian: Vendar pa se ti dogodki niso pojavljali pogosteje pri uporabi transdermalnega obliža z rivastigminom 13,3 mg/24 h v
English: Manufacturer Enestia
Slovenian: Izdelovalec Enestia
English: After oral administration, the Cmax of rivastigmine was approximately 60% higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Slovenian: Po peroralnem odmerjanju je bila Cmax rivastigmina za približno 60 % večja in AUC rivastigmina več kot dvakrat večja pri osebah z blago do zmerno jetrno okvaro kot pri zdravih osebah.
English: The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations ((Cmax-Cmin)/Cavg), was 0.58 for rivastigmine 4.6 mg/24 h transdermal patches, 0.77 for rivastigmine 9.5 mg/24 h transdermal patches and 0.72 for rivastigmine 13.3 mg/24 h transdermal patches, thus demonstrating a much smaller fluctuation between trough and peak concentrations than for the oral formulation (FI = 3.96 (6 mg/day) and 4.15 (12 mg/day)).
Slovenian: Fluktuacijski indeks(FI), ki izraža relativno razliko med najvišjimi in najnižjimi koncentracijami ((Cmax-Cmin)/Cavg; pri tem je Cavg povprečna koncentracija v obdobju odmerjanja), je bil 0,58 pri transdermalnih obližih z rivastigminom 4,6 mg/24 h, 0,77 pri transdermalnih obližih z rivastigminom 9,5 mg/24 h in 0,72 pri transdermalnih obližih z rivastigminom 13,3 mg/24 h, kar kaže na veliko manjšo fluktuacijo od najnižjih do najvišjih koncentracij kot pri peroralnem odmerjanju (FI = 3,96 za odmerjanje 6 mg/dan in 4,15 za odmerjanje
English: The most commonly observed severe symptoms with rivastigmine 9.5 mg/24 h transdermal patches were pruritus (1.7%) and erythema (1.1%).
Slovenian: Najpogosteje opažena huda simptoma s transdermalnimi obliži z rivastigminom 9,5 mg/24 h sta bila srbenje (1,7%) in rdečina (1,1%).
English: Reapplication to the exact same skin location within 14 days should be avoided to minimise the potential risk of skin irritation.
Slovenian: Da bi kar najbolj zmanjšali možnost draženja kože, se transdermalnega obliža ne sme ponovno namestiti na isti predel kože v roku 14 dni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En transdermalni obliž sprosti 4,6 mg rivastigmina na 24 ur.
English: Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with rivastigmine capsules or oral solution can be switched to Rivastigmine 3M Health Care Ltd. transdermal patches as follows: - A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Slovenian: Prehod z zdravljenja s kapsulami ali peroralno raztopino na zdravljenje z obliži Glede na to, da je izpostavljenost rivastigminu primerljiva pri peroralni in transdermalni aplikaciji (glejte poglavje 5.2), lahko bolniki, ki se zdravijo s kapsulami ali peroralno raztopino rivastigmina, preidejo na zdravljenje s transdermalnimi obliži Rivastigmin 3M Health Care Ltd. na naslednji način: - Bolnik, ki jemlje rivastigmin peroralno v odmerku 3 mg/dan, lahko preide na zdravljenje s
English: Rivastigmine 13.3 mg/24 h
Slovenian: Rivastigmin 13,3 mg/24 h
English: What you need to know before you use Rivastigmine 3M Health Care Ltd.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Rivastigmin 3M Health Care Ltd.
English: After switching to 4.6 mg/24 h transdermal patches, provided these are well tolerated after a minimum of four weeks of treatment, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, which is the recommended effective dose.
Slovenian: Če bolnik po prehodu na zdravljenje s transdermalnimi obliži 4,6 mg/24 h ta odmerek dobro prenaša, je treba po najmanj štirih tednih zvišati odmerek s 4,6 mg/24 h na 9,5 mg/24 h, kar je priporočeni učinkoviti
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En transdermalni obliž sprosti 9,5 mg rivastigmina na 24 ur.
