natgillin/translations-raw huggingface dataset:
3 Although these adverse reactions are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.
Čeprav naj bi bile te neželene reakcije povezane z ergolinsko strukturo teh spojin, ni znano, ali jih povzročajo tudi drugi agonisti dopamina, ki niso pridelani iz ergota.
Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also section 4.5).
3 Bolnikom, ki jemljejo agoniste dopamina, se proti bruhanju ne sme dajati nevroleptikov (glejte tudi poglavje 4. 5).
Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts.
Poročila v literaturi nakazujejo, da pri zdravljenju sindroma nemirnih nog z dopaminergičnimi zdravili lahko pride do avgmentacije, kar v tem primeru pomeni zgodnji pojav simptomov zvečer (ali celo popoldne), povečano resnost simptomov in razširitev simptomov po drugih delih telesa.
It is recommended that the application site should be rotated on a daily basis (e. g. from the right side to the left side and from the upper body to the lower body).
Mesto aplikacije je priporočljivo vsak dan zamenjati (npr. z desne strani na levo in z zgornjega dela telesa na spodnjega).
If application site reactions occur which last for more than a few days or are persistent, if there is an increase in severity, or if the skin reaction spreads outside the application site, an assessment of the risk/ benefit balance for the individual patient should be conducted.
Če se pojavijo reakcije na mestu aplikacije, ki trajajo več kot nekaj dni ali ne izginejo, če se slabšajo ali če se razširijo zunaj mesta uporabe, je treba oceniti razmerje koristi in tveganja zdravljenja za tega bolnika.
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals.
Če se zaradi transdermalnega sistema pojavijo kožni izpuščaji ali je koža razdražena, se je treba izogibati izpostavljanju tega mesta neposredni sončni svetlobi, dokler se koža ne zaceli.
Exposure could lead to changes in the skin color.
Izpostavljanje lahko povzroči spremembe barve kože.
If a generalised skin reaction (e. g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Neupro is observed, Neupro should be discontinued.
Če se pojavijo splošne kožne reakcije (npr. alergijski izpuščaj, vključno z eritematoznim, makuloznim ali papuloznim izpuščajem ali pruritus), povezane z uporabo obliža zdravila Neupro, je treba zdravljenje z zdravilom Neupro prekiniti.
Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e. g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Neupro, and co-administration should be avoided.
Rotigotin je agonist dopamina, zato se predpostavlja, da lahko antagonisti dopamina, kot so nevroleptiki (npr. fenotiazini, butirofenoni, tioksanteni) ali metoklopramid, zmanjšajo učinkovitost zdravila Neupro, in se je treba njihovi sočasni uporabi izogibati.
Because of possible additive effects, caution should be advised when patients are taking sedating medicinal products or other CNS (central nervous system) depressants (e. g. benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with rotigotine.
Zaradi morebitnega aditivnega učinka je potrebna previdnost, kadar bolniki v kombinaciji z rotigotinom jemljejo sedative ali druge zaviralce osrednjega živčevja (npr. benzodiazepine, antipsihotike, antidepresive) ali alkohol.
Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.
Sočasna uporaba L- dope in karbidope z rotigotinom ni imela učinka na farmakokinetiko rotigotina, rotigotin pa ni imel učinka na farmakokinetiko L- dope in karbidope.
Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/ day, had no effect on the pharmacokinetics and metabolism of rotigotine in healthy volunteers.
Sočasna uporaba omeprazola (inhibitor CYP2C19) v odmerkih 40 mg/ dan nima nobenega vpliva na farmakokinetiko in metabolizem rotigotina pri zdravih prostovoljcih.
Co-administration of rotigotine (3 mg/ 24 h) did not affect the pharmacodynamics and pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).
Sočasna uporaba rotigotina (3 mg/ 24 h) ni vplivala na farmakodinamiko in farmakokinetiko peroralnih kontraceptivov (0, 03 mg etinilestradiol, 0, 15 mg levonorgestrel).
There are no adequate data from the use of Neupro in pregnant women.
Ni zadostnih podatkov o uporabi zdravila Neupro pri nosečnicah.
