natgillin/translations-raw huggingface dataset:
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.
Enkratni dnevni odmerek začnemo s 4 mg/ 24 h in ga nato povečujemo v tedenskih korakih po 2 mg/ 24 h do učinkovitega odmerka, največ do 16 mg/ 24 h.
4 mg/ 24 h or 6 mg/ 24 h may be effective doses in some patients.
4 mg/ 24 h ali 6 mg/ 24 h lahko zadoščata kot učinkovita odmerka za nekatere bolnike.
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.
Pri večini bolnikov se učinkovit odmerek doseže v 3 do 7 tednih pri odmerkih od 8 mg/ 24 h do največjega odmerka 16 mg/ 24 h.
10 mg/ 24 h may be reached by combination of a 6 mg/ 24 h and a 4 mg/ 24 h patch.
Pri odmerkih nad 8 mg/ 24 h lahko za doseganje končnega odmerka uporabimo več obližev, npr. odmerek 10 mg/ 24 h lahko dosežemo s kombinacijo obližev z odmerkom 6 mg/ 24 h in 4 mg/ 24 h.
Treatment discontinuation Restless Legs Syndrome Neupro should be discontinued gradually.
Prekinitev zdravljenja Sindrom nemirnih nog 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 je treba zmanjševati po 1 mg/ 24 h, po možnosti vsak drugi dan, do popolne odtegnitve zdravila Neupro (glejte poglavje 4. 4).
Parkinson’ s disease Neupro should be discontinued gradually.
Parkinsonova bolezen 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 zmanjšujemo po 2 mg/ 24 h, po možnosti vsak drugi dan, do popolne odtegnitve zdravila Neupro (glejte poglavje 4. 4).
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 rigotina (glejte poglavje 5. 2).
Method of administration The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm.
Način uporabe Obliž namestimo na čisto, suho, nepoškodovano zdravo kožo na trebuhu, stegnih, kolkih, bokih, ramah ali nadlahteh.
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 pa namestimo in močno pritisnemo na kožo.
11 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
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)
Če je odziv bolnika s Parkinsonovo boleznijo na zdravljenje z rotigotinom nezadosten, lahko prehod na drugega agonista dopamina ponuja dodaten uspeh zdravljenja (glejte poglavje 5. 1).
The backing layer of Neupro contains aluminium.
11 Oporna plast obliža zdravila Neupro vsebuje aluminij.
Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also section 4.5).
Bolnikom, ki jemljejo agoniste dopamina, se proti bruhanju ne sme dajati nevroleptikov (glejte tudi poglavje 4. 5).
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.
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.
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.
12 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.
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.
V kliničnih študijah pri bolnikih s Parkinsonovo boleznijo je bila po šestih mesecih specifična pogostnost perifernih edemov približno 4- odstotna in je taka ostala ves čas opazovanja do 36 mesecev.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5
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.
Zdravilo Neupro lahko ojača dopaminergične neželene učinke L- dope in povzroči in/ ali poslabša obstoječo diskinezijo, kot je opisano pri drugih agonistih dopamina.
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.
Sindrom nemirnih nog 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,
Vomiting, Dyspepsia
bruhanje, dispepsija,
General disorders and administration
Splošne težave in spremembe na mestu aplikacije Bolezni imunskega sistema
Application and instillation site a
razdražljivost preobčutljivost
Irritability
Bolezni živčevja
site conditions
glavobol
reactions (incl. erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, excoriation, urticaria, hypersensitivity) Fatigue
somnolenca
Immune system disorders
Obsesivno
Hypersensitivity
Psihiatrične motnje
Nervous system disorders
napadi spanca,
Headache
impulzivne motnje
Somnolence
kompulzivna
Psychiatric
motnje spolnega poželenjaa (vključno s hiperseksualnostjo, povečanim libidom), nespečnost, motnje spanja, nenavadne sanje
Sleep attacks,
(vključno s patološkim hazardiranjem in ponavljanjem nesmiselnih dejanj)
Impulse
motnja
control a
14 Organski sistem po
Obsessive
Zelo pogosti
Sexual desire a
Občasni
disorder (incl.
Redki
compulsive
MedDRA
disorder (incl. hypersexuality, libido increased), Insomnia, Sleep disorder, Abnormal dreams
≥1/ 10
pathological gambling, punding)
≥1/ 100, < 1/ 10
disorder
≥1/ 1. 000, < 1/ 100
Skin and subcutaneous tissue disorders
≥1/ 10. 000, ≤1/ 1. 000
14 Vascular disorders a) High Level Term
pruritus Bolezni kože in podkožja Žilne bolezni a) Izraz visoke stopnje
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.
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.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro transdermal patch are nausea, dizziness, somnolence and application site reactions.
Neželeni učinki, o katerih so poročali pri več kot 10% bolnikov, zdravljenih s transdermalnim obližem zdravila Neupro, so navzea, omotica, somnolenca in reakcije na mestu aplikacije.
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.
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 35, 7% od 830 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 treatment with Neupro in only 4.3% of all subjects receiving Neupro.
Večina teh reakcij je bila blagih ali zmernih, omejenih na mesto aplikacije, zdravljenje z zdravilom Neupro pa so zaradi njih prekinili le pri 4, 3% vseh bolnikov, ki so prejemali zdravilo Neupro.
The following table covers adverse drug reactions from all studies in patients with Parkinson’ s disease.
V spodnji tabeli so navedeni neželeni učinki zdravila, zbrani v vseh študijah na bolnikih s Parkinsonovo boleznijo.
> 1/ 1,000, ≤ 1/ 100
> 1/ 1. 000, ≤1/ 100
≤ 1/ 1,000
≤1/ 1. 000
Immune system disorder
preobčutljivost Bolezni imunskega sistema anoreksija, Presnovne in zmanjšan apetit prehranske motnje Psihiatrične motnje
hypersensitivity
motnje percepcijeb
Metabolism and nutrition disorders
napadi spancaa,
anorexia, decreased appetite a
(halucinacijea, vizualne halucinacijea, zvočne halucinacije, iluzije), zmedenost, nenavadne sanjea, nespečnosta
Psychiatric
psihotične motnje (vključno s paranoidno psihozo), kompulzivne motnje (vključno s patološkim hazardiranjem in ponavljanjem nesmiselnih dejanj), povečan libido (vključno s hiperseksualnostjo), tesnoba, motnje spanjaa, nočne more, dezorientiranost
perception
Bolezni živčevja
sleep attacks,
somnolencaa,
(hallucination, visual a hallucination,
diskinezijaa,
(including paranoid psychosis), compulsive
sinkopa,
disorders (including pathologic gambling, punding), increased
konvulzija, izguba
a
Organski sistem po
a
Zelo pogosti
Nervous system disorders
Pogosti
somnolence, a dizziness
Občasni
dyskinesia, dizziness postural, a headache
Redki
syncope, vasovagal syncope, dystonia, hypersomnia, lethargia, disturbance in attention, memory impaired, paraesthesia, dysgeusia, balance disorder, tremor
MedDRA
convulsion, loss of consciousness
> 1/ 10
Eye disorders (see section 4.4)
> 1/ 100, ≤1/ 10
visual disturbance, photopsia, blurred vision
> 1/ 1. 000, ≤1/ 100
Ear and labyrinth disorders
≤1/ 1. 000
vertigo (incl. positional)
Očesne bolezni
Cardiac disorders
omoticaa
atrial fibrillation, heart rate increased, palpitations a
posturalna omotica, glavobola
supraventricular tachycardia
vazovagalna sinkopa, distonija, hipersomnija, letargija, motnje pozornosti, poslabšanje spomina, parestezija, disgevzija, motnje ravnotežja, tremor motnje vida,
Vascular disorders
zavesti
orthostatic hypotension (see section 4.4)
(glejte poglavje 4. 4)
hypertension, hypotension a
fotopsija, zamegljen vid
Respiratory, thoracic and mediastinal disorders
navzeaa,
cough, hiccup, dyspnoea
bruhanjea, driskaa,
Gastrointestinal disorders
bolečine v trebuhu
nausea
Bolezni jeter, žolčnika in žolčevodov
vomiting, a diarrhoea, constipation,
zaprtjea, dispepsijaa, suha ustaa povišanje jetrnih encimov (vključno z γ- GT, ALT, AST)
abdominal pain (incl. upper
(vklj. z bolečinami v zgornjem predelu trebuha), neprijeten občutek v želodcu
a a
Bolezni kože in
abdominal pain),
izpuščaj (vključno
dyspepsia, dry a mouth
razširjen pruritus,
stomach discomfort
podkožja
Hepato-biliary disorder
z alergijskim
hepatic enzyme increased (including GGT, ALAT, ASAT)
kontaktni
Skin and subcutaneous tissue disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva Motnje reprodukcije in dojk
rash (incl. rash, allergic; macular, exanthema)(see section 4.4), a erythema; pruritus, a hyperhydrosis,
izpuščajem, makuloznim izpuščajem, eksantemom) (glejte poglavje 4. 4), eritema, pruritus, hiperhidrozaa
generalized pruritus, dermatitis contact, skin irritation
dermatitis, draženje kože otekanje sklepov erektilna disfunkcija
16
16 Organski sistem po
a
Občasni
a
Redki
General disorders
MedDRA
application site b
> 1/ 10
gait disturbance,
> 1/ 1. 000, ≤1/ 100
and administration site conditions
≤1/ 1. 000
reactions (including a erythema, a
Splošne težave in
a
reakcije na mestu
asthenic b conditions (incl. a fatigue, asthenia,
periferni edema,
feeling abnormal, a weight increased,
motnje hojea,
pruritus
spremembe na
, irritation, a
aplikacijeb,
malaise), weight
astenična stanjab
burning, dermatitis,
nenavadno počutje,
a
(vključno z
decreased
(vključno z
inflammation, papulae, vesicle, blister, pain, hypersensitivity) (see section 4.4) Injury, poisoning and procedural complications a
utrujenostjoa, astenijo, občutkom nelagodja), zmanjšanje telesne mase padci
fall
masea
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.
Both indications Neupro has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
Obe indikaciji Zdravilo Neupro je povezano s somnolenco, vključno s prekomerno dnevno somnolenco, in epizodami nenadnega spanca.
See also section 4.4 and 4.7
Glejte tudi poglavji 4. 4 in 4. 7.
The efficacy of Neupro was evaluated in 5 placebo-controlled trials with more than 1,400 patients with idiopathic Restless Legs Syndrome (RLS).
17 Klinične študije pri sindromu nemirnih nog Učinkovitost zdravila Neupro so ocenili v petih s placebom kontroliranih študijah z več kot 1. 400 bolniki z idiopatičnim sindromom nemirnih nog (Restless Legs Syndrome - RLS).
The changes from baseline in the International RLS Rating Scale (IRLS) and CGI-item 1 (severity of illness) were primary efficacy parameters.
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).
For both primary endpoints statistically significant 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.
Clinical studies in Parkinson’ s disease 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 pri Parkinsonovi bolezni 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.
Two trials investigating the effectiveness of Neupro in the treatment of the signs and symptoms of idiopathic Parkinson’ s disease were conducted in patients who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or previous L-dopa treatment was ≤ 6 months.
Dve preskušanji, pri katerih so preučevali učinkovitost zdravila Neupro pri zdravljenju znakov in simptomov idiopatične Parkinsonove bolezni, so opravili na bolnikih, ki niso prejemali sočasnega zdravljenja z agonistom dopamina in ki bodisi niso nikoli prejemali L- dope ali katerih predhodno zdravljenje z L- dopo je trajalo ≤ 6 mesecev.
The primary outcome assessment was the score for the Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part III) of the Unified Parkinson’ s Disease Rating Scale (UPDRS).
Ocena primarne končne točke raziskave je bila rezultat komponente dnevnih aktivnosti (ADL) (2. del) in komponente motoričnega pregleda (3. del) mednarodne lestvice za oceno kakovosti življenja in simptomov Parkinsonove bolezni (UPDRS – Unified Parkinson’ s Disease Rating Scale).
Efficacy was determined by the subject’ s response to therapy in terms of responder and absolute points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III).
Učinkovitost je bila določena glede na bolnikov odziv na zdravljenje, izražen kot izboljšanje stopnje odziva bolnika in absolutnega števila točk skupnega rezultata ADL in motoričnega pregleda lestvice UPDRS (2. + 3. del).
In one double blind study, 177 patients received rotigotine and 96 patients received placebo.
V eni dvojno slepi študiji je 177 bolnikov prejemalo rotigotin, 96 bolnikov pa placebo.
The patients were titrated to their optimal dose of rotigotine or placebo in weekly increments of 2 mg/ 24 h starting at 2 mg/ 24 h to a maximum dose of 6 mg/ 24 h.
Bolnikom so odmerek postopno povečevali do optimalnega odmerka rotigotina ali placeba v tedenskih korakih po 2 mg/ 24 h, od 2 mg/ 24 h do največjega odmerka 6 mg/ 24 h.
At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i. e.
Na koncu vzdrževalnega zdravljenja je bil optimalni odmerek pri 91% bolnikov, ki so prejemali rotigotin, največji dovoljeni odmerek, tj.
An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29% CI95% 18%; 39%, p < 0.0001).
20- odstotno izboljšanje so opazili pri 48% bolnikov, ki so prejemali rotigotin, in pri 19% bolnikov, ki so prejemali placebo (razlika 29%, CI95% 18% - 39%, p < 0, 0001).
With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was -3.98 points (baseline 29.9 point) whereas in the placebo-treated arm a worsening of 1.31 points was observed (baseline 30.0 points) The difference was 5.28 points and statistically significant (p < 0.0001).
Razlika je bila 5, 28 točke in je bila statistično pomembna (p < 0, 0001).
In a second double-blind study, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo.
V drugi dvojno slepi študiji je 213 bolnikov prejemalo rotigotin, 227 bolnikov je prejemalo ropinirol, 117 bolnikov pa placebo.
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.
Bolnikom so odmerek 4 tedne postopno povečevali do optimalnega odmerka rotigotina v tedenskih korakih po 2 mg/ 24 h, od 2 mg/ 24 h do največjega odmerka 8 mg/ 24 h.
In the ropinirole group, patients were titrated to their optimal dose up to a maximum of 24 mg/ day over 13 weeks.
V skupini, ki je prejemala ropinirol, so bolnikom 13 tednov postopno povečevali odmerek do optimalnega odmerka, do največ 24 mg/ dan.
At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i. e.
Na koncu vzdrževalnega zdravljenja je bil optimalni odmerek pri 92% bolnikov, ki so prejemali rotigotin, največji dovoljeni odmerek, tj.
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.
The difference in effect between ropinirole and rotigotine was also statistically significant in favour of ropinirole.
Razlika v učinku med ropinirolom in rotigotinom je bila tudi statistično pomembna v prid ropinirolu.
18 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.
The primary outcome assessment was the reduction in “ off” time (hours).
Primarna ocena izida je bilo zmanjšanje časa » izklop « (v urah).
Efficacy was determined by the subject’ s response to therapy in terms of responder and absolute improvement in the time spent “ off”.
Učinkovitost je bila določena glede na bolnikov odziv na zdravljenje, izražen kot izboljšanje stopnje odziva bolnika in absolutnega časa v fazi » izklop «.
In one double blind study, 113 patients received rotigotine up to a maximum dose of 8 mg/ 24 h, 109 patients received rotigotine up to a maximum dose of 12 mg/ 24 h and 119 patients received placebo.
V eni dvojno slepi študiji je 113 bolnikov prejemalo rotigotin do največjega odmerka 8 mg/ 24 h, 109 bolnikov je prejemalo rotigotin do največjega odmerka 12 mg/ 24 h, 119 bolnikov pa je prejemalo placebo.
The patients were titrated to their optimal doses of rotigotine or placebo in weekly increments of 2 mg/ 24 h starting at 4 mg/ 24 h.
Bolnikom so odmerek postopno povečevali do optimalnega odmerka rotigotina ali placeba v tedenskih korakih po 2 mg/ 24 h, z začetnim odmerkom 4 mg/ 24 h.
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 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).
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).
With rotigotine, the mean reductions in “ off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm a reduction of 0.9 hours was observed.
Pri skupini, ki je prejemala placebo, je bilo zmanjšanje 0, 9 ure.
The differences were statistically significant (p < 0.001 and p=0.003, respectively).
Razlike so bile statistično pomembne (p < 0, 001 v prvi skupini in p = 0, 003 v drugi).
In a second double-blind study, 201 patients received rotigotine, 200 received pramipexole and 100 patients received placebo.
V drugi dvojno slepi študiji je 201 bolnikov prejemalo rotigotin, 200 jih je prejemalo pramipeksol, 100 bolnikov pa je prejemalo placebo.
The patients were titrated to their optimal dose of rotigotine in weekly increments of 2 mg/ 24 h starting at 4 mg/ 24 h to a maximum dose of 16 mg/ 24 h.
Bolnikom so odmerek postopno povečevali do optimalnega odmerka rotigotina v tedenskih korakih po 2 mg/ 24 h, od 4 mg/ 24 h do največ 16 mg/ 24 h.
In the pramipexole group, patients received 0,375 mg in the first week, 0.75 mg in the second week and were titrated further in weekly increments of 0.75 mg to their optimal dose up to a maximum of 4.5 mg/ day.
V skupini, ki je prejemala pramipeksol, so bolniki prvi teden prejemali 0, 375 mg, drugi teden 0, 75 mg, nato pa so odmerek postopno povečevali v tedenskih korakih po 0, 75 mg do optimalnega odmerka največ 4, 5 mg/ 24 h.
At the end of the maintenance treatment an improvement of at least 30% was seen in 60% of the subjects receiving rotigotine, 67% of the subjects receiving pramipexole and 35% of the subjects receiving placebo (Difference rotigotine versus placebo 25%; CI95% 13%; 36%, difference pramipexole versus placebo 32% CI95% 21%; 43%, difference pramipexole versus rotigotine 7%; CI95% -2%; 17%). The mean reduction in the “ off” time was 2.5 hours in the rotigotine arm, 2.8 hours in the pramipexole arm and 0.9 hours in the placebo arm.
Srednja vrednost zmanjšanja časa » izklop « je bila pri skupini, ki je prejemala rotigotin, 2, 5 ure, pri skupini, ki je prejemala pramipeksol, 2, 8 ure, pri skupini, ki je prejemala placebo, pa 0, 9 ure.