English: These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance-based measure of cognition) and the ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the ADCS-ADL (Alzheimer's Disease Cooperative StudyActivities of Daily Living, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities related to finances).
Slovenian: Med njimi so ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, Lestvica za oceno kognitivnih sposobnosti bolnikov z Alzheimerjevo boleznijo, merilo kognitivne zmogljivosti, ki temelji na izvrševanju aktivnosti), ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change, Zdravnikova ocena spremembe bolezni po Kooperativni študiji Alzheimerjeve bolezni, vsestranska globalna ocena bolnika, ki jo poda zdravnik ob upoštevanju negovalčeve ocene) in ADCS-ADL (Alzheimer's Disease Cooperative Study - Activities of Daily Living, ocena vsakodnevnih aktivnosti po Kooperativni študiji Alzheimerjeve bolezni, negovalčeva ocena vsakodnevnih aktivnosti, med drugim osebne higiene, hranjenja, oblačenja, gospodinjskih opravil, na primer nakupovanja, ohranjanja zmožnosti orientacije v okolju kot tudi ukvarjanja z denarnimi zadevami).
English: If you are pregnant, the benefits of using Rivastigmine 3M Health Care Ltd. transdermal patches must be assessed against the possible effects on your unborn child. Rivastigmine 3M Health Care Ltd. should not be used during pregnancy unless clearly necessary.
Slovenian: V primeru, da ste noseči, je treba pretehtati koristi uporabe zdravila Rivastigmin 3M Health Care Ltd. in možne učinke na nerojenega otroka.
English: Each transdermal patch consists of three layers; a backing layer, an adhesive layer containing the medicine and a transparent, split release liner.
Slovenian: En obliž je sestavljen iz treh plasti; krovne plasti, adhezivne plasti, ki vsebuje zdravilo, in prozorne zaščitne plasti, ki se jo odstrani.
English: Less than 1% of the administered dose is excreted in the faeces.
Slovenian: Manj kot 1 % apliciranega
English: Patients involved in the active comparator controlled study had an initial baseline MMSE score of 10-24.
Slovenian: 48-tedenska študija, kontrolirana z aktivnim primerjalnim zdravilom Bolniki, vključeni v aktivno kontrolirano študijo, so imeli začetni rezultat MMSE ob izhodišču med 10 in 24.
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.
Slovenian: Pri bolnikih z Alzheimerjevo boleznijo je bila stopnja inhibicije AChE v CSF s peroralnim rivastigminom odvisna od odmerka do največjega preizkušanega odmerka 6 mg, danega dvakrat na dan. Inhibicija aktivnosti butirilholinesteraze v CSF pri 14 bolnikih z Alzheimerjevo boleznijo, zdravljenih s peroralnim rivastigminom, je bila podobna kot inhibicija
English: The backing layer is transparent to translucent and labelled with “R5” (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or “R10” (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
Slovenian: Krovna plast je prozorna do prosojna in in označena z oznako “R5” (Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni obliž) ali “R10” (Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni obliž).
English: In the 24-week doubleblind study, the most commonly observed symptoms (skin irritation rating scale) with rivastigmine 9.5 mg/24 h transdermal patches were very slight (21.8%), mild (12.5%) or moderate (6.5%) erythema or very slight (11.9%), mild (7.3%) or moderate (5.0%) pruritus.
Slovenian: V 24-tedenski dvojno slepi študiji so bili najbolj pogosto opaženi simptomi (po lestvici ocene draženja kože) s transdermalnimi obliži z rivastigminom 9,5 mg/24 h zelo blaga (21,8%), blaga (12,5%) ali zmerna (6,5%) rdečina ali zelo blago (11,9%), blago (7,3%) ali zmerno (5,0%) srbenje.
English: Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4).
Slovenian: Uporaba zdravila je kontraindicirana tudi pri bolnikih, ki imajo v anamnezi reakcije na mestu apliciranja, ki bi bile lahko znak alergijskega kontaktnega dermatitisa pri uporabi transdermalnih obližev z rivastigminom (glejte poglavje 4.4).
English: Always use this medicine exactly as described in this leaflet and as your doctor has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte napotke v tem navodilu in navodila zdravnika.
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
Slovenian: - jetrne motnje (porumenelost kože, porumenelost očesnih beločnicm nenormalno temen urin ali nepojasnjena slabost v želodcu, bruhanje, utrujenost in izguba apetita) - spremembe v izvidih preiskav za oceno delovanja jeter
English: - Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patches: Each patch releases 4.6 mg of rivastigmine per 24 hours, is 4.15 cm2 and contains 7.17 mg of rivastigmine.
Slovenian: - Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni obliži: en obliž sprosti 4,6 mg rivastigmina na 24 ur, je velik 4,15 cm2 in vsebuje 7,17 mg rivastigmina.
English: - Store in the original package in order to protect from light.
Slovenian: - Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: - Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patches: Each patch releases 9.5 mg of rivastigmine per 24 hours, is 8.3 cm2 and contains 14.33 mg of rivastigmine.
Slovenian: - Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni obliži: en obliž sprosti 9,5 mg rivastigmina na 24 ur, je velik 8,3 cm2 in vsebuje 14,33 mg rivastigmina.
English: - Hepatic impairment: No dose adjustment is necessary for patients with hepatic impairment.
Slovenian: - Okvara ledvic: Pri bolnikih z okvaro ledvic ni potrebno prilagajati odmerjanja.
English: Store in the original package in order to protect from light.
Slovenian: Shranjujte v originali ovojnini za zagotovitev zaščite pred svetlobo.
English: - Renal impairment: Patients with clinically significant renal impairment might experience more adverse reactions (see sections 4.2 and 5.2).
Slovenian: - Okvara ledvic: Pri bolnikih s klinično pomembno okvaro ledvic je lahko število neželenih učinkov večje (glejte poglavji 4.2 in 5.2).
English: You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.
Slovenian: Če bruhanje ali driska trajata dolgo, lahko postanete dehidrirani (izgubite preveč tekočine),
English: The inter-patient variability in a steady-state study in Alzheimer's dementia was at most 45% (Cmax) and 43% (AUC0-24h) after use of the transdermal patch, and 71% and 73%, respectively, after administration of the oral form.
Slovenian: Interindividualna variabilnost v študiji dinamičnega ravnovesja pri bolnikih z Alzheimerjevo demenco je bila največ 45% za Cmax in 43% za AUC0-24h po uporabi transdermalnega obliža v primerjavi z 71% za Cmax in 73% za AUC0-24h po aplikaciji peroralne oblike.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 transdermal patch of 8.3 cm2 contains 14.33 mg rivastigmine and delivers 9.5 mg/24 h.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 transdermalni obliž velikosti 8,3 cm2 vsebuje 14,33 mg rivastigmina in sprosti 9,5 mg/24 h.
English: The 48-week results for the two assessment tools are summarised in Table 4.
Slovenian: 48-tedenski rezultati teh dveh metod ocenjevanja so
English: Although less pronounced than with the oral formulation, exposure to rivastigmine (Cmax and AUC) increased over-proportionally by a factor of 2.6 and 4.9 when escalating from 4.6 mg/24 h to 9.5 mg/24 h and to 13.3 mg/24 h, respectively.
Slovenian: Čeprav manj izrazito kot pri peroralnem odmerjanju, se je pri stopnjevanju z odmerka 4,6 mg/24 h na 9,5 mg/24 h oziroma na 13,3 mg/24 h izpostavljenost rivastigminu (Cmax in AUC) nesorazmerno povečala za faktor 2,6 oziroma 4,9.