Animal studies do not indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice at materno-toxic doses (see section 5.3).
Študije na živalih ne kažejo kakršnihkoli teratogenih učinkov pri podganah in kuncih, vendar so pri podganah in miših opazili toksične učinke na zarodek pri odmerkih, ki so bili toksični za mater (glejte poglavje 5. 3).
Rotigotine should not be used during pregnancy.
Rotigotina ne uporabljajte med nosečnostjo.
4 Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected.
Rotigotin zmanjša izločanje prolaktina pri človeku, zato je pričakovano zaviranje laktacije.
Studies in rats have shown that rotigotine and/ or its metabolite(s) is excreted in breast milk.
Študije na podganah so pokazale, da se rotigotin in/ ali njegovi presnovki izločajo v materino mleko.
Patients being treated with rotigotine and presenting with somnolence and/ or sudden sleep episodes must be informed not to drive or engage in activities (e. g. operating machines) where impaired alertness may put themselves or others at risk of serious injury or death until such recurrent episodes and somnolence have resolved (see also sections 4.4 and 4.5).
Bolnike, ki se zdravijo z rotigotinom in pri katerih se pojavita somnolenca in/ ali epizode nenadnega spanca, morate opozoriti, da naj ne vozijo ali opravljajo aktivnosti (npr. upravljanje strojev), pri katerih lahko zaradi zmanjšane budnosti sebe ali druge izpostavijo povečanemu tveganju za resne poškodbe ali smrti, vse dokler taki ponavljajoči se napadi in somnolenca ne prenehajo (glejte tudi poglavji 4. 4 in 4. 5).
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Neupro- and 214 placebo-treated patients, 65.0% of the patients on Neupro and 32.7% of patients on placebo reported at least one adverse reaction.
Z analizo zbranih, s placebom nadzorovanih kliničnih preskušanj, v katerih je sodelovalo 748 bolnikov, zdravljenih z zdravilom Neupro, in 214 bolnikov, ki so prejemali placebo, so ugotovili, da se je pri 65, 0% bolnikov, ki so prejemali zdravilo Neupro, in pri 32, 7% bolnikov, ki so prejemali placebo, pojavil vsaj en neželen učinek.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro are nausea, application site reactions, fatigue and headache.
Neželeni učinki, o katerih so poročali pri več kot 10% bolnikov, zdravljenih s transdermalnim obližem zdravila Neupro, so navzea, reakcije na mestu aplikacije, utrujenost in glavobol.
In trials where the application sites were rotated as reflected in the instructions provided in the SPC and package leaflet, 34.2% of 748 patients using Neupro, experienced application site reactions.
Pri preskušanjih, v katerih so mesto aplikacije spreminjali po navodilih iz povzetka glavnih značilnosti zdravila in navodila za uporabo, so se reakcije na mestu aplikacije pojavile pri 34, 2% od 748 bolnikov, ki so uporabljali transdermalni obliž zdravila Neupro.
The majority of these reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of Neupro in 7.2% of subjects.
Večina teh reakcij je bila blagih ali zmernih, omejenih na mesto aplikacije, zdravljenje z zdravilom Neupro pa so zaradi njih prekinili le pri 7, 2% vseh bolnikov, ki so prejemali zdravilo Neupro.
The following table covers adverse drug reactions from all studies in patients with Restless Legs Syndrome.
V spodnji tabeli so navedeni neželeni učinki zdravila, zbrani v vseh študijah na bolnikih s sindromom nemirnih nog.
