FrancophonIA/ELRC3.0 huggingface dataset:
English: 116 patients were switched from previous oral therapy to receive up to 8 mg/24 h of rotigotine, among these were 47 who had been treated with ropinirole up to 9 mg/day, 47 who had been treated with pramipexole up to 2 mg/day and 22 who had been treated with cabergoline up to 3 mg/day.
Danish: Heriblandt var 47, som havde været i behandling med ropinirol, op til 9 mg/dag, 47, som havde været i behandling med pramipexol, op til 2 mg/dag og 22, som havde været i behandling med cabergolin, op til 3 mg/dag.
English: • For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available strengths), multiple patches must be applied to achieve the final dose.
Danish: • Til doser højere end 8 mg/24 timer (doser ordineret af Deres læge som er højere end de tilgængelige styrker) bruges flere plastre for at opnå den endelige dosis.
English: The box contains 7, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets.
Danish: Æsken indeholder 7, 28, 30 eller 84 (multipakning med 3 pakninger a 28) depotplastre, individuelt forseglede i breve.
English: hypersexuality, libido increased), confusional state, disorientation d,
Danish: hyperseksualite t, øget libido), forvirring, desorienteringd, agitationd
English: • Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7).
Danish: • Bagsidelag: Polyesterfilm, silikoniseret, aluminiseret, overtrukket med et farvet pigmentlag (titandioxid (E 171), pigment gul 95, pigment rød 166) med tekst påtrykt (pigment rød 144, pigment gul 95, pigment sort 7).
English: Peripheral oedema has been observed in clinical trials conducted in patients with RLS.
Danish: Der er blevet observeret perifere ødemer i kliniske studier med patienter med RLS.
English: For example, a daily dose of 14 mg may be reached by applying one patch of 6 mg/24 h and one patch of 8 mg/24 h and likewise, a daily dose of 16 mg can be reached by applying two patches of 8 mg/24 h.
Danish: For eksempel kan en daglig dosis på 14 mg nås ved at bruge ét plaster på 6 mg/24 timer og ét plaster på 8 mg/24 timer, og ligeledes kan en daglig dosis på 16 mg nås ved at bruge to plastre på 8 mg/24 timer.
English: • metoclopramide - used to treat nausea (feeling sick) and vomiting.
Danish: • metoclopramid - bruges til at behandle kvalme og opkastning.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige bivirkninger: kan forekomme hos flere end 1 ud af 10 personer
English: 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 Leganto (see section 4.4).
Danish: Den daglige dosis bør reduceres i trin på 2 mg/24 t, hvor dosisreduktion hver anden dag er at foretrække, indtil behandlingen med Leganto er ophørt helt (se pkt.
English: Peel off sachet in a cardboard carton: One side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene (innermost layer), aluminium, ethylene copolymer and paper.
Danish: 6.5 Emballagetype og pakningsstørrelser ”Peel off”-brev i papæske: Den ene side består af en copolymer af ethylen(inderlag), en aluminiumsfolie, LDPE-film og papir; den anden side består af polyethylen (inderste lag), aluminium, en copolymer af ethylen og papir.
English: Peel off sachet in a plastic box: One side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene (innermost layer), aluminium, ethylene copolymer and paper.
Danish: 6.5 Emballagetype og pakningsstørrelser ”Peel off”-brev i plastikæske: Den ene side består af en copolymer af ethylen(inderlag), en aluminiumsfolie, LDPE-film og papir; den anden side består af polyethylen (inderste lag), aluminium, en copolymer af ethylen og papir.
English: For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available strengths), multiple patches must be applied to achieve the final dose.
Danish: Til doser højere end 8 mg/24 timer (doser ordineret af Deres læge som er højere end de tilgængelige styrker ) bruges flere plastre for at opnå den endelige dosis.
English: 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 Leganto (see section 4.4).
Danish: Den daglige dosis bør reduceres i trin på 1 mg/24 t, hvor dosisreduktion hver anden dag er at foretrække, indtil behandlingen med Leganto er ophørt helt (se pkt.
English: hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disorders a,d
Danish: hyperseksualite t, øget libido), søvnløshed, søvnforstyrrels er, unormale drømme, impulskontrolf orstyrrelsera,d
English: In trials where the application sites were rotated as reflected in the instructions provided in the SmPC and package leaflet, 34.2% of 748 patients using Leganto, experienced application site reactions.
Danish: I studier, hvor applikationsstedet blev vekslet som beskrevet i instruktionerne i produktresumeet og indlægssedlen, fik 34,2% af de 748 patienter, som brugte Leganto, reaktioner på applikationssstedet.
English: Malignant tumours were noted predominantly in the uterus of mid- and high-dose females.
Danish: Maligne tumorer sås især i livmoderen hos hunner, som fik middel eller høj dosis.
English: 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. 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.
Danish: Patienterne blev titreret til deres optimale rotigotin-dosis i ugentlige trin på 2 mg/24 t startende ved 4 mg/24 t til en maksimumdosis på 16 mg/24 t. I pramipexol-gruppen fik patienterne 0,375 mg den første uge, 0,75 mg den anden uge og blev yderligere titreret i ugentlige trin på 0,75 mg til deres optimale dosis op til et maksimum på 4,5 mg/dag.
English: 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.
Danish: Området, hvor plasteret sidder, bør ikke udsættes for ekstern varme (kraftigt sollys, varmepude og andre varmekilder såsom sauna og varme bade).
English: Hypertension Orthostatic hypotension
Danish: Hypertension Ortostatisk hypotension
English: • generalised itching, skin irritation
Danish: • generaliseret kløe, hudirritation
English: • Press the patch down firmly with the palm of your hand.
Danish: • Pres plasteret fast på huden med håndfladen.
English: In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo.
Danish: I det dobbeltblinde studie SP513 del I fik 213 patienter rotigotin, 227 fik ropinirol og 117 patienter fik placebo.
English: Magnetic resonance imaging and cardioversion
Danish: MR-scanning og kardioversion
English: • feeling sleepy, falling asleep suddenly without warning, difficulty in sleeping, sleep problems,
Danish: • træthed, falder i søvn pludseligt uden varsel, søvnløshed, søvnforstyrrelser, usædvanlige drømme
English: Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache.
Danish: Bivirkninger rapporteret hos mere end 10% af patienterne behandlet med Leganto er kvalme, opkastninger, reaktioner på applikationsstedet, døsighed, svimmelhed og hovedpine.
English: OUTER LABEL (WITH BLUE BOX) BOX OF 84 PATCHES CONTAINING 3 BOXES OF 28 PATCHES
Danish: ÆSKE MED 84 PLASTRE INDEHOLDENDE 3 ÆSKER MED 28 PLASTRE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREV ETIKET
English: To avoid skin irritation
Danish: For at forebygge hudirritation
English: In trials where the application sites were rotated as reflected in the instructions provided in SmPC and package leaflet, 35.7% of 830 patients using the Leganto transdermal patch, experienced application site reactions.
Danish: I studier, hvor applikationsstedet blev vekslet som beskrevet i instruktionerne i produktresumeet og indlægssedlen, fik 35,7% af de 830 patienter, som brugte Leganto, reaktioner på applikationssstedet.
English: • increased sex drive
Danish: • øget sexlyst
English: Dosing in patients with advanced stage Parkinson's disease with fluctuations:
Danish: Dosering til patienter med Parkinsons sygdom i fremskredne stadier med udsving:
English: Sleep attacks/sudden onset of sleep, paranoia, sexual desire disorders a
Danish: Søvnanfald/plu dselig søvn, paranoia, forstyrret seksuel adfærda
English: The effects were more pronounced in female rats.
Danish: Effekten var tydeligst hos hunrotter.
English: How to use Leganto
Danish: Sådan skal De bruge Leganto
English: Observed in studies performed in patients with Parkinson's disease Parkinson's disease
Danish: Observeret hos patienter med Parkinsons sygdom
English: syncope, syncope vasovagal, loss of consciousness), dyskinesia e,
Danish: synkope, vasogal synkope, tab af bevidsthed), dyskinesie,
English: The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm. Reapplication to the same site within 14 days should be avoided.
Danish: Plasteret skal anbringes på et rent, tørt, intakt, sundt hudområde på mave, lår, hofter, side, skulder eller overarm.
English: 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).
Danish: Ved slutningen af vedligeholdelsesbehandlingen sås en forbedring på mindst 30% hos 57% og 55% af forsøgspersonerne, som fik henholdsvis rotigotin 8mg/24t og 12mg/24t og hos 34% af forsøgspersonerne, som fik placebo (en forskel på henholdsvis 22% og 21%, CI95% henholdsvis 10%; 35% og 8%; 33%, p<0,001 for begge rotigotingrupper).
English: hallucination, hallucination visual, hallucination auditory, illusion), insomnia, sleep disorder, nightmare, abnormal dreams, impulsecontrol disorders a,d
Danish: hallucinationer, visuelle hallucinationer, auditive hallucinationer, illusioner), insomni, søvnforstyrrels er, mareridt, unormale drømme, impulskontrolf orstyrrelsera,d
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid Leganto nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Take the patch out of the sachet.
Danish: Tag plasteret ud af brevet.
English: For most patients with early stage Parkinson's disease, the right dose is reached within 3 or 4 weeks, at doses of 6 mg per day or 8 mg per day respectively.
Danish: De fleste patienter med Parkinsons sygdom på tidlige stadier når den passende dosis inden for 3-4 uger ved doser på henholdsvis 6 mg dagligt eller 8 mg dagligt.
English: Rare: may affect up to 1 in 1,000 people
Danish: Sjældne bivirkninger: kan forekomme hos op til 1 ud af 1.000 personer
English: For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. 10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch.
Danish: Ved højere doser end 8 mg/24 t kan der anvendes flere plastre for at opnå den endelige dosis, fx kan 10 mg/24 t opnås ved at kombinere et plaster på 6 mg/24 t og et plaster på 4 mg/24 t.
English: If the patch falls off, put on a new patch for the rest of the day - then replace the patch at the usual time.
Danish: Hvis plasteret falder af, sættes der et nyt plaster på til resten af dagen.
English: With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was -3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was observed (baseline 30.0 points).
Danish: Med rotigotin var den gennemsnitlige forbedring i UPDRS scoren (del II og III) -3,98 point (baseline 29,9 point), mens der i den behandlingsarm, der fik placebo, sås en forværring på 1,31 point (baseline 30,0 point).
English: For most patients with advanced-stage Parkinson's disease the right dose is reached within 3 to 7 weeks, at doses of 8 mg per day up to a maximum dose of 16 mg per day.
Danish: De fleste patienter med Parkinsons sygdom på et fremskredent stadium når den passende dosis inden for 3 til 7 uger ved doser på 8 mg dagligt op til en maksimal dosis på 16 mg dagligt.
English: If you are not sure about this, talk to your doctor, pharmacist or nurse first.
Danish: Hvis De er i tvivl, så spørg først Deres læge, apotekspersonalet eller sygeplejerske.
English: To open the sachet, hold the sachet in both hands.
Danish: Hold på brevet med begge hænder for at åbne det.
English: Psychotic disorder, obsessivecompulsive disorder, aggressive behaviour/ aggression b,
Danish: Psykotisk lidelse, obsessivkompulsiv sygdom, aggressiv
English: • redness, increased sweating
Danish: • rødme, øget svedtendens
English: • increased heart rate
Danish: • øget puls
English: How to use the Leganto patches:
Danish: Sådan skal Leganto-plasteret bruges:
English: Vision blurred, visual impairment, photopsia
Danish: Sløret syne, nedsat syne, fotopsie
English: • feeling weak (fatigue)
Danish: • følelse af svaghed (træthed)
English: At the beginning of the third week, you should take Leganto 6 mg (package marked with “Week 3”).
Danish: I den tredje uge anvendes Leganto 6 mg (æske mærket ”Uge 3”).
English: • The maximum dose is 16 mg each day.
Danish: • Den maksimale dosis er 16 mg dagligt.
English: At the beginning of the fourth week, you should take Leganto 8 mg (package marked with “Week 4”).
Danish: I den fjerde uge anvendes Leganto 8 mg (æske mærket ”Uge 4”).
English: The maximum dose is 8 mg per day.
Danish: Den maksimale dosis er 8 mg dagligt.
English: Posology
Danish: Bagsidelag
English: Transdermal patch rotigotine
Danish: Depotplaster rotigotin
English: Very common Common Uncommon
Danish: Meget almindelig
English: • redness, increased sweating, itching
Danish: • rødme, øget svedtendens, kløe
English: AST, ALT, GGT), weight increased e, heart rate increased e,
Danish: ASAT, ALAT, GGT), vægtøgninge, øget pulse, forhøjet CKd,e
English: Each patch of 15 cm contains 6.75 mg of rotigotine.
Danish: Hvert plaster på 15 cm2 indeholder 6,75 mg rotigotin.
English: Each patch of 30 cm contains 13.5 mg of rotigotine.
Danish: Hvert plaster på 30 cm2 indeholder 13,5 mg rotigotin.
English: The strengths are 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h for the treatment of Parkinson's disease.
Danish: Styrkerne er 2 mg/24 timer, 4 mg/24 timer, 6 mg/24 timer og 8 mg/24 timer til behandlingen af Parkinsons sygdom.
English: 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.
Danish: Hos de fleste patienter opnås en effektiv dosis inden for 3-4 uger ved doser på henholdsvis 6 mg/24 t eller 8 mg/24 t.
English: 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.
Danish: Hos de fleste patienter opnås en effektiv dosis inden for 3-7 uger ved doser på 8 mg/24 t op til en maksimal dosis på 16 mg/24 t.
English: In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed in patients treated with placebo.
Danish: Der er blevet observeret synkope i kliniske studier med rotigotin med en forekomst på niveau med forekomsten observeret hos patienter, som fik placebo.
English: • The maximum dose is 3 mg per day.
Danish: • Den maksimale dosis er 3 mg dagligt.
English: Tell your doctor, pharmacist or nurse if you notice any side effects.
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis De oplever bivirkninger.
English: Nervous system disorders
Danish: Nervesystemet Hovedpine
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet.Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger viadet nationale rapporteringssystem anført i Appendiks V.
English: Each patch of 20 cm contains 9.0 mg of rotigotine.
Danish: Hvert plaster på 20 cm2 indeholder 9,0 mg rotigotin.
English: repetitive meaningless actions, uncontrolled shopping or spending too much
Danish: • manglende evne til at modstå trangen til at udføre en skadelig handling, herunder overdreven spillelyst, gentagne meningsløse handlinger, ukontrollerbar købe - eller forbrugslyst
English: Each patch of 40 cm contains 18.0 mg of rotigotine.
Danish: Hvert plaster på 40 cm2 indeholder 18,0 mg rotigotin.
English: Each patch of 5 cm contains 2.25 mg of rotigotine.
Danish: Hvert plaster på 5 cm2 indeholder 2,25 mg rotigotin.
English: Dopamine dysregulation syndromec, perception disturbances e
Danish: Dopamindysregulationssyndromc, sanseforstyrrels ere (inkl.
English: • psychotic disorders
Danish: • psykotiske lidelser
English: These occurred in 3.4% of Japanese subjects on rotigotine compared to 1.9% on placebo in double-blind Parkinson's disease and RLS studies.
Danish: I dobbeltblinde studier af Parkinsons sygdom og RLS forekom disse bivirkninger hos 3,4% af de japanske patienter, som blev behandlet med rotigotin, sammenlignet med hos 1,9% af patienterne i placebogruppen.
English: For example the daily dose of 10 mg may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.
Danish: For eksempel kan en daglig dosis på 10 mg nås ved at anvende ét plaster på 6 mg/24 timer og ét plaster på 4 mg/24 timer.
English: If your liver problems get worse during treatment, talk to your doctor straight away.
Danish: Fortæl det omgående til lægen, hvis Deres leverproblemer forværres under behandlingen.
English: 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. Patients in each treatment group were maintained at their optimal dose for 6 months.
Danish: Patienterne blev titreret til deres optimale doser rotigotin eller placebo i ugentlige trin på 2 mg/24 t startende ved 4 mg/24 t. Patienterne i hver behandlingsgruppe opretholdt deres optimale dosis i 6 måneder.
English: Common: may affect up to 1 in 10 people
Danish: Almindelige bivirkninger: kan forekomme hos op til 1 ud af 10 personer
English: 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 16 mg/24 h over 8 weeks, followed by a maintenance period of 4 weeks.
Danish: Patienterne blev titreret til deres optimale dosis rotigotin eller placebo i ugentlige trin på 2 mg/24 t startende ved 2 mg/24 t til maksimumdosis på 16 mg/24 t i løbet af 8 uger, efterfulgt af en vedligeholdelsesperiode på 4 uger.
English: Component of a multipack, can't be sold separately
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 28 depotplastre, del af multipakning, må ikke sælges separat.
English: Early morning motor function, assessed by UPDRS part III, and nocturnal sleep disturbances, measured by the modified Parkinson's Disease Sleep Scale (PDSS-2), were co-primary outcome measures.
Danish: det modificerede vurderingsskema Parkinson's Disease Sleep Scale (PDSS-2), var co-primære effektmål.
English: At the beginning of the second week, you should take Leganto 4 mg (package marked with “Week 2”).
Danish: I den anden uge anvendes Leganto 4 mg (æske mærket ”Uge 2”).
English: Talk to your doctor or pharmacist if you notice any of the side effects listed above.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis De bemærker en eller flere af ovenstående bivirkninger.
English: Dosing in patients with early-stage Parkinson's disease:
Danish: Dosering til patienter med Parkinsons sygdom i tidlige stadier:
English: This is because the effects of rotigotine on pregnancy and the unborn baby are not known.
Danish: Graviditet og amning Brug ikke Leganto, hvis De er gravid, da rotigotins effekt på graviditet og det ufødte barn ikke kendes.
English: Vascular disorders
Danish: Depotplaster
English: Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above.
Danish: Fortæl det til Deres læge hvis De bemærker en eller flere ændringer i adfærd, tanker eller begge, som er på ovenstående liste.
English: • 1 mg/24 h:
Danish: • 1 mg/24 timer:
English: • constipation, dry mouth, heartburn
Danish: • forstoppelse, mundtørhed, halsbrand
English: Dizziness e, disturbances in consciousness NEC
Danish: Svimmelhede, bevidsthedsfors tyrrelser NECe
English: 4 mg/24 h
Danish: • 4 mg/24 timer
English: 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. 8 mg/24 h. 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%).
Danish: Der sås en forbedring på 20% hos 52% af patienterne, som fik rotigotin, hos 68% af patienterne, som fik ropinirol og hos 30% af patienterne, som fik placebo (forskel rotigotin vs. placebo 21,7%, CI95% 11,1%; 32,4%, forskel ropinirol vs. placebo 38,4%, CI95% 28,1%; 48,6%, forskel ropinirol vs. rotigotin 16,6%, CI95% 7,6%; 25,7%).
English: The signs include:
Danish: Styrkerne er:
English: • vomiting, heartburn
Danish: • opkastning, halsbrand
English: Each patch of 10 cm contains 4.5 mg of rotigotine.
Danish: Hvert plaster på 10 cm2 indeholder 4,5 mg rotigotin.
English: 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.
Danish: Patienterne blev titreret til deres optimale dosis rotigotin i ugentlige trin på 2 mg/24 t startende ved 2 mg/24 t til maksimumdosis på 8 mg/24 t i 4 uger.
English: 28 transdermal patches.
Danish: 28 depotplastre
English: • The maximum dose is 8 mg each day.
Danish: • Den maksimale dosis er 8 mg dagligt.
English: Rash generalised
Danish: Generaliseret udslæt
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity)
Danish: erythem, pruritus, irritation, udslæt, dermatitis, vesikler, smerte, eksem, inflammation, hævelse, misfarvning, papler, eksfoliation, urticaria, overfølsomhed)
English: 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. Patients in each treatment group were maintained at their optimal dose for 6 months.
Danish: Patienterne blev titreret til deres optimale dosis rotigotin eller placebo i ugentlige trin på 2 mg/24 t startende ved 2 mg/24 t til maksimumdosis på 6 mg/24 t. Patienterne i hver behandlingsgruppe opretholdt deres optimale dosis i 6 måneder.
English: Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis De bemærker en eller flere af ovenstående bivirkninger.
English: e
Danish: Det
English: syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy
Danish: Ikke kendt synkope, tab af bevidsthed), dyskinesie, postural svimmelhede, letargie, krampee
English: • feeling weak (fatigue), feeling tired
Danish: • følelse af svaghed og træthed
English: • abnormal heart beat
Danish: • unormal hjerterytme