natgillin/translations-raw huggingface dataset:
søvnanfald, sexual desire disordera (inkl. hyperseksualitet, øget libido), søvnløshed, søvnforstyrrelser, unormale drømme
disorder (incl. hypersexuality, libido increased), Insomnia, Sleep disorder, Abnormal dreams
tvangsforstyrrelser (inkl. patologisk spil og tvangshandlinger)
pathological gambling, punding)
obsessiv- kompulsiv lidelse
disorder
Vaskulære sygdomme a) Overordnet begreb
Vascular disorders a) High Level Term
hypertension
Hypertension
ortostatisk hypotension
Orthostatic hypotension
Neupro er forbundet med døsighed inklusive udpræget døsighed om dagen og pludselige søvnepisoder.
Neupro has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
I isolerede tilfælde er ” pludselig indsættende søvn ” opstået under kørsel og har resulteret i biluheld.
In isolated cases “ sudden onset of sleep” occurred while driving and resulted in motor vehicle accidents.
4. 4 og 4. 7.
See also section 4.4 and 4.7.
Disse er som regel reversible efter dosisreduktion eller seponering af behandlingen.
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.
Der foreligger ingen kendt antidot mod overdosis af dopaminagonister.
There is no known antidote for overdose of dopamine agonists.
I tilfælde af mistænkt overdosis skal plasteret/ plastrene omgående fjernes fra patienten.
In case of suspected overdose, the patch(es) should immediately be removed from the patient.
Rotigotinniveauet falder, efter plasteret er blevet fjernet.
Levels of rotigotine decrease after patch removal.
4. 2, før rotigotinbehandlingen seponeres fuldstændigt.
Before stopping use of rotigotine completely see section 4.2.
Patienten bør monitoreres nøje, herunder hjertefrekvens, hjerterytme og blodtryk.
The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.
Da over 90% af rotigotin er bundet til proteiner, forventes dialyse ikke at være gavnligt.
Because rotigotine is over 90% protein bound, dialysis would not be expected to be beneficial.
Dopaminagonister; ATC- kode:
Dopamine agonists; ATC code:
Rotigotin er en non- ergolin D3/ D2/ D1- dopaminagonist til behandling af Parkinsons syge.
Rotigotine is a non-ergolinic D3/ D2/ D1 dopamine agonist for the treatment of Parkinson’ s disease.
Det menes, at de positive effekter opnås ved aktivering af D3 -, D2 - og D1- receptorerne i nucleus caudatus og putamen i hjernen.
It is believed to elicit its beneficial effect by activation of the D3, D2 and D1 receptors of the caudate- putamen in the brain.
Rotigotin mildner tegn og symptomer ved idiopatisk Parkinsons sygdom.
Rotigotine alleviates signs and symptoms of idiopathic Parkinson’ s disease.
Kliniske forsøg:
Clinical studies:
Neupros virkning blev vurderet i 5 placebokontrollerede forsøg med mere end 1. 400 patienter med idiopatisk Restless Legs Syndrome (RLS).
The efficacy of Neupro was evaluated in 5 placebo-controlled trials with more than 1,400 patients with idiopathic Restless Legs Syndrome (RLS).
Virkningen blev demonstreret i kontrollerede forsøg med patienter behandlet i op til 29 uger.
Efficacy was demonstrated in controlled trials in patients treated for up to 29 weeks.
Virkningen blev opretholdt i en periode på 6 måneder.
The effect was maintained over a 6 months period.
Ændringen fra baseline af International RLS Rating Scale (IRLS) og CGI- item 1 (sværhedsgrad af sygdom) var primære effektparametre.
The changes from baseline in the International RLS Rating Scale (IRLS) and CGI-item 1 (severity of illness) were primary efficacy parameters.
For begge primære endpoints er statistiske signifikante forskelle observeret ved doser på 1 mg/ 24 t, 2 mg/ 24 t og 3 mg/ 24 t ved sammenligning med placebo.
For both primary endpoints statistically significant
6 Efter 6 måneders vedligeholdelsesbehandling hos patienter med moderat til svær RLS var baseline IRLS scoren forbedret fra 30, 7 til 20, 7 for placebo og fra 30, 2 til 13, 8 for Neupro.
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.