System/ organ
Organski sistem po
classes acc. to MedDRA
MedDRA
≥ 1/ 1,000, < 1/ 100
≥1/ 1. 000, < 1/ 100
≥ 1/ 10,000, ≤ 1/ 1,000
≥1/ 10. 000, ≤1/ 1. 000
Gastrointestinal disorders
Bolezni prebavil Splošne težave in spremembe na mestu aplikacije Bolezni imunskega sistema
Nausea
navzea, reakcije na mestu aplikacijea, (vključno z eritemom, pruritusom, draženjem, izpuščajem, dermatitisom, mehurji, bolečino, ekcemom, vnetjem, oteklino, razbarvanjem, papulami, lupljenjem, koprivnico, preobčutljivostjo) utrujenost
General disorders and administration
bruhanje, dispepsija, razdražljivost preobčutljivost
Application and instillation site a
Bolezni živčevja
Irritability
glavobol
site conditions
somnolenca
Immune system disorders
Psihiatrične motnje
Hypersensitivity
napadi spanca,
Nervous system
impulzivne motnje
disorders
Obsesivno
Psychiatric
Organski sistem po MedDRA
Sleep attacks,
Zelo pogosti ≥1/ 10
Sexual desire a
Pogosti ≥1/ 100, < 1/ 10 motnje spolnega
disorder (incl.
Občasni ≥1/ 1. 000, < 1/ 100 (vključno s
compulsive
Redki ≥1/ 10. 000, ≤1/ 1. 000 kompulzivna
disorder (incl. hypersexuality, libido increased), Insomnia, Sleep disorder, Abnormal dreams
poželenjaa (vključno s hiperseksualnostjo, povečanim libidom), nespečnost, motnje spanja, nenavadne sanje
pathological gambling, punding)
patološkim hazardiranjem in ponavljanjem nesmiselnih dejanj)
Pruritus
motnja
Vascular disorders a) High Level Term
pruritus Bolezni kože in podkožja Žilne bolezni a) Izraz visoke stopnje
Orthostatic hypotension
ortostatska hipotenzija
Neupro has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
Zdravilo Neupro je povezano s somnolenco, vključno s prekomerno dnevno somnolenco, in epizodami nenadnega spanca.
In isolated cases “ sudden onset of sleep” occurred while driving and resulted in motor vehicle accidents.
V posameznih primerih je prišlo do "nenadnega spanca" med vožnjo, zaradi katerega so se zgodile prometne nesreče.
See also section 4.4 and 4.7.
Glejte tudi poglavji 4. 4 in 4. 7.
Patients treated with dopamine agonists including Neupro, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Pri bolnikih, zdravljenih z agonisti dopamina, vključno z zdravilom Neupro, so poročali o znakih patološkega hazardiranja, povečanega libida in hiperseksualnosti, ki so pa bili po navadi reverzibilni po zmanjšanju odmerka ali po prekinitvi zdravljenja.
In case of suspected overdose, the patch(es) should immediately be removed from the patient.
Ob sumu na preveliko odmerjanje je treba obliž (obliže) takoj odstraniti z bolnika.
Levels of rotigotine decrease after patch removal.
Raven rotigotina se po odstranitvi obliža zmanjša.
Before stopping use of rotigotine completely see section 4.2.
Preden povsem prekinete z uporabo rotigotina, glejte poglavje 4. 2.
Because rotigotine is over 90% protein bound, dialysis would not be expected to be beneficial.
Več kot 90% rotigotina je vezanega na beljakovine, zato ni pričakovati, da bi dializa koristila.
Dopamine agonists; ATC code:
Agonisti dopamina; oznaka ATC:
Rotigotine is a non-ergolinic D3/ D2/ D1 dopamine agonist for the treatment of Parkinson’ s disease.
Rotigotin je neergolinični D3/ D2/ D1 agonist dopamina za zdravljenje Parkinsonove bolezni.
It is believed to elicit its beneficial effect by activation of the D3, D2 and D1 receptors of the caudate- putamen in the brain.
Domneva se, da zdravilni učinek doseže z aktivacijo receptorjev D3, D2 in D1 kavdatnega jedra in putamena v možganih.
Rotigotine alleviates signs and symptoms of idiopathic Parkinson’ s disease.
Rotigotin blaži znake in simptome idiopatične Parkinsonove bolezni.
The efficacy of Neupro was evaluated in 5 placebo-controlled trials with more than 1,400 patients with idiopathic Restless Legs Syndrome (RLS).
Učinkovitost je bila
Efficacy was demonstrated in controlled trials in patients treated for up to 29 weeks.
6 dokazana v kontrolnih študijah na bolnikih, zdravljenih do 29 tednov.
For both primary endpoints statistically significant
Primarna parametra učinkovitosti sta sprememba izhodiščne vrednosti na mednarodni lestvici sindroma nemirnih nog (International Restless Legs Syndrome Rating Scale - IRLS) in sprememba stopnje 1 splošne ocene kliničnega stanja – resnost bolezni (Clinical Global Impressions Item 1 – CGI- Item 1).
6 differences have been observed for the doses 1 mg/ 24 h, 2 mg/ 24 h and 3 mg/ 24 h in comparison to placebo.
Končne vrednosti obeh parametrov so bile statistično signifikantno različne pri odmerkih 1 mg/ 24 h, 2 mg/ 24 h and 3 mg/ 24 h v primerjavi s placebom.
After 6 months of maintenance treatment in patients with moderate to severe RLS, the baseline IRLS score improved from 30.7 to 20.7 for placebo and from 30.2 to 13.8 for Neupro.
Po 6 mesecih vzdrževalnega zdravljenja so se pri bolnikih z zmerno do hudo obliko RLS vrednosti IRLS izboljšale iz 30, 7 na 20, 7 za placebo in iz 30, 2 na 13, 8 za zdravilo Neupro.
The adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p < 0.0001).
Prilagojena srednja razlika je bila - 6, 5 točk (CI95% - 8, 7 - - 4, 4, p < 0, 0001).
CGI-I responder rates (much improved, very much improved) were 43.0% and 67.5% for placebo and Neupro respectively (difference 24.5% CI 95%:
Stopnje odziva po CGI- 1 (precej izboljšan, zelo izboljšan) so bile 43, 0% za placebo in 67, 5% za zdravilo Neupro (razlika 24, 5% CI95%:
In a placebo-controlled, 7-week trial polysomnographic parameters were investigated.
14, 2% - 34, 8%, p < 0, 0001) V 7- tedenski študiji, kontrolirani s placebom so bili raziskani polisomnografski parametri.
Neupro significantly reduced the periodic limb movement index (PLMI) from 50.9 to 7.7 versus 37.4 to 32.7 for placebo (p < 0.0001).
- PLMI) iz 50, 9 na 7, 7 proti 37, 4 na 32, 7 za placebo (p < 0, 0001).
Absorption Following application, rotigotine is continuously released from the transdermal patch and absorbed through the skin.
Absorpcija Po aplikaciji se rotigotin neprekinjeno sprošča iz transdermalnega obliža in absorbira skozi kožo.
Steady-state concentrations are reached after one to two days of patch application and are maintained at a stable level by once daily application in which the patch is worn for 24 hours.
Koncentracije v stanju dinamičnega ravnovesja se dosežejo po enem do dveh dnevih po namestitvi obliža in se vzdržujejo na stabilni ravni z vsakodnevno namestitvijo novega obliža, ki ga bolnik nosi 24 ur.
Rotigotine plasma concentrations increase dose-proportionally over a dose range of 1 mg/ 24 h to 24 mg/ 24 h.
Koncentracija rotigotina v plazmi se povečuje sorazmerno z odmerkom pri intervalu odmerkov od 1 mg/ 24 h do 24 mg/ 24 h.
Approximately 45% of the active substance within the patch is released to the skin in 24 hours.
V 24 urah se iz obliža sprosti v kožo približno 45% zdravilne učinkovine.
The absolute bioavailability after transdermal application is approximately 37%.
Absolutna biološka uporabnost po transdermalni uporabi je približno 37%.
Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder versus thigh).
Razlike biološke uporabnosti rotigotina so se spreminjale od 2% (nadlaht v primerjavi z bokom) do 46% (rama v primerjavi s stegnom).
Distribution The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Porazdelitev Vezava rotigotina na beljakovine v plazmi in vitro je približno 92%.
The apparent volume of distribution in humans is approximately 84 l/ kg.
Navidezni volumen porazdelitve pri človeku je 84 l/ kg.
