natgillin/translations-raw huggingface dataset:
The apparent volume of distribution in humans is approximately 84 l/ kg.
19 Navidezni volumen porazdelitve pri človeku je 84 l/ kg.
19 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.
However, a contribution of these metabolites to clinical effects is unlikely.
Ravni konjugatov rotigotina in njegovih presnovkov po dealkilaciji v plazmi se pri okvarjenem delovanju ledvic povečajo, vendar ni vpliva teh presnovkov na klinične učinke
Neupro 3 mg/ 24 h transdermal patch
Neupro 3 mg/ 24 h transdermalni obliž
Each patch of 15 cm2 contains 6.75 mg of rotigotine.
En obliž s površino 15 cm2 vsebuje 6. 75 mg rotigotina.
The outside of the backing layer is tan-coloured and imprinted with Neupro 3 mg/ 24 h.
Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom Neupro 3 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 oblike idiopatičnega sindroma nemirnih nog pri odraslih.
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)
Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section 5.2).
Akutno poslabšanje ledvične funkcije lahko nepričakovano privede do kopičenja rotigotina (glejte poglavje 5. 2).
23 Children and adolescents:
23 Otroci in mladostniki:
(see section 4.4)
Zdravilo Neupro ne smemo namestiti na rdečo, razdraženo ali poškodovano kožo (glejte poglavje 4. 4).
24 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.
24 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.
25 Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected.
Rotigotin zmanjša izločanje prolaktina pri človeku, zato je pričakovano zaviranje laktacije.
reactions (incl. erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, excoriation, urticaria, hypersensitivity) Fatigue
reakcije na mestu aplikacijea, (vključno z eritemom, pruritusom, draženjem, izpuščajem, dermatitisom, mehurji, bolečino, ekcemom, vnetjem, oteklino, razbarvanjem, papulami, lupljenjem, koprivnico, preobčutljivostjo) utrujenost
Immune system disorders
razdražljivost preobčutljivost
Hypersensitivity
Bolezni živčevja
Psychiatric
Organski sistem po
Sleep attacks,
Zelo pogosti
Impulse
Pogosti
control a
Občasni
Obsessive
Redki
disorders
MedDRA
Sexual desire a
≥1/ 10
disorder (incl.
≥1/ 100, < 1/ 10
compulsive
≥1/ 1. 000, < 1/ 100
disorder (incl. hypersexuality, libido increased), Insomnia, Sleep disorder, Abnormal dreams
≥1/ 10. 000, ≤1/ 1. 000
pathological gambling, punding)
napadi spanca,
disorder
kompulzivna
Skin and subcutaneous tissue disorders
motnje spolnega poželenjaa (vključno s hiperseksualnostjo, povečanim libidom), nespečnost, motnje spanja, nenavadne sanje
Efficacy was demonstrated in controlled trials in patients treated for up to 29 weeks.
27 dokazana v kontrolnih študijah na bolnikih, zdravljenih do 29 tednov.
27 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.
However, a contribution of these metabolites to clinical effects is unlikely.
28 5. 3 Predklinični podatki o varnosti
5.3 Preclinical safety data 28 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.
6.4 Special precautions for storage
29 6. 4 Posebna navodila za shranjevanje
29 Store in a refrigerator (2°C – 8°C).
Shranjujte v hladilniku (2 °C - 8 °C).
Neupro 4 mg/ 24 h transdermal patch
Neupro 4 mg/ 24 h transdermalni obliž
Each patch of 20 cm2 contains 9.0 mg of rotigotine.
En obliž s površino 20 cm2 vsebuje 9, 0 mg rotigotina.
The outside of the backing layer is tan-coloured and imprinted with Neupro 4 mg/ 24 h.
Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom Neupro 4 mg/ 24 h.
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 nihanje » vklop- izklop «).
Dosing in patients with early-stage Parkinson’ s disease:
Odmerjanje pri bolnikih v zgodnji fazi Parkinsonove bolezni:
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:
Odmerjanje pri bolnikih v napredovali fazi Parkinsonove bolezni z nihanji:
31 Treatment discontinuation Neupro should be discontinued gradually.
31 Prekinitev zdravljenja Zdravljenje z obližem zdravila Neupro je treba prekiniti postopno.
A dose reduction might be needed in case of worsening of the hepatic impairment.
