natgillin/translations-raw huggingface dataset:
Patienter bør kontrolleres regelmæssigt for evt. udvikling af mani og delirium. 
Patients should be regularly monitored for the development of mania and delirium.
Fortæl din læge, hvis du eller din familie/pårørende bemærker, at du er ved at udvikle mani (føle sig oprørt, opstemt eller ophidset) eller delirium (nedsat bevidsthed, forvirring eller manglende realitetsopfattelse). 
Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion or loss of reality).
Den justerede gennemsnitsforskel var -4,3 point (CI 95 % -6,4; -2,1 procent, p-værdi <0,0001). 
The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value <0.0001).
• Ændret eller øget seksuel interesse og adfærd, der vækker stor bekymring hos dig eller andre, for eksempel en øget seksualdrift. 
• Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Ca. 90 % af en 14°C-mærket dosis udskilles via nyrerne og mindre end 2 % via fæces. 
Approximately 90 % of 14C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
(mg base) 
(mg of base)
• Væskeophobning, ofte i benene (perifere ødemer) 
• Excess of fluid, usually in the legs (peripheral oedema)
I alt blev 63 patienter randomiseret (43 til pramipexol, 20 til placebo). 
A total of 63 patients were randomised (43 on pramipexole, 20 on placebo).
Inhibitorer/kompetitive hæmmere af den renale eliminationsvej Cimetidin reducerede den renale clearance af pramipexol med ca. 34 %, antagelig ved hæmning af det kationiske sekretionstransportsystem i de renale tubuli. 
Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34 %, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Alvorlig kardiovaskulær sygdom 
Severe cardiovascular disease
Hvis behandlingen afbrydes i flere dage, skal den initieres på ny med dosistitrering, som ovenfor beskrevet. 
If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
• Vægtforøgelse 
• Weight increase
Parkinsons sygdom Den daglige dosis skal deles i 3 lige store doser. 
Parkinson's disease The daily dose is to be taken divided into 3 equal doses.
Kvalme og træthed blev oftere rapporteret hos kvindelige patienter behandlet med pramipexol (henholdsvis 20,8 % og 10,5 %) sammenlignet med mandlige patienter (henholdsvis 6,7 % og 7,3 %). 
Nausea and fatigue were more often reported in female patients treated with pramipexole (20.8 % and 10.5 %, respectively) compared to males (6.7 % and 7.3 %, respectively).
Hallucinationer er en kendt bivirkning ved behandling med dopaminagonister og levodopa. 
Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa.
Selvom dystoni kan være et symptom på Parkinsons sygdom, er symptomerne hos disse patienter blevet mildere 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.
63 % af patienterne i pramipexolbehandling og 52 % af patienterne i placebobehandling rapporterede mindst en bivirkning. 
63 % of patients on pramipexole and 52 % of patients on placebo reported at least one adverse drug reaction.
• 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)*
Tal med din læge, hvis du tager følgende medicin: 
Take care if you are taking the following medicines:
Placebokontrollerede kliniske undersøgelser inkluderede ca. 1.800 patienter på Hoehn & Yahr stadier I-V behandlet med pramipexol. 
Placebocontrolled clinical trials included approximately 1,800 patients of Hoehn and Yahr stages I - V treated with pramipexole.
• Uhensigtsmæssig udskillelse af antidiuretisk hormon* 
• Inappropriate antidiuretic hormone secretion*
I en kontrolleret dobbeltblind klinisk undersøgelse af 2 års varighed forsinkede initial behandling med pramipexol signifikant fremkomsten af motoriske komplikationer og reducerede deres forekomst sammenlignet med initial behandling med levodopa. 
In a controlled double blind clinical trial of 2 year duration, initial treatment with pramipexole significantly delayed the onset of motor complications, and reduced their occurrence compared to initial treatment with levodopa.
Forsinket kønslig udvikling er observeret hos rotter (dvs. forsinket præputial separation og forsinket vaginalåbning). 
A delay in sexual development (i.e., preputial separation and vaginal opening) was observed in rats.
Der blev ikke observeret nogen forskel på pramipexol og placebo for hverken det primære endepunkt eller for nogen af de sekundære endepunkter herunder 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).
Ved tidlig og fremskreden Parkinsons sygdom, var virknngen af pramipexol i de kontrollerede kliniske undersøgelser bevaret i ca. 6 måneder. 
In early and advanced Parkinson's disease, efficacy of pramipexole in controlled clinical trials was maintained for approximately six months.
Der er ingen kendt antidot ved overdosering af en dopaminagonist. 
There is no established antidote for overdose of a dopamine agonist.
Hvis du har en alvorlig nyresygdom, er Pramipexol Teva måske ikke den egnede behandling for dig. 
If you have severe kidney disease, Pramipexole Teva may not be a suitable treatment for you.
Denne forsinkelse af motoriske komplikationer med pramipexol skal opvejes imod en større bedring af motorisk funktion med levodopa (målt ved den gennemsnitlige ændring i UPDRS-score). 
This delay in motor complications with pramipexole should be balanced against a greater improvement in motor function with levodopa (as measured by the mean change in UPDRS-score).
Pramipexol Teva er indiceret til voksne til behandling af tegn og symptomer på idiopatisk Parkinsons sygdom, alene (uden levodopa) eller i kombination med levodopa dvs. i hele sygdomsforløbet, ved sene stadier når virkningen af levodopa klinger af eller bliver ustadig og svingninger i den terapeutiske virkning opstår ("end of dose" eller "on off" svingninger). 
Pramipexole Teva is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
Din læge skal muligvis justere din dosis eller afbryde behandlingen. 
Your doctor may need to adjust or stop your dose.
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 tager Pramipexol Teva. 
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.
• 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)).
Toksicitetsstudier med gentagne doser viser, at pramipexol udøver funktionelle virkninger, som hovedsageligt involverer CNS og det kvindelige reproduktionssystem, antagelig stammende fra en overdreven farmakodynamisk virkning af lægemidlet. 
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
• Hjertesvigt (hjerteproblemer, der kan forårsage åndenød eller hævede ankler)* 
• Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
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.
• Lavt blodtryk (hypotension) 
• Hypotension (low blood pressure)
Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Tyskland 
Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany
Derfor udtrykkes doseringen både som pramipexolbase og pramipexolsalt (i parentes). 
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Høj koncentration i hjernevæv blev observeret hos rotter (omkring 8 gange sammenlignet med plasma). 
High brain tissue concentrations were observed in the rat (approx. 8-fold compared to plasma).
Udskillelsen af pramipexol i modermælk er ikke blevet undersøgt hos kvinder. 
The excretion of pramipexole into breast milk has not been studied in women.
Fald i det diastoliske og systoliske blodtryk og hjerterytmen blev fundet hos minigrise, og en tendens til en hypotensiv virkning blev erkendt hos aber. 
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to a hypotensive effect was discerned in the monkey.
Hvis du har restless legs syndrom, kan du få følgende bivirkninger: 
If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Pramipexol 
Pramipexole
Patienter skal kontrolleres regelmæssigt for evt. udvikling af manglende impulskontrol. 
Patients should be regularly monitored for the development of impulse control disorders.
Det er ikke relevant at anvende Pramipexol Teva hos den pædiatriske population ved indikationen Parkinsons sygdom. 
There is no relevant use of Pramipexole Teva in the paediatric population for the indication of Parkinson's Disease.
De mulige uafhængige risikofaktorer for unormal adfærd omfatter dopaminbehandling, højere doser af dopaminbehandling, en yngre alder (≤ 65 år), at være ugift og at have arvelig ludomani. 
Possible independent risk factors for impulse control disorders included dopaminergic treatments and higher doses of dopaminergic treatment, younger age ( ≤ 65 years), not being married and self-reported family history of gambling behaviours.
• Ukontrollerbart overdrevent indkøbsmønster og forbrug. 
• Uncontrollable excessive shopping or spending
Efter 12 ugers behandling var baseline IRLS scoren forbedret fra 23,5 til 14,1 point for placebo og fra 23,4 til 9,4 point for pramipexol (kombinerede doser). 
After 12 weeks of treatment the baseline IRLS score improved from 23.5 to 14.1 points for placebo and from 23.4 to 9.4 points for pramipexole (doses combined).
Følgende bivirkninger var mere almindelige hos de pramipexolbehandlede patienter end hos de placebobehandlede patienter: Hovedpine (27,9 %, placebo 25,0 %), døsighed (7,0 %, placebo 5,0 %), kvalme (18,6 %, placebo 10,0 %), opkastning (11,6 %, placebo 0,0 %), øvre abdominalsmerter (7,0 %, placebo 5,0 %), ortostatisk hypotension (9,3 %, placebo 5,0 %), myalgi (9,3 %, placebo 5,0 %), søvnforstyrrelser (7,0 %, placebo 0,0 %), dyspnø (7,0 %, placebo 0,0 %) og infektion i de øvre luftveje (7,0 %, placebo 5,0 %). 
Adverse events occurring in at least 5% of patients in the pramipexole group and more common in the pramipexole-treated patients than in patients on placebo were: headache (27.9%, placebo 25.0%), somnolence (7.0%, placebo 5.0%), nausea (18.6%, placebo 10.0%), vomiting (11.6%, placebo 0.0%), upper abdominal pain (7.0%, placebo 5.0%), orthostatic hypotension (9.3%, placebo 5.0%), myalgia (9.3%, placebo 5.0%), sleep disorder (7.0%, placebo 0.0%), dyspnoea (7.0%, placebo 0.0%) and upper respiratory tract infection (7.0%, placebo 5.0%).
Behandling af overdosering kan kræve generel understøttende behandling med udpumpning, intravenøst drop, indgivelse af aktivt kul og elektrokardiografisk overvågning. 
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
Lægemidler, som således hæmmer den aktive, renale eliminationsvej eller elimineres via denne vej, såsom cimetidin, amantadin, mexiletin, zidovudin, cisplatin, quinin og procainamid kan være årsag til interaktioner med pramipexol, resulterende i reduceret clearance af pramipexol. 
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine mexiletine, zidovudine, cisplatin, quinine, and procainamide may interact with pramipexole resulting in reduced clearance of pramipexole.
De andre indholdsstoffer er mannitol, mikrokrystallinsk cellulose, natriumstivelsesglycolat, povidon, magnesiumstearat, natriumstearylfumarat, kolloid siliciumdioxid. 
The other ingredients are mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide.
Klinisk virkning og sikkerhed ved restless legs syndrom Virkningen af pramipexol er blevet evalueret i fire placebokontrollerede kliniske forsøg hos cirka 1.000 patienter med moderat til meget svær idiopatisk restless legs syndrom. 
Clinical efficacy and safety in Restless Legs Syndrome The efficacy of pramipexole was evaluated in four placebo-controlled clinical trials in approximately 1,000 patients with moderate to very severe idiopathic Restless Legs Syndrome.
Hvis det er nødvendigt at stoppe behandlingen, nedsætter lægen gradvis din dosis. 
If you have to stop taking this medicine, your doctor will reduce the dose gradually.
Pludseligt ophør af dopaminbehandling kan føre til udvikling af neuroleptisk malignt syndrom. 
Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
Andre signifikante bivirkninger, der førte til seponering af forsøgsmedicinen hos de patienter, der fik pramipexol, var konfusionstilstand, taleforstyrrelse og forværret tilstand (se pkt. 
Other significant adverse events leading to discontinuation of study medication for patients receiving pramipexole were confusional state, speech disorder and aggravated condition (see section 4.2).
Brugen af Pramipexol Teva har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion. 
The use of Pramipexole Teva has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Patienter og pårørende bør informeres om, at mani og delirium kan forekomme hos patienter i behandling med pramipexol. 
Patients and carers should be made aware that mania and delirium can occur in patients treated with pramipexole.
Patienterne bør informeres om dette og tilrådes forsigtig brug ved bilkørsel eller betjening af maskiner under behandling med Pramipexol Teva. 
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Pramipexole Teva.
Din læge vil tale med dig, om du skal fortsætte med at tage Pramipexol Teva. 
Your doctor will then discuss with you if you should continue to take Pramipexole Teva.
Virkningsmekanismen for prampipexol til behandling af restless legs syndrom er ukendt. 
The mechanism of action of pramipexole as treatment for Restless Legs Syndrome is unknown.
Hyppigere bivirkninger i kombination med levodopa var dyskinesi. 
A more frequent adverse drug reaction in combination with levodopa was dyskinesia.
Bemærk: 
Please note:
I tilfælde af at centralnervesystemet synes at være stimuleret, kan et neuroleptisk middel anvendes. 
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Baseret på analysen af poolede placebokontrollerede kliniske forsøg, der i alt omfattede 1.923 patienter i behandling med pramipexol og 1.354 patienter i placebobehandling, blev bivirkninger hyppigt rapporteret for 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.
I kliniske undersøgelser blev ca. 5 % af patienterne 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).
Manglende impulskontrol 
Impulse control disorders
Biotransformation Pramipexol metaboliseres kun i ringe omfang hos mennesket. 
Biotransformation Pramipexole is metabolised in man only to a small extent.
Fortæl det til din læge, hvis du udvikler en manglende evne til at holde din krop og nakke lige og oprejst (aksial dystoni). 
Tell your doctor if you are developing an inability of keeping your body and neck straight and upright (axial dystonia).
Tag ikke Pramipexol Teva: 
Do not take Pramipexole Teva:
Infektioner og parasitære sygdomme pneumoni1 
Infections and infestations pneumonia1
Tabletten kan deles i to lige store halvdele. 
The tablet can be divided into equal halves.
Hvis dette er tilfældet, vil din læge øge dosis op til et maksimum på 3,3 mg pramipexol om dagen. 
If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day.
DATO FOR ÆNDRING AF TEKSTEN Detaljeret information vedrørende dette produkt er tilgængelig på European Medicines Agency's hjemmeside http://www.ema.europa.eu/ 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
I et klinisk studie med raske, frivillige forsøgspersoner, hvor dosisjustering af pramipexol-depottabletter var hurtigere (hver 3. dag) end anbefalet, op til 3,15 mg pramipexolbase/dag (4,5 mg salt), blev der observeret en stigning i blodtrykket samt en forøgelse af hjerterytmen. 
In a clinical trial with healthy volunteers, where pramipexole 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.
Dyskinesi 
Dyskinesia
Dette kaldes manglende impulskontrol og kan omfatte adfærd som ludomani, overdreven madindtagelse eller trang til indkøb, en unormal stor sexlyst eller sex-interesse med seksuelle tanker eller følelser. 
These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.
• Så kontakt lægen eller skadestuen med det samme. 
• Contact your doctor or nearest hospital casualty department immediately for advice.
Pramipexol Teva indeholder det aktive stof pramipexol og hører til en gruppe lægemidler kendt som dopaminagonister, som stimulerer dopaminreceptorer i hjernen. 
Pramipexole Teva contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
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 Pramipexol Teva-behandling. 
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Pramipexole Teva treatment.
Dyrestudier har vist, at pramipexol hæmmer dopaminsyntese, -frigørelse og -omsætning. 
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
CGI-I-responsraten (meget forbedret, rigtig meget forbedret) var 50,3 % (80/159) og 68,5 % (111/162) for henholdsvis placebo og pramipexol (p = 0,001), svarende til ”number needed to treat” (NNT) på 6 patienter (95 %CI: 3,5, 13,4). 
CGI-I responder rates (much improved, very much improved) were 50.3% (80/159) and 68.5% (111/162) for placebo and pramipexole, respectively (p = 0.001), corresponding to a number needed to treat (NNT) of 6 patients (95%CI: 3.5, 13.4).
Pramipexol Teva indeholder natrium 
Pramipexole Teva contains sodium
Ved fremskreden Parkinsons sygdom kan pramipexoldoser højere end 1,1 mg (1,5 mg salt) i døgnet være nyttige hos patienter, hvor en reduktion af levodopabehandlingen er tilsigtet. 
In advanced Parkinson's disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Der anbefales oftalmologisk undersøgelse med regelmæssige mellemrum eller hvis der fremkommer synsabnormaliteter. 
Ophthalmologic monitoring Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Pramipexol letter det parkinsonistiske motoriske underskud ved stimulation af dopaminreceptorer i Corpus striatum. 
Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Ændring af libido Pramipexol kan forbindes med libidosygdomme (øget eller nedsat). 
Libido disorders Pramipexole may uncommonly be associated with libido disorders (increased or decreased).
• Zidovudin (medicin mod aids (erhvervet immundefekt syndrom), en sygdom i immunsystemet) 
• zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system)
• Alvorlige hjerte- eller karsygdomme. 
• Severe heart or blood vessels disease.
Det endokrine system uhensigtsmæssig udskillelse af antidiuretisk hormon1 
Endocrine disorders inappropriate antidiuretic hormone secretion1
Dosering af pramipexol refererer i litteraturen til saltformen. 
Pramipexole doses as published in the literature refer to the salt form.
Pramipexol udviser lineær kinetik og kun en lille interpatient variation i plasmaniveau. 
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
I et retrospektivt screening- og case-kontrol-studie med 3090 Parkinsonpatienter, fik 13,6 % af alle patienter behandlet med dopamin eller non-dopamine lægemidler, i løbet af de sidste 6 måneders behandling, symptomer på unormal adfærd. 
In a cross-sectional, retrospective screening and case-control study including 3,090 Parkinson's disease patients, 13.6% of all patients receiving dopaminergic or non-dopaminergic treatment had symptoms of an impulse control disorder during the past six months.
Eliminationen af pramipexol er afhængig af nyrefunktionen. 
The elimination of pramipexole is dependent on renal function.
Patienter med en kreatininclearance over 20 ml/min behøver ingen reduktion i den daglige dosis. 
Patients with a creatinine clearance above 20 ml/min require no reduction in daily dose.
Det kan anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Pramipexol Teva, afhængigt af den enkelte patients reaktioner (se pkt. 
It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with Pramipexole Teva, depending on reactions in individual patients (see section 4.5).
• Psykoser (f.eks. som ved symptomer på skizofreni) 
• Psychosis (e.g. comparable with symptoms of schizophrenia).
(≥1/100 til 
(≥1/100 to
Når Pramipexol Teva gives i kombination med levodopa, anbefales det at reducere levodopadosis og at holde doseringen af andre antiparkinson-lægemidler konstant, mens dosis af Pramipexol Teva øges. 
When Pramipexole Teva 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 Pramipexole Teva.
(≥1/100 til <1/10) 
(≥1/1,000 to <1/100)
(≥1/1.000 til 
(≥1/1,000 to