Metabolism Rotigotine is metabolised to a great extent.
Presnova Rotigotin se presnavlja v veliki meri.
Rotigotine is metabolised by N-dealkylation as well as direct and secondary conjugation.
Njegova presnova poteka z N- dealkilacijo ter z neposredno in sekundarno konjugacijo.
In vitro results indicate that different CYP isoforms are able to catalyse the N-dealkylation of rotigotine.
Rezultati in vitro kažejo, da N- dealkilacijo rotigotina lahko katalizirajo različne izooblike CYP.
The infomation on metabolites is incomplete.
Podatki o presnovkih so nepopolni.
Elimination Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is excreted in faeces.
Izločanje Približno 71% odmerka rotigotina se izloči z urinom, manjši delež, približno 23%, pa z blatom.
The clearance of rotigotine after transdermal administration is approximately 10 l/ min and its elimination half-life is 5 to 7 hours.
Po transdermalni uporabi je očistek rotigotina približno 10 l/ min, razpolovni čas izločanja pa 5 do 7 ur.
Because the patch is administered transdermally, no effect of food and gastrointestinal conditions is expected.
Obliž se uporablja transdermalno, zato ni pričakovati učinkov hrane in prebavnih pogojev.
Special patient groups Because therapy with Neupro is initiated at a low dose and gradually titrated according to clinical tolerability to obtain the optimum therapeutic effect, adjustment of the dose based on gender, weight, or age is not necessary.
Posebne skupine bolnikov Zdravljenje z zdravilom Neupro se začne z majhnim odmerkom, ki se za doseganje optimalnega učinka zdravljenja postopno povečuje glede na klinično toleranco, zato prilagajanje odmerka glede na spol, telesno maso ali starost ni potrebno.
Plasma levels of conjugates of rotigotine and its desalkyl metabolites increase with impaired renal function.
Ravni konjugatov rotigotina in njegovih presnovkov po dealkilaciji v plazmi se pri okvarjenem delovanju ledvic povečajo, vendar ni vpliva teh presnovkov na klinične učinke.
However, a contribution of these metabolites to clinical effects is unlikely.
7 5. 3 Predklinični podatki o varnosti
5.3 Preclinical safety data 7 In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.
Pri študijah ponavljajočih se odmerkov in dolgotrajne toksičnosti je bila večina učinkov povezana s farmakodinamiko agonistov dopamina in posledičnim zmanjšanjem izločanja prolaktina.
After a single dose of rotigotine, binding to melanin-containing tissues (i. e., eyes) in the pigmented rat and monkey was evident, but was slowly cleared over the 14-day observation period.
Po enkratnem odmerku rotigotina je bila njegova vezava na tkiva, ki vsebujejo melanin (tj. oči), pri pigmentiranih podganah in opicah očitna, vendar se je v 14- dnevnem opazovalnem obdobju postopno sprostila.
Retinal degeneration was observed by transmission microscopy at a dose equivalent to 2.8 times the maximum recommended human dose on a mg/ m² basis in a 3-month study in albino rats.
V 3- mesečni študiji na albino podganah so pri odmerkih, ki ustrezajo 2, 8- kratnim največjim priporočenim odmerkom za človeka v mg/ m2, s transmisijsko mikroskopijo opazili razpad mrežnice.
In a carcinogenicity study, male rats developed Leydig cell tumours and hyperplasia.
V študiji karcinogenosti je pri podganjih samcih prišlo do pojava tumorjev in hiperplazije Leydigovih celic.
These changes are well-known effects of dopamine agonists in rats after life-long therapy and assessed as not relevant to man.
Ocenili so, da za človeka niso pomembni.
Backing layer:
Oporna plast:
Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α -tocopherol (E307).
Samolepilna matriksna plast: poli( dimetilsiloksan, trimetilsililsilikat) - kopolimerizat, povidon K90, natrijev metabisulfit (E223), askorbilpalmitat (E304) in DL- α- tokoferol (E307).
Protective liner:
Zaščitna plast:
10 months.
10 mesecev.
8 Store in a refrigerator (2°C – 8°C).
Shranjujte v hladilniku (2 °C - 8 °C).
Peel off sachet in a cardboard carton:
Zaščitna vrečka (Peel- off) v kartonski škatli:
One side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene (innermost layer), aluminium, ethylene copolymer and paper.
Ena stran je izdelana iz etilenskega kopolimera (notranja plast), aluminijeve folije, filma iz polietilena majhne gostote in papirja; druga stran je izdelana iz polietilena (notranja plast), aluminija, etilenskega kopolimera in papirja.
The carton contains 7, 20, 28, 30, 56, 60, 84, 90 or 100 transdermal patches, individually sealed in sachets.
Škatla vsebuje 7, 20, 28, 30, 56, 60, 84, 90 ali 100 transdermalnih obližev, posamezno pakiranih v zaščitne vrečke.
6.6 Special precaution for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje
After removal, the used patch should be folded in half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and then discarded out of the reach of children.
Po odstranitvi je treba obliž prepogniti na pol, z lepljivo plastjo navznoter, tako da matriksna plast ni izpostavljena, ga dati v originalno zaščitno vrečko in nato odstraniti tako, da je zunaj dosega otrok.
Shannon, Industrial Estate, Co. Clare, Ireland
Clare, Irska
Neupro 2 mg/ 24 h transdermal patch
Neupro 2 mg/ 24 h transdermalni obliž
Each patch of 10 cm2 contains 4.5 mg of rotigotine.
En obliž s površino 10 cm2 vsebuje 4, 5 mg rotigotina.
The outside of the backing layer is tan-coloured and imprinted with Neupro 2 mg/ 24 h.
Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom Neupro 2 mg/ 24 h.
Restless Legs Syndrome Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
Sindrom nemirnih nog Zdravilo Neupro je indicirano za simptomatično zdravljenje zmerne do hude oblike idiopatičnega sindroma nemirnih nog pri odraslih.
Parkinson’ s disease Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’ s disease as monotherapy (i. e. without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘ on-off’ fluctuations).
Uporablja se kot monoterapija (brez L- dope) ali v kombinaciji z L- dopo, v poteku bolezni, do poznih faz, ko učinek L- dope popušča ali postane neustrezen ter ko se pojavijo nihanja terapevtskega učinka (ob koncu odmerjanja ali nihanja » vklop- izklop «).
The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application.
Obliž ostane na koži 24 ur, nato ga nadomestimo z novim, za katerega izberemo drugo mesto namestitve
Restless Legs Syndrome A single daily dose should be initiated at 1 mg/ 24 h.
Sindrom nemirnih nog Enkratni dnevni odmerek začnemo z 1 mg/ 24 h.
Parkinson’ s disease Dosing in patients with early-stage Parkinson’ s disease:
Parkinsonova bolezen Odmerjanje pri bolnikih v zgodnji fazi Parkinsonove bolezni:
A single daily dose should be initiated at 2 mg/ 24 h and then increased in weekly increments of 2 mg/ 24 h to an effective dose up to a maximal dose of 8 mg/ 24 h.
Enkratni dnevni odmerek začnemo z 2 mg/ 24 h in ga nato povečujemo v tedenskih korakih po 2 mg/ 24 h do učinkovitega odmerka, največ do 8 mg/ 24 h.
4 mg/ 24 h may be an effective dose in some patients.
4 mg/ 24 h lahko zadošča kot učinkovit odmerek za nekatere bolnike.
For most patients an effective dose is reached within 3 or 4 weeks at doses of 6 mg/ 24 h or 8 mg/ 24 h, respectively.
Pri večini bolnikov se učinkovit odmerek doseže v 3 ali 4 tednih pri odmerkih 6 mg/ 24 h ali 8 mg/ 24 h.
10 The maximal dose is 8 mg/ 24 h.
Največji odmerek je 8 mg/ 24 h.
Dosing in patients with advanced stage Parkinson’ s disease with fluctuations:
10 Odmerjanje pri bolnikih v napredovali fazi Parkinsonove bolezni z nihanji: