natgillin/translations-raw huggingface dataset:
Inhibitorer/kompetitiv hæmmere af den renale eliminationsvej Cimetidin reducerer den renale clearance af pramipexol med ca. 34%, antagelig ved en 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.
Det samlede AUC blev ikke påvirket ved samtidig fødeindtagelse.
Total exposure (AUC) was not affected by concomitant food intake.
Virkningen blev bevaret hos 87 ud af 103 patienter, som skiftede til pramipexol depottabletter.
Efficacy was maintained in 87 of 103 patients switched to pramipexole prolonged-release tablets.
Der er ingen pharmakokinetisk interaktion med selegelin og levodopa.
There is no pharmacokinetic interaction with selegiline and levodopa.
Tag dine almindelige Oprymea tabletter som normalt dagen før, du skifter.
Take your Oprymea (immediate release) tablets as normal the day before you switch.
Således kan symptomerne optræde tidligere på aftenen (eller tilmed om eftermiddagen), og symptomerne kan forværres og kan involvere andre ekstremiteter.
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.
3 ugers behandlingsstart pakke
3-week treatment initiation pack
En reduktion af dosis eller ophør med behandling kan overvejes.
Furthermore a reduction of dose or termination of therapy may be considered.
- Lægen har ordineret dette lægemiddel dig personligt.
- This medicine has been prescribed for you only.
Patienter, som har oplevet døsighed, somnolens og/eller en episode med pludseligt opstået søvn, må ikke køre bil eller betjene maskiner.
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Det er ukendt, hvilken virkning Oprymea kan have på det ufødte barn.
The effect of Oprymea on the unborn child is not known.
Oprymea kan tages alene eller i kombination med levodopa (medicin til behandling af Parkinsons sygdom).
It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
Hvis du har restless legs syndrom, kan du muligvis få følgende bivirkninger:
If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Denne forsinkelse af motoriske komplikationer med pramipexol skal opvejes imod en større bedring af den motoriske 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).
Oprymea indeholder - Det aktive stof er pramipexol.
What Oprymea contains - The active substance is pramipexole.
Samtidig indtagelse af mad påvirker generelt ikke biotilgængeligheden af pramipexol.
Concomitant administration with food does generally not affect the bioavailability of pramipexole.
Forsinket kønsudvikling 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.
Hos rotter var koncentrationen af lægemidlet højere i modermælken end i plasma.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
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 packaging after EXP.
Malignt neuroleptika syndrom
Neuroleptic malignant syndrome
Brugen af pramipexol har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion.
The use of pramipexole has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Steady-state koncentration opnås senest 5 dage efter kontinuerlig dosering.
Steady state of exposure is reached at the latest after 5 days of continuous dosing.
Ved tidlig og fremskreden Parkinsons sygdom blev virkningen 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.
Oprymea 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.
Oprymea 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).
AUC bliver ikke påvirket af kropsvægten, men det gør fordelingsvolumen og dermed Cmax.
While body weight has no impact on the AUC, it was found to influence the volume of distribution and therefore the peak concentrations Cmax.
I de fase-III forsøg, hvor sikkerhed og virkning af pramipexol depottabletter blev undersøgt, blev patienterne instrueret i at tage studiemedicinen uden hensyntagen til fødeindtagelse.
In the Phase III studies that established safety and efficacy of pramipexole prolonged-release tablets, patients were instructed to take study medication without regard to food intake.
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.
Ca. 90% af en 14C-mærket dosis udskilles via nyrerne og mindre end 2% via fæces.
Approximately 90% of C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Hvis behandlingen afbrydes i flere dage, skal den initieres påny 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.
Sjælden: - Mani (føle sig oprørt, opstemt eller ophidset)
Rare: - Mania (agitation, feeling elated or over-excited)
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.
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.
Dele af tabletterne kan lejlighedsvis passere gennem systemet og udskilles i afføringen, hvor de kan ligne hele tabletter.
Parts of tablets may occasionally be passed and seen in the stool (faeces) and may look like whole tablets.
2 af studierne blev udført hos patienter med tidlig Parkinsons sygdom, og det 3. studie blev udført hos patienter med fremskreden Parkinsons sygdom.
Two trials were conducted in patients with early Parkinson's disease and one trial was conducted in patients with advanced Parkinson's disease.
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.
Tag Oprymea depottabletter den næste morgen, og tag så ikke flere almindelige Oprymea tabletter.
Then take your Oprymea prolonged-release tablets next morning and do not take any more Oprymea (immediate release) tablets.
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%).
Hvis du holder op med at tage Oprymea
If you stop taking Oprymea
Den potentielle indflydelse af nedsat leverfunktion på Oprymeas farmakokinetik kendes ikke.
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
Der er ingen kendt antidot ved overdosering af dopaminagonister.
There is no established antidote for overdose of a dopamine agonist.
Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
<2D barcode carrying the unique identifier included.>
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.
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.
Pludseligt ophør med dopamin-behandling kan føre til udvikling af malignt neuroleptikasyndrom.
Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
Blister (Aluminium/Aluminium)
BLISTER/(Alu/Alu)
20 tabletter 30 tabletter 60 tabletter 90 tabletter 100 tabletter
20 tablets 30 tablets 60 tablets 90 tablets 100 tablets
YDRE ÆSKE (behandlingsstart pakke indeholdende 3 pakninger med 7 depottabletter)
OUTER BOX (treatment initiation pack containing 3 boxes of 7 prolonged-release tablets)
Dyrestudier har vist, at pramipexol hæmmer dopaminsyntese,frigørelse og -omsætning.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
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
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).
Den daglige dosis kan fordeles på 2 daglige doser, hvis kreatininclearance er mellem 20 og 50 ml/minog gives om en enkeltdosis, hvis kreatininclearance er under 20 ml/min.
The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/min, and as a single daily dose if creatinine clearance is less than 20 ml/min.
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).
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).
Pga. mangel på humane data må Oprymea ikke anvendes under amning.
In the absence of human data, Oprymea should not be used during breast-feeding.
Det bør overvejes at nedsætte pramipexoldosis i tilfælde, hvor disse lægemidler administreres samtidigt med Oprymea.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with Oprymea.
Pramipexol var ikke teratogen i rotter og kaniner, men var embryotoksisk i rotter ved maternotoksiske doser.
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Virkningen på graviditet og amning hos mennesker er ikke kendt.
The effect on pregnancy and lactation has not been investigated in humans.
Der anbefales oftalmologisk undersøgelse med regelmæssige mellemrum eller hvis der opstår synsabnormaliteter.
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Det endokrine system uhensigtsmæssig udskillelse af antidiuretisk hormon
Endocrine disorders inappropriate antidiuretic hormone secretion
Det kan anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Oprymea, 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 Oprymea, depending on reactions in individual patients (see section 4.5).
Hvis du har glemt at tage Oprymea
If you forget to take Oprymea
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.
I den første uge er den sædvanlige daglige dosis 0,26 mg pramipexol.
During the first week, the usual daily dose is 0.26 mg pramipexole.
Oprymea depottabletter er specialfremstillede tabletter, hvor det aktive stof langsomt frigives efter indtagelse af tabletten.
Oprymea prolonged-release tablet is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested.
Du må ikke tygge, dele eller knuse depottabletten.
Do not chew, divide or crush the prolonged-release tablets.
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.
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.
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.
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.
Pramipexol depottabletter var non-inferior i forhold til pramipexoltabletter vurderet ud fra UPDRS del II+III score ved uge 33.
Pramipexole prolonged-release tablets were non-inferior to pramipexole immediate release tablets as assessed on the UPDRS Parts II+III score at week 33.
Oprymea bruges til:
What Oprymea is and what it is used for
Symptomer:
Symptoms
Oprymea depottabletter er én-gang-daglig oral formulering af pramipexol.
Oprymea prolonged-release tablets are a once-a-day oral formulation of pramipexole.
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 udviser lineær kinetik og kun en lille interpatient variation i plasmaniveauet.
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
I et karcinogenitets-studie udviklede hanrotter Leydig-cellehyperplasi og adenomer, pga. pramipexols prolaktinhæmmende virkning.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Tabletten kan deles i to lige store dele.
The tablet can be divided into equal doses.
Hvis du har en alvorlig nyresygdom, skal du muligvis behandles med en anden type pramipexolmedicin.
If you have serious kidney problems, your doctor may need to switch you to a different pramipexole medicine.
Samme studie viste tillige, i albinorotter, der fik doser på 2 mg/kg (salt) pramipexol og derover, en sammenhæng med retinal degeneration.
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.
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.
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.
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.
Nogle patienter har rapporteret om rester i afføringen, der kan ligne intakte Oprymea depottabletter.
Some patients have reported the occurrence of remnants in faeces which may resemble intact Oprymea prolonged-release tablets.
Virkning blev set ved 0,088 mg base (0,125 mg salt) pr. dag efter den første uges behandling.
Efficacy was observed with 0.088 mg of base (0.125 mg of salt) per day after the first week of treatment.
Hos mennesket er proteinbindingen af pramipexol meget lav (< 20%) og fordelingsvolumet stort (400 l).
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Ikke almindelig (≥1/1.000 til
Uncommon (≥1/1,000 to
Oprymea kan nedsætte mælkeproduktionen og kan også overføres til din baby via brystmælk.
Oprymea can reduce the production of breast milk.
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.
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).
Kun en patient, som skiftede til pramipexol depottabletter, fik en lægemiddelrelateret bivirkning, der medførte seponering.
Only one patient switched to pramipexole prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
- Øvrige indholdsstoffer: Mannitol, majsstivelse, pregelatineret majsstivelse, povidon K25, kolloid vandfri silica og magnesiumstearat.
- The other ingredients are mannitol, maize starch, pregelatinised maize starch, povidone K25, colloidal anhydrous silica and magnesium stearate.
Rester i afføringen
Remnants in stool
Disse punkter skal overvejes ved initiering af pramipexol behandling hos patienter med Parkinsons sygdom.
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
Oprymea kan påvirke evnen til at føre motorkøretøj og betjene maskiner i væsentlig grad.
Oprymea can have a major influence on the ability to drive and use machines.
I dyrestudier påvirkede pramipexol brunstperioden og nedsatte fertiliteten hos hunner som forventet for en dopaminagonist.
In animal studies, pramipexole affected oestrous cycles and reduced female fertility as expected for a dopamine agonist.
Bivirkningerne kan forekomme med en given hyppighed, som defineres på følgende måde:
Evaluation of these side effects is based on the following frequencies:
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.
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.
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.
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.
Den maksimale plasmakoncentration opnås ca. 6 timer efter administration af pramipexol depottabetter givet en gang daglig.
The maximum plasma concentrations occur at about 6 hours after administration of pramipexole prolonged-release tablets once daily.
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.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Oprymea treatment.
Det skal du vide, før du begynder at tage Oprymea
What you need to know before you take Oprymea
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.
Oprymea with food, drink and alcohol You should be cautious while drinking alcohol during treatment with Oprymea.
I et placebo-kontrolleret polysomnografi-studie over 3 uger reducerede pramipexol signifikant antallet af periodiske benbevægelser, mens forsøgspersonerne var sengeliggende.
In a placebo-controlled polysomnography study over 3 weeks pramipexole significantly reduced the number of periodic limb movements during time in bed.
Blisterpakke (OPA/Alu/tørremiddel/PE-Alu folie): 21 depottabletter (3 blisterark med 7 tabletter): - 7 depottabletter indeholdende 0,26 mg
Blister (OPA/Alu/desiccant/PE-Alu foil): 21 prolonged-release tablets (3 blisters of 7 tablets): - 7 prolonged-release tablets of 0.26 mg
Patienter, der i forvejen tager Oprymea tabletter, kan fra dag til dag skifte til den samme daglige dosis af Oprymea depottabletter.
Patients already taking Oprymea tablets may be switched to Oprymea prolonged-release tablets overnight, at the same daily dose.
Patienterne bør informeres om dette, og rådes til forsigtighed ved bilkørsel og betjening af maskiner.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
I disse tilfælde bør levodopa-dosis reduceres.
If they occur, the dose of levodopa should be decreased.
- Søvnighed og episoder med pludseligt indsættende søvn - Psykoser (f.eks. som ved symptomer på skizofreni) - Synsnedsættelse.
- Sleepiness and episodes of suddenly falling asleep - Psychosis (e.g. comparable with symptoms of schizophrenia) - Vision impairment.
Oftalmologisk monitorering
Ophthalmologic monitoring
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.
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.