natgillin/translations-raw huggingface dataset:
- Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second half of the protective liner.
- Lepljivo stran obliža položite na zgornji ali spodnji del hrbta, nadlaket ali na prsi in nato odstranite drugo polovico
Rivastigmine 3M Health Care Ltd. can be used with food, drink and alcohol.
Zdravilo Rivastigmin 3M Health Care Ltd. lahko uporabljate skupaj s hrano, pijačo in alkoholom.
Not all pack sizes may be marketed in your country.
V vaši državi morda na trgu ni vseh navedenih pakiranj.
Gastrointestinal disorders such as nausea, vomiting and diarrhoea are dose-related, and may occur when initiating treatment and/or increasing the dose (see section 4.8).
Prebavne motnje, na primer navzea, bruhanje in driska, so povezane z velikostjo odmerka in se lahko pojavijo na začetku zdravljenja in/ali ob povečanju odmerka (glejte poglavje 4.8).
This leaflet was last revised in {month YYYY}
Navodilo je bilo nazadnje revidirano dne
Rivastigmine interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes.
Rivastigmin medsebojno reagira s svojima tarčnima encimoma, tako da z njima oblikuje kovalentno vezan kompleks, ki encima začasno inaktivira.
When administered to rabbit eyes in primary eye irritation studies, rivastigmine caused reddening and swelling of the conjunctiva, corneal opacities and miosis which persisted for 7 days.
Ko so rivastigmin nanesli na oči kuncev v primarnih študijah draženja oči, je povzročil rdečino in otekanje očesne veznice, motnjave roženice in miozo, ki je vztrajala 7 dni.
The patch should be worn continuously until it is time to replace it with a new one.
Obliž morate nositi neprekinjeno, dokler ga ne zamenjate z novim.
In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
In vitro kaže ta presnovek zelo majhno stopnjo zaviranja holinesteraze (<10 %).
Functional decline was assessed by the investigator and cognitive decline was defined as a decrease in the MMSE score of >2 points from the previous visit or a decrease of >3 points from baseline.
Funkcionalni upad so ocenjevali raziskovalci, kognitivni upad pa je bil opredeljen kot zmanjšanje rezultata pri MMSE za več kot 2 točki od predhodnega obiska ali kot zmanjšanje rezultata za več kot 3 točke od izhodišča.
In these cases, treatment should be discontinued (see section 4.3).
V takem primeru je treba zdravljenje prekiniti (glejte poglavje
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Če kaj od navedenega velja za vas, vas bo zdravnik med jemanjem zdravila morda moral natančneje
With multiple dosing (such as at steady state), after the previous transdermal patch is replaced with a new one, plasma concentrations initially decrease slowly for about 40 minutes on average, until absorption from the newly applied transdermal patch becomes faster than elimination, and plasma levels begin to rise again to reach a new peak at approximately 8 hours.
Po večkratnem odmerjanju (tako da doseže stanje dinamičnega ravnovesja) se po zamenjavi predhodnega transdermalnega obliža z novim koncentracija v plazmi najprej počasi zmanjšuje v povprečju približno 40 minut, dokler hitrost absorpcije iz novega transdermalnega obliža ne preseže hitrosti izločanja, tako da koncentracija v plazmi začne spet naraščati do novega vrha, ki ga doseže v približno 8 urah.
In a 48-week active-controlled clinical trial, cases of skin irritation were captured as patient or caregiver reported adverse reactions.
V 48-tedenski, aktivno kontrolirani klinični študiji so primere kožnih reakcij zabeležili kot neželene učinke, o katerih so poročali bolniki ali negovalci.
- A protective liner covers the sticky side of the patch.
- Lepljivo stran obliža pokriva zaščitna plast.
3M Health Care Limited, 1 Morley Street, Loughborough, Leicestershire, LE11 1EP
3M Health Care Limited, 1 Morley Street, Loughborough, Leicestershire,
Misuse of the medicinal product and dosing errors resulting in overdose Misuse of the medicinal product and dosing errors with rivastigmine transdermal patches have resulted in serious adverse reactions; some cases have required hospitalisation, and rarely led to death (see section 4.9).
Preveliko odmerjanje zaradi nepravilne uporabe in napak pri odmerjanju zdravila Zaradi nepravilne uporabe in napak pri odmerjanju transdermalnih obližev z rivastigminom je prišlo do resnih neželenih učinkov; v nekaterih primerih je bila potrebna hospitalizacija, redko pa je prišlo do smrtnega izida (glejte poglavje 4.9).
LOCF - Last Observation Carried Forward.
ITT: namen zdraviti (Intent-To-Treat); LOCF: zadnje opazovanje preneseno naprej (Last Observation
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Simptomatsko zdravljenje blage do zmerno težke Alzheimerjeve demence.
Very rare (may affect up to 1 in 10,000 people) - Stiff arms or legs - Trembling hands
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) - okorele roke ali noge - tresenje rok
Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
V Preglednici 1 so neželeni učinki navedeni glede na organski sistem po MedDRA klasifikaciji in glede na kategorijo pogostnosti.
Most cases of misuse of the medicinal product and dosing errors have involved not removing the old patch when putting on a new one and the use of multiple patches at the same time.
V večini primerov nepravilne uporabe zdravila in napak pri odmerjanju je šlo za to, da bolniki niso odstranili starega obliža, ko so namestili novega, in da so hkrati uporabljali več kot en obliž.
Positive ADCS-ADL changes indicate improvement.
Pozitivna sprememba na ADCS-ADL lestvici pomeni izboljšanje.
There was no relevant accumulation of rivastigmine or the metabolite NAP226-90 in plasma in patients with Alzheimer's disease, except that plasma levels were higher on the second day of transdermal patch therapy than on the first.
Do pomembnega kopičenja rivastigmina ali presnovka NAP226-90 v plazmi bolnikov z Alzheimerjevo boleznijo ni prišlo, razen koncentracij v plazmi, ki so bile drugi dan zdravljenja s transdermalnim obližem višje kot prvi dan.
Oral and topical repeated-dose toxicity studies in mice, rats, rabbits, dogs and minipigs revealed only effects associated with an exaggerated pharmacological action.
Raziskave toksičnosti peroralnih in lokalnih ponavljajočih se odmerkov na miših, podganah, kuncih, psih in pritlikavih prašičkih so razkrile le učinke, povezane s pretiranim farmakološkim delovanjem.
Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Rivastigmin je zaviralec acetilholinesteraze in butirilholinesteraze karbamatne vrste, za katerega velja, da izboljšuje holinergični živčni prenos tako, da upočasnjuje razgradnjo acetilholina, ki ga sproščajo funkcionalno intaktni holinergični nevroni.
If a patch falls off, apply a new one for the rest of the day, then replace it at the same time as usual the next day.
Če se obliž odlepi, namestite novega za preostanek tega dne, nato pa ga naslednji dan zamenjajte ob istem času kot običajno.
Tear the pouch open where indicated and remove the patch from the pouch.
Vrečko odprite, kjer je označeno in izvlecite obliž iz vrečke.
Heat-sealed pouches made of paper/aluminium/acrylonitrile-methacrylate copolymer laminate.
Toplotno zavarjene vrečke iz laminata, sestavljenega iz papirja/aluminija/kopolimera akrilonitril-metakrilata.
In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
Če pride zdravilo v stik z očmi ali če po rokovanju z obližem oči postanejo rdeče, jih je treba takoj izpirati z obilo vode in poiskati zdravniško pomoč, če simptomi ne izzvenijo.
Patients with Alzheimer's disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine.
Bolniki z Alzheimerjevo boleznijo lahko hujšajo v času jemanja zaviralcev holinesteraze, tudi rivastigmina.
Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Rivastigmin deluje tako, da zavira delovanje dveh encimov, ki razgrajujeta acetilholin, to sta acetilholin-esteraza in butirilholin-esteraza.
