natgillin/translations-raw huggingface dataset:
Målestokken for virkningen var, hvor lang tid om dagen patienterne indberettede som ” off- periode ” (når de havde for mange symptomer på Parkinsons sygdom til at leve normalt).
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).
I den første undersøgelse blev virkningen af to forskellige doser af Neupro sammenlignet med placebo, og i den anden undersøgelse blev den sammenlignet med pramipexol (en anden dopamin- agonist) og placebo.
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.
Ved Restless Legs Syndrom blev Neupro undersøgt i to hovedundersøgelser af i alt 963 patienter med moderat til svær sygdom.
For restless legs syndrome, Neupro has been studied in two main studies involving a total of 963 patients with moderate to severe disease.
24 timer blev sammenlignet med virkningen af placebo.
The effectiveness of Neupro at doses between 0.5 and 3 mg/ 24 h was compared with that of placebo.
Den vigtigste målestok for virkningen var ændringen i symptomerne mellem begyndelsen af undersøgelsen og efter seks måneders behandling med en stabil dosis, målt ved hjælp af to skalaer.
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.
Neupro var mere virkningsfuldt end placebo til behandling af Parkinsons sygdom.
Neupro was more effective than placebo in treating Parkinson’ s disease.
I de tidligere sygdomsstadier gav Neupro bedre score- værdier end placebo i UPDRS- spørgeskemaet.
In early-stage disease, the scores obtained with Neupro showed an improvement compared with placebo in the UPDRS.
Der blev opnået en forbedring på 20% i scoreværdierne hos 48 – 52% af de patienter, der fik Neupro og hos 19 til 30% af de patienter, der fik placebo.
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.
Neupro var ikke så effektivt som ropirinol: en forbedring på 20% sås også hos 68% af de patienter, der fik ropinirol.
Neupro was less effective than ropinirole: a 20% improvement was seen in 68% of the subjects receiving ropinirole.
Ved fremskreden Parkisons sygdom var der en større aftagen i “ off- perioden ” hos patienter, der fik Neupro end dem, der fik placebo (fald på 2, 1 til 2, 7 timer med Neupro sammenlignet med 0, 9 time med placebo).
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).
Aftagningen for pramipexol var 2, 8 timer.
The decrease with pramipexole was 2.8 h.
24 timer end dem, der anvendte placebo i de to undersøgelser, målt ved hjælp af begge symtomskalaer.
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.
Hvilke risici er der forbundet med Neupro?
What is the risk associated with Neupro?
De hyppigste bivirkninger ved Neupro hos patienter med Parkinsons sygdom (set hos flere end 1 ud af 10 patienter) er søvnighed, svimmelhed, kvalme og reaktioner på påsætningsstedet som irritation og brændende hud.
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.
Hos patienter med Restless Legs Syndrom var de hyppigste bivirkninger (set hos flere end 1 ud af 10 patienter) kvalme, reaktioner på påsætningsstedet, træthed og hovedpine.
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.
Det er vigtigt, at plasteret bruges som anbefalet for at begrænse reaktionerne fra huden.
It is important to use the patch as instructed to limit skin reactions.
Tendensen til søvnighed kan nedsætte patientens evne til at føre motorkøretøj.
Somnolence can affect the ability of the patient to drive.
En fuldstændig liste over de indberettede bivirkninger for Neupro fremgår af indlægssedlen.
For the full list of all side effects reported with Neupro, see the Package Leaflet.
Neupro må ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for rotigotin eller nogen af indholdsstofferne.
Neupro should not be used in people who may be hypersensitive (allergic) to rotigotine or any of the other ingredients.
For at undgå forbrænding af huden skal Neupro aftages, hvis patienten skal have foretaget MR- scanning eller 2/ 3 kardioversion (en proces, der genetablerer normal hjerterytme).
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).
En fuldstændig liste over begrænsningerne fremgår af indlægssedlen.
For the full list of restrictions, see the Package Leaflet.
Hvorfor blev Neupro godkendt?
2/ 3 Why has Neupro been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved Neupro er større end dets risici ved symptomatisk behandling af moderat til svær idiopatisk Restless Legs Syndrom hos voksne og til behandling af tegn og symptomer på idiopatisk Parkinsons sygdom.
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.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Neupro.
The Committee recommended that Neupro be given marketing authorisation.
Hvilke forholdsregler træffes der for at sikre risikofri anvendelse af Neupro?
Which measures are being taken to ensure the safe use of Neupro?
(anfald af søvnighed og udvikling af hårdt væv i hjerteklapperne).
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).
Andre oplysninger om Neupro:
Other information about Neupro:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Neupro til Schwarz Pharma Limited den 15. februar 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Neupro to Schwarz Pharma Ltd. on 15 February 2006.
Den fuldstændige EPAR for Neupro findes her.
The full EPAR for Neupro can be found here.
EU nummer.
EU Number
EU/ 1/ 05/ 331/ 001
EU/ 1/ 05/ 331/ 001
2 mg/ 24 timer
2 mg/ 24h
Depotplaster Transdermal anvendelse
Transdermal patch
Brev (papir / LDPE / alu / ET copolymer PE / Alu / ET copolymer / papir)
sachet (paper/ LDPE/ alu/ ET copolymer PE/ Alu/ ET copolymer/ paper)
100 depotplastre
100 patches
4 mg/ 24 timer
4 mg/ 24h
6 mg/ 24 timer
6 mg/ 24h
8 mg/ 24 timer
8 mg/ 24h
EU/ 1/ 05/ 331/ 012
EU/ 1/ 05/ 331/ 012
28 depotplastre (7x 2mg/ 24 timer, 7x 4mg/ 24 timer, 7x 6mg/ 24 timer, 7x 8mg/ 24 timer)
28 patches (7x 2mg/ 24h, 7x 4mg/ 24h, 7x 6mg/ 24h, 7x 8mg/ 24h)
1/ 4 EU/ 1/ 05/ 331/ 014
EU/ 1/ 05/ 331/ 014
(papir / LDPE / alu / ET copolymer PE / ET copolymer / papir)
sachet (paper/ LDPE/ alu/ ET copolymer PE/ Alu/ ET copolymer/ paper)
20 depotplastre
20 patches
(papir / LDPE / alu / ET copolymer PE / ET copolymer / papir))
sachet (paper/ LDPE/ alu/ ET copolymer PE/ Alu/ ET copolymer/ paper)
56 depotplastre
56 patches
60 depotplastre
60 patches
90 depotplastre
90 patches
EU/ 1/ 05/ 331/ 022
EU/ 1/ 05/ 331/ 022
2/ 4 EU/ 1/ 05/ 331/ 031
EU/ 1/ 05/ 331/ 031
EU/ 1/ 05/ 331/ 033
EU/ 1/ 05/ 331/ 033
1 mg/ 24 timer
1 mg/ 24h
EU/ 1/ 05/ 331/ 044
EU/ 1/ 05/ 331/ 044
3 mg/ 24 timer
3 mg/ 24h
3/ 4 EU/ 1/ 05/ 331/ 048
EU/ 1/ 05/ 331/ 048
EU/ 1/ 05/ 331/ 054
EU/ 1/ 05/ 331/ 054
Neupro 1 mg/ 24 timer depotplaster
Neupro 1 mg/ 24 h transdermal patch
Hvert plaster afgiver 1 mg rotigotin per 24 timer.
Each patch releases 1 mg of rotigotine per 24 hours.
Hvert plaster på 5 cm2 indeholder 2, 25 mg rotigotin.
Each patch of 5 cm2 contains 2.25 mg of rotigotine.
Den ydre side af bagsidelaget er beige og påtrykt Neupro 1 mg/ 24 timer.
The outside of the backing layer is tan-coloured and imprinted with Neupro 1 mg/ 24 h.
Neupro er indiceret til symptomatisk behandling af moderat til svær idiopatisk Restless Legs Syndrome hos voksne.
Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
Dosering Dosisanbefalingerne er angivet i den nominelle dosis.
Dosage The dose recommendations made are in nominal dose.
En daglig enkeltdosis bør indledes med 1 mg/ 24 t.
A single daily dose should be initiated at 1 mg/ 24 h.
Afhængigt af det individuelle patientrespons, kan dosis øges i ugentlige trin på 1 mg/ 24 t til en maksimal dosis på 3 mg/ 24 t.
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.
Behandlingsseponering Behandlingen med Neupro bør seponeres gradvist.
Treatment discontinuation Neupro should be discontinued gradually.
Den daglige dosis bør reduceres med trin på 1 mg/ 24 t, hvor dosisreduktion hver anden dag er at foretrække, indtil behandlingen med Neupro er ophørt helt (se pkt.
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).
Når denne fremgangsmåde blev fulgt, blev der ikke observet rebound (forværring af symptomer i forhold til udgangssymptomer efter seponering af behandlingen).
Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) was not observed.
Nedsat lever - og nyrefunktion:
Hepatic and renal impairment:
Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion eller hos patienter med let til svært nedsat nyrefunktion inklusive dialysepatienter.
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.
Det tilrådes at udvise forsigtighed ved behandling af patienter med svært nedsat leverfunktion, da denne kan resultere i nedsat rotigotinclearance.
Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance.
Neupro er ikke undersøgt hos denne patientgruppe.
Neupro has not been investigated in this patient group.
5. 2).
Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section 5.2).
Neupro bør ikke anvendes til børn og unge p. g. a. manglende dokumentation for sikkerhed og virkning.
Neupro is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Anvendelsesmåde Plasteret skal anbringes på et rent, tørt, intakt, sundt hudområde på mave, lår, hofter, side, skulder eller overarm.
Method of administration The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm.
Neupro må ikke placeres på hud, som er rød, irriteret eller beskadiget (se pkt.
Neupro should not be placed on skin that is red, irritated or damaged.
Anvendelse og håndtering:
Use and handling:
Den ene halvdel af beskyttelseslaget fjernes, og den klæbende side påsættes og presses fast mod huden.
One half of the protective liner should be removed and the sticky side should be applied and pressed firmly to the skin.
Derefter foldes plasteret tilbage, og den anden halvdel af beskyttelseslaget fjernes.
Then, the patch is fold back and the second part of the release liner is removed.
Plasteret skal presses fast mod huden med håndfladen i 20- 30 sekunder, så det klæber godt.
The patch should be pressed down firmly with the palm of the hand for about 20 to 30 seconds, so that it sticks well.
Hvis et plaster falder af, bør et nyt plaster påsættes til det resterende 24- timers dosisinterval.
In the event that a patch should fall off, a new patch should be applied for the remainder of the 24 hour dosing interval.
4. 4).
Magnetic resonance imaging or cardioversion (see section 4.4).
For at undgå forbrænding af huden skal Neupro fjernes, hvis patienten skal have foretaget MR- scanning eller kardioversion.
To avoid skin burns, Neupro should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion.
Dopaminagonister er kendt for at svække den systemiske regulering af blodtrykket og dermed forårsage postural/ ortostatisk hypotension.
Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/ orthostatic hypotension.
Disse hændelser blev også observeret under behandling med Neupro, men forekomsten var på niveau med forekomsten hos patienter, som fik placebo.
These events were also observed during treatment with Neupro, however the incidence was similar to that in placebo-treated patients.
Der sås synkope i forbindelse med Neupro, men også i tilsvarende grad hos patienter, som fik placebo.
Syncope was observed in association with Neupro, but also at a similar rate in patients treated with placebo.
Neupro har været forbundet med søvnighed og episoder med pludseligt indsættende søvn.
Neupro has been associated with somnolence and episodes of sudden sleep onset.
Patologisk spil, øget libido og hyperseksualitet er blevet rapporteret hos patienter, der behandles med dopaminagonister, herunder rotigotin.
Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotigotine.
Selvom det ikke er rapporteret ved Neupro, er symptomer, der tyder på neuroleptisk malignt syndrom, rapporteret ved pludselig seponering af dopaminbehandling.
Although not reported with Neupro, symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
4. 2).
Therefore it is recommended to taper treatment (see section 4.2).
Der er rapporteret om hallucinationer, og patienter bør informeres om, at hallucinationer kan forekomme.
Hallucinations have been reported and patients should be informed that hallucinations can occur.
Fibrotiske komplikationer:
Fibrotic complications:
Der er rapporteret tilfælde med retroperitoneal fibrose, pulmonære infiltrater, pleuraleksudat, pleural fortykkelse, pericarditis og kardial valvulopati hos nogle patienter, som behandles med dopaminerge ergolinderivater.
Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents.
Selv om disse komplikationer kan fortage sig, når behandling ophører, er det ikke altid de forsvinder fuldstændigt.
While these complications may resolve when treatment is discontinued, complete resolution does not always occur.
3 Selvom disse bivirkninger menes at være relateret til disse stoffers ergoline struktur, vides det ikke, om andre non- ergoline dopaminagonister kan forårsage dem.
3 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.
4. 5).
Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also section 4.5).
Rapporter fra litteraturen indikerer, at behandling af Restless Legs Syndrome med dopaminerge lægemidler kan resultere i augmentation.
Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Området, hvor plasteret sidder, bør ikke udsættes for ekstern varme (kraftigt sollys, varmepuder og andre varmekilder som sauna og varme bade).
External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) should not be applied to the area of the patch.
Det anbefales, at applikationsstedet veksles dagligt (f. eks. fra højre side til venstre side og fra overkrop til underkrop).
It is recommended that the application site should be rotated on a daily basis (e. g. from the right side to the left side and from the upper body to the lower body).
Hvis der forekommer reaktioner på applikationsstedet, som varer mere end nogle få dage, eller som er vedvarende, hvis deres sværhedsgrad øges, eller hvis hudreaktionerne breder sig ud over applikationsstedet, bør der foretages en vurdering af fordele og ulemper for den enkelte patient.
If application site reactions occur which last for more than a few days or are persistent, if there is an increase in severity, or if the skin reaction spreads outside the application site, an assessment of the risk/ benefit balance for the individual patient should be conducted.
Hvis depotplasteret forårsager hududslæt eller irritation, bør direkte sollys på området undgås, til huden heler.
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals.
Udsættelse for sollys kan medføre ændringer i hudfarven.
Exposure could lead to changes in the skin color.
Hvis der observeres en generaliseret hudreaktion (f. eks. allergisk udslæt, inklusive erythem, maculopapulært udslæt eller pruritus) i forbindelse med anvendelsen af Neupro, skal behandlingen seponeres.
If a generalised skin reaction (e. g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Neupro is observed, Neupro should be discontinued.
Da rotigotin er en dopaminagonist, antages det, at dopaminantagonister som neuroleptika (f. eks. fenothiaziner, butyrofenoner, thioxanthener) eller metoclopramid kan reducere Neupros effekt, og samtidig brug bør undgås.
Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e. g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Neupro, and co-administration should be avoided.
På grund af mulig additiv effekt bør der udvises forsigtighed, når patienter tager beroligende lægemidler eller andre CNS- depressiva (centralnervesystem) (f. eks. benzodiazepiner, antipsykotika, antidepressiva) eller indtager alkohol i kombination med rotigotin.
Because of possible additive effects, caution should be advised when patients are taking sedating medicinal products or other CNS (central nervous system) depressants (e. g. benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with rotigotine.
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 administrering af domperidon og rotigotin havde ingen effekt på rotigotins farmakokinetik.
Co-administration of domperidone with rotigotine had no effect on the pharmacokinetics of rotigotine.
Samtidig administration af omeprazol (CYP2C19- hæmmer) i doser på 40 mg/ dag, havde ingen effekt på rotigotins farmakokinetik eller metabolisme hos raske frivillige.
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.
Samtidig administration af rotigotin (3 mg/ 24 t) havde ingen effekt på perorale kontraceptiva (0, 03 mg ethinyløstradiol, 0, 15 mg levonorgestrel).
Co-administration of rotigotine (3 mg/ 24 h) did not affect the pharmacodynamics and pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).
Der foreligger ikke tilstrækkelige data fra brug af Neupro hos gravide kvinder.
There are no adequate data from the use of Neupro in pregnant women.
5. 3).
Animal studies do not indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice at materno-toxic doses (see section 5.3).
4 Da rotigotin nedsætter prolaktinsekretionen hos mennesker, forventes det, at mælkedannelsen hæmmes.
4 Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected.
Forsøg med rotter har vist, at rotigotin og/ eller dets metabolit( ter) udskilles i modermælk.
Studies in rats have shown that rotigotine and/ or its metabolite(s) is excreted in breast milk.
Rotigotin kan have betydelig virkning på evnen til at føre motorkøretøj eller betjene maskiner.
Rotigotine may have major influence on the ability to drive and use machines.
4. 4 og 4. 5).
Patients being treated with rotigotine and presenting with somnolence and/ or sudden sleep episodes must be informed not to drive or engage in activities (e. g. operating machines) where impaired alertness may put themselves or others at risk of serious injury or death until such recurrent episodes and somnolence have resolved (see also sections 4.4 and 4.5).
Baseret på analysen af de samlede placebo- kontrollerede kliniske forsøg, som i alt omfatter 748 Neupro - og 214 placebo- behandlede patienter, rapporterede 65, 0% af patienterne på Neupro og 32, 7% af patienterne på placebo mindst en bivirkning.
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.
Bivirkninger rapporteret hos mere end 10% af patienterne behandlet med Neupro depotplaster er kvalme, reaktioner på administrationsstedet, døsighed og hovedpine.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro are nausea, application site reactions, fatigue and headache.
I forsøg, hvor applikationsstedet blev vekslet som beskrevet i instruktionerne i produktresumeet og indlægssedlen, fik 34, 2% af de 748 patienter, som brugte Neupro, reaktioner på applikationssstedet.
In trials where the application sites were rotated as reflected in the instructions provided in the SPC and package leaflet, 34.2% of 748 patients using Neupro, experienced application site reactions.
Størstedelen af disse reaktioner var lette eller moderate i intensitet, begrænset til applikationsområderne og førte hos 7, 2% af patienterne til seponering af behandlingen med Neupro.
The majority of these reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of Neupro in 7.2% of subjects.
Følgende tablet omfatter bivirkninger fra alle forsøg hos patienter med Restless Legs Syndrome.
The following table covers adverse drug reactions from all studies in patients with Restless Legs Syndrome.
Systemorganklasse i
System/ organ
henhold til MedDRA
classes acc. to MedDRA
almindelig ≥1/ 10
≥ 1/ 10
≥1/ 100, ≤1/ 10
≥ 1/ 100, < 1/ 10
≥1/ 1. 000, ≤1/ 100
≥ 1/ 1,000, < 1/ 100
≥1/ 10. 000, ≤1/ 1. 000
≥ 1/ 10,000, ≤ 1/ 1,000
kvalme
Nausea
opkastning, dyspepsi
Vomiting, Dyspepsia
Almene symptomer og reaktioner på administrationsstede t
General disorders and administration
reaktioner på administrations - steda (inkl. erythem, pruritus, irritation, udslæt, dermatitis, vesikler, smerte, eksem, inflammation, hævelse, misfarvning, papler, ekskoriation, urticaria, overfølsomhed) udmattelse
Application and instillation site a
irritabilitet
Irritability
Immunsystemet
site conditions
overfølsomhed
Hypersensitivity
døsighed
Somnolence
Systemorganklasse i
disorders
Meget
5
Almindelig
Psychiatric
Usædvanlig
Sleep attacks,
Sjælden
Impulse
henhold til MedDRA
control a
almindelig ≥1/ 10
Obsessive
≥1/ 100, ≤1/ 10
disorders
≥1/ 1. 000, ≤1/ 100
Sexual desire a
≥1/ 10. 000, ≤1/ 1. 000
disorder (incl.
Psykiske forstyrrelser
compulsive