Den justerede gennemsnitsforskel var - 6, 5 point (CI95% - 8, 7; - 4, 4, p < 0, 0001).
The adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p < 0.0001).
CGI- I svarrater (stor forbedring, meget stor forbedring) var henholdsvis 43, 0% og 67, 5% for placebo og Neupro (forskel 24, 5% CI95%:
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%:
14, 2%; 38, 8%, p < 0, 0001).
14.2%; 34.8%, p < 0.0001).
I et placebokontrolleret forsøg med en varighed på 7 uger, blev polysomnografiske parametre undersøgt.
In a placebo-controlled, 7-week trial polysomnographic parameters were investigated.
Neupro reducerede antallet af periodiske benbevægelser (periodic limb movement index (PLMI)) signifikant fra 50, 9 til 7, 7 versus 37, 4 til 32, 7 for placebo (p < 0, 0001).
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).
Absorption Efter applikation frigives rotigotin kontinuerligt fra depotplasteret og absorberes gennem huden.
Absorption Following application, rotigotine is continuously released from the transdermal patch and absorbed through the skin.
Steady- state- koncentrationer opnås efter en til to dages brug af plasteret og opretholdes på et stabilt niveau ved applikation en gang daglig, hvor plasteret bæres i 24 timer.
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.
Rotigotins plasmakoncentrationer øges dosisproportionalt over et dosisinterval fra 1 mg/ 24 t til 24 mg/ 24 t.
Rotigotine plasma concentrations increase dose-proportionally over a dose range of 1 mg/ 24 h to 24 mg/ 24 h.
Cirka 45% af det aktive stof i plasteret frigives til huden på 24 timer.
Approximately 45% of the active substance within the patch is released to the skin in 24 hours.
Den absolutte biotilgængelighed efter transdermal applikation er cirka 37%.
The absolute bioavailability after transdermal application is approximately 37%.
Forskellene i rotigotins biotilgængelighed lå i intervallet fra 2% (overarm versus side) til 46% (skulder versus lår).
Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder versus thigh).
Distribution Rotigotins in vitro- binding til plasmaproteiner er cirka 92%.
Distribution The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Det tilsyneladende distributionsvolumen hos mennesker er cirka 84 l/ kg.
The apparent volume of distribution in humans is approximately 84 l/ kg.
Metabolisme Rotigotin metaboliseres i høj grad.
Metabolism Rotigotine is metabolised to a great extent.
Rotigotin metaboliseres både ved N- dealkylering og ved direkte og sekundær konjugation.
Rotigotine is metabolised by N-dealkylation as well as direct and secondary conjugation.
In vitro- resultater viser, at forskellige CYP- isoformer er i stand til at katalysere rotigotins N- dealkylering.
In vitro results indicate that different CYP isoforms are able to catalyse the N-dealkylation of rotigotine.
Hovedmetabolitterne er sulfater og glucuronidkonjugater af moderstoffet samt N- desalkyl- metabolitter, som er biologisk inaktive.
Main metabolites are sulfates and glucuronide conjugates of the parent compound as well as N-desalkyl-metabolites, which are biologically inactive.
Informationen om metabolitter er ufuldstændig.
The infomation on metabolites is incomplete.
Elimination Cirka 71% af rotigotindosen udskilles med urinen, og en mindre del på omkring 23% udskilles i fæces.
Elimination Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is excreted in faeces.
Rotigotins clearance efter transdermal administrering er cirka 10 l/ min., og eliminationshalveringstiden er 5- 7 timer.
The clearance of rotigotine after transdermal administration is approximately 10 l/ min and its elimination half-life is 5 to 7 hours.
Særlige patientgrupper Da behandling med Neupro indledes med en lav dosis og gradvis titreres i overensstemmelse med klinisk tolerabilitet for at opnå optimal behandlingseffekt, er det ikke nødvendigt at foretage dosisjustering baseret på køn, vægt eller alder.
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.
7 I kroniske - og langtids- toksicitetsforsøg blev hovedeffekten forbundet med dopaminagonist- relateret farmakodynamisk effekt og den deraf følgende reducerede prolaktinsekretion.
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.
Efter en enkeltdosis rotigotin var der en tydelig binding til væv, som indeholder melanin (dvs. øjne), hos den pigmenterede rotte og abe, men den fortog sig langsomt i den 14- dages observationsperiode.
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.
Der sås retinal degeneration ved transmissionsmikroskopi ved en dosis svarende til 2, 8 gange den maksimale anbefalede dosis for mennesker på en mg/ m2- basis i et 3- måneders forsøg med albinorotter.
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.
Der har ikke været foretaget flere forsøg for yderligere at vurdere den specifikke patologi.
Additional studies to further evaluate the specific pathology have not been performed.
Der sås ingen retinal degeneration under den rutinemæssige, histopatologiske vurdering af øjnene i nogen toksikologiske studier hos nogen af de anvendte arter.
Retinal degeneration was not observed during the routine histopathological evaluation of the eyes in any of the toxicology studies in any species used.
I et carcinogenicitetsforsøg udviklede hanrotter Leydig celle- tumorer og - hyperplasi.
In a carcinogenicity study, male rats developed Leydig cell tumours and hyperplasia.
Rotigotin inducerede ikke genmutationer i Ames- testen, men udviste in vitro i muselymfomtesten effekt med metabolisk aktivering og svagere effekt uden metabolisk aktivering.
Rotigotine did not induce gene mutations in the Ames test, but did show effects in the in vitro Mouse Lymphoma Assay with metabolic activation and weaker effects without metabolic activation.
Denne mutagene effekt kan muligvis tilskrives rotigotins clastogene effekt, men denne effekt bekræftedes ikke in vivo i musemikronukleustesten eller i UDS- testen (Unscheduled DNA Synthesis) med rotter.
This effect was not confirmed in vivo in the Mouse Micronucleus Test in the rat Unscheduled DNA Synthesis (UDS) test.
Polyesterfilm, silikoniseret, aluminiseret, overtrukket med et farvet pigmentlag (titaniumdioxid (E171), pigment gul 95, pigment rød 166) med tekst påtrykt (pigment rød 144, pigment gul 95, pigment sort 7).
Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7).
Selvklæbende matrixlag:
Self adhesive matrix layer:
Poly( dimethylsiloxan, trimethylsilylsilikat) - copolymerisat, Povidone K90, Natriummetabisulfit (E223), Ascorbylpalmitat (E304) og DL- α- tocopherol (E307).
Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α -tocopherol (E307).
Beskyttelseslag:
Protective liner:
Transparent fluoropolymer- overtrukken polyesterfilm.
Transparent fluoropolymer coated polyester film.
10 måneder.
10 months.
8 Opbevares i køleskab (2°C – 8°C).
8 Store in a refrigerator (2°C – 8°C).
” Peel off ” - brev i papæske:
Peel off sachet in a cardboard carton:
Den ene side består af en ethylen copolymer (inderlag), en aluminiumsfolie, LPDE- film og papir; den anden side består af polyethylen (inderste lag), aluminium, ethylen copolymer og papir.
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.
Æsken indeholder 7, 20, 28, 30, 56, 60, 84, 90 eller 100 depotplastre, individuelt forseglede i breve.
The carton contains 7, 20, 28, 30, 56, 60, 84, 90 or 100 transdermal patches, individually sealed in sachets.
6. 6 Regler for destruktion
6.6 Special precaution for disposal
Efter at plasteret er fjernet, bør det brugte plaster foldes på midten med den klæbende side indad, således at matrixlaget ikke er synligt, placeres i det originale brev og derefter bortskaffes uden for børns rækkevidde.
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.
Brugte eller ubrugte plastre bør destrueres i henhold til lokale retningslinier eller returneres til apoteket.
Any used or unused patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Clare, Irland
Shannon, Industrial Estate, Co. Clare, Ireland
< MM/ ÅR >
{DD/ MM/ YYYY}
< MM/ ÅR >
{MM/ YYYY}
Neupro 2 mg/ 24 timer depotplaster
Neupro 2 mg/ 24 h transdermal patch
Hvert plaster afgiver 2 mg rotigotin per 24 timer.
Each patch releases 2 mg of rotigotine per 24 hours.
Hvert plaster på 10 cm2 indeholder 4, 5 mg rotigotin.
Each patch of 10 cm2 contains 4.5 mg of rotigotine.
Den ydre side af bagsidelaget er beige og påtrykt Neupro 2 mg/ 24 timer.
The outside of the backing layer is tan-coloured and imprinted with Neupro 2 mg/ 24 h.
Restless Legs Syndrome Neupro er indiceret til symptomatisk behandling af moderat til svær idiopatisk Restless Legs Syndrome hos voksne.
Restless Legs Syndrome Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
Parkinsons sygdom Neupro er indiceret som monoterapi (dvs. uden L- dopa) til behandling af tegn og symptomer på idiopatisk Parkinsons sygdom i tidlige stadier eller i kombination med L- dopa, dvs. under hele sygdommens forløb og i de sene stadier, hvor virkningen af L- dopa aftager eller bliver svingende, og der optræder udsving i den terapeutiske effekt (ved slutningen af hver dosis eller ” on- off ” - udsving).
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).
Restless Legs Syndrome En daglig enkeltdosis bør indledes med 1 mg/ 24 t.
Restless Legs Syndrome A single daily dose should be initiated at 1 mg/ 24 h.
Parkinsons sygdom Dosering til patienter med Parkinsons sygdom i tidlige stadier:
Parkinson’ s disease Dosing in patients with early-stage Parkinson’ s disease:
En daglig enkeltdosis bør indledes med 2 mg/ 24 t og øges i ugentlige trin på 2 mg/ 24 t, til der opnås en effektiv dosis.
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.
Den maksimale dosis er 8 mg/ 24 t.
4 mg/ 24 h may be an effective dose in some patients.
4 mg/ 24 t kan være en effektiv dosis hos nogle patienter.
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.
Den maksimale dosis er 8 mg/ 24 t.
10 The maximal dose is 8 mg/ 24 h.
10 Dosering til patienter med Parkinsons sygdom i fremskredne stadier med udsving:
Dosing in patients with advanced stage Parkinson’ s disease with fluctuations:
Den maksimale dosis er 16 mg/ 24 t.
A single daily dose should be initiated at 4 mg/ 24 h and then increased in weekly increments of 2 mg/ 24 h to an effective dose up to a maximal dose of 16 mg/ 24 h.
4 mg/ 24 t eller 6 mg/ 24 t kan være effektive doser hos nogle patienter.
4 mg/ 24 h or 6 mg/ 24 h may be effective doses in some patients.
For de fleste patienter opnås en effektiv dosis inden for 3 til 7 uger ved doser fra 8 mg/ 24 t op til en maksimal dosis på 16 mg/ 24 t.
For most patients an effective dose is reached within 3 to 7 weeks at doses of 8 mg/ 24 h up to a maximum dose of 16 mg/ 24 h.
For højere doser end 8 mg/ 24 t kan der anvendes flere plastre til at opnå den endelige dosis, f. eks. kan 10 mg/ 24 t opnås ved at kombinere et plaster på 6 mg/ 24 t og et plaster på 4 mg/ 24 t.
10 mg/ 24 h may be reached by combination of a 6 mg/ 24 h and a 4 mg/ 24 h patch.
Behandlingsseponering Restless Legs Syndrome Behandlingen med Neupro bør seponeres gradvist.
Treatment discontinuation Restless Legs Syndrome Neupro should be discontinued gradually.
Parkinsons sygdom Behandlingen med Neupro bør seponeres gradvis.
Parkinson’ s disease Neupro should be discontinued gradually.
4. 4).
The daily dose should be reduced in steps of 2 mg/ 24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see section 4.4).
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
11 4.4 Special warnings and precautions for use
5. 1).
If a Parkinson’ s disease patient is insufficiently controlled while on treatment with rotigotine switching to another dopamine agonist might provide additional benefit (see section 5.1)
Selvom disse bivirkninger menes at være relateret til disse stoffers ergoline struktur, vides det ikke, om andre non- ergoline dopaminagonister kan forårsage dem.
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.
Hvis der forekommer reaktioner på applikationsstedet, som varer mere end nogle få dage, eller som er vedvarende, hvis
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.
Hvis depotplasteret forårsager hududslæt eller irritation, bør direkte sollys på området undgås, til huden heler.
12 If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals.
Incidensen af nogle dopaminerge bivirkninger som hallucinationer, dyskinesi og perifere ødemer er generelt højere i kombination med L- dopa hos patienter med Parkinsons sygdom.
