natgillin/translations-raw huggingface dataset:
Sikkerhed og virkning af pramipexol depottabletter ved behandling af Parkinsons sygdom blev undersøgt i et multinationalt klinisk udviklingsprogram bestående af 3 randomiserede, kontrollerede studier.
The safety and efficacy of pramipexole prolonged-release tablets in the treatment of Parkinson's disease was evaluated in a multinational drug development program consisting of three randomised, controlled trials.
I fase-III studier hos Parkinsons patienter blev det ikke observeret, at kropsvægt har nogen klinisk relevant påvirkning på den terapeutiske virkning og tolerabiliteten af pramipexol depottabletter.
However, in Phase III trials in Parkinson's disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of pramipexole prolonged-release tablets was detected.
Da pramipexol hæmmer sekretionen af prolaktin hos mennesker, forventes amningen også at blive hæmmet.
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Fortæl det til din læge, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande: - Nyresygdomme - Hallucinationer (ser, hører eller føler ting, som ikke er der).
Tell your doctor if you have or have had or develop any medical conditions or symptoms, especially any of the following: - Kidney disease - Hallucinations (seeing, hearing or feeling things that are not there).
GÆLDER KUN FOR BEHANDLINGSSTART PAKKE MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
TREATMENT INITIATION PACK ONLY MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Hvis du har en nyresygdom, vil din læge eventuelt anbefale dig at tage den sædvanlige startsdosis på 0,26 mg depottablet hveranden dag den første uge.
If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets only every other day for the first week.
Tabletter
Tablet
Ved kreatininclearance mindre end 30 ml/min anbefales det ikke at anvende Oprymea depottabletter, da der ikke findes data for denne patientpopulation.
The treatment of patients with a creatinine clearance below 30 ml/min with Oprymea prolongedrelease tablets is not recommended as no data are available for this patient population.
Blisterpakning (alu/alu folie): 20, 30, 60, 90 eller 100 tabletter i en æske.
Blister pack (Alu/Alu foil): 20, 30, 60, 90 or 100 tablets, in a box.
Behandlingsstart pakke
Treatment initiation pack
Hvis du har glemt at tage en Oprymea dosis, men kommer i tanke om det indenfor 12 timer fra det sædvanlige tidspunkt, hvor du skulle have taget en dosis, skal du tage den sædvanlige tablet.
If you forget to take a dose of Oprymea, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
I et 26 ugers placebokontrolleret forsøg blev der hos 10% af patienterne (14 ud af 135) observeret rebound af RLS-symptomer (forværring af symptomer i forhold til baseline) efter pludseligt behandlingsophør.
In a 26 week placebo controlled trial, rebound of RLS symptoms (worsening of symptom severity as compared to baseline) was observed in 10% of patients (14 out of 135) after abrupt discontinuation of treatment.
Hvis du har en moderat til alvorlig nyresygdom, skal du have en lavere dosis.
If you have moderate or severe kidney disease, your doctor will prescribe a lower dose.
Oprymea må ikke anvendes under amning.
Oprymea should not be used during breast-feeding.
Ved kreatininclearance mellem 30 og 50 ml/min bør behandlingen starte med 0,26 mg Oprymea depottabletter hver anden dag.
In patients with a creatinine clearance between 30 and 50 ml/min, treatment should be started with 0.26 mg Oprymea prolonged-release tablets every other day.
angst, træthed, svedtendens eller smerter kan forekomme (kaldet dopaminagonist abstinenssyndrom eller dopamine agonist withdrawal syndrome - DAWS).
sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
Pramipexol er ikke teratogent i rotter og kaniner; men er embryotoksisk i rotter ved maternotoksiske doser (se pkt.
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Hver pakke med 21 depottabletter til 3 ugers behandling indeholder: 7 tabletter indeholdende Oprymea 0,26 mg
Each pack of 21 prolonged-release tablets for a 3-week treatment schedule contains: 7 tablets of Oprymea 0.26 mg
- behandling af voksne patienter med symptomer på moderat til svær restless legs syndrom
- treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
Brug af anden medicin sammen med Oprymea
Other medicines and Oprymea
Virkningen og tolerabiliteten hos patienter, som fra dag til dag skiftede behandling fra pramipexol tabletter til pramipexol depottabletter, blev undersøgt i et dobbelblindt klinisk studie hos patienter med tidlig udvikling af Parkinsons sygdom.
The efficacy and tolerability of an overnight switch from pramipexole tablets to pramipexole prolonged-release tablets at the same daily dose were evaluated in a double-blind clinical study in patients with early Parkinson's disease.
Hvis patienten glemmer en dosis, bør Oprymea depottabletter tages indenfor 12 timer fra det sædvanlige tidspunkt.
When the intake of a dose is missed, Oprymea prolonged-release tablets should be taken within 12 hours after the regularly scheduled time.
63% af patienterne i pramipexolbehandling og 52% af patienterne i placebobehandling rapporterede mindst én bivirkning.
63 % of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
Derefter vil din læge muligvis øge dosis til én 0,26 mg depottablet hver dag.
After that, your doctor may increase the dosing frequency to one 0.26 mg prolonged-release tablet every day.
Symptomerne er blandt andet: - nedsat evne til at bevæge sig, dvs. tab af muskelbevægelighed (akinesi) - muskelstivhed - feber - ustabilt blodtryk - øget hjerterytme (takykardi) - forvirring - påvirket bevidsthedstilstand, f.eks koma
The symptoms include: - akinesia (loss of muscle movement) - rigid muscles - fever - unstable blood pressure - tachycardia (increased heart rate) - confusion - depressed level of consciousness (e.g. coma).
67% af patienterne i pramipexolbehandling og 54% af patienterne i placebobehandling rapporterede mindst én bivirkning.
67% of patients on pramipexole and 54% of patients on placebo reported at least one adverse drug reaction.
Ændring af libido Pramipexol kan i ikke almindelige tilfælde være forbundet med ændringer i libido (øget eller nedsat).
Libido disorders Pramipexole may uncommonly be associated with libido disorders (increased or decreased).
Den anbefalede startdosis for Oprymea er 0,088 mg base (0,125 mg salt), som tages 1 gang dagligt 2-3 timer før sengetid.
The recommended starting dose of Oprymea is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Blister (OPA/alu/tørremiddel/PE-alu): 10, 30, 90 eller 100 depottabletter i en æske.
Blister (OPA/Alu/desiccant/PE-Alu foil): 10, 30, 90 or 100 prolonged-release tablets, in a box.
Du må ikke holde op med at tage Oprymea uden at spørge din læge til råds.
Do not stop taking Oprymea without first talking to your doctor.
Pramipexol er kun i ringe udstrækning bundet til plasmaproteiner (< 20%), og der er kun set beskeden biotransformation hos mennesker.
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Synkes hele - må ikke tygges, deles eller knuses.
Swallow whole, do not chew, divide or crush.
Hvis der er gået mere end 12 timer, skal du ikke tage den glemte dosis, men blot tage næste dosis på det sædvanlige tidspunkt.
If you forget for more than 12 hours, simply take the next single dose at the usual time.
Oprymea anbefales ikke til børn og unge under 18 år, da sikkerhed og virkning ikke er klarlagt hos denne population.
Oprymea is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Hos patienter med leversvigt er dosisjustering ikke nødvendig, da ca. 90% af det absorberede aktive stof bliver udskilt via nyrerne.
Dose adjustment in patients with hepatic failure is not required, as approx. 90% of absorbed active substance is excreted through the kidneys.
Oprymea tabletter skal synkes hele med vand.
Swallow the tablets whole with water.
Farmakodynamisk virkning Hos frivillige forsøgspersoner fandt man et dosisafhængigt fald i prolaktin.
Pharmacodynamic effects In human volunteers, a dose-dependent decrease in prolactin was observed.
- Hvis du oplever, at symptomerne ved RLS begynder tidligere på dagen end sædvanligt, er mere intense og omfatter flere legemesdele (dette kaldes augmentation).
You may experience that symptoms start earlier than usual, be more intense and involve other limbs.
Hvis yderligere dosisøgning er nødvendig, vil din læge øge dosis trinvist med 0,26 mg pramipexol.
If a further dose increase is necessary, your doctor may adjust it in steps of 0.26 mg pramipexole.
I den første uge er dosis oftest 1 tablet Oprymea á 0,088 mg tre gange dagligt (svarende til 0,264 mg om dagen):
During the first week, the usual dose is 1 tablet Oprymea 0.088 mg three times a day (equivalent to 0.264 mg daily):
Den daglige dosis bør ikke overstige 6 tabletter Oprymea 0,088 mg eller en dosis af 0,54 mg (0,75 mg pramipexolsalt)
The daily dose should not exceed 6 tablets Oprymea 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Ved indtagelse af fedtholdige måltider hos raske frivillige forsøgspersoner er der set en stigning i plasmakoncentrationen (Cmax) på ca. 24% efter administration af en enklet dosis og ca. 20% efter flere doser.
Intake of a high fat meal induced an increase in peak concentration (Cmax) of about 24% after a single dose administration and about 20% after multiple dose administrations and a delay of about 2 hours in time to reach peak concentration in healthy volunteers.
Dosisreduktion er sandsynligvis ikke nødvendig for patienter med nedsat leverfunktion, da omkring 90% af det absorberede aktive stof udskilles via nyrerne.
Dose adjustment in patients with hepatic failure is probably not necessary, as approx. 90% of absorbed active substance is excreted through the kidneys.
Uge 1
Week 1
Oprymea tabletter bør synkes med vand, og kan både tages sammen med eller uden mad.
The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Pga. en mulig additiv virkning, bør forsigtighed udvises, når patienter tager andre sedative lægemidler eller alkohol i kombination med pramipexol (se pkt.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see sections 4.4, 4.7 and 4.8).
Almindelig: - Forandring af søvnmønster, såsom søvnløshed (insomni) og søvnighed - Træthed (udmattelse) - Hovedpine - Unormale drømme - Forstoppelse - Svimmelhed - Opkastning
Common: - Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness - Tiredness (fatigue) - Headache - Abnormal dreams - Constipation - Dizziness - Vomiting (being sick)
Oprymea kan give hallucinationer (du ser, hører eller føler ting, der ikke er der), og det kan påvirke din evne til at køre bil og betjene maskiner.
Oprymea can cause hallucinations (seeing, hearing or feeling things that are not there).
Hos patienter reducerer pramipexol tegn og symptomer på idiopatisk Parkinsons sygdom.
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson's disease.
GÆLDER KUN FOR BAHANDLINGSSTART PAKKE MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
TREATMENT INITIATION PACK ONLY PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Sifrol anbefales ikke til børn og unge under 18 år p.g.a. manglende dokumentation for sikkerhed og virkning.
Oprymea is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Pramipexol lindrer det motoriske underskud forbundet med Parkinsons sygdom ved stimulation af dopaminreceptorer i corpus striatum.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
- Øvrige indholdsstoffer er hypromellose, majsstivelse, vandfri kolloid silica og magnesiumstearat.
- The other ingredients are hypromellose, maize starch, colloidal anhydrous silica and magnesium stearate.
En analyse af poolede placebokontrollerede kliniske forsøg, omfattende 1.778 Parkinsonpatienter i behandling med pramipexol og 1.297 patienter i placebobehandling, viste, at bivirkninger var hyppigt rapporteret i begge grupper.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,778 Parkinson's disease patients on pramipexole and 1,297 patients on placebo, adverse drug reactions were frequently reported for both groups.
Et dobbeltblindet, placebokontrolleret studie med 517 patienter med fremskreden Parkinsons sygdom, som samtidig blev behandlet med levodopa, viste, at pramipexol depottabletter havde en bedre virkning (superior) end placebo efter 18 ugers behandling på både det primære (UPDRS del II+III) og vigtigste sekundære (off-time) endepunkter.
In a double-blind placebo-controlled trial including a total of 517 patients with advanced Parkinson's disease who were on concomitant levodopa therapy superiority of pramipexole prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (off-time) efficacy endpoints.
- Uhæmmet madindtagelse (spise store mængder mad i en kort periode) eller overdreven madindtagelse (spise mere mad end sædvanligt og mere end nødvendigt for at dække sulten)*
- Binge eating (eating large amounts of food in a short time period) or compulsive eating
Der findes pakninger med 10, 30, 90 og 100 tabletter i blisterpakninger med 10 tabletter i hver.
Boxes of 10, 30, 90 and 100 tablets in blisters of 10 tablets are available.
1 gang daglig Aften dosis (mg af salt)
Once Daily Evening Dose (mg of salt)
BLISTER (uge 1)
Blister (week 1)
Da der i litteraturen refereres til doser af pramipexol i saltformen, er doseringen anført både som pramipexolbase og som pramipexolsalt (i parentes).
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
De forventede bivirkninger vil relateres til den farmakodynamiske profil for en dopaminagonist herunder kvalme, opkastning, hyperkinesi, hallucinationer, agitation og hypotension.
The expected adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Oprymeas sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
The safety and efficacy of Oprymea in children below 18 years has not been established.
Uge 3
Week 3
En præcis estimering af frekvens er ikke mulig, da bivirkningen ikke fandtes i en database med data for kliniske forsøg med 1.395 patienter med med Restless Legs syndrom behandlet med pramipexol.
A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 1,395 patients with Restless Legs Syndrome treated with pramipexole.
Patienter og pårørende bør informeres om, at adfærdsmæssige symptomer på manglende impulskontrol herunder ludomani, forøget libido, hyperseksualitet, tvangshandlinger, der fører til overdrevent indkøbsmønster og uhæmmet og overdreven madindtagelse, kan forekomme hos patienter i behandling med dopaminagonister, herunder Oprymea.
Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Oprymea.
Dyskinesi ses hyppigere i kombination med levodopa.
A more frequent adverse drug reaction in combination with levodopa was dyskinesia.
En analyse af poolede placebokontrollerede kliniske forsøg, omfattende 1.923 patienter i behandling med pramipexol og 1.354 patienter i placebobehandling viste, at rapportering af bivirkninger var hyppigt forekommende i begge grupper.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Udskillelsen af pramipexol i human mælk er ikke kendt.
The excretion of pramipexole into breast milk has not been studied in women.
Hvis du tager levodopa (medicin mod Parkinsons sygdom), bør dosis nedsættes, når du starter behandling med Oprymea.
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Oprymea.
Meget almindelig Kan forekomme hos flere end 1 ud af 10 patienter Almindelig
Very common may affect more than 1 in 10 people
- pakningen markeret ”Uge 2” indeholder 1 blisterark med 7 tabletter indeholdende 0,52 mg, - pakningen markeret ”Uge 3” indeholder 1 blisterark med 7 tabletter indeholdende 1,05 mg
3-week treatment initiation pack contains 21 prolonged-release tablets in 3 packages: - the package marked "Week 1" contains 1 blister of 7 tablets of 0.26 mg, - the package marked "Week 2" contains 1 blister of 7 tablets of 0.52 mg, - the package marked "Week 3" contains 1 blister of 7 tablets of 1.05 mg.
1 tablet Oprymea 0,35 mg og 1 tablet Oprymea 0,18 mg
1 tablet Oprymea 0.35 mg and 1 tablet Oprymea 0.18 mg
Det er ikke relevant at anvende Oprymea hos den pædiatriske population ved indikationen Parkinsons sygdom.
There is no relevant use of Oprymea in the paediatric population for the indication of Parkinson's Disease.
BLISTER (uge 2)
Blister (week 2)
BLISTER (uge 3)
Blister (week 3)
Oprymea påvirker nerveimpulser i hjernen, som kontrollerer kroppens bevægelser, ved at stimulere dopaminreceptorerne.
Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
Almindeligste bivirkninger ved restless legs syndrom De mest almindeligt (≥ 5%) rapporterede bivirkninger hos patienter med restless legs syndrom, behandlet med pramipexol var: kvalme, hovedpine, svimmelhed og træthed.
Restless Legs Syndrome, most common adverse reactions The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with pramipexole were nausea, headache, dizziness and fatigue.
Beskrivelse af udvalgt bivirkninger
Description of selected adverse reactions
Ved kreatininclearance mellem 20 og 50 ml/min bør initialdosis af Oprymea fordeles på 2 daglige doser begyndende med 0,088 mg base (0,125 mg salt) to gange dagligt svarende til 0,176 mg base (0,25 mg salt) per døgn.
In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of Oprymea should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/0.25 mg of salt daily).
Kolloid, vandfri silica Magnesiumstearat
Colloidal anhydrous silica Magnesium stearate
Meget almindelig: - Unormale, ufrivillige bevægelser (dyskinesi) - Søvnighed - Svimmelhed - Kvalme
Very common: - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) - Sleepiness - Dizziness - Nausea (sickness)
Symptomer, der ligner malignt neuroleptika syndrom, har været set i forbindelse med pludseligt ophør med dopaminbehandling (se pkt.
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2).
Oprymea bruges til: - behandling af voksne patienter med symptomer på Parkinsons sygdom.
Oprymea is used to: - treat the symptoms of primary Parkinson's disease in adults.
Hvis din nyresygdom er moderat, er startdosis oftest 1 tablet Oprymea á 0,088 mg 2 gange daglig.
If you have moderate kidney disease, the usual starting dose is 1 tablet Oprymea 0.088 mg twice a day.
Det bindes med høj selektivitet og specificitet til undergruppen dopamin D2 receptorerne og har primært affinitet til D3 receptorer.
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity.
Hvis yderligere dosisøgning er nødvendig, bør dosis øges med 0,26 mg pramipexolbase/uge op til en maksimal dosis på 1,57 mg pramipexolbase (2,25 mg salt) daglig.
If a further dose increase is necessary, doses should be increased by 0.26 mg pramipexole base at weekly intervals up to a maximum dose of 1.57 mg pramipexole base (2.25 mg of salt) per day.
Det er almindeligt, at pramipexolbehandling er forbundet med døsighed, men det er ikke almindeligt, at det er forbundet med somnolens i dagtimerne og pludseligt opståede søvnepisoder (se også pkt.
Pramipexole is commonly associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (see also section 4.4).
Patienter, som bliver behandlet med Oprymea, og som har oplevet døsighed, somnolens og/eller episoder med pludseligt opstået søvn, bør informeres om, at de skal afstå fra at køre bil eller deltage i aktiviteter, hvor nedsat årvågenhed kan udsætte dem eller andre for alvorlig fare eller død (f.eks. betjening af maskiner), indtil sådanne tilbagevendende episoder, døsighed og/eller somnolens er ophørt (se også pkt.
Patients being treated with Oprymea and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
21 depottabletter: EU/1/08/469/054
21 prolonged-release tablets: EU/1/08/469/054
Ca. 5% af patienterne i de kliniske forsøg blev behandlet med doser mindre end 1,05 mg base (1,5 mg salt).
In clinical trials approximately 5% of patients were treated at doses below 1.05 mg of base (1.5 mg of salt).
Opbevares i den originale pakning for at beskytte mod fugt
Store in the original package in order to protect from moisture.
Samtidig behandling med antipsykotiske lægemidler og pramipexol bør undgås (se pkt.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
De mest almindeligt ( 5%) rapportede bivirkninger hos patienter med Parkinsons sygdom, som oftere ses efter behandling med pramipexol end efter behandling med placebo er kvalme, dyskinesi, hypotension, svimmelhed, døsighed, søvnløshed, forstoppelse, hallucinationer, hovedpine og træthed.
The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson's disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Det er ikke relevant at anvende Oprymea depottabletter hos den pædiatriske population ved indikationen Parkinsons sygdom.
There is no relevant use of Oprymea prolonged-release tablets in the paediatric population for the indication of Parkinson's Disease.
Sådan skal du tage Oprymea
How to take Oprymea
Ca. 5% af patienterne i de kliniske forsøg blev behandlet med doser mindre end 1,1 mg (1,5 mg salt).
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg of base (1.5 mg of salt).
Ved kreatininclearance over 50 ml/min er reduktion af dosis eller doseringshyppighed ikke nødvendig.
Patients with a creatinine clearance above 50 ml/min require no reduction in daily dose or dosing frequency.
7 tabletter indeholdende Oprymea 1,05 mg
7 tablets of Oprymea 1.05 mg
Ved kreatininclearance mindre end 20 ml/min bør Oprymea gives som en enkeltdosis begyndende med 0,088 mg base (0,125 mg salt) per døgn.
In patients with a creatinine clearance less than 20 ml/min, the daily dose of Oprymea should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.