Če pride do poslabšanja jetrne okvare bo mogoče potrebno znižanje odmerka.
Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section 5.2).
Akutno poslabšanje ledvične funkcije lahko nepričakovano privede do kopičenja rotigotina (glejte poglavje 5. 2)
32 Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotigotine.
32 Pri bolnikih, zdravljenih z agonisti dopamina, vključno z rotigotinom, so poročali o patološkem hazardiranju, povečanem libidu in hiperseksualnosti.
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.
Pogostnost nekaterih dopaminergičnih neželenih učinkov, kot so halucinacije, diskinezija in periferni edem, je na splošno večja pri uporabi v kombinaciji z L- dopo pri bolnikih s Parkinsonovo boleznijo.
33 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.
33 Sočasna uporaba omeprazola (inhibitor CYP2C19) v odmerkih 40 mg/ dan nima nobenega vpliva na farmakokinetiko in metabolizem rotigotina pri zdravih prostovoljcih.
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.
Z analizo zbranih, s placebom nadzorovanih kliničnih preskušanj, v katerih je sodelovalo 1. 083 bolnikov, zdravljenih z zdravilom Neupro, in 508 bolnikov, ki so prejemali placebo, so ugotovili, da se je pri 73, 0% bolnikov, ki so prejemali zdravilo Neupro, in pri 56, 3% bolnikov, ki so prejemali placebo, pojavil vsaj en neželen učinek.
System/ organ
Organski
classes acc. to MedDRA
sistem po MedDRA
> 1/ 10
≤1/ 1. 000
> 1/ 100, ≤ 1/ 10
napadi spancaa,
> 1/ 1,000, ≤ 1/ 100
(halucinacijea,
≤ 1/ 1,000
psihotične motnje
Immune system disorder
Bolezni
hypersensitivity
somnolencaa,
34 Metabolism and nutrition disorders
diskinezijaa,
anorexia, decreased appetite a
sinkopa,
Psychiatric
konvulzija,
perception
živčevja
b
omoticaa
sleep attacks,
posturalna omotica,
disorders
vazovagalna
disturbances
izguba zavesti
a
Očesne bolezni
psychotic disorder
glavobola
(hallucination, visual a hallucination,
sinkopa, distonija, hipersomnija, letargija, motnje pozornosti, poslabšanje spomina, parestezija, disgevzija, motnje ravnotežja, tremor motnje vida,
(including paranoid psychosis), compulsive
(glejte poglavje 4. 4)
auditory hallucination, illusion), confusion state, abnormal a dreams, insomnia
Ušesne bolezni, vključno z motnjami labirinta
disorders (including pathologic gambling, punding), increased
vrtoglavica (vključno s pozicijsko)
a
Srčne bolezni
libido (including hypersexuality), anxiety, sleep a disorder, nightmares, disorientation
atrijska fibrilacija,
a
supraventrikularn
a
Žilne bolezni
Nervous system disorders
ortostatska hipotenzij
somnolence, a dizziness
pospešeno bitje srca, palpitacije hipertenzijaa,
dyskinesia, dizziness postural, a headache
a tahikardija
Eye disorders (see section 4.4)
a (glejte poglavje 4. 4)
visual disturbance, photopsia, blurred vision
hipotenzija
Ear and labyrinth disorders Cardiac disorders
Zelo pogosti
vertigo (incl. positional) atrial fibrillation, supraventricular heart rate increased, tachycardia palpitations a
Redki
Vascular disorders
sistem po MedDRA
orthostatic hypotension (see section 4.4)
> 1/ 100, ≤1/ 10
hypertension, hypotension a
> 1/ 1. 000, ≤1/ 100
Respiratory, thoracic and mediastinal disorders
kašelj, kolcanjea, Bolezni dihal, dispneja prsnega koša in mediastinalneg a prostora
a
Bolezni
nauseaa
prebavil
vomiting, a diarrhoea, a
zaprtjea, dispepsijaa,
abdominal pain (incl. upper
(vklj. z bolečinami
constipation, a
Bolezni jeter, žolčnika in žolčevodov
abdominal pain),
suha ustaa povišanje jetrnih encimov (vključno z γ- GT, ALT, AST)
dyspepsia, dry a mouth
v zgornjem predelu trebuha), neprijeten občutek v želodcu
stomach discomfort
Bolezni kože in
Hepato-biliary disorder
izpuščaj (vključno z
hepatic enzyme increased (including GGT, ALAT, ASAT)
razširjen pruritus,
35 Skin and subcutaneous tissue disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva Motnje reprodukcije in dojk
Musculoskeletal and connective tissue disorder
Splošne težave
joint swelling
reakcije na
Reproductive system and breast disorder
periferni edema, astenična stanjab
erectile dysfunction
motnje hojea,
a
in spremembe
a
mestu
General disorders
nenavadno
application site b
na mestu
oedema peripheral,
aplikacijeb,
gait disturbance,
(vključno z
and administration site conditions
počutje, povečanje
reactions (including a erythema, a
aplikacije
asthenic b conditions (incl. a fatigue, asthenia,
(vključno z
feeling abnormal, a weight increased,
utrujenostjoa,
pruritus, irritationa, a
telesne masea
malaise), weight
Poškodbe in zastrupitve a
burning, a dermatitis, inflammation, papulae, vesicle, blister, pain, hypersensitivity) (see section 4.4)
eritemoma, pruritusoma, draženjema, pečenjema, dermatitisoma, vnetjem, papulami, vezikli, mehurji, bolečino, preobčutljivostjo) (glejte poglavje 4. 4)
Injury, poisoning and procedural complications a
astenijo, občutkom nelagodja), zmanjšanje telesne mase padci
These adverse drug reactions have been reported in the pooled placebo-controlled trials 1% more frequent than in the placebo-treated patients b High Level Term
O teh neželenih učinkih so v zbranih, s placebom nadzorovanih preskušanjih, poročali najmanj 1% pogosteje kot pri bolnikih, ki so prejemali placebo. b Izraz visoke stopnje.
Neupro has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
36 Zdravilo Neupro je povezano s somnolenco, vključno s prekomerno dnevno somnolenco, in epizodami nenadnega spanca.
36 Pharmacotherapeutic group:
Farmakoterapevtska skupina:
Dopamine agonists; ATC code:
Agonisti dopamina,; oznaka ATC:
The effectiveness of Neupro in the treatment of the signs and symptoms of idiopathic Parkinson's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies.
Klinične študije Učinkovitost zdravila Neupro pri zdravljenju znakov in simptomov idiopatične Parkinsonove bolezni so ocenili v večnacionalnem programu za razvoj zdravila, sestavljenem iz štirih ključnih, vzporednih, randomiziranih, dvojno slepih s placebom nadzorovanih kliničnih študij.
In a second double-blind study, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo.
37 V drugi dvojno slepi študiji je 213 bolnikov prejemalo rotigotin, 227 bolnikov je prejemalo ropinirol, 117 bolnikov pa placebo.
An improvement of 20% was seen in 52% of the subjects receiving rotigotine, 68% of the subjects receiving ropinirole and 30% of the subjects receiving placebo (Difference rotigotine versus placebo 21.7%; CI95% 11.1%; 32.4%, difference ropinirole versus placebo 38.4% CI95% 28.1%; 48.6%, difference ropinirole versus rotigotine 16.6%; CI95% .7.6%; 25.7%). The mean improvement in the UPDRS score (Parts II + III) was 6.83 points (baseline 33.2 points) in the rotigotine arm, 10.78 point in the ropinirole arm (baseline 32.2 points) and 2.33 points in the placebo arm (baseline 31.3 points).
Srednja vrednost izboljšanja rezultata UPDRS (2. in 3. del) je bila pri bolnikih, ki so prejemali rotigotin, 6, 83 točke (izhodiščna vrednost 33, 2 točke), pri bolnikih, ki so prejemali ropinirol, 10, 78 točke (izhodiščna vrednost 32, 2 točke), pri bolnikih, ki so prejemali placebo, pa 2, 33 točke (izhodiščna vrednost 31, 3 točke).
Two additional trials were conducted in patients who were receiving concomitant levodopa therapy.
Dve dodatni preskušanji so opravili pri bolnikih, ki so prejemali sočasno zdravljenje z L- dopo.
At the end of the maintenance treatment an improvement of at least 30% was seen in 57% and 55% of the subjects receiving rotigotine 8 mg/ 24 h and 12 mg/ 24 h, respectively and in
Na koncu vzdrževalnega zdravljenja so opazili vsaj 30 - odstotno izboljšanje pri 57% bolnikov, ki so prejemali 8 mg rotigotina/ 24 h, pri 55% bolnikov, ki so prejemali 12 mg rotigotina/ 24 h, in pri 34% bolnikov, ki so prejemali placebo (pri skupini, ki je prejemala 8 mg rotigotina/ 24 h, je bila razlika 22%; CI95% 10% - 35%, pri skupini, ki je prejemala 12 mg rotigotina/ 24 h, pa 21%; CI95% 8% - 33%, p < 0, 001 pri obeh skupinah, ki sta prejemali rotigotin).
37 34% of the subjects receiving placebo (Differences 22% and 21%, respectively CI95% 10%; 35% and 8%; 33%, respectively, p < 0.001 for both rotigotine groups).
Pri rotigotinu je bila srednja vrednost zmanjšanja časa » izklop « 2, 7 ure pri skupini, ki je prejemala 8 mg rotigotina/ 24 h, in 2, 1 ure pri skupini, ki je prejemala 12 mg rotigotina/ 24 h.
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
38 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.
However, a contribution of these metabolites to clinical effects is unlikely.
Ravni konjugatov rotigotina in njegovih presnovkov po dealkilaciji v plazmi se pri okvarjenem delovanju ledvic povečajo, vendar ni vpliva teh presnovkov na klinične učinke.
Rotigotine did not influence male fertility in rats, but clearly reduced female fertility in rats and mice, because of the effects on prolactin levels which are particularly significant in rodents.
Rotigotin ni vplival na plodnost podganjih samcev, vendar je očitno zmanjšal
6.6 Special precaution for disposal
40 6. 6 Posebni varnostni ukrepi za odstranjevanje
Neupro 6 mg/ 24 h transdermal patch
Neupro 6 mg/ 24 h transdermalni obliž
Each patch of 30 cm2 contains 13.5 mg of rotigotine.
En obliž s površino 30 cm2 vsebuje 13, 5 mg rotigotina.
The outside of the backing layer is tan-coloured and imprinted with Neupro 6 mg/ 24 h.
Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom Neupro 6 mg/ 24 h.
4 mg/ 24 h or 6 mg/ be effective doses in some patients.
4 mg/ 24 h ali 6 mg/ 24 h lahko zadoščata kot učinkovita odmerka za nekatere bolnike.
41 Treatment discontinuation Neupro should be discontinued gradually.
42 Prekinitev zdravljenja Zdravljenje z obližem zdravila Neupro je treba prekiniti postopno.
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).
Dnevni odmerek je treba zmanjševati po 2 mg/ 24 h, po možnosti vsak drugi dan, do popolne odtegnitve zdravila Neupro (glejte poglavje 4. 4).
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned.
43 ali zaspanosti morda ne bodo omenili, dokler ne bodo neposredno vprašani.
42 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.
Co-administration of domperidone with rotigotine had no effect on the pharmacokinetics of rotigotine.
44 Sočasna uporaba domperidona in rotigotina ne vpliva na farmakokinetiko rotigotina.
43 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.
System/ organ
45 Organski sistem
classes acc. to MedDRA
po MedDRA
Immune system disorder
motnje percepcijeb
hypersensitivity
napadi spancaa,
44 Metabolism and nutrition disorders
motnje
anorexia, decreased appetite a
(halucinacijea, vizualne
Psychiatric
psihotične motnje
b
somnolencaa,
sleep attacks,
diskinezijaa, posturalna
disorders
sinkopa,
disturbances
konvulzija, izguba
psychotic disorder
Očesne bolezni
(hallucination, visual a hallucination,
omoticaa
(including paranoid psychosis), compulsive
omotica, glavobola
auditory hallucination, illusion), confusion state, abnormal dreamsa, insomnia
vazovagalna sinkopa, distonija, hipersomnija, letargija, motnje pozornosti, poslabšanje spomina, parestezija, disgevzija, motnje ravnotežja, tremor motnje vida,
disorders (including pathologic gambling, punding), increased
(glejte poglavje 4. 4)
a
fotopsija, zamegljen vid
libido (including hypersexuality), anxiety, sleep a disorder, nightmares, disorientation
Ušesne bolezni, vključno z motnjami labirinta
Nervous system disorders
vrtoglavica (vključno s pozicijsko)
somnolence, dizzinessa
Srčne bolezni
dyskinesia, dizziness postural, a headache
atrijska fibrilacija,
Eye disorders (see section 4.4)
supraventrikularna
visual disturbance, photopsia, blurred vision
Žilne bolezni
Ear and labyrinth disorders Cardiac disorders
ortostatska hipotenzija
vertigo (incl. positional) atrial fibrillation, supraventricular heart rate increased, tachycardia palpitations a
pospešeno bitje srca, palpitacije hipertenzijaa,
Vascular disorders
tahikardija
hypertension, hypotension a
hipotenzija
Respiratory, thoracic and mediastinal disorders
46 Organski sistem
cough, hiccup, dyspnoea
Zelo pogosti
a
Pogosti
Gastrointestinal disorders
po MedDRA
nausea
> 1/ 10
vomiting, a diarrhoea, a
> 1/ 100, ≤1/ 10
abdominal pain (incl. upper
> 1/ 1. 000, ≤1/ 100
constipation, a
≤1/ 1. 000
abdominal pain),
navzeaa,
dyspepsia, dry a mouth
bruhanjea, driskaa,
stomach discomfort
bolečine v trebuhu
Hepato-biliary disorder
Bolezni jeter, žolčnika in žolčevodov
hepatic enzyme increased (including GGT, ALAT, ASAT)
zaprtjea, dispepsijaa, suha ustaa povišanje jetrnih encimov (vključno z γ - GT, ALT, AST)
45 Skin and subcutaneous tissue disorders
(vklj. z bolečinami v zgornjem predelu trebuha), neprijeten občutek v želodcu
rash (incl. rash, allergic; macular, exanthema)(see section 4.4), a erythema; pruritus, a hyperhydrosis,
izpuščaj (vključno z
generalized pruritus, dermatitis contact, skin irritation
razširjen pruritus,
joint swelling
podkožja
Reproductive system and breast disorder
alergijskim izpuščajem,
erectile dysfunction
kontaktni
a
makuloznim izpuščajem, eksantemom) (glejte poglavje 4. 4), eritema, pruritus, hiperhidrozaa
a
dermatitis, draženje kože otekanje sklepov erektilna disfunkcija
application site b
reakcije na mestu
oedema peripheral,
periferni edema,
gait disturbance,
motnje hojea,
and administration site conditions
spremembe na
reactions (including a erythema, a
aplikacijeb,
a
astenična stanjab
asthenic b conditions (incl. a fatigue, asthenia,
nenavadno počutje,
feeling abnormal, a weight increased,
mestu aplikacije
pruritus
(vključno z
, irritation, a
(vključno z
malaise), weight
povečanje telesne
burning, dermatitis,
Poškodbe in zastrupitve a
a
eritemoma, pruritusoma, draženjema, pečenjema, dermatitisoma, vnetjem, papulami, vezikli, mehurji, bolečino, preobčutljivostjo) (glejte poglavje 4. 4)
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.
47 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.
46 Pharmacotherapeutic group:
Farmakoterapevtska skupina:
The patients were titrated to their optimal dose of rotigotine in weekly increments of 2 mg/ 24 h starting at 2 mg/ 24 h to a maximum dose of 8 mg/ 24 h over 4 weeks.
V
In the ropinirole group, patients were titrated to their optimal dose up to a maximum of 24 mg/ day over 13 weeks.
48 skupini, ki je prejemala ropinirol, so bolnikom 13 tednov postopno povečevali odmerek do optimalnega odmerka, do največ 24 mg/ dan.
47 34% of the subjects receiving placebo (Differences 22% and 21%, respectively CI95% 10%; 35% and 8%; 33%, respectively, p < 0.001 for both rotigotine groups).
Pri rotigotinu je bila srednja vrednost zmanjšanja časa » izklop « 2, 7 ure pri skupini, ki je prejemala 8 mg rotigotina/ 24 h, in 2, 1 ure pri skupini, ki je prejemala 12 mg rotigotina/ 24 h.
Approximately 45% of the active substance within the patch is released to the skin in 24 hours.
49 V 24 urah se iz obliža sprosti v kožo približno 45% zdravilne učinkovine.
48 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.
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.
Ta mutageni
This mutagenic effect could be attributed to a clastogenic effect of rotigotine.
50 učinek lahko pripišemo klastogenim učinkom rotigotina.