Patients with severe hepatic impairment have not been studied (see sections 4.4 and 5.2).
Uporabe zdravila pri bolnikih s hudo jetrno okvaro niso proučili (glejte poglavji 4.4 in 5.2).
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Rivastigmine 3M Health Care Ltd. is marketed, at launch and after launch of the transdermal patch all physicians who are expected to prescribe Rivastigmine 3M Health Care Ltd. are provided with an information pack containing the following elements:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo po razpravi in pridobitvi soglasja nacionalnega pristojnega organa v vsaki državi članici, kjer je zdravilo RIVASTIGMIN 3M HEALTH CARE LTD. dostopno na trgu, ob prihodu transdermalnega obliža na trg in po njem vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo RIVASTIGMIN 3M HEALTH CARE LTD., prejeli komplet navodil, ki bo vseboval sledeče:
What Rivastigmine 3M Health Care Ltd. is and what it is used for What you need to know before you use Rivastigmine 3M Health Care Ltd. How to use Rivastigmine 3M Health Care Ltd.
Kaj je zdravilo Rivastigmin 3M Health Care Ltd. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Rivastigmin 3M Health Care Ltd. Kako uporabljati zdravilo Rivastigmin 3M Health Care Ltd.
The efficacy of rivastigmine transdermal patches in patients with Alzheimer's dementia has been demonstrated in a 24-week double-blind, placebo-controlled core study and its open-label extension phase and in a 48-week double-blind comparator study.
Učinkovitost transdermalnih obližev z rivastigminom pri bolnikih z Alzheimerjevo demenco so dokazali v 24-tedenski dvojno slepi, s placebom kontrolirani osnovni študiji in njenem odprtem podaljšku ter v 48-tedenski dvojno slepi primerjalni študiji.
Less NAP226-90 is formed following application of the transdermal patch, presumably because of the lack of presystemic (hepatic first pass) metabolism, in contrast to oral administration.
Po aplikaciji transdermalnega obliža je nastajalo manj NAP226-90, verjetno zaradi odsotnosti predsistemske presnove (učinka prvega prehoda skozi jetra) za razliko od peroralne aplikacije.
Transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by tight clothing.
Transdermalne obliže je treba enkrat na dan namestiti na čist, suh, neporaščen in nepoškodovan predel kože na zgornjem ali spodnjem delu hrbta, na nadlakti ali na prsih, na mesto, ki ga ne drgnejo oblačila.
At least 4 points improvement on ADAS-Cog with no worsening on ADCSCGIC and ADCS-ADL
Izboljšanje na ADAS-Cog za vsaj 4 točke brez poslabšanja pri ADCS-CGIC in ADCSADL
left upper chest or right upper chest (avoid breast)
• levi zgornji del prsi ali desni zgornji del prsi (ne na dojko)
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalcev, odgovornih za sproščanje serije
If you use more Rivastigmine 3M Health Care Ltd. than you should If you accidentally apply more than one patch, remove all the patches from your skin, then inform your doctor that you have accidentally applied more than one patch.
Če ste uporabili večji odmerek zdravila Rivastigmin 3M Health Care Ltd. , kot bi smeli Če ste nehote namestili več kot en obliž, odstranite s kože vse obliže in obvestite zdravnika, da ste nehote namestili več kot en obliž.
You may have side effects more often when you start your medicine or when your dose is increased.
Neželeni učinki bodo morda pogostejši na začetku uporabe zdravila in ob zviševanju odmerka.
Some people who have accidentally taken too much Rivastigmine 3M Health Care Ltd. have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Pri nekaterih ljudeh, ki so nehote vzeli preveč zdravila Rivastigmin 3M Health Care Ltd., je prišlo do navzee (slabosti s siljenjem na bruhanje), bruhanja, driske, visokega krvnega tlaka in halucinacij.
Concomitant administration of rivastigmine with commonly prescribed medicinal products, such as antacids, antiemetics, antidiabetics, centrally acting antihypertensives, beta blockers, calcium channel blockers, inotropic agents, antianginals, non-steroidal anti-inflammatory agents, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with an alteration in the kinetics of rivastigmine or an increased risk of clinically relevant untoward effects.
Sočasna uporaba rivastigmina s katerim od pogosto predpisanih zdravil, kot so antacidi, antiemetiki, antidiabetiki, antihipertenzivi z osrednjim delovanjem, zaviralci adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov, inotropne učinkovine, antianginiki, nesteroidne protivnetne učinkovine, estrogeni, analgetiki, benzodiazepini in antihistaminiki, ni bila povezana s spremembami kinetike rivastigmina ali s povečanim tveganjem za klinično pomembne neželene učinke.
The exposure to rivastigmine and its metabolites was approximately equivalent to human exposure with highest doses of rivastigmine capsules and transdermal patches.
Izpostavljenost rivastigminu in njegovim presnovkom je bila približno enakovredna izpostavljenosti pri ljudeh pri uporabi kapsul in transdermalnih obližev z največjimi odmerki.
The use of this medicinal product is contraindicated in patients with known hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Uporaba tega zdravila je kontraindicirana pri bolnikih, ki imajo ugotovljeno preobčutljivost na zdravilno učinkovino rivastigmin, druge derivate karbamata ali katero koli pomožno snov, navedeno v
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
left upper back or right upper back left lower back or right lower back
• levi spodnji del hrbta ali desni zgornji del hrbta
INSTRUCTIONS ON USE
Način uporabe
It is possible that some patients sensitised to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form.
Lahko se zgodi, da nekateri bolniki, pri katerih je zaradi uporabe rivastigmina v transdermalnem obližu prišlo do senzitizacije na rivastigmin, ne bi mogli več uporabljati rivastigmina v nobeni obliki.
Application site reactions were mostly mild to moderate in severity and were rated as severe in less than 2% of patients.
Reakcije na mestu aplikacije so bile večinoma blago do zmerno izražene, kot hude jih je opredelilo manj kot 2 % bolnikov.
One transdermal patch is sealed in one pouch.
V eni vrečki je zaprt en transdermalni obliž.
The 24-week results for the three assessment tools are summarised in Table 2.
24-tedenski rezultati teh treh metod ocenjevanja so zbrani v Preglednici 2.
As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Ker je rivastigmin zaviralec holinesteraze, lahko močno poveča učinke mišičnih relaksantov tipa sukcinilholina med anestezijo.
No effects on fertility or embryofoetal development were observed in rats and rabbits, except at doses related to maternal toxicity.
Pri podganah in kuncih niso opazili nikakršnih učinkov na plodnost ali razvoj zarodka ali ploda, razen v odmerkih, povezanih s toksičnostjo za mater.
The typical symptoms reported among these cases are similar to those seen with cases of overdose associated with rivastigmine oral formulations.
Značilni simptomi, o katerih so poročali pri teh primerih, so podobni kot pri primerih prevelikega odmerjanja peroralnih oblik z rivastigminom.
If this applies to you, tell your doctor and do not apply Rivastigmine 3M Health Care Ltd. transdermal patches.
Če kaj od navedenega velja za vas, povejte svojemu zdravniku in ne uporabljajte transdermalnih obližev Rivastigmin 3M Health Care Ltd..
- After removing a patch, fold it in half with the sticky sides on the inside and press them together.
- Po odstranitvi obliža s kože ga prepognite na pol z lepljivo stranjo navznoter in stisnite.
Caution is recommended when selecting anaesthetic agents.
Pri izbiri sredstva za anestezijo je priporočena previdnost.
- Do not expose the patch to any external heat sources (e.g. excessive sunlight, saunas, solarium)
- Obliža ne izpostavljajte zunanjim virom toplote (na primer prekomernemu sončenju, savni,
Patients who show signs or symptoms of dehydration resulting from prolonged vomiting or diarrhoea can be managed with intravenous fluids and dose reduction or discontinuation if recognised and treated promptly.
Bolnike z znaki ali s simptomi dehidracije zaradi dolgotrajnega bruhanja ali driske je v primeru prepoznavanja stanja in takojšnjega ukrepanja mogoče zdraviti z intravenskim nadomeščanjem tekočin in z znižanjem ali prekinitvijo odmerjanja.
Specific dermal studies in pregnant animals have not been conducted.
Posebnih kožnih študij na brejih živalih niso opravili.
It is not recommended to apply the transdermal patch to the thigh or to the abdomen due to decreased bioavailability of rivastigmine observed when the transdermal patch is applied to these areas of the body.
Na stegno ali na trebuh transdermalnega obliža ni priporočljivo nameščati, ker so opazili zmanjšano biološko uporabnost rivastigmina v primerih namestitve na te predele.
Rectangular patches, approximately 2.5 cm by 1.8 cm with rounded corners.
Pravokotni, približno 2,5 cm krat 1,8 cm veliki obliži z zaobljenimi vogali.
Description of selected adverse reactions
Opis izbranih neželenih dogodkov
Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
V peroralnih študijah na brejih podganah in kuncih se niso pokazali nikakršni znaki teratogenega potenciala rivastigmina.
Otherwise treatment should be re-initiated with 4.6 mg/24 h.
V nasprotnem primeru je treba zdravljenje ponovno začeti z odmerkom 4,6 mg/24 h.
Total plasma clearance of rivastigmine was approximately 130 litres/h after a 0.2 mg intravenous dose and decreased to 70 litres/h after a 2.7 mg intravenous dose, which is consistent with the non-linear, over-proportional pharmacokinetics of rivastigmine due to saturation of its elimination.
Celotni plazemski očistek rivastigmina je bil po intravenskem odmerku 0,2 mg približno 130 l/h, po intravenskem odmerku 2,7 mg pa se je zmanjšal na 70 l/h, kar je v skladu z nelinerano nesorazmerno farmakokinetiko rivastigmina zaradi saturacije njegovega izločanja.
By blocking these enzymes, Rivastigmine 3M Health Care Ltd. allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease.
Zdravilo Rivastigmin 3M Health Care Ltd. z zaviranjem navedenih encimov omogoča zvišanje koncentracije acetilholina v možganih in s tem pomaga pri zmanjševanju simptomov Alzheimerjeve bolezni.
It is recommended to apply the first transdermal patch on the day following the last oral dose.
Prvi transdermalni obliž je priporočljivo namestiti na dan, ki sledi dnevu zadnjega peroralnega
- The patch should not be exposed to any external heat sources (e.g. excessive sunlight, saunas,
- Obliža se ne sme izpostavljati zunanjim virom toplote (na primer prekomernemu sončenju,
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.
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.
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.
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.
In peri/postnatal studies in rats, an increased gestation time was observed.
V perinatalnih in postnatalnih študijah pri podganah so opazili podaljšano obdobje brejosti.
In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered.
Pri prevelikem odmerku, ki ga spremljata huda navzea in bruhanje, pridejo v poštev antiemetiki.
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).
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).
The increase in prothrombin time induced by warfarin is not affected by administration of oral rivastigmine.
Na podaljšanje protrombinskega časa, ki ga povzroči varfarin, dajanje peroralnega rivastigmina ne vpliva.
Negative ADAS-Cog changes indicate improvement.
Negativna sprememba na ADAS-Cog lestvici pomeni izboljšanje.
*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.
*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
The transdermal patch should not be applied to skin that is red, irritated or cut.
Transdermalnega obliža se ne sme namestiti na pordelo, razdraženo ali porezano/spraskano kožo.
Therefore, the patient/caregiver should avoid contact with the eyes after handling of the patch (see section 4.4).
Zato se bolniki/negovalci ne smejo dotikati oči po rokovanju z obližem (glejte poglavje 4.4).
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.
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.
- The patch should not be cut into pieces.
- Obliža se ne sme rezati na manjše dele.