FrancophonIA/ELRC3.0 huggingface dataset:
English: Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
Danish: Augmentation vil sige, at symptomerne optræder tidligere om aftenen (eller tilmed om eftermiddagen) og at symptomerne forværres og involverer andre ekstremiteter.
English: The following dose schedule is suggested for initiation of therapy:
Danish: Følgende doseringsregime foreslås som begyndelsesterapi:
English: In humans, the protein binding of pramipexole is very low (< 20 %) and the volume of distribution is large (400 l).
Danish: Hos mennesket er proteinbindingen af pramipexol meget lav (<20 %) og fordelingsvoluminet stort (400 l).
English: • Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
Danish: • Forandring af søvnmønster, såsom søvnløshed (insomni) og søvnighed
English: The active substance is pramipexole.
Danish: Det aktive stof er pramipexol.
English: The usual maintenance dose is 1.1 mg per day.
Danish: Vedligeholdelsesdosis er oftest 1,1 mg om dagen.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apotekspersonalet til råds, før du tager nogen form for medicin.
English: Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Danish: Hypotension kan forekomme i begyndelsen af behandlingen, specielt hvis pramipexol bliver titreret for hurtigt.
English: Antipsychotic medicinal products
Danish: Antipsykotiske lægemidler
English: Simply leave out that dose completely and then take your next dose at the right time.
Danish: Spring denne dosis over og tag næste dosis på det sædvanlige tidspunkt.
English: The primary endpoint was change from baseline on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).
Danish: Det primære endepunkt var ændring fra baseline i Total Tic Score (TTS) på Yale Global Tic Severity Scale (YGTSS).
English: Providing patients do not experience intolerable undesirable effects, the dose should be titrated to achieve a maximal therapeutic effect.
Danish: Forudsat at patienten ikke får uacceptable bivirkninger, skal dosis titreres indtil den maksimale terapeutiske virkning.
English: Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
Danish: Pga. de valgte dyrearter og det begrænsede antal undersøgte parametre, er pramipexols bivirkninger i forbindelse med graviditet og mandlig fertilitet ikke fuldt belyst.
English: • quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria))
Danish: • Quinin (medicin til forebyggelse af smertefulde natlige lægkramper og til behandling af en malariatype kendt som falciparum malaria (ondartet malaria))
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natrium-frit.
English: If you suffer from Parkinson's disease, you may experience the following side effects:
Danish: Hvis du har Parkinsons sygdom, kan du få følgende bivirkninger:
English: There is no pharmacokinetic interaction with selegiline and levodopa.
Danish: Der er ingen farmakokinetisk interaktion med selegilin og levodopa.
English: Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: Fortæl , hvis du eller din familie/pårørende bemærker, at du er ved at udvikle trang til at opføre dig på måder, der er usædvanlige for dig, og du ikke kan modstå trangen eller fristelsen til at udføre visse aktiviteter, der kan skade dig selv eller andre.
English: The total clearance of pramipexole is approximately 500 ml/min and the renal clearance is approximately 400 ml/min.
Danish: Den totale clearance for pramipexol er omkring 500 ml/min., og den renale clearance er omkring 400 ml/min.
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opført efter systemorganklasse og hyppighed (antal patienter, der forventes, at opleve en bivirkning) ved brug af følgende kategorier: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ualmindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden
English: In a pharmacoepidemiological study pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole (observed risk ratio 1.86; 95% CI, 1.21
Danish: I et farmakoepidemiologisk forsøg var brug af pramipexol associeret med en øget risiko for hjertesvigt sammenlignet med ikke-brug af pramipexol (observeret risikoratio 1,86; 95 % CI
English: Hallucinations
Danish: Hallucinationer
English: However, these studies did not indicate direct or indirect harmful effects with respect to male fertility.
Danish: Disse studier viste ikke tegn på direkte eller indirekte skadelig virkning på fertiliteten hos hanner.
English: The majority of adverse drug reactions usually start early in therapy and most tend to disappear even as therapy is continued.
Danish: Hovedparten af bivirkningerne starter sædvanligvis tidligt i behandlingen, og de fleste har tendens til at forsvinde, også selv ved fortsat behandling.
English: Restless Legs Syndrome
Danish: Restless legs syndrom
English: • cisplatin (to treat various types of cancers)
Danish: • Cisplatin (medicin mod forskellige typer kræft)
English: The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
Danish: Den samlede incidens af hallucinationer og somnolens var generelt højere i den gradvise dosisøgningsfase med pramipexolgruppen.
English: Augmentation was observed in 11.8% of patients in the pramipexole group (N = 152) and 9.4% of patients in the placebo group (N = 149).
Danish: Augmentation blev observeret hos 11,8 % af patienterne i pramipexolgruppen (N = 152) og hos 9,4 % af patienterne i placebogruppen (N = 149).
English: These points should be considered when initiating pramipexole treatment in patients with Parkinson's disease.
Danish: Disse punkter skal overvejes ved initiering af pramipexolbehandling hos patienter med Parkinsons sygdom.
English: Patients should be regularly monitored for the development of mania and delirium.
Danish: Patienter bør kontrolleres regelmæssigt for evt. udvikling af mani og delirium.
English: 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).
Danish: 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).
English: The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value <0.0001).
Danish: Den justerede gennemsnitsforskel var -4,3 point (CI 95 % -6,4; -2,1 procent, p-værdi <0,0001).
English: • Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Danish: • Ændret eller øget seksuel interesse og adfærd, der vækker stor bekymring hos dig eller andre, for eksempel en øget seksualdrift.
English: Approximately 90 % of 14C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Danish: Ca. 90 % af en 14°C-mærket dosis udskilles via nyrerne og mindre end 2 % via fæces.
English: (mg of base)
Danish: (mg base)
English: • Excess of fluid, usually in the legs (peripheral oedema)
Danish: • Væskeophobning, ofte i benene (perifere ødemer)
English: A total of 63 patients were randomised (43 on pramipexole, 20 on placebo).
Danish: I alt blev 63 patienter randomiseret (43 til pramipexol, 20 til placebo).
English: 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.
Danish: 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.
English: Severe cardiovascular disease
Danish: Alvorlig kardiovaskulær sygdom
English: If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Danish: Hvis behandlingen afbrydes i flere dage, skal den initieres på ny med dosistitrering, som ovenfor beskrevet.
English: • Weight increase
Danish: • Vægtforøgelse
English: Parkinson's disease The daily dose is to be taken divided into 3 equal doses.
Danish: Parkinsons sygdom Den daglige dosis skal deles i 3 lige store doser.
English: 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).
Danish: 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 %).
English: Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa.
Danish: Hallucinationer er en kendt bivirkning ved behandling med dopaminagonister og levodopa.
English: Although dystonia may be a symptom of Parkinson's disease, the symptoms in these patients have improved after reduction or withdrawal of pramipexole.
Danish: Selvom dystoni kan være et symptom på Parkinsons sygdom, er symptomerne hos disse patienter blevet mildere efter reduktion eller seponering af pramipexol.
English: 63 % of patients on pramipexole and 52 % of patients on placebo reported at least one adverse drug reaction.
Danish: 63 % af patienterne i pramipexolbehandling og 52 % af patienterne i placebobehandling rapporterede mindst en bivirkning.
English: • 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)*
Danish: • 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)*
English: Take care if you are taking the following medicines:
Danish: Tal med din læge, hvis du tager følgende medicin:
English: Placebocontrolled clinical trials included approximately 1,800 patients of Hoehn and Yahr stages I - V treated with pramipexole.
Danish: Placebokontrollerede kliniske undersøgelser inkluderede ca. 1.800 patienter på Hoehn & Yahr stadier I-V behandlet med pramipexol.
English: • Inappropriate antidiuretic hormone secretion*
Danish: • Uhensigtsmæssig udskillelse af antidiuretisk hormon*
English: 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.
Danish: 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.
English: A delay in sexual development (i.e., preputial separation and vaginal opening) was observed in rats.
Danish: Forsinket kønslig udvikling er observeret hos rotter (dvs. forsinket præputial separation og forsinket vaginalåbning).
English: 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).
Danish: 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).
English: In early and advanced Parkinson's disease, efficacy of pramipexole in controlled clinical trials was maintained for approximately six months.
Danish: Ved tidlig og fremskreden Parkinsons sygdom, var virknngen af pramipexol i de kontrollerede kliniske undersøgelser bevaret i ca. 6 måneder.
English: There is no established antidote for overdose of a dopamine agonist.
Danish: Der er ingen kendt antidot ved overdosering af en dopaminagonist.
English: If you have severe kidney disease, Pramipexole Teva may not be a suitable treatment for you.
Danish: Hvis du har en alvorlig nyresygdom, er Pramipexol Teva måske ikke den egnede behandling for dig.
English: 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).
Danish: 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).
English: 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).
Danish: 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).
English: Your doctor may need to adjust or stop your dose.
Danish: Din læge skal muligvis justere din dosis eller afbryde behandlingen.
English: 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.
Danish: 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.
English: • Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)).
Danish: • Dystoni (manglende evne til at holde din krop og nakke lige og oprejst (aksial dystoni)).
English: 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.
Danish: 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.
English: • Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
Danish: • Hjertesvigt (hjerteproblemer, der kan forårsage åndenød eller hævede ankler)*
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Hypotension (low blood pressure)
Danish: • Lavt blodtryk (hypotension)
English: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany
Danish: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Tyskland
English: Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Danish: Derfor udtrykkes doseringen både som pramipexolbase og pramipexolsalt (i parentes).
English: High brain tissue concentrations were observed in the rat (approx. 8-fold compared to plasma).
Danish: Høj koncentration i hjernevæv blev observeret hos rotter (omkring 8 gange sammenlignet med plasma).
English: The excretion of pramipexole into breast milk has not been studied in women.
Danish: Udskillelsen af pramipexol i modermælk er ikke blevet undersøgt hos kvinder.
English: 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.
Danish: Fald i det diastoliske og systoliske blodtryk og hjerterytmen blev fundet hos minigrise, og en tendens til en hypotensiv virkning blev erkendt hos aber.
English: If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Danish: Hvis du har restless legs syndrom, kan du få følgende bivirkninger:
English: Pramipexole
Danish: Pramipexol
English: Patients should be regularly monitored for the development of impulse control disorders.
Danish: Patienter skal kontrolleres regelmæssigt for evt. udvikling af manglende impulskontrol.
English: There is no relevant use of Pramipexole Teva in the paediatric population for the indication of Parkinson's Disease.
Danish: Det er ikke relevant at anvende Pramipexol Teva hos den pædiatriske population ved indikationen Parkinsons sygdom.
English: 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.
Danish: 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.
English: • Uncontrollable excessive shopping or spending
Danish: • Ukontrollerbart overdrevent indkøbsmønster og forbrug.
English: 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).
Danish: 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).
English: 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%).
Danish: 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 %).
English: Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
Danish: Behandling af overdosering kan kræve generel understøttende behandling med udpumpning, intravenøst drop, indgivelse af aktivt kul og elektrokardiografisk overvågning.
English: 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.
Danish: 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.
English: The other ingredients are mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide.
Danish: De andre indholdsstoffer er mannitol, mikrokrystallinsk cellulose, natriumstivelsesglycolat, povidon, magnesiumstearat, natriumstearylfumarat, kolloid siliciumdioxid.
English: 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.
Danish: 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.
English: If you have to stop taking this medicine, your doctor will reduce the dose gradually.
Danish: Hvis det er nødvendigt at stoppe behandlingen, nedsætter lægen gradvis din dosis.
English: Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
Danish: Pludseligt ophør af dopaminbehandling kan føre til udvikling af neuroleptisk malignt syndrom.
English: 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).
Danish: Andre signifikante bivirkninger, der førte til seponering af forsøgsmedicinen hos de patienter, der fik pramipexol, var konfusionstilstand, taleforstyrrelse og forværret tilstand (se pkt.
English: The use of Pramipexole Teva has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Danish: Brugen af Pramipexol Teva har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion.
English: Patients and carers should be made aware that mania and delirium can occur in patients treated with pramipexole.
Danish: Patienter og pårørende bør informeres om, at mani og delirium kan forekomme hos patienter i behandling med pramipexol.
English: Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Pramipexole Teva.
Danish: Patienterne bør informeres om dette og tilrådes forsigtig brug ved bilkørsel eller betjening af maskiner under behandling med Pramipexol Teva.
English: Your doctor will then discuss with you if you should continue to take Pramipexole Teva.
Danish: Din læge vil tale med dig, om du skal fortsætte med at tage Pramipexol Teva.
English: The mechanism of action of pramipexole as treatment for Restless Legs Syndrome is unknown.
Danish: Virkningsmekanismen for prampipexol til behandling af restless legs syndrom er ukendt.
English: A more frequent adverse drug reaction in combination with levodopa was dyskinesia.
Danish: Hyppigere bivirkninger i kombination med levodopa var dyskinesi.
English: Please note:
Danish: Bemærk:
English: If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Danish: I tilfælde af at centralnervesystemet synes at være stimuleret, kan et neuroleptisk middel anvendes.