FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: In clinical trials approximately 5 % of patients were treated at doses below 1.1 mg of base (1.5 mg of salt).
Danish: I kliniske undersøgelser blev ca. 5 % af patienterne behandlet med doser mindre end 1,1 mg (1,5 mg salt).
English: Impulse control disorders
Danish: Manglende impulskontrol
English: Biotransformation Pramipexole is metabolised in man only to a small extent.
Danish: Biotransformation Pramipexol metaboliseres kun i ringe omfang hos mennesket.
English: Tell your doctor if you are developing an inability of keeping your body and neck straight and upright (axial dystonia).
Danish: Fortæl det til din læge, hvis du udvikler en manglende evne til at holde din krop og nakke lige og oprejst (aksial dystoni).
English: Do not take Pramipexole Teva:
Danish: Tag ikke Pramipexol Teva:
English: Infections and infestations pneumonia1
Danish: Infektioner og parasitære sygdomme pneumoni1
English: The tablet can be divided into equal halves.
Danish: Tabletten kan deles i to lige store halvdele.
English: If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day.
Danish: Hvis dette er tilfældet, vil din læge øge dosis op til et maksimum på 3,3 mg pramipexol om dagen.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Detaljeret information vedrørende dette produkt er tilgængelig på European Medicines Agency's hjemmeside http://www.ema.europa.eu/
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: Dyskinesia
Danish: Dyskinesi
English: 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.
Danish: 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.
English: • Contact your doctor or nearest hospital casualty department immediately for advice.
Danish: • Så kontakt lægen eller skadestuen med det samme.
English: 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.
Danish: Pramipexol Teva indeholder det aktive stof pramipexol og hører til en gruppe lægemidler kendt som dopaminagonister, som stimulerer dopaminreceptorer i hjernen.
English: Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Pramipexole Teva 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 Pramipexol Teva-behandling.
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: 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 Teva contains sodium
Danish: Pramipexol Teva indeholder natrium
English: 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.
Danish: 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.
English: Ophthalmologic monitoring Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Danish: Der anbefales oftalmologisk undersøgelse med regelmæssige mellemrum eller hvis der fremkommer synsabnormaliteter.
English: Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Danish: Pramipexol letter det parkinsonistiske motoriske underskud ved stimulation af dopaminreceptorer i Corpus striatum.
English: Libido disorders Pramipexole may uncommonly be associated with libido disorders (increased or decreased).
Danish: Ændring af libido Pramipexol kan forbindes med libidosygdomme (øget eller nedsat).
English: • zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system)
Danish: • Zidovudin (medicin mod aids (erhvervet immundefekt syndrom), en sygdom i immunsystemet)
English: • Severe heart or blood vessels disease.
Danish: • Alvorlige hjerte- eller karsygdomme.
English: Endocrine disorders inappropriate antidiuretic hormone secretion1
Danish: Det endokrine system uhensigtsmæssig udskillelse af antidiuretisk hormon1
English: Pramipexole doses as published in the literature refer to the salt form.
Danish: Dosering af pramipexol refererer i litteraturen til saltformen.
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 plasmaniveau.
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 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.
English: The elimination of pramipexole is dependent on renal function.
Danish: Eliminationen af pramipexol er afhængig af nyrefunktionen.
English: Patients with a creatinine clearance above 20 ml/min require no reduction in daily dose.
Danish: Patienter med en kreatininclearance over 20 ml/min behøver ingen reduktion i den daglige dosis.
English: 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).
Danish: Det kan anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Pramipexol Teva, afhængigt af den enkelte patients reaktioner (se pkt.
English: • Psychosis (e.g. comparable with symptoms of schizophrenia).
Danish: • Psykoser (f.eks. som ved symptomer på skizofreni)
English: (≥1/100 to
Danish: (≥1/100 til
English: 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.
Danish: 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.
English: (≥1/1,000 to <1/100)
Danish: (≥1/100 til <1/10)
English: (≥1/1,000 to
Danish: (≥1/1.000 til
English: If dystonia occurs, the dopaminergic medication regimen should be reviewed and an adjustment in the dose of pramipexole considered.
Danish: Hvis der opstår dystoni, bør det dopaminerge medicineringsregime gennemgås og en justering af pramipexol-dosen overvejes.
English: For both primary endpoints statistically significant differences have been observed for the pramipexole dose groups 0.25 mg, 0.5 mg and 0.75 mg pramipexole salt in comparison to placebo.
Danish: For begge primære endpoints er statistiske signifikante forskelle set for pramipexol doserne 0,25 mg, 0,5 mg og 0,75 mg (salt) sammenlignet med placebo.
English: If you have moderate or severe kidney disease, your doctor will prescribe a lower dose.
Danish: Hvis du har en nyresygdom i moderat til svær grad, vil din læge give dig en lavere dosis.
English: fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
Danish: apati, angst, træthed, svedtendens eller smerter kan forekomme (kaldet dopaminagonist abstinenssyndrom eller dopamine agonist withdrawal syndrome - DAWS).
English: After 26 weeks of treatment, there was an adjusted mean reduction in IRLS total score of 13.7 and 11.1 points in the pramipexole and placebo group, respectively, with a statistically significant (p = 0.008) mean treatment difference of -2.6.
Danish: Efter 26 ugers behandling var der en gennemsnitlig justeret reduktion i IRLS total-score på mindst 13,7 og 11,1 point i henholdsvis pramipexol- og placebogruppen med en statistisk signifikant (p = 0,008) gennemsnitlig behandlingsforskel på -2,6.
English: Your doctor will review your treatment after 3 months to decide whether or not to continue the treatment.
Danish: Efter 3 måneders behandling bør det vurderes af din læge, om du skal fortsætte med behandlingen.
English: Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with Pramipexole Teva.
Danish: Reduktion af pramipexoldosen bør overvejes i tilfælde, hvor disse lægemidler administreres samtidigt med Pramipexol Teva.
English: Pramipexole Teva 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).
Danish: Pramipexol Teva 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.
English: A.
Danish: C.
English: Number of tablets
Danish: Antal tabletter
English: Microcrystalline cellulose Sodium starch glycolate Povidone K25
Danish: Mikrokrystallinsk cellulose Natriumstivelsesglycolat Povidon K25
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, dobbeltblindt, randomiseret, placebokontrolleret fleksibelt dosis-studie.
English: • treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
Danish: • behandling af voksne patienter med symptomer på moderat til svær restless legs syndrom
English: • Paranoia (e.g. excessive fear for one's own well-being)*
Danish: • Paranoia (f.eks. overdreven frygt for sit helbred)*
English: The expected adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Danish: De forventede bivirkninger vil relateres til den farmakodynamiske profil for en dopaminagonist, herunder kvalme, opkastning, hyperkinesi, hallucinationer, agitation og hypotension.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25 °C.
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 5 symptomer i forhold til baseline) efter pludseligt behandlingsophør.
English: • Paranoia (e.g. excessive fear for one's own well-being)
Danish: • Paranoia (såsom overdreven frygt for sit helbred)
English: Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity.
Danish: Pramipexol er en dopaminagonist og bindes med høj selektivitet og specificitet til D2-undergruppen af dopaminreceptorer og har primært affinitet til D3-receptorer.
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 hos albinorotter, at doser på 2 mg/kg (salt) pramipexol og derover blev sat i forbindelse med retinal degeneration.
English: • Pramipexole Teva tablets are available in blister packs of 30, 30 x 1, 50 x 1, 100 x 1 and 100 tablets and bottles containing 90 tablets.
Danish: • Pramipexol Teva-tabletter er tilgængelige i blisterkort a 30, 30 x 1, 50 x 1, 100 x 1 og 100 tabletter og glas indeholdende 90 tabletter.
English: 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).
Danish: Du kan især opleve, at dit hoved og din nakke falder fremad (denne tilstand kaldes antecollis), at din lænd bøjer fremad (denne tilstand kaldes camptocormia), eller at din ryg falder til siden (denne tilstand kaldes pleurothotonus eller Pisa-syndrom).
English: Rare: • Mania (agitation, feeling elated or over-excited)
Danish: Sjælden: - Mani (føle sig oprørt, opstemt eller ophidset)
English: As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Danish: Da behandling med pramipexol hæmmer sekretionen af prolaktin hos mennesker, forventes derfor også hæmning af amningen.
English: However, the potential influence of hepatic insufficiency on Pramipexole Teva pharmacokinetics has not been investigated.
Danish: Den potentielle indflydelse af nedsat leverfunktion på Pramipexol Tevas farmakokinetik kendes ikke.
English: Neuropharmacological evidence suggests primary dopaminergic system involvement.
Danish: Neurofarmakologisk evidens foreslår primært involvering af det dopaminerge system.
English: 1st week
Danish: 1. uge
English: Patients with psychotic disorders
Danish: Patienter med psykotiske lidelser
English: • Delirium (decreased awareness, confusion, loss of reality)
Danish: - Delirium (nedsat bevidsthed, forvirring, manglende realitetsopfattelse)
English: • Sleeplessness (insomnia)
Danish: • Søvnløshed (insomni)
English: • Delirium (decreased awareness, confusion, loss of reality)*
Danish: • Delirium (nedsat bevidsthed, forvirring, manglende realitetsopfattelse)*
English: In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Danish: I et karcinogenstudie udviklede hanrotter Leydig-cellehyperplasi og adenomer pga. pramipexols prolaktinhæmmende virkning.
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 placebokontrolleret polysomnografi-studie over 3 uger reducerede pramipexol signifikant antallet af periodiske benbevægelser, mens forsøgspersonerne var sengeliggende.
English: In animal studies, pramipexole affected oestrous cycles and reduced female fertility as expected for a dopamine agonist.
Danish: I dyrestudier påvirkede pramipexol brunstperioder og nedsatte fertiliteten hos hunner som forventet for en dopaminagonist.
English: Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Danish: Pramipexol var ikke teratogent hos rotter og kaniner, men var embryotoksisk hos rotter ved maternotoksiske doser.
English: This effect was found to be similar across all doses.
Danish: Denne indvirkning blev fundet at være uafhængig af dosis.
English: Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including pramipexole.
Danish: Ikke-motoriske bivirkninger kan forekomme, når dopaminagonister, inklusive pramipexol, nedtrappes eller seponeres.
English: The effect of Pramipexole Teva on the unborn child is not known.
Danish: Det er ukendt, hvilken virkning Pramipexol Teva kan have på det ufødte barn.
English: MARKETING AUTHORISATION HOLDER Teva B.V.
Danish: Indehaver af markedsføringstilladelsen Teva B.V.
English: 30 tablets 50 x 1 tablets 100 tablets 30 x 1 tablets 100 x 1 tablets
Danish: 30 tabletter 50 x 1 tablet 100 tabletter 30 x 1 tablet 100 x 1 tablet
English: Pack sizes: 90 tablets.
Danish: Pakningsstørrelser: 90 tabletter.
English: • Weight loss including decreased appetite
Danish: • Vægttab samt nedsat appetit
English: INSTRUCTIONS ON USE Not applicable
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: Axial dystonia including antecollis, camptocormia and pleurothotonus (Pisa Syndrome) has occasionally been reported in patients with Parkinson's disease following initiation or incremental dose increase of pramipexole.
Danish: Der er en gang imellem rapporteret om aksial dystoni, herunder antecollis, camptocormia og pleurothotonus (Pisa-syndrom) hos patienter med Parkinsons sygdom efter påbegyndelse af behandling med eller efter gradvis dosisøgning af pramipexol.
English: However, your dose may have to be increased even further.
Danish: Muligvis har du brug for en højere dosis.
English: Pramipexole Teva 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: Pramipexol Teva 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: • amantadine (which can be used to treat Parkinson's disease)
Danish: • Amantadin (medicin mod Parkinsons sygdom)
English: • Mania (agitation, feeling elated or over-excited)*
Danish: • Mani (føle sig oprørt, opstemt eller ophidset)*
English: Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease.
Danish: Pramipexol er blevet forbundet med somnolens og episoder med pludseligt opståede søvnanfald, især hos patienter med Parkinsons sygdom.
English: • cimetidine (to treat excess stomach acid and stomach ulcers)
Danish: • Cimetidin (medicin mod meget mavesyre og mavesår)
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)/dag efter den første uges behandling.
English: For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days to a maximum of 0.54 mg of base (0.75 mg of salt) per day (as shown in the table below).
Danish: For patienter som behøver yderligere symptomatisk lindring, kan dosis øges hver 4.-7. dag til et maksimum på 0,54 mg base (0,75 mg salt) dagligt, som vist i tabellen nedenfor.
English: Patients being treated with Pramipexole Teva 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).
Danish: Patienter som bliver behandlet med Pramipexol Teva og som har oplevet somnolens og/eller pludselige søvnepisoder, bør informeres om at afstå fra at køre bil eller deltage i aktiviteter, hvor nedsat årvågenhed kan udsætte dem selv eller andre for alvorlig fare eller død (f.eks. betjening af maskiner), indtil sådanne tilbagevendende episoder og somnolens er ophørt (se også pkt.
English: Pramipexole is bound to plasma proteins to a very low (< 20 %) extent, and little biotransformation is seen in man.
Danish: Pramipexol er kun i ringe udstrækning bundet til plasmaproteiner (<20 %), og der er kun set beskeden biotransformation hos mennesker.
English: Initial treatment
Danish: Initial dosis
English: Pramipexole Teva can have a major influence on the ability to drive and use machines.
Danish: Pramipexol Teva kan påvirke evnen til at føre motorkøretøj og betjene maskiner i væsentlig grad.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with pramipexole in one or more subsets of the paediatric population in Restless Legs Syndrome (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med pramipexol i en eller flere undergrupper af den pædiatriske population med restless legs syndrom (se pkt.
English: 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 Pramipexole Teva.
Danish: 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 Pramipexol Teva.
English: Pramipexole Teva is used to:
Danish: Pramipexol Teva anvendes til:
English: A lower maintenance dose of three Pramipexole Teva 0.088 mg tablets a day is also possible.
Danish: En lavere vedligeholdelsesdosis på tre Pramipexol Teva 0,088 mg tabletter dagligt er også mulig.
English: Most hallucinations are visual.
Danish: De fleste hallucinationer er syns-hallucinationer
English: • Allergic reactions (e.g. rash, itching, hypersensitivity)
Danish: • Allergiske reaktioner (f.eks. udslæt, kløe, overfølsomhed)
English: In case of severe cardiovascular disease, care should be taken.
Danish: Forsigtighed tilrådes i tilfælde af alvorlig kardiovaskulær sygdom.
English: Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Danish: Fortæl det til din læge, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande:
English: Pramipexole is commonly associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (see also section 4.4).
Danish: Pramipexol er forbundet med somnolens og er i usædvanlige tilfælde blevet forbundet med overdreven somnolens i dagtimerne og pludseligt opståede søvnepisoder (se også pkt.
English: Total daily dose (mg)
Danish: Total daglig dosis (mg)