natgillin/translations-raw huggingface dataset:
Patienter med nyresygdomme Hvis du har en alvorlig nyresygdom, er MIRAPEXIN måske ikke den egnede behandling for dig. 
Patients with kidney disease If you have severe kidney disease, MIRAPEXIN may not be a suitable treatment for you.
Anvendelse af Mirapexin tabletter bør overvejes i stedet. 
The use of MIRAPEXIN tablets should be considered.
Selvom dystoni kan være et symptom på Parkinsons sygdom, er symptomerne hos disse patienter bedret efter reduktion eller seponering af pramipexol. 
Although dystonia may be a symptom of Parkinson's disease, the symptoms in these patients have improved after reduction or withdrawal of pramipexole.
• Dystoni (manglende evne til at holde din krop og nakke lige og oprejst (aksial dystoni)). 
- Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)).
Der blev ikke observeret nogen forskel på pramipexol og placebo for hverken det primære endepunkt eller for nogen af de sekundære endepunkter inklusive YGTSS total score, Patient Global Impression of Improvement (PGI-I), Clinical Global Impression of Improvement (CGI-I) eller Clinical Global Impressions of Severity of Illness (CGI-S). 
No difference was observed for pramipexole as compared to placebo for either the primary endpoint or for any of the secondary efficacy endpoints including YGTSS total score, Patient Global Impression of Improvement (PGI-I), Clinical Global Impression of Improvement (CGI-I), or Clinical Global Impressions of Severity of Illness (CGI-S).
Farmakoterapeutisk klassifikation: Anti-Parkinson lægemiddel, dopaminreceptoragonist, ATC-kode: N04BC05 
Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05.
Det anbefales at monitorere blodtrykket, særlig i starten af behandlingen, på grund af risikoen for postural hypotention i forbindelse med dopaminbehandling. 
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Disse punkter skal overvejes ved initiering af pramipexol behandling hos patienter med Parkinsons sygdom. 
These points should be considered when initiating pramipexole treatment in patients with Parkinson's disease.
I de fase-III-studier, hvor sikkerhed og virkning af Mirapexin depottabletter blev undersøgt, blev patienterne instrueret i at tage studiemedicinen uden hensyntagen til fødeindtagelse. 
In the Phase III studies that established safety and efficacy of MIRAPEXIN prolonged-release tablets, patients were instructed to take study medication without regard to food intake.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the carton after EXP.
6.4 Særlige opbevaringsforhold Må ikke opbevares ved temperaturer over 30 °C. 
6.4 Special precautions for storage Do not store above 30°C.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 tabletter 
PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Parkinsons sygdom Døgndosis bør indtages ligeligt fordelt på 3 daglige doser. 
Parkinson's disease The daily dose is to be taken divided into 3 equal doses.
To af studierne blev udført hos patienter med tidlig Parkinsons sygdom, og det 3. studie blev udført hos patienter med fremskreden Parkinsons sygdom. 
Two trials were conducted in patients with early Parkinson's disease and one trial was conducted in patients with advanced Parkinson's disease.
Tag dine almindelige MIRAPEXIN tabletter som normalt dagen før, du skifter. 
Take your MIRAPEXIN (immediate release) tablets as normal the day before you switch.
Brugen af Mirapexin har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion. 
The use of MIRAPEXIN has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tagerMIRAPEXIN. 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Din læge vil tale med dig, om du skal fortsætte med at tage MIRAPEXIN. 
Your doctor will then discuss with you if you should continue to take MIRAPEXIN.
Advarsler og forsigtighedsregler Kontakt lægen, før du tager MIRAPEXIN. 
Warnings and precautions Talk to your doctor before taking MIRAPEXIN.
Det er ukendt, hvilken virkning MIRAPEXIN kan have på det ufødte barn. 
The effect of MIRAPEXIN on the unborn child is not known.
Den daglige dosis kan fordeles på 2 daglige doser, hvis kreatininclearance er mellem 20 og 50 ml/minog gives om en enkeltdosis, hvis kreatininclearance er under 20 ml/min. 
The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/min and as a single daily dose if creatinine clearance is less than 20 ml/min.
Pramipexol absorberes fuldstændigt efter oral administration. 
Pramipexole is completely absorbed following oral administration.
Mirapexin bør ikke anvendes til børn og unge med Tourettes sygdom på grund af en negativ balance mellem fordele og ulemper ved denne sygdom (se pkt. 
MIRAPEXIN should not be used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for this disorder (see section 5.1).
Hvert blisterkort indeholder 10 tabletter. 
Each blister strip contains 10 tablets.
Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 59320 Ennigerloh Tyskland 
Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 59320 Ennigerloh Germany
Fortæl din læge, hvis du oplever symptomer såsom depression, apati, angst, træthed, svedtendens eller smerter, efter at du er stoppet med eller har nedsat dosis i din MIRAPEXIN-behandling. 
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your MIRAPEXIN treatment.
Sjælden: • Mani (føle sig oprørt, opstemt eller ophidset) 
Rare: - Mania (agitation, feeling elated or over-excited)
Tag ikke MIRAPEXIN: - hvis du er allergisk over for pramipexol eller et af de øvrige indholdsstoffer i MIRAPEXIN 
Do not take MIRAPEXIN: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
Øvrige indholdsstoffer: hypromellose 2208, majsstivelse, carbomer 941, kolloid vandfri silica, magnesiumstearat. 
The other ingredients are hypromellose 2208, maize starch, carbomer 941, colloidal anhydrous silica, magnesium stearate.
Der anbefales oftalmologisk undersøgelse med regelmæssige mellemrum eller hvis der opstår synsabnormaliteter. 
Ophthalmologic monitoring Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Tabletterne kan deles i to lige store dele. 
Tablets can be divided into equal halves.
Mirapexin depottabletter var non-inferior i forhold til pramipexoltabletter vurderet ud fra UPDRS del II+III score ved uge 33. 
MIRAPEXIN prolonged-release tablets were non-inferior to pramipexole immediate release tablets as assessed on the UPDRS Parts II+III score at week 33.
MIRAPEXIN depottabletter er specialfremstillede tabletter, hvor det aktive stof langsomt frigives efter indtagelse af tabletten. 
MIRAPEXIN prolonged-release tablets is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested.
I et placebo-kontrolleret polysomnografi-studie over 3 uger reducerede Mirapexin signifikant antallet af periodiske benbevægelser, mens forsøgspersonerne var sengeliggende. 
In a placebo-controlled polysomnography study over 3 weeks MIRAPEXIN significantly reduced the number of periodic limb movements during time in bed.
Ved kreatininclearance mindre end 30 ml/min anbefales det ikke at anvende Mirapexin depottabletter, da der ikke findes data for denne patientpopulation. 
The treatment of patients with a creatinine clearance below 30 ml/min with MIRAPEXIN prolongedrelease tablets is not recommended as no data are available for this patient population.
Du må ikke tygge, dele eller knuse depottabletten. 
Do not chew, divide or crush the prolongedrelease tablets.
På grund af mangel på humane data må Mirapexin ikke anvendes under amning. 
In the absence of human data, MIRAPEXIN should not be used during breast-feeding.
Skema for dosisøgning af Mirapexin Uge 
Ascending dose schedule of MIRAPEXIN Week
Nogle patienter har rapporteret om rester i afføringen, der kan ligne intakte Mirapexin depottabletter. 
Some patients have reported the occurrence of remnants in faeces which may resemble intact MIRAPEXIN prolonged-release tablets.
Det bør overvejes at nedsætte pramipexoldosis i tilfælde, hvor disse lægemidler administreres samtidigt med Mirapexin. 
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with MIRAPEXIN.
Aktivt stof: pramipexol. 
The active substance is pramipexole.
Sikkerhed og virkning af Mirapexin depottabletter ved behandling af Parkinsons sygdom blev undersøgt i et multinationalt klinisk udviklingsprogram bestående af 3 randomiserede, kontrollerede studier. 
The safety and efficacy of MIRAPEXIN prolonged-release tablets in the treatment of Parkinson's disease was evaluated in a multinational drug development program consisting of three randomised, controlled trials.
Tag MIRAPEXIN depottabletter den næste morgen, og tag så ikke flere almindelige MIRAPEXIN tabletter. 
Then take your MIRAPEXIN prolonged-release tablets next morning and do not take any more MIRAPEXIN (immediate release) tablets.
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 Mirapexin 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 MIRAPEXIN prolonged-release tablets was detected.
Den potentielle indflydelse af nedsat leverfunktion på Mirapexins farmakokinetik kendes ikke. 
However, the potential influence of hepatic insufficiency on MIRAPEXIN pharmacokinetics has not been investigated.
Mirapexin depottabletter er én-gang-daglig oral formulering af pramipexol. 
MIRAPEXIN prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Den maksimale plasmakoncentration opnås ca. 6 timer efter administration af Mirapexin depottabetter givet en gang daglig. 
The maximum plasma concentrations occur at about 6 hours after administration of MIRAPEXIN prolonged-release tablets once daily.
Mirapexin er indiceret til voksne til symptomatisk behandling af moderat til svær idiopatisk restless legs syndrom i doser op til 0,54 mg base (0,75 mg salt) (se pkt. 
MIRAPEXIN is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Mirapexin i en eller flere undergrupper af den pædiatriske population med restless legs syndrom (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with MIRAPEXIN in one or more subsets of the paediatric population in Restless Legs Syndrome (see section 4.2 for information on paediatric use).
Kun en patient, som skiftede til Mirapexin depottabletter, fik en lægemiddelrelateret bivirkning, der medførte seponering. 
Only one patient switched to MIRAPEXIN prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Øvrige indholdsstoffer: mannitol, majsstivelse, kolloid vandfri silica, povidon K 25 og magnesiumstearat. 
The other ingredients are mannitol, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.
Når Mirapexin gives i kombination med levodopa, anbefales det at reducere levodopa-dosis og at holde dosis af andre antiparkinson-lægemidler konstant, mens dosis af Mirapexin øges. 
When MIRAPEXIN is given in combination with levodopa, it is recommended that the dose of levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while increasing the dose of MIRAPEXIN.
Du kan især opleve, at dit hoved og din nakke falder forover (denne tilstand kaldes antecollis), at din lænd bøjer forover (denne tilstand kaldes camptocormia), eller at din ryg falder til siden (denne tilstand kaldes pleurothotonus eller Pisa-syndrom) 
In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome).
Emballagetype og pakningsstørrelser OPA/aluminium/PVC-aluminium blister. 
OPA/aluminium/PVC-aluminium blisters.
Hvis du har glemt at tage en MIRAPEXIN 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 MIRAPEXIN, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
MIRAPEXIN kan tages alene eller i kombination med levodopa (medicin til behandling af Parkinsons sygdom) 
It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
Patienter, som bliver behandlet med Mirapexin, 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 MIRAPEXIN 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).
• Udtalt træthed om dagen og episoder med pludselig indsættende søvn 
- Sleepiness and episodes of suddenly falling asleep
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.
Mirapexin kan påvirke evnen til at føre motorkøretøj og betjene maskiner i væsentlig grad. 
MIRAPEXIN can have a major influence on the ability to drive and use machines.
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 Mirapexin. 
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 MIRAPEXIN.
Ved kreatininclearance mellem 30 og 50 ml/min bør behandlingen starte med 0,26 mg Mirapexin depottabletter hver anden dag. 
In patients with a creatinine clearance between 30 and 50 ml/min, treatment should be started with 0.26 mg MIRAPEXIN prolonged-release tablets every other day.
I et klinisk studie med raske frivillige forsøgspersoner, hvor dosisjustering af Mirapexin depottabletter var hurtigere (hver 3. dag) end anbefalet, op til 3,15 mg pramipexolbase (4,5 mg salt)/dag, blev der observeret en stigning i blodtrykket samt en forøgelse af hjerterytmen. 
In a clinical trial with healthy volunteers, where MIRAPEXIN prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed.
Hvis du skifter fra almindelige MIRAPEXIN tabletter Din læge vil basere din dosis af MIRAPEXIN depottabletter på den dosis af almindelige MIRAPEXIN tabletter, som du hidtil har taget. 
If you are switching from MIRAPEXIN (immediate release) tablets Your doctor will base your dose of MIRAPEXIN prolonged-release tablets on the dose of MIRAPEXIN (immediate release) tablets you were taking.
MIRAPEXIN kan nedsætte mælkeproduktionen og kan også overføres til din baby via brystmælk. 
MIRAPEXIN can reduce the production of breast milk.
Et vægttab på 30 kg viste en Cmax-stigning på 45%. 
A decreased body weight by 30 kg results in an increase in
- 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 (eating more food than normal and more than is needed to satisfy your hunger)* - Delirium (decreased awareness, confusion, loss of reality)
Du må ikke holde op med at tage MIRAPEXIN uden at spørge din læge til råds. 
Do not stop taking MIRAPEXIN without first talking to your doctor.
Tabletterne har delekærv på begge sider og kan deles i to lige store dele. 
Tablets are scored on both sides and breakable in halves.
Virkningen og tolerabiliteten hos patienter, som fra dag til dag skiftede behandling fra Mirapexin tabletter til Mirapexin 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 MIRAPEXIN tablets to MIRAPEXIN prolonged-release tablets at the same daily dose were evaluated in a double-blind clinical study in patients with early Parkinson's disease.
Brug af MIRAPEXIN sammen med mad, drikke og alkohol Ved behandling med MIRAPEXIN, skal du være forsigtig med indtagelse af alkohol, da din reaktionsevne kan blive markant nedsat. 
MIRAPEXIN with food, drink and alcohol You should be cautious while drinking alcohol during treatment with MIRAPEXIN.
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.
Alle tabletter har Boehringer Ingelheims firma logo præget på den ene side og koden P6, P7, P8 eller P9 på den anden, hvilket repræsenterer tabletstyrker på henholdsvis 0,088 mg, 0,18 mg, 0,35mg og 0,7 mg. 
All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P6, P7, P8, or P9 on the other side, representing the tablet strengths 0.088 mg, 0.18 mg, 0.35 mg, and 0.7 mg, respectively.
MIRAPEXIN må ikke anvendes under amning. 
MIRAPEXIN should not be used during breast-feeding.
• Alvorlige hjerte- eller karsygdomme. 
- Severe heart or blood vessels disease.
1 gang daglig Aften dosis 
nd week rd week th week
Mirapexin anbefales ikke til børn og unge under 18 år p.g.a. manglende dokumentation for sikkerhed og virkning. 
MIRAPEXIN is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Den daglige dosis bør ikke overstige 6 MIRAPEXIN tabletter á 0,088 mg eller en dosis af 0,54 mg (0,75 mg pramipexolsalt) 
The daily dose should not exceed 6 tablets MIRAPEXIN 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Må ikke opbevares ved temperaturer over 30 C. 
Do not store above 30°C.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Mirapexin i alle undergrupper af den pædiatriske population med Parkinsons sygdom (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with MIRAPEXIN in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use).
Hvis du holder op med at tage MIRAPEXIN 
If you stop taking MIRAPEXIN
Hvis du har glemt at tage MIRAPEXIN 
If you forget to take MIRAPEXIN
DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk. 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Mirapexins sikkerhed og virkning hos børn under 18 år er ikke klarlagt. 
The safety and efficacy of MIRAPEXIN in children below 18 years has not been established.
Opbevares i den originale yderpakning for at beskytte tabletterne mod lys. 
Store in the original package to protect the tablets from light.
MIRAPEXIN kan enten tages sammen med mad eller alene. 
MIRAPEXIN can be taken with or without food.
På grund af 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).
Mirapexin anbefales ikke til børn og unge under 18 år, da sikkerhed og virkning ikke er klarlagt hos denne population. 
MIRAPEXIN is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Patienter, der i forvejen tager Mirapexin tabletter, kan fra dag til dag skifte til den samme daglige dosis af Mirapexin depottabletter. 
Patients already taking MIRAPEXIN tablets may be switched to MIRAPEXIN prolonged-release tablets overnight, at the same daily dose.
Hvis patienten glemmer en dosis, bør Mirapexin depottabletter tages indenfor 12 timer fra det sædvanlige tidspunkt. 
When the intake of a dose is missed, MIRAPEXIN prolonged-release tablets should be taken within 12 hours after the regularly scheduled time.
6.5 Emballagetype og pakningsstørrelser OPA/aluminium/PVC-aluminium blister. 
6.5 Nature and contents of container OPA/aluminium/PVC-aluminium blisters.
Det er ikke relevant at anvende Mirapexin hos den pædiatriske population ved indikationen Parkinsons sygdom. 
There is no relevant use of MIRAPEXIN in the paediatric population for the indication of Parkinson's Disease.
MIRAPEXIN indeholder: 
What MIRAPEXIN contains
Den anbefalede startdosis for Mirapexin er 0,088 mg base (0,125 mg salt), som tages 1 gang dagligt 23 timer før sengetid. 
The recommended starting dose of MIRAPEXIN is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Ludomani, forøget libido, hyperseksualitet og tvangshandlinger, der fører til overdrevent indkøbsmønster og uhæmmet og overdreven madindtagelse, kan forekomme hos patienter i behandling med dopaminagonister, herunder Mirapexin (se pkt. 
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including MIRAPEXIN (see section 4.4).
MIRAPEXIN bruges til 
What MIRAPEXIN is and what it is used for
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 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
MIRAPEXIN 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg og 3,15 mg depottabletter er hvide til råhvide og ovale. 
MIRAPEXIN 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg prolonged-release tablets are white to off-white and of oval shape.