The incidence of some dopaminergic adverse events, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa in Parkinson’ s patients.
4%, og den forblev på dette niveau i det samlede observationstidsrum på op til 36 måneder.
In clinical studies in Parkinson’ s patients, the 6 month-specific rates of peripheral edema remained at about 4% through the entire observation period up to 36 months.
Neupro kan forstærke L- dopas dopaminerge bivirkning og forårsage og/ eller forværre allerede eksisterende dyskinesi, som beskrevet med andre dopaminerge agonister.
Neupro may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/ or exacerbate pre-existing dyskinesia, as described with other dopamine agonists.
Patienter i behandling med rotigotin, som kommer ud for episoder med døsighed og/ eller pludselig søvn, skal informeres om, at de, indtil de tilbagevendende episoder og døsigheden er ophørt, skal undlade at føre motorkøretøj eller foretage aktiviteter (f. eks. betjene maskiner), hvor forringet
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).
Restless Legs Syndrome Baseret på analysen af de samlede placebo- kontrollerede kliniske forsøg, som i alt omfatter 748 Neupro - og 214 placebo- behandlede patienter, rapporterede 65, 0% af patienterne på Neupro og 32, 7% af patienterne på placebo mindst en bivirkning.
13 Restless Legs Syndrome 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.
Størstedelen af disse reaktioner var lette eller moderate i intensitet, begrænset til applikationssområderne og førte hos 7, 2% af patienterne til seponering af behandlingen med 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.
Opkastning, dyspepsi
Vomiting, Dyspepsia
Reaktioner på administrations - steda (inkl. erythem, pruritus, irritation, udslæt, dermatitis, vesikler, smerte, eksem, inflammation, hævelse, misfarvning, papler, ekskoriation, urticaria, overfølsomhed) Udmattelse
Application and instillation site a
Søvnanfald, sexual
Sleep attacks,
Tvangsforstyrrelser
Impulse
Obsessiv -
control a
forstyrrelser
Obsessive
kompulsiv
disorders
lidelse
Sexual desire a
Hud og subkutane
disorder (incl.
Pruritus
compulsive
Systemorganklasse i henhold til MedDRA væv
disorder (incl. hypersexuality, libido increased), Insomnia, Sleep disorder, Abnormal dreams
Meget almindelig ≥1/ 10
pathological gambling, punding)
Almindelig ≥1/ 100, ≤1/ 10
disorder
Usædvanlig ≥1/ 1. 000, ≤1/ 100
Skin and subcutaneous tissue disorders
Sjælden ≥1/ 10. 000, ≤1/ 1. 000
Pruritus
Vaskulære sygdomme a) Overordnet begreb
14 Vascular disorders a) High Level Term
Parkinsons sygdom Baseret på analysen af de samlede placebo- kontrollerede kliniske forsøg, som i alt omfatter 1. 083 Neupro - og 508 placebo- behandlede patienter, rapporterede 73, 0% af patienterne på Neupro og 56, 3% af patienterne på placebo mindst en bivirkning.
Parkinson’ s disease Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,083 Neupro- and 508 placebo-treated patients, 73.0% of the patients on Neupro and 56.3% of patients on placebo reported at least one adverse reaction.
Bivirkninger rapporteret hos mere end 10% af patienterne behandlet med Neupro depotplaster er kvalme, svimmelhed, døsighed og reaktioner på applikationsstedet.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro transdermal patch are nausea, dizziness, somnolence and application site reactions.
I forsøg, hvor applikationsstedet blev vekslet som beskrevet i instruktionerne i produktresumeet og indlægssedlen, fik 35, 7% af de 830 patienter, som brugte Neupro depotplaster, reaktioner på applikationsstedet.
In trials where the application sites were rotated as reflected in the instructions provided in SPC and package leaflet, 35.7% of 830 patients using the Neupro transdermal patch, experienced application site reactions.
Størstedelen af disse reaktioner var lette eller moderate i intensitet, begrænset til applikationsområderne og førte kun hos 4, 3% af patienterne til seponering af behandlingen med Neupro.
The majority of these reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of treatment with Neupro in only 4.3% of all subjects receiving Neupro.