natgillin/translations-raw huggingface dataset:
picture 4). ed
oblikovali vsaj 3 cm široko kožno gubo (dvakratna širina konice ra
5.
Zd
The pre-filled pen has a safety cover that will protect you from needle sticks or loss of drug by accidental bumping or touching.
Napolnjeni injekcijski peresnik ima pokrovček, ki preprečuje, da bi se po nesreči zbodli z iglo ali da bi zaradi naključnega sunka ali dotika
Safety cover out
pokrovček na mestu
Safety cover
umaknjen
fully retracted At start, keep thumb clear of green button
45 Sprva ne pritiskajte na zeleni gumb
Hold down.
Napolnjeni injekcijski peresnik prislonite pravokotno na sredino jekcijski kožne gube (pod kotom 90 stopinj), nato ga čvrsto pritisnite na kožo in zadržite.
Maintaining firm skin pinch, (1) press and (2) release the green button on top.
B. pritisnite Ko čvrsto držite kožno gubo, (1) pritisnite in (2) spustite zeleni
You will hear a “click”.
et B. gumb na vrhu.
Do not lift the pre- filled pen.
Pri tem boste zaslišali “ klik ”.
ed is or C.
Ne dvigajte
After the second “click” (or a count of 15) lift the pre-filled
m napolnjenega injekcijskega peresnika.
th pen from the injection site.
C.
au er If you experience difficulties choose a more firm injection site. ng
Ko boste zaslišali drugi “ klik ” (ali prešteli do 15), dvignite napolnjeni injekcijski peresnik z mesta za injiciranje.
The needle safety cover will move down over the needle and lock into place.
a nj Če se pojavijo težave, izberite čvrstejše mesto za injiciranje. lje Varnostni pokrovček igle se bo pomaknil navzdol preko igle in se bo zaskočil.
The inspection window lo
Kontrolno okence bo vo
will be green, confirming the injection is complete. o tn
zeleno, kar dokazuje, da je injiciranje dokončano. do
If needed, you may cover the injection site with a bandage. uc
Če je potrebno, lahko injekcijsko mesto prekrijete s povojem. ā
Only use a single Neupopeg pre-filled pen for each injection. od pr
Vsak napolnjeni injekcijski peresnik Neupopega uporabite samo za eno injiciranje. ve
Remember al
Ne pozabite a
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice. in ic
Če imate kakršnekoli težave, naj vas ne bo strah poprositi svojega zdravnika ali medicinske sestre za m
Disposing of used pre-filled pens ed
Odlaganje rabljenih napolnjenih injekcijskih peresnikov lo
• Due to the protective safety cover it is not recommended to put the grey needle shield back on M
• Zaradi varnostnega pokrovčka ni priporočljivo, da bi sivi ščitnik igle nameščali nazaj na vi
the used pre-filled pen.
uporabljen injekcijski peresnik. ra
• Keep used pens out of the reach and sight of children.
Zd
Neupro is a range of transdermal patches (patches that deliver a medicine across the skin).
Zdravilo Neupro je serija transdermalnih obližev (obližev, ki dovajajo zdravilo skozi kožo).
Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active substance rotigotine over 24 hours.
Vsak obliž sprosti 1, 2, 4, 6 ali 8 mg zdravilne učinkovine rotigotin v obdobju 24 ur.
Neupro is used for to treat the symptoms of the following diseases in adults: • Parkinson’ s disease.
Zdravilo Neupro se uporablja za zdravljenje odraslih s simptomi naslednjih bolezni: • Parkinsonove bolezni.
Neupro is used on its own in early-stage disease, or in combination with levodopa (another medicine used in Parkinson’ s disease) at any stage of the disease, including the later stages when levodopa starts becoming less effective. • moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Zdravilo Neupro se uporablja samostojno v zgodnji fazi bolezni ali v kombinaciji z levodopo (drugim zdravilom za zdravljenje Parkinsonove bolezni) v kateri koli fazi bolezni, vključno v poznih fazah, ko začne učinek levodope popuščati. • zmernega do hudega sindroma nemirnih nog, obolenja, pri katerem ima bolnik nenadzorovano potrebo po premikanju okončin, da bi na ta način odpravil neprijetne, boleče ali nenavadne občutke v telesu, ki se navadno pojavljajo ponoči.
Neupro is used when a specific cause for the disorder cannot be identified.
Zdravilo Neupro se uporabi v primeru, ko ne moremo odkriti specifičnega vzroka za to obolenje.
Neupro is applied once a day at about the same time every day.
Zdravilo Neupro se namesti enkrat dnevno, vsak dan ob približno istem času.
The patch is applied to dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm.
Obliž se namesti na suho, čisto, zdravo kožo na trebuhu, stegnih, kolkih, bokih, ramah ali nadlahteh.
The patch remains on the skin for 24 hours and is then replaced by a new one in a different place.
Obliž ostane na koži 24 ur, nato pa se ga nadomesti z novim na drugem mestu.
The same place must not be used again until two weeks later.
Obliža se v naslednjih dveh tednih ne sme namestiti na isto mesto.
In early-stage Parkinson’ s disease, the starting dose is 2 mg/ 24 h, which is increased every week by 2 mg/ 24 h until an effective dose is reached or up to a maximum dose of 8 mg/ 24 h.
V zgodnji fazi Parkinsonove bolezni začetni odmerek znaša 2 mg/ 24 h, ki ga vsak teden povečamo za 2 mg/ 24 h, dokler ne dosežemo učinkovitega odmerka ali do maksimalnega odmerka 8 mg/ 24 h.
For most patients, an effective dose is reached within three or four weeks.
Pri večini bolnikov se učinkoviti odmerek doseže v treh do štirih tednih.
A special pack with patches of four different strengths is available to help when starting treatment.
Za lažjo uporabo je na začetku zdravljenja bolnikom na voljo poseben komplet z obliži vseh štirih jakosti.
If the control of the disease is not sufficient, patients may benefit from switching to another similar medicine.
Če se ne vzpostavi zadosten nadzor nad boleznijo, se bolniku priporoča, da preide na drugo podobno zdravilo.
In advanced disease, the starting dose is 4 mg/ 24 h, which is increased every week by 2 mg/ 24 h until an effective dose is reached or up to a maximum dose of 16 mg/ 24 h.
Pri napredovali bolezni je začetni odmerek 4 mg/ 24 h, ki ga vsak teden povečamo za 2 mg/ 24 h, dokler ne dosežemo učinkovitega odmerka ali do maksimalnega odmerka 16 mg/ 24 h.
Some doses may need the application of more than one patch.
Za nekatere odmerke je morda potrebno namestiti več kot en obliž.
In restless legs syndrome, the starting dose is 1 mg/ 24 h.
Pri sindromu nemirnih nog znaša začetni odmerek 1 mg/ 24 h.
Depending on the patient’ s response, the dose can be increased every week by 1 mg/ 24 h until an effective dose is reached or up to a maximum dose of 3 mg/ 24 h.
Odmerek lahko vsak teden v odvisnosti od bolnikovega odziva povečamo za 1 mg/ 24 h, dokler ne dosežemo učinkovitega odmerka ali do maksimalnega odmerka 3 mg/ 24 h.
The need for continued treatment should be assessed by a doctor every six months.
Vsakih šest mesecev mora zdravnik presoditi, ali je potrebno nadaljevati z zdravljenjem.
The active substance in Neupro, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Zdravilna učinkovina v zdravilu Neupro je rotigotin, ki je agonist dopamina, kar pomeni, da posnema delovanje dopamina.
In patients with Parkinson’ s disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Pri bolnikih s Parkinsonovo boleznijo pričnejo celice, ki proizvajajo dopamin, odmirati, zato se količina dopamina v možganih zmanjša.
Neupro delivers a constant supply of rotigotine through the skin into the bloodstream.
Zdravilo Neupro dovaja skozi kožo v krvni obtok stalno količino rotigotina.
Rotigotine then stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’ s disease, such as stiffness and slowness of movement.
Rotigotin zatem stimulira možgane na enak način kot dopamin, tako da bolniki ponovno vzpostavijo nadzor nad svojimi gibi in kažejo manj znakov in simptomov Parkinsonove bolezni, kot so togost in počasnost gibov.
The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Domneva se, da sindrom povzročajo težave v načinu delovanja dopamina v možganih, kar pa lahko izboljšamo z uporabo rotigotina.
The effectiveness of Neupro in the treatment of early-stage Parkinson’ s disease was studied in a total of 830 patients in two studies.
Učinkovitost zdravila Neupro pri zdravljenju zgodnje faze Parkinsonove bolezni so preučevali v dveh študijah pri skupno 830 bolnikih.
The studies measured the scores before and after treatment obtained with a standard questionnaire called the Unified Parkinson’ s Disease Rating Scale (UPDRS).
V okviru teh študij so merili rezultat pred zdravljenjem in po njem, pridobljen s pomočjo standardnega vprašalnika, imenovanega enotna ocenjevalna lestvica za Parkinsonovo bolezen (Unified Parkinson’ s Disease Rating Scale, UPDRS).
An improvement of 20% in the score after treatment was taken as a measure of a benefit that would be relevant for patients.
Merilo za ugotavljanje koristi zdravljenja je bilo 20- odstotno izboljšanje rezultata po zdravljenju.
In the first study, the effectiveness of Neupro was compared with that of placebo (a dummy treatment) and in the second, it was compared with ropinirole (another dopamine agonist) and with placebo.
V prvi študiji so učinkovitost zdravila Neupro primerjali s placebom (zdravilom brez zdravilne učinkovine), v drugi študiji pa z ropinirolom (drugim agonistom dopamina) in placebom.
In advanced Parkinson’ s disease, Neupro was studied in a total of 842 patients in two studies.
Pri napredovali Parkinsonovi bolezni so zdravilo Neupro preučevali v dveh študijah pri skupno 842 bolnikih.
The measure of effectiveness was the length of time during the day that the patients recorded as ‘ off’ (when they had too many Parkinson’ s disease symptoms to be able to live normally).
Merilo učinkovitosti je bila dolžina časa v teku dneva, ki so ga bolniki označili kot „ izklop “ (ko so imeli preveč simptomov Parkinsonove bolezni naenkrat za normalno življenje).
In the first study, the effectiveness of two different doses of Neupro was compared with that of placebo and in the second, it was compared with pramipexole (another dopamine agonist) and with placebo.
V prvi študiji so učinkovitost dveh različnih odmerkov zdravila Neupro primerjali z učinkovitostjo placeba, v drugi študiji pa so jo primerjali s pramipeksolom (drugim agonistom dopamina) in placebom.
For restless legs syndrome, Neupro has been studied in two main studies involving a total of 963 patients with moderate to severe disease.
Pri sindromu nemirnih nog so zdravilo Neupro preučevali v dveh glavnih študijah, ki sta vključevali skupno 963 bolnikov z zmerno do hudo boleznijo.
The effectiveness of Neupro at doses between 0.5 and 3 mg/ 24 h was compared with that of placebo.
Učinkovitost zdravila Neupro v odmerkih od 0, 5 do 3 mg/ 24 h so primerjali z učinkovitostjo placeba.
The main measure of effectiveness was the change in symptoms between the start of the study and after six months of treatment with a stable dose, measured using two standard scales.
Glavno merilo učinkovitosti je bila sprememba v simptomih, izmerjena z uporabo dveh standardnih lestvic na podlagi primerjave med simptomi na začetku študije in simptomi po šestih mesecih zdravljenja s stalnim odmerkom.
Neupro was more effective than placebo in treating Parkinson’ s disease.
Zdravilo Neupro je bilo pri zdravljenju Parkinsonove bolezni učinkovitejše od placeba.
In early-stage disease, the scores obtained with Neupro showed an improvement compared with placebo in the UPDRS.
V zgodnji fazi bolezni so rezultati, doseženi z zdravilom Neupro, izkazali izboljšanje v primerjavi s placebom po lestvici UPDRS.
A 20% improvement in scores was seen in 48 to 52% of the patients using Neupro and in 19 to 30% of those using placebo.
20- odstotno izboljšanje rezultatov je bilo opaženo pri 48 do 52% bolnikov, ki so uporabljali zdravilo Neupro, in pri 19 do 30% bolnikov, ki so uporabljali placebo.
Neupro was less effective than ropinirole: a 20% improvement was seen in 68% of the subjects receiving ropinirole.
20- odstotno izboljšanje je bilo opaženo pri 68% bolnikov, ki so uporabljali ropinirol.
In advanced Parkinson’ s disease, patients using Neupro had a greater decrease in their ‘ off ’ time than those taking placebo (a decrease of 2.1 to 2.7 h with Neupro compared with 0.9 h with placebo).
Pri napredovali Parkinsonovi bolezni se je pri bolnikih, ki so uporabljali zdravilo Neupro, čas, preživet v fazi „ izklop “, skrajšal bolj (zmanjšanje za 2, 1 do 2, 7 ure pri uporabi zdravila Neupro v primerjavi s zmanjšanjem za 0, 9 ure pri uporabi placeba).
The decrease with pramipexole was 2.8 h.
Skrajšanje časa pri uporabi pramipeksola je znašalo 2, 8 ure.
In restless legs syndrome, patients using doses of Neupro between 1 and 3 mg/ 24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.
Na podlagi rezultatov, izmerjenih z obema lestvicama simptomov, je v obeh študijah pri sindromu nemirnih nog prišlo do večjega izboljšanja pri bolnikih, ki so uporabljali zdravilo Neupro v odmerku od 1 do 3 mg/ 24 h, kot pri bolnikih, ki so uporabljali placebo.
The most common side effects with Neupro in patients with Parkinson’ s disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, nausea (feeling sick) and application site reactions such as irritation and burning of the skin.
Najpogostejši neželeni učinki zdravila Neupro pri bolnikih s Parkinsonovo boleznijo (opaženi pri več kot 1 bolniku izmed 10) so zaspanost, omotica, slabost in reakcije na mestu nanosa, kot npr. draženje in pekoč občutek na koži.
In patients with restless legs syndrome, the most common side effects (seen in more than 1 patient in 10) are nausea, application site reactions, fatigue (tiredness) and headache.
Pri bolnikih s sindromom nemirnih nog so najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku izmed 10) slabost, reakcije na mestu nanosa, utrujenost in glavobol.
It is important to use the patch as instructed to limit skin reactions.
Za zmanjšanje kožnih reakcij je pomembno, da se obliž uporablja v skladu z navodili.
Somnolence can affect the ability of the patient to drive.
Zaspanost lahko vpliva na bolnikovo sposobnost vožnje.
For the full list of all side effects reported with Neupro, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Neupro, glejte navodilo za uporabo.
Neupro should not be used in people who may be hypersensitive (allergic) to rotigotine or any of the other ingredients.
Zdravila Neupro ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) rotigotin ali katero koli drugo sestavino zdravila.
The backing layer of Neupro contains aluminium.
Zunanja plast obliža Neupro vsebuje aluminij.
To avoid skin burns, Neupro should be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart’ s normal rhythm).
Če je treba pri bolniku opraviti magnetnoresonančno slikanje (MRI) ali kardioverzijo (postopek za ponovno 2/ 3 vzpostavitev normalnega srčnega ritma), je treba obliž Neupro odstraniti, da se preprečijo opekline kože.
2/ 3 Why has Neupro been approved?
Zakaj je bilo zdravilo Neupro odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Neupro’ s benefits are greater than its risks for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults, and the treatment of the signs and symptoms of idiopathic Parkinson’ s disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Neupro pri simptomatskem zdravljenju zmernega do hudega idiopatskega sindroma nemirnih nog pri odraslih in pri zdravljenju znakov in simptomov idiopatske Parkinsonove bolezni večje od z njim povezanih tveganj.
The Committee recommended that Neupro be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Neupro odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Neupro?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Neupro?
The company that makes Neupro is studying some of the side effects that have been seen with similar medicines (sleep attacks and development of hard tissue in the valves of the heart).
Družba, ki proizvaja zdravilo Neupro, preučuje nekatere neželene učinke zdravila, ki so bili opaženi pri uporabi podobnih zdravil (napade spanca in tvorbo trdega tkiva v srčnih zaklopkah).
Other information about Neupro:
Druge informacije o zdravilu Neupro:
The European Commission granted a marketing authorisation valid throughout the European Union for Neupro to Schwarz Pharma Ltd. on 15 February 2006.
Evropska komisija je dovoljenje za promet z zdravilom Neupro, veljavno po vsej Evropski uniji, odobrila družbi Schwarz Pharma Ltd. dne 15. februarja 2006.
The full EPAR for Neupro can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Neupro je na voljo tukaj.
sachet (paper/ LDPE/ alu/ ET copolymer PE/ Alu/ ET copolymer/ paper)
Zaščitna vrečka (papir/ polietilen majhne gostote/ aluminij/ etilenski kopolimer polietilen/ aluminij/ etilenski kopolimer/ papir)
100 patches
100 transdermalnih obližev
EU/ 1/ 05/ 331/ 011
1/ 6 EU/ 1/ 05/ 331/ 011
28 patches (7x 2mg/ 24h, 7x 4mg/ 24h, 7x 6mg/ 24h, 7x 8mg/ 24h)
28 transdermalnih obližev (7x 2mg/ 24h, 7x 4mg/ 24h, 7x 6mg/ 24h, 7x 8mg/ 24h)
20 patches
20 transdermalnih obližev
56 patches
56 transdermalnih obližev
60 patches
60 transdermalnih obližev
90 patches
90 transdermalnih obližev
EU/ 1/ 05/ 331/ 021
2/ 6 EU/ 1/ 05/ 331/ 021
EU/ 1/ 05/ 331/ 032
3/ 6 EU/ 1/ 05/ 331/ 032
EU/ 1/ 05/ 331/ 047
5/ 6 EU/ 1/ 05/ 331/ 047
Neupro 1 mg/ 24 h transdermal patch
Neupro 1 mg/ 24 h transdermalni obliž
Each patch of 5 cm2 contains 2.25 mg of rotigotine.
En obliž s površino 5 cm2 vsebuje 2, 25 mg rotigotina.
The outside of the backing layer is tan-coloured and imprinted with Neupro 1 mg/ 24 h.
Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom Neupro 1 mg/ 24 h.
Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
Zdravilo Neupro je indicirano za simptomatsko zdravljenje zmerne do hude idiopatične oblike sindroma nemirnih nog pri odraslih.
Neupro is applied once a day.
Zdravilo Neupro namestimo enkrat dnevno.
Dosage The dose recommendations made are in nominal dose.
Odmerjanje Priporočila za odmerjanje so v nominalnih odmerkih.
A single daily dose should be initiated at 1 mg/ 24 h.
Enkratni dnevni odmerek začnemo z 1 mg/ 24 h.
Depending on the individual patient response, the dose may be increased in weekly increments of 1 mg/ 24 h to a maximal dose of 3 mg/ 24 h.
Odvisno od odziva posameznega bolnika lahko odmerek povečujemo v tedenskih korakih po 1 mg/ 24 h, največ do 3 mg/ 24 h.
Treatment discontinuation Neupro should be discontinued gradually.
Prekinitev zdravljenja Zdravljenje z obližem zdravila Neupro je treba prekiniti postopno.
The daily dose should be reduced in steps of 1 mg/ 24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see section 4.4).
Dnevni odmerek zmanjšujemo v korakih po 1 mg/ 24 h, po možnosti vsak drugi dan, do popolne odtegnitve zdravila Neupro (glejte poglavje 4. 4).
Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) was not observed.
