FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended to apply the first transdermal patch on the day following the last oral dose.
Slovenian: Prvi transdermalni obliž je priporočljivo namestiti na dan, ki sledi dnevu zadnjega peroralnega
English: - The patch should not be exposed to any external heat sources (e.g. excessive sunlight, saunas,
Slovenian: - Obliža se ne sme izpostavljati zunanjim virom toplote (na primer prekomernemu sončenju,
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.
Slovenian: Bolniki, pri katerih reakcija na mestu apliciranja kaže, da bi lahko šlo za alergijski kontaktni dermatitis na rivastigmin iz transdermalnega obliža in kljub temu potrebujejo zdravljenje z rivastigminom, lahko preidejo na zdravljenje s peroralno obliko rivastigmina samo v primeru, da je pri njih izvid testiranja na alergijo negativen, nato pa lahko rivastigmin jemljejo le pod skrbnim zdravniškim nadzorom.
English: As rivastigmine has a plasma half-life of about 3.4 hours and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose all Rivastigmine 3M Health Care Ltd. transdermal patches should be removed immediately and no further transdermal patch should be applied for the next 24 hours.
Slovenian: Ker ima rivastigmin plazemski razpolovni čas okrog 3,4 ure in trajanje zaviranja acetilholinesteraze okrog 9 ur, v primeru asimptomatičnega prevelikega odmerka priporočamo takojšnjo odstranitev vseh transdermalnih obližev Rivastigmin 3M Health Care Ltd.. Bolniku se v naslednjih 24 urah ne sme namestiti novih transdermalnih obližev.
English: In peri/postnatal studies in rats, an increased gestation time was observed.
Slovenian: V perinatalnih in postnatalnih študijah pri podganah so opazili podaljšano obdobje brejosti.
English: In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered.
Slovenian: Pri prevelikem odmerku, ki ga spremljata huda navzea in bruhanje, pridejo v poštev antiemetiki.
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).
Slovenian: Izločanje je omejeno s hitrostjo absorpcije (flipflop učinek), kar pojasnjuje daljši t½ pri uporabi transdermalnih obližev (3,4 ure) v primerjavi s peroralnim ali intravenskim odmerjanjem (1,4 do 1,7 ure).
English: The increase in prothrombin time induced by warfarin is not affected by administration of oral rivastigmine.
Slovenian: Na podaljšanje protrombinskega časa, ki ga povzroči varfarin, dajanje peroralnega rivastigmina ne vpliva.
English: Negative ADAS-Cog changes indicate improvement.
Slovenian: Negativna sprememba na ADAS-Cog lestvici pomeni izboljšanje.
English: *A marketing authorisation for Rivastigmine 3M Health Care Ltd. 13.3 mg/24 h transdermal patch is currently not available, this presentation may although be available from other marketing authorisation holders.
Slovenian: *Dovoljenje za promet za zdravilo Rivastigmin 3M Health Care Ltd. 13,3 mg/24 h transdermalni obliž trenutno ni na razpolago, čeprav obstaja možnost, da imajo to jakost na razpolago drugi imetniki
English: The transdermal patch should not be applied to skin that is red, irritated or cut.
Slovenian: Transdermalnega obliža se ne sme namestiti na pordelo, razdraženo ali porezano/spraskano kožo.
English: Therefore, the patient/caregiver should avoid contact with the eyes after handling of the patch (see section 4.4).
Slovenian: Zato se bolniki/negovalci ne smejo dotikati oči po rokovanju z obližem (glejte poglavje 4.4).
English: Table 1 displays the adverse reactions reported in 854 patients with Alzheimer's dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with rivastigmine transdermal patches for a duration of 24-48 weeks and from post-marketing data.
Slovenian: V Preglednici 1 so navedeni neželeni učinki o katerih so poročali pri 854 bolnikih z Alzheimerjevo demenco, zdravljenih v okviru randomiziranih dvojno slepih, s placebom in aktivno kontroliranih kliničnih študij s transdermalnimi obliži z rivastigminom, ki so trajale od 24 do 48 tednov, in neželeni učinki po podatkih iz obdobja trženja zdravila.
English: - The patch should not be cut into pieces.
Slovenian: - Obliža se ne sme rezati na manjše dele.
English: Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g. increasing erythema, oedema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal.
Slovenian: Na alergijski kontaktni dermatitis je treba pomisliti v primeru, da se reakcija na mestu apliciranja razširi preko površine, ki jo pokriva obliž, in je mogoče opaziti večjo izraženost lokalne reakcije (na primer vse bolj izražen eritem, oteklino, rdečino, papularen ali vezikulozen izpuščaj), simptomi pa se v 48 urah po odstranitvi obliža bistveno ne izboljšajo.
English: After the peak, plasma concentrations slowly decrease over the remainder of the 24-hour period of application.
Slovenian: Cmax doseže po 10-16 urah, nato koncentracija v plazmi počasi upada v preostalem času 24-urnega obdobja aplikacije.
English: Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Slovenian: Rivastigmin sodi v skupino učinkovin, ki jih imenujemo zaviralci holinesteraze.
English: The DLSM, 95% CI, and p-value are based on an ANCOVA (analysis of covariance) model adjusted for country and baseline ADAS-cog score.
Slovenian: Vrednosti razlik po metodi najmanjših kvadratov (DLSM), 95 % IZ in vrednosti p temeljijo na modelu ANCOVA (analizi kovariance) s prilagajanjem na državo in izhodiščno oceno pri lestvici ADAS-cog * p<0,05
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.
Slovenian: Pri zdravih mladih moških peroralni odmerek 3 mg zmanjša aktivnost acetilholinesteraze (AChE) v cerebrospinalni tekočini (CSF) za približno 40 % v poldrugi uri po zaužitju.
English: Table 2
Slovenian: Preglednica 2
English: - Do not use this medicine if you see that the patch is damaged or shows signs of tampering.
Slovenian: - Ne uporabljajte obliža, če je ovojnina poškodovana ali opazite, da je bila že odprta.
English: - Do not use this medicine after the expiry date, which is stated on the carton and pouch after
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečki poleg oznake Uporabno do/EXP.
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.
Slovenian: Klinično pomembno izboljšanje je bilo opredeljeno a priori kot izboljšanje na ADAS-Cog lestvici za vsaj 4 točke, brez poslabšanja v razvrstitvi ADCS-CGIC in brez poslabšanja
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
English: Initial dose Treatment is started with 4.6 mg/24 h.
Slovenian: Začetni odmerek Zdravljenje se začne z odmerkom 4,6 mg/24 h.
English: No pharmacokinetic interaction was observed between oral rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Slovenian: Med peroralnim rivastigminom in digoksinom, varfarinom, diazepamom ali fluoksetinom v študijah na zdravih prostovoljcih niso opazili farmakokinetičnega medsebojnega delovanja.
English: According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Slovenian: Glede na njegovo presnovo se zdi presnovno medsebojno delovanje z drugimi zdravili malo verjetno, čeprav lahko rivastigmin zavre presnovo drugih učinkovin, v katero je vključena butirilholinesteraza.
English: Return the used patch to its sachet and dispose of it in such a way that children cannot handle it. Do not touch your eyes with your fingers and wash your hands with soap and water after removing the patch.
Slovenian: Po odstranjevanju obliža se s prsti ne dotikajte oči, roke si umijte z vodo in milom.
English: They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Slovenian: Pri teh bolnikih je lahko število neželenih učinkov večje, obstaja pa tudi večja verjetnost, da bodo zaradi neželenih učinkov zdravljenje prekinili.
English: The results for clinically relevant responders from the 24-week placebo-controlled study are provided in Table 3.
Slovenian: Rezultati bolnikov s klinično pomembnim odzivom iz 24-tedenske s placebom kontrolirane študije so navedeni v Preglednici 3.
English: In animals, rivastigmine crosses the placenta and is excreted into milk.
Slovenian: Pri živalih rivastigmin prehaja skozi posteljico in se izloča v mleko.
English: For patients starting treatment for the first time and for patients restarting Rivastigmine 3M Health Care Ltd. after treatment interruption, please begin with the second picture.
Slovenian: Bolniki, ki si prvič nameščate obliž ali ponovno začenjate z uporabo zdravila Rivastigmin 3M Health Care Ltd. po prekinitvi zdravljenja, lahko začnete z naslednjim korakom.
English: Rivastigmine 3M Health Care Ltd. might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine or meclizine).
Slovenian: Zdravilo Rivastigmin 3M Health Care Ltd. lahko vpliva na antiholinergična zdravila, med katera sodijo zdravila, ki se uporabljajo za lajšanje želodčnih krčev (npr. diciklomin), za zdravljenje Parkinsonove bolezni (npr. amantadin) ali za preprečevanje potovalne slabosti (npr. difenhidramin,
English: Can you wear your Rivastigmine 3M Health Care Ltd. transdermal patch when you are bathing, swimming, or in the sun?
Slovenian: Se sme transdermalni obliž Rivastigmin 3M Health Care Ltd. nositi med kopanjem in plavanjem ter na soncu?
English: - Patients with body weight below 50 kg: Particular caution should be exercised in titrating patients with body weight below 50 kg above the recommended effective dose of 9.5 mg/24 h (see section 4.4).
Slovenian: - Bolniki s telesno maso manjšo od 50 kg: Pri bolnikih s telesno maso manjšo od 50 kg je pri zviševanju odmerka nad priporočeni učinkoviti odmerek 9,5 mg/24 h potrebna posebna previdnost (glejte poglavje 4.4).
English: Therefore, women on rivastigmine should not breast-feed.
Slovenian: Zato naj matere, ki jemljejo rivastigmin, ne dojijo.
English: However, due to increased exposure in these populations as observed with the oral forms, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant hepatic impairment might experience more adverse reactions.
Slovenian: Vendar se je treba zaradi povečane izpostavljenosti zdravilu pri teh populacijah, kar so opažali pri uporabi peroralnih oblik zdravila, natančno ravnati po priporočilih, naj se odmerjanje titrira glede na individualno prenašanje, saj je pri bolnikih s klinično pomembno okvaro jeter lahko število neželenih učinkov večje.
English: When doses higher than 13.3 mg/24 h were used in the above-mentioned placebo-controlled study, insomnia and cardiac failure were observed more frequently than with 13.3 mg/24 h or placebo, suggesting a dose effect relationship.
Slovenian: Kadar so v eni od zgoraj navedenih študij, s placebom kontrolirani študiji, uporabljali odmerke, ki so bili višji od 13,3 mg/24 h, so opažali nespečnost in popuščanje srca pogosteje kot pri odmerku 13,3 mg/24 h ali pri placebu, kar nakazuje odvisnost od velikosti odmerka.
English: Absorption of rivastigmine from rivastigmine transdermal patches is slow.
Slovenian: Rivastigmin se iz transdermalnih obližev z rivastigminom absorbira počasi.
English: Your doctor will tell you which Rivastigmine 3M Health Care Ltd. transdermal patch is most suitable for you.
Slovenian: Zdravnik vam bo povedal, kateri transdermalni obliž Rivastigmin 3M Health Care Ltd. je za vas najbolj primeren.
English: If you have to undergo surgery whilst using Rivastigmine 3M Health Care Ltd. transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.
Slovenian: Če morate v času uporabe transdermalnih obližev Rivastigmin 3M Health Care Ltd. na kirurški poseg, morate obvestiti zdravnika, da jih uporabljate, ker lahko med anestezijo povečajo učinke nekaterih
English: Not known (frequency cannot be estimated from the available data) - Allergic reaction where the patch was used, such as blisters or inflamed skin - The signs of Parkinson's disease get worse - such as tremor, stiffness and shuffling - Inflammation of the pancreas - signs include serious upper stomach pain, often with feeling sick
Slovenian: Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov) - alergijske reakcije na mestu uporabe obliža, kot je pojav mehurjev ali vnete kože - poslabšanje znakov Parkinsonove bolezni - kot so tremor, okorelost in težave pri hoji - vnetje trebušne slinavke - med znaki so hude bolečine v zgornjem delu trebuha, pogosto skupaj z občutkom slabosti (navzeo) ali bruhanjem
English: 4.5 Interaction with other medicinal products and other forms of interaction No specific interaction studies have been performed with Rivastigmine 3M Health Care Ltd. transdermal patches.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij S transdermalnimi obliži Rivastigmin 3M Health Care Ltd. niso izvedli specifičnih študij medsebojnega
English: The study was designed to compare the efficacy of the 13.3 mg/24 h transdermal patch against the 9.5 mg/24 h transdermal patch during a 48-week double-blind treatment phase in Alzheimer's disease patients who demonstrated functional and cognitive decline after an initial 24-48 week openlabel treatment phase while on a maintenance dose of 9.5 mg/24 h transdermal patch.
Slovenian: .Študija je bila zasnovana za primerjavo učinkovitosti transdermalnega obliža 13,3 mg/24 h z učinkovitostjo transdermalnega obliža 9,5 mg/24 h v 48-tedenskem obdobju dvojno slepega zdravljenja bolnikov z Alzheimerjevo demenco, pri katerih je po začetnem 24-48-tedenskem obdobju odprtega zdravljenja z vzdrževalnim odmerkom z uporabo transdermalnega obliža 9,5 mg/24 h prišlo do funkcionalnega in kognitivnega upada.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
English: Treatment should be temporarily interrupted if gastrointestinal adverse reactions are observed until these adverse reactions resolve.
Slovenian: Če pride do gastrointestinalnih neželenih učinkov, je treba zdravljenje začasno prekiniti, dokler ti neželeni učinki ne izzvenijo.
English: Patients and their caregivers must be instructed on important administration instructions for Rivastigmine 3M Health Care Ltd. transdermal patch (see section 4.2).
Slovenian: Bolnike in njihove negovalce je treba opozoriti na pomembne napotke za uporabo transdermalnega obliža Rivastigmin 3M Health Care Ltd. (glejte poglavje 4.2).
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.
Slovenian: Glede koncentracij, ki jih rivastigmin dosega v plazmi v obdobju 24 ur, odmerka rivastigmina, ki se v 24 urah sprosti iz transdermalnega obliža (v mg/24 h), ni mogoče neposredno enačiti s količino rivastigmina (v mg), ki jo vsebuje kapsula.
English: Uncommon (may affect up to 1 in 100 people) - Problems with your heartbeat such as slow heartbeat - Seeing things that are not really there (hallucinations) - Stomach ulcer - Dehydration (losing too much fluid) - Hyperactivity (high level of activity, restlessness) - Aggression
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - motnje srčnega ritma, kot je prepočasen srčni utrip - vidna zaznava nečesa, česar v resnici ni tam (halucinacije) - želodčna razjeda - dehidracija (čezmerna izguba tekočine) - hiperaktivnost (povečana stopnja aktivnosti, nemir) - agresivnost
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.
Slovenian: - če opazite kožno reakcijo, ki se širi preko površine, ki jo pokriva transdermalni obliž, če je reakcija na tem mestu močneje izražena (če se pojavijo mehurčki, če je vnetje oziroma oteklina vse bolj izrazita) in če se ti znaki v 48 urah po odstranitvi transdermalnega obliža ne izboljšajo.
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.
Slovenian: Kdaj namestiti transdermalni obliž Rivastigmin 3M Health Care Ltd. in za koliko časa - Da bi vam zdravljenje koristilo, morate obliž zamenjati vsak dan, če se le da vsak dan ob istem
English: This may indicate a potential for rivastigmine transdermal patches to induce mild erythema in patients.
Slovenian: To lahko nakazuje možnost, da bi transdermalni obliži z rivastigminom sprožili nastanek blage rdečine pri bolnikih.
English: rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Slovenian: Po zaužitju rivastigmina, označenega s 14C, je bilo ledvično izločanje hitro, saj se je dejansko ves (>90%) izločil v 24 urah.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POUCH
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Special populations - Paediatric population: There is no relevant use of Rivastigmine 3M Health Care Ltd. in the paediatric population in the treatment of Alzheimer's disease.
Slovenian: - Pediatrična populacija: Zdravila Rivastigmin 3M Health Care Ltd. ni smiselno uporabljati za zdravljenje Alzheimerjeve bolezni pri pediatrični populaciji.
English: Rectangular patches, approximately 3.5 cm by 2.6 cm with rounded corners.
Slovenian: Pravokotni, približno 3,5 cm krat 2,6 cm veliki obliži z zaobljenimi vogali.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: The metabolite-to-parent AUC∞ ratio was around 0.7 after transdermal patch administration versus 3.5 after oral administration, indicating that much less metabolism occurred after dermal compared to oral treatment.
Slovenian: Razmerje med AUC∞ presnovka in izhodne učinkovine je bilo približno 0,7 po namestitvi transdermalnega obliža v primerjavi s 3,5 po peroralni aplikaciji zdravila, kar nakazuje, da je bil metabolizem precej manj obsežen po dermalnem zdravljenju v primerjavi s peroralnim.
English: Where to apply your Rivastigmine 3M Health Care Ltd. transdermal patch - Before you apply a patch, make sure that your skin is clean, dry and hairless, free of any powder, oil, moisturiser or lotion that could keep the patch from sticking to your skin properly, free of cuts, rashes and/or irritations.
Slovenian: Kam namestiti transdermalni obliž Rivastigmin 3M Health Care Ltd. - Preden namestite obliž, se prepričajte, da je izbrani predel kože čist, suh in neporaščen, da na izbranem predelu kože ni pudra, olja, vlažilne kreme ali losjona, ki bi lahko preprečili, da se obliž pravilno prilepi na kožo, in da na izbranem predelu kože ni ureznin, izpuščajev ter da
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.
Slovenian: Zaradi njegovih farmakodinamičnih učinkov se rivastigmina ne sme uporabljati skupaj z drugimi holinomimetičnimi snovmi.
English: Rare (may affect up to 1 in 1,000 people) - Falling
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - padci
English: After oral administration, Cmax and AUC of rivastigmine were more than twice as high in Alzheimer patients with moderate renal impairment compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in Alzheimer patients with severe renal impairment.
Slovenian: Po peroralnem odmerjanju sta bili Cmax in AUC pri bolnikih z Alzheimerjevo demenco in z zmerno ledvično okvaro rivastigmina več kot dvakrat večji kot pri zdravih osebah, pri osebah z Alzheimerjevo demenco in s težko ledvično okvaro pa ni bilo sprememb Cmax in AUC rivastigmina.
English: Rivastigmine 3M Health Care Ltd. transdermal patches may cause fainting or severe confusion.
Slovenian: Transdermalni obliži Rivastigmin 3M Health Care Ltd. lahko povzročajo omedlevico ali hudo zmedenost.
English: ADCS-CGIC scores <4 indicate improvement.
Slovenian: <4 na lestvici ADCS-CGIC pomeni izboljšanje.
English: However, due to increased exposure in these populations as observed with the oral forms, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal impairment might experience more adverse reactions (see sections 4.4 and 5.2).
Slovenian: Vendar se je treba zaradi povečane izpostavljenosti zdravilu pri teh populacijah, kar so opažali pri uporabi peroralnih oblik zdravila, natančno ravnati po priporočilih, naj se odmerjanje titrira glede na individualno prenašanje, saj je pri bolnikih s klinično pomembno okvaro ledvic lahko število neželenih učinkov večje (glejte poglavji 4.4 in 5.2).
English: Patients and caregivers should be instructed on important administration instructions: - The previous day's patch must be removed before applying a new one every day (see section 4.9).
Slovenian: Bolnike in negovalce je treba opozoriti na pomembne napotke za uporabo zdravila: - Vsak dan je treba pred nameščanjem novega obliža odstraniti obliž predhodnega dne (glejte
English: There have been rare post-marketing reports of patients experiencing disseminated skin hypersensitivity reactions when administered rivastigmine irrespective of the route of administration (oral, transdermal).
Slovenian: V redkih poročilih iz obdobja po prihodu zdravila na trg so opisovali bolnike, pri katerih je pri aplikaciji rivastigmina prišlo do diseminirane kožne preobčutljivostne reakcije ne glede na način vnosa zdravila (peroralno ali transdermalno).
English: Special populations: - Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions (see section 4.2).
Slovenian: Posebne skupine bolnikov: - Pri bolnikih s telesno maso manjšo od 50 kg je lahko število neželenih učinkov večje, obstaja pa tudi večja verjetnost, da bodo zaradi neželenih učinkov zdravljenje prekinili (glejte poglavje 4.2).
English: Rivastigmine 9.5 mg/24 h N = 271
Slovenian: Rivastigmin 9,5 mg/24 h N = 271