English: - Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.
Slovenian: - Nato obliž z dlanjo čvrsto pritiskajte na kožo najmanj 30 sekund, da se robovi obliža dobro prilepijo.
English: Most skin reactions were limited to the application site and resulted in discontinuation in only 2.4% of the patients in the rivastigmine 9.5 mg/24 h transdermal patch group.
Slovenian: Zaradi kožnih reakcij je zdravljenje prekinilo le 2,4 % bolnikov v skupini s transdermalnimi obliži z
English: - Hepatic impairment: Patients with clinically significant hepatic impairment might experience more adverse reactions (see sections 4.2 and 5.2).
Slovenian: - Okvara jeter: Pri bolnikih s klinično pomembno okvaro jeter je lahko število neželenih učinkov večje (glejte poglavji 4.2 in 5.2).
English: To prevent interference with the adhesive properties of the transdermal patch, no cream, lotion or powder should be applied to the skin area where the medicinal product is to be applied.
Slovenian: Da ne bi vplivali na lepljivost transdermalnega obliža, se na predel kože, ki je predviden za namestitev transdermalnega obliža, ne sme nanašati kreme, losijona ali pudra.
English: - Keep this medicine out of the sight and reach of children.
Slovenian: - Zdravilo shranjujte nedosegljivo otrokom!
English: - Only wear one Rivastigmine 3M Health Care Ltd. patch at a time and replace the patch with a new one after 24 hours.
Slovenian: - Nosite samo en transdermalni obliž Rivastigmin 3M Health Care Ltd. naenkrat in ga po 24 urah
English: What Rivastigmine 3M Health Care Ltd. looks like and contents of the pack The transdermal patches are rectangular with rounded corners, approximately 2.5 cm by 1.8 cm (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or 3.5 cm by 2.6 cm (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
Slovenian: Izgled zdravila Rivastigmin 3M Health Care Ltd. in vsebina pakiranja Pravokotni, približno 2,5 cm krat 1,8 cm (Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni obliž) ali 3,5 cm krat 2,6 cm (Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni obliž) veliki transdermalni obliži z zaobljenimi vogali.
English: - The other ingredients are polyester, ethyl vinyl acetate, acrylate copolymer adhesive and isopropyl myristate.
Slovenian: - Druge sestavine zdravila so poliester, etilvinilacetat, adhezivni akrilatni kopolimer in
English: The single-dose inter-subject variability in rivastigmine pharmacokinetic parameters (normalised to dose/kg bodyweight) was 43% (Cmax) and 49% (AUC0-24h) after transdermal administration versus 74% and 103%, respectively, after the oral form.
Slovenian: Pri enkratnem odmerjanju je bila interindividualna variabilnost farmakokinetičnih parametrov rivastigmina (normalizirana na odmerek/kg telesne mase) 43 % za Cmax in 49 % za AUC0-24h pri transdermalni aplikaciji v primerjavi s 74 % za Cmax in 103 % za AUC0-24h pri uporabi peroralne oblike.
English: Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of rivastigmine transdermal patch.
Slovenian: Med neželenimi učinki, ki so jih opažali pri uporabi transdermalnega obliža z rivastigminom, so najbolj pogoste kožne reakcije na mestu apliciranja (običajno blaga do zmerna rdečina kože na mestu apliciranja).
English: Contact with the eyes should be avoided after handling Rivastigmine 3M Health Care Ltd. transdermal patches (see section 5.3).
Slovenian: Po rokovanju s transdermalnimi obliži Rivastigmin 3M Health Care Ltd. se ne sme dotikati oči (glejte poglavje 5.3).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 transdermal patch of 4.15 cm2 contains 7.17 mg rivastigmine and delivers 4.6 mg/24 h.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 transdermalni obliž velikosti 4,15 cm2 vsebuje 7,17 mg rivastigmina in sprosti 4,6 mg/24 h.