natgillin/translations-raw huggingface dataset:
Følgende tabel indeholder bivirkninger fra alle forsøg med patienter med Parkinsons sygdom.
The following table covers adverse drug reactions from all studies in patients with Parkinson’ s disease.
almindelig > 1/ 10
> 1/ 10
> 1/ 100, ≤1/ 10
> 1/ 100, ≤ 1/ 10
> 1/ 1. 000, ≤1/ 100
> 1/ 1,000, ≤ 1/ 100
≤1/ 1. 000
≤ 1/ 1,000
Immunsystemet Metabolisme og ernæring
Metabolism and nutrition disorders
overfølsomhed anoreksi, nedsat appetit
anorexia, decreased appetite a
sanseforstyrrelserb a
perception
søvnanfalda,
sleep attacks,
(hallucination, visuelle hallucinationera,
disturbances
psykotiske forstyrrelser (inkl. paranoid psykose),
psychotic disorder
hørehallucinationer, tvangsforstyrrelser illusioner), forvirret (inklusive
(hallucination, visual a hallucination,
tilstand, unormale drømmea, søvnløsheda
(including paranoid psychosis), compulsive
patologisk spil og tvangshandlinger), øget libido (inklusive hyperseksualitet), angst, søvnforstyrrelsera mareridt, forvirring
auditory hallucination, illusion), confusion state, abnormal a dreams, insomnia
Nervesystemet
disorders (including pathologic gambling, punding), increased
døsigheda, svimmelheda
a
dyskinesia, postural synkope, vasovagal krampe, svimmelhed, synkope, dystoni, bevidstløshed a hovedpine hypersomni, letargi, opmærksomheds - forstyrrelse, paræstesi, dysgeusi,
libido (including hypersexuality), anxiety, sleep a disorder, nightmares, disorientation
15 Systemorganklasse i
15
Meget
a
Almindelig
a
Usædvanlig
Nervous system disorders
Sjælden
somnolence, a dizziness
henhold til MedDRA
dyskinesia, dizziness postural, a headache
almindelig > 1/ 10
convulsion, loss of consciousness
> 1/ 100, ≤1/ 10
Eye disorders (see section 4.4)
> 1/ 1. 000, ≤1/ 100
visual disturbance, photopsia, blurred vision
≤1/ 1. 000
Ear and labyrinth disorders
balanceforstyrrelse, rysten Øjne visuel forstyrrelse, (se pkt.
vertigo (incl. positional)
4. 4) Øre og labyrint
Cardiac disorders
fotopsi, sløret syn svimmelhed (inkl. positions - svimmelhed)
atrial fibrillation, heart rate increased, palpitations a
Hjerte
supraventricular tachycardia
atriefibrillation, øget hjertefrekvens, hjertebanken
Vascular disorders
supraventrikulær takykardi
orthostatic hypotension (see section 4.4)
Vaskulære sygdomme
hypertension, hypotension a
4. 4)
Respiratory, thoracic and mediastinal disorders
hypertensiona, hypotension
cough, hiccup, dyspnoea
Luftveje, thorax og mediastinum
a
hoste, hikkea, dyspnø
a
kvalmea,
nausea
opkastninga, diarréa, forstoppelsea, dyspepsia, a
vomiting, a diarrhoea, constipation,
mavesmerter (inkl. smerter i mellemgulvet),
abdominal pain (incl. upper
mundtørhed
abdominal pain),
ubehag i maven
dyspepsia, dry a mouth
Lever og galdeveje
stomach discomfort
øgede hepatiske enzymer (inkl.
Hepato-biliary disorder
udslæt (inkl. allergisk udslæt, makulært udslæt, exanthem) (se pkt.
rash (incl. rash, allergic; macular, exanthema)(see section 4.4), a erythema; pruritus, a hyperhydrosis,
4. 4), erythema, pruritus, hyperhidrosisa
generalized pruritus, dermatitis contact, skin irritation
generaliseret pruritus, kontaktdermatitis, hudirritation
Musculoskeletal and connective tissue disorder
Knogler, led, muskler og bindevæv
Reproductive system and breast disorder
hævede led
General disorders
Det reproduktive system og mammae
application site b
erektil dysfunktion
oedema peripheral,
Almene symptomer og reaktioner på administrationsstede t
and administration site conditions
reaktioner på administrations - stedb (inkl. erythema, pruritusa, irritationa, brændena, dermatitisa, inflammation, papler, vesikler, blistre, smerte overfølsomhed) (se pkt.
reactions (including a erythema, a
perifere ødemera, asteniske tilstandeb (inkl. trætheda, svaghed, utilpashed), vægttab
asthenic b conditions (incl. a fatigue, asthenia,
gangforstyrrelsea, ildebefindende, vægtøgninga
feeling abnormal, a weight increased,
Traumer, forgiftninger og behandlingskomplik ationer
inflammation, papulae, vesicle, blister, pain, hypersensitivity) (see section 4.4) Injury, poisoning and procedural complications a
fald
fall
16 a Disse bivirkninger er i samlede placebokontrollerede forsøg rapporteret mindst 1% hyppigere end hos de patienter, som fik placebo b Overordnet begreb
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
Begge indikationer Neupro er forbundet med døsighed inklusive udpræget døsighed om dagen og pludselige søvnepisoder.
Both indications Neupro has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
4. 4 og 4. 7.
See also section 4.4 and 4.7
Kliniske forsøg ved Restless Legs Syndrome 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).
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 differences have been observed for the doses 1 mg/ 24 h, 2 mg/ 24 h and 3 mg/ 24 h in comparison to placebo.
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.
17 Neupros effekt ved behandlingen af tegn og symptomer ved idiopatisk Parkinsons sygdom er vurderet i et multinationalt lægemiddeludviklingsprogram bestående af fire pivotale, parallelle, randomiserede, dobbeltblinde, placebokontrollerede forsøg.
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.
To forsøg, som undersøgte Neupros behandlingseffekt ved tegn og symptomer på idiopatisk Parkinsons sygdom blev udført med patienter, som ikke samtidig blev behandlet med en dopaminagonist, og som enten var L- dopa- naive, eller hvor den tidligere L- dopa- behandling varede ≤ 6 måneder.
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.
Den primære resultatvurdering var scoren for dagligdagsaktiviteter (del II) samt motorisk undersøgelse (del III) på UPDRS- skalaen (Unified Parkinson’ s Disease Rating Scale).
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).
Effekten blev bedømt i henhold til patientens respons på behandling som respondentforbedring og forbedring af absolut pointtal i de samlede scorer for dagligdagsaktiviteter og motorisk undersøgelse (UPDRS del II og III).
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).
I et dobbeltblindt forsøg fik 177 patienter rotigotin, og 96 patienter fik placebo.
In one double blind study, 177 patients received rotigotine and 96 patients received placebo.
Patienterne blev titreret til deres optimale dosis rotigotin eller placebo med ugentlige trin på 2 mg/ 24 t startende ved 2 mg/ 24 t til maksimumdosis på 6 mg/ 24 t.
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.
Patienterne i hver behandlingsgruppe opretholdte deres optimale dosis i 6 måneder.
Patients in each treatment group were maintained at their optimal dose for 6 months.
6 mg/ 24 t, hos 91% af patienterne i rotigotin- armen.
6 mg/ 24 h.
Der sås en forbedring på 20% hos 48% af patienterne, som fik rotigotin og hos 19% af patienterne, som fik placebo (forskel 29% CI95% 18%; 39%, p < 0, 0001).
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).
Forskellen var 5, 28 point og statistisk signifikant (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).
I et andet dobbeltblindt forsøg fik 213 patienter rotigotin, 227 fik ropinirol og 117 patienter fik placebo.
In a second double-blind study, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo.
Patienterne blev titreret til deres optimale dosis rotigotin med ugentlige trin på 2 mg/ 24 t startende med 2 mg/ 24 t til maksimumdosis på 8 mg/ 24 t i 4 uger.
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.
I ropinirol- gruppen blev patienterne titreret til deres optimale dosis op til maksimum på 24 mg/ dag i 13 uger.
In the ropinirole group, patients were titrated to their optimal dose up to a maximum of 24 mg/ day over 13 weeks.
Patienterne i hver behandlingsgruppe opretholdte deres optimale dosis i 6 måneder.
Patients in each treatment group were maintained for 6 months.
8 mg/ 24 t, hos 92% af patienterne i rotigotin- armen,.
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.
(Forskellen på rotigotin versus placebo:
8 mg/ 24 h.
Den gennemsnitlige forbedring i UPDRS- scoren (del II og III) var 6, 83 point (baseline 33, 2 point) i rotigotin- armen, 10, 78 point i ropinirol- armen (baseline 32, 2 point) og 2, 33 point i placebo- armen (baseline 31, 3 point).
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).
Forskellen i effekt mellem ropinirol og rotigotin var også statistisk signifikant til fordel for ropinirol.
The difference in effect between ropinirole and rotigotine was also statistically significant in favour of ropinirole.
Der blev foretaget to yderligere forsøg med patienter, som samtidig blev behandlet med L- dopa.
18 Two additional trials were conducted in patients who were receiving concomitant levodopa therapy.
Den primære resultatvurdering var reduktion i “ off ” - tid (timer).
The primary outcome assessment was the reduction in “ off” time (hours).
Effekten blev bedømt i henhold til patientens respons på behandlingen som respondentforbedring og absolut forbedring med hensyn til “ off ” - tiden.
Efficacy was determined by the subject’ s response to therapy in terms of responder and absolute improvement in the time spent “ off”.
I et dobbeltblindt forsøg fik 113 patienter rotigotin op til en maksimumdosis på 8 mg/ 24 t, 109 patienter fik rotigotin op til en maksimumdosis på 12 mg/ 24 t, og 119 patienter fik placebo.
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.
Patienterne blev titreret til deres optimale dosis af rotigotin eller placebo med ugentlige trin på 2 mg/ 24 t startende ved 4 mg/ 24 t.
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.
(Forskellen var på henholdsvis 22% og 21%, CI95% henholdsvis 10%; 35% og 8%; 33%, p < 0, 001 for begge rotigotingrupper).
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).
Med rotigotin var middelreduktionen i “ off ” - tid henholdsvis 2, 7 og 2, 1 timer, mens der i den placebobehandlede arm sås en reduktion på 0, 9 timer.
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.
Forskellen var statistisk signifikant (henholdsvis p < 0, 001 og p=0, 003).
The differences were statistically significant (p < 0.001 and p=0.003, respectively).
I et andet dobbeltblindt forsøg fik 201 patienter rotigotin, 200 fik pramipexol og 100 patienter fik placebo.
In a second double-blind study, 201 patients received rotigotine, 200 received pramipexole and 100 patients received placebo.
Patienterne blev titreret til deres optimale rotigotin- dosis med ugentlige trin på 2 mg/ 24 t startende ved 4 mg/ 24 t til en maksimumdosis på 16 mg/ 24 t.
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.
I pramipexol- gruppen fik patienterne 0, 375 mg den første uge, 0, 75 mg i den anden uge og blev yderligere titreret med ugentlige trin på
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.
18 0, 75 mg til deres optimale dosis op til et maksimum på 4, 5 mg/ dag.
Patients in each treatment group were maintained for 4 months.
(Forskellen på rotigotin versus placebo 25%; CI95% 13%; 36%, forskel pramipexol versus placebo 32% CI95% 21%; 43%, forskel pramipexol versus rotigotin 7%; CI95% - 2%; 17%). Middelreduktionen i “ off ” - tid var 2, 5 timer i rotigotin- armen, 2, 8 timer i pramipexol- armen og 0, 9 timer i placebo- armen.
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.
Alle forskelle imellem de aktive behandlinger og placebo var statistisk signifikante.
All differences between the active treatments and placebo were statistically significant.
Forskellene i rotigotins biotilgængelighed lå i intervallet 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).
Elimination Cirka 71% af rotigotindosen udskilles med urinen, og en mindre del på omkring 23% udskilles i fæces.
19 Elimination Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is excreted in faeces.
19 I kroniske - og langtids- toksicitetsforsøg blev hovedeffekten forbundet med dopaminagonist- relateret farmakodynamisk effekt og den deraf følgende reducerede prolaktinsekretion.
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.
Selvklæbende matrixlag:
20 Self adhesive matrix layer:
20 Opbevares i køleskab (2°C – 8°C).
Store in a refrigerator (2°C – 8°C).
Neupro 3 mg/ 24 timer depotplaster
Neupro 3 mg/ 24 h transdermal patch
Hvert plaster afgiver 3 mg rotigotin per 24 timer.
Each patch releases 3 mg of rotigotine per 24 hours.
Hvert plaster på 15 cm2 indeholder 6, 75 mg rotigotin.
Each patch of 15 cm2 contains 6.75 mg of rotigotine.
Den ydre side af bagsidelaget er beige og påtrykt Neupro 3 mg/ 24 timer.
The outside of the backing layer is tan-coloured and imprinted with Neupro 3 mg/ 24 h.
22 Børn og unge:
23 Children and adolescents:
23 Selvom disse bivirkninger menes at være relateret til disse stoffers ergoline struktur, vides det ikke, om andre non- ergoline dopaminagonister kan forårsage dem.
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.
Augmentation vil sige, at symptomerne optræder tidligere om aftenen (eller tilmed om eftermiddagen), og symptomerne forværres og involverer andre kropsdele.
Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts.
24 Da rotigotin nedsætter prolaktinsekretionen hos mennesker, forventes det, at mælkedannelsen hæmmes.
25 Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected.
Meget
26
26 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.
27 I kroniske - og langtids- toksicitetsforsøg blev hovedeffekten forbundet med dopaminagonist- relateret farmakodynamisk effekt og den deraf følgende reducerede prolaktinsekretion.
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.
28 Opbevares i køleskab (2°C – 8°C).
29 Store in a refrigerator (2°C – 8°C).
Neupro 4 mg/ 24 timer depotplaster
Neupro 4 mg/ 24 h transdermal patch
Hvert plaster afgiver 4 mg rotigotin per 24 timer.
Each patch releases 4 mg of rotigotine per 24 hours.
Hvert plaster på 20 cm2 indeholder 9, 0 mg rotigotin.
Each patch of 20 cm2 contains 9.0 mg of rotigotine.
Den ydre side af bagsidelaget er beige og påtrykt Neupro 4 mg/ 24 timer.
The outside of the backing layer is tan-coloured and imprinted with Neupro 4 mg/ 24 h.
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).
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).
Dosering til patienter med Parkinsons sygdom i tidlige stadier:
Dosing in patients with early-stage Parkinson’ s disease:
Hos de fleste patienter opnås en effektiv dosis inden for 3 eller 4 uger ved doser på henholdsvis 6 mg/ 24 t eller 8 mg/ 24 t.
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.
The maximal dose is 8 mg/ 24 h.
Dosering til patienter med Parkinsons sygdom i fremskredne stadier med udsving:
Dosing in patients with advanced stage Parkinson’ s disease with fluctuations:
30 Behandlingsseponering Behandlingen med Neupro bør seponeres gradvist.
31 Treatment discontinuation Neupro should be discontinued gradually.
Ordinerende læger bør løbende vurdere patienterne for døsighed eller søvnighed,
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned.
Patologisk spil, øget libido og hyperseksualitet er blevet rapporteret hos patienter, der behandles med dopaminagonister, herunder rotigotin.
32 Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotigotine.
Oftalmologisk monitorering anbefales med regelmæssige mellemrum, eller hvis der forekommer synsabnomalier.
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
32 Samtidig administration af L- dopa og karbidopa med rotigotin havde ingen effekt på rotigotins farmakokinetik, og rotigotin havde ingen indflydelse på L- dopa og karbidopas farmakokinetik.
Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.
Samtidig administration af omeprazol (CYP2C19- hæmmer) i doser på 40 mg/ dag, havde ingen effekt på rotigotins farmakokinetik eller metabolisme hos raske frivillige.
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.
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.
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.
33 Systemorganklasse i
System/ organ
Immunsystemet Metabolisme og ernæring
34 Metabolism and nutrition disorders
forstyrrelser
disturbances
(hallucination, visuelle hallucinationera,
(hallucination, visual a hallucination,
psykotiske forstyrrelser (inkl. paranoid psykose),
(including paranoid psychosis), compulsive
hørehallucinationer, tvangsforstyrrelser illusioner), forvirret (inklusive
auditory hallucination, illusion), confusion state, abnormal a dreams, insomnia
tilstand, unormale drømmea, søvnløsheda
disorders (including pathologic gambling, punding), increased
patologisk spil og tvangshandlinger), øget libido (inklusive hyperseksualitet), angst, søvnforstyrrelsera mareridt, forvirring
libido (including hypersexuality), anxiety, sleep a disorder, nightmares, disorientation
døsigheda, svimmelheda
somnolence, a dizziness
dyskinesia, postural synkope, vasovagal svimmelhed, synkope, dystoni, a hovedpine hypersomni, letargi, opmærksomheds - forstyrrelse, paræstesi, dysgeusi, balanceforstyrrelse, rysten
syncope, vasovagal convulsion, loss of syncope, dystonia, consciousness hypersomnia, lethargia, disturbance in attention, memory impaired, paraesthesia, dysgeusia, balance disorder, tremor
krampe, bevidstløshed
Eye disorders (see section 4.4)
4. 4) Øre og labyrint
Ear and labyrinth disorders Cardiac disorders
visuel forstyrrelse, fotopsi, sløret syn svimmelhed (inkl. positions - svimmelhed)
vertigo (incl. positional) atrial fibrillation, supraventricular heart rate increased, tachycardia palpitations a
atriefibrillation, øget hjertefrekvens, hjertebanken
orthostatic hypotension (see section 4.4)
supraventrikulær takykardi
hypertension, hypotension a
4. 4)
cough, hiccup, dyspnoea
hoste, hikkea, dyspnø
vomiting, a diarrhoea, a
Mave- tarm- kanalen
constipation, a
kvalmea,
abdominal pain),