Ob upoštevanju navedenega postopka ni bilo opaziti poslabšanja stanja (poslabšanje simptomov z intenziteto, višjo od začetne, po prekinitvi zdravljenja).
Hepatic and renal impairment:
Jetrna in ledvična okvara:
Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment or in patients with mild to severe renal impairment including those requiring dialysis.
Prilagajanje odmerka pri bolnikih z blago do zmerno jetrno okvaro ali pri bolnikih z blago do hudo ledvično okvaro, vključno z bolniki, ki potrebujejo dializo, ni potrebno.
Neupro has not been investigated in this patient group.
Uporaba zdravila Neupro ni bila raziskana v tej ciljni skupini.
A dose reduction might be needed in case of worsening of the hepatic impairment.
Če pride do poslabšanja jetrne okvare, bo lahko potrebno znižanje odmerka.
2 Children and adolescents:
Akutno poslabšanje ledvične funkcije lahko nepričakovano privede do kopičenja rotigotina (glejte poglavje 5. 2).
Neupro is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Neupro pri otrocih in mladostnikih ni priporočljiva.
Method of administration The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm.
2 Način uporabe Obliž namestimo na čisto, suho, nepoškodovano zdravo kožo na trebuhu, stegnih, kolkih, bokih, ramah ali nadlahteh.
(see section 4.4)
Zdravila Neupro ne smemo namestiti na rdečo, razdraženo ali poškodovano kožo (glejte poglavje 4. 4).
Use and handling:
Priprava in ravnanje z zdravilom:
One half of the protective liner should be removed and the sticky side should be applied and pressed firmly to the skin.
Eno polovico zaščitne plasti odstranimo, lepljivo stran namestimo in močno pritisnemo na kožo.
In the event that a patch should fall off, a new patch should be applied for the remainder of the 24 hour dosing interval.
Če se obliž odlepi, je treba za preostanek 24- urnega intervala odmerjanja namestiti novega.
Magnetic resonance imaging or cardioversion (see section 4.4).
Magnetnoresonančno slikanje ali kardioverzija (glejte poglavje 4. 4).
Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/ orthostatic hypotension.
Znano je, da agonisti dopamina okvarijo sistemsko regulacijo krvnega tlaka, kar povzroča posturalno/ ortostatsko hipotenzijo.
These events were also observed during treatment with Neupro, however the incidence was similar to that in placebo-treated patients.
Ta pojav so opazili tudi pri zdravljenju z zdravilom Neupro, vendar je bila pogostnost podobna kot pri bolnikih, ki so prejemali placebo.
Syncope was observed in association with Neupro, but also at a similar rate in patients treated with placebo.
V povezavi z zdravilom Neupro so opazili sinkopo, vendar je bila pogostnost podobna kot pri bolnikih, ki so prejemali placebo.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthostatic hypotension associated with dopaminergic therapy.
Priporočeno je nadzorovati krvni tlak, zlasti v začetku zdravljenja, zaradi splošnega tveganja ortostatske hipotenzije, povezanega z dopaminergičnim zdravljenjem.
Neupro has been associated with somnolence and episodes of sudden sleep onset.
Zdravilo Neupro je povezano s somnolenco in epizodami nenadnega spanca.
Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotigotine.
Pri bolnikih, zdravljenih z agonisti dopamina, vključno z rotigotinom, so poročali o patološkem hazardiranju, povečanem libidu in hiperseksualnosti.
Although not reported with Neupro, symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
Pri nenadni prekinitvi dopaminergičnega zdravljenja so poročali o simptomih, ki kažejo na maligni nevroleptični sindrom, vendar pri zdravljenju z zdravilom Neupro takih poročil ni bilo.
Therefore it is recommended to taper treatment (see section 4.2).
Zato se priporoča, da se zdravljenje opušča počasi (glejte poglavje 4. 2).
Hallucinations have been reported and patients should be informed that hallucinations can occur.
Poročali so o halucinacijah, zato je treba bolnike seznaniti o možnosti tega pojava.
Fibrotic complications:
Fibrotični zapleti: