FrancophonIA/ELRC3.0 huggingface dataset:
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 påny med dosistitrering, som ovenfor beskrevet.
English: Rare: - Mania (agitation, feeling elated or over-excited)
Danish: Sjælden: - Mani (føle sig oprørt, opstemt eller ophidset)
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 pramipexole signifikant fremkomsten af motoriske komplikationer, og reducerede deres forekomst sammenlignet med initial behandling med levodopa.
English: Parts of tablets may occasionally be passed and seen in the stool (faeces) and may look like whole tablets.
Danish: Dele af tabletterne kan lejlighedsvis passere gennem systemet og udskilles i afføringen, hvor de kan ligne hele tabletter.
English: Two trials were conducted in patients with early Parkinson's disease and one trial was conducted in patients with advanced Parkinson's disease.
Danish: 2 af studierne blev udført hos patienter med tidlig Parkinsons sygdom, og det 3. studie blev udført hos patienter med fremskreden 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: Then take your Oprymea prolonged-release tablets next morning and do not take any more Oprymea (immediate release) tablets.
Danish: Tag Oprymea depottabletter den næste morgen, og tag så ikke flere almindelige Oprymea tabletter.
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: If you stop taking Oprymea
Danish: Hvis du holder op med at tage Oprymea
English: However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
Danish: Den potentielle indflydelse af nedsat leverfunktion på Oprymeas farmakokinetik kendes ikke.
English: There is no established antidote for overdose of a dopamine agonist.
Danish: Der er ingen kendt antidot ved overdosering af dopaminagonister.
English: <2D barcode carrying the unique identifier included.>
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
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 placebo kontrollerede kliniske forsøg hos cirka 1.000 patienter med moderat til meget svær idiopatisk restless legs syndrom.
English: Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
Danish: Pludseligt ophør med dopamin-behandling kan føre til udvikling af malignt neuroleptikasyndrom.
English: BLISTER/(Alu/Alu)
Danish: Blister (Aluminium/Aluminium)
English: 20 tablets 30 tablets 60 tablets 90 tablets 100 tablets
Danish: 20 tabletter 30 tabletter 60 tabletter 90 tabletter 100 tabletter
English: OUTER BOX (treatment initiation pack containing 3 boxes of 7 prolonged-release tablets)
Danish: YDRE ÆSKE (behandlingsstart pakke indeholdende 3 pakninger med 7 depottabletter)
English: Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Danish: Dyrestudier har vist, at pramipexol hæmmer dopaminsyntese,frigørelse og -omsætning.
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 inklusive YGTSS total score, Patient Global Impression of Improvement (PGI-I), Clinical Global Impression of Improvement (CGI-I) eller
English: 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.
Danish: 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.
English: CGI-I responder rates (improved, very much improved) were 51.2% and 72.0% for placebo and pramipexole, respectively (difference 20% CI 95%: 8.1%; 31.8%, p<0.0005).
Danish: CGI-I svarrater (forbedret, meget forbedret) var henholdsvis 51,2% og 72,0% for placebo og pramipexol (forskel 20% CI 95%: 8,1%; 31,8%, p<0,0005).
English: In the absence of human data, Oprymea should not be used during breast-feeding.
Danish: Pga. mangel på humane data må Oprymea ikke anvendes under amning.
English: Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with Oprymea.
Danish: Det bør overvejes at nedsætte pramipexoldosis i tilfælde, hvor disse lægemidler administreres samtidigt med Oprymea.
English: Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Danish: Pramipexol var ikke teratogen i rotter og kaniner, men var embryotoksisk i rotter ved maternotoksiske doser.
English: The effect on pregnancy and lactation has not been investigated in humans.
Danish: Virkningen på graviditet og amning hos mennesker er ikke kendt.
English: Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Danish: Der anbefales oftalmologisk undersøgelse med regelmæssige mellemrum eller hvis der opstår synsabnormaliteter.
English: Endocrine disorders inappropriate antidiuretic hormone secretion
Danish: Det endokrine system uhensigtsmæssig udskillelse af antidiuretisk hormon
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with Oprymea, depending on reactions in individual patients (see section 4.5).
Danish: Det kan anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Oprymea, afhængigt af den enkelte patients reaktioner (se pkt.
English: If you forget to take Oprymea
Danish: Hvis du har glemt at tage Oprymea
English: 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.
Danish: 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.
English: During the first week, the usual daily dose is 0.26 mg pramipexole.
Danish: I den første uge er den sædvanlige daglige dosis 0,26 mg pramipexol.
English: Oprymea prolonged-release tablet is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested.
Danish: Oprymea depottabletter er specialfremstillede tabletter, hvor det aktive stof langsomt frigives efter indtagelse af tabletten.
English: Do not chew, divide or crush the prolonged-release tablets.
Danish: Du må ikke tygge, dele eller knuse depottabletten.
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 hovedsagelig involverer CNS og det kvindelige reproduktionssystem, antagelig stammende fra en overdreven farmakodynamisk virkning af lægemidlet.
English: The efficacy of pramipexole (0.0625-0.5 mg/day) with paediatric patients aged 6-17 years with Tourette Disorder was evaluated in a 6-week, double-blind, randomised, placebo-controlled flexible dose study.
Danish: Klinisk virkning og sikkerhed ved Tourettes sygdom Virkningen af pramipexol (0,0625-0,5 mg/dag) hos pædiatriske patienter mellem 6-17 år med Tourettes sygdom blev evalueret i et 6-ugers, dobbeltblind, randomiseret, placebokontrolleret fleksibelt dosis-studie.
English: Pramipexole prolonged-release tablets were non-inferior to pramipexole immediate release tablets as assessed on the UPDRS Parts II+III score at week 33.
Danish: Pramipexol depottabletter var non-inferior i forhold til pramipexoltabletter vurderet ud fra UPDRS del II+III score ved uge 33.
English: What Oprymea is and what it is used for
Danish: Oprymea bruges til:
English: Symptoms
Danish: Symptomer:
English: Oprymea prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Danish: Oprymea depottabletter er én-gang-daglig oral formulering af pramipexol.
English: 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).
Danish: 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).
English: Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Danish: Pramipexol udviser lineær kinetik og kun en lille interpatient variation i plasmaniveauet.
English: In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Danish: I et karcinogenitets-studie udviklede hanrotter Leydig-cellehyperplasi og adenomer, pga. pramipexols prolaktinhæmmende virkning.
English: The tablet can be divided into equal doses.
Danish: Tabletten kan deles i to lige store dele.
English: If you have serious kidney problems, your doctor may need to switch you to a different pramipexole medicine.
Danish: Hvis du har en alvorlig nyresygdom, skal du muligvis behandles med en anden type pramipexolmedicin.
English: The same study also showed that, at doses of 2 mg/kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
Danish: Samme studie viste tillige, i albinorotter, der fik doser på 2 mg/kg (salt) pramipexol og derover, en sammenhæng med retinal degeneration.
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: When Oprymea 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 Oprymea.
Danish: Når Oprymea gives i kombination med levodopa, anbefales det at reducere levodopa-dosis og at holde dosis af andre antiparkinson-lægemidler konstant, mens dosis af Oprymea øges.
English: Some patients have reported the occurrence of remnants in faeces which may resemble intact Oprymea prolonged-release tablets.
Danish: Nogle patienter har rapporteret om rester i afføringen, der kan ligne intakte Oprymea depottabletter.
English: Efficacy was observed with 0.088 mg of base (0.125 mg of salt) per day after the first week of treatment.
Danish: Virkning blev set ved 0,088 mg base (0,125 mg salt) pr. dag efter den første uges behandling.
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 fordelingsvolumet stort (400 l).
English: Uncommon (≥1/1,000 to
Danish: Ikke almindelig (≥1/1.000 til
English: Oprymea can reduce the production of breast milk.
Danish: Oprymea kan nedsætte mælkeproduktionen og kan også overføres til din baby via brystmælk.
English: Oprymea 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).
Danish: Oprymea 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.
English: Only one patient switched to pramipexole prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Danish: Kun en patient, som skiftede til pramipexol depottabletter, fik en lægemiddelrelateret bivirkning, der medførte seponering.
English: - The other ingredients are mannitol, maize starch, pregelatinised maize starch, povidone K25, colloidal anhydrous silica and magnesium stearate.
Danish: - Øvrige indholdsstoffer: Mannitol, majsstivelse, pregelatineret majsstivelse, povidon K25, kolloid vandfri silica og magnesiumstearat.
English: Remnants in stool
Danish: Rester i afføringen
English: These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
Danish: Disse punkter skal overvejes ved initiering af pramipexol behandling hos patienter med Parkinsons sygdom.
English: Oprymea can have a major influence on the ability to drive and use machines.
Danish: Oprymea kan påvirke evnen til at føre motorkøretøj og betjene maskiner i væsentlig grad.
English: In animal studies, pramipexole affected oestrous cycles and reduced female fertility as expected for a dopamine agonist.
Danish: I dyrestudier påvirkede pramipexol brunstperioden og nedsatte fertiliteten hos hunner som forventet for en dopaminagonist.
English: Evaluation of these side effects is based on the following frequencies:
Danish: Bivirkningerne kan forekomme med en given hyppighed, som defineres på følgende måde:
English: 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.
Danish: I et retrospektivt screening og case-kontrol studie med 3.090 Parkinsonpatienter fik 13,6% af alle patienter behandlet med dopaminerge eller non-dopaminerge lægemidler symptomer på unormal adfærd i løbet af de sidste 6 måneders behandling.
English: If you are switching from Oprymea (immediate release) tablets Your doctor will base your dose of Oprymea prolonged-release tablets on the dose of Oprymea (immediate release) tablets you were taking.
Danish: Hvis du skifter fra almindelige Oprymea tabletter Din læge vil basere din dosis af Oprymea depottabletter på den dosis af almindelige Oprymea tabletter, som du hidtil har taget.
English: The maximum plasma concentrations occur at about 6 hours after administration of pramipexole prolonged-release tablets once daily.
Danish: Den maksimale plasmakoncentration opnås ca. 6 timer efter administration af pramipexol depottabetter givet en gang daglig.
English: Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Oprymea treatment.
Danish: 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 Oprymea-behandling.
English: What you need to know before you take Oprymea
Danish: Det skal du vide, før du begynder at tage Oprymea
English: Oprymea with food, drink and alcohol You should be cautious while drinking alcohol during treatment with Oprymea.
Danish: Brug af Oprymea sammen med mad, drikke og alkohol Ved behandling med Oprymea, skal du være forsigtig med indtagelse af alkohol, da din reaktionsevne kan blive markant nedsat.
English: In a placebo-controlled polysomnography study over 3 weeks pramipexole significantly reduced the number of periodic limb movements during time in bed.
Danish: I et placebo-kontrolleret polysomnografi-studie over 3 uger reducerede pramipexol signifikant antallet af periodiske benbevægelser, mens forsøgspersonerne var sengeliggende.
English: Blister (OPA/Alu/desiccant/PE-Alu foil): 21 prolonged-release tablets (3 blisters of 7 tablets): - 7 prolonged-release tablets of 0.26 mg
Danish: Blisterpakke (OPA/Alu/tørremiddel/PE-Alu folie): 21 depottabletter (3 blisterark med 7 tabletter): - 7 depottabletter indeholdende 0,26 mg
English: Patients already taking Oprymea tablets may be switched to Oprymea prolonged-release tablets overnight, at the same daily dose.
Danish: Patienter, der i forvejen tager Oprymea tabletter, kan fra dag til dag skifte til den samme daglige dosis af Oprymea depottabletter.
English: Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
Danish: Patienterne bør informeres om dette, og rådes til forsigtighed ved bilkørsel og betjening af maskiner.
English: If they occur, the dose of levodopa should be decreased.
Danish: I disse tilfælde bør levodopa-dosis reduceres.
English: - Sleepiness and episodes of suddenly falling asleep - Psychosis (e.g. comparable with symptoms of schizophrenia) - Vision impairment.
Danish: - Søvnighed og episoder med pludseligt indsættende søvn - Psykoser (f.eks. som ved symptomer på skizofreni) - Synsnedsættelse.
English: Ophthalmologic monitoring
Danish: Oftalmologisk monitorering
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, der hæmmer den aktive, renale eliminationsvej eller elimineres via denne vej, såsom cimetidin, amantadin, mexiletin, zidovudin, cisplatin, quinin og procainamid, kan være årsag til interaktioner, resulterende i nedsat clearance af pramipexol.
English: 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.
Danish: Sikkerhed og virkning af pramipexol depottabletter ved behandling af Parkinsons sygdom blev undersøgt i et multinationalt klinisk udviklingsprogram bestående af 3 randomiserede, kontrollerede studier.
English: 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.
Danish: 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.
English: As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Danish: Da pramipexol hæmmer sekretionen af prolaktin hos mennesker, forventes amningen også at blive hæmmet.
English: 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).
Danish: 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).
English: TREATMENT INITIATION PACK ONLY MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: GÆLDER KUN FOR BEHANDLINGSSTART PAKKE MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: 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.
Danish: 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.
English: Tablet
Danish: Tabletter
English: 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.
Danish: Ved kreatininclearance mindre end 30 ml/min anbefales det ikke at anvende Oprymea depottabletter, da der ikke findes data for denne patientpopulation.
English: Blister pack (Alu/Alu foil): 20, 30, 60, 90 or 100 tablets, in a box.
Danish: Blisterpakning (alu/alu folie): 20, 30, 60, 90 eller 100 tabletter i en æske.
English: Treatment initiation pack
Danish: Behandlingsstart pakke
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: If you have moderate or severe kidney disease, your doctor will prescribe a lower dose.
Danish: Hvis du har en moderat til alvorlig nyresygdom, skal du have en lavere dosis.
English: Oprymea should not be used during breast-feeding.
Danish: Oprymea må ikke anvendes under amning.
English: 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.
Danish: Ved kreatininclearance mellem 30 og 50 ml/min bør behandlingen starte med 0,26 mg Oprymea depottabletter hver anden dag.
English: sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
Danish: angst, træthed, svedtendens eller smerter kan forekomme (kaldet dopaminagonist abstinenssyndrom eller dopamine agonist withdrawal syndrome - DAWS).
English: Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Danish: Pramipexol er ikke teratogent i rotter og kaniner; men er embryotoksisk i rotter ved maternotoksiske